Agricultural Marketing Service
Forest Service
Rural Business-Cooperative Service
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
Indian Health Service
National Institutes of Health
Coast Guard
National Park Service
Surface Mining Reclamation and Enforcement Office
Federal Aviation Administration
National Highway Traffic Safety Administration
Surface Transportation Board
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Nuclear Regulatory Commission.
Direct final rule; confirmation of effective date.
The U.S. Nuclear Regulatory Commission (NRC) is confirming the effective date of September 8, 2015, for the direct final rule that was published in the
Please refer to Docket ID NRC–2015–0067 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Solomon Sahle, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415–3781; email:
On June 23, 2015 (80 FR 35829), the NRC published a direct final rule amending its regulations in § 72.214 of Title 10 of the
In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on September 8, 2015. The NRC received 10 comment submittals on the companion proposed rule (80 FR 35872). Electronic copies of these comments can be obtained from the Federal Rulemaking Web site,
The NRC received 10 comment submittals on the proposed rule, many raising multiple and overlapping issues. As explained in the June 23, 2015, direct final rule (80 FR 35829), the NRC would withdraw the direct final rule only if it received a “significant adverse comment.” This is a comment where the
(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:
(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;
(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or
(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.
(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.
(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or Technical Specifications (TSs).
The NRC determined that none of the comments submitted on this direct final rule met any of these criteria. The comments either were already addressed by the NRC staff's safety evaluation report (SER) (ADAMS Accession No. ML15070A149), or were beyond the scope of this rulemaking. The NRC has not made any changes to the direct final rule as a result of the public comments. However, the NRC is taking this opportunity to respond to some of the comments in an effort to clarify information about the 10 CFR part 72 CoC rulemaking process.
For rulemakings amending or revising a CoC, the scope of the rulemaking is limited to the specific changes requested by the applicant in the request for the amendment or amendment revision. Therefore, comments about the system or spent fuel storage in general that are not applicable to the changes requested by the applicant are outside the scope of this rulemaking. Comments about details of the particular system that is the subject of the rulemaking, but that are not being addressed by the specific changes requested, have already been resolved in prior rulemakings. Persons who have questions or concerns about prior rulemakings and the resulting final rules may consider the NRC's process for petitions for rulemaking under 10 CFR 2.802. Additionally, safety concerns about any NRC-regulated activity may be reported to the NRC in accordance with the guidance posted on the NRC's Web site at
The NRC identified the following issues raised in the comments, and the NRC's responses to these issues follow.
Several commenters raised concerns regarding the ability of this CoC system to withstand seismic events, particularly if the system were to be used at specific sites with known seismic activity, such as San Onofre Nuclear Generating Station (SONGS). These commenters stated that Holtec casks have not been tested for newly discovered potential Supersonic Shear Earthquakes, which might result in a rupture after Supersonic Shear Earthquake Events. According to the comments, cask venting can be blocked after a tsunami leading to cask failure.
These comments are outside the scope of this rulemaking because they are not specific to the amendment at issue in the rule, but instead raise concerns with the general 10 CFR part 72 requirements and process for certification of the CoC systems. This rule adds Amendment No. 1 to the HI–STORM UMAX Canister Storage System, CoC No. 1040. Applicants submitting CoC's for approval are required to document a design bases for their CoC or amendment CoC, which includes seismic parameters. Under 10 CFR 72.212(b)(6), general licensees (power reactors seeking to use those CoC systems at their specific sites) are required to conduct a review of the CoC's Final Safety Analysis Report (FSAR) and the related NRC SER prior to use of the general license to ensure that the reactor site parameters, including analyses of earthquake intensity, are enveloped by the cask design bases considered in these reports. This rulemaking makes no determination regarding the acceptability of this amended system for use at any specific site. Nor does this rule seek to change the existing generic nature of CoC approvals or the technical qualifications outlined for CoC approval, as currently envisioned in 10 CFR part 72. Commenters with concerns regarding the existing 10 CFR part 72 regulations for technical review and approval of CoC systems could consider filing a petition for rulemaking under 10 CFR 2.802.
Commenters stated that according to NUREG–2174 “Impact of Variation in Environmental Conditions on the Thermal Performance of Dry Storage Casks” (ADAMS Accession No. ML15054A207), low-speed wind conditions increased the peak cladding temperature on underground systems, and asked whether this was considered in the development of the heat load limits of the HI–STORM UMAX Canister Storage System.
The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule. The NRC evaluated and approved the HI–STORM UMAX Canister Storage System heat loads in the initial CoC certification, and this is provided in its SER (ADAMS Accession No. ML15093A510). The Amendment No. 1 application requested no thermal changes that required NRC evaluation.
A commenter stated that the thin stainless steel MPC canisters are subject to pitting and corrosion (particularly from marine environments like chloride-induced stress corrosion cracking). According to the comment, since cracks may initiate during the initial licensing period in these canisters, cracking canisters should be included in the seismic analysis for MPC's stored while in the HI–STORM UMAX Canister Storage System since it would be of more concern in high risk seismic areas as proposed for this UMAX Amendment.
The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule. The NRC has evaluated the design of the HI–STORM UMAX Canister Storage System and has determined that the design is robust, and contains a number of layers of acceptable confinement systems in compliance with 10 CFR part 72 requirements. Furthermore, the NRC has evaluated the susceptibility to and effects of stress corrosion cracking and other corrosion mechanisms on safety significant systems for spent nuclear fuel (SNF) dry cask storage (DCS) systems during an initial certification period. The NRC staff has determined that the HI–STORM UMAX Canister Storage System, when used within the requirements of the proposed CoC, will safely store SNF and prevent radiation releases and exposure consistent with
Commenters ask if the transfer casks were approved for storage of an MPC in case of a failed MPC.
To the extent that this comment raises a concern with the availability of a transfer cask, it raises an issue that was addressed in the NRC's evaluation of this amendment and fails to cite any specific information that would alter the NRC's conclusions. In this case, the transfer cask utilized in the HI–STORM UMAX Canister Storage System is described in the HI–STORM Flood/Wind (F/W) Multipurpose Canister (MPC) Storage System FSAR (ADAMS Accession No. ML15177A336). The HI–STORM UMAX transfer cask is authorized to transfer intact MPC's in accordance with the CoC No. 1040 TSs.
A commenter asked if there is a plan to remediate a failed canister.
The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises a concern with the general 10 CFR part 72 requirement and process for certification of the CoC systems. Implementing corrective actions in the event of a failed MPC is the responsibility of the general licensee and those corrective actions are not incorporated into CoC No. 1040.
Commenters questioned the maximum MPC thickness allowed in this amendment, noting that although the FSAR indicated 0.5″ as the maximum thickness, Holtec has proposed using a thickness of 0.625 at San Onofre (SONGS). The commenters raised concerns regarding the implications of such a change outside of a license amendment where it could be properly evaluated to determine if the change in limiting parameters will affect seismic, thermal, weight, dimensions and other critical analyses.
The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of the CoC systems. The nominal MPC thickness for the canisters certified under CoC No. 1040, Amendment No. 1 is 0.5″. The NRC has no knowledge of a Holtec proposal to increase the thickness of an MPC to 0.625″. If presented with an amendment request to do so, the NRC will evaluate it in accordance with 10 CFR part 72 requirements.
Commenters requested the NRC require a definition of “long-term” in the FSAR.
The comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises general concerns regarding terminology. The definitions required by the NRC to support the evaluation and approval of CoC No. 1040, Amendment No. 1, are provided in Appendix A of the CoC, Technical Specifications for the HI–STORM UMAX Canister Storage System. “Long-term” is a general descriptive term that is not required to support any regulatory or technical evaluation, and thus is not required to be more formally defined.
Commenters requested the NRC define the term “underground” as used in this system. The comments raised concerns that a structure that is only partially underground, but covered on the side with an “earthen berm,” could still be considered “underground” for compliance with this CoC.
The comments regarding the need to define the term “underground” as used in the HI–STORM UMAX Canister Storage System are outside the scope of this rulemaking because they are not specific to the amendment at issue in the rule, but instead raise concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. In this instance, Holtec has provided and analyzed specific structure placement parameters, and the NRC has evaluated these parameters that bound the placement of such a system in the ground. Pursuant to the regulatory requirements in 10 CFR 72.212(b), any general licensee that seeks to use this system must determine that the design and construction of the system, structures, and components are bounded by the conditions of the CoC by analyzing the generic parameters provided and analyzed in the FSAR and SER to ensure that its site specific parameters are enveloped by the cask design bases established in these reports. The NRC is aware of the SONGS proposed configuration submitted to the California Coastal Commission and is closely monitoring this issue. The NRC will continue to ensure that the facility constructed at SONGS meets the requirements of the CoC and TS of the specific DCS system selected by Southern California Edison.
One commenter stated that the FSAR indicates that changes to storage cell kW heat loads were made and requested that the NRC determine if this was evaluated in the amendment request. The comment also requested clarification on the placement configuration of SNF assemblies in the MPC, as well as the rationale for the heat load configuration.
This comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. The comment is addressing revision bars that are incorporated into the HI–STORM UMAX Canister Storage System FSAR, Revision 2 (ADAMS Accession No. ML14202A031). The tables referenced in the comment were revised due to changes made during the original HI–STORM UMAX Canister Storage System evaluation; 10 CFR 72.248(a)(1) requires that an updated FSAR reflecting any changes made during the NRC review process be submitted within 90 days after an approval of the cask design. The loading patterns were evaluated and approved by the NRC staff in its initial SER (ADAMS Accession No. ML15093A510). The Amendment No. 1 application required no further changes to these tables requiring NRC evaluation.
A commenter requested that the NRC clarify that the MPC leak test inspection, that is used to verify the integrity of the confinement boundary, is performed before the MPC is loaded with fuel.
This comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. The HI–
Some commenters raised an issue with Holtec's claim that there is no credible mechanism for gross fuel cladding degradation of fuel classified as undamaged during storage in the HI–STORM UMAX Canister Storage System.
These comments are outside the scope of this rulemaking because they are not specific to the amendment at issue in the rule. Instead, these comments raise issues that would be addressed during any renewal application review. The NRC has determined that fuel cladding degradation is not an issue during the initial 20-year certification period, but instead, is an issue that would have to be addressed if a CoC holder requested renewal of the CoC for a period beyond the initial 20 years. If a renewal application is filed, NRC regulations require that the application include programs to manage the effects of aging, including necessary monitoring and inspection programs. Those programs would have to be reviewed and determined acceptable by the NRC before any CoC renewal is approved.
Commenters questioned Holtec's claims of a design life of 60 years, a service life of 100 years and a licensed life of 40 years. Since no substantiation was provided for these claims, the commenters requested the claims be removed from the FSAR.
This issue is outside of the scope of this rulemaking because the term of a certificate is determined in the original certification, not in amendments to that certification. This rulemaking seeks to add Amendment No. 1 to CoC No. 1040. In this case, the UMAX CoC was approved on March 6, 2015 (80 FR 12073), for an initial 20-year term. This 20-year term will also apply to Amendment No. 1. Use of this system beyond the expiration date of 20 years would require an evaluation of a renewal application for this CoC which would be addressed in a subsequent rulemaking process.
Some commenters questioned whether the HI–STORM UMAX Canister Storage System design provided a safe and accessible method to perform inspections within the license period given that high seismic risk areas are more likely to cause cracking or other structural changes, and indicated that such an evaluation should be part of the NRC's review process.
This comment is outside the scope of this rulemaking because it is not specific to the amendment at issue in the rule, but instead raises concerns with the general 10 CFR part 72 requirements and process for certification of CoC systems. The NRC has determined that concrete degradation is not an issue requiring inspection during the initial 20-year certification period, but instead, is an issue that would have to be addressed if a CoC holder requested renewal of the CoC for a period beyond the initial 20 years. If a renewal application is filed, NRC regulations require that the application include programs to manage the effects of aging, including necessary monitoring and inspection programs. Those programs would have to be reviewed and determined acceptable by the NRC before any CoC renewal is approved.
Commenters also raised questions regarding the long-term acceptability of the extended storage of high burnup fuel (HBF).
To the extent these comments raise issues about the storage of HBF in the CoC for the first 20 years, these comments are outside the scope of this rulemaking. The NRC has evaluated the acceptability of storage of HBF for the initial 20-year certification term for the HI–STORM UMAX Canister Storage System during its review of the initial certificate. As documented in the NRC staff's SER under Docket ID NRC–2014–0120, the NRC staff has determined that the use of the HI–STORM UMAX Canister Storage System, including storage of HBF, will be conducted in compliance with the applicable regulations of 10 CFR part 72, and the CoC should be approved for the initial 20-year term. This amendment does not impact the analysis conducted by the NRC staff during the initial certification of this system.
Additionally, to the extent these comments raise concerns regarding the storage of HBF beyond the initial term of 20 years, the comments are also outside the scope of this rulemaking. A request to store HBF beyond the initial 20 years provided in the certification of this system will require the applicant to submit a license renewal application with the inclusion of Aging Management Programs addressing HBF. In that regard, a demonstration project is being planned by the U.S. Department of Energy to provide confirmatory data on the performance of HBF in DCS. The NRC plans to evaluate the data obtained from the project to confirm the accuracy of current models that are relied upon for authorizing the storage of HBF for extended storage periods beyond the initial 20-year certification term.
The NRC staff has concluded that the comments received on the companion proposed rule for the Holtec HI–STORM UMAX Canister Storage System, CoC No. 1040, Amendment No. 1, are not significant adverse comments as defined in NUREG/BR–0053, Revision 6, “United States Nuclear Regulatory Commission Regulations Handbook.” Therefore, this rule will become effective as scheduled.
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the
This rule is effective September 8, 2015. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 8, 2015.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590–0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS–420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954–4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260–3, 8260–4, 8260–5, 8260–15A, and 8260–15B when required by an entry on 8260–15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722.
RESCINDED: On July 31, 2015 (80 FR 45604), the FAA published an Amendment in Docket No. 31026, Amdt No. 3651, to Part 97 of the Federal Aviation Regulations under section 97.29. The following entry for Las Vegas, NV, effective August 20, 2015 is hereby rescinded in its entirety:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective September 8, 2015. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 8, 2015.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops–M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC, 20590–0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS–420) Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone: (405) 954–4164.
This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P–NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air Traffic Control, Airports, Incorporation by reference, Navigation (Air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective September 8, 2015. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 8, 2015.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC 20590–0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS–420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125), Telephone: (405) 954–4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260–3, 8260–4, 8260–5, 8260–15A, and 8260–15B when required by an entry on 8260–15A.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective September 1, 2015. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 1, 2015.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC, 20590–0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Navigation Products, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Richard A. Dunham III, Flight Procedure Standards Branch (AFS–420), Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone: (405) 954–4164.
This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P–NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034;
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Department of State.
Interim final rule with request for comment.
The Department of State amends the Schedule of Fees for Consular Services (Schedule) for certain passport fees and citizenship services fees. More specifically, the rule amends the passport book application services fee and passport book security surcharge. The Department is adjusting these fees in light of the findings of the most recent annual update to the Cost of Service Model to ensure that the fees for consular services better align with the costs of providing those services. The passport fee changes will not alter the total fee paid by passport customers. The rule also renames the “Administrative Processing of Formal Renunciation of U.S. Citizenship” fee, as the “Administrative Processing of Request for Certificate of Loss of Nationality” fee, applying the fee to any request for a Certificate of Loss of Nationality whether the individual has relinquished nationality by taking an oath of renunciation or by voluntarily and intentionally performing another potentially expatriating act specified by statute.
Section 22.1, Items 2.(a), 2.(b), and 2.(g) of this rule become effective September 23, 2015. Section 22.1, Item 8 becomes effective November 9, 2015. Written comments must be received on or before November 9, 2015.
Interested parties may submit comments to the Department by any of the following methods:
• Visit the Regulations.gov Web site at:
• Mail (paper, disk, or CD–ROM): U.S. Department of State, Office of the Comptroller, Bureau of Consular Affairs (CA/C), SA–17 8th Floor, Washington, DC 20522–1707.
• Email:
• All comments should include the commenter's name, the organization the commenter represents, if applicable, and the commenter's address. If the Department is unable to read your comment for any reason, and cannot contact you for clarification, the Department may not be able to consider
Jill Warning, Special Assistant, Office of the Comptroller, Bureau of Consular Affairs, Department of State; phone: 202–485–6681, telefax: 202–485–6826; email:
The rule makes changes to the Schedule of Fees for Consular Services of the Department of State's Bureau of Consular Affairs. The Department sets and collects its fees based on the concept of full cost recovery. The Department completed its most recent review of current consular fees and will implement several changes to the Schedule of Fees based on the costs of services calculated by the Fiscal Year 2013 update to the Cost of Service Model.
The Department of State derives the general authority to set fees based on the cost of the consular services it provides, and to charge those fees, from the general user charges statute, 31 U.S.C. 9701.
Several statutes address specific fees relating to passports. For instance, 22 U.S.C. 214 authorizes the Secretary of State to set the passport application fee by regulation. In addition, another statute authorizes the Department to collect and retain a surcharge on passports to help pay for efforts to enhance border security. See 8 U.S.C. 1714. Although this passport surcharge was originally frozen statutorily at $12, subsequent legislation authorized the Department to amend this surcharge administratively, provided, among other things, that the resulting surcharge is “reasonably related to the costs of providing services in connection with the activity or item for which the surcharges are charged.” Public Law 109–472, 6, 120 Stat. 3554, reproduced at 8 U.S.C. 1714 (note).
Certain people are exempted by law or regulation from paying specific fees. These are noted in the Schedule of Fees. They include, for instance, exemptions from the passport execution and application fees for officers or employees of the United States government proceeding abroad in the discharge of official duties.
Although the funds collected for many consular fees must be deposited into the general fund of the Treasury pursuant to 31 U.S.C. 3302(b), various statutes permit the Department to retain some or all of the fee revenue it collects. For example, the Department retains the immigrant visa and passport security surcharges,
The Department last changed fees for passport services in an interim final rule dated June 28, 2010.
Some fees in the Schedule, including Items 20(a) and (b), 31(a) and (b) and 35(c), are set by the Department of Homeland Security (DHS). These DHS fees were most recently updated by that agency on November 23, 2010, and are subject to change in the future.
Consistent with OMB Circular A–25 guidelines, the Department recently completed a fee review using its Cost of Service Model. This review was conducted from September 2013 through May 2014 and provides the basis for updating the Schedule. The results of that review are outlined in this rule.
Similar to the 2012 fee review, upon which the current Schedule is based, costs are generated by an activity-based costing model that takes into account all costs to the U.S. government. Unlike a typical accounting system, which accounts for only traditional general-ledger-type costs such as salaries, supplies, travel and other business expenses, activity-based costing (ABC) models measure the costs of activities, or processes, and then provide an additional view of costs by the products and services produced by an organization through the identification of the key cost drivers of the activities. Below is a description of activity-based costing excerpted from the Supplemental Notice of Proposed Rulemaking published on March 24, 2010 (75 FR 14111).
OMB Circular A–25 states that it is the objective of the United States Government to “(a) ensure that each service, sale, or use of Government goods or resources provided by an agency to specific recipients be self-sustaining; [and] (b) promote efficient allocation of the Nation's resources by establishing charges for special benefits provided to the recipient that are at least as great as costs to the Government of providing the special benefits . . .” OMB Circular A–25, 5(a)–(b); see also 31 U.S.C. 9701(b)(2)(A) (agency “may prescribe regulations establishing the charge for a service or thing of value provided by the agency . . . based on . . . the costs to the Government . . .”). To set prices that are “self-sustaining,” the Department must determine the full cost of providing consular services.
The Government Accountability Office (GAO) defines activity-based costing as a “set of accounting methods used to identify and describe costs and required resources for activities within processes.” Because an organization can use the same staff and resources (computer equipment, production facilities, etc.) to produce multiple products or services, ABC models seek to precisely identify and assign costs to processes and activities and then to individual products and services through the identification of key cost drivers referred to as “resource drivers” and “activity drivers.”
Example: Imagine a government agency that has a single facility it uses to prepare and issue a single product—a driver's license. In this simple scenario, every cost associated with that facility (the salaries of employees, the electricity to power the computer terminals, the cost of a blank driver's license, etc.) can be attributed directly to the cost of producing that single item. If that agency wants to ensure that it is charging a “self-sustaining” price for driver's licenses, it only has to divide its total costs for a given time period by an estimate of the number of driver's licenses to be produced during that same time period.
However, if that agency issues multiple products (driver's licenses, non-driver ID cards, etc.), has employees that work on other activities besides licenses (for example, accepting payment for traffic tickets), and operates out of multiple facilities it shares with other agencies, it becomes much more complex for the agency to determine exactly how much it costs to produce any single product. In those instances, the agency would need to know what percent of time its employees spend on each service and how much of its overhead (rent, utilities, facilities maintenance, etc.) can be allocated to the delivery of each service to determine the cost of producing each of its various products—the driver's license, the non-driver ID card, etc. Using an ABC model allows the agency to identify separate costs for those different services.
As noted in SFFAS Statement 4, “activity-based costing has gained broad acceptance by manufacturing and service industries as an effective managerial tool” (SFFAS Statement 4, 147). There are no “off-the-shelf” ABC models that allow the Department (or any other entity) to simply populate a few data points and generate an answer. ABC models require financial and accounting analysis and modeling skills combined with a detailed understanding of all the organization's business processes, which, in an entity the size of the Department's Bureau of Consular Affairs, are exceedingly complex. More specifically, ABC models require an organization to:
• Identify all of the activities that are required to produce a particular product or service (“activities”);
• Identify all of the resources allocated to the production of (costs) that product or service (“resources”);
• Measure the quantity of resources consumed (“resource driver”); and
• Measure the frequency and intensity of demand placed on activities to produce services (“activity driver”).
For additional details on an activity-based costing model, see the Supplemental Notice of Proposed Rulemaking published on March 24, 2010 (75 FR 14111).
Although much of the modeling methodology has remained the same between fee reviews, the methodology for capturing the Department's historical support costs and projected costs has been revised to reflect the change in the Department's workload. In order to accurately account for the costs associated with growing demand for consular services, the current fee review also incorporates two years of projected costs in addition to two years of historical costs and one year of current costs. The new fees represent a weighted average of the annual costs by service for fiscal years 2011 through 2015. Costs for individual fiscal years were weighted by the projected workload volume for that year. These weighted costs by fiscal year were then added together to generate a single cost per service upon which the fees are determined.
The Department is decreasing the application fee for an adult (age 16 and older) passport book from $70 to $50, and the application fee for a minor (under age 16) passport book from $40 to $20. These changes apply to all applicants except those persons who are statutorily exempted from paying fees. The reduction in the passport application fee (and corresponding increase in the passport security surcharge noted below) will result in a reduction of funds deposited in the general fund at the Treasury and an increase in the revenue retained by the Department of State. The passport fee changes will not alter the total fee paid by passport customers.
Since the passport book application services fee was last changed in 2010, the Department has enhanced its Cost of Service Model to more accurately identify which costs should be attributed to the application fee and which should be attributed to the passport security surcharge. The application fee includes all costs of passport issuance and use that are not included in the passport security surcharge, such as the cost of providing emergency services for American citizens overseas and the cost of collecting passport fees and initial data entry through a lockbox service. The 2013 Cost of Service Model reflected that these costs were lower than the previous fee of $70 (including the “WHTI surcharge” described below) and thus the Department is lowering the fee to more precisely reflect these costs.
Because a minor passport book has a validity of just five years, in contrast with the ten-year validity period of an adult passport book, the Department charges a lower, below-cost fee for minor passport books and allocates the remainder of the cost of processing minor passport book applications to the adult passport application fee. The Department is also decreasing the minor passport book application fee by $20.
As described in 22 CFR 51.51(d), the passport application services fee incorporates a surcharge (the “Western Hemisphere Travel Initiative surcharge” or “WHTI surcharge”) to recover the costs of meeting the increased demand for passports as a result of actions taken to comply with section 7209(b) of Pub. L. 108–458 (reproduced at 8 U.S.C. 1185 note) (“WHTI”). The 2013 Cost of Service Model revealed that there has been no change in the costs attributable to WHTI and thus the surcharge remains $22 for adults. This surcharge is embedded within the passport book application services fee and not charged separately or separately itemized in the Schedule of Fees, see 22 CFR 51.51(d) (noting absence of separate itemization). This portion of the application fee has decreased from $22 to $20 for minors to allow the Department to keep the overall passport application fee for minors (including the security
The Department is increasing the passport security surcharge, which is applicable to all applicants except those persons who are statutorily exempted from paying fees, from $40 to $60. The passport security surcharge includes costs associated with the passport application processing fee that support enhanced border security, such as the secure book and card materials, passport printers, and compensation associated with passport adjudication, including fraud prevention. The 2013 Cost of Service Model results indicated that these costs amount to approximately $60 per passport. This change will result in a reduction of revenue deposited in the general fund of the Treasury and increase the revenue retained by the Department of State. This fee increase is due in part to new technology and more secure passport materials since 2010.
The Department is expanding the application of and renaming item 8 in the Schedule of Fees to “Administrative Processing of Request for Certificate of Loss of Nationality.” The fee will be applied to cover not only services to U.S. nationals (
The consular officer must also ensure that the commission of an expatriating act was as prescribed by statute, which is often an issue in non-renunciation relinquishment cases. The loss of nationality service must be documented on several forms and in consular systems as well as in a memorandum from the consular officer to the Department's Directorate of Overseas Citizens Services in Washington, DC (“OCS”), in the Bureau of Consular Affairs. All forms and memoranda are closely reviewed in OCS by a country officer and a senior approving officer, and may include consultation with legal advisers. This review entails close examination of whether the requirements of voluntariness and intent are satisfied in the individual case. Some applications require multiple rounds of correspondence between post and the Department. The final approval of the loss of nationality must be done by law within the Department (8 U.S.C. 1501), by OCS, after which the case is returned to the consular officer overseas for final delivery of the Certificate of Loss of Nationality to the individual. In addition, every individual issued a Certificate of Loss of Nationality is advised of the possibility of seeking a future Administrative Review of the loss of nationality, a time-consuming process that is conducted by OCS's Office of Legal Affairs.
Currently, nationals who renounce nationality pay a fee of $2,350, while nationals who apply for documentation of relinquishment of nationality by the voluntary commission of an expatriating act with the intention to lose nationality, do not pay a fee. However the services performed in both situations are similar, requiring close and detailed case-by-case review of the factors involved in a request for a Certificate of Loss of Nationality, and both result in similar costs to the Department.
In the past, individuals seldom requested Certificates of Loss of Nationality from the Department to document relinquishment. Although the Department was aware that an individual relinquishment service was among the most time consuming of consular services, it was rarely performed so the overall cost to the Department was low and the Department did not establish a fee. Requests for a Certificate of Loss of Nationality on the basis of a non-renunciatory relinquishment have increased significantly in recent years, and the Department expects the number to grow in the future, causing the total cost of this service to increase. At the same time, the Department funds consular services completely from user fees. The Cost of Service Model continues to demonstrate that such costs are incurred by the Department when accepting, processing, and adjudicating relinquishment of nationality cases; therefore, the Department will collect a fee from all individuals seeking a Certificate of Loss of Nationality. Taking into account the costs of both renunciation and non-renunciation relinquishment processes, the fee will be $2,350.
The Department is publishing this rule as an interim final rule with request for comment, with a 60-day provision for post-promulgation comments and with an effective date for § 22.1, Items 2.(a), 2.(b), and 2.(g) of less than 30 days from the date of publication, based on the “good cause” exception set forth at 5 U.S.C. 553(b)(3)(B) and 553(d)(3). Delaying implementation of this rule would be contrary to the public interest because consular services are directly
The Department has reviewed this rule and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities as defined in 5 U.S.C. 601(6).
This rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501–1504.
This rule is not a major rule as defined by 5 U.S.C. 804(2).
The Department has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Orders. This rule has been submitted to OMB for review.
This rule is necessary in light of the Department of State's Fiscal Year 2013 update to the Cost of Service Model finding that the cost of processing passports has changed since those fees were last amended in 2010. The Department is setting the new fees in accordance with 31 U.S.C. 9701 and other applicable legal authorities, as described in detail above.
Details of the fee changes are as follows:
This regulation will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on
The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.
This rule does not impose any new reporting or record-keeping requirements subject to the Paperwork Reduction Act.
Consular services, Fees, Passports.
Accordingly, for the reasons stated in the preamble, 22 CFR part 22 is amended as follows:
8 U.S.C. 1101 note, 1153 note, 1183a note, 1351, 1351 note, 1714, 1714 note; 10 U.S.C. 2602(c); 11 U.S.C. 1157 note; 22 U.S.C. 214, 214 note, 1475e, 2504(a), 4201, 4206, 4215, 4219, 6551; 31 U.S.C. 9701; Exec. Order 10,718, 22 FR 4632 (1957); Exec. Order 11,295, 31 FR 10603 (1966).
The revisions read as follows:
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Interim rule.
Section 238 of the Department of Housing and Urban Development Appropriations Act, 2015 (2015 Appropriations Act) amended the requirements in the United States Housing Act of 1937 (1937 Act) for public housing agencies (PHAs) to set flat rents in public housing. These requirements were previously amended by Department of Housing and Urban Development Appropriations Act, 2014 (2014 Appropriations Act). This interim rule amends HUD regulations implementing the Fiscal Year (FY) 2014 statutory language regarding public housing flat rents to allow PHAs to take advantage of the FY 2015 authority that provides PHAs with more flexibility in setting flat rents. This interim rule supersedes the portion of a proposed rule issued by HUD earlier this year that addressed the issue of setting flat rents in public housing, and HUD continues to seek comment on this issue.
Interested persons are invited to submit comments regarding this interim rule. All communications must refer to the above docket number and title. There are two methods for submitting public comments.
1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410–0500.
2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.
No Facsimile Comments. Facsimile (fax) comments are not acceptable.
Public Inspection of Public Comments. All properly submitted comments and communications submitted to HUD will be available for public inspection and copying between
Todd Thomas, Program Analyst, Public Housing Management and Occupancy Division, Office of Public and Indian Housing, Department of Housing and Urban Development, 40 Marietta Street NW., Atlanta, GA 30303, telephone (678) 732–2056 (this is not a toll-free number) or at
Section 3(a)(2)(B) of the 1937 Act (42 U.S.C. 1437a(a)(2)(B)) requires PHAs to set a flat rental amount for each public housing unit. In the 2014 Appropriations Act,
In the 2015 Appropriations Act,
In addition to providing additional flexibility to the 80 percent of an applicable FMR and allowing PHAs to apply for an exception, the 2015 Appropriations Act struck the statutory language requiring flat rents to be based on the rental value of the unit and the language requiring PHAs to comply with the statutory provisions by June 1, 2014.
HUD's January 6, 2015 rule proposed regulatory changes to conform to several statutory changes made to the 1937 Act that were designed to streamline and ease the burden of administrative requirements, imposed primarily on PHAs but also on multifamily housing owners administering programs and certain HUD Multifamily Housing and HUD Community Planning and Development programs. The January 6, 2015, proposed rule addresses a variety of administrative requirements, including verification of Social Security numbers, annual reexamination for families on fixed incomes, utility reimbursements, and the Earned Income Disregard used in several HUD programs. That proposed rule also included changes to 24 CFR 960.253(b), the regulations addressing public housing flat rents,
This interim rule replaces only the proposed changes with respect to flat rents in § 960.253(b); the changes proposed in January for other portions of § 960.253 remain in place, and are not effective until HUD issues a final rule that addresses all the regulatory changes proposed by HUD on January 6, 2015. HUD intends to issue a single final rule that takes into consideration all public comments received on both the January 6, 2015, proposed rule and this interim rule.
This interim rule, consistent with statutory authority and the notice implementing the changes in the 2014 Appropriations Act, establishes a standard flat rent amount at not less than 80 percent of the applicable FMR for a given unit.
However, the 2015 Appropriations Act allowed PHAs flexibility when establishing flat rents if 80 percent of the applicable FMR did not reflect the market value of a unit.
While the new statutory authority grants PHAs additional flexibility in establishing flat rents, PHAs are not required to exercise such flexibility. PHAs may opt to continue to implement flat rents equal to not less than 80 percent of the applicable FMR, as determined under 8(c) of the 1937 Act. Some PHAs may want to wait for the conclusion of public comment and the final rule before taking advantage of the new authority, and HUD understands and supports this position.
However, consistent with the 2014 Appropriations Act and the implementing PIH Notice 2014–12, PHAs are required to adjust flat rents downward to account for tenant-paid utilities and to revise flat rents within 90 days of HUD's issuance of new FMRs. In addition, the family's rent must not increase by more than 35 percent in a single year as a result of the new flat rent rules.
Finally, this interim rule removes language requiring documentation on the part of the PHA regarding the PHA's methods of determining a unit's flat rent, as the process setting flat rents is now less reliant upon discretionary actions by the PHA, except in the case of exception requests, which require documentation provided by PHAs.
In general, HUD publishes rules for advance public comment in accordance with its rule on rulemaking at 24 CFR part 10. However, under 24 CFR 10.1, HUD may omit prior public notice and comment if it is “impracticable, unnecessary, or contrary to the public interest.” Under such circumstances, HUD may publish an interim rule without soliciting public comment. In this instance, HUD has determined that it is unnecessary to delay the effectiveness of this rule for advance public comment.
First, section 238 of the 2015 Appropriations Act is effective immediately and introduces statutory changes intended to provide relief to PHAs and tenants burdened by the current statute. This interim rule implements those statutory changes.
Second, while the interim rule does exercise some discretion on the part of HUD, the exercise is minimal and generally relies on the PHA requesting action by HUD to initiate the action. HUD is not mandating that PHAs use the flexibility authorized by the new statutory language, but is rather allowing PHAs the option to utilize the new authority if they so choose. PHAs may elect to continue to establish flat rents in accordance with the changes allowed under the 2014 Appropriations Act. Given that many PHAs want to use the new authority, this interim rule strikes the right balance of allowing them to implement this new authority but not requiring them to do so.
Finally, although HUD has determined that good cause exists to publish this rule for effect without prior solicitation of public comment, HUD recognizes the value and importance of public input in the rulemaking process. Accordingly, HUD is issuing these regulatory amendments on an interim basis and providing a 60-day public comment period.
The Office of Management and Budget (OMB) reviewed this rule under Executive Order 12866, “Regulatory Planning and Review.” This rule was determined to be a “significant regulatory action,” as defined in section 3(f) of the order (although not an economically significant regulatory action under the order). The docket file is available for public inspection in the Regulations Division, Office of the General Counsel, 451 7th Street SW., Room 10276, Washington, DC 20410– 0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the docket file by calling the Regulations Division at 202–708–3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Information Relay Service at 800–877–8339 (this is a toll-free number).
The information collection requirements contained in this interim rule have been submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520) and assigned OMB control numbers 2577–0220 and –0169. In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This interim rule will not impose any Federal mandates on any State, local, or tribal governments or the private sector within the meaning of UMRA.
A Finding of No Significant Impact (FONSI) with respect to the environment was made in accordance with HUD regulations in 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)), in connection with HUD's publication of the Streamlining Administrative Regulations proposed rule, published on January 6, 2015, at 80 FR 423. That FONSI remains applicable to this interim rule, and is available for public inspection during regular business hours in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW., Room 10276, Washington, DC 20410–0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the FONSI by calling the Regulations Division at 202–708–3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at 800–877–8339 (this is a toll-free number).
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Notwithstanding HUD's belief that this interim rule will not have a significant effect on a substantial number of small entities, HUD specifically invites comments regarding any less burdensome alternatives to this interim rule that will meet HUD's objectives as described in this preamble.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This interim rule does not have federalism implications and does not impose substantial direct compliance costs on State and local governments nor preempt State law within the meaning of the Executive order.
The Catalog of Federal Domestic Assistance number for the Public Housing program is 14.872.
Aged, Grant programs—housing and community development, Individuals with disabilities, Pets, Public housing.
Accordingly, for the reasons stated in the preamble, HUD amends 24 CFR part 960 as follows:
42 U.S.C. 1437a, 1437c, 1437d, 1437n, 1437z–3, and 3535(d).
(b)
(1) The PHA must establish a flat rent for each public housing unit that is no less than 80 percent of the applicable Fair Market Rent (FMR) as determined under 24 CFR part 888, subpart A; or
(2) HUD may permit a flat rent of no less than 80 percent of an applicable small area FMR (SAFMR) or unadjusted rent, if applicable, as determined by HUD, or any successor determination, that more accurately reflects local market conditions and is based on an applicable market area that is geographically smaller than the applicable market area used in paragraph (b)(1) of this section. If HUD has not determined an applicable SAFMR or unadjusted rent, the PHA must rely on the applicable FMR under paragraph (b)(1) or may apply for an exception flat rent under paragraph (b)(3).
(3) The PHA may request, and HUD may approve, on a case-by-case basis, a flat rent that is lower than the amounts in paragraphs (b)(1) and (2) of this section, subject to the following requirements:
(i) The PHA must submit a market analysis of the applicable market.
(ii) The PHA must demonstrate, based on the market analysis, that the proposed flat rent is a reasonable rent in comparison to rent for other comparable unassisted units, based on the location, quality, size, unit type, and age of the public housing unit and any amenities, housing services, maintenance, and utilities to be provided by the PHA in accordance with the lease.
(iii) All requests for exception flat rents under this paragraph (b)(3) must be submitted to HUD.
(4) For units where utilities are tenant-paid, the PHA must adjust the flat rent downward by the amount of a utility allowance for which the family might otherwise be eligible under 24 CFR part 965, subpart E.
(5) The PHA must revise, if necessary, the flat rent amount for a unit no later than 90 days after HUD issues new FMRs.
(6) If a new flat rent would cause a family's rent to increase by more than 35 percent, the family's rent increase must be phased in at 35 percent annually until such time that the family chooses to pay the income-based rent or the family is paying the flat rent established pursuant to this paragraph.
Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD.
Final rule.
This final rule establishes a procedure whereby construction of new manufactured housing that is substantially completed in the factory can be completed at the installation site, rather than in the plant. Before this rule, a manufacturer would first be required to obtain HUD approval for on-site completion of each of its designs using the alternate construction provisions of HUD's regulations. This final rule simplifies this process by establishing uniform procedures by which manufacturers may complete construction of their homes at the installation site without having to obtain advance approval from HUD. This final rule applies only to the completion of homes subject to the Manufactured Home Construction and Safety Standards, not to the installation of homes subject to the Model Manufactured Home Installation Standards. Moreover, this final rule would not apply when a major section of a manufactured home is to be constructed on-site.
Pamela B. Danner, Administrator, Office of Manufactured Housing Programs, Department of Housing and Urban Development, 451 7th Street SW., Room 9168, Washington, DC 20410; telephone 202–708–6423 (this is not a toll-free number). Persons with hearing or speech impairments may access this number via TTY by calling the Federal Relay Service at 1–800–877–8389 (this is a toll-free number).
The National Manufactured Housing Construction and Safety Standards Act of 1974 (42 U.S.C. 5401
This final rule establishes procedures to permit completion of new manufactured housing at the installation site, rather than in the factory, under certain circumstances. Prior to this rule, manufacturers were required to request and obtain advanced HUD approval to permit alternative construction (AC) under § 3282.14(b), for each model of home that it wanted to complete on-site rather than in the production facility. Among other things, manufacturers
This final rule follows a proposed rule published on June 23, 2010 (75 FR 35902), and takes into account public comments received on the proposed rule. In preparing this final rule, HUD also reconsidered and incorporated some of the earlier comments provided by the Manufactured Housing Consensus Committee (MHCC) during the development of the proposed rule. The MHCC is a Federal Advisory Committee authorized by the Manufactured Housing Improvement Act of 2000 (Pub. L. 106–569) (42 U.S.C. 5403). The MHCC was established to provide HUD with periodic recommendations regarding Federal Manufactured Housing Construction and Safety Standards and related procedural and enforcement regulations.
This final rule follows publication of the June 23, 2010, proposed rule and takes into consideration the public comments received on the proposed rule. In response to public comment, a discussion of which is presented in the following section of this preamble, and in further consideration of issues addressed at the proposed rule stage, the Department is making the following changes at this final rule:
• Section 3280.5 has been revised to conform to this final rule to require that the manufacturer's data plate contain information, if applicable, stating that, except for the components completed on-site, the home has been substantially completed in accordance with an approved design and has been inspected in accordance with the Construction and Safety Standards.
• Section 3280.305 has been revised to provide that the attic floor of homes with high-pitched roofs (with slopes of 7:12 or greater), completed on-site, be designed to support live loads of 40 pounds per square inch. The attic floor of homes with roofs with slopes less than 7:12 that contain an attic space that can be used for storage must be designed for a storage live load of 20 pounds per square foot.
• Section 3282.603(d) has been revised to provide that the contents of the Design Approval Primary Inspection Agency (DAPIA) approval, in addition to items listed in this section in the proposed rule, must include a unique site completion numeric identification for each approval for each manufacturer (
• Section 3282.604(c) of the proposed rule which would have required the DAPIA to determine if complex work requires special criteria or qualification for the IPIA inspector has been removed in this final rule.
• Section 3282.605(a) has been revised to permit the “SC” designation to be used as either a prefix or suffix in the serial number for homes or sections of homes completed on-site.
• Section 3282.605(b) has been revised to remove the requirement that the manufacturer include a green, on-site certification label of the same size, location, material, and fastening as provided by § 3280.11. Rather, this final rule provides that the manufacturer have a label affixed to the home, in accordance with § 3282.362(c)(2).
• Section 3282.605(d)(4) has been revised to provide that the manufacturer must, within 5 business days after receiving notification from the IPIA regarding acceptance of its final site inspection report, provide the purchaser or lessor, as applicable, the manufacturer's final site inspection report.
• Section 3282.607 has been revised to provide that the IPIA is responsible for reporting to HUD, the DAPIA, and manufacturer if one or more homes has not been site inspected prior to occupancy or when arrangements for one or more manufactured homes to be site inspected have not been made.
• Section 3282.608 has been revised in several ways. First, HUD removed the requirement that the manufacturer certify the home by affixing the on-site completion certification label as proposed at paragraph (f), and that the manufacturer notify a State or local jurisdiction of any add-on to the home as proposed by paragraph (n). HUD also revised paragraph (e) by adding the requirement that the manufacturer maintain a copy of any applicable DAPIA-approved quality assurance manual for on-site completion, the approved instructions for completing the construction work on-site, and the approved inspection checklist at the job site until all on-site work is completed and accepted by the IPIA. HUD also added paragraph (f) which makes the manufacturer responsible for the satisfactory completion of all on-site construction and required repairs and for authorizing a licensed contractor or a similarly qualified person to complete site construction and needed repairs. HUD also added paragraph (g) to require that the manufacturer provide a written certification to the lessor or purchaser when all site construction work is completed that each home, to the best of the manufacturer's knowledge and belief, is constructed in conformance with the Federal Manufactured Home Construction and Safety Standards. Finally, HUD revised paragraph (m) of the final rule to require the manufacturer to provide a copy of the site report to a State Administrative Agency (SAA), upon request.
• Section 3285.801(f)(2) has been revised to provide that homes with roof slopes of less than 7:12, including any designs incorporating peak cap construction or peak flip construction, are exempt from IPIA inspection and are to be inspected in accordance with 24 CFR part 3286.
The public comment period for the June 23, 2010 (75 FR 35902), proposed rule closed August 23, 2010. In addition to soliciting comments on the proposal as a whole, HUD invited comments on 26 specific questions. HUD received 20 public comments. Comments were submitted by individuals; a housing alliance; a housing and community development organization; a vertically integrated manufactured housing company; a marketer of factory-built homes; a fire, building, and life-safety organization; manufactured housing associations; an industry trade journal; a State licensed installer/manager; a producer of manufactured housing; and a trade association representing all segments of the factory-built housing industry. The following section of this preamble summarizes the significant issues raised by the commenters on the June 23, 2010, proposed rule and HUD's responses to these comments.
To assist in HUD's development of this final rule, HUD solicited feedback on specific questions and issues associated with its on-site completion procedures. Each question will be followed by the comments received and HUD's responses to those commenters in developing this final rule.
HUD responded to comments submitted in response to this question in Section A, General Comments, of this preamble.
Prior to this rule, HUD reviewed and approved requests for on-site completion of construction of manufactured homes under § 3282.14. This procedure can be lengthy and, when originally implemented, was not intended to address the evolution and sophistication of the current modern manufactured housing construction techniques. Manufactured homes now include home design features, such as stucco or brick, that cannot reasonably be completed in the factory and which are currently being completed on-site under the AC process. HUD also recognizes that many parts of modern manufactured homes, such as components of smoke alarm, heating, ventilation, air conditioning, and plumbing systems, are typically shipped loose with the home. It is only when these systems are completed that the homes comply with the Construction and Safety Standards.
This final rule establishes simplified, uniform procedures at 24 CFR part 3282, subpart M, that permit manufacturers to complete the construction of manufactured housing on-site, rather than in the factory, under certain circumstances, without obtaining advance approval from HUD. Under this final rule, HUD's approved DAPIAs and IPIAs (collectively known as Primary Inspection Agencies (PIAs) are authorized to approve and inspect certain construction for manufactured homes designed to be completed on-site. Delegating this responsibility to HUD's PIAs is consistent with HUD's policy to expand regulatory flexibility, encourage innovation in the construction of manufactured homes, and facilitate the timely completion of manufactured homes on-site.
As a result of this final rule, manufacturers may now complete the home in the factory, in accordance with the Construction and Safety Standards and an approved quality assurance manual, or may complete work on certain aspects of the home on-site in accordance with procedures established by this rule, which bring the home in conformance with the Construction and Safety Standards. The designs for construction work to be done on-site in accordance with the procedures in this final rule are subject to Construction and Safety Standards; accordingly, State and local jurisdictions are preempted from establishing their own design requirements for these aspects of the home, unless the requirements are identical to the Construction and Safety Standards. Manufacturers also may continue to seek approval through the AC process under the procedures established by § 3282.14 for construction that does not comply with the Construction and Safety Standards.
The Federal Manufactured Housing program is based upon national Construction and Safety Standards that are enforced through the manufacturer's quality control systems, in-plant compliance inspections by HUD-approved third-party agencies, and performance monitoring of those agencies in the plant. Given these conditions, this final rule does not permit major portions of a home to be completed beyond the plant, as that would avoid the normal inspection and certification process, and may frustrate legitimate local and State code enforcement efforts. Notwithstanding, § 3282.602 of this final rule lists aspects of construction of a manufactured home that may be approved to be completed on-site. Examples of the types of work that are not considered to involve substantial completion and which cannot be reasonably expected to be completed in the factory and to which the final rule applies include:
(a) Completion of roof dormers;
(b) Addition of stucco, stone, brick, or other siding that is subject to damage in transit;
(c) Retailer changes to the home on-site (such as add-ons subject to requirements established by the local authority having jurisdiction), when the home is taken out of compliance with the Construction and Safety Standards and then is brought back into compliance with the Standards. However, this provision does not apply to attached garages as this subject is under current review by the MHCC and is expected to be addressed in future rulemaking by HUD;
(d) Any hinged roof that is not considered part of the installation of the home (see § 3285.801(f)). Based on the recent recommendations of the MHCC and the comments received, the final rule now allows peak flip and peak cap construction in which the roof pitch of the hinged roof is less than 7:12, when located in Wind Zone I, to be deemed part of installation and exempt from IPIA inspection under the Regulations;
(e) Site installed appliances that are listed or certified for use in manufactured homes, such as a cooking range, furnace, or water heater; and
(f) Completion of any high-pitch (
The procedures established by this final rule eliminate much of the reporting for site inspections of completed homes previously required under the AC process. Under this final rule, the manufacturer is only required to report, to HUD or its agent, the State of first location of the home, its serial number, and a brief description of the work done on-site. This information is to be included on an updated HUD Manufactured Home Monthly Production Report (Form 302), which manufacturers have in the past used to report to their IPIA and to HUD (or their monitoring contractor) certain completion and shipping information on labeled units.
As stated in this preamble, manufacturers may continue to seek approval through the AC process, under the procedures established by § 3282.14, for construction that does not comply with the Construction and Safety Standards. HUD will utilize § 3282.14, as originally intended, to encourage innovation and the use of new technology that are not in conformance with the Construction and Safety Standards. The AC process is limited to specific circumstances and requires the manufacturer to submit a formal request to HUD and show that the construction it proposes provides performance that is equivalent or superior to that required by the Construction and Safety Standards. Examples of designs in which the completed home does not comply with the Construction and Safety Standards when finished and would therefore continue to require an AC approval include:
(a) Multistory homes that do not comply with the standards because of
(b) A home installed without floor insulation over a basement; that is, the existence of a basement will not substitute for insulation under the construction and safety standards (however, if the floor is properly insulated at the factory, it may be installed over a basement without having to use either the on-site or AC approval processes); and
(c) Attached garages, as this subject is under current review by the MHCC and is expected to be addressed in future rulemaking by HUD.
The procedures established by this final rule for on-site completion differ from the AC. Initially, this final rule applies to homes that can be certified as substantially meeting the requirements of the Construction and Safety Standards when labeled in the factory and that comply fully with those Standards when completed on-site. In addition, the on-site completion procedures established by this rule eliminate the direct HUD review and approval currently required under the AC process. Rather, this rule requires that manufacturers work directly with their DAPIAs and IPIAs to obtain approval to complete aspects of construction at the final home site.
This final rule will encourage the use of innovative designs and techniques that will further demonstrate the adaptability and versatility of manufactured housing. As manufacturers continue to make significant improvements to both the quality and the aesthetics of such homes, providing for simplified, uniform procedures that permit manufacturers to complete the construction of manufactured housing on-site, rather than in the factory, will support the increased recognition of manufactured homes as a viable source of unsubsidized, affordable housing and encourage zoning policies that do not discriminate against manufactured housing.
1.
2.
3.
In addition, the DAPIA must approve the part of the manufacturer's written quality assurance manual that is applicable to completing the manufactured homes on-site under the Construction and Safety Standards. When the part of the quality assurance manual applicable to the on-site completion also has received the concurrence of the IPIA, the system may be approved as part of the manufacturer's quality assurance manual. If this approval is not done as part of the initial approval of the entire quality assurance manual, the pertinent part of the manufacturer's manual will be deemed a change to be incorporated into the manual in accordance with established procedures (see §§ 3282.203(e) and 3282.361(c)(4)). The approval will also include other requirements, such as a quality control checklist to verify that all required components, materials, labels, and instructions needed for site completion are provided by the manufacturer and an inspection checklist, developed by the manufacturer and approved by the DAPIA, to be used in the manufacturer's and IPIA's final inspections. As with the procedures followed under an approval for AC, the manufacturer's IPIA is responsible for ensuring that the homes the IPIA inspects under the new procedures comply with the changes in the quality assurance manual, as provided in § 3282.362(a) of the existing regulations, and with the approved design or, where the design is not specific, to the Construction and Safety Standards.
4.
(a) Verifying that the manufacturer submits all required information, when a manufacturer seeks a DAPIA's approval to complete any aspect of construction on-site under § 3282.603;
(b) Reviewing and approving the manufacturer's designs, site completion instructions, and quality assurance manuals for the site work that is to be performed;
(c) Determining whether there are any other requirements or limitations deemed necessary or appropriate; and
(d) Revoking or amending its approval for on-site construction, as provided in § 3282.609, after determining that the manufacturer is: (1) Not complying with the terms of the approval or the requirements of § 3282.610; (2) the approval was not issued in conformance with the requirements of § 3282.603; (3) a home produced under the approval fails to comply with the Federal construction and safety standards or contains an imminent safety hazard; or (4) the manufacturer failed to make arrangements for one or more manufactured homes to be inspected by the IPIA prior to occupancy. Upon revocation or amendment of a DAPIA approval, the DAPIA must immediately notify the manufacturer, the IPIA, and HUD.
5.
Based on the comments received, the final rule does not require a unique on-site completion label as indicated in the proposed rule, but instead requires that homes or sections of such homes have a label affixed in accordance with § 3282.362(c)(2) and be shipped with a Consumer Information Notice that meets the requirements of § 3282.606. Approved designs for completion of aspects of construction outside of the manufacturer's plant must be marked with the identification code for the appropriate approved set of designs, and must be included as a separate part of the manufacturer's approved design package. All aspects of construction that are completed on the final home site remain the responsibility of the manufacturer, which must ensure that the home is properly labeled and, as part of its final on-site inspection report provided to the IPIA, certify that the work is consistent with DAPIA-approved instructions and conforms with approved designs or, as appropriate under § 3282.362(a)(1)(iii), conforms to the Construction and Safety Standards. The IPIA is required to review all of the manufacturer's final on-site inspection reports and to inspect all on-site work completed pursuant to an approval under this new process. If the IPIA determines that the manufacturer is not performing adequately in conformance with the approval, the IPIA may require reinspections, until it is satisfied that the manufacturer is conforming to the conditions included in the approval. Based on public comments HUD has revised § 3282.605(d)(4) to require that the manufacturer provide the purchaser or lessor a copy of the final site inspection report within 5 business days of the IPIA's notification of its acceptance of the report.
6.
The sale or lease of the manufactured home to the purchaser will not be considered complete (see § 3282.252(b)) until the purchaser has been provided with a copy of the manufacturer's final site inspection report, including the certification of completion that has been reviewed and accepted by the IPIA. However, HUD does not intend that failure to provide this report within 5 days of the date of the IPIA's notification will constitute a breach of contract. The manufacturer must maintain in its labeling records an indication that the final on-site inspection report and certification of completion has been provided to the purchaser and the retailer.
7.
(a) Working with the manufacturer and the manufacturer's DAPIA to ensure that the manufacturer's quality control system has the proper procedures and controls to assure that the on-site construction work will conform to DAPIA-approved designs and HUD's construction and safety standards;
(b) Providing the certification labels that the manufacturer may use to label a home that has been substantially completed in the factory;
(c) Monitoring the manufacturer's system for tracking the status of homes built under the approval until the on-site work and necessary inspections have been completed, to assure that the work is being performed properly on all applicable homes;
(d) Performing the required inspections of the manufacturer's reports and site work, to verify compliance with the manufacturer's quality control system, the approved designs, and, as appropriate, the Construction and Safety Standards. Only the IPIA, or other qualified independent inspector acceptable to and acting on behalf of the IPIA, may perform these inspections. The inspector must be free of any conflict of interest (see § 3282.359) and not be involved in the sale or site completion of the home; and
(e) Maintaining a copy of each final site inspection report submitted by a manufacturer and each inspection report prepared or accepted by the IPIA, and reporting to HUD, the DAPIA, and manufacturer if one or more manufactured homes has not been site inspected prior to occupancy or if arrangements have not been made to site inspect one or more manufactured homes.
8.
(a) Certifying the completed home is constructed in conformance with the Federal Manufactured Home Construction and Safety Standards, as indicated on the label, in § 3282.362(c)(2) of the Manufactured Home Procedural and Enforcement Regulations;
(b) Completing all work performed on a home that is necessary to assure compliance with the Construction and Safety Standards, regardless of who does the work or where it is completed. Such responsibility would not extend to any limited close-up work for multiple-section homes, as defined as installation work in the model installation standards;
(c) Working with the DAPIA and IPIA to obtain approval and concurrence on the quality control system the manufacturer will use to assure that the on-site work is performed according to DAPIA-approved designs, and to incorporate this system into the manufacturer's quality assurance manual;
(d) Working with the DAPIA to develop an approved checklist, providing the IPIA with the checklist to be used when the IPIA inspects the home after completion on-site, and notifying the IPIA that the home is ready to be inspected;
(e) Maintaining a system for tracking the status of homes built under the approval, to ensure that each home installed on a building lot has the on-site work and necessary inspections completed;
(f) Paying IPIA costs for performing on-site inspections;
(g) Providing inside the home and to the IPIA, a copy of the instructions for completing the work on-site, for monitoring/inspection purposes (the copy provided in the home may be provided with the installation instructions in the home). Either before, or at the time on-site work commences, the manufacturer must provide the IPIA with a copy of any applicable, DAPIA-approved quality assurance manual for on-site completion changes; the approved instructions for completing the construction work on-site; and the approved inspection checklist;
(h) Satisfactory completion of all on-site work construction and required repairs or authorizing a licensed contractor or similarly qualified person to complete all site inspection and repairs.
(i) Providing a copy of the final site inspection report and certificate of completion to the IPIA; first purchaser or lessor of the home, prior to occupancy; to the appropriate retailer, and to the SAA upon request;
(j) Maintaining a copy of the site inspection report and the notification of the IPIA's approval or acceptance of this report;
(k) Notifying the appropriate State or local jurisdiction of any add-on to the home, as referenced in § 3282.8(j), that is not covered by the manufacturer's inspection and certification of completion, but about which the manufacturer knows or reasonably should have known. The manufacturer is not required to provide this notification if the manufacturer knows that the State or local jurisdiction has already inspected the add-on; and
(l) Providing cumulative quarterly production inspection reports to HUD or its agent.
9.
This final rule includes conforming changes to 24 CFR part 3280. Initially, HUD is revising § 3280.5 to require that the manufacturer's data plate contain information, if applicable, stating that, except for the components completed on-site, the home has been substantially completed in accordance with an approved design and has been inspected in accordance with the Construction and Safety Standards.
In addition, and as discussed in the preamble of the proposed rule, HUD is revising the structural design requirements in § 3280.305 for attic areas with high- or low-pitched roofs. As discussed in the preamble of the June 23, 2010, proposed rule, HUD stated that this rule as proposed would apply to the completion of any high-pitched (
The final rule includes conforming changes to three other sections of 24 CFR part 3282. A conforming amendment is made to § 3282.252 (b) to change the term “dealer” to “retailer.” HUD is also conforming this section to this final rule by providing that the sale is complete upon delivery to the site, except that sales under this final rule will not be considered complete until the purchaser or lessor has been provided with a final site inspection report. A conforming amendment is also made to § 3282.552 to specify the information that is included on the reports currently submitted under 24 CFR part 3282. Finally, HUD is also using this rulemaking to make a technical correction to the heading of § 3282.8(a), which would be updated from “mobile homes” to “manufactured homes”.
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if the regulation is necessary, to select the regulatory approach that maximizes net benefits. Because this final rule allows manufactured housing manufacturers to complete construction of certain homes at the installation site without seeking advance approval from HUD, and thereby eliminating costly processing and construction delays, the rule was determined to not be a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and therefore was not reviewed by the Office of Management and Budget (OMB).
This final rule establishes simplified, uniform procedures at 24 CFR part 3282, subpart M, that permit manufacturers to complete the construction of manufactured housing on-site, rather than in the factory, under certain circumstances, without obtaining advanced approval from HUD. Given the objective of the Federal Manufactured Housing program, this final rule does not permit major
This final rule will encourage the use of innovative designs and techniques that will further demonstrate the adaptability and versatility of manufactured housing and eliminate the need for manufactures to apply for advance approval to complete construction of a manufactured home on-site. Easing the process for on-site construction of manufactured homes supports achievement of the goal of widely available safe, durable, and affordable manufactured housing.
This final rule contains provisions that are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). As required by the Paperwork Reduction Act, HUD published a description of these provisions, with estimates of annual reporting, recordkeeping, and notice requirements, on June 15, 2015, at 80 FR 34165. Interested persons are encouraged to review and provide comment on HUD's proposed information collection. The 180-day delayed effective date for this rule will provide HUD the opportunity to complete the approval process for this final rule prior to its effective date. In accordance with the Paperwork Reduction Act, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number.
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This final rule does not impose any Federal mandates on any State, local, or tribal governments or the private sector within the meaning of UMRA.
A Finding of No Significant Impact (FONSI) with respect to the environment was approved at the proposed rule stage in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection between the hours of 8 a.m. and 5 p.m., weekdays, in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410–0500. Due to security measures at the HUD headquarters building, please schedule an appointment to review the FONSI by calling the Regulations Division at 202–402–3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the Federal Information Relay Service at 800–877–8339 (this is a toll-free number).
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This rule also alleviates burden for all manufacturers, large and small, because it makes tangible streamlined improvements to the system regulating on-site construction of manufactured homes. This rule establishes procedures whereby manufacturers could complete construction of new manufactured housing on-site without being required to apply for HUD approval for on-site construction. This rule would apply only to work done to complete the manufacturing process required by the Manufactured Home Construction and Safety Standards. It would not affect the installation of homes subject to the model Manufactured Home Installation Standards, or apply in instances where a major portion of the home is to be constructed on site. In addition, this rule applies only to a subset of the total number of manufactured housing manufacturers—those that decide to incorporate the new design elements into their products. It is not a requirement that all manufacturers do so.
Finally, this final rule will have a beneficial effect by reducing the paperwork burden and costs of construction delays for all housing manufacturers, large or small. These manufacturers will no longer be required to apply repeatedly for variances regarding on-site construction utilizing design elements and innovations that are expected to become commonplace over time. Easing the process for on-site construction of manufactured homes supports achievement of the goal of widely available safe, durable, and affordable manufactured housing.
Accordingly, the undersigned certifies that this rule would not have a significant economic impact on a substantial number of small entities.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments and is not required by statute or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive order. This final rule does not have federalism implications and would not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive order.
Fire prevention, Housing standards.
Administrative practice and procedure, Consumer protection, Intergovernmental relations, Investigations, Manufactured homes, Reporting and recordkeeping requirements.
Housing standards, Incorporation by reference, Installation, Manufactured homes.
Accordingly, for the reasons discussed in this preamble, HUD amends 24 CFR parts 3280, 3284 and 3285 as follows:
42 U.S.C. 3535(d), 5403, and 5424.
(c) The applicable statement:
This manufactured home is designed to comply with the Federal Manufactured Home Construction and Safety Standards in force at the time of manufacture.or
This manufactured home has been substantially completed in accordance with an approved design and has been inspected (except for the components specifically identified in the instructions for completion on-site) in accordance with the Federal Manufactured Home Construction and Safety Standards and the requirements of the Department of Housing and Urban Development (HUD) in effect on the date of manufacture.
(k)
(2) For roofs with slopes less than 7:12 that contain an attic area or for portions of roofs with slopes 7:12 or greater that do meet the ceiling height/living space requirements of the standards, the attic floor must be designed for a storage live load of 20 pounds per square foot (psf).
28 U.S.C. 2461 note; 42 U.S.C. 3535(d); 42 U.S.C. 5424.
(kk)
(a)
(e) * * * When applicable under § 3282.605, the IPIA must concur in the change before it can be approved by the DAPIA.
(b) This prohibition applies to any affected manufactured homes until the completion of the entire sales transaction. A sales transaction with a purchaser is considered completed when all the goods and services that the retailer agreed to provide at the time the contract was entered into have been provided. Completion of a retail sale will be at the time the retailer completes installation of the manufactured home, if the retailer has agreed to provide the installation, or at the time the retailer delivers the home to a transporter, if the retailer has not agreed to transport or install the manufactured home. The sale is also complete upon delivery to the site if the retailer has not agreed to provide installation as completion of sale, except that any sale or lease under subpart M and as provided in § 3286.117(a) will not be considered complete until the purchaser or lessor, as applicable, has been provided with a final site inspection report.
(c) * * *
(4)
(d) * * *
(5) Records of all site inspections made as required under procedures applicable to approval of AC or on-site completion pursuant to §§ 3282.14 or 3282.610.
The manufacturer must submit to the IPIA in each of its manufacturing plants, and to HUD or to the Secretary's agent, a monthly production report that includes the serial numbers of each manufactured home manufactured and labeled at that plant during the preceding month. The report must also include the date of manufacture, State of first location of these manufactured homes after leaving the plant, type of unit, and any other information required under this part. For all homes to be completed pursuant to subpart M of these regulations, the production report must also include a brief description of the work to be completed on site. The State of first location is the State of the premises of the retailer or purchaser to whom the manufactured home is first shipped. The monthly report must be submitted by the 10th day of each month and contain information describing the manufacturer's previous month's activities. The manufacturer is encouraged to submit the report electronically, when feasible.
(a)
(b)
(1) Be substantially completed in the factory;
(2) Meet the requirements of the Construction and Safety Standards upon completion of the site work; and
(3) Be inspected by the manufacturer's IPIA as provided in this subpart, unless specifically exempted as installation under HUD's Model Installation Standards, 24 CFR part 3285. This subpart does not apply to Alternative Construction (see § 3282.14) that does not comply with the Manufactured Home Construction and Safety Standards.
(a) The manufacturer, the manufacturer's DAPIA acting on behalf of HUD, and the manufacturer's IPIA acting on behalf of HUD may agree to permit certain aspects of construction of a manufactured home to be completed to the Construction and Safety Standards on-site in accordance with the requirements of this subpart. The aspects of construction that may be approved to be completed on-site are the partial completion of structural assemblies or systems (
(1) Hinged roof and eave construction, unless exempted as installation by § 3285.801(f) of the Model Manufactured Home Installation Standards and completed and inspected in accordance with the Manufactured Home Installation Program;
(2) Any work required by the home design that cannot be completed in the factory, or when the manufacturer authorizes the retailer to provide an add-on, not including an attached garage, to the home during installation, when that work would take the home out of conformance with the construction and safety standards and then bring it back into conformance;
(3) Appliances provided by the manufacturer, installer, retailer, or purchaser, including fireplaces to be installed on site;
(4) Components or parts that are shipped loose with the manufactured home and that will be installed on-site, unless exempted as installation by the installation standards;
(5) Exterior applications such as brick siding, stucco, or tile roof systems; and
(6) Other construction such as roof extensions (dormers), site-installed windows in roofs, removable or open floor sections for basement stairs, and sidewall bay windows.
(b) The manufacturer or a licensed contractor or similarly qualified professional with prior authorization from the manufacturer may perform the on-site work in accordance with the DAPIA approvals and site completion instructions. However, the manufacturer is responsible for the adequacy of all on-site completion work regardless of who does the work, and must prepare and provide all site inspection reports, as well as the certification of completion, and must fulfill all of its responsibilities and maintain all records at the factory of origin as required by § 3282.609.
(a)
(b)
(1) Approve the request if it is consistent with this section and the objectives of the Act; or
(2) Deny the proposed on-site completion and set out the reasons for the denial.
(c)
(d)
(1) Include a unique site completion numeric identification for each approval for each manufacturer (
(2) Identify the work to be completed on-site;
(3) List all models to which the approval applies, or indicate that the approval is not model-specific;
(4) Include acceptance by the DAPIA of a quality assurance manual for on-site completion meeting the requirements of paragraph (e) of this section;
(5) Include the IPIA's written agreement to accept responsibility for completion of the necessary on-site inspections and accompanying records;
(6) Identify instructions authorized for completing the work on-site that meet the requirements of paragraph (f) of this section;
(7) Include the manufacturer's system for tracking the status of homes built under the approval until the on-site work and necessary inspections have been completed, to assure that the work is being performed properly;
(8) Include a quality control checklist to be used by the manufacturer and IPIA and approved by the DAPIA to verify that all required components, materials, labels, and instructions needed for site completion are provided in each home prior to shipment;
(9) Include an inspection checklist developed by the IPIA and manufacturer and approved by the DAPIA, that is to be used by the final site inspectors;
(10) Include a Consumer Information Notice developed by the manufacturer and approved by the DAPIA that explains the on-site completion process and identifies the work to be completed on-site; and
(11) Include any other requirements and limitations that the DAPIA deems
(e)
(f)
The DAPIA, acting on behalf of HUD, for any manufacturer proceeding under this section is responsible for:
(a) Verifying that all information required by § 3282.603 has been submitted by the manufacturer;
(b) Reviewing and approving the manufacturer's designs, quality control checklist, site inspection checklist, site completion instructions, and quality assurance manuals for site work to be performed;
(c) Maintaining all records and approvals for at least 5 years;
(d) Revoking or amending its approvals in accordance with § 3282.609; and
(e) Reviewing its approvals under this section at least every 3 years or more frequently if there are changes made to the Manufactured Home Construction and Safety Standards, 24 CFR part 3280, to verify continued compliance with the Standards.
(a)
(b)
(c)
(d)
(2) Each approved final site inspection report must include:
(i) The name and address of the manufacturer;
(ii) The serial number of the manufactured home;
(iii) The address of the home site;
(iv) The name of the person and/or agency responsible for the manufacturer's final site inspection;
(v) The name of each person and/or agency who performs on-site inspections on behalf of the IPIA, the name of the person responsible for acceptance of the manufacturer's final on-site inspection report on behalf of the IPIA, and the IPIA's name, mailing address, and telephone number;
(vi) A description of the work performed on-site and the inspections made;
(vii) When applicable, verification that any problems noted during inspections have been corrected prior to certification of compliance; and
(viii) Certification by the manufacturer of completion in accordance with the DAPIA-approved instructions and that the home conforms with the approved design or, as appropriate under § 3282.362(a)(1)(iii), the construction and safety standards.
(3) The IPIA must review each manufacturer's final on-site inspection report and determine whether to accept that inspection report.
(i) Concurrent with the manufacturer's final site inspection, the IPIA or the IPIA's agent must inspect all of the on-site work for homes completed using an approval under this section. The IPIA must use the inspection checklist approved by the DAPIA in accordance with § 3282.603(d)(9).
(ii) If the IPIA determines that the manufacturer is not performing adequately in conformance with the approval, the IPIA must redtag and reinspect until it is satisfied that the manufacturer is conforming to the conditions included in the approval. The home may not be occupied until the manufacturer and the IPIA have provided reports, required by this section, confirming compliance with the Construction and Safety Standards.
(iii) The IPIA must notify the manufacturer of the IPIA's acceptance of the manufacturer's final site inspection report. The IPIA may indicate acceptance by issuing its own final site inspection report or by indicating, in writing, its acceptance of the manufacturer's site inspection report showing that the work completed on-site is in compliance with the DAPIA approval and the Construction and Safety Standards.
(4) Within 5 business days of the date of IPIA's notification to the manufacturer of the acceptance of its final site inspection report, the manufacturer must provide to the purchaser or lessor, as applicable, the manufacturer's final site inspection report. For purposes of establishing the manufacturer's and retailer's responsibilities under the Act and subparts F and I of this part, the sale or lease of the manufactured home will not be considered complete until the purchaser or lessor, as applicable, has been provided with the report.
(e)
(2) The report must be consistent with the DAPIA approval issued pursuant to this section.
(3) The manufacturer must submit a copy of the report, or a separate listing
(a)
This home has been substantially completed at the factory and certified as having been constructed in conformance with the Federal Manufactured Home Construction and Safety Standards when specified work is performed and inspected at the home site. This on-site work must be performed in accordance with manufacturer's instructions that have been approved for this purpose. The work to be performed on-site is [insert description of all work to be performed in accordance with the construction and safety standards].
This notice may be removed by the purchaser or lessor when the manufacturer provides the first purchaser or lessor with a copy of the manufacturer's final site inspection report, as required by regulation. This final report must include the manufacturer's certification of completion. All manufactured homes may also be subject to separate regulations requiring approval of items not covered by the Federal Manufactured Home Construction and Safety Standards, such as installation and utility connections.
(b)
(c)
(d)
The IPIA, acting on behalf of HUD, for any manufacturer proceeding under this section is responsible for:
(a) Working with the manufacturer and the manufacturer's DAPIA to incorporate into the DAPIA-approved quality assurance manual for on-site completion any changes that are necessary to ensure that homes completed on-site conform to the requirements of this section;
(b) Providing the manufacturer with a supply of the labels described in this section, in accordance with the requirements of § 3282.362(c)(2)(i)(A);
(c) Overseeing the effectiveness of the manufacturer's quality control system for assuring that on-site work is completed to the DAPIA-approved designs, which must include:
(1) Verifying that the manufacturer's quality control manual at the installation site is functioning and being followed;
(2) Monitoring the manufacturer's system for tracking the status of each home built under the approval until the on-site work and necessary inspections have been completed;
(3) Reviewing all of the manufacturer's final on-site inspection reports; and
(4) Inspecting all of the on-site construction work for each home utilizing an IPIA inspector or an independent qualified third-party inspector acceptable to the IPIA and acting as the designee or representative:
(i) Prior to close-up, unless access panels are provided to allow the work to be inspected after all work is completed on-site; and
(ii) After all work is completed on-site, except for close-up;
(d) Designating an IPIA inspector or an independent qualified third-party inspector acceptable to the IPIA, as set forth under § 3282.358(d), who is not associated with the manufacturer and is not involved with the site construction or completion of the home and is free of any conflict of interest in accordance with § 3282.359, to inspect the work done on-site for the purpose of determining compliance with:
(1) The approved design or, as appropriate under § 3282.362(a)(1)(iii), the Construction and Safety Standards; and
(2) The DAPIA-approved quality assurance manual for on-site completion applicable to the labeling and completion of the affected manufactured homes;
(e) Notifying the manufacturer of the IPIA's acceptance of the manufacturer's final site inspection report (see § 3282.605(d)(3)(iii));
(f) Preparing final site inspection reports and providing notification to the manufacturer of its acceptance of the manufacturer's final site inspection report within 5 business days of preparing its report. The IPIA is to maintain its final site inspection reports and those of the manufacturer for a period of at least 5 years. All reports must be available for HUD and SAA review in the IPIA's central record office as part of the labeling records; and
(g) Reporting to HUD, the DAPIA, and the manufacturer if one or more homes has not been site inspected prior to occupancy or when arrangements for one or more manufactured homes to be site inspected have not been made.
A manufacturer proceeding under this section is responsible for:
(a) Obtaining DAPIA approval for completion of construction on-site, in accordance with § 3282.603;
(b) Obtaining the IPIA's agreement to perform on-site inspections as necessary under this section and the terms of the DAPIA's approval;
(c) Notifying the IPIA that the home is ready for inspection;
(d) Paying the IPIA's costs for performing on-site inspections of work completed under this section;
(e) Either before or at the time on-site work commences, providing the IPIA
(f) Satisfactorily completing all on-site construction and required repairs or authorizing a licensed contractor or similarly qualified person to complete all site construction and any needed repairs;
(g) Providing a written certification to the lessor or purchaser, when all site construction work is completed, that each home, to the best of the manufacturer's knowledge and belief, is constructed in conformance with the Construction and Safety Standards;
(h) Ensuring that the consumer notification requirements of § 3282.606 are met for any home completed under this subpart;
(i) Maintaining a system for tracking the status of homes built under the approval until the on-site work and necessary inspections have been completed, such that the system will assure that the work is performed in accordance with the quality control manual and other conditions of the approval;
(j) Ensuring performance of all work as necessary to assure compliance with the Construction and Safety Standards upon completion of the site work, including § 3280.303(b) of this chapter, regardless of who does the work or where the work is completed;
(k) Preparing a site inspection report upon completion of the work on-site, certifying completion in accordance with DAPIA-approved instruction and that the home conforms with the approved design or, as appropriate under § 3282.362(a)(1)(iii), the construction and safety standards;
(l) Arranging for an on-site inspection of each home upon completion of the on-site work by the IPIA or its authorized designee prior to occupancy to verify compliance of the work with the DAPIA-approved designs and the Construction and Safety Standards;
(m) Providing its final on-site inspection report and certification of completion to the IPIA and, after approval, to the lessor or purchaser and, as applicable, the appropriate retailer, and to the SAA upon request;
(n) Maintaining in its records the approval notification from the DAPIA, the manufacturer's final on-site inspection report and certification of completion, and the IPIA's acceptance of the final site inspection report and certification, and making all such records available for review by HUD in the factory of origin;
(o) Reporting to HUD or its agent the serial numbers assigned to each home completed in conformance with this section and as required by § 3282.552; and
(p) Providing cumulative quarterly production reports to HUD or its agent that include the site completion numeric identification number(s) for each home (see § 3282.603(d)(1)); the serial number(s) for each home; the HUD label number(s) assigned to each home; the retailer's name and address for each home; the name, address, and phone number for each home purchaser; the dates of the final site completion inspection for each home; and whether each home was inspected prior to occupancy.
(q) Maintaining copies of all records for on-site completion for each home, as required by this section, in the unit file to be maintained by the manufacturer.
(a) The DAPIA that issued an approval or the Secretary may revoke or amend, prospectively, an approval notification issued under § 3282.603. The approval may be revoked or amended whenever the DAPIA or HUD determines that:
(1) The manufacturer is not complying with the terms of the approval or the requirements of this section;
(2) The approval was not issued in conformance with the requirements of § 3282.603;
(3) A home produced under the approval fails to comply with the Federal construction and safety standards or contains an imminent safety hazard; or
(4) The manufacturer fails to make arrangements for one or more manufactured homes to be inspected by the IPIA prior to occupancy.
(b) The DAPIA must immediately notify the manufacturer, the IPIA, and HUD of any revocation or amendment of DAPIA approval.
In addition to other sanctions available under the Act and this part, HUD may prohibit any manufacturer or PIA found to be in violation of the requirements of this section from carrying out their functions of this Subpart in the future, after providing an opportunity for an informal presentation of views in accordance with § 3282.152(f). Repeated infractions of the requirements of this section may be grounds for the suspension or disqualification of a PIA under §§ 3282.355 and 3282.356.
If the manufacturer and IPIA, as applicable, complies with the requirements of this section and the home complies with the construction and safety standards for those aspects of construction covered by the DAPIA approval, then HUD will consider a manufacturer or retailer that has permitted a manufactured home approved for on-site completion under this section to be sold, leased, offered for sale or lease, introduced, delivered, or imported to be in compliance with the certification requirements of the Act and the applicable implementing regulations in this part 3282 for those aspects of construction covered by the approval.
42 U.S.C. 3535(d), 5403, 5404, and 5424.
(f) * * *
(2) In which the roof pitch of the hinged roof is less than 7:12, including designs incorporating peak cap construction or peak flip construction; and
Internal Revenue Service (IRS), Treasury.
Final regulations and removal of temporary regulations.
This document contains final regulations that address certain integrated transactions that involve a foreign currency denominated debt instrument and multiple associated hedging transactions. The regulations provide that if a taxpayer has identified multiple hedges as being part of a qualified hedging transaction, and the taxpayer has terminated at least one but less than all of the hedges (including a portion of one or more of the hedges), the taxpayer must treat the remaining hedges as having been sold for fair market value on the date of disposition of the terminated hedge.
Sheila Ramaswamy, at (202) 317–6938 (not a toll-free number).
On September 5, 2012, the Treasury Department and the IRS issued temporary regulations (TD 9598) (the “Temporary Regulations”) that revised the legging out rules of § 1.988–5(a)(6)(ii) applicable to hedging transactions under section 988(d). No public hearing was requested or held. One comment was received, which is available at
The only comment received on the Temporary Regulations suggested that the promulgation of the Temporary Regulations was unnecessary because the prior regulations did not support the taxpayer reporting position that the Temporary Regulations were designed to prevent. The comment considered the taxpayer position addressed in the Temporary Regulations to be inconsistent with both the purposes of section 988(d) and the economic substance of the transaction. Although the comment finds the Temporary Regulations ultimately unnecessary, it acknowledges that the section 988 hedging rules are a complicated area of law and that the prior regulations could be improved to provide greater certainty to taxpayers. The Treasury Department and the IRS have determined that the Temporary Regulations are useful in clarifying the section 988(d) integration rules—as well as in preventing unintended approaches to legging out under those rules—and thus should be adopted as final.
The comment recommended that the Treasury Department and the IRS consider aligning the hedge integration regime under section 988 with the approach taken in regulations under section 1275 on the basis that the section 1275 approach is more consistent with economic reality. The § 1.1275–6 regulations generally allow the integration of a qualifying debt instrument with a hedge or combination of hedges if the combined cash flows of the components are substantially equivalent to the cash flows on a fixed or variable rate debt instrument. However, a financial instrument that hedges currency risk cannot be integrated as a § 1.1275–6 hedge.
The Treasury Department and the IRS have determined that achieving greater alignment between the hedge integration regimes under sections 988 and 1275 is beyond the scope of this project and unnecessary to achieve the purpose of the Temporary Regulations. The limited purpose of the Temporary Regulations was to clarify the application of the legging out rules under § 1.988–5 to a particular fact pattern rather than to undertake a more general revision of those rules. When some of the hedge components of a qualified hedging transaction are disposed of on a leg-out date, deeming a disposition of all remaining components is sufficient to achieve a clear reflection of income. Continuing to treat the remaining components as integrated, as under the rule of § 1.1275–6, would represent a departure from the approach taken in the original § 1.988–5 regulations. Nonetheless, the Treasury Department and the IRS will continue to consider whether the hedge integration regimes under sections 988 and 1275 should be modified and brought into closer conformity.
As further support for the recommendation to achieve better alignment between §§ 1.988–5 and 1.1275–6, the comment also suggested that the provision in § 1.988–5T(a)(6)(ii)(F) of the Temporary Regulations, which was also included in the prior final regulations, would be unnecessary if the regulations were modified to conform to § 1.1275–6. Under § 1.988–5T(a)(6)(ii)(F), if a taxpayer legs out of a qualified hedging transaction and realizes a gain with respect to the debt instrument or hedge that is disposed of or otherwise terminated, then the taxpayer is not treated as legging out if during the period beginning 30 days before the leg-out date and ending 30 days after that date the taxpayer enters into another transaction that, taken together with any remaining components of the hedge, hedges at least 50 percent of the remaining currency flow with respect to the qualifying debt instrument that was part of the qualified hedging transaction. Section 1.988–5T(a)(6)(ii)(F) also provides a similar rule where a taxpayer has a qualified hedging transaction comprised of multiple components. In such a case, the taxpayer will not be treated as legging out of the qualified hedging transaction if the taxpayer terminates all or a part of one or more of the components and
The comment suggests that this provision of the section 988 hedging rules is unnecessarily complex, as well as incomplete because it does not cover situations in which, upon legging out, a taxpayer recognizes a loss on the debt instrument or hedge that is disposed of or otherwise terminated. However, as stated in this preamble, in issuing the Temporary Regulations, the Treasury Department and the IRS only sought to clarify the application of the section 988 hedging rules to a particular fact pattern and did not seek to undertake a more general revision of those rules. Accordingly, the Treasury Department and the IRS have determined that modifications to § 1.988–5T(a)(6)(ii)(F) are beyond the scope of this guidance project. However, the Treasury Department and the IRS will continue to consider whether any modifications to the rule are necessary or appropriate.
Finally, the comment also recommended that, even if the final regulations do not adopt the recommendation to align with the approach taken in § 1.1275–6, the Temporary Regulations should be modified to provide that, when an issuer of a qualifying debt instrument legs out but continues to be the obligor on the qualifying debt instrument, the issuer should be deemed to repurchase and reissue the debt instrument for its then fair market value. The Temporary Regulations instead provide that, in such a case, the debt instrument is “treated as sold for its fair market value.” The comment notes that the sale of a debt instrument has no tax consequences for the issuer of the instrument. The Treasury Department and the IRS agree that this aspect of the Temporary Regulations should be modified and, for the sake of consistency, these final regulations adopt the phrasing “treated as sold or otherwise terminated by the taxpayer for its fair market value,” which is used in § 1.988–5(a)(6)(i)(C) (regarding legging in).
The final regulations also update the dates in two existing examples, to be consistent with the applicability date of the revised legging out rules. Additionally, the final regulations reflect minor wording changes to the Temporary Regulations for purposes of improving clarity. The Treasury Department and the IRS do not intend these changes to be interpreted as substantive changes to the Temporary Regulations.
Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that these regulations will not have a significant impact on a substantial number of small entities. This certification is based upon the fact that these regulations merely clarify an existing standard and do not impose a collection of information on small entities. Accordingly, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding this regulation was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
The principal author of these regulations is Sheila Ramaswamy, Office of Associate Chief Counsel (International). However, other personnel from the IRS and the Treasury Department participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
The revisions and addition read as follows:
(a) * * *
(6) * * *
(ii)
(A) The transaction will be treated as a qualified hedging transaction during the time the requirements of this paragraph (a) were satisfied.
(B) If all of the instruments comprising the hedge (each such instrument, a component) are disposed of or otherwise terminated, the qualifying debt instrument is treated as sold or otherwise terminated by the taxpayer for its fair market value on the date the hedge is disposed of or otherwise terminated (the leg-out date), and any gain or loss (including gain or loss resulting from factors other than movements in exchange rates) from the identification date to the leg-out date is realized and recognized on the leg-out date. The spot rate on the leg-out date is used to determine exchange gain or loss on the debt instrument for the period beginning on the leg-out date and ending on the date such instrument matures or is disposed of or otherwise terminated. Proper adjustment must be made to reflect any gain or loss taken into account. The netting rule of § 1.988–2(b)(8) applies. See paragraph
(C) If a hedge has more than one component (and such components have been properly identified as being part of the qualified hedging transaction) and at least one but not all of the components that comprise the hedge has been disposed of or otherwise terminated, or if part of any component of the hedge has been terminated (whether a hedge consists of a single or multiple components), the date such component (or part thereof) is disposed of or terminated is considered the leg-out date and the qualifying debt instrument is treated as sold or otherwise terminated by the taxpayer for its fair market value in accordance with the rules of paragraph (a)(6)(ii)(B) of this section on such leg-out date. In addition, all of the remaining components (or parts thereof) that have not been disposed of or otherwise terminated are treated as sold by the taxpayer for their fair market value on the leg-out date, and any gain or loss from the identification date to the leg-out date is realized and recognized on the leg-out date. To the extent relevant, the spot rate on the leg-out date is used to determine exchange gain or loss on the remaining components (or parts thereof) for the period beginning on the leg-out date and ending on the date such components (or parts thereof) are disposed of or otherwise terminated. See paragraph (a)(9)(iv) of this section,
(D) If the qualifying debt instrument is disposed of or otherwise terminated in whole or in part, the date of such disposition or termination is considered the leg-out date. Accordingly, the hedge (including all components making up the hedge in their entirety) that is part of the qualified hedging transaction is treated as sold by the taxpayer for its fair market value on the leg-out date, and any gain or loss from the identification date to the leg-out date is realized and recognized on the leg-out date. To the extent relevant, the spot rate on the leg-out date is used to determine exchange gain or loss on the hedge (including all components thereof) for the period beginning on the leg-out date and ending on the date such hedge is disposed of or otherwise terminated.
(E) Except as provided in paragraph (a)(8)(iii) of this section (regarding identification by the Commissioner), the part of the qualified hedging transaction that has not been disposed of or otherwise terminated (that is, the remaining debt instrument in its entirety even if partially hedged, or the remaining components of the hedge) cannot be part of a qualified hedging transaction for any period after the leg-out date.
(F) If a taxpayer legs out of a qualified hedging transaction and realizes a net gain with respect to the debt instrument that is disposed of or otherwise terminated, then paragraph (a)(6)(ii)(B), (C), and (D) of this section, as appropriate, will not apply if during the period beginning 30 days before the leg-out date and ending 30 days after that date the taxpayer enters into another transaction that, taken together with any remaining components of the hedge, hedges at least 50 percent of the remaining currency flow with respect to the qualifying debt instrument that was part of the qualified hedging transaction or, if appropriate, an equivalent amount under the hedge (or any remaining components thereof) that was part of the qualified hedging transaction. Similarly, in a case in which a hedge has multiple components that are part of a qualified hedging transaction, if the taxpayer legs out of a qualified hedging transaction by terminating one such component or a part of one or more such components and realizes a net gain with respect to the terminated component, components, or portions thereof, then paragraphs (a)(6)(ii)(B), (C), and (D) of this section, as appropriate, will not apply if the remaining components of the hedge (including parts thereof) by themselves hedge at least 50 percent of the remaining currency flow with respect to the qualifying debt instrument that was part of the qualified hedging transaction. See paragraph (a)(9)(iv) of this section,
(9) * * *
(iv) * * *
(i) K is a domestic corporation with the U.S. dollar as its functional currency. On January 1, 2013, K borrows 100 British pounds (£) for two years at a 10% rate of interest payable on December 31 of each year with no principal payment due until maturity on December 31, 2014. Assume that the spot rate on January 1, 2013, is £1=$1. On the same date, K enters into two swap contracts with an unrelated counterparty that economically results in the transformation of the fixed rate £100 borrowing to a floating rate dollar borrowing. The terms of the swaps are as follows:
(A)
(
(
(B)
(ii) Assume that K properly identifies the pound borrowing and the swap contracts as a qualified hedging transaction as provided in paragraph (a)(8)(i) of this section and that the other relevant requirements of paragraph (a) of this section are satisfied.
(iii) On January 1, 2014, the spot exchange rate is £1=$2; the U.S. dollar LIBOR rate of interest is 9%; the market value of K's note in pounds has not changed; and K terminates swap #2. Because interest rates have increased from 8% to 9%, K will incur a loss of ($.92) (the present value of the ($1) difference between the 8% and 9% interest payments discounted at the current interest rate of 9%) with respect to the termination of such swap on January 1, 2014. Pursuant to paragraph (a)(6)(ii)(C) of this section, K must treat swap #1 as having been sold for its fair market value on the leg-out date, which is the date swap #2 is terminated. K must realize and recognize gain of $100.92 (the present value of £110 discounted in pounds to equal £100 × $2 ($200) less the present value of $108 ($99.08)). The loss inherent in the pound borrowing from January 1, 2013 to January 1, 2014 is realized and recognized on January 1, 2014. Such loss is exchange loss in the amount of $100 (the present value of £110 that was to be paid at the end of the year discounted at pound interest rates to equal £100 times the change in exchange rates: (£100 × $1, the spot rate on January 1, 2013)−(£100 × $2, the spot rate on January 1, 2014)). Pursuant to paragraph (a)(6)(ii)(E) of this section, except as provided in paragraph (a)(8)(iii) of this section (regarding identification by the Commissioner), the pound borrowing and currency swap cannot be part of a qualified hedging transaction for any period after the leg-out date.
(iv) Assume the facts are the same as in paragraph (iii) of this
(10) * * *
(iv)
(B) The rules of paragraph (a)(6)(ii) and
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Alaska (the State). The submission addresses transportation conformity and general conformity requirements. The EPA is approving the submission in accordance with the requirements of the Clean Air Act (the Act).
This rule is effective on November 9, 2015, without further notice, unless the EPA receives adverse comment by October 8, 2015. If the EPA receives adverse comment, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA–R10–OAR–2015–0447, by any of the following methods:
•
•
•
•
Karl Pepple at telephone number: (206) 553–1778, email address:
Throughout this document wherever “we”, “us” or “our” is used, it is intended to refer to the EPA. Information is organized as follows:
On September 27, 1995, the EPA approved the general conformity rules in Article 7 of the Alaska Administrative Code (AAC) Title 18, Chapter 50 into the Alaska SIP (60 FR 49765). General conformity is a requirement of section 176(c) of the CAA to ensure that no federally supported actions outside of highway and transit projects interfere with the purpose of the approved SIP,
On December 29, 1999, the EPA approved the transportation conformity rules in Article 7 of the Alaska Administrative Code (AAC) Title 18, Chapter 50 into the Alaska SIP (64 FR 72940). Transportation conformity is required under section 176(c) of the Act to ensure that federally supported highway, transit projects, and other activities are consistent with (“conform to”) the purpose of the SIP. Transportation conformity currently applies to areas that are designated nonattainment, and to areas that have been redesignated to attainment after 1990 (maintenance areas) with plans developed under section 175A of the Act, for the following transportation related criteria pollutants: Ozone, particulate matter (PM
On August 10, 2005, the “Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users” (SAFETEA–LU) transportation act was signed into law, and among other things, it amended the CAA to eliminate the requirement for states to adopt and submit general conformity SIPs. On April 5, 2010 (75 FR 17254), the EPA updated the general conformity SIP regulations to be consistent with the transportation act by eliminating the Federal regulatory requirement for states to adopt and submit general conformity SIPs. See 40 CFR 51.851. On May 7, 2015, with a supplementary letter received July 29, 2015, the Alaska Department of Environmental Conservation (ADEC) submitted a request to update the transportation conformity regulations and to remove the general conformity regulations from the Alaska SIP.
We reviewed the State of Alaska's (the State) transportation conformity and general conformity SIP submittal to ensure consistency with the current CAA, as amended by the transportation act, and EPA regulations governing state procedures for both transportation and general conformity.
Alaska's submittal revises transportation conformity criteria and procedures related to interagency consultation, and enforceability of certain transportation related control and mitigation measures. Alaska's SIP revision updates the State's transportation conformity provisions, Article 7 of the Alaska Administrative Code (AAC) Title 18, Chapter 50 (18 AAC 50), to be consistent with the Act as amended by SAFETEA–LU and EPA regulations (40 CFR part 93 and 40 CFR 51.390). The EPA has reviewed the submittal to assure consistency with the Act as amended by SAFETEA–LU and EPA regulations (40 CFR part 93 and 40 CFR 51.390) governing state procedures for transportation conformity and interagency consultation and has concluded that the submittal is approvable. Details of our review are set forth in a technical support document (TSD), which has been included in the docket for this action. Specifically, in the TSD, the EPA identifies how the submitted procedures, as clarified by the State's July 29, 2015, supplement, satisfy the requirements under 40 CFR 93.105 for interagency consultation with respect to the development of transportation plans and programs, SIPs, and conformity determinations, the resolution of conflicts, and the provision of adequate public consultation, and our requirements under 40 CFR 93.122(a)(4)(ii) and 93.125(c) for enforceability of control measures and mitigation measures.
Alaska's SIP revision also addresses general conformity requirements. The revision removes the general conformity regulations from the Alaska SIP. These
The EPA is approving and incorporating by reference into the Alaska SIP the revisions to 18 AAC 50 Article 7, Transportation Conformity, and supporting definitions in 18 AAC 50 Article 9, General Provisions, submitted by the State of Alaska on May 7, 2015, and supplemented on July 29, 2015. The revisions are State effective April 17, 2015. We note that we are not approving the revision to 18 AAC 50.735 because the State determined it was submitted in error, and requested in the July 29, 2015 supplement that the EPA not approve the revision. The State intends to rescind the rule section in the near future. We also note that the May 7, 2015 submittal included a number of rule revisions to 18 AAC 50 Articles 1 and 2, which are not related to transportation and general conformity. We intend to address those rule revisions in a separate action.
The EPA is approving but not incorporating by reference supplementary letter submitted by Alaska on July 29, 2015. The July 29, 2015 supplement clarifies that Alaska Statute (AS) 40.25.110 and AS 40.25.115, and implementing regulations at 2 AAC 96, Public Information, adequately address availability of materials and reasonable costs associated with access to public records with respect to Transportation Conformity.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is incorporating by reference the provisions set forth below. The EPA has made, and will continue to make, these documents generally available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104–4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 9, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
Environmental protection, Air pollution control, Carbon monoxide, General conformity, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Transportation conformity, Volatile organic compounds.
For the reasons stated in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions and additions read as follows:
(c) * * *
(e) * * *
Environmental Protection Agency (EPA).
Direct final rule; correction.
The Environmental Protection Agency (EPA) is correcting a direct final rule that appeared in the
Effective on September 8, 2015.
Kevin Gong, EPA Region IX, (415) 972–3073,
The EPA published a document in the
In FR Doc. 2015–16627 appearing on page 38964 in the
“(460) The following plan revision was submitted on September 29, 2014, by the Governor's designee.
(i) [Reserved]
(ii) Additional Material.
(A) Feather River Air Quality Management District.
(
National Institutes of Health, Department of Health and Human Services.
Final rule.
The National Institutes of Health (NIH), through the Department of Health and Human Services (HHS), is issuing regulations governing the National Institute on Minority Health and Health Disparities (NIMHD) endowment grants awarded to section 736 and section 464z–4 Centers of Excellence to facilitate minority health disparities research and other health disparities research.
This final rule is effective October 8, 2015.
Jerry Moore, NIH Regulations Officer, Office of Management Assessment, NIH, 6011 Executive Boulevard, Room 601, MSC 7669, Rockville, MD 20852; by email at
Section 464z–3 (42 U.S.C. 285t) of the Public Health Service (PHS) Act authorizes the Director of the NIMHD to carry out a program to facilitate minority health disparities research and other health disparities research by providing research endowments to eligible centers of excellence under sections 736 and 464z–4 of the PHS Act. The program is called the NIMHD Research Endowment Program (Endowment Program). The objective of the Endowment Program is to build research and training capacity and infrastructure at eligible section 736 health professions schools (42 U.S.C. 293) and section 464z–4 biomedical and behavioral research institutions (42 U.S.C. 285t–1) to facilitate minority health and other health disparities research to close the disparity gap in the burden of illness and death experienced by racial and ethnic minority Americans and other health disparity populations. Endowment Program activities may include strengthening the research
Section 464z–4 of the PHS Act authorizes the NIMHD Director to make awards to designated biomedical and behavioral research institutions, alone or as a participant in a consortium, that meet certain criteria for the purpose of assisting the institutions in supporting programs of excellence in training for individuals who are members of minority health disparity populations or other health disparity populations. This program is called the NIMHD Centers of Excellence Program. Section 464z–4(f) of the PHS Act permits the NIMHD Director to expend a portion of such an award for research endowment.
To be eligible to apply for the Endowment Program, Centers of Excellence (funded under section 736 or section 464z–4 of the PHS Act) must have an institutional endowment that is equal to or less than 50 percent of the national median of endowment funds at institutions that conduct similar biomedical research and training of health professionals. Endowment Program applications filed by institutions meeting eligibility requirements undergo peer review by outside experts to evaluate the scientific and technical merit of the proposed activities and the adequacy of the endowment fund management plan. Reviewers use the criteria of significance, investigators, innovation, approach, and environment to determine the overall impact of the application. After receiving an Endowment Program award, a grantee must provide documentation to the NIMHD over a 20-year period regarding endowment fund activity, including investments, income, and expenditures for activities consistent with its strategic plan.
This final rule specifies the endowment research grants or endowment portion of an award to which the regulations apply (section 52i.1), the definitions (section 52i.2), who is eligible (section 52i.3) and how to apply for a grant under the program (section 52i.5), and under what conditions an eligible institution that is a recipient may transfer to a foundation a research endowment grant (section 52i.4). Additionally, the final rule specifies how endowment grant applications will be evaluated (section 52i.6), the nature of the grant awards (52i.7), how much endowment fund income a grantee may withdraw and spend and for what purpose (sections 52i.9 and 52i.10), what a grantee must record and report (section 52i.11), and when and for what purposes a grantee may spend the endowment fund corpus (section 52i.8). This final rule also specifies what happens if a grantee fails to administer the research endowment grant in accordance with applicable regulations (section 52i.12), what other HHS policies and regulations apply (section 52i.13), and what additional conditions the NIMHD Director may impose when, in the Director's judgment, the conditions are necessary (section 52i.14).
NIH announced its intentions to take this rulemaking action, through HHS, in the notice of proposed rulemaking (NPRM) titled “National Institute on Minority Health and Health Disparities Research Endowments” published in the
Three respondents, two of whom submitted identical comments, expressed general support for the regulations. One of these respondents cited the importance of clarity regarding eligibility, the application process, and other required terms and conditions. The other two respondents discussed health disparities in the United States and research as a means to support health equity for all people in the United States. These supportive comments did not result in any necessary changes to this final rule.
One respondent stated that the Department of Health and Human Services (HHS) should require all municipalities and States that receive Federal funds from HHS for the provision of health care to notify HHS of the reasons for not considering or exploring solicited or non–solicited health disparities proposals they have received within 90 days. Since this comment is not related to any of the provisions of the Endowment Program, we did not consider the comment relevant to this rulemaking.
A fifth respondent provided comments addressing a number of issues relevant to the rulemaking, which are discussed below. This respondent requested clarification of the definition of a “Center of Excellence,” specifically, whether the act of receiving funds under section 736 or section 464z–4 is necessary for an institution to meet the definition of a Center of Excellence for purposes of the Endowment Program. The designation as a Center of Excellence for the purposes of the Endowment Program requires both receiving funding under section 736 or section 464z–4 of the Public Health Service Act and meeting certain specific nonfinancial institutional operational requirements as specified in section 736(c)(2)–(5) or section 464z–4(c)(1), respectively. The funding component of the definition in section 52i.2 is intended to clarify that an institution must be an active Center of Excellence under section 736 or section 464z–4 to be eligible for an endowment grant under this program. An institution is not eligible merely because it may be able to satisfy the nonfinancial requirements to qualify for funding under section 736 or section 464z–4.
This respondent also requested that institutions be allowed to apply for another Endowment Program grant prior to their last year of funding. We disagree with the comment. The intent of the language in the regulation is to prevent an eligible entity with an active award from having more than a single endowment grant at any given time.
This respondent additionally inquired whether awardee institutions may now directly conduct health disparities research projects instead of capacity building for the conduct of research projects because Endowment Program applications undergo scientific peer review. This is not the case. At the NIH, the peer review of applications determines the technical and scientific merit of the proposed project. The process of peer review does not in itself convey any meaning regarding the particular activities allowed under a grant program. The Endowment Program supports the development of research infrastructure and capacity which is the underpinning of the conduct of research projects.
This respondent raised concerns regarding the scientific peer review of applications and the expertise of the members of the review groups, suggesting that applicants be able to suggest potential candidates for each review group. We disagree with the comment. One of the hallmarks of the NIH is objective, peer review of applications for financial support. The organizational units within NIH that are responsible for the review of applications take deliberate steps to ensure that the reviewers have the appropriate expertise for the
This respondent also expressed the belief that requiring the endowment fund corpus to be maintained for 20 years after the end of the award period is too restrictive, suggesting that awardees be given greater flexibility and allowed to expend a proportion of the endowment fund corpus earlier than 20 years. We disagree with the comment. Institutional endowments, in general, are designed to create a long–term asset capable of generating income for an extended period of time. Since the focus of the Endowment Program is to build institutional capacity and infrastructure to conduct health disparities research, any diminution of the endowment corpus in the short–term would be at odds with the goals and objectives of the Endowment Program.
This respondent requested clarity on what actions would satisfy the requirement that awardees take “appropriate actions” in cases where the investments have eroded into the value of the endowment corpus. We have not specified a strict definition for “appropriate actions” in order to allow each institution the flexibility to manage their endowment funds effectively. Certainly, a review and change of investment strategy to a more conservative approach would be an option. A temporary suspension of investment due to adverse market conditions could also be an appropriate action. We did not want to be prescriptive, but would expect actions to be reasonable and consistent with prevailing practices in the management of institutional endowments.
This respondent also inquired as to whether management costs for the endowment fund can be paid from the endowment fund itself. Section 52i.11(a)(4) of the proposed rule provided that expenses and charges associated with the management of the endowment funds may be paid from “the grant funds.” Since the endowment fund corpus cannot be used for this purpose, section 52i.11(a)(4) has been amended to replace “the grant funds” with “endowment fund income” to clarify the issue. Awardees are expected to ensure that those costs are appropriately recorded.
This respondent suggested adding a reference to an “institution's policies and procedures” to section 52i.9(b) regarding the expenditure of endowment fund income. We disagree with the comment. Section 52i.7(b) already specifies the need for the awardee to adhere to the institution's spending rules and policies, provided that such spending rules are not inconsistent with applicable federal regulations and policies.
This respondent requested clarification on the timing for the filing of the final Financial Status Report under section 52.11(d). Upon approval of an application for the Endowment Program, NIMHD agrees to provide financial support for a specified project period, usually five years. Due to the unique nature of the program, it is reasonable for the long–term reporting requirement to begin at the end of the project period. To clarify the filing requirement, section 52i.11(d) has been amended to replace “date of the original award” with “end of the project period.” In addition, sections 52i.7(e) and 52i.8(a) have been amended in a consistent manner to replace “date of award” with “end of the project period.”
Finally, with regard to actions that may be taken if a grantee fails to administer the endowment in accordance to the regulations, this respondent believes that the awardee should be given an opportunity to rectify an error, unless such an error or failure was intentional. We agree with the comment with the following qualification. The specific language in section 52i.12 is consistent with the financial stewardship responsibilities of the Federal government. The opportunity for a full and fair hearing is provided and the Director of NIMHD has discretion regarding any action to be taken depending on the circumstances of the breach in responsibilities. Limiting the range of actions available to the NIH in situations of an awardee's poor endowment fund management, even if non–intentional, would not be appropriate.
The published NPRM contained two typographical errors that have been corrected in this final rule. First, under the definition of “endowment fund” in section 52i.2, the reference to “section 464z–4” should have been “section 464z–3” of the PHS Act. Second, in the discussion of the sections of the proposed regulations that contain requirements subject to the Paperwork Reduction Act of 1995, the reference to section “52i.9” should have been specified as section “52i.9(b)”. That error has been corrected in the final rule, consistent with the correct identification of section 52i.9(b) in the Reporting part of the Estimated Annual Reporting and Recordkeeping Burden table included in the NPRM and this final rule. The published NPRM contained a table on the cost burdens for reporting and recordkeeping for the NIMHD Research Endowment Program. In the final rule it has been labeled “ESTIMATED ANNUALIZED COST BURDEN TO THE RESPONDENTS FOR REPORTING AND RECORDKEEPING UNDER THE NIMHD RESEARCH ENDOWMENT PROGRAM.” An additional column (designated as the 4th) was added to the table as “Average Burden per Respondents (in hours)” and columns 1, 2 3, 5, and 6 were re–titled as “Final Rule Citations,” “Number of Respondents,” Number of Responses per Respondent,” “Hourly Wage Rate,” and “Total Cost Burden,” respectively. The dollar amounts in the Hourly Wage Rate column were edited to reflect the actual cost per hour for responses. In addition, the footnotes for the table were edited to be consistent with the table.
The Regulatory Flexibility Act section of the final rule has been revised to clarify that while all eligible institutions are considered small entities, the impact of the final rule will not exceed five percent of revenues of the entities.
We have examined the impacts of this rule as required by Executive Order 12866, Regulatory Planning and Review (September 30, 1993); Executive Order 13563, Improving Regulation and Regulatory Review (January 18, 2011); the Regulatory Flexibility Act (5 U.S.C. 601–612); the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4); and Executive Order 13132, Federalism (August 4, 1999).
Executive Order 12866, Regulatory Planning and Review, directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in one year). Based on our analysis, we believe that the final rule does not constitute an economically significant regulatory action. Additionally, if a regulatory action is deemed to fall within the scope of the definition of the term “significant regulatory action” contained in section 3(f) of Executive Order 12866, pre–publication review by the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) is required. This final
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
The final rule will add transparency for potential applicants regarding who is eligible and how to apply for a grant under the program, how grant applications will be evaluated, and under what conditions an eligible institution that is a recipient may transfer to a foundation a research endowment grant. Additionally, the final rule specifies the nature of the grants, how much endowment fund income a grantee may withdraw and for what purpose, what a grantee must record and report, and when and for what purposes a grantee may spend the endowment fund corpus.
This final rule also enhances compliance and effective fiduciary responsibilities for the federal government. It specifies what happens if a grantee fails to administer the research endowment grant in accordance with applicable regulations, what other HHS policies and regulations apply, and additional conditions the NIMHD Director may impose when, in the Director's judgment, the conditions are necessary. The Director may, with respect to any grant award, impose additional conditions prior to, or at the time of, any award when in the Director's judgment the conditions are necessary to ensure the carrying out of the purposes of the award, the interests of the public health, or the conservation of grant funds.
Based on the provisions of the PHS Act, approximately twelve Institutions of Higher Education (IHEs) are eligible for the NIMHD Research Endowment Program. Costs for participation can be subdivided into those associated with the application process and those required for the necessary recordkeeping. The application process includes a competitive submission, as well as noncompetitive progress report for those institutions awarded funds under the NIMHD Research Endowment Program for subsequent years within the project period. Based on estimates provided in the PHS 424 instructions, an average application should require approximately 22 hours to complete and 15 hours for a subsequent progress report, according to the PHS 2590 instructions. The contribution of various professional disciplines such as biomedical researchers, contract/grants specialists, and technical staff to the reporting and recordkeeping requirements varies. Cost estimates are based on a blended analysis of institutional salary structure and prevailing market conditions for certain categories of personnel. In addition, fiscal year 2012 NIH salary limitations were included in the derivation of cost estimates, where applicable.
The unique and complex nature of the NIMHD Research Endowment Program with regard to the management of endowment funds, restrictive nature of expenditures, and strict reporting provides a challenge to the necessary federal oversight. The final rule provides the guidelines for the creation of an operation structure of the institutional program. The implementation of the final rule will provide clarity to eligible and participating institutions with regard to expectations as a grantee under the program, as well as enhance the ability of the federal government to ensure the grantees are in compliance with all the applicable provisions of the statute.
The Regulatory Flexibility Act (5 U.S.C. 601–612) requires agencies to analyze regulatory options that would minimize any significant impact of the rule on small entities. For the purposes of this analysis, small entities include small business concerns as defined by the Small Business Administration, usually businesses with fewer than 500 employees. Also a nonprofit entity is defined by the Regulatory Flexibility Act as small if it is not dominant in its field, regardless of the number of employees. Eligibility requirements of the Research Endowment program, as codified in Public Law 111–148, limits the universe of potential applicants to approximately twelve institutions of higher education (IHEs). Utilizing sources of information such as local business bureaus, workforce statistics, and institution Web sites, a reasonable determination was made as to the approximate number of employees at eligible institutions. The range estimates are from 175–550 for the smallest institution to 3,976 for the largest and none are considered dominant in their field. While all eligible institutions are considered small entities, the impact of the final rule will not exceed five percent of revenues of the entities. Accordingly, the Secretary certifies that this rule will not have a significant impact on a significant number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation [with base year of 1995]) in any 1 year.” The current inflation-adjusted statutory threshold is approximately $141 million based on the Bureau of Labor Statistics inflation calculator. The Secretary certifies that this rule does not mandate any spending by state, local or tribal government in the aggregate or by the private sector. Participation in the NIMHD Research Endowment Program is voluntary and not mandated.
Executive Order 13132, Federalism, requires federal agencies to consult with state and local government officials in the development of regulatory policies with federalism implications. The Secretary reviewed this rule as required under the Executive Order and determined that it does not have federalism implications. The Secretary certifies that this rule will not have an effect on the states or on the distribution of power and responsibilities among the various levels of government.
This rule contains requirements that are subject to OMB approval under the Paperwork Reduction Act of 1995, as amended (44 U.S.C. chapter 35). Sections 52i.3(b)(2), 52i.4(a), 52i.4(c), 52i.5(a), 52i.9(b), 52i.11(b), and 52i.11(d) contain reporting and information collection requirements that are subject to OMB approval under the Paperwork Reduction Act. Sections 52i.10, 52i.11(a)(1), 52i.11(a)(2), 52i.11(a)(3), 52i.11(a)(4), and 52i.11(b) contain recordkeeping requirements that are subject to OMB review under the Paperwork Reduction Act. The title, program description, and respondent description of the information collection and recordkeeping requirements contained in this rule will be submitted to OMB for review. Organizations and individuals can submit comments on the information collection and recordkeeping requirements, including the burden estimates, to: (1) Seleda Perryman, Project Clearance Officer, National Institutes of Health, Rockledge Center 1, 6705 Rockledge Drive, Room 3509, Bethesda, MD 29817, telephone 301–594–7949 (not a toll-free number); and (2) the Office of Information and Regulatory Affairs, OMB, OIRA_submission@omb.eop or by fax to 202–395–6974, and mark “Attention: Desk Officer for the National Institutes of Health, Department of Health and Human Services.” After we obtain OMB approval, we will publish the OMB control number in the
The Catalogue of Federal Domestic Assistance-numbered program applicable to this rule is: 93.307—Minority Health and Health Disparities Research.
Grant programs—Health, Medical research.
For reasons described in the preamble, title 42 of the Code of Federal Regulations is amended by adding part 52i to read as follows.
42 U.S.C. 216, 285t–285t–1.
This part applies to grants awarded under section 464z–3(h) of the Public Health Service Act (the Act), which authorizes the Director of the National Institute on Minority Health and Health Disparities (NIMHD) to carry out a program of research endowment grants to eligible institutions to facilitate minority health and health disparities research (the NIMHD Research Endowment Program), and, with the exception of §§ 52i.5 and 52i.6, applies to that portion of an award made under section 464z–4(f) of the Act authorized by the NIMHD Director for research endowment.
As used in this part:
(1) Unique to, more serious, or more prevalent in such individuals;
(2) For which the factors of medical risk or types of medical intervention may be different for such individuals, or for which it is unknown whether such factors or types are different for such individuals; or
(3) With respect to which there has been insufficient research involving such individuals as subjects or insufficient data on such individuals.
(a) To be eligible for a grant under section 464z–3(h) of the Act an applicant:
(1) Must be a Center of Excellence under section 736 (42 U.S.C. 293) or section 464z–4 (42 U.S.C. 285t–1) of the Act, and
(2) Must have an institutional endowment that is equal to or less than 50 percent of the national median of endowment funds at institutions that conduct similar biomedical research and training of health professionals.
(b) To be eligible for a portion of a grant award to be expended as a research endowment under section 464z–4(f) of the Act, an applicant:
(1) Must be a designated biomedical and behavioral research institution under section 464z–4 of the Act, and
(2) Must submit those materials prescribed by the Director, NIMHD.
A number of universities and other organizations have established closely affiliated, but separately incorporated, organizations to facilitate the administration of research and other programs supported by federal funds. Such legally independent entities are often referred to as “foundations,” although this term does not necessarily appear in the name of the organization. An institution awarded an endowment grant under section 464z–3(h) of the Act or using designated grant funds for endowment purposes under section 464z–4(f) of the Act may designate a foundation associated with the institution to receive the endowment funds only for investment purposes if:
(a) The institution assures in its application that the foundation is legally authorized to receive the endowment funds and to administer the endowment funds in accordance with the regulations set forth in this part;
(b) The foundation agrees to administer the endowment funds in accordance with the regulations in this part;
(c) The institution agrees to be liable for any violation by the foundation of any applicable regulation, including any violation resulting in monetary liability; and
(d) The grantee institution has control and is responsible for the administration of the grant accounts.
(a) Each institution interested in applying for a grant under section 464z–3(h) of the Act must submit an application at such time and in such form and manner as the Secretary may prescribe.
(b) An institution described in § 52i.3 that has received a grant under this part may apply for another grant under this part if:
(1)(i) The institution still meets the eligibility requirements in § 52i.3; and
(ii) The institution is in the last year of funding provided by NIH under this part; or
(2) The institution no longer has an active grant under this part from NIH.
All applications filed in accordance with this part and meeting the minimal eligibility requirements shall be evaluated and recommended by technical and scientific peer review. The review evaluation shall take into account, among other pertinent factors:
(a) The scientific and technical merit of the proposed project to facilitate minority health disparities research and other health disparities research;
(b) The likelihood of its producing meaningful results;
(c) The adequacy of the applicant's resources available for the project; and
(d) The adequacy of the applicant's plan for managing the endowment fund.
(a) Within the limits of funds, and upon such review and recommendation as may be required by law, the Director shall award a grant to those applicants whose approved projects will in the Director's judgment best promote the purposes of this part.
(b) An institution described in § 52i.3 that receives a grant under this part or an institution described in section 464z–4(f) of the Act authorized to use grant funds for endowment purposes shall follow the spending rules under the law of the state in which the institution is located and the spending rules/policies adopted by the recipient institution, provided that such spending rules are not inconsistent with applicable federal regulations/policies.
(c) Grants awarded under this part or grant funds designated for endowment purposes as described under section 464z–4(f) of the Act must be invested no later than 90 days after the start date of the grant.
(d) The institution, in investing the endowment fund established under this section, shall exercise the judgment and care, under the circumstances then prevailing, that a person of prudence, discretion, and intelligence would exercise in the management of such person's own affairs and avoid all appearances of conflict of interest in the management of this fund.
(e) The total amount of an endowment grant under this part or the designated amount of the grant under section 464z–4(f) of the Act must be maintained as corpus by the institution for 20 years from the end of the project period.
(f) In the case of situations in which investment conditions result in the corpus referred to in paragraph (e) of this section having a net market value less than the value of the funds at the time of their receipt, appropriate actions must be taken (
(g) An institution described in § 52i.3 receiving an endowment grant under section 464z–3(h) of the Act may not simultaneously receive endowment funds under section 464z–4(f) of the Act.
(h) Consistent with section 464z–4(f) of the Act, the Director, NIMHD, may designate for a research endowment some of the funds awarded to a Center of Excellence for research education and training.
(a) A grantee may not withdraw or spend any part of the endowment fund corpus for a total of 20 years from the end of the project period.
(b) At the end of the 20-year period, during which the endowment corpus must be maintained, the grantee institution is encouraged to preserve the endowment fund corpus but may use the endowment fund corpus for any
(a) Any endowment income realized in the initial year following the grant award under this part shall not be expended to support programmatic activities until after conclusion of the initial year of the grant.
(b) After the first year of the grant, a grantee awarded funds under this part may spend endowment income realized from funds it receives solely in accordance with the regulations of this part, the terms and conditions of the award, NIMHD policies and procedures, and the grantee's strategic plan that has been approved by the NIMHD and includes priorities for the use of the endowment fund income.
A grantee awarded funds under this part shall calculate the amount of endowment fund income that it may withdraw and spend at a particular time as follows:
(a) On each date that the grantee plans a withdrawal of endowment fund income, the grantee must determine the amount of the income by calculating the value of the fund that exceeds the endowment fund corpus.
(b) If the total value of the endowment fund exceeds the endowment fund corpus, the grantee may withdraw and spend the excess amount,
A grantee awarded funds under this part shall:
(a) Maintain appropriate records in compliance with this part and other requirements as referenced in terms of the award, including documentation of:
(1) The type and amount of investments of the endowment fund;
(2) The amount of endowment fund income and corpus;
(3) The amount and purpose of expenditures of endowment fund income; and
(4) The expenses and charges associated with the management of the endowment funds if such expenses and charges were paid from endowment fund income.
(b) Retain records in accordance with 45 CFR 74.53. The endowment fund corpus, fund income, and fund expenditures must be reported over a 20-year period, and supporting records are to be retained for 3 years after the submission of the final report to the NIMHD;
(c) Permit authorized officials the authority to conduct a review, as set forth in 45 CFR 74.53(e) (which states that the Department of Health and Human Services (HHS) awarding agencies, the HHS Inspector General, the U.S. Comptroller General, and any of their duly authorized representatives “have the right of timely and unrestricted access to any books, documents, papers, or other records of recipients that are pertinent to the awards, in order to make audits, examinations, excerpts, transcripts, or copies of such documents”); and
(d) Submit Financial Status Reports, as set forth in 45 CFR 74.52, as required by the NIMHD and in the form prescribed. A final Financial Status Report shall be required 20 years after the end of the project period.
(a) The Director, after giving notice and an opportunity for a hearing, may authorize the termination of a grant awarded and/or recovery of funds under this part during the 20-year period if the grantee:
(1) Withdraws or spends any part of the endowment fund corpus in violation of this part;
(2) Spends any portion of the endowment fund income not permitted to be spent in this part;
(3) Fails to invest the endowment fund corpus in accordance with the investment standards set forth in this part;
(4) Fails to meet the requirements in § 52i.7; or
(5) Otherwise fails to comply with the terms and conditions of the award.
(b) Recovery of funds may include up to the amount of endowment awards plus any income earned.
Several other regulations and policies apply to grants under this part. These include, but are not limited to:
(a) 2 CFR part 376—HHS Nonprocurement debarment and suspension.
(b) 42 CFR part 50, subpart D—Public Health Service grant appeals procedure.
(c) 42 CFR part 93—Public Health Service policies on research misconduct.
(d) 45 CFR part 16—Procedures of the Departmental Grant Appeals Board.
(e) 45 CFR part 46—Protection of human subjects.
(f) 45 CFR part 74—Uniform administrative requirements for awards and subawards to institutions of higher education, hospitals, other nonprofit organizations, and commercial organizations; and certain grants and agreements with states, local governments, and Indian tribal governments.
(g) 45 CFR part 80—Nondiscrimination under programs receiving federal assistance through the Department of Health and Human Services effectuation of Title VI of the Civil Rights Act of 1964.
(h) 45 CFR part 81—Practice and procedure for hearings under part 80 of this chapter.
(i) 2 CFR part 382—Requirements for drug-free workplace (financial assistance).
(j) 45 CFR part 84—Nondiscrimination on the basis of handicap in programs or activities receiving federal financial assistance.
(k) 45 CFR part 86—Nondiscrimination on the basis of sex in education programs or activities receiving federal financial assistance.
(l) 45 CFR part 91—Nondiscrimination on the basis of age in programs or activities receiving federal financial assistance from HHS.
(m) 45 CFR part 92—Uniform administrative requirements for grants and cooperative agreements to State, local, and tribal governments.
(n) 45 CFR part 93—New restrictions on lobbying.
(o) NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules at
(p) NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research at
(q) NIH Grants Policy Statement (October 1, 2013). This version is located on the NIH Web site at
(r) Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, NIH (Revised August 2002). [Note: this policy is subject to change, and interested persons should contact the Office of Laboratory Animal Welfare, NIH, Rockledge 1, Suite 360, MSC 7982, 6705 Rockledge Drive, Bethesda, MD 20892–7982 (telephone 301–594–2382, not a toll-free number), to obtain references to the current version and any amendments. Information may be obtained also via the OLAW Web site at
The Director may, with respect to any grant award, impose additional conditions prior to, or at the time of, any award when in the Director's judgment the conditions are necessary to ensure the carrying out of the purposes of the award, the interests of the public health, or the conservation of grant funds.
Federal Communications Commission.
Final rule.
The Federal Communications Commission (the Commission) acts to improve the Commission's efficiency, effectively manage Commission resources, and align the Commission's field enforcement activities with contemporary needs for a field enforcement presence. The Commission, the Office of Managing Director and the Enforcement Bureau will take several actions to realign the mission and resources of its 24 field offices. The Bureau's field offices will primarily support the enforcement of the Commission's radio frequency spectrum rules and other key regulations in a manner likely to have the greatest impact, in the most cost effective way possible.
Effective September 8, 2015.
William Davenport, Enforcement Bureau, (202) 418–1034.
This is a summary of the Commission's Order; FCC 15–81, adopted and released on July 16, 2015. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY–A257, 445 12th Street SW., Washington, DC 20554 or at the following Internet address:
1. Through this Order, we act to improve the Commission's efficiency, effectively manage Commission resources, and align the Commission's field enforcement activities with contemporary needs for a field enforcement presence. With its 24 field offices (“Field”) and Equipment Development Group, the Enforcement Bureau resolves interference issues, assists with disaster recovery, and enforces technical compliance with Commission rules and the Communications Act. The current model of the Field was adopted approximately 20 years ago.
2. The Commission has determined to make changes to the Field in order to create a more effective organization within the limits of our budgetary constraints. By this action we restructure the Enforcement Bureau's field operations to implement the changes. The Field reorganization will better align the Field's mission with the priorities of the Commission, increase efficiency in terms of both employee performance and management oversight, and enable updating the employee skillset and equipment deployed in the Field. We take this action after extensive outreach to internal and external stakeholders, including a survey of field personnel and interviews with field staff, current and former management, outside experts, regulatees, and other government agencies. We also reviewed field operations by other federal agencies and examined the Bureau's enforcement activity database to assess the Field's caseload, efficiency, and effectiveness.
3. Based on that comprehensive review, the Commission, the Office of Managing Director and the Enforcement Bureau will take several actions to realign the mission and resources of the Field. The Bureau's field offices will primarily support the enforcement of the Commission's radiofrequency interference requirements and other key rules. These enforcement efforts will be guided by the priorities of the Commission and the Enforcement Bureau and occur in the manner likely to have the greatest impact, in the most cost effective way possible.
4. The Field will embark on a program to update its equipment and employee skillset to address the likely issues that will accompany new and expanded uses of spectrum. This program will include the expanded use of remotely operated monitoring equipment to supplement field staff, as well as the identification and use of portable devices capable of assessing interference issues in bands expected to experience heavy spectrum use. Upon completion of all required implementation steps, the Commission will first apply the net savings resulting from this reorganization effort to this
5. The Bureau will close its field offices in or near Anchorage, Alaska; Buffalo, New York; Detroit, Michigan; Houston, Texas; Kansas City, Missouri; Norfolk, Virginia; Philadelphia, Pennsylvania; San Diego, California; San Juan, Puerto Rico; Seattle, Washington; and Tampa, Florida. Relatedly, the Enforcement Bureau field offices in or near Atlanta, Georgia; Columbia, Maryland; and San Francisco, California will relocate to FCC-owned properties nearby or in the same metropolitan areas. In addition, recognizing that current work volume does not require full-time employees, the Bureau will contract with local personnel to maintain a field presence in Alaska and Puerto Rico and will also periodically dispatch field agents to Kansas City, Missouri.
6. All Bureau field agents shall have electrical engineering backgrounds.
7. The relocated offices identified in paragraph 5 and the remaining offices in or near New York City, New York; Miami, Florida; Dallas, Texas; Chicago, Illinois; Boston, Massachusetts; Denver, Colorado; Honolulu, Hawaii; New Orleans, Louisiana; Portland, Oregon; and Los Angeles, California will be staffed and equipped to maintain the Commission's Field program.
8. Within 6 weeks of release of this Order, the Bureau will establish procedures for industry and public safety complainants to escalate their complaints within the Field organization.
9. The Commission will continue to work with outside stakeholders to develop a comprehensive policy and enforcement approach to the issue of unlicensed radio broadcasting.
10. The Commission will implement a nationwide outplacement effort to assist all displaced employees to find positions in the public or private sectors, including other vacancies within the Commission for which they are qualified and selected.
11. The amendments adopted herein pertain to agency organization, procedure, and practice. Some of the amendments are administrative updates to rules that were inadvertently not revised during prior agency organization efforts.
This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104–13.
The Commission will not send a copy of this Order pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A), because the adopted rules pertain to agency organization, procedure, and practice.
12. Accordingly, It is ordered that, pursuant to Sections 4(f)(1), 4(g), 4(i), 5(b), 5(c)(1) and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(f)(1), (g), (i), 155(b), 155(c)(1), and 303(r) the Enforcement Bureau's Field operations be restructured.
13. It is further ordered that the field offices in or near Anchorage, Alaska; Buffalo, New York; Detroit, Michigan; Houston, Texas; Kansas City, Missouri; Norfolk, Virginia; Philadelphia, Pennsylvania; San Diego, California; San Juan, Puerto Rico; Seattle, Washington; and Tampa, Florida be closed. The Bureau will contract with local personnel to maintain a field presence in Alaska and Puerto Rico and will also periodically dispatch field agents to Kansas City, Missouri.
14. It is further ordered that the Enforcement Bureau relocate field offices in or near Atlanta, Georgia; Columbia, Maryland; and San Francisco, California to nearby FCC-owned properties.
15. It is further ordered that all Enforcement Bureau field agents shall have electrical engineering backgrounds.
16. It is further ordered that the Commission devote resources to provide its field staff with the training and equipment to address new interference threats in bands that are currently in use, as well as bands that are not yet widely utilized. The equipment should focus on portable, cost-effective devices as well as remotely-operated spectrum monitoring equipment deployable on a permanent or temporary basis. Upon completion of all required implementation steps, the Commission will first apply the net savings resulting from this reorganization effort to this program, before applying those monies to the agency's general fund. The net savings will not be used to increase the number of full time non-field-related employees in the headquarters office of the Enforcement Bureau.
17. It is further ordered that, within 6 weeks of release of this Order, the Enforcement Bureau will establish procedures for industry and public safety complainants to escalate their complaints within the Field organization.
18. It is further ordered that the Commission will continue to work with outside stakeholders to develop a comprehensive policy and enforcement approach to the issue of unlicensed radio broadcasting.
19. It is further ordered that the Commission implement a nationwide outplacement effort to assist all displaced employees to find positions in the public or private sectors, including other vacancies within the Commission for which they are qualified and selected.
20. It is further ordered that effective upon publication of this Order in the
Organization and functions (Government agencies), Reporting and recordkeeping requirements.
Disaster assistance, Radio.
Radio.
Communications equipment, Reporting and recordkeeping requirements.
Medical devices, Reporting and recordkeeping requirements, Scientific equipment.
Communications equipment, Radio, and Reporting and recordkeeping requirements.
Radio, Reporting and recordkeeping requirements, and Television.
Cable television, Reporting and recordkeeping requirements.
Vessels, Marine safety, and Reporting and recordkeeping requirements.
Communications equipment, Radio.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 0, 2, 11, 15, 18, 73, 74, 76, 78, 80, 90, 95, and 97 as follows:
Sec. 5, 48 Stat. 1068, as amended; 47 U.S.C. 155, 225, unless otherwise noted.
The Consumer and Governmental Affairs Bureau has primary responsibility for addressing individual informal complaints from consumers against common carriers (wireline, wireless and international) and against other wireless licensees, and informal consumer complaints involving access to telecommunications services and equipment for persons with disabilities. The International Bureau has primary responsibility for complaints regarding international settlements rules and policies.
The Consumer and Governmental Affairs Bureau has primary responsibility for addressing individual informal complaints from consumers against non-common carriers subject to the Commission's jurisdiction under Title II of the Communications Act and related provisions.
The Media Bureau has primary responsibility for complaints regarding children's television programming requirements, and for political and related programming matters and equal employment opportunity matters involving broadcasters, cable operators and other multichannel video programming distributors. The relevant licensing Bureau has primary responsibility for complaints involving tower sitting and the Commission's environmental rules. The Media Bureau has primary responsibility for complaints regarding compliance with conditions imposed on transfers of control and assignments of licenses of Cable Television Relay Service authorizations.
The Regional Directors are delegated authority to act upon applications, requests, or other matters, which are not in hearing status, and direct the following activities necessary to conduct investigations or inspections:
The application, authorization, and other appropriate files of the Enforcement Bureau are designated as the Commission's official records of action taken pursuant to authority delegated under §§ 0.311 and 0.314, and shall constitute the official Commission minutes entry of such actions. The official records of action are maintained in the Reference Information Center in the Consumer and Governmental Affairs Bureau.
(a) * * *
(4) For the locations of the field offices, contact the Enforcement Bureau.
All forms for use in submitting applications for radio authorization, together with instructions and information as to filing such forms, may be obtained at
(a) * * *
(2) Individuals may request that copies of records be sent directly to them. In such cases, individuals must verify their identity as described in § 0.554(b)(2) and provide an accurate return mailing address or email address. Records shall be sent only to that address.
47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted.
US270 * * *
(a) The peak envelope power of an amateur station shall not exceed 50 watts in the following areas, unless expressly authorized by the FCC after mutual agreement, on a case-by-case basis, between the Regional Director of the applicable field office and the military area frequency coordinator at the applicable military base. For areas (5) through (7), the appropriate military coordinator is located at Peterson AFB, CO.
(a) That as soon as possible after the beginning of such emergency use, notice be sent to the Public Safety and
(c) That the Public Safety and Homeland Security Bureau of the Commission at Washington, D.C., shall be notified immediately when such special use of the station is terminated: Provided further,
47 U.S.C. 151, 154(i) and (o), 303(r), 544(g) and 606.
(c) If repair or replacement of defective equipment is not completed within 60 days, an informal request shall be submitted to the Regional Director of the FCC field office serving the area in which the EAS Participant is located, or in the case of DBS and SDARS providers to the Regional Director of the FCC field office serving the area where their headquarters is located, for additional time to repair the defective equipment. This request must explain what steps have been taken to repair or replace the defective equipment, the alternative procedures being used while the defective equipment is out of service, and when the defective equipment will be repaired or replaced.
47 U.S.C. 154, 302a, 303, 304, 307, 336, 544a, and 549.
(d) A custom built telemetry intentional radiator operating in the frequency band 88–108 MHz and used for experimentation by an educational institute need not be certified provided the device complies with the standards in this part and the educational institution notifies the Office of Engineering and Technology, in writing, in advance of operation, providing the following information:
47 U.S.C. 4, 301, 302, 303, 304, 307.
(b) If the operator of ISM equipment is notified by the Commission's Regional Director that operation of such equipment is endangering the functioning of a radionavigation or safety service, the operator shall immediately cease operating the equipment. Operation may be resumed on a temporary basis only for the purpose of eliminating the harmful interference. Operation may be resumed on a regular basis only after the harmful interference has been eliminated and approval from the Regional Director obtained.
(c) When notified by the Regional Director that a particular installation is causing harmful interference, the operator or manufacturer shall arrange for an engineer skilled in techniques of interference measurement and control to make an investigation to ensure that the harmful interference has been eliminated. The Regional Director may require the engineer making the investigation to furnish proof of his or her qualifications.
(a) An interim report on investigations and corrective measures taken pursuant to § 18.115 of this part shall be filed with the Regional Director of the local FCC office within 30 days of notification of harmful interference. The final report shall be filed with the Regional Director within 60 days of notification.
(b) The date for filing the final report may be extended by the Regional Director when additional time is required to put into effect the corrective measures or to complete the investigation. The request for extension of time shall be accompanied by a progress report showing what has been accomplished to date.
47 U.S.C. 154, 303, 334, 336, and 339.
(c) * * *
(2) If conditions beyond the control of the licensee prevent the restoration of the meter to service within the above allowed period, informal request in accordance with § 73.3549 may be filed for such additional time as may be required to complete repairs of the defective instrument.
(c) * * *
(2) In the event that calculated value of expected field exceeds 10 mV/m (−65.8 dBW/m2) at the reference coordinates, or if there is any question whether field strength levels might exceed the threshold value, advance consultation with the FCC to discuss any protection necessary should be considered. Prospective applicants may communicate with the Public Safety and Homeland Security Bureau.
(c) * * *
(7) * * *
(ii) If the station is located in or near a radio quiet zone, radio coordination zone, or a Commission monitoring station (see § 73.1030 and § 0.121(c) of this chapter), the licensee or permittee must have secured written concurrence from the affected radio quiet zone, radio coordination zone, or the Commission's Public Safety and Homeland Security Bureau in the case of a monitoring station, to increase effective radiated power PRIOR to implementation. A copy of that concurrence must be submitted with the license application
47 U.S.C. 154, 302a, 303, 307, 309, 336 and 554.
(i) Short-term operation of a remote pickup broadcast base station, a remote pickup automatic relay station, an aural broadcast STL station, an aural broadcast intercity relay station, a TV STL station, a TV intercity relay station or a TV translator relay station in the National Radio Quiet Zone, the Table Mountain Radio Receiving Zone, or near FCC monitoring stations is subject to the same advance notification procedures applicable to regular applications as provided for in § 73.1030 of this chapter and § 74.12, except that inasmuch as short-term operation does not involve an application process, the provisions relating to agency objection procedures shall not apply. It shall simply be necessary for the licensee to contact the potentially affected agency and obtain advance approval for the proposed short-term operation. Where protection to FCC monitoring stations is concerned, approval for short-term operation may be given by the Regional Director of a Commission field facility.
(d) Operation under this section shall be suspended immediately upon notification from the Commission or by the Regional Director of a Commission field facility, and shall not be resumed until specific authority is given by the Commission or Regional Director. When authorized by the Regional Director, short test operations may be made.
47 U.S.C. 151, 152, 153, 154, 301, 302, 302a, 303, 303a, 307, 308, 309, 312, 315, 317, 325, 338, 339, 340, 341, 503, 521, 522, 531, 532, 534, 535, 536, 537, 543, 544, 544a, 545, 548, 549, 552, 554, 556, 558, 560, 561, 571, 572, 573.
(c) If harmful interference to radio communications involving the safety of life and protection of property cannot be promptly eliminated by the application of suitable techniques, operation of the offending MVPD or appropriate elements thereof shall immediately be suspended upon notification by the Regional Director for the Commission's local field office, and shall not be resumed until the interference has been eliminated to the satisfaction of the Regional Director. When authorized by the Regional Director, short test operations may be made during the period of suspended operation to check the efficacy of remedial measures.
(d) The MVPD may be required by the Regional Director to prepare and submit a report regarding the cause(s) of the interference, corrective measures planned or taken, and the efficacy of the remedial measures.
Secs. 2, 3, 4, 301, 303, 307, 308, 309, 48 Stat., as amended, 1064, 1065, 1066, 1081, 1082, 1083, 1084, 1085; 47 U.S.C. 152, 153, 154, 301, 303, 307, 308, 309.
(e) The license of a CARS pickup station authorizes the transmission of program material, and related communications necessary to the accomplishment of such transmission, from the scenes of events occurring in places other than a cable television studio or the studio of another eligible system, to the studio, headend, or transmitter of its associated cable television system or other eligible system, or to such other cable television or other eligible systems as are carrying the same program material. CARS pickup stations may be used to provide temporary CARS studio-to-headend links, studio-to-transmitter links, or CARS circuits consistent with this part without further authority of the Commission: Provided, however, That prior Commission authority shall be obtained if the transmitting antenna to be installed will increase the height of any natural formation or manmade structure by more than 6.1 meters (20 feet) and will be in existence for a period of more than 2 consecutive days: And provided, further, That if the transmitting equipment is to be operated for more than 1 day outside of the area to which the CARS station has been licensed, the Commission, the Regional Director for the area in which the station is licensed to operate, and the Regional Director for the area in which the equipment will be temporarily operated shall be notified at least 1 day prior to such operation. If the decision to continue operation for more than 1 day is not made until the operation has begun, notice shall be given to the Commission and the relevant Regional Directors within 1 day after such decision. In all instances, the Commission and the relevant Regional Directors shall be notified when the transmitting equipment has been returned to its licensed area.
(e) * * *
(2) In the event that calculated value of expected field exceeds 10 mV/m (−65.8 dBW/m2) at the reference coordinates, or if there is any question whether field strength levels might exceed the threshold value, advance consultation with the FCC to discuss any protection necessary should be considered. Prospective applicants may communicate with the Public Safety and Homeland Security Bureau, Federal Communications Commission, Washington, DC 20554.
Secs. 4, 303, 307(e), 309, and 332, 48 Stat. 1066, 1082, as amended; 47 U.S.C. 154, 303, 307(e), 309, and 332, unless otherwise noted. Interpret or apply 48 Stat. 1064–1068, 1081–1105, as amended; 47 U.S.C. 151–155, 301–609; 3 UST 3450, 3 UST 4726, 12 UST 2377.
(d)
(a) Ships must have the required equipment inspected at least once every 12 months by an FCC-licensed technician holding a GMDSS Radio Maintainer's License. If the ship passes the inspection the technician will issue a Safety Certificate. Safety Certificates may be obtained from the Commission's National Call Center at 1–888–CALL FCC (1–888–225–5322). The effective date of the ship Safety Certificate is the date the station is found to be in compliance or not later than one business day later. The FCC-licensed technician must use the latest FCC Information Bulletin, How to Conduct a GMDSS Inspection, which may be obtained at
Sections 4(i), 11, 303(g), 303(r), and 332(c)(7) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 161, 303(g), 303(r), and 332(c)(7), and Title VI of the Middle Class Tax Relief and Job Creation Act of 2012, Pub. L. 112–96, 126 Stat. 156.
(a) * * *
(4) * * *
(ii) In the Industrial/Business Pool, licensees may request the Commission's Wireless Telecommunications Bureau to approve the use of special mobile unit identifiers in lieu of the assigned call sign. Such requests, however, will not be granted where it appears that harmful interference to international operations may be caused by stations below 50 MHz, or by stations operating in areas within 80 km (50 miles) of an international boundary, or where it appears that the proposed method of identification will not adequately distinguish the mobile units of the applicant from the mobile units of other licensees in the area.
47 U.S.C. 154, 301, 302(a), 303, and 307(e).
Every station in a GMRS system must use transmitters the FCC has certificated for use in the GMRS. Transmitters that have been certified for use in the GMRS may be found on the FCC Web site at
(d) If your R/C station is located near an airport, and if you antenna structure is more than 6.1 meters (20 feet) high, your may have to obey additional restrictions. The highest point of your antenna must not exceed one meter above the airport elevation for every hundred meters of distance from the nearest point of the nearest airport runway. Differences in ground elevation between your antenna and the airport runway may complicate this formula. If your R/C station is near an airport, see
(b) You may examine a list of certificated transmitters on the FCC Web site at
(d) If your CB station is located near an airport, and if your antenna structure is more than 6.1 meters (20 feet) high, you may have to obey additional restrictions. The highest point of your antenna must not exceed one meter above the airport elevation for every hundred meters of distance from the nearest point of the nearest airport runway. Differences in ground elevation between your antenna and the airport runway may complicate this formula. If your CB station is near an airport, see
(a) You must use an FCC certificated CB transmitter at your CB station. You can identify an FCC certificated transmitter by the certification label placed on it by the manufacturer. You may examine a list of certificated equipment on the FCC Web site at
48 Stat. 1066, 1082, as amended; 47 U.S.C. 154, 303. Interpret or apply 48 Stat. 1064–1068, 1081–1105, as amended; 47 U.S.C. 151–155, 301–609, unless otherwise noted.
(b) A station within 1600 m (1 mile) of an FCC monitoring facility must protect that facility from harmful interference. Failure to do so could result in imposition of operating restrictions upon the amateur station pursuant to § 97.121. Geographical
(d) When a station is being automatically controlled, the control operator need not be at the control point. Only stations specifically designated elsewhere in this part may be automatically controlled. Automatic control must cease upon notification by a Regional Director that the station is transmitting improperly or causing harmful interference to other stations. Automatic control must not be resumed without prior approval of the Regional Director.
(f) A beacon must cease transmissions upon notification by a Regional Director that the station is operating improperly or causing undue interference to other operations. The beacon may not resume transmitting without prior approval of the Regional Director.
(b) Where authorized by §§ 97.305(c) and 97.307(f), a station may transmit a RTTY or data emission using an unspecified digital code, except to a station in a country with which the United States does not have an agreement permitting the code to be used. RTTY and data emissions using unspecified digital codes must not be transmitted for the purpose of obscuring the meaning of any communication. When deemed necessary by a Regional Director to assure compliance with the FCC Rules, a station must:
(c) When deemed necessary by a Regional Director to assure compliance with this part, a station licensee must:
(f) No station may transmit with a transmitter power exceeding 50 W PEP on the UHF 70 cm band from an area specified in paragraph (a) of footnote US270 in § 2.106, unless expressly authorized by the FCC after mutual agreement, on a case-by-case basis, between the Regional Director of the applicable field facility and the military area frequency coordinator at the applicable military base. An Earth station or telecommand station, however, may transmit on the 435–438 MHz segment with a maximum of 611 W effective radiated power (1 kW equivalent isotropically radiated power) without the authorization otherwise required. The transmitting antenna elevation angle between the lower half-power (−3 dB relative to the peak or antenna bore sight) point and the horizon must always be greater than 10°.
Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Final rule; correction.
DoD, GSA, and NASA are issuing a correction to FAR Case 2014–022; Inflation Adjustment of Acquisition-Related Thresholds (Item I), which was published in the
Mr. Michael O. Jackson, Procurement Analyst, at 202–208–4949, for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202–501–4755. Please cite FAC 2005–83; FAR Case 2014–022; Correction.
In rule FR Doc. 2015–16206 published in the
40 U.S.C. 121(c); 10 U.S.C. chapter 137; and 51 U.S.C. 20113.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a temporary safety zone for certain waters of the Atlantic Ocean off Jacksonville Beach, Florida during the Jacksonville Sea and Sky Spectacular air show. The event is scheduled to take place from October 22 through October 25, 2015. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Jacksonville or a designated representative. The Coast Guard invites your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before October 8, 2015.
You may submit comments identified by docket number USCG–2015–0790 using any one of the following methods:
(1)
(2)
(3)
(4)
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
If you have questions about this proposed rulemaking, call or email Lieutenant Allan Storm, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone 904–564–7563, email
On December 31, 2014, the City of Jacksonville submitted a marine event application to the Coast Guard for the Jacksonville Sea and Sky Spectacular air show that will take place from 10 a.m. to 4:30 p.m. on October 22 through October 25, 2015. The air show will consist of various flight demonstrations over the Atlantic Ocean, just offshore from Jacksonville Beach, FL. Over the years, there have been unfortunate instances of aircraft mishaps that involve crashing during performances at various air shows around the world. During aircraft crashes, there is typically a wide area of scattered debris that can damage property or cause significant injury or death to the public observing the air shows. The Captain of the Port (COTP) Jacksonville has determined that a safety zone is necessary to protect the general public from hazards associated with aerial flight demonstrations.
The purpose of the rulemaking is to ensure the safety of vessels and persons during the air show on the navigable waters of the Atlantic Ocean in Jacksonville Beach, FL. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The COTP proposes to establish a safety zone from 9 a.m. to 5:30 p.m. on October 22 through October 25, 2015. The safety zone will encompass all waters within an area approximately three nautical miles parallel to the shoreline, and one half mile out into the Atlantic Ocean offshore from Jacksonville Beach, Florida. The duration of the zone is intended to ensure the safety of the public and these navigable waters before, during, and after the aerial flight demonstrations. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text the Coast Guard is proposing appears at the end of this document.
The Coast Guard developed this proposed rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. A summary of the statutory analyses, analyses of E.O.s, and discussion of First Amendment rights of protestors is included below.
E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic would be able to safely transit around this safety zone which would impact a small designated area of the Atlantic Ocean for eight and a half hours on each of the three days the air show is occurring. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF–FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601–612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this proposed rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, the Coast Guard discusses the effects of this rule elsewhere in this preamble.
The Coast Guard analyzed this proposed rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321–4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a safety zone that will help protect the general public from hazards associated with aerial flight demonstrations occurring during the air show, and will be in effect from 9 a.m. to 5:30 p.m. on October 22 through October 25, 2015.
It is categorically excluded from further review under paragraph 34(g) of Figure 2–1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to
If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. To submit your comment online, go to
The Coast Guard views public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you go to the online docket by following instructions in the next paragraph, and sign up for email alerts, you will be notified whenever comments are submitted or a final rule is published.
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Jacksonville by telephone at 904–564–7511, or a designated representative via VHF–FM radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port Jacksonville or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Jacksonville or a designated representative.
(3) The Coast Guard will provide notice of the regulated area through Broadcast Notice to Mariners via VHF—FM channel 16.
(d)
Environmental Protection Agency (EPA) and National Highway Traffic Safety Administration (NHTSA), DOT.
Proposed rule; extension of comment period.
The Environmental Protection Agency (EPA) and the National Highway Traffic Safety Administration (NHTSA) are extending the comment period for the joint proposed rules “Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles—Phase 2,” and also for NHTSA's Draft Environmental Impact Statement (DEIS). The proposed rules were published in the
The comment period for the proposed rule published July 13, 2015 (80 FR 40139) is extended. Written comments for both documents must be received on or before October 1, 2015.
For EPA, direct your comments to Docket number EPA–HQ–OAR–2014–0827. For NHTSA, direct your comments to Docket number NHTSA–2014–0132. For NHTSA's DEIS, direct your comments to Docket number NHTSA–2014–0074. Comments may be submitted using the
Questions concerning the NHTSA proposed rule should be addressed to NHTSA: Ryan Hagen or Analiese Marchesseault, Office of Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone: (202) 366–2992. Questions concerning the EPA proposed rule
In response to requests for an extension, we are extending the public comment period for the Heavy-Duty Phase 2 Notice of Proposed Rulemaking (80 FR 40139, July 13, 2015; also available in Docket Nos. EPA–HQ–OAR–2014–0827 and NHTSA–2014–0132) to October 1, 2015. As NHTSA published (to Docket No. NHTSA–2014–0074) an accompanying DEIS for NHTSA's proposed rule, we are also extending the comment period for that document to October 1, 2015. This extension will provide the public additional time to provide comment on the proposed rules and DEIS. Both the proposed rules and the DEIS are available at
In this joint proposal, there are many issues common to both EPA's and NHTSA's proposals. For the convenience of all parties, comments submitted to the EPA docket will be considered comments submitted to the NHTSA docket, and vice versa. An exception is that comments submitted to the NHTSA docket on NHTSA's (DEIS) will not be considered submitted to the EPA docket. Therefore, the public only needs to submit comments to either one of the two agency dockets, although they may submit comments to both if they so choose. Comments that are submitted for consideration by one agency should be identified as such, and comments that are submitted for consideration by both agencies should be identified as such. Absent such identification, each agency will exercise its best judgment to determine whether a comment is submitted on its proposal.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Alaska (the State). The submission addresses transportation conformity requirements. EPA is approving the submission in accordance with the requirements of the Clean Air Act (the Act).
Comments must be received on or before October 8, 2015.
Submit your comments, identified by Docket ID No. EPA–R10–OAR–2015–0447, by any of the following methods:
•
•
•
•
Please see the direct final rule which is located in the Rules section of this
Karl Pepple at telephone number: (206) 553–1778, email address:
For further information, please see the direct final action, of the same title, which is located in the Rules section of this
If the EPA receives adverse comments, the EPA will withdraw the direct final rule and it will not take effect. The EPA will address all public comments in a subsequent final rule based on this proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
In proposed rule 2015–21763 appearing on page 53088 in the issue of Wednesday, September 2, 2015, make the following correction:
On page 53088, in the second column, in the sixth line, “September 11, 2015” should read “September 28, 2015”.
Surface Transportation Board.
Proposed rule, withdrawn.
The Board is withdrawing the proposed rules and discontinuing the EP 697 rulemaking proceeding which proposed a formal process for the National Railroad Passenger Corporation (Amtrak) to seek emergency routing orders. Based on comments received, the Board will continue the practice of appointing an individual who can act immediately on behalf of the Board.
The proposed rule is withdrawn and the rulemaking proceeding is discontinued on September 8, 2015.
Gabriel Meyer, (202) 245–0150. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at (800) 877–8339.
On January 6, 2011, the Board issued a Notice of Proposed Rulemaking (NPRM) seeking public comment on regulations concerning Amtrak.
The Board solicited comments and, on February 7, 2011, The Kansas City Southern Railway Company (KCSR), the Association of American Railroads (AAR), and Amtrak filed separate comments on the proposed rules. On February 22, 2011, KCSR and Amtrak filed separate replies to the comments. Amtrak expressed concern that, compared with the informal procedures that the Board has historically used, the proposed rules would make it more difficult for Amtrak to obtain emergency relief on an “immediate” basis. KCSR generally opposed the proposed rules, claiming that they allow unannounced access to a carrier's track without waiting for a reply from the affected carrier. AAR raised a similar point to KCSR, and suggested that, to provide greater participation by a host carrier, the Board issue a decision within two days following Amtrak's submission of an application.
Based on further consideration of these comments, we believe the proposed rules are not practical. Most importantly, the record reveals that the rules do not provide the prompt relief mandated by § 24308(b), which is necessary to handle emergencies that are happening in real-time. The comments thus indicate that the proposed rules, rather than serving the Board's goal of improving the process, would complicate and hinder it. We therefore will not adopt the formal process proposed in the NPRM and will continue the past practice of appointing a Board staff member who can order access immediately on behalf of the Board. Specifically, a staff member in the Office of Public Assistance, Governmental Affairs, and Compliance (OPAGAC) can respond to emergency rerouting requests via telephone in a timely manner and contact appropriate representatives of the involved carriers. We are simultaneously issuing a companion decision appointing the Director of OPAGAC, or in the Director's absence, a Deputy Director to act on behalf of the Board in such circumstances.
These emergency routing orders allow for the continued operation of Amtrak and typically will not address compensation terms. If the parties cannot agree on such terms and conditions of access, they can subsequently petition the Board to set them. We expect parties to work together and with the Director or a Deputy Director of OPAGAC to reach a practical and efficient resolution of an access issue during an emergency situation.
This action will not significantly affect either the quality of the human environment or the conservation of energy resources.
By the Board, Chairman Elliott, Vice Chairman Begeman, and Commissioner Miller.
Agricultural Marketing Service, USDA.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, as amended, (5 U.S.C. App.), the Agricultural Marketing Service (AMS), Department of Agriculture, is announcing a meeting of the National Organic Standards Board (NOSB) to assist the Department in the development of standards for substances to be used in organic production and to advise the Secretary of Agriculture on any other aspects of the implementation of Organic Foods Production Act.
The Board will hold two webinars at which it will receive public comment: October 13 and October 20, from 1:00 p.m. to 4:00 p.m. Eastern Time. A face-to-face meeting will be held October 26–29, 2015, from approximately 9:00 a.m. to approximately 6:00 p.m. Eastern Time. Deadline to sign up for oral comment: midnight Eastern Time, 30 days after publication of this notice. Deadline to submit written comments: midnight Eastern Time, 30 days after publication of this notice.
The October 13 and 20 meetings will take place via webinar (access information will be available prior to the webinars). The October 26–29, 2015 meeting will take place at the Stoweflake Conference Center, 1746 Mountain Road Stowe, VT 05672, (802) 253–7355,
Ms. Michelle Arsenault, Advisory Committee Specialist, National Organic Standards Board, USDA–AMS–NOP, 1400 Independence Ave. SW., Room 2642-So., Mail Stop 0268, Washington, DC 20250–0268; Phone: (202) 720–3252; Email:
The NOSB makes recommendations to the Department of Agriculture about whether substances should be allowed or prohibited in organic production and/or handling, assists in the development of standards for organic production, and advises the Secretary on other aspects of the implementation of the Organic Foods Production Act (7 U.S.C. 6501–6522). The public meeting allows the NOSB to discuss and vote on proposed recommendations to the USDA, receive updates from the USDA National Organic Program (NOP) on issues pertaining to organic agriculture, and receive comments from the organic community. The meeting is open to the public. The meeting agenda, NOSB proposals and discussion documents, instructions for submitting and viewing public comments, and instructions for requesting time for oral comments will be available on the NOP Web site at
Public Comments:
Written comments:
Written public comments will be accepted on or before midnight Eastern Time, 30 days after publication of this notice via
Oral Comments:
The NOSB is providing the public multiple dates and opportunities to provide oral comments and will accommodate as many individuals and organizations as time permits. Persons or organizations wishing to make oral comments must pre-register by midnight Eastern Time, 30 days after publication of this notice, and can only register for one speaking slot: either during one of the two webinars, October 13 or 20, 2015, or at the face-to-face meeting October 26–29, 2015. Instructions for registering and participating in the webinar can be found at
Food Safety and Inspection Service, USDA.
Notice of proposed new system of records; request for comment.
In accordance with the Privacy Act of 1974, as amended, the U.S. Department of Agriculture (USDA) proposes to establish a new system of
The mission of FSIS is to protect public health by ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled. Thus, the Agency must detect food safety vulnerabilities as early and as specifically as possible so that the potential for harm can be promptly prevented, reduced, or eliminated. The CCMS II helps FSIS to effectively identify potentially unsafe meat, poultry, or processed egg products regulated by FSIS by recording, sorting, analyzing, and tracking consumer complaints regarding products' potential adverse effects, and by tracking any subsequent analyses and investigations of those complaints.
You may submit comments, identified by docket number FSIS–2011–0030, by one of the following methods.
•
•
•
For general questions, please contact Dr. Karen Becker, Director, Applied Epidemiology Staff, Office of Public Health Systems, Food Safety and Inspection Service, Department of Agriculture, Washington, DC 20024; telephone (202) 690–6045. For privacy questions, please contact Ravoyne Payton, Acting Chief Privacy Officer, Policy, E-Government and Fair Information Practices, Office of the Chief Information Officer, Department of Agriculture, Washington, DC 20250; telephone (202) 720–8755.
The Privacy Act of 1974, as amended (5 U.S.C. 552a), requires agencies to publish in the
A complaint that is put into CCMS II can be initiated in any of the following ways: (1) Calls from consumers or their representatives, or from representatives of State or local health departments and Federal agencies, including USDA's Agricultural Marketing Service (AMS) and Food and Nutrition Service (FNS), (2) electronic hand-off from the USDA's Meat and Poultry Hotline system, and (3) web forms submitted by consumers. Trained analysts review the complaint information. Once reviewed, the case is entered into the system directly or indirectly via a transfer from the Meat and Poultry Hotline System.
Epidemiologists in the FSIS Office of Public Health Science (OPHS) analyze the information in CCMS II to determine necessary further analyses, investigation, or processing. OPHS leads the management and investigation of all cases entered into the system. Technical and scientific support is provided to other program areas, as necessary.
Personal information about individuals collected in CCMS II includes first and last name, home or work address, telephone number or email, and details of the complaint, which can include medical symptoms and medical treatment obtained. Specific information about food items eaten also is collected in CCMS II. A unique case number is assigned to each complaint and provided to the individual making the report and can be used in lieu of or in addition to the personal information noted above for retrieving system information.
Under the Federal Meat Inspection Act (21 U.S.C. 601
In summary, all of these authorities allow FSIS to perform the functions of this system: To gather and maintain information related to foodborne hazards that will support investigations aimed to trace back foodborne illness outbreaks to its sources and to identify potentially unsafe meat, poultry, or processed egg products from entering commerce; to collaborate with federal,
CCMS II system programs and use of resources comply with procedures for avoiding waste, fraud, abuse, or mismanagement; for obtaining, reporting, and using reliable and timely information for decision-making; and for appropriately identifying and managing program risks. To enable management and audit oversight, CCMS II includes management controls and performance measures for supported activities to ensure that decision-making is accurate, timely, complete, and effective.
There are no Privacy Act exemptions being made for this application. Consistent with USDA's public health mission, information stored in CCMS II may be shared with other USDA components, as well as with appropriate Federal, State, local, tribal, foreign, or international government agencies. This sharing will take place only after USDA determines that the receiving component or agency has a need to know the information to carry out national security, law enforcement, immigration, intelligence, or other functions consistent with the routine uses set forth in this system of records notice.
In accordance with 5 U.S.C. 552a(r), as implemented by Office of Management and Budget Circular A–130, FSIS has provided a report of this new system of records to: The Chairman, Committee on Homeland Security and Governmental Affairs, United States Senate; the Ranking Member, Committee on Homeland Security and Governmental Affairs, United States Senate; the Chairman, Committee on Oversight and Government Reform, House of Representatives; the Ranking Member, Committee on Oversight and Governmental Reform, House of Representatives; and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget.
USDA/FSIS–03, FSIS Consumer Complaint Monitoring System (CCMS) II.
Unclassified.
Records are maintained at the U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250, and at USDA's National Information Technology Center facility at 8930 Ward Parkway, Kansas City, Missouri 64114.
Federal employees and private citizens involved in an FSIS investigation, including individuals who submit complaints; those who work in the food industry under FSIS' inspection, such as private citizens who operate or work at establishments; those who work for operations that may be subject to FSIS surveillance or enforcement, such as private citizens employed at retail operations that grind meat or poultry; members of volunteer organizations who prepare or have prepared food; and State, tribal, and local government employees responsible for food safety or public health.
This system contains information pertaining to investigations of consumer complaints to aid in identifying and tracking potential public health crises. This information includes personal information, such as first and last names, home or work address, telephone number or email, and details concerning medical symptoms and care and cause of complaint. Each record is associated with an assigned case code to ease retrieval.
• Poultry Products Inspection Act (21 U.S.C. 451
• Federal Meat Inspection Act (21 U.S.C. 601
• Egg Products Inspection Act (21 U.S.C 1031
Dr. David Goldman, Assistant Administrator, Office of Public Health Science (OPHS), Food Safety and Inspection Service(FSIS), U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250, Rm. 341–E JLW Bldg. Telephone (202) 720–2644.
Or Dr. Karen Becker, Director Applied Epidemiology Division, Office of Public Health Science, Food Safety and Inspection Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250. Telephone (202) 690–6045; Fax:(202) 720–8213.
The records provided by and about individuals in this system are used by FSIS to sort, evaluate, and investigate possible adverse effects from FSIS-regulated products. The information also supports trace back to the source of foodborne illness outbreaks and tracing hazardous products forward to identify distribution and disposition. CCMS II data and associated processes help FSIS to analyze, evaluate, and identify foodborne hazards in products regulated by the Agency; to assess the risk to human health; and to determine the appropriate response to known, emerging, or potential threats to the food supply or to the agriculture sector.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, all or a portion of the records or information contained in this system may be disclosed outside USDA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
1. To the U.S. Department of Justice (DOJ) (including United States Attorney Offices) or other Federal agency conducting litigation, or in proceedings before any court, adjudicative or administrative body, when it is necessary for the litigation, and one of the following is a party to the litigation or has an interest in the litigation:
a. USDA or any component thereof;
b. any employee of USDA in his/her official capacity;
c. any employee of USDA in his/her individual capacity where DOJ or USDA has agreed to represent the employee; or
d. the United States or any agency thereof, and USDA determines that the records are both relevant and necessary to the litigation and the use of such records is compatible with the purpose for which USDA collected the records.
2. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the written request of the individual to whom the record pertains.
3. To the National Archives and Records Administration (NARA) or other Federal government agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
4. To an agency, organization, or individual for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function. This would include, but not be limited to the
5. To appropriate agencies, entities, and persons when:
a. USDA or FSIS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;
b. USDA has determined that, as a result of the suspected or confirmed compromise, there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by USDA or another agency or entity), or harm to the individual or individuals that rely upon the compromised information; and
c. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with USDA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
6. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for USDA, when necessary to accomplish an agency function related to this system of records. Individuals who provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to USDA officers and employees.
7. To an appropriate Federal, State, tribal, local, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, where a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.
8. To an appropriate Federal, State, tribal, local, international, or foreign law enforcement agency or appropriate authority responsible for protecting public health, preventing or monitoring disease or illness outbreaks, or ensuring the safety of the food supply. This includes the Department of Health and Human Services and its agencies, including the Centers for Disease Control and Prevention and the Food and Drug Administration, other Federal agencies, and State, tribal, and local health departments. Certain complaint-related information may be shared with the producing establishment for purposes of investigating the complaints. Except as stated, disclosure is made pursuant to requests under the Freedom of Information Act (FOIA).
None
Records in this system are stored electronically in a dedicated virtual server or on paper in secure facilities in a locked drawer behind a locked door within USDA facilities. Electronically stored records, including backup records maintained on their own dedicated virtual server in a separate location, are stored on magnetic disc, tape, digital media, and CD–ROM. (Paper records are printed from electronic storage only in limited quantities and on rare occasions when needed as working copies. Such paper records are kept in secure facilities in a locked drawer behind a locked door within USDA facilities, and immediately are shredded upon termination of the need for a working copy.) Security guards safeguard the buildings where the electronic and the working copies of records reside.
Retrieval is generally performed using the case code (a sequentially assigned, system-generated code created at the time of initial contact) or other database fields, such as establishment number or type of complaint. A name can also be used to retrieve individual records; however, using the case code or other database fields reduces the need for retrieval by information that could identify an individual.
Records in this system are safeguarded in accordance with applicable rules and policies, including all applicable USDA automated systems security and access policies. This includes protection behind firewalls, network protection against intrusion, and vulnerability scanning and protection. Only users with a business need are allowed access through the use of an encrypted password. Role-based access controls are used to restrict access to CCMS II, which is accessible via the FSIS Intranet. Furthermore, multiple levels of access exist, based on the user's system role and job function. Each time users sign in to the application, the login credentials are checked against authorized system user role memberships to ensure the user's access privileges are restricted to assigned level-of-access roles. User activity is also monitored, logged, and audited. Additionally, all users are required to undergo USDA-approved computer security awareness training prior to access and must complete computer security training yearly in order to retain access. An access agreement describes prohibited activities, such as browsing.
Records will be destroyed or maintained in accordance with the USDA's published records disposition schedules, as approved by NARA. A backup of the Master File is created at the end of the calendar year, and backup records are maintained in accordance with General Records Schedule Authority N1–462–07–01, Item 2. System inputs are maintained in accordance with General Records Schedule Authority GRS 20, Item 2(a)(4), while system outputs (reports) are maintained in accordance with General Records Schedule Authority GRS 20, Item 16.
Dr. Karen Becker, Director, Applied Epidemiology Staff, Office of Public Health Science, Food Safety and Inspection Service, 355 E Street SW. PPIII, 9th Floor Office 9–232, Washington, DC 20024. Telephone (202) 690–6045.
An individual may request information regarding this system of records, or information as to whether this system contains records pertaining to such individual from the System Manager listed above. Individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the Headquarters or FSIS Freedom of Information Act (FOIA) Officer, whose contact information can be found at
When seeking records about yourself from this system of records or any other USDA system of records, your request must conform with the Privacy Act regulations set forth in 7 CFR part 1. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief FOIA Officer, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250. In addition, you should provide the following:
• An explanation of why you believe USDA would have information on you,
• Which components of USDA you believe may have the information about you,
• When you believe the records would have been created,
• Any other information that will help the FOIA staff determine which USDA component agency may have responsive records,
• If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records.
Without this bulleted information, the component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity.
See “Notification Procedure” above.
See “Notification Procedure” above.
Information generally is obtained directly from the individual who is the subject of the records, or from someone acting on their behalf, such as Federal, State and Local health agencies, relatives, or a friend of the consumer.
None
The mission of the Food Safety and Inspection Service (FSIS) is to protect public health by ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled. Natural events, accidents, or intentional acts can put the safety of food and the food supply chain at risk, and by doing so, put the health and welfare of consumers at risk. FSIS developed the Consumer Complaint Monitoring System (CCMS II) to help Agency personnel quickly and effectively identify potentially unsafe meat, poultry, or processed egg products. CCMS II is an electronic database accessed from FSIS' Intranet and is used to record, sort, evaluate, and track complaints about possible adverse effects from meat, poultry, or processed egg products regulated by FSIS. CCMS II is also used to track subsequent analysis and investigations of these complaints.
Under the Federal Meat Inspection Act (21 U.S.C. 601,
Further, under 21 U.S.C. 679c(a)(1) and (3), the Secretary is authorized to give high priority to enhancing the ability of FSIS “. . . to ensure the safety and wholesomeness of meat and poultry products” and to “strengthen the ability of [FSIS] to collaborate with relevant agencies within the Department of Agriculture and with other entities in the Federal Government, the States, and Indian tribes . . . through the sharing of information and technology.” CCMS II helps to identify products in commerce that are potentially adulterated and enables FSIS to determine whether reported products are safe and wholesome. In addition, the system allows the Agency to collaborate with federal, State, local, and tribal public health partners in identifying potentially unsafe meat or poultry products—and helps the Agency to protect the consuming public from further harm.
A complaint can be initiated by calls from consumers or their representatives, by representatives of State or local health departments and Federal agencies, including USDA's Agricultural Marketing Service and Food and Nutrition Service, or via electronic hand-off from USDA's Meat and Poultry Hotline system and through web forms submitted by consumers. The information from these complaints, collected in CCMS II, is analyzed, evaluated, and classified as needing further action by trained analysts in FSIS' Office of Public Health Science (OPHS). These and other analysts identify the organization that will perform any subsequent action, provide ongoing updates, coordinate communication with other USDA agencies as needed, and alert management in the event of a non-routine incident. OPHS will also determine and coordinate any needed laboratory analysis and provide technical and scientific support to other program areas. Until the complaint is resolved, any action taken is updated in CCMS II. CCMS II data can include certain information about individuals, such as first and last names, home or work address, telephone number or email, food product consumed, medical symptoms experienced, and medical care received. Some of this information can be and is used to retrieve records, such as first and last name, but by design and in general practice, a system-generated case code is used for retrieval. The case code is sequentially assigned at the time of the initial contact, and is provided to the submitter of the complaint. Other database fields, such as establishment number or type of complaint, can also be used for retrieval.
The data within CCMS II is specifically used for the reasons the information was obtained: to help determine the safety of specific food products consumed by individuals who reported problems with the food items. Information from CCMS II may be shared in a controlled manner within FSIS and, as needed, with other public health partners, to determine whether there is a potential problem with the product, to help identify the origin of the product, to trace forward the product's distribution or disposition, to follow-up with the individual who reported the problem, to ascertain whether others experienced similar problems with the same product, or for other reasons that derive directly from the reason the information was originally collected. There are other routine uses of CCMS II data permitted under U.S.C. 552a(b)(3), as contained in the
To the Department of Justice for litigation purposes; to National Archives and Records Administration for records management; to a Congressional Office in response to an inquiry from the relevant constituent; to an appropriate authority for audit purposes; to an appropriate authority in response to a threat to information security or confidentiality; to an appropriate law enforcement authority in response to investigations, prosecutions, or enforcement actions; to contractors and agents performing a function on behalf of the agency relating to the collection of information to support surveillance, investigations, and facilitation of rapid detection and response to food borne hazards; to appropriate authorities responsible for public health/monitoring illness outbreaks/ensuring safety of the food supply because the data supports public
CCMS II data and investigations also support other activities, including complaint-related verification of Hazard Analysis and Critical Control Points in producing establishments, analysis of school lunch product manufacturing specifications, and recall coordination for product(s) identified as adulterated or unwholesome.
FSIS has taken significant actions to safeguard the identifiable information about an individual in CCMS II and to control access to the system itself. Access to CCMS II is restricted to trained, authorized FSIS employees and to a limited number of users representing FSIS' public health partners in the Department of Health and Human Services. Authorized users are assigned level-of-access roles based on their job functions. The level of access for the user restricts the data that may be seen and the degree to which data may be modified by the user. Firewalls and other security controls further prevent unauthorized access. As a result, the potential effect of CCMS II on an individual's privacy is minimal.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, records maintained in the system may be disclosed outside USDA for eight routine uses. These routine uses may be described as functional and housekeeping uses.
The records are protected by the confidentiality requirements of USDA's Office of the Chief Information Officer Cyber Security Manuals and the provisions of the Privacy Act. Only authorized USDA employees and contractors will have access to the records in this system, and this access will be on a need-to-know basis. Role-based access controls are used to restrict access to CCMS II, which is accessible via the FSIS Intranet.
The system has been categorized as a Moderate impact system as identified in Federal Information Processing Standard (FIPS) 199. The security controls implemented within the system will correspond with those published in the National Institute of Standards and Technology Special Publication 800–53, Recommended Security Controls for Federal Information Technology Systems (Revision1) for a Moderate impact system. Users are granted system access only upon successful completion of security training and must successfully complete security training each year to retain access. Each user is supplied with a unique and strong user-id and password. The user roles are restrictive and based on the principle of least privilege allowing for adequate performance of job functions and access to information based on a need to know.
Where appropriate, the system also will adhere to the security controls identified in the Federal Information Security Control Audit Manual (FISCAM). The mandatory requirements of FIPS 199 and FIPS 200 support the Federal Information Security Management Act and FISCAM supports the mandated Office of Management and Budget Circular A–123, Management of Internal Controls.
Moreover, system managers and users observe and adhere to specific USDA security requirements as set forth in the USDA Cyber Security Manuals, including but not limited to USDA Departmental Manual (DM) 3545–000, Personnel Security, and DM 3510–001, Physical Security Standards for Information Technology Restricted Space.
Office of the Chief Economist, U.S. Department of Agriculture.
Request for Public Comment on Climate Change, Global Food Security, and the U.S. Food System Assessment Report.
The U.S. Department of Agriculture (USDA) has led the development of an interagency assessment report entitled “Climate Change, Global Food Security, and the U.S. Food System.” The report has been developed to support the National Climate Assessment of the U.S. Global Change Research Program, and is called for under the President's Climate Action Plan. USDA is requesting input from the public. This request is being published in the
Comments must be received by 11:59 p.m. Eastern Time on October 8, 2015 will be considered.
Comments from the public will be accepted electronically via
William Hohenstein, Director, USDA Climate Change Program Office, telephone: 202–720–9978, Email:
The public comment draft can be found online at
All comments received will be considered by the report's authors and will become part of the public record once the final report is issued. However, until the report is finalized and released to the public, commenters' identities will not be shared with the authors. When the report is released in final form to the public, the comments, in association with the commenter's name, will be made available upon request. No additional information a commenter submits as part of the registration process (such as an email address) will be disclosed publicly.
The Department of Agriculture will publish a notice informing the public of the final report when it is issued.
Forest Service, USDA.
Notice of meeting.
The Rogue and Umpqua Resource Advisory Committee (RAC) will meet in Roseburg, Oregon. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The meeting will be held October 14–15, 2015, at 9:30 a.m.–4 p.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at Umpqua National Forest Supervisor's Office, 2900 NW Stewart Parkway, Roseburg, Oregon.
Written comments may be submitted as described under
Cheryl Caplan, RAC Coordinator, by phone at 541–957–3270 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to:
1. Review projects proposals; and
2. Make project recommendations for Title II funding.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by October 13, 2015, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Cheryl Caplan, RAC Coordinator, Umpqua National Forest Supervisor's Office, 2900 NW Stewart Parkway, Roseburg, Oregon 97471; by email to
Rural Business-Cooperative Service, USDA.
Notice.
This Notice announces that the Rural Business-Cooperative Service (Agency) is accepting fiscal year (FY) 2015 applications for the Delta Health Care Services Grant (DHCS) Program as authorized by the Consolidated and Further Continuing Appropriations Act of 2015 (Pub.L. 113–235). Approximately $5 million is available to be competitively awarded. The purpose of this program is to provide financial assistance to address the continued unmet health needs in the Delta Region through cooperation among health care professionals, institutions of higher education, research institutions and economic development entities in the Delta Region. The Agency is encouraging applications that grants to projects based in or serving census tracts with poverty rates greater than or equal to 20 percent. This emphasis will support Rural Development's (RD) mission of improving the quality of life for Rural Americans and its commitment to directing resources to those who most need them.
You must submit completed applications for grants according to the following deadlines:
• Paper copies must be postmarked and mailed, shipped, or sent overnight no later than December 7, 2015.
• Electronic copies must be received by December 2, 2015. Late applications are not eligible for funding under this Notice and will not be evaluated.
You should contact your USDA Rural Development State Office (State Office) if you have questions about eligibility or submission requirements. You are encouraged to contact your State Office well in advance of the application deadline to discuss your project and to ask any questions regarding the application process. A list of State Office contacts can be found at
A supplementary application guide has also been created for your assistance. You may obtain application guides and materials for this Notice in the following ways:
• Through the Internet at the RBS Cooperative Programs Web site:
• By requesting application guides and materials from your local State Office. A list of State Office contacts can be found at
You must submit either:
• A complete paper application to the State Office located in the State where the project will primarily take place,
• A complete electronic grant application at
Grants Division, Cooperative Programs, Rural Business-Cooperative Programs, 1400 Independence Ave. SW., STOP 3253, Washington, DC 20250–3253; or call (202) 690–1376.
This Executive Order imposes requirements on RD in the development of regulatory policies that have tribal implications or preempt tribal laws. RD has determined that this Notice does not have a substantial direct effect on one or more Indian tribe(s) or on either the relationship or the distribution of powers and responsibilities between the Federal Government and the Indian tribes. Thus, this Notice is not subject to the requirements of Executive Order 13175. Tribal Consultation inquiries and comments should be directed to RD's Native American Coordinator at
The Paperwork Reduction Act requires Federal agencies to seek and obtain Office of Management and Budget (OMB) approval before undertaking a collection of information directed to ten or more persons. In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Agency conducted an analysis to determine the number of applications the Agency estimates that it will receive under the Delta Health Care Services Grant Program. It was determined that the estimated number of applications was fewer than nine and in accordance with 5 CFR 1320, thus no OMB approval is necessary at this time.
This Notice announces the availability of funds for the DHCS grant program, which is authorized under Section 379G of the Consolidated Farm and Rural Development Act (7 U.S.C. 2008u). The primary objective of the program is to provide financial assistance to address the continued unmet health needs in the Delta Region through cooperation among health care professionals, institutions of higher education, research institutions, and other individuals and entities in the Delta Region. Grants are awarded on a competitive basis. The maximum award amount per grant is $500,000.
The terms and conditions provided in this Notice are applicable to this Notice only. In addition, the term “you” referenced throughout this Notice should be understood to mean the applicant and the terms “we,” “us,” and “our” should be understood to mean Rural Business-Cooperative Services, Rural Development, USDA.
• A combination of a medical school, one or more other health profession schools or educational training programs (such as allied health, dentistry, graduate studies, nursing, pharmacy, public health, veterinary medicine), and one or more owned or affiliated teaching hospitals or health systems; or
• A health care nonprofit organization or health system, including nonprofit medical and surgical hospitals, that conduct health related research exclusively for scientific or educational purposes.
• Not in a city or town that has a population of more than 50,000 inhabitants, according to the latest
• The contiguous and adjacent urbanized area,
• Urbanized areas that are rural in character as defined by 7 U.S.C. 1991 (a) (13), as amended by Section 6018 of the Food, Conservation, and Energy Act of 2008, Public Law 110–246 (June 18, 2008).
• For the purposes of this definition, cities and towns are incorporated population centers with definite boundaries, local self-government, and legal powers set forth in a charter granted by the State.
Applicants must meet all of the following eligibility requirements. Your application will not be considered for funding if it does not provide sufficient information to determine eligibility or is missing required elements. Applicants that fail to submit the required elements by the application deadline will be deemed ineligible and will not be evaluated further. Information submitted after the application deadline will not be accepted.
Grants funded through DHCS may be made to a Consortium as defined in Paragraph A of this Notice. Consortiums are eligible to receive funding through this Notice. One member of the Consortium must be designated as the lead entity by the other members of the Consortium and have legal authority to contract with the Federal government.
The lead entity is the recipient (See 2 CFR 200.86) of the DHCS grant funds and accountable for monitoring and reporting on the project performance and financial management of the grant. In addition, the lead entity (recipient) is responsible for subrecipient monitoring and management in accordance with 2 CFR 200.330 and 200.331, respectively. The remaining consortium members are subrecipients (See 2 CFR 200.93). They may receive subawards (See 2 CFR 200.94) from the recipient and are responsible for monitoring and reporting the project performance and financial management of their subaward to the recipient.
(a) An applicant is ineligible if they do not submit “Evidence of Eligibility” and “Consortium Agreements” as described in Section D.2. of this Notice.
(b) An applicant is ineligible if they have been debarred or suspended or otherwise excluded from or ineligible for participation in Federal assistance programs under Executive Order 12549, “Debarment and Suspension.” The Agency will check the System for Award Management (SAM) to determine if the applicant has been debarred or suspended. In addition, an applicant will be considered ineligible for a grant due to an outstanding judgment obtained by the U.S. in a Federal Court (other than U.S. Tax Court), is delinquent on the payment of Federal income taxes, or is delinquent on Federal debt. The applicant must certify as part of the application that they do not have an outstanding judgement against them. The Agency will check the Credit Alert Interactive Voice Response System (CAIVRS) to verify this.
(c) Any corporation (i) that has been convicted of a felony criminal violation under any Federal law within the past 24 months or (ii) that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance provided with funds appropriated by the Consolidated and Further Continuing Appropriations Act, 2015, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
(d) Applications will be deemed ineligible if the application includes any funding restrictions identified under Section D.6.
(e) Applications will be deemed ineligible if the application is not complete in accordance with the requirements stated in Section C.3.g.
Matching funds are not required. However, if you are adding any other contributions to the proposed Project, you must provide documentation indicating who will be providing the matching funds, the amount of funds, when those funds will be provided, and how the funds will be used in the project budget. Examples of acceptable documentation include: A signed letter from the source of funds stating the amount of funds, when the funds will be provided, and what the funds can be used for or a signed resolution from your governing board authorizing the use of a specified amount of funds for specific components of the project. The matching funds you identify must be specifically dedicated to the project and cannot include your organization's general operating budget. No credit will be given for in-kind donations of time, goods, and/or services from any organization, including the applicant organization. Additionally, we will not consider program income or expected revenue as other contributions, unless a commitment letter from the organization that will be paying the fees provides a letter stating the amount of the funds that will be paid, when they will be paid, and what they can be used for, if applicable. If you choose, you may use a template to summarize the matching funds. The template is available either from your Rural Development State Office or the program Web site at:
The following additional eligibility requirements apply to this program:
(a)
• Health care services;
• health education programs;
• health care job training programs; and
• the development and expansion of public health-related facilities in the Delta Region.
(b)
(c)
(d)
(e)
(f)
(g)
(h)
Please see instructions below on how to access and submit a complete application for this funding opportunity.
The application guide and copies of necessary forms for the DHCS Grant Program are available from these sources:
• The Internet at
• For paper copies of these materials, please call (202) 690–1376.
You may submit your application in paper form or electronically through Grants.gov. Your application must contain all required information.
To submit an application electronically, you must follow the instructions for this funding announcement at
You can locate the Grants.gov downloadable application package for this program by using a keyword, the program name, or the Catalog of Federal Domestic Assistance Number for this program.
When you enter the Grants.gov Web site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
To use Grants.gov, you must already have a DUNS number and you must also be registered and maintain registration in SAM. We strongly recommend that you do not wait until the application deadline date to begin the application process through Grants.gov.
You must submit all of your application documents electronically through Grants.gov. Applications must include electronic signatures. Original signatures may be required if funds are awarded.
After electronically submitting an application through Grants.gov, you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number.
If you want to submit a paper application, send it to the State Office located in the State where you are headquartered. You can find State Office contact information at:
You are strongly encouraged, but not required, to utilize the DHCS Application Guide found at
The organization submitting the application will be considered the lead entity. The Contact/Program Manager must be associated with the lead entity submitting the application.
A completed application must include the following:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
An eligible start and end date for the project and for individual project tasks must be clearly shown and may not exceed Agency specified timeframes for the grant period. You must show the source and use of both grant and other contributions for all tasks. Other contributions must be spent at a rate equal to, or in advance of, grant funds.
(l)
(m)
(n)
(o)
(p)
(q)
(r)
In order to be eligible (unless you are exempted under 2 CFR 25.110(b), (c) or (d), you are required to:
(a) Provide a valid DUNS number in your application, which can be obtained at no cost via a toll-free request line at (866) 705–5711;
(b) Register in SAM before submitting your application. You may register in SAM at no cost at
(c) Continue to maintain an active SAM registration with current information at all times during which you have an active Federal award or an application or plan under consideration by a Federal awarding agency.
The Agency may not make a Federal award to you until you have complied with all applicable DUNS and SAM requirements. If you have not fully complied with requirements by the time the Agency is ready to make a Federal award, the Agency may determine that the applicant is not qualified to receive a Federal award and the Agency may use this determination as a basis for making an award to another applicant.
Application Deadline Date: December 7, 2015.
Explanation of Deadlines: Complete paper applications must be postmarked and mailed, shipped, or sent overnight by December 7, 2015. The Agency will determine whether your application is late based on the date shown on the postmark or shipping invoice. You may also hand carry your application to one of our field offices, but it must be received by close of business on the deadline date. If the due date falls on a Saturday, Sunday, or Federal holiday, the reporting package is due the next business day. Late applications are not eligible for funding.
Electronic applications must be RECEIVED by
Executive Order (EO) 12372, Intergovernmental Review of Federal Programs, applies to this program. This EO requires that Federal agencies provide opportunities for consultation on proposed assistance with State and local governments. Many States have established a Single Point of Contact (SPOC) to facilitate this consultation. A list of States that maintain a SPOC may be obtained at
You are also encouraged to contact Cooperative Programs at 202–690–1376 or
The use of project funds, including grant funds and other contributions, cannot be used for ineligible purposes. In addition, you shall not use project funds for the following:
(a) To duplicate current services or to replace or to substitute support previously provided. If the current service is inadequate, however, project funds may be used to expand the level of effort or a service beyond what is currently being provided;
(b) To pay for costs to prepare the application for funding under this Notice;
(c) To pay for costs of the project incurred prior to the effective date of the period of performance;
(d) To pay expenses for applicant employee training;
(e) Fund political activities;
(f) To pay for assistance to any private business enterprise which does not have at least 51 percent ownership by those who are either citizens of the United States or reside in the United States after being legally admitted for permanent residence;
(g) To pay any judgment or debt owed to the United States.
(h) Engage in any activities that are considered a Conflict of Interest, as defined by this Notice; or
(i) Fund any activities prohibited by 2 CFR 200.
In addition, your application will not be considered for funding if it does any of the following:
• Requests more than the maximum grant amount: or
• Proposes ineligible costs that equal more than 10 percent of the project funds.
If you include funds in your budget that are for ineligible purposes, we will consider the application for funding if the ineligible purposes total 10 percent or less of an applicant's project funds. However, if the application is successful, those ineligible costs must be removed from the work plan and budget and replaced with eligible costs before we will make the grant award, or the grant award will be reduced accordingly. If we cannot determine the percentage of ineligible costs, the application will not be considered for funding.
(a) You should not submit your application in more than one format. You must choose whether to submit your application in hard copy or electronically. Applications submitted in hard copy should be mailed or hand-delivered to the State Office where the project will primarily take place. You can find State Office contact information at:
(b) National Environmental Policy Act.
This Notice has been reviewed in accordance with 7 CFR part 1940, subpart G, “Environmental Program.” We have determined that an Environmental Impact Statement is not required because the issuance of regulations and instructions, as well as amendments to them, describing administrative and financial procedures for processing, approving, and implementing the Agency's financial programs is categorically excluded in the Agency's National Environmental Policy Act (NEPA) regulation found at 7 CFR 1940.310(e)(3) of subpart G, “Environmental Program.” We have determined that this Notice does not constitute a major Federal action significantly affecting the quality of the human environment. Non-construction projects applying under this Notice are hereby classified as Categorical Exclusions according to 7 CFR 1940.310(e), the award of financial assistance for planning purposes, management and feasibility studies, or environmental impact analyses, which do not require any additional documentation.
(c) Civil Rights Compliance Requirements.
All grants made under this Notice are subject to Title VI of the Civil Rights Act of 1964 as required by the USDA (7 CFR part 15, subpart A) and Section 504 of the Rehabilitation Act of 1973.
We will review your application to determine if it is complete and eligible. If at any time we determine that your application is ineligible, you will be notified in writing as to the reasons it was determined ineligible and you will be informed of your review and appeal rights.
We will only score applications in which the lead entity, partnering Consortium member entities, and the project are eligible. The applications must also be complete and sufficiently responsive to program requirements.
We will review each application to determine if it is eligible for funding and complete, based on the requirements of this Notice as well as other applicable Federal regulations.
Applications that are determined to be eligible and complete will be evaluated based on the criteria described below.
For each criterion, you must show how the Project has merit and why it is likely to be successful. If you do not address all parts of a criterion your application will be deemed ineligible. If you do not sufficiently communicate relevant Project information, you will receive lower scores. DHCS is a competitive program, so you will receive scores based on the quality of your responses. Simply addressing the criteria will not guarantee higher scores. The maximum number of points that can be awarded to your application is 100. For this announcement, the minimum score requirement for funding is 60 points. It is at the Agency's discretion to fund applications with a score of 59 or less if it is in the best interest of the Federal government.
The evaluation criteria are detailed in the DHCS Grant Application Guide which can be found at
(a) Rurality of the Project and communities served (maximum of 30 points)—The rurality of the communities served by the Project is an
(b) The Community Needs and Benefits derived from the Project (maximum of 30 points)—We will assess how the Project's purpose and goals benefit the residents in the Delta Region. This criterion will be scored based on the documentation in support of the community needs for health services and public health-related facilities and the benefits to people living in Delta Regional derived from the implementation of the proposed Project. It should lead clearly to the identification of the Project participant pool and the target population for the Project, and provide convincing links between the Project and the benefits to the community to address its health needs. RBS will consider:
(1) The extent of the applicant's documentation explaining the health care needs, issues, and challenges facing the service area. Include what problems the residents face and how the Project will benefit the residents in the region.
(2) The extent to which the applicant is able to show the relationship between the Project's design, outcome, and benefits.
(3) The extent to which the applicant explains the Project and its implementation and provides milestones which are well-defined and can be realistically completed.
(4) The extent to which the applicant clearly outlines a plan to track, report, and evaluate performance outcomes.
Applicants should attempt to quantify benefits in terms of outcomes from the Project; that is, ways in which peoples' lives, or the community, will be improved. Provide estimates of the number of people affected by the benefits arising from the project. The Agency has also established annual performance measures to evaluate the DHCS program. Use this section to provide estimates on the following performance measures as part of your narrative:
• Number of businesses assisted;
• Number of jobs created;
• Number of jobs saved;
• Number of individuals assisted/trained.
It is permissible to have a zero in a performance element. When you calculate jobs created, estimates should be based upon actual jobs to be created by your organization as a result of the DHCS funding or actual jobs to be created by businesses as a result of assistance from your organization. When you calculate jobs saved, estimates should be based only on actual jobs that would have been lost if your organization did not receive DHCS funding or actual jobs that would have been lost without assistance from your organization.
You can also suggest additional performance elements for example where job creation or jobs saved may not be a relevant indicator. These additional criteria should be specific, measurable performance elements that could be included in an award document.
(c) The Project Management and Organization Capability (maximum of 40 points)—We will evaluate the Consortium's experience, past performance, and accomplishments addressing health care issues to ensure effective Project implementation. This criterion will be scored based on the documentation of the Project's management and organizational capability. RBS will consider:
(1) The degree to which the organization has a sound management and fiscal structure including: well-defined roles for administrators, staff, and established financial management systems.
(2) The extent to which the applicant identifies and demonstrates that qualifications, capabilities, and educational background of the identified key personnel (at a minimum the Project Manager) who will manage and implement programs are relevant and will contribute to the success of the Project.
(3) The extent to which the applicant demonstrates current successful and effective experience (or recent past experience) addressing the health care issues in the Delta Region.
(4) The extent to which the applicant has experience managing grant-funded programs.
(5) The extent to which the applicant is able to correlate and support the budget to the project phases and implementation timeline.
(6) The extent to which administrative/management costs are balanced with funds designated for the provision of programs and services.
(7) The extent and depth of membership in the applicant's Consortium of regional institutions of higher education, academic health and research institutes and economic development entities located in the Delta Region.
The State Offices will review applications to determine if they are eligible for assistance based on requirements in this Notice and other applicable Federal regulations. If determined eligible, your application will be scored by a panel of National and State Office employees in accordance with the point allocation specified in this Notice. A recommendation will be submitted to the Administrator to fund applications in highest ranking order, subject to availability of funds. It is at the Agency's discretion to fund applications with a score of 59 or less if it is in the best interest of the Federal government. If your application is evaluated, but not funded, it will not be carried forward into the next competition.
If you are selected for funding, you will receive a signed notice of Federal award by postal mail from the State Office where your application was submitted, containing instructions on requirements necessary to proceed with execution and performance of the
Once the conditions of the award are met, we will issue a grant agreement, which must be signed by the lead entity and us before the period of performance can begin. The lead entity may administer the award using the traditional subaward approach to the other Consortium members.
If you are not selected for funding, you will be notified in writing via postal mail and informed of any review and appeal rights. See 7 CFR part 11 for USDA National Appeals Division procedures. Funding of successfully appealed applications will be limited to available FY 2015 funding. You must comply with all applicable statutes, regulations, and notice requirements before the grant will be approved.
Additional requirements that apply to grantees selected for this in program can be found in 2 CFR parts 180, 200, 400, 415, 417, 418, 421, 25, and 170; and 48 CFR 31.2, and successor regulations to these parts. In addition, all recipients of Federal financial assistance are required to comply with the Federal Funding Accountability and Transparency Act of 2006 and must report information about sub-awards and executive compensation (see 2 CFR part 170). These recipients must also maintain their registration in the SAM database as long as their grants are active. These regulations may be obtained at
The following additional requirements apply to grantees selected for this program:
• Agency-approved Grant Agreement.
• Letter of Conditions.
• Form RD 1940–1, “Request for Obligation of Funds.”
• Form RD 1942–46, “Letter of Intent to Meet Conditions.”
• Form AD–1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters—Primary Covered Transactions.”
• Form AD–1048, “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion—Lower Tier Covered Transactions.”
• Form AD–1049, “Certification Regarding a Drug-Free Workplace Requirement (Grants).”
• Form AD–3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.”
• Form RD 400–4, “Assurance Agreement.”
• RD Instruction 1940–Q, Exhibit A–1, “Certification for Contracts, Grants and Loans”
• SF–LLL, “Disclosure of Lobbying Activities” if applicable.
(a)
(1) An SF–425, “Federal Financial Report,” must be submitted listing expenditures according to agreed upon budget categories, on a semiannual basis. Reporting periods end each August 31 and February 28. Reports are due 30 days after the reporting period ends.
(2) A final project and financial status report within 90 days after the expiration or termination of the grant.
(3) Provide outcome project performance reports and final deliverables.
(b)
Semiannual performance reports should compare accomplishments to the objectives stated in the proposal. Identify all tasks completed to date and provide documentation supporting the reported results. If the original schedule provided in the work plan is not being met, the report should discuss the problems or delays that may affect completion of the project. Objectives for the next reporting period should be listed. Compliance with any special condition on the use of award funds should be discussed. Reports are due as provided in paragraph 3.a. of this section.
(c)
The lead entity must have the necessary processes and systems in place to comply with the reporting requirements for first-tier sub-awards and executive compensation under the Federal Funding Accountability and Transparency Act of 2006 in the event the applicant receives funding unless such applicant is exempt from such reporting requirements pursuant to 2 CFR 170.110(b). The reporting requirements under the Transparency Act pursuant to 2 CFR part 170 are as follows:
(1) First Tier Sub-Awards of $25,000 or more in non-Recovery Act funds (unless they are exempt under 2 CFR part 170) must be reported by the Recipient to
(2) The Total Compensation of the Recipient's Executives (five most highly compensated executives) must be reported by the Recipient (if the Recipient meets the criteria under 2 CFR part 170) to
(3) The Total Compensation of the Subrecipient's Executives (five most highly compensated executives) must be reported by the Subrecipient (if the Subrecipient meets the criteria under 2 CFR part 170) to the Recipient by the end of the month following the month in which the sub-award was made. Further details regarding these requirements can be obtained at
(d)
Grant closeout activities include a letter to the grantee with final instructions and reminders for amounts to be de-obligated for any unexpended grant funds, final project performance reports due, submission of outstanding deliverables, audit requirements, or other outstanding items of closure.
(e)
You must provide a report suitable for public distribution that describes the accomplishments made during this project. We may use this report as a success story to promote this program.
If you have questions about this Notice, please contact the State Office as identified in the
USDA prohibits discrimination in all its programs and activities on the basis of race, color, national origin, age, disability, and where applicable, sex, marital status, familial status, parental status, religion, sexual orientation, genetic information, political beliefs, reprisal, or because all or part of an individual's income is derived from any public assistance program. (Not all prohibited bases apply to all programs.) Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact
If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF) found online at
Individuals who are deaf, hard of hearing, or have speech disabilities and who wish to file either an EEO or program complaint, please contact USDA through the Federal Relay Service at (800) 877–8339 or (800) 845–6136 (in Spanish).
Persons with disabilities who wish to file a program complaint, please see information above on how to contact us by mail directly or by email. If you require alternative means of communication for program information (
United States Commission on Civil Rights.
Notice of Commission Business Meeting.
Lenore Ostrowsky, Acting Chief, Public Affairs Unit (202) 376–8591.
Hearing-impaired persons who will attend the briefing and require the services of a sign language interpreter should contact Pamela Dunston at (202) 376–8105 or at
This meeting is open to the public.
International Trade Administration, Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration is organizing an Aerospace Executive Service Trade Mission (AESTM) to Singapore in conjunction with the Singapore Airshow 2016 (
The AESTM will include representatives from a variety of U.S. aerospace-industry manufacturers and service providers. The mission participants will be introduced to international agents, distributors and end-users whose capabilities are targeted to each participant's needs. This year a key mission goal is to recruit U.S. firms that have not previously participated in this AESTM to the Singapore Airshow.
Mission participants will also be briefed by key local industry leaders who can advise on local market conditions and opportunities.
In addition, the Commercial Service will offer its AsiaNow Showtime program during the Singapore Airshow, where mission participants can meet one-on-one with Commercial Service aerospace and defense industry specialists from various markets in Asia. The industry specialists will be on-hand to discuss market trends and opportunities in their respective markets.
The mission's goal for the Aerospace Executive Service (AES) at the Singapore Airshow is to facilitate an effective presence for small to medium-sized U.S. companies without the major expenses associated with purchasing and staffing exhibition space. The AES will enable U.S. aerospace companies to familiarize themselves with this important air show, conduct market research, and explore export opportunities through pre-screened meetings with potential partners. It will give the U.S. companies a small presence at the show, with an office infrastructure environment and the support of knowledgeable U.S. Commercial Service staff focused on furthering company-specific objectives. This mission also seeks to recruit a minimum of six participants new to the AESTM at the Singapore Airshow.
Within the U.S. Pavilion at the 2016 Singapore Airshow, the Commercial Service will maintain a 66-square-meter booth that will include 48 square meters of kiosk space for the mission participants, where each participant may display company literature and conduct meetings with visitors to the air show, including buyer delegations from the Asia-Pacific region recruited by Commercial Service staff as part of the AsiaNow program. The Commercial Service booth will also house an area for meetings with Commercial Service staff and a Business Information Office (BIO) reception area (18 square meters). Commercial Service staff will be available to provide market information and offer logistical assistance to AESTM participants throughout the trade mission duration at the Singapore Airshow.
• In summary, participation in the AESTM includes:
• Pre-show breakfast briefing on February 15;
• Daily transportation to and from the designated hotel and Singapore Airshow;
• Pre-scheduled meetings with potential partners, distributors, and end users recruited by the Commercial Service;
• One show entry pass per company representative;
• Participation in U.S. Exhibitors Welcome Reception;
• One invitation to the U.S. Ambassador's reception per participant;
• Access to Official U.S. Pavilion/BIO amenities, including meeting area and shared business center when not in use for AsiaNow one-on-one appointments;
• Individual kiosk space (4.0 m
• Copy of the official 2016 Singapore Airshow Exhibitor's Directory;
• Meetings with Commercial Service aerospace and defense industry specialists from U.S. Embassies and Consulates across the Asia-Pacific region;
• On-site logistical support by U.S. Commercial Service staff.
All parties interested in participating in the AESTM at the Singapore Airshow must complete and submit an application package for consideration by the Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. A maximum of 12 companies will be selected to participate in the mission from the applicant pool. As a condition of the Singapore Airshow organizer on Commercial Service use of booth space at this event, half of the mission participation (at least six participants) is reserved for companies that have not previously participated in the AESTM at the Singapore Airshow. These will be selected on a first-come, first-served basis. The remaining participants, up to the maximum of 12, may include companies that have previously participated in the AESTM, also to be selected on a first-come, first-served basis. U.S. companies already doing business in Singapore or elsewhere in the Asia-Pacific region as well as U.S. companies seeking to enter those markets for the first time may apply.
After a company has been selected to participate on the mission, a payment to the Department of Commerce in the form of a participation fee is required. The participation fee will be $9,400 for large firms and $8,700 for a small or medium-sized enterprise (SME).
• An applicant must submit a completed and signed mission application and supplemental application materials, including adequate information on the company's products and/or services, primary market objectives, and goals for participation. The applicant must also state whether the company has previously participated in the AESTM at the Singapore Airshow. If the Department of Commerce receives an incomplete application, the Department may reject the application, request additional information, or take the lack of information into account when evaluating the applications.
• Each applicant must also certify that the products and services it seeks to export through the mission are either produced in the United States, or, if not, marketed under the name of a U.S. firm and have at least 51 percent U.S. content of the value of the finished product or service.
• Each applicant's products must meet the Singapore Airshow trade fair rules, which can be found at
Selection will be based on the following criteria:
• Suitability of the company's products or services to the Asia Pacific markets.
• Applicant's potential for business in Asia Pacific, including likelihood of exports resulting from the mission.
• Consistency of the applicant's goals and objectives with the stated scope of the mission.
As explained above, as a condition of the Singapore Airshow organizer on Commercial Service use of booth space at this event, half of the mission participation (at least six participants) is reserved for companies that have not previously participated in the AESTM at the Singapore Airshow. Previous participation in the AESTM at the Singapore Airshow will be considered in making selection decisions for these six opportunities to participate. Previous experience will not be considered when selecting applicants for the remaining six opportunities.
Referrals from political organizations and any documents containing references to partisan political activities (including political contributions) will be removed from an applicant's submission and not considered during the selection process.
Mission recruitment will be conducted in an open and public manner, including publication in the
Recruitment for the mission will begin immediately and conclude no later than November 30, 2015. The mission will open on a first-come, first-served basis, as outlined above in the
National Institute of Standards and Technology, Commerce.
Notice of open meeting.
The National Institute of Standards and Technology (NIST) announces that the Manufacturing Extension Partnership (MEP) Advisory Board will hold an open meeting on Thursday September 24, 2015, from 8:30 a.m. to 4:30 p.m. Central Time.
The meeting will be held Thursday, September 24, 2015, from 8:30 a.m. to 4:30 p.m. Central Time.
The meeting will be held at the Hyatt Regency Dallas, 300 Reunion Boulevard, Dallas, TX 75207. Please note admittance instructions in the
Kari Reidy, Manufacturing Extension Partnership, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 4800, Gaithersburg, Maryland 20899–4800, telephone number (301) 975–4919, email:
The MEP Advisory Board (Board) is authorized under Section 3003(d) of the America COMPETES Act (Pub. L. 110–69); codified at 15 U.S.C. 278k(e), as amended, in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App. The Board is composed of 10 members, appointed by the Director of NIST. Hollings MEP is a unique program, consisting of centers across the United States and Puerto Rico with partnerships at the state, federal, and local levels. The Board provides a forum for input and guidance from Hollings MEP program stakeholders in the formulation and implementation of tools and services focused on supporting and growing the U.S. manufacturing industry, provides advice on MEP programs, plans, and policies, assesses the soundness of MEP plans and strategies, and assesses current performance against MEP program plans.
Background information on the Board is available at
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the MEP Advisory Board will hold an open meeting on Thursday, September 24, 2015, from 8:30 a.m. to 4:30 p.m. Central Time. This meeting will focus on updates from the Advisory Board Sub-committees on (1) Update on MEP Competition (2) Evaluation System (3) Updates from Board Subcommittees (4) Strategic Planning.
The final agenda will be posted on the MEP Advisory Board Web site at
Individuals and representatives of organizations who would like to offer comments and suggestions related to the MEP Advisory Board's business are invited to request a place on the agenda. Approximately 15 minutes will be reserved for public comments at the end of the meeting. Speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received but is likely to be no more than three to five minutes each. The exact time for public comments will be included in the final agenda that will be posted on the MEP Advisory Board Web site as
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meetings.
NMFS announces that the Center for Independent Experts (CIE) will meet to review methods for assessing stocks in coral reef fisheries using information on fish length and life history.
See
The meeting location is in Room 208, Hemenway Hall, University of Hawaii, 2445 Campus Road, Honolulu, HI 96822.
Christofer H. Boggs, (808) 725–5364, or
The meeting schedule and agenda are as follows:
The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.
Although non-emergency issues not contained in this agenda may come up at the meeting for discussion, those issues may not be the subject of formal action during the meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Direct requests for sign language interpretation or other auxiliary aids to Christofer Boggs, (808) 725–5364 or
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Western Pacific Fishery Management Council (Council) will convene a half-day meeting on Friday, September 25, 2015 regarding social, economic, ecological, and management uncertainty (SEEM) factors pertinent to setting annual catch limits (ACLs) for bottomfish fisheries in American Samoa, Guam, and the Commonwealth of the Northern Mariana Islands.
The meeting will be held on Friday, September 25, 2015, starting at 1 p.m. Hawaii Standard Time.
The meeting will be held at the Council office, 1164 Bishop St., 14th Floor, Honolulu, HI 96813 and via teleconference; conference telephone: (808) 522–3560.
Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; telephone: (808) 522–8220.
Following introductions, participants will review the overfishing limit for territorial bottomfish fisheries and the results of risk analyses that considered quality of the stock assessment, uncertainty characteristics, stock status, and productivity and susceptibility. Participants will then discuss social, economic, ecological, and management uncertainty factors relevant to these fisheries that may warrant the Council to consider additional catch limit reductions. Finally, individuals will score these factors and these scores will be averaged in order to reach consensus on a recommendation to the Council.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 45 pre-workshop webinar for Gulf of Mexico Vermilion Snapper.
The SEDAR assessment of the Gulf of Mexico Vermilion Snapper will consist of one in-person workshop and a series of webinars. See
The SEDAR pre-Workshop webinar will be held September 25, 2015, from 10 a.m. to 12 p.m. Eastern Standard Time.
Julie A. Neer, SEDAR Coordinator; (843) 571–4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a multi-step process including: (1) Data/Assessment Workshop, and (2) a series of webinars. The product of the Data/Assessment Workshop is a report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses, and describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, HMS Management Division, and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion in the Assessment Process webinars are as follows: Panelists will present summary data, and discuss data needs and treatments.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental harassment authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that we have issued an incidental harassment authorization (IHA) to the U.S. Army Corp of Engineers (the Corps) to incidentally harass, by Level B harassment only, six species of marine mammals during activities related to the rehabilitation of Jetty A at the mouth of the Columbia River (MCR).
This authorization is effective from May 1, 2016 through April 30, 2017.
Robert Pauline, Office of Protected Resources, NMFS, (301) 427–8401.
An electronic copy of the Corps' application and supporting documents, as well as a list of the references cited in this document, may be obtained by visiting the Internet at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS' review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as “any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”
On February 13, 2015 NMFS received an application from the Corps for the taking of marine mammals incidental to the rehabilitation of Jetty A at the MCR. On June 9, 2015 NMFS received a revised application. NMFS determined that the application was adequate and complete on June 12, 2015. The Corps proposes to conduct in-water work that may incidentally harass marine mammals (
The Corps is seeking an IHA for the first year of pile installation and, possibly, removal work at Jetty A related to construction and maintenance of a barge offloading facility. The barge facility will be used for activities associated with the rehabilitation of Jetty A. The Corps is seeking this authorization by the end of August 2015 for contract bid scheduling reasons.
Work on the first year of pile installation may begin as early as May 2016 and would extend through September 2017. Because the work may extend to two seasons the Corps has requested a Letter of Authorization (LOA) that would come into effect immediately after the IHA expires for the second year of pile maintenance and removal at Jetty A. The LOA would also
This activity will take place at Jetty A at the MCR jetty system in Pacific County, Washington.
We provided a description of the proposed action in our
The scheduled rehabilitation of Jetty A would occur as part of the Corps' Major Rehabilitation program for the MCR jetty system. During the first year of the project, operators would install and potentially remove up to 24 24-in steel piles and 93 sections of Z or H piles using a vibratory hammer. USACE expects those activities to take 17 days and would limit them to daylight hours only.
A notice of NMFS' proposal to issue an IHA was published in the
There are six marine mammal species known to occur in the vicinity of the MCR which may be subjected to Level B harassment. These are the killer whale, Steller sea lion, gray whale, harbor porpoise, California sea lion, and harbor seal.
We have reviewed the Corps' detailed species descriptions, including life history information, for accuracy and completeness and refer the reader to Section 3 of the Corps' application as well as the proposed incidental harassment authorization published in the
Table 1 lists marine mammal stocks that could occur in the vicinity of the Jetty A project that may be subject to Level B harassment and summarizes key information regarding stock status and abundance. Taxonomically, we follow Committee on Taxonomy (2014). Please see NMFS' Stock Assessment Reports (SAR), available at
The
We described potential impacts to marine mammal habitat in detail in our
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, “and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking” for certain subsistence uses.
Measurements from similar pile driving events were coupled with practical spreading loss to estimate zones of influence (ZOI; see “Estimated Take by Incidental Harassment”). ZOIs are often used to establish a mitigation zone around each pile (when deemed practicable) to prevent Level A harassment to marine mammals, and also provide estimates of the areas within which Level B harassment might occur. ZOIs may vary between different diameter piles and types of installation methods. The Corps will employ the following mitigation measures:
(a) Conduct briefings between construction supervisors and crews, marine mammal monitoring team, and the Corps' staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.
(b) For in-water heavy machinery work other than pile driving (using,
The following measures apply to the Corps' mitigation through shutdown and disturbance zones:
In order to document observed incidents of harassment, observers record all marine mammal observations, regardless of location. The observer's location, as well as the location of the pile being driven, is known from a GPS. The location of the animal is estimated as a distance from the observer, which is then compared to the location from the pile and the estimated ZOIs for relevant activities (
The following additional measures apply to visual monitoring:
(1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. One observer will be placed on or near the drilling rig near Jetty A while a second observer will be stationed on the opposite side of the observable zone of influence on Clatsop Spit. Qualified observers are trained biologists, with the following minimum qualifications:
(a) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;
(b) Advanced education in biological science or related field (undergraduate degree or higher required);
(c) Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience);
(d) Experience or training in the field identification of marine mammals, including the identification of behaviors;
(e) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
(f) Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and
(g) Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
(2) Prior to the start of pile driving activity, the shutdown zone will be monitored for 30 minutes to ensure that it is clear of marine mammals. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals; animals will be allowed to remain in the shutdown zone (
If waters exceed a sea-state which restricts the observers' ability to make observations within the marine mammal shutdown zone (
The waters will be scanned 30 minutes prior to commencing pile driving at the beginning of each day, and prior to commencing pile driving after any stoppage of 30 minutes or greater. If marine mammals enter or are observed within the designated marine mammal shutdown zone during or 30 minutes prior to pile driving, the monitors will notify the on-site construction manager to not begin until the animal has moved outside the designated radius.
If any marine mammal species are encountered during activities that are not listed in Table 1 for authorized taking and are likely to be exposed to sound pressure levels (SPLs) greater than or equal to 120 dB re 1mPa (rms), then the Holder of this Authorization must stop pile driving activities and report observations to NMFS' Office of Protected Resources at (301) 847–8401.
If a marine mammal approaches or enters the shutdown zone during the course of vibratory pile driving operations, activity will be halted and delayed until the animal has voluntarily left and been visually confirmed beyond the shutdown zone. If a marine mammal is seen above water and then dives below, the contractor would wait 15 minutes for pinnipeds and 30 minutes for cetaceans. If no marine mammals are seen by the observer in that time it will be assumed that the animal has moved beyond the exclusion zone.
Monitoring will be conducted throughout the time required to drive a pile.
(3) Marine mammal presence within the Level B harassment zone will be monitored, but vibratory driving will not be stopped if marine mammals are found to be present. Any marine mammal documented within the Level B harassment zone during vibratory driving would constitute a Level B take (harassment), and will be recorded and reported as such.
We have carefully evaluated the Corps' proposed mitigation measures and considered their effectiveness in past implementation to determine whether they are likely to effect the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another: (1) The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals, (2) the proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and (3) the practicability of the measure for applicant implementation.
Any mitigation measure(s) we prescribe should be able to accomplish, have a reasonable likelihood of accomplishing (based on current
(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
(2) A reduction in the number (total number or number at biologically important time or location) of individual marine mammals exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).
(3) A reduction in the number (total number or number at biologically important time or location) of times any individual marine mammal would be exposed to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing takes by behavioral harassment only).
(4) A reduction in the intensity of exposure to stimuli expected to result in incidental take (this goal may contribute to 1, above, or to reducing the severity of behavioral harassment only).
(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying particular attention to the prey base, blockage or limitation of passage to or from biologically important areas, permanent destruction of habitat, or temporary disturbance of habitat during a biologically important time.
(6) For monitoring directly related to mitigation, an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on our evaluation of the Corps' proposed measures, including information from monitoring of implementation of mitigation measures very similar to those described here under previous IHAs from other marine construction projects, we have determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for incidental take authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.
Any monitoring requirement we prescribe should improve our understanding of one or more of the following:
(1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;
(2) An increase in our understanding of how many marine mammals are likely to be exposed to levels of pile driving that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS;
(3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:
Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);
Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);
Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;
(4) An increased knowledge of the affected species; and
(5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.
The Corps consulted with NMFS to create a marine mammal monitoring plan as part of the IHA application for this project.
• Two individuals meeting the minimum qualifications previously identified will monitor the marine mammal buffer area and Level B harassment zones during vibratory pile. Monitors will be stationed on the drilling rig or Jetty A as well as on Clatsop Spit.
• During vibratory pile driving, the area within 10 meters of pile driving activity will be monitored and maintained as a marine mammal buffer area in which pile installation will not commence or will be suspended temporarily if any marine mammals are observed within or approaching the area of potential disturbance. The Level B harassment area will be monitored by 2 observers at locations listed above. The monitoring staff will record any presence of marine mammals by species, will document any behavioral responses noted, and record Level B takes when sightings overlap with pile installation activities.
• The individuals will scan the waters within each monitoring zone activity using binoculars (Vector 10X42 or equivalent), spotting scopes (Swarovski 20–60 zoom or equivalent), and visual observation.
• The area within which the Level B harassment thresholds could be exceeded during vibratory pile driving will be monitored for the presence of marine mammals. Marine mammal presence within these zones, if any, will be monitored but pile driving activity will not be stopped if marine mammals were found to be present. Any marine mammal documented within the Level B harassment zone will constitute a Level B take, and will be recorded and used to document the number of take incidents.
• If waters exceed a sea-state which restricts the observers' ability to make observations within the marine mammal buffer zone (
• The waters will be scanned for 30 minutes before, during, and 30 minutes after any and all pile driving and removal activities.
• If marine mammals enter or are observed within the designated marine mammal buffer zone (10 m) during or 30 minutes prior to pile driving, the monitors will notify the on-site construction manager to not begin until the animal has moved outside the designated radius.
• If a marine mammal approaches the shutdown zone prior to initiation of pile driving, the Corps cannot commence activities until the marine mammal (a) is observed to have left the Level A harassment zone or (b) has not been seen or otherwise detected within the Level A harassment zone for 30 minutes.
• The waters will continue to be scanned for at least 30 minutes after pile driving has completed each day, and
We require that observers use approved data forms. Among other pieces of information, the Corps will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the Corps will attempt to distinguish between the number of individual animals taken and the number of incidents of take. We require that, at a minimum, the following information be collected on the sighting forms:
• Date and time that monitored activity begins or ends;
• Construction activities occurring during each observation period;
• Weather parameters (
• Water conditions (
• Species, numbers, and, if possible, sex and age class of marine mammals;
• Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity;
• Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;
• Locations of all marine mammal observations; and
• Other human activity in the area.
The Corps will notify NMFS prior to the initiation of the pile driving activities. The Corps will provide NMFS with a draft monitoring report within 90 days of the conclusion of the proposed construction work. This report will detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. If no comments are received from NMFS within 30 days, the draft final report will constitute the final report. If comments are received, a final report must be submitted within 30 days after receipt of comments.
Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: “. . . any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].”
All anticipated takes would be by Level B harassment resulting from vibratory pile driving/removal and involving temporary changes in behavior. Injurious or lethal takes are not expected due to the expected source levels and sound source characteristics associated with the activity, and the planned mitigation and monitoring measures are expected to further minimize the possibility of such take.
Given the many uncertainties in predicting the quantity and types of impacts of sound in every given situation on marine mammals, it is common practice to estimate how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound, based on the available science.
This practice potentially overestimates the numbers of marine mammals taken for stationary activities, as it is likely that some smaller number of individuals may accrue a number of incidences of harassment per individual than for each incidence to accrue to a new individual, especially if those individuals display some degree of residency or site fidelity and the impetus to use the site (
The Corps requested authorization for the incidental taking of small numbers of killer whale, Gray whale, harbor porpoise, Steller sea lion, California sea lion, and harbor seal near the MCR project area that may result from vibratory pile driving and removal during construction activities associated with the rehabilitation of Jetty A at the MCR.
In order to estimate the potential incidents of take that may occur incidental to the specified activity, we must first estimate the extent of the sound field that may be produced by the activity and then consider in combination with information about marine mammal density or abundance in the project area. We provided detailed information on applicable sound thresholds for determining effects to marine mammals as well as describing the information used in estimating the sound fields, the available marine mammal density or abundance information, and the method of estimating potential incidences of take, in our
Table 2 above illustrated that during vibratory driving the120 dB Level B harassment threshold could be exceeded at 7,356 meters. Note that the actual area ensonified by pile driving activities is significantly constrained by local topography relative to the identified threshold radii.
The method used for calculating potential exposures to vibratory pile driving noise for each threshold was estimated using local marine mammal data sets, the Biological Opinion, best professional judgment from state and federal agencies, and data from IHA estimates on similar projects with similar actions. All estimates are conservative and include the following assumptions:
• During construction, each species could be present in the project area each day. The potential for a take is based on a 24-hour period. The model assumes that there can be one potential take (Level B harassment exposure) per individual per 24-hours.
• All pilings installed at each site would have an underwater noise disturbance equal to the piling that causes the greatest noise disturbance (
• Exposures were based on an estimated 17 days of in-water work.
Southern resident killer whales have been observed offshore near the study area and ZOI, but the Corps does not have fine-scale details on frequency of use. While killer whales do occur in the Columbia River plume, where fresh water from the river intermixes with salt water from the ocean, they are rarely seen in the interior of the Columbia River Jetty system. The ensonified area associated with the proposed action at Jetty A does not extend out into the open ocean where killer whales are likely to be found. Furthermore, the Corps has limited its pile installation window in order to avoid peak salmon runs and any overlap with the presence of Southern residents. To ensure no Level B acoustical harassment occurs, the Corps will restrict pile installation from October 1 until April 30 of each season. However, this restriction was
Western Transient killer whales may be traversing offshore over a greater duration of time than the feeding resident. They are rarely observed inside of the jetty system. The Southwest Fisheries Science Center (SWFSC) stratum model under the Marine Animal Monitor Model provides an estimated density of 0.00070853 animals per km
The following formula was used to calculate exposure using
Where:
Given the low density and rare occurrence of transient killer whales in the ZOI, exposure of feeding or transient killer whales to Level B acoustical harassment from pile driving is unlikely to occur. However, NMFS proposes to authorize take of small number due to the remote chance that transient orcas remain in the vicinity to feed on pinnipeds that frequent the haulouts at the South Jetty.
NMFS believes that an authorized take of 8 transients is warranted because solitary killer whales are rarely observed, and transient whales travel in pods of 2–15 members. NMFS has assumed a pod size of 8.
Based on anecdotal information and sightings between 2006 and 2011 (Halpin
The Pacific Coast Feeding Group or northbound summer migrants would be the most likely gray whales to be in the vicinity of MCR. Since no information pertaining to gray whale densities could be identified, NMFS elected to apply proxy data for estimating densities. As a proxy, data pertinent to humpback whales (0.0039 animals per km
The following formula was used to calculate exposure:
Migrating gray whales often travel in groups of 2, although larger pods do occur. For gray whales, NMFS believes 4 Level B authorized takes is reasonable.
Harbor porpoises are known to occupy shallow, coastal waters and, therefore, are likely to be found in the vicinity of the MCR. They are known to occur within the proposed project area, however, density data for this region is unavailable (Griffith 2015).
The SWFSC stratum model under the Marine Animal Monitor Model provides an estimated density per km
The formula previously described was used to arrive at a take estimate for harbor porpoise.
Based on the density model suggested by NOAA (2015), the Corps has provided a very conservative maximum estimate of 1,464 harbor porpoise disturbance exposures over the 17 days of operation. However, this number of potential exposures does not accurately reflect the actual number of animals that would potentially be taken for the MCR jetty project. Rather, it is more likely that the same pod may be exposed more than once during the 17-day operating window. The highest estimated number of animals exposed on any single day based on the modeled proxy density (Barlow
NMFS conservatively assumed that a single, large feeding pod of 50 animals forms within the ZOI for Jetty A on each day of pile installation. Though this is likely much higher than actual use by multiple pods in the vicinity, it more realistically represents a worst-case scenario for the number of animals that could potentially be affected by the proposed work. This calculation also assumes that it is a new pod of individuals would be affected on each installation day, which is also unlikely given pod residency. Therefore, NMFS is permitting a Level B take for 850 animals.
There are haulout sites on the South Jetty used by pinnipeds, especially Steller sea lions. It is likely that pinnipeds that use the haulout area in would be exposed to 120 dB threshold acoustic threshold during pile driving activities. The number of exposures would vary based on weather conditions, season, and daily fluctuations in abundance. Based on a survey by the Washington Department of Fish & Wildlife (WDFW) the number of affected Steller sea lions could be between 200–800 animals per month; California sea lion numbers could range from 1 to 500 per month and the number of harbor seals could be as low as 1 to as high as 57 per month. Exposure and take estimates below are based on past pinniped data from WDFW (2000–2014 data), which had a more robust monthly sampling frequency relative to Oregon Department of Fish &Wildlife (ODFW) counts. The exception to this was for harbor seal counts, for which ODFW (also 2000–2014 data) had more sampling data in certain months. Therefore, ODFW harbor seal data was used for the months of May and July. Exposure estimates are much higher than take estimates. This is because unlike the exposure estimate which assumes all new individuals, the take estimate request assumes that some of the same individuals will remain in the area and be exposed multiple times during the short 17-day installation period to complete and remove each offloading facility (for a total of about 68 days). NMFS examined the estimated monthly average number of animals from 2000–2014 hauled on South Jetty during May and June, which are the most likely months for pile installation as is shown in Table 3. There are no anticipated airborne exposures since the main haul out sites are not in close proximity to Jetty A. Note that the formula used by NMFS is different than that employed by the Corps in their application as NMFS is only analyzing potential impacts associated with Jetty A. To reiterate, these exposure estimates assume a new individual is exposed every day throughout each acoustic disturbance, for the entire duration of the project.
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the discussion of our analyses applies to all the species listed in Table 4 given that the anticipated effects of this pile driving project on marine mammals are expected to be relatively similar in nature. There is no information about the size, status, or structure of any species or stock that would lead to a different analysis for this activity, else species-specific factors would be identified and analyzed.
Pile driving activities associated with the rehabilitation of Jetty A at the mouth of the Columbia River, as outlined
No injury, serious injury, or mortality is anticipated given the nature of the activity and measures designed to minimize the possibility of injury to marine mammals. The potential for these outcomes is minimized through the construction method and the implementation of the planned mitigation measures. Specifically, vibratory hammers will be the only method of installation utilized. No impact driving is planned. Vibratory driving does not have significant potential to cause injury to marine mammals due to the relatively low source levels produced (site-specific acoustic monitoring data show no source level measurements above 180 dB rms) and the lack of potentially injurious source characteristics. The likelihood that marine mammal detection ability by trained observers is high under the environmental conditions described for the rehabilitation of Jetty A at MCR further enables the implementation of shutdowns to avoid injury, serious injury, or mortality.
The Corps' proposed activities are localized and of short duration. The entire project area is limited to the Jetty A area and its immediate surroundings. Actions covered under the Authorization would include installing a maximum of 24 piles for use as dolphins and a maximum of 93 sections of Z or H piles for retention of rock fill over 17 days. The piles would be a maximum diameter of 24 inches and would only be installed by vibratory driving method. The possibility exists that smaller diameter piles may be used but for this analysis it is assumed that 24 inch piles will be driven.
These localized and short-term noise exposures may cause brief startle reactions or short-term behavioral modification by the animals. These reactions and behavioral changes are expected to subside quickly when the exposures cease. Moreover, the proposed mitigation and monitoring measures are expected to reduce potential exposures and behavioral modifications even further. Additionally, no important feeding and/or reproductive areas for marine mammals are known to be near the proposed action area. Therefore, the take resulting from the proposed project is not reasonably expected to and is not reasonably likely to adversely affect the marine mammal species or stocks through effects on annual rates of recruitment or survival.
The project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section. The project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.
Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (
In summary, this negligible impact analysis is founded on the following factors: (1) The possibility of injury, serious injury, or mortality may reasonably be considered discountable; (2) the anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior and; (3) the presumed efficacy of the proposed mitigation measures in reducing the effects of the specified activity to the level of least practicable impact. In combination, we believe that these factors, as well as the available body of evidence from other similar activities, demonstrate that the potential effects of the specified activity will have only short-term effects on individuals. The specified activity is not expected to impact rates of recruitment or survival and will therefore not result in population-level impacts.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from the Corps' rehabilitation of Jetty A at MCR will have a negligible impact on the affected marine mammal species or stocks.
Table 4 illustrates the number of animals that could be exposed to received noise levels that could cause Level B behavioral harassment for the proposed work associated with the rehabilitation of Jetty A at MCR. The analyses provided above represents between <0.01%—20.9% of the populations of these stocks that could be affected by Level B behavioral harassment. The numbers of animals authorized to be taken for all species would be considered small relative to the relevant stocks or populations even if each estimated taking occurred to a new individual—an extremely unlikely scenario. For pinnipeds occurring in the vicinity of Jetty A, there will almost certainly be overlap in individuals present day-to-day, and these takes are likely to occur only within some small portion of the overall regional stock.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, which are expected to reduce the number of marine mammals potentially affected by the proposed action, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.
There are no subsistence uses of marine mammals in the proposed project area; and, thus, no subsistence uses impacted by this action.
There are two marine mammal species that are listed as endangered under the ESA with confirmed or possible occurrence in the study area: humpback whale and Southern resident killer whale. For the purposes of this IHA, NMFS determined that take of Southern resident killer whales was highly unlikely given the rare occurrence of these animals in the project area. A similar conclusion was reached for humpback whales. On March 18, 2011, NMFS signed a Biological Opinion concluding that the proposed action is not likely to jeopardize the continued existence of humpback whales and may affect, but is not likely to adversely affect Southern resident killer whales.
The Corps issued the
As a result of these determinations, we have issued an IHA to the Corps for conducting the described activities related to the rehabilitation of Jetty A at the MCR from May 1, 2016 through April 30, 2017 provided the previously described mitigation, monitoring, and reporting requirements are incorporated.
United States Transportation Command (USTRANSCOM), DoD.
Notice.
DoD has developed a Concept of Operations (CONOPS) to test expansion of the personal property volume move criteria to include select high-volume channel/traffic lanes. Under the pilot test, personal property shipments will be awarded both directions (to/from) by the responsible origin/destination Joint Personal Property Shipping Office (JPPSO) on the participating pilot lanes. The CONOPS was developed utilizing general traffic management principles in concert with the Defense Transportation Regulation (DTR) Part IV (DTR 4500.9R), and Government household goods tariff (400NG) (as amended).
Comments must be received on or before November 9, 2015.
Do not submit comments directly to the point of contact under
• Federal eRulemaking Portal:
• Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301–9010.
Mr. Jim Teague, United States Transportation Command, TCJ5/4–PI, 508 Scott Drive, Scott Air Force Base, IL 62225–5357; (618) 220–4803.
The pilot test CONOPS is available for review and comment on the USTRANSCOM Web site at
Any subsequent modification(s) to the business rules will be published in the
A complete version of the DTR is available via the Internet on the USTRANSCOM homepage at
Assistant Secretary of Defense (Health Affairs), DoD.
Notice of meeting.
The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Uniform Formulary Beneficiary Advisory Panel (hereafter referred to as the Panel).
Wednesday, September 30, 2015, from 9 a.m. to 1 p.m.
Naval Heritage Center Theater, 701 Pennsylvania Avenue NW., Washington, DC 20004.
CAPT Edward Norton, DFO, Uniform Formulary Beneficiary Advisory Panel, 7700 Arlington Boulevard, Suite 5101, Falls Church, VA 22042–5101. Telephone: (703) 681–2890. Fax: (703) 681–1940. Email Address:
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (Title 5, United States Code (U.S.C.), Appendix, as amended) and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended).
To ensure timeliness of comments for the official record, the Panel encourages that individuals and interested groups consider submitting written statements instead of addressing the Panel.
President's Board of Advisors on Historically Black Colleges and Universities, Office of Undersecretary, U.S. Department of Education.
Announcement of an open meeting.
This notice sets forth the agenda for the September 23, 2015, meeting of the President's Board of Advisors on Historically Black Colleges and Universities (PBA) and provides information to members of the public on submitting written comments and on the process as to how to request time to
The PBA meeting will be held on September 23, 2015, from 9 a.m. to 1 p.m. E.D.T. at the Washington Marriott Wardman Park, 2660 Woodley Road NW., Washington, DC 20008, in the Wilson Rooms (Mezzanine Level).
U.S. Department of Education, White House Initiative on Historically Black Colleges and Universities, 400 Maryland Avenue SW., Washington, DC 20202.
Sedika Franklin, Program Specialist, U.S. Department of Education, White House Initiative on Historically Black Colleges and Universities, 400 Maryland Avenue SW., Washington, DC 20204; telephone: (202) 453–5634 or (202) 453–5630, fax: (202) 453–5632, or email
The Board shall advise the President and the Secretary in the following areas: (i) Improving the identity, visibility, and distinctive capabilities and overall competitiveness of HBCUs; (ii) engaging the philanthropic, business, government, military, homeland-security, and education communities in a national dialogue regarding new HBCU programs and initiatives; (iii) improving the ability of HBCUs to remain fiscally secure institutions that can assist the nation in reaching its goal of having the highest proportion of college graduates by 2020; (iv) elevating the public awareness of HBCUs; and (v) encouraging public-private investments in HBCUs.
Below is a list of agencies, invited to provide updates on fiscal year 2015 activities and outreach during the September 23, 2015 meeting:
• National Science Foundation
• U.S. Department of Transportation
• U.S. Department of Agriculture
• U.S. Social Security Administration
All oral comments made will become part of the official record of the Board. Similarly, written materials distributed during oral presentations will become part of the official record of the meeting.
Presidential Executive Order 13532, continued by Executive Order 13652.
Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Environmental Management Advisory Board (EMAB). The Federal Advisory Committee Act (Pub. L. 92–463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Wednesday, September 30, 2015, 1 p.m.–5 p.m.
The Key Bridge Marriott, 1404 Lee Highway, Arlington, Virginia 22209.
Kristen G. Ellis, Designated Federal Officer, EMAB (EM–3.2), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585. Phone (202) 586–5810; fax (202) 586–0293 or email:
Public Participation: EMAB welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristen G. Ellis at least seven days in advance of the meeting at the phone number or email address listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda should contact Kristen G. Ellis at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.
Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy (DOE).
Notice and request for comments.
The Department of Energy pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years an information collection request with the Office of Management and Budget. Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of DOE, including whether the information shall have practical utility; (b) the accuracy of DOE's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments regarding this proposed information collection must be received on or before November 9, 2015. If you anticipate difficulty in submitting comments within that period, contact the person listed below as soon as possible.
Written comments should be sent to: Desk Officer for the Department of Energy, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW., Washington, DC 20503. And to Mr. Dennis Smith, Office of Energy Efficiency and Renewable Energy (EE–3V), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585–0121, or by fax at 202–586–1600, or by email at
Mr. Dennis Smith at the address listed above in
DOE is proposing to extend an information collection pursuant to the Paperwork Reduction Act of 1995. The approved collection is being used for two Clean Cities programmatic efforts. The first is related to a scorecard that assists DOE's Clean Cities coalitions and stakeholders in assessing the level of readiness of their communities for plug-in electric vehicles (PEV). The second effort is intended to develop information that enables DOE to measure the impact and progress of DOE's National Clean Fleets Partnership (Partnership). DOE is not proposing to expand the scope of these information collection efforts.
This information collection request contains: (1) OMB No. 1910–5171; (2) Information Collection Request Title: Clean Cities Vehicle Programs; (3) Type of Review: Renewal; (4) Purpose: DOE's Clean Cities initiative has developed two voluntary mechanisms by which communities and certain fleets can get a better understanding of their readiness to deploy alternative fuel vehicles and their progress in doing so. The voluntary PEV Scorecard is intended to assist its coalitions and stakeholders in assessing the level of readiness of their communities for plug-in electric vehicles. The principal objective of the scorecard is to provide respondents with an objective assessment and estimate of their respective community's readiness for PEV deployment as well as understand the respective community's commitment to deploying these vehicles successfully. DOE intends the scorecard to be completed by a city/county/regional sustainability or energy coordinator. As the intended respondent may not be aware of every aspect of
DOE expects a total respondent population of approximately 1,250 respondents. Selecting the multiple choice answers in completing a scorecard questionnaire is expected to take under 30 minutes, although additional time of no more than 20 hours may be needed to assemble information necessary to be able to answer the questions, leading to a total burden of approximately 25,625 hours. Assembling information to update questionnaire answers in the future on a voluntary basis would be expected to take less time, on the order of 10 hours, as much of any necessary time and effort needed to research information would have been completed previously.
For the Clean Fleets Partnership information collection, the Partnership is targeted at large, private-sector fleets that own or have contractual control over at least 50 percent of their vehicles and have vehicles operating in multiple States. DOE expects approximately 50 fleets to participate in the Partnership and, as a result, DOE expects a total respondent population of approximately 50 respondents. Providing initial baseline information for each participating fleet, which occurs only once, is expected to take 60 minutes. Follow-up questions and clarifications for the purpose of ensuring accurate analyses are expected to take up to 90 minutes. The total burden is expected to be 125 hours.
The combined burden for the two information collections is 25,750 hours.
(5) Type of Respondents: Public; (6) Annual Estimated Number of Respondents for both information collections: 1,300; (7) Annual Estimated Number of Total Responses: 1,300; (7) Annual Estimated Number of Burden Hours: 25,750 (25,625 for PEV Scorecard, and 125 for Clean Fleets Partnership); and (8) Annual Estimated Reporting and Recordkeeping Cost Burden: There is no cost associated with reporting and recordkeeping.
42 U.S.C. 13233; 42 U.S.C. 13252 (a)–(b); 42 U.S.C. 13255.
Take notice that the Commission received the following electric rate filings:
Description: Initial rate filing: Reactive Power Service Rate Schedule to be effective 1/1/2016.
Description: Baseline eTariff Filing: Triolith Energy Fund LP Tariff to be effective 9/4/2015.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Midwest Electric Power, Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 21, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b
c.
d.
e.
f.
g.
h.
i.
j.
All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. Description of Request: The licensee filed a revised recreation plan in response to a Commission staff request following an inspection which found that several sites on the approved recreation plan were either closed to the public or received little to no public recreational use. The proposed revised plan would close the fishing access areas at the Inskip Powerhouse and Coleman Forebay. To offset these closures, the licensee proposes to improve a fishing access area at the North Battle Creek Reservoir and create a new fishing access area on the Cross Country Canal off of Rock Creek Road. Aside from these revisions and deletion of extraneous or outdated information, other aspects of the current recreation plan would remain the same.
l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502–8371. This filing may also be viewed on the Commission's Web site at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of Public Service Company of Colorado, Tucson Electric Power Company, UNS Electric, Inc., Public Service Company of New Mexico, Arizona Public Service Company, El Paso Electric Company, Black Hills Power, Inc., Black Hills Colorado Electric Utility Company, LP, Cheyenne Light, Fuel, & Power Company, Arizona Public Service Company, and NV Energy, Inc.:
The above-referenced meetings will be held at:
The above-referenced meetings will be available via web conference and teleconference.
The above-referenced meetings are open to stakeholders.
Further information may be found at
The discussions at the meetings described above may address matters at issue in the following proceedings:
For more information contact Gabriel Aguilera, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (202) 502–8489 or
Take notice that on August 24, 2015, Colorado Interstate Gas Company, L.L.C. (CIG) and Wyoming Interstate Company, L.L.C. (WIC), jointly filed an application pursuant to section 7(b) of the Natural Gas Act (NGA) and Part 157 of the Commission's Regulations, for approval to abandon, by sale and in place, CIG's Powder River Lateral Pipeline and associated metering facilities located in Converse County and Albany County, Wyoming. Also, the applicants request the Commission's approval the termination of an associated Powder River Lateral capacity lease agreement between CIG and WIC. The filing may also be viewed on the web at
Any questions regarding this application should be directed to Francisco Tarin, Director, Regulatory Affairs, Colorado Interstate Gas Company, L.L.C., P.O. Box 1087, Colorado Springs, Colorado, 80944, telephone (719) 667–7517, fax (719) 520–4697; or Mark A. Minich, Assistant General Counsel, Colorado Interstate Gas Company, L.L.C., P.O. Box 1087, Colorado Springs, Colorado, 80944, telephone (719) 520–4416, fax (719) 520–4415.
CIG requests the approval of an abandonment buy sale to Copano Pipelines/Rocky Mountain LLC (CP/RM) of its approximate 100-mile Powder River Lateral Pipeline (Line No. 72A) located in Converse County and Albany County, Wyoming. CIG also proposes to abandon in place of its Powder River Meter Station, North Platte Meter Station, Glenrock Meter Station, and a farm tap located on Line No. 72A. In addition, CIG and WIC request an approval the termination of the CIG/WIC capacity lease agreement currently in effect for capacity on Line No. 72A and through WIC's Laramie Jumper Compressor Station.
Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
Motions to intervene, protests and comments may be filed electronically via the internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's approval of the State of Alabama's request to revise/modify its State Operating Permit Programs EPA-authorized program to allow electronic reporting.
EPA's approval is effective September 8, 2015.
Karen Seeh, U.S. Environmental
On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the
On July 29, 2015, the Alabama Department of Environmental Management (ADEM) submitted an application titled “Air Emissions Electronic Reporting System” for revision/modification to its EPA-approved operating permit program under title 40 CFR to allow new electronic reporting. EPA reviewed ADEM's request to revise/modify its EPA-authorized Part 70—State Operating Permit Program and, based on this review, EPA determined that the application met the standards for approval of authorized program revision/modification set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Alabama's request to revise/modify its Part 70—State Operating Permit Program to allow electronic reporting under 40 CFR part 70 is being published in the
ADEM was notified of EPA's determination to approve its application with respect to the authorized program listed above.
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's approval of the State of Mississippi's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.
EPA's approval is effective September 8, 2015.
Karen Seeh, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566–1175,
On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the
On June 22, 2015, the Mississippi Department of Environmental Quality (MDEQ) submitted an application titled “Network Discharge Monitoring Report System” for revisions/modifications to its EPA-approved stormwater and industrial pretreatment programs under title 40 CFR to allow new electronic reporting. EPA reviewed MDEQ's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Mississippi's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 122 and 403, is being published in the
MDEQ was notified of EPA's determination to approve its application with respect to the authorized programs listed above.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10667 Southern Community Bank, Fayetteville, GA (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Southern Community Bank (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective September 01, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10473 Chipola Community Bank, Marianna, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Chipola Community Bank (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective September 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10318 Paramount Bank, Farmington Hills, Michigan (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Paramount Bank (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective September 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10066 First National Bank of Anthony, Anthony, KS (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of First National Bank of Anthony (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective September 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10274, NorthWest Bank and Trust, Acworth, GA (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of NorthWest Bank and Trust (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective September 1, 2015, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10201, American National Bank, Parma, Ohio (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of American National Bank (Receivership Estate); The Receiver has made all dividend distributions required by law.
The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.
Effective September 1, 2015 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than September 22, 2015.
A. Federal Reserve Bank of New York (Ivan Hurwitz, Vice President) 33 Liberty Street New York, New York 10045–0001:
1.
B. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309:
1.
C. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001:
1.
Board of Governors of the Federal Reserve System, September 2, 2015.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 2, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414:
1.
B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001:
1.
Board of Governors of the Federal Reserve System, September 2, 2015.
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to
National Healthcare Safety Network (NHSN) (OMB No. 0920–0666, exp. 12/31/2017)—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. The NHSN currently consists of five components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), and Dialysis. The Outpatient Procedure Component is on track to be released in NHSN in 2016/2017. The development of this component has been previously delayed to obtain additional user feedback and support from outside partners.
Changes were made to seven facility surveys. Based on user feedback and internal reviews of the annual facility surveys it was determined that questions and response options be amended, removed, or added to fit the evolving uses of the annual facility surveys. The surveys are being increasingly used to help intelligently interpret the other data elements reported into NHSN. Currently the surveys are used to appropriately risk adjust the numerator and denominator data entered into NHSN while also guiding decisions on future division priorities for prevention.
Additionally, minor revisions have been made to 27 forms within the package to clarify and/or update surveillance definitions. Two forms are being removed as those forms will no longer be added to the NHSN system.
The previously approved NHSN package included 54 individual collection forms; the current revision request removes two forms for a total of 52 forms. The reporting burden will increase by 583,825 hours, for a total of 4,861,542 hours.
This document corrects a notice that was published in the
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the National Health and Nutrition Examination Survey (NHANES). NHANES programs produce descriptive statistics which measure the health and nutrition status of the general population.
Written comments must be received on or before November 9, 2015.
You may submit comments, identified by Docket No. CDC–2015–0078 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services
The National Health and Nutrition Examination Survey (NHANES), (OMB No. 0920–0950, expires 11/30/2016)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on the extent and nature of illness and disability; environmental, social and other health hazards; and determinants of health of the population of the United States. The National Health and Nutrition Examination Surveys (NHANES) have been conducted periodically between 1970 and 1994, and continuously since 1999 by the National Center for Health Statistics, CDC. Annually, approximately 14,410 respondents participate in some aspect of the full survey. Up to 3,500 additional persons might participate in tests of procedures, special studies, or methodological studies.
NHANES programs produce descriptive statistics which measure the health and nutrition status of the general population. Through the use of physical examinations, laboratory tests, and interviews NHANES studies the relationship between diet, nutrition and health in a representative sample of the United States. NHANES monitors the prevalence of chronic conditions and risk factors. NHANES data are used to produce national reference data on height, weight, and nutrient levels in the blood. Results from more recent NHANES can be compared to findings reported from previous surveys to monitor changes in the health of the U.S. population over time. NCHS collects personal identification information. Participant level data items will include basic demographic information, name, address, social security number, Medicare number and participant health information to allow for linkages to other data sources such as the National Death Index and data from the Centers for Medicare and Medicaid Services (CMS).
A variety of agencies sponsor data collection components on NHANES. To keep burden down, NCHS cycles in and out various components. The 2015–2016 NHANES physical examination includes the following components: oral glucose tolerance test (ages 12 and older), anthropometry (all ages), 24-hour dietary recall (all ages), physician's examination (all ages, blood pressure is collected here), oral health examination (ages 1 and older), hearing (ages 20–59), dual X-ray absorptiometry (total body composition ages 6–59 and osteoporosis, vertebral fractures and aortic calcification ages 40 and older).
While at the examination center additional interview questions are asked (6 and older), a second 24-hour dietary recall (all ages) is scheduled to be conducted by phone 3–10 days later, and an appointment is made to return to the MEC to begin a 24-hour urine collection (one-half sample of ages 20– 69). In 2014, a 24-hour urine collection was added to the NHANES protocol to better understand sodium intake and provide a population baseline for use in monitoring trends in sodium intake in the future. In 2015, FDA is scheduled to implement a plan to promote broad, gradual reduction of added sodium in the food supply. One half of those successfully completing the initial collection will be asked to complete a second 24-hour urine. After completing the 24-hour urine participants are asked to provide 2 home urine collections (first morning and an evening) and mail them back. The urines collected in the morning and evening will be compared to the 24-hour urine collection.
NHANES also plans to conduct a waist circumference methodology study. The study population will be NHANES participants aged 20 and over who participate in the body measurements component in the Mobile Examination Center (MEC).
The bio-specimens collected for laboratory tests include urine, blood, vaginal and penile swabs, oral rinses and household water collection. Serum, plasma and urine specimens are stored for future testing if the participant consents.
The following major examination or laboratory items, that had been included in the 2013–2014 NHANES, were cycled out for NHANES 2015–2016: physical activity monitor, taste and smell component and upper body muscle strength (grip test).
Most sections of the NHANES interviews provide self-reported information to be used either in concert with specific examination or laboratory content, as independent prevalence estimates, or as covariates in statistical analysis (
NHANES data users include the U.S. Congress; numerous Federal agencies such as other branches of the Centers for Disease Control and Prevention, the National Institutes of Health, and the United States Department of Agriculture; private groups such as the American Heart Association; schools of public health; and private businesses.
Participation in NHANES is completely voluntary and confidential. A three-year approval is requested. There is no cost to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed revision of the information collection request entitled
Written comments must be received on or before November 9, 2015.
You may submit comments, identified by Docket No. CDC–2015–0079 by any of the following methods:
•
•
Please note: All public comment should be submitted through the Federal eRulemaking portal (
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS–D74, Atlanta, Georgia 30329; phone: 404–639–7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
Restrictions on Interstate Travel of Persons (42 CFR part 70) (OMB Control No. 0920–0488 exp. 3/31/2016)—Revision—Division of Global Migration and Quarantine, National Center for Emerging Zoonotic and Infectious Diseases, Centers for Disease Control and Prevention (CDC).
This revision to an existing information collection request is intended to ensure that CDC can continue to collect pertinent information related to communicable disease or deaths that occur aboard conveyances during interstate travel within the United States, as authorized under 42 Code of Federal Regulations part 70.
The intended use of the information is to ensure that CDC can assess and respond to reports of communicable disease or death that occur on conveyances engaged in interstate travel, and assist state and local health authorities if an illness or death occurs that poses a risk to public health. Generally, the primary source of this
This revision makes several modification to this information collection. They are as follows:
• In current practice, CDC does not process applications for travel permits. The issuance of travel restrictions is a collaborative process between public health partners,
• Reports of communicable disease or death from domestic conveyances are almost always submitted electronically via radio, so the current Master of Vessel or Conveyance Illness Report has been rendered obsolete. In addition, CDC has issued guidance stating that reports to CDC, instead of local health authorities, regarding domestic reports of communicable disease or death on board conveyances meet the requirements of the regulation; therefore, information collections related to copies sent to state health departments are no longer necessary. This primary concerns interstate flights.
• CDC is also requesting an adjustment to the burden associated with reports of communicable disease or death from domestic conveyances. CDC is reducing the burden from 15 minutes per report to 7 minutes. This is due to the facilitation of reporting using electronic means,
The resulting change in burden is a reduction of 3,678 hours.
For reports of death or communicable disease made by master of a vessel or person in charge of a conveyance engaged in interstate traffic, the requested burden is approximately 23 hours. This total is estimated from 200 respondents submitting domestic reports of death or communicable disease a year, with an average burden of 7 minutes per report. This totals 23 hours. There is no burden to respondents other than the time required to make the report of illness or death.
National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of draft document available for public comment.
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document for public comment entitled
This guidance document does not have the force and effect of law.
Electronic or written comments must be received by November 9, 2015.
You may submit comments, identified by CDC–2015–0075 and Docket Number NIOSH–288, by either of the two following methods:
•
•
Deborah V. Hirst, NIOSH, Division of Applied Research and Technology, Alice Hamilton Laboratories, 1090 Tusculum Avenue, MS R–5, Cincinnati, Ohio 45226, (513) 841–4141 (not a toll free number), Email:
The purpose of the protocol is to test a closed system transfer device's (CSTD) capability to perform as a closed system. During an evaluation of the protocol,
A panel consisting of peer reviewers and stakeholders was asked to review and comment on the draft guidance document and protocol. NIOSH reviewed the recommendations of the peer reviewers and stakeholders then made the final determination regarding document content as well as the decision not to propose a specific pass/fail performance threshold. The protocol is being published for comment in CDC–2015–0075 and Docket Number NIOSH–288 and can be found at
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by October 8, 2015.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786–1326.
Reports Clearance Office at (410) 786–1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
Consistent with the recent reauthorization of the CCDBG statute, ACF requests reinstatement and revision of the ACF–800 including a number of changes and clarifications to the reporting requirements and instructions. Most notably, section 658K(a)(2)(F) of the CCDBG Act now requires States to report the number of fatalities occurring among children while in the care and facility of child care providers serving CCDF children. The new data element will be required with the reporting period beginning on October 1 of 2015 (FFY 2016).
Respondents: States, the District of Columbia, and Territories including Puerto Rico, Guam, the Virgin Islands, American Samoa, and the Northern Marianna Islands.
OMB No.:
Description:
On March 1, 2003, the Homeland Security Act of 2002, Section 462, transferred responsibilities for the care and placement of unaccompanied children from the Commissioner of the Immigration and Naturalization Service to the Director of the Office of Refugee Resettlement (ORR). ORR is also governed by the provisions established by the Flores Agreement in 1997 and the William Wilberforce Trafficking Victims Protection Reauthorization Act (TVPRA) of 2008.
The ORR Unaccompanied Children's Program provides placement, care, custody and services for UC until they can be successfully released to a sponsor, are repatriated to their home country, or able to obtain legal status.
Through cooperative agreements and contracts, ORR funds residential care providers that provide temporary housing and other services to unaccompanied children in ORR custody. These care provider facilities are State licensed and must meet ORR requirements to ensure a high level quality of care. They provide a continuum of care for children, including placements in ORR foster care, group homes, shelter, staff secure, secure, and residential treatment centers. The care providers provide children with classroom education, health care, socialization/recreation, vocational training, mental health services, access to legal services, and case management.
Under the law, ORR and its care providers are required to:
(1) Collect information about each UC who is entrusted to the care of ORR in order to determine the most appropriate and least restrictive placement, provide adequate services, and identify qualified sponsors for the timely release of the child or youth. ORR has developed instruments to assess the child or youth and his or her needs and conditions throughout his or her stay with ORR as well as the identification and assessment of potential sponsors. These instruments allow for consistency and compliance of standards across care providers and help ORR monitor programs and identify problems and issues that need corrective action.
(2) Keep up-to-date records to ensure the child or youth's safety and security and care and to provide accountability with all Federal and State, licensing, and other standards by care providers.
(3) Notify UC of their rights and responsibilities under the law, including notice about ORR services, the fact that that they have the right to apply for Special Immigrant Juvenile (SIJ) status, and their legal responsibility to attend an immigration hearing.
These tasks are mainly conducted through the ORR online database (The UC Portal), which provides a central location for case records and the documentation of other activities (for example, when a child or youth is transferred to another facility). Many of these records are “auto-populated” on the UC Portal once the original data points are completed (such as DOB, A number, date of initial placement).
The data collection described here pertains to activities involving UC and care providers from initial intakes of UC into ORR care to his or her release from ORR care. It does not cover information collection for potential sponsors (Submitted via separate OMB request in January 2015.)
ORR has applied the following assumptions to this request:
(1) Items related to tasks that are routine and customary for care providers and others are excluded. This includes quarterly or annual financial or other reports, grant related requests from ORR Project Officers or others for monitoring performance and progress, and third party notifications to other government agencies, such as U.S. Department of Homeland Security (DHS) or U.S. Department of Justice (DOJ). (For financial and other reports, Care Providers use templates posted on
(2) Data collection and reporting requirements do not reflect those required by State or local licensing or accreditation requirements.
(3) Acknowledgement of receipt of information or other acknowledgements via signature by either the UC or the care provider or others are not included in this information request as these are administrative in nature in order to help care providers and UC track personal belongings, DHS related documents, medical records, and other important items required by the UC following release from ORR care.
The components of this information request include:
(1) UC Portal Capacity Report: Care providers complete the sections on “In Care” and “Beds in Reserve” as well as the section recording the UC who have been discharged on a daily basis so that ORR Intakes has a complete picture of available beds for UC placements.
(2) The Further Assessment Swift Track (FAST) Placement Tool (Versions for Secure and Staff Secure placements): Initially used by ORR Intakes to determine when a UC warrants a placement in Secure or Staff Secure Care. Care providers must use the tool to update a status for UC who are placed in Secure Care at least every 30 days. (Care providers are not required to re-use tool for UC who have been placed in Staff Secure Care).
(3) Placement Authorization: Auto-generated. Requires a signature from the care provider acknowledging a particular UC placement into their facility.
(4) Notice of Placement in Secure or Staff Secure Facility: Acknowledges UC's placement in a secure or staff secure care provider facility with signature of UC and facility witness.
(5) Initial Intakes Assessment: Biographical information is auto-
(6) UC Assessment: Care provider must complete within 7 days of UC's admission, covers biographic, family, legal, migration, medical, substance abuse, and mental health history.
(7) Individual Service Plan: Documents the services that have been provided (for example, number of counseling sessions, educational assessment and classes) and is updated every 30 days. When a child is transferred to a new facility, a new ISP is developed.
(8) UC Case Review Form: Documents any new information not indicated in the UC Assessment.
(9) New Sponsor Form: Identifies any potential sponsor(s) for a particular UC. In addition to serving as a record for a particular case, helps ORR track individuals who are attempting to sponsor numerous UC, which may suggest a possible trafficking or abuse situation.
(10) Transfer Request and Tracking Form: Auto-populated and used to obtain ORR permission for transfer to another care facility. (Filled out by both ORR and care providers) and used to document when a UC is transferred from one facility to another (requires signatures of both facilities).
(11) Long Term Foster Care Placement Memo: When ORR identifies a placement of a UC with a long term foster care facility, the long term foster care provider or national VOLAG receiving the transfer request completes the memo and sends to ORR to ensure continuity of services and tracking of records for a UC.
(12) Travel Request form for UC Long Term Foster Care: Must be filled out by program at least 10 days prior to travel start date.
(13) Notice of Transfer to ICE Chief Counsel and Change of Address: Required so that the Chief Counsel of ICE may file a Motion for Change of Venue and/or Change of Address with the Executive Office for Immigration Review (EOIR), if applicable, to ensure immigration hearing may proceed.
(14) Care Provider Release Checklist: Care providers must complete and affirm that all documents, forms, and steps are completed in the release process.
(15) Release Request: Provides care provider recommendation for release of a UC to a sponsor. All releases must be approved by ORR prior to UC release.
(16) Discharge Notification: Includes date and type of discharge (transfer, home country, sponsor release) and is sent to ICE.
(17) Verification of Release: Signed by sponsor as notification that named UC has been released according to the law. Sponsor must also acknowledge agreement with the provisions of the Sponsor Care Agreement pertaining to the minor's care, safety, and well-being, and the sponsor's responsibility for ensuring the minor's presence at all future proceedings before the Department of Homeland Security and EOIR.
(18) Child Advocate Referral and Appointment Form: Used by the Child Advocate Program to recommend that ORR appoint an independent child advocate for a victim of child trafficking or in other cases involving vulnerable children.
(19) Notice of Rights Handout and Notice of Rights and Provision of Services: Care providers are required to provide to all UC under the Flores v. Reno Settlement Agreement.
(20) Legal Service Provider List for UC: List of organizations who offer free legal representation and help for UC with State and Federal courts, immigration hearings, and appeals. Required under the Flores Settlement Agreement.
(21) URM Application: Certain populations of children and youth in ORR custody may become eligible for the Unaccompanied Refugee Minors Program, which is a State administered foster care program. In such instances the care provider facility or other interested party may complete this application form on behalf of the child.
(22) Withdrawal of Application or Declination of Placement Form: If a youth who has submitted an application for the URM Program wishes to withdraw this application, or if he or she has been offered placement and wishes to decline this placement, the youth must complete this form.
(23) Standard Shelter Tour Request: Used by members of the public and the media to submit to care providers in order to tour a shelter facility.
Staff in ORR's Care Provider Network, including those in shelter care, secure and staff secure care, foster care, and residential treatment centers.
Approved sponsors of UC released from ORR care.
In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by November 9, 2015.
Submit electronic comments on the collection of information to:
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002,
Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information “Environmental Impact Considerations.” The National Environmental Policy Act (NEPA) (42 U.S.C. 4321–4347) states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an
FDA's NEPA regulations are in part 25 (21 CFR part 25). All applications or petitions requesting Agency action require the submission of a claim for categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Sections 25.15(a) and (d) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (§ 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Sections 25.40(a) and (c) specifies the content requirements for EAs for non-excluded actions.
This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statues for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse events cannot be avoided, the Agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a
Any final EIS would contain additional information gathered by the Agency after the publication of the draft EIS, a copy or a summary of the comments received on the draft EIS, and the Agency's responses to the comments, including any revisions resulting from the comments or other information. When the Agency finds that no significant environmental effects are expected, the Agency prepares a finding of no significant impact.
FDA estimates the burden of this collection of information as follows:
Under 21 CFR 312.23(a)(7)(iv)(
Under 21 CFR 71.1, 171.1, 170.39, and 170.100, food additive petitions, color additive petitions, requests from exemption from regulation as a food additive, and submission of a food contact notification for a food contact substance must contain either a claim of categorical exclusion under § 25.30 or § 25.32 or an EA under § 25.40. Annually, FDA receives approximately 97 industry submissions. FDA received an annual average of 42 claims of categorical exclusions as required under § 25.15(a) and (d) and 33 EAs as required under §§ 25.40(a) and (c). FDA estimates that approximately 42 respondents will submit an average of 1 application for categorical exclusion and 33 respondents will submit an average of 1 EA. FDA estimates that, on average, it takes petitioners, notifiers, or requestors approximately 8 hours to prepare a claim of categorical exclusion and approximately 210 hours to prepare an EA.
Under 21 CFR 814.20(b)(11), premarket approvals (PMAs) (original PMAs and supplements) must contain a claim for categorical exclusion under § 25.30 or § 25.34 or an EA under § 25.40. In 2012 to 2014, FDA received an average of 39 claims (original PMAs and supplements) for categorical exclusions as required under §§ 25.15(a) and (d), and 0 EAs as required under §§ 25.40(a) and (c). FDA estimates that approximately 39 respondents will submit an average of 1 application for categorical exclusion annually. Based on information provided by sponsors, FDA estimates that it takes approximately 6 hours to prepare a claim for a categorical exclusion.
Under 21 CFR 601.2(a), BLAs as well as INDs (§ 312.23), NDAs (§ 314.50), ANDAs (§ 314.94), and PMAs (§ 814.20) must contain either a claim of categorical exclusion under § 25.30 or 25.32 or an EA under § 25.40. Annually, FDA receives approximately 34 BLAs from 18 applicants, 801 BLA supplements to license applications from 156 applicants, 345 INDs from 256 sponsors, 1 NDA from 1 applicant, 26 supplements to NDAs from 8 applicants, 1 ANDA from 1 applicant, 1 supplement to ANDAs from 1 applicant, 8 PMAs from 3 applicants, and 33 PMA supplements from 16 applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA.
FDA has received approximately 481 claims for categorical exclusion as required under §§ 25.15(a) and (d) annually and 2 EAs as required under §§ 25.40(a) and (c) annually. Therefore, FDA estimates that approximately 247 respondents will submit an average of 2 applications for categorical exclusion and 2 respondents will submit an average of 1 EA. Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim of categorical exclusion and approximately 3,400 hours to prepare an EA for a biological product.
Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1) supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new animal drug applications (INADs), and 21 CFR 571.1(c) food additive petitions must contain a claim for categorical exclusion under § 25.30 or 25.33 or an EA under § 25.40. Annually, FDA's Center for Veterinary Medicine has received approximately 698 claims for categorical exclusion as required under §§ 25.15(a) and (d), and 10 EAs as required under §§ 25.40(a) and (c). FDA estimates that approximately 70 respondents will submit an average of 10 applications for categorical exclusion and 10 respondents will submit an average of 1 EA. FDA estimates that it takes sponsors/applicants approximately 3 hours to prepare a claim of categorical exclusion and an average of 2,160 hours to prepare an EA.
Under sections 905, 910, and 911 of the Federal Food, Drugs, and Cosmetic Act (21 U.S.C. 387, 387j, and 387k), product applications and supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco products must contain a claim for categorical exclusion or an EA. In 2015, FDA estimated it will receive approximately 5 premarket review of new tobacco PMTAs from 5 respondents, 509 reports intended to demonstrate the substantial equivalence of a new tobacco product (SEs) from 509 respondents, 15 exemption from substantial equivalence requirements applications (SE Exemptions) from 15 respondents, and 3 modified risk tobacco product applications (MRTPAs) from 3 respondents. FDA is not accepting claims for categorical exclusions at this time, and estimates that there will be 532 EAs from 532 respondents as required under §§ 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 532 respondents will submit an average of 1 application for environmental assessment. Part of the information in the EA will be developed while writing other parts of a PMTA, SE, Exemption from SE, or MRTPA. Based on FDA's experience, previous information provided by potential sponsors and knowledge that part of the EA information has already been produced in one of the tobacco product applications, FDA estimates that it takes approximately 80 hours to prepare an EA.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing a second edition of the guidance for industry entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions”. FDA is issuing the second edition to provide further information on demonstrating substantial equivalence (SE) of a new tobacco product, including demonstrating SE when the new tobacco product has: A modified label that renders it distinct from, but has identical characteristics to, a valid predicate product; or a change in product quantity from, but where the per weight composition is identical to, a valid predicate product.
Submit either electronic or written comments on Agency guidances at any time.
All communications in response to this notice should be identified with Docket No. FDA–2011–D–0147. Submit electronic comments on the guidance to
Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002; 1–877–287–1373,
We are announcing the availability of the second edition of the guidance for industry entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (second edition SE FAQ guidance). We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115).
In September 2011, FDA issued draft guidance responding to frequently asked questions covering a range of topics on demonstrating the SE of a new tobacco product (September 9, 2011, 76 FR 55927). In March 2015, FDA issued a final guidance on many of the topics included in the September 2011 draft ((March 5, 2015, 80 FR 12011) (March 2015 FAQ guidance)). In May 2015, FDA announced that an interim enforcement policy would be in effect while it considered comments submitted on the March 2015 FAQ guidance. This interim enforcement policy will continue to be in effect for 30 days from the date of issuance of the
The second edition FAQ guidance describes FDA's current thinking on whether and when a change to a tobacco product's label, product quantity in the package, additives, or specifications renders that product a “new tobacco product” subject to premarket review. It explains that a manufacturer may submit streamlined SE reports for certain modifications to labels and changes to product quantity. The guidance also explains FDA's plans and processes for review of the streamlined SE reports. Finally, this guidance responds to several questions that have been raised about the SE process more generally.
The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved information collections. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in sections 905(j) and 910 of the FD&C Act (21 U.S.C. 387e(j) and 387j, respectively), as amended by the Tobacco Control Act (Pub. L. 111–31), have been approved under OMB control number 0910–0673; the collections of information in 21 CFR part 25 have been approved under OMB control number 0910–0322.
Interested persons may submit either electronic comments regarding this document to
Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
Please note that your name, contact information, and other information identifying you will be posted on
Persons with access to the Internet may obtain an electronic version of the guidance at either
Health Resources and Services Administration, HHS.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this Information Collection Request must be received no later than November 9, 2015.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
OMB No. 0906–xxxx—New
These data will describe the population served by the MIECHV Program, including the unduplicated count of the number of participants and participant groups by primary insurance coverage. These data will provide other socio-demographic characteristics of program participants and their utilization of services, such as program retention. Additionally, these data will describe several select clinical indicators of program participants, such as the percent of eligible participants who deliver their child preterm. This information will be collected from participants once, at enrollment in home visiting services and aggregated and reported to HRSA by state/territory grantees once annually.
These data constitute a discrete set of standardized performance and outcome indicators that correspond with the statutorily identified benchmark areas. These data will provide aggregate totals, percentages, and rates for performance and outcome indicators that are salient to the MIECHV Program, home visiting services more generally, and the at-risk populations served. These data will be collected from participants based on the appropriate measurement period defined for each measure and aggregated and reported to HRSA by state/territory grantees once annually.
This information will be used to demonstrate accountability with legislative and programmatic requirements. It will also be used to monitor and provide continued oversight for grantee performance and to target technical assistance resources to grantees. In the future, it is anticipated the MIECHV funding decisions may be allocated based on grantee performance, including on benchmark performance areas.
HHS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Indian Health Service, HHS.
Notice and request for comments. Request for extension of approval.
In compliance with the Paperwork Reduction Act of 1995, Public Law (Pub. L.) 104–13 [44 United States Code (U.S.C.) section 3507(a)(1)(D)], the Indian Health Service (IHS) is submitting to the Office of Management and Budget (OMB) a request for an extension of a previously approved collection of information titled, “Addendum to Declaration for Federal Employment, Child Care and Indian Child Care Worker Positions,” Office of Management and Budget (OMB) Control Number 0917–0028, which expires November 30, 2015.
This previously approved information collection project was last published in the
A copy of the supporting statement is available at
The IHS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children [25 U.S.C. 3207(a)(1) and (2)]. Title 25 U.S.C. 3207(b) requires regulations prescribing the minimum standards of character to ensure that none of the individuals appointed to positions involving regular contact with, or control over, Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution; crimes against persons; or offenses committed against children.
In addition, 42 U.S.C. 13041 requires each agency of the Federal Government, and every facility operated by the Federal Government (or operated under contract with the Federal Government), that hires (or contracts for hire) individuals involved with the provision of child care services to children under the age of 18 to assure that all existing and newly hired employees undergo a criminal history background check. The background investigation is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal Government, or for a facility or program operated by (or through contract with) the Federal Government, in positions involved with the provision of child care services to children under the age of 18, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child.
The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Average burden hour per response, and Total annual burden hour(s).
There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
(a) Whether the information collection activity is necessary to carry out an agency function;
(b) whether the agency processes the information collected in a useful and timely fashion;
(c) the accuracy of the public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information);
(d) whether the methodology and assumptions used to determine the estimates are logical;
(e) ways to enhance the quality, utility, and clarity of the information being collected; and
(f) ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
To request additional information, please contact Tamara Clay by one of the following methods:
•
•
•
•
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council for Complementary and Integrative Health.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Office of the Assistant Secretary for Policy Development and Research, HUD.
Notice of Proposed Fiscal Year (FY) 2016 Fair Market Rents (FMRs).
Section 8(c)(1) of the United States Housing Act of 1937 (USHA) requires the Secretary to publish FMRs periodically, but not less than annually, adjusted to be effective on October 1 of each year. The primary uses of FMRs are to determine payment standards for the Housing Choice Voucher (HCV) program, to determine initial renewal rents for some expiring project-based Section 8 contracts, to determine initial rents for housing assistance payment contracts in the Moderate Rehabilitation Single Room Occupancy program, and to serve as rent ceilings for rental assistance units in the HOME Investment Partnerships program. FMRs are used in the calculation of maximum award amounts for Continuum of Care grantees and are also used in the calculation of flat rents in Public Housing units. Today's notice provides proposed FY 2016 FMRs for all areas that reflect the estimated 40th and 50th percentile rent levels trended to April 1, 2016. The FY 2016 FMRs are based on “5-year” data collected by the American Community Survey (ACS) from 2009 through 2013. These data are updated by one-year 2013 ACS data for areas where statistically valid one-year ACS data is available. HUD continues to use ACS data in different ways according to the statistical reliability of rent estimates. The Consumer Price Index (CPI) rent and utility indexes are used to further update the data to 2014. These values are then trended forward to FY 2016 using the annualized change in median gross rents as measured across the most recent 5 years of available 1 year ACS data. While HUD will continue to use this trend factor for the calculation of FY 2016 FMRs, the Department is considering replacing it with a forward-looking forecast for the FY 2017 FMRs. For example, HUD is evaluating the use of a model that would forecast national rent and utility CPI indices based on economic assumptions used in the formulation of the President's Budget. HUD seeks public comments on this or alternative methodologies, as well as other data sources, for trending rent levels forward.
The proposed FY 2016 FMRs in this notice incorporate a change in the level of statistical reliability that is allowed for an ACS estimate to be used in the calculation of FMRs. Previously, if the error of the estimate was less than the estimate itself, HUD used the estimate. The Proposed FMRs in this notice use ACS estimates where the size of the error is limited to half of the estimate.
An additional change to the proposed FY 2016 FMRs is the incorporation of the February 28, 2013, Office of Management and Budget (OMB) metropolitan area definition update based on the 2010 Decennial Census data. The 2013 ACS data are the first to use the new area definitions in the compilation of the ACS data.
In a June 2, 2015 advanced notice of proposed rulemaking, HUD solicited comments on several topics related to the calculation of FMRs, including possible measures the Department is considering that would reduce the concentration of Section 8 voucher tenants. For example, HUD is evaluating alternatives to the current 50th percentile FMR program, which was implemented to mitigate excessive geographic concentration of voucher tenants. Comments were requested to determine interest in a program that is based on different measures for determining how many and which areas would receive special FMRs to encourage deconcentration, as well as on alternative FMR-based tools for promoting deconcentration, such as Small Area FMRs estimated at the ZIP code level. The Department appreciates the comments provided and is currently analyzing this input to inform the next steps in the rulemaking process. For the FY 2016 FMRs, however, the current 50th percentile FMR program is still in place with no change to existing regulations.
Interested persons are invited to submit comments regarding the proposed FMRs to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW., Room 10276, Washington, DC 20410–0001. Communications must refer to the above docket number and title and should contain the information specified in the “Request for Comments” section. There are two methods for submitting public comments.
1. Submission of Comments by Mail. Comments may be submitted by mail to
2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at
No Facsimile Comments. Facsimile (FAX) comments are not acceptable.
Public Inspection of Public Comments. All properly submitted comments and communications regarding this notice submitted to HUD will be available for public inspection and copying between 8 a.m. and 5 p.m. weekdays at the above address. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202–708–3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the Federal Relay Service at 800–877–8339. Copies of all comments submitted are available for inspection and downloading at
For technical information on the methodology used to develop FMRs or a listing of all FMRs, please call the HUD USER information line at 800–245–2691 or access the information on the HUD USER Web site
Questions related to use of FMRs or voucher payment standards should be directed to the respective local HUD program staff. Questions on how to conduct FMR surveys may be addressed to Marie L. Lihn or Peter B. Kahn of the Economic and Market Analysis Division, Office of Economic Affairs, Office of Policy Development and Research at HUD headquarters [451 7th Street SW., Room 8208, Washington, DC 20410]; telephone number 202–402–2409 (this is not a toll-free number), or they may be reached at
Electronic Data Availability. This
Section 8 of the USHA (42 U.S.C. 1437f) authorizes housing assistance to aid lower-income families in renting safe and decent housing. Housing assistance payments are limited by FMRs established by HUD for different geographic areas. In the HCV program, the FMR is the basis for determining the “payment standard amount” used to calculate the maximum monthly subsidy for an assisted family (see 24 CFR 982.503). In general, the FMR for an area is the amount that would be needed to pay the gross rent (shelter rent plus utilities) of privately owned, decent, and safe rental housing of a modest (non-luxury) nature with suitable amenities is typically set at the 40th percentile of the distribution of gross rents. In addition, all rents subsidized under the HCV program must meet reasonable rent standards. HUD's regulations at 24 CFR 888.113 permit the Department to establish 50th percentile FMRs for certain areas.
Section 8(c)(1) of the USHA requires the Secretary of HUD to publish FMRs periodically, but not less frequently than annually. Section 8(c)(1) states, in part:
Proposed fair market rentals for an area shall be published in the
HUD's regulations at 24 CFR part 888 provide that HUD will develop proposed FMRs, publish them for public comment, provide a public comment period of at least 30 days, analyze the comments, and publish final FMRs. (See 24 CFR 888.115.)
In addition, HUD's regulations at 24 CFR 888.113 set out procedures for HUD to assess whether areas are eligible for FMRs at the 50th percentile. Minimally qualified areas
In FY 2015 there were 16 areas using 50th-percentile FMRs. Of these 16 areas, 6 areas completed three years of program participation and were evaluated. Only two of the 6 areas will continue as 50th-percentile FMR areas; three of the remaining four areas do not show measurable deconcentration over the three-year period, will not continue as 50th-percentile FMR areas, and will not be evaluated for three years. One area that was evaluated, the New Haven-Meriden, CT HUD Metro FMR Area, graduated from the program and will be evaluated each year. Housing authorities operating in these areas are encouraged to review the rules at 24 CFR 982.503(f) to determine if they qualify for continued use of the 50th percentile rents when setting their payment standards. The table below lists the three areas that are not eligible for 50th percentile FMRs until 2019.
The Washington, DC–VA–MD HUD Metro FMR Area returns as a 50th percentile area after failing to deconcentrate in FY 2013. In summary, there will be 13 50th-percentile FMR areas in FY 2016. These areas are indicated by an asterisk in Schedule B, where all FMRs are listed by state. The following table lists the FMR areas along with the year of their next evaluation.
This section provides a brief overview of how the FY 2016 FMRs are computed. For complete information on how FMR areas are determined, and on how each area's FMRs are derived, see the online documentation at
The proposed FY 2016 FMRs are based on the updated metropolitan area definitions published by OMB on February 28, 2013. Counties that have been removed from metropolitan areas will be nonmetropolitan counties. Counties that have been added to metropolitan areas will be treated as metropolitan county subareas. They will receive rents based on their own data if the local data is statistically reliable (with an error that is less than one-half of the estimate) or receive the metropolitan rent if their subarea estimate does not exist or is statistically unreliable.
The U.S. Census Bureau released standard tabulations of 5-year ACS data collected between 2009 through 2013 in December of 2014. For Proposed FY 2016 FMRs, HUD uses the 2009–2013 5-year ACS data to update the base rents. HUD has updated base rents each year based on new 5-year data since FY 2012, for which HUD used 2005–2009 ACS data. HUD is also updating base rents for Puerto Rico FMRs using the 2009–2013 Puerto Rico Community Survey (PRCS); HUD first updated the Puerto Rico base rents in FY 2014 based on 2007–2011 PRCS data collected through the ACS program.
HUD historically based FMRs on gross rents for recent movers (those who have moved into their current residence in the last 24 months). However, due to the way Census constructs the 5-year ACS data, HUD developed a new methodology for calculating recent-mover FMRs in FY 2012. As in FY 2012, HUD assigns all areas a base rent, which is the two-bedroom standard quality 5-year gross rent estimate from the ACS.
Following the assignment of the standard quality two-bedroom rent described above, HUD applies a recent mover factor to these rents. The calculation of the recent mover factor for FY 2016 is similar to the methodology HUD used in FY 2015, with the only difference being the use of updated ACS data and the change to the statistical reliability assessment of the ACS data. The following describes the process for determining the appropriate recent mover factor.
In general, HUD uses the 1-year ACS-based two-bedroom recent mover gross rent estimate from the smallest geographic area encompassing the FMR area for which the estimate is statistically reliable to calculate the recent mover factor.
A base rent has also been calculated for the insular areas using the 2010 decennial census of American Samoa, Guam, the Northern Mariana Islands, and the Virgin Islands. This is the first time American Samoa and the Northern Mariana Islands will have an FMR that is separate from Guam. In addition St. Johns, VI will receive a separate FMR; previously it was combined with St. Thomas. The 2010 rent data is updated to 2013 using the change in national ACS rents from 2010 to 2013.
HUD does not use the ACS as the base rent or recent mover factor for eight areas where the FY 2016 FMR was adjusted based on survey data collected in 2012 for Hood River County, OR, Mountrail County, ND, Ward County, ND, and Williams County, ND and data collected from PHAs in 2014 for Bennington County, VT, Windham County, VT, Windsor County, VT, and Seattle, WA. HUD has not allocated funds to conduct surveys of FMR areas, and so future surveys must be paid for by the PHAs.
HUD updates the ACS-based “as of” 2013 rent through the end of 2014 using the annual change in CPI from 2013 to 2014. As in previous years, HUD uses local CPI data coupled with Consumer Expenditure Survey (CEX) data for FMR areas with at least 75 percent of their population within Class A metropolitan areas covered by local CPI data. HUD uses Census region CPI data for FMR areas in Class B and C size metropolitan areas and nonmetropolitan areas without local CPI update factors. Additionally, HUD is using CPI data collected locally in Puerto Rico as the basis for CPI adjustments from 2013 to 2014 for all Puerto Rico FMR areas. Following the application of the appropriate CPI update factor, HUD trends the estimate from 2014 to the middle of FY 2016. As in FY 2015, HUD continues to calculate the trend factor as the annualized change in median gross rents as measured across the most recent 5 years of available 1 year ACS data. The national median gross rent in 2008 was $824 and $905 in 2013. The overall change between 2008 and 2013 is 1.098 percent and the annualized change is 1.0189 percent. This annual trend factor is applied from the middle of 2014 (the mid-point of the annual 2014 CPI update) to the middle of FY 2016, or for a period of seven quarters. The trend factor for the seven quarter period is 1.0334 percent.
The gross rent data from the 2009 to 2013 Puerto Rico Community Survey (PRCS) coupled with the CPI data measured across Puerto Rico includes the utility rate increases from Commonwealth-owned utility companies that gave each FMR area in Puerto Rico an adjustment in both FY 2014 and FY 2015. The FY 2016 FMRs no longer include the utility adjustment; any changes in the Puerto Rico energy tariffs have been in effect long enough to be included in the Puerto Rico CPI.
HUD calculates the primary FMR estimates for two-bedroom units. This is generally the most common sized rental unit and, therefore, the most reliable to survey and analyze. Formerly, after each Decennial Census, HUD calculated rent relationships between two-bedroom units and other unit bedroom counts and used them to set FMRs for other units. HUD did this because it is much easier to update two-bedroom estimates and to use pre-established cost relationships with other unit bedroom counts than it is to develop independent FMR estimates for each unit bedroom count. When calculating FY 2013 FMRs, HUD updated the bedroom ratio adjustment factors using 2006–2010 5-year ACS data. The bedroom ratio methodology used in this update was the same methodology that was used when calculating bedroom ratios using 2000 Census data. The bedroom ratios HUD used in the calculation of FY 2016 FMRs have been updated using average data from three five-year data series (2007–2011, 2008–2012, and 2009–2013).
HUD establishes bedroom interval ranges based on an analysis of the range of such intervals for all areas with large enough samples to permit accurate bedroom ratio determinations. These ranges are: Efficiency FMRs are constrained to fall between 0.59 and 0.81 of the two-bedroom FMR; one-bedroom FMRs must be between 0.74 and 0.84 of the two-bedroom FMR; three-bedroom FMRs must be between 1.15 and 1.36 of the two-bedroom FMR; and four-bedroom FMRs must be between 1.24 and 1.64 of the two-bedroom FMR. (The maximums for the three-bedroom and four-bedroom FMRs are irrespective of the adjustments discussed in the next paragraph.) HUD adjusts bedroom rents for a given FMR area if the differentials between bedroom-size FMRs were inconsistent with normally observed patterns (
HUD further adjusts the rents for three-bedroom and larger units to reflect HUD's policy to set higher rents for these units. This adjustment is intended to increase the likelihood that the largest families, who have the most difficulty in leasing units, will be successful in finding eligible program units. The adjustment adds 8.7 percent to the unadjusted three-bedroom FMR estimates and adds 7.7 percent to the unadjusted four-bedroom FMR estimates. The FMRs for unit sizes larger than four bedrooms are calculated by adding 15 percent to the four-bedroom FMR for each extra bedroom. For example, the FMR for a five-bedroom unit is 1.15 times the four-bedroom FMR, and the FMR for a six-bedroom unit is 1.30 times the four-bedroom FMR. FMRs for single-room occupancy units are 0.75 times the zero-bedroom (efficiency) FMR.
For low-population, nonmetropolitan counties with small or statistically insignificant data for any two of the three 5-year ACS standard quality rents series used in the average, HUD uses state non-metropolitan data to determine bedroom ratios for each unit bedroom count. HUD made this adjustment to protect against unrealistically high or low FMRs due to insufficient sample sizes.
The FMR used to establish payment standard amounts for the rental of manufactured home spaces in the HCV program is 40 percent of the FMR for a two-bedroom unit. HUD will consider modification of the manufactured home space FMRs where public comments present statistically valid survey data showing the 40th-percentile manufactured home space rent (including the cost of utilities) for the entire FMR area.
All approved exceptions to these rents that were in effect in FY 2015 were updated to FY 2016 using the same data used to estimate the HCV program FMRs. If the result of this computation was higher than 40 percent of the new two-bedroom rent, the exception remains and is listed in Schedule D. The FMR area definitions used for the rental of manufactured home spaces are the same as the area definitions used for the other FMRs.
Public housing authorities (PHA) in the Dallas, TX HUD Metro FMR Area (HMFA), along with the Housing Authority of the County of Cook (IL), the City of Long Beach (CA) Housing Authority, the Chattanooga, TN Housing Authority, the Town of Mamaroneck (NY) Housing Authority, and the Laredo, TX Housing Authority continue to be the only PHAs managing their voucher programs using Small Area Fair Market Rents (SAFMRs). These FMRs are listed in the Schedule B addendum.
SAFMRs are calculated using a rent ratio determined by dividing the median gross rent across all bedrooms for the small area (a ZIP code) by the similar median gross rent for the metropolitan area of the ZIP code. This rent ratio is multiplied by the current two- bedroom rent for the entire metropolitan area containing the small area to generate the current year two-bedroom rent for the small area. In small areas where the median gross rent is not statistically reliable, HUD substitutes the median gross rent for the county containing the ZIP code in the numerator of the rent ratio calculation. HUD has been criticized for continuing to use 2010 5-year ACS data as the basis for the Small Area FMR rent ratios, instead of updating these each year. HUD kept the rent ratios based on 2006–2010 5-year ACS data in order to provide stability in the Small Area FMRs and proposed only updating these ratios with the 2011–2015 ACS 5-year data, when all the underlying survey data would have been replaced. However, HUD's current experience with 5-year data for small areas reveals that this may create a greater disruption to Small Area FMRs than if HUD adjusted the ratios annually by applying a smoothing technique such as averaging of several years of 5-year ACS data. By implementing a rolling-average Small Area FMR rent ratio calculation, the Department believes more current data could be used without introducing excessive year-to-year variability in Small Area FMR rent ratios due to sampling variance. Therefore, for proposed FY 2016 SAFMRs, HUD has updated the rent ratios to use an average of the rent ratios calculated from the 2007–2011, 2008–2012, and 2009–2013 5-year ACS estimates.
HUD seeks public comments on the methodology used to calculate FY 2016 Proposed FMRs including Small Area FMRS, and the FMR levels for specific areas. Due to its current funding levels, HUD no longer has sufficient resources to conduct local surveys of rents to address comments filed regarding the FMR levels for specific areas. Commenters submitting comments on FMR levels must include sufficient information (including local data and a full description of the rental housing survey methodology used or a description of the methodology intended to be used to collect the necessary data) to justify any proposed changes. Questions on how to conduct FMR surveys may be addressed to Marie L. Lihn or Peter B. Kahn of the Economic and Market Analysis Division, Office of Economic Affairs, Office of Policy Development and Research at HUD headquarters [451 7th Street SW., Room 8208, Washington, DC 20410]; telephone number 202–402–2409, or they may be reached at
For small metropolitan areas without one-year ACS data and nonmetropolitan counties, HUD has developed a methodology using mail surveys that is discussed on the bottom of the FMR Web page:
While HUD has not developed a specific methodology for mail surveys in areas with 1-year ACS data, HUD would apply the standard established for Random-Digit Dialing (RDD) telephone rent surveys. The statistical difference of these survey results will be compared with the current FMR which means that the survey confidence interval must be outside the FMR. The survey should collect results based on 200 one-bedroom and two-bedroom eligible recent mover units to provide a small enough confidence interval for significant results in large market mail surveys. Areas with statistically reliable 1-year ACS data are not considered to be good candidates for local surveys due to the size and completeness of the ACS process.
Other survey methodologies are acceptable in providing data to support comments if the survey methodology can provide statistically reliable, unbiased estimates of the gross rent of the entire FMR area. In general, recommendations for FMR changes and supporting data must reflect the rent levels that exist within the entire FMR area and should be statistically reliable.
PHAs in nonmetropolitan areas may, in certain circumstances, conduct surveys of groups of counties. HUD must approve all county-grouped surveys in advance. PHAs are cautioned that the resulting FMRs may not be identical for the counties surveyed; each individual FMR area will have a separate FMR based on the relationship of rents in that area to the combined rents in the cluster of FMR areas. In addition, PHAs are advised that counties where FMRs are based on the combined rents in the cluster of FMR areas will not have their FMRs revised unless the grouped survey results show a revised FMR statistically different from the combined rent level.
Survey samples should preferably be randomly drawn from a complete list of rental units for the FMR area. If this is not feasible, the selected sample must be drawn to be statistically representative of the entire rental housing stock of the FMR area. Surveys must include units at all rent levels and be representative by structure type (including single-family, duplex, and other small rental properties), age of housing unit, and geographic location. The 2008–2012 5-year ACS data should be used as a means of verifying if a sample is representative of the FMR area's rental housing stock.
A PHA or contractor that cannot obtain the recommended number of sample responses after reasonable efforts should consult with HUD before abandoning its survey; in such situations, HUD may find it appropriate to relax normal sample size requirements.
The Department has developed guidance on how to provide data-supported comments on Small Area FMRs using HUD's special tabulations of the distribution of gross rents by bedroom unit size for ZIP Code
HUD will consider increasing manufactured home space FMRs where public comment demonstrates that 40 percent of the two-bedroom FMR is not adequate. In order to be accepted as a basis for revising the manufactured home space FMRs, comments must include a pad rental survey of the mobile home parks in the area, identify the utilities included in each park's rental fee, and provide a copy of the applicable public housing authority's utility schedule.
As stated earlier in this notice, HUD is required to use the most recent data available when calculating FMRs. Therefore, in order to re-evaluate an area's FMR, HUD requires more current rental market data than the 2013 ACS. HUD encourages a PHA or other interested party that believes the FMR in their area is incorrect to file a comment even if they do not have the resources to provide market-wide rental data. In these instances, HUD will use the comments, should survey funding be restored, when determining the areas HUD will select for HUD-funded local area rent surveys.
This Notice involves the establishment of fair market rent schedules, which do not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this Notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Accordingly, the Fair Market Rent Schedules, which will not be codified in 24 CFR part 888, are proposed to be amended as shown in the Appendix to this notice:
a. Metropolitan Areas—Most FMRs are market-wide rent estimates that are intended to provide housing opportunities throughout the geographic area in which rental-housing units are in direct competition. HUD is using the metropolitan Core-Based Statistical Areas (CBSAs), which are made up of one or more counties, as defined by the Office of Management and Budget (OMB), with some modifications. HUD is generally assigning separate FMRs to the component counties of CBSA Micropolitan Areas.
b. Modifications to OMB Definitions—Following OMB guidance, the estimation procedure for the FY 2016 proposed FMRs incorporates the OMB definitions of metropolitan areas based on the CBSA standards as implemented with 2000 Census data and updated by the 2010 Census in February 23, 2013. The adjustments made to the 2000 definitions to separate subparts of these areas where FMRs or median incomes would otherwise change significantly are continued. To follow HUDs policy of providing FMRs at the smallest possible area of geography, no counties were added to existing metropolitan areas. All counties added to metropolitan areas will still be treated as separate counties. New multicounty metropolitan areas are not subdivided. All metropolitan areas that have at least one subarea will also receive a subarea, that is the rents from a county that is a subarea will not be used for the remaining metropolitan subarea rent determination.
The specific counties and New England towns and cities within each state in MSAs and HMFAs were not changed by the February 28, 2013 OMB metropolitan area definitions. These areas are listed in Schedule B.
Schedule B shows the FMRs for zero-bedroom through four-bedroom units. The Schedule B addendum shows Small Area FMRs for all PHAs operating using Small Area FMRs (please see section V of this notice for a list of participating PHAs). The FMRs for unit sizes larger than four bedrooms are calculated by adding 15 percent to the four-bedroom FMR for each extra bedroom. For example, the FMR for a five-bedroom unit is 1.15 times the four-bedroom FMR, and the FMR for a six-bedroom unit is 1.30 times the four-bedroom FMR. FMRs for single-room-occupancy (SRO) units are 0.75 times the zero-bedroom FMR.
a. The FMR areas in Schedule B are listed alphabetically by metropolitan FMR area and by nonmetropolitan county within each state. The exception FMRs for manufactured home spaces in Schedule D are listed alphabetically by state.
b. The constituent counties (and New England towns and cities) included in each metropolitan FMR area are listed immediately following the listings of the FMR dollar amounts. All constituent parts of a metropolitan FMR area that are in more than one state can be identified by consulting the listings for each applicable state.
c. Two nonmetropolitan counties are listed alphabetically on each line of the non-metropolitan county listings.
d. The New England towns and cities included in a nonmetropolitan county are listed immediately following the county name.
National Park Service, Interior.
Amended meeting notice.
In accordance with the Federal Advisory Committee Act (16 U.S.C. Appendix 1–16), notice is hereby given of a change in the meeting schedule of the Cape Krusenstern National Monument Subsistence Resource Commission (SRC), July 22, 2015, meeting to September 17–18, 2015, at the Northwest Arctic Heritage Center in Kozebue, Alaska which was published in the
For more detailed information regarding this meeting or if you are interested in applying for SRC membership contact Designated Federal Official Frank Hays, Superintendent, at (907) 442–3890, or via email at
National Park Service, Interior.
Notice of intent.
The National Park Service (NPS) will prepare an Environmental Impact Statement (EIS) for a Breach Management Plan at Fire Island National Seashore (Seashore), New York. The purpose of the Breach Management Plan is to address issues associated with a breach that developed within the Otis Pike Fire Island High Dune Wilderness at the Seashore. The Breach Management Plan and EIS process is needed to analyze all the feasible alternatives and to make a decision on whether or not to close the breach.
The public scoping period will commence on the date this notice is published in the
Information will be available for public review online at
Elizabeth Rogers (631–687–4766) or Michael Bilecki (631–687–4760)
Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the NPS is preparing a Breach Management Plan and EIS to address issues associated with a breach that developed within the Otis Pike Fire Island High Dune Wilderness at the Seashore.
In October 2012, Hurricane Sandy caused two breaches on Fire Island within the boundaries of Fire Island National Seashore (FIIS): (1) within Smith Point County Park (which was subsequently closed by Suffolk County); and (2) within the vicinity of Old Inlet in the only federally designated wilderness in the State of New York.
Since Hurricane Sandy, and in accordance with the 1997 Breach Contingency Plan (BCP) prepared by the U.S. Army Corps of Engineers (USACE), the NPS, US Geological Survey (USGS), USACE, and other coastal experts have been monitoring the breach at Old Inlet and associated water levels and water quality in Great South Bay and breach channel conditions.
The Breach Management Plan and EIS process is needed to analyze all the feasible alternatives and to make a
If you wish to comment on the purpose, need, objectives, or on any other issues associated with the plan, you may submit your comments via the Internet at
The responsible official for this Draft Breach Management Plan/EIS is the Regional Director, NPS Northeast Region, U.S. Custom House, 200 Chestnut Street, Fifth Floor, Philadelphia, PA 19106.
Office of Surface Mining Reclamation and Enforcement, Interior.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSMRE) is announcing its intention to seek the Office of Management and Budget (OMB) approval to continue the collection of information for our General provisions. This information collection activity was previously approved by OMB and assigned clearance number 1029–0094.
Comments on the proposed information collection activity must be received by November 9, 2015, to be assured of consideration.
Submit comments to John Trelease, Office of Surface Mining Reclamation and Enforcement, 1951 Constitution Ave, NW., Room 203–SIB, Washington, DC 20240. Comments may also be submitted electronically to
To receive a copy of the information collection request contact John Trelease, at (202) 208–2783 or via email at
The Office of Management and Budget (OMB) regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104–13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8 (d)]. This notice identifies an information collection that OSMRE will be submitting to OMB for approval. This collection is contained in 30 CFR part 700—General. OSMRE will request a 3-year term of approval for this information collection activity. Responses are required to obtain a benefit. We may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Comments are invited on: (1) The need for the collection of information for the performance of the functions of the agency; (2) the accuracy of the agency's burden estimates; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the information collection burden on respondents, such as use of automated means of collection of the information. A summary of the public comments will accompany OSMRE's submission of the information collection request to OMB.
This notice provides the public with 60 days in which to comment on the following information collection activity:
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 15) granting intervenor status to Conexant Systems Inc. and Waves Audio Ltd.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708–5468. Copies of non-confidential documents filed in connection with this
The Commission instituted this investigation on March 18, 2015, based on a complaint filed by Andrea Electronics Corp. of Bohemia, New York (“Andrea”). 80 FR 14159–60 (March 18, 2015). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation, sale for importation, and sale after importation of audio processing articles that infringe five U.S. patents. The notice of investigation named numerous respondents, some of whom have been previously terminated. The notice also named the Office of Unfair Import Investigations as a party.
On July 2, 2015, Conexant Systems Inc. (“Conexant”) moved to obtain intervenor status in the investigation. Conexant argued that, because Andrea alleges that Conexant's audio technology contained in the respondents' products infringes the asserted patents, Conexant has an interest in the subject matter of the investigation. Conexant further argues that the respondents do not adequately represent Conexant's interests because Andrea has accused the audio technology made by multiple companies, so the respondents may not necessarily have an interest in defending Conexant's specific audio technology. On July 14, 2015, Andrea filed a response in opposition to the motion and the Commission Investigative Attorney (“IA”) filed a response in support of the motion.
On July 14, 2015, Waves Audio, Ltd. (“Waves Audio”) moved to obtain intervenor status in the investigation for substantially the same reasons as Conexant. Additionally, Waves Audio argued that it has indemnity obligations to the extent that its products are a part of the investigation. On July 20, 2015, Andrea filed a response in opposition to the motion and the IA filed a response in support of the motion.
On August 7, 2015, the ALJ issued the subject ID, granting intervenor status to Conexant and Waves Audio. The ALJ found that the motions complied with 19 CFR 210.19 and Federal Rule of Civil Procedure 24 because the motions were timely and showed that Conexant and Waves Audio had an interest in the subject matter of the investigation that was not adequately represented by the existing parties. No petitions for review of the subject ID were filed.
The Commission has determined not to review the subject ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)), instituted this review on April 1, 2015 (80 FR 17496) and determined on July 6, 2015 that it would conduct an expedited review (80 FR 43461, July 22, 2015).
The Commission made this determination pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). It completed and filed its determination in this review on August 20, 2015. The views of the Commission are contained in USITC Publication 4561 (August 2015), entitled
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)), instituted this review on April 1, 2015 (80 FR 17499) and determined on July 6, 2015 that it would conduct an expedited review (80 FR 43118, July 21, 2015).
The Commission made this determination pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)). It completed and filed its determination in this review on August 31, 2015. The views of the Commission are contained in USITC Publication 4560 (August 2015), entitled
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 4) of the presiding administrative law judge (“ALJ”) terminating the above-captioned investigation based upon a consent order stipulation and consent order. The Commission has also determined to issue a consent order.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708–5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205–2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on July 16, 2015, based on a complaint filed by Canon Inc. of Tokyo, Japan; Canon U.S.A., Inc. of Melville, New York; and Canon Virginia, Inc. of Newport News, Virginia (together, “Canon”). 80 FR 42119–20. The complaint alleges that respondents General Plastic Industrial Co., Ltd. of Wu-Chi Town, Taiwan, and Color Imaging, Inc., of Norcross, Georgia (together, “Respondents”), are in violation of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of infringement of certain claims of U.S. Patent Nos. 8,909,094 and 9,046,820.
On August 4, 2015, Respondents filed an unopposed motion to terminate the investigation based upon a consent order stipulation and proposed consent order. The ALJ granted the motion that same day. He found that the motion for termination by consent order stipulation complies with the requirements of Commission Rule 210.21(c), 19 CFR 210.21(c). He further found, pursuant to Commission Rule 210.50(b)(2), that termination of the investigation would not be contrary to the public interest. No petitions for review of the ID were received.
The Commission has determined not to review the ID and to issue a consent order. The investigation is terminated in its entirety.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
Executive Office for Immigration Review, Department of Justice.
30-day notice.
The Department of Justice (DOJ), Executive Office for Immigration Review, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until October 8, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Charles Adkins-Blanch, Acting General Counsel, Executive Office for Immigration Review, U.S. Department of Justice, Suite 2600, 5107 Leesburg Pike, Falls Church, Virginia 22041; telephone: (703) 305–0470. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1
2
3
4
5
6
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
On September 1, 2015, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of Maine in the lawsuit entitled
In this action the United States sought recovery, pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), 42 U.S.C. 9601
The publication of this notice opens a period for public comment on the proposed consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the proposed consent decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $4.00 (25 cents per page reproduction cost) payable to the United States Treasury.
On September 1, 2015, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Northern District of Alabama in the lawsuit entitled
In this action, the United States seeks civil penalties for violations of the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act, Toxic Substances Control Act, and the reporting requirements of the Emergency Planning and Community Right-to-Know Act, together with their implementing regulations and permits, at two of McWane's facilities, one in Birmingham, Alabama and one in Phillipsburg, New Jersey. McWane is a national company that operates iron foundries, brass foundries, and various valve and tank manufacturing facilities. The Alabama Department of Environmental Management is a co-plaintiff in this action.
Under the proposed Consent Decree, McWane will pay a total civil penalty of $471,031, of which $341,383 will go to the United States Treasury, $2,782 to the Oil Spill Liability Trust Fund to resolve alleged violations relating to its spill prevention program, and $126,866 to the State of Alabama. McWane will also implement a Supplemental Environmental Project, at an estimated cost of $2,500,000. McWane has already undertaken corrective measures to resolve all historical violations alleged in the Complaint, at an estimated cost of over $10 million. The proposed Consent Decree resolves only the specific violations alleged in the Complaint.
The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the Consent Decree may be examined and downloaded at this Justice
Please enclose a check or money order for $12.25 (25 cents per page reproduction cost) payable to the United States Treasury.
Department of Justice.
60-day notice.
The Department of Justice (DOJ) will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until November 9, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Mr. Neil Ryder, Director—Internal Review and Evaluation Office, United States Department of Justice, Justice Management Division, Two Constitution Square, 145 N Street NE., Room 8W–222, Washington, DC 20530.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
1.
2.
3.
Form number: None.
Component: Department of Justice, Justice Management Division.
4.
Primary: Business or other for-profit.
Other: Not-for-profit institutions and Federal Government stakeholders.
Abstract: The Department of Justice (DOJ) Senior Procurement Executive will use the information to help identify DOJ acquisition process improvements and increase customer satisfaction.
5.
6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Room 3E–405B, Washington, DC 20530.
National Aeronautics and Space Administration (NASA).
Notice of information collection.
The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. 3506(c)(2)(A)).
All comments should be submitted within 60 calendar days from the date of this publication.
All comments should be addressed to Ms. Frances Teel, JF000, National Aeronautics and Space Administration, Washington, DC 20546–0001.
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Frances Teel, NASA Clearance Officer, NASA Headquarters, 300 E Street SW., JF0000, Washington, DC 20546,
To ensure accurate reporting of Government-owned, contractor-held property on the financial statements and to provide information necessary for effective property management in accordance with FAR Part 45, NASA obtains summary data annually from the official Government property records maintained by its contractors. The information is submitted via the NASA Form 1018, at the end of each fiscal year.
Electronic.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
Nuclear Regulatory Commission.
License amendment application; opportunity to comment, request a hearing, and petition for leave to intervene; order.
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of an amendment to Facility Operating License No. NPF–038, issued to Entergy Operations, Inc. (the licensee), for operation of the Waterford Steam Electric Station, Unit 3. The proposed amendment will modify Technical Specification (TS) 3.1.3.4, “Control Element Assembly [CEA] Drop Time,” and the Final Safety Analysis Report (FSAR), Chapter 15, “Accident Analyses.” Specifically, the amendment would change TS 3.1.3.4 to revise the arithmetic average of all CEA drop times to be less than or equal to 3.5 seconds.
Submit comments by October 8, 2015. Requests for a hearing or petition for leave to intervene must be filed by November 9, 2015.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
• Federal Rulemaking Web site: Go to
• Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN–12–H08, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001.
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Michael D. Orenak, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555–0001; telephone: 301–415–3229, email:
Please refer to Docket ID NRC–2015–0205 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1–F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Please include Docket ID NRC–2015–0205 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
The NRC is considering issuance of an amendment to Facility Operating License No. NPF–38, issued to Entergy Operations, Inc., for operation of the Waterford Steam Electric Station, Unit 3, located in St. Charles County, Louisiana.
By letter dated July 2, 2015 (ADAMS Accession No. ML15197A106), as supplemented by letter dated August 14, 2015 (ADAMS Accession No. ML15226A346), the licensee submitted an application for a license amendment request. The proposed amendment would change TS 3.1.3.4 to revise the arithmetic average of all CEA drop times to be less than or equal to 3.5 seconds.
Before any issuance of the proposed license amendment, the NRC will need to make the findings required by the Atomic Energy Act of 1954, as amended (the Act), and NRC's regulations.
The NRC has made a proposed determination that the license amendment request involves no significant hazards consideration. Under the NRC's regulations in § 50.92 of Title 10 of the
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change increases the TS 3.1.3.4 average and individual CEA drop time limits. The CEA drop time is required to be verified prior to Modes 1 or 2 of plant operations. The probability of an accident previously evaluated remains unchanged since the CEAs drop into the core as a result of an accident or transient condition, and the fact that the CEA drop time was increased does not in itself initiate an accident.
The proposed change to the CEA drop time requirements have been evaluated for impact on the accident analyses. The accident analyses all remain within the regulatory acceptance criteria.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change increases the TS 3.1.3.4 average and individual CEA drop time limits. The proposed change does not involve a physical alteration of the plant (no new or different type of equipment will be installed) or a change in the methods governing plant operations. The proposed change will not introduce new failure modes or effects and will not, in the absence of other unrelated failures, lead to an accident whose consequences exceed the consequences of accidents previously analyzed.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The increase in CEA drop time as proposed in this TS 3.1.3.4 change has been determined to have no significant impact on the accident analyses described in the FSAR which means this change does not have a significant reduction on the existing margins of safety for the fuel, the fuel cladding, the reactor coolant system boundary, or the containment building. The change in CEA drop time does not impact the fuel rod design or mechanical design analysis. The slightly slower drop time would produce a smaller impact on the fuel assembly and lower stresses on the CEAs. The accident analysis consequences became slightly more adverse but all remained within the regulatory acceptance limits, thus this change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the license amendment request involves a No Significant Hazards Consideration.
The NRC is seeking public comments on this proposed determination that the license amendment request involves no significant hazards consideration. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day notice period if the Commission concludes the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this
As required by 10 CFR 2.309, a request for hearing or petition for leave to intervene must set forth with particularity the interest of the petitioner in the proceeding and how that interest may be affected by the results of the proceeding. The hearing request or petition must specifically explain the reasons why intervention should be permitted, with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The hearing request or petition must also include the specific contentions that the requestor/petitioner seeks to have litigated at the proceeding.
For each contention, the requestor/petitioner must provide a specific statement of the issue of law or fact to be raised or controverted, as well as a brief explanation of the basis for the contention. Additionally, the requestor/petitioner must demonstrate that the issue raised by each contention is within the scope of the proceeding and is material to the findings that the NRC must make to support the granting of a license amendment in response to the application. The hearing request or petition must also include a concise statement of the alleged facts or expert opinion that support the contention and on which the requestor/petitioner intends to rely at the hearing, together with references to those specific sources and documents. The hearing request or petition must provide sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact, including references to specific portions of the application for amendment that the petitioner disputes and the supporting reasons for each dispute. If the requestor/petitioner believes that the application for amendment fails to contain information on a relevant matter as required by law, the requestor/petitioner must identify each failure and the supporting reasons for the requestor's/petitioner's belief. Each contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who does not satisfy these requirements for at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the
Hearing requests or petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)–(iii).
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
For further details with respect to this action, see the application for license amendment dated July 2, 2015, and supplement dated August 14, 2015.
A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing SUNSI.
B. Within 10 days after publication of this notice of hearing and opportunity to petition for leave to intervene, any potential party who believes access to SUNSI is necessary to respond to this notice may request such access. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI submitted later than 10 days after publication of this notice will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
C. The requester shall submit a letter requesting permission to access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, Washington, DC 20555–0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email address for the Office of the Secretary and the Office of the General Counsel are
(1) A description of the licensing action with a citation to this
(2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1); and
(3) The identity of the individual or entity requesting access to SUNSI and the requester's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly-available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention.
D. Based on an evaluation of the information submitted under paragraph C.(3) the NRC staff will determine within 10 days of receipt of the request whether:
(1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to SUNSI.
E. If the NRC staff determines that the requestor satisfies both D.(1) and D.(2) above, the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order
F. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI must be filed by the requestor no later than 25 days after the requestor is granted access to that information. However, if more than 25 days remain between the date the petitioner is granted access to the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline. This provision does not extend the time for filing a request for a hearing and petition to intervene, which must comply with the requirements of 10 CFR 2.309.
G. Review of Denials of Access.
(1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and need for access, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) The requester may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an administrative law judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) officer if that officer has been designated to rule on information access issues.
H. Review of Grants of Access. A party other than the requester may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed with the Chief Administrative Judge within 5 days of the notification by the NRC staff of its grant of access.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by
I. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. Attachment 1 to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
For the Nuclear Regulatory Commission.
U.S. Nuclear Regulatory Commission.
Notice of meeting.
The U.S. Nuclear Regulatory Commission will convene a teleconference meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on October 28, 2015, to discuss the ACMUI subcommittee's report on the ACMUI review and comments of Petitions for Rulemaking (PRM)–20–28, 20–29, and 20–30, “Linear No-Threshold Model and Standards for Protection Against Radiation.” Meeting information, including a copy of the agenda and handouts, will be available at
The teleconference meeting will be held on Wednesday, October 28, 2015, 2:00 p.m. to 4:00 p.m. Eastern Standard Time.
Any member of the public who wishes to participate in the teleconference should contact Ms. Holiday using the contact information below.
Ms. Sophie Holiday, email:
Dr. Philip Alderson, ACMUI Vice Chairman, will preside over the meeting. Dr. Alderson will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting:
1. Persons who wish to provide a written statement should submit an electronic copy to Ms. Holiday at the contact information listed above. All submittals must be received by October 23, 2015, three business days prior to the meeting, and must pertain to the topic on the agenda for the meeting.
2. Questions and comments from members of the public will be permitted during the meetings, at the discretion of the Vice Chairman.
3. The draft transcript and meeting summary will be available on ACMUI's Web site
This meeting will be held in accordance with the Atomic Energy Act of 1954, as amended (primarily section 161a); the Federal Advisory Committee Act (5 U.S.C. App); and the Commission's regulations in title 10 of the
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License amendment request; opportunity to comment, request a hearing, and petition for leave to intervene; order.
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of one amendment request. The amendment request is for Vermont Yankee Nuclear Power Station. For this amendment request, the NRC proposes to determine that it involves no significant hazards consideration. In addition, the amendment request contains sensitive unclassified non-safeguards information (SUNSI).
Comments must be filed by October 8, 2015. A request for a hearing must be filed by November 9, 2015. Any potential party as defined in § 2.4 of Title 10 of the
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Janet Burkhardt, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555–0001; telephone: 301–415–1384, email:
Please refer to Docket ID NRC–2015–0193 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC–2015–0193, facility name, unit number(s), application date, and subject in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the NRC is publishing this notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This notice includes notice of an amendment containing SUNSI.
The Commission has made a proposed determination that the following amendment request involves no significant hazards consideration. Under the Commission's regulations in 10 CFR 50.92, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously evaluated, or (2) create the possibility of a new or different kind of accident from any accident previously evaluated, or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for the amendment request is shown below.
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example, in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish a notice of issuance in the
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license or combined license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the NRC's PDR, located at One White Flint North, Room O1–F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also set forth the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the requestor/petitioner to relief. A requestor/petitioner who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of any amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i)–(iii).
For further details with respect to this amendment action, see the application for amendment which is available for public inspection at the NRC's PDR, located at One White Flint North, Room O1–F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. Publicly available documents created or received at the NRC are accessible electronically through ADAMS in the NRC Library at
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change to the CSP Implementation Schedule is administrative in nature. This change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems, and components (SSCs) relied upon to mitigate the consequences of postulated accidents and has no impact on the probability or consequences of an accident previously evaluated.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed change to the CSP Implementation Schedule is administrative in nature. This change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the SSCs relied upon to mitigate the consequences of postulated accidents and does not create the possibility of a new or different kind of accident previously evaluated.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
Plant safety margins are established through limiting conditions for operation, limiting safety system settings, and safety limits specified in the Technical Specifications. The proposed change to the CSP Implementation Schedule is administrative in nature. In addition, the milestone date delay for full implementation of the CSP has no substantive impact because other measures have been taken which provide adequate protection during this period of time. Because there is no change to established safety margins as a result of this change, the proposed change does not involve a significant reduction in a margin of safety.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing SUNSI.
B. Within 10 days after publication of this notice of hearing and opportunity to petition for leave to intervene, any potential party who believes access to SUNSI is necessary to respond to this notice may request such access. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI submitted later than 10 days after publication of this notice will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
C. The requester shall submit a letter requesting permission to access SUNSI to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, Washington, DC 20555–0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email address for the Office of the Secretary and the Office of the General Counsel are
(1) A description of the licensing action with a citation to this
(2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1); and
(3) The identity of the individual or entity requesting access to SUNSI and the requester's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly-available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention.
D. Based on an evaluation of the information submitted under paragraph C.(3) the NRC staff will determine within 10 days of receipt of the request whether:
(1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to SUNSI.
E. If the NRC staff determines that the requestor satisfies both D.(1) and D.(2) above, the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order
F. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI must be filed by the requestor no later than 25 days after the requestor is granted access to that information. However, if more than 25 days remain between the date the petitioner is granted access to the information and the deadline for filing all other contentions (as established in the notice of hearing or opportunity for hearing), the petitioner may file its SUNSI contentions by that later deadline. This provision does not extend the time for filing a request for a hearing and petition to intervene, which must comply with the requirements of 10 CFR 2.309.
G. Review of Denials of Access.
(1) If the request for access to SUNSI is denied by the NRC staff after a determination on standing and need for access, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) The requester may challenge the NRC staff's adverse determination by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an administrative law judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) officer if that officer has been designated to rule on information access issues.
H. Review of Grants of Access. A party other than the requester may challenge an NRC staff determination granting access to SUNSI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed with the Chief Administrative Judge within 5 days of the notification by the NRC staff of its grant of access.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.
I. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. Attachment 1 to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
For the Nuclear Regulatory Commission.
September 7, 14, 21, 28, October 5, 12, 2015.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of September 14, 2015.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of October 5, 2015.
There are no meetings scheduled for the week of October 12, 2015.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Glenn Ellmers at 301–415–0442 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301–415–1969), or email
Nuclear Regulatory Commission.
Standard review plan-final section; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a final revision to NUREG–0800, “Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” Section 17.5, “Quality Assurance Program Description—Design Certification, Early Site Permit and New License Applicants.”
The effective date of this Standard Review Plan (SRP) update is October 8, 2015.
Please refer to Docket ID NRC–2014–0204 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
• The NRC posts its issued staff guidance on the NRC's external Web page (
Mark Notich, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415–3053; email:
On September 24, 2014 (79 FR 57143), the NRC published for public comment the proposed SRP Section 17.5, “Quality Assurance Program Description—Design Certification, Early Site Permit and New License Applicants,” in Chapter 17, “Quality Assurance,” of NUREG–0800. The staff received a total of nine comments on the draft section. A summary of the comments and the staff's disposition of the comments are available in a separate document, “
The SRP Section 17.5 provides guidance to the staff for reviewing applications for a construction permit and an operating license under part 50 of Title 10 of the
Issuance of this SRP section revision does not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) nor is it inconsistent with the issue finality provisions in 10 CFR part 52. The NRC's position is based upon the following considerations.
1.
The SRP provides internal guidance to the NRC staff on how to review an application for NRC regulatory approval in the form of licensing. Changes in internal staff guidance are not matters for which either nuclear power plant applicants or licensees are protected under either the Backfit Rule or the issue finality provisions of 10 CFR part 52.
2.
The NRC staff does not intend to impose or apply the positions described in the SRP to existing licenses and regulatory approvals. Hence, the issuance of this SRP—even if considered guidance within the purview of the issue finality provisions in 10 CFR part 52—does not need to be evaluated as if it were a backfit or as being inconsistent with issue finality provisions. If, in the future, the NRC staff seeks to impose a position in the SRP on holders of already issued licenses in a manner that does not provide issue finality as described in the applicable issue finality provision, then the staff must make the showing as set forth in the Backfit Rule or address the criteria for avoiding issue finality as described in the applicable issue finality provision.
3.
Applicants and potential applicants are not, with certain exceptions, protected by either the Backfit Rule or any issue finality provisions under 10 CFR part 52. Neither the Backfit Rule nor the issue finality provisions under 10 CFR part 52—with certain exclusions—were intended to apply to every NRC action that substantially changes the expectations of current and future applicants.
The exceptions to the general principle are applicable whenever an applicant references a 10 CFR part 52 license (
This action is a rule as defined in the Congressional Review Act (5 U.S.C. 801–808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202–789–6820.
On August 31, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2015–133 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than September 9, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2015–133 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than September 9, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an additional Global Expedited Package Services 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202–789–6820.
On August 31, 2015, the Postal Service filed notice that it has entered into an additional Global Expedited Package Services 3 (GEPS 3) negotiated service agreement (Agreement).
To support its Notice, the Postal Service filed a copy of the Agreement, a copy of the Governors' Decision authorizing the product, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket No. CP2015–132 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filing is consistent with 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than September 9, 2015. The public portions of the filing can be accessed via the Commission's Web site (
The Commission appoints JP Klingenberg to serve as Public Representative in this docket.
1. The Commission establishes Docket No. CP2015–132 for consideration of the matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, JP Klingenberg is appointed to serve as an officer of the Commission to represent the interests of the general public in this proceeding (Public Representative).
3. Comments are due no later than September 9, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Securities and Exchange Commission.
Notice of meeting.
The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing notice that it will hold a public meeting on Wednesday, September 23, 2015, in Multi-Purpose Room LL–006 at the Commission's headquarters, 100 F Street NE., Washington, DC. The meeting will begin at 9:30 a.m. (EDT) and will be open to the public. The meeting will be webcast on the Commission's Web site at
The public meeting will be held on Wednesday, September 23, 2015. Written statements should be received on or before September 21, 2015.
The meeting will be held at the Commission's headquarters, 100 F Street NE., Washington, DC. Written statements may be submitted by any of the following methods:
• Use the Commission's Internet submission form (
• Send an email message to
• Send paper statements to Brent J. Fields, Federal Advisory Committee Management Officer, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
Statements also will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10 a.m. and 3 p.m. All statements received will be posted without change; we do not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly.
Julie Z. Davis, Senior Special Counsel, at (202) 551–3460, Office of Small Business Policy, Division of Corporation Finance, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–3628.
In accordance with Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C.-App. 1, and the regulations thereunder, Keith Higgins, Designated Federal Officer of the Committee, has ordered publication of this notice.
On July 7, 2015, NYSE Arca, Inc. (the “Exchange” or “NYSE Arca”) filed with the Securities and Exchange Commission (“Commission”), pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change, so that it has sufficient time to consider this proposed rule change.
Accordingly, the Commission, pursuant to section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
By letter dated September 1, 2015 (the “Letter”), as supplemented by conversations with the staff of the Division of Trading and Markets, counsel for Greenbacker Renewable Energy Company LLC (the “Company”) requested that the Commission grant an exemption from Rule 102(a) of Regulation M to permit the Company to effect repurchases of shares of its common stock pursuant to its proposed share repurchase program (the “Repurchase Program”).
As a consequence of the continuous offering of the Company's shares, the Company will be engaged in a distribution of shares of its common stock pursuant to Rule 102 of Regulation M. As a result, bids for or purchases of shares of its common stock or any reference security by the Company or any affiliated purchaser of the Company are prohibited during the restricted period specified in Rule 102, unless specifically excepted by or exempted from Rule 102.
Based on the representations and facts presented in its Letter, we find that it is appropriate in the public interest and consistent with the protection of investors to grant a conditional exemption from Rule 102 of Regulation M to permit the Company to repurchase shares of its common stock under its Repurchase Program while the Company is engaged in a distribution of shares of its common stock. In granting this exemption, we considered the following representations and facts, among others:
• There is no trading market for the Company's common stock;
• The Company will terminate its Repurchase Program in the event a secondary market for its common stock develops;
• Shares of the Company will be offered on a continuous basis until the earlier of when the full amount of shares registered under the registration statement have been sold and August 7, 2016, though the Company may decide to extend the offering beyond this date if Greenbacker Capital Management LLC, the Company's advisor (“Advisor”), determines, and the Company's board agrees, that the maximum amount has not been met at the expiration date but the Advisor believes there is sufficient investor interest or a need for additional capital to pursue an additional investment;
• The Company represents that the structure is similar to non-listed REITs;
• Net asset value (“NAV”) is computed based on the fair value of the Company's assets, which is determined by the Advisor, on a quarterly basis in accordance with ASC 820;
• The report prepared by the Advisor regarding its NAV determination and methodology is reviewed and approved by the Company's audit committee and board of directors on a quarterly basis, reviewed by the Company's independent auditors on a quarterly basis, and audited by the Company's independent auditors as part of its annual audit;
• The Company disclosed in its prospectus the original valuation methodology and will disclose in a prospectus supplement any material changes to the valuation methodology prior to implementation;
• The Company will repurchase shares of its common stock under its Repurchase Program at a price that does not exceed the then current public offering price of its common stock;
• The offering price for each class of shares consists of the NAV per share plus selling commissions and dealer manager fees, which are set at a fixed percentage of the offering price depending on the share class, and organization and offering expenses, which have been calculated as a percentage of gross offering proceeds;
• The method of calculating these commissions and fees and their current values are set forth in the prospectus;
• Because the Company will repurchase shares at a price equal to the then-current offering price less the selling commissions and dealer manager fees associated with such class of shares, the Company will purchase at a price directly and mechanically linked to NAV; and
• The terms of the Repurchase Program, including the above methodology regarding the repurchase price, will be fully disclosed in the Company's prospectus.
This exemptive relief is subject to the following conditions:
• The Company shall terminate its Repurchase Program during the distribution of its common stock if a secondary market for its common stock develops.
• The Company will repurchase shares of its common stock under its Repurchase Program at a price that does not exceed the then current public offering price, a price directly and mechanically linked to NAV, of its common stock.
This exemptive relief is subject to modification or revocation at any time the Commission determines that such action is necessary or appropriate in furtherance of the purposes of the Exchange Act. This exemption is based on the facts presented and the representations made in the Letter. Any different facts or representations may require a different response. In the event that any material change occurs in the facts or representations in the Letter, the Repurchase Program must be discontinued, pending presentation of the facts for our consideration. In addition, persons relying on this exemption are directed to the anti-fraud and anti-manipulation provisions of the federal securities laws, particularly Section 10(b) of the Exchange Act, and Rule 10b–5 thereunder. Responsibility for compliance with these and any other applicable provisions of the federal securities laws must rest with the persons relying on this exemption. This order should not be considered a view with respect to any other question that the proposed transactions may raise, including, but not limited to, the adequacy of the disclosure concerning, and the applicability of other federal or state laws to, the proposed transactions.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
ISE Gemini proposes to adopt a principles-based approach to prohibit the misuse of material, non-public information by market makers by deleting Rule 810. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included
The Exchange proposes to adopt a principles-based approach to prohibit the misuse of material, non-public information by market makers by deleting Rule 810. In so doing, the Exchange would harmonize its rules amongst its Members
The Exchange has two classes of registered market makers. Pursuant to Rule 800, a market maker is a Member with Designated Trading Representatives that is registered with the Exchange for the purpose of making transactions as a dealer-specialist. As the rule further provides, a market maker can be either a CMM or a PMM. All market makers are subject to the requirements of Rules 803 and 804, which set forth the obligations of market makers, particularly relating to quoting.
Rule 803 specifies the obligations of market makers, which include making markets that, absent changed market conditions, will be honored for the number of contracts entered into the Exchange's System in all series of options classes to which the market maker is appointed. The quoting obligations of market makers are set forth in Rule 804. That rule sets forth the main difference between PMMs and CMMs, namely that PMMs have a heightened quoting obligation as compared to CMMs.
Importantly, all market makers have access to the same information in the order book that is available to all other market participants. Moreover, none of the Exchange's market makers have agency obligations to the Exchange's order book. As such, the distinctions between PMMs and CMMs are the quoting requirements set forth in Rule 804.
Notwithstanding that market makers have access to the same Exchange trading information as all other market participants on the Exchange, the Exchange has specific rules governing how market makers may operate. Rule 810 allows market makers to engage in Other Business Activities
The Exchange believes that the guidelines in Rule 810, for market makers, are no longer necessary and proposes to delete it. Rather, the Exchange believes that Rule 408(a) governing the misuse of material, non-public information provides for an appropriate, principles-based approach to prevent the market abuses Rule 810 is designed to address. Specifically Rule 408(a) requires every Exchange Member to establish, maintain and enforce written policies and procedures reasonably designed, taking into consideration the nature of the Member's business, to prevent the misuse of material, non-public information by such Member or associated person. For purposes of this requirement, the misuse of material, non-public information includes, but is not limited to, the following:
(a) Trading in any securities issued by a corporation, partnership, or Funds, as defined in Rule 502(h), or a trust or similar entities, or in any related securities or related options or other derivative securities, or in any related non-U.S. currency, non-U.S. currency options, futures or options on futures on such currency, or any other derivatives based on such currency, or in any related commodity, related commodity futures or options on commodity futures or any other related commodity derivatives, while in possession of material nonpublic information concerning that corporation or those Funds or that trust or similar entities;
(b) trading in an underlying security or related options or other derivative securities, or in any related non-U.S. currency, non-U.S. currency options, futures or options on futures on such currency, or in any related commodity, related commodity futures or options on commodity futures or any other related commodity derivatives, or any other derivatives based on such currency while in possession of material nonpublic information concerning imminent transactions in the above; and
(c) disclosing to another person any material nonpublic information involving a corporation, partnership, or Funds or a trust or similar entities whose shares are publicly traded or an imminent transaction in an underlying security or related securities or in the underlying non-U.S. currency or any related non-U.S. currency options, futures or options on futures on such currency, or in any related commodity, related commodity futures or options on commodity futures or any other related commodity derivatives, or any other derivatives based on such currency for the purpose of facilitating the possible misuse of such material nonpublic information.
Because market makers are already subject to the requirements of Rule 408(a) and because market makers do not have any trading or information advantage over other Members, the Exchange does not believe that it is necessary to separately require specific limitations on dealings between market makers and their affiliates. Deleting Rule 810 would provide market makers and Members with the flexibility to adapt their policies and procedures as reasonably designed to reflect changes to their business model, business activities, or the securities market in a manner similar to how Members on the Exchange currently operate and consistent with Rule 408(a). However, the Exchange notes that deleting Rule 810 does not obviate the need for reasonably designed information barriers in certain situations.
As noted above, PMMs and CMMs are distinguished under Exchange rules only to the extent that PMMs have heightened obligations and allocation guarantees. However, none of these heightened obligations provides different or greater access to non-public information than any other market participant on the Exchange.
The Exchange notes that even with this proposed rule change, pursuant to Rule 408(a), a market maker would still be obligated to ensure that its policies and procedures reflect the current state of its business and continue to be reasonably designed to achieve compliance with applicable federal securities law and regulations, and with applicable Exchange rules, including being reasonably designed to protect against the misuse of material, non-public information. While information barriers would not specifically be required under the proposal, Rule 408(a) already requires that a Member consider its business model or business activities in structuring its policies and procedures, which may dictate that an information barrier or a functional separation be part of the set of policies and procedures that would be reasonably designed to achieve compliance with applicable securities law and regulations, and with applicable Exchange rules.
The Exchange is not proposing to change what is considered to be material, non-public information and, thus does not expect there to be any changes to the types of information that an affiliated brokerage business of a market maker could share with such market maker. In that regard, the proposed rule change will not permit the EAM unit of a member to have access to any non-public order or quote information of the affiliated market maker, including hidden or undisplayed size or price information of such orders and quotes. Market makers are not allowed to post hidden or undisplayed orders and quotes on the Exchange. Members do not expect to receive any additional order or quote information as a result of this proposed rule change.
Further, the Exchange does not believe that there will be any material change to member information barriers as a result of removal of the Exchange's pre-approval requirements. In fact, the Exchange anticipates that eliminating the pre-approval requirement should facilitate implementation of changes to member information barriers as necessary to protect against the misuse of material, non-public information. The Exchange also suggests that the pre-approval requirement is unnecessary because market makers do not have agency responsibilities to the book, or time and place information advantages because of their market role. However, as is the case today with market makers, information barriers of new entrants would be subject to review as part of a new firm application. Moreover, the policies and procedures of market makers, including those relating to information barriers, would be subject to review by FINRA, on behalf of the Exchange, pursuant to a Regulatory Services Agreement.
The Exchange further notes that under Rule 408(a), a Member would be able to structure its firm to provide for its options market makers, as applicable, to be structured with its equities and customer-facing businesses, provided that any such structuring would be done in a manner reasonably designed to protect against the misuse of material, non-public information. For example, pursuant to Rule 408(a) a market maker on the Exchange could be in the same independent trading unit, as defined in Rule 200(f) of Regulation SHO,
The Exchange believes that the proposed reliance on the principles-based Rule 408(a) would ensure that a Member that operates a market maker would be required to protect against the misuse of any material, non-public information. As noted above, Rule 408(a) already requires that firms refrain from trading while in possession of material, non-public information concerning imminent transactions in the security or related product. The Exchange believes that moving to a principles-based approach rather than prescribing how and when to wall off a market maker from the rest of the firm would provide Members operating as market makers with appropriate tools to better manage risk across a firm, including integrating options positions with other positions of the firm or, as applicable, by the respective independent trading unit. Specifically, the Exchange believes that it is appropriate for risk management
The Exchange further notes that if market makers are integrated with other market making operations, they would be subject to existing rules that prohibit Members from disadvantaging their customers or other market participants by improperly capitalizing on a member organization's access to the receipt of material, non-public information. As such, a member organization that integrates its market maker operations together with equity market making would need to protect customer information consistent with existing obligations to protect such information. The Exchange has rules prohibiting Members from disadvantaging their customers or other market participants by improperly capitalizing on the Members' access to or receipt of material, nonpublic information. For example, Rule 609 requires members to establish, maintain, enforce, and keep current a system of compliance and supervisory controls, reasonably designed to achieve compliance with applicable securities laws and Exchange rules. Additionally, Rule 400 prevents a person associated with a Member, who has knowledge of all material terms and conditions of (i) an order and a solicited order, (ii) an order being facilitated, or (iii) orders being crossed; the execution of which are imminent, to enter, based on such knowledge, an order to buy or sell an option for the same underlying security as any option that is the subject of the order, or an order to buy or sell the security underlying such class, or an order to buy or sell any related instrument unless certain circumstances are met.
Additionally, the Exchange proposes to amend the text of Supplementary Material .06 to Rule 717 to match a recent change made by International Securities Exchange, LLC (“ISE”).
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange believes that the proposed rule change would remove impediments to and perfect the mechanism of a free and open market by adopting a principles based approach to permit a Member operating a market maker to maintain and enforce policies and procedures to, among other things, prohibit the misuse of material, non-public information and eliminate restrictions on how a Member structures its market making operations. The Exchange notes that the proposed rule change is based on an approved rule of the Exchange to which market makers are already subject—Rule 408(a)—and harmonizes the rules governing market makers and Members. Moreover, Members operating market makers would continue to be subject to federal and Exchange requirements for protecting material, non-public order information.
The Exchange further believes the proposal is designed to prevent fraudulent and manipulative acts and practices and to promote just and equitable principles of trade because existing rules make clear to market makers and Members the type of conduct that is prohibited by the Exchange. While the proposal eliminates requirements relating to the misuse of material, non-public information, market makers and Members would remain subject to existing Exchange rules requiring them to establish and maintain systems to supervise their activities, and to create, implement, and maintain written procedures that are reasonably designed to comply with applicable securities laws and Exchange rules, including the prohibition on the misuse of material, non-public information.
The Exchange notes that the proposed rule change would still require that Members operating market makers maintain and enforce policies and procedures reasonably designed to ensure compliance with applicable federal securities laws and regulations and with Exchange rules. Even though there would no longer be pre-approval of market maker information barriers, any market maker's written policies and procedures would continue to be subject to oversight by the Exchange and therefore the elimination of prescribed restrictions should not reduce the effectiveness of the Exchange rules to protect against the misuse of material, non-public information. Rather, Members will be able to utilize a flexible, principles-based approach to modify their policies and procedures as appropriate to reflect changes to their business model, business activities, or to the securities market itself. Moreover, while specified information barriers may no longer be required, a Member's business model or business activities may dictate that an information barrier or functional separation be part of the set of policies and procedures that would be reasonably designed to achieve compliance with applicable
Finally, the Exchange believes that proposed rule change to Rule 717 is consistent with Section 6(b)(5) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes that the proposal will enhance competition by allowing market makers to comply with applicable Exchange rules in a manner best suited to their business models, business activities, and the securities markets, thus reducing regulatory burdens while still ensuring compliance with applicable securities laws and regulations and Exchange rules. The Exchange believes that the proposal will foster a fair and orderly marketplace without being overly burdensome upon market makers.
Moreover, the Exchange believes that the proposed rule change would eliminate a burden on competition for Members which currently exists as a result of disparate rule treatment between the options and equities markets regarding how to protect against the misuse of material, non-public information. For those Members that are also members of equity exchanges, their respective equity market maker operations are now subject to a principles-based approach to protecting against the misuse of material non-public information.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any written comments from members or other interested parties.
The Exchange believes that the foregoing proposed rule change may take effect upon filing with the Commission pursuant to Section19(b)(3)(A) of the Act and Rule 19b–4(f)(6) thereunder because the foregoing proposed rule change does not (i) significantly affect the protection of investors or the public interest, (ii) impose any significant burden on competition, and (iii) become operative for 30 days after its filing date, or such shorter time as the Commission may designate.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 1, 2015, NYSE Arca, Inc. (the “Exchange” or “NYSE Arca”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change, so that it has sufficient time to consider this proposed rule change.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Mitsubishi Motors North America, Inc. (MMNA), has determined that certain model year (MY) 2015 Mitsubishi Outlander Sport multipurpose passenger vehicles do not fully comply with paragraph S6 of Federal Motor Vehicle Safety Standard (FMVSS) No. 205,
The closing date for comments on the petition is October 8, 2015.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited at the beginning of this notice and submitted by any of the following methods:
•
•
•
Comments may also be faxed to (202) 493–2251.
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that your comments were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
Documents submitted to a docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will be published in the
I.
This notice of receipt of MMNA's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
II.
III.
IV.
S6 Tire Markings. Except as specified in paragraphs, each tire shall be marked on each sidewall with the information specified in paragraphs (a) through (j) of this section. . .
V.
(A) MMNA stated that the quarter panel glass windows otherwise meet all other marking and performance requirements of FMVSS No. 205.
(B) MMNA believes that because the affected glazing fully meets all of the applicable performance requirements, the absence of the correct “M” number in their monogram has no effect upon the degree of driver visibility or the possibility of occupants being thrown through the vehicle windows in a collision.
(C) MMNA stated its belief that NHTSA has previously granted inconsequential noncompliance petitions regarding what it believes are similar noncompliances.
(D) MMNA is not aware of any crashes, injuries, customer complaints or field reports associated with this condition.
In summation, MMNA believes that the described noncompliance of the subject vehicles is inconsequential to motor vehicle safety, and that its petition, to exempt MMNA from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject vehicles that MMNA no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant vehicles under their control after MMNA notified them that the subject noncompliance existed.
(49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8)
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of Petition.
Maserati S.p.A and Maserati North America, Inc. (collectively referred to as “MNA”) has determined that certain MY 2011–2014 Maserati passenger vehicles do not fully comply with paragraph S4.4(c)(2), of Federal Motor Vehicle Safety Standard (FMVSS) No. 138,
The closing date for comments on the petition is October 8, 2015.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited at the beginning of this notice and submitted by any of the following methods:
• Mail: Send comments by mail addressed to: U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590.
• Hand Deliver: Deliver comments by hand to: U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
• Electronically: Submit comments electronically by: logging onto the Federal Docket Management System (FDMS) Web site at
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that your comments were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
Documents submitted to a docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will be published in the
Pursuant to 49 U.S.C. 30118(d) and 30120(h) and the rule implementing those provisions at 49 CFR part 556, MNA submitted a petition for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
This notice of receipt of MNA's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
Affected are approximately 8,789 MY 2011–2013 Maserati Quattroporte and 2011–2014 Maserati Granturismo/Granturismo Convertible passenger vehicles.
MNA explains that the noncompliance is that when the vehicle's TPMS detects a missing or inactive wheel sensor the vehicles do not fully comply with paragraph S4.4(c)(2) of FMVSS No. 138 because the malfunction indicator does not always illuminate as required.
Specifically, after the car's ignition is switched to the on position, the TPMS immediately seeks to confirm if all wheel sensors are present. If the TPMS then detects a sensor is not present, an internal timer is started. If the sensor detected as missing was also detected as missing during the previous ignition cycle, and the engine is not restarted, then the TPMS malfunction indicator will illuminate as required to indicate a hardware fault is still present. If the engine is then started and left in its steady state (engine not cold) idle, the warning lamp will continue to remain illuminated as required. However, if the car is then driven, the warning lamp will extinguish [in violation of the standard] as the system prepares to confirm that all wheel sensors are fitted to the vehicle. Once the vehicle has been moving above 22 mph for a period of 15 seconds the TPMS will seek to confirm that all wheel sensors are fitted to the vehicle. If the internal timer reaches 160 seconds, and the vehicle has been moving above 22 mph for 15 seconds, the TPMS malfunction indicator will illuminate correctly. Once the malfunction indicator is illuminated, it remains so throughout that ignition cycle, regardless of the vehicle's speed.
S4.4
(c)
(2) Flashes for a period of at least 60 seconds but no longer than 90 seconds upon detection of any condition specified in S4.4(a) after the ignition locking system is activated to the “On” (“Run”) position. After each period of prescribed flashing, the telltale must remain continuously illuminated as long as a malfunction exists and the ignition locking system is in the “On” (“Run”) position. This flashing and illumination sequence must be repeated each time the ignition locking system is placed in the “On” (“Run”) position until the situation causing the malfunction has been corrected . . .
MNA stated its belief that the subject noncompliance is inconsequential to motor vehicle safety for the following reasons:
(A) MNA states that the malfunction indicator will illuminate no later than 160 seconds after the vehicle's ignition is switched on, and the car has traveled above 22 mph for at least 15 seconds.
(B) MNA also states that if the TPMS fails to detect the wheel sensors, the TPMS will display on the TPMS pressures screen contained within the instrument cluster no value for the tire pressure, indicating that the status of the wheel sensor is unconfirmed.
(C) MNA further stated that the primary function of the TPMS is not affected by the noncompliance and the vehicle will operate as intended. Adding, that the noncompliance is confined to one particular aspect of the functionality of an otherwise compliant TPMS malfunction indicator and that all other aspects of the low-pressure monitoring system functionality are fully compliant with the requirements of FMVSS No. 138. Along with this argument, MNA also made mention that on April 8, 2005, NHTSA published a rule where it states “A TPMS malfunction does not itself represent a safety risk to vehicle occupants, and we expect that the chances of having a TPMS malfunction and a significantly under-inflated tire at the same time are unlikely.”
(D) MNA says that NHTSA has previously granted petitions for Inconsequential Non-Compliances pertaining to FMVSS No. 138, Tire Pressure Monitoring System (TPMS), in which the monitoring system would not illuminate in the manner required by FMVSS No. 138 due to a software malfunction.
(E) MNA is not aware of any customer complaints, field communications, incidents or injuries related to this condition.
MNA has additionally informed NHTSA that all unsold vehicles in MNA's custody and control will have a reprogramming of the TPMS Electronic Control Unit prior to sale.
In summation, MNA believes that the described noncompliance of the subject vehicles is inconsequential to motor vehicle safety, and that its petition, to exempt MNA from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject vehicles that MNA no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant vehicles under their control after MNA notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Baby Jogger, LLC (Baby Jogger), has determined that certain Baby Jogger rear-facing infant seats and bases do not fully comply with paragraphs S5.5, S5.6, S5.8, and S8.1 of Federal Motor Vehicle Safety Standard (FMVSS) No. 213,
The closing date for comments on the petition is October 8, 2015.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited at the beginning of this notice and submitted by any of the following methods:
• Mail: Send comments by mail addressed to: U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590.
• Hand Deliver: Deliver comments by hand to: U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue SE., Washington, DC 20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
• Electronically: Submit comments electronically by: logging onto the Federal Docket Management System (FDMS) Web site at
Comments may also be faxed to (202) 493–2251.
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that your comments were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
Documents submitted to a docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
The petition, supporting materials, and all comments received before the close of business on the closing date indicated below will be filed and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will be published in the
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), Baby Jogger submitted a petition for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
This notice of receipt of Baby Jogger's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
Affected are approximately 15,103 of the following Baby Jogger rear-facing infant seats and bases manufactured between November 3, 2014 and April 30, 2015:
• City GO Infant Car Seat/Model No. BJ64510
• City GO Infant Car Seat/Model No. BJ64529
• City GO Base for Infant Car Seat/Model No. BJ80400
• City GO Base for Infant Car Seat/Model No. BJ61500
• City Mini Infant Cars Seat/Stroller Travel System/Model No.BJ72510
• Vue Lite Infant Car Seat/Stroller Travel System/Model No. BJ70411
• Vue Lite Infant Car Seat/Stroller Travel System/Model No. BJ70424
• Vue Lite Infant Car Seat/Stroller Travel System/Model No. BJ70431
Baby Jogger explains that the affected child restraints do not fully comply with the numerous paragraphs of FMVSS No. 213 for the following reasons:
Paragraph S5.5.2—The required information in English is no smaller than 10 point type, but the Spanish information is smaller at about 7 point type. This only applies to models BJ64510 and BJ64529.
Paragraph S5.5.2(d)—The “manufactured in address” on the label is in about 8 font which is smaller than the required 10 point type.
Paragraph S5.5.2(m)—The required “Child restraints could be recalled for safety reasons . . .” text is on a black background with white text instead of black text on a white background.
Paragraph S5.5.2(g)(1)—The label has the “Follow all instructions. . .” ahead of the “Secure this child restraint statement . . .” instead of the reverse order as required. This noncompliance only affects models BJ64510 and BJ64529.
Paragraph S5.5.2(n)—The label has “This child restraint is certified for use in motor vehicles and aircraft.” Other than the first word, no words other words are capitalized.
Paragraph S5.5.2.(k)(3)(ii)—The message area measures 23.4 square cm on models BJ70411, BJ70424 and BJ70431 which is less than the minimum required message area of 30 square cm.
Paragraph S5.5.2.(k)(3)(iii)—On models BJ70411, BJ70424 and BJ70431 the red circle on the required pictogram is 29mm in diameter which is less than the required 30mm in diameter.
Paragraph S5.6.1.7—The instruction manuals do not include reference to the required Web site in the section regarding child restraint recalls.
Paragraph S5.6.3—The instruction manuals do not include the required statement “A snug strap should not allow any slack . . .”
Paragraph S5.8.2(a)(1)—The electronic registration form does not have the required statement “FOR YOUR CHILD'S CONTINUED SAFETY . . .”
Paragraph S5.8.1(b)(2)—Figure 9a requires minimum 10% screen tint on the lower half of the form. The form is missing the required tinting.
Paragraph S8.1—No instructions for installing the system in an aircraft passenger seat were provided.
Baby Jogger organized its reasoning to substantiate inconsequentiality into the following five groupings that it believes are similar issues between the numerous noncompliances:
a. Information Type Size/Capitalization/Presentation order
b. Background color
c. On-Product Label Message Area and Pictogram Sizes
d. Omitted Information
e. Spanish Language Type Size
Refer to Baby Jogger's petition for their complete reasoning and associated
Baby Jogger additionally informed NHTSA that they have corrected all labeling noncompliances and that all future productions of the infant car seat/stroller systems and stand-alone units will be in full compliance with FMVSS No. 213.
In summation, Baby Jogger believes that the described noncompliance of the subject infant car seat/stroller systems and standalone units is inconsequential to motor vehicle safety, and that its petition, to exempt Baby Jogger from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject child restraints that Baby Jogger no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve child restraint distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant child restraints under their control after Baby Jogger notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
Surface Transportation Board, DOT.
Notice of construction and operation exemption.
The Board is granting an exemption under 49 U.S.C. 10502 from the prior approval requirements of 49 U.S.C. 10901 for Six County Association of Governments (Six County) to construct and operate a new line of railroad between Salina, Utah, and a connection with an existing line of the Union Pacific Railroad Company near Juab, Utah. The rail line would provide an alternative rail service option to local industries, particularly the Southern Utah Fuel Company coal mine located about 30 miles northeast of Salina. This exemption is subject to environmental mitigation conditions.
The exemption will be effective on October 3, 2015; petitions for reconsideration must be filed by September 23, 2015.
An original and 10 copies of all pleadings, referring to Docket No. FD 34075 must be filed with the Surface Transportation Board, 395 E Street SW., Washington DC 20423–0001. In addition, one copy of each filing in this proceeding must be served on petitioner's representative: Sandra L. Brown, Thompson Hine LLP, 1919 M Street NW., Suite 700, Washington, DC 20036–1600.
Nathaniel Bawcombe, (202) 245–0376. (Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at: (800) 877–8339). Copies of written filings will be available for viewing and self-copying at the Board's Public Docket Room, Room 131, and will be posted to the Board's Web site.
Additional information is contained in the Board's decision. Board decisions and notices are available on our Web site at “
By the Board, Chairman Elliott, Vice Chairman Begeman, and Commissioner Miller.
Surface Transportation Board, DOT.
30-day notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501–3519 (PRA), the Surface Transportation Board (Board) gives notice that it is requesting from the Office of Management and Budget (OMB) approval of an extension of the information collection—Statutory Licensing and Consolidation Authority—further described below. The Board previously published a notice about this collection in the
Under 49 U.S.C. 10901–03 and §§ 11323–26, rail carriers and non-carriers are required to file an application with the Board, or seek an exemption (through petition or notice) from the full application process under § 10502, before they may construct, acquire, or operate a line of railroad; abandon or discontinue operations over a line of railroad; or consolidate their interests through a merger or common-control arrangement. (The relevant information collections are described in more detail below.)
Comments are requested concerning: (1) The accuracy of the Board's burden estimates; (2) ways to enhance the quality, utility, and clarity of the information collected; (3) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, when appropriate; and (4) whether the collection of information is necessary for the proper performance of the functions of the Board, including whether the collection has practical utility.
Comments on this information collection should be submitted by October 8, 2015.
Written comments should be identified as “Paperwork Reduction Act Comments, Surface Transportation Board, Statutory Licensing and Consolidation Authority.” These comments should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: Chandana L. Achanta, Surface Transportation Board Desk Officer, by email at
For further information regarding the Statutory Licensing and Consolidation Authority, contact Chris Oehrle, Surface Transportation Board, via mail at 395 E Street SW., Washington, DC 20423–0001, telephone at (202) 245–0271, or email at
Under §§ 10901–03 and 11323–26, an application must be filed to seek authority under these sections, but an applicant may file a petition or notice pursuant to an exemption under 49 U.S.C. 10502. Respondents seeking authority from the Board under these provisions must submit certain information required under the Board's related regulations. The table below shows the statutory and regulatory provisions under which the Board requires the information collections that are the subject of this notice.
Under the PRA, a federal agency conducting or sponsoring a collection of information must display a currently valid OMB control number. A collection of information, which is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c), includes agency requirements or requests that persons submit reports, keep records, or provide information to the agency, third parties, or the public. Section 3507(b) of the PRA requires, concurrent with an agency's submitting a collection to OMB for approval, a 30-day notice and comment period through publication in the
Surface Transportation Board, DOT.
30-day notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501–3519 (PRA), the Surface Transportation Board (Board) gives notice that it is requesting from the Office of Management and Budget (OMB) approval of an extension of the information collection—Statutory Authority to Preserve Rail Service—further described below. The Board previously published a notice about this collection in the
Under these statutory provisions, the Board administers programs designed to preserve railroad service or rail rights-of-way. When a line is proposed for abandonment, affected shippers, communities, or other interested persons may seek to preserve rail service by filing with the Board: an offer of financial assistance (OFA) to subsidize or purchase a rail line for which a railroad is seeking abandonment (49 U.S.C. 10904), including a request for the Board to set terms and conditions of the financial assistance; a request for a public use condition (§ 10905); or a trail-use request (16 U.S.C. 1247(d)). Similarly, when a line is placed on a system diagram map identifying it as an anticipated or potential candidate for abandonment, affected shippers, communities, or other interested persons may seek to preserve rail service by filing with the Board a feeder line application to purchase the identified rail line (§ 10907). When a line is so placed on the map, the feeder line applicant need not demonstrate that the public convenience and necessity require or permit the sale of the line, but need only pay the constitutional minimum value to acquire it. Additionally, the railroad owning the rail line subject to abandonment must, in some circumstances, provide information to the applicant or offeror. The relevant information collections are described in more detail below.
Comments are requested concerning: (1) The accuracy of the Board's burden estimates; (2) ways to enhance the quality, utility, and clarity of the information collected; (3) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology when appropriate; and (4) whether the collection of information is necessary for the proper performance of the functions of the Board, including whether the collection has practical utility.
The collection by the Board of these offers, requests, and applications, and the railroad's replies (when required), enables the Board to meet its statutory duty to regulate the referenced rail transactions.
Comments on this information collection should be submitted by October 8, 2015.
Written comments should be identified as “Paperwork Reduction Act Comments, Surface Transportation Board, Statutory Authority to Preserve Rail Service.” These comments should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: Chandana L. Achanta, Surface Transportation Board Desk Officer, by email at
For further information regarding the Statutory Authority to Preserve Rail Service, contact Chris Oehrle, Surface Transportation Board, 395 E Street SW., Washington, DC 20423–0001, or email
Respondents seeking authority from the Board to preserve rail lines must submit certain information required under the Board's related regulations and, in some circumstances, railroads seeking to abandon a line must disclose certain information to the offeror or applicant.
Under the PRA, a federal agency conducting or sponsoring a collection of information must display a currently valid OMB control number. A collection of information, which is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c), includes agency requirements or requests that persons submit reports, keep records, or provide information to the agency, third parties, or the public. Section 3507(b) of the PRA requires, concurrent with an agency's submitting a collection to OMB for approval, a 30-day notice and comment period through publication in the
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, October 28, 2015.
Lisa Billups at 1–888–912–1227 or (214) 413–6523.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Joint Committee will be held Wednesday, October 28, 2015, at 1:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. For more information please contact Lisa Billups at 1–888–912–1227 or 214–413–6523, or write TAP Office 1114 Commerce Street, Dallas, TX 75242–1021, or post comments to the Web site:
The agenda will include various committee issues for submission to the IRS and other TAP related topics. Public input is welcomed.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 5472, Information Return of a 25% Foreign-Owned U.S. Corporation or a Foreign Corporation Engaged in a U.S. Trade or Business.
Written comments should be received on or before October 8, 2015 to be assured of consideration.
Direct all written comments to Martha Brinson, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Kerry Dennis, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224 or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held October 6, 2015.
Donna Powers at 1–888–912–1227 or (954) 423–7977.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Tax Forms and Publications Project Committee will be held Tuesday October 6, 2015 at 1:00 p.m.. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Donna Powers. For more information please contact: Donna Powers at 1–888–912–1227 or (954) 423–7977 or write: TAP Office, 1000 S. Pine Island Road, Plantation, FL 33324 or contact us at the Web site:
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, October 21, 2015.
Linda Rivera at 1–888–912–1227 or (202) 317–3337.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Toll-Free Phone Line Project Committee will be held
The committee will be discussing Toll-free issues and public input is welcomed.
Internal Revenue Service (IRS), Department of the Treasury (Treasury).
Notice.
The purpose of this notice is to publish the names of those IRS employees who will serve as members on IRS's Fiscal Year 2015 Senior Executive Service (SES) Performance Review Boards.
This notice is effective September 1, 2015.
Cheryl Huffman, IRS, 250 Murall Drive, Kearneysville, WV 25430, (304) 264–5572.
Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members to the IRS's SES Performance Review Boards. The names and titles of the executives serving on the boards are as follows:
This document does not meet the Treasury's criteria for significant regulations.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, October 8, 2015.
Theresa Singleton at 1–888–912–1227 or 202–317–3329.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be held Thursday, October 8, 2015, at 12:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Theresa Singleton. For more information please contact: Theresa Singleton at 1–888–912–1227 or 202–317–3329, TAP Office, 1111 Constitution Avenue NW., Room 1509, National Office, Washington, DC 20224, or contact us at the Web site:
The agenda will include a discussion on various letters, and other issues related to written communications from the IRS.
Internal Revenue Service (IRS) Treasury
Notice of Meeting.
An open meeting of the Taxpayer Advocacy Panel Special Projects Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, October 1, 2015.
Kim Vinci at 1–888–912–1227 or 916–974–5086.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Special Projects Committee will be held Thursday, October 1, 2015, at 2:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Kim Vinci. For more information please contact: Kim Vinci at 1–888–912–1227 or 916–974–5086, TAP Office, 4330 Watt Ave, Sacramento, CA 95821, or contact us at the Web site:
The agenda will include a discussion on various special topics with IRS processes.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, October 1, 2015.
Antoinette Ross at 1–888–912–1227 or (202) 317–4110.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be held Thursday, October 1, 2015, at 3:00 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Antoinette Ross. For more information please contact: Antoinette Ross at 1–888–912–1227 or (202) 317–4110, or write TAP Office, 1111 Constitution Avenue NW., Room 1509, National Office, Washington, DC 20224, or contact us at the Web site:
The committee will be discussing various issues related to Taxpayer Communications and public input is welcome.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)).
Written comments should be received on or before November 9, 2015 to be assured of consideration.
Direct all written comments to Christie A. Preston, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Please send separate comments for each specific information collection listed below. You must reference the information collection's title, form number, reporting or record-keeping requirement number, and OMB number (if any) in your comment.
To obtain additional information, or copies of the information collection and instructions, or copies of any comments received, contact Elaine Christophe, at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet, at
The Department of the Treasury and the Internal Revenue Service, as part of their continuing effort to reduce paperwork and respondent burden, invite the general public and other Federal agencies to take this opportunity to comment on the proposed or continuing information collections listed below in this notice, as required by the Paperwork Reduction Act of 1995, (44 U.S.C. 3501
Request for Comments: Comments submitted in response to this notice will be summarized and/or included in our request for Office of Management and Budget (OMB) approval of the relevant information collection. All comments will become a matter of public record. Please do not include any confidential or inappropriate material in your comments.
We invite comments on: (a) Whether the collection of information is necessary for the proper performance of the agency's functions, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide the requested information. Currently, the IRS is seeking comments concerning the following forms, and reporting and record-keeping requirements:
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Wednesday, October 14, 2015.
Otis Simpson at 1–888–912–1227 or 202–317–3332.
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will be held Wednesday, October 14, 2015, at 3:00 p.m. Eastern Time. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Otis Simpson. For more information please contact: Otis Simpson at 1–888–912–1227 or 202–317–3332, TAP Office, 1111 Constitution Avenue NW., Room 1509–National Office, Washington, DC 20224, or contact us at the Web site:
The committee will be discussing various issues related to the Taxpayer Assistance Centers and public input is welcomed.
Department of Veterans Affairs.
Notice of funding availability (grant renewals).
The Department of Veterans Affairs (VA) is announcing the availability of funds under the Grants for Transportation of Veterans in Highly Rural Areas. This Notice contains information concerning the Grants for Transportation of Veterans in Highly Rural Areas program, grant renewal application process, and amount of funding available.
Darren Wallace, National Coordinator, Highly Rural Transportation Grants, Veterans Transportation Program, Chief Business Office (10NB2G), 2957 Clairmont Road, Atlanta, GA 30329; (404) 828–5380 (this is not a toll-free number); and Sylvester Wallace at
The application can be found at
Applications may not be sent by facsimile. Applications must be submitted to
Access to VA care for Veterans that are in highly rural areas continues to be an issue across the United States. The VA has established this program to help address barriers to access to care. This program funds innovative approaches to transporting veterans in highly rural areas who typically have longer commute times to Department of Veterans Affairs Medical Centers (VA Medical Centers).
VA Veterans Transportation Program (VTP) is pleased to announce that it is seeking grant renewal applications for Grants for Transportation of Veterans in Highly Rural Areas. This program furthers the Department's mission by offering renewal grants to current grantees to enable them to continue to assist veterans in highly rural areas through innovative transportation services to travel to VA Medical Centers and to otherwise assist in providing transportation services in connection with the provision of VA medical care to these veterans.
Funding applied for under this Notice is authorized by section 307 of the Caregivers and Veterans Omnibus Health Services Act of 2010, Public Law 111–163, section 307 (the 2010 Act), as implemented by regulations codified at 38 CFR 17.700 through 17.730, Grants for Transportation of Veterans in Highly Rural Areas. Funds made available under this Notice are subject to the requirements of the aforementioned regulations and other applicable laws and regulations.
In accordance with 38 CFR 17.710, VA is issuing this Notice of Funding Availability (Notice) for renewal grants under the Grants for Transportation of Veterans in Highly Rural Areas Program for fiscal year 2015. Approximately $3 million is authorized to be appropriated for this fiscal year. If additional funding becomes available, VA will issue additional Notices of Funding Availability to permit other grantees to apply for Grants under the Program (in accordance with the terms and conditions of such Notices of Funding Availability). The following requirements apply to grants awarded under this Notice:
• One renewal grant may be awarded to each grantee for fiscal year 2015 for each highly rural area in which the grantee provides transportation services. Transportation services may not be simultaneously provided by more than one grantee in any single highly rural area.
• No single grant will exceed $50,000.
• A veteran who is provided transportation services through a grantee's use of these grant monies will not be charged for such services.
• Renewal grants awarded under this Notice will be for a 1-year period.
• All awards are subject to the availability of appropriated funds and to any modifications or additional requirements that may be imposed by law.
Current 2014 grantees are the only eligible entities that are eligible to apply for a renewal grant. Interested eligible entities must submit a complete renewal grant application package to be considered for a grant renewal. Further, a renewal grant will only be awarded if the grantee's program will remain substantially the same as the program for which the original grant was awarded. How the grantee will meet this requirement must be specifically addressed in the renewal grant application.
This solicitation does not require grantees to provide matching funds as a condition of receiving such grants.
Additional grant application requirements are specified in the application package. Submission of an incorrect or incomplete application package will result in the application being rejected during the threshold review, the initial review conducted by VA, to ensure the application package contains all required forms and certifications. Complete packages will then be subject to the evaluation/scoring and selection processes described in § 17.705(c) and (d), respectively. Applicants will be notified of any additional information needed to confirm or clarify information provided in the renewal grant application and the deadline by which to submit such information.
Renewal applications will be submitted through Grants.gov. Grants.gov is a “one-stop storefront” that provides a unified process for all customers of federal awards to find funding opportunities and apply for funding. Complete instructions on how to register and submit a renewal grant application can be found at
Registration in Grants.gov is required prior to submission. VA strongly encourages registering with Grants.gov several weeks before the deadline for application submission. The deadline for applying for funding under this announcement is October 8, 2015.
Search for the funding opportunity on Grants.gov. Please use the following identifying information when searching for the funding opportunity on Grants.gov. The Catalog of Federal Domestic Assistance (CFDA) number for this solicitation is 64.035, titled “Veterans transportation program,” and the funding opportunity number is VA–HRTG–2015.
Submit an application consistent with this solicitation by following the directions in Grants.gov. Within 24–48 hours after submitting the electronic application, the applicant should receive an email validation message from Grants.gov. The validation message will state whether the renewal grant application has been received and validated, or rejected, with an explanation. Important: Applicants are urged to submit their applications at least 72 hours prior to the due date of the application to allow time to receive the validation message and to correct any problems that may have caused a rejection notification.
If an applicant experiences unforeseen Grants.gov technical issues beyond the applicant's control that prevent submission of its application by the deadline, the applicant must contact the Veterans Transportation Program Office staff no later than 24 hours after the deadline and request approval to submit its application. At that time, Veterans Transportation Program Office staff will instruct the applicant to submit specific information detailing the technical difficulties. The applicant must email: A description of the technical difficulties, a timeline of submission efforts, the complete grant application, the applicant DUNS number, and Grants.gov Help Desk tracking number(s) received. After the program office reviews all of the information submitted, and contacts the Grants.gov Help Desk to validate the technical issues reported, VA will contact the applicant to either approve or deny the request to submit a late application. If the technical issues reported cannot be validated, the application will be rejected as untimely.
To ensure a fair competition for limited discretionary funds, the following conditions are not valid reasons to permit late submissions: (1) Failure to begin the registration process in sufficient time, (2) failure to follow Grants.gov instructions on how to register and apply as posted on its Web site, (3) failure to follow all of the instructions in the VA solicitation, and (4) technical issues experienced with the applicant's computer or information technology (IT) environment. Notifications regarding known technical problems with Grants.gov, if any, are posted on the Grants.gov Web site.
This section describes what a renewal application must include. Applicants should anticipate that failure to submit an application that contains all of the specified elements will result in the rejection of their application at the threshold review stage. Moreover, applicants should anticipate that if applications are not adequately responsive to the scope of the solicitation, particularly to any critical element, or fail to include a program narrative, budget detail worksheet including a budget narrative, tribal resolution (if applicable), eligibly entity designation, or a list of the highly rural county or counties to be served, they will be rejected and receive no further consideration.
• Application deadline: Applications not received by the application deadline through
• Eligibility: Applications that do not conform to the eligibility requirements at the beginning section of this document will not be reviewed.
• Budget detail worksheet including a budget narrative. VA strongly recommends use of appropriately descriptive file names (
• Information to complete the Application for Federal Assistance (SF–424). The SF–424 is a standard form required for use as a cover sheet for submission of pre-applications, applications, and related information. Grants.gov takes information from the applicant's profile to populate the fields on this form.
• Program Narrative (Only required if you are making significant changes that do not substantially change the nature of the originally funded program.) The title should read, “Change of Scope”. Provide a detailed narrative of your program scope and specifically discuss the innovative modes and methods of transportation services to be provided. If the provision of transportation services will necessitate procurement or use of specific equipment, such equipment must be specifically listed.
Note on project evaluations: Applicants that propose to use funds awarded through this solicitation to conduct project evaluations should be aware that certain project evaluations (such as systematic investigations designed to develop or contribute to knowledge) may constitute research. However, project evaluations that are intended only to generate internal improvements to a program or service or are conducted only to meet VA's performance measure data reporting requirements likely do not constitute research. Research, for the purposes of VA-funded programs, is defined as, “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” 38 CFR 16.102(d). In addition, research involving human subjects is subject to certain added protections, as set forth in 38 CFR part 16. Applicants should provide sufficient information for VA to determine whether particular project activities they propose would either intentionally or unintentionally collect and/or use information in such a way that it meets VA's regulatory definition of research and thereby invoke the requirements and procedures set forth 38 CFR part 16.
A sample SF 424A Budget Detail Worksheet can be found at
Budget Narrative: The Budget Narrative should thoroughly and clearly describe
Budget Brief (example):
Indirect costs are allowed only if the applicant has a federally approved indirect cost rate. (This requirement does not apply to units of local government.) A copy of the rate approval must be attached. If the applicant does not have an approved rate, one can be requested by contacting the applicant's cognizant federal agency, which will review all documentation and approve a rate for the applicant organization or, if the applicant's accounting system permits, costs may be allocated in the direct cost categories. If VA is the cognizant federal agency, obtain information needed to submit an indirect cost rate proposal at the contact person listed in this solicitation.
If an application identifies a subrecipient that is either (1) a tribe or tribal organization or (2) a third party proposing to provide direct services or assistance to residents on tribal lands, then a current authorizing resolution of the governing body of the tribal entity or other enactment of the tribal council or comparable governing body authorizing the inclusion of the tribe or tribal organization and its membership must be included with the application. In those instances when an organization or consortium of tribes proposes to apply for a grant on behalf of a tribe or multiple specific tribes, then the application must include a resolution from all tribes that will be included as a part of the services/assistance provided under the grant. A consortium of tribes for which existing consortium bylaws allow action without support from all tribes in the consortium (
Renewal grant applications under the Grants for Transportation of Veterans in Highly Rural Areas Program must be submitted to
The application can be found at
Renewal grant applications may not be sent by facsimile. These applications must be submitted to
Some states require that applicants must contact their State's Single Point of Contact (SPOC) to find out and comply with the State's process, to comply with Executive Order (E.O.) 12372 (1982). Names and addresses of the SPOCs are listed in the Office of Management and Budget's homepage at
Grants will only be awarded to those organizations that are eligible under law as described in the eligibility information section.
For technical assistance with submitting the application, contact the Grants.gov Customer Support Hotline at 800–518–4726 or via email to
The Grants.gov Support Hotline hours of operation are 24 hours a day, 7 days a week, except Federal holidays. For assistance with any other requirement of this solicitation, contact Darren Wallace, National Program Coordinator for Grants for Transportation of Veterans in Highly Rural Areas, at (404) 828–5380 (this is not a toll-free number) or by email to
Additional forms that may be required in connection with an award are available for download on
VA is committed to ensuring a fair and open process for awarding these renewal grants. The Veterans Transportation Program Office will review the renewal grant application to make sure that the information presented is reasonable, understandable, measurable, and achievable, as well as consistent with the solicitation. Peer reviewers will conduct a threshold review of all applications submitted under this solicitation to ensure they meet all of the critical elements and all other minimum requirements as identified herein. The Veterans Transportation Program Office may use either internal peer reviewers, external peer reviewers, or a combination to review the applications under this solicitation. An external peer reviewer is an expert in the field of the subject matter of a given solicitation who is NOT a current U.S. Department of Veterans Affairs employee. An internal reviewer is a current U.S. Department of Veterans Affairs employee who is well-
The Chief Business Office Veterans Transportation Program Office conducts a financial review of applications for potential discretionary awards to evaluate the fiscal integrity and financial capability of applicants; examines proposed costs to determine if the Budget Detail Worksheet and Budget Narrative accurately explain project costs; and determines whether costs are reasonable, necessary, and allowable under applicable federal cost principles and agency regulations.
Absent explicit statutory authorization or written delegation of authority to the contrary, the Veterans Health Administration, through the Veterans Transportation Program Office, will forward the reviewers' recommendations for award to the Secretary of Veterans Affairs who will then review and approve each award decision. Such determinations by the Secretary will be final. VA will also give consideration to factors including, but not limited to, underserved populations, geographic diversity, strategic priorities, and available funding when making awards.
Selection of Renewal Grants for Transportation of Veterans in Highly Rural Areas is very competitive. Listed below are the scoring and selection criteria:
1. Renewal Grant Scoring: Renewal applications will be scored using the following selection criteria:
A. VA will award up to 55 points based on the success of the grantee's program, as demonstrated by the following: Application shows that the grantee or identified subrecipient provided transportation services which allowed participants to be provided medical care timely and as scheduled; and application shows that participants were satisfied with the transportation services provided by the grantee or identified subrecipient, as described in the Notice of Fund Availability;
B. VA will award up to 35 points based on the cost effectiveness of the program, as demonstrated by the following: The grantee or identified subrecipient administered the program on budget and grant funds were utilized in a sensible manner, as interpreted by information provided by the grantee to VA under § 17.725(a)(1) through (a)(7); and
C. VA will award up to 15 points based on the extent to which the program complied with the grant agreement and applicable laws and regulations.
2. Renewal Grant Selection: VA will use the following process to award renewal grants:
A. VA will rank those grantees who receive at least the minimum amount of total points and points per category set forth in the Notice of Fund Availability. The grantees will be ranked in order from highest to lowest scores.
B. VA will use the grantee's ranking as the basis for selection for funding. VA will fund the highest-ranked grantees for which funding is available.
Successful applicants will receive a Notice of Award (NoA) signed and dated by the Veterans Transportation Program Office that will set forth the amount of the award and other pertinent information. The NoA is the legal document/instrument issued to notify the awardee that an award has been made and that funds may be requested. It will also include standard Terms and Conditions related to participation in the Program.
The NoA will be sent through the U.S. Postal Service to the awardee organization as listed on its SF 424. Note that any communication between the Veterans Transportation Program Office and awardees prior to the issuance of the NoA is
Unsuccessful applicants will be notified of their status by letter, which will likewise be sent through the U.S. Postal Service to the applicant organization as listed on its SF 424.
After an applicant is selected for a renewal grant in accordance with § 17.705(d), VA will draft a renewal grant agreement to be executed by Chief Business Officer in VA and the grantee. Upon execution of the renewal grant agreement, VA will obligate the approved amount. The renewal grant agreement will provide that:
1. The grantee must operate the program in accordance with the provisions of this section and the grant application;
2. If a grantee's renewal application identified a subrecipient, such subrecipient must operate the program in accordance with the provisions of this section and the grant application; and
3. If a grantee's application identified that funds will be used to procure or operate vehicles to directly provide transportation services, the following requirements must be met:
A. Title to the vehicles must vest solely in the grantee or in the identified subrecipient or with leased vehicles in an identified lender.
B. The grantee or identified subrecipeint must, at a minimum, provide motor vehicle liability insurance for the vehicles to the same extent they would insure vehicles procured with their own funds.
C. All vehicle operators must be licensed in a U.S. State or Territory to operate such vehicles.
D. Vehicles must be safe and maintained in accordance with the manufacturer's recommendations; and
E. Vehicles must be operated in accordance with applicable Department of Transportation regulations concerning transit requirements under the Americans with Disabilities Act.
Successful applicants selected for awards must agree to comply with additional applicable legal requirements upon acceptance of an award. (VA strongly encourages applicants to review the information pertaining to these additional requirements prior to submitting a renewal application.) As to those additional requirements, we note that while their original grants were subject to additional legal requirements as set forth in 38 CFR parts 43 and 49 those regulatory provisions have since been superseded by the Common Rule governing all Federal Grant Programs. The Common Rule is codified at 2 CFR part 200. Thus, grantees and identified subrecipients awarded renewal grants under the Program must agree as part of their grant agreement to comply with all requirements of the Common Rule, as applicable.
Awardees must agree to cooperate with any VA evaluation of the program and provide required quarterly, annual, and final (at the end of the fiscal year reports in a form prescribed by VTP. A final report consists of a summation of grant activities which include progress toward goals, financial administration of grant funds, grant administration issues and barriers. Reports are to be submitted electronically. These reports must outline how grant funds were used, describe program progress and barriers, and provide measurable outcomes.
Required quarterly and annual reports must include the following information:
• Record of time expended assisting with the provision of transportation services.
• Record of grant funds expended assisting with the provision of transportation services.
• Trips completed.
• Total distance covered.
• Veterans served.
• Locations which received transportation services.
• Results of veteran satisfaction survey
The Veterans Transportation Program is responsible for program monitoring. All awardees will be required to cooperate in providing the necessary data elements to the VTP. The goal of program monitoring is to ensure program requirements are met; this will be accomplished by tracking performance and identifying quality and compliance problems through early detection. Methods of program monitoring may include: Monitoring the performance of a grantee's or subrecipient's personnel, procurements, and/or use of grant-funded property; collecting, analyzing data, and assessing program implementation and effectiveness; assessing costs and utilization; and providing technical assistance when needed. Site visit monitoring will include the above-described activities, in addition to the conduct of safety assessments and, if applicable, verification of both current driver's licenses and vehicle insurance coverage.
Awardees are required to submit the
Awardees must comply with the audit requirements of Office of Management and Budget (OMB) Uniform Guidance 2 CFR part 200, subpart F. Information on the scope, frequency and other aspects of the audits can be found on the Internet at
Any changes in a grantee's program activities which result in deviations from the grant renewal agreement must be reported to VA.
Additional reporting requirements may be requested by VA to allow VA to fully assess program effectiveness.
Applicants should anticipate that all recipients (excluding an individual recipient of Federal assistance) of awards of $25,000 or more under this solicitation, consistent with the Federal Funding Accountability and Transparency Act of 2006 (FFATA), Public Law 109–282 (Sept. 26, 2006) will be required to report award information on the subaward reporting system of any first-tier subawards totaling $25,000 or more, and, in certain cases, to report information on the names and total compensation of the five most highly compensated executives of the recipient and first-tier subrecipients. Each applicant entity must ensure that it has the necessary processes and systems in place to comply with the reporting requirements should it receive funding.
It is expected that reports regarding subawards will be made through the FFATA Subaward Reporting System (FSRS) found at
Please note also that applicants should anticipate that no subaward of an award made under this solicitation may be made to a subrecipient that is subject to the terms of FFATA unless the potential subrecipient acquires and provides a Data Universal Numbering System (DUNS) number.
Pursuant to § 17.730(a), VA may recover from the grantee any funds that are not used in accordance with a grant agreement. If VA decides to recover funds, VA will issue to the grantee a notice of intent to recover grant funds, and the grantee will then have 30 days to submit documentation demonstrating why the grant funds should not be recovered. After review of all submitted documentation, VA will determine whether action will be taken to recover the grant funds. When VA determines action will be taken to recover grant funds from the grantee, the grantee is then prohibited under § 17.730(b) from receipt of any further grant funds.
Notice.
The Department of Veterans Affairs (VA) is seeking nominees to be considered for membership on the Research Advisory Committee on Gulf War Veterans' Illnesses (Committee). The Committee is authorized by Public Law 105–368, § 104 (the statute), to provide advice to the Secretary of Veterans Affairs (Secretary) on the proposed research studies, plans, and strategies related to understanding and treating the health consequences of military service in the Southwest Asia theatre of operations during the 1990–1991 Gulf War. In accordance with the statute and the Committee's current charter, the majority of the membership shall consist of non-Federal employees, appointed by the Secretary from the general public, serving as Special Government Employees. The Committee provides, not later than December 1 of each year, an annual report summarizing its activities for the preceding year. The Committee reports to the Secretary through the Under Secretary for Health. The Secretary appoints Committee members for a period of 2 to 3 years. A term of service for any member may not exceed 3 years. The Secretary may reappoint members for additional terms.
Self-nominations and nominations of non-Veterans will be accepted. Any letters of nomination from organizations or other individuals should accompany the package when it is submitted.
In accordance with OMB guidance, federally-registered lobbyists may not serve on Federal advisory committees in their individual capacity. Additional information regarding this issue can be found at:
In accordance with the statute, the members of the Committee are appointed by the Secretary from the general public, including but not limited to:
(1) Gulf War Veterans;
(2) Representatives of such Veterans;
(3) Members of the medical and scientific communities representing disciplines, such as, but not limited to, epidemiology, immunology, environmental health, neurology, and toxicology.
The Committee meets at least once and up to three times annually. In accordance with Federal Travel Regulation, VA will cover travel expenses—to include per diem—for all members of the Committee, for any travel associated with official Committee duties. A copy of the Committee's most recent charter and a list of the current membership can be found at
The Department makes every effort to ensure that the membership of its advisory committees is fairly balanced, in terms of points of view represented. In the review process, consideration is given to nominees' potential to address the Committee's demographic needs (regional representation, race/ethnicity representation, professional expertise, war era service, gender, former enlisted or officer status, branch of service, etc.). Other considerations to promote a balanced membership include longevity of military service, significant deployment experience, ability to handle complex issues, experience running large organizations, and ability to contribute to the health care and benefits needs of Gulf War Veterans.
Nomination packages must be typed (12 point font) and include: (1) A cover letter from the nominee, and (2) a current resume that is no more than four pages in length. The cover letter must summarize: The nominees' interest in serving on the committee and contributions she/he can make to the work of the committee; any relevant Veterans service activities she/he is currently engaged in; the military branch affiliation and timeframe of military service (if applicable). To promote a balanced membership, please provide information about your personal and professional qualifications and background that would give you a diverse perspective on Gulf War Veterans' matters. Finally, please include in the cover letter the nominee's complete contact information (name, address, email address, and phone number); and a statement confirming that she/he is not a Federally-registered lobbyist. The resume should show professional work experience, and Veterans service involvement, especially service that involves Gulf War Veterans' issues.
Nominations for membership on the Committee must be received by October 9, 2015, no later than 4:00 p.m., Eastern Standard Time. All nomination packages should be sent to:
Should you need additional information, you may contact Dr. Kalasinsky at the address above or by phone at (202) 443–5600. (NOTE: This is not a toll-free number.) You may also email the nomination package to
Department of Homeland Security; Department of Agriculture; Department of Energy; National Aeronautics and Space Administration; Department of Commerce; Social Security Administration; Agency for International Development; Department of Justice; Department of Labor; Department of Defense; Department of Education; Department of Veterans Affairs; Environmental Protection Agency; Department of Health and Human Services; National Science Foundation; and Department of Transportation.
Notice of proposed rulemaking.
The departments and agencies listed in this document propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. This NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. This proposed rule is an effort to modernize, simplify, and enhance the current system of oversight. The participating departments and agencies propose these revisions to the human subjects regulations because they believe these changes would strengthen protections for research subjects while facilitating important research.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on December 7, 2015.
You may submit comments, identified by docket ID number HHS–OPHS–2015–0008, by one of the following methods:
•
•
Comments received, including any personal information, will be posted without change to
Jerry Menikoff, M.D., J.D., Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240–453–6900 or 1–866–447–4777; facsimile: 301–402–2071; email:
Individuals who are the subjects of research may be asked to contribute their time and assume risk to advance the research enterprise, which benefits society at large. U.S. federal regulations governing the protection of human subjects in research have been in existence for more than three decades. The Department of Health, Education, and Welfare (HEW) first published regulations for the protection of human subjects in 1974, and the Department of Health and Human Services (HHS) revised them in the early 1980s. During the 1980s, HHS began a process that eventually led to the adoption of a revised version of the regulations by 15 U.S. federal departments and agencies in 1991. The purpose of this effort was to promote uniformity, understanding, and compliance with human subject protections as well as to create a uniform body of regulations across Federal departments and agencies (subpart A of 45 CFR part 46), often referred to as the “Common Rule” for the Protection of Human Subjects.
Since the Common Rule was promulgated, the volume and landscape of research involving human subjects have changed considerably. Research with human subjects has grown in scale and become more diverse. Examples of developments include: An expansion in the number and type of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral research being used in human subjects research; increased use of sophisticated analytic techniques for use with human biospecimens; and the growing use of electronic health data and other digital records to enable very large data sets to be analyzed and combined in novel ways. Yet these developments have not been accompanied by major change in the human subjects research oversight system, which has remained largely unchanged over the last two decades.
The regulations are codified in each department or agency's title or chapter of the Code of Federal Regulations (CFR). The Common Rule was based on HHS' regulations, 45 CFR part 46, subpart A, and includes identical language in the separate regulations of each department and agency.
Although they have not issued the Common Rule in regulations, three departments and agencies currently comply with all subparts of the HHS protection of human subjects regulations at 45 CFR part 46. These are the Central Intelligence Agency (CIA), the Department of Homeland Security (DHS), and the Social Security Administration (SSA). DHS, and SSA are joining this proposed rulemaking with the intent of codifying the final rule in their own agency regulations.
Pursuant to Executive Order 12333 of December 4, 1981, as amended, elements of the Intelligence Community must comply with the guidelines issued by the Department of Health and Human Services regarding research on human subjects found in 45 CFR part 46. This proposed rulemaking does not supersede the Executive Order. The Office of the Director of National Intelligence and the CIA will continue to adhere to the HHS guidelines, pursuant to the Executive Order, when the final rule is implemented.
DHS, created after issuance of the Common Rule, is required by statute (Pub. L. 108–458, title VIII, section 8306) to comply with 45 CFR part 46, or with equivalent regulations promulgated by the Secretary of Homeland Security or his designee. This proposed rulemaking initiates the process of promulgating equivalent regulations, consistent with statute. Once DHS executes a final rule, DHS will comply with the DHS regulations as the requirements will be equivalent to compliance with HHS regulations at 45 CFR part 46, subpart A.
SSA was separated from HHS in 1995 and, pursuant to the transition rules provided in Section 106 of title 1 of Public Law 103–296, must apply all regulations that applied to SSA before the separation, absent action by the Commissioner. Once the final rule is codified in SSA regulations, SSA will follow the SSA regulations instead of HHS regulations at 45 CFR part 46, subpart A. See Public Law 103–296 § 106(b), 108 Stat. 1464, 1476.
Another department is joining this proposed rulemaking. The Department of Labor (DOL) is not a signatory to the current Common Rule, and is joining this proposed rulemaking in order to promulgate the Common Rule in DOL regulations and to apply the regulations to human subjects research that DOL may conduct or support, pending the scope of the final rule.
Finally, note that there are two current Common Rule agencies that are not listed as part of this proposed rulemaking. The Department of Housing and Urban Development (HUD) supports this proposal, but due to certain statutory prepublication requirements governing HUD rules, HUD will adopt this proposal through a separate rulemaking. The Consumer Product Safety Commission (CPSC), subject to Commission vote, also intends to adopt this proposed rule through a separate rulemaking.
On July 26, 2011, the Office of the Secretary of HHS, in coordination with the Executive Office of the President's Office of Science and Technology Policy (OSTP), published an advanced notice of public rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective.
Since the publication of the ANPRM, science has continued to advance, as has the dialogue regarding the changing nature of research and the preferred balance of protections for research participants among the principles of respect for persons, beneficence, and justice. Important elements of that debate have centered on the appropriate level of transparency in government and medicine and how patient and research participant expectations should be incorporated into government policies.
The proposal also benefits from public comments submitted in response to more recent policy proposals regarding specific topics such as informed consent through the Office for Human Research Protection (OHRP)'s Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care
Finally, the NPRM more thoroughly addresses behavioral and social science research perspectives and the broader types of research conducted or otherwise supported by the other Common Rule agencies. Similarly, the proposal benefits from continuing efforts at HHS to harmonize human subjects policies, particularly between OHRP and the U.S. Food and Drug Administration (FDA).
The goals of the NPRM are to increase human subjects' ability and opportunity to make informed decisions; reduce potential for harm and increase justice by increasing the uniformity of human subject protections in areas such as information disclosure risk, coverage of clinical trials, and coverage of IRBs; and facilitate current and evolving types of research that offer promising approaches to treating and preventing medical and societal problems through reduced ambiguity in interpretation of the regulations, increased efficiencies in the performance of the review system, and reduced burdens on researchers that do not appear to provide commensurate protections to human subjects. It is hoped that these changes will also build public trust in the research system.
An example of some major changes being proposed that will better protect research subjects and help build public trust are the rules relating to informed consent. With regard to informed consent in general (such as consent to participating in clinical trials), the rules would be significantly tightened to make sure that the process becomes more meaningful. Consent forms would no longer be able to be unduly long documents, with the most important information often buried and hard to find. They would need to give appropriate details about the research that is most relevant to a person's decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information. In addition, to assure that these rules do indeed change current practices, there will be a one-time posting requirement for the consent forms for clinical trials, so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.
In addition, informed consent would generally be required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. Such consent would not need to be obtained for each specific research use of the biospecimen, but rather could be obtained using a “broad” consent form in which a person would give consent to future unspecified research uses.
The NPRM also attempts to strengthen the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm or danger to be avoided. Research that poses greater risk to subjects should receive more oversight and deliberation than less risky research. The NPRM seeks to avoid requirements that do not enhance protection and impose burden, which can decrease efficiency, waste resources, erode trust, and obscure the true ethical challenges that require careful deliberation and stakeholder input. Cumbersome and outdated regulatory standards overwhelm and distract institutions, IRBs, and investigators in ways that stymie efforts to appropriately address the real risks and benefits of research.
The result of these types of changes, as the NPRM proposes to implement them, is that some studies that currently require IRB review would now become exempt. Some that are currently exempt would specifically be declared as outside the scope of the regulations (“excluded”), and thus would not require any administrative or IRB review. Further, in terms of determining when a study is exempt, a web-based “decision tool” will be created. That decision tool will provide a determination of whether or not a study is exempt. That result, so long as the tool was provided with accurate information, will be presumed by the Common Rule agencies to be an appropriate determination of exempt status. Thus, it is expected that in many instances the tool would be used by the investigators themselves, thus obviating both the need for further review and the concern that the institution might be subjecting itself to future liability by allowing investigators to use the tool. For all of the excluded and exempt research activities, this NPRM also affirms the importance of applying the ethical principle of respect for persons, in addition to the importance of abiding by this principle in fully regulated non-exempt research involving human subjects.
The following list encompasses the most significant changes to the Common Rule proposed in the NPRM:
(1) Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.
(2) Generally require informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. That consent would generally be obtained by means of broad consent (
(3) Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.
(4) Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review. Certain exempt and all non-exempt research would be required to provide privacy safeguards for biospecimens and identifiable private information. New categories include:
a. certain research involving benign interventions with adult subjects;
b. research involving educational tests, surveys, interviews or observations of public behavior when sensitive information may be collected, provided that data security and information privacy protections policies are followed;
c. secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given;
d. storing or maintaining biospecimens and identifiable private information for future, unspecified secondary research studies, or conducting such studies, when a broad consent template to be promulgated by the Secretary of HHS is used, information and biospecimen privacy safeguards are followed, and limited IRB approval of the consent process used is obtained.
(5) Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances.
(6) Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions. To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance-holding institution (“unaffiliated IRBs”), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance with the Common Rule.
(7) Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.
(8) Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.
In sum, the proposed modifications described above are designed to continue to uphold the ethical principles upon which the Common Rule is based, as applied to the current social, cultural, and technological environment.
The legal authority for the departments and agencies that are signatories to this action is as follows:
Department of Homeland Security, 5 U.S.C. 301; Public Law 107–296, sec. 102, 306(c); Public Law 108–458, sec. 8306. Department of Agriculture, 5 U.S.C. 301. Department of Energy, 5 U.S.C. 301; 42 U.S.C. 7254. National Aeronautics and Space Administration, 5 U.S.C. 301. Department of Commerce, 5 U.S.C. 301. Social Security Administration, 5 U.S.C. 301; 42 U.S.C. 289(a). Agency for International Development, 5 U.S.C. 301. Department of Justice, 5 U.S.C. 301; 28 U.S.C. 509–510. Department of Labor, 5 U.S.C. 301; 29 U.S.C. 551. Department of Defense, 5 U.S.C. 301. Department of Education, 5 U.S.C. 301; 20 U.S.C. 1221e–3, 3474. Department of Veterans Affairs, 5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334. Environmental Protection Agency, 5 U.S.C. 301. Department of Health and Human Services, 5 U.S.C. 301; 42 U.S.C. 289. National Science Foundation, 5 U.S.C. 301. Department of Transportation, 5 U.S.C. 301.
Table 1 summarizes the quantified and non-quantified benefits and costs of all proposed changes to the Common Rule. Over the 2016–2025 period, present value benefits of $2,629 million and annualized benefits of $308 million are estimated using a 3 percent discount rate; present value benefits of $2,047 million and annualized benefits of $291 million are estimated using a 7 percent discount rate. Present value costs of $13,342 million and annualized costs of $1,564 million are estimated using a 3 percent discount rate; present value costs of $9,605 million and annualized costs of $1,367 million are estimated using a 7 percent discount rate. Non-quantified benefits include improved human subjects protections in clinical trials and biospecimen research not currently subject to oversight; enhanced oversight of research reviewed by unaffiliated IRBs; increased uniformity in regulatory requirements among Common Rule agencies; standardization of human subjects protections when variation among review IRBs is not warranted; revised informed consent forms and processes; improved protection of biospecimens and individually identifiable private information; and increased transparency of Common Rule agency-supported clinical trials to inform the development of new consent forms. Non-quantified costs include the time needed for consultation among Common Rule agencies before federal guidance is issued; and the time needed by investigators to obtain, document, and track the permissible uses of biospecimens and identifiable private information for secondary research use.
In the last two decades there has been a paradigm shift in how research is conducted. Evolving technologies, including imaging, mobile technologies, and the growth in computing power have changed the scale of information collected in many disciplines. Computer scientists, engineers, and social scientists are developing techniques to integrate different types of data so they can be combined, mined, analyzed, and shared. Research has also increased, evolved, and diversified in other areas, such as national security, crime and crime prevention, economics, education, and the environment, using a wide array of methodologies in the social sciences and multidisciplinary fields. The advent of sophisticated computer software programs, the internet, and mobile technology has created new areas of research activity, particularly within the social and behavioral sciences. In biomedical science, the Human Genome Project laid the foundation for precision medicine and promoted an environment of data sharing and innovation in analytics and technology, and drew attention to the need for policies that support a changing research landscape. New technologies, including genomic sequencing, have quickly led to exponential growth in the data to which investigators have access. The sheer volume of data that can be generated in research, the ease with which it can be shared, and the ways in which it can be used to identify individuals were simply not possible, or even imaginable, when the Common Rule was first adopted.
Research settings are also shifting. While much biomedical research continues to be conducted in academic medical centers, more research is being conducted in clinical care settings, thus combining research and medical data. Biospecimen repositories and large databases have made it easier to do research on existing biospecimens and data. Clinical research networks connected through electronic health records (EHRs) have developed methods for extracting clinical data for research purposes and are working toward integration of research data into EHRs in a meaningful way. The overall volume of research has increased across the board, with growing reliance on research networks and multi-site studies. Large cohort studies number well into the hundreds in the United States alone and many collect biospecimens and data on the same people over many years. Recent trends clearly show that the scientific community recognizes the value of data sharing and open-source resources and understands that pooling intellectual resources and capitalizing on efficient uses of data and technology represent the best ways to advance knowledge.
At the same time, the level of public engagement in the research enterprise has changed; more people want to play an active role in research, particularly related to health, and they have different expectations than when the Common Rule was first established. A more participatory research model is emerging in social, behavioral, and biomedical research, one in which potential research subjects and communities express their views about the value and acceptability of research studies. This participatory model has emerged alongside a broader trend in American society, facilitated by the widespread use of social media, in which Americans are increasingly sharing identifiable personal information and expect to be involved in decisions about how to further share the personal information, including health-related information that they have voluntarily chosen to provide. In many ways, these changes are extensions of the fact that over the past half-century, rather than being passive recipients of health advice and treatment, patients have gradually become more active in decisions about their health and health care. The shift from a paternalistic research environment to one where participants are active partners in biomedical and behavioral research is a critical development in human subjects research.
As technology evolves, so does the nature of the risks and benefits of participating in certain types of research. Many studies do not involve interaction with research subjects, but instead involve, for example, analyzing information obtained from medical records, administrative claims data, education records, criminal justice records, research data shared through data repositories, and existing biospecimens stored in repositories. Risks related to these types of research studies are largely informational, not physical; that is, harms could result primarily from the inappropriate release of information and not from the research interventions themselves. Nonetheless, those harms can be significant.
New methods, more powerful computers, and easy access to large administrative datasets produced by local, state, and federal governments have meant that some types of data that formerly were treated as non-identified can now be re-identified through combining large amounts of information from multiple sources. In 2013, scientists demonstrated that the identity of individual research subjects could be ascertained by collating and analyzing certain types of genomic data, including genomic data from publicly available information sources.
Because of these shifts in science, technology, and public engagement expectations, a wide range of stakeholders have raised concerns about the limitations of the existing framework, arguing for a re-evaluation of how the fundamental principles that underlie the Common Rule —respect for persons, beneficence, and justice—are applied in practice to the myriad new contexts in which U.S. research is conducted in the 21st century.
• Is sufficiently supportive of a participant-centered research model that adequately respects participants as partners;
• is not sufficiently risk-based, resulting in both over- and under-regulation of research activities;
• is sufficiently tailored to new and emerging areas of research, including social and behavioral research and research involving the collection and use of genetic information;
• effectively informs subjects of psychological, informational, or privacy risks;
• adequately accounts for the needs of a “learning” healthcare system for continual quality improvement;
• provides sufficient mechanisms to ensure the consistency, quality, and accountability of IRB decision-making.
The revisions to the Common Rule proposed here are based upon a variety of sources of public, stakeholder, and expert comments and advice. First, the NPRM more thoroughly addresses social science and behavioral research perspectives, benefiting from guidance provided by a National Research Council's consensus report entitled “Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences.”
Second, since the publication of the ANPRM, HHS has continued to solicit public comment on a variety of human subjects related issues, including consent, the use of a single IRB for multi-site studies, and sharing of genomic data. Although these policies were more specific than the issues raised in the ANPRM, the responses received from public comments provide insight for refining the proposals initially put forward in the ANPRM. Of particular interest:
• NIH's proposal that it expects the use of a single IRB for all multi-site research studies funded or conducted by the NIH.
• OHRP's draft guidance discussing the required content of consent language for research done within the standard of care.
• To enhance human subject protections and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the agencies' regulatory requirements and guidance for human subject research, and the FDA's draft guidance, “Use of Electronic Informed Consent in Clinical Investigations” was developed as part of these efforts. The draft guidance was issued in conjunction with an OHRP
• NIH's proposal to promote sharing of large-scale human genomic data generated from studies funded or conducted by NIH.
There have also been developments on the legislative front that have informed the discussions leading up to this NPRM. In December of 2014, the Newborn Screening Saves Lives Reauthorization Act of 2014 (Pub. L. 113–240), was signed into law. The new law makes a number of changes relevant to the HHS regulations for protecting research subjects, including declaring that research with newborn dried blood spots that is federally funded pursuant to the Public Health Service Act is to be considered research with human subjects, and the provisions allowing IRBs to waive consent will not apply. These changes will be effective until updates to the Common Rule are promulgated. In addition, in April of 2015, the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114–10) was passed. That law requires HHS to issue a clarification or modification of the Common Rule with regard to how they apply to activities involving clinical data registries.
Most recently, with the launch of the President's Precision Medicine Initiative (PMI),
In 1979, the Belmont Report
A distinct aspect of the principle of beneficence concerns the benefits and risks to the specific persons who would be participating in a particular research study. In the example of a randomized clinical trial comparing two treatments for a disease, the benefits and risks to the subjects in the trial are distinct from the possible benefits to society as a whole from learning which of the two treatments is better. This aspect of beneficence assumes that there are limits on the risks to which people should be subject, even if they are willing to undergo those risks.
Society is in an information age. In all facets of one's life information about that person is generated, stored, shared, analyzed, and often provides tremendous societal value. People share information about themselves with large numbers of people with the click of a button, and this trend of rapid and widespread sharing is only likely to grow. The increase in concern about unauthorized and inadvertent information disclosure, in combination with newer research techniques that increase the volume and nature of identifiable data suggest the need for the Common Rule to more explicitly address data security and privacy protection.
Of particular interest for this proposal is addressing risks from inappropriate disclosure of information generated from biospecimens. One way to protect subjects from such risks is to bring under oversight research for which risks are greater of subjects being identified and information being inappropriately disclosed. Although it may be difficult to identify individuals from their non-identified biospecimens at present, and most investigators would have no need to do so unless they were seeking additional associated phenotypic information, certain technologies and methods can be used to generate data that are unique to the individual who provides the biospecimen, and those data can sometimes be combined with other data sources to identify the individual. In the future, technologies will facilitate the use and analysis of greater variety and volumes of information, and there is a possibility that it will be increasingly difficult, if not impossible, to make biospecimens fully non-identified. In fact, a number of reports have already demonstrated the ability to re-identify individuals from biospecimens or data that lack direct identifiers.
Obtaining informed consent from human subjects for the collection and analysis of information about them is one means of implementation of respect for persons in the research context. Informed consent is designed to ensure that each individual approached to participate in a research study fully understands the risks and potential benefits of the study so that they have sufficient information to make an individualized calculation as to whether or not the tradeoffs inherent in participation are worth it for them to agree to participate. Both the potential harms and benefits tend to be greater in the context of a clinical trial where subjects are randomized to one or another of two possible treatments with significantly different suspected risks than in situations where subjects are simply asked to provide, for instance, a urine sample.
Notice, in which individuals are informed about how data will be used, but explicit consent is not obtained, is another means of facilitating transparency. Notice is sometimes used in the context of informing people about how data collected for non-research purposes (
Related, implicit consent might be obtained when a research subject completes a questionnaire. If they did not wish to provide the information, presumably they would not be answering the questions. The NPRM contains a number of provisions that are designed to further promote respect for participants through increases in both transparency and opportunities for consent.
The three ethical principles of the Belmont Report often cannot all be fulfilled at the same time. In many cases, it will be necessary to choose which of those principles will deserve the greatest adherence. This NPRM, at its heart, represents an attempt to evaluate the weights to be applied to each of these three core principles in a variety of specific contexts. Giving greater weight to one of the principles will frequently mean a decreased ability to fulfill one of the other principles. By necessity, value judgments, influenced by the social norms of the time, drive the implementation of the broad principles underlying the Belmont Report. The efficacy of the oversight system also requires proportionality in weighing the application of these three principles. This is reflected in the analysis that follows, in terms of evaluating the specific aspects of beneficence, respect for persons, and justice that relate to a particular issue, and weighing those aspects against one another. Research that poses greater risk should receive more attention and deliberation than less risky research, and the degree and type of oversight should be commensurate with the level of risk. In addition, requirements that do not enhance protection but that impose burden can increase inefficiency, waste resources, erode trust, and obscure the ethical challenges that require careful deliberation and stakeholder input. Cumbersome and outdated regulatory standards overwhelm and distract oversight bodies and other stakeholders from appropriately addressing the real risks and benefits of research.
There is tremendous support for research in this country. American society values advances in knowledge and has reaped the reward of many key insights that have led to increases in quality of life and a doubling of our life expectancy in the last century. There would not have been such strides in medical and behavioral research without the willingness of individuals to join research studies. Participants are told that they are not likely to benefit directly from any given study, yet they choose to participate for the greater good. Beneficence is a powerful driver. On the other hand, members of the public deserve, and indeed now expect, to know how publicly-funded research is being conducted and overseen, and need to have confidence that the interests of research participants are adequately protected. Transparency is key for developing trust, especially between investigators, funders, regulators, and the public.
Our reassessment of these ethical principles in the context of current technology and social norms suggests the need for changes to the Common Rule that: (1) Increase subject autonomy by increasing human subjects' ability and opportunity to make informed decisions; (2) reduce potential for harm and increase justice by increasing the uniformity of human subject protections in areas such as information disclosure risk, coverage of clinical trials, and coverage of IRBs; and (3) increase beneficence by facilitating current and evolving types of research that offer promising approaches to treating and preventing medical and societal problems though reduced ambiguity in interpretation of the regulations, increased efficiencies in the performance of the review system, and reduced burdens on researchers that do not appear to provide commensurate protections to human subjects. If a reasonable balance is struck between protecting human research subjects, minimizing the administrative burden of the system, and engendering public trust, this should maximize beneficence and raise all ships.
Public comment is sought not only on the provisions outlined below, but on whether the proposals strike a reasonable balance among the core
Finally, it is important to note that, to the extent appropriate, the intent is to eventually amend the other subparts of the HHS human subjects protection regulations in 45 CFR part 46 (subparts B, C, D, and E), and consider the need for updates to FDA regulations and other relevant Federal departmental or agency regulations with overlapping scope.
1. Public comment is sought on whether the proposed changes will achieve the objectives of (i) decreasing administrative burden, delay and ambiguity for investigators, institutions, and IRBs, and (ii) strengthening, modernizing, and making the regulations more effective in protecting research subjects.
Section II of the NPRM, which immediately follows, describes in detail the major proposals for revisions to the Common Rule. In general, the changes that are likely to be of greatest significance are discussed in the earlier parts of section II of this preamble. Section II.A is devoted to changes that affect which activities are subject to the Common Rule. Following that section are discussions devoted to changes relating to informed consent (section II.B), changes relating to privacy safeguards for the research use of information and biospecimens (section II.C), and a proposal to encourage greater harmonization of guidance across the agencies that adhere to the Common Rule (section II.D). Discussions of changes relating to how IRBs operate, including a proposal to reduce the number of reviews by different IRBs that take place for multi-site studies, are in the several sections that follow (sections II.E, F and G). The final section (section II.H) collects a variety of other changes, including expanding the scope of the rule to cover clinical trials that are not federally funded but are conducted at institutions that received some federal funding for research with human subjects.
The three sections that follow then discuss various administrative review requirements: Regulatory Impact Analyses (section III), Environmental Impact (section IV), and Paperwork Reduction Act (section V). The final section of the document (section VII) provides the full regulatory text of the proposed changes to the Common Rule. Section VI provides a comprehensive summary of responses received to the 2011 Common Rule ANPRM.
This section focuses on the ethical principles associated with the secondary research use of biospecimens. These biospecimens may have been originally collected from either research or non-research settings (
One of the goals of this NPRM is facilitating cutting edge research in genomics and other `omics' such as the transcriptome and the microbiome, which generate a wealth of data from biospecimens designed to inform the development of treatments and preventative measures for chronic diseases such as cancer. Facilitating such research, however, requires navigating complex ethical issues. The key question is, under what circumstances should the Common Rule govern what research investigators are able to do with biospecimens that have been collected for some other (
However, there is a growing recognition that many people want to have some degree of control over the circumstances in which an investigator can derive information about them, above and apart from their interest in whether or not that information might be inappropriately disclosed. More specifically, a growing body of literature shows that in general people prefer to have the opportunity to consent (or refuse to consent) to research involving their own biological materials.
In assigning weights to the principles of beneficence and respect for persons in the context of research with biospecimens, strong consideration was given to the fact that failure to acknowledge and give appropriate weight to this distinct autonomy interest in research using biospecimens could, in the end, diminish public support for such research, and ultimately jeopardize our ability to be able to conduct the appropriate amount of future research with biospecimens. To that end, the proposals given below are designed to meet the goals of increasing transparency in when and how biospecimens collected in a variety of circumstances will be used for research purposes and increasing opportunities for consent. Various ways in which these goals might be achieved are the subject of alternative proposals discussed below.
The application of the current regulations to secondary research use of a biospecimen is tied to the identifiability of the biospecimen in the hands of the researcher. In particular, the definition of human subject in the current Common Rule at § __.102(f) states that a human subject is a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. Private information is described as information that is individually identifiable (
Consistent with historical interpretation of identifiable private information under the Common Rule, the terms “non-identified” or “non-identifiable” are used throughout this
Thus, where there is no intervention or interaction with an individual, central to determining whether human subjects are involved in a research activity covered by the current Common Rule is determining the meaning of “identifiable.” Under the current Rule, provided the biospecimens and data were collected for purposes other than the currently proposed research, it is permissible for investigators to conduct research on biospecimens and data that have been stripped of all identifiers without obtaining consent because the non-identified biospecimens and data do not meet the regulatory definition of human subject.
It is, however, worth noting that although informed consent is not strictly required by the current regulations when research takes place using non-identified biospecimens, some IRBs have indicated that they are requiring that investigators explicitly obtain consent for future analysis of biospecimens collected in the research setting, and some are refusing to waive consent for use of biospecimens collected in non-research contexts.
The ANPRM asked whether consent should be required before an investigator could conduct research on a non-identified biospecimen. It further asked, if consent were to be required, could such consent be obtained by having a person provide consent for unspecified future research with the biospecimen, instead of requiring that specific consent be obtained each time that the biospecimen would actually be used in a research study.
Although HHS does not consider whole genome analysis to produce identifiable private information unless additional information is available to the investigator that would enable the investigator to “readily ascertain” the identity of the individual, it is acknowledged that a time when investigators will be able readily ascertain the identity of individuals from their genetic information may not be far away. The ANPRM suggested that, regardless of what information is removed, it is theoretically possible to extract DNA from a biospecimen itself and potentially link it to otherwise available data to identify individuals. In addition, irrespective of whether biospecimens are considered individually identifiable, the ANPRM sought comment on whether the regulations should be changed to allow human subjects to decide whether their biospecimens would be available for research.
The ANPRM asked whether some types of genomic data should be considered identifiable and, if so, which types (
The ANPRM also suggested that the definition of identifiability in the Common Rule be modified to better harmonize it with other regulatory definitions of identifiability within HHS. The ANPRM considered adopting the HIPAA Privacy Rule's standards of what constitutes individually identifiable information, a limited data set, and de-identified information (as defined under HIPAA), in order to address inconsistencies regarding these definitions and concepts between the HIPAA Privacy Rule and the Common Rule.
More specifically, as described above, private information is not considered to be identifiable under the current Rule if the identity of the subject is not or may not be “readily ascertained” by the investigator from the information or associated with the information. In contrast, under the HIPAA Privacy Rule, health information is de-identified and thus exempt from that rule only if it neither identifies nor provides a reasonable basis to believe that the information can be used to identify an individual. The HIPAA Privacy Rule provides two ways to de-identify information: (1) A formal determination by a qualified expert that the risk is very small that an individual could be identified; or (2) the removal of all 18 specified identifiers of the individual and of the individual's relatives, household members, and employers, as long as the covered entity has no actual knowledge that the remaining information could be used to identify the individual (45 CFR 164.514(b)).
The HIPAA Privacy Rule addresses some informational risks by imposing restrictions on how individually identifiable health information collected by health plans, health care clearinghouses, and most health care providers (“covered entities”) may be used and disclosed, including for research. In addition, the HIPAA Security Rule (45 CFR parts 160 and, subparts A and C of part 164) requires that these entities implement certain administrative, physical, and technical safeguards to protect this information, when in electronic form, from unauthorized use or disclosure. However, the HIPAA Rules apply only to covered entities (and in certain situations to their business associates), and thus not all investigators are part of a covered entity and required to comply with those rules. Moreover, the HIPAA Rules do not apply specifically to biospecimens in and of themselves.
Public comments in response to the 2011 ANPRM regarding covering all biospecimens raised a series of important concerns. A majority of the commenters opposed the ANPRM's suggested requirement of consent for research use of all biospecimens, regardless of identifiability, particularly if applied to samples collected before the effective date of the regulation. Some commenters cited lack of convincing evidence of harm caused by research use of non-identified clinical biospecimens without consent; they noted that they were not convinced that the principle of autonomy outweighs or trumps the principle of beneficence. They expressed concern that doing so would significantly slow advances in research and human health.
Others acknowledged the erosion of public trust that can result from high-profile disputes involving the use of non-identified biospecimens collected during research.
Some patient advocacy organizations also expressed concerns about the consequences of requiring consent for the use of non-identified biospecimens. Other commenters noted that the recommendation to require consent might inappropriately give greater weight to the Belmont Report's principle of autonomy over the principle of justice, because requiring consent could result in lower participation rates in research by
Many commenters expressed the opinion that the existing regulatory framework is adequate and that current practices should be maintained, stressing that the research use of non-identified data or biospecimens does not involve risk to the research participant. Furthermore, several commenters noted that, although it is theoretically plausible to identify a person based on their biospecimen, the likelihood remains remote enough to argue against the presumption that the sources of all biospecimens are identifiable and cited a study showing that the risk of re-identification from a system intrusion of databases was only 0.22%.
Several commenters stated that if the Common Rule were modified such that all biospecimens were covered under the rule regardless of identifiability there still might be some activities involving biospecimens that should be considered exempt or excluded from coverage. Suggestions included:
With respect to the 2011 proposal to adopt the HIPAA Privacy Rule's definition of identifiability, a majority of the public commenters strongly opposed the idea. They indicated that the HIPAA Privacy Rule's standard of identifiability would expand what is considered identifiable for purposes of the Common Rule and thus greatly impede relatively low-risk research without adding meaningful protections for human subjects. In particular, they asserted that the HIPAA standards were created to protect against disclosure of health information contained in medical records. As such, commenters argued, they are not appropriate for many types of research that would be covered by the Common Rule (
Regardless of the scale on which harms may have occurred in the past, continuing to allow secondary research with biospecimens collected without consent for research places the publicly-funded research enterprise in an increasingly untenable position because it is not consistent with the majority of the public's wishes, which reflect legitimate autonomy interests. As such, one of the most fundamental changes proposed in this NPRM is to the definition of human subject (proposed § __.102(e)). The proposal is for the obtaining, use, study, or analysis of biospecimens to be covered under the Common Rule, regardless of identifiability. Covering biospecimens regardless of identifiability avoids codifying any given interpretation of the quickly evolving debates regarding whether certain analytic results (
Thus, the focus of this proposal is to require informed consent for research involving biospecimens in all but a limited number of circumstances. The consent would not need to be obtained for
An increase in trust and partnership is likely to increase participation rates in research; using individuals' samples and data without permission will hinder true partnership. Better communication and community engagement with patients, particularly in geographic areas and for population subgroups where consent rates are lower than average, should be a priority for the research community.
In response to comments received about the 2011 ANPRM, the NPRM proposes to have the new definition of human subject apply prospectively, that is, it will only apply to research involving biospecimens that will be collected in the future. Additionally, in recognizing that this proposal will have major implications for the operational functioning of the research enterprise, compliance with this provision would be delayed until three years after publication of a final rule.
Also consistent with comments received on the ANPRM, it is proposed that a subset of secondary research on stored biospecimens would be allowed without consent. Specifically, research designed to only generate information about the person that is already known would be considered outside of the scope of the Common Rule. This exclusion would include but not be limited to the development and validation of certain tests and assays (such as research to develop a diagnostic test for a condition using specimens from individuals known to have the condition and those known not to have the condition), quality assurance and control activities, and proficiency testing. This provision would be implemented through a new exclusion from the regulations at § __.101(b)(3)(i), which has specifically been designed to reflect the underlying ethical principles.
If the research is designed not to generate any new information about the
In addition, the proposal permits IRBs to waive the requirement for informed consent, but the requirements for approval of such waivers would be very strict, and such waivers will only occur in rare circumstances. Note also that the exclusions proposed in § ;____.101(b)(1)(i), (iii)–(vi) would also allow for the use of biospecimens without consent in certain limited circumstances; these additional exclusions are discussed in section II.A.2 of this preamble, below.
This proposal would not modify the Common Rule standard of identifiability (in contrast to what was discussed in the 2011 ANPRM). That is, the standard for determining when an investigator has sufficient information to readily ascertain the identity of an individual is not being changed under this proposal. Thus, coverage of information derived from biospecimens (whether or not the biospecimen was initially collected in the research or non-research context), or indeed any other type of information, would be the same under this proposal as is the case under the current Common Rule.
In this section, we discuss two alternative proposals, both of which maintain “identifiability” as the lynchpin for determining applicability of the Common Rule to biospecimens. These models increase transparency and opportunities for consent over and above what is provided for in the current Common Rule, but in a smaller set of circumstances than provided for under the primary proposal discussed above.
Rather than consider all research using biospecimens as constituting human subjects research, this alternative proposal would expand the definition of human subjects to include only specifically whole genome sequencing data, or any part of the data generated as a consequence of whole genome sequencing, regardless of the individual identifiability of biospecimens used to generate such data. Under this alternative, whole genome sequencing would be considered the sequencing of a human germline or somatic biospecimen with the intent to generate the genome or exome sequence of that biospecimen.
Thus, under this alternative, the regulations would then apply both to research that would generate whole genome sequencing data, the use of any part of the generated data, and to research involving secondary use of any part of whole genome sequencing data that was originally generated for other purposes than the proposed research. Investigators conducting whole genome sequencing research could not avoid the need to comply with the Common Rule by removing identifiers from biospecimens or data, because whole genome sequence data in and of itself would meet the definition of human subject. Under this alternative, a new exemption would also be created that would allow such research to be considered exempt if consent to secondary future research use were obtained in accordance with proposed new requirements at § __.116(c) and standards were met for protecting information and biospecimens as proposed at § __.105. A waiver of consent would be permitted, but would be modeled on the more stringent waiver criteria proposed for research involving biospecimens at § __.116(f)(2).
Explicit consent to conduct research using whole genome sequencing data can be considered ethically important because such data can provide important insights into the health of individuals as well as their relatives. Moreover, whole genome sequence data gathered for one purpose may reveal important information, perhaps unanticipated and unplanned for, years later. Finally, whole genome sequence data are unique for each individual, or at the very least, highly unlikely to be the same as any other individual. Thus, the current allowable practice of removing identifiers from biospecimens and data to conduct whole genome sequencing research without consent might not sufficiently protect both the privacy and autonomy interests of the subject.
As is currently the case, under this alternative, investigators' use of individually identifiable biospecimens, collected for purposes other than the currently proposed research study, would continue to be considered human subjects research. However, the secondary research use of non-identified information or non-identified biospecimens would continue to fall outside of the scope of the Common Rule, with the exception of whole genome sequence data as described above.
One of the less obvious differences in scope between the primary proposal and this Alternative A relates to what research could be done with the data generated from whole genome sequencing that had taken place for clinical purposes. Under the primary proposal, the data produced by such sequencing could continue to be used for research, without additional consent, so long as it did not meet the definition of being identifiable private information. (HHS does not currently consider whole genome sequencing data to meet that definition for purposes of the Common Rule.) Under this Alternative A, consent would be required before using that data for research purposes.
In contrast with the primary proposal in this NPRM, this Alternative Proposal A could be viewed as giving greater weight to the principle of beneficence, while giving less weight to the principle of respecting the autonomy of persons. It would require consent only for the type of studies that many people seem most concerned about (genomic research, including secondary use of genomic information that was produced for clinical purposes). And given that at the moment there is relatively little whole genome sequencing research taking place (in comparison to other types of biospecimen research; see section III.F of this preamble for more information), it would appear to currently impose a somewhat lesser burden in terms of obtaining and tracking consent than the main NPRM proposal.
The major concern with this alternative proposal is that it would codify only a single technology as producing information that would be subject to the Common Rule, necessitating a re-evaluation of the scope of the Rule when technologies now in development to study, for instance, other “omics,” become more widespread.
This Alternative Proposal B would expand the definition of human subjects to include the research use of information that was produced using a
There are three separate conditions that would all need to be met before information would constitute bio-unique information: (1) It would have to have been produced by applying to a biospecimen a technology that is capable of producing information that is unique to an individual; (2) The technology would have to be used to produce enough information such that the information produced is likely to be unique to an individual; and (3) There would need to be publicly available information that, when combined with the information produced by the use of the technology, would create the possibility that some of the individuals whose biospecimens were analyzed using the technologies could be identified.
The major concern with this alternative proposal is that, in order to make such a requirement responsive to scientific and technological developments, HHS would have to continually evaluate new technologies and the nature and amount of information produced using such technologies. Not only would this involve resources and expertise that may not be available to Federal departments and agencies, it would introduce ongoing uncertainty that may actually increase delays in important research.
• It is anticipated that the compliance date for the proposed expansion of the definition would be three years after the publication date. The main consequence of this change would be that informed consent (which could be broad, as described in sections II.A.3.d and II.B of this preamble) would generally be required before research use of biospecimens not covered by an exclusion.
• All biospecimens used for research purposes that do not fall under an exclusion (see proposed § __.101(b)(3)(i), and also § __.101(b)(1)(i), (iii)–(vi)) and are collected after the compliance date would be subject to the requirements of this rule, regardless of identifiability.
2. Would providing a definition of biospecimen be helpful in implementing this provision? If so, how might the definition draw a line between when a biospecimen is covered by the Common Rule, and when processing of biological materials (
3. To what extent do the issues raised in this discussion suggest the need to be clearer and more direct about the definition of identifiable private information? How useful and appropriate is the current modifier “may be readily ascertained” in the context of modern genomic technology, widespread data sharing, and high speed computing? One alternative is to replace the term “identifiable private information” with the term used across the Federal Government: Personally identifiable information (PII). The Office of Management and Budget's
4. Which of the three proposals regarding the definition of human subject achieves the most reasonable tradeoff between the principles of autonomy (including transparency and level of trust) versus beneficence (as measured by facilitating valuable research)?
5. Public comment is sought regarding any concerns that you have about each of the three proposals, including concerns about implementation or burden to investigators and institutions.
The NPRM creates a new section in the regulations referred to as “exclusions.” This section outlines eleven specific types of activities that will be outside the scope of the regulations. These activities will therefore not have to satisfy any regulatory requirements, nor is it expected (unlike exempt research) that they will undergo any type of review process to determine this status. The exclusions will eliminate uncertainty regarding some activities that are not research, and identify some activities that arguably might be judged to be research, but whose contribution to public welfare is so imperative that they should proceed without having to satisfy the regulatory requirements. The exclusions also identify certain research activities that are sufficiently low-risk and nonintrusive that the protections provided by the regulations are an unnecessary use of time and resources, whereas the potential benefits of the research are substantial.
The Common Rule has been criticized for not being clear about how to interpret what activities are covered by the policy and for inappropriately being applied to and inhibiting certain activities. The first six exclusion categories are for activities that are deemed not to be research for the purposes of this policy, without needing to consider whether the regulatory definition applies. The definition of research does not provide such a clear and precise way of distinguishing among similar activities that it is immediately obvious which activities fall under the definition and which do not. By creating exclusion categories that are deemed not research, these activities are more clearly distinguished as not having to satisfy the regulatory requirements.
Three of the exclusions seek to eliminate any uncertainty about whether certain internal program improvement activities, historical or journalistic inquiries, or quality assurance or improvement activities satisfy the definition of research. The other three exclusions include some
The next four categories of proposed exclusions are for activities that are considered low-risk either in themselves or because there are appropriate safeguards already in place independent of the Common Rule. Here the level of risk, the potential benefits, and the nature of human participation in this research are such that the principle of beneficence determines that the research activities may go forward without the need to impose the protections of the Common Rule.
The last exclusion applies to research involving the secondary use of non-identified biospecimens when the research is limited to generating information about the subject that is already known. As such, this research does not need any additional protections provided by these regulations and the potential benefits of this research justify it under the principle of beneficence. Because this exclusion directly relates to the proposed changes in the definition of “human subject” to include all biospecimens, it is discussed above in section II.A.1 of this preamble.
It should be noted that the fact that the NPRM now specifically includes a list of certain excluded activities should not be seen as altering the fact that many other activities that do not meet the criteria for being subject to the Common Rule remain outside the scope of the rule. For example, an activity that does not meet the regulatory definition of research, or does not involve human subjects, would still not be subject to these regulations.
Currently, the Common Rule excludes from coverage (1) activities that do not meet the definition of research (§ __.102(d) of the current Rule); (2) activities that are not described as research subject to regulation (§ __.102(e) of the current Rule); and (3) activities that do not involve a human subject (§ __.102(f) of the current Rule).
The ANPRM asked questions about the definition of research and whether various activities should be excluded from the Common Rule, either by changing the definition of research or by adding exemptions, or both. The ANPRM sought comment on whether and, if so, how, the Common Rule should be changed to clarify whether quality improvement activities, program evaluation studies, or public health activities are covered. It also asked whether there are specific types of studies for which the existing rules are inappropriate. If so, comments were sought on whether this problem should be addressed through modifications to the exemption categories, or by changing the definition of “research” used in the Common Rule to exclude some of these studies, or a combination of both.
If the definition of research were to be changed, public comment was sought on how excluded activities should be defined (
The first set of six exclusions involve activities that will be excluded from the regulations because they will be deemed to not involve research. Three of the first six exclusions (discussed in sections II.A.1.a.i, ii, and iv, below) provide clarity regarding the applicability of the Common Rule to activities about which institutions have raised questions in the past as to whether these activities meet the regulatory definition of research. These exclusions aim to reduce the time and effort involved trying to determine whether the regulations apply, and in unnecessary reviews of these activities.
The other three of these exclusions (discussed in sections II.A.1.iii, v, and vi below) apply to activities that are largely inherently government functions that have purposes other than research, and, when conducted by a government employee or contractor, are subject to a variety of other statutes, regulations, and polices that are designed to protect individual privacy and data security, as well as provide notice to those providing the information as to the uses to which the information will be put (see, for example, the Privacy Act of 1974). These activities promote recognized specific goods that are crucial to the public welfare, and because of this they should be carried out without any hindrances that satisfying the Common Rule regulatory requirements might impose. For these activities, the principle of beneficence outweighs any intrusions on individual autonomy that the regulations might have prevented, and this allows these important activities to proceed without delay.
The ANPRM asked whether various activities such as quality improvement, public health activities, or program evaluations studies should be excluded from the rule.
The first exclusion, proposed in the NPRM at § __.101(b)(1)(i), is for data collection and analysis, including the use of biospecimens, for an institution's own internal operational monitoring and program improvement purposes, if the data collection and analysis is limited to the use of data or biospecimens originally collected for any purpose other than the currently proposed activity, or is obtained through oral or written communications with individuals (
An example of an activity that would satisfy this exclusion is a survey of hospital patients to evaluate and improve the quality of meals delivered to hospital patients. An example of an activity that would not satisfy this exclusion is a prospective observational
6. Public comment is sought for whether this excluded activity should simply be discussed in the text of the final rule's preamble, and guidance produced to assist investigators in making such a determination, or whether any other similar exclusions should be addressed.
7. Public comment is sought for whether biospecimens should not be included in any of these exclusion categories, and if so, which ones.
The ANPRM asked whether there were any fields of study (such as classics, history, languages, literature, and journalism) whose usual methods of inquiry were not intended to or should not be covered by the Common Rule.
The second proposed exclusion, in the NPRM at § __.101(b)(1)(ii) is for oral history, journalism, biography and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.
The overwhelming majority of public comments to the 2011 ANPRM responding to the question about excluding specific fields of study from the regulatory requirements of the Common Rule supported explicitly excluding certain activities from the definition of research versus modifying the exemption categories. The overwhelming majority of these comments focused on oral history. Some of the comments were virtually identical and appear to have been coordinated. Many of the comments reflected the view that the Common Rule was not designed or intended to include oral history activities, and that the ethical codes pertaining to oral history procedures are not consistent with the application of the ethical principles reflected in the Common Rule.
A smaller number of similar comments were submitted with respect to various humanities disciplines and journalism. A significant minority of commenters opposed the exclusion of any fields of study, arguing that the activity itself rather than the academic discipline or training of the investigator should be the basis for the assessment of whether the activity should be excluded. Some of the commenters recommended that the definition of research be focused more explicitly by being limited to “biomedical and behavioral research,” in accordance with the statutory provision underlying the Common Rule. A significant number of commenters recommended that guidance should be issued to clarify how the definition of research should be applied, with cases and explanations.
While the NPRM does not propose to modify the definition of “research”, it does propose to explicitly exclude oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information or biospecimens is collected. In the kinds of activities referred to here, the ethical requirement is to provide an accurate and evidence-based portrayal of the individuals involved, and not to protect them from public scrutiny. Therefore, the protections afforded to individuals by the Common Rule seem unhelpful in furthering the aforementioned ethical goal in this context. Additionally, these fields of research have their own codes of ethics, according to which, for example, consent is obtained for oral histories. It is believed that because of these reasons, explicit exclusion of these activities from the scope of the Common Rule is appropriate.
The third category of activities that the NPRM excludes from the proposed rule encompasses data collection and analysis that enables the uniform delivery of criminal justice. The scope of this exclusion is collection and analysis of data, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. The activities excluded are necessary for the operation and implementation of the criminal justice system.
The provision would essentially codify current Federal interpretation that such activities are not deemed to be research under the Common Rule. The addition of this provision is designed to avoid the imposition of disparate requirements by IRBs with overlapping jurisdiction when a data collection or analysis activity encompasses the development of methods required by law or court order for criminal justice or criminal investigative purposes. For example, the Federal Bureau of Investigation (FBI) is charged by law with setting standards governing the collection and processing of DNA biospecimens and information taken (forcibly if necessary) from certain federal and state criminal offenders incident to their arrest or conviction for prescribed offenses under the National DNA Identification Act of 1994 and other acts. Similarly, the FBI is charged by law with setting standards governing the collection and processing of fingerprints and related biographical information taken from federal and state criminal offenders and certain sensitive civil employment applicants. At the same time, through its Laboratory Division and other components the FBI routinely collects human biospecimens at crime scenes from or relating to victims and offenders both known and unknown. Incident to these activities, the FBI is also charged with maintaining, and authenticating through identification processes, the criminal record history information of criminal offenders for the Federal Government and for the overwhelming majority of state governments who elect to participate and share information through those FBI systems.
The fourth category of excluded activities covers quality assurance or improvement activities involving the implementation of an accepted practice to improve the delivery or quality of care or services (including, but not limited to, education, training, and changing procedures related to care or services) if the purposes are limited to altering the utilization of the accepted practice and collecting data or biospecimens to evaluate the effects on the utilization of the practice. This exclusion does not cover the evaluation of an accepted practice itself.
As an example of an activity that would satisfy this exclusion, assume that there is an accepted practice that is known to reduce the likelihood of an infection after the insertion of a central line. A randomized study in which half the participating institutions would be assigned to have the staff undergo an educational intervention about the need to use that accepted practice, and the other half would not undergo that intervention, would satisfy this exclusion, since it would only be intended to see if the intervention resulted in greater use of the accepted practice. In contrast, imagine a different study that was designed to determine
Over the past several years, including in response to the 2011 ANPRM, OHRP has received comments from many individuals and organizations expressing concern that some readings of the definition of “research” would imply that the regulations apply to quality improvement activities, thereby potentially interfering with the ability of health care and other professionals to enhance the delivery or quality of care or services involving the use of accepted practices. Indeed, a majority of commenters to the 2011 ANPRM supported excluding quality improvement activities from the scope of the Common Rule. These quality improvement activities are in many instances conducted by health care and other organizations under clear legal authority to change internal operating procedures to increase safety or otherwise improve performance, often without the consent of staff or clients, followed by monitoring or evaluation of the effects. These activities are generally conducted in circumstances where independent privacy, confidentiality, and security safeguards are in place, minimizing the chances of harm. These efforts, some of which could be judged to be research, should be carried out because of the recognized public good they achieve. This exclusion is intended to avoid impeding such efforts where the Common Rule's requirements might have a chilling effect on the ability to learn from, and conduct, important types of innovation.
Recognizing that some quality improvement efforts should not be considered to involve research as it is defined in the Common Rule can allay many of these concerns. Thus, this exclusion is being proposed to deal with quality improvement activities that are aimed at implementing practices that are already accepted, with the goal of improving the
This provision also covers quality improvement activities that are not related to delivery of patient care, but rather involve the delivery or quality of other public benefit or social services. For example, institutions and other entities may provide social services, educational offerings, or other beneficial activities where there is empirical evidence of the value of those efforts, and they may wish to evaluate different ways of enhancing the delivery or quality of those existing services. This exclusion has been written broadly to include such activities.
The rationale for this excluded category is that these activities are designed only to improve the implementation of a practice that is already accepted, not to evaluate the effectiveness and value of the accepted practice itself, and thus would generally be expected to pose little if any risks to the recipients of those practices, and are directly aimed at improving the practical use of those practices. This does not include quality improvement activities designed with a research purpose relating to the safety and efficacy of the accepted practice. It is accordingly important to note that activities that
The fifth category of excluded activities involves public health surveillance activities, including the collection and testing of biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority and limited to those necessary to allow the public health authority to identify, monitor, assess, or investigate potential public health signals or the onset of a disease outbreak, including trends, or signals, and patterns in diseases, or sudden increase in injuries from using a consumer product, or conditions of public health importance, from data, and including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health, including natural or man-made disasters. A majority of commenters to the 2011 ANPRM supported excluding public health activities from the scope of the Common Rule.
The rationale for excluding some public health surveillance activities is that when a public health authority conducts public health surveillance activities to fulfill its legal mandate to protect and maintain the health and welfare of the populations it oversees, the regulatory protections of the Common Rule should not impede its ability to accomplish its mandated mission of promoting this recognized public good, in keeping with the principle of beneficence. Other protections independent of the Common Rule exist that serve to protect the rights and welfare of individuals participating in such activities, including privacy, confidentiality and security safeguards for the information collected.
Public health surveillance refers to the collection, analysis, and use of data to target public health prevention. It is the foundation of public health practice. Surveillance uses data from a variety of sources, including mandatory reporting of certain conditions, routine monitoring, vital records, medical billing records, and public health investigations in response to reports of potential outbreaks. The line between public health surveillance and epidemiological research can be difficult to draw, as the same techniques may be used in both. Generally, the difference between the activities is the purpose or context in which the investigation is being conducted and the role of the public health authority.
The following are examples of activities that meet the public health surveillance exclusion:
• Safety and injury surveillance activities designed to enable a public health authority to identify, monitor, assess, and investigate potential safety signals for a specific product or class of products (for example, the surveillance activities of the FDA's Adverse Event Reporting System (AERS), the Vaccine Adverse Event Reporting System (VAERS), Manufacturer and User Facility Device Experience (MAUDE) database, the Medical Product Safety Network (MedSun), and the Sentinel Initiative);
• Surveillance activities designed to enable a public health authority to identify unexpected changes in the
• Surveillance activities designed to enable a public health authority to identify the prevalence of known risk factors associated with a health problem in the context of a domestic or international public health emergency;
• Surveillance activities designed to enable a public health authority to locate the range and source of a disease outbreak or to identify cases of a disease outbreak;
• Surveillance activities designed to enable a public health authority to detect the onset of disease outbreaks or provide timely situational awareness during the course of an event or crisis that threatens the public health, such as a natural or man-made disaster.
On the other hand, subsequent research using information collected during a public health surveillance activity, for instance genetic analysis of biospecimens, would not fall under this exclusion, but would likely be covered under one or more of the other exclusions for low-risk research or exemptions.
Additional examples of activities that would not fall under the exclusion include: Exploratory studies designed to better understand risk factors, including genetic predisposition, for chronic diseases; exploratory studies designed elucidate the relationships between biomarkers of exposure and biomarkers of disease; exploratory studies of potential relationships between behavioral factors (
8. Public comment is requested on whether the parameters of the exclusions are sufficiently clear to provide the necessary operational guidance, or whether any additional criteria or parameters should be applied to clarify or narrow any of these exclusions.
The sixth category of excluded activities that will not be considered research involves surveys, interviews, surveillance activities and related analyses, or the collection and use of biospecimens where these activities are conducted by a defense, national security, or homeland security authority solely for authorized intelligence, homeland security, defense, or other national security purposes.
The rationale for excluding the defense or national security-related activities is similar to that described above regarding public health surveillance activities. The lawful conduct of the departments' and agencies' mandated missions for actively protecting national security, homeland security, and homeland defense are fundamentally not research. These activities may incorporate the collection and analysis of identifiable information, but they are not designed to develop or contribute to generalizable knowledge; rather, they are solely conducted to fulfill a department or agency's legal mandate to ensure the safety and protection of the United States, its people, and its national security interests. This exclusion codifies the current interpretation of the Common Rule. Research conducted or sponsored by Federal departments and agencies using this exclusion will continue to be subject to this regulation.
The NPRM proposes to exclude four categories of research activities that do not entail physical risk and are non-intrusive, either in themselves or because they are subject to policies that provide oversight independent of the Common Rule. Although the activities are research, they will not be required to receive any form of determination or IRB approval—including expedited review. Additionally, statements of purpose, benefit, and voluntariness as well as consent are not required unless the entity conducting the research, collecting data, or providing data is also subject to separate statutes and regulations requiring such statements. Some of the activities proposed for exclusion are categories that appear as exemptions in the current Rule. It is proposed that the marginal protections provided by the Common Rule are not consistent with the amount of researcher time and institutional resources that they currently draw.
By reclassifying certain research activities from being exempt to being excluded, the proposed rule would eliminate the need for any administrative or IRB review. All investigators performing excluded studies are expected to act in a way that is consistent with the principles outlined in the Belmont Report, even if the Common Rule does not impose requirements on excluded work. For instance, consistent with the spirit of respect for persons, investigators should tell prospective subjects the purpose of the information collection and, where appropriate, that they can choose to participate or not in these activities, although investigators are not explicitly required to do so.
Designating certain research fully outside of the bounds of the Common Rule means that investigators are self-determining whether their own research is covered by the law. As such, the proposal to add these categories is based on the assumption that all investigators will be accurately determining whether their proposed activity is outside the scope of the Common Rule. There is no current proposal outlining how decisions will be made for determining whether a research activity is eligible for exclusion and by whom or how differences among collaborators would be handled. As readers review each of the exclusion categories below, please consider whether the benefits associated with reducing the delay for researchers are countervailed by potential increases in risk of harm.
Throughout this NPRM, the term “low-risk” is used to denote research activities that do not entail physical risk, and where both the probability and magnitude of other risks, once required protections are applied, are hypothesized to be low. Public comment is sought on whether there are instances in the regulatory text where the term “low-risk” is used, but these conditions do not apply, and whether there is a better way to characterize this category of risk.
The ANPRM discussed criticisms of the current rule that it does not adequately calibrate the review process to the level of risk of the research, particularly in social and behavioral research. It also discussed whether answering questions should be sufficient indication of willingness to participate in survey or interview
The exclusion at § __.101(b)(2)(i) is for research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators, if at least one of the following is met:
• The information is recorded by the investigator in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; or
• Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
• The research will involve a collection of information subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
The exclusion does not include research activities in which any sort of intervention is used, in addition to the specified methods of information collection. Also, the term “survey” as used here refers to information collected about individuals via questionnaire or similar procedures (
This exclusion includes the research activities in current exemption category 2 in the (current Common Rule at § __.101(b)(2)), and some additional government information collection research activities using the same methods. As in the current exemption category 2, this proposed exclusion includes research studies whose methods consist of the use of educational tests, survey procedures or interview procedures, or observation of public behavior uninfluenced by the investigators, if the data are recorded anonymously, or the information is recorded with identifiers, but is not sensitive such that its disclosure could result in harm to the subjects. The exclusion provides a list of the specific harms that must be considered, which is the same as in the current exemption category, with the addition of the specific harm of being damaging to the subjects' educational advancement. This potential harm has been added because of the obvious relevance to the effects of the disclosure of responses in research involving educational tests.
This proposed exclusion does not include the first element in the current exemption category at § __.101(b)(3)(i), which is the element pertaining to research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior if the human subjects are elected or appointed public officials or candidates for public office. The rationale for this change in the proposed NPRM is that it does not seem appropriate to single out this category of subjects for different treatment in this way.
The third element of this proposed exclusion covers research activities using the same methods identified above even when the data are recorded with identifiers and the information recorded may be personally sensitive or private but not explicitly damaging to an individual, if the research is subject to specified federal statutes and regulations that require data security and subject privacy protections. Under this proposal, the preponderance of research conducted by Federal employees and contractors that collects information exclusively through educational tests, questionnaires, or observations of behavior would no longer be subject to the Common Rule because most such collections would be subject to the Paperwork Reduction Act of 1995, would be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, and all of the information collected, used, or generated as part of the research would be maintained in a system or systems of records subject to the Privacy Act of 1974. Furthermore, consistent with these laws, OMB's Standard 2.2 in its “Standards and Guidelines for Statistical Surveys”
Specifically, Standard 2.2 states that Federal agencies must ensure that each information collection instrument clearly states the reasons the information is planned to be collected; the way such information is planned to be used to further the proper performance of the functions of the agency; whether responses to the collection of information are voluntary or mandatory (citing authority); the nature and extent of confidentiality to be provided, if any (citing authority); an estimate of the average respondent burden together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden; the OMB control number; and a statement that an agency may not conduct and a person is not required to respond to an information collection request unless it displays a currently valid OMB control number. These policies are rooted in the Fair Information Practice Principles that cover the following concepts: Individual participation, transparency, authority, purpose specification and use limitation, minimization, access and amendment, redress, quality and integrity, security, training, integration, and accountability. It is proposed that the information risk protections afforded by these laws and their implementing regulations are generally stronger than the privacy protections that result from IRB review, and would result in affording more uniform protections to participants.
The rationale for excluding these research activities from the Common Rule, even when the research is not otherwise subject to additional federal controls, is that consent is inherent to participation and that the risks most likely to be experienced by subjects are related to disclosure of anonymous, non-sensitive information and are thus categorized as “low.” Said another way, all individuals, including vulnerable populations, would understand that actively providing response to
This exclusion is based on the assumption that the activities covered by this category are largely informational, and thus the most important role that an IRB might play with respect to reducing potential harms is to ensure data security and privacy protections. Under this assumption, the proposed exclusion is consistent with the principle of respect for persons and the preservation of autonomy. In the case of observation of public behavior, even if the subject does not know that an investigator is watching his or her actions, the subject's behavior is public and could be observed by others and thus the research observation is not inappropriately intrusive. However, there are situations in which this assumption would not always hold. For instance, administration of a questionnaire or participation in a focus group on a sensitive topic may induce significant stress in some individuals, or individuals approached about taking a survey may feel compelled to participate. Whether and how the exclusion should be bounded so that the final rule achieves a balance among the principles of beneficence, autonomy, and justice is the subject of the request for comment on this proposed exclusion.
In addition, this exclusion is in keeping with one of the goals of this NPRM, namely to reduce burden on research that includes sufficient protections to research subjects. By proposing that this exclusion could be satisfied if the information to be collected is subject to the Paperwork Reduction Act of 1995, would be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, and all of the information collected, used, or generated as part of the research would be maintained in a system or systems of records subject to the Privacy Act of 1974, the NPRM notes that the privacy protections afforded by these laws are generally comparable, if not stronger, than the privacy protections that result from IRB review.
9. Public comment is requested on the extent to which covering any of these activities under the Common Rule would substantially add to the protections provided to human research subjects.
10. Public comment is sought on whether this exclusion should only apply to research activities in which notice is given to prospective subjects or their legally authorized representatives as a regulatory requirement. If so, please comment on what kind of information should be included in the notice such as the research purpose, privacy safeguards, contact information, ability to opt-out, etc. Would requiring notice as a condition of this exempt research strike a good balance between autonomy and beneficence?
11. Public comment is sought regarding whether it is reasonable to rely on investigators to make self-determinations for the types of research activities covered in this particular exclusion category. If so, should documentation of any kind be generated and retained?
12. Public comment is sought regarding whether some or all of these activities should be exemptions rather than exclusions.
13. Public comment is sought regarding whether these exclusions should be narrowed such that studies with the potential for psychological risk are not included. Are there certain topic areas of sensitive information that should not be covered by this exclusion? If so, please provide exemplary language to characterize such topic areas in a manner that would provide clarity for implementing the Rule.
14. For activities captured under the third element of this exclusion, do the statutory, regulatory, and other policy requirements cited provide enough oversight and protection that being subject to expedited review under the Common Rule would produce minimal additional subject protections? If so, should the exclusion be broadened to also cover secondary analysis of information collected pursuant to such activities?
15. Public comment is requested on the extent to which excluding any of these research activities from the Common Rule could result an actual or perceived reduction or alteration of existing rights or protections provided to human research subjects. Are there any risks to scientific integrity or public trust that may result from excluding these research activities from the Common Rule?
This exclusion appears in the current Common Rule as exemption category 4 (current Rule at § __.101(b)(4)). This exemption currently applies to research involving the use of existing data, documents, records, and pathological or diagnostic specimens, but only if the sources are publicly available or if the information is recorded by investigators in such a manner that subjects cannot be identified, directly or through identifiers linked to them.
The ANPRM proposed retaining this exemption as an exemption (not an exclusion). The ANPRM asked questions about whether the current limitations specified in exempt category 4 (research involving the use of existing information or biospecimens, § __.101(b)(4) in the current Rule) should be eliminated. Specifically, the ANPRM suggested that the category would be revised to eliminate the word “existing.” With this elimination, the exemption would be broadened to cover the use of information or biospecimens that were or will be collected for purposes other than the suggested research, rather than requiring that all of the information or biospecimens already exist at the time the study is suggested for exemption.
The second category of low-risk research activities excluded from the proposed rule is a revised version of the current Rule's exemption category 4 (current Rule at § __.101(b)(4)). The NPRM proposal is that the excluded category at § __.101(b)(2)(ii) includes research involving the collection or study of information that has been or will be acquired solely for non-research activities or was acquired for research studies other than the proposed research study when the sources are publicly available, or the information is recorded by the investigator in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects or otherwise conduct an analysis that could lead to
In light of the proposed expansion of the rule to cover certain biospecimens regardless of identifiability, this category has been modified such that it does not include secondary research use of biospecimens. Many of the comments supported the discussion in the ANPRM of eliminating the requirement that the information be “existing” at the time the study was suggested for exemption. Thus, in addition to changing this category of activities from being exempted to being excluded, the proposed exclusion does not require that the data exist as of the time that the study commences, but rather is expanded to include the secondary research use of data collected in the future for research or non-research purposes. The underlying logic behind the exclusion in proposed § __.101(b)(2)(ii) is that such research involves no direct interaction or intervention with human subjects, and any research use of the information does not impose any additional personal or informational risk to the subjects, because (1) the information is already available to the public, and so any risk it may include exists already, or (2) the information recorded by the investigator cannot be identified, and no connection to or involvement of the subjects is contemplated. Any requirements of the Common Rule would not provide additional protections to subjects, and could add substantial administrative burden on IRBs, institutions, and investigators. Creating this excluded category avoids that problem.
16. Public comment is sought regarding whether it is reasonable to rely on investigators to make self-determinations for the types of research activities covered in this particular exclusion category. If so, should documentation of any kind be generated and retained?
17. Public comment is requested on the extent to which covering any of these activities under the Common Rule would substantially add to the protections provided to human research subjects. Is there a way in which this exclusion should be narrowed? Public comment is also sought regarding whether activities described here should appear as an exclusion or as an exemption.
The third category of low-risk research activities excluded from the proposed rule at § __.101(b)(2)(iii) is research conducted by a federal department or agency using government-generated or government-collected information obtained for non-research purposes (including criminal history data), if the information originally involved a collection of information subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
18. Public comment is sought on whether this or a separate exclusion should also include research involving information collected for non-research purposes by non-federal entities where there are comparable privacy safeguards established by state laws and regulations, or whether such non-federally conducted research would be covered by the proposed exemption at § __.104(e)(2).
19. Public comment is requested on the extent to which covering any of these activities under the Common Rule would substantially add to the protections provided to human research subjects.
20. Public comment is sought regarding whether it is reasonable to rely on investigators to make self-determinations for the types of research activities covered in this particular exclusion category. If so, should documentation of any kind be generated and retained?
21. Public comment is sought regarding whether some or all of these activities should be exemptions rather than exclusions.
The public was asked to comment on whether it might be useful to adopt the distinction made by the HIPAA Privacy Rule, which distinguishes between “health care operations” and “research” activities, defining “health care operations” to include, among other activities, “conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities.” The public was asked to comment about this specifically in the context of quality improvement activities.
The fourth category of low-risk research activities excluded from the proposed rule, found at § __.101(b)(2)(iv), covers activities that are regulated under the HIPAA Privacy Rule (
A majority of comments on the 2011 ANPRM favored distinguishing between research and health care operations, as such terms are defined in the HIPAA Privacy Rule and the Health Information Technology for Economic and Clinical Health (HITECH) Act, and excluding the latter from the policy. Some commenters noted that people involved in these various activities are protected in other ways, and alluded to the sorts of measures that provide protection. Others suggested that any exclusions should be limited to data collection and analysis activities, or to activities below a certain threshold of risk (
22. Public comment is requested on whether the protections provided by the HIPAA Rules for identifiable health information used for health care operations, public health activities, and research activities are sufficient to protect human subjects involved in such activities, and whether the current process of seeking IRB approval meaningfully adds to the protection of human subjects involved in such research studies.
23. Public comment is sought regarding to what extent the HIPAA Rules and HITECH adequately address the beneficence, autonomy, and justice aspects for the collection of new information (versus information collected or generated in the course of clinical practice,
24. Public comment is requested on whether additional or fewer activities regulated under the HIPAA Privacy Rule should be included in this exclusion.
The current Common Rule does not contain exclusion categories, though as discussed above, some of the proposed exclusions are similar to activities that are exempt under the current regulations, which therefore might provide a basis for comparison.
All of the current exemption categories can be applied to research that is subject to subpart B. None of the current exemption categories can be applied to research that is subject to subpart C.
The exemptions in the current Rule generally apply to subpart D. However, the exemption at § __.101(b)(2), for research involving educational tests, survey or interview procedures, or observation of public behavior does not apply to subpart D except for research involving educational tests or observations of public behavior when the investigators do not participate in the activities being observed.
Language specifying the application of the exclusions to the subparts can be found in the NPRM at § __.101(b)(2) and (3).
It is proposed that all of the exclusion categories in § __.101(b)(2) and (3) apply to research that is subject to subpart B, and therefore the requirements imposed by subpart B would not need to be met.
It is similarly proposed that all of the exclusion categories in § __.101(b)(2) and (3) apply to research involving prisoners, therefore the requirements of subpart C would not need to be met. This would narrow the scope of research currently requiring subpart C review and certification to OHRP. Considerations in favor of this conclusion include the preponderance of low-risk socio-behavioral research designed to improve prisoner welfare, including studies that focus on substance abuse treatment, community reintegration, and services utilization; the occurrence of prisoner-subjects in research not targeting prisoner populations; the occurrence of prisoner-subjects in databases or registries; and the broad regulatory interpretation of the subpart C “prisoner” definition. Public comment is requested on whether the application of these exclusions to research involving prisoners is appropriate and acceptable.
It is proposed that all of the exclusion categories in § __.101(b)(2) apply to research subject to subpart D, with the exception that the exclusion proposed under § __.101(b)(2)(i) would only apply to research involving educational tests or observations of public behavior when the investigator does not participate in the activities being observed. This limitation would maintain the protection currently provided by the similar application of the current exemption § __.101(b)(2) to research involving children, and would continue to require IRB review under the Common Rule and additional IRB review under subpart D of 45 CFR part 46 when the research involves surveys or interview procedures with children or observation of public behavior when the investigator participates in the activities being observed.
25. Should research involving prisoners be allowed to use any or all of the exclusions found at § __.101(b)(2) and (3), as currently proposed?
26. Are there certain provisions within the broader categories proposed at § __.101(b)(2) and (3) to which the subparts should or should not apply?
The Common Rule has been criticized for inadequately calibrating the review process to the risk of research. Some have argued that, particularly given the paucity of information suggesting significant risks to subjects in certain types of survey and interview-based research, the current system overregulates such research. Further, many critics see little evidence that most IRB review of social and behavioral research effectively protects subjects from psychological or informational risks. Overregulating social and behavioral research in general may serve to distract attention from identification of social and behavioral research studies that do pose ethical challenges and thus merit significant oversight.
The proposed exemption categories and attendant policies and procedures related to exemptions appear in the NPRM at § __.104, and are guided by the following policy goals:
• To create procedural efficiencies for IRBs, administrators and investigators in making and receiving exemption determinations, thereby reducing the overall IRB workload and the wait time for investigators to begin their work.
• To ensure that reasonable safeguards are in place for certain lower risk research activities not fully excluded under the current Common Rule by requiring that research in certain exemption categories follow elements of the proposed rule, but not be required to undergo full IRB review according to the full set of criteria at § __.111(a)(1)–(8) and other regulatory requirements of the Common Rule .
Note that all of the exemption categories in the current Rule have been carried over to the proposed Rule in one or another form. In particular, some of the current Rule's exemptions have now become exclusions under the NPRM (and thus subject to no administrative or IRB review), while some remain in the NPRM's exempt categories section.
Under the current Common Rule, research may qualify for exemption from the regulatory policy if it falls into one of the six current categories at § __.101(b)(1)–(6). Such studies are fully exempt from the regulations. The current regulations do not specify who at an institution may determine that research is exempt under § __.101(b). However, in the past OHRP has recommended that because of the potential for conflict of interest, investigators not be given the authority to make an independent determination that human subjects research is exempt. OHRP has recommended that institutions should implement exemption policies that most effectively address the local setting and programs of research. OHRP has recognized that this may result in a variety of configurations of exemption authority, any of which are acceptable assuming compliance with applicable regulations.
The NPRM proposes to retain the term “exempt,” (rather than “excused,” as suggested in the ANPRM) but require that exempt research comply with certain provisions of the proposed rule such as proposed privacy safeguards at § __.105 (discussed below). This policy retains and, in important respects (through a new safe harbor provision), expands the current flexibility of institutions to develop a system in which someone at the institution—including the investigator, unless prohibited by law—uses an exemption decision tool to make the exemption determination.
It is important to recognize that while in some cases there are new requirements that have been imposed on the exemption categories that do not exist in the current version of the exemption categories, this usually does not actually represent a tightening of the rules for those exemptions. To the contrary, these changes are generally being made to allow the exemption in question to be expanded to cover activities that are not currently exempt. For example, adherence to new privacy standards is a new requirement in order for certain surveys to be exempt, but these are surveys that under the current Common Rule would require IRB review.
The proposed eight exemptions are divided into three groupings according to the kind of risk characteristically involved and what protections are called for: (1) Low-risk interventions that do not require application of standards for information and biospecimen protection; (2) research that may involve sensitive information that requires application of standards for information and biospecimen protection described in proposed § __.105; and (3) secondary research involving biospecimens and identifiable private information that requires application of privacy safeguards discussed at proposed § __.105, broad consent as discussed in proposed § __.116(c), and limited IRB review as discussed in proposed § __.111(a)(9).
The goal of this NPRM proposal is to create procedures for appropriate exemption determinations in a manner that does not waste time and effort.
In developing policies and procedures addressing the exemptions, OHRP currently recommends that when an exemption determination is made, the specific exemption category or categories should be included in the record of the material supplied to the IRB and this information should be available for oversight purposes. In addition, OHRP guidance has said that institutional policies and procedures should identify clearly who is responsible for making exemption decisions. OHRP notes that under current policy a Common Rule Department or Agency retains final authority as to whether a particular human subjects research study conducted or supported by that Department or Agency is exempt from the Common Rule (§ __.101(c)) and that authority continues under the proposed regulations.
The ANPRM discussed a mechanism to (1) register exempt research, and (2) audit a small but appropriate portion of such research, which would still be subject to other regulatory protections such as the suggested data security and information protection standards and certain consent requirements.
The ANPRM discussed a tracking mechanism to enable institutions to assure that such research meets the criteria for inclusion in the suggested “excused” categories. The original recommendations would require investigators to register their study with an institutional office by completing a brief form, thus eliminating the current practice of not allowing investigators to begin conducting such studies until a reviewer had determined it meets the criteria for excused research. This would make the institution aware of key information about the research (such as the purpose of the research and the name of the study's principal investigator), without also requiring that the activity undergo a review that, if not done in a timely manner, could slow the research without adding any significant protection to subjects. In addition, the institution could choose to review some of the submissions at the time they are filed and, if deemed appropriate, require that the study be sent for expedited review or, in rare cases, convened IRB review. It would be made clear that the regulations would not require, and in fact, would discourage, having each of these registration forms undergo a comprehensive administrative or IRB review prior to commencing the study or even afterward.
The auditing requirement was intended to encourage institutions to use the regulatory flexibility suggested for the exempt categories of research. The auditing requirement would have provided institutions with information needed to assess their compliance with the new “excused” categories without unnecessarily subjecting all such research to either prospective review, or even routine review sometime after the study is begun. Note that currently, OHRP recommends that there be some type of review by someone other than the investigator to confirm that a study qualifies as exempt, and many institutions do impose such a requirement even though such a requirement is extra-regulatory.
The ANPRM also asked whether it was acceptable for investigators to independently determine whether their research was exempt, whether review of all registrations should be required, and whether there should be a time limitation or waiting period before excused research could begin.
The ANPRM also asked whether it was appropriate to require institutions holding a Federalwide assurance (FWA) to conduct retrospective audits of a percentage of the excused studies to make sure they qualify for inclusion in an excused category, and if so, how such audits should be conducted.
The NPRM proposes to adopt an exemption determination documentation requirement which is somewhat different from the registration system suggested in the 2011 ANPRM. To assist investigators and institutions in making a timely and accurate determination of exemption status the NPRM at § __.104(c) states that federal departments or agencies will develop one or more exemption determination tools. Federal departments or agencies may create their own tool, or rely on a tool created by another department or agency (including the web-based tool created by HHS). The tool, which has not yet been developed, will be designed in such a way that if the person using the tool inputs accurate information about the study, the tool will produce an outcome which is the determination as to whether the study is exempt or not. Institutions may rely on use of the federally developed tool by investigators as a “safe harbor” for this determination: So long as the information that was provided to the tool was accurate, result of the application of the tool will be presumed by the federal departments or agencies to be an appropriate determination of exempt status. Use of the tool will be voluntary; each institution and agency would determine whether to rely on the decision tool for their determinations, and if so, who would be allowed to operate it. Institutions, if they so choose, could continue to have such determinations made by an individual who is knowledgeable about the exemption categories and who has access to sufficient information to make an informed and reasonable determination. In general, it is expected that investigators would not be allowed to make exemption determinations for themselves without the use of the decision tool, due to considerations of a conflict of interest. It should also be noted that for FDA-regulated device studies IRB review is required by statute.
The NPRM also proposes that the institution or IRB be required to maintain records of exemption determinations, which records must include, at a minimum, the name of the research study, the name of the investigator, and the exemption category applied to the research study. Maintenance of the output of the completed decision tool would fulfill this recordkeeping requirement.
In general, commenters to the 2011 ANPRM were not necessarily opposed to the concept of registration but sought further information on what this process would entail. Public commenters also expressed concerns about allowing an investigator to independently make the determination that his or her research is exempt. Other commenters suggested that this practice would be acceptable for some investigators, whose research is well known to IRB members, and is clearly within an exempt category. The ANPRM noted concerns that some exempt research was unnecessarily delayed by requirements of some institutions to review the research to make an exemption decision.
Several institutions reported that they already as a matter of policy require investigators to submit exempt studies to the IRB, not necessarily for full board review, but to ensure that the exempt determination is valid. These decisions typically are made by the IRB administrator and never involve full review unless there is concern about the exemption status. Thus, they felt the registration requirement was unnecessary and would add new administrative burdens for research already considered low-risk.
Other commenters, such as investigators conducting research currently considered exempt, were strongly opposed to a registration requirement because it would add a new burden to conducting less than minimal risk and exempt research. In addition, commenters raised concerns about the administrative burden and need for a retrospective audit system of registered research.
This NPRM proposal is anticipated to provide more flexibility than the registration requirement originally proposed, while helping to ensure that correct determinations of exempt status are made. The existence of a “safe harbor” mechanism will hopefully encourage institutions to create policies that allow investigators to use the tool, and thus to be able to more quickly commence their research without needing additional administrative or IRB reviews for these types of studies. Other people at the institution who have access to accurate information about a proposed study may also utilize the tool, which will also allow research to go forward unimpeded.
In addition, it is proposed that a change to § __.109(a) be made to clarify that the Common Rule does not give IRBs the authority to review or approve, require modification in or disapprove research that qualifies for exemption under § __.104(d), (e), or (f)(2).
There is no auditing requirement in this NPRM proposal. Consequently, it does not address concerns raised at the ANPRM stage regarding potential conflict of interest if the investigator is providing the information to operate the decision tool. Public comment is sought on this idea regarding the operational details for further development of this proposal. Depending upon the comments received on this proposal, additional operational details regarding the proposed federally sponsored decision tool would be developed and subject to public comment. It should also be noted that the lack of an auditing requirement would not prohibit an institution from performing post-approval monitoring of exemption determinations according to the institution's standard operating procedure.
27. Public comment is sought regarding how likely it would be that institutions would allow an investigator to independently make an exempt determination for his or her own research without additional review by an individual who is not involved in the research and immersed in human research protection
28. Public comment is sought regarding whether an investigator would be able to contrive his or her responses to the automated exemption decision tool in order to receive a desired result
29. Public comment is sought on whether it would be more appropriate for some of the exempt categories than others to rely on the exemption determination produced by the decision tool where investigators themselves input the data into the tool, or whether there should be further administrative review in such circumstances.
30. Public comment is sought regarding whether relying on the exemption determination produced by the decision tool where investigators themselves input the data into the tool
31. Public comment is sought regarding how likely it would be that institutions would rely on such a decision tool to provide a safe harbor for an investigator making a determination that the proposed research qualifies for an exemption, or whether developing such a tool would not be worthwhile, and whether institutions would be able to adequately manage exemption determinations without the use of the decision tool.
32. Public comment is sought regarding what additional information should be required to be kept as a record other than the information submitted into the decision tool, for example, a study abstract, the privacy safeguards to be employed, or any notice or consent document that will be provided.
33. Public comment is sought regarding the value of adding an auditing requirement.
Four exemptions are proposed that will not be subject to any additional requirements apart from the need to keep a record of the determination that the study was exempt. Three of these four exemptions in proposed § __.104(d) are versions of exemptions found in the current rule. A revised version of exemption category 1 in the current Common Rule (research conducted in established or commonly accepted educational settings) is found at proposed § __.104(d)(1) in the NPRM. A revised version of the current exemption category 5 (research and demonstration projects) is found at proposed § __.104(d)(2). Exemption category 6 in the current Common Rule (taste and food quality evaluations) is found in the NPRM at § __.104(d)(4), and is unchanged.
The goal is to retain an exemption for a considerable portion of education research, but to provide for review if the research might adversely affect students' opportunity to learn required educational content, or the assessment of educators.
The current exemption category 1 (§ __.101(b)(1) in the current Rule) is for research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
The first exemption category is for research conducted in established or commonly accepted educational settings when it specifically involves normal educational practices. This includes most research on regular and special education instructional strategies, and research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods, so long as the research is not likely to adversely impact students' opportunity to learn required educational content in that educational setting or the assessment of educators who provide instruction.
This exemption category is a revised version of the first exemption category in the current Common Rule. The rationale for the revision is that there are concerns about whether the conduct of some research projects of this type might draw sufficient time and attention away from the delivery of the regular educational curriculum, and thereby have a detrimental effect on student achievement. The current education system places a strong emphasis on student performance on tests in core curriculum areas such as reading, science, and mathematics, which have a significant effect on such things as grade promotion and student assignment to different courses, and cumulatively influence student attainment and achievement. It could also have a negative effect on teachers being evaluated on the basis of student performance. The exemption category is designed to not include such research projects. Otherwise, the exemption is retained in order to allow for the conduct of education research that may contribute to the important public good of improving education, consistent with the principle of beneficence.
34. Public comment is sought on whether this exemption category should only apply to research activities in which notice that the information collected will be used for research purposes is given to prospective subjects or their legally authorized representatives as a regulatory requirement, when not already required under the Privacy Act of 1974. If so, comment is sought on what kind of information should be included in the notice, such as the research purpose, privacy safeguards, contact information, etc. Comment is also sought on how such a notice should be delivered,
35. Public comment is sought on whether the privacy safeguards of § __.105 should apply to the research included in § __.104(d)(1), given that such research may involve risk of disclosure of identifiable private information.
The NPRM exemption proposed at § __.104(d)(2) is for research and demonstration projects involving public benefit or service programs, and is a slightly revised version of exemption 5 in the current Common Rule.
The proposed regulatory revision and change in interpretation of the exemption is designed to clarify the scope of the exemption so that more research studies would be exempt. It is believed that these changes would make the exemptions easier to apply. It is also designed to allow the Federal Government to carry out important evaluations of its public benefit and service programs to ensure that those programs are cost effective and deliver social goods, consistent with the principle of beneficence.
The current version of this exemption category was originally created based on the recognition that alternative processes are in place in which ethical issues raised by research in public benefit or service programs are be addressed by the officials who are familiar with the programs and responsible for their successful operation under state and federal laws. These alternative processes implicitly consider risk, but there is not a predefined scope for the likelihood or
OHRP has interpreted the current exemption category 5 (§ __.101(b)(5) in the current Common Rule) to apply only to those research and demonstration projects designed to study a “public benefit or service program” that a Common Rule department or agency itself administers, and for which the public benefit or service program exists independent of any research initiative. As an example, OHRP has in the past said that a research study to evaluate a Centers for Medicare & Medicaid Services (CMS)-administered demonstration project comparing two different mechanisms for reimbursing providers under Medicare or Medicaid would meet this exemption. However, this exemption would not apply to some types of research, for example, the evaluation of clinical trials (
The ANPRM asked several questions about the interpretation and applicability of current exemption category 5 (current Common Rule at § __.101(b)(5)), including the scope of the current interpretation of the category 5 exemption. The ANPRM also asked if the current category 5 guidance entitled, “OPRR Guidance on 45 CFR 46.101(b)(5),”
More specifically, the ANPRM asked whether this exemption should be revised to assure that it is not misinterpreted or misapplied, whether broadening it would result in inappropriately increasing risks to subjects, how such risks might be mitigated, and whether OHRP guidance should be revised.
The second proposed exemption category (NPRM at § __.104(d)(2)) is for research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
It is proposed that each federal department or agency conducting or supporting the research and demonstration projects would be required to establish, on a publicly accessible federal Web site or in such other manner as the department or agency head may prescribe, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project would be required to be published on this list prior to or upon commencement of the research. Agencies and departments would be able to create or use their own Web sites for this purpose, or use a Web site created by OHRP. Note that for studies exempted pursuant to § __.104(d)(2), the recordkeeping requirement at proposed § __.104(c) would be deemed to be satisfied by the published list required under proposed § __.104(d)(2)(i).
There were few responses to the questions posed on this exemption in the 2011 ANPRM. However, those that did comment noted that this category is often misunderstood by IRBs and, at best, would benefit from clearer guidance. Commenters said that examples would help investigators and IRBs understand when research activities included in demonstration projects constitute human subjects research subject to the Common Rule. Commenters noted that many activities in demonstration projects do not contribute to generalizable knowledge as they produce results that are relevant only to the program being assessed; as such, many of these activities do not meet the Common Rule's regulatory definition of “research” and thus fall outside of the rule. Other commenters said that some activities in this category are mandated or required by law or regulation and should not be considered to be under the purview of the Common Rule. It was noted that the critical issue in these studies should be protecting privacy and as long as measures are in place to do so, additional protections are not required.
The revision of the language in this exemption clarifies the original language to say that a federally conducted project examining any aspect of a public benefit or service program would qualify for the exemption. The clauses concerning procedures for obtaining benefits, other changes in programs and procedures, and changes in methods or levels of payment are merely examples of such projects, and are not considered to be all-inclusive.
In addition, OHRP proposes to clarify its interpretation of public benefit and service programs which are being evaluated as part of the research to include public benefit or service programs that a Common Rule department or agency does not itself administer through its own employees or agents, but rather funds (
It is believed that these changes would make the exemptions easier to apply. It is also designed to allow the Federal Government to carry out important evaluations of its public benefit and service programs to ensure that those programs are cost effective and deliver social goods. The proposed changes to this exemption would require OHRP to revise its existing guidance document on this exemption accordingly.
These changes would bring the language into conformance with other provisions of the rule that refer to research “conducted or supported” by Federal agencies. Both current practice and the edited language cover such
Although research such as that described above is exempt, an additional requirement is proposed. In the interest of transparency, each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible federal Web site or in such other manner as the Secretary may prescribe, a list of the research and demonstration projects which the federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to or upon commencement of the research. The agency determines what will be included on this list and maintains its oversight. Agencies that already publish research and demonstration projects on a publicly accessible Web site could satisfy this proposed requirement if the existing Web site were to include a statement indicating which of the studies were determined to meet this exemption. The goal of this proposed requirement is to promote transparency of federally conducted or supported activities affecting the public that are not subject to oversight under the Common Rule. It should not create any delay to the research. HHS will develop a resource that all Common Rule agencies may use to satisfy the requirement at proposed § __.104(d)(2)(i). Alternatively, an agency can make its own Web site.
Currently, there is no such comprehensive listing of studies that have been determined to have met this exemption, so this requirement would also enable Common Rule departments and agencies to better assess the types of projects that use this exemption, and consider whether any changes to its scope would be appropriate.
36. Public comment is sought on whether this exemption category should only apply to research activities in which notice is given to prospective subjects or their legally authorized representatives as a regulatory requirement. If so, comment is sought on what kind of information should be included in the notice,
37. Public comment is sought on whether this exemption category is appropriate based on the recognition that alternative processes are in place in which ethical issues raised by research in public benefit or service programs would be addressed by the officials who are familiar with the programs and responsible for their successful operation under state and federal laws, rather than meeting specific risk-based criteria, or whether risk limitations should be included, and if so, what those limitations should be. Though long-standing, this exemption has never identified specific risk-based criteria, or risk limitations to bound the type of projects that may be covered. When originally promulgated, the exemption did stipulate that following the review of such projects, if the Secretary determines that the research or demonstration project presents a danger to the physical, mental, or emotional well-being of a participant or subject, then written informed consent would be required. Public comment is sought on whether to limit the risk that can be imposed on subjects while using this exemption, and if so, how to characterize those limits in a clear fashion. If more than minimal risk interventions are included, public comment is sought on whether, for transparency, this should be made clear in the regulatory text.
With regard to the issue of risks encountered by participants in such research or demonstration projects, comments are also sought regarding the argument that any and every demonstration project involving changes in public benefit or service programs (
38. Public comment is sought on whether the existing privacy safeguards for such activities, including the Privacy Act, HIPAA rules, and other federal or state privacy safeguards provide sufficient independent controls, or whether other safeguards such as the privacy safeguards of § __.105 should be applied.
The goal of this proposed new exemption for studies that involve benign interventions is to eliminate IRB review of these low-risk studies to reduce time and effort, allow IRBs to focus more attention on research with higher risks or presenting other ethical challenges, and to enable this research to go forward.
Currently, research studies in the social and behavioral sciences that do not qualify for exemption category 2 (current Common Rule at § __.101(b)(2)), but that involve certain types of well-understood interactions with subjects (
The ANPRM considered whether to include on the list of exempt studies certain types of social and behavioral research conducted with competent adults that would involve specified types of benign interventions commonly used in social and behavioral research, that are known to involve virtually no risk to subjects, and for which prior review does little to increase protections to subjects. These would be methodologies that are familiar to people in everyday life and in which verbal or similar responses would constitute the research data being collected. The ANPRM asked whether this category should include research in which there is deception.
The proposed exemption at § __.104(d)(3) is new and includes research involving benign interventions in conjunction with the collection of data from an adult subject through verbal or written responses (including data entry) or video recording if the subject prospectively agrees to the intervention and data collection and at least one of the following is met:
• The information obtained is recorded in such a manner that human subjects cannot be identified directly or through identifiers linked to the subjects; or
• Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
For the purpose of this proposed provision, benign interventions would be brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and it would be required that the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. If these criteria were met, such benign interventions might include research activities in which a subject is asked to read materials, review pictures or videos, play online games, solve puzzles, or perform cognitive tasks. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption would not be applicable unless the subject authorizes the deception. For the purpose of this proposed provision, authorized deception would be prospective agreement by the subject to participate in research where the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Many commenters to the 2011 ANPRM supported adding another exemption category of research for certain types of social and behavioral activities, conducted with competent adults, that would involve specified types of benign interventions beyond educational tests, surveys, focus groups, interviews, and similar procedures that are commonly used in social and behavioral research, that are known to involve virtually no risk to subjects, and for which IRB review does little to increase protections for subjects. However, many commenters were opposed to the requirement that subjects be “competent adults” in order for the expanded exemption to apply, asking whether tests of competency would be required for such research to proceed.
This new exemption category addresses research involving benign interventions, in which information is collected through verbal or written responses and recorded in a manner such that human subjects cannot be identified, or where the disclosure of responses would not place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation. Here, a “benign intervention” is categorized as one that is temporary and painless, producing no lasting negative impacts. Examples of benign interventions might include research activities in which a subject is asked to read materials, review pictures or videos, play online games, solve puzzles, or perform cognitive tasks, so long as the interventions meet the requirements for this category.
The NPRM proposes to allow this type of research to occur without the requirements of informed consent or data security protections because neither the intervention nor the identifiability of the information is likely to result in harm to the subject, and the subject must prospectively agree to the intervention and the data collection. This exemption would include some research using authorized deception, where there is a prospective agreement by the research subject to participate in the activity after being informed that he or she will be unaware or misled regarding the nature of the research (§ __.104(d)(3)(iii)–(iv)). Subjects must be adults, but the provision does not specify that they must be competent, and so tests of competency are not necessary; however, the presumption is that in keeping with the principle of respect for persons, these subjects will not be taken advantage of. This new exemption category is being added because respect for persons is accomplished through the prospective subject's prospective agreement or authorization, the research activities pose little risk to subjects, and the use of this exemption for many social or behavioral studies will enable IRBs to devote more time and attention to research studies involving greater risks or ethical challenges.
39. Public comment is sought on whether this exemption category should only apply to research activities in which notice is given to prospective subjects or their legally authorized representatives as a regulatory requirement. If so, comment is sought on what kind of information should be included in the notice, such as the research purpose (if authorized deception is not utilized), privacy safeguards, contact information, etc. Would requiring notice as a condition of this exempt research strike a good balance between autonomy and beneficence?
40. Public comment is sought regarding what improvements could be made to the language describing the type of interventions in this exemption category so as to make clear what interventions would or would not satisfy this exemption category.
41. Public comment is sought on whether it is reasonable, for purposes of this exemption, to rely on the exemption determination produced by the decision tool where investigators
The exemption proposed in § __.104(d)(4) is found in the current Common Rule at § __.101(b)(6). This exemption is for taste and food quality evaluation and consumer acceptance studies if wholesome foods without additives are consumed, or if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by FDA or approved by the EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
This exemption is retained unchanged from the current Common Rule. The research activities included under this intervention are relatively benign, no sensitive information is collected, and presumably subjects are made aware of the nature of the activity before they participate, and may exercise their autonomy in choosing whether or not to participate. However, since the research activities involve physical interventions with the subject, the rules relating to exemption determinations and the record-keeping requirement for exempt activities are appropriate.
42. Public comment is sought on whether this exemption category should be narrowed to apply only to research activities in which notice is given to prospective subjects or their legally authorized representatives as a regulatory requirement. If so, comment is sought on what kind of information should be included in the notice such as the research purpose, privacy safeguards, contact information, etc. Would requiring notice as a condition of this exempt research strike a good balance between autonomy and beneficence? Should prospective subjects be given the explicit opportunity to opt out of such research?
Two exemption categories are proposed which will be subject to the documentation requirement and the new privacy safeguards. The first exemption category is for certain research involving educational tests, surveys, interviews, or observation of public behavior. The second category is for secondary research use of identifiable private information originally collected for non-research purposes where notice was given.
One of the functions of IRB review when a study presents only informational risks is to ensure the sufficiency of the investigator's plan for protecting any identifiable private information that will be collected, created, or used as part of the study. In keeping with one of the goals of this NPRM and as discussed in section II.A.3 of this preamble, to reduce burden associated with research that includes sufficient protections to research subjects, this NPRM proposes to eliminate the need for IRB review for studies involving the collection of identifiable private information when collected through educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording), or in studies involving only the secondary analysis of identifiable private information originally collected for non-research purposes when the proposed privacy safeguards at § __.105 are met. The newly proposed § __.105 offers three avenues to meeting the data security and privacy protection requirements, all three of which are posited to be at least as protective as those usually that result from IRB review.
• The investigator is required by law to comply with, or voluntarily complies with, the HIPAA Rules;
• The activity is conducted by federal departments and agencies, and the activity is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and the research will involve a collection of information subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
• The investigator complies with the privacy safeguards promulgated by the Secretary of HHS (which standards will be designed so that they could be readily implemented by an individual investigator, and would involve minimal cost and effort to implement).
It is believed that the protections afforded by the Paperwork Reduction Act, section 208 of the E-Government Act, and the Privacy Act in combination with each other are generally equivalent to the privacy protections that result from IRB review. It is similarly believed that the privacy protections afforded by HIPAA in the context of the studies exempted under § __.104(e) justify eliminating IRB review.
The proposed section 105 also includes limitations on the use, release, and disclosure of the identifiable private information collected or maintained for research subject to this Rule.
Although most if not all of these requirements are already in effect for federal entities and HIPAA covered entities, they will likely be new to some institutions and their investigators. The intent is that Secretary would develop a list of “reasonable and appropriate safeguards” that would be easily implemented by investigators. As such, it is envisioned that the Secretary's privacy safeguards described in proposed § __.105 would be designed as a checklist that could be easily monitored by investigators and IRB members alike. In the case where IRB members have additional expertise, they may choose to deviate from the Secretary's list. Acknowledging that it is difficult for the public to fully comment on the implications of such a checklist before it has been developed; the Rule includes a requirement that the Secretary solicit public comment on the proposed minimum safeguards.
43. Public comment is sought on the concept of requiring such minimum safeguards and limitations on disclosure, as well as whether the requirements of the proposed § __.105 would constitute a broadening of IRB responsibilities rather than a streamlining of the implementation of responsibilities that many IRBs already adopted. If an institution does view this as an inordinate broadening of responsibilities, does the institution currently have in place alternative mechanisms for ensuring data security and participant privacy in a research context? Suggestions for alternative approaches to meeting public expectation that federally sponsored research safeguard their data and protect privacy are sought during this public comment period.
44. Public comment is sought regarding whether the proposed Rule's information security requirements for biological specimens and identifiable private information are highly technical and require a level of expertise not currently available to most IRBs. Do these security requirements unrealistically expand IRB responsibilities beyond current competencies?
The goal of the proposed exemption at § __.104(e)(1) is to eliminate the need for IRB review of certain low-risk studies that involve collecting information by means of educational tests, surveys, interviews, or observation of public behavior. The intent is that this change would reduce IRB and investigator time and effort in reviewing and submitting protocols, and would allow IRBs to focus more attention on research with higher risks or presenting other ethical challenges, would respect autonomy, and would enable this research to go forward.
The current Common Rule only allows these activities, involving the recording of identifiable information about research subjects, to be exempt if the disclosure of the identifiable information outside the research could not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
The ANPRM discussed criticisms of the current Common Rule that it does not adequately calibrate the review process to the level of risk of the research, particularly in social and behavioral research. It also discussed whether answering questions should be sufficient indication of willingness to participate in survey or interview research. It distinguished between informational or psychological risks and physical risks, and raised questions about how effectively IRB review provides protections from informational or psychological risks.
Specifically, the ANPRM discussed expanding the current exemption category 2 (current Rule at § __.101(b)(2)) to include all studies involving educational tests, surveys, interviews, and similar procedures, so long as the subjects are competent adults, without any further qualifications (but subject to the data security and information protection standards).
The exemption proposed in § __.104(e)(1) covers research, not including interventions, involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording), if the information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects. The research in this category is exempt from most requirements of the NPRM, but investigators must adhere to the privacy safeguards outlined in proposed § __.105. Note that the language used in this exemption is very similar to that used in the current exemption 2, proposed exclusion § __.101(b)(2)(i), and the proposed exemption at § __.104(d)(3); unlike the language in those three places, however, the proposed exemption at § __.104(e)(1) would allow for research to be exempt where sensitive identifiable private information is collected the release of which could pose some measure of risk. However, the exemption is subject to adherence to the proposed § __.105 privacy safeguards, which are designed to limit the chances that the release of that information would lead to harm. This exemption category includes research involving test development, and use of tests that have not already been shown to be valid or reliable, inasmuch as such research activity is desirable in order to determine the their validity and reliability, and the exemption category provides safeguards to ensure that results will not be used to evaluate student achievement. Note that the activities that are currently exempted under exemption category 2 (involving similar ways to collect information, but only where either the identity of the subject is not recorded or disclosure of the information would not have any adverse consequences to the subject) would be moved under the NPRM to the proposed exclusion at § __.101(b)(2)(i), rather than being under an exemption. That proposed exclusion is discussed in section II.A.2 of this preamble. Note also that this proposed exemption would cover the research activities under the exemption in the current Rule at § __.101(b)(3)(ii), such as the research activities funded subject to the Department of Justice statute related to certificates of confidentiality (42 U.S.C. 3789g) and the information collections subject to the confidentiality provisions of the Education Sciences Reform Act (20 U.S.C. 9573) of the Department of Education. Presumably the safeguards provided by these statutes satisfy the privacy safeguards of the proposed § __.105.
Consistent with the spirit of the principle of respect for persons, investigators should provide prospective subjects with sufficient information to make an informed decision about participation. Public comment is sought regarding whether some kind of notice must be given as a regulatory requirement for this exemption, and if so, what kind of information must be included in that notice.
The rationale for characterizing these activities as low-risk is that prospective subjects can decline to participate or answer specific questions in procedures they are already familiar with from the experiences of daily life, and, importantly, that the information will be protected through the new privacy safeguards of § __.105. The availability of this exemption is designed to reduce the volume of information collection that IRBs process, thereby enabling them to devote more time and attention to research studies which pose greater risks or involve ethical challenges.
The underlying assumptions and rationale for this exemption mirror the rationale for the exclusion proposed in § __.101(b)(2)(i)(C). Here again it is presumed that the subjects are sufficiently familiar with survey and interview procedures and educational tests to be able to knowingly and willingly provide the information, or decline to participate. The rationale for this exemption category is that prospective subjects can decline to participate or answer specific questions in procedures they are already familiar with from the experiences of daily life, and that the information collected will be protected through the privacy safeguards of § __.105.
However, there are situations in which these assumptions would not always hold. For instance, administration of a questionnaire or participation in a focus group on a sensitive topic may induce significant stress in some individuals, or individuals approached about taking a survey may feel compelled to participate. Whether and how this exemption should be bounded so that the final rule archives a balance among the principles of beneficence, autonomy, and justice is the subject of a request for public comment on this proposed exemption. The use of this exemption is designed to enable IRBs to devote more time and attention to research studies which pose greater risks or involve more challenging ethical concerns.
45. Public comment is sought on whether the proposed exemption regarding the use of educational tests, survey procedures, interview procedures, or observation of public behavior (§ __.104(e)(1)) should be applied to research involving the use of educational tests with children and whether it should also be applied to research involving the use of survey or interview procedures with children. If so, for research involving children, should the permissible survey or interview topics be limited in some way?
46. Public comment is sought on whether this exemption category should only apply to research activities in which notice is given to prospective subjects or their legally authorized representatives as a regulatory requirement. If so, comment is sought on what kind of information should be included in the notice such as the research purpose, privacy safeguards, contact information, etc. Would requiring notice as a condition of this exempt research strike a good balance between autonomy and beneficence? Should prospective subjects be given the explicit opportunity to opt out of such research?
47. Public comment is sought on whether it is reasonable, for purposes of this exemption, to rely on the exemption determinations produced by the decision tool where investigators themselves input the data into the tool, or whether there should be further administrative review in such circumstances?
48. Public comment is sought on whether this exemption category should be narrowed such that studies with the potential for psychological risk are not included. Are there certain topic areas of sensitive information that should not be covered by this exemption? If so, please provide exemplary language to characterize such topic areas in a manner that would provide clarity for implementing the Rule.
The goal of the proposed new exemption category at § __.104(e)(2) is to facilitate secondary research using identifiable private information that has been or will be collected or generated for non-research purposes, when prior notice has been given and privacy safeguards and prohibitions on re-use of the information are in place. Technological developments and the creation of large databases have significantly increased the potential benefits of secondary research analyses. The proposed exemption category would eliminate the need for IRB review of certain low-risk studies that only involve secondary use of identifiable private information that was collected for non-research purposes. The information would be protected under the privacy safeguards of § __.105, and respect for persons would be demonstrated through a requirement for notice. The proposed exemption is limited to the research use of the identifiable private information for the purposes of the specific research for which the investigator or recipient entity requested access to the information, not for any further secondary research use. This proposed exemption is intended to reduce IRB and investigator time and effort, and allow IRBs to focus more attention on research with higher risks or presenting other ethical challenges. The exemption would enable beneficial secondary research to occur without being impeded by administrative or IRB review, but with privacy safeguards to avoid harm and a notice requirement to show respect for persons. Public comment is sought regarding this proposal, including what limits in scope it should have, what controls and protections should be attached above and beyond the privacy safeguards of § __.105, and how best to respect the autonomy or other interests of the individuals who are the subjects of the information.
Under the current Common Rule, secondary research studies using identifiable private information undergo IRB review and approval, often using the expedited review procedure. If the activity satisfies the relevant criteria, the IRB may waive the requirement for informed consent, which IRBs typically do.
The ANPRM proposed that with regard to an investigator's use of pre-existing data (
Second, the ANPRM proposed that if the data were originally collected for research purposes, then consent would be required regardless of whether the investigator obtains identifiers. This would have been a change with regard to the current interpretation of the Common Rule in the case where the investigator does not obtain any identifiers. That is, the allowable current practice of telling the subjects, during the initial research consent, that the information they are providing will be used for one purpose, and then after stripping identifiers, allowing it to be used for a new purpose to which the subjects never consented, would not have been allowed.
The NPRM proposal here is for a new exemption covering the secondary research use of identifiable private information that has been or will be acquired for non-research purposes, if the following are met:
• Prior notice has been given to the individuals to whom the identifiable private information pertains that such information may be used in research;
• The privacy safeguards of § __.105 are required; and
• The identifiable private information is used only for purposes of the specific research for which the investigator or recipient entity requested access to the information.
Under the current system, IRBs frequently waive consent for research involving the secondary use of identifiable private information, particularly when the data sets are large or drawn from multiple institutions. In such circumstances, IRBs often impose privacy and data security protection requirements. However, since this proposed exemption category requires that the privacy safeguards at § __.105 are in place, requiring these studies to undergo IRB review will provide little or no additional protections to subjects, while continuing to generate potentially substantial burdens on investigators and IRBs and diverting IRB resources away from research that may involve more serious ethical challenges.
Under this proposed exemption there will be greater protections for these research subjects than is currently the case. The new privacy safeguards of § __.105 would be applied to this research, and would be the same safeguards that would be used for many other types of research under the NPRM. In addition, the scope of the exemption is limited to the specific research for
Further, in many cases, other laws such as HIPAA also provide protections in the research context for the information that would be subject to this proposed exemption (
The NPRM proposal limits the use of this exemption to cases in which individuals have been informed that the information may be used in research with the goal of ensuring that research under this exemption exhibits respect for persons. In particular, by ensuring that subjects are notified that their information may be used for research, this notice requirement may enhance subject autonomy.
Alternative scopes for this provision are also proposed for consideration. A narrower scope could be envisioned that would limit the exemption to data generated by the Federal Government for which a privacy impact assessment has been conducted pursuant to section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3601
Alternatively, it could be broadened to allow additional research uses of the information beyond the specific research for which the investigator or recipient entity obtained the information.
The proposed exemption category could also be revised to change the manner in which respect for persons would be demonstrated by requiring that individuals have been given the opportunity to opt out of any secondary research with their identifiable private information. This would mean that subjects could exercise their autonomy to choose not to allow their information to be used, although this would not meet the even higher standard of fully informed active consent. Under this alternative, which would give prospective subjects the opportunity to opt out, it could be argued that the balance would be struck even more in favor of respect for persons by limiting the exemption to research where more than prior notice was required. This would restrict the exemption to research where an even greater measure of respect for persons had occurred, that is, that the individuals had been given the right to decline to participate in research, rather than simply being notified that such research was going to take place. Public comment is sought regarding this alternative approach as well.
Finally, it also should be noted that section 511 of the Medicare Access and CHIP Reauthorization Act of 2015 requires the Secretary to issue a clarification or modification with respect to the application of these regulations to certain activities involving clinical data registries. This exemption category might allow certain research activities of these clinical data registries not otherwise covered by the proposed HIPAA-related exclusion at § __.101(b)(2)(iv) (
49. Public comment is sought on the types of research that should fall under the proposed exemption. Should the proposed exemption be available to all types of research using identifiable data collected for non-research purposes or should the exemption be available only to a more limited subset of research? For example, should the proposed exemption apply only for research using records and information already subject to comprehensive privacy and other protections in other Federal laws (
Depending upon the scope of the exemption, the relationship between this exemption and the exemption proposed at § __.104(f)(2) would need to be clarified. Since a major justification for including this exemption is to reduce burden on IRBs, should the proposed exemption apply only to research for which IRBs typically waive informed consent, that is, where the research could not practicably be carried out without a waiver of informed consent, and the rights and welfare of subjects will not be adversely affected by the waiver? Finally, is there a sufficient need for this exemption at all given the other proposed exclusions and exemptions?
50. Public comment is sought regarding whether the proposed exemption should be limited to research in which individuals had been informed of the potential future research use of their information, and given the opportunity to opt out of having their identifiable private information used for research. If the proposed exemption should be limited in this way, what information should be included in the opportunity to opt out? If the opportunity to opt out is made a condition of the exemption category how should it be structured (
51. Public comment is sought regarding what should constitute notice for purposes of this exemption category. Given the many different types of data that would be covered by this provision (
52. Public comment is sought on whether, on the other hand, prior notice is necessary. Is the notice requirement proposed for this exemption a meaningful and important measure to respect individual autonomy, particularly if the notice requirement could be fulfilled through a general public posting? Current practices suggest that IRBs will frequently waive informed consent for studies involving the secondary use of identifiable private information collected for non-research purposes. If the exemption were to exclude the notice requirement, but continue to require application of the data security and privacy safeguards of § __.105 and restrict the use of identifiable private information to only purposes of the specific research for which the investigator obtained the information, would the exemption better strike a reasonable balance between respect for persons and beneficence, while eliminating the current requirement for IRB review?
53. Public comment is sought as to whether this exemption would provide appropriate protections for research conducted by clinical data registries, while enabling these research activities to proceed without delay, and what should be included in guidance regarding such activities. Public comment is sought regarding the extent to which other exclusions or exemption categories would apply to research conducted by clinical data registries, such that the conditions of this exemption category would not apply.
The goal of this proposed rule is to enable the conduct of research in the rapidly growing area of research involving biospecimens, especially genetic analyses, while recognizing the autonomy interests of people to decide whether or not to participate in this area of research. Some people have a particular interest in whether research will be carried out with their biospecimens, and want to exercise some control over their biospecimens. At the same time, biospecimen repositories are being created to enable innumerable research studies in the future, and the pace of technology development is such that the specific research studies to be carried out with those biospecimens is unknown at the time the biospecimens are collected.
The current Rule requires IRB review and approval of research involving identifiable private information, including individually identifiable biospecimens. IRB waiver of informed consent is allowable under the Common Rule, if the research study satisfies the criteria for waiver of informed consent. The current Rule also allows for research without consent when a biospecimen is used for research under conditions where the investigator does not possess information that would allow him or her to identify the person whose biospecimen is being studied.
The ANPRM considered requiring written general consent for secondary research use of biospecimens originally collected in research or non-research settings regardless of whether they include identifiers. The ANPRM proposed an excused or exempt category for research involving the secondary use of biospecimens originally collected for either research or non-research purposes if there was written broad consent for the research use of the biospecimens, typically obtained at the time of the original collection. The ANPRM also considered whether the broad consent should include check-off boxes allowing subjects to consent or decline consent for types of research raising unique concerns.
The NPRM includes two exemptions proposed in § __.104(f) to facilitate storage, maintenance, and secondary research use of biospecimens and identifiable private information. Generally the exemption at § __.104(f)(1) will first be employed to allow the storage or maintenance for secondary research use of biospecimens or identifiable private information, by means of broad consent being obtained. Following that, the secondary research that will be conducted using such biospecimens or identifiable private information could often be exempted under § __.104(f)(2).
A majority of commenters opposed the suggestion that there be consent requirements for the research use of non-identifiable biospecimens collected for purposes other than the current research study. Some commenters also favored requiring IRB review and approval for specific studies involving the use of identifiable private information and identifiable biospecimens, rather than permitting the use of a broad consent for future use to satisfy the regulatory requirement for consent. These commenters indicated that IRB review of specific research studies, and the IRB's consideration of whether a study-specific informed consent should be required or whether informed consent could be waived, was more protective of human subjects than the ANPRM recommendation permitting use of a broad consent for future use.
Commenters to the 2011 ANPRM were mostly concerned with the cost and burden that would be imposed by the requirement to obtain consent for future research use of all biospecimens, regardless of identifiability. Commenters anticipated these costs to include obtaining consent from participants and the administrative efforts required to keep track of the consent status of biospecimens. Most commenters did not provide detailed cost estimates with their comments; data are specifically requested in response to this NPRM. In addition, estimates of the type and number of studies that could not be pursued using existing samples and data because of the absence of sufficient consent are requested. Comment is also sought on the value to the public and research participants of being asked their permission for research use of their data and biospecimens.
While consideration was given to the opposition expressed by ANPRM commenters of a consent requirement for secondary research use of non-identified biospecimens, the NPRM proposes to require that consent be obtained for the research use of non-identified biospecimens, but to allow for that consent to be broad. Thus, while consent would be required for the research use of non-identified biospecimens, one would not have to obtain study-specific consent for the research use of those biospecimens, drastically reducing the burden imposed by this new requirement.
The NPRM proposal includes several protections for secondary research use of biospecimens in addition to the broad consent. Research activities falling under the exemption at § __.104(f) are subject to the requirements under proposed § __.104(c). This would require that exemption determinations be made by someone knowledgeable of the regulations, or by the to-be-created exemption determination tool (when utilized by an investigator or other
The first exemption in this group, at proposed § __.104(f)(1), is for storage or maintenance for secondary research use of biospecimens or identifiable private information that have been or will be acquired for research studies other than for the proposed research study, or for non-research purposes, if the following criteria are met:
• Written consent for the storage, maintenance, and secondary research use of the information or biospecimens is obtained using the broad consent template that the Secretary of HHS will develop. Oral consent, if obtained during the original data collection and in accordance with the elements of broad consent outlined in § __.116(c) and (d)(3), would be satisfactory for the research use of identifiable private information initially acquired in accordance with activities excluded under § __.101(b)(2)(i) or exempt in accordance with § __.104(d)(3) or (4), or § __.104(e)(1); and
• The reviewing IRB conducts a limited IRB review of the process through which broad consent will be sought, and, in some cases, of the adequacy of the privacy safeguards described in § __.105.
This exemption category only allows for the storage or maintenance for secondary research use of biospecimens or identifiable private information. Note that this exemption does not exempt the creation of any data or the actual new collection of any biospecimens from a person through a research interaction or intervention. (For example, if the proposed research activities involved creating a research repository of DNA samples that would be obtained from people through cheek swabs, the collection of the cheek swabs would mean that the creation of the research repository would require IRB review, and would not be exempt.) This exempt category is for secondary research use of biospecimens and identifiable private information and applies to biospecimens and identifiable private information that were initially collected for purposes other than the proposed research activity. The term `other than the proposed activity' here means that the information or biospecimens were or will be collected for a different research study or for a non-research purpose.
In the case of a research study involving the actual new collection of biospecimens such as a clinical trial, the informed consent process could include obtaining informed consent for the original study (which study would not be exempt and would require IRB review and the usual type of consent document as required under § __.116(a) and (b)), and for secondary research use of the biospecimens. The informed consent form for the latter step (the secondary research use) could make use of the Secretary's template, in which case the biospecimen would be eligible for maintenance or storage under § __.104(f)(1) with limited IRB review or for a secondary research study under § __.104(f)(2). If the Secretary's template for broad consent is not used, the storage or maintenance for secondary research use would not meet this exemption and the consent form would need to be reviewed and approved by an IRB, either along with the IRB review of the original study, if the maintenance and storage for secondary research is known and described, or later, if it is not. Note also that if the Secretary's template is not used, the § __.104(f)(2) exemption, as discussed below, would not apply to exempt any actual secondary research studies conducted using the stored biospecimens. IRB review would be needed for each of those studies, unless the research met one of the proposed exclusions at § __.101(b)(1) or (b)(3), or the exemption found in proposed § __.104(d)(2).
This exemption requires written informed consent using the Secretary's template for broad consent for secondary research, or oral consent, in specified circumstances. This broad consent requirement will enable subjects the choice to include their biospecimens and information in this research. The consent form using the Secretary's template would include the information required in § __.116(c). Oral broad consent would also need to include all of the elements of consent at § __.116(c), and would only be permissible for the research use of identifiable private information, not biospecimens, when the identifiable private information was initially acquired as part of any of the following four excluded or exempt categories of research: (1) The exclusion related to research, not involving interventions, that involves the use of educational tests, survey procedures, interview procedures, or observation of public behavior (§ __.101(b)(2)(i)); (2) the exemption related to research involving benign interventions (§ __.104(d)(3)); (3) the exemption related to taste and food quality evaluation and consumer acceptance studies (§ __.104(d)(4)); or (4) the exemption related to research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior (§ __.104(e)(1)).
It is proposed that oral broad consent only be permitted to satisfy these exemptions regarding the secondary use of identifiable private information (§ __.104(f)(1) and (f)(2)) if the identifiable private information was initially acquired as part of any of the four above-mentioned exclusion and exemption categories because these four categories are the only ones that are expected to typically involve some interaction with human subjects, and thus give investigators the opportunity to obtain oral consent from subjects for the secondary use of research data obtained as part of the initial research study.
This exemption also requires adhering to the privacy safeguards described in the proposed section § __.105.
The exemption also includes a requirement for limited IRB review (§ __.111(a)(9)). The purpose of this limited IRB review is to ensure that the process of obtaining consent will occur in an appropriate way, because there may be some circumstances (for example, when someone is admitted for emergency care), when the individual is not able to make an informed considered decision. This IRB review will, for many institutions, be essentially a “one-time” event (as opposed to being needed for specific research studies); the IRB would review an overall general institutional protocol for the manner in which people can provide broad consent for the maintenance or storage of their biospecimens for future secondary research. Such a general institutional protocol would need to identify the circumstances in which broad consent would be sought for secondary research use of biospecimens so that the IRB could determine that these circumstances are consistent with the requirements for voluntary informed consent as described in the introductory language to proposed § __.116.
In addition, if there will be a change in the way the biospecimens and information will be maintained for the secondary research purposes, rather
The second exemption in this exemption group, at § __.104(f)(2), is for research involving the use of biospecimens or identifiable private information that have been stored or maintained for secondary research use, if consent for the storage and maintenance of the information and biospecimens was obtained as detailed using the broad consent template that the Secretary of HHS will develop. Note that oral broad consent would be allowed to the extent permitted under proposed § __.104(f)(1)(i)(A). If the investigator anticipates that individual research results will be provided to a research subject, the research may not be exempted under this provision and must be reviewed by the IRB and informed consent for the research must be obtained to the extent required by proposed § __.116(a) and (b).
This exemption category at § __.104(f)(2) is for the actual secondary research studies that will be conducted using biospecimens or identifiable private information that have been stored for unspecified secondary research studies. This exemption does not include additional analyses being conducted to support or augment the original research study for which the information or biospecimens were originally collected.
The proposed exemption category at § __.104(f)(2) requires that the privacy safeguards at § __.105 are met, and that broad consent to the earlier storage or maintenance of the biospecimens and information had already been obtained consistent with the requirements of § __.104(f)(1). This means that for secondary research using biospecimens informed consent must have been obtained using a consent form using the Secretary's template. It is presumed that research involving newborn blood spots would frequently take place using this provision.
The rationale for these two exemptions is that they provide for obtaining broad consent from subjects for the research use of specimens, honoring the principle of respect for persons, they provide protections for the information involved through the privacy safeguards of § __.105, and the limited IRB review proposed at § __.111(a)(9) ensures that the privacy safeguards and informed consent process are indeed adequate.
The exemption at § __.104(f)(2) would not apply to research in which the investigator anticipates that research results will be provided to a subject. If it is anticipated that individual research results will be returned to subjects, then the research would not meet this exemption and IRB review and approval would be required, and informed consent would need to be obtained to the extent required by § __.116(a) and (b). If the investigator does not anticipate that individual research results will be provided to a research subject as part of the research plan, but later decides to return research results to subjects, an IRB must review and approve the plan for returning these results to the subjects. It is understood that the prospective IRB review provision set forth here does not override existing law, such as the HIPAA Privacy Rule or the Federal Privacy Act, which give individuals the right to access certain information about themselves in specified circumstances. In addition, it is recognized that clinical care needs may demand prompt reporting of findings to patients who are also human subjects, in which case it is expected that investigators would anticipate that such research results will be provided to a subject, and this exemption would not apply.
It is generally recognized that where, for example, a series of genetic analyses are performed, in a significant percentage of instances investigators will be learning information, not necessarily related to the specific purpose of their studies, that would nonetheless be significant to participants in terms of making decisions about their health care. For example, it might be learned that a woman has a gene mutation that significantly increases her risk of breast or ovarian cancer. The proposed rule does not specifically impose any obligations on investigators to provide such information to participants, so long as the consent form is clear that no such information will be given to the participants. This could have a negative impact on the current efforts to increase the willingness of people to allow their biospecimens to be used in research, if they are less inclined to provide broad consent to such research when investigators are not making any commitment to return important information that is unexpectedly learned about a participant. This could lead some investigators to decide to include in their protocols provisions for returning such results to subjects. The consequence is that such protocols will not be eligible for the proposed exemption at § __.104(f)(2), and thus would undergo full IRB review primarily for the purpose of determining what information participants should be provided regarding such “unexpected” (
At the same time, it is likely that many IRBs do not have any particular unique expertise in making these determinations about returning results, which again could lead to inappropriate variability in disclosure from study to study, and would seem to be in conflict with the ethical goal of justice.
One option that has been considered would be to create a federal panel of experts to make determinations about which unexpected findings should be disclosed to human subjects in research, and what information should be given to subjects about themselves. If this alternative proposal were adopted, then it would not be necessary to have full IRB review of these protocols. A consequence of this option would be that these types of studies could be exempt even if they proposed to return research results to subjects, so long as disclosures were made consistent with the rules announced by the federal panel. However, it is not clear that such a panel's guidance would be superior to that of IRBs.
54. Public comment is sought on whether the NPRM's proposal of exemption § __.104(f)(2) is the best option, or whether there is a better way to balance respect for persons with facilitating research.
55. Public comment is sought on whether and how the provision regarding the return of research results in the proposed exemption § __.104(f)(2) should be revised.
56. Public comment is sought on whether there should be an additional exemption that would permit the
In the current Common Rule, the application of the exemptions articulated in the current Common Rule in § __.101(b) to the subparts is specified through footnote 1 of the current Rule. It states that the exemptions do not apply to research involving prisoners, and are also limited in their application to research involving children. The current exemption at § __.101(b)(2) for research involving educational tests, survey or interview procedures or observations of public behavior does not apply to subpart D, except for research involving educational tests or observations of public behavior when the investigator does not participate in the activities being observed. The current exemptions do apply to subpart B.
While the exemptions in the NPRM are based largely on exemptions in the current Common Rule, not all of the exemptions proposed in the NPRM will apply to subparts B–D. Language at § __.104(b) explains how the proposed exemptions may be applied to the subparts. The language at § __.104(b)(1) states that all of the exemptions at § __.104 may be applied to research conducted under subpart B. Language at § __.104(b)(2) states that none of the § __.104 exemptions may be applied to research conducted under subpart C, except for research aimed at a broader population that consists mostly of non-prisoners but that incidentally includes some number of prisoners. Finally, § __.104(b)(3) states that the exemptions at § __.104(d)(1), (2), (4), § __.104(e)(2) and (f)(1) and (2) may be applied to research conducted under subpart D. The exemption at § __.104(e)(1) cannot be applied to research involving children under subpart D, because protections including IRB review and parental permission are appropriate for research involving educational tests, surveys or interview procedures, or observation of public behavior when the information collected may be individually identified and sensitive in nature.
Although this NPRM does not propose changes to the HHS regulations at 45 CFR part 46, subparts B, C and D, consideration is being given to whether the proposed exemption categories articulated in § __.104 should apply in research involving prisoners under subpart C, either if the research consists mostly of non-prisoners and only incidentally includes some number of prisoners, as proposed in the NPRM, or if the research intends to involve prisoners as research subjects. Originally developed in 1976 by the National Commission, subpart C has at times come under scrutiny for its restrictive construction. The subpart was written in the wake of harsh criticism regarding research abuses involving prisoners that occurred or became public in the 1960s and 1970s. As a result, subpart C was written to permit research involving incarcerated persons only if the study fits one of four categories at 45 CFR 46.306(a)(2) (an “epidemiological waiver” category was added in 2002
Public comment is requested on whether the revised exemption categories should be permitted to apply to research involving prisoners. Considerations include the preponderance of low-risk, socio-behavioral research focused on prisoner welfare, substance abuse treatment, community reintegration, and services utilization; the occurrence of prisoner-subjects in databases or registries; and the broad interpretation of the subpart C “prisoner” definition that includes, for example, subjects in court-mandated residential substance abuse treatment.
57. Public comment is sought on whether research involving prisoners should be permitted to apply any or all of the exemption categories found at proposed § __.104, either if the research consists mostly of non-prisoners and only incidentally includes some number of prisoners, as proposed in the NPRM, or if the research intends to involve prisoners as research subjects.
58. Would it be preferable for language at § __.104(b)(2) to resemble the 2002 epidemiologic waiver criteria and state that the exemptions apply except for research where prisoners are a particular focus of the research?
59. Is the proposed application of the exemptions to subparts B and D appropriate?
• All exemption language would be found at § __.104.
• The eight proposed exemptions in § __.104 would be divided into three groupings: (1) Low-risk interventions where no other requirement of the proposed rule (including informed consent and data protection) are necessary other than the determination and recording requirements (§ __.104(d)); (2) research activities where the information protection measures at § __.105 must be applied (§ __.104(e)); (3) secondary research involving biospecimens and identifiable private information that requires application of privacy safeguards at proposed § __.105, broad consent as discussed at proposed § __.116(c), and limited IRB review as discussed at proposed § __.111(a)(9).
• Existing exemption categories 1, 5, and 6 (current § __.101(b)(1), (5), and (6)) would be retained at § __.104(d)(1), (2), and (4). Specifically the current exemption for research on public benefit programs or demonstration projects (§ __.101(b)(5) in the current Rule; § __.104(d)(2) in the NPRM) would be clarified and OHRP's guidance would be changed to include the applicability of the exemption to cover research on public benefit and service programs that an agency does not itself administer through its own employees or agents. A requirement for publishing a list of studies under this exemption would apply for Federal agencies or departments conducting or supporting such studies.
• A new exemption would be created for certain research involving benign interventions.
• A new exemption would be created for certain research involving educational tests, survey or interview procedures, or observation of public behavior where identifiable private information was recorded so long as data protection standards are met.
• A new exemption would be created for secondary research use of identifiable private information originally collected for non-research purposes.
• A new exemption would be created for activities relating to the storage and maintenance, for secondary research use, of biospecimens and identifiable private information.
• A new exemption would be created to exempt secondary research studies
The NPRM proposals address: (1) The organization and presentation of information included in the consent document and the process to facilitate a prospective subject's decision about whether to participate in research; (2) the elements of consent, basic and additional; (3) broad consent to the storage or maintenance for secondary research use of biospecimens and identifiable private information, and the use of such stored biospecimens and information for specific research studies; and (4) attendant changes in the waiver or alteration criteria for consent.
The NPRM proposes several changes to the Common Rule with regard to the elements of informed consent and when it must be obtained (see further discussion below regarding proposed changes to the conditions for waiver of consent). In addition, it makes several new proposals that were not included in the ANPRM questions, but are offered in response to public comments received as well as internal discussions within HHS and with the other Common Rule agencies.
These include the development of a Secretary's template, which will be issued in draft for public comment at a later date (the NPRM at § __.116(d)) for broad consent to the storage or maintenance for secondary research use of biospecimens, and identifiable private information and the use of such stored biospecimens and information for specific research studies. Broad consent would be permissible for the storage or maintenance for secondary research use of such information and biospecimens that were originally collected for either research studies other than the proposed research or non-research purposes. This broad consent document would meet the consent requirements for the storage or maintenance of biospecimens and identifiable private information for secondary research, as well as the use of such stored material for individual research studies.
Because biospecimens and information that have been collected for clinical use or purposes other than for the proposed research are often an important source of information and material for investigators, and the re-use of existing information and materials can be an efficient mechanism for conducting research without presenting additional physical or psychological risks to the individual, it seems prudent to consider changes to current regulations relating to those issues. Some critics, including potential and former research subjects, object to research performed on a person's biospecimens or information without consent. Conversely, investigators and patient advocacy groups are concerned that the need for informed consent for every use of a biospecimen or data element will greatly inhibit research. They worry that obtaining individual consent for each separate research study will create unmanageable logistical demands, making valuable research impossible.
As an additional means of increasing transparency and facilitating the development of more informative informed consent forms, it is proposed that a copy of the final version of the consent form for clinical trials conducted or supported by a Common Rule department or agency would need to be posted on a publicly available Federal Web site. Within 60 days after the trial was closed to recruitment, the awardee or the federal department or agency conducting the clinical trial would be required to post the consent document, the name of the clinical trial and information about whom to contact for additional details about the trial.
In addition to the specific changes proposed to § __.116, comment is sought on whether Common Rule agencies should modify the definition of “legally authorized representative” (LAR). The current Rule defines LAR at § __.102(c) as an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. While the NPRM proposes to retain this language, OHRP is aware that this definition has been problematic for states in which there is no applicable law permitting an LAR to consent in either a clinical or a research context. In the absence of such a law, it is almost always the case that community or other standards (such as institutional policies) define hierarchies or identify individuals who may provide legally acceptable consent, for clinical (non-research) purposes, on behalf of others who cannot consent for themselves. However, the current regulations are interpreted to not allow such standards to constitute applicable law for purposes of the regulations, and thus such individuals are not considered legally authorized representatives for purposes of the Common Rule. Concerns that the Common Rule's current definition of LAR may be inappropriately hindering the conduct of research with subjects who lack capacity to consent have been raised by the Secretary's Advisory Committee on Human Research Protections (SACHRP),
Comment is therefore sought on whether a revision that would expand the current definition to also permit an LAR to be defined by an accepted common practice standard that is used in a state for determining who can legally consent to clinical care would be consistent with the ethical principles underlying the Common Rule. Such a revision would broaden the definition of LAR and permit investigators to use accepted common practice, such as an established state or local hierarchy, to allow another person to provide consent to research participation. In the absence of such a revision, it would remain the case that in certain states, there would appear to be no way (short of taking the often difficult legal step of obtaining the appointment of a legal guardian) to enroll subjects lacking decision-making capacity in research studies. Given that the current interpretation of current § __.102(c) generally is based on the proposition that the person who can legally consent on behalf of someone else for a particular clinical procedure to take place should have the authority to consent for research purposes, it could be viewed as inappropriate to maintain the current Rule, which produces different results in terms of when research can take place in those states that have specific laws governing such clinical consent and those that accomplish the same legal outcome through less formal regimes.
Many claim that consent forms have evolved to protect institutions rather than to provide potential research subjects with some of the most important pieces of information that a person would need in order to make an informed decision about whether to
The goal of the proposed changes to the informed consent form and process is to facilitate prospective subjects' decision about whether or not to participate in a research study, thereby enhancing autonomy.
Currently, under the Common Rule, investigators generally must ensure that the subjects' informed consent to participate in research is obtained.
The ANPRM discussed revising the regulations to provide greater specificity about how consent forms should be written and what information they should contain. The goal would be consent documents that are shorter, when appropriate, more readily understood, less confusing, that contain all of the key information in sufficient detail, and that can serve as an aid to help someone make an informed decision about whether to participate in a study.
Public comments were largely in favor of finding ways to improve consent forms. However, commenters cited several systemic concerns that could be obstacles to shortening and simplifying forms, such as regulatory, legal, and institutional requirements, and the complexity of some studies. Of those responding to questions about the causative factors, blame for making forms long and complex was shared by sponsors of clinical trials, IRBs, regulatory agencies, and institutional legal counsel. The types of information cited as contributing to the excessive lengths of forms included the requirement to describe all reasonably foreseeable research risks and the complexity of study procedures. There was no consensus on how to better explain alternatives to research participation and few comments were submitted on this topic.
Commenters offered a few suggestions for modifying or deleting the required elements of consent, such as removing boilerplate language that only protects institutions and research sponsors, as well as removing some of the required elements for minimal risk research. However, many felt that guidance, rather than regulatory change, would better improve the development of consent forms. Although many commenters noted the need for shorter and more comprehensible consent forms, most felt that the required elements of consent articulated in the Common Rule are sufficient. Commenters overwhelmingly supported the goals articulated in the ANPRM, but cautioned against an overly prescriptive or rigid approach to consent forms. However, several commenters requested guidance on what might be included in a consent form for future research use of identifiable information and identifiable biospecimens to ensure that such forms satisfied the consent requirements of the Common Rule.
A majority of commenters supported the development of regulations or guidance designed to encourage assessment of the extent to which human subjects comprehend consent forms, at least for certain types of higher risk studies or certain types of subject populations. Others argued that the regulations at § __.116 already contain language implying the need to ensure comprehension through the use of the terms “legally effective informed consent” and “language understandable to the subject.”
Finally, many commenters supported making changes to HIPAA authorization requirements, as necessary, to conform to provisions of the Common Rule. In addition, most commenters were supportive of requiring investigators to disclose in consent forms certain information about the financial relationships they have with study sponsors.
To that end, the NPRM proposes adding new language to the introductory text of § __.116 to address the questions asked in the ANPRM about strengthening the informed consent requirements. It reorients the language to emphasize the need to first provide essential information that a reasonable person would want to know in order to make an informed decision about whether to participate, and to provide an opportunity to discuss that information. It requires that the information be presented in sufficient detail relating to the specific research. Furthermore, in recognition of the complaints that current consent forms are too commonly complicated documents that primarily are used to protect sponsors from legal liability, the NPRM would require (as described in the in the revised introductory language to § __.116) that the information in these forms be organized and presented in a way that did not merely provide lists of isolated facts, but rather facilitated the prospective subject's or representative's understanding of the reasons why one might or might not want to participate. For example, for some research studies, it could be important for the discussion of the purpose of the research and the reasonably foreseeable risks of the research to be discussed together so that prospective subjects would better understand how participation in the study might alter their clinical care and ultimately, their health.
It is also proposed that in obtaining informed consent, the investigator would be required to present first the information required by this section, before providing other information, if any, to the subject. This would mean that the consent document could only include the elements of consent that were required by the rule, with any other information included in an appendix. This is intended to lead to substantially shorter consent forms, with prospective subjects receiving the most important information in the body of these relatively short forms, instead of that key information being buried in a long and overly complex document.
Public comments did not provide consensus on desirable changes to the elements of informed consent. Thus,
In addition, the NPRM proposes to clarify in the introductory language at § __.116 that if a HIPAA authorization is combined with a consent form, the authorization elements required by 45 CFR 164.508 must be included in the consent document and not the appendices. In other words, when consent is combined with authorization, the authorization elements should be considered to constitute one of the required elements of consent.
Since research with non-identified data does not involve “human subjects” under proposed § __.102(e), it is proposed that a new element of informed consent be required to better ensure that subjects are informed of the possibility that identifiers collected as part of a research study could be removed from the data and then used for secondary research studies without the protections provided by this policy. The new basic element of consent at § __.116(a)(9) would apply to all research collecting identifiable private information. Based on the investigator's plans, the informed consent form and process would need to inform subjects either that: (1) Identifiers might be removed from the data and that the non-identified data could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the representative, if this might be a possibility; or (2) the subject's data collected as part of the research would not be used or distributed for future research studies, even in a non-identified form. This proposed additional element of informed consent is intended to create greater transparency and enable prospective research subjects to make a more informed decision about whether to participate in research. Prospective subjects can always decline to participate in the initial research if they object to the statement provided. These changes would not apply to ongoing human subjects research in which human subjects were involved prior to the effective date of this rule.
It is anticipated that very few investigators will elect to offer the option to restrict the future research use of non-identified data, in part because of the challenges of marking and tracking such decisions. However, should they offer this option, then institutions and investigators will have to develop a system for tracking impermissible uses of non-identified information. Since most investigators will likely elect to inform subjects that identifiers might be removed from the data and distributed for future research without additional informed consent, it would be reasonable for investigators and institutions to generally assume that the secondary research use of non-identified information would be permissible unless marked otherwise.
It is possible that investigators could choose to include additional statements about their plans to use non-identified data for future research studies. For example, investigators could agree to give subjects an option about whether subjects' non-identified research data could be used for future research studies, or could agree to seek additional informed consent from subjects before using or sharing non-identified data for future research studies. However, it is anticipated that such commitments by investigators would be uncommon, and so the NPRM does not propose including such statements in the informed consent form or process. If such commitments about the future use of non-identified information were made by investigators in the informed consent form or process, investigators would need to satisfy these commitments, which would also require the development of a tracking system.
The NPRM also proposes adding three additional elements of consent at § __.116(b)(7)–(9) that, when appropriate, would be required to be included in the informed consent form and process. These three additional elements of consent all pertain to issues that have become more relevant in recent years as science has advanced and the nature of research has changed. The proposed new element at § __.116(b)(7) would require that prospective subjects be informed that their biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit. The proposed new element at § __.116(b)(8) would require that prospective subjects be informed of whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions. The proposed new element at § __.116(b)(9) would provide subjects or their legally authorized representatives with an option to consent, or refuse to consent, to investigators re-contacting the subject to seek additional information or biospecimens or to discuss participation in another research study. Since the information that would be required to be disclosed under these three proposed additional elements of consent is often relevant to an individual's decision of whether to participate in a research study, currently such information is sometimes included in informed consent forms under the current Common Rule. The NPRM proposes to require inclusion of these additional elements, when appropriate, to better ensure that prospective subjects are more consistently provided with this information when it is information that a reasonable person would want to know in order to make an informed decision about whether to participate in a research study. These three proposed additional elements of consent are also relevant to seeking an individual's broad consent to the storage, maintenance, and secondary research use of biospecimens or identifiable private information, so it is proposed that broad consent obtained under § __.116(c) also include these additional elements, when applicable. These clarifications and additions would have to meet the documentation requirements at § __.117(b)(1)–(2).
• New language would strengthen the informed consent requirements to make sure that the most appropriate information is presented to prospective subjects in sufficient detail and in a format that is tied to understandability.
• New language would clarify that, when a HIPAA authorization is combined with consent, the HIPAA authorization elements must be part of the core elements of the consent.
• When identifiable private information is collected for research purposes, consent would be required to notify subjects if their non-identified
• The Secretary will publish guidance in the future to explain how consent forms can be written to comply with the regulatory requirements.
• Three additional elements of consent would be required, when appropriate.
60. What topics should be addressed in future guidance on improving the understandability of informed consent?
One of the primary objectives of the NPRM is to make the strength of protections commensurate with the level of risks of the research, and by so doing, reduce unnecessary administrative burdens on research. That objective has been viewed as being particularly relevant to research involving only secondary use of biospecimens and identified data, which is relatively low-risk if appropriate protections of privacy and confidentiality are in place, including protections against the misuse of biospecimens or data that could cause harm to research subjects.
The increasing use of information and biospecimens in research, often into the future and beyond the point at which an individual is directly involved in the information or biospecimen collection, requires rethinking the elements of consent in those circumstances to ensure that potential research subjects understand how their information or biospecimens might be used as well as the risks and potential benefits of such use. Critics of the existing rules have observed that the current requirements for informed consent for future research with pre-existing information and biospecimens are confusing and consume substantial amounts of investigators' and IRBs' time and resources.
Under the current requirements of the Common Rule, if identifiers are removed, biospecimens and data that have been collected for purposes other than the proposed research can be used without any requirement for informed consent. Similarly, under the HIPAA Privacy Rule, if data are de-identified or HIPAA identifiers do not accompany biospecimens, then the Privacy Rule does not apply. When identifiers have not been removed, under the Common Rule investigators may be allowed in certain situations to obtain a consent that is broader than for a specific research study, such as for a research repository that involves obtaining biospecimens from living individuals to create a repository for future research studies. In these cases, an IRB may determine that the original consent for the creation of the research repository satisfies the requirements of the Common Rule for the conduct of the future research, provided that the elements of consent under § __.116 continue to be satisfied for the future research. Despite this existing flexibility in the Common Rule, it is believed that the current elements of consent required under § __.116 often do not continue to be satisfied for the future research.
With respect to HIPAA, HHS's prior interpretation of the HIPAA Privacy Rule was that authorizations for research needed to be study-specific, and thus, that such authorizations could not authorize certain future unspecified research. However, in January 2013, the Office for Civil Rights modified its prior interpretation.
The ANPRM suggested generally requiring written consent for research use of any biospecimens collected for clinical purposes after the effective date of the new rules (such as research with excess pathological specimens). Such consent could be obtained by use of a brief standard consent form agreeing to generally permit future research. This brief consent could be broad enough to cover all biospecimens to be collected related to a particular set of encounters with an institution (
The ANPRM suggested that this standardized broad consent form would permit the subject to say no to all future research. In addition, the ANPRM acknowledged that there are likely to be a handful of special categories of research with biospecimens that, given the unique concerns they might raise for a significant segment of the public, could be dealt with by check-off boxes allowing subjects to separately agree (or not) to that particular type of research. More specifically, the ANPRM asked whether certain flexible consent requirements could be imposed on some of these studies that would permit the use of a broad consent for future use, with a requirement that a subject's specific consent would be required before their biospecimens could be used for special categories of research.
Further, the ANPRM suggested maintaining the current prohibition that participation in a research study (such as a clinical trial) could not be conditioned on agreeing to allow future open-ended research using a biospecimen. With regard to the secondary research use of pre-existing data, on those occasions when oral consent was acceptable under the regulations for the initial data collection, the ANPRM envisioned that subjects would have typically provided their oral consent for future research at the time of the initial data collection; a written consent form would not have to be signed in that circumstance.
The ANPRM also noted that there would be rules that would allow for waiver of consent under specified circumstances, though those conditions would not necessarily be the same as those for other types of research.
Similar to what was discussed in the 2011 ANPRM, the NPRM proposes to allow broad consent to cover the storage or maintenance for secondary research use of biospecimens and identifiable private information. Broad consent would be permissible for the storage or maintenance for secondary research of such information and biospecimens that
Since it is proposed that the definition of human subject be expanded to include all biospecimens, the NPRM proposes to facilitate research using biospecimens by permitting broad consent to be obtained for their storage or maintenance for secondary research. In addition, a new exemption at § __.104(f)(2) would permit the secondary research use of biospecimens without a subject being given information about the specific research study if broad consent under § __.116(c) and (d) was obtained and the privacy safeguards at § __.105 were met.
Public comments on the 2011 ANPRM revealed variable opinions on the issue of broad consent. Several commenters indicated that there is no need for additional regulations, with one university stating that it “strongly opposes more restrictive regulations about the use of these biospecimens and sees no need to change the current regulations, even or perhaps especially in the case of secondary data analysis.” Other commenters opposed broad consent, stating that investigators and clinicians should obtain specific consent from individuals for each research project. This opposition was made on the ethical grounds that because individuals are not fully informed of specific research purposes for broad consent, they can never be truly informed about the use of their data. In contrast, other commenters expressed clear support for general consent for secondary research use of biospecimens and data collected during research to exempt the research from IRB review, noting that “we support the suggestion in the ANPRM to encourage general consent for the secondary research use of biospecimens and data and where this is not obtained IRB review is required.” Other commenters favored requiring IRB review over permitting the use of a broad consent to approve secondary research use of identifiable data or biospecimens. These commenters believed that IRB consideration of consent requirements for individual research studies was more protective of human subjects than the ANPRM suggestions to permit broad consent for future use.
It is envisioned that the proposed broad consent provision would be used by institutions and investigators to give individuals the choice to either allow or disallow the use of their biospecimens and identifiable private information for secondary research. In some cases, institutions would be expected to seek broad consent under § __.116(c) and (d) as part of a research protocol to create a research repository of biospecimens or information. However, in other cases it is expected that institutions, particularly institutions that do not typically conduct human subjects research, might not develop a research protocol to create a research repository, but still choose to seek broad consent from individuals for the research use of their biospecimens or identifiable private information. In such cases, these institutions might simply “tag” biospecimens and information as either available or not available for secondary research.
Since broad consent is a different form of informed consent than informed consent for a specific research study, in which individuals must be given information about a particular research study to be conducted with their biospecimens and information, the proposed requirements for broad consent under § __.116(c) and (d) would include several of the basic and additional elements of informed consent under § __.116(a) and (b), but not all, and would include several additional required elements. The proposed elements of broad consent are intended to ensure that the individual would be provided with sufficient information to make an informed decision about whether to agree to provide broad consent for a wide variety of research that may be unforeseen at the time in which consent is being sought.
The NPRM proposes to require that the broad consent describe the biospecimens and identifiable private information that would be covered by the consent, recognizing that the biospecimens and information to be used in future research studies might be collected after the consent was obtained. Broad consent for the research use of biospecimens or identifiable private information that were originally collected for a research study would generally be described in the consent document for the study that would be generating the research biospecimens or information. Therefore, it is proposed that broad consent to the secondary research use of biospecimens and identifiable private information collected as part of a research study could cover all such research material.
However, in the non-research context, it is recognized that the biospecimens and information that the subject would be asked to permit to be stored or maintained and used for a wide range of secondary research studies would not be as readily understood as in the research context, since such non-research collections are usually less predictable or defined. Therefore, the NPRM proposes that broad consent for the research use of biospecimens or identifiable private information obtained for non-research purposes would be limited to covering either or both of the following: (1) Biospecimens or identifiable private information that exist at the time at which broad consent is sought; and (2) biospecimens or identifiable private information that will be collected up to 10 years after broad consent is obtained for adult subjects, and, for research involving children as subjects, biospecimens or identifiable private information that will be collected up to 10 years after broad consent is obtained or until the child reaches the legal age of consent to the treatments or procedures involved in the research, whichever comes first.
The rationale for these limitations is that individuals will not know what biospecimens and information about them will be collected by an institution in the future. The 10-year time limit may make it more likely that an individual will have a better understanding of the biospecimens and information that would be covered by the broad consent, and may be a sufficiently long enough time period to appropriately facilitate secondary research using biospecimens and information. The NPRM proposes to include the standard for who is a child based upon the definition of “children” as defined at 45 CFR 46.402(a). At the time the child became an adult, the broad consent or permission would no longer be valid and either broad consent would need to be sought from the child-turned adult, or the investigator would need to seek a waiver of informed consent in order to use the individual's
The Common Rule departments and agencies contemplated proposing that the scope of broad consent to secondary research use of individually identifiable clinical information or biospecimens that were originally collected for non-research purposes would be limited to (1) clinical information and biospecimens already existing at the institution at the time broad consent was sought, and (2) clinical information and biospecimens collected as part of an identified clinical encounter. Although it was recognized that this limitation related to an identified clinical encounter would give individuals more meaningful information about the scope of future clinical information and biospecimens that would be covered by their broad consent, it was determined that limiting the scope of the broad consent in this manner would be very difficult to implement and would require rigorous tracking on an individual-subject basis. Therefore, this proposal was not included in the NPRM, and was instead replaced with the above proposal that uses a limitation based on a period of years.
In addition, the Common Rule departments and agencies contemplated proposing that for nonclinical information collected for non-research purposes (
The proposed element of broad consent, at (§ __.116(c)(1)(iv)), includes a requirement that subjects be informed that they may withdraw consent, if feasible, for research use or distribution of the subject's information or biospecimens at any time without penalty or loss of benefits to which the subject is otherwise entitled. Information that has been stripped of identifiers might not be traceable. Thus, it might not be feasible to withdraw consent for future use or distribution in this case. If, however, an investigator committed to permitting a subject to discontinue the use of such information, it is expected that the investigator would honor this commitment by not stripping identifiers. The regulations would not require investigators to make such a commitment.
Another of the proposed elements of broad consent, at (§ __.116(c)(1)(viii)), relates to the public posting of non-identifiable data about a subject. This proposed element of broad consent would include an option, when relevant, for an adult subject or the subject's legally authorized representative to consent or refuse to consent, to the inclusion of the subject's data, with removal of the identifiers listed in the HIPAA Privacy Rule at 45 CFR 164.514(b)(2)(i)(A) through (Q), in a database that is publicly available and openly accessible to anyone. This provision is being proposed in the context of increasing interest in inviting study participants to allow their study data, in some cases including genomic data, to be made publicly available in order to maximize the potential for research that spurs increased understanding of disease processes. Under this provision, the consent document would be required to prominently note the option for the participant to allow the investigator to publically post (
To facilitate the use of broad consent, the NPRM proposes that the Secretary of HHS will publish in the
In addition, two exemptions are proposed related to facilitating secondary research use of biospecimens and identifiable private information when the Secretary's broad consent template is used. These exemptions are described in section II.A.3 of this preamble.
The NPRM also proposes that the template for consent established by the Secretary may serve as the written consent form in circumstances when the proposed exemption categories at § __.104(f) require written consent. In circumstances where § __.104(f)(1) allows for oral consent, a subject's oral consent for secondary research use of identifiable private information must be documented such that the consent is associated with the subject's identifiable information. If this requirement is met through the use of written documentation, the subject would not be required to sign anything.
• No change would be made in the current regulatory framework allowing research use of non-identified private information without consent, except that, when relevant, individuals would be given an option to consent or refuse to consent to the inclusion of their data, with the removal of certain identifiers, in a publicly available database.
• Broad consent would be permissible for the storage or maintenance for secondary research use of biospecimens and identifiable private information, and for the use of such stored material for individual research studies.
• No change would be made to the definition of “legally authorized representative.”
61. Public comment is sought on whether broad consent to secondary research use of information and biospecimens collected for non-research purposes should be permissible without a boundary, or whether there should be a time limitation or some other type of limitation on information and biospecimens collected in the future that could be included in the broad consent as proposed in the NPRM. If a time limit should be required, is the NPRM proposal of up to 10 years a reasonable limitation? Would a limitation related to an identified clinical encounter better inform individuals of the clinical information and biospecimens that would be covered by a broad consent document?
62. Public comment is sought on whether all of the elements of consent proposed at § __.116(c) should be required for the secondary use of biospecimens or identifiable private information originally collected as part of a research study that was conducted without consent because either the original research study met an exclusion or exempt category of research, or a waiver of consent was approved by an IRB.
63. Public comment is sought on whether oral consent should be permissible in limited circumstances as proposed under exemption § __.104(f)(1).
64. Would research subjects continue to be appropriately protected if the
The goals of the proposals related to the waiver of informed consent and the documentation of informed consent are to uphold individuals' autonomy interests in determining whether their biospecimens and identifiable private information may be used for secondary research, to facilitate the recruitment of prospective research subjects, and to create more flexible rules for documenting informed consent for certain subject populations.
Currently the Common Rule permits an IRB to waive the requirements for obtaining informed consent under two sets of circumstances described at § __.116(c) or (d)). The most common set of circumstances requires that four specific criteria be satisfied (§ __.116(d)).
Under the current Common Rule at § __.117(c), IRBs may waive the requirement for the investigator to obtain a signed consent form for some or all subjects. The current criteria for such a waiver may not be flexible enough for dealing with a variety of circumstances, such as when federally sponsored research is conducted in an international setting where for cultural or historical reasons signing documents may be viewed as offensive and problematic.
The ANPRM asked whether changes to the regulations would clarify the current four criteria for waiver of informed consent and facilitate their consistent application. The ANPRM also asked for comments on the information investigators should be required to provide to prospective subjects in circumstances where the regulations would permit oral consent. Additional questions focused on whether there are additional circumstances under which it should be permissible to waive the usual requirements for obtaining or documenting informed consent, and whether there are types of research in which oral consent without documentation should not be permitted.
Many commentators have argued that these conditions for waiver of consent are vague and applied haphazardly at different institutions.
Further, some have argued that the requirements for obtaining waivers of informed consent or waivers of documentation of informed consent are confusing and inflexible, which leads to inconsistent application.
The NPRM offers several proposals related to the waiver or alteration of informed consent provisions (§ __.116(c) and (d) in the current rule, § __.116(e) and (f) in the NPRM). The NPRM proposes at § __.116(f)(1)(iv) to retain the language found in § __.116(d)(2) of the current Rule regarding the necessity to evaluate the rights and welfare of subjects before issuing a waiver of consent or altering consent procedures. Despite the vagueness of the term, IRBs should consider whether there are considerations distinct from the risk of harm and discomfort that the IRB should be able to take into account in deciding whether to approve a waiver or alteration of informed consent. Note that SACHRP's recommendations included a comment that the IRB should determine “. . . that the waiver or alteration does not adversely impact the ethical nature or scientific rigor of the research. . . ,” which implies that there could be ethical considerations other than the degree of risk that could legitimately affect the IRB's decision.
This criterion can be interpreted to include rights conferred by pertinent federal law or regulation, relevant state or local law, the stipulations at § __.101(e) and (f) (in both the NPRM and the current Rule), or laws in other countries where research is to be conducted. It could also include considerations of privacy or the right to decide how someone is going to be treated, where the IRB determines that subjects have such a right that the waiver would adversely impact, or where the waiver would preclude them from obtaining a benefit they would otherwise receive. We recognize that further guidance regarding this criterion would be helpful.
HHS has also evaluated the utility of the term “practicably” contained in the elements of waiver or alteration of consent (§ __.116(d)(3) in the current Rule). The NPRM proposes to keep this terminology at § __.116(f)(1)(ii) in the NPRM. SACHRP has noted that the commonly accepted definitions of the term “practicably” are (1) feasible; (2) capable of being effected, done or put into practice; and (3) that may be practiced or performed; capable of being done or accomplished with available means or resources. SACHRP emphasized this criterion states that the research could not practicably be carried out without the waiver or alteration. In other words, it would not be practicable to perform the research (as it has been defined in the protocol by its specific aims and objectives) if consent was required. Thus it is impracticable to perform the research, and not just impracticable to obtain consent. SACHRP also offered the following concepts to help an IRB determine whether the research could not be practicably carried out without the waiver of consent: (1) Scientific validity would be compromised if consent was required; (2) ethical concerns would be raised if consent were required; (3) there is a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained; (4) practicability should not be determined
SACHRP's recommendations are consistent with OHRP's interpretation of this waiver criterion. Consideration was given to replacing the term practicably with another term such as feasibly, but HHS is uncertain whether such a change would improve the understanding of this criterion. Thus the NPRM proposes to retain this phrase.
Few comments to the 2011 ANPRM were received on this topic although many commenters expressed support for clarifying the key terms through guidance or altering the criteria. In particular, most comments on this topic noted the confusion that IRBs face when trying to understand the meaning of the terms “practicably” and “adversely affect the rights and welfare of subjects.” Some commenters expressed the opinion that the waiver criterion concerning rights and welfare should be interpreted to include reference to rights conferred by other federal laws or regulations, state or local laws, or laws in other countries where research is to be conducted. Some comments reflected concerns about privacy or security. Several commenters also pointed to the need to consider community norms throughout the consent process, including its documentation.
The NPRM proposes to add a new waiver criterion at § __.116(f)(1)(iii), which would require that, for research involving access to or use of identifiable biospecimens or identifiable information, the research could not practicably be carried out without accessing or using identifiers. This criterion was modeled on the comparable criterion in the HIPAA Privacy Rule, which requires that the research could not practicably be conducted without access to and use of the protected health information. The principle embodied in this additional criterion is that non-identified information should be used whenever possible in order to respect subjects' interests in protecting the confidentiality of their data and biospecimens.
Additional more stringent waiver conditions apply to research involving biospecimens, specifically that (1) there are compelling scientific reasons for the research use of the biospecimens; and (2) the research could not be conducted with other biospecimens for which informed consent was or could be obtained. Under this new, more stringent waiver standard, the circumstances in which a waiver could be granted by an IRB should be extremely rare.
The Common Rule departments and agencies considered whether to require institutions or IRBs to report to OHRP when this waiver of consent for research involving the use of biospecimens was approved by an IRB. If such a reporting were required, it is envisioned that OHRP could use the information to consider whether the waiver provision was being implemented appropriately or whether regulatory changes might be needed (
The Common Rule departments and agencies also considered whether the NPRM should propose that a waiver of consent not be permissible for secondary research involving the use of biospecimens. The purpose of such a requirement would be to encourage investigators to seek broad consent for such research. This proposal was not included in the NPRM, but public comments are requested on whether such a prohibition to waive informed consent should be included in the final rule.
In addition, the NPRM proposes that the Common Rule prohibit IRBs from waiving informed consent if individuals were asked and refused to provide broad consent to the storage and maintenance for secondary research use of biospecimens and identifiable private information. If a subject refused to provide broad consent, it is proposed that this refusal would need to be recorded by the investigator to better ensure that the subject's wishes would be honored.
The proposal to not allow any waivers of consent by an IRB with regard to the secondary research use of identifiable private information if an individual was asked to consent to such use, and refused to consent, was thoroughly considered during the drafting of this document. On the one hand, a core initial motivation for this NPRM has been the recognition that we should not be imposing unnecessary burdens on low-risk research that is capable of producing important knowledge. Re-using data that has been generated for other purposes, when appropriate protections for privacy and confidentiality are in place, seems to fit within that category.
Moreover, with society's growing abilities to rapidly generate massive data sets, and manipulate such data using cutting-edge algorithms, research using “big data” seems more important than ever. At the same time, however, it is recognized that if an individual is asked to provide consent and declines or refuses to do so, the individual's choice should be honored, except perhaps under only very rare circumstances that justify overriding an individual's autonomy interest.
Most of the provisions in this NPRM regarding the research use of identifiable private information have led to the conclusion that, when there are appropriate privacy protections in place, the balance between respect for persons and beneficence should come out in favor of facilitating the research, including not requiring informed consent in many instances. In recognition of this circumstance, while the NPRM proposes new consent requirements related to biospecimens (justified primarily by the special autonomy interest of a person in controlling the research use of such biospecimens), it does not impose such consent requirements with regard to research use of a person's identifiable private information. Accordingly, in most respects, the current Rules—which do allow such use without consent, provided that an IRB has reviewed the study and found that it meets the criteria for the waiver of consent—are retained with regard to the secondary research use of such information. For research involving the secondary use of identifiable private information, waivers of consent appear to currently be quite frequently given by IRBs, and represent a significant (and likely growing) portion of the research universe.
Accordingly, even after the implementation of this NPRM, an individual will still generally not have the right to prevent secondary research taking place using their identifiable private information, in the event that an IRB approves a waiver of consent for such a study. (Indeed, this is only one of the circumstances in which the NPRM allows such research to take place without consent; the NPRM has actually expanded such circumstances through some of the exclusions and exemptions, based on the ethical analysis mentioned above.) The main alteration of this rule by the NPRM
This is a complicated issue, and as discussed below, comments are sought on various aspects of the proposal to allow for broad consent for secondary use of identifiable private information, including whether it is appropriate to include the limitation on an IRB's ability to waive consent where a person has been asked to sign a broad consent form, but refused.
The NPRM also clarifies that waivers of informed consent and the waivers related to documenting informed consent might not be permitted for research subject to FDA regulation. For example, research conducted with a waiver of informed consent, or its documentation, may, if submitted in support of a marketing application to FDA, become subject to certain applicable informed consent requirements under 21 CFR part 50.
A provision has also been added at § __.116(g) in the NPRM to address concerns that the current regulations require an IRB to determine that informed consent can be waived under the current § __.116(d) (§ __.116 (e) and (f) in the NPRM) before investigators may record identifiable private information for the purpose of identifying and contacting prospective subjects for a research study. This requirement to waive informed consent is viewed as burdensome and unnecessary to protect subjects, and is not consistent with FDA's regulations, which do not require informed consent or a waiver of informed consent for such activities. This proposal in the NPRM is intended to address these concerns and to make the Common Rule consistent with the FDA's regulations by eliminating the requirement for the IRB to waive informed consent for these activities while explicitly assuring that the information will be protected.
With regard to documentation requirements, the NPRM proposes to alter the language at § __.117(b)(1) to specify that the consent document should include only the language required by § __.116, with appendices included to cover any additional information. The goal here is to reduce the length and complexity of the document and to ensure that the elements of information essential to decision-making receive priority by appearing in the main document.
In addition, the NPRM would make it explicit in the regulatory language at proposed § __.117(c)(1)(iii) that if the subjects are members of a distinct cultural group or community for whom signing documents is not the norm, so long as the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained, the requirement to obtain a signed consent form may be waived. Documentation must include a description as to why signing forms is not the norm for the distinct cultural group or community.
Finally, as discussed above, to facilitate tracking of broad consent to storage or maintenance for secondary research use of biospecimens or identifiable private information, and to provide information to IRBs should IRB review be required, waiver of documentation of consent for the research use of such biospecimens would not be allowed based upon a new provision at § __.117(c)(3). The regulatory language proposed at § __.117(c)(4) would also clarify that waivers of documentation may not be permitted for research subject to regulation by FDA.
• A new waiver criterion would be added at § __.116(f)(1)(iii) requiring that, for research involving access to or use of biospecimens or identifiable information, the research could not practicably be carried out without accessing or using identifiers.
• Additional waiver criteria would apply to research involving the use of biospecimens.
• If a person was asked to provide broad consent to store or maintain for secondary research use biospecimens or identifiable private information and refused to do so, a waiver of consent would not be allowed with respect to the research use of such person's biospecimens or private identifiable information.
• A new provision would be added at § __.116(g) stating that an IRB may approve a research proposal in which investigators obtain identifiable private information without individuals' informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective human subjects of research, through oral or written communication or by accessing records, in order to obtain informed consent, if the research proposal includes an assurance that the investigator will implement standards for protecting the information obtained in accordance with and to the extent required by § __.105.
• The language at § __.117(b)(1) would be altered to specify that the consent document should include only the language required by § __.116, with appendices included to cover any additional information. The goal here is to reduce the length and complexity of the document and to ensure that the elements of information essential to decision-making receive priority by appearing in the consent document.
• A new provision would be added at § __.117(c)(1)(iii) allowing a waiver of the requirement for a signed consent form if the subjects are members of a distinct cultural group or community for whom signing documents is not the norm. This would be allowed only if the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative method for documenting that informed consent was obtained.
65. Public comment is sought on how the waiver criterion regarding “practicably” at § __.116(d)(3) could be explicitly defined or otherwise clarified (
66. Public comment is sought on the proposed differences between the criteria for waiving informed consent for the research use of biospecimens versus identifiable information.
67. Public comment is sought on whether the proposal to permit an IRB to waive consent for research involving the use of biospecimens should be included in the regulations.
68. Public comment is sought on the proposal to permit an IRB to waive consent for the secondary use of biospecimens or information originally collected for
69. Public comment is sought regarding how likely investigators are to seek broad consent for the use of identifiable private information (as contrasted with biospecimens), given that there are provisions within the NPRM that would make it easier to do such research without consent (such as the new exemption at § __.104(e)(2)). In this regard, note that the NPRM proposal to prohibit waiver of consent by an IRB if a person has been asked for broad consent and refused to provide it might create a disincentive on the part of investigators from choosing to seek broad consent for research involving secondary use of identifiable private information. Given the costs and time and effort involved in implementing the system for obtaining broad consent for the use of identifiable private
70. Public comment is sought on the proposed prohibition on waiving consent when an individual has been asked to provide broad consent under § __.116(c) and refused. In particular, how would this prohibition on waiving consent affect the secondary research use of identifiable private information? If an individual was asked to provide such consent, should the absence of a signed secondary use consent be considered a refusal? Does this prohibition on waiving consent for the secondary use of identifiable private information create a disincentive for institutions to seek broad secondary use consent and instead seek a waiver of consent from an IRB? Under what circumstances, if any, would it be justified to permit an IRB to waive consent even if an individual declined or refused to consent?
Public posting of consent forms is intended to increase transparency, enhance confidence in the research enterprise, increase accountability, and inform the development of future consent forms.
Thus, the NPRM proposes a new provision at § __.116(h)(1) that would require that a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency be posted on a publicly available federal Web site that will be established as a repository for such consent forms. The name of the protocol and contact information would be required to be included with the submission of the consent form. The primary purpose of this provision is to improve the quality of consent forms in federally funded research by assuring that—contrary to current practices, under which it is often very difficult to ever obtain a copy of these documents—they eventually would become subject to public scrutiny. It is anticipated that the Web site will be searchable.
Under proposed § __.116(h)(2), the consent form must be published on the Web site within 60 days after the trial is closed for recruitment. By final consent form, it is anticipated that investigators generally will post the version of the consent form that had been most recently approved by an IRB. Note that even though a newer consent form could be developed after the timeframe specified here, investigators would only be required to post one consent form. Thus, even if a modification to a consent form occurs after it has been posted, investigators would not be required to re-post an updated document. Moreover, only one posting would be required for each multi-site study. There is no expectation that a version would need to be posted for each study site.
A Web site would be developed by HHS, which could be used by other Federal departments or agencies, or the other Federal departments or agencies could create their own Web sites for the posting of these consent forms.
• A new provision at § __.116(h) would require that, for clinical trials conducted or supported by a Common Rule department or agency, a copy of the final version of a consent form would have to be posted on a publicly available federal Web site within 60 days after the trial is closed for recruitment.
IRBs were not designed to evaluate risks to privacy and confidentiality, and often have little expertise in these matters. Setting uniform specific standards will help to assure appropriate privacy and confidentiality protections to all subjects, without the administrative burden of needing a specific committee review of the privacy and confidentiality protections of each study.
Increasing research use of genetic information, information obtained from biospecimens, and the ability to more easily merge multiple sources of administrative and survey datasets (
The goal of the NPRM here is to create information privacy protections that would apply to research, calibrated to the level of identifiability and sensitivity of the information being collected.
Currently, the Common Rule at § __.111(a)(7) requires that IRBs evaluate each study with regard to all levels of risk and are expected to determine whether the privacy of subjects and the confidentiality of their information are protected. Under the Common Rule, IRBs must review each individual study's protection plan to determine whether it is adequate with respect to the informational risks of that study.
In addition, the HIPAA Privacy Rule addresses some of these informational risks by imposing restrictions on how individually identifiable health information collected by health plans, health care clearinghouses, and most health care providers (“covered entities”) may be used and disclosed, including for research. In addition, the HIPAA Security Rule (45 CFR parts 160 and 164, Subparts A and C) requires that these entities implement certain administrative, physical, and technical safeguards to protect this information when in electronic form from unauthorized use or disclosure. However, the HIPAA Rules apply only to covered entities (and in certain respects to their business associates), and not all investigators are part of a covered entity. Moreover, the Privacy Rule does not apply specifically to biospecimens in and of themselves.
Separate from the HIPAA Rules, the Privacy Act of 1974, as amended (5 U.S.C. 552a) requires Federal agencies to protect certain information in their possession and control. However, it does not apply to non-Federal investigators.
The ANPRM suggested establishment of mandatory data security and information protection standards for all studies that involve the collection, generation, storage, or use of identifiable or potentially identifiable information that might exist electronically or in paper form or contained in a biospecimen. It put forward the idea that these standards might be modeled after certain standards of the HIPAA Rules and asked a series of questions about how best to protect private information.
Some public comments reflected confusion about the focus of the suggested standards and whether they would apply to information or biospecimens that were not individually identifiable. Although most commenters confirmed the need to protect the privacy and confidentiality of information of human subjects in research, a majority expressed serious concerns about the merits of requiring all investigators to meet standards modeled on certain HIPAA standards, such as those in the HIPAA Security Rule. Most commenters expressed the opinion that certain HIPAA standards are not well suited to some research of various kinds carried out by investigators not subject to the HIPAA Rules. Some commenters claimed that the HIPAA privacy safeguards do not adequately protect individuals' information. Many commenters claimed that standards modeled after certain HIPAA standards would be unnecessarily burdensome for studies in the behavioral and social sciences where the data are often less sensitive than health information.
Some comments maintained that HIPAA-like standards would not always be suitable for the variety of research methods and procedures for the collection and storage of information in research activities not subject to the HIPAA Rules. Some commented that certain HIPAA standards would not be suitable because of the location of the research activity, or because the kind of institution supporting the research was significantly different from a covered entity. Others thought the HIPAA standards create confusion and complications for investigators and institutions that would increase if standards modeled on certain HIPAA standards were applied across the board. At the same time, regardless of the specific standards to be employed under this approach, several commenters noted that the additional administrative burden that might be created by establishing a data security and information protection system could be offset by the decreased time and attention IRBs would have to invest in reviewing every study that required data or biospecimen protections. They also noted that many institutions already have required data and biospecimen protection systems in place.
Some commenters noted that expansion of some of the exemption categories could only be ethically acceptable if those research activities were subject to a requirement for data security and information protection, because information collected for some research studies would no longer be collected under a research plan approved by an IRB. With regard to an absolute prohibition against re-identifying de-identified data, many commenters expressed concern, and provided reasons why re-identification might be valid or even desirable, including the need to return clinically relevant research results to an individual. For example, if the research uncovers information that might have important clinical significance for an individual, re-identification could be used so that the individual could get care. In addition, they pointed out that the current Common Rule requires investigators who re-identify non-identified private information as part of a research study to comply with the current Common Rule regulatory requirements.
The NPRM proposes to require that investigators and institutions conducting research subject to the Common Rule implement reasonable safeguards for protecting against risks to the security or integrity of biospecimens or identifiable private information. Given the significant concerns of public commenters about the idea discussed in the ANPRM of adopting the standards solely modeled on certain standards of the HIPAA Rules, the NPRM proposes several sets of standards, and allows a choice about which to use. First, the NPRM proposes to have the Secretary of HHS publish a list of specific measures that an institution or investigator can use to meet the requirements. The list would be evaluated and amended, as appropriate, after consultation with other Common Rule departments and agencies. The proposed list will be published in the
The list of specific safeguards that would be identified by the Secretary will be designed such that they could be readily implemented by the individual investigator, could build on existing safeguards already in place to protect research data, and would involve minimal cost and effort to implement. These standards would include security safeguards to assure that access to physical biospecimens or data is limited only to those who need access for research purposes. These standards would also assure that access to electronic information is only authorized for appropriate use. Finally, these safeguards would assure that information and biospecimens posing informational risks to subjects would be protected according to appropriate standards.
Second, if an institution or investigator is currently required to comply with the HIPAA rules, then the safeguards required by the Common Rule would be satisfied. No additional requirements are proposed to protect information that is subject to the HIPAA Rules. The NPRM also proposes to clarify at § __.105(d) that the provisions at § __.105 do not amend or repeal the requirements of 45 CFR parts 160 and 164 for the institutions or investigators to which these regulations apply pursuant to 45 CFR 160.102. Institutions or investigators that are not required to follow HIPAA could voluntarily implement the HIPAA Rules and be considered to satisfy the § __.105 privacy protections requirements. For Federal departments and agencies that conduct research activities that are or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and the research will involve a collection of information subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
For the purposes of informing the development of the § __.105 privacy safeguards, comment is sought on what types of safeguards would be appropriate.
There are additional statutes or acts that mandate the protection of privacy and confidentiality of identifiable private information that may be reasonable to include in § __.105(b) as additional standards which, if research is already subject to those standards or a voluntarily election to comply with them is made, should perhaps be viewed as meeting the new requirement. These include:
• The Confidential Information Protection and Statistical Efficiency Act, 44 U.S.C. 3501 note;
• The Family Educational Rights and Privacy Act of 1974, 20 U.S.C. 1232g;
• The Census Act, 13 U.S.C. 1
• Agency for Healthcare Research & Quality (AHRQ) statutory provision protecting the confidentiality of identifiable data obtained for research purposes by AHRQ or its contractors and grantees, 42 U.S.C. 299c–3(c);
• The CDC National Center for Health Statistics (NCHS) statutory confidentiality provision at Section 308(d) of the Public Health Service Act,
• The Substance Abuse and Mental Health Services Administration authorizing statute regarding confidentiality of alcohol and drug abuse patient records at 42 U.S.C. 290dd–2;
• The Department of Justice statute related to confidentiality of information used by the Office of Justice Programs at 42 U.S.C. 3789g;
• The Department of Education statute related to Education Sciences Reform at 20 U.S.C. 9573.
Public comment is sought on whether any of the above referenced statutes or acts would serve the goals of § __.105. Note that the statutes and acts referenced in § __.105(b) are currently referenced in the proposed exclusions at § __.101(b)(2)(i) (exclusion for surveys, educational tests, and public observation) and § __.101(b)(2)(iii) (exclusion for federal departments or agencies to use pre-existing federally generated non-research data). To that end, public comment is also sought as to whether the goals of the NPRM are served by referencing any of the aforementioned statutes, acts, or standards in the exclusions proposed in § __.101(b)(2)(i) and (iii).
In order to reduce burden on IRBs that may under the current regulation be tasked with ensuring that safeguards are commensurate with informational risk, IRB review of required safeguards generally would not be required. Note that while the proposed language at § __.111(a)(7) requires that IRBs consider if the privacy safeguards at § __.105 are sufficient to protect the privacy of subjects and the confidentiality of data, the presumption would be that these privacy safeguards are sufficient in most circumstances.
The new section includes conditions for use and disclosure of research information to other entities, consistent with those protections to participants in research conducted by Federal employees and their contractors. It requires that protections be in place when biospecimens or identifiable private information are shared for appropriate research or other purposes as specified in the rule. Unless required by law, the NPRM would limit the re-disclosure of biospecimens and identifiable private information that were obtained for research purposes to the following four purposes: (1) For human subjects research regulated under the Common Rule; (2) for public health purposes; (3) for any lawful purpose with the consent of the subject; or (4) for other research purposes if the institution or investigator has obtained adequate assurances that: The recipient investigator will implement and maintain the level of safeguards required by this provision, and the research has been approved by an IRB under § __.111 (except for human subjects research that qualifies for exclusion under proposed § __.101(b) or exemption under proposed § __.104 and the recipient will not further disclose the biospecimens or identifiable private information except as permitted by this provision (NPRM at § __.105(c)).
These four purposes are additional uses or disclosures of biospecimens or identifiable private information collected in research, because the subjects themselves consented, or because the information and biospecimens will continue to be safeguarded, or because the public health will be served. For the purposes of this requirement, an institution or investigator must obtain adequate assurances through the use of a written agreement with the recipient of the biospecimens or identifiable private information that the recipient will abide by these conditions. In developing this provision, Common Rule departments and agencies discussed whether it was appropriate to limit the re-disclosure of biospecimens and identifiable private information “unless [such a disclosure was] required by law” or if some other standard (such as “unless [such a disclosure was] authorized by law”) would be appropriate. Public comment is sought on whether limiting re-disclosure to four specific circumstances unless such a disclosure was “required by law” is too restrictive, or whether more permissive standards would better facilitate the NPRM goal of fostering the secondary research use of information.
Also, research involving the collection and use of biospecimens or identifiable private information that would qualify for an exemption under section § __.104(e) and (f) must conform to the privacy safeguards proposed in § __.105. A proposed change also appears at § __.115(c), requiring that IRB records that contain identifiable private information also be safeguarded through compliance with the safeguards proposed at § __.105.
In addition to ensuring that biospecimens and identifiable private information are protected, a benefit of this new provision is that IRBs would not be required to review the individual plans for safeguarding information and biospecimens for each research study, so long as investigators will adhere to them. While there is a presumption that the proposed § __.105 privacy safeguards are sufficient, an IRB may determine that a particular activity requires more than what is discussed in § __.105. Once IRBs are familiar with standard institutional and investigator adopted protections, it is anticipated that they will become more comfortable with the fact that they need not review every protocol for privacy safeguards. In addition, there will be an overall reduction in regulatory burden because IRBs will not have to review security provisions on a case-by-case basis.
Finally, the proposed exemptions found at § __.104(e) and (f), which will permit a larger number of protocols to proceed without IRB review if specific conditions are met, are conditioned on investigators and institutions meeting these privacy and security requirements. Note that there is currently no requirement for an IRB to determine whether investigators are adhering to the § __.105 privacy safeguards for research exempted under § __.104(e) or (f).
• The NPRM would create a set of standards for the protection of information for research to create an effective and efficient means of implementing appropriate protections for information and biospecimens.
• The NPRM also proposes to include limitations for the use and disclosure of information and biospecimens.
• IRBs would be required to safeguard their records in compliance with the provisions at § __.105 if the records contain identifiable private information.
71. Public comment is sought regarding whether particular information security measures should be required for certain types of information or research activities and, if so, what measures and for what types of information or research. Specifically, should the safeguards be calibrated to the sensitivity of the information to be collected?
72. Are the proposed limitations on re-disclosure more or less restrictive than necessary? Are there additional purposes for which re-disclosure of biospecimens or identifiable private information should be permitted?
From the outset of the development of the Common Rule, the importance of consistency across the Federal Government has been recognized. Each
As the label of the Common Rule suggests, there seems to be a compelling case for consistency across Federal departments and agencies regarding guidance on the protections of human subjects. Nevertheless, there are arguments in favor of some departments or agencies imposing specific requirements, apart from the Common Rule, that are tailored to certain types of research. The various agencies that oversee the protection of human subjects range from regulatory agencies, to those agencies and departments that conduct research, and to those that support and sponsor research. In addition, in some cases, statutory differences among the agencies have resulted in different regulatory requirements and agency guidance. Not only do the agencies have different relationships to the research, but they also oversee very different types and phases of research and thus there may be reasonable justifications for differences in guidance. Moreover, achieving consensus across the entire Federal Government may be arduous, preventing timely issuance of guidance.
Each Common Rule agency, and the FDA, is authorized to issue its own guidance with regard to interpreting and implementing the regulations protecting human subjects. That guidance may substantially differ from agency to agency.
Currently, there are multiple efforts to address variation in guidance across the Federal Government, but there is no regulatory requirement for agencies to consult other departments prior to issuance of a policy, to the extent appropriate. As a result, inter-departmental communication is at times uneven, leading to potentially avoidable inconsistencies. The Common Rule departments and agencies have procedures for sharing proposed guidance before it is adopted, and these procedures have generally been successful. Additionally, FDA and OHRP have been working closely to ensure harmonization of guidance and regulation to the extent possible, given the differing statutory authorities and regulatory missions.
The ANPRM did not suggest any specific approaches to harmonization but asked for public comment on a set of questions focused on: (1) The extent to which differences in guidance on research protections from different agencies strengthen or weaken protections for human subjects; (2) the extent to which differences in guidance on research protections from different agencies facilitate or inhibit the conduct of research domestically and internationally; and (3) the desirability of all Common Rule agencies issuing one set of guidance.
Responses to questions in the 2011 ANPRM about the need for harmonization across Common Rule agencies reflected widespread support for such efforts. Several commenters acknowledged the difficulty of getting all Common Rule agencies to agree on all issues, as each has a different mission and research portfolio. However, they encouraged seeking harmonized guidance whenever possible.
Thus, the NPRM proposes that the regulations contain language at § __.101(j) requiring consultation among the Common Rule agencies for the purpose of harmonization of guidance, to the extent appropriate, before federal guidance on the Common Rule is issued, unless such consultation is not feasible.
The Department believes this proposal appropriately recognizes the importance of harmonized guidance by creating an expectation that guidance should only be issued after consultation among the Common Rule agencies, while also permitting guidance to be issued without such consultation when it is not feasible. The proposal also recognizes that harmonization will not always be possible or desirable given the varied missions of the agencies that oversee the protection of human subjects and differences in statutory authorities. Although the NPRM proposal is limited to requiring consultation for the purpose of harmonization, the Common Rule agencies may wish to consult with one another before issuing guidance for reasons other than the purpose of harmonization, and the proposal would not preclude this. Some concerns have been expressed that the proposed language in § __.101(j) does not go far enough to mandate harmonization in guidance between Common Rule agencies. Others are concerned that this provision would, in effect, mean that Common Rule agencies issue fewer guidance documents because of lengthy internal government review and approval processes. Public comment is sought about the effectiveness of the consultation language proposed in § __.101(j), and whether this language should require more (or less) than consultation amongst Common Rule agencies before guidance is issued.
For example, FDA intends to modify its regulations in light of this NPRM, to the extent appropriate, considering its unique statutory framework and regulatory mission. In developing guidance that interprets its human subject protection regulations that mirror the requirements found in the Common Rule, FDA may seek consultation with the Common Rule agencies, to the extent feasible. Further, FDA and OHRP will continue to work together in developing guidance on their respective regulatory requirements that are found both in FDA regulations and in the Common Rule, to the extent feasible.
• The regulations would contain language at § __.101(j) requiring consultation among the Common Rule agencies for the purpose of harmonization of guidance, to the extent appropriate, before federal guidance on the Common Rule is issued, unless such consultation is not feasible.
73. Will the proposed language at § __.101(j) be effective in achieving greater harmonization of agency guidance, and if not, how should it be modified?
The goal is to enhance and streamline the review process, reduce inefficiencies, and hold unaffiliated IRBs directly accountable for regulatory compliance, without compromising ethical principles and protections.
Currently, an institution engaged in non-exempt human subjects research conducted or supported by any Federal department or agency that has adopted the Common Rule is required to hold an OHRP-approved FWA or another assurance of compliance approved by the Federal department or agency conducting or supporting the research. The FWA mandates the application of the Common Rule only to certain federally funded research projects. Most institutions voluntarily extend the applicability of the Common Rule to all the research conducted at their
In addition, IRBs not affiliated with an institution holding an FWA are not directly subject to oversight for compliance through the vehicle of the FWA. OHRP's current practice of enforcing compliance with the Common Rule in situations where an institution relies on an external IRB is through the institutions that are engaged in human subjects research, even in circumstances when the regulatory violation is directly related to the responsibilities of an external IRB. Thus, certain aspects of the regulations are not directly applied to external IRBs.
External IRB review of cooperative research may be problematic given the current lack of direct regulatory accountability and the large volume of cooperative reviews. The inefficiencies of multiple IRB reviews for cooperative studies adds bureaucratic complexity to the review process, and delays initiation of research projects without evidence that multiple reviews provide additional protections to subjects.
The Common Rule currently requires that each institution engaged in a cooperative research study obtain IRB approval of the study, although it does not require that a separate local IRB at each institution conduct such review. In many cases, however, a local IRB for each institution does independently review the research protocol, informed consent forms and other materials, sometimes resulting in hundreds of reviews for one study. When any one of these IRBs requires changes to the research protocol that are adopted for the entire study, investigators must re-submit the revised protocol to all of the reviewing IRBs. This process can take many months and can significantly delay the initiation of research projects and recruitment of subjects into studies.
In 2006, the FDA issued guidance intended to assist sponsors, institutions, IRBs, and clinical investigators by facilitating the use of a centralized IRB review process in cooperative clinical trials of investigational new drugs.
Currently, the choice to have cooperative research reviewed by a central IRB, or by an IRB at another institution, is voluntary under the Common Rule. In practice, most institutions have been reluctant to replace review by their local IRBs with review by a central IRB.
The choice to have cooperative research reviewed by a single unaffiliated IRB (or by an external IRB operated by or affiliated with another FWA-holding institution) currently is voluntary. In practice, most institutions have been reluctant to replace review by their local IRBs with review by a single IRB. Participants in two meetings on alternative IRB models co-sponsored by OHRP in November 2005 and November 2006 indicated that one of the key factors influencing institutions' decisions about this issue is OHRP's current practice of enforcing compliance with the Common Rule through the institutions that were engaged in human subjects research,
In 2009, OHRP issued an ANPRM in the
The ANPRM sought public comment on the feasibility, advantages, and disadvantages of mandating that all domestic (United States) sites in a study involving more than one institution rely on a single IRB for that study. This would apply regardless of whether the study underwent convened review or expedited review. Further, it would only affect which IRB would be designated as the reviewing IRB for institutional compliance with the IRB review requirements of the Common Rule. It would not relieve any site of its other obligations under the regulations to protect human subjects. Nor would it prohibit institutions from choosing, for their own purposes, to conduct additional internal ethics reviews, though such reviews would no longer have any regulatory status in terms of compliance with the Common Rule.
Based on public comments received to the 2009 ANPRM
In late 2014, NIH issued a Request for Comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multisite Research. The response to NIH's proposed policy was robust and largely supportive, with many institutions citing both reduced duplication of effort and faster initiation of research as important factors. A minority, however, pointed to the importance of maintaining independent local IRB review, and expressed doubt over the anticipated efficiencies and cost savings that would be incurred through a centralized model. SACHRP commented on this draft policy, and was generally supportive of voluntary increased use of a single IRB for multi-site studies, as such use may decrease differences among site implementation of protocols. SACHRP concluded that a uniform mandate of single IRB review for all domestic multi-site studies was premature, and recommended a more incentivized approach at this time.
These issues attracted a large number of comments to the 2011 ANPRM, and revealed nearly evenly divided perspectives. Investigators and disease advocacy groups tended to favor the single IRB review requirement. IRB and institutional representatives tended to be opposed to the possible requirement, though many indicated single IRB review should be encouraged. Support was especially strong for single IRB review for cooperative clinical trials for which the evaluation of a study's social value, scientific validity, and risks and benefits, and the adequacy of the informed consent form and process generally do not require the unique perspective of a local IRB. Moreover, depending on the nature of the study, FDA may not permit differences in protocols across sites, which further bolstered commenters' views that the requirements be harmonized across the Common Rule and FDA requirements. Commenters reported incidences of IRBs continuously second-guessing each other, which delayed studies to the point that subject recruitment opportunities were foregone or lost. This problem seemed especially critical in studies of rare diseases and cancers, which nearly always involve multiple research sites.
Support for the use of a single IRB, however, was not restricted to clinical trials. Several commenters cited long delays and burdensome requirements resulting from multiple reviews of studies in the behavioral and social sciences. In addition to the view that these administrative requirements do not enhance protections, supporters of a single IRB review of cooperative studies cited the frequent need for maintaining consistency across sites, which can be degraded by multiple reviews.
Despite support for the ANPRM suggestion, several commenters expressed concern about making such a provision mandatory, stating that the current regulations at § __.114 permit the use of joint review arrangements for cooperative research. They noted that although this option exists, institutions might be hesitant to use it because of liability concerns and the unwillingness of institutions or IRBs to rely on the judgment of other institutions or IRBs. However, several commenters expressed concern about signaling the acceptability of a single IRB for review while allowing institutions to continue to conduct their own ethics review, fearing that such a policy would not correct the current situation, which tends to favor multiple reviews. Thus, they commented that mandating a single IRB might be the only way to achieve the goals of streamlining review while ensuring protections.
Another issue raised was the need to set clearer expectations of the responsibilities of local IRBs that are not designated as the central IRB. A number of commenters supporting the requirement for a central IRB also requested that OHRP issue guidance on how to select the IRB, responsibilities of all parties, and compliance and enforcement policies. Several commenters also requested that OHRP develop a template for reliance agreements to replace inter-institutional agreements currently in use.
Those who expressed concern about the use of a single IRB said some studies, especially in the behavioral and social sciences, might involve significant contextual issues reflecting community norms, standards, and practices, or local culture and customs. Use of a distant IRB might not consider and best protect subjects based on community norms. Others noted that such concerns can be addressed by investigators or IRBs submitting “points to consider” regarding significant contextual or cultural considerations of relevance to their site.
A primary issue posed by those opposed to mandating use of a single IRB in cooperative studies focused on potential loss of accountability and increased liability for the institutions where the research is conducted but where the reviewing IRB is not located.
Taking into consideration this public debate and various sources of public comments, the NPRM proposes a requirement at § __.114(b)(1) mandating that all institutions located in the United States engaged in cooperative research rely on a single IRB as their reviewing IRB for that study. Under proposed § __.114(b)(2), this requirement would not apply to: (1) Cooperative research for which more than single IRB review is required by law (
Based on comments to OHRP's 2011 ANPRM, the NPRM also proposes to add a new provision at § __.101(a) that would explicitly give Common Rule departments and agencies the authority to enforce compliance directly against unaffiliated IRBs that are not operated by an assured institution. This change is proposed to address concerns about OHRP's current practice of enforcing compliance with the Common Rule through the institutions that are engaged in human subjects research, even in circumstances when the regulatory violation is directly related to the responsibilities of an external IRB. In large part, this change was made to facilitate the use of a single IRB in cooperative research, allowing OHRP to enforce compliance with the Common Rule through non-compliant external IRBs rather than the institutions that were engaged in human subjects research. This proposal should encourage institutions to be more willing to rely on a single IRB for cooperative research as required under the NPRM proposal at § __.114. It would reassure institutions using an external IRB because compliance actions could be taken directly against the IRB responsible for the flawed review, rather than the institutions that relied on that review.
Some public commenters responding to the 2011 ANPRM cautioned that extending compliance oversight to external IRBs might serve as a disincentive for some IRBs to be the IRB of record for cooperative research. A majority of commenters expressed an opposing view; that is, holding external IRBs directly accountable for compliance with the regulations would increase the comfort level of institutions in accepting the regulatory review of an external IRB.
Related to this issue is a new provision proposed at § __.103(e) regarding policies for documenting an institution's reliance on an external IRB. That provision states that for non-exempt research involving human subjects covered by this policy that takes place at an institution in which IRB oversight is conducted by an IRB that is not affiliated with the institution, the institution and the IRB should establish and follow written procedures identifying the compliance responsibilities of each entity. These procedures should be set forth in an agreement between the institution and the IRB specifying the responsibilities of each entity in ensuring compliance with the requirements of this policy.
This would only apply to U.S.-conducted portions of studies because the flexibility to make use of external local IRB reviews of international sites should be maintained; it might be difficult for an IRB in the United States to adequately evaluate local conditions in a foreign country that could play an important role in the ethical evaluation of the study.
This policy would apply regardless of whether the study underwent convened review or expedited review. This proposal only affects the decision regarding how an IRB would be designated as the reviewing IRB for institutional compliance with the IRB review requirements of the Common Rule. The reviewing IRB is expected to be selected either by the funding agency or, if there is no funding agency, by the lead institution conducting the study. An agency may solicit input regarding which IRB would be most appropriate to designate as the IRB of record. Public comment is sought on how this will work in practice.
This policy would not relieve any site of its other obligations under the regulations to protect human subjects. Nor would it prohibit institutions from choosing, for their own purposes, to conduct additional internal IRB reviews, though such reviews would no longer have any regulatory status in terms of compliance with the Common Rule. Although a local IRB may conduct its own additional internal review, such a review would not be binding on the local site if not adopted by the single IRB, and the terms of it would not be enforced by OHRP.
Relevant local contextual issues (
The proposal also modifies the current regulations by removing the requirement that only with the approval of the department or agency head may an institution participating in a cooperative project enter into a joint review arrangement, rely upon the review of another IRB, or make similar arrangements for avoiding duplication of effort. Such approval is no longer required.
Some detractors of mandated single IRB review for cooperative research point to concerns regarding implementation logistics, and the time necessary to establish new policies, procedures, and agreements; recognizing this concern, the proposed compliance date is three years from the publication of the final rule.
• IRBs not affiliated with an assured institution that review research covered by the Common Rule would be subject to direct compliance oversight regarding IRB regulatory requirements.
• All U.S. institutions engaged in a cooperative study would rely upon a single IRB for that study, with some exceptions.
74. Is mandated single IRB review for all cooperative research a realistic option at this time? Please provide information about the likely costs and benefits to institutions. Will additional resources be necessary to meet this requirement in the short term? Should savings be anticipated in the long run?
75. What areas of guidance would be needed for institutions to comply with this requirement? Is there something that OHRP could do to address concerns about institutional liability, such as the development of model written agreements?
76. Would it be useful for this requirement to include criteria that Federal departments or agencies would need to apply in determining whether to make exceptions to the use of a single IRB requirement? If so, what should these criteria be?
77. Are the exceptions proposed appropriate and sufficient, or should there be additional exceptions to this mandate for single IRB review than those proposed in the NPRM? If additional exceptions should be included, please provide a justification for each additional exception recommended.
78. Is three years appropriate timing to establish compliance with this provision?
The goal is to reduce or eliminate the need for continuing review in specific circumstances, thereby reducing regulatory burden that does not meaningfully enhance protection of subjects.
The current regulations at § __.109(e) require that IRBs conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year. Except when an expedited review procedure is used, continuing review of research must occur at convened meetings at which a majority of the IRB members are present, including at least one member whose primary concerns are in nonscientific areas. In order for research undergoing continuing review to be approved, it must receive the approval of a majority of those members present at the meeting (§ __.108(b)).
An IRB may use an expedited review procedure to conduct continuing review of research for some or all of the research appearing on the list of research eligible for expedited review
The ANPRM requested comments on eliminating continuing review for all minimal risk studies that undergo expedited review, unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects. For studies initially reviewed by a convened IRB, continuing review would not be required, unless
The NPRM proposes at § __.109(f) eliminating continuing review for many minimal risk studies (namely those that qualify for expedited review), unless the reviewer documents why continuing review should take place (as would be required by § __.115(a)(8)). Moreover, for studies initially reviewed by a convened IRB, continuing review would not be required, unless specifically mandated by the IRB, after the study reaches the stage where it involves one or both of the following: (1) Analyzing data (even if it is identifiable private information), or (2) accessing follow-up clinical data from procedures that subjects would undergo as part of standard care for their medical condition or disease.
In addition, continuing review would not be required for research involving certain secondary research using information and biospecimens that requires limited IRB review in order to qualify for exemption under § __.104(f)(1).
Further, the NPRM proposes at § __.109(f)(2) that an IRB must receive annual confirmation that such research is ongoing and that no changes have been made that would require the IRB to conduct continuing review (that is, the study still qualifies for expedited review because it still meets the criteria listed above and still involves no greater than minimal risk). This confirmation allows the IRB to administratively account for research that is occurring without continuing review. Investigators would continue to be required to submit changes to the protocol to the IRB. This requirement aims to address concerns some might have about institutional liability relating to the status of ongoing research, the possibility for increased noncompliance among investigators no longer required to “check in,” and possible breakdowns in lines of communications between investigators and IRBs. Institutions will have significant flexibility in how they implement this requirement. For example, some might rely on an automated electronic communication with the investigator at one-year intervals after the study was initiated that might merely require the investigator to type “yes” indicating that the study is ongoing and that no changes have been made. It is therefore anticipated that this requirement can be met with minimal time and effort on the part of investigators and IRBs. Investigators would still have the current obligations to report various developments (such as unanticipated problems or proposed changes to the study) to the IRB.
If an IRB chooses to conduct continuing review even when these conditions are met, the rationale for doing so must be documented according to a new provision at § __.115(a)(8).
The NPRM, at § __.115(a)(3), proposes a new requirement for IRBs to maintain records of continuing reviews. Because the NPRM proposes a new provision that eliminates the need for continuing review under specific circumstances (§ __.109(f)(1)), the NPRM at § __.115(a)(8) also proposes that IRBs need to justify the need for continuing review in cases where they will not follow the provision in § __.109(f)(1).
• Continuing review would be eliminated for all studies that undergo expedited review, unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects. For studies initially reviewed by a convened IRB, once certain specified procedures are all that remain for the study, continuing review would not be required, unless specifically mandated by the IRB. However, investigators would be required to provide annual confirmation to the IRB that such research is ongoing and that no changes have been made that would require the IRB to conduct continuing review.
• Continuing review would not be required for research involving certain secondary research using information and biospecimens that requires limited IRB review in order to qualify for exemption under § __.104(f)(1).
IRBs report challenges in assessing the level of risk presented by some studies in order to make the critical minimal risk determination. This is, in part, due to the difficulties in applying the current definition of minimal risk within the Common Rule, particularly because the terms “ordinarily encountered in daily life” and “routine physical or psychological examinations” are not clarified. The goal is to help eliminate this ambiguity as it pertains to expedited review, and improve the efficiency and consistency of minimal risk determinations for some activities.
The concept of “minimal risk” is central to numerous aspects of the Common Rule, the determination of which affects the type of review required, considerations for IRBs in the review process, and the frequency of review. In sum, the review process has been calibrated, for the most part, to the risk of the research.
The current definition of minimal risk at § __.102(i) encompasses research activities where “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
Under the Common Rule at § __.110, a research study can receive expedited review if the research activities to be conducted appear on the list of activities published by the Secretary of HHS that are eligible for such review,
The ANPRM suggested updating the current list of research activities eligible for expedited review; this list was last updated in 1998. It also considered mandating that a federal panel periodically (such as every year or every two years) review and update the list, based on a systematic, empirical assessment of the levels of risk. This would provide greater clarity about what would be considered to constitute minimal risk, and create a process that allows for routinely reassessing and updating the list of research activities that would qualify as minimal risk. The ANPRM asked for public comments on categories of research that should be considered for addition to the current list.
The ANPRM asked for public comment on whether the current regulatory definition of minimal risk is appropriate. The ANPRM further suggested that the “default” assumption would be that a study otherwise eligible for expedited review will be considered minimal risk unless a reviewer documents the rationale for classifying the study as involving more than minimal risk.
Finally, the ANPRM discussed the idea that continuing review would not be required of studies that are eligible for expedited review unless the reviewer, at the time of initial review, determines that continuing review is required, and documents why. In follow-up to this discussion, the ANPRM asked for comments on whether IRBs should be required to report instances when they overrode the default presumption that research appearing on the posted list did not warrant review by a convened IRB.
Based on public comments on the ANPRM, the NPRM proposes changes to the current regulatory language at § __.110(b)(1) regarding expedited review, and will allow expedited review to occur for studies on the Secretary's list
This proposal is in line with public comment to the 2011 ANPRM. Commenters overwhelmingly welcomed the clarification that categories of research found on the published list should be presumed to be minimal risk. However, commenters were largely opposed to requiring IRBs to report instances when they conducted a review by the convened membership (versus an expedited review) for studies appearing on the list. They were opposed because of the additional administrative burden and also because they felt such a requirement would undermine the purview of local review and open IRBs up to second-guessing by OHRP.
Public comments to the 2011 ANPRM expressed both a desire to retain the current definition (slightly less than half) and a desire for changing it (slightly more than half). There were few common themes in the suggested changes to the language other than seeking clarification on what baselines an IRB should consider in determining the meaning of “daily life” and “routine physical or psychological examinations.” Several commenters acknowledged the difficulty of arriving at a concise definition for all circumstances. Those opposed to changing the definition said that IRBs generally understand how to interpret the language and that difficult or challenging application of the definition will persist regardless of the definition for those areas of research where risks are difficult to assess. Commenters recognized that the risks encountered in daily life can vary greatly depending on many factors, for example, where people live, what kind of work they are involved in, what their social and economic environment is, and their baseline health status. Thus, IRBs need to consider all of these issues in making a determination about the level of risk.
Thus, the NPRM does not propose to modify the definition of minimal risk (NPRM at § __.102(j)), but rather proposes adding to the definition a requirement that the Secretary of HHS create and publish a list of activities that qualify as “minimal risk.” This Secretary's list will be re-evaluated periodically, but at least every 8 years, based on recommendations from federal departments and agencies and the public. Note that this will not be an exhaustive list of all activities that should be considered minimal risk under the Common Rule, but will allow IRBs to rely on the determination of minimal risk for activities appearing on the list. IRBs will still need to make minimal risk determinations about activities that do not appear on this list.
In addition, the NPRM proposes to eliminate the parenthetical phrase “of one year or less” at § __.110(b)(2) since annual continuing review of research eligible for expedited review and research that progresses to the point of only involving specified limited activities will no longer be required for all ongoing human subjects research. The NPRM also proposes that the regulations be revised at § __.110(a) to require evaluation of the list of expedited review categories every 8 years, followed by publication in the
For several reasons, the NPRM proposes no changes in the requirement that expedited review be conducted by an IRB member. First, public comments on the 2011 ANPRM were divided on the value of allowing a non-IRB member to conduct such reviews. Those with concerns questioned whether permitting someone other than an IRB member to conduct expedited review would have unintended consequences, such as either increasing or decreasing the number of studies deemed acceptable for expedited review, or by increasing liabilities for the institution. Second, IRB staff members would likely constitute the pool of non-IRB members qualified to conduct expedited review, and the current regulations permit IRB staff members to be IRB members. HHS does not believe a regulatory change is warranted to facilitate expedited review.
Finally, the NPRM contains a requirement at § __.115(a)(9) that IRBs document the rationale for an expedited reviewer's determination that research appearing on the expedited review list is more than minimal risk (
• Expedited review can occur for studies on the Secretary's list
• Evaluation of the list of expedited review categories would occur every 8 years, followed by publication in the
• IRBs will be required to document their rationale when they override the presumption that studies on the
• The Secretary of HHS will create and publish and maintain a list of activities that should be considered minimal risk.
79. How often should the Secretary's list of minimal risk activities be updated? Should advice be solicited from outside parties when updating the list?
80. Is this Secretarial list of minimal research activities a useful tool for the research community, or does it represent a loss of IRB flexibility in risk determination?
These revisions modernize the rule by (1) creating new forms of IRB review for activities relating to storing or maintaining data and biospecimens for later secondary use, and for the review of studies involving certain types of such secondary use; (2) revising two of the existing criteria for approval of research, where there are special considerations related to the involvement of vulnerable populations and for privacy and confidentiality of data provisions; and (3) adding a provision regarding plans to review the return of individual results to participants.
There are several determinations that an IRB must generally make before it can approve a study, which are spelled out in current Common Rule at § __.111. These relate, among other things, to minimizing risks to subjects, determining that there is an appropriate relationship between risks and benefits, and assuring the equitable selection of subjects. The regulations generally require all of these determinations to be made with regard to any study that must undergo IRB review.
The ANPRM asked whether all of the § __.111 criteria should still be required for approval of studies that qualify for expedited review, and if not, which ones should not be required. Currently, before an IRB may approve a research study, including research that is being reviewed under an expedited procedure, the IRB must find that the criteria at § __.111 have been met.
Based on comment to the 2011 ANPRM, the NPRM does not propose to modify the § __.111 criteria that apply to research reviewed under the expedited procedure versus research reviewed under full board review. The NPRM does however propose a number of changes regarding the criteria for IRB approval of research, including (1) creating a new form of IRB review for activities relating to storing or maintaining data and biospecimens for later secondary use; (2) revising two of the existing criteria for approval of research, where there are special considerations related to the involvement of vulnerable populations and for privacy and confidentiality of data provisions; and (3) adding a provision regarding plans to review the return of individual results to participants.
The first set of changes relates to updating the IRB review criteria for research activities relating to storing or maintaining information and biospecimens, and to the secondary use of such information and biospecimens. Paragraph (a)(9)(i) of proposed § __.111 would apply to storage or maintenance for secondary research use of biospecimens or identifiable private information. This provision would eliminate the need for an IRB to make the usual determinations with regard to such an activity. Instead, the IRB would be required to determine that the procedures for obtaining broad consent to the storage or maintenance of the biospecimens or information were appropriate, and met the standards included in the introductory paragraph of § __.116. In addition, if these storage and maintenance activities involved a change for research purposes from the way the biospecimens or information had been stored or maintained, then the IRB would have to determine that the biospecimen and privacy safeguards at § __.105 are satisfied for the creation of any related storage database or repository. Note that in many instances there will be no such change. For example, an individual could sign a consent form allowing broad unspecified future research use of information contained in their medical records, and that information would remain where it is, but be tagged in some manner to indicate that the individual has provided such consent.
This in effect means that the default for such secondary research studies using either biospecimens or identifiable information will be that the initial broad consent would be sufficient, and that there will be no need to obtain a new consent from individuals for each specific research study that is conducted with the biospecimens and information.
The second proposal, relating to vulnerable subjects, is intended to address an inconsistency in the current regulations among three provisions in the current Common Rule that address requirements related to the consideration of vulnerable populations: §§ __.107(a), __.111(a)(3), and __.111(b). Under the current Rule, only § __.111(b) of these three provisions provides that vulnerability to coercion or undue influence is the type of vulnerability that should be considered. It is proposed that the criterion at § __.111(a)(3) be revised to align with the language of § __.111(b) to reflect that the vulnerability of the populations in these research studies should be considered to be a function of the possibility of coercion or undue influence, and that this vulnerability alone should be the IRB focus of concern with respect to this criterion. The proposed change is intended to provide greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections. A comparable change is also proposed at § __.107(a), pertaining to IRB membership. In addition, of these same three provisions in the current Rule, only § __.107(a) identifies “handicapped” individuals (which the NPRM proposes be changed to “physically disabled” individuals as discussed below in section II.G.2.c. of the preamble) as a vulnerable category of subjects. Therefore, to enhance consistency and clarity among these three provisions, it is proposed that the term “physically disabled” be inserted at § __.111(a)(3) and (b). This would mean that physically disabled persons would be among the individuals that the IRB may consider in determining that the selection of subjects is equitable (§ __.111(a)(3)), and that the IRB may consider to be vulnerable to coercion or undue influence (§ __.111(b)). Public comment is being sought on these proposed changes to the provisions related to vulnerable populations. Since it is proposed that the only vulnerability that needs to be considered is vulnerability to coercion or undue influence, and not other types of vulnerability, it is appropriate to review the subject populations to determine whether all of these subject populations identified in these three provisions should be considered vulnerable to coercion or undue influence. In particular, public comment is sought
The third proposed change would be an addition of paragraph (a)(8) to § __.111 clarifying that if an investigator submits as part of the protocol a plan for returning individual research results, the IRB will evaluate the appropriateness of the plan. IRBs need not determine
An additional change is related to the proposed changes at § __.105, and would clarify that it is not an IRB responsibility to review the security plans for biospecimens and identifiable private information for every protocol (
• A new version of more limited IRB approval criteria would be created for activities relating to the storage or maintenance of biospecimens and identifiable private information for the purposes of later doing secondary research with them.
• IRBs considering the § __.111(a)(3) approval criterion regarding equitable selection of subjects would need to focus on issues related to coercion or undue influence in research with vulnerable populations and not other considerations related to vulnerability.
• Physically disabled persons would be among the individuals that the IRB may consider in determining that the selection of subjects is equitable (§ __.111(a)(3)), and that the IRB may consider to be vulnerable to coercion or undue influence (§ __.111(b)).
• IRBs would need to consider the requirements for investigators to protect information, and biospecimens as a criterion for approval of research only if they find the protections under § __.105 are not sufficiently protective.
• If a plan for returning research results is included as part of a protocol, IRBs would be required to determine whether the plan is appropriate. IRBs would not be required to determine whether such a plan is needed.
81. What should IRBs consider when reviewing the plans for returning research results, for example, what ethical, scientific, or clinical concerns?
82. Is the § __.111(a)(3) and (b) focus on issues related to coercion or undue influence in research with vulnerable populations, and not other considerations related to vulnerability, appropriate? Note that this focus also appears in proposed § __.107(a).
83. Should pregnant women and those with physical disabilities be included in the category of subpopulations that may be vulnerable to coercion or undue influence?
The goal is to improve IRB operations and make relevant sections consistent with other areas of the NPRM.
The current Rule outlines IRB functions and operations at §§ __.108 and __.103, and membership requirements at § __.107.
The NPRM contains several proposals for changes in IRB operations, functions, and membership requirements. First, the requirements for recordkeeping by IRBs no longer appear in § __.103 of the rule. They are now described in § __.108(a)(2), (3), and (4).
Also as previously discussed, IRBs would be required to safeguard their records in compliance with the privacy protections described in proposed § __.105 if the records contain individually identifiable information.
Finally, there are four changes to the IRB membership requirements at § __.107(a). The first change is the elimination of the requirement that IRBs not consist entirely of individuals of one gender or profession. This provision is unnecessary, because the requirement that IRB membership reflect members of varying backgrounds and diversity, including gender, will accomplish the same effect. The deletion of this provision in the NPRM is not intended to alter the composition of IRBs from what had been established in the current Rule.
For the reasons discussed above in section II.G.1.d, three additional changes are proposed to § __.107(a). It is proposed that § __.107(a) be modified so that consideration of vulnerability of a subject population would be limited to vulnerability to coercion or undue influence. This proposed change is consistent with the proposal at § __.111(a)(3). The proposed change is intended to result in greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections.
The third change in § __.107(a) is the insertion of “economically or educationally disadvantaged persons” as an example of a vulnerable population, requiring an IRB to give consideration to membership expertise in this area. This language is already included in the current Rule at § __.111(a)(3) and § __.111(b). Adding this category of individuals to
In order to modernize the regulatory language, the fourth change in proposed § __.107(a) is the replacement of the term “handicapped” persons with “physically disabled persons” as an example of a vulnerable population, requiring an IRB to give consideration to membership expertise in this area.
• The provision regarding IRBs avoiding membership that consists entirely of individuals of one gender or profession would be eliminated because the requirement that IRB membership reflect members of varying backgrounds and diversity, including gender, would accomplish the same goal.
• The provision regarding the IRB's expertise in the review of research involving a vulnerable category of subjects would be limited to the subjects' vulnerability to coercion or undue influence
• The phrase economically or educationally disadvantaged persons is included as an example of a vulnerable category of subjects, requiring an IRB to give consideration to membership expertise in this area.
• The term “handicapped” persons is replaced with “physically disabled persons” as an example of a vulnerable category of subjects, requiring an IRB to give consideration to membership expertise in this area.
84. Should populations be considered vulnerable for reasons other than vulnerability to coercion or undue influence? Are the proposed categories appropriate?
The goal of this proposal is to ensure that studies that generally pose the most risk to potential subjects (such as surgical clinical trials), are encapsulated by the Common Rule. The proposal attempts to balance the goals of ensuring that studies where the Common Rule provides meaningful protections to subjects are covered under the rule, while studies where the administrative burdens of the Common Rule outweigh any potential benefits to subjects are not covered.
The Common Rule applies to all research involving human subjects that is conducted or supported by a Federal department or agency that has adopted the policy (§ __.101(a)).
The ANPRM discussed the possibility of the Common Rule applying to all studies, regardless of funding source, that are conducted by a U.S. institution that receives some federal funding for human subjects research from a Common Rule agency.
The ANPRM also asked the public to consider a regulatory option to partially fulfill the goal of extending Common Rule protections to all human subjects research in the United States. The discussed policy would require domestic institutions that receive some federal funding from a Common Rule agency for non-exempt research with human subjects to extend the Common Rule protections to all human subjects research studies conducted at their institution.
In response to ANPRM feedback, the Common Rule NPRM proposes an extension that would ensure that clinical trials are covered by the Common Rule if conducted at an institution in the United States that receives federal support for non-exempt and non-excluded human subjects research, regardless of the funding source of the specific clinical trial.
Note that the purpose of the clinical trials extension is to ensure that clinical trials that would otherwise not be covered by some body of federal research ethics regulations are covered. To that end, if a clinical trial is already subject to FDA oversight but not Common Rule oversight, since that clinical trial is subject to human subjects protection regulations, this change would not affect it. Also note that this proposed extension is based on whether an institution receives funding specifically for non-exempt and non-excluded research. This is because the Common Rule departments and agencies have a more substantial relationship with institutions that receive support from a Common Rule department or agency to conduct non-exempt and non-excluded human subjects research than those institutions that receive such support for only exempt and excluded human subjects research.
Although supporting the principle that all human subjects research regardless of funding source should be conducted ethically, public commenters generally expressed concern and caution about the ANPRM consideration for a variety of reasons. Behavioral and social science investigators thought that this approach would unnecessarily bring less-than-minimal-risk research funded by non-federal sources (
Others argued that such a change was an overreach of federal oversight and constituted an unfunded mandate. Commenters from large academic research institutions felt that this change inappropriately focused heavily on academic institutions, which generally extend protections to all human subjects research at their institution, even if they have not “checked the box”
Industry also expressed concern about having to comply with two sets of regulations, that is, FDA regulations as well as the Common Rule. The ANPRM did not clarify that the changes under consideration would not require compliance with the Common Rule of non-federally funded research subject to regulation by FDA. However, there might continue to be research that would be subject to both sets of regulations involving federal funding of research concerning an FDA-regulated product.
Those commenters who supported a formal extension of the regulations cited the need to have one set of standards for all research, regardless of funding source; however, many noted that absent legislation covering all human subjects research conducted in the United States, it would be difficult to cover all research through a regulatory approach alone—gaps would still remain.
Thus, the NPRM proposes changes in the regulatory language at § __.101(a)(2) to state that the policy extends to all clinical trials as defined by this policy, irrespective of funding source, that meet all of three conditions: (1) The clinical trials are conducted at an institution that receives support from a federal department or agency for human subjects research that is not excluded from this policy under § __.101(b)(2), and the research does not qualify for exemption in accordance with § __.104; (2) The clinical trials are not subject to FDA regulation; and (3) The clinical trials are conducted at an institution located within the United States.
For purposes of this policy, the NPRM proposes at § __.102(b) that a clinical trial be a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. By the term “behavioral outcomes,” the NPRM contemplates the reality that clinical trials may occur outside of the biomedical context. The studies addressed in the proposed definition of clinical trial at § __.102(b) are more likely to involve greater-than-minimal risk, and, therefore, require the highest level of oversight. Limiting the extension of the regulations to only the highest risk research is consistent with the goal of a more risk-based approach to review. For example, surgical clinical trials that do not receive support from a Common Rule department or agency often are outside of the scope of FDA's human subjects protection regulations. Thus, many of these unfunded activities are currently not subject to the protections afforded by the human subjects protection system. This NPRM proposal would cause many of these trials to come under the purview of the Common Rule.
• Clinical trials as defined by proposed § __.102(b), irrespective of funding source, would be subject to oversight, given specified conditions.
85. Public comment is sought on whether there might be unintended consequences from the clinical trials expansion proposed in the NPRM in § __.101(a)(2)(i)). Unintended consequences may include an increase in burden or costs, or an inappropriate redistribution of costs.
86. Public comment is sought as to whether the criterion that the policy extends to all clinical trials conducted at an institution that receives federal support (see the NPRM at § __.101(a)(2)(i)) should be further clarified in some way. For example, should it specify a timeframe for support (
87. Public comment is sought on whether the definition of clinical trial (NPRM at § __.102(b)) should include additional explanation of what is encompassed by the term behavioral health-related outcomes.
There has been concern expressed by some, such as SACHRP, that the current assurance process may be unduly burdensome for institutions and does not provide meaningful protections for human subjects. The changes proposed to the assurance process are intended to reduce unnecessary administrative burdens.
Requirements at § __.103 delineate procedural requirements for institutions and IRBs to follow to comply with the Common Rule.
A number of substantive and procedural modifications are proposed to § __.103 of the Common Rule. The NPRM proposes to move the IRB recordkeeping requirements from § __.103(b)(4) and (5) of the Common Rule. They are now described in the NPRM in § __.108(a)(3) and (4), which pertains to IRB functions and operations
Additionally, the NPRM proposes to eliminate the current Common Rule requirement at § __.103(b)(1) that an institution provide a statement of ethical principles with which an institution will abide as part of the assurance process. This change was made because this provision is generally not enforced. Further, for international institutions that may receive U.S. government funding for research activities, it creates the impression that these international institutions must modify their internal procedures to comport with the set of principles designated on the FWA for activities conducted at those institutions that receive no U.S. government funding. OHRP specifically has received many questions about the extent to which international institutions must adhere to the ethical principles designated as part of the assurance process in research activities conducted by the institution that receive no Common Rule department or agency funding. In order to provide clarity to these international institutions that such measures are not required, the NPRM proposes to delete the requirement at § __.103(b)(1).
The NPRM also proposes to eliminate the requirement in § __.103(b)(2) that an institution designate one or more IRBs on its FWA established in accordance with the Common Rule. The requirement in the current Common Rule at § __.103(b)(2) that IRBs have sufficient meeting space and staff to support IRB reviews and recordkeeping requirements is found in the NPRM at § __.108(a)(1). Note that federal departments or agencies retain the ability to ask for information about which IRBs review research conducted at an institution as part of the assurance process, even if that requirement is not explicitly mandated in the regulations.
Additionally, the NPRM proposes to eliminate the current requirement in § __.103(b)(3) that an up-to-date list of the IRB members and their qualifications be included in an institution's assurance. Instead, proposed §§ __.108(a)(2) and __.115(a)(5) require that an IRB or the institution prepare and maintain a current list of IRB members. This modification also eliminates the current requirement in § __.103(b)(3) that changes in IRB membership be reported to the department or agency head or to OHRP when the existence of an assurance approved by HHS for federalwide use is accepted. SACHRP recommended on March 28, 2008, that OHRP pursue harmonizing the Common Rule with FDA's human subjects protection regulations by eliminating the requirement to submit IRB membership lists. SACHRP members felt that submitting IRB membership lists and reporting all changes in IRB membership to OHRP added little to the protection of human subjects and that eliminating these requirements therefore would reduce unnecessary
Note that in implementing the NPRM an additional, non-regulatory change is planned to the assurance mechanism. The current option of “checking the box” on an FWA to extend HHS's (or other Common Rule supporting agencies') regulatory authority to studies conducted by an institution that do not receive federal support would be eliminated. Importantly, for research other than clinical trials, institutions could, if they so desired, continue for purposes of their own internal rules to voluntarily extend the regulations to all research conducted by the institution, but this voluntary extension would no longer be part of the assurance process and the research would not be subject to OHRP oversight. This change would be expected to have the beneficial effect of encouraging some institutions to explore a variety of new flexible approaches to overseeing low-risk research that is not funded by a Common Rule agency, thus furthering the goal of this NPRM to decrease inappropriate administrative burdens on such research.
In addition, the NPRM proposes to remove the provision found in the current Common Rule at § __.103(d) that a department or agency head's evaluation of an assurance will take into consideration the adequacy of the proposed IRB(s) designated under the assurance in light of the anticipated scope of the institution's activities and the types of subject populations likely to be involved, the appropriateness of the proposed initial and continuing review procedures in light of the probable risks, and the size and complexity of the institution.
To further strengthen the new provision at § __.101(a) giving Common Rule departments and agencies explicit authority to enforce compliance directly against IRBs that are not affiliated with an assured institution, language is proposed at § __.103(e) requiring each IRB, institution, or organization that has oversight responsibility for non-exempt research involving human subjects covered by this policy and conducted by another institution to have and follow procedures for documenting the institution's reliance on the unaffiliated IRB and the respective responsibilities of each entity for meeting the regulatory requirements of this policy. This is already a requirement under the terms of a FWA. Such agreements would have to be included as part of the IRB records, per a proposed requirement at § __.115(a)(10). This change is proposed to address concerns about OHRP's current practice of enforcing compliance with the Common Rule through the institutions that were engaged in human subjects research, even in circumstances when the regulatory violation is directly related to the responsibilities of an external IRB.
Finally, the NPRM would eliminate the requirement in the current Common Rule at § __.103(f) that grant applications undergo IRB review and approval for the purposes of certification. The grant application is often outdated by the time the research study is submitted for IRB review and contains detailed information about the costs of a study, personnel, and administrative issues that go beyond the mission of the IRB to protect human subjects. Therefore, experience suggests that review and approval of the grant application is not a productive use of IRB time.
Note that each assured institution continues to have responsibility for ensuring that the IRBs upon which it relies are registered with OHRP and are appropriately constituted to review and approve the human subjects research, as required under §§ __.107 and __.108.
In developing the NPRM proposals related to the assurance process, consideration was given to the 2014 SACHRP recommendation that the assurance of compliance required under § __.103 be provided through the grant-making or contract process, as one of multiple “Representations and Certifications” already made by institutions when they apply for federal grants, contracts or cooperative agreements.
Ultimately, SACHRP's recommendation was not adopted as an NPRM proposal because of concerns regarding the impact that removal of the FWA process would have on the ability for Common Rule departments and agencies to determine their compliance authority in certain circumstances. As part of SACHRP's recommended change to the assurance process, it was envisioned that only the primary awardee of a grant or contract would be required to obtain an assurance, and that this assurance would be provided through the grant-making or contract process. Subawardees or subcontractors may also be engaged in human subjects research, which extends the funding Common Rule department's or agency's authority to such institutions. However, Common Rule departments or agencies may not be able to ascertain that such institutions are required to follow the Common Rule for such human subjects research at their institution in the absence of an assurance filed with a Common Rule department or agency (including OHRP). In addition, some institutions have over a thousand grants or contracts with Common Rule departments and agencies and therefore would have over a thousand assurances. Certain institutional changes (for example, changes in the signatory official or human protections administrator) will require assurances to be updated. Ensuring that assurances are appropriately updated and keeping track of these updates are likely to pose challenges to Common Rule departments or agencies.
• The regulatory requirement that an institution identify a set of ethical principles on which an institution will rely in all research conducted at that institution, regardless of funding source for the activity, would be deleted.
• The regulatory requirement that a written assurance include a list of IRB members for each IRB designated under the assurance would be replaced by the requirement that a written assurance include a statement that, for each designated IRB, the institution, or when appropriate the IRB, prepares and maintains a current detailed list of the IRB members with information sufficient to describe each member's chief anticipated contributions to IRB deliberation and any employment or other relationship between each member and the institution.
• The regulatory requirement specifying that changes in IRB membership be reported to the department or agency head, or to OHRP when the existence of an HHS-approved assurance is accepted, would be deleted.
• The requirement would be deleted that a department or agency head's evaluation of an assurance take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's activities and
• For non-exempt human subjects research that takes place at an institution in which IRB oversight is conducted by an IRB not affiliated with that institution, the institution and non-affiliated IRB must establish and follow written procedures that identify compliance responsibilities of each entity that are set forth in a written agreement between the institution and the IRB.
88. Would protection to human subjects in research be enhanced if OHRP conducted routine periodic inspections to ensure that the membership of IRBs designated under FWAs satisfy the requirements of § __.107?
The goals of the NPRM revisions in these sections are to: (1) Formally codify the general practice that the ethical standards articulated in the Belmont Report is the ethical standard that Common Rule departments or agencies will use in determining whether an activity is covered under this policy; and (2) ensure that when relevant, either the department or agency conducting or supporting an activity may require additional protections for human subjects.
The current Common Rule allows in § __.101(c), (d), (i) for Federal department or agency heads to determine which specific activities or classes of activities are covered by the rule.
As described in section II.A.2 above, the NPRM proposes to exclude specific categories of low-risk research and non-research activities from the scope of the Common Rule in order to reduce regulatory burden. Of course, there will be cases that call for the exercise of careful judgment in determining whether activities are in an exclusion category, or whether they are within the scope of the Common Rule. The NPRM proposes to retain the Common Rule's current requirement that Federal department or agency heads retain final judgment about the coverage of particular research activities under the Common Rule (§ __.101(c)) and proposes an additional clause that Federal department or agency heads must exercise their authority consistent with the principles of the Belmont Report, in order to require these Federal department and agency heads to make these judgments in consideration of the ethical protection of human research subjects.
The NPRM also proposes at § __.101(d) that the agency may require additional protections for specific types of research supported or conducted by the agency or department; however advance public notice will be required when those additional requirements apply to entities outside of the Federal agency itself. This requirement is intended to promote harmonization between Federal agencies or departments, to the extent possible, and to ensure transparency between funding entities and the regulated community.
Finally, at § __.101(i) the NPRM proposes to amend the criteria for a department or agency waiving the applicability of some or all of the provisions of the policy, by stating that the waiver must be supported by an argument that the alternative procedures to be followed are consistent with the principles of the Belmont Report. Here again, the addition of this provision is to make explicit the ethical basis underpinning how waiver decisions have and must be considered.
New definitions of “Department or agency head” and “Federal department or agency” are provided at § __.102(c) and (d) in the NPRM to help clarify these requirements. The NPRM proposes in § __.102(d) adding a definition of “Federal department or agency” in order to avoid confusion as to whether this phrase encompasses Federal departments or agencies that do not follow the Common Rule, and to clarify that this phrase refers to the department or agency itself, not its bureaus, offices or divisions. This is consistent with HHS's historical interpretation of the current Rule. To distinguish this from the definition of Department or agency head found in the current regulations at § __.102(a) (and found in the NPRM at § __.102(c)), the example of the Secretary of HHS has been inserted to provide clarity. In addition, the definition of “institution” has been changed at § __.102(f) in the NPRM to clarify that departments can be considered institutions for the purposes of this policy.
The current Common Rule at § __.101(h) articulates that when research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. The current provision provides the Declaration of Helsinki, as amended in 1989, as an example of internationally recognized ethical standards that a foreign country might use as its ethical base. In this situation, the current Common Rule provides that if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy.
The NPRM proposes to remove the specific example provided in this provision. A concern with providing a specific example of internationally recognized ethical document is that such a document is subject to change independent of HHS or other Common Rule agencies, and therefore could be modified to contain provisions that are inconsistent with U.S. laws and regulations.
It is anticipated that the effective date of the final rule will be one year after publication in the
• the proposed exclusions in § __.101(b);
• the proposed exemptions in § __.104(d), (e) and (f);
• the proposal to no longer require IRB review of grant applications (§ __.103(f) in the current Common Rule);
• the proposal to eliminate the regulatory requirement in § __.103 specifying that changes in IRB membership be reported to the department or agency head, or to OHRP when an HHS-approved assurance is approved;
• the proposed provision in § __.109(f) to eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow up in conjunction with standard clinical care;
• the proposed provision in § __.116(g) stating that an IRB may approve a research proposal in which investigators obtain identifiable private information without individuals' informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective human subjects of research, through oral or written communication or by accessing records, in order to obtain informed consent, if the research proposal includes an assurance that the investigator will implement standards for protecting the information obtained in accordance with and to the extent required by the § __.105 privacy safeguards; and
• the new provision in § __.117(c)(1)(iii) allowing a waiver of the requirement for a signed consent form if the subjects are members of a distinct cultural group or community for whom signing documents is not the norm, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative method for documenting that informed consent was obtained.
In two cases, institutions would have longer than one year to comply: (1) The proposal for the Common Rule to cover all biospecimens (§ __.102(e) in the NPRM); and (2) the proposal in § __.114(b)(1) regarding identifying a single IRB that would be responsible for the review of certain multi-institutional clinical trials. The compliance date for these requirements would be three years after the publication of the final rule to allow institutions the necessary time to develop institutional policies and procedures necessary to implement these provisions. Comment is sought about whether a different approach to phasing in these provisions would allow the regulated community to better implement the changes proposed in this NPRM. Additional possibilities discussed amongst the Common Rule agencies included providing smaller institutions more time to implement these two changes, and somehow incentivizing early compliance with these provisions.
Further, the extension of the regulations to clinical trials that are not directly funded by a Common Rule department or agency, but that are conducted at an institution that receives funding from a Common Rule department or agency for other human subjects research, would not apply to an institution until the institution received federal funding for non-exempt research in an award made after the effective date of the final rule.
The ANPRM suggested that any change related to the extent to which biospecimens are covered under the Common Rule would only apply to biospecimens collected after the effective date of the revised Common Rule. Commenters noted concerns about imposing consent requirements on the use of biospecimens already collected—that is, not grandfathering in such resources—especially if these biospecimens are non-identified. Requiring that consent be obtained for the use of these materials could result in their being rendered useless for research, which would represent a cost of its own in terms of lost opportunity. This concern was based on the practical limitations involved in obtaining consent for biospecimens that were de-identified in the past, given that it may not be possible to re-contact the original source.
The NPRM addresses the transition provisions for human subjects research (as defined in the NPRM) initiated before the effective date of the policy. Ongoing human subjects research initiated prior to the effective date of the final rule may choose to comply with the provisions that provide additional regulatory flexibility discussed above, but would not need to comply with additional requirements related to:
• Coverage of clinical trials (§ __.101(a)(2));
• Written procedures for documenting an institution's reliance on an unaffiliated IRB (§ __.103(e));
• New exempt research categories and determination requirements (§ __.104(c)–(f));
• Information and biospecimen protection requirements (§ __.105);
• New IRB roster and written procedural requirements (§ __.108(a)(2));
• Continuing review requirements (§ __.109(f)(2));
• Additional IRB approval criteria for information safeguards and return of results plans (§ __.111(a)(7) and (8));
• Requirements for cooperative research (§ __.114);
• IRB recordkeeping requirements for documenting an institution's reliance on an unaffiliated IRB and exemption determinations (§ __.115(a)(10) and (11)); and
• Requirements for obtaining and documenting informed consent (§§ __.116 and __.117) that become effective on the date of the final rule.
Research involving the use of prior collections of biospecimens is permitted if the biospecimens were collected for either research or non-research purposes before the effective date of this subpart, and research use of the biospecimens occurs only after removal of any individually identifiable information associated with the biospecimens.
If prior collections of biospecimens are not individually identifiable, research using such non-identified biospecimens would continue to be not covered by the regulations even after the effective date of this policy.
Similarly, if prior collections of biospecimens are being stored or maintained in an individually identifiable form, but identifiers are removed from the biospecimens before being obtained by an investigator, the investigator's use of such nonidentifiable biospecimens would continue to be not covered by the regulations even after the effective date of this policy.
HHS has examined the impacts of this proposed rule under Executive Order 12866 on Regulatory Planning and Review (September 30, 1993); Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011); the Regulatory Flexibility Act of 1980, Public Law 96–354 (September 19, 1980); the Unfunded Mandates Reform Act of 1995, Public Law 104–4, (March 22, 1995); and Executive Order 13132 on Federalism (August 4, 1999).
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select
The Regulatory Flexibility Act (RFA) requires agencies that issue a regulation to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on state and local governments or has federalism implications. HHS has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. The proposed changes in the rule represent the Federal Government regulating its own program. Accordingly, HHS concludes that the proposed rule does not contain policies that have federalism implications as defined in Executive Order 13132 and, consequently, a federalism summary impact statement is not required.
This NPRM is being issued to propose revisions to modernize, strengthen, and make more effective the current regulations for protecting human subjects. This proposed rule enhances clarity and transparency of the consent process by imposing stricter new requirements regarding the information that must be given to prospective subjects including the elements of consent in a variety of circumstances. It will also allow consent to the secondary research use of biospecimens and identifiable private information, given specific conditions are met. Enhanced protections to subjects are also achieved through greater transparency by posting of informed consent forms used in clinical trials. Several proposed changes (such as explicitly excluding certain activities from the rule, expanding the categories of research exempt from some of the requirements of the proposed rule, and eliminating continuing review by an IRB in some situations) would relieve the burden of unnecessary or unwarranted stringent review of some low-risk studies that do not pose threats to the welfare of subjects. Other proposed changes expand the reach of the regulations by covering all clinical trials, regardless of funding source, and by changing the definition of human subject to include research in which an investigator uses, studies, or analyzes a biospecimen. Single IRB review for multi-institutional studies would also be generally required, except where local IRB review is required by law, to reduce duplicative IRB reviews. Still other revisions clarify or revise requirements for and responsibilities of IRB review and documentation. New exempt categories are proposed, requiring that investigators and institutions comply with minimum standards for protecting privacy. A new process is also proposed through which investigators may input information about a prospective study into a tool in order for that tool to generate exemption determinations.
Table 1 summarizes the quantified and non-quantified benefits and costs of all proposed changes to the Common Rule. Over the 2016–2025 period, present value benefits of $2,629 million and annualized benefits of $308 million are estimated using a 3 percent discount rate; present value benefits of $2,047 million and annualized benefits of $291 million are estimated using a 7 percent discount rate. Present value costs of $13,342 million and annualized costs of $1,564 million are estimated using a 3 percent discount rate; present value costs of $9,605 million and annualized costs of $1,367 million are estimated using a 7 percent discount rate. Non-quantified benefits include improved human subjects protections in clinical trials and biospecimen research not currently subject to oversight; enhanced oversight of research reviewed by unaffiliated IRBs; increased uniformity in regulatory requirements among Common Rule agencies; standardization of human subjects protections when variation among review IRBs is not warranted; revised informed consent forms and processes; improved protection of biospecimens and identifiable private information; and increased transparency of Common Rule agency-supported clinical trials to inform the development of new consent forms. Non-quantified costs include the time needed for consultation among Common Rule agencies before federal guidance is issued; and the time needed by investigators to obtain, document, and track the permissible uses of biospecimens and identifiable private information for secondary research use.
Table 2 summarizes the quantified present value benefits and costs of each proposed change to the Common Rule using a 3 percent discount rate.
Federal regulations governing the protection of human subjects in research have been in place for more than three decades, and 20 years have passed since the Common Rule was adopted by 15 Federal departments and agencies
Under the current system, the regulated community notes that limited IRB resources are often diverted away from focusing on higher-risk studies because of the considerable time spent reviewing low-risk and minimal-risk research. Theoretically, this can result in inadequate attention devoted to research that could seriously harm subjects and unnecessary delay of very low-risk research. From the perspective of human subjects participating in research, the length and complexity of consent forms has been increasing even for relatively low-risk studies, hindering subject understanding of the research activities in which they participate. Current and prospective research subjects have increasingly indicated that they would like to be asked about the future research use of their biospecimens. This desire is not necessarily based on concern of inappropriate disclosure or use of personally identifiable private information generated from the biospecimen, but rather is rooted in the sense that subjects should, whenever possible, be asked about such future research use. Finally, the current system contains some oversight gaps that should be addressed to ensure that the system is covering the riskiest studies and that should compliance-related issues occur, the IRBs responsible for these issues may be held responsible. Provisions are needed to ensure the Rule's consistency with the principles of Belmont Report and to protect privacy in the context of increasing cybercrime and the introduction of modern research methods that may jeopardize subject privacy while not unnecessarily slowing research.
Thus, this NPRM proposes a number of measures to address the issues described above. Provisions that strengthen the requirements for informed consent and promote transparency in the informed consent process include: (1) Requiring that the informed consent form be designed and presented in such a way that facilitates a prospective subject's understanding of why one would want to participate in a research study or not; (2) requiring that the informed consent form present the required information before providing any other information to a prospective subject; (3) revising and adding to the required elements of consent; (4) requiring for certain clinical trials the posting of a copy of at least one version of a consent form on a publicly available federal Web site; and (5) changing the conditions and requirements for waiver or alteration of consent to remove ambiguity, including a new provision that under specific conditions an IRB may approve a research proposal in which investigators obtain identifiable private information without individuals' informed consent for the purpose of screening, recruiting, or determining eligibility of prospective human subjects of research.
Provisions that strengthen humans subjects protections include: (1) A provision that would hold IRBs not affiliated with engaged institutions directly responsible for compliance; (2) extending the scope of the policy to research most likely to involve greater-than-minimal risk, that is, clinical trials; and (3) creating standard privacy safeguards for biospecimens and information.
Provisions that strengthen the extent to which the ethics system promotes the principle of respect for persons: (1) Requiring informed consent for most research activities involving biospecimens, regardless of identifiability; (2) allowing for waiver of informed consent in research activities involving biospecimens only in rare circumstances; and (3) adding a provision that would prohibit waiver of consent if someone has been asked to provide their broad consent for future research use of their biospecimens or identified private information, and that person refuses to give such consent.
New provisions that would allow IRBs greater flexibility to focus resources on higher-risk research include: (1) Distinguishing categories of activities that would be excluded from the rule; and (2) expanding and clarifying categories of exempt research. Provisions that streamline or reduce burden for IRBs or institutions include: (1) Requiring consultation among the Common Rule agencies for the purpose of harmonizing guidance; (2) eliminating an administrative requirement for reporting IRB rosters; (3) removing the requirement that IRBs must review and approve grant applications; (4) eliminating under certain specific circumstances, continuing review for minimal risk studies that undergo expedited review; (5) clarifying when expedited review can occur; and (6) mandating use of a single IRB for multi-institutional studies.
In this section, the analysis of the quantified and non-quantified benefits and costs of the proposed changes to the Common Rule are presented. First, the common assumptions of the analysis are discussed. Then, this section presents the estimated quantified and non-quantified benefits and costs of the specific changes. Because of the lack of available data about IRB effectiveness and how IRBs function operationally,
The analysis relies on common data elements and assumptions, detailed below, concerning the domestic entities, individuals, and IRB reviews affected by the proposed changes to the Common Rule. Many of the estimates are derived from a 1998 NIH-sponsored evaluation of the implementation of Section 491 of the Public Health Service Act, which involved nationally representative surveys of IRBs, institutions, and investigators. Based on a review of the literature, this study contains the best available data on the time spent on protocol reviews as well as the
According to the OHRP database of registered institutions and IRBs, there are approximately 8,035 institutions with a FWA, of which 2,871 have an IRB. Some institutions have multiple IRBs and some IRBs are not affiliated with an institution with an FWA, for a total of 3,499 IRBs.
The OHRP database of registered institutions and IRBs shows that there are 675,390 annual reviews of non-exempt protocols involving human subjects. It is estimated that there are 324,187 initial protocol reviews (48 percent) and 351,203 continuing protocol reviews (52 percent) based on estimates reported in Bell et al.
Based on queries of ClinicalTrials.gov, it is estimated that HHS supports 909 new clinical trials annually, of which 575 are regulated by FDA. In addition, it is estimated that there are 1,399 clinical trials currently not subject to oversight by either the Common Rule or FDA regulations. Finally, based on queries of ClinicalTrials.gov, Common Rule agencies support approximately 5,270 studies total.
Many individuals in various occupations would be affected by the proposed changes to the Common Rule. It is estimated that an average of one institution official at each institution with an FWA would be affected by these changes, for a total of 2,871 institution officials. The OHRP database of registered institutions and IRBs shows that there are 10,197 full-time equivalents (FTEs) staff persons at IRBs working as administrators or administrative staff, and that 89.8 percent of IRBs have an administrator. It is assumed that these individuals work full-time, implying a total of 3,193 IRB administrators and 7,004 IRB administrative staff. The OHRP database of IRB rosters contains 3,359 individuals who serve as IRB chairs and an additional 32,518 voting members. The number of IRB chairs is less than the number of IRBs because some individuals chair multiple IRBs. It is assumed that there are 439,968 investigators who conduct human subjects research in the United States.
The hourly wages of individuals affected by the proposed changes to the Common Rule is estimated using information on annual salaries provided by the U.S. Bureau of Labor Statistics and the U.S. Office of Personal Management. The salary of postsecondary education administrators is used as a proxy for the salary of institution officials; the salary of lawyers is used as a proxy for the salary of institution legal staff and IRB administrators; the salary of office and administrative support workers is used as a proxy for the salary of IRB administrative staff; the salary of postsecondary health teachers is used as a proxy for the salary of IRB chairs and IRB voting members; the salary of postsecondary teachers is used as a proxy for the salary of investigators; the salary of database and systems administrators and network architects is used as a proxy for the salary of database administrators; and the salary of all occupations, as a proxy for the salary of prospective human subjects. The federal employees affected by the proposed changes to the Common Rule are assumed to be Step 5 within their GS-level and earn locality pay for the District of Columbia, Baltimore, and Northern Virginia. Annual salaries are divided by 2,087 hours to derive hourly wages. To project wages over 2016–2025, wages are adjusted for growth over time using the average annual per capita growth in real wage income over 1929–2012 reported by the U.S. Bureau of Economic Analysis, which is 2.1 percent. The total dollar value of labor, which includes wages, benefits, and overhead, is assumed to be equal to 200 percent of the wage rate.
The RIA calculates person-hours by occupation per initial protocol review and per continuing protocol review based on each occupation's share of total person-hours reported in Bell et al. In particular, Bell et al. reports that institution officials account for 4 percent, IRB administrators account for 28 percent, IRB administrative staff account for 30 percent, IRB chairs account for 7 percent, and IRB voting members account for 31 percent of total person-hours. The RIA assumes that the average number of person-hours spent per review equals the weighted average of the person-hours spent per convened review and the person-hours spent per expedited review. It is further assumed that convened review requires twice as many person-hours as expedited review.
Table 3 shows the number of entities affected by the proposed changes to the Common Rule and other common assumptions of the analysis (described above).
Presented below is an analysis of the quantified and non-quantified benefits and costs of the proposed changes to the Common Rule. For each proposed change, we describe and explain the need for the change, provide a qualitative summary of the anticipated benefits and costs, describe the methods we use to quantify benefits and costs, and then present estimates.
Domestic institutions, IRBs, and investigators would need to spend time learning the proposed changes to the Common Rule once training materials become available to them. In addition, IRBs and OHRP would need to update training materials for investigators. Finally, OHRP would need to develop guidance, templates, lists, and a number of electronic resources (as stated in the NPRM).
The RIA estimates that institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators would each spend 5 hours to learn the proposed changes to the Common Rule. It is also estimated that institution officials would spend two hours to learn new procedures, IRB administrators would spend 20 hours, and administrative staff would spend 80 hours. Based on the estimates presented in Table 3, the dollar value of their time is calculated by multiplying hours by their estimated 2016 wages and adjusting for overhead and benefits. For example, to calculate the dollar value of time spent by institution officials to learn the proposed changes to the Common Rule in 2016, we multiply the number of institution officials (2,871) by the number of hours spent per institutional official (5), by the projected hourly wage of institution officials ($48.20), and by the adjustment factor for benefits and overhead (2).
In order to develop the resources required by the NPRM, it is anticipated that OHRP would need:
• Three staff people at the GS–14 level to: (1) Promote harmonization efforts to issue guidance across Common Rule agencies and departments; (2) develop a number of “Secretary's Lists” (akin to guidance documents) referenced in the rule that would be periodically reviewed and revised; (3) develop template agreements/contracts for use by the regulated community; (4) manage the administrative transition to the new processes proposed in the NPRM; and, (5) develop the language and technical requirements for a web-based tool that would allow investigators (and others) to determine if a project fits into a category of research exempt from certain regulatory requirements.
• One staff person at the GS–13 level to manage process changes proposed in the NPRM, and assist with implementation for the web-based tools and portals proposed.
• One staff person at the GS–9 level to provide technical support for the web-based portals proposed in the NPRM.
In addition, the first year after a final rule is published staffing resources beyond what is described above would be necessary:
• Three staff people at the GS–14 level to draft new guidance and revise old guidance.
• One staff person at the GS–14 level to conduct educational seminars.
OHRP also anticipates the following in non-personnel costs:
• Technical development of a web-based tool that investigators (and others) may use to determine if a project fits into a category of research that is exempt from certain regulatory requirements ($350,000)
• Technical development of two web-based portals for investigators to post final consent forms for HHS-funded clinical trials, and for investigators that conduct certain types of demonstration projects to post information about said projects ($200,000)
• Developing five educational seminars (including travel) to educate the public about the requirements of the new rule ($200,000)
• Upgrading equipment for education activities ($50,000)
Present value costs of $208 million and annualized costs of $24.3 million are estimated using a 3 percent discount rate; present value costs of $199 million and annualized costs of $28.3 million are estimated using a 7 percent discount rate. Table 4 summarizes the quantified
The NPRM proposes a change to place unaffiliated IRBs within the realm of entities to which the policy applies. This new provision gives Common Rule departments and agencies explicit authority to enforce compliance directly against IRBs that are not affiliated with an assured institution. This change addresses concerns about OHRP's current practice of enforcing compliance with the Common Rule through the institutions that were engaged in human subjects research, even in circumstances when the regulatory violation is directly related to the responsibilities of an external IRB. This change should encourage institutions to more willingly rely on qualified unaffiliated IRBs for cooperative research, as is required under the proposed changes at § __.114 (see section III.D.2.s of this RIA below).
The OHRP database of assured institutions and registered IRBs shows that there are approximately 449 IRBs not affiliated with an institution holding an FWA that would now be subject to oversight. These IRBs would develop an estimated average of 10 written agreements with other institutions each year as a result of this proposal. It is further estimated that each agreement would require an average of 10 hours of institution legal staff time and 5 hours of IRB administrator time to complete.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value costs of $84.6 million and annualized costs of $9.93 million are estimated using a 3 percent discount rate; present value costs of $69.2 million and annualized costs of $9.86 million are estimated using a 7 percent discount rate. Table 5 summarizes the quantified and non-quantified benefits and costs of extending oversight to IRBs unaffiliated with an institution holding an FWA.
The proposed rule would extend the regulations to cover clinical trials conducted at an institution in the United States that receives federal support from a Common Rule department or agency for non-exempt, non-excluded human subjects research, regardless of the funding source of the specific clinical trial. Extension of the rules would not apply to clinical trials already regulated by FDA.
A small percentage of clinical trials currently are not subject to oversight by either the Common Rule or FDA regulations. This change in policy gives OHRP the authority to conduct oversight compliance of clinical trials not otherwise subject to human subjects protection regulations. The benefits to be gained in terms of equitable and just distribution of protections to all subjects of clinical trials warrant closing this gap in the current system. Moreover, while it is expected that this extension would apply to only a small percentage of clinical trials, they are the type of studies that often pose the greatest risks to subjects. Since this extension is expected to bring research that poses the most risk to research subjects under the rules, it is presumed that the current option in the FWA that allows institutions to voluntarily extend the funding Common Rule department or agency's compliance oversight authority to all research conducted at an institution regardless of funding source (
Although more research would be covered by the policy, the extension is contingent on an entity receiving federal support for non-exempt human subjects research; thus, the entity already should have an established IRB in place and would not incur costs establishing one or contracting with an unaffiliated IRB.
The RIA estimates that there are 1,399 clinical trials currently not subject to oversight by either the Common Rule or FDA regulations. It is estimated that in 2016 all 1,399 of these clinical trials would undergo convened initial review. In subsequent years, an estimated 672 protocols would undergo convened initial review, 502 would undergo convened continuing review, and 225 would undergo expedited continuing review based on the distribution of reviews presented in Table 3.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value costs of $18.3 million and annualized costs of $2.15 million are estimated using a 3 percent discount rate; present value costs of $15.1 million and annualized costs of $2.15 million are estimated using a 7 percent discount rate. Table 6 summarizes the quantified and non-quantified benefits and costs of oversight for clinical trials currently not subject to oversight.
Six categories of activities would be excluded from the regulatory requirements of the Common Rule because they are not considered research as defined in § __.102(l) in the NPRM: (1) Certain data collection and analysis activities conducted for an institution's own internal operation and program improvement purposes; (2) certain activities that focus directly on the specific individuals about whom the information is collected (
Federal agencies (and some institutions in the regulated community) engaged in activities considered in these exclusions already interpret such activities as excluded from the regulations. Thus, in general, the exclusions found in proposed § __.101(b)(1) represent a proposed codification of current practice. However, comments to the ANPRM suggested that at many institutions, activities that would now be explicitly excluded from the policy are being routinely reviewed by IRBs. While many
Institutions, investigators, and IRBs involved in supporting, conducting, or reviewing these activities would no longer incur the costs of IRB review and approval and continuing review. Activities that were not intended to be subject to the regulations would clearly be excluded, allowing such activities to proceed without delays caused by the need for IRB submission, review, and approval.
It is estimated that 6,754 annual reviews of protocols (1.0 percent) would no longer be conducted as a result of the exclusions proposed in § __.101(b)(1). Of these reviews, 2,237 would have undergone convened initial review, 1,005 would have undergone expedited initial review, 2,423 would have undergone convened continuing review, and 1,089 would have undergone expedited continuing review based on the distribution of reviews presented in Table 3.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $74.0 million and annualized benefits of $8.67 million are estimated using a 3 percent discount rate, and present value benefits of $60.5 million and annualized benefits of $8.61 million are estimated using a 7 percent discount rate. Table 7 summarizes the quantified and non-quantified benefits and costs of excluding these activities from the requirements of the Common Rule.
The NPRM proposes that four additional categories of research activities be explicitly excluded from the regulatory requirements of the Common Rule because they are low-risk and already subject to independent controls in the absence of the protections of the Common Rule. These are: (1) Certain research activities that involve the use of certain educational tests, survey procedures, interview procedures, or observation of public behavior (a revised version of current exemption category 2); (2) certain research activities involving the collection or study of information (a revised version of current exemption category 4); (3) certain research activities conducted by a government agency using government-generated, non-research data; and (4) certain data collection and analysis activities using identifiable health information subject to the HIPAA Privacy Rule.
The current Common Rule articulates two exemptions (current Rule at § __.101(b)(2) and (4)) that appear in a similar format in the proposed NPRM exclusions. Current Common Rule exemption category 2 is found in the NPRM in § __.101(b)(2)(i); current exemption category 4 is found in NPRM § __.101(b)(2)(ii). In addition to being considered excluded from the rule (rather than exempt from certain requirements of the rule), current exemption category 2 (NPRM § __.101(b)(2)(i)) has been clarified to state that interventions in conjunction with collection of data through the use of educational tests, survey procedures, interview procedures or observation of public behavior uninfluenced by the investigator (including visual or auditory recording) may not be used in research activities that qualify for this exclusion. For the research activities at issue in the NPRM at § __.101(b)(2)(i), it is presumed that the activities poses little to no risk to subjects, and that the subjects knowingly and willingly
Four changes are proposed to current exemption category 4 (NPRM at § __.101(b)(2)(ii)). First, the provision would now be considered excluded from the rule, not just exempt from certain requirements of the rule. Second, the provision no longer includes pathological specimens or diagnostic specimens. Third, NPRM § __.101(b)(2)(ii) removes the word “existing” from the provisions. This is intended to clarify the scope of the exclusion to allow for information that will be collected in the future. Finally, a condition is added requiring that the exclusion may only be used when the investigator has no plans to contact subjects, re-identify subject, or otherwise conduct an analysis that could lead to creating identifiable private information.
Neither the exclusion at NPRM § __.101(b)(2)(iii) (certain research activities conducted by a government agency using government-generated, non-research data) nor the exclusion at NPRM § __.101(b)(2)(iv) (certain data collection and analysis activities using identifiable health information subject to the HIPAA Privacy Rule) appear in the current Rule. These research activities are excluded because human subjects are independently protected through other mechanisms or laws. It is anticipated that the exclusion of activities regulated by HIPAA as health care operation activities, public health activities, or research (NPRM at § __.101(b)(2)(iv)) would represent a significant reduction in the volume of activities an IRB reviews. For example, the proposed exclusion at § __.101(b)(2)(iv) would mean that at institutions subject to the HIPAA regulations, projects where one is simply analyzing protected health information from medical charts would not be required to undergo IRB review.
Institutions, investigators, and IRBs involved in supporting, conducting, or reviewing these activities would no longer incur the costs of IRB review, approval, and continuing review. Activities that were not intended to be subject to the regulations would clearly be excluded, allowing such activities to proceed without delays caused by the need for IRB submission, review, and approval.
The RIA estimates that 67,539 annual reviews of protocols (10.0 percent) would no longer be conducted as a result of the proposed exclusions in § __.101(b)(2). It is anticipated that the exclusion of certain activities covered by the HIPAA Privacy Rule would drive the estimated reduction in annual IRB reviews of protocols. Of these reviews, 22,369 would have undergone convened initial review, 10,050 would have undergone expedited initial review, 24,233 would have undergone convened continuing review, and 10,887 would have undergone expedited continuing review based on the distribution of reviews presented in Table 3.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $740 million and annualized benefits of $86.7 million are estimated using a 3 percent discount rate, and present value benefits of $605 million and annualized benefits of $86.1 million are estimated using a 7 percent discount rate. Table 8 summarizes the quantified and non-quantified benefits and costs of excluding these activities from the requirements of the Common Rule.
The proposed rule would require consultation among the Common Rule agencies for the purpose of harmonization of guidance, to the extent appropriate, before federal guidance on the Common Rule is issued, unless such consultation is not feasible. The proposal also recognizes that harmonization would not always be possible or desirable given the varied missions of the agencies that oversee the protection of human subjects and differences in statutory authorities. Note that this is a codification of harmonization efforts currently occurring across Common Rule agencies.
This proposal appropriately recognizes the importance of harmonized guidance for the regulated community by creating, as much as possible, consistent interpretations of the regulations.
There is no compliance requirement for the regulated community associated with this provision. It is anticipated that harmonization would create greater
As this change likely would not impact staffing requirements at Common Rule agencies, no costs are quantified here. It is possible however, that the harmonization requirement could result in it taking longer for Common Rule agency guidance to be approved and issued to the public. Similarly, as it is unclear the extent to which this change would reduce the time IRBs spend on reviewing protocols, benefits are also not quantified. Table 9 summarizes the non-quantified benefits and costs of clarifying and harmonizing regulatory requirements and agency guidance.
The NPRM proposes to expand the definition of human subjects to include research in which an investigator obtains, uses, studies or analyzes a biospecimen. This would apply regardless of the identifiability of the biospecimen. Generally, investigators would not be allowed to remove identifiers from biospecimens without obtaining informed consent or a waiver of consent. Written consent would generally be required for such activities. Thus, this change will significantly expand the amount of research that is subject to the Common Rule. This requirement would not apply to biospecimens and information already collected at the time the final rule is published. Proposed § __.101(b)(3)(i) would exclude research activities involving non-identified biospecimens where no new information about an individual is generated. While activities such as developing new testing assays could be excluded under this provision, it is anticipated that under the NPRM proposals, most research with biospecimens would now fall under the Rule.
At its core, this proposal is intended to promote the ethical principle of respect for persons. In addition to promoting respect for persons in the research enterprise, the proposed regulatory structure for research with biospecimens (whereby consent is sought for almost all research activities involving biospecimens) will encourage investigators to retain identifiers, which can enhance research by preserving the ability to link to important additional information about the subject. Additionally, members of the regulated community have reported situations where, even though not currently required by regulation, investigators were told by an IRB that they needed to obtain study-specific consent for research activities involving non-identified biospecimens. Under the current NPRM proposals, such a situation would not occur because consent—be it broad or study specific—would always be obtained for research involving biospecimens.
While this proposal will promote the ethical principle of respect for persons, it also will significantly increase the volume of studies for which investigators must seek and document informed consent (unless more stringent waiver criteria are met). The RIA estimates that there are 250,000 studies using biospecimens each year that are not currently subject to oversight by either the Common Rule or FDA regulations because they have been stripped of identifiers. Extrapolations from 1999 data
In the absence of comprehensive data, to calculate the number of protocols that will now be covered, two approaches are proposed; public comment is requested on these estimates and approaches. Under method one, it is estimated that approximately 50 biospecimens will be used on average per research protocol involving biospecimens. This gives a potential 300,000 new research protocols using
Under method two, biospecimen repository representatives report that roughly 90 percent of their collections are used in non-identified form in research activities that do not fall under the current Common Rule. Thus, only 10 percent of biospecimen studies are currently covered by the Common Rule, representing a 9:1 ratio of studies involving non-identified biospecimens to studies involving identifiable biospecimens. Of the 246,382 new protocols each year that are non-exempt (Table 3), we assume conservatively that 10–15 percent are using identifiable biospecimens. This equates to between 24,638 and 36,957 new studies each year using identifiable biospecimens. As previously discussed, it is estimated that the number of biospecimen studies that occur on non-identified biospecimens each year is approximately 9 times the number of studies using identifiable biospecimens, or between 221,741 and 332,613 studies each year. Thus, under method two, an estimate of 250,000 new studies on non-identified biospecimens each year is also reasonable.
In order to facilitate research with biospecimens, the NPRM proposes to create separate elements of broad consent (NPRM at § __.116(c), discussed in III.D.2.u below) such that investigators and institutions may seek, and individuals may grant, consent for future unspecified research activities. The NPRM also proposes an exemption that relies on obtaining broad consent for future, unspecified research studies (NPRM at § __.104(f)(2)). In order to be eligible for the exemption proposed in § __.104(f)(2), broad consent must have been sought and obtained using the Secretary's template for broad consent (described in proposed § __.116(d)(3)), and the investigator must not anticipate returning individual research results to subjects. To facilitate secondary research using biospecimens and identifiable private information, the NPRM also proposes an exemption for the storage and maintenance of biospecimens and identifiable private information for future, unspecified, secondary research activities (NPRM at § __.104(f)(1)), which is described in more detail in Section III.D.2.n below).
The exemption proposed at § __.104(f)(2) is specifically for secondary research studies involving biospecimens and identifiable private information that have been or will be acquired for purposes other than the currently proposed research study. If a secondary research study does not meet the requirements of this exemption category, the investigator would need to seek IRB review of the study, and would need to obtain either study-specific consent or a waiver of informed consent under the Common Rule. Note that for biospecimens an IRB would apply the more stringent waiver criteria at proposed § __.116(e)(2) or (f)(2). For identifiable private information, an IRB would apply the waiver criteria at proposed § __.116(e)(1) or (f)(1), which are almost identical to the waiver criteria in the current Common Rule.
The proposed exemption at § __.104(f)(2), also ensures that in secondary research conducted with biospecimens or identifiable private information, appropriate privacy safeguards are in place (through requiring adherence to the privacy safeguards described in § __.105). Thus, although this provision is an expansion in the nature of research that is exempt, it is accompanied by certain requirements and safeguards.
It is anticipated that a majority of studies that utilize this exemption will be biospecimen studies. The extent to which individuals conducting secondary research studies involving identifiable private information will utilize this exemption is unknown given that there are additional pathways under this proposed rule to facilitate secondary research activities involving identifiable private information is unknown. To that end, the benefits and costs associated with this provision only take into consideration secondary research involving biospecimens. It is further anticipated that these revisions will result in higher value research with biospecimens being conducted with subjects' consent and without the need for full IRB review, or the need to go back to subjects to obtain consent for every secondary research study, as long as certain conditions are met.
Because the estimated 250,000 biospecimen studies each year that will be newly covered under the rule as a result of the proposed modification to the definition of human subject will likely be low or minimal risk, the RIA assumes that all of these will be eligible for the § __.104(f)(2) exemption (so long as consent—broad or study specific—was sought and obtained). Benefits and costs associated with obtaining and tracking broad consent are discussed below in section III.D.2.u of this RIA. Because the compliance date for the expansion to the definition of human subject will be three years after the date of publication of a final rule, the benefits and costs described below assume a start date of 2019.
As required under § __.104(c), an exemption determination must be made and documented for each of the 250,000 newly covered biospecimen studies. It is anticipated that in 50 percent of these studies (125,000 studies), investigators will spend 30 minutes entering information into the HHS-created decision tool in order for that tool to generate an exemption determination. In the remaining 125,000 studies, it is anticipated that investigators will spend 30 minutes preparing and submitting information about the study to an individual able to make exemption determinations (per § __.104(c)). An individual at the IRB voting member level will spend an estimated 30 minutes per study to make an exemption determination.
In the absence of the proposed exempt category of research at § __.104(f)(2) but taking into consideration the expansion to the definition of human subject, it is estimated that each year, all 250,000 of these studies will undergo convened initial review. In subsequent years, it is estimated estimate that 120,000 protocols would undergo convened initial review, 89,700 would undergo convened continuing review, and 40,300 would undergo expedited continuing review based on the distribution of reviews presented in Table 3.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value costs of $101 million and annualized costs of $11.9 million are estimated using a 3 percent discount rate; present value costs of $77.8 million and annualized costs of $11.1 million are estimated using a 7 percent discount rate. Table 10 summarizes the quantified and non-quantified benefits and costs of amending the definition of human subject.
The NPRM proposes to modify the requirements of the assurance process in the following ways. First, the NPRM proposes to delete the requirement in the current Common Rule at § __.103(b)(1) of identifying a statement of principles governing all research at an institution. As discussed in section II.H.2 of this preamble, the requirement for institutions to designate a set of ethical principles to which that institution will abide in all research activities is generally not enforced. Further, for international institutions that may receive U.S. government funding for research activities, it creates the impression that these international institutions must modify their internal procedures to comport with the set of principles designated on the FWA for activities conducted at those institutions that receive no U.S. government funding. In order to provide clarity to these international institutions that such measures are not required for activities that receive no Common Rule department or agency support, this provisions has been deleted.
The requirement that a written assurance include a list of IRB members for each IRB designated under the assurance would be replaced by the requirement that the assurance include a statement that for each designated IRB the institution, or when appropriate the IRB, prepares and maintains a current detailed list of the IRB members with information sufficient to describe each member's chief anticipated contributions to IRB deliberation; and any employment or other relationship between each member and the institution. The regulatory requirement at § __.103(b)(3) that changes in IRB membership be reported to the department or agency head, or to OHRP when the existence of an HHS-approved assurance is accepted, would be deleted, eliminating the requirement. Instead, an institution would be required under proposed § __.108(a)(2) to maintain a current IRB roster, but such a roster would not need to be submitted to OHRP or other agency managing the assurance of compliance process.
The proposed changes to the IRB roster requirement are expected to reduce administrative burden and have the following additional beneficial effects, without having any significant impact on the protection of human subjects:
• Reduction in the administrative burdens on institutions related to the submission of IRB membership lists to OHRP and, in some cases, to the departments and agencies that process their own assurances;
• Reduction in the administrative burdens on OHRP with respect to reviewing and processing new and updated IRB membership lists as part of the IRB registration process, as well as reductions, in some cases, in the administrative burdens on other departments and agencies that receive and review IRB membership lists and changes in IRB membership as part of their own assurance processes;
• In some cases, reduction in the volume of records that need to be created and retained by the departments and agencies regarding the review and processing of IRB membership lists; and
• Simplification of the process for the electronic submission and acceptance of IRB registrations via the OHRP Web site.
In addition, HHS anticipates modifying the FWA so that institutions would no longer have the option to “check the box” on an assurance and voluntarily extend the funding Common Rule department or agency's regulatory authority to all research conducted at an institution regardless of funding source. For research other than clinical trials, institutions could continue to voluntarily apply the regulations to all research conducted by the institution, but this voluntary extension would no longer be part of the FWA. Members of the regulated community report that whether or not they “check the box” on an assurance form, they tend to voluntarily apply the regulations to all research activities taking place at an institution regardless of funding. Thus, the removal of this option on an assurance form likely would not impact community practice. To that end, no costs have been associated with this provision.
Finally, the current requirement at § __.103(d) that a department or agency head's evaluation of an assurance take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's activities and the types of subject populations likely to be involved, the appropriateness of the proposed initial
The deletion of this provision would eliminate an administrative process that is no longer meaningful given the purpose and design of the FWA and OHRP's processes for reviewing IRB registrations and reviewing and approving FWAs. This change also harmonizes the Common Rule with FDA's human subjects protection regulations by eliminating the requirement to submit IRB membership lists.
The RIA estimates that administrative staff at each IRB would spend 5 fewer hours complying with the assurance requirements. Based on the estimates presented in Table 3, the dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $5.81 million and annualized benefits of $0.68 million are estimated using a 3 percent discount rate; present value benefits of $4.10 million and annualized benefits of $0.58 million are estimated using a 7 percent discount rate. Table 11 summarizes the quantified and non-quantified benefits and costs of the proposed change to the IRB roster requirement.
Language is proposed at § __.103(e) requiring each IRB, institution, or organization that has oversight responsibility for non-exempt research involving human subjects covered by this policy and conducted by another institution to have a written agreement identifying the respective responsibilities of the IRB organization and the engaged institution for meeting the regulatory requirements of this policy. This is already a requirement under the terms of an FWA but this requirement increases the level of detail that has to be included in such agreements, specifically the roles and responsibilities of each party. In addition, a requirement is added at § __.115(a)(10) that institutions or IRBs retain the agreement between the institution and IRB specifying the responsibilities that each entity would undertake to ensure compliance with the requirements of proposed § __.103(e).
The new requirements for agreements between institutions and external IRBs would not apply to research initiated before the effective date of the rule. However, the new requirements would affect existing agreements between institutions and external IRBs in cases where the existing agreements are not study-specific, but rather pertain to all research conducted by the institution or to a category or categories of human subjects research.
Initially, costs would be involved in drafting, revising, and conducting managerial review of agreements to ensure they satisfy these new requirements. Anticipated benefits include enhanced protection of human subjects in research reviewed by nonaffiliated IRBs, and greater reliance on external IRBs as the IRB of record for cooperative research, as stipulated in proposed § __.114.
Table 3 shows that there are 5,164 FWA-holding institutions without an IRB and 2,871 FWA-holding institutions with an IRB. We assume that the 5,164 FWA-holding institutions without an IRB have an average of 1 IRB authorization agreement that would need to be modified as a result of the new requirements for agreements between institutions and external IRBs in 2016. In addition, we assume that the 2,871 FWA-holding institutions with an IRB have an average of 0.20 IRB authorization agreements that would need to be modified in 2016. We estimate that each agreement would require an average of 10 hours of institution legal staff time and 5 hours of IRB administrator time to complete. The dollar value of their time is calculated by multiplying hours by their estimated 2016 wages and adjusting for overhead and benefits.
Present value costs of $11.3 million and annualized costs of $1.32 million are estimated using a 3 percent discount rate; present value costs of $10.8 million and annualized costs of $1.54 million are estimated using a 7 percent discount rate. Table 12 summarizes the quantified and non-quantified benefits and costs of the requirement for written procedures and agreements for reliance on external IRBs (§§ __.103(e) and __.115(a)(10) in the NPRM).
The proposed rule would eliminate the requirement in the current Rule at § __.103(f) that grant applications undergo IRB review and approval for the purposes of certification. As described in section II.h.2 of this preamble, the grant application is often outdated by the time the research study is submitted for IRB review and contains detailed information about the costs of a study, personnel, and administrative issues that go beyond the mission of the IRB to protect human subjects. Therefore, experience suggests that review and approval of the grant application is not a productive use of IRB time.
Eliminating the requirement that the grant application undergo IRB review and approval would reduce administrative costs to investigators and IRB voting members. The proposed change likely would not reduce protections for human subjects or impose other costs.
The RIA estimates that there are 324,187 initial reviews of protocols annually, of which 223,689 involve convened review and 100,498 involve expedited review based on the distribution of reviews presented in Table 3. For the purpose of this analysis, it is assumed that each protocol reviewed by an IRB is associated with one grant application or other funding proposal. The RIA estimates that investigators spend an average of 15 minutes compiling their grant applications when they submit a protocol for initial review. Further, it is estimated that IRBs typically use two primary reviewers for convened review and one primary reviewer for expedited review, and that primary reviewers spend an average of 30 minutes reviewing the grant application. Based on the estimates in Table 3, the dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $310 million and annualized benefits of $36.3 million are estimated using a 3 percent discount rate, and present value benefits of $219 million and annualized benefits of $31.1 million are estimated using a 7 percent discount rate. Table 13 summarizes the quantified and non-quantified benefits and costs of eliminating the requirement that the grant application undergo IRB review and approval.
New in the NPRM is a proposal at § __.104(c) that Federal departments and agencies would develop an exemption determination tool for use by investigators and institutions. Under the proposed rule, unless otherwise required by law, exemption determinations may be made by (1) an individual who is knowledgeable about the exemption categories and who has access to sufficient information to make an informed and reasonable determination, or (2) the investigator who accurately inputs information into the federally created web-based decision tool (NPRM at § __.104(c)). Also new in the NPRM is a requirement at proposed § __.115(a)(11) that an IRB maintain records of exemption determinations. Additionally, proposed § __.104(c) specifies that the use of the exemption determination tool would satisfy the documentation requirement in proposed § __.115(a)(11).
While the documentation requirement for exemption determinations is new, comments from members of the regulated community suggest that most institutions have systems in place already to make and document exemption determinations. Thus, the requirement of proposed § __.115(a)(11) would likely have a negligible impact on institutions. Additionally, it is anticipated that use of the exemption determination tool described in proposed § __.104(c) would likely represent a reduction in burden for institutions and investigators. First, institutions are not responsible for creating the decision tool; the Federal Government is. The costs associated with the development and maintenance of this tool are discussed above in section III.D.2.a of this RIA. Second, except for protocols for which IRB review is required by law and those for which the exemption tool is unable to issue determinations (and therefore still have to be submitted to an IRB for review), IRB offices would no longer need to devote significant resources to processing and reviewing studies for exemption because the use of the tool by the investigator would suffice. Third, the investigator would no longer need to engage in the time-intensive task of developing and submitting a formal application to an IRB for an exemption determination, which is standard practice at many institutions. Instead, the investigator would be able to answer questions in the to-be-created tool, and then be able to commence work if determination generated by the tool indicates that the proposed research activity meets one of the exemption categories.
The quantifiable benefits and costs associated with the use of the § _.104(c) decision tool are documented in each RIA discussion of exemption categories (sections II.D.2.f, l, m, n of this RIA). Note that while § _104(c) requires that an exemption determination be made before an exempt study may begin, the use of the proposed exemption determination tool is not mandated. Rather, the tool to be created by HHS is an option proposed in order to reduce burden on the investigators and institutions. Additionally, note that at present it is unknown how many studies are exempted under the current Rule each year. Thus, this RIA is only able to provide quantifiable benefits and costs for studies that are estimated to be newly exempted.
Table 14 summarizes the non-quantified benefits and costs of the tracking requirements for exemption determinations and the criteria for those eligible to make exemption decisions in NPRM § _.104(c).
l. Exemption for Research and Demonstration Projects (NPRM at § _.104(d)(2))
The current exemption related to research and demonstration projects (current Rule at § _.101(b)(5)) would be revised to clarify that certain Common Rule agency or department supported activities currently fall within that scope. OHRP also proposes to broaden its interpretation of public benefit and service programs which are being evaluated as part of the research to include public benefit or service programs that an agency does not itself administer through its own employees or agents, but rather funds (
The proposed regulatory revision and change in OHRP's interpretation of the exemption is designed to clarify and broaden the scope of the exemption so that more research studies would be exempt. It is believed that these changes would make the exemption easier to apply appropriately and is expected to
In addition, a requirement has been added that each Federal department or agency conducting or supporting the research and demonstration projects must establish on a publicly accessible federal Web site or in such other manner as the Secretary of HHS may prescribe, a list of the research and demonstration projects which the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to or upon commencement of the research. This exemption is needed for government entities to carry out activities related to their important public health mission and functions; in acknowledgement of the fact that more-than-minimal-risk studies could be conducted under this exemption, the posting requirement promotes increased transparency in these activities.
Note that a study's exemption documentation requirement at § _.104(c) is satisfied by a Federal department or agency posting minimal information about the research or demonstration project on a federal, publicly accessible Web site. Thus, in general, an institutional official would not have to post any information to this Web site.
It is estimated that approximately 1,000 exempt research and demonstration studies are currently conducted each year.
The 4,377 estimated annual studies conducted under this exemption would need to be posted to a federal Web site as required by § _.104(d)(2)(i). It is anticipated that it would take individuals at the IRB administrative staff level 15 minutes per study to post the study to the Web site. Note that costs related to developing the Web site to which information about demonstration projects would be posted are calculated in section III.D.2.a of this RIA.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $37.0 million and annualized benefits of $4.34 million are estimated using a 3 percent discount rate, and present value benefits of $30.3 million and annualized benefits of $4.31 million are estimated using a 7 percent discount rate. Present value costs of $0.36 million and annualized costs of $0.04 million are estimated using a 3 percent discount rate; present value costs of $0.30 million and annualized costs of $0.04 million are estimated using a 7 percent discount rate. Table 15 summarizes the quantified and non-quantified benefits and costs of amending an exempt category.
Three proposed exemptions in the NPRM would expand the types of activities that could occur without any IRB review (expedited or full-board). A new exemption at proposed § __.104(d)(3) covers research involving benign interventions in conjunction with the collection of data from an adult subject through verbal or written responses (including data entry) or video recording if the subject prospectively agrees to the intervention and data collection and at least one of two criteria is met.
A second exemption at proposed § __.104(e)(1) covers research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording), if the information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects. A third exemption at proposed § __.104(e)(2) would permit the secondary research use of identifiable private information originally collected for non-research purposes, so long as notice was provided to the prospective human subjects about the research activities and the identifiable private information is used only for purposes of the specific research for which the investigator or recipient entity obtained the information.
Because the new exemptions at § __.104(e)(1) and (2) permits investigators to record potentially sensitive information about research subjects in an identifiable form, such activities must comply with the privacy safeguards found at § __.105 in the proposed Rule. Some of this research may be eligible for expedited review under the current rule, and would now be exempt from even that level of IRB review under the proposed rule. This would result in costs savings associated with IRB submission, review, and approval. In addition, most institutions already have information protection systems and policies in place and are likely to already meet the privacy safeguards of proposed § __.105.
It is estimated that 6,754 annual reviews of protocols (0.5 percent) would no longer be conducted as a result of these proposed changes. Of these reviews, 2,236 would have undergone convened initial review, 1,004 would have undergone expedited initial review, 2,424 would have undergone convened continuing review, and 1,088 would have undergone expedited continuing review based on the distribution of reviews presented in Table 3.
As required under § __.104(c), an exemption determination must be made and documented for each of these 6,754 newly exempted studies. It is anticipated that in 50 percent of these studies (3,377 studies), investigators will spend 30 minutes entering information into the HHS-created decision tool in order for that tool to generate an exemption determination. In the remaining 3,377 studies, it is anticipated that investigators will spend 30 minutes preparing and submitting information about the study to an individual able to make exemption determinations (per § __.104(c)). An individual at the IRB voting member level will spend an estimated 30 minutes per study to make an exemption determination.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
The estimated costs associated with new privacy and security standards are presented section III.D.2.o of this RIA. Present value benefits of $70.0 million and annualized benefits of $8.20 million are estimated using a 3 percent discount rate, and present value benefits of $57.2 million and annualized benefits of $8.16 million are estimated using a 7 percent discount rate. Table 16 summarizes the quantified and non-quantified benefits and costs of modifying the exemption categories for research involving adults.
The NPRM proposes a specific exemption for storage and maintenance of biospecimens (regardless of identifiability) and identifiable private information for future, unspecified secondary research activities after consent has been sought and obtained. The idea behind this exemption is that an institution can store and maintain biospecimens and identifiable private information for future research studies without being required to have a specific repository creation protocol developed, reviewed, and approved by an IRB. To be eligible for the exemption, the institution or an investigator must seek broad consent for the future use of biospecimens and information using the Secretary's broad consent template. Biospecimens and identifiable private information from both the research or non-research contexts may be designated under this exemption for future unspecified research studies. As part of the condition for this proposed exemption, an IRB would be required to do a one-time, limited review of the consent process using the expedited review procedure (as would be required in proposed § _ _.111(a)(9)). The privacy safeguards outlined in proposed § _ _.105 would apply to these activities. Note that if moving the biospecimens or information collected for use in future unspecified research studies is envisioned, as part of the limited IRB review described in § _ _.111(a)(9), an IRB would also need to review the adequacy of the privacy safeguards described in § _ _.105.
Non-quantified benefits of this provision include clearer instructions to the regulated community about the extent to which creating system for storing and maintaining biospecimens and identifiable private information for future, unspecified secondary research activities is governed by this rule. Additionally, by reducing the IRB burden associated with approving this type of activity, this provision also incentivizes the creation of institution-wide, comprehensive systems for the storage and maintenance of biospecimens and identifiable private information for future, unspecified secondary research activities, which would foster more research while remaining respectful of subject autonomy. Because of the benefits to investigators of being eligible for a new exemption if secondary research activities are conducted using biospecimens or identifiable private information maintained or stored according to § _ _.104(f)(1), institutions would be further incentivized to implement and develop such a system. Also note that while FDA is unable to harmonize with the Common Rule on many of the exemptions due to specific requirements in FDA's authorizing statutes, including the § _ _.104(f)(2) exemption, research that is also subject to the FDA regulations would be eligible for this exemption.
Because of the proposal for the rule to cover all biospecimens regardless of identifiability, it is anticipated that a majority of institutions would elect to develop a system for storing and maintaining biospecimens and identifiable private information for future, unspecified secondary research activities as allowed under the proposed exemption at § _ _.104(f)(1). This RIA estimates that 6,428 FWA holding institutions (80 percent) would develop such a mechanism for storing and maintaining biospecimens and identifiable private information for future, unspecified secondary research activities. The RIA anticipates that 1,607 FWA institutions (20 percent) would not develop this type of mechanism, either due to the lower volume of research overall conducted at that institution or because the institution conducts mostly social and behavioral research. At each of the 6,428 institutions where a storage and maintenance schema exemptible under NPRM § _ _.104(f)(1) is developed, it is assumed that an individual at the IRB administrator level would spend two hours at each institution reviewing the consent process through which a subject's broad consent to future research uses of his or her biospecimens or information is sought.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value costs of $1.58 million and annualized benefits of $0.19 million are estimated using a 3 percent discount rate, and present value benefits of $1.48 million and annualized benefits of $0.21 million are estimated using a 7 percent discount rate. Table 17 summarizes the quantified and non-quantified benefits and costs of modifying the exemption categories for research involving adults.
Increasing research use of genetic information, information obtained from biospecimens, medical records, and administrative claims data has altered the nature of the risks to those whose information is being used in research. The risks related to these types of research are not physical but rather are informational through, for example, the unauthorized release or use of information about subjects. Currently, IRBs evaluate each study with regard to all levels of risk and are expected to determine whether the privacy of subjects and the confidentiality of their information is protected. Under the current Common Rule, IRBs must review each individual study's protection plan to determine whether it is adequate with respect to the informational risks of that study.
The proposed rule would impose a new requirement that institutions and investigators implement appropriate security safeguards for biospecimens and identifiable private information. The purpose of these safeguards is to assure that access to biospecimens and individually identifiable private information is only authorized in appropriate circumstances and that informational risks are managed by applying appropriate safeguards to information and biospecimens. To ensure that the requisite limitations on use and disclosure are met, an institution or investigator can obtain adequate assurances through the use of a written agreement with the recipient of the information or biospecimens. In addition, a new provision is proposed at § __.115(c) that requires that the institution or IRB retaining IRB records shall safeguard, if relevant, individually identifiable private information contained in those records in compliance with the privacy safeguards proposed at § __.105.
Under the proposal, the HHS Secretary would develop a set of minimum standards for the protection of information for research outside of the current scope of the HIPAA standards to create an effective and efficient means of implementing appropriate protections for biospecimens and information. This list would be developed in consultation with other Common Rule agencies and would be published in the
Consequently, the IRBs would not be required to review the individual plans for safeguarding information and biospecimens for each research study, so long as investigators would adhere to one or the other set of standards. It is anticipated that once IRBs are familiar with standard institutional- and investigator-imposed protections they would become more comfortable with the fact that they need not review every protocol for security standards. In addition, IRBs would not have to review security provisions on a case-by-case basis, which would result in cost savings in terms of time.
It is expected that most research institutions would already have most of these protections in place, especially those institutions that are subject in whole or part to the HIPAA rules. Other fiduciary, legal, and proprietary responsibilities related to obtaining and storing biospecimens are likely to encompass the protections proposed for securing biospecimens. Also note that the envisioned security measures that will appear on the Secretary's List would be less stringent than what many institutions have already implemented. It should also be noted that the NPRM proposal would result in uniform baseline standards for security. Costs associated with developing the Secretary's List in accordance with proposed § __.105 are accounted for in section III.D.2.a of this RIA.
It is estimated that 803 of the 8,035 institutions with FWAs (10 percent) would need to update their privacy and security standards to comply with the new requirements. At these institutions, institutional officials and institutional legal staff would each spend an estimated 80 hours in 2016 and 20 hours in subsequent years to update and monitor their privacy and security standards. In addition, the RIA estimates that 43,997 of 439,968 investigators (10 percent) would be required to adopt the updated privacy and security standards. These investigators would each spend an 40 hours in 2016 and 10 hours in subsequent years to comply. Based on the estimates presented in Table 3, the dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits. Public comments are requested on these estimates.
Present value costs of $457 million and annualized costs of $53.6 million are estimated using a 3 percent discount rate; present value costs of $347 million and annualized costs of $49.4 million are estimated using a 7 percent discount rate. Table 18 summarizes the quantified and non-quantified benefits and costs to protect information and biospecimens.
The NPRM proposes eliminating continuing review for many minimal risk studies, unless the reviewer explicitly justifies why continuing review would enhance protection of research subjects. For studies initially reviewed by a convened IRB, continuing review would not be required, unless specifically mandated by the IRB, after the study reaches the stage where it involves one or both of the following: (1) Analyzing data (even if it is identifiable private), or (2) accessing follow-up clinical data from procedures that subjects would undergo as part of standard care for their medical condition or disease. If an IRB chooses to conduct continuing review even when these conditions are met, the rationale for doing so must be documented according to a new provision at § __.115(a)(3).
It is also proposed that continuing review of research eligible for expedited review in accordance with § __.110 not be required, although an IRB may determine that continuing review of research eligible for expedited review is necessary. When an IRB requires continuing review of such studies, this too must be documented in compliance with a proposed requirement at § __.115(a)(8).
Requiring continuing review for studies that are minimal risk (and eligible for expedited review at the onset) or that no longer pose greater than minimal risk presents a regulatory burden that does not meaningfully enhance protection of subjects. Further, the requirement takes time from the IRB's review of higher risk studies.
This would result in less time spent by institutions, IRBs, and investigators in terms of time spent preparing for and conducting continuing review. This is a one-time compliance burden in Year 1 for institutions to update their systems to no longer send continuing review reminders to certain investigators. There would be increased recordkeeping requirements, however, for institutions to comply with § __115(a)(3) and (a)(8). Because we estimate that 90 percent of protocols that previously had to undergo continuing view would no longer need to, there is an overall net benefit. However, 10 percent of studies would require a new recordkeeping component. The benefits in terms of cost savings would begin in year one and extend indefinitely. However, costs would be associated with the requirement that IRBs document cases in which they elect to conduct continuing review when it is not a regulatory requirement.
The RIA estimates that there are 108,873 expedited continuing reviews of protocols annually based on the distribution of reviews presented in Table 3. Of these reviews, the RIA further estimates that 81,546 reviews (75 percent) would not be eliminated by other proposed changes to the Common Rule (such as the modifications proposed at §§ __.101(b); __.104(d)(1)–(3), (e)(1), and (f)). It is estimated that 40,773 of these 81,546 reviews (50 percent) would be discontinued and the remaining 40,773 reviews (50 percent) would continue and require documentation of the rationale for doing so. The RIA also estimates that IRB voting members would spend 1 hour per review providing documentation. In addition, administrative staff at each IRB would spend an estimated 10 hours in 2016 updating their communication systems to no longer send continuing review reminders to certain investigators.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $145 million and annualized benefits of $17.0 million are estimated using a 3 percent discount rate, and present value benefits of $119 million and annualized benefits of $16.9 million are estimated using a 7 percent discount rate. Present value costs of $38.8 million and annualized costs of $4.55 million are estimated using a 3 percent discount rate; present value costs of $31.9 million and annualized costs of $4.54 million are estimated using a 7 percent discount rate. Table 19 summarizes the quantified and non-quantified benefits and costs of the elimination of continuing review of research under specific conditions.
The proposed rule would make minor changes regarding expedited review, to change the default position such that expedited review can occur for studies on the HHS Secretary's list unless the reviewer(s) determine(s) that the study involves more than minimal risk. The NPRM also proposes that, in consultation with other Common Rule departments or agencies, the expedited review categories be reviewed every eight years and amended as appropriate, followed by publication in the
The proposed changes to the expedited review procedures are expected to reduce the IRB workload by increasing the number of studies that undergo expedited review rather than convened review. The documentation requirement does not produce additional requirements because IRBs must keep records of determinations regardless. This just stipulates that the reason for an override must be described. However, costs would be associated with the requirement that IRBs document cases in which they elect to conduct convened IRB review when it is not a regulatory requirement.
It is estimated that there are 223,689 convened initial reviews and 242,330 convened continuing reviews of protocols annually based on the distribution of reviews presented in Table 3. Of these 223,689 convened initial reviews, it is estimated that 2,237 reviews (1 percent) are eligible for expedited review because they are in a category of research that appears on the HHS Secretary's list. Of these 2,237 reviews, it is estimated that 1,118 reviews (50 percent) would undergo expedited review and the remaining 1,118 reviews (50 percent) would undergo convened review and require documentation of the rationale for doing so.
Of the 242,330 convened continuing reviews, it is estimated that 2,423 reviews (1 percent) are eligible for expedited review because they are in a category of research that would appear on the Secretary's list. Of these 2,423 reviews, the RIA estimates that 1,212 reviews (50 percent) would undergo convened review and would require documentation of the rationale for doing so. Due to the proposed elimination of continuing review of research under specific conditions (§ __.109(e) and (f); § __.115(a)(3) and (a)(8)), the remaining 1,212 reviews (50 percent) would not require review. Of these 1,212 reviews, the RIA estimates that 606 reviews (50 percent) would not occur and the remaining 606 reviews (50 percent) would undergo expedited continuing review and require documentation of the rationale for doing so. The RIA estimates that IRB voting members would spend 1 hour per review providing documentation when required. The cost associated with reviewing and amending the list is accounted for in section III.D.2.a of this RIA.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $16.8 million and annualized benefits of $1.97 million are estimated using a 3 percent discount rate, and present value benefits of $13.7 million and annualized benefits of $1.95 million are estimated using a 7 percent discount rate. Present value costs of $2.71 million and annualized costs of $0.32 million are estimated using a 3 percent discount rate; present value costs of $2.21 million and annualized costs of $0.32 million are estimated using a 7 percent discount rate. Table 20 summarizes the quantified and non-quantified benefits and costs of the elimination of expedited review procedures.
Two changes are proposed in the criteria for IRB approval of research. One pertains to the new requirements proposed at § __.105 to protect biospecimens and individually identifiable private information used in research. The regulations at § __.111(a)(7) currently require that in order to approve research covered by this policy, the IRB shall determine that when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. This requirement would be modified to recognize that the requirements at § __.105 would apply to all non-exempt research (unless the criteria for exemptions are met). The default position should be that if the provisions at § __.105 are being met, there is no need for additional IRB review of a research study's privacy and confidentiality protections. However, there might be extraordinary cases in which an IRB determines that privacy safeguards above and beyond those called for in § __.105 are necessary. Therefore, it is proposed that IRBs would be responsible for ensuring there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data only if the IRB determines that the protections required in § __.105 are insufficient.
The second proposed change relates to the new exemption at § __.104(f)(2) that includes a criterion at (f)(2)(ii) that the exemptions do not apply if the investigator intends to return individual research results to subjects. Thus, a new provision would be added at § __.111(a)(8) clarifying that IRBs need to review any plan in a research protocol for returning individual research results to subjects and to determine whether it is appropriate. Although many IRBs probably already review plans for return of results, and many studies do not include this feature, it would not be required that IRBs review all projects to determine if there should be a plan.
The RIA estimates that there are 324,187 initial reviews of protocols annually, of which 223,689 involve convened review and 100,498 involve expedited review based on the distribution of reviews presented in Table 3. The RIA estimates that IRBs typically use two primary reviewers for convened review and one primary reviewer for expedited review, and that primary reviewers spend an average of 15 minutes reviewing the security plans for biospecimens or identifiable private information. Of the 324,187 initial reviews, we estimate that 108,062 reviews (33 percent) would include a plan for returning results to subjects and that primary reviewers would spend an average of 15 minutes reviewing these plans. Based on the estimates in Table 3, the dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $126 million and annualized benefits of $14.8 million are estimated using a 3 percent discount rate, and present value benefits of $89.1 million and annualized benefits of $12.7 million are estimated using a 7 percent discount rate. Present value costs of $66.6 thousand and annualized costs of $7.8 thousand using a 3 percent discount rate; present value costs of $62.3 thousand and annualized costs of $8.9 thousand using a 7 percent discount rate. Table 21 summarizes the quantified and non-quantified benefits and costs of the revised criteria for IRB approval of research.
The proposed rule would mandate that all domestic sites in a cooperative study rely upon a single IRB for that study, regardless of the source of funding, unless otherwise required by law (
Currently, the choice to have cooperative research reviewed by a single IRB is voluntary under the Common Rule. In practice, most institutions have been reluctant to replace review by their local IRBs with review by a single IRB in part because of OHRP's current practice of enforcing compliance with the Common Rule through the institutions that were engaged in human subjects research, even in circumstances when the regulatory violation is directly related to the responsibilities of an external IRB. Review by multiple IRBs for cooperative research can add bureaucratic complexity to the review process and delay initiation of research projects without evidence that multiple reviews provide additional protections to subjects. Thus, the proposed changes at § __.101(a) are included in this NPRM to address this concern in anticipation of greater reliance on external IRBs in cooperative research, and to promote less bureaucratic complexity in the review process in multi-site studies.
Ultimately, these revisions are expected to lower costs associated with multiple reviews for investigators, institutions, and IRBs. There may be some cost shifting as certain IRBs take on the role of reviewing IRB; however, these will be offset by savings at other IRBs no longer required to conduct additional reviews of the same research study. Initially, IRBs and institutions will have to draft and revise their policies regarding their reliance on single IRBs. It is expected that over time standardization in agreements will be achieved, and that reliance on single IRBs will be accepted because of their assured inclusion in oversight, which will result in reduced costs associated with multiple reviews and time savings for investigators who no longer must wait for multiple reviews to occur, with subsequent revisions and amendments. Likely, the hours spent here will replace hours spent reviewing and processing a submission that otherwise would be approved by the institution's IRB.
The OHRP database of registered institutions and IRBs shows that there are 8,035 institutions with an FWA. The RIA estimates that these institutions would develop an average of 10 written joint review agreements with other institutions in 2019 prior to the first year of compliance. The RIA further estimates that each agreement would require an average of 10 hours of institution legal staff time and 5 hours of IRB administrator time to complete. The dollar value of their time is calculated by multiplying hours by their estimated 2016 and 2019 wages and adjusting for overhead and benefits.
It is estimated that there are 202,617 annual reviews of multi-site protocols, and an average of 5 reviews per multi-site protocol, implying that there are 40,523 multi-site protocols reviewed each year. Of these protocols, an estimated 36,471 protocols (90 percent) do not involve medical devices; as a result, 4 of every 5 reviews would be eliminated. Accordingly, the RIA estimates that 145,884 annual reviews of protocols would no longer be conducted as a result of these proposed changes. Of these reviews, 48,317 would have undergone convened initial review, 21,708 would have undergone expedited initial review, 52,343 would have undergone convened continuing review, and 23,517 would have undergone expedited continuing review based on the distribution of reviews presented in Table 3.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews and based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2019–2025 wages and adjusting for overhead and benefits.
Present value benefits of $1,103 million and annualized benefits of $129 million are estimated using a 3 percent discount rate, and present value benefits of $849 million and annualized benefits of $121 million are estimated using a 7 percent discount rate. Present value costs of $155 million and annualized costs of $18.1 million are estimated using a 3 percent discount rate; present value costs of $138 million and
t. Changes in the Elements of Consent, Including Documentation (NPRM at §§ __.116(a)(9), (b)(7)–(9), and __.117(b) in the NPRM)
A new element of consent at § __.116(a)(9) applies to identifiable private information collected as part of a research activity. When identifiable private information is collected for research purposes, subjects must be provided with a statement describing the extent to which a subject's information will be made non-identified and used in future activities. An investigator must include in a consent form one of two statements:
• A statement that all identifiable information might be removed from the data and the data that is not identifiable could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject, if this might be a possibility; or
• A statement that the subject's data collected as part of the research, from which identifiable information is removed, will not be used or distributed for future research studies.
The addition of the requirement to notify subjects of how their non-identified information might be used is viewed as a measure of respect for subjects, by informing them of possible uses of their information. Potential subjects can always decline to participate in the initial research if they are not willing to consent to the statement provided. This measure addresses concerns about people not being fully informed that their non-identified information could be used for research without their consent. These changes are expected to improve informed consent forms and processes, and ideally result in more informed decisions by prospective research subjects about whether to participate in research. The intent is to create greater transparency and improve the informed consent process. This addition would have to meet the documentation requirements at § __.117(b).
While this new provision would require investigators to inform prospective subjects of how their non-identified information originally collected for research purposes might be used in future research studies, it is not expected that this change to have a measurable effect on the administrative costs to the research system. Under the current regulations, a majority of investigators do not restrict the future research use of non-identifiable information. Therefore, it is expected that in implementing this new notification requirement, the vast majority of investigators would elect option (1). In addition, under the current regulations, investigators may voluntarily restrict the future research use of non-identifiable information, such as in certain research involving vulnerable populations or a rare disease. We do not expect the new notification requirement to result in an increase in the number of investigators who would include option (2) in their consent forms and processes. When investigators choose to restrict the future research use of non-identifiable information under the current Rules, statements about such restricted future use are generally already included in the consent forms and processes. Therefore, for such research, the notification requirement is not expected to result in any change in practice.
Since this notification requirement is not expected to change investigators' secondary use of non-identifiable information originally collected for research purposes, it is anticipated that investigators and institutions already have systems in place to track any restrictions investigators currently choose to implement. As likely is currently the case, it is anticipated that very few investigators would elect to offer the second option listed above because of the challenges of marking and tracking such decisions. Furthermore, since most investigators will likely elect the first option listed above, it would be reasonable for investigators and institutions to assume that the secondary research use of information would be permissible unless marked otherwise. Therefore, it would not be necessary to routinely track information obtained using the first option.
Three additional elements of consent are proposed in § __.116(b)(7)–(9). These three require that a subject be informed of the following, when relevant:
• That the subject's biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit;
• Whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
• An option for the subject or the representative to consent, or refuse to consent, to investigators re-contacting the subject to seek additional information or biospecimens or to discuss participation in another research study.
These additional elements of consent are proposed to promote the goal of respect for persons and greater transparency in the research enterprise. Additionally, including the information referenced in these provisions in a consent form will help ensure that prospective subjects are given all information necessary for understanding why one might want to participate (or not) in a research study.
The RIA estimates that there are 246,382 new protocols annually using identifiable information. For each protocol, it is estimated that investigators would spend an average of 15 minutes in 2016 updating consent forms to comply with the new requirements found in the NPRM at § __.116(a)(9) or (b)(7)–(9). Based on the estimates presented in Table 3, the dollar value of investigators' time is calculated by multiplying hours by their estimated 2016 wages and adjusting for overhead and benefits.
The RIA assumes that no additional investigators would elect to offer the second option at § __.116(a)(9), and that the investigators who currently offer equivalent options already track the permissible and impermissible uses of information in line with the requirements discussed above. As a result, the RIA estimates that there are no additional costs associated with tracking. Public comment is requested on these assumptions.
Present value costs of $4.55 million and annualized costs of $0.53 million are estimated using a 3 percent discount rate; present value costs of $4.25 million and annualized costs of $0.60 million are estimated using a 7 percent discount rate. Table 23 summarizes the quantified and non-quantified benefits and costs of changes in the basic elements of consent, including documentation.
The NPRM proposes to allow the use of broad consent to secondary research use of biospecimens or identifiable private information for unspecified research purposes. Such broad consent would have specified elements and limitations, and could be collected in both the research and non-research setting.
Given the creation of the exemption for the maintenance and storage of biospecimens and identifiable private information for future, unspecified secondary research activities found in the NPRM at § __.104(f)(1), it is envisioned that institutions creating these research repositories would need to develop tracking systems to monitor which biospecimens or what information may be used in secondary research by investigators. The Secretary of HHS would publish in the
Seeking and obtaining consent to secondary research use of biospecimens and identifiable information is an additional flexibility proposed in the NPRM. However, it is not required. If broad consent has not been sought for the future research use of biospecimens or identifiable private information, then an investigator would need to have his or her project reviewed by an IRB and seek either study-specific consent or a waiver of informed consent under the Common Rule. As discussed in section II.B of this preamble, the NPRM proposes stricter waiver criteria (NPRM at § __.116(e)(2) and (f)(2)) for biospecimens than for identifiable private information; these strict waiver criteria would apply regardless of whether the biospecimens are readily identifiable to the investigator. These waiver criteria would in effect make secondary research using a biospecimen largely impossible in the absence of obtaining subjects' broad consent for future use of their biospecimens. Because investigators would be required to use the Secretary's template for obtaining broad consent in order to be eligible for the new exemptions proposed in § __.104(f), it is expected that minimal time would be spent updating consent forms or drafting wholly new consent forms. OHRP would develop one or more Secretary's templates for obtaining broad consent to secondary use of biospecimens or identifiable private information for subsequent use by investigators and institutions. OHRP staff time associated with developing this resource is
As discussed earlier in this RIA (section III.D.2.n) it is anticipated that 6,428 FWA holding institutions (80 percent) would store and maintain clinical and non-clinical biospecimens and identifiable private information for unspecified future research studies in the manner prescribed under the new proposed exemption at § __.104(f)(1).
As also discussed previously, extrapolations from 1999 data
In the clinical setting, approximately 21 million individuals' biospecimens (70 percent of the estimated 30 million individuals' biospecimens collected each year) are collected for clinical purposes. In the first year that the rule is implemented, as many as 21 million broad, secondary use consent forms could be collected from individuals. The RIA anticipates 10 minutes of a subject's time to engage in the consent process. The RIA further anticipates 10 minutes of an institutional employee's time at the IRB Administrative Staff level to seek consent and put the information in the appropriate tracking system.
The NPRM proposes in § __.116(c)(1)(ii)(B) that once an individual gives broad consent to use his or her biospecimens in future, unspecified research studies, that consent may cover any biospecimen collected over the course of a 10 year period. Note that an institution may retain and use the biospecimens collected indefinitely. This provision is merely stating that every 10 years an institution must ask people whether or not they may use newly collected biospecimens in research. Given that an institution must seek broad consent from an individual only once over the course of a 10 year period, it is assumed that after the first year the rule is implemented, the number of individuals from whom an institution seeks broad consent will decrease.
To account for this, the RIA assumes that after the first year that the rule is implemented, a fraction of the clinical subjects from whom secondary use consent is sought in year one would be sought in subsequent years. It is anticipated that in year two, secondary use consent would be sought in the clinical context from 10.5 million subjects (50 percent of the number of individuals involved in the year one estimates). It is anticipated that in year three and after, secondary use consent would be sought in the clinical context from approximately 6.3 million subjects each year (30 percent of the number of individuals involved in the year one estimates). As in year one, the RIA assumes that a prospective subject would spend 10 minutes of time undergoing the consent process and that an institutional employee at the IRB Administrative Staff level would spend 10 minutes of time conducting the consent process with an individual and updating the appropriate tracking system.
Note that assumptions are not made about the extent to which institutions will use the tracked broad consent for the use of identifiable private information. While all institutions that conduct research with biospecimens will essentially need to create a research repository to continue that type of work under the NPRM proposals, such is not the case with identifiable private information. Identifiable private information is covered under the NPRM as it is under the current Rule. To that end, a research repository containing identifiable private information is not necessary to the research enterprise. Thus, the RIA notes that institutions likely will elect to store identifiable private information in these repositories, but it is unknown the extent to which institutions will elect to do this and the volume of identifiable private information that might be stored. Therefore, estimates are not provided specifically about the potential costs of obtaining broad consent and tracking the consent for future use of identifiable private information.
The costs of the tracking system associated with an institution-wide secondary use research repository are the design, implementation, and operation of the informatics system that would be required to document and keep up with thousands of consent documents per year. In addition, the institution would have to come up with some system to “mark” or otherwise note which biospecimens and pieces of identifiable private information had been consented for use, and which ones had not, to make sure an individual's wishes regarding future use of his or her biospecimens and identifiable private information are carried out. It is estimated that these requirements would impose additional costs to develop or modify existing tracking systems at 80 percent of 8,035 institutions with FWAs. It is estimated that these requirements would require 1.0 database administrator FTEs on average at these institutions. Based on the estimates presented in Table 3, we calculate the dollar value of their time by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits. Public comment is requested on these estimates.
Present value costs of $12,245 million and annualized costs of $1,435 million are estimated using a 3 percent discount rate; present value costs of $8,697 million and annualized costs of $1,238 million are estimated using a 7 percent discount rate. Table 24 summarizes the quantified and non-quantified benefits and costs of obtaining consent to secondary use of biospecimens and identifiable private information.
The proposed rule would allow an IRB to approve a research proposal in which investigators obtain identifiable private information without individuals' informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective human subjects of research, through oral or written communication or by accessing records, if the research proposal includes appropriate provisions to protect the privacy of those individuals and to maintain the confidentiality of the identifiable private information.
This addresses concerns that the current regulations require an IRB to determine that informed consent can be waived under the current § __.116(d) before investigators may record identifiable private information for the purpose of screening, recruiting, or determining the eligibility of prospective subjects for a research study, provided that the research proposal includes an assurance that the investigator would meet the requirements for protecting the information as described in proposed § __.105. The current requirement is viewed as burdensome and unnecessary to protect subjects, and is inconsistent with FDA's regulations, which do not require a waiver of consent for such recruitment activities.
This should result in some time and cost savings for both investigators and IRBs, but it would likely be small. The savings would come from IRBs no longer needing to consider whether informed consent can be waived for such preparatory-to-research activities. Savings would accrue for investigators who can proceed with such activities in less time.
The RIA estimates that 1,621 annual initial reviews of protocols (0.5 percent) involve a waiver of consent for recruitment activities that would not be required as a result of these proposed changes. Of these reviews, 1,118 would have undergone convened initial review and 502 would have undergone expedited initial review based on the distribution of reviews presented in Table 3. It is estimated that investigators spend an average of 15 minutes requesting a waiver of consent for recruitment activities when they submit a protocol for initial review. It is further estimated that IRBs typically use two primary reviewers for convened review and one primary reviewer for expedited review, and that primary reviewers spend an average of 15 minutes determining whether informed consent can be waived. Based on the estimates in Table 3, the dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value benefits of $1.21 million and annualized benefits of $0.14 million are estimated using a 3 percent discount rate, and present value benefits of $0.85 million and annualized benefits of $0.12 million are estimated using a 7 percent discount rate. Table 25 summarizes the quantified and non-quantified benefits and costs of eliminating the requirement to waive consent in certain subject recruitment activities.
A new provision would require that investigators or institutions post a copy of the final version of the consent form for each clinical trial conducted or supported by HHS on a publicly available federal Web site that would be established as an archive for such consent forms. The name of the clinical trial and information about whom to contact for additional information must be published with the consent form. The consent form must be published on the federal Web site within 60 days after the trial is closed to recruitment.
It is recognized that certain information contained in an informed consent form is protected from disclosure under the Freedom of Information Act, the Trade Secrets Act, and/or FDA implementing regulations, and, therefore all informed consent forms for FDA-regulated trials covered by this requirement would be subject to redaction before being posted.
It is believed that public posting of consent forms would increase transparency, enhance confidence in the research enterprise, increase accountability, and inform the development of future consent forms, possibly resulting in future savings in time for investigators developing consent forms.
It is expected that the Federal Web site would enable consent documents to be easily uploaded. Additional costs to the government would involve managing and maintaining the archive.
According to queries of
In addition, submitted consent forms must be reviewed and made accessible to persons with disabilities in compliance with Section 508 Amendment to the Rehabilitation Act of 1973. We estimate that each consent form contains an average of 10 pages and that 508-compliance costs an average of $30 per page. Based on the estimates presented in Table 3, the dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
Present value costs of $14.6 million and annualized costs of $1.71 million are estimated using a 3 percent discount rate; present value costs of $10.4 million and annualized costs of $1.49 million are estimated using a 7 percent discount rate. Table 26 summarizes the quantified and non-quantified benefits and the requirement for posting of consent forms for HHS-supported clinical trials.
A new provision would be added allowing a waiver of the requirement to obtain a signed informed consent form if the subjects are members of a distinct cultural group or community for whom signing documents is not the norm. This would be allowed only if the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative method for documenting that informed consent was obtained.
Under the current Rule IRBs may waive the requirement for the investigator to obtain a signed consent form for some or all subjects. The current criteria for such a waiver may not be flexible enough for dealing with a variety of circumstances, such as when federally sponsored research that is conducted in an international setting where, for example, cultural or historical reasons suggest that signing documents may be viewed as offensive and problematic.
This should not involve costs as its intent is to improve the informed consent process by providing more flexibility regarding the documentation of consent, an ethical gain, while reducing administrative requirements for investigators and research subjects in specific circumstances.
Benefits and costs of this new provision are not quantified. Table 27 summarizes the non-quantified benefits and costs of alteration in waiver for documentation of informed consent in certain circumstances.
The total estimated costs of the proposed changes to the Common Rule are sensitive to assumptions regarding consent to secondary use of biospecimens and information. The RIA estimates that 60 percent of institutions with an assurance would implement a tracking system. Those institutions would require 1.0 FTEs on average to develop and maintain a tracking system. The sensitivity of estimated costs to these baseline assumptions is analyzed by calculating costs under alternative assumptions. That these institutions could instead require 0.75 FTEs or 1.25 FTEs on average to develop and maintain a tracking system is considered. That 50 percent or 70 percent of assurance holding institutions could implement such a tracking system (rather than 60 percent) is also considered. Table 28 reports present value costs using a 3 percent discount rate for these alternative and baseline assumptions.
Two alternative approaches for the treatment of biospecimens under the proposed rule were considered. These alternative proposals centered on concerns about potential identifiability of biospecimens and data derived from biospecimens.
Under Alternative Proposal A, the regulations at proposed § __.102(e) would be amended to expand the
This requirement would not apply to specimens and information already collected at the time the final rule is published.
Recent developments have made it possible to use whole genome sequencing information to re-identify non-identified data. Thus, even if such information is not “individually identifiable” (per the current Rule's standard of identifiability) it is appropriate to expand the definition of human subjects research in this way to afford individuals who are the subjects of such research the same protections as those given to the subjects of research using identifiable information or specimens. Therefore, it is anticipated that this change would increase protections for subjects of whole genome sequencing research. It would also increase the volume of studies for which investigators must seek and document informed consent, unless more stringent waiver criteria were met, and institutions will have to track the consent status of specimens and data. In addition, IRBs would have to review these studies unless the research meets the new proposed exemption in proposed § __.104(f)(2).
It is estimated that there are 300 studies using whole genome sequencing data that are not subject to oversight by either the Common Rule or FDA regulations. This RIA estimates that under this alternative, 90 percent of these studies (270) would be eligible for the exemption proposed in § __.104(f)(2). For the remaining 30 studies, it is anticipated that these would not be eligible for the exemption, and would require full IRB review. As required under § __.104(c), an exemption determination would be made and documented for each of the 270 exemptible whole genome sequencing studies. It is anticipated that in 50 percent of these studies (135 studies), investigators will spend 30 minutes entering information into the HHS-created decision tool in order for that tool to generate an exemption determination. In the remaining 135 studies, it is anticipated that investigators will spend 30 minutes preparing and submitting information about the study to an individual able to make exemption determinations (per § __.104(c)). An individual at the IRB voting member level will spend an estimated 30 minutes per study to make an exemption determination.
In the absence of the proposed exempt category at § __.104(f)(2), we estimate that in 2016 all 300 of these studies would undergo convened initial review. In subsequent years, an estimated 144 protocols would undergo convened initial review, 108 would undergo convened continuing review, and 48 would undergo expedited continuing review, based on the distribution of reviews presented in Table 3.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
For Alternative Proposal A, present value costs of $0.57 million and annualized costs of $0.07 million are estimated using a 3 percent discount rate; and present value costs of $0.47 million and annualized costs of $0.07 million are estimated using a 7 percent discount rate. Table 29 summarizes the quantified and non-quantified benefits and costs of amending the definition of human subject.
Under Alternative Proposal B, the regulations at proposed § __.102(e) would be expanded to include biospecimens used in a technology capable of producing biologically unique information about a subject as well as the biologically unique information derived from a biospecimen. Only those technologies specifically listed on a newly created Secretary's List would be considered to have met this definition. For example, if whole genome sequencing was a technology included on the Secretary's List, then activities where a biospecimen (regardless of the investigator's ability to readily identify the person from whom the biospecimen was collected) was used in whole
This expansion would modestly increase the studies encompassed under the rule. This estimate is based on what is known about whole genomic research technologies that results in genome sequencing data (including DNA and RNA sequence data) that is unique to a single individual. It is estimated that there are 898 genomic research studies not currently subject to oversight that result in genome sequencing data unique to a single individual.
One of the primary objectives of the NPRM has been to make the strength of protections commensurate with the level of risks of the research, and by doing so reduce unnecessary administrative burdens on research. That objective has been viewed as being particularly relevant to research involving only secondary use of biospecimens and data, which is relatively low-risk if appropriate protections of privacy and confidentiality are in place. Alternative Proposal B targets activities involving biospecimens where concerns about information risks indicate that additional regulatory oversight for these studies is appropriate.
When the proposed exemption category at § __.104(f)(2) is considered, this RIA estimates that under Alternative Proposal B, 808 studies (90 percent) would be eligible for exemption. For the remaining 89 studies, it is anticipated that these would not satisfy the § __.104(f)(2) requirements and would require full IRB review.
As required under § __.104(c), an exemption determination would be made and documented for each of the 808 exemptible genomic research studies described above. It is anticipated that in 50 percent of these studies (404 studies), investigators will spend 30 minutes entering information into the HHS-created decision tool in order for that tool to generate an exemption determination. In the remaining 404 studies, it is anticipated that investigators will spend 30 minutes preparing and submitting information about the study to an individual able to make exemption determinations (per § __.104(c)). An individual at the IRB voting member level will spend an estimated 30 minutes per study to make an exemption determination.
In the absence of the proposed exempt category of research at § __.104(f)(1), the RIA estimates that as a result of the proposed expansion to the definition of human subject, all 898 of these studies would undergo convened initial review. In subsequent years, an estimated 431 protocols will undergo convened initial review, 322 will undergo convened continuing review, and 145 will undergo expedited continuing review based on the distribution of reviews presented in Table 3.
The estimated costs to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews are based on the estimates presented in Table 3. The dollar value of their time is calculated by multiplying hours by their estimated 2016–2025 wages and adjusting for overhead and benefits.
For Alternative B, present value costs of $1.69 million and annualized costs of $0.20 million are estimated using a 3 percent discount rate; present value costs of $1.39 million and annualized costs of $0.20 million are estimated using a 7 percent discount rate. Table 30 summarizes the quantified and non-quantified benefits and costs of amending the definition of human subject.
As discussed above, the RFA requires agencies that issue a regulation to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. HHS considers a rule to have a significant economic impact on a substantial number of small entities if at least 5 percent of small entities experience an impact of more than 3 percent of revenue.
We calculate the costs of the proposed changes to the Common Rule to institutions with an FWA over 2016–2025 and then subtract the cost savings to these institutions over the same period. The estimated average annualized net cost to institutions with an FWA is $153,671 using a 3 percent discount rate. The U.S. Small Business Administration establishes size standards that define a small entity. According to these standards, colleges, universities, and professional schools with revenues below $27.5 million and hospitals with revenues below $38.5 million are considered small entities. It is not anticipated that a majority of
We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed rule contains collections of information that are subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), as amended (44 U.S.C. 3501–3520). A description of these provisions is given in this document with an estimate of the annual reporting and recordkeeping burden.
We invite comments on these topics: (1) The accuracy of the estimate of burden of the proposed collection of information; (2) ways to enhance the quality, utility, and clarity of the information to be collected; and, (3) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information and technology.
Section __.101 is being amended to place unaffiliated Institutional Review Boards (IRBs) within the realm of entities to which the policy applies as described in § __.101(a) . This new provision gives Common Rule departments and agencies explicit authority to enforce compliance directly against IRBs that are not affiliated with an assured institution. This change should encourage institutions to more willingly rely on qualified unaffiliated IRBs for cooperative research, as is required under the proposed changes at § __.114. Burden estimates are included below in § __.114 summary.
Section __.101 is also being amended to extend the regulations to cover clinical trials conducted at an institution in the United States that receives federal support from a Common Rule department or agency for non-exempt human subjects research, regardless of the funding source of the trial as described in § __101(a)(2). Extension of the regulations would not apply to clinical trials already regulated by FDA. We estimate that there are 1,399 clinical trials currently not subject to oversight by either the Common Rule or FDA regulations. We estimate that in 2016 all 1,399 of these clinical trials will undergo convened initial review. In subsequent years, we estimate that 672 protocols will undergo convened initial review, 502 will undergo convened continuing review, and 225 will undergo expedited continuing review. We estimate the burden to institution officials, IRB administrators, IRB administrative staff, IRB chairs, IRB voting members, and investigators of conducting these reviews (24 hours per protocol) based on the estimates presented in Table 3 of section III of the preamble.
Section __.103 is being amended, at § __.103(e), to require that for non-exempt research involving human subjects covered by this policy that takes place at an institution in which IRB oversight is conducted by an unaffiliated IRB that is not operated by the institution, the institution and the organization operating the IRB shall establish and follow procedures for documenting the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (
Section __.104 is being proposed, as described in § __.104(c), to require federal departments and agencies to develop a decision tool to assist in exemption determinations. Under the proposed rule, unless otherwise required by law, exemption determinations may be made by an individual who is knowledgeable about the exemption categories and who has access to sufficient information to make an informed and reasonable determination, or by the investigator or another individual at the institution who enters accurate information about the proposed research into the decision tool, which would provide a determination as to whether the study is exempt. If the tool is used, further assessment or evaluation of the exemption determination is not required. Burden estimates are included below in § __.115(a)(11).
Section __.104 is being proposed, as described in § __.104(d)(2), to require each federal department or agency conducting or supporting the research or demonstration projects exempted under § __.104(d), to establish on a publicly accessible federal Web site or in such other manner as the department or agency head may prescribe, a list of the research and demonstration projects that the federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to or upon commencement of the research. We estimate that 4,377 exempt research and demonstration studies will be posted to the Web site annually, and that the information will be submitted to the Web site by individuals at the IRB administrative staff level, an estimate of 1.82 person-hours per protocol (7966.14 burden hours).
Section __.105 is being proposed, as detailed in § __.105(a), to require institutions and investigators conducting research subject to the Common Rule, or that is exempt under §§ __.104(e) or (f) to implement and maintain reasonable and appropriate safeguards to protect biospecimens, or identifiable private information they collect, store or use for research. The Secretary of HHS will establish and publish a list of specific measures that the institution or investigator may implement that will be deemed to satisfy the requirement for reasonable
We estimate that 803 of the 8,035 institutions with FWAs (10 percent) will be required to update their privacy and security standards to comply with the new requirements. At these institutions, we estimate that institutional officials and institutional legal staff will each spend 80 hours in 2016 and 20 hours in subsequent years to update and monitor their privacy and security standards. In addition, we estimate that 43,997 of 439,968 investigators (10 percent) will be required to adopt the updated privacy and security standards. We estimate that these investigators will each spend 40 hours in 2016 and 10 hours in subsequent years to do so.
Section __.111 is being amended at § __.111(a)(8) to add a new requirement that if the investigator proposes a research plan for returning relevant results to subjects, then the IRB must determine that the plan is appropriate. We estimate that there are 324,187 initial reviews of protocols annually. Of the 324,187 initial reviews, we estimate that 108,062 reviews (33 percent) will include a plan for returning results to subjects and that primary reviewers will spend an average of 15 minutes reviewing these plans.
Section __.114 is being amended, as described in § __.114(b)(1) to require any institution located in the United States (U.S.) that is engaged in cooperative research to rely upon approval by a single IRB for that portion of the research conducted in the U.S. As described in § __.114(b)(2), cooperative research for which more than single IRB review is required by law (
Section __.115 is being amended, in § __.115(a)(8), to require the rationale for requiring continuing review for research that otherwise would not require continuing review as described in § __.109(f)(1).
We estimate that there are 108,873 expedited continuing reviews of protocols annually based on the distribution of reviews presented in Table 3 of the Regulatory Impact Analyses section of the preamble. Of these reviews, we estimate that 81,546 reviews (75 percent) will not be eliminated by other proposed changes to the Common Rule at §§ __.101(b), __.104(d)(1)–(3), __.104(e)(1). We estimate that 40,773 of these 81,546 reviews (50 percent) will be discontinued and the remaining 40,773 reviews (50 percent) will continue and require documentation of the rationale for doing so. We estimate that IRB voting members will spend 1 hour per review providing documentation. In addition, we estimate that administrative staff at each IRB (total of 3,499 IRBs) will spend 10 hours in 2016 updating their communication systems to no longer send continuing review reminders to certain investigators.
Section __.115 is being amended at § __.115(a)(9) to require that the rationale for an expedited reviewer's determination that research appearing on the expedited list described in § __.111(b)(1)(i) is more than minimal risk (
We estimate that there are 223,689 convened initial reviews and 242,330 convened continuing reviews of protocols annually based on the distribution of reviews presented in Table 3 of the Regulatory Impact Analyses section of the preamble. Of these 223,689 convened initial reviews, we estimate that 2,237 reviews (1 percent) are eligible for expedited review because they are in a category of research that appears on the Secretary's list. Of these 2,237 reviews, we estimate that 1,118 reviews (50 percent) will undergo expedited review and the remaining 1,118 reviews (50 percent) will undergo convened review and require documentation of the rationale for doing so.
Of the 242,330 convened continuing reviews, we estimate that 2,423 reviews (1 percent) are eligible for expedited review because they are in a category of research that appears on the HHS Secretary's list. Of these 2,423 reviews, we estimate that 1,212 reviews (50 percent) will undergo convened review and will require documentation of the rationale for doing so. Due to the proposed elimination of continuing review of research under specific conditions (§§ __.109(f); __.115(a)(3), (8)), the remaining 1,212 reviews (50 percent) will not require review. Of these 1,212 reviews, we estimate that 606 reviews (50 percent) will not occur and the remaining 606 reviews (50 percent) will undergo expedited continuing review and require documentation of the rationale for doing so. We estimate that IRB voting members will spend 1 hour per review providing documentation when required.
Section__.115 is being amended, at § __.115(a)(10) to require the written agreement between an institution and an external IRB specifying the responsibilities that each entity will undertake to ensure compliance with the requirements described in § __.103(e).
Table 3 of section III of the preamble shows that there are 5,164 FWA-holding institutions without an IRB and 2,871 FWA-holding institutions with an IRB. We assume that the 5,164 FWA-holding institutions without an IRB have an average of 1 IRB authorization agreement that would need to be
Section __.115, is being amended, in § __.115(a)(11), to require records relating to exemption determinations as described in § __.104(c). As part of this new requirement, OHRP will create an interactive exemption determination tool. We estimate that 6,754 annual reviews of protocols would no longer be conducted as a result of proposed changes under § __.104. As required under § __.104(c), an exemption determination must be made and documented for each of these 6,754 newly exempted studies. It is anticipated that in 50 percent of these studies (3,377 studies), investigators will spend 30 minutes entering information into the HHS-created decision tool in order for that tool to generate an exemption determination. In the remaining 3,377 studies, it is anticipated that investigators will spend 30 minutes preparing and submitting information about the study to an individual able to make exemption determinations (per § __.104(c)). An individual at the IRB voting member level will spend an estimated 30 minutes per study to make an exemption determination.
Section __.116 is being amended, as described in § __.116(a)(9), to add a new basic element of consent that would apply to any research collection of identifiable private information. One of the following statements about such research collection much be provided to subjects: (i) A statement that identifiers might be removed from the data and the data that is not identifiable could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the representative, if this might be a possibility; or, (ii) a statement that the subject's data collected as part of the research, from which identifiers are removed, will not be used or distributed for future research studies. We estimate that there are 246,382 new protocols annually using individually identifiable information. For each protocol, we estimate that investigators will spend an average of 15 minutes in 2016 updating consent forms to comply with the new requirements.
Section __.116 is being amended, as described in § __.116(c) to allow broad consent to cover the storage, maintenance, and secondary research use of biospecimens and identifiable private information. Broad consent would be permissible for the storage or maintenance for secondary research of such information and biospecimens that were originally collected for either research studies other than the proposed research or non-research purposes. The broad consent document would also meet the consent requirement for the use of such stored biospecimens and information for individual research studies.
We anticipate 6,428 FWA holding institutions (80 percent) will develop an institution-wide research repository of biospecimens and identifiable private information available for future research in the manner prescribed under the new proposed exemption at § __.104(f)(1). We estimate that 80 percent of institutions with an FWA (6,428 institutions) will implement a tracking system. Those institutions will require 1.0 FTEs on average to develop and maintain a tracking system.
It is anticipated that many investigators will choose to seek such consent in order to save time and burden by avoiding the need to (1) seek and obtain consent to every specific future research use, (2) seek full IRB review for research that meets one of the exempt research categories, or (3) seek IRB review for a waiver of consent.
Section__.116 is being amended, as described in § __.116(h), to require that a copy of the final version of the consent form for each clinical trial conducted or supported by a Federal department or agency component conducting the trial on a publicly available federal Web site that will be established as a repository for such consent forms. The informed consent form must be posted in such form and manner as the department or agency head may prescribe, which will include at a minimum posting, in addition to the informed consent form, the name of the clinical trial and information about whom to contact for additional details about the clinical trial. The consent form must be published on the federal Web site within 60 days after the trial is closed to recruitment.
We estimate that Common Rule departments and agencies supports 5,270 new clinical trials annually, of which 575 are regulated by provisions in the FD&C Act and Trade Secrets Act based on the information presented in Table 3 of the Regulatory Impact Analyses section of the preamble. For the purpose of this analysis, we assume that each clinical trial is associated with one consent form that must be submitted by an investigator. We estimate that investigators will spend an average of 15 minutes submitting each consent form. In addition, for the 575 clinical trials regulated by provisions in the FD&C Act and Trade Secrets Act, we estimate that investigators will spend an average of 30 minutes redacting information before submission.
The total estimated burden imposed by these information collection requirements is 12,155,926 burden hours.
It should be noted that the burden estimates for the Common Rule include those approved information requirements in: (1) OMB No. 0990–0260, Protection of Human Subjects: Compliance with Federal Policy/IRB Recordkeeping/Informed Consent/Consent Documentation, approved through May 31, 2018; (2) OMB No. 0990–0263, Assurance Identification/IRB Certification/Declarations of Exemption Form (Common Rule), approved through March 31, 2018; (3) OMB No. 0990–0278, Federalwide Assurance (FWA) for the Protection of Human Subjects, approved through August 31, 2017; and, (4) OMB No. 0990–0279, HHS, Registration of an Institutional Review Board ((IRB), approved through August 31, 2015. As such, they will be amended and submitted to OMB as revisions to currently approved collections once the rule is finalized and the collections are due for renewal.
To ensure that comments on these new information collection requirements are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: [OS Desk Officer, FAX: 202–395–6974, or emailed to
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the information collection provisions of this proposed rule will be submitted to OMB for review. These requirements will not be effective until OMB approves them.
In considering changes in the Common Rule, the ANPRM requested comment on possible changes to seven aspects of the current regulatory framework.
1. Ensuring Risk-Based Protections
2. Streamlining IRB Review of Cooperative Studies
3. Improving Informed Consent
4. Strengthening Data Protections To Minimize Information Risks
5. Data Collection To Enhance System Oversight
6. Extension of Federal Regulations
7. Clarifying and Harmonizing Regulatory Requirements and Agency Guidance
Public comments on the ANPRM initially were requested by September 26, 2011; however, in response to public requests for an extension, the comment period was extended until October 26, 2011. A total of 1,051 comments were received, with many commenters responding to all 74 questions posed. Investigators comprised the largest group of commenters. Comments were also received from: Trade and professional associations; medical and social/behavioral research organizations; disease and patient advocacy groups; IRB members and staff; individual, private companies and the organizations representing them; and patients and research subjects. A large number of comments were lengthy and detailed, reflecting thoughtful consideration of the issues discussed. Many responses reflected the input of large research and health care organizations, including public university systems, research universities, academic medical centers, and medical schools, as well as networked health care providers. The greatest number of comments focused on the section addressing risk-based protections.
In addition to reviewing the public responses to the ANPRM, in preparing the NPRM, the deliberations of the Presidential Commission for the Study of Bioethical Issues (the Commission) were taken into account. Consideration was also given to public comments received on the request for information issued by the Commission on March 2,
These suggested revisions to the Common Rule may affect other regulatory protections, such as the other subparts of the HHS human subjects protection regulations in 45 CFR part 46 (Subparts B, C, and D, which deal with particular populations of vulnerable subjects, and Subpart E which addresses registration of IRBs), FDA regulations, and the HIPAA Privacy Rule (45 CFR parts 160 and 164, Subparts A and E). It is contemplated that other regulatory provisions implicated by the changes to the Common Rule may need to be harmonized, to the extent appropriate, with any final regulations modifying the Common Rule, through rule modification or guidance. Additionally, guidance and other information would also be revised and/or written to the extent necessary and appropriate.
The ANPRM asked for public comments regarding two potential changes to the regulations at § __.101. The first would subject unaffiliated IRBs (IRBs that are not operated by an FWA-holding institution) that review research covered by the Common Rule to the requirements of the Common Rule. The second would extend the scope of research covered by the regulations.
Based on public comments received to a 2009 ANPRM
Some public commenters responding to the 2011 ANPRM cautioned that extending compliance oversight to unaffiliated IRBs might serve as a disincentive for some IRBs to be the IRB of record for cooperative research. A majority of commenters expressed an opposing view; that is, holding external IRBs directly accountable for compliance with the regulations would increase the comfort level of institutions in accepting the regulatory review of an external IRB.
Although supporting the principle that all human subjects research regardless of funding source should be conducted ethically, public commenters generally expressed concern and caution about the ANPRM consideration for a variety of reasons. Behavioral and social science researchers thought that this approach would unnecessarily bring less-than-minimal-risk research funded by non-federal sources (
Others argued that such a change was an overreach of federal oversight and constituted an unfunded mandate. Commenters from large academic research institutions felt that this change inappropriately focused heavily on academic institutions, which generally extend protections to all human subjects research at their institution, even if they have not “checked the box”
Industry also expressed concern about having to comply with two sets of regulations, that is, FDA regulations at 21 CFR parts 50 and 56 as well as the Common Rule. The ANPRM did not clarify that the changes under consideration would not require compliance with the Common Rule of non-federally funded research subject to regulation by FDA. However, there might continue to be research that would be subject to both sets of regulations involving federal funding of research concerning an FDA-regulated product.
Those commenters who supported a formal extension of the regulations cited the need to have one set of standards for all research, regardless of funding source; however, many noted that absent legislation covering all human subjects research conducted in the United States, it would be difficult to cover all research through a regulatory approach alone—gaps would still remain.
Private information is not considered to be identifiable under the Common Rule if the identity of the subject is not or may not be “readily ascertained” by the investigator from the information or associated with the information. In contrast, under the HIPAA Privacy Rule, health information is de-identified and thus exempt from the Rule only if it neither identifies nor provides a reasonable basis to believe that the information can be used to identify an individual. The HIPAA Privacy Rule provides two ways to de-identify information: (1) A formal determination by a qualified expert that the risk is very small that an individual could be identified; or (2) the removal of all 18 specified identifiers of the individual and of the individual's relatives, household members, and employers, as long as the covered entity has no actual knowledge that the remaining information could be used to identify the individual (45 CFR 164.514(b)).
The HIPAA Privacy Rule addresses some informational risks by imposing restrictions on how individually identifiable health information collected by health plans, health care clearinghouses, and most health care providers (“covered entities”) may be used and disclosed, including for research. In addition, the HIPAA Security Rule (45 CFR parts 160 and Subparts A and C of part 164) requires that these entities implement certain administrative, physical, and technical safeguards to protect this information, when in electronic form, from unauthorized use or disclosure. However, the HIPAA Rules apply only to covered entities (and in certain respects to their business associates), and not all investigators are part of a covered entity. Moreover, the HIPAA Rules do not apply specifically to biospecimens in and of themselves.
A majority of the public commenters strongly opposed the ideas discussed in the ANPRM regarding the definition of “identifiability”. Many indicated that the HIPAA Privacy Rule's more stringent standard of identifiability would expand what is considered identifiable for purposes of the Common Rule and thus greatly impede generally low-risk research without adding meaningful protections for human subjects. In particular, they asserted that the HIPAA standards were created to protect against disclosure of health information contained in medical records. As such, commenters argued, they are not appropriate for many types of research that would be covered by the Common Rule (
Several commenters expressed concern about a prohibition against re-identifying de-identified private information (as defined by HIPAA), noting that sometimes it will be appropriate for investigators to re-identify such information, for example, to return research results that have clinical relevance to the subjects. Also, some commenters noted that some research is specifically designed to test strategies for re-identifying de-identified (as defined by HIPAA) information, so an absolute prohibition against re-identification would halt such research.
Some public comments reflected confusion about the focus of the suggested standards and whether they would apply to information or biospecimens that were not individually identifiable. Although most commenters confirmed the need to protect the privacy and confidentiality of information of human subjects in research, a majority expressed serious concerns about the merits of requiring all investigators to meet standards modeled on certain HIPAA standards, such as those in the HIPAA Security Rule. Most commenters expressed the opinion that certain HIPAA standards are not well suited to some research of various kinds carried out by investigators not subject to the HIPAA Rules. Some commenters claimed that the HIPAA privacy standards do not adequately protect individuals' information. Many commenters claimed that standards modeled after certain HIPAA standards would be unnecessarily burdensome for studies in the behavioral and social sciences where the data are often less sensitive than health information.
Some comments maintained that HIPAA like standards would not always be suitable for the variety of research methods and procedures for the collection and storage of information in research activities not subject to the HIPAA Rules. Some commented that certain HIPAA standards would not be suitable because of the location of the research activity, or because the kind of institution supporting the research was significantly different from a covered entity. Others thought the HIPAA standards create confusion and complications for investigators and institutions that would increase if standards modeled on certain HIPAA standards were applied across the board. At the same time, regardless of the specific standards to be employed under this approach, several commenters noted that the additional administrative burden that might be created by establishing a data security and information protection system could be offset by the decreased time and attention IRBs would have to invest in reviewing every study that required data or biospecimen protections. They also noted that many institutions already have required data and biospecimen protection systems in place.
Some commenters noted that expansion of some of the exemption categories could only be ethically acceptable if those research activities were subject to a requirement for data security and information protection, because information collected for some research studies would no longer be collected under a research plan approved by an IRB. With regard to an absolute prohibition against re-identifying de-identified data, many commenters expressed concern, and provided reasons why re-identification might be valid or even desirable, including the need to return clinically relevant research results to an individual. For example, if the research uncovers information that might have important clinical significance for an individual, re-identification could be used so that the individual could get care. In addition, they pointed out that
The public was asked to comment on: The length and complexity of informed consent forms; additional information, if any, that should be required by the regulations to assure that consent forms appropriately inform subjects about alternatives to participation, as well as whether or not there should be modifications or deletions to the required elements; whether subject comprehension should be assessed, and if so, under what circumstances; whether changes to the Common Rule would necessitate conforming changes to the authorization requirements of the HIPAA privacy requirements; and whether additional requirements in the consent process are warranted, such as financial disclosures by investigators. The ANPRM also requested comment on the need for regulation of consent for the following: Research use of biospecimens collected for clinical purposes, consent for research use of pre-existing data, and consent to secondary research use of data and biospecimens.
The ideas presented in the ANPRM would be a substantial change from the current Rules in several ways. First, the current Rules allow research without consent when a biospecimen is used for research under conditions where the researcher does not possess information that would allow them to identify the person whose biospecimen is being studied. Thus, biospecimens collected as part of a non-research protocol (
A majority of the commenters opposed the ANPRM's suggested requirement to have consent for research use of all biospecimens, regardless of identifiability, on both administrative and ethical grounds. Administrative reasons for opposition to the suggested consent requirements included the prohibitive costs to collect, log, and track consent status of data and biospecimens, and the considerable administrative efforts that would be required to keep track of the consent status. Commenters opposed to the suggested consent requirements on ethical grounds cited increased privacy risks to subjects arising from the need to maintain links between the consent documents and the biospecimens or data in order to ensure that any restrictions on the research use of such resources were honored. They also expressed their belief that convincing evidence of harm caused by research use of nonidentified clinical biospecimens without consent is lacking, especially when considering the public health benefit of such use, and noting that they were not convinced that the principle of autonomy outweighs or trumps the principle of beneficence. Some patient advocacy organizations also expressed concerns about the consequences of requiring consent for the use of nonidentified biospecimens. Yet, most of the comments from individual members of the public strongly supported consent requirements for use of their biospecimens, regardless of identifiability, or data.
Many commenters expressed the opinion that the existing regulatory framework is adequate and that current practices should be maintained, stressing that the research use of nonidentified data or biospecimens does not involve risk to the research participant. One commenter noted that “In our extensive professional experience working with biospecimens on a daily basis, the current system has worked well and has greatly enriched the opportunity for discoveries that were unknown at the time of collection and when research does not require subject identification or involve patient risk.” In contrast, some commenters supported the idea of requiring consent for research use of all biospecimens, with one commenter noting simply that “research use of data initially collected for non-research purposes should always require informed consent.” Commenters particularly noted concerns about imposing consent requirements on the use of biospecimens already collected—that is, not grandfathering in such resources—especially if these biospecimens are nonidentified. Requiring that consent be obtained for the use of these materials could result in their being rendered useless for research, which would represent a cost of its own in terms of lost opportunity. This concern was based on the practical limitations involved in obtaining consent for biospecimens that were de-identified in the past, given that it may not be possible to re-contact the original source.
The objections raised by the commenters about the possible adverse consequences of requiring consent for the use of nonidentified biospecimens—including, in particular, the proposition that such a change might significantly compromise an important and relatively low-risk area of research—resulted in suggestions in the comments that this should be systematically assessed before suggesting any new rules. In fact, several commenters suggested that data be collected on the cost and feasibility of instituting such a requirement before revising the Common Rule.
Second, if the data were originally collected for research purposes, then consent would be required regardless of whether the investigator obtains identifiers. Note that this would be a
Public comments revealed variable opinions on this issue. Several commenters indicated that there is no need for additional regulations, with one university stating that it “strongly opposes more restrictive regulations about the use of these biospecimens and sees no need to change the current regulations, even or perhaps especially in the case of secondary data analysis.” Other commenters opposed broad consent, stating that researchers and clinicians should obtain specific consent from individuals for each research project. This opposition was made on the ethical grounds that because individuals are not fully informed of specific research purposes for broad consent, they can never be truly informed about the use of their data. In contrast, other commenters expressed clear support for general consent for secondary research use of biospecimens and data collected during research to exempt the research from IRB review, noting that “we support the suggestion in the ANPRM to encourage general consent for the secondary research use of biospecimens and data and where this is not obtained IRB review is required.” Other commenters favored requiring IRB review over permitting the use of a broad consent to approve secondary research use of identifiable data or biospecimens. These commenters believed that IRB consideration of consent requirements for individual research studies was more protective of human subjects than the ANPRM suggestions to permit broad consent for future use.
With regard to the burden of obtaining consent for the research use of de-identified biospecimens, this requirement could be less burdensome than anticipated due to the ANPRM's suggested allowance of broad consent. While the ANPRM suggested requiring consent for the use of biospecimens, it suggested allowing a one-time, broad consent for future uses to be obtained with a template form which, if used without changes, would not require IRB review, and could be obtained at the same time as the initial research or clinical consent. Some commenters, particularly patients and patient advocacy groups, expressed concern about the burden of re-consenting patients for broad consent after biospecimens were collected.
Several commenters suggested that data be collected on the cost and feasibility of instituting such a requirement before revising the Common Rule.
In most instances, the consent requirements described above would have been met at the time that the biospecimens or data were initially collected, when, under the ANPRM the subject would have signed a standard, brief general consent form allowing for secondary research. This brief consent could be broad enough to cover all data and biospecimens to be collected related to a particular set of encounters with an institution (
The ANPRM suggested that this standardized broad consent form would permit the subject to say no to all future research. In addition, the ANPRM acknowledged that there are likely to be a handful of special categories of research with biospecimens that, given the unique concerns they might raise for a significant segment of the public, could be dealt with by check-off boxes allowing subjects to separately say agree or disagree to that particular type of research.
Further, the ANPRM suggested that the current prohibition that participation in a research study (such as a clinical trial) could not be conditioned on agreeing to allow future open-ended research using a biospecimen would be maintained. With regard to the secondary research use of pre-existing data, on those occasions when oral consent was acceptable under the regulations for the initial data collection, the ANPRM envisioned that subjects would have typically provided their oral consent for future research at the time of the initial data collection; a written consent form would not have to be signed in that circumstance.
The ANPRM suggested that these changes would only be applied prospectively, not retrospectively. In other words, they would only apply to biospecimens and data that are collected after the effective date of the new rules. It also noted that there would be rules that would allow for waiver of consent under specified circumstances, though those conditions would not necessarily be the same as those for other types of research.
Commenters offered a few suggestions for modifying or deleting the required elements of consent, such as removing boilerplate language that only protects institutions and research sponsors, as well as removing some of the required elements for minimal risk research. However, many felt that guidance, rather than regulatory change, would better improve the development of consent forms. Although many commenters noted the need for shorter and more comprehensible consent forms, most felt that the required elements of consent articulated in the Common Rule are sufficient. Commenters overwhelmingly supported the goals articulated in the ANPRM, but cautioned against an overly prescriptive or rigid approach to consent forms. However, several commenters requested guidance on what might be included in a consent form for future research use of identifiable information and identifiable biospecimens to ensure that such forms satisfied the consent requirements of the Common Rule.
A majority of commenters supported the development of regulations or guidance designed to encourage
Finally, many commenters supported making changes to HIPAA authorization requirements, as necessary to conform to provisions of the Common Rule. In addition, most commenters were supportive of requiring investigators to disclose in consent forms certain information about the financial relationships they have with study sponsors.
The ANPRM also asked for comments on the information investigators should be required to provide to prospective subjects in circumstances where the regulations would permit oral consent. Additional questions focused on whether there are additional circumstances under which it should be permissible to waive the usual requirements for obtaining or documenting informed consent, and whether there are types of research in which oral consent without documentation should not be permitted. There were few responses to these questions and no common themes or consensus among those submitted. However, several commenters pointed to the need to consider community norms throughout the consent process, including its documentation.
The ANPRM asked the public to consider a number of changes to improve the current system for the real-time prompt collection of data regarding adverse events. The changes that the ANPRM stated were under consideration were intended to simplify and consolidate the reporting of information that is already required to be reported by an investigator, and not to expand the information that has to be reported. In addition to these changes, the ANPRM indicated that the Federal Government was also considering creating a central web-based repository to house a great deal of the information collected through the portal.
Although a number of commenters applauded the goal of easing and harmonizing reporting requirements, most expressed concerns about collecting data on unanticipated problems and adverse events in a central database. Those who supported the concept of centralized reporting asked for more detail on what such a system would entail. More specifically, several commenters noted that IRBs sometimes struggle with what should be reported and with distinguishing between the Common Rule term “unanticipated problems” and the FDA term “adverse events.” Commenters noted that under the Common Rule at § __.103(b)(5), each institution determines through its own policies the procedures for reporting unanticipated problems to department or agency heads. As a result, there is no standardized definition of “unanticipated problems,” so each institution may be reporting different events. Commenters also sought better guidance on those terms and encouraged agencies to clarify meanings and reporting requirements.
Commenters stated that a standardized, streamlined set of data elements, a single web-based reporting tool that facilitates delivery to agencies and oversight bodies, and harmonized Federal agency guidance would simplify the process. However, many expressed skepticism that harmonization across Federal agencies could occur.
With regard to a centralized database, many commenters expressed concerns regarding the value in terms of cost and time with compiling such data, gleaned from diverse studies and sources, in order to conduct an integrated analysis. They commented that it is unclear how the data would be useful beyond a specific study and unclear who would have access to the data and how it would be managed and interpreted to better inform the regulatory process. Commenters asked, if the data reporting is real-time, who is expected to develop such a system and review incoming data to coordinate the appropriate response? Many commenters questioned the validity of data collected in such a generic manner and the ability to draw generalizable conclusions based on data collected from varied sources and contexts. Several commenters said that before implementing such a central repository, a thorough cost-benefit analysis should be conducted regarding strengths and limitations of similar data repositories. Until the utility of such a centralized system could be demonstrated, especially when compared to the current decentralized system, many felt the burden of creating such a system would not be counterbalanced by the benefit of added protections. Along these lines, commenters also questioned the utility of counting how many human subjects are enrolled in trials, stating that this would not be a meaningful way to develop risk estimates.
Many commenters cited the adequacy of current reporting systems, despite the need for improvement. Centralized reporting of adverse events would represent a dramatic change from how events are collected and reported now. For example, sponsors of clinical trials are responsible for continuously monitoring their trials, adverse events must be reported to sponsors, and new reporting would not substitute for reports to sponsors. In addition, under FDA regulations, when applicable, safety information from non-U.S. clinical trials may need to be reported. Moreover, sponsors and funding agencies probably would not rely on extracting information from a federal database as the source of information to meet all of their safety oversight obligations and would likely still require investigators to complete adverse event case report forms as well as rely on the use of Data Safety Monitoring Boards. Commenters also raised concerns that the use of an electronic centralized reporting system could be a substantial burden on investigators, may potentially decrease investigators' willingness to participate in trials, and may encourage the conduct of studies outside the regulations. If reporting systems were now required to also gather and store unanticipated problems in addition to adverse events, commenters said the system would become unwieldy, run the risk of creating long lag times in analysis, and draw low risk events into a system that should be focused on the
Based on the public comments, the NPRM does not pursue a centralized reporting system and thus this issue is not addressed further. OHRP will continue to engage in discussions with FDA and Common Rule departments and agencies regarding clarifying reporting terms and requirements.
The ANPRM suggested that, regardless of what information is removed, it is possible to extract DNA from a biospecimen itself and potentially link it to otherwise available data to identify individuals. In addition, irrespective of whether biospecimens are considered individually identifiable, the ANPRM sought comment on whether the regulations should be changed to respect individuals' interest in being able to decide whether their biospecimens would be available for research, even if the biospecimen was not associated with any identifiable information. Consequently, it asked for public comment on the value of categorizing all research involving the primary collection of biospecimens as well as storage and secondary analysis of existing biospecimens as research involving identifiable information.
The ANPRM asked whether some types of genomic data should be considered identifiable and, if so, which types (
Commenters were mostly concerned with the cost and burden that would be imposed by the requirement to obtain consent. Commenters anticipated these costs to include obtaining consent from participants and the administrative efforts required to keep track of the consent status of biospecimens. Most commenters did not provide detailed cost estimates with their comments; data are specifically requested in response to this NPRM. In addition, estimates of the type and number of studies that could not be pursued using existing samples and data because of the absence of sufficient consent are requested. Comment is also sought on the value to the public and research participants of being asked their permission for research use of their data and specimens.
Several commenters also stated that if the Common Rule were modified such that all biospecimens were covered under the rule regardless of their identifiability, there still might be some activities involving biospecimens or types of biospecimens that should be considered exempt or “excused.” Suggestions included:
• Identifying markers for cancer prognosis or prediction of response to cancer therapy, or identifying cancer molecular targets (molecular research)
• Basic science research (including analysis of biological processes)
• Research of rare conditions and diseases
• Pediatric research
• Research with samples that lack potentially identifying information, such as serum or plasma not containing DNA
• Biospecimens lacking nucleic acids (such as certain red blood cells, expiratory gases)
• Blood culture bacteria
• Bacterial and viral specimens (this was listed in a comment as a public health issue)
• Protein analysis
• Statistical method development (to the extent that this development is related to biospecimens)
• New molecular methods to detect infectious agents
• Use of specimens to develop and validate new assays for infectious agents
• Archival paraffin blocks
One commenter also suggested that the Rule could propose a definition for biospecimen such that the term does not include sample types that lack DNA.
In addition, some commenters noted that the recommendation to require consent might privilege the Belmont Report's principle of autonomy over the principle of justice, because requiring consent could result in lower participation rates in research by minority groups and marginalized members of society. The literature on consent rates in studies involving biospecimens suggests that while minority consent rates in some cases may be lower than non-minorities, when asked to consent, minority consent rates are still higher than projected.
The ANPRM asked questions about the definition of research and whether various activities should be excluded from the Common Rule, either by changing the definition of research or by adding exemptions, or both. The ANPRM sought comment on whether and, if so, how, the Common Rule should be changed to clarify whether quality improvement activities, program evaluation studies, or public health activities are covered. It also asked whether there are specific types of studies for which the existing rules are inappropriate. If so, comments were sought on whether this problem should be addressed through modifications to the exemption categories, or by changing the definition of “research” used in the Common Rule to exclude
If the definition of research were to be changed, public comment was sought on how excluded activities should be defined (
A majority of public comments supported excluding the following from the regulatory requirements: quality improvement activities, public health activities, and program evaluation. Many of these commenters argued that the public benefits resulting from these activities justified their practice, particularly given the generally low risk involved. Some argued that for some legally mandated activities designed to accomplish a public good, it would be inappropriate for IRBs or individuals to be able to impede or thwart the execution of those mandated activities. A majority of comments also favored distinguishing between research and health care operations, as such terms are defined in the HIPAA Privacy Rule, and excluding the latter from the policy.
Some commenters noted that people involved in these various activities are protected in other ways, and alluded to the sorts of measures that provide a measure of protection. Others suggested that any exclusions should be limited to data collection and analysis activities, or to activities below a certain threshold of risk (
The overwhelming majority of public comments responding to the question about excluding specific fields of study from the regulatory requirements of the Common Rule supported explicitly excluding certain activities from the definition of research versus modifying the exemption categories. The overwhelming majority of these comments focused on oral history. Some of the comments were virtually identical and appear to have been coordinated. Many of the comments reflected the view that the Common Rule was not designed or intended to include oral history activities, and that the ethical codes pertaining to oral history procedures are not consistent with the application of ethical principles reflected in the Common Rule.
A smaller number of similar comments were submitted with respect to various humanities disciplines and journalism. A significant minority of commenters opposed the exclusion of any fields of study, arguing that the activity itself rather than the academic discipline or training of the investigator should be the basis for the assessment of whether the activity should be excluded. Some of the commenters recommended that the definition of research be focused more explicitly by being limited to “biomedical and behavioral research,” in accordance with the statutory provision underlying the Common Rule. A significant number of commenters recommended that guidance should be issued to clarify how the definition of research should be applied, with cases and explanations.
The ANPRM discussed a tracking mechanism to enable institutions to assure that such research meets the criteria for inclusion in the suggested “excused” categories. The original recommendations would require investigators to register their study with an institutional office by completing a brief form, thus eliminating the current practice of not allowing investigators to begin conducting such studies until a reviewer had determined it met the criteria for excused research. This would make the institution aware of key information about the research (such as the purpose of the research and the name of the study's principal investigator), without also requiring that the activity undergo a review that, if not done in a timely manner, could slow the research without adding any significant protection to subjects. In addition the institution could choose to review some of the submissions at the time they are filed and, if deemed appropriate, require that the study be sent for expedited review or, in rare cases, convened IRB review. It would be made clear that the regulations would not require, and in fact, would discourage, having each of these registration forms undergo a comprehensive administrative or IRB review prior to commencing the study or even afterward.
The auditing requirement was intended to encourage institutions to use the regulatory flexibility suggested for the “excused” categories of research. The auditing requirement would have provided institutions with information needed to assess their compliance with the new “excused” categories without unnecessarily subjecting all such research to either prospective review, or even routine review sometime after the study is begun. Note that currently, OHRP recommends that there be some type of review by someone other than the investigator to confirm that a study qualifies as exempt, and many institutions do impose such a requirement even though such a requirement is extra-regulatory.
The ANPRM also asked whether this research should be called “excused” or some other term, whether it was acceptable for investigators to independently determine whether their research was excused, whether review of all registrations should be required, and whether there should be a time limitation or waiting period before excused research could begin. The ANPRM also asked whether it was appropriate to require institutions holding an FWA to conduct retrospective audits of a percentage of the excused studies to make sure they qualify for inclusion in an excused category, and if so, how such audits should be conducted.
Commenters overwhelmingly expressed concerns about adopting the term “excused” to describe this area of research and suggested the term “registered” should such a system be adopted. Commenters recommended the term “registered” because such studies would not be exempt or excused from other requirements, such as compliance with data and security provisions as well as, in certain circumstances, informed consent requirements. In general, commenters were not necessarily opposed to the concept of registration but sought further information on what this process would entail.
Public commenters also expressed concerns about allowing an investigator to independently make the determination that his or her research is exempt. Other commenters suggested that this practice would be acceptable for some investigators, whose research is well known to IRB members, and is clearly within an exempt category. The ANPRM noted concerns that some exempt research was unnecessarily delayed by requirements of some institutions to review the research to make an exemption decision.
Several institutions reported that they already as a matter of policy require investigators to submit exempt studies to the IRB, not necessarily for full board review, but to ensure that the exempt determination is valid. These decisions typically are made by the IRB administrator and never involve full review unless there is concern about the exemption status. Thus, they felt the registration requirement was unnecessary and would add new administrative burdens for research already considered low risk.
Other commenters, such as investigators conducting research currently considered exempt, were strongly opposed to a registration requirement because it would add a new burden to conducting less than minimal risk and exempt research. In addition, commenters raised concerns about the administrative burden and need for a retrospective audit system of registered research.
The ANPRM also considered whether to include on the list of exempt studies certain types of social and behavioral research conducted with competent adults that would involve specified types of benign interventions commonly used in social and behavioral research, that are known to involve virtually no risk to subjects, and for which prior review does little to increase protections to subjects. These would be methodologies that are familiar to people in everyday life and in which verbal or similar responses would constitute the research data being collected. For example, an investigator might ask subjects to watch a video, read a paragraph, or solve puzzles, and then ask them some questions to elicit word associations or time performance of activities. The specific methodologies might be spelled out in regulations, or they might be promulgated via a periodic mechanism to announce and update lists similar to the list that is published for activities that may be reviewed by an IRB using the expedited review procedures.
A majority of commenters supported the ANPRM discussion on expanding current exemption category 2 (current Rule at § __.101(b)(2)) by eliminating the limitations related to the recording of identifiable information and the harm that could result if a subject's responses were disclosed. However, many commenters were opposed to the requirement that subjects be “competent adults” in order for the expanded exemption to apply, asking whether tests of competency would be required for such research to proceed.
Many commenters also supported adding another exemption category of research for certain types of social and behavioral activities, conducted with competent adults, that would involve specified types of benign interventions beyond educational tests, surveys, focus groups, interviews, and similar procedures that are commonly used in social and behavioral research, that are known to involve virtually no risk to subjects, and for which IRB review does little to increase protections for subjects.
The ANPRM asked questions about whether the current limitations specified in exempt category 4 (research involving the use of existing information or biospecimens, § __.101(b)(4) in the current Rule) should be eliminated. Specifically, the ANPRM suggested that the category would be revised to eliminate the word “existing.” With this elimination, the exemption would be broadened to cover the use of information or biospecimens that were or will be collected for purposes other than the suggested research, rather than requiring that all of the information or biospecimens already exist at the time the study is suggested for exemption.
The ANPRM also discussed whether research involving only the use of data or biospecimens collected for other purposes, even if the investigator intends to retain identifiers, should come within a new exemption category; studies that include a plan to provide individual research results to subjects would not qualify for this proposed exemption. In addition, the ANPRM asked whether certain flexible consent requirements could be imposed on some of these studies that would permit the use of a broad consent for future use, with a requirement that a subject's specific consent would be required before their biospecimens could be used for special categories of research.
Many of the comments supported the discussion in the ANPRM of eliminating the requirement that the information or biospecimens be “existing” at the time the study was suggested for exemption. However, a majority strongly disagreed that biospecimens should be considered or treated as though they were inherently identifiable. A majority also opposed the suggestion that there be consent requirements for the research use of nonidentifiable biospecimens collected for purposes other than the current research study.
Some commenters also favored requiring IRB review and approval for the use of identifiable private information and identifiable biospecimens, rather than permitting the use of a broad consent for future use to satisfy the regulatory requirement for consent. These commenters indicated that IRB review of specific research studies, and the IRB's consideration of whether a study specific informed consent should be required or whether informed consent could be waived, was more protective of human subjects than the ANPRM recommendation of permitting use of a broad consent for future use.
The ANPRM asked several questions about the interpretation and applicability of current exemption category 5 (current Rule at
There were few responses to these questions. However, those that did comment noted that this category is often misunderstood by IRBs and, at best, would benefit from clearer guidance. Commenters said that examples would help investigators and IRBs understand when research activities included in demonstration projects constitute human subjects research subject to the Common Rule. Commenters noted that many activities in demonstration projects do not contribute to generalizable knowledge as they produce results that are relevant only to the program being assessed; as such, many of these activities do not meet the Common Rule's regulatory definition of “research” and thus fall outside of the rule. Other commenters said that some activities in this category are mandated or required by law or regulation and should not be considered to be under the purview of the Common Rule. It was noted that the critical issue in these studies should be protecting privacy and as long as measures are in place to do so, additional protections are not required.
The ANPRM discussed and sought comment on three possible changes to the review of research through expedited review: (1) Revising the definition of minimal risk, which is one of the criteria for determining whether a study is eligible for expedited review; (2) changing the default position so that research on the expedited review list could generally be presumed to involve minimal risk; (3) revising the criteria for approval of research studies under expedited review; and (4) allowing appropriately trained individuals who are not IRB members to conduct expedited reviews.
Several commenters provided suggestions for additions to the list of research activities eligible for expedited review. Others encouraged OHRP to consider developing principles for expedited review, rather than creating a revised list of research activities. Commenters suggested a more timely and consistent review of the list because of the rapidly changing state of science and technology.
The ANPRM also discussed the potential adoption of a default presumption in the rule that a study that includes only activities on the expedited review list is a minimal risk study and should receive expedited review. A reviewer would have the option of determining that the study should be reviewed by a convened IRB when that conclusion is supported by the specific circumstances of the study. The ANPRM also asked for comments on whether IRBs should be required to report instances when they overrode the default presumption that research appearing on the posted list did not warrant review by a convened IRB.
Commenters overwhelmingly welcomed the clarification that categories of research found on the published list should be presumed to be minimal risk. However, commenters were largely opposed to requiring IRBs to report instances when they conducted a review by the convened membership (versus an expedited review) for studies appearing on the list. They were opposed because of the additional administrative burden and also because they felt such a requirement would undermine the purview of local review and open IRBs up to second-guessing by OHRP.
With regard to revising the criteria used for expedited review, comments were mixed. Nearly half of those commenting expressed concerns about establishing two sets of ethical standards for IRB review—one for convened review and one for expedited review. They asserted ethical and administrative concerns about operating under two sets of conditions and principles—that is, expedited review should not be viewed as less stringent than review conducted by a convened IRB.
Those commenters in favor of retaining the current criteria wrote that a double standard could result in arbitrary IRB decision making. In addition, many wrote that the current criteria are well understood by IRB members and the tendency to review a protocol through a convened IRB when expedited review would be permissible is more a function of institutional
Those in favor of revising the elements most often cited the irrelevance of some of the criteria for minimal risk research, such as the need to ensure that risks to subjects are reasonable in relation to anticipated benefits (§ __.111)(a)(2)). They stated that in the case of minimal risk research, the need to balance risks with benefits is not pertinent. Some commenters asked OHRP to develop guidance for the expedited reviewer in interpreting the most relevant criteria during expedited review.
Several commenters noted that if the revised regulations remove the requirement for continuing review of studies initially reviewed through expedited review it would alleviate administrative burden; thus more extreme measures such as revising the review criteria would be less compelling.
With regard to allowing a non-IRB member to conduct expedited review, comments were divided nearly evenly between those who opposed such a change and those who supported it. Those who opposed it cited the need for continuity and consistency across IRBs, as well as expressing concerns about accountability and liability. Those in favor of such a revision cited the expertise of IRB staff members and their ability to review many expedited studies at the same level as a member of the IRB.
To address institutions' concerns about OHRP's practice of enforcing compliance with the Common Rule through the institutions that are engaged in human subjects research, the ANRPM also suggested that appropriate accompanying changes could be made in enforcement procedures to hold external IRBs directly accountable for compliance with certain regulatory requirements.
This issue attracted a large number of comments, and revealed nearly evenly divided perspectives. Researchers and disease advocacy groups tended to favor the single IRB review requirement. IRB and institutional representatives tended to be opposed to the possible requirement, though many indicated single IRB review should be encouraged. Support was especially strong for single IRB review for cooperative clinical trials for which the evaluation of a study's social value, scientific validity, and risks and benefits, and the adequacy of the informed consent form and process generally do not require the unique perspective of a local IRB. Moreover, depending on the nature of the study, FDA may not permit differences in protocols across sites, which further bolstered commenters' views that the requirements be harmonized across the Common Rule and FDA requirements. Commenters reported incidences of IRBs continuously second-guessing each other, which delayed studies to the point that subject recruitment opportunities were foregone or lost. This problem seemed especially critical in studies of rare diseases and cancers, which nearly always involve multiple research sites.
Support for the use of a single IRB, however, was not restricted to clinical trials. Several commenters cited long delays and burdensome requirements resulting from multiple reviews of studies in the behavioral and social sciences. In addition to the view that these administrative requirements do not enhance protections, supporters of a single IRB review of cooperative studies cited the frequent need for maintaining consistency across sites, which can be degraded by multiple reviews.
Despite support for the ANPRM suggestion, several commenters expressed concern about making such a provision mandatory, stating that the current regulations at § __.114 currently permit the use of joint review arrangements for cooperative research. They noted that although this option exists, institutions might be hesitant to use it because of liability concerns and the unwillingness of institutions or IRBs to rely on the judgment of other institutions or IRBs. However, several commenters expressed concern about signaling the acceptability of a single IRB for review while allowing institutions to continue to conduct their own ethics review, fearing that such a policy would not correct the current situation, which tends to favor multiple reviews. Thus, they commented that mandating a single IRB might be the only way to achieve the goals of streamlining review while ensuring protections.
Another issue raised was the need to set clearer expectations of the responsibilities of local IRBs that are not designated as the central IRB. A number of commenters supporting the requirement for a central IRB also requested that OHRP issue guidance on how to select the IRB, responsibilities of all parties, and clarifying compliance and enforcement policies. Several commenters also requested that OHRP develop a template for reliance agreements to replace inter-institutional agreements currently in use.
Those who expressed concern about the use of a single IRB said some studies, especially in the behavioral and social sciences, might involve significant contextual issues reflecting community norms, standards, and practices, or local culture and customs. Use of a distant IRB might not consider and best protect subjects based on community norms. Others noted that such concerns can be addressed by investigators or IRBs submitting “points to consider” regarding significant contextual or cultural considerations of relevance to their site.
A primary issue posed by those opposed to mandating use of a single IRB in cooperative studies focused on potential loss of accountability and increased liability for the institutions
The ANPRM further suggested that standard templates for protocols and consent forms and sample versions of those documents that are specifically designed for use in the most common types of studies might facilitate expedited review. Such forms would need to be carefully designed to eliminate those elements that are of relevance only in studies that pose greater than minimal risks and to substantially reduce the current burden of researchers involved in producing these documents and of the IRB members who review them. The ANPRM asked whether there were specific changes that could be made to reduce the burden imposed on investigators and their staffs in terms of meeting the requirements to submit documents to an IRB, without decreasing protections to subjects.
There were few comments on streamlining the document submission requirements for expedited review, and there was no consensus among those who did comment about how to achieve that goal.
Additionally, the ANPRM suggested that, for studies initially reviewed by a convened IRB, continuing review would not be required after the study reaches the stage where procedures are limited to either: (1) Analyzing data (even if it is identifiable), or (2) accessing follow-up clinical data from procedures that subjects would undergo as part of standard care for their medical condition or disease (such as periodic CT scans to monitor whether the subjects' cancers have recurred or progressed) unless specifically mandated by the IRB,. This would be a change from the current Rules, which require at least expedited IRB review of the activities described in (1) and (2) above. The requirement that research involving greater than minimal risk be reviewed by a convened IRB would not be changed from the current system.
By eliminating the requirement for continuing review of these activities, the ANPRM suggested that this change would allow for more effective use of IRBs' time by enabling the IRB to focus on reviewing information that is necessary to ensure protection of research subjects. Requiring annual continuing review of research studies involving only activities that are already well-documented to generally involve no more than minimal risk may provide little if any added protection to subjects, and it may be preferable for IRB resources to be devoted to research that poses greater than minimal risk.
The ANPRM asked for public comment on whether it would be appropriate to require IRBs to submit periodic reports to OHRP in the instances in which they choose to override the default policy of no continuing review required for the situations described above. The information, if collected by OHRP, might be useful in developing future guidance or revising the categories of research eligible for expedited review.
A large majority of public comments were in favor of the suggested revisions. Many were comfortable with continuing to allow IRBs or reviewers the discretion to require continuing review in certain circumstances, citing the historical position of OHRP in considering the regulations as the floor, rather than the ceiling, for protecting the subjects of research. Those who were opposed to the revisions cited concerns about institutional liability, the possibility for increased noncompliance among investigators no longer required to “check in,” and possible breakdowns in lines of communications between investigators and IRBs. Others expressed concerns about how an IRB will know that a study has ended and suggested that investigators be required to file a notice of closure of a study.
Note that the November 10, 2010, document entitled, “Guidance on IRB Continuing Review of Research” states:
OHRP is aware that many IRBs require investigators to submit final closeout reports when a research study is completed or no longer involves human subjects. Since the HHS regulations at 45 CFR part 46 do not require submission of such reports, institutions are free to decide whether and when such reports are required and what their content should include.
Commenters overwhelmingly opposed requiring IRBs to periodically report on the instances when they (or a reviewer) elect to override the default position of no continuing review required. The reasons for opposition included: (1) Additional administrative burden that would negate the reduced burden gained; (2) the possibility that requiring such reporting would discourage IRBs/reviewers from making an override decision; and (3) concerns that such reports would lead to OHRP second-guessing IRB decisions and imposing compliance oversight in an extra-regulatory decision. Several commenters suggested that OHRP could use other means than this requirement for developing guidance and improving educational efforts regarding expedited and continuing review.
The ANPRM did not suggest any specific approaches to harmonization but asked for public comment on a set of questions focused on: (1) The extent to which differences in guidance on research protections from different agencies strengthen or weaken protections for human subjects; (2) the extent to which differences in guidance on research protections from different agencies facilitate or inhibit the conduct of research domestically and internationally; and (3) the desirability of all Common Rule agencies issuing one set of guidance.
Responses to questions about the need for harmonization across Common Rule agencies reflected widespread support for such efforts. Several commenters acknowledged the difficulty of getting all Common Rule agencies to agree on all issues, as each has a different mission and research portfolio. However, they encouraged seeking harmonized guidance whenever possible.
For the reasons set forth in the preamble, it is proposed that the Federal Policy for the Protection of Human Subjects be amended as follows:
(a) Except as provided in paragraph (b) of this section, and as detailed in § __.104, this policy applies to the research described in paragraphs (a)(1) and (2) of this section. The entities that must comply with this policy are institutions that are engaged in research described in paragraphs (a)(1) or (2) of this section, and institutional review boards (IRBs) reviewing research that is subject to this policy.
(1) All research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.
(2) All clinical trials as defined by this policy, irrespective of funding source, that meet all of the following conditions:
(i) The clinical trials are conducted by an institution that receives support from a Federal department or agency for human subjects research that is not excluded from this policy under § __.101(b)(2) and does not qualify for exemption in accordance with § __.104;
(ii) The clinical trials are not subject to regulation by the Food and Drug Administration; and
(iii) The clinical trials are conducted at an institution located within the United States.
(b) The following categories of activities are excluded from this policy, and no procedural, recordkeeping, or other requirements of this policy apply to the activities other than the conditions specified for the relevant category or categories:
(1) The following activities are excluded because they are
(i) Data collection and analysis, including the use of biospecimens, for an institution's own internal operational monitoring and program improvement purposes, if the data collection and analysis is limited to the use of data or biospecimens originally collected for any purpose other than the currently proposed activity, or is obtained through oral or written communications with individuals (
(ii) Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.
(iii) Collection and analysis of data, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(iv) Quality assurance or improvement activities involving the implementation of an accepted practice to improve the delivery or quality of care or services (including, but not limited to, education, training, and changing procedures related to care or services) if the purposes are limited to altering the utilization of the accepted practice and collecting data or biospecimens to evaluate the effects on the utilization of the practice. This exclusion does not cover the evaluation of an accepted practice itself.
(v) Public health surveillance activities, including the collection and testing of biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority and limited to those necessary to allow the public health authority to identify, monitor, assess, or investigate potential public health signals or the onset of a disease outbreak, including trends, or signals, and patterns in diseases, or a sudden increase in injuries from using a consumer product, or conditions of public health importance, from data, and including those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health, including natural or man-made disasters.
(vi) Surveys, interviews, surveillance activities and related analyses, or the collection and use of biospecimens conducted by a defense, national security, or homeland security authority solely for authorized intelligence, homeland security, defense, or other national security purposes.
(2) The following activities are excluded because they are considered to be
(i) Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators, if at least one of the following criteria is met:
(A) The information is recorded by the investigator in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects
(C) The research will involve a collection of information subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
(ii) Research involving the collection or study of information that has been or will be acquired solely for non-research activities or were acquired for research studies other than the proposed research study, when either of the following two criteria is met:
(A) These sources are publicly available, or
(B) The information is recorded by the investigator in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects or otherwise conduct an analysis that could lead to creating identifiable private information.
(iii) Research conducted by a Federal department or agency using government-generated or government-collected information obtained for non-research purposes (including criminal history data), if the information originally involved a collection of information subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
(iv) Research as defined by this policy that involves only data collection and analysis involving the recipient's use of identifiable health information when such use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for the purpose of “public health activities” as described under 45 CFR 164.512(b).
(3) The following activities are excluded because they are considered to be
(i) The secondary research use of a non-identified biospecimen that is designed only to generate information about an individual that already is known, including but not limited to the development and validation of certain tests and assays (such as research to develop a diagnostic test for a condition using specimens from individuals known to have the condition and those known not to have the condition), quality assurance and control activities, and proficiency testing.
(ii) [Reserved]
(c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy, which judgment shall be exercised consistent with the ethical principles of the Belmont Report.
(d) Department or agency heads may require additional protections for specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise covered by this policy. Advance public notice will be required when those additional requirements apply to entities outside of the Federal department or agency itself.
(e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide additional protections for human subjects.
(f) This policy does not affect any state or local laws or regulations that may otherwise be applicable and that provide additional protections for human subjects.
(g) This policy does not affect any foreign laws or regulations that may otherwise be applicable and that provide additional protections to human subjects of research.
(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. In these circumstances, if a department or agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the department or agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the department or agency head, notices of these actions as they occur will be published in the
(i) Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes of research activities otherwise covered by this policy provided the alternative procedures to be followed are consistent with the principles of the Belmont Report.
(j) Federal guidance on the requirements of this policy shall be issued only after consultation, for the purpose of harmonization (to the extent appropriate), with other Federal departments and agencies that have adopted this policy, unless such consultation is not feasible.
(k)
(2)
(i) The biospecimens were collected for either research or non-research purposes before the compliance date for the additional requirements of this subpart at § __.102(e)(1)(iii), and
(ii) Research use of the biospecimens occurs only after removal of any individually identifiable information associated with the biospecimens.
(a)
(b)
(c)
(d)
(e)(1)
(i) Obtains data through intervention or interaction with the individual, and uses, studies, or analyzes the data;
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information; or
(iii) Obtains, uses, studies, or analyzes biospecimens.
(2)
(3)
(4)
(5)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(a) Each institution engaged in research that is covered by this policy, with the exception of research excluded from this policy under § __.101(b) or eligible for exemption under § __.104(d), and that is conducted or supported by a Federal department or agency shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for federalwide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB.
(b) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes.
(c) The department or agency head may limit the period during which any assurance shall remain effective or
(d) Certification is required when the research is supported by a Federal department or agency and not otherwise excluded under § __.101(b), waived under § __.101(i), or exempted under § __.104(d), (e), or (f)(2). Institutions shall certify that each proposal for research covered by this § __.103 has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this § __.103 be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB.
(e) For non-exempt research involving human subjects covered by this policy that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall establish and follow procedures for documenting the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (
(a) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraphs (d) through (f) of this section are not subject to the requirements of this policy, other than those specified in the category.
(b)
(1)
(2)
(3)
(c) Federal departments and agencies shall develop a decision tool to assist in exemption determinations. Unless otherwise required by law, exemption determinations shall be made by an individual who is knowledgeable about the exemption categories and who has access to sufficient information to make an informed and reasonable determination, or by the investigator or another individual at the institution who enters accurate information about the proposed research into the decision tool, which will provide a determination as to whether the study is exempt. If the decision tool is used, further assessment or evaluation of the exemption determination is not required. An institution or, when appropriate, the IRB, must maintain records of exemption determinations made for research subject to the requirements of this policy for which the institution or IRB exercises oversight responsibility. These records must include, at a minimum, the name of the research study, the name of the investigator, and the exemption category applied to the research study. Maintenance of the completed decision tool shall be considered to fulfill this recordkeeping requirement.
(1) For studies exempted pursuant to paragraph (d)(2) of this section, the recordkeeping requirement will be deemed satisfied by the published list required at paragraph (d)(2)(i) of this section.
(2) [Reserved].
(d) The following categories of exempt human subjects research generally involve a low-risk intervention with human subjects, must be recorded as required in paragraph (c) of this section, and do not require application of standards for information and biospecimen protection provided in § __.105 or informed consent. Only paragraph (d)(2) of this section allows for the collection and use of biospecimens:
(1) Research conducted in established or commonly accepted educational settings when it specifically involves normal educational practices. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods that are not likely to adversely impact students' opportunity to learn required educational content in that educational setting or the assessment of educators who provide instruction.
(2) Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible federal Web site or in such other manner as the department or agency head may prescribe, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to or upon commencement of the research.
(ii) [Reserved]
(3)(i) Research involving benign interventions in conjunction with the collection of data from an adult subject through verbal or written responses (including data entry) or video recording if the subject prospectively agrees to the intervention and data collection and at least one of the following criteria is met:
(A) The information obtained is recorded in such a manner that human subjects cannot be identified directly or through identifiers linked to the subjects; or
(B) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.
(ii) For the purpose of this provision, benign interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. If these criteria are met, such benign interventions might include research activities in which a subject is asked to read materials, review pictures or videos, play online games, solve puzzles, or perform cognitive tasks.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception as described in paragraph (d)(3)(iv) of this section.
(iv) For the purpose of this provision, authorized deception is prospective agreement by the subject to participate in research where the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
(4) Taste and food quality evaluation and consumer acceptance studies
(i) If wholesome foods without additives are consumed, or
(ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
(e) The following categories of exempt human subjects research allow for the collection of sensitive information about human subjects, must not involve biospecimens, must be recorded as required in paragraph (c) of this section, and require application of standards for information and biospecimen protection provided in § __.105:
(1) Research, not including interventions, involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording), if the information obtained is recorded in such a manner that human subjects can be identified directly or through identifiers linked to the subjects.
(2) Secondary research use of identifiable private information that has been or will be acquired for non-research purposes, if the following criteria are met:
(i) Prior notice has been given to the individuals to whom the identifiable private information pertains that such information may be used in research; and
(ii) The identifiable private information is used only for purposes of the specific research for which the investigator or recipient entity requested access to the information.
(f) The following categories of exempt human subjects research involve biospecimens or identifiable private information, must be recorded as required in paragraph (c) of this section, require application of standards for information and biospecimen protection as described in § __.105, and require informed consent and limited IRB review to the extent described in each category or otherwise required by law:
(1)(i) Storage or maintenance for secondary research use of biospecimens or identifiable private information that have been or will be acquired for research studies other than for the proposed research study, or for non-research purposes, if the following criteria are met:
(A) Written consent for the storage, maintenance, and secondary research use of the information or biospecimens is obtained in accordance with § __.116(c) and (d)(2), and the template published by the Secretary of HHS in accordance with § __.116(d)(1) must be used. Oral consent, if obtained during the original data collection and in accordance with § __.116(c) and (d)(3), would be satisfactory for the research use of identifiable private information initially acquired in accordance with activities excluded from this policy under § __.101(b)(2)(i) or exempt from this policy in accordance with § __.104(d)(3) or (4), or § __.104(e)(1);
(B) The reviewing IRB makes the determinations required by § __.111(a)(9).
(ii) [Reserved.]
(2)(i) Research involving the use of biospecimens or identifiable private information that have been stored or maintained for secondary research use, if consent for the storage, maintenance, and secondary research use of the information and biospecimens was obtained as detailed in paragraph (f)(1)(i)(A) of this section.
(ii) If the investigator anticipates that individual research results will be provided to a research subject, the research may not be exempted under this provision and must be reviewed by the IRB and informed consent for the research must be obtained to the extent required by § __.116(a) and (b).
(a)
(b)
(c)
(1) For human subjects research regulated by this policy;
(2) For public health purposes;
(3) For any lawful purpose with the consent of the subject; or
(4) For other research purposes if the institution or investigator has obtained adequate assurances from the recipient that
(i) The recipient will implement and maintain the level of safeguards required by paragraph (b) of this section;
(ii) Except for research that qualifies for exclusion under § __.101(b) or exemption under § __.104 the releasing or disclosing institution or investigator shall obtain documentation from the recipient that the research has been approved under § __.111 to the extent required before releasing biospecimens or disclosing identifiable private information; and
(iii) The recipient shall not further release the biospecimens or disclose identifiable private information except for human subjects research regulated by this policy, or for other purposes permitted by this paragraph. For the purposes of this requirement, an institution or investigator shall obtain adequate assurances through the use of a written agreement with the recipient that the recipient will abide by these conditions.
(d) The provisions of this section do not amend or repeal, and shall not be construed to amend or repeal, the requirements of 45 CFR parts 160 and 164 for the institutions or investigators, including Federal departments or agencies, to which these regulations are applicable pursuant to 45 CFR 160.102.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.
(b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
(c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.
(d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
(e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.
(a) In order to fulfill the requirements of this policy each IRB shall:
(1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties;
(2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant;
(3) Establish and follow written procedures for:
(i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;
(ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and
(iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.
(4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of
(i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and
(ii) Any suspension or termination of IRB approval.
(b) Except when an expedited review procedure is used (as described in § __.110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy that do not qualify for exemption pursuant to § __.104(d), (e), or (f)(2).
(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with § __.116. The IRB may require that information, in addition to that specifically mentioned in § __.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.
(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § __.117.
(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
(e) An IRB shall conduct continuing review of research requiring review by
(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:
(i) Research eligible for expedited review in accordance with § __.110;
(ii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
(A) Data analysis, including analysis of identifiable private information, or
(B) Accessing follow-up clinical data from procedures that subjects would undergo as part of standard care for their medical condition; or
(iii) Research reviewed by the IRB in accordance with the limited IRB review procedure described in § __.111(a)(9).
(2) The IRB must receive confirmation on an annual basis that the research is still ongoing and that no changes have been made to the research that would require the IRB to conduct continuing review of the research.
(g) An IRB shall have authority to observe or have a third party observe the consent process and the research.
(a) The Secretary of HHS, has established, and published as a Notice in the
(b)(1) An IRB may use the expedited review procedure to review the following:
(i) Some or all of the research appearing on the list, unless the reviewer determines that the study involves more than minimal risk;
(ii) Minor changes in previously approved research during the period for which approval is authorized; or
(iii) Research that is being reviewed to determine whether it qualifies for exemption in accordance with § __.104(f)(1) in order to determine that the requirements of § __.111(a)(9) are satisfied.
(2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in § __.108(b).
(c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure.
(d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized:
(i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
(ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, § __.116.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by, § __.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data, in addition to the requirements in § __.105, if the IRB determines that the standards for information and biospecimen protection in § __.105 are not sufficient to protect the privacy of subjects and the confidentiality of data.
(8) If the investigator proposes a research plan for returning clinically relevant results to subjects, that the plan is appropriate.
(9) For purposes of conducting the limited IRB review as required by § __.104(f)(1), the IRB need not make the determinations at paragraphs (a)(1) through (8) of this section, and shall determine that the following requirements are satisfied:
(i) The procedures for obtaining broad consent for storage, maintenance, and secondary research use of biospecimens or identifiable private information will be conducted in accordance with the requirements of the first paragraph in § __.116.
(ii) If there will be a change for research purposes in the way the biospecimens or information are stored or maintained, that the privacy and information protection standards at § __.105 are satisfied for the creation of any related storage database or repository.
(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those
An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head.
(a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy.
(b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be selected by the Federal department or agency supporting or conducting the research or, if there is no funding agency, by the lead institution conducting the research.
(2) The following research is not subject to the requirements of this provision:
(i) Cooperative research for which more than single IRB review is required by law; or
(ii) Research for which the Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular study.
(c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort.
(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:
(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects.
(2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.
(3) Records of continuing review activities, including the rationale for conducting continuing review of research that has progressed to the point that it involves only one or both of the following:
(i) Data analysis, including analysis of identifiable private information, or
(ii) Accessing follow-up clinical data from procedures that subjects would undergo as part of standard care for their medical condition.
(4) Copies of all correspondence between the IRB and the investigators.
(5) A list of IRB members in the same detail as described in § __.108(a)(2).
(6) Written procedures for the IRB in the same detail as described in § __.108(a)(3) and (4).
(7) Statements of significant new findings provided to subjects, as required by § __.116(b)(5).
(8) The rationale for requiring continuing review for research that otherwise would not require continuing review as described in § __.109(f)(1).
(9) The rationale for an expedited reviewer's determination that research appearing on the expedited review list described in § __.110(b)(1)(i) is more than minimal risk.
(10) The written agreement between an institution and an organization operating an IRB specifying the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy, as described in § __.103(e).
(11) Records relating to exemption determinations, as described in § __.104(c).
(b) The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized representatives of the Federal department or agency at reasonable times and in a reasonable manner.
(c) The institution or IRB retaining the records shall safeguard identifiable private information contained within these records in compliance with § __.105.
Except as provided elsewhere in this policy, no investigator may involve a human subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. The prospective subject or the representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. The information must be presented in sufficient detail relating to the specific research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or representative's understanding of the reasons why one might or might not want to participate. In obtaining informed consent, the investigator must present first the information required by this section, before providing other information, if any, to the subject or the representative. Any informed consent form must include only the requirements of informed consent under this section, and appendices that include any other information provided to the subject or the representative. If an authorization required by 45 CFR parts 160 and 164 is combined with a consent form, the authorization elements required by 45 CFR 164.508 must be included in the consent form and not the appendices. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.
(a)
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental;
(2) A description of any reasonably foreseeable risks or discomforts to the subject;
(3) A description of any benefits to the subject or to others that may reasonably be expected from the research;
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
(9) One of the following statements about any research that involves the collection of identifiable private information:
(i) A statement that identifiers might be removed from the data and the data that is not identifiable could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the representative, if this might be a possibility; or
(ii) A statement that the subject's data collected as part of the research, from which identifiers are removed, will not be used or distributed for future research studies.
(b)
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's or the representative's consent;
(3) Any additional costs to the subject that may result from participation in the research;
(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject;
(6) The approximate number of subjects involved in the study;
(7) A statement that the subject's biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit;
(8) A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
(9) An option for the subject or the representative to consent, or refuse to consent, to investigators re-contacting the subject to seek additional information or biospecimens or to discuss participation in another research study.
(c)(1)
(i) A general description of the types of research that may be conducted with information and biospecimens and the information that is expected to be generated from the research, the types of information or biospecimens that might be used in research, and the types of institutions that might conduct research with the biospecimens or information;
(ii) A description of the scope of the informed consent must be provided, including:
(A) A clear description of the types of biospecimens or information that were or will be collected and the period of time during which biospecimen or information collection will occur. This may include all biospecimens and information from the subject's medical record or other records existing at the institution at the time informed consent is sought; and
(B) For purposes of paragraph (c)(1)(ii)(A) of this section, the period of time during which biospecimen or information collection will occur cannot exceed 10 years from the date of consent. For research involving children as subjects, that time period cannot exceed 10 years after parental permission is obtained or until the child reaches the legal age for consent to the treatments or procedures involved in the research, whichever time period is shorter. The time limitations described do not apply to biospecimens or information that initially will be collected for research purposes.
(iii) A description of the period of time during which an investigator can continue to conduct research using the subject's biospecimens and information described in paragraph (c)(1)(ii)(A) of this section (
(iv) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may withdraw consent, if feasible, for research use or distribution of the subject's information or biospecimens at any time without penalty or loss of benefits to which the subject is otherwise entitled, and information about whom to contact in order for the subject to withdraw consent. The statement must make clear that information or biospecimens that already have been distributed for research use may not be retrieved;
(v) If applicable, a statement notifying the subject or the representative that the subject or the representative will not be informed of the details of any specific research studies that might be conducted, including the purposes of the research, that will use the subject's information and biospecimens;
(vi) If applicable, a statement notifying the subject or the
(vii)The names of the institution or set of institutions at which the subject's biospecimens or information were or will be collected, to the extent possible (in recognition that institutions might change names or cease to exist); and
(viii) If relevant, an option for an adult subject or the representative to consent, or refuse to consent, to the inclusion of the subject's data, with removal of the identifiers listed in 45 CFR 164.514(b)(2)(i)(A) through (Q), in a database that is publicly and openly accessible to anyone. This option must be prominently noted, and must include a description of risks of public access to the data.
(2) [Reserved]
(d)(1) The Secretary of HHS will establish, and publish in the
(2) If § __.104(f)(1) requires written consent, the consent for research use of biospecimens or identifiable private information must be documented by the use of a written consent form signed by the subject or the representative. The template for consent for research use established by the Secretary may serve as the written consent form. A copy shall be given to the person signing the form.
(3) If § __.104(f)(1) allows for oral consent, a subject's or the representative's oral consent for research use of identifiable private information must be documented such that the consent is associated with the subject's identifiable private information. If this requirement is met through the use of written documentation, the subject or the representative is not required to sign the documentation.
(4) If the subject or the representative declines to consent to the research use of biospecimens or identifiable private information, this must be documented appropriately.
(e)(1) Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials. An IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth above, or waive the above requirement to obtain informed consent, provided the IRB finds and documents that:
(i) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
(A) Public benefit or service programs;
(B) Procedures for obtaining benefits or services under those programs;
(C) Possible changes in or alternatives to those programs or procedures; or
(D) Possible changes in methods or levels of payment for benefits or services under those programs; and
(ii) The research could not practicably be carried out without the waiver or alteration.
(2) Additional criteria for waiver or alteration of consent for biospecimens. For research involving the use of biospecimens, an IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth above, or waive the above requirements to obtain informed consent, provided the IRB finds and documents the criteria in paragraph (e)(1) of this section, and the following additional criteria:
(i) There are compelling scientific reasons to conduct the research; and
(ii) The research could not be conducted with other biospecimens for which informed consent was obtained or could be obtained.
(3) If an individual was asked to consent to the storage or maintenance for secondary research use of biospecimens or identifiable private information in accordance with the requirements of this section at paragraph (c) of this section, and refused to consent, an IRB cannot waive consent for either the storage or maintenance for secondary research use, or for the secondary research use, of those biospecimens or information.
(f)(1) Waiver or alteration of consent. An IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth above, or waive the above requirements to obtain informed consent, provided the IRB finds and documents that:
(i) The research involves no more than minimal risk to the subjects;
(ii) The research could not practicably be carried out without the requested waiver or alteration;
(iii) If the research involves accessing or using identifiable biospecimens or identifiable information, the research could not practicably be carried out without accessing or using identifiers;
(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
(v) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
(2) Additional criteria for waiver or alteration of consent for research involving biospecimens. For research involving the use of biospecimens, an IRB may approve a consent procedure that does not include, or that alters, some or all of the elements of informed consent set forth above, or waive the above requirements to obtain informed consent, provided the IRB finds and documents the criteria in paragraph (f)(1) of this section, and the following additional criteria:
(i) There are compelling scientific reasons for the research use of the biospecimens; and
(ii) The research could not be conducted with other biospecimens for which informed consent was obtained or could be obtained.
(3) If an individual was asked to consent to the storage or maintenance for secondary research use of biospecimens or identifiable private information, in accordance with the requirements of paragraph (c) of this section, and refused to consent, an IRB cannot waive consent for either the storage or maintenance for secondary research use, or for the secondary research use, of those biospecimens or information.
(g) An IRB may approve a research proposal in which investigators obtain, through oral or written communication or by accessing records, identifiable private information without individuals' informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective human subjects of research, provided that the research proposal includes an assurance that the investigator will implement standards for protecting the information obtained, in accordance with and to the extent required by § __.105.
(h)(1) A copy of the final version of the informed consent form for each clinical trial conducted or supported by a Federal department or agency must be posted by the awardee or the Federal department or agency component conducting the trial on a publicly available federal Web site that will be established as a repository for such informed consent forms . The informed consent form must be posted in such form and manner as the department or agency head may prescribe, which will
(2) The informed consent form must be posted on the federal Web site within 60 days after the trial is closed to recruitment.
(i) The informed consent requirements in this policy are not intended to preempt any applicable Federal, state, or local laws that require additional information to be disclosed in order for informed consent to be legally effective.
(j) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.
(a) Except as provided in paragraph (c) of this section, and except for research for which consent is obtained in accordance with § __.116(c), informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the informed consent form.
(b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following:
(1) A written informed consent form that includes a form containing only the information required by § __.116, and appendices that include any other information. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative.
(2) A short form written informed consent form stating that the elements of informed consent required by § __.116 have been presented orally to the subject or the subject's legally authorized representative, and that the information required by § __.116 was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.
(c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
(i) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
(ii) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
(iii) If the subjects are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained. Documentation must include a description as to why signing forms is not the norm for the distinct cultural group or community.
(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
(3) This waiver does not apply to research for which consent is required to be documented in accordance with § __.116(d)(2), (3), or (4).
(4) Documentation of informed consent may not be waived under paragraphs (c)(1)(i) or (iii) of this section for research subject to regulation by the Food and Drug Administration unless otherwise authorized by 21 CFR 56.109(c)(1).
Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research excluded under § __.101(b), waived under § __.101(i), or exempted under § __.104(d), (e), or (f)(2), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research.
Except for research excluded under § __.101(b), waived under § __.101(i), or exempted under § __.104(d), (e), or (f)(2), in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component.
(a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Federal department or agency through such officers and employees of the Federal department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.
(b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.
Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.
(a) The department or agency head may require that Federal department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy.
(b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation).
With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Homeland Security proposes to add 6 CFR part 46, as set forth at the end of the common preamble of this document.
5 U.S.C. 301; Pub. L. 107–296, sec. 102, 306(c); Pub. L. 108–458, sec. 8306.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Agriculture proposes to revise 7 CFR part 1c, as set forth at the end of the common preamble of this document.
5 U.S.C. 301.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Energy proposes to revise 10 CFR part 745, as set forth at the end of the common preamble of this document.
5 U.S.C. 301; 42 U.S.C. 7254.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the National Aeronautics and Space Administration proposes to revise 14 CFR part 1230, as set forth at the end of the common preamble of this document.
5 U.S.C. 301.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Commerce proposes to revise 15 CFR part 27, as set forth at the end of the common preamble of this document.
5 U.S.C. 301.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Social Security Administration proposes to add 20 CFR part 431, as set forth at the end of the common preamble of this document.
5 U.S.C. 301; 42 U.S.C. 289(a).
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Agency for International Development proposes to revise 22 CFR part 225, as set forth at the end of the common preamble of this document.
5 U.S.C. 301.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Justice proposes to revise 28 CFR part 46, as set forth at the end of the common preamble of this document.
5 U.S.C. 301; 28 U.S.C. 509–510.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Social Security Administration proposes to add 29 CFR part 21, as set forth at the end of the common preamble of this document.
5 U.S.C. 301; 29 U.S.C. 551.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Defense proposes to revise 32 CFR part 219, as set forth at the end of the common preamble of this document.
5 U.S.C. 301.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Education proposes to amend 34 CFR part 97 as follows:
5 U.S.C. 301; 20 U.S.C. 1221e–3, 3474.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Veterans Affairs proposes to revise 38 CFR part 16, as set forth at the end of the common preamble of this document.
5 U.S.C. 301; 38 U.S.C. 501, 7331, 7334.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend 40 CFR part 26 as follows:
5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109–54, 119 Stat. 531.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Health and Human Services proposes to amend 45 CFR part 46 as follows:
5 U.S.C. 301; 42 U.S.C. 289.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the National Science Foundation proposes to revise 45 CFR part 690, as set forth at the end of the common preamble of this document.
5 U.S.C. 301.
Human research subjects, Reporting and record-keeping requirements, Research.
For the reasons stated in the preamble, the Department of Transportation proposes to revise 49 CFR part 11, as set forth at the end of the common preamble of this document.
5 U.S.C. 301.
Internal Revenue Service, Treasury
Notice of systems of records.
In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Internal Revenue Service, Treasury, is publishing its inventory of Privacy Act systems of records.
Pursuant to the Privacy Act of 1974 (5 U.S.C. 552a) and the Office of Management and Budget (OMB) Circular No. A–130, the Internal Revenue Service (IRS) has completed a review of its Privacy Act systems of records notices to identify minor changes that will more accurately describe these records.
The changes throughout the document are editorial in nature and consist principally of changes to system manager titles, clarifications to the individuals or records covered, and updates to addresses.
Eleven systems of records have been amended and published to the IRS' inventory of Privacy Act notices since August 10, 2012.
The following three systems of records maintained by the IRS Division Commissioner, Wage and Investment (W&I) were amended on December 11, 2014, beginning at 79 FR 73702:
The following two systems of records maintained by the IRS Director, Facilities Management and Security Services, were amended on February 11, 2015, beginning at 80 FR 7685, and March 11, 2013, beginning at 78 FR 15407, respectively:
The following system of records maintained by the IRS Director, Office of Professional Responsibility (OPR) was amended on September 14, 2012, beginning at 77 FR 56913:
This publication also incorporates the changes to systems of records maintained by the IRS Chief, Criminal Investigation, as published on March 7, 2014, beginning at 79 FR 13089:
Several existing systems of records notices included only one of a matched pair of routine uses which are standard for the IRS. The matched pair of routine uses provides for disclosure, (1) by IRS to the Department of Justice (DOJ) when IRS determines the records are relevant to DOJ's ability to provide legal assistance to the IRS, or are relevant to litigation which DOJ is handling; and (2) by IRS or DOJ before a court, tribunal, or other adjudicative body when IRS or DOJ determines the information is relevant or necessary for purposes of the proceeding. Both routine uses are included in many notices and adding the missing routine use of the pair merely clarifies that records in these systems of records may be disclosed in the same manner as similar records in other notices. Adding the first routine use clarifies that IRS can disclose records to DOJ when IRS determines the records are relevant and useful to DOJ's ability to properly perform duties on behalf of the IRS. Adding the second routine use clarifies that either the IRS or DOJ may disclose records in a proceeding before a court, tribunal, or other adjudicative body when those records are relevant and necessary to the proceeding. The following systems of records have been updated to reflect a matched pair of routine uses:
Additionally, IRS 36.003, General Personnel and Payroll, was updated to provide a non-exclusive list of the categories of records included under the broad category of general personnel and payroll records. The categories of records were updated to better define personnel and payroll records (
Routine uses for two systems of records were updated to reflect that returns and return information may be disclosed only as authorized in Internal Revenue Code (IRC) 6103. Updates were made to:
Records retention information has been updated to reflect that Records Control Schedules 8 through 37 are now found in Document 12990, and Schedules 38 through 64 are now found in Document 12829.
Finally, system of records 22.012 will be withdrawn as of January 1, 2017, unless the IRS receives information supporting continuing maintenance of these records; the tax credit expired as of January 1, 2014, and the records are scheduled for destruction three years after the end of their usage.
The following systems are withdrawn:
This system is withdrawn because the use of private collection agencies was discontinued in 2009, and these records are no longer maintained.
The system is withdrawn because it duplicated records described by other systems included in the amended revisions of IRS Criminal Investigation systems.
This notice covers all systems of records maintained by the IRS as of September 8, 2015. The system notices
Correspondence Files and Correspondence Control Files—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Initiators of correspondence; persons upon whose behalf the correspondence is initiated (including customers and employees who are asked to complete surveys); and subjects of correspondence.
Correspondence received and sent with respect to matters under the jurisdiction of the IRS. Correspondence includes letters, telegrams, memoranda of telephone calls, email, and other forms of communication. Correspondence may be included in other systems of records described by specific notices.
5 U.S.C. 301 and 26 U.S.C. 7801.
To track correspondence including responses from voluntary surveys.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority that has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to foreign governments in accordance with international agreements.
(6) Disclose information to the news media as described in IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(7) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(8) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(9) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
System Manager may be any IRS supervisor. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Initiators of correspondence and information secured internally from other systems of records in order to prepare responses.
None.
Correspondence Files: Inquiries about Enforcement Activities—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Initiators of correspondence; persons upon whose behalf the correspondence was initiated; and subjects of the correspondence. Includes individuals for whom tax liabilities exist, individuals who have made a complaint or inquiry, or individuals for whom a third party is interceding relative to an internal revenue tax matter.
Taxpayer name, address, and, if applicable, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To track correspondence concerning enforcement matters.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to foreign governments in accordance with international agreements.
(6) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(7) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(8) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(9) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioners, SB/SE, TE/GE, and W&I, and Chief, Criminal Investigation. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3); (d)(1)–(4); (e)(1); (e)(4)(G)–(I); and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Taxpayer Advocate Service and Customer Feedback and Survey Records—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Individuals who provide feedback (both complaints and compliments) about IRS employees, including customer responses to surveys from IRS business units and IRS employees about whom complaints and compliments are received by the Taxpayer Advocate Service.
Quality review and tracking information, customer feedback, and reports on current and former IRS employees and the resolution of that feedback.
5 U.S.C. 301; 26 U.S.C. 7801; and Sec. 1211 of Pub. L. 104–168, Taxpayer Bill of Rights (TBOR) 2.
To improve quality of service by tracking customer feedback (including complaints and compliments), and to analyze trends and to take corrective action on systemic problems.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise
Paper records and electronic media.
By taxpayer name, Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Taxpayer Advocate Service National Office and field offices or Head of the Office where the records are maintained. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Customer feedback and information from IRS employees.
None.
Employee Complaint and Allegation Referral Records—Treasury/IRS.
Operations Support: Human Capital Office (Workforce Relations: Employee Conduct and Compliance Office). (See the IRS Appendix below for address.)
Current or former IRS employees or contractors of the IRS who are the subject of complaints received by the IRS, including complaints received by the Treasury Inspector General for Tax Administration (TIGTA) that are forwarded to the IRS; and individuals who submit these complaints.
Documents containing the complaint, allegation or other information regarding current and former IRS employees and contractors; documents reflecting investigations or other inquiries into the complaint, allegation or other information; and documents reflecting management's actions taken in response to a complaint, allegation or other information.
5 U.S.C. 301; 26 U.S.C. 7801; Sections 3701 and 7803 of Public Law 105–206, IRS Restructuring and Reform Act of 1998 (RRA1998); and Section 1211 of Public Law 104–168, Taxpayer Bill of Rights 2 (TBOR2).
To provide a timely and appropriate response to complaints and allegations concerning current and former IRS employees and contractors; and to advise complainants of the status, and results, of investigations or inquiries into those complaints or allegations.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to professional organizations or associations with which individuals covered by this system of records may be affiliated, such as state bar disciplinary authorities, to meet their responsibilities in connection with the administration and maintenance of standards of conduct and discipline.
(7) Disclose information to complainants or victims to provide such persons with information and explanations concerning the progress and/or results of the investigation or case arising from the matters of which they complained and/or of which they were a victim. Information concerning the progress of the investigation or case is limited strictly to whether the investigation/case is opened or closed. Information about any disciplinary action is provided only after the subject of the action has exhausted all reasonable appeal rights.
(8) Disclose information to a contractor, including an expert witness or a consultant hired by the IRS, to the extent necessary for the performance of a contract.
(9) Disclose information to complainants or victims to provide such persons with information and explanations concerning the progress and/or results of the investigation or case arising from the matters of which they complained and/or of which they were a victim. Information concerning the progress of the investigation or case is limited strictly to whether the case is open or closed. Information about any disciplinary action is provided only after the subject of the action has exhausted all reasonable appeal rights.
(10) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name of individual who submitted the complaint, allegation or other information; or by name of the individual who is the subject of the complaint, allegation or other information.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief Human Capital Officer (Operations Support, National Office). (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
This system of records is exempt from the Privacy Act provision which requires that record source categories be reported.
This system has been designated exempt from sections (c)(3), (d), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act pursuant to U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Recorded Quality Review Records—Treasury/IRS.
Wage & Investment (W&I) call sites. A list of these sites is available on-line at:
Employees who respond to taxpayer assistance calls.
Quality review and employee performance feedback program records.
5 U.S.C. 301 and 26 U.S.C. 7801.
To administer quality review programs at call sites. Information maintained includes questions and other statements from taxpayers or their representatives on recordings. The primary focus of the system is to improve service of, and retrieve information by, the employee and not to focus on the taxpayer.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a contractor, including an expert witness or a consultant hired by the IRS, to the extent necessary for the performance of a contract.
(4) To appropriate agencies, entities, and persons when: (a) The IRS suspects
Paper records and electronic media.
By IRS employee/assistor's name or identification number (
Access controls are not less than those provided for by IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990). Audio recordings and screen capture images are kept long enough for the review and discussion process to take place, generally not more than 45 days.
Director, Customer Account Services, W&I. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Records in this system are provided by IRS employees identifying themselves when they provide information to assist a taxpayer.
None.
Taxpayer Assistance Center (TAC) Recorded Quality Review Records—Treasury/IRS.
W&I Taxpayer Assistance Centers. A list of these sites is available on-line at:
Employees who respond to in-person taxpayer assistance contacts.
Audio recordings of conversations with taxpayers, captured computer screen images of taxpayer records reviewed during the conversation, and associated records required to administer quality review and employee performance feedback programs.
5 U.S.C. 301 and 26 U.S.C. 7801.
To evaluate and improve employee performance and the quality of service at TAC sites.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(4) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(5) Disclose information to a contractor, including an expert witness or a consultant hired by the IRS, to the extent necessary for the performance of a contract.
(6) Disclose information to an arbitrator, mediator, or other neutral, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges. Information may also be disclosed to the parties in the alternative dispute resolution proceeding.
(7) Disclose information to the Office of Personnel Management, Merit Systems Protection Board, the Office of Special Counsel, or the Equal Employment Opportunity Commission when the records are relevant and
(8) Disclose information to the Federal Labor Relations Authority, including the Office of the General Counsel of that authority, the Federal Service Impasses Board, or the Federal Mediation and Conciliation Service, when the records are relevant and necessary to resolving any labor management matter within the jurisdiction of these offices.
(9) Disclose information to the Office of Government Ethics when the records are relevant and necessary to resolving any conflict of interest, conduct, financial statement reporting, or other ethics matter within the jurisdiction of that office.
(10) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name of the employee to whom they apply.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990). Audio recordings and screen capture images are kept long enough for the review and discussion process to take place, generally not more than 45 days.
The agency may keep audio recordings and captured computer screen images for a longer period under certain circumstances, including, but not limited to, resolution of matters pertaining to poor employee performance, security (threat, altercation, etc.), or conduct-related issues.
Director, Customer Account Services, W&I. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Records in this system are provided by taxpayers, employees, and IRS taxpayer account records.
None.
Third Party Contact Records— Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals on whom Federal tax assessments have been made; individuals believed to be delinquent in filing Federal tax returns or in paying Federal taxes, penalties or interest; individuals who are or have been considered for examination for tax determination purposes,
Records of third party contacts including the taxpayer's name; Taxpayer Identification Number (TIN) (
5 U.S.C. 301; 26 U.S.C. 7602(c); and 7801.
To comply with 26 U.S.C. 7602(c), records document third party contacts with respect to the determination or collection of the tax liability of the taxpayer. Third party contact data is provided periodically to taxpayers and upon the taxpayer's written request.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer's name or TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Collection, Small Business/Self-Employed Division (SB/SE). (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax records of the individual; public information sources; third parties including individuals, city and state governments, other Federal agencies, taxpayer's employer, employees and/or clients, licensing and professional organizations, and foreign governments under tax treaties.
None.
Third Party Contact Reprisal Records—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals on whom Federal tax assessments have been made; individuals believed to be delinquent in filing Federal tax returns or in paying Federal taxes, penalties or interest; individuals who are or have been considered for examination for tax determination purposes;
Records of third party contacts as described in 26 U.S.C. 7602(c), where reprisal determinations have been made, including the taxpayer name, Taxpayer Identification Number (TIN) (
5 U.S.C. 301; 26 U.S.C. 7602(c); and 7801.
To track the number of reprisal determinations made pursuant to 26 U.S.C. 7602(c)(3)(B).
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name and/or TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Collection, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records is exempt from the Privacy Act provision which requires that record source categories be reported.
This system has been designated exempt from sections (c)(3); (d)(1)–(4); (e)(1); (e)(4)(G)–(I); and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Biographical Files, Communications and Liaison—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
IRS employees.
Records are biographical data and photographs of key IRS employees.
5 U.S.C. 301.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the media and the public.
(2) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By key employee's name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Communications & Liaison. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
By employees.
None.
Stakeholder Relationship Management and Subject Files—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Individuals who have stakeholder relationships with the IRS, including individuals who attend IRS forums and educational outreach meetings.
Records include stakeholder relationship information, correspondence, newspaper clippings, email and other forms of communication.
5 U.S.C. 301.
To track stakeholder relationships and inform individuals about tax administration.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the media and the public.
(2) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name or administrative case control number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Communications & Liaison. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Information from news media, and correspondence within the IRS and from IRS stakeholders.
None.
Volunteer Records—Treasury/IRS.
W&I National Office, field and campus offices. See IRS the IRS Appendix below for addresses.
Individuals who promote and participate in IRS volunteer programs;
Volunteer names; contact information; Electronic Filing Identification Numbers (EFINs); and information to be used in program administration; and information pertaining to reviews of each site and other information about volunteer operations.
5 U.S.C. 301 and 26 U.S.C. 7801.
To manage IRS volunteer programs, including determining assignments of IRS resources to various volunteer programs and making recommendations for training or other quality improvement measures.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) the IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) the IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the Department of Justice (DOJ) has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a contractor, including an expert witness or a consultant, hired by the IRS to the extent necessary for the performance of a contract.
(4) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(5) Provide information to volunteers who coordinate activities and staffing at taxpayer assistance sites.
(6) To appropriate agencies, entities, and persons when: (a) the IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By the name of the volunteer. Records pertaining to electronic filing capabilities may also be retrieved by the electronic filing identification number (EFIN).
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, W&I. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
Individuals seeking to contest content of a record in this system of records may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B.
Treasury employees; Federal, state, or local agencies that sponsor free financial services in coordination with IRS; taxpayers who visit these sites; and volunteer individuals and organizations that provide free tax preparation and tax-related services to these taxpayers.
None.
Tax Administration Advisory Services Resources Records—Treasury/IRS.
Office of Tax Administration Advisory Services (TAAS), LB&I (See the IRS Appendix below for address.)
Past and potential tax administration advisors who have served or indicated an interest in serving on advisory assignments, and selected officials engaged in tax administration and related fields for matters pertaining to international issues.
Applicant roster database, locator cards or lists with names, addresses, telephone numbers, and organizational affiliations of officials engaged in tax administration; work assignment or application folders of past and potential tax administration advisors, which contain employment history, information, medical abstracts, security clearances, and passport information; bio-data sketches on IRS employees and others engaged in tax administration and related fields.
5 U.S.C. 301 and 26 U.S.C. 7801.
To identify employees who have expressed an interest in overseas assignments, and to identify historical and current activities pertaining to international issues.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) To appropriate agencies, entities, and persons when: (a) the IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By employee name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, (LB&I). (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be address to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Individuals, organizations with which they are associated, or other knowledgeable tax administration experts.
None.
Annual Listing of Undelivered Refund Checks—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Taxpayers whose refund checks have been returned as undeliverable since the last Annual Listing of Undelivered Refund Checks was produced.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To keep track of refund checks returned as undeliverable.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name or TIN.
Access controls are not less than those published in IRM 10.8, Information
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioners, W&I and SB/SE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
File of Erroneous Refunds—Treasury/IRS.
Campus offices. (See the IRS Appendix below for address.)
Taxpayers issued erroneous refunds.
Case reference taxpayer name, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To maintain records necessary to resolve erroneous refunds.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioners, W&I and SB/SE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
Health Coverage Tax Credit (HCTC) Program Records—Treasury/IRS.
W&I National Office and HCTC contractor location offices. (See the IRS Appendix below for address.)
Individuals who apply for and are eligible for the credit.
Records required to administer the HCTC program.
5 U.S.C. 301, 26 U.S.C. 35, 7527, and 7801.
To administer the health care tax credit (HCTC) provisions.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise
Paper records and electronic media.
By taxpayer name, Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, W&I. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below. The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Individuals eligible under HCTC program; IRS taxpayer account information; Health Coverage providers; Department of Labor; Pension Benefit Guaranty Corporation; state workforce agencies, and the Department of Health and Human Services.
None.
Form 1042S Index by Name of Recipient—Treasury/IRS.
Campus offices. (See the IRS Appendix below for address.)
U.S. citizens living abroad subject to federal tax withholding.
Records include taxpayer's name, address, country of residence and Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To administer the back-up withholding laws and regulations.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, (LB&I) (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below. The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
Foreign Information System (FIS)—Treasury/IRS.
Large Business and International (LB&I) National Office, field, and
Individual taxpayers who file Form 5471, Information Return with Respect to a Foreign Corporation and Form 5472, Information Return of a Foreign Owned Corporation.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To administer laws and regulations relative to foreign owned corporations.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Documents are stored and retrieved by Document Locator Number (DLN).
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, (LB&I). (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
Disclosure Authorizations for U.S. Residency Certification Letters—Treasury/IRS.
Philadelphia Campus. (See the IRS Appendix below for address.)
Individuals and third parties who are subjects of correspondence and who initiate correspondence requesting U.S. Residency Certification.
Records relating to the individual requesting certification, including identifying information of the individual requesting certification, and records relating to the identity of third party designees authorized to receive tax information specific to the U.S. Residency Certification request.
5 U.S.C. 301 and 26 U.S.C. 7801.
To certify filing and payment of U.S. income tax returns and taxes to allow a reduction in foreign taxes due in accordance with various treaty provisions for U.S. citizens living abroad and U.S. domestic corporations conducting business in foreign countries.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, (LB&I). (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Individuals seeking certification, or persons acting on their behalf.
None.
Individual Microfilm Retention Register—Treasury/IRS.
Computing centers and through terminals at field and campus offices. (See the IRS Appendix below for address.)
Individuals who file, or may be required to file, individual income tax returns (
Selected data elements that have been archived from the Individual Master File (IMF).
5 U.S.C. 301 and 26 U.S.C. 7801.
To archive individual tax account information after a certain period of inactivity on the master file in order not to overburden the computer system required for active accounts.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By individual taxpayer name Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Directors, Computing Centers. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
Subsidiary Accounting Files—Treasury/IRS.
Campuses. (See the IRS Appendix below for address.)
Taxpayers affected by one or more of the transactions reflected in the categories of records listed below.
Documents containing name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To administer the accounting files relevant to the types of transactions described in “CATEGORIES OF RECORDS IN THE SYSTEM:” above.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN, or document locator number (DLN).
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioners, W&I and SB/SE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
Automated Non-Master File (ANMF)—Treasury/IRS.
Computing Centers and through terminals at field and campus offices. (See the IRS Appendix below for address.)
Taxpayers whose accounts are not compatible with the normal master file processes.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To track taxpayer account information that is not input to the Master File.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN, or document locator number (DLN).
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioners, W&I and SB/SE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's account.
None.
Information Return Master File (IRMF)—Treasury/IRS.
Computing Centers and through terminals at field and campus offices. (See the IRS Appendix below for address.)
Individual payors and payees of various types of income for which information reporting is required (
Information returns.
5 U.S.C. 301 and 26 U.S.C. 7801.
To administer tax accounts related to the filing of information returns.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By payor and payee name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, W&I. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3); (d)(1)–(4); (e)(1); (e)(4)(G), (H), (I); and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Electronic Filing Records—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Electronic return providers (electronic return preparers, electronic return collectors, electronic return originators, electronic filing transmitters, individual filing software developers) who have applied to participate, are participating, or have been rejected, expelled or suspended from participation, in the electronic filing program (including Volunteer Income Tax Assistance (VITA) volunteers). Individuals who attend, or have indicated interest in attending, seminars and marketing programs to encourage electronic filing and improve electronic filing programs (including individuals who provide opinions or suggestions to improve electronic filing programs), or who otherwise indicate interest in participating in electronic filing programs.
Records pertaining to individual electronic filing providers, including applications to participate in electronic filing, credit reports, reports of misconduct, law enforcement records, Device ID, and other information from investigations into suitability for participation. Records pertaining to the marketing of electronic filing, including surveys and opinions about improving electronic filing programs.
5 U.S.C. 301, 26 U.S.C. 6011, 6012, and 7803.
To administer and market electronic filing programs.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding,
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(7) Disclose information to a contractor, including an expert witness or a consultant, hired by the IRS, to the extent necessary for the performance of a contract.
(8) Disclose information to state taxing authorities to promote joint and state electronic filing, including marketing such programs and enforcing the legal and administrative requirements of such programs.
(9) Disclose to the public the names and addresses of electronic return originators, electronic return preparers, electronic return transmitters, and individual filing software developers, who have been suspended, removed, or otherwise disciplined. The Service may also disclose the effective date and duration of the suspension, removal, or other disciplinary action.
(10) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and magnetic media.
By electronic filing provider name or Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Return Preparer Office. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. See “Record Access Procedures” above for records that are not tax records.
(1) Electronic filing providers; (2) informants and third party witnesses; (3) city and state governments; (4) IRS and other Federal agencies; (5) professional organizations; (6) business entities; and (7) participants in marketing efforts or who have otherwise indicated interest in electronic filing programs.
None.
Customer Account Data Engine (CADE) Individual Master File (IMF)—Treasury/IRS.
Computing Centers and through terminals at field and campus offices. (See the IRS Appendix below for address.).
Individuals who file Federal Individual Income Tax Returns; individuals who file other information filings; and individuals operating under powers of attorney.
Tax records for each applicable tax period or year, representative authorization information (including Centralized Authorization Files (CAF)), Device ID and a code identifying taxpayers who threatened or assaulted IRS employees. An indicator will be added to any taxpayer's account if a state reports to IRS that the taxpayer owes past due child and/or spousal support payments.
5 U.S.C. 301 and 26 U.S.C. 7801.
To maintain records of tax returns, return transactions, and authorized taxpayer representatives.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, W&I. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual or taxpayer representative and agency entries made in the administration of the individual's tax account.
None.
Customer Account Data Engine Business Master File—Treasury/IRS.
Computing Centers and through terminals at field and campus offices. (See the IRS Appendix below for address.)
Individuals who file business tax and information returns; individuals who file other information filings; and individuals operating under powers of attorney for these businesses.
Tax records for each applicable tax year or period, including employment tax returns, partnership returns, excise tax returns, retirement and employee plan returns, wagering returns, estate tax returns; information returns; representative authorization information; and Device ID
5 U.S.C. 301 and 26 U.S.C. 7801.
To maintain records of business tax returns, return transactions, and authorized taxpayer representatives.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By electronic filing provider name or Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
Audit Underreporter Case Files—Treasury/IRS.
Campus offices. (See the IRS Appendix below for address.)
Recipients of income (payees) with a discrepancy between the income tax returns they file and information returns filed by payors with respect to them.
Payee and payor name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To reconcile discrepancies between tax returns and information returns filed.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Payee's and payor's names and TINs.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioners, W&I and SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Information returns filed by payors and income tax returns filed by taxpayers.
This system has been designated exempt from sections (c)(3); (d)(1)–(4); (e)(1); (e)(4)(G)–(I); (e)(5); (e)(8); and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Acquired Property Records—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals with delinquent tax accounts whose property has been acquired by the government by purchase or right of redemption.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To track property acquired under 26 U.S.C. 6334.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3); (d)(1)–(4); (e)(1); (e)(4)(G)–(I); and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Form 2209, Courtesy Investigations—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals on whom a delinquency or other investigation is located in one IRS office, but the individual is now living or has assets located in the jurisdiction of another IRS office.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To track the assignment of, and progress of, these investigations.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3); (d)(1)–(4); (e)(1); (e)(4)(G)–(I); and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36.)
Lien Files—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals on whom Notices of Federal Tax Liens have been filed.
Open and closed Federal tax liens, including Certificates of Discharge of Property from Federal Tax Lien; Certificates of Subordination; Certificates of Non-Attachment; Exercise of Government's Right of Redemption of Seized Property; and Releases of Government's Right of Redemption.
5 U.S.C. 301, 26 U.S.C. 6323 and 7801.
To identify those individuals on whom a Notice of Federal Tax Lien,
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account.
None.
Offer in Compromise (OIC) Files—Treasury/IRS.
Field, campus and computing center offices. (See the IRS Appendix below for address.)
Individuals who have submitted an offer to compromise a tax liability.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To process offers to compromise a tax liability.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36.)
Trust Fund Recovery Cases/One Hundred Percent Penalty Cases—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals against whom Federal tax assessments have been made or are being considered as a result of their being deemed responsible for payment of unpaid corporation withholding taxes and social security contributions.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To administer and enforce Trust Fund Recovery Penalty cases under 26 U.S.C. 6672.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN; cross-referenced to business name from which the penalty arises.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36.)
Record 21, Record of Seizure and Sale of Real Property—Treasury/IRS.
Field offices. (See the IRS Appendix below for address.)
Individuals against whom tax assessments have been made and whose real property was seized and sold to satisfy their tax liability. Names and addresses of purchasers of this real property.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To administer sales of real property.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic records.
By taxpayer name, TIN, and seizure number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Property records and information supplied by third parties pertaining to property records.
None.
Taxpayer Delinquent Account (TDA) Files—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals on whom Federal tax assessments have been made and persons who owe child support obligations.
Investigatory records generated or received in the collection of Federal taxes and all other related sub-files related to the processing of the tax case. This system also includes other management information related to a case and used for tax administration purposes including the Debtor Master File, and records that have a code identifying taxpayers that threatened or assaulted IRS employees.
5 U.S.C. 301 and 26 U.S.C. 7801.
To provide inventory control of delinquent accounts.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Field and campus offices. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36.)
Taxpayer Delinquency Investigation (TDI) Files—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals who are, or may be, delinquent in filing Federal tax returns.
Taxpayer name, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To track information on taxpayers who may be delinquent in Federal tax payments or obligations.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic records.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36.)
Transferee Files—Treasury/IRS.
Field and campus offices. (See the IRS Appendix below for address.)
Individuals on whom tax assessments have been made but who have, or may have, transferred their assets in order to place them beyond the reach of the government.
Taxpayer name, address, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To provide inventory control on taxpayers believed to have transferred assets that may not be available to satisfy their delinquent tax accounts.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in RECORD ACCESS PROCEDURES, above.
This system of records contains investigatory material compiled for Law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Requests for Printed Tax Materials Including Lists—Treasury/IRS.
Field and campus offices. See the IRS Appendix below for addresses.
Individuals that request various IRS printed and electronic materials.
Name and address of individuals wanting to receive tax forms, newsletters, publications or educational products.
5 U.S.C. 301.
The purpose of this system is to administer tracking and responses to requests for printed tax materials.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to mailing or distribution services contractors for the purpose of executing mail outs, order fulfillment, or subscription fulfillment.
(2) Disclose information to mailing or distribution services contractors for the purpose of maintaining mailing lists.
(3) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Alphabetically by name or numerically by zip code.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Agency Wide Shared Services (Publishing Services). (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
The information is supplied by the individual making the request and agency entries made in fulfilling the request.
None.
Security Violations—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Individuals who violate physical security regulations.
Name of violator, circumstances of violation (
5 U.S.C. 301.
The purpose of this system is to administer programs to track and take appropriate action for security violations.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) To appropriate agencies, entities, and persons when: (a) The IRS suspects
Paper records and electronic media.
By name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Agency Wide Shared Services (Property, Security, and Records). (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Contract guard force and security inspections.
None.
Assignment and Accountability of Personal Property Files—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
Individuals receiving government property for use and repair.
Descriptions of property, receipts, reasons for removal, and property passes.
5 U.S.C. 301.
To maintain an inventory control over government property assigned to IRS employees for their use and to account for government property requiring repair.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(4) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(5) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By employee name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Agency Wide Shared Services (Space and Property). (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Individuals who receive government property; request property passes; or who request repairs on equipment.
None.
Safety Program Files—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
To administer safety programs.
Employees and other individuals involved in IRS motor vehicle accidents, accidents, or injuries, on IRS property, or who have brought tort or personal property claims against the Service; individuals issued IRS driver's licenses.
Individual driving records and license applications, motor vehicle accident reports, lost time and no-lost time personal injury reports, tort and personal property claims case files, informal and formal investigative report files. Injury information is contained in the Safety and Health Information System (SHIMS), which is part of the records of Treasury .011—Treasury Safety Incident Management Information System (70
5 U.S.C. 301 and Executive Order 12196.
To administer the agency's health and safety program.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(4) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(5) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(6) Provide information to the Department of Labor in connection with investigations of accidents occurring in the work place.
(7) Provide information to other federal agencies for the purpose of effecting inter-agency salary offset or interagency administrative offset.
(8) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By employee or other individual's name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Agency Wide Shared Services. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Individuals seeking access to any non-tax record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
IRS employees, and other claimants and third party witnesses.
None.
Emergency Preparedness Cadre Assignments and Alerting Rosters Files—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
Employees who have been identified as emergency preparedness points of contact.
Cadre assignments: Personal information on employees;
5 U.S.C. 301.
To identify emergency preparedness team members and their responsibilities; and to provide a means of contacting cadre members in the event of any emergency.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By employee name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12820 and 12990).
Director, Facilities Management and Security Services. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Cadre members.
None.
Identification Media Files System for Employees and Others Issued IRS Identification—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
Employees and contractors having one or more items of identification.
Name, home address, and other personal information and reports on loss, theft, or destruction of pocket commissions, enforcement badges and other forms of identification.
5 U.S.C. 301.
To track the issuance and loss of identification media used to authenticate IRS employees and to plan for efficient allocation and utilization of space based upon records showing use of IRS facilities.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By employee, contractor, or visitor's name and identification media serial number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Facilities Management and Security Services. See IRS Appendix below for address.
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Document 882, New Identification Badge Request; Form 11646, Proximity Card Badge Application; Form 12598, Lost Badge Record; Form 4589, Lost or Forgotten Badge Record; Form 9516, Visitor Badge.
None.
Motor Vehicle Registration and Entry Pass Files—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
Individuals who are issued parking permits because they require continued access to IRS facilities; and parking area violators.
Name of employee, registered owner of vehicle, office branch, telephone number, description of car, license number, employee's signature, name and expiration date of insurance, decal number; parking violations.
5 U.S.C. 301.
To track individuals to whom parking permits are issued and to whom parking violations are issued.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) any IRS
(3) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By employee or other individual's name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Facilities Management and Security Services. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below. The IRS may assert 5 U.S.C. 552a (d)(5) as appropriate.
See “Record Access Procedures” above.
Parking permits: Employees and other individuals to whom they are issued. Parking violations: Security guard personnel who issue the tickets.
None.
Security Clearance Files—Treasury/IRS.
Personnel Security Office. (See the IRS Appendix below for address.)
Employees and contractors who require security clearance, or have their security clearance canceled or transferred; individuals who have violated IRS security regulations regarding classified national security information.
Name, employing office, date of security clearance, level of clearance, reason for the need for the national security clearance, and any changes in such clearance. Security violations records contain name of violator, circumstance of violation and supervisory action taken.
5 U.S.C. 301 and Executive Order 11222.
To administer the national security clearance program.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to agencies and on a need-to-know basis to determine the current status of an individual's security clearance.
(4) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name or Social Security Number of the employee.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Personnel Security (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Security Clearance Records: Employee, employee's personnel records, employee's supervisor. Security Violation Records: guard reports, security inspections, supervisor's reports, etc.
None.
Personnel Security Investigations—Treasury/IRS.
Personnel Security Office. See IRS Appendix below for address.
Current, former and prospective employees of IRS, and private contractors at IRS and lock box facilities.
Records pertaining to background investigations including application information, references, military service, work and academic history, financial and tax information, reports of findings and contacts with third party witnesses.
5 U.S.C. 301, 26 U.S.C. 7801, Executive Orders 10450 and 11222.
To carry out personnel security investigations as to a person's character, reputation and loyalty to the United States, so as to determine that person's suitability for employment, retention in employment, or the issuance of security clearances.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(6) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(7) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By employee's name or Social Security Number or administrative case control number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Personnel Security. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(5).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(5).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
Subjects of investigation (through employment application forms and interviews, or financial information); third parties including Federal, state and local government agencies (police, court and vital statistics records), credit reporting agencies, schools and others; and tax returns and examination results.
This system has been designated exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(5). (See 31 CFR 1.36).
Automated Background Investigations System (ABIS)—Treasury/IRS.
Personnel Security Office. (See the IRS Appendix below for address.)
Current and former employees of IRS, contractors for IRS/Treasury and Lockbox employees.
Records pertaining to background investigations, including: (1) ABIS records contain Personnel Security employee name, office, start of employment, series/grade, title, separation date; (2) ABIS tracking records contain investigative status information from point of initiation through conclusion; (3) ABIS timekeeping records contain assigned cases and distribution of time; (4) ABIS records contain background investigations; and (5) levels of clearance, date of clearance and any change in status of clearance.
5 U.S.C. 301, 26 U.S.C. 7801, and Executive Order 11222.
To track and administer background investigation records and to analyze trends in suitability matters.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(7) Disclose information to professional organizations or associations with which individuals covered by this system of records may be affiliated, such as state bar disciplinary authorities, to meet their responsibilities in connection with the administration and maintenance of standards of conduct and discipline.
(8) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name of individual to whom it applies, Social Security Number, alias, or date of birth.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Personnel Security. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(5).
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(5).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
Personnel Security employees, Subjects of investigation (through employment application forms and interviews, or financial information); third parties including Federal, state and local government agencies (police, court and vital statistics records), credit reporting agencies, schools and others; and tax returns and examination results.
This system has been designated exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(5). (See 31 CFR 1.36).
Audit Trail and Security Records—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
Individuals who have accessed, by any means, information contained within IRS electronic or paper records or who have otherwise used any IRS computing equipment/resources, including access to Internet sites; individuals whose information is accessed using IRS computing equipment/resources; and IRS employees and contractors who use IRS equipment to end electronic communications.
Records concerning the use of IRS computing equipment or other resources by employees, contractors, or other individuals to access IRS information; records concerning individuals whose information was accessed using IRS computing equipment/resources; records identifying what information accessed; records concerned the use of IRS computer equipment and other resources to send electronic communications; and records concerning the investigation of such incidents.
5 U.S.C. 301, 26 U.S.C. 7801, and 18 U.S.C. 1030(a)(2)(B).
To identify and track any unauthorized accesses to sensitive but unclassified information and potential breaches or unauthorized disclosures of such information or inappropriate use of government computers to access Internet sites for any purpose forbidden by IRS policy (
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(4) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to a contractor, including an expert witness or a consultant, hired by the IRS, to the extent necessary for the performance of a contract.
(7) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name, Social Security Number (SSN), or the standard employee identification number (SEID) of employee, contractor, or other individual who has been granted access to IRS information, or to IRS equipment and resources, and by incident number. Also by name, SSN or Taxpayer Identification Number (TIN) of entities whose records were accessed.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Facilities Management and Security Services. See IRS Appendix below for address.
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Reasonable Accommodation Request Records—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
Prospective, current and former employees with disabilities who request reasonable accommodation.
Records that are used to determine qualification for reasonable accommodation (RA), including medical documentation.
5 U.S.C. 301; Title VII of the Civil Rights Act of 1964, as amended; Civil Rights Act of 1991; The Rehabilitation Act of 1973, 29 U.S.C. 701
To track and administer reasonable accommodation requests.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(6) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(7) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(8) Disclose information to a contractor, including an expert witness or a consultant, hired by the IRS, to the extent necessary for the performance of a contract.
(9) Disclose information to an arbitrator, mediator, or other neutral, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges. Information may also be disclosed to the parties in the alternative dispute resolution proceeding.
(10) Disclose information to the Merit Systems Protection Board and the Office
(11) Disclose information to foreign governments in accordance with international agreements.
(12) Disclose information to the Office of Personnel Management and/or to the Equal Employment Opportunity Commission in personnel, discrimination, and labor management matters when relevant and necessary to their duties.
(13) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Name of employee or applicant for employment who requests reasonable accommodation, and administrative case control number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Office of Equal Employment and Diversity. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Individual requesting accommodation; individual's manager, individual's medical practitioner; agency medical representative.
None.
Appeals, Grievances and Complaints Records—Treasury/IRS.
National Office, field, computer center, and campus offices. (See the IRS Appendix below for address.)
Applicants for Federal employment, current and former Federal employees (including annuitants) who submit appeals, grievances, or complaints for resolution.
This system of records contains information or documents relating to a decision or determination made by the IRS or other organization (
5 U.S.C. 1302, 3301, 3302, 4308, 5115, 5338, 5351, 5388, 7105, 7151, 7154, 7301, 7512, 7701 and 8347, Executive Orders 9830, 10577, 10987, 11222, 11478 and 11491; and Pub. L. 92–261 (EEO Act of 1972), and Pub. L. 93–259.
To track, and process, employment-related appeals, grievances and complaints.
Disclosure of returns and return information may be only made as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public
(5) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(6) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(7) Disclose information to a contractor, including an expert witness or a consultant, hired by the IRS, to the extent necessary for the performance of a contract.
(8) Disclose information to a Member of Congress regarding the status of an appeal, complaint or grievance.
(9) Disclose information to other agencies to the extent provided by law or regulation and as necessary to report apparent violations of law to appropriate law enforcement agencies.
(10) Disclose information to the Office of Personnel Management, Merit Systems Protection Board or Equal Employment Opportunity Commission for the purpose of properly administering Federal Personnel Systems in accordance with applicable laws, Executive Orders and regulations.
(11) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name of the individual and administrative case control number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Office of Equal Employment and Diversity and Human Capital Officer. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Individuals who file complaints or grievances, IRS and/or other authorized Federal officials, affidavits or statements from employees, testimony of witnesses, official documents relating to the appeal, grievance, or complaints, and third party correspondence.
None.
General Personnel and Payroll Records—Treasury/IRS.
Current employee personnel records: National Office, field, computing center and campus offices. Current employee payroll records: Transactional Processing Center (TPC), U.S. Department of Agriculture, National Finance Center. Former employee personnel records: The National Archives and Records Administration, National Personnel Records Center.
Prospective, current and former employees.
This system consists of a wide variety of records relating to personnel actions and determinations made about an individual while employed in the Federal service, including information required by the Office of Personnel Management (OPM) and maintained in the Official Personnel File (OPF) or Employee Personnel File (EPF). Information is also maintained electronically in Automated Labor and Employee Relations Tracking System (ALERTS) and Totally Automated Personnel System (TAPS). Listing of employee pseudonyms and Forms 3081 is also included. This system also includes personnel and payroll records (
5 U.S.C. 301, 1302, 2951, 4118, 4308, 4506 and Executive Orders 9397 and 10561.
To administer personnel and payroll programs.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(6) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(7) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(8) Disclose information to a contractor, including an expert witness or a consultant, hired by the IRS, to the extent necessary for the performance of a contract.
(9) Disclose information to a prospective employer of an IRS employee or former IRS employee.
(10) Disclose information to hospitals and similar institutions or organizations involved in voluntary blood donation activities.
(11) Disclose information to educational institutions for recruitment and cooperative education purposes.
(12) Disclose information to financial institutions for payroll purposes.
(13) Disclose information about particular Treasury employees to requesting Federal agencies or non-Federal entities under approved computer matching efforts, limited to only those data elements considered relevant to making a determination of eligibility under particular benefit programs administered by those agencies or entities or by the Department of the Treasury or any constituent unit of the Department, to improve program integrity, and to collect debts and other monies owed under those programs.
(14) Disclose information to respond to state and local authorities for support garnishment interrogatories.
(15) Disclose information to private creditors for the purpose of garnishment of wages of an employee if a debt has been reduced to a judgment.
(16) Disclose records to the Office of Personnel Management, Merit Systems Protection Board, Equal Employment Opportunity Commission, and General Accounting Office for the purpose of properly administering Federal Personnel systems or other agencies' systems in accordance with applicable laws, Executive Orders, and applicable regulations;
(17) Disclose information to a Federal, state, or local agency so that the agency may adjudicate an individual's eligibility for a benefit, such as a state unemployment compensation board, housing administration agency and Social Security Administration;
(18) Disclose information to another agency such as the Department of Labor or Social Security Administration and state and local taxing authorities as required by law for payroll purposes;
(19) Disclose information to Federal agencies to effect inter-agency salary offset; to effect inter-agency administrative offset to the consumer reporting agency for obtaining commercial credit reports; and to a debt collection agency for debt collection services;
(20) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Disclosures pursuant to 5 U.S.C. 552a(b)(12). Disclosures of debt information concerning a claim against an individual may be made from this system to consumer reporting agencies as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) or the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).
Paper records and electronic media.
Name, Social Security Number (SSN) or other employee identifier, such as standard employee identification number (SEID) or badge number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Human Capital Office. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its
See “Record Access Procedures” above.
Personnel and payroll records come from the individual to whom they apply or from agency officials.
None
Correspondence, Miscellaneous Records, and Information Management Records—Treasury/IRS.
Office of Professional Responsibility (OPR), Internal Revenue Service (IRS), Washington, DC; Detroit Computing Center, Detroit, Michigan; Martinsburg, West Virginia; and Memphis, Tennessee.
Individuals who correspond with OPR, individuals on whose behalf correspondence is initiated, and individuals who are the subject of correspondence; individuals who file, pursuant to 31 CFR part 10, program sponsor agreements for continuing professional education for enrolled agents or enrolled retirement plan agents; individuals who request, pursuant to 31 CFR part 10, authorization to make a special appearance before the IRS to represent another person in a particular matter; former Government employees who, pursuant to 31 CFR part 10, submit statements that their current firm has isolated them from representations that would create a post-employment conflict of interest; individuals who appeal from determinations that they are ineligible to engage in limited practice before the IRS under 31 CFR part 10; and individuals who serve as point of contact for organizations (including organizations that apply for recognition as a sponsor of continuing professional education for enrolled agents or enrolled retirement plan agents and tax clinics that request OPR to issue authorizations for special appearances to tax clinic personnel to practice before the IRS).
Correspondence (including, but not limited to, letters, faxes, telegrams, and emails) sent and received; mailing lists of, and responses to, quality and improvement surveys of individuals; program sponsor agreements for continuing professional education; requests for authorization to make a special appearance before the IRS; statements of isolation from representations that would create a post-employment conflict of interest; appeals from determinations of ineligibility to engage in limited practice; records pertaining to consideration of these matters; and workload management records.
5 U.S.C. 301, 26 U.S.C. 7801 and 7803, and 31 U.S.C. 330.
To permit OPR to manage correspondence, to track responses from quality and improvement surveys, to manage workloads, and to collect and maintain other administrative records that are necessary for OPR to perform its functions under the regulations governing practice before the IRS, which are set out at 31 CFR part 10 and are published in pamphlet form as Treasury Department Circular No. 230, and its functions under other grants of authority.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems the purpose of the disclosure to be compatible with the purpose for which the IRS collected the records and no privilege is asserted:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding; and the IRS determines that the information is relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding; and the IRS or the DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, tribal, or foreign agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee or to issuing, or continuing, a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to a Federal, state, local, tribal, or foreign agency or other public authority responsible for implementing or enforcing, or for investigating or prosecuting, the violation of a statute, rule, regulation, order, or license when a record on its face, or in conjunction with other records, indicates a violation or potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to a contractor to the extent necessary to perform the contract.
(6) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the IRS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By individual's name. Non-unique names will be distinguished by addresses.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Office of Professional Responsibility, SE:OPR, 1111 Constitution Avenue NW., Washington, DC 20224.
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, Appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, Appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Record Access Procedures” above.
Individuals, other correspondents, and Treasury Department records.
None.
Practitioner Disciplinary Records—Treasury/IRS.
Office of Professional Responsibility (OPR), Internal Revenue Service (IRS), Washington, DC; Martinsburg, West Virginia; and Memphis, Tennessee.
Subjects and potential subjects of disciplinary proceedings relating to attorneys, certified public accountants, enrolled agents, enrolled actuaries, enrolled retirement plan agents, appraisers, registered tax return preparers, and any individual who for compensation prepares or assists with the preparation of all or substantially all of a tax return, claim for refund, or other document pertaining to any taxpayer's liability for submission to the IRS; subjects or potential subjects of actions to deny eligibility to engage in limited practice before the IRS or actions to withdraw eligibility to practice before the IRS in any other capacity; individuals who have received disciplinary sanctions or whose eligibility to practice before the IRS has been denied or withdrawn; and individuals who have submitted to OPR information concerning potential violations of 31 CFR part 10.
Information sent to, or collected by, OPR concerning potential violations of 31 CFR part 10, including disciplinary decisions and orders (and related records) of Federal or state courts, agencies, bodies, and other licensing authorities; records pertaining to OPR's investigation and evaluation of such information; records of disciplinary proceedings brought by OPR before administrative law judges, including records of appeals from decisions in such proceedings; petitions for reinstatement to practice before the IRS (and related records); Federal court orders enjoining individuals from representing taxpayers before the IRS; and press releases concerning such injunctions.
5 U.S.C. 301, 26 U.S.C. 7801 and 7803, and 31 U.S.C. 330.
To enforce and administer the regulations governing practice before the IRS, which are set out at 31 CFR part 10 and are published in pamphlet form as Treasury Department Circular No. 230; to make available to the general public information about disciplinary proceedings and disciplinary sanctions; to assist public, quasi-public, or private professional authorities, agencies, organizations, and associations and other law enforcement and regulatory authorities in the performance of their duties in connection with the administration and maintenance of standards of integrity, conduct, and discipline; and to assist state tax agencies in their efforts to ensure compliance with ethical rules and standards of conduct by individuals authorized to practice or individuals who seek permission to practice before the agency.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems the purpose of the disclosure to be compatible with the purpose for which the IRS collected the records and no privilege is asserted:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding; and the IRS determines that the information is relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding; and the IRS or the DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, tribal, or foreign agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee or to issuing, or continuing, a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to a Federal, state, local, tribal, or foreign agency or other public authority responsible for implementing or enforcing, or for investigating or prosecuting, the violation of a statute, rule, regulation, order, or license when a record on its face, or in conjunction with other records, indicates a violation or potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement,
(5) Disclose information to a contractor to the extent necessary to perform the contract.
(6) Disclose information to third parties during the course of an investigation to the extent deemed necessary by the IRS to obtain information pertinent to the investigation.
(7) Subject to the protective measures in 31 CFR part 10, make available for public inspection or otherwise disclose to the general public reports and decisions of the Secretary of the Treasury, or his delegate, in disciplinary proceedings, including any reports and decisions of the administrative law judge.
(8) Make available for public inspection or otherwise disclose to the general public, after the final agency decision has been issued or after OPR has taken final action: (a) The name, mailing address, professional designation (attorney, certified public accountant, enrolled agent, enrolled actuary, enrolled retirement plan agent, or appraiser), type of disciplinary sanction, effective dates, and information about the conduct that gave rise to the sanction pertaining to individuals who have been censured, individuals who have been suspended or disbarred from practice before the IRS, individuals who have resigned as an enrolled agent or an enrolled retirement plan agent in lieu of a disciplinary proceeding being instituted or continued, individuals upon whom a monetary penalty has been imposed, and individual appraisers who have been disqualified; and (b) the name, mailing address, representative capacity (family member; general partner; full-time employee or officer of a corporation, association, or organized group; full-time employee of a trust, receivership, guardianship, or estate; officer or regular employee of a government unit; an individual representing a taxpayer outside the United States; or unenrolled return preparer), the fact of the denial of eligibility for limited practice, effective dates, and information about the conduct that gave rise to the denial pertaining to individuals who have been denied eligibility to engage in limited practice before the IRS pursuant to 31 CFR part 10.
(9) Make available for public inspection or otherwise disclose to the general public: The name, mailing address, professional designation or representative capacity, the fact of being enjoined from representing taxpayers before the IRS, the scope of the injunction, effective dates, and information about the conduct that gave rise to the injunction pertaining to individuals who have been enjoined by any Federal court from representing taxpayers before the IRS.
(10) Disclose information to a public, quasi-public, or private professional authority, agency, organization, or association, which individuals covered by this system of records may be licensed by, subject to the jurisdiction of, a member of, or affiliated with, including but not limited to state bars and certified public accountancy boards, to assist such authorities, agencies, organizations, or associations in meeting their responsibilities in connection with the administration and maintenance of standards of integrity, conduct, and discipline.
(11) Disclose upon written request to a member of the public who has submitted to OPR written information concerning potential violations of the regulations governing practice before the IRS: (a) That OPR is currently investigating or evaluating the information; (b) that OPR has determined that no action will be taken, because jurisdiction is lacking, because a disciplinary proceeding would be time-barred, or because the information does not constitute actionable violations of the regulations; (c) that OPR has determined that the reported conduct does not warrant a censure, suspension, or disbarment; and (d) if applicable, the name of the authority, agency, organization, or association or Department of the Treasury or IRS office to which OPR has referred the information.
(12) Disclose to the Office of Personnel Management the identity and status of disciplinary cases in order for the Office of Personnel Management to process requests for assignment of administrative law judges employed by other Federal agencies to conduct disciplinary proceedings.
(13) Disclose information to a state tax agency for tax administration purposes, including the agency's efforts to ensure compliance with ethical rules and standards of conduct by individuals authorized to practice or individuals who seek permission to practice before the agency.
(14) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the IRS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By individual's name, Social Security Number (SSN) (where available), or complaint number pertaining to a disciplinary proceeding. Non-unique names will be distinguished by addresses.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained in accordance IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Office of Professional Responsibility, SE: OPR, 1111 Constitution Avenue NW., Washington, DC 20224.
This system of records may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Records Access Procedures” above.
Individuals covered by this system of records; witnesses; Federal or state
Pursuant to section (k)(2) of the Privacy Act, 5 U.S.C. 552a(k)(2), the records contained within this system are exempt from the following sections of the Act: (c)(3), (d), (e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I), and (f). (See 31 CFR 1.36.)
Enrolled Agent and Enrolled Retirement Plan Agent Records —Treasury/IRS.
Return Preparer Office (RPO), Internal Revenue Service (IRS), Washington, DC; Detroit Computing Center, Detroit, Michigan; Martinsburg, West Virginia, and Memphis, Tennessee.
Individuals currently or formerly enrolled to practice before the IRS; applicants for enrollment to practice before the IRS, including those who have appealed denial of applications for enrollment; and candidates for enrollment examinations.
Applications for enrollment to practice before the IRS; records pertaining to RPO's investigation and evaluation of eligibility for enrollment; appeals from denials of applications for enrollment (and related records); records relating to enrollment examinations, including candidate applications, answer sheets, and examination scores; applications for renewal of enrollment, including information on continuing professional education; and administrative records pertaining to enrollment status, including current status, dates of enrollment, dates of renewal, and dates of resignation or termination.
5 U.S.C. 301, 26 U.S.C. 7801 and 7803, and 31 U.S.C. 330.
To administer the enrollment program under the regulations governing practice before the IRS, which are set out at 31 CFR part 10 and are published in pamphlet form as Treasury Department Circular No. 230; to make available to the general public sufficient information to assist taxpayers in locating enrolled individuals and in accurately verifying individuals' enrollment status; to assist public, quasi-public, or private professional authorities, agencies, organizations, and associations and other law enforcement and regulatory authorities in the performance of their duties in connection with the administration and maintenance of standards of integrity, conduct, and discipline; and to assist state tax agencies in their efforts to ensure compliance with ethical rules and standards of conduct by individuals authorized to practice or individuals who seek permission to practice before the agency.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems the purpose of the disclosure to be compatible with the purpose for which the IRS collected the records and no privilege is asserted:
(1) Disclose information to the Department of Justice (DOJ when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding; and the IRS determines that the information is relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding; and the IRS or the DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, tribal, or foreign agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee or to issuing, or continuing, a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to a Federal, state, local, tribal, or foreign agency or other public authority responsible for implementing or enforcing, or for investigating or prosecuting, the violation of a statute, rule, regulation, order, or license when a record on its face, or in conjunction with other records, indicates a violation or potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to a contractor to the extent necessary to perform the contract.
(6) Disclose information to third parties during the course of an investigation to the extent deemed necessary by the IRS to obtain information pertinent to the investigation.
(7) Make available for public inspection or otherwise disclose to the general public the name, enrollment number, and enrollment status (active, inactive, inactive retired, terminated for failure to meet the requirements for renewal of enrollment, or resigned for reasons other than in lieu of a disciplinary proceeding being instituted or continued, including effective dates), as well as the mailing address, company or firm name, telephone number, fax number, email address, and Web site address, pertaining to individuals who are, or were, enrolled to practice before the IRS.
(8) Disclose information to a public, quasi-public, or private professional authority, agency, organization, or association, which individuals covered by this system of records may be licensed by, subject to the jurisdiction of, a member of, or affiliated with, including but not limited to state bars and certified public accountancy boards, to assist such authorities, agencies, organizations, or associations in meeting their responsibilities in connection with the administration and maintenance of standards of integrity, conduct, and discipline.
(9) Disclose information to a state tax agency for tax administration purposes, including the agency's efforts to ensure compliance with ethical rules and standards of conduct by individuals authorized to practice or individuals who seek permission to practice before the agency.
(10) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the
Paper records and electronic media.
By individual's name (including other names used), Social Security Number (SSN) (where available), enrollment examination candidate number, enrollment application control number, enrollment number, or street address. Non-unique names will be distinguished by addresses.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained in accordance with IRM 1.15, Records Management (also see Documents 12820 and 12990).
Director, Return Preparer Office. See IRS Appendix below for address.
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
Individuals covered by this system of records; witnesses; Federal or state courts, agencies, or bodies; professional authorities, agencies, organizations, or associations; state tax agencies; Treasury Department records; and public records.
Pursuant to section (k)(2) of the Privacy Act, 5 U.S.C. 552a(k)(2), the records contained within this system are exempt from the following sections of the Act: (c)(3), (d), (e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I), and (f). (See 31 CFR 1.36.)
Preparer Tax Identification Number (PTIN) Records—Treasury/IRS.
National Office, Field Offices, Campuses, and Computing Centers. (See IRS Appendix below for addresses.)
Applicants for a PTIN; registered paid tax return preparers (individuals issued a PTIN); individuals whose application or registration is rejected, revoked, or suspended. Individual providers of continuing education for paid tax return preparers, including applicants for IRS approval, approved providers, and former providers. Individual contractors who assist the IRS in reviewing continuing education provider applications. Individuals who communicate with the IRS regarding the paid tax return preparer registration program or about any specific paid tax return preparer or continuing education provider.
Administrative records pertaining to paid tax return preparers, including records pertaining to applications for registration, renewal of registration, revocations, suspensions, and appeals; records pertaining to IRS investigation and evaluation of eligibility for registration; records relating to proof of identity for applicants who do not have Social Security Numbers; records related to competency testing, including applications, answer sheets, and test scores; records related to background, fingerprint, and tax compliance checks; records on continuing education requirements to become a registered paid tax return preparer; and information related to testing and education exemptions due to supervised status and types of returns prepared. Records pertaining to individual providers of continuing education for paid tax return preparers, including applications for IRS approval of courses or programs, grants and denials of such applications, and records of participation in offered courses and programs. Records pertaining to individual contractors who assist IRS in reviewing continuing education provider applications. Records pertaining to received communications.
Note: Disciplinary records pertaining to registered paid tax return preparers are maintained in Treasury/IRS 37.007, Practitioner Disciplinary Records.
5 U.S.C. 301; 26 U.S.C. 7801 and 7803; 31 U.S.C. 330.
To administer records pertaining to the issuance of PTINs to registered paid tax return preparers.
Returns and return information may be disclosed only as authorized by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to
(3) Disclose information to an arbitrator, mediator, or other neutral, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges. Information may also be disclosed to the parties in the alternative dispute resolution proceeding.
(4) Disclose to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(5) Disclose pertinent information to an appropriate Federal, state, local, or tribal agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(6) Disclose information to foreign governments in accordance with international agreements.
(7) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(8) Make available for public inspection or otherwise disclose to the general public, after the final agency decision has been issued or after OPR has taken final action: (a) The name, mailing address, professional designation (attorney, certified public accountant, enrolled agent, enrolled actuary, enrolled retirement plan agent appraiser, registered tax return preparer, or any individual who for compensation prepares or assists with the preparation of all or substantially all of a tax return, claim for refund, or other document pertaining to any taxpayer's liability for submission to the IRS), type of disciplinary sanction, effective dates, and information about the conduct that gave rise to the sanction pertaining to individuals who have been censured, individuals who have been suspended or disbarred from practice before the IRS, individuals who have resigned as an enrolled agent, an enrolled retirement plan agent, or a registered tax return preparer in lieu of a disciplinary proceeding being instituted or continued, individuals upon whom a monetary penalty has been imposed, and individual appraisers who have been disqualified; and (b) the name, mailing address, representative capacity (family member; general partner; full-time employee of officer of a corporation, association, or organized group; full-time employee of a trust, receivership, guardianship, ore state; officer or regular employee of a government unit; an individual representing a taxpayer outside the United States; or unenrolled return preparer), the fact of the denial of eligibility for limited practice, effective dates, and information about the conduct that gave rise to the denial pertaining to individuals who have been denied edibility to engage in limited practice before the IRS pursuant to 31 CFR part 10.
(9) To the extent consistent with the American Bar Association's Model Rules of Professional Conduct, Rule 4.2, disclose to a person the fact that his chosen legal representative may not be authorized to represent him before the IRS.
(10) Disclose information to a contractor, including an expert witness or a consultant, hired by the IRS, to the extent necessary for the performance of a contract.
(11) Disclose information to a supervised tax return preparer sufficient to identify the supervising tax return preparer, and information to a supervising tax return preparer sufficient to identify the tax return preparers who have named that individual as their supervisor.
(12) Disclose information to a contractor's financial institution to the extent necessary for the processing of PTIN application and registration fee payments.
(13) Disclose information to a former employee of the IRS to the extent necessary for personnel-related or other official purposes when the IRS requires information and/or consultation assistance from the former employee regarding a matter within that person's former area of responsibility.
(14) Disclose information to the public sufficient to identify individuals who have registered with the IRS as a paid tax return preparer and been issued a PTIN, and to advise the public when such an individual is removed from the program.
(15) Disclose information to the public sufficient to identify individual providers of continuing education for paid tax return preparers, including contact information.
(16) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper and electronic media.
Records pertaining to paid tax return preparers may be retrieved by the preparer's PTIN, name, Taxpayer Identification Number (Social Security Number or Employer Identification Number), or application number. Records pertaining to individual continuing education providers may be retrieved by provider name, Taxpayer Identification Number, application number, or course or program number. Records pertaining to contractors may be retrieved by contractor name or Taxpayer Identification Number, or by contract number. Records pertaining to communications with individuals regarding the paid tax return preparer registration program may be retrieved by the name of the individual or the name or other identifying information of a paid tax return preparer or a continuing education provider identified in the communication. Records may also be retrieved by IRS employee identification number for the employee assigned to the case, project, or determination.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Record retention will be established in accordance with the National Archives and Records Administration Regulations Part 1228, Subpart B—Scheduling Records.
Director, Return Preparer Office. See IRS Appendix below for address.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR, Part 1, Appendix B. Inquiries should be addressed as in “Record Access Procedures” below. This system of records contains records that are exempt from the notification, access and contest requirements pursuant to 5 U.S.C. 552a(k)(2).
See “Notification Procedure” above.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. With respect to records other than tax records, see “Notification Procedure” above.
Applicants and registered paid tax return preparers; Treasury and other Federal agency records; state and municipal government agencies; contractors; continuing education providers; witnesses; professional organizations; publicly available records such as real estate records and news media.
Some of the records in this system are exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36)
Examination Administrative Files—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
Taxpayers who are being considered for examination, or who are, or were, examined to determine an income, estate and gift, excise, or employment tax liability.
Investigatory materials required in making a tax determination or other verification in the administration of tax laws and all other sub-files related to the processing of the tax case. This system also includes other management information related to a case and used for tax administration purposes, including classification and scheduling records.
5 U.S.C. 301 and 26 U.S.C. 7801.
To document the examinations of tax returns or other determinations as to a taxpayer's tax liability; to document determinations whether or not to examine a taxpayer; and to analyze trends in taxpayer compliance.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer's name, Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management.
Division Commissioners, W&I, SB/SE., TE/GE, and LB&I. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Taxpayers' returns, books and records; informants and other third party witnesses; city and state governments; other Federal agencies; examinations of other taxpayers; and taxpayers' representatives.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Excise Compliance Programs—Treasury/IRS.
SB/SE (Excise Program) area and campus offices. (See the IRS Appendix below for address.)
These records include information about individuals engaged in any taxable activity related to excise taxes; the filing, preparing, or transmitting of Federal excise taxes; or witnesses or other parties with knowledge of such taxable activity.
These records include information about individuals who are the subject of excise tax compliance programs administered by the IRS, including records pertaining to witnesses or other parties with knowledge of such taxable activity.
5 U.S.C. 301 and 26 U.S.C. 7801.
These records are used to administer the Federal Excise Compliance Program.
Disclosure of return and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Records are retrievable by taxpayer name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner SB/SE (Excise Program), (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
Filed IRS Forms 720, 720–TO/CS, 637, 2290, 8849; Customs Form 7501, Entry Summary; dyed diesel fuel inspections; individuals engaged in any activity related to excise taxes, or the filing, preparing, or transmitting of excise taxes; witnesses or other parties with knowledge of such activity.
Records maintained in this system have been designated as exempt from 5 U.S.C. 552a(c)(3), (d)(1), (2), (3), and (4), (e)(1), (e)(4)(G), (H), and (I), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Whistleblower Office Records—Treasury/IRS.
Whistleblower Office, Washington, DC, and Ogden Campus, Ogden, Utah.
These records include information about individuals who submit allegations of possible tax noncompliance and claims for award to the Whistleblower Office (“claimants”), claimants' representatives, and the taxpayers and third parties about whom the information is received, which is pertinent to a claim for award.
These records include claimant identity information, allegation information received, claims or award (including supporting information or documentation), information pertaining to any civil or criminal investigation initiated, or expanded, as a result of the allegations received by the Whistleblower Office, any other information pertinent to the Whistleblower Office's determination as to the amount, if any, of any award for which the claimant may be eligible under 26 U.S.C. 7623, including information pertaining to appeals of award determinations to the Tax Court (including the results of such appeals).
26 U.S.C. 7623 and 7801, and 5 U.S.C. 301.
The records in this system will be used to administer the claimant award program under 26 U.S.C. 7623.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103.
To the extent authorized by 26 U.S.C. 6103, disclosure may also be made to appropriate agencies, entities, and persons when: (1) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Data is retrieved by the name or Taxpayer Identification Number (TIN) of the claimant(s), of the taxpayer(s) who are the subject(s) of the allegation(s), or of third parties identified in the records; the name or Centralized Authorization File (CAF) number of the claimant's representative; or an award claim number assigned by the Whistleblower Office.
Access controls are not less than those published in IRM 10.8, Information
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Whistleblower Office, SE: WO, 1111 Constitution Avenue NW., Washington, DC 20224.
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Claimants and their representatives; Department of the Treasury employees and records; newspapers, court records, and other publicly available information.
This system has been designated as exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). See 31 CFR 1.36.
Audit Information Management System (AIMS)—Treasury/IRS.
National Office, field, and campus offices. (See the IRS Appendix below for address.)
Taxpayers whose tax returns are under the jurisdiction of examiners in W&I, SB/SE., TE/GE and LB&I
Name, address, and Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To maintain information about returns in inventory and closed returns.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
AND DISPOSING OF RECORDS IN THE SYSTEM:
Paper records and electronic media.
By taxpayer name and TIN.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 1220).
Division Commissioners, W&I, SB/SE., TE/GE and LB&I. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and examination files.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
International Enforcement Program Information Files—Treasury/IRS.
Division Commissioner, LB&I (See the IRS Appendix below for address.)
Any individual having foreign business or financial activities.
Listing of individual taxpayers, Taxpayer Identification Number (TIN) (
5 U.S.C. 301 and 26 U.S.C. 7801.
To monitor the International Enforcement Program.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Disclosure of tax convention information may be made only as provided by 26 U.S.C. 6105. All other records may be used as
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN).
Division Commissioner, LB&I. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax convention and treaty partners; individual's tax returns; examinations of other taxpayers; and public sources of information.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4),(e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Compliance Programs and Projects Files—Treasury/IRS.
National Office, field, and campus offices. (See the IRS Appendix below for address.)
Individuals who may be involved in tax evasion schemes or noncompliance schemes, including but not limited to withholding noncompliance or other areas of noncompliance grouped by industry, occupation, or financial transactions; individuals who may be selling or promoting abusive tax schemes or abusive tax avoidance transactions; individuals who may be in noncompliance with tax laws concerning tax exempt organizations, return preparers, corporate kickbacks, or questionable Forms W–4, tax evasion schemes involving identity theft, among others.
Records pertaining to individuals in compliance projects and programs, and records used to consider individuals for selection in these compliance projects and programs.
5 U.S.C. 301 and 26 U.S.C. 7801.
To track information relating to special programs and projects to identify non-compliance schemes and to select individuals involved in such schemes for enforcement actions.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioners, W&I, SB/SE. TE/GE, and LB&I. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I)
Data on Taxpayers' Filings on Foreign Holdings—Treasury/IRS.
Division Commissioner, LB&I. (See the IRS Appendix below for address.)
Individuals who file Form 5471, Information Return with respect to a Foreign Corporation.
Names of individuals who file Form 5471.
5 U.S.C. 301 and 26 U.S.C. 7801.
To monitor individuals who file Form 5471, Controlled Foreign Corporation.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, LB&I. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Form 5471.
None.
Anti-Money Laundering/Bank Secrecy Act (BSA) and Form 8300 Records—Treasury/IRS.
Computing Center and field offices. (See the IRS Appendix below for address.)
Individuals subject to the reporting and recordkeeping requirements of the BSA, including:
(1) Individuals whose businesses provide any of the financial services which subject them to the reporting, recordkeeping or registration requirements of the laws commonly known as the Bank Secrecy Act (BSA), or the related reporting and recordkeeping requirements of 26 U.S.C. 6050I.
(2) Individuals acting as employees, owners or customers of such institutions or involved, directly or indirectly, in any transaction with such institutions. Examples of institutions that offer financial services are: Currency dealers, check cashiers, money order or traveler's check issuers, sellers, or redeemers, casinos, card clubs, and other money transmitters.
(3) Individuals who are required to file reports or maintain records required under the Bank Secrecy Act, such as the Report of Foreign Bank and Financial Accounts and related records.
(4) Persons who may be witnesses or may otherwise provide information concerning these individuals.
Records relate to the administration of the IRS anti-money laundering program including the registration, reporting and recordkeeping requirements of the BSA and 26 U.S.C. 6050I. They may also relate to individuals who, based upon certain tolerances, exhibit patterns of financial transactions suggesting noncompliance with the registration, reporting and recordkeeping requirements of the BSA and 26 U.S.C. 6050I. Records may also relate to individuals who are required to file reports or maintain records required under the Bank Secrecy Act, such as the Report of Foreign Bank and Financial Accounts and related records. Records may also relate to IRS administrative actions, such as notification, educational or other outreach efforts, examination results, and civil or criminal referrals.
5 U.S.C. 301, 31 U.S.C. 5311–5332, 26 U.S.C. 6050I, and 7801.
To administer 26 U.S.C. 6050I and the Bank Secrecy Act.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to appropriate Federal, state, local or foreign agencies responsible for investigating or prosecuting the violations of or for enforcing or implementing a statute, rule, regulation, order, or license, where the Service becomes aware of an indication of a potential violation of civil or criminal law or regulation, or the use is required in the conduct of intelligence or counter-intelligence activities, including analysis, to protect against international terrorism.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(7) Disclose information to any agency, including any State financial institutions supervisory agency, United States intelligence agency or self-regulatory organization registered with the Securities and Exchange Commission or the Commodity Futures Trading Commission, upon written request of the head of the agency or organization. The records shall be available for a purpose that is consistent with title 31, as required by 31 U.S.C. 5319.
(8) Disclose information to representatives of the National Archives and Records Administration (NARA) who are conducting records management inspections under authority of 44 U.S.C. 2904 and 2906.
(9) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
The system contains material for which sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Qualifying Therapeutic Discovery Project Records—Treasury/IRS.
IRS Campus, Ogden, UT.
Individuals who file an Application for a Qualifying Therapeutic Discovery Project credit (or grant in lieu of credit) in their individual capacity or on behalf of their sole proprietorship.
These records include information pertaining to the IRS's administration of the Qualifying Therapeutic Discovery Project Program. Records include, but are not limited to the application, including Form 8942 and the Project Information Memorandum, representative authorization information, and a unique administrative control identifier associated with each application for certification. The records may contain taxpayer names, Taxpayer Identification Numbers (TIN), and (Social Security Numbers (SSN).
5 U.S.C. 301 and 26 U.S.C. 48D and 7801. Section 9023(a) of The Patient Protection and Affordable Care Act (Pub. L. 111–148) as amended by the Health Care and Education
To administer, in consultation with the Department of Health & Human Services, a qualifying therapeutic discovery project program to consider and award certifications for qualified investments eligible for the credit (or, at the taxpayer's election, the grant) to qualifying therapeutic discovery project sponsors.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) To disclose certain information to the public regarding the amount of the grant, the identity of the person to whom the grant was made, and a description of the project with respect to which the grant was made in accordance with the intent of Congress to publicize the projects that show significant potential to produce new and cost-saving therapies, support good jobs, and increase U.S. competitiveness.
(2) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(3) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to a contractor, including an expert witness or a consultant hired by the IRS, to the extent necessary for the performance of a contract.
(7) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
(8) Disclose information to professional organizations or associations with which individuals covered by this system of records may be affiliated, such as state bar disciplinary authorities, to meet their responsibilities in connection with the administration and maintenance of standards of conduct and discipline.
Paper records and electronic media.
By taxpayer name and Taxpayer Identification Number (TIN) (Social Security Number (SSN), Employer Identification Number (EIN), or similar number assigned by the IRS).
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, SB/SE., 5000 Ellin Road, New Carrollton, MD 20706.
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below. The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. For all other records, see “Records Access Procedures” above.
Records in this system are provided by the applicants, the Department of Health and Human Services, and the IRS taxpayer account records.
None.
Appeals Case Files—Treasury/IRS.
National Office, campus, and field offices. (See the IRS Appendix below for address.)
Taxpayers who seek administrative review of IRS proposed adjustments and collection actions with which they disagree. Persons who seek administrative review of initial Freedom
Investigatory materials required in making a tax determination or other verification in the administration of tax laws and all other sub-files related to the processing of the tax case, including history notes and work papers required in an administrative review of an assessment or other initial tax determination, collection action, or FOIA determination. This system also includes other management information related to a case.
5 U.S.C. 301, 5 U.S.C. 552, and 26 U.S.C. 7801.
To document the actions taken during Appeals' administrative review of IRS proposed adjustments, collection actions, or Freedom of Information Act (FOIA) initial determinations.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By individual's name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Appeals. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Appeals Centralized Data (ACD)—Treasury/IRS.
National Office, field, and campus offices. (See the IRS Appendix below for address.)
Taxpayers who seek administrative review of IRS proposed adjustments and collection actions with which they disagree. Individuals who seek administrative review of initial Freedom of Information Act (FOIA) determinations.
Information from 24.030, 24.046, 42.001, and 44.001 systems, related internal management information, including the taxpayer's DIF Score, and a code identifying taxpayers that threatened or assaulted IRS employees. Information pertaining to FOIA cases under administrative appeal.
5 U.S.C. 301, 5 U.S.C. 552, and 26 U.S.C. 7801.
To track information about cases in inventory and closed cases.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name and Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Appeals. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Tax returns and other filings made by the individual and agency entries made in the administration of the individual's tax account. FOIA administrative appeals and agency entries made in the administration of the FOIA appeal. Also, time reports prepared by Appeals Officers.
None.
Art Case Files—Treasury/IRS.
National Office (Appeals). (See the IRS Appendix below for address.)
Famous or noted artists whose works have been evaluated by the Commissioner's Art Panel or its staff for use in a taxpayer's case.
Commissioner's Art Panel or its staff decisions on values of works of art by named artists and appraisal documentation.
5 U.S.C. 301 and 26 U.S.C. 7801.
To establish value of art works for purposes of tax administration.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(7) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(8) Disclose information to foreign governments in accordance with international agreements.
(9) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer, artist, and appraiser name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Appeals. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Commissioner's Art panel and staff decisions and appraisal documentation.
None.
Expert Witness and Fee Appraiser Files—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Expert witnesses for litigation and appraisers, including Art Advisory Panelists whose services may be or are used.
Biographical data, application letters, or list of expert/appraiser names by specialty.
5 U.S.C. 301 and 26 U.S.C. 7801.
To track individuals available for expert witness and appraisal services.
Records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(7) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(8) Disclose information to foreign governments in accordance with international agreements.
(9) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Expert witness or appraiser name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Appeals. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Records Access Procedure” above.
Expert witnesses, appraisers, or public sources.
None.
Criminal Investigation Management Information System (CIMIS) and Case Files—Treasury/IRS.
National Office (Criminal Investigation), field, campus, and computing center offices. (See the IRS Appendix below for address.)
Subjects and potential subjects of Criminal Investigation (CI) investigations and other individuals of interest to CI, such as witnesses and associates of subjects or potential subjects of CI investigations; individuals about whom CI has received information alleging their commission of, or involvement with, a violation of Federal laws with IRS jurisdiction, including individuals who may be victims of identity theft or other fraudulent refund or tax schemes; individuals identified as potentially posing a threat to the Commissioner, other Agency officials, or visiting dignitaries, or as having inappropriately contacted the Commissioner or other Agency officials; IRS employees assigned to work matters handled by CI.
Records pertaining to possible violations of laws under the enforcement jurisdiction of the IRS, received by the IRS from other sources or developed during investigative activities, that identify or may identify criminal or civil nonconformance with Federal tax laws and other Federal laws delegated to CI for investigation or enforcement; information arising from investigative activities conducted by CI in conjunction with other Federal, state, local, or foreign law enforcement, regulatory, or intelligence agencies; personal, identification, criminal history, and other information, including information sources, pertaining to individuals identified as person(s) of interest by Special Agents assigned to the Dignitary Protection Detail; personnel and workload management information. Records include biographical, travel, communication, financial, and surveillance information.
5 U.S.C. 301, 31 U.S.C. 5311–5332, 26 U.S.C. 7801, and Department of the Treasury Delegation Orders and Directives authorizing CI to conduct investigations into specified non-tax crimes.
To maintain, analyze, and process sensitive investigative information that identifies or may identify criminal noncompliance with Federal tax laws and other Federal laws delegated to CI for investigation or enforcement, and that identifies or may identify the individuals connected to such activity. To establish linkages between identity theft and refund or other tax fraud schemes, and the individuals involved in such schemes, that may be used to further investigate such activity and to perfect filters that identify fraudulent returns upon filing and to facilitate tax account adjustments for taxpayer victimized by these schemes.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. Disclosure of information covered by 31 U.S.C. 5311,
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to Federal, state, local, tribal, and foreign law enforcement and regulatory agencies regarding violations or possible violations of Bank Secrecy Act, money laundering, tax, and other financial laws when relevant and necessary to obtain information for an investigation or enforcement activity.
(4) Disclose information to a Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(6) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(7) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(8) Disclose information to foreign governments in accordance with international agreements.
(9) Disclose information to the news media as described in IRS Policy Statement 11–94 (formerly P–1–183), News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.19.1.9.
(10) Disclose information to a defendant in a criminal prosecution, the DOJ, or a court of competent jurisdiction when required in criminal discovery or by the Due Process Clause of the Constitution.
(11) Disclose information, to the extent deemed necessary and appropriate for use in announcements to the general public that the IRS or the Department of the Treasury seeks to locate, detain or arrest specified individuals in connection with criminal activity under CI's investigative jurisdiction.
(12) Disclose information to appropriate agencies, entities, and
Paper records and electronic media.
By name, address, Social Security Number, Taxpayer Identification Number, or telephone, passport, financial account, driver or professional license, or criminal record numbers, or other identifying detail contained in the investigative records, including financial information, geographical location/travel information, surveillance records, communication and contact information, or biographical data of the subject or an associate of the subject, a witness, or a victim of alleged identify theft or other fraudulent refund or tax scheme; identity of the individuals(s) who provided information; name or employee number of assigned employee(s).
Access controls are not less than those published in IRM 10.2, Physical Security Program, and IRM 10.8, Information Technology (IT) Security.
Records pertaining to persons of interest identified by Special Agents assigned to the Dignitary Protection Detail are maintained until such time that the individual or group no longer poses a threat. Other records are retained and disposed of in accordance with the record control schedules applicable to the records of Criminal Investigation, Document 12990, Record Control Schedule 30 (formerly IRM 1.15.30).
Chief, Criminal Investigation. (See the IRS Appendix below for address.)
Individuals seeking notification of an access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, subpart C, Appendix B. Written inquiries should be addressed as stated in the Appendix published in the
See “Notification Procedure” above.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3)–(4), (d)(1)–(4), (e)(1)–(3), (e)(4)(G)–(I), (e)(5), (e)(8), (f) and (g) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2). (See 31 CFR 1.36).
Confidential Informants—Treasury/IRS.
National Office (Criminal Investigation) and field offices. (See the IRS Appendix below for address.)
Current and former confidential informants; subjects of confidential informants' reports.
Information about current and former confidential informants, including their personal and financial information and investigative activities with which each confidential informant is connected.
5 U.S.C. 301, 26 U.S.C. 7801 and 7803; 31 U.S.C. 5311
To maintain a file of the identities and background material of current and former confidential informants.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. Disclosure of information covered by 31 U.S.C. 5311,
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to Federal, state, local, tribal, and foreign law enforcement and regulatory agencies regarding violations or possible violations of Bank Secrecy Act, money laundering, tax, and other financial laws when relevant and necessary to obtain information for an investigation or enforcement activity.
(4) Disclose information to a Federal, state, local, or tribal agency, or other public authority responsible for
(5) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(6) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(7) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(8) Disclose information to foreign governments in accordance with international agreements.
(9) Disclose information to the news media as described in IRS Policy Statement 11–94 (formerly P–1–183), News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.19.1.9.
(10) Disclose information to a defendant in a criminal prosecution, the DOJ, or a court of competent jurisdiction when required in criminal discovery or by the Due Process Clause of the Constitution.
(11) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentially of information in the system of records has been compromise; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interest, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.
Paper records and electronic media.
By confidential informant's name, address, or Taxpayer Identification Number; investigation number; or other identifying detail (such as telephone, driver's license, passport, or financial account numbers); name of the subject or other persons identified in the confidential informant's report or memoranda; name or employee number of assigned employee(s).
Access controls are not less than those published in IRM 10.2, Physical Security Program, and IRM 10.8, Information Technology (IT) Security.
Records are retained and disposed of in accordance with the record control schedules applicable to the records of Criminal Investigation, Document 12990, Record Control Schedule 30 (formerly IRM 1.15.30).
Chief, Criminal Investigation. (See the IRS Appendix below for address.)
Individuals seeking notification of an access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, subpart C, Appendix B. Written inquiries should be addressed as stated in the Appendix published in the
See “Notification Procedure” above.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3)–(4), (d)(1)–(4), (e)(1)–(3), (e)(4)(G)–(I), (e)(5), (e)(8), (f) and (g) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2). (See 31 CFR 1.36).
Electronic Surveillance and Monitoring Records—Treasury/IRS.
National Office (Criminal Investigation). (See the IRS Appendix below for address.)
Subjects of electronic surveillance including associates identified by the surveillance or otherwise.
Information received or developed during CI's investigative activities relating to authorized electronic surveillance activities; investigative reports and files regarding electronic surveillance conducted by CI independently or in conjunction with other Federal, state, local or foreign law enforcement, or intelligence agencies.
5 U.S.C. 301, and 26 U.S.C. 7801 and 7803; 31 U.S.C. 5311
To maintain, analyze, and process sensitive investigative data obtained through authorized electronic surveillance that identifies or may identify criminal noncompliance with Federal tax law or other laws delegated to CI for enforcement.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. Disclosure of information covered by 31 U.S.C. 5311,
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) Any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to Federal, state, local, tribal, and foreign law enforcement and regulatory agencies regarding violations or possible violations of Bank Secrecy Act, money laundering, tax, and other financial laws when relevant and necessary to obtain information for an investigation or enforcement activity.
(4) Disclose information to a Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute, rule, regulation, order, or license, then a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(6) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(7) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(8) Disclose information to foreign governments in accordance with international agreements.
(9) Disclose information to the news media as described in IRS Policy Statement 11–94 (formerly P–1–183), News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.19.1.9.
(10) Disclose information to a defendant in a criminal prosecution, the DOJ, or a court of competent jurisdiction when required in criminal discovery or by the Due Process Clause of the Constitution.
(11) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentially of information in the system of records has been compromise; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interest, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name, address, Taxpayer Identification Number, or other identifying detail (telephone, driver's license, passport, criminal record, or financial account numbers) of the subject or an associate of the subject; investigation number; address, telephone number, or other locational criteria of the person or location under surveillance; name or employee number of assigned employee(s).
Access controls are not less than those published in IRM 10.2, Physical Security Program, and IRM 10.8, Information Technology (IT) Security.
Records are retained and disposed of in accordance with the record control schedules applicable to the records of Criminal Investigation, Document 12990, Record Control Schedule 30 (formerly IRM 1.15.30).
Chief, Criminal Investigation. (See the IRS Appendix below for address.)
Individuals seeking notification of an access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, subpart C, Appendix B. Written inquiries should be addressed as stated in the Appendix published in the
See “Notification Process” above.
See “Notification Process” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3)–(4), (d)(1)–(4), (e)(1)–(3), (e)(4)(G)–(I), (e)(5), (e)(8), (f) and (g) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2). (See 31 CFR 1.36).
Relocated Witnesses—Treasury/IRS.
Chief, Criminal Investigation. (See the IRS Appendix below for address.)
Relocated witnesses.
Records pertaining to the relocation of witnesses for their protection.
5 U.S.C. 301 and 26 U.S.C. 7801.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By relocated witness' name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Criminal Investigation. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(j)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(j)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system has been designated exempt from sections (c)(3)–(4), (d)(1)–(4), (e)(1)–(3), (e)(4)(G)–(I), (e)(5), (e)(8), (f) and (g) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2). (See 31 CFR 1.36).
Automated Information Analysis and Recordkeeping System—Treasury/IRS.
National Office (Criminal Investigation), field, campus, and computing center offices. (See the IRS Appendix below for address.)
Taxpayers and other individuals involved in financial transactions that require the filing of information reflected in the “Categories of records” below.
Financial records pertaining to transactions with reporting requirements under the Internal Revenue Code, the Bank Secrecy Act, or other Federal law, and reports of suspicious activity pertaining to such transaction. Such transactions include international transportation of currency or monetary instruments, cash payments of $10,000 received in a trade or business, financial institution currency transaction reports, registrations of money services businesses, and maintenance of accounts in banks or other financial institutions outside the U.S. Some records in this system are copies from other systems of record, including: Customer Account Data Engine Individual Master File (Treasury/IRS 24.030); Customer Account Data Engine Business Master File (Treasury/IRS 24.046); Currency Transaction Reports (CTRs) (FinCEN.003); Report of International Transportation of Currency or Monetary Instruments (CMIRs)(FinCEN.003); Suspicious Activity Reports (SARs)(FinCEN.002); Foreign Bank and Financial Accounts (FBARs)(FinCEN.003); Reports of Cash Payments over $10,000 Received in a Trade or Business (FinCEN.003); Registration of Money Services Business; and other forms required by the Bank Secrecy Act (FinCEN.003).
5 U.S.C. 301, and 26 U.S.C. 7801 and 7803; 31 U.S.C. 5311
To maintain, analyze, and process records and information that may identify patterns of financial transactions indicative of criminal and/or civil noncompliance with tax, money laundering, Bank Secrecy Act, and other financial laws and regulations delegated to CI for investigation or enforcement, and that identifies or may identify the individuals connected to such activity. To establish linkages between fraudulent transactions or other activities, and the individuals involved in such actions, that may be used to further investigate such activity and to perfect filters that identify information pertaining to such activity.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. Disclosure of information covered by 31 U.S.C. 5311,
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) Any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) Any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of
(3) Disclose information to Federal, state, local, tribal, and foreign law enforcement and regulatory agencies regarding violations or possible violations of Bank Secrecy Act, money laundering, tax, and other financial laws when relevant and necessary to obtain information for an investigation or enforcement activity.
(4) Disclose information to a Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute, rule, regulation, order, or license, then a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(6) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(7) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(8) Disclose information to foreign governments in accordance with international agreements.
(9) Disclose information to the news media as described in IRS Policy Statement 11–94 (formerly P–1–183), News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.19.1.9.
(10) Disclose information to a defendant in a criminal prosecution, the DOJ, or a court of competent jurisdiction when required in criminal discovery or by the Due Process Clause of the Constitution.
(11) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentially of information in the system of records has been compromise; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interest, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and to prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name, address, Taxpayer Identification Number, or other identifying detail (such as telephone, driver license, passport, criminal record, financial account, or professional license numbers) of the subject or an associate of the subject, a witness, or a victim of alleged identity theft or other fraudulent refund or tax scheme; identity of the individual who provided information; name or employee number of the assigned employee(s).Social Security Number
Access controls are not less than those published in IRM 10.2, Physical Security Program, and IRM 10.8, Information Technology (IT) Security.
Records are retained and disposed of in accordance with the record control schedules applicable to the records of Criminal Investigation, Document 12990, Record Control Schedule 30 (formerly IRM 1.15.30).
Chief, Criminal Investigation. (See the IRS Appendix below for address.)
Individuals seeking notification of an access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, subpart C, Appendix B. Written inquiries should be addressed as stated in the Appendix published in the
See “Notification Process” above.
See “Notification Process” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (c)(4), (d)(1)–(4), (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(4)(I), (e)(5), (e)(8), (f), and (g) of the Privacy Act pursuant to 5 U.S.C. 552a(j)(2) and (k)(2). Additionally, pursuant to 5 U.S.C. 552a(k)(2), it is exempt from 5 U.S.C. 552a (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act. (See 31 CFR 1.36).
Disclosure Records—Treasury/IRS.
National Office, field, computing center, and campus offices. (See the IRS Appendix below for address.)
(1) Subjects of ex parte orders or written requests for tax information in non-tax criminal matters or with respect to terrorist activities under 26 U.S.C. 6103(i).
(2) Persons who have made requests or demands for IRS information under Treas. Reg. 301.9000–1 through –6 in matters falling under the jurisdiction of Privacy, Governmental Liaison and Disclosure (PGLD).
(3) Requesters of and intended recipients of letter forwarding services.
(4) Persons who have applied for Federal employment or presidential appointments and applicants for Department of Commerce “E” Awards, for whom tax checks have been requested.
(5) Requesters for access to records pursuant to 26 U.S.C. 6103, the Freedom of Information Act (FOIA), 5 U.S.C. 552, and initiators of requests for access, amendment or other action pursuant to the Privacy Act of 1974, 5 U.S.C. 552a.
(6) Individuals identified on Forms 10848, Report of Inadvertent Disclosure of Tax and Privacy Act Information.
(7) Individuals identified by, or initiating other correspondence or inquiries with, matters falling under the jurisdiction of PGLD.
Correspondence, demands and requests for IRS records, responses to those requests, notes and other background information, copies of records secured, testimony authorizations, tax check
5 U.S.C. 301, 552, 552a and 26 U.S.C. 7801.
To track the processing of requests or demands for agency records under applicable laws and regulations concerning the disclosure of official information.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof: (b) Any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(4) Disclose debtor information to a Federal payer agency for purposes of salary and administrative offsets, to a consumer reporting agency to obtain commercial credit reports, and to a debt collection agency for debt collection services.
(5) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(6) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name or Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management also see Documents 12829 and 12990.
Director, Privacy, Governmental Liaison & Disclosure. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Defunct Special Service Staff Files Being Retained Because of Congressional Directive—Treasury/IRS.
National Office (Privacy, Governmental Liaison & Disclosure). (See the IRS Appendix below for address.)
Individuals suspected of violating the internal revenue law by the Special Service Staff before its discontinuation on August 23, 1973.
Individual Master File printouts; returns and field reports; information from other law enforcement government investigative agencies; Congressional Reports, and news media articles.
5 U.S.C. 301 and 26 U.S.C. 7801.
To preserve under Congressional Directive the activities of the Special
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS determines that the records are relevant and necessary to the proceeding or advice sought.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a part to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records.
By subject name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Privacy, Governmental Liaison & Disclosure. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below. The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
News media articles, taxpayers' returns and records, informant and third party information, other Federal agencies and examinations of related or other taxpayers.
None.
Collateral and Information Requests System—Treasury/IRS.
National Office, field, campus, and computing center offices. (See the IRS Appendix below for address.)
U.S. citizens, resident aliens, and nonresident aliens whose tax matters come under the jurisdiction of the U.S. competent authority in accordance with pertinent provisions of tax treaties with foreign countries.
Records of interviews with witnesses regarding financial transactions of taxpayers; employment data; bank and brokerage house records; probate records; property valuations; public documents; payments of foreign taxes; inventories of assets; business books and records.
These records relate to tax investigations conducted by the IRS where some aspects on an investigation must be pursued in foreign countries pursuant to the various tax conventions between the United States and foreign governments. The records also include individual case files of taxpayers on whom information (as is pertinent to carrying out the provisions of the convention or preventing fraud or fiscal evasion in relation to the taxes which are the subject of this convention) is exchanged with foreign tax officials of treaty countries.
5 U.S.C. 301 and 26 U.S.C. 7801.
To maintain records of correspondence and other documentation with respect to the exchange of information requests by or to foreign governments with which the U.S. maintains tax treaties.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Disclosure of tax treaty information may be made only as provided by 26 U.S.C. 6105. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, LB&I. See the IRS Appendix below for address.
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Tax Treaty Information Management System—Treasury/IRS.
National Office, field, campus, and computing center offices. (See the IRS Appendix below for address.)
U.S. citizens, resident aliens, and nonresident aliens whose tax matters come under the jurisdiction of the U.S. competent authority in accordance with pertinent provisions of tax treaties with foreign countries.
Management information regarding investigations of, or information exchange requests about taxpayers pursuant to tax treaties between the United States and foreign governments, including information from the Master File, including the taxpayer's DIF Score, and a code identifying taxpayers that threatened or assaulted IRS employees.
5 U.S.C. 301 and 26 U.S.C. 7801.
To track the inventory of individual case files of taxpayers who request competent authority assistance pursuant to the provisions of income tax treaties, or about whom information exchange requests are made by foreign governments pursuant to applicable tax treaties.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Disclosure of tax treaty information may be made only as provided by 26 U.S.C. 6105. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, LB&I. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(2).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
This system of records contains investigatory material compiled for law enforcement purposes whose sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I)
Tax Exempt & Governmental Entities (TE/GE) Correspondence Control Records—Treasury/IRS.
National Office, field, campus, and computing center offices (TE/GE). (See the IRS Appendix below for address.)
Requesters of letter rulings and determination letters, and subjects of field office requests for technical advice and assistance and other correspondence, including correspondence associated with section 527 organizations.
Name, date, nature and subject of an assignment, and work history. Sub-systems include case files and section 527 records that contain the correspondence, internal memoranda, digests of issues involved in proposed revenue rulings, and related material.
5 U.S.C. 301 and 26 U.S.C. 7801.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103 and 6104 where applicable. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name of requester or the subject of a letter ruling, determination letter, or other correspondence.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, TE/GE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, Appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Individuals who request rulings, determination letters, or submit other correspondence, and field offices requesting technical advice or assistance.
None.
Tax Exempt & Government Entities (TE/GE) Reports of Significant Matters—Treasury/IRS.
National Office, field, and campus offices. (See the IRS Appendix below for address.)
Individuals who submit letter ruling requests or determination letter requests with respect to organizations, or who are the subjects of technical advice requests, where the matter raised has some significance to tax administration.
Summaries of significant technical matters pertaining to letter rulings or determination letters under the jurisdiction of the Division Commissioner, TE/GE.
5 U.S.C. 301 and 26 U.S.C. 7801.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103 and 6104 where applicable. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By name of the requester or the subject of a letter ruling, determination letter, or other correspondence.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, TE/GE. (See the IRS Appendix below for address.)
Individuals seeking to determine if this system of records contains a record pertaining to themselves may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed as in “Record Access Procedures” below.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Individuals who submit determination or letter ruling requests and the employees who process them.
None.
Tax Exempt/Government Entities (TE/GE) Case Management Records—Treasury/IRS.
Office of the Division Commissioner, Tax Exempt/Government Entities (TE/GE), National Office, Area Offices, Local Offices, Service Campuses, and Computing Centers. (See the IRS Appendix below for addresses.)
Individuals who are the subject of or are connected to TE/GE examinations and tax determinations, including compliance projects, regarding Federal tax exemption requirements, employee plan requirements, and employment tax requirements.
These records include case identification, assignment, and status information from TE/GE examination and tax determination files, information about individuals pertaining to TE/GE's methods of investigating exempt organizations, retirement plans, and government entities with regard to their compliance with statutory Federal requirements and/or their tax exempt status. In addition, this system contains identifying information regarding informants who have provided information that is significant and relevant to TE/GE investigations of taxpayers.
5 U.S.C. 301; 26 U.S.C. 7801.
This system will provide TE/GE records for case management, including employee assignments and file tracking. TE/GE maintains records on businesses, organizations, employee plans, government entities, and Indian Tribal Government entities and individuals, such as principals and officers, connected with these entities. Records in this system are used for law enforcement investigations and may contain identifying information about informants who have provided significant information relevant to investigations of taxpayers.
Disclosure of return and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer name, Taxpayer Identification Number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Division Commissioner, TE/GE. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual. The records are exempt under 5 U.S.C. 552a(k)(2) from the notification provisions of the Privacy Act.
This system may not be accessed to inspect or contest the content of records. The records are exempt under 5 U.S.C. 552a(k)(2) from the access provisions of the Privacy Act.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Information is obtained from tax returns, application returns and supporting material, determination files, examination files, compliance review files, compliance programs and projects, and IRS personnel records.
This system has been designated as exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36.)
Employee Protection System Records—Treasury/IRS.
National Office, field and campus offices. (See the IRS Appendix below for address.)
Individuals attempting to interfere with the administration of internal revenue laws through assaults, threats, suicide threats, filing or threats of filing frivolous criminal or civil legal actions against Internal Revenue Service (IRS) employees, or IRS contractors or the employees' or contractors' immediate family members, or through forcible interference against any officer, government contractor or employee while discharging the official duties at his/her position. An individual is designated as a potentially dangerous taxpayer (PDT), based on reliable information, furnished to the IRS or Treasury Inspector General for Tax Administration (TIGTA), that fits any of the criteria (1) through (5) below: (1) Individuals who assault employees or members of the employees' immediate families; (2) individuals who attempt to intimidate or threaten employees or members of the employees' immediate families through specific threats of bodily harm, a show of weapons, the use of animals, or through other specific threatening or intimidating behavior; (3) individuals who are active members of groups that advocate violence against IRS employees specifically, or against Federal employees generally where advocating such violence could reasonably be understood to threaten the safety of IRS employees and impede the performance of their official duties; (4) individuals who have committed the acts set forth in any of the above criteria, but whose acts have been directed against employees or contractors of other governmental agencies at Federal, state, county, or local levels; and (5) individuals who are not designated as potentially dangerous taxpayers through application of the above criteria, but who have demonstrated a clear propensity toward violence through act(s) of violent behavior within the five-year period immediately preceding the time of referral of the individual to the Employee Protection System (EPS). An individual is designated as a taxpayer who should be approached with caution (CAU), based on reliable information furnished to the IRS or the TIGTA, individuals who have threatened physical harm that is less severe or immediate than necessary to satisfy PDT criteria, suicide threat by the taxpayer, or individuals who have filed or threatened to file a frivolous civil or criminal legal action (including liens, civil complaints in a court, criminal charges) against any IRS employee or contractor, or their immediate families.
Documents reporting the incident; documentary evidence of the incident (
5 U.S.C. 301 and 26 U.S.C. 7801.
To maintain reports by IRS employees or contractors of attempts by individuals to obstruct or impede them or other law enforcement personnel in the performance of their official duties, investigations into the matters reported, and determinations whether the taxpayers should be designated a PDT or CAU.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding and the IRS or DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a Federal, state, local, or tribal agency, or other public authority, which has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(4) Disclose information to an appropriate Federal, state, local, tribal, or foreign agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of, a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(6) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(7) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems
Paper records and electronic media.
By name or Social Security Number (SSN) of individual with respect to whom the PDT or CAU designation is being considered and by administrative case control number.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Chief, Office of Employee Protection. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(2).
This system may not be accessed to inspect or contest the content of records. The records are exempt under 5 U.S.C. 552a(k)(2) from the access provisions of the Privacy Act.
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records. Other records are exempt from contest as stated in “Record Access Procedures” above.
SOURCE CATEGORIES:
The system contains material for which sources need not be reported.
This system is exempt from 5 U.S.C. 552a(c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I) and (f) of the Privacy Act pursuant to 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36.).
Individual Income Tax Returns, Statistics of Income—Treasury/IRS.
National Office and campus offices. (See the IRS Appendix below for address.)
Individual taxpayers whose data is selected for compilation into a statistical sample.
Sources of income, exemptions, deductions, income tax, and tax credits, as reported on Form 1040 series of U.S. Individual income tax return. The records are used to prepare and publish statistics. The statistics, studies, and compilations are designed so as to prevent disclosure of any particular taxpayer's identity.
5 U.S.C. 301, 26 U.S.C. 6108 and 7801.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103 and 6108. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which IRS collected the records, and no privilege is asserted.
To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with IRS efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By taxpayer identification number (TIN) (
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are maintained in accordance with IRM 1.15, Records Management (also see Documents 12829 and 12990).
Director, Research Analysis, and Statistics. (See the IRS Appendix below for address.)
This system may not be accessed for purposes of determining whether the system contains a record pertaining to a particular individual; the records are exempt under 5 U.S.C. 552a(k)(4).
This system may not be accessed for purposes of inspection or in order to contest the content of records; the records are exempt under 5 U.S.C. 552a(k)(4).
26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Form 1040 series of U.S. Individual Income Tax Returns.
This system has been designated exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(4). See 31 CFR. 1.36.
Chief Counsel Management Information System Records —Treasury/IRS.
Office of the Chief Counsel; Office of the Special Counsel to the National Taxpayer Advocate; Offices of the Associate Chief Counsel (Corporate),
(1) Individuals who are the subjects of, or are connected to, matters received by or assigned to the Office of Chief Counsel.
(2) Chief Counsel employees.
Records that contain summary information concerning the description and status of assignments received in the Office of Chief Counsel. These records include the names or subjects of a case, the case file number, case status, issues, professional time expended, and due dates. These records may be used to produce management information on case inventory by taxpayer or employee name and professional time required to complete an assignment.
5 U.S.C. 301; 26 U.S.C. 7801 and 7803; 31 U.S.C. 330.
The computerized Counsel Automated System Environment (CASE) system is used to track, count, and measure the workload of the Office of Chief Counsel, capturing summary information (such as the name of principal parties or subjects, case file numbers, assignments, status, and classification) of cases and other matters assigned to Counsel personnel throughout their life cycle. CASE is used to generate reports to assist management and other employees to keep track of resources and professional time devoted to individual assignments and broad categories of workload. CASE information is also useful in the preparation of budget requests and other reports to the IRS, to the Treasury Department, or the Congress. CASE also serves as a timekeeping function for employees of the Office of Chief Counsel directly involved in cases and other matters.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which the IRS collected the records and no privilege is asserted. Accordingly, the IRS may:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to the parties and to an arbitrator, mediator, or other neutral party, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges.
(4) Disclose information to a former employee of the IRS to the extent necessary to refresh their recollection for official purposes when the IRS requires information and/or consultation assistance from the former employee regarding a matter within that individual's former area of responsibility.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(7) Disclose information to a Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(8) Disclose information to a Federal, state, local, or tribal agency, or other public authority that has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(9) To the extent consistent with the American Bar Association's Model Rules of Professional Conduct, Rule 4.2, disclose to any person the fact that his chosen legal representative may not be authorized to represent him before the IRS.
(10) Disclose information to a public, quasi-public, or private professional authority, agency, organization, or association, with which individuals covered by this system of records may be licensed by, subject to the jurisdiction of, a member of, or affiliated with, including but not limited to state bars and certified accountancy boards, to assist such authorities, agencies, organizations and associations in meeting their responsibilities in connection with the administration and maintenance of standards of integrity, conduct, and discipline.
(11) Disclose information to foreign governments in accordance with international agreements.
(12) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(13) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems
Paper records and electronic media.
Records are retrieved by the name or Taxpayer Identification Number of the individual to whom they apply, employees assigned, and by workload case number. If there are multiple parties to a proceeding, then the record is generally retrieved only by the name of the first listed person in the complaint or other document.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained and disposed of in accordance with the records control schedules applicable to the records of the Office of Chief Counsel, Document 12990, Record Control Schedules 12 through 15 (formerly IRM 1.15.13 through 1.15.15).
Associate Chief Counsel (Finance & Management). See the IRS Appendix below for the address.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, appendix B. Written inquiries should be addressed to Chief, Disclosure and Litigation Support Branch, Legal Processing Division, IRS Office of Chief Counsel, CC:PA:LPD:DLS, 1111 Constitution Avenue NW., Washington, DC 20224. This system of records may contain records that are exempt from the notification, access, and contest requirements pursuant to 5 U.S.C. 552a(j)(2) and (k)(2). The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
See “Notification Procedure” above.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
IRS and Chief Counsel employees; Department of Treasury employees; court records.
Some of the records in this system are exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2) and 552a(k)(2). See 31 CFR 1.36.
Chief Counsel Litigation and Advice (Civil) Records—Treasury/IRS.
Office of the Chief Counsel; Offices of the Associate Chief Counsel (Corporate), (Financial Institutions & Products), (General Legal Services), (Income Tax & Accounting), (International), (Passthroughs & Special Industries), and (Procedure & Administration); Office of the Division Counsel/Associate Chief Counsel (Tax Exempt & Government Entities); Offices of the Division Counsel (Large Business & International), (Small Business/Self Employed) and (Wage & Investment); Office of the Special Counsel to the National Taxpayer Advocate; Office of the Special Counsel to the Office of Professional Responsibility; and Area Counsel offices. (See the IRS Appendix below for address.)
(1) Individuals who have requested advice in the form of a letter ruling, closing agreement, or information letter as set forth under the first annual revenue procedure published by the IRS each year.
(2) Individuals who are the subject of technical advice that responds to any request on the interpretation and proper application of tax laws, tax treaties, regulations, revenue rulings, notices, or other precedents to a specific set of facts that concerns the treatment of an item in a year under examination or appeal, which is submitted under the second annual revenue procedure published by the IRS each year.
(3) Individuals about whom advice has been requested or provided under any other internal rules and procedures, such as may be set forth in the Internal Revenue Manual (IRM) or Chief Counsel Notices.
(4) Individuals who are subjects of, or provide information pertinent to, matters under the jurisdiction of the Office of Professional Responsibility, when such matters are brought to the attention of Counsel;
(5) Individuals who are parties to litigation with the IRS, or in litigation in which the IRS has an interest, or in proceedings before an administrative law judge.
(6) Individuals who have corresponded with, or who are the subjects of correspondence to, the IRS regarding a matter under consideration by these offices.
(1) Advice files;
(2) Litigation files;
(3) Correspondence files;
(4) Reference copies of selected work products.
5 U.S.C. 301; 26 U.S.C. 7801 and 7803; 31 U.S.C. 330 and 5314.
To represent the IRS' interests in litigation before the United States Tax Court and in proceedings before administrative law judges; to assist the Department of Justice in representing the IRS' interests in litigation before other Federal and state courts; to provide legal advice and assistance on civil tax administration matters, including matters pertaining to practice before the IRS and the regulation of tax return preparers; to respond to general inquiries and other correspondence related to these matters; to assist Counsel staff in coordinating and preparing future litigation, advice, or correspondence, to ensure the consistency of such work products and to retain copies of work products for historical, legal research, investigational, and similar purposes.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems the purpose of the disclosure is compatible with the purpose for which the IRS collected the records, and no privilege is asserted. Accordingly, the IRS may:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to the parties and to an arbitrator, mediator, or other neutral, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges.
(4) Disclose information to a former employee of the IRS to the extent necessary to refresh their recollection for official purposes when the IRS requires information and/or consultation assistance from the former employee regarding a matter within that individual's former area of responsibility.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(7) Disclose information to a Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(8) Disclose information to a Federal, state, local, or tribal agency, or other public authority that has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(9) To the extent consistent with the American Bar Association's Model Rules of Professional Conduct, Rule 4.2, and Circular 230, disclose to any person the fact that his chosen legal representative may not be authorized to represent him before the IRS.
(10) Disclose information to a public, quasi-public, or private professional authority, agency, organization, or association, with which individuals covered by this system of records may be licensed by, subject to the jurisdiction of, a member of, or affiliated with, including but not limited to state bars and certified accountancy boards, to assist such authorities, agencies, organizations and associations in meeting their responsibilities in connection with the administration and maintenance of standards of integrity, conduct, and discipline.
(11) Disclose information to foreign governments in accordance with international agreements.
(12) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(13) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(14) Disclose information to other Federal agencies holding funds of an individual for the purpose of collecting a liability owed by the individual.
(15) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the IRS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Records of the Office of the Associate Chief Counsel (General Legal Services), including the various Area Counsel (General Legal Services), may also be used as described below if the IRS deems the purpose of the disclosure is compatible with the purpose for which the IRS collected the records, and no privilege is asserted.
(16) Disclose information to the Joint Board of Actuaries in enrollment and disciplinary matters.
(17) Disclose information to the Office of Personnel Management, Merit Systems Protection Board, the Office of Special Counsel, and the Equal Employment Opportunity Commission in personnel, discrimination, and labor management matters.
(18) Disclose information to arbitrators, the Federal Labor Relations Authority, including the Office of the General Counsel of that authority, the Federal Service Impasses Board, and the Federal Mediation and Conciliation Service in labor management matters.
(19) Disclose information to the General Services Administration in property management matters.
(20) Disclose information regarding financial disclosure statements to the IRS, which makes the statements available to the public as required by law.
(21) Disclose information to other federal agencies for the purpose of effectuating inter-agency salary offset or inter-agency administrative offset.
(22) Disclose information to the Office of Government Ethics in conflict of interest, conduct, financial statement reporting, and other ethics matters.
Disclosures of debt information concerning a claim against an individual may be made from this system to consumer reporting agencies as defined in the Fair Credit Reporting Act, 15 U.S.C. 1681a(f) or the Federal Claims Collection Act of 1966, 31 U.S.C. 3701(a)(3).
Paper records and electronic media.
By the (1) name(s) of the individual(s) to whom the records pertain, and related individuals; (2) subject matter; (3) certain key administrative dates; and (4) the internal control number for correspondence. If there are multiple parties to litigation, or other proceeding, then the record is generally retrieved
A background investigation is made on personnel. Offices are located in secured areas. Access to keys to these offices is restricted. Access to records storage facilities is limited to authorized personnel or individuals in the company of authorized personnel. Access controls are not less than those provided by the Physical Security Standards, IRM 1.16, and Information Technology (IT) Security Policy and Standards, IRM 10.8.
Records are retained and disposed of in accordance with the records control schedules applicable to the records of the Office of Chief Counsel, Document 12990, Record Control Schedules 12 through 15, and 30 (formerly IRM 1.15.13 through 1.15.15, and 1.15.30).
The Chief Counsel, Special Counsel to the National Taxpayer Advocate, Special Counsel to the Office of Professional Responsibility, each Associate Chief Counsel, and each Division Counsel is the system manager of the system in that office. See the IRS Appendix below for addresses.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, appendix B. Written inquiries should be addressed to Chief, Disclosure and Litigation Support Branch, Legal Processing Division, IRS Office of Chief Counsel, CC:PA:LPD:DLS, 1111 Constitution Avenue NW., Washington, DC 20224. This system of records may contain records that are exempt from the notification, access, and contest requirements pursuant to 5 U.S.C. 552a(k)(2). The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
See “Notification Procedure” above.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Taxpayers and their representatives; Department of the Treasury personnel; other Federal agencies; state, local, tribal, and foreign governments, and other public authorities; witnesses; informants; parties to disputed matters of fact or law; judicial and administrative proceedings; congressional offices; labor organizations; public records such as telephone books, Internet Web sites, court documents, and real estate records; individual subjects of legal advice, written determinations, and other correspondence.
Some of the records in this system are exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(2). See 31 CFR 1.36.
Chief Counsel Litigation and Advice (Criminal) Records—Treasury/IRS.
Office of the Chief Counsel; Office of the Division Counsel/Associate Chief Counsel (Criminal Tax); and Area Counsel (Criminal Tax) offices. (See the IRS Appendix below for address.)
(1) Individual subjects of investigations as to their compliance with tax and other laws under the jurisdiction of IRS Criminal Investigation, with respect to whom criminal recommendations have been made.
(2) Individuals who have requested advice, and about whom advice has been requested, concerning tax-related and criminal offenses under the jurisdiction of IRS Criminal Investigation, where these matters or issues are brought to Counsel's attention.
(3) Individuals who have filed petitions for the remission or mitigation of forfeitures or who are otherwise directly involved as parties in judicial or administrative forfeiture matters.
(4) Individuals who have requested advice, about whom advice has been requested, or with respect to whom a criminal recommendation has been made concerning non-tax criminal matters delegated to the IRS for enforcement and investigation, such as money laundering (18 U.S.C. 1956 and 1957) and the Bank Secrecy Act (31 U.S.C. 5311–5330).
(5) Individuals about whom advice has been requested or provided under any internal rules and procedures, as may be set forth in the Internal Revenue Manual (IRM), Chief Counsel Notices, or other internal issuances.
(6) Individuals who are parties to litigation with the IRS, or in litigation in which the IRS has an interest.
(7) Individuals who have corresponded with the IRS regarding a matter under consideration by these offices.
(1) Advice files;
(2) Litigation files;
(3) Correspondence files;
(4) Reference copies of selected work products.
5 U.S.C. 301; 26 U.S.C. 7801 and 7803; 31 U.S.C. 330 and 5311–5332.
To provide legal advice and assistance on criminal tax administration matters, and on nontax criminal matters delegated to the IRS; to assist the Department of Justice (DOJ) in representing the IRS' interests in litigation before Federal and state courts; to respond to general inquiries and other correspondence related to these matters; to assist Counsel staff in coordinating and preparing future litigation, advice, or correspondence to ensure the consistency of such work products and to retain copies of work products for historical, legal research, investigational, and similar purposes.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems the purpose of the disclosure is compatible with the purpose for which the IRS collected the records, and no privilege is asserted. Accordingly, the IRS may:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other
(3) Disclose information to the parties and to an arbitrator, mediator, or other neutral, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges.
(4) Disclose information to a former employee of the IRS to the extent necessary to refresh their recollection for official purposes when the IRS requires information and/or consultation assistance from the former employee regarding a matter within that individual's former area of responsibility.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(7) Disclose information to a Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(8) Disclose information to a Federal, state, local, or tribal agency, or other public authority that has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(9) To the extent consistent with the American Bar Association's Model Rules of Professional Conduct, Rule 4.2, disclose to any person the fact that his chosen legal representative may not be authorized to represent him before the IRS.
(10) Disclose information to a public, quasi-public, or private professional authority, agency, organization, or association, with which individuals covered by this system of records may be licensed by, subject to the jurisdiction of, a member of, or affiliated with, including but not limited to state bars and certified accountancy boards, to assist such authorities, agencies, organizations and associations in meeting their responsibilities in connection with the administration and maintenance of standards of integrity, conduct, and discipline.
(11) Disclose information to foreign governments in accordance with international agreements.
(12) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(13) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(14) Disclose information to other Federal agencies holding funds of an individual for the purpose of collecting a liability owed by the individual.
(15) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the IRS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
By the (1) name(s) of the individual(s) to whom the records pertain, and related individuals; (2) subject matter; (3) certain key administrative dates; and (4) the internal control number for correspondence. If there are multiple parties to a proceeding, then the record is generally retrieved only by the name of the first listed person in the complaint or other document.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained and disposed of in accordance with the records control schedules applicable to the records of the Office of Chief Counsel, Document 12990, Record Control Schedules 13 through 15, and 30 (formerly IRM 1.15.13 through 1.15.15, and 1.15.30).
The Division Counsel/Associate Chief Counsel (Criminal Tax) is the system manager. See the IRS Appendix, below for addresses.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, appendix B. Written inquiries should be addressed to Chief, Disclosure and Litigation Support Branch, Legal Processing Division, IRS Office of Chief Counsel, CC:PA:LPD:DLS, 1111 Constitution Avenue NW., Washington, DC 20224. This system of records may contain records that are exempt from the notification, access, and contest requirements pursuant to 5 U.S.C. 552a(j)(2). The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
See “Notification Procedure” above.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Taxpayers, or other subjects of investigation, and their representatives; Department of the Treasury personnel; other Federal agencies; state, local, tribal, and foreign governments, and other public authorities; witnesses; informants; parties to disputed matters of fact or law; judicial and administrative proceedings; congressional offices; labor organizations; public records such as telephone books, Internet Web sites, court documents, and real estate records; individual subjects of legal
Some of the records in this system are exempt from sections (c)(3)–(4); (d)(1)–(4); (e)(1)–(3); (e)(4)(G)–(I); (e)(5); (e)(8); (f) and (g) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2). (See 31 CFR 1.36).
Chief Counsel Legal Processing Division Records—Treasury/IRS.
Office of the Associate Chief Counsel (Procedure & Administration), National Office. (See the IRS Appendix below for address.)
Individuals who communicate with the IRS regarding access requests under the Freedom of Information Act (FOIA), Privacy Act of 1974, or 26 U.S.C. 6110, where these matters or issues are brought to Counsel's attention; payers of user fees under 26 U.S.C. 7528, 6103(p), and 31 U.S.C. 9701; recipients of payments of court judgments; individual taxpayers who are the subject of written determinations or other work products processed for public inspection under the FOIA or 26 U.S.C. 6110.
(1) Correspondence files.
(2) FOIA, Privacy Act, and 26 U.S.C. 6110 requests for Chief Counsel National Office records.
(3) Privacy Act requests to amend Chief Counsel National Office records.
(4) User fee files.
5 U.S.C. 301; 552, and 552a; 26 U.S.C. 7801 and 7803.
To coordinate searches and to make disclosure determinations with respect to Chief Counsel National Office records sought under FOIA, the Privacy Act, and 26 U.S.C. 6110. To respond to Privacy Act requests to amend Chief Counsel National Office records. To process user fees pertaining to Private Letter Rulings, Change in Accounting Methods (Form 3115), Change in Accounting Periods (Form 1128), Advance Pricing Agreements, and Closing Agreements. To process files for the payment of court judgments.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which the IRS collected the records, and no privilege is asserted. Accordingly, the IRS may:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to the parties and to an arbitrator, mediator, or other neutral, in the context of alternative dispute resolution, to the extent relevant and necessary for resolution of the matters presented, including asserted privileges.
(4) Disclose information to a former employee of the IRS to the extent necessary to refresh their recollection for official purposes when the IRS requires information and/or consultation assistance from the former employee regarding a matter within that individual's former area of responsibility.
(5) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(6) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(7) Disclose information to an appropriate Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(8) Disclose information to a Federal, state, local, or tribal agency, or other public authority that has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(9) To the extent consistent with the American Bar Association's Model Rules of Professional Conduct, Rule 4.2, disclose to any person the fact that his chosen legal representative may not be authorized to represent him before the IRS.
(10) Disclose information to a public, quasi-public, or private professional authority, agency, organization, or association, with which individuals covered by this system of records may be licensed by, subject to the jurisdiction of, a member of, or affiliated with, including but not limited to state bars and certified accountancy boards, to assist such authorities, agencies, organizations and associations in meeting their responsibilities in connection with the administration and maintenance of standards of integrity, conduct, and discipline.
(11) Disclose information to foreign governments in accordance with international agreements.
(12) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(13) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(14) Disclose information to other Federal agencies holding funds of an individual for the purpose of collecting a liability owed by the individual.
(15) Disclose information to appropriate agencies, entities, and
Paper records and electronic media.
By the (1) name(s) of the individual(s) to whom the records pertain, and related individuals; (2) subject matter; (3) certain key administrative dates; and (4) the internal control number for correspondence. If there are multiple parties to a proceeding, then the record is generally retrieved only by the name of the first listed person in the complaint or other document.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained and disposed of in accordance with the records control schedules applicable to the records of the Office of Chief Counsel, Document 12990, Record Control Schedules 13 through 15 (formerly IRM 1.15.13 through 1.15.15). Freedom of Information Act request files are retained and disposed of in accordance with Schedule 13.
Associate Chief Counsel (Procedure & Administration), National Office. See the IRS Appendix below for the address.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, appendix B. Written inquiries should be addressed to Chief, Disclosure and Litigation Support Branch, Legal Processing Division, IRS Office of Chief Counsel, CC:PA:LPD:DLS, 1111 Constitution Avenue NW., Washington, DC 20224. This system of records may contain records that are exempt from the notification, access, and contest requirements pursuant to 5 U.S.C. 552a(j)(2) and (k)(2). The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
See “Notification Procedure” above.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Persons who communicate with the IRS regarding FOIA, Privacy Act, and 26 U.S.C. 6110 requests, user fees or judgment payments; Department of Treasury employees; state, local, tribal, and foreign governments, and other public authorities; other Federal agencies; witnesses; informants; public sources such as telephone books, Internet Web sites, court documents, and real estate records.
User fee and judgment payment files can be accessed as described above. All other records in this system have been designated as exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2) and 5 U.S.C. 552a(k)(2). (See 31 CFR 1.36).
Chief Counsel Library Records
Office of the Associate Chief Counsel (Finance & Management), National Office. (See the IRS Appendix below for address.)
(1) IRS employees who check out materials from the Library or through inter-library loans.
(2) Individuals who are the subject of the work products maintained for reference (legal research) purposes on tax issues.
(1) Reference work product, including General Counsel Memoranda (GCMs), Office Memoranda (OMs), Actions on Decision (AODs), briefs, and other historical issuances dating back to 1916.
(2) Internal control records used to catalog and cross-reference records for legal research purposes.
5 U.S.C. 301; 26 U.S.C. 7801 and 7803; and 31 U.S.C. 330.
To track the location of materials borrowed from the library or through inter-library loan and to permit the research of the internal revenue laws.
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. Material covered by rule 6(e) of the Federal Rules of Criminal Procedure may be disclosed only as permitted by that rule. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which the IRS collected the records, anxd no privilege is asserted. Accordingly, the IRS may:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are relevant and useful.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof, (b) any IRS employee in his or her official capacity, (c) any IRS employee in his or her personal capacity where the IRS or the Department of Justice (DOJ) has agreed to provide representation for the employee, or (d) the United States is a party to, has an interest in, or is likely to be affected by such proceeding, and the IRS or the DOJ determines that the information is relevant and necessary and not otherwise privileged. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(4) Disclose information to a Federal, state, local, or tribal agency, or other public authority, responsible for implementing or enforcing, or for investigating or prosecuting the violation of a statute, rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(5) Disclose information to a Federal, state, local, or tribal agency, or other public authority that has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(6) Disclose information to foreign governments in accordance with international agreements.
(7) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(8) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their duties of exclusive representation.
(9) To appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the IRS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
Paper records and electronic media.
Records are retrieved by the name of the individual(s) to whom they pertain. If there are multiple parties to a proceeding, then the record is generally retrieved only by the identity of the first listed person in the complaint or other document.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained and disposed of in accordance with the records control schedules applicable to the records of the Office of Chief Counsel, Document 12990, Record Control Schedules 13 through 15 (formerly IRM 1.15.13 through 1.15.15).
Associate Chief Counsel (Finance & Management), National Office. See the IRS Appendix below for the address.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, appendix B. Written inquiries should be addressed to Chief, Disclosure and Litigation Support Branch, Legal Processing Division, IRS Office of Chief Counsel, CC:PA:LPD:DLS, 1111 Constitution Avenue NW., Washington, DC 20224. This system of records may contain records that are exempt from the notification, access, and contest requirements pursuant to 5 U.S.C. 552a(j)(2) or (k)(2). The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
See “Notification Procedure” above.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
IRS employees; Congress; Department of the Treasury personnel; taxpayers and their representatives; other Federal agencies; witnesses; informants; state, local, tribal, and foreign governments, and other public authorities; parties to disputed matters of fact and law; other persons who communicate with the IRS; libraries to and from which inter-library loans are made; public sources such as telephone books, Internet Web sites, court documents, and real estate records.
Some of the records in this system are exempt from sections (c)(3)–(4); (d)(1)–(4); (e)(1)–(3); (e)(4)(G)–(I); (e)(5); (e)(8); (f) and (g) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2). Some of the records in this system are exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(j)(2) and 5 U.S.C. 552a(k)(2). See 31 CFR 1.36.
Chief Counsel Human Resources and Administrative Records—Treasury/IRS.
All Chief Counsel offices. (See the IRS Appendix below for address.)
(1) Current and former employees of the Office of Chief Counsel;
(2) Applicants for employment in the Office of Chief Counsel;
(3) Tax Court witnesses whose expenses are paid by the IRS.
(1) Records relating to personnel actions and determinations made about an individual while employed with the Office of Chief Counsel. These records include the records maintained in current and former employees' Official Personnel Folders and Employee Performance Folders, in accordance with Office of Personnel Management (OPM)'s regulations and instructions, which are described in the notices of OPM's government-wide systems of records, OPM/GOVT–1 and OPM/GOVT–2, respectively. The records reflect employment qualifications; employment history (including performance improvement plan or discipline records); training and awards; reasonable accommodation and similar records potentially containing medical information; and other recognition. These records include data documenting reasons for personnel actions, decisions, or recommendations and background material leading to any personnel action (including adverse action).
(2) Records relating to payroll processing, such as employee name, date of birth, Social Security Number (SSN), home address, grade or rank, employing organization, timekeeper identity, salary, civil service retirement fund contributions, pay plan, number of hours worked, leave accrual rate, usage, and balances, deductions for Medicare and/or FICA, Federal, state and city tax withholdings, Federal Employees Governmental Life Insurance withholdings, Federal Employees Health Benefits withholdings, awards,
(3) Employee recruiting records for attorney and non-attorney Chief Counsel Employees (including application files, eligible applicant listings, and internal control records).
(4) Financial records such as travel expenses, notary public expenses, moving expenses, expenses of Tax Court witnesses, fees and expenses of expert witnesses, and miscellaneous expenses.
5 U.S.C. 301; 26 U.S.C. 7801 and 7803; and 31 U.S.C. 330.
To carry out personnel management responsibilities, including but not limited to: (1) Recommending or taking personnel actions such as appointments, promotions, separations (
Disclosure of returns and return information may be made only as provided by 26 U.S.C. 6103. All other records may be used as described below if the IRS deems that the purpose of the disclosure is compatible with the purpose for which the IRS collected the records, and no privilege is asserted. Accordingly, the IRS may:
(1) Disclose information to the Department of Justice (DOJ) when seeking legal advice, or for use in any proceeding, or in preparation for any proceeding, when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her individual capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by the proceeding, and the IRS determines that the records are both relevant and necessary to the proceeding or advice sought. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(2) Disclose information in a proceeding (including discovery) before a court, administrative tribunal, or other adjudicative body when: (a) The IRS or any component thereof; (b) any IRS employee in his or her official capacity; (c) any IRS employee in his or her personal capacity if the IRS or the DOJ has agreed to provide representation for the employee; or (d) the United States is a party to, has an interest in, or is likely to be affected by, the proceeding, and the IRS or the DOJ determines that the information is relevant and necessary to the proceeding. Information may be disclosed to the adjudicative body to resolve issues of relevancy, necessity, or privilege pertaining to the information.
(3) Disclose information to a court, authorized official acting pursuant to a court order or state or local law, a state agency, or the office of a bankruptcy trustee, for the purpose of implementing a garnishment or wage assignment order.
(4) Disclose information to all individuals, and/or a court, adjudicative body, or other administrative body, where multiple related individuals are represented before the Service by one attorney, and a potential or actual conflict of interest arises, and the attorney fails to provide adequate confirmation to the Service that full disclosure of the conflict of interest situation has been made to all taxpayers and that all agree to the representation.
(5) Disclose information to the defendant in a criminal prosecution, the Department of Justice, or a court of competent jurisdiction where required in criminal discovery or by the Due Process Clause of the Constitution.
(6) Disclose information to the parties and to arbitrators, the Federal Labor Relations Authority, including the Office of the General Counsel of that authority, the Federal Service Impasses Board and the Federal Mediation and Conciliation Service in labor management matters.
(7) Disclose the results of a drug test performed at the work site, as provided by section 503 of the Supplemental Appropriations Act of 1987, Pub. L. 100–71, (101 Stat. 391, 468–471).
(8) Disclose information to a former employee of the IRS to the extent necessary to refresh their recollection for official purposes when the IRS requires information and/or consultation assistance from the former employee regarding a matter within that individual's former area of responsibility.
(9) Disclose information to third parties during the course of an investigation to the extent necessary to obtain information pertinent to the investigation.
(10) Disclose information to a contractor hired by the IRS, including an expert witness or a consultant, to the extent necessary for the performance of a contract.
(11) Disclose pertinent information to a Federal, state, local, or tribal agency, or other public authority responsible for implementing, enforcing, investigating, or prosecuting the violation of a statute rule, regulation, order, or license, when a record on its face, or in conjunction with other records, indicates a potential violation of law or regulation and the information disclosed is relevant to any regulatory, enforcement, investigative, or prosecutorial responsibility of the receiving authority.
(12) Disclose information to a Federal, state, local, or tribal agency, or other public authority that has requested information relevant or necessary to hiring or retaining an employee, or issuing or continuing a contract, security clearance, license, grant, or other benefit.
(13) To the extent consistent with the American Bar Association's Model Rules of Professional Conduct, Rule 4.2, disclose to any person the fact that his chosen legal representative may not be authorized to represent him before the IRS.
(14) Disclose information to a public, quasi-public, or private professional authority, agency, organization, or association, with which individuals covered by this system of records may be licensed by, subject to the jurisdiction of, a member of, or affiliated with, including but not limited to state bars and certified accountancy boards, to assist such authorities, agencies, organizations and associations in meeting their responsibilities in connection with the administration and maintenance of standards of integrity, conduct, and discipline.
(15) Disclose information to foreign governments in accordance with international agreements.
(16) Disclose information to officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and
(17) Disclose information to the news media as described in the IRS Policy Statement P–1–183, News Coverage to Advance Deterrent Value of Enforcement Activities Encouraged, IRM 1.2.1.2.41.
(18) Disclose information regarding financial disclosure statements to the IRS, which makes the statements available to the public as required by law.
(19) Disclose information to other Federal agencies holding funds of an individual for the purpose of collecting a liability owed by the individual.
(20) Disclose information to the Joint Board of Actuaries in enrollment and disciplinary matters.
(21) Disclose information to the Office of Personnel Management, Merit Systems Protection Board, the Office of Special Counsel, and the Equal Employment Opportunity Commission in personnel, discrimination, and labor management matters.
(22) Disclose information to the General Services Administration in property management matters.
(23) Disclose information to the Office of Government Ethics in conflict of interest, conduct, financial statement reporting, and other ethics matters.
(24) Disclose information to appropriate agencies, entities, and persons when: (a) The IRS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the IRS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the IRS or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the IRS' efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
(25) Disclose information to the General Services Administration Board of Contract Appeals, the Government Accountability Office, and other Federal agencies that address contracting issues in connection with disputes and protests of procurement actions and decisions.
Disclosures of debt information concerning a claim against an individual may be made from this system to consumer reporting agencies as defined in the Fair Credit Reporting Act, 15 U.S.C. 1681a(f) or the Federal Claims Collection Act of 1966, 31 U.S.C. 3701(a)(3).
Paper records and electronic media.
Records are generally retrieved by the name or taxpayer identity number of the individual to whom they apply. Records pertaining to expert witnesses may also be retrieved by the name of a party to the proceeding for which the expert was retained.
Access controls are not less than those published in IRM 10.8, Information Technology (IT) Security, and IRM 10.2, Physical Security Program.
Records are retained and disposed of in accordance with the records control schedules applicable to the records of the Office of Chief Counsel, Document 12990, Record Control Schedules 13 through 15 (formerly IRM 1.15.13 through 1.15.15), and to personnel records, Document 12829, Record Control Schedules 38 and 39 (formerly IRM 1.15.38 and 1.15.39).
The Division Counsel/Associate Chief Counsel is the system manager of records in their respective offices. See the IRS Appendix below for addresses.
Individuals seeking notification and access to any record contained in this system of records, or seeking to contest its content, may inquire in writing in accordance with instructions appearing at 31 CFR part 1, appendix B. Inquiries should be addressed as in “Record Access Procedures” below. This system of records may contain records that are exempt from the notification, access, and contest requirements pursuant to 5 U.S.C. 552a(k)(2). The IRS may assert 5 U.S.C. 552a(d)(5) as appropriate.
Individuals seeking access to any record contained in this system of records, or seeking to contest its content, may inquire in accordance with instructions appearing at 31 CFR part 1, subpart C, appendix B. Inquiries should be addressed to the Disclosure Office for Privacy Act requests listed in the IRS Appendix below.
See “Notification Procedure” above. 26 U.S.C. 7852(e) prohibits Privacy Act amendment of tax records.
Department of the Treasury personnel; Tax Court and expert witnesses; other Federal agencies; witnesses; state, local, tribal, and foreign governments, and other public authorities; references provided by the applicant, employee, or expert witness; former employers; public records such as telephone books, Internet Web sites, court documents, and real estate records.
Some of the records in this system are as exempt from sections (c)(3), (d)(1)–(4), (e)(1), (e)(4)(G)–(I), and (f) of the Privacy Act, pursuant to 5 U.S.C. 552a(k)(5). See 31 CFR 1.36.
This appendix contains the addresses of Treasury/IRS system locations along with the title of the principal system manager(s). Internal Revenue Service (IRS) system locations are geographically dispersed through field offices. Additional information regarding the structure and locations of the IRS is available on the Internet at
Access and amendment requests for records maintained in IRS systems should be marked “Privacy Act Request” on the outside and mailed to the following address: Internal Revenue Service, Disclosure Scanning Operation—Stop 93A, Post Office Box 621506, Atlanta, GA 30362–3006.
The National Office of the IRS and the address for the following systems managers is: 1111 Constitution Avenue NW., Washington, DC. The listing below is arranged according to organizational lines. Any exception to the location of an office is indicated accordingly.
The National Offices of the Chief Counsel for the Internal Revenue Service are located at: 1111 Constitution Avenue NW., Washington, DC. Offices at this address include:
Various components of Chief Counsel may have offices at the same Area Counsel office location. The abbreviations following each address indicate the Chief Counsel divisions having offices at that location. The abbreviations represent the following offices:
Environmental Protection Agency (EPA).
Proposed rule.
This action proposes technical and editorial corrections and revisions to regulations related to source testing of emissions. This proposed rule will make corrections and updates to testing provisions that contain inaccuracies and outdated procedures, and provide alternatives to existing testing regulations. These revisions will improve the quality of data and provide testers flexibility to use recently-approved alternative procedures. Many of these changes were suggested by testers and other end-users, and they will not impose new substantive requirements on source owners or operators.
Comments must be received on or before November 9, 2015.
Submit your comments, identified by Docket ID No. EPA–HQ–OAR–2014–0292, by one of the following methods:
•
•
•
•
•
Ms. Lula H. Melton, Office of Air Quality Planning and Standards, Air Quality Assessment Division (E143–02), Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541–2910; fax number: (919) 541–0516; email address:
The supplementary information in this preamble is organized as follows:
The proposed amendments apply to industries that are already subject to the current provisions of parts 51, 60, 61, and 63. For example, Performance Specification 4A applies to municipal waste combustors and hazardous waste incinerators. We did not list all of the specific affected industries or their North American Industry Classification System (NAICS) codes herein since there are many affected sources. If you have any questions regarding the applicability of this action to a particular entity, consult either the air permitting authority for the entity or your EPA regional representative as listed in 40 CFR 63.13.
1.
2.
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
In addition to being available in the docket, an electronic copy of this proposed rule will also be available on the Worldwide Web (WWW) through the Technology Transfer Network (TTN). Following signature, a copy of this proposed rule will be posted at the following address:
The EPA has been cataloging errors and corrections, as well as revisions that are needed to test methods, performance specifications, and associated regulations in 40 CFR parts 51, 60, 61, and 63. The most recent final rule that updated and revised methods was published on February 27, 2014 (79 FR 11228). Many of the corrections and revisions herein have been brought to our attention by affected parties and end-users. The corrections and revisions consist primarily of typographical errors, technical errors in equations and diagrams, updates to procedures, and the addition of alternative equipment and methods the Agency has found acceptable to use.
In paragraph (4)(a) of appendix M to part 51, we propose to add Methods 30A and 30B to the list of methods not requiring the use of audit samples. Consistent with the criteria used in establishing the original list of methods for which no audit samples are required (75 FR 55636), Method 30A is an instrumental test method that already has sufficient calibration and quality assurance requirements. Method 30B has sufficient performance-based quality assurance measures including analysis of an independent calibration standard with each set of field samples.
In Method 201A, the constant in equation 9, which is shown as 0.07657, will be corrected to 0.007657.
In Method 202, we propose to add section 3.8 to incorporate ASTM E617–13 by reference. The first sentence in paragraph 8.5.4.3 will be revised by adding “back half of the filterable PM filter holder.” Section 9.10 erroneously states “You must purge the assembled train as described in sections 8.5.3.2 and 8.5.3.3.” The statement will be corrected to reference section 8.5.3. Sections 10.3 and 10.4 will be added to require calibration of the balance used to weigh impingers and to require a multipoint calibration of the analytical balance. During the most recent revision of Method 202, sections 11.2.2.1, 11.2.2.2, 11.2.2.3, 11.2.2.4 and figure 7 were inadvertently deleted and will be re-inserted into the method.
In appendix P to part 51, section 3.3 erroneously refers to section 2.1 of Performance Specification 2 of appendix B of part 60. The citation will be corrected to section 6.1. Section 5.1.3 erroneously refers to paragraph 4.1.4, which does not exist; the text will be changed to reflect the correct references to paragraphs 3.1.4 and 3.1.5.
In the General Provisions of part 60, § 60.8(f) will be revised to require the reporting of specific emissions test data in test reports. These data elements will be required regardless of whether the report is submitted electronically or in paper format. We are proposing these modifications to ensure that emissions test reporting includes all data necessary to assess and assure the quality of the reported emissions data and appropriately describes and identifies the specific unit covered by the emissions test report. Section 60.17(g) will be revised to add ASTM D6911–15 to the list of incorporations by reference and to re-number the remaining consensus standards that are incorporated by reference in alpha-numeric order.
In Table 2 of subpart JJJJ, Methods 18 and 320 and ASTM D 6348–03 will be deleted as test method options for measuring VOC, and only Method 25A will be allowed.
In Method 1, section 11.2.1.2, the word “istances” will be changed to “distances” in the second sentence. In addition, there are two figures labeled Figure 1–2. The second figure will be deleted.
In Method 2, instructions are given for conducting S-type pitot calibrations. Currently, the same equipment is commonly used for both Methods 2 and 2G (same S-type pitot), but the calibration procedure is slightly different in each method. Other key pieces that enhance the quality assurance/quality control (QA/QC) of the calibrations will be added to Method 2, and the amount of blockage allowed will be reduced to tighten up calibration accuracy. To address these issues, changes will be made to sections 6.7, 10.1.2.3, 10.1.3.4, 10.1.3.7, and 10.1.4.1.3 of Method 2. Section 10.1.4.3 inadvertently references section 10.1.4.4. The reference will be corrected to section 12.4.4. The side of Figure 2–10 labeled (b) will be deleted, and the label (a) will be removed from the figure.
In Method 2G, instructions are given for conducting S-type pitot calibrations. Currently the same equipment is commonly used for both Methods 2 and 2G (same S-type pitot), but the calibration procedure is slightly different in each method. Other key pieces that enhance the QA/QC of the calibrations will be added to the method, and the amount of blockage allowed will be reduced to tighten up calibration accuracy. Changes will be made to sections 6.11.1, 6.11.2, 10.6.6, and 10.6.8 of Method 2G to address these issues.
In Method 3C, section 6.3 will be revised to add subsections (6.3.1, 6.3.2, 6.3.3, 6.3.4, and 6.3.5) that clarify the requirements necessary to check analyzer linearity.
In Method 4, section 10.3 (Field Balance) will be added to require calibration of the balance used to weigh impingers. Section 12.2.5 will be added, which provides another option for calculating the approximate moisture content. Section 16.4 will be revised to clarify that a fuel sample must be taken and analyzed to develop F-factors required by the alternative. Also, in section 16.4, percent relative humidity is inadvertently defined as “calibrated hydrometer acceptable”; the word “hydrometer” will be replaced with “hygrometer.”
In Method 5, we erroneously finalized the reference to the Isostack metering system in 79 FR 11228. Therefore, we will remove this reference from section 6.1.1.9 and continue to issue broadly applicable test method determinations or letters of assessments regarding whether specific alternative metering equipment meets the specifications of the method as was our intent in the “Summary of Comments and Responses on Revisions to Test Methods and Testing Regulations” (EPA–HQ–OAR–2010–0114–0045). The phrase “after ensuring that all joints have been wiped clean of silicone grease” will be removed from section 8.7.6.2.5. Sections 10.7 and 10.8 will be added to require calibration of the balance used to weigh impingers and to require a multipoint calibration of the analytical balance.
In Method 5H, sections 10.4 and 10.5 will be added to require calibration of the balance used to weigh impingers and to require a multipoint calibration of the analytical balance.
In Method 5I, sections 10.1 and 10.2 will be added to require calibration of the balance used to weigh impingers and to require a multipoint calibration of the analytical balance.
In Method 6C, due to numerous comments and questions, the language detailing the methodology for performing interference checks in section 8.3 will be revised to clarify and streamline the procedure. We continue to believe that the interference test need only be repeated if major components are replaced with different model parts.
In Method 7E, section 8.1.2 will be revised to be consistent with the requirements in Performance Specification 2. In cases where the 3-point sampling is used, the three points along the measurement line exhibiting the highest average concentration during the stratification test will be 0.4, 1.2, and 2.0 meters instead of 0.4, 1.0, and 2.0 meters.
Also, in Method 7E, due to numerous comments and questions, the language in section 8.2.7 detailing the methodology for performing interference checks will be revised to clarify and streamline the procedure. We continue to believe that the interference test need only be repeated if major components are replaced with different model parts. Also, the word “equations” will be replaced with “equation” in the sentence in section 12.8 that reads “If desired, calculate the total NO
In Method 10, sections 6.2.5 and 8.4.2 will be revised, and section 6.2.6 will be added to clarify the types of sample tanks allowed for integrated sampling.
Methods 10A and 10B will be revised to allow the use of sample tanks as an alternative to flexible bags for sample collection.
In Method 15, section 8.3.2 will be revised to clarify the calibrations that represent partial calibration.
In Method 16C, equation 16–1C will be revised to replace C
In Method 18, section 8.2.1.5.2.3 will be removed because the requirement to analyze two field audit samples as described in section 9.2 has been moved to the General Provisions.
In Method 25C, section 9.1 incorrectly references section 8.4.1; this reference will be corrected to section 8.4.2. Section 11.2 will be deleted because the audit sample analysis is now covered under the General Provisions. The nomenclature will be revised in section 12.1, and equation 25C–2 will be revised in section 12.3. Sections 12.4, 12.5, 12.5.1, and 12.5.2 will be added to incorporate equations to correct sample concentrations for ambient air dilution.
In Method 26, section 13.3 will be revised to indicate the correct method detection limit.
In Method 26A, language will be added to section 4.3 indicating that dissociating chloride salts at elevated temperatures interfere with halogen acid measurement in this method, but maintaining particulate probe/filter temperatures at 120+/−14 °C (248+/−25 °F) minimizes this interference. Sections 6.1.7 and 8.1.5 will be revised to delete reference to other temperatures around the probe and filter holder during sampling as specified by the applicable subpart or approved by the Administrator for a particular application. Also, the error in “. . . between 120 and 134 °C (248 and 275 °F . . .”) will be corrected to “. . . between 120 and 134 °C (248 and 273 °F . . .”) in section 8.1.6.
In Method 29, section 8.2.9.3 will be revised to require rinsing impingers containing permanganate with hydrogen chloride (HCl) to ensure consistency with the application of Method 29 across various stationary source categories and since there is evidence that HCl is needed to release the mercury (Hg) bound in the precipitate from the permanganate. Sections 10.4 and 10.5 will be added to require calibration of the balance used to weigh impingers and to require a multipoint calibration of the analytical balance.
In Method 30A, the heading of section 8.1 will be changed from “Sample Point Selection.” to “Selection of Sampling Sites and Sampling Points.”
In Method 30B, the heading of section 8.1 will be changed from “Sample Point Selection.” to “Selection of Sampling Sites and Sampling Points.” In section 8.3.3.8, the reference to ASTM WK223 will be changed to ASTM D6911–15. ASTM WK223 was the draft standard that was available at the time that Method 30B was first promulgated; it has since been finalized to ASTM D6911–15.
In the index to appendix B to part 60, Performance Specification 16—Specifications and Test Procedures for Predictive Emission Monitoring Systems in Stationary Sources will be added.
In Performance Specification 1, paragraph 8.1(2)(i) will be revised to not limit the location of a continuous opacity monitoring system (COMS) to a point at least four duct diameters downstream and two duct diameters upstream from a control device or flow disturbance, but it will refer to paragraphs 8.1(2)(ii) and 8.1(2)(iii) for additional options.
In Performance Specification 2, the definition of span value will be revised in section 3.11. Also, in section 6.1.1, the data recorder language will be revised. In section 16.3.2, the characters “|dverbar” will be replaced with
In Performance Specification 3, we will revise section 13.2 to clarify how to calculate relative accuracy.
In Performance Specification 4A, we will revise the response time test procedure in sections 8.3 and 8.3.1. The language specifying that the response time is a check of the entire system was previously deleted. However, we have had several inquiries about this, and we believe that the entire system should be checked with the response time test procedure; therefore, we will put this requirement back into the performance specification. We will also revise section 13.3 because we have received information indicating that the response time of 1.5 minutes is too stringent; we will relax the response time requirement to 2.0 minutes.
In Performance Specification 11, equations 11–1 and 11–2 will be revised in section 12.1, and the response range will be used in lieu of the upscale value in section 13.1.
In Performance Specification 15, the statement “An audit sample is obtained from the Administrator” will be deleted from paragraph 9.1.2. Also, in Performance Specification 15, reserved sections 14.0 and 15.0 will be added.
In Performance Specification 16, we will change Table 16–1 to make be consistent with conventional statistical applications; the two columns currently labeled “n-1” will be re-labeled “n.” We will also revise section 12.2.3 for selection of n-1 degrees of freedom.
In Procedure 2, equations 2–2 and 2–3 in section 12.0 will be revised to correctly define the denominator when calculating calibration drift. Also, equation 2–4 in section 12.0 will be revised to correctly define the denominator when calculating accuracy.
Section 61.13(e)(1)(i) of the General Provisions of Part 61 will be revised to add Methods 30A and 30B to the list of methods not requiring the use of audit samples. Consistent with the criteria used in establishing the original list of methods for which no audit samples are required (75 FR 55636), Method 30A is an instrumental test method that already has sufficient calibration and QA requirements. Method 30B has sufficient performance-based QA measures including analysis of an independent calibration standard with each set of field samples.
In Method 107, the term “Geon” will be deleted from the heading in section 11.7.3.
The General Provisions of part 63, § 63.7(c)(2)(iii)(A) will be revised to add Methods 30A and 30B to the list of methods not requiring the use of audit samples. Consistent with the criteria used in establishing the original list of methods for which no audit samples are required (75 FR 55636), Method 30A will be added because it is an instrumental test method that already has sufficient calibration and QA requirements, and Method 30B will be added because it has sufficient performance-based QA measures including analysis of an independent calibration standard with each set of field samples.
Also in the General Provisions of part 63, § 63.7(g)(2) will be revised to require the reporting of specific emissions test data in test reports. These data elements will be required regardless of whether the report is submitted electronically or in paper format. We will make these revisions to ensure that emissions test reporting includes all data necessary to assess and assure the quality of the reported emissions data and appropriately describes and identifies the specific unit covered by the emissions test report.
In Method 320, sections 13.1, 13.4, and 13.4.1 will be revised to indicate the correct Method 301 reference.
The Agency is reviewing the adequacy of its current test methods in regard to sampling site selection and sampling point requirements. Emission gas flow patterns affect representative testing, and this is not addressed in many EPA test methods. Method 1 contains provisions for sampling point locations, traversing, and determination of cyclonic flow, and Method 7E was revised to contain procedures for determining gaseous stratification in 2006. However, there are currently no requirements in most methods for gaseous compounds to follow the Method 1 or 7E procedures.
Method 7E allows stratification to be assessed through either a 3- or 12-point traverse while measuring variations in either a pollutant or diluent concentration. The degree of stratification determines whether a single-point, 3-point, or 12-point traverse is used for the emissions test. There are no requirements to check for cyclonic flow in Method 7E.
We have some information that suggests deficiencies exist in the 3-point test in a number of cases and that at least a 5-point, dual axis test should be required. A summary of this information has been included in the docket for this action. We are also reconsidering the appropriateness of measuring variations in a diluent gas for the test instead of the regulated pollutant.
In this rule, we propose to update the General Provisions of parts 60, 61, and 63 to include evaluations of gas stratification and cyclonic flow with all compliance tests. The Agency solicits comments and data to aid in establishing effective and equitable procedures.
The Agency also requests comments on the proposed changes to the response time test in Performance Specification 4A. The Agency has received some information to suggest that a system response time test criteria of less than two minutes may be difficult to accomplish. Therefore, the Agency solicits comments and data to assist in establishing appropriate criteria.
This action is not a “significant regulatory action” under the terms of Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993) and is, therefore, not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
This action does not impose an information collection burden under the PRA. The amendments being proposed in this action to the test methods, performance specifications, and testing regulations do not add information collection requirements but make corrections and updates to existing testing methodology. In addition, the proposed amendments clarify performance testing requirements.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This proposed rule will not impose emission measurement requirements beyond those specified in the current regulations, nor does it change any emission standard. We have, therefore, concluded that this action will have no net regulatory burden for all directly regulated small entities.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175. This action simply corrects and updates existing testing regulations. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2–202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This action involves technical standards. The EPA proposes to use
The EPA proposes to use ASTM E617–13 for laboratory weights and precision mass standards in Methods 4, 5, 5H, 5I, 29, and 202. The ASTM E617–13 standard covers weights and mass standards used in laboratories for specific classes.
The ASTM D6911–15 and ASTM E617–13 standards were developed and adopted by the American Society for Testing and Materials (ASTM). These standards may be obtained from
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment.
Environmental protection, Air pollution control, Performance specifications, Test methods and procedures.
Environmental protection, Air pollution control, Incorporation by reference, Performance specifications, Test methods and procedures.
Environmental protection, Air pollution control, Performance specifications, Test methods and procedures.
For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend title 40, chapter I of the Code of Federal Regulations as follows:
23 U.S.C. 101; 42 U.S.C. 7401–7671q.
4.0 * * *
a. The source owner, operator, or representative of the tested facility shall obtain an audit sample, if commercially available, from an AASP for each test method used for regulatory compliance purposes. No audit samples are required for the following test methods: Methods 3A and 3C of appendix A–3 of part 60 of this chapter, Methods 6C, 7E, 9, and 10 of appendix A–4 of part 60, Methods 18 and 19 of appendix A–6 of part 60, Methods 20, 22, and 25A of appendix A–7 of part 60, Methods 30A and 30B of appendix A–8 of part 60, and Methods 303, 318, 320, and 321 of appendix A of part 63 of this chapter. If multiple sources at a single facility are tested during a compliance test event, only one audit sample is required for each method used during a compliance test. The compliance authority responsible for the compliance test may waive the requirement to include an audit sample if they believe that an audit sample is not necessary. “Commercially available” means that two or more independent AASPs have blind audit samples available for purchase. If the source owner, operator, or representative cannot find an audit sample for a specific method, the owner, operator, or representative shall consult the EPA Web site at the following URL,
12.5 * * *
For N
For N
The additions and revisions read as follows:
Method 202—Dry Impinger Method for Determining Condensable Particulate Emissions From Stationary Sources
3.8
8.5.4.3
9.10 Field Train Recovery Blank. You must recover a minimum of one field train blank for each source category tested at the facility. You must recover the field train blank after the first or second run of the test. You must assemble the sampling train as it will be used for testing. Prior to the purge, you must add 100 ml of water to the first impinger and record this data on Figure 4. You must purge the assembled train as described in Section 8.5.3. You must recover field train blank samples as described in Section 8.5.4. From the field sample weight, you will subtract the condensable particulate mass you determine with this blank train or 0.002 g (2.0 mg), whichever is less.
10.3 Field Balance Calibration Check. Check the calibration of the balance used to weigh impingers with ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” Class 3 tolerance (or better) weight of at least 500g or within 50g of a loaded impinger weight. Daily before use, the field balance must measure the weight within ± 0.5 g of the certified mass. If the daily balance calibration check fails, perform corrective measures and repeat check before use of balance.
10.4 Analytical Balance Calibration. Perform a multipoint calibration (at least five points spanning the operational range) of the analytical balance before the first use and semiannually, thereafter. The calibration of the analytical balance must be conducted using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” Class 2 (or better) tolerance weights. Audit the balance each day it is used for gravimetric measurements by weighing at least one ASTM E617–13 Class 2 tolerance (or better) calibration weight that corresponds to 50 to 150 percent of the weight of one filter or 5 g. If the scale cannot reproduce the value of the calibration weight to within 0.5 mg of the certified mass, perform corrective measures, and conduct the multipoint calibration before use.
11.2.2 * * *
11.2.2.1 Determine the inorganic fraction weight. Transfer the aqueous fraction from the extraction to a clean 500-ml or smaller beaker. Evaporate to no less than 10 ml liquid on a hot plate or in the oven at 105 °C and allow to dry at room temperature (not to exceed 30 °C (85 °F)). You must ensure that water and volatile acids have completely evaporated before neutralizing nonvolatile acids in the sample. Following evaporation, desiccate the residue for 24 hours in a desiccator containing anhydrous calcium sulfate. Weigh at intervals of at least 6 hours to a constant weight. (See Section 3.0 for a definition of Constant weight.) Report results to the nearest 0.1 mg on the CPM Work Table (see Figure 6 of Section 18) and proceed directly to Section 11.2.3. If the residue cannot be weighed to constant weight, re-dissolve the residue in 100 ml of deionized distilled ultra-filtered water that contains 1 ppmw (1 mg/L) residual mass or less and continue to Section 11.2.2.2.
11.2.2.2 Use titration to neutralize acid in the sample and remove water of hydration. If used, calibrate the pH meter with the neutral and acid buffer solutions. Then titrate the sample with 0.1N NH4OH to a pH of 7.0, as indicated by the pH meter or colorimetric indicator. Record the volume of titrant used on the CPM Work Table (see Figure 6 of Section 18).
11.2.2.3 Using a hot plate or an oven at 105 °C, evaporate the aqueous phase to approximately 10 ml. Quantitatively transfer the beaker contents to a clean, 50-ml pre-tared weighing tin and evaporate to dryness at room temperature (not to exceed 30 °C (85 °F)) and pressure in a laboratory hood. Following evaporation, desiccate the residue for 24 hours in a desiccator containing anhydrous calcium sulfate. Weigh at intervals of at least 6 hours to a constant weight. (See Section 3.0 for a definition of Constant weight.) Report results to the nearest 0.1 mg on the CPM Work Table (see Figure 6 of Section 18).
11.2.2.4 Calculate the correction factor to subtract the NH
3.3
5.1.3 The values used in the equations under paragraph 5.1 are derived as follows:
E = pollutant emission, g/million cal (lb/million BTU),
C = pollutant concentration, g/dscm (lb/dscf), determined by multiplying the average concentration (ppm) for each hourly period by 4.16x10
%O
42 U.S.C. 7401
(f) Unless otherwise specified in the applicable subpart, each performance test shall consist of three separate runs using the applicable test method.
(1) Each run shall be conducted for the time and under the conditions specified in the applicable standard. For the purpose of determining compliance with an applicable standard, the arithmetic means of results of the three runs shall apply. In the event that a sample is accidentally lost or conditions occur in which one of the three runs must be discontinued because of forced shutdown, failure of an irreplaceable portion of the sample train, extreme meteorological conditions, or other circumstances, beyond the owner or operator's control, compliance may, upon the Administrator's approval, be determined using the arithmetic mean of the results of the two other runs.
(2) Contents of report (electronic or paper submitted copy). Unless otherwise specified in a relevant standard or test method, or as otherwise approved by the Administrator in writing, results of a performance test shall include general identification information for the facility including a mailing address, the actual address, the owner or operator or responsible official (where they are applicable) or an appropriate representative and an email address for this person, and the appropriate Federal Registry System (FRS) number for the facility; the purpose of the test including the regulation requiring the test, the pollutant being measured, the units of the standard or the pollutant emissions units, and any process parameter component; a brief process description; a complete unit description, including a description of feed streams and control devices, the appropriate source classification code (SCC), and the latitude and longitude of the emission point being tested, and the permitted maximum process rate (where applicable); sampling site description; description of sampling and analysis procedures and any modifications to standard procedures; quality assurance procedures; record of operating conditions, including operating parameters for which limits are being set, during the test; record of preparation of standards; record of calibrations; raw data sheets for field sampling; raw data sheets for field and laboratory analyses; chain-of-custody documentation; explanation of laboratory data qualifiers; example calculations of all applicable stack gas parameters, emission rates, percent reduction rates, and analytical results, as applicable; identification information for the company conducting the performance test including a contact person and his/her email address; and any other information required by the test method, a relevant standard, or the Administrator.
The additions read as follows:
(g) * * *
(190) ASTM D6911–15, Standard Guide for Packaging and Shipping Environmental Samples for Laboratory Analysis, IBR approved for appendix A–8 to this part: Method 30B, section 8.3.3.8.
(201) ASTM E617–13, Standard Specification for Laboratory Weights and Precision Mass Standards, IBR approved for appendix M to part 51 of this chapter: Method 202, sections 10.3 and 10.4; appendix A–3 to this part: Method 4, section 10.3; Method 5, sections 10.7 and 10.8, Method 5H, sections 10.4 and 10.5, Method 5I, sections 10.7 and 10.8; and appendix A–8 to this part: Method 29, section 10.4.
As stated in § 60.4244, you must comply with the following requirements for performance tests within 10 percent of 100 percent peak (or the highest achievable) load:
The revisions read as follows:
11.2.1.2 When the eight- and two-diameter criterion cannot be met, the minimum number of traverse points is determined from Figure 1–1. Before referring to the figure, however, determine the distances from the measurement site to the nearest upstream and downstream disturbances, and divide each distance by the stack diameter or equivalent diameter, to determine the distance in terms of the number of duct diameters.
6.7 Calibration Pitot Tube. Calibration of the Type S pitot tube requires a standard Pitot tube for a reference.
10.1.2.3 The flow system shall have the capacity to generate a test-section velocity around 910 m/min (3,000 ft/min). This velocity must be constant with time to guarantee constant and steady flow during the entire period of calibration. A centrifugal fan is recommended for this purpose, as no flow rate adjustment for back pressure of the fan is allowed during the calibration process. Note that Type S pitot tube coefficients obtained by single-velocity calibration at 910 m/min (3,000 ft/min) will generally be valid to ±3 percent for the measurement of velocities above 300 m/min (1,000 ft/min) and to ±6 percent for the measurement of velocities between 180 and 300 m/min (600 and 1,000 ft/min). If a more precise correlation between the pitot tube coefficient, (Cp), and velocity is desired, the flow system should have the capacity to generate at least four distinct, time-invariant test-section velocities covering the velocity range from 180 to 1,500 m/min (600 to 5,000 ft/min), and calibration data shall be taken at regular velocity intervals over this range (see References 9 and 14 in section 17.0 for details).
10.1.3.4 Read Δp
10.1.3.7 Repeat Steps 10.1.3.3 through 10.1.3.6 until three pairs of Δp readings have been obtained for the A side of the Type S pitot tube, with all the paired observations conducted at a constant fan speed (no changes to fan velocity between observed readings).
10.1.4.1.3 For Type S pitot tube combinations with complete probe assemblies, the calibration point should be located at or near the center of the duct; however, insertion of a probe sheath into a small duct may cause significant cross-sectional area interference and blockage and yield incorrect coefficient values (Reference 9 in section 17.0). Therefore, to minimize the blockage effect, the calibration point may be a few inches off-center if necessary, but no closer to the outer wall of the wind tunnel than 4 inches. The maximum allowable blockage, as determined by a projected-area model of the probe sheath, is 2 percent or less of the duct cross-sectional area (Figure 2–10a). If the pitot and/or probe assembly blocks more than 2 percent of the cross-sectional area at an insertion point only 4 inches inside the wind tunnel, the diameter of the wind tunnel must be increased.
10.1.4.3 For a probe assembly constructed such that its pitot tube is always used in the same orientation, only one side of the pitot tube need be calibrated (the side which will face the flow). The pitot tube must still meet the alignment specifications of Figure 2–2 or 2–3, however, and must have an average
The revisions and additions read as follows:
6.11.1 Test section cross-sectional area. The flowing gas stream shall be confined within a circular, rectangular, or elliptical duct. The cross-sectional area of the tunnel must be large enough to ensure fully developed flow in the presence of both the calibration pitot tube and the tested probe. The calibration site, or “test section,” of the wind tunnel shall have a minimum diameter of 30.5 cm (12 in.) for circular or elliptical duct cross-sections or a minimum width of 30.5 cm (12 in.) on the shorter side for rectangular cross-sections. Wind tunnels shall meet the probe blockage provisions of this section and the qualification requirements prescribed in section 10.1. The projected area of the portion of the probe head, shaft, and attached devices inside the wind tunnel during calibration shall represent no more than 2 percent of the cross-sectional area of the tunnel. If the pitot and/or probe assembly blocks more than 2 percent of the cross-sectional area at an insertion point only 4 inches inside the wind tunnel, the diameter of the wind tunnel must be increased.
6.11.2 Velocity range and stability. The wind tunnel should be capable of achieving and maintaining a constant and steady velocity between 6.1 m/sec and 30.5 m/sec (20 ft/sec and 100 ft/sec) for the entire calibration period for each selected calibration velocity. The wind tunnel shall produce fully developed flow patterns that are stable and parallel to the axis of the duct in the test section.
10.6.6 Read the differential pressure from the calibration pitot tube (ΔP
10.6.8 Take paired differential pressure measurements with the calibration pitot tube and tested probe (according to sections 10.6.6 and 10.6.7). The paired measurements in each replicate can be made either simultaneously (
6.3 Analyzer Linearity Check and Calibration. Perform this test before sample analysis.
6.3.1 Using the gas mixtures in section 5.1, verify the detector linearity over the range of suspected sample concentrations with at least three concentrations per
6.3.2 You may extend the use of the analyzer calibration by performing a single point calibration verification. Calibration verifications shall be performed by triplicate injections of a single-point standard gas. The concentration of the single-point calibration must either be at the midpoint of the calibration curve or at approximately the source emission concentration measured during operation of the analyzer.
6.3.3 Triplicate injections must agree within 5 percent of their mean, and the average calibration verification point must agree within 10 percent of the initial calibration response factor. If these calibration verification criteria are not met, the initial calibration described in section 6.3.1, using at least three concentrations, must be repeated before analysis of samples can continue.
6.3.4 For each instrument calibration, record the carrier and detector flow rates, detector filament and block temperatures, attenuation factor, injection time, chart speed, sample loop volume, and component concentrations.
6.3.5 Plot a linear regression of the standard concentrations versus area values to obtain the response factor of each compound. Alternatively, response factors of uncorrected component concentrations (wet basis) may be generated using instrumental integration.
Peak height may be used instead of peak area throughout this method.
The revisions and additions read as follows:
10.3 Field Balance Calibration Check. Check the calibration of the balance used to weigh impingers using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 3 tolerance (or better) weight of at least 500g or within 50g of a loaded impinger weight. Daily before use, the field balance must measure the weight within ±0.5g of the certified mass. If the daily balance calibration check fails, perform corrective measures and repeat check before use of balance.
12.2.5 Using F-factors to determine approximate moisture for estimating moisture content where no wet scrubber is being used, for the purpose of determining isokinetic sampling rate settings with no fuel sample is acceptable using the average F
Btu (scm/J). See Table 19–2 in Method 19.
scf/10
16.4 Using F-factors to determine moisture is an acceptable alternative to Method 4 for a combustion stack not using a scrubber and where a fuel sample is taken during the test run and analyzed for development of an F
If this option is selected, calculate the moisture content as follows:
Values of B
Free water in fuel is minimal for distillate oil and gases, such as propane and natural gas, so this step may be omitted for those fuels.
6.1.1.9 Metering System. Vacuum gauge, leak-free pump, calibrated temperature sensors (rechecked at at least one point after each test), dry gas meter (DGM) capable of measuring volume to within 2 percent, and related equipment, as shown in Figure 5–1. Other metering systems capable of maintaining sampling rates within 10 percent of isokinetic and of determining sample volumes to within 2 percent may be used, subject to the approval of the Administrator. When the metering system is used in conjunction with a pitot tube, the system shall allow periodic checks of isokinetic rates.
8.7.6.2.5 Clean the inside of the front half of the filter holder by rubbing the surfaces with a Nylon bristle brush and rinsing with acetone. Rinse each surface three times or more if needed to remove visible particulate. Make a final rinse of the brush and filter holder. Carefully rinse out the glass cyclone, also (if applicable). After all acetone washings and particulate matter have been collected in the sample container, tighten the lid on the sample container so that acetone will not leak out when it is shipped to the laboratory. Mark the height of the fluid level to allow determination of whether leakage occurred during transport. Label the container to identify clearly its contents.
10.7 Field Balance Calibration Check. Check the calibration of the balance used to weigh impingers using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 3 tolerance (or better) weight of at least 500g or within 50g of a loaded impinger weight. Daily before use, the field balance must measure the weight within ±0.5g of the certified mass. If the daily balance calibration check fails, perform corrective measures and repeat check before use of balance.
10.8 Analytical Balance Calibration. Perform a multipoint calibration (at least five points spanning the operational range) of the analytical balance before the first use and semiannually, thereafter. The calibration of the analytical balance must be conducted using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 2 (or better) tolerance weights. Audit the balance each day it is used for gravimetric measurements by weighing at least one ASTM E617–13 Class 2 tolerance (or better) calibration weight) that corresponds to 50 to 150 percent of the weight of one filter or 5g. If the scale cannot reproduce the value of the calibration weight to within 0.5 mg of the certified mass, perform corrective measures, and conduct the multipoint calibration before use.
10.4 Field Balance Calibration Check. Check the calibration of the balance used to weigh impingers using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 3 tolerance (or better) weight of at least 500g or within 50g of a loaded impinger weight. Daily before use, the field balance must measure the weight within ± 0.5g of the certified mass. If the daily balance calibration check fails, perform corrective measures and repeat check before use of balance.
10.5 Analytical Balance Calibration. Perform a multipoint calibration (at least five points spanning the operational range) of the analytical balance before the first use and semiannually, thereafter. The calibration of the analytical balance must be conducted using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 2 (or better) tolerance weights. Audit the balance each day it is used for gravimetric measurements by weighing at least one ASTM E617–13 Class 2 tolerance (or better) calibration weight that corresponds to 50 to 150 percent of the weight of one filter or 5g. If the scale cannot reproduce the value of the calibration weight to within 0.5 mg of the certified mass, perform corrective measures, and conduct the multipoint calibration before use.
10.1 Field Balance Calibration Check. Check the calibration of the balance used to weigh impingers using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 3 tolerance (or better) weight of at least 500g or within 50g of a loaded impinger weight. Daily before use, the field balance must measure the weight within ±0.5g of the certified mass. If the daily balance calibration check fails, perform corrective measures and repeat check before use of balance.
10.2 Analytical Balance Calibration. Perform a multipoint calibration (at least five points spanning the operational range) of the analytical balance before the first use and semiannually, thereafter. The calibration of the analytical balance must be conducted using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 2 (or better) tolerance weights. Audit the balance each day it is used for gravimetric measurements by weighing at least one ASTM E617–13 Class 2 tolerance (or better) calibration weight that corresponds to 50 to 150 percent of the weight of one filter or 5g. If the scale cannot reproduce the value of the calibration weight to within 0.5 mg of the certified mass, perform corrective measures, and conduct the multipoint calibration before use.
The revisions and additions read as follows:
8.3
8.1.2
8.2.7
12.8 NO
6.2.5
6.2.6 Sample Tank. Stainless steel or aluminum tank equipped with a pressure indicator with a minimum volume of 4 liters.
8.4.2
6.1.6 Flexible Bag. Tedlar, or equivalent, with a capacity of 10 liters (0.35 ft
6.1.7 Sample Tank. Stainless steel or aluminum tank equipped with a pressure indicator with a minimum volume of 10 liters.
6.1.8 Valves. Stainless-steel needle valve to adjust flow rate, and stainless-steel 3-way valve, or equivalent.
6.1.9 CO
6.1.10 Volume Meter. Dry gas meter, capable of measuring the sample volume under calibration conditions of 300 ml/min (0.01 ft
6.1.11 Pressure Gauge. A water filled U-tube manometer, or equivalent, of about 30 cm (12 in.) to leak-check the flexible bag.
8.1 Sample Bag or Tank Leak-Checks. While a leak-check is required after bag or sample tank use, it should also be done before the bag or sample tank is used for sample collection. The tank should be leak-checked according to the procedure specified in section 8.1.2 of Method 25. The bag should be leak-checked in the inflated and deflated condition according to the following procedure:
8.2.1 Evacuate and leak check the sample bag or tank as specified in section 8.1. Assemble the apparatus as shown in Figure 10A–1. Loosely pack glass wool in the tip of the probe. Place 400 ml of alkaline permanganate solution in the first two impingers and 250 ml in the third. Connect the pump to the third impinger, and follow this with the surge tank, rate meter, and 3-way valve. Do not connect the bag or sample tank to the system at this time.
8.2.3 Purge the system with sample gas by inserting the probe into the stack and drawing the sample gas through the system at 300 ml/min ± 10 percent for 5 minutes. Connect the evacuated bag or sample tank to the system, record the starting time, and sample at a rate of 300 ml/min for 30 minutes, or until the bag is nearly full, or the sample tank reaches ambient pressure. Record the sampling time, the barometric pressure, and the ambient temperature. Purge the system as described above immediately before each sample.
6.1 Sample Collection. Same as in Method 10A, section 6.1 (paragraphs 6.1.1 through 6.1.11).
8.3.2 Determination of Calibration Drift. After each run, or after a series of runs made within a 24-hour period, perform a partial recalibration using the procedures in section 10.0. Only H
The revisions read as follows:
12.1 Nomenclature.
12.2 Analyzer Calibration Error. For non-dilution systems, use Equation 16C–1 to calculate the analyzer calibration error for the low-, mid-, and high-level calibration gases.
The revisions and additions read as follows:
9.1 Miscellaneous Quality Control Measures.
12.1 Nomenclature.
12.3 Nitrogen Concentration in the landfill gas. Use equation 25C–2 to calculate the measured concentration of nitrogen in the original landfill gas.
12.4 Oxygen Concentration in the landfill gas. Use equation 25C–3 to calculate the measured concentration of oxygen in the original landfill gas.
12.5 You must correct the NMOC Concentration for the concentration of nitrogen or oxygen based on which gas or gases passes the requirements in section 9.1.
12.5.1 NMOC Concentration with nitrogen correction. Use Equation 25C–4 to calculate the concentration of NMOC for each sample tank when the nitrogen concentration is less than 20 percent.
12.5.2 NMOC Concentration with oxygen correction. Use Equation 25C–4 to calculate the concentration of NMOC for each sample tank if the landfill gas oxygen is less than 5 percent and the landfill gas nitrogen concentration is greater than 20 percent.
The revisions and additions read as follows:
13.3 Detection Limit. A typical IC instrumental detection limit for C1
4.3 Dissociating chloride salts (
6.1.7 Heating System. Any heating system capable of monitoring and maintaining temperature around the filter shall be used to ensure a sample gas temperature exiting the filter of 120 ± 14 °C (248 ± 25 °F) during sampling or such other temperature as specified by an applicable subpart of the standards. The monitoring and regulation of the temperature around the filter may be done with the filter temperature sensor or another temperature sensor.
8.1.5 Sampling Train Operation. Follow the general procedure given in Method 5, section 8.5. Maintain a temperature around the probe, through the filter (and cyclone, if used) of 120 ± 14 °C (248 ± 25 °F) or such other temperature as specified by an applicable subpart of the standards to avoid dissociating halogen salts and to maintain acid gases in the vapor phase since it is extremely difficult to purge acid gases off these components. (These components are not quantitatively recovered and hence any collection of acid gases on these components will result in potential under reporting these emissions.) For each run, record the data required on a data sheet such as the one shown in Method 5, Figure 5–3. If the condensate impinger becomes too full, it may be emptied, recharged with 50 ml of 0.1 N H
8.1.6 Post-Test Moisture Removal (Optional). When the optional cyclone is included in the sampling train or when liquid is visible on the filter at the end of a sample run even in the absence of a cyclone, perform the following procedure. Upon completion of the test run, connect the ambient air conditioning tube at the probe inlet and operate the train with the filter heating system between 120 and 134 °C (248 and 273 °F) at a low flow rate (
It is critical that this is repeated until the cyclone is completely dry.
8.2.9.3 Wash the two permanganate impingers with 25 ml of 8 N HCl, and place the wash in a separate sample container labeled No. 5C containing 200 ml of water. First, place 200 ml of water in the container. Then wash the impinger walls and stem with the 8 N HCl by turning the impinger on its side and rotating it so that the HCl contacts all inside surfaces. Use a total of only 25 ml of 8 N HCl for rinsing
10.4 Field Balance Calibration Check. Check the calibration of the balance used to weigh impingers using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 3 tolerance (or better) weight of at least 500g or within 50g of a loaded impinger weight. Daily before use, the field balance must measure the weight within ± 0.5g of the certified mass. If the daily balance calibration check fails, perform corrective measures and repeat check before use of balance.
10.5 Analytical Balance Calibration. Perform a multipoint calibration (at least five points spanning the operational range) of the analytical balance before the first use and semiannually, thereafter. The calibration of the analytical balance must be conducted using ASTM E617–13 “Standard Specification for Laboratory Weights and Precision Mass Standards” (incorporated by reference—see 40 CFR 60.17) Class 2 (or better) tolerance weights. Audit the balance each day it is used for gravimetric measurements by weighing at least one ASTM E617–13 Class 2 tolerance (or better) calibration weight that corresponds to 50 to 150 percent of the weight of one filter or 5 g. If the scale cannot reproduce the value of the calibration weight to within 0.5 mg of the certified mass, perform corrective measures, and conduct the multipoint calibration before use.
8.1 Selection of Sampling Sites and Sampling Points. * * *
8.1 Selection of Sampling Sites and Sampling Points. * * *
8.3.3.8 Sample Handling, Preservation, Storage, and Transport. While the performance criteria of this approach provides for verification of appropriate sample handling, it is still important that the user consider, determine, and plan for suitable sample preservation, storage, transport, and holding times for these measurements. Therefore, procedures in ASTM D6911–15 “Standard Guide for Packaging and Shipping Environmental Samples for Laboratory Analysis” (incorporated by reference—see 40 CFR 60.17) shall be followed for all samples, where appropriate.
The revisions and additions read as follows:
8.1 * * *
(2) * * *
(i) Measurement Location. * * * Alternatively, you may select a measurement location specified in paragraph 8.1(2)(ii) or 8.1(2)(iii).
3.11
6.1.1 Data Recorder. The portion of the CEMS that provides a record of analyzer output. The data recorder may record other pertinent data such as effluent flow rates, various instrument temperatures or abnormal CEMS operation. The data recorder output range must include the full range of expected concentration values in the gas stream to be sampled including zero and span values.
16.3.2 For diluent CEMS:
Waiver of the relative accuracy test in favor of the alternative RA procedure does not preclude the requirements to complete the CD tests nor any other requirements specified in an applicable subpart for reporting CEMS data and performing CEMS drift checks or audits.
13.2 CEMS Relative Accuracy Performance Specification. The RA of the CEMS must be no greater than 20.0 percent of the mean value of the reference method (RM) data when calculated using equation 3–1. The results are also acceptable if the result of Equation 3–2 is less than or equal to 1.0 percent O2 (or CO2).
8.3 Response Time Test Procedure. The response time test applies to all types of CEMS, but will generally have significance only for extractive systems. The entire system is checked with this procedure including applicable sample extraction and transport, sample conditioning, gas analyses, and data recording.
8.3.1 Introduce zero gas into the system. When the system output has stabilized (no change greater than 1 percent of full scale for 30 sec), introduce an upscale calibration gas and wait for a stable value. Record the time (upscale response time) required to reach 95 percent of the final stable value. Next, reintroduce the zero gas and wait for a stable reading before recording the response time (downscale response time). Repeat the entire procedure three times and determine the mean upscale and downscale response times. The slower or longer of the two means is the system response time.
13.3 Response Time. The CEMS response time shall not exceed 2.0 min to achieve 95 percent of the final stable value.
12.1 How do I calculate upscale drift and zero drift? You must determine the difference in your PM CEMS output readings from the established reference values (zero and upscale check values) after a stated period of operation during which you performed no unscheduled maintenance, repair, or adjustment.
(1) Calculate the upscale drift (UD) using Equation 11–1:
(2) Calculate the zero drift (ZD) using Equation 11–2:
13.0 What are the performance criteria for my PM CEMS?
13.1 What is the 7-day drift check performance specification? Your daily PM CEMS internal drift checks must demonstrate that the average daily drift of your PM CEMS does not deviate from the value of the reference light, optical filter, Beta attenuation signal, or other technology-suitable reference standard by more than 2 percent of the response range. If your CEMS includes diluent and/or auxiliary monitors (for temperature, pressure, and/or moisture) that are employed as a necessary part of this performance specification, you must determine the calibration drift separately for each ancillary monitor in terms of its respective output (see the appropriate performance specification for the diluent CEMS specification). None of the calibration drifts may exceed their individual specification.
9.1.2 Test Procedure. Spike the audit sample using the analyte spike procedure in section 11. The audit sample is measured directly by the FTIR system (undiluted) and then spiked into the effluent at a known dilution ratio. Measure a series of spiked and unspiked samples using the same procedures as those used to analyze the stack gas. Analyze the results using sections 12.1 and 12.2. The measured concentration of each analyte must be within ±5 percent of the expected concentration (plus the uncertainty),
12.2.3 Confidence Coefficient. Calculate the confidence coefficient using Equation 16–3 and Table 16–1 for n−1 degrees of freedom.
(3) How do I calculate daily upscale and zero drift? You must calculate the upscale drift using Equation 2–2 and the zero drift using Equation 2–3:
(4) How do I calculate SVA accuracy? You must use Equation 2–4 to calculate the accuracy, in percent, for each of the three SVA tests or the daily sample volume check:
Before calculating SVA accuracy, you must correct the sample gas volumes measured by your PM CEMS and the independent calibrated reference device to the same basis of temperature, pressure, and moisture content. You must document all data and calculations.
42 U.S.C. 7401
(e) * * *
(1) * * *
(i) The source owner, operator, or representative of the tested facility shall obtain an audit sample, if commercially available, from an AASP for each test method used for regulatory compliance purposes. No audit samples are required for the following test methods: Methods 3A and 3C of appendix A–3 of part 60 of this chapter; Methods 6C, 7E, 9, and 10 of appendix A–4 of part 60; Method 18 and 19 of appendix A–6 of part 60; Methods 20, 22, and 25A of appendix A–7 of part 60; Methods 30A and 30B of appendix A–8 of part 60; and Methods 303, 318, 320, and 321 of appendix A of part 63 of this chapter. If multiple sources at a single facility are tested during a compliance test event, only one audit sample is required for each method used during a compliance test. The compliance authority responsible for the compliance test may waive the requirement to include an audit sample if they believe that an audit sample is not necessary. “Commercially available” means that two or more independent AASPs have blind audit samples available for purchase. If the source owner, operator, or representative cannot find an audit sample for a specific method, the owner, operator, or representative shall consult the EPA Web site at the following URL,
11.7.3 Dispersion Resin Slurry and Latex Samples. * * *
42 U.S.C. 7401
The revision and addition read as follows:
(c) * * *
(2) * * *
(iii) * * *
(A) The source owner, operator, or representative of the tested facility shall obtain an audit sample, if commercially available, from an AASP for each test method used for regulatory compliance purposes. No audit samples are required for the following test methods: Methods 3A and 3C of appendix A–3 of part 60 of this chapter; Methods 6C, 7E, 9, and 10 of appendix A–4 of part 60; Methods 18 and 19 of appendix A–6 of part 60; Methods 20, 22, and 25A of appendix A–7 of part 60; Methods 30A and 30B of appendix A–8 of part 60; and Methods 303, 318, 320, and 321 of appendix A of this part. If multiple sources at a single facility are tested during a compliance test event, only one audit sample is required for each method used during a compliance test. The compliance authority responsible for the compliance test may waive the requirement to include an audit sample if they believe that an audit sample is not necessary. “Commercially available” means that two or more independent AASPs have blind audit samples available for purchase. If the source owner, operator, or representative cannot find an audit sample for a specific method, the owner, operator, or representative shall consult the EPA Web site at the following URL,
(g) * * *
(2) Contents of report (electronic or paper submitted copy). Unless otherwise specified in a relevant standard or test method, or as otherwise approved by the Administrator in writing, results of a performance test shall include general identification information for the facility including a mailing address, the actual address, the owner or operator or responsible official (where they are applicable) or an appropriate representative and an email address for this person, and the appropriate Federal Registry System (FRS) number for the facility; the purpose of the test including the regulation requiring the test, the pollutant being measured, the units of the standard or the pollutant emissions units, and any process parameter component; a brief process description; a complete unit description, including a description of feed streams and control devices, the appropriate source classification code (SCC), and the latitude and longitude of the emission point being tested, and the permitted maximum process rate (where applicable); sampling site description; description of sampling and analysis procedures and any modifications to standard procedures; quality assurance procedures; record of operating conditions, including operating parameters for which limits are being set, during the test; record of preparation of standards; record of calibrations; raw data sheets for field sampling; raw data sheets for field and laboratory analyses; chain-of-custody documentation; explanation of laboratory data qualifiers; example calculations of all applicable stack gas parameters, emission rates, percent reduction rates, and analytical results, as applicable; identification information for the company conducting the performance test including a contact person and his/her email address; and any other information required by the test method, a relevant standard, or the Administrator.
13.1 Section 6.0 of Method 301 (40 CFR part 63, appendix A), the Analyte Spike procedure, is used with these modifications. The statistical analysis of the results follows section 12.0 of EPA Method 301. Section 3 of this method defines terms that are not defined in Method 301.
13.4
13.4.1
Office for Civil Rights (OCR), Office of the Secretary, HHS.
Notice of proposed rulemaking.
The Department of Health and Human Services (HHS or “the Department”) is issuing this proposed rule on Section 1557 of the Affordable Care Act (ACA) (Section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the ACA authorizes the Secretary of the Department to promulgate regulations to implement the nondiscrimination requirements of Section 1557. In addition, the Secretary is authorized to prescribe regulations for the Department's governance, conduct, and performance of its business, including, here, how HHS will apply the standards of Section 1557 to HHS-administered health programs and activities.
Submit comments on or before November 9, 2015.
You may submit comments, identified by RIN Number 0945–AA02, by any of the following methods:
•
•
•
•
Claudia Adams, at (800) 368–1019 or (800) 537–7697 (TDD).
Section 1557 of the ACA provides that an individual shall not, on the grounds prohibited under Title VI of the Civil Rights Act of 1964 (Title VI), 42 U.S.C. 2000d
On August 1, 2013, the Office for Civil Rights of the Department (OCR) published a Request for Information (RFI) in the
OCR has carefully reviewed all comments received, and has referenced them where appropriate and relevant in this preamble. The proposed rule both clarifies and codifies existing nondiscrimination requirements, and also sets forth new standards to implement Section 1557, particularly with respect to the prohibition of discrimination on the basis of sex in health programs other than those provided by educational institutions and the prohibition of various forms of discrimination in health programs administered by the Department and entities established under Title I of the ACA. The Department invites comment on this proposed rule by all interested parties, including comment from Tribes on application of the rule to them.
Proposed § 92.1 states that the purpose of this part is to implement Section 1557 of the ACA, which prohibits discrimination in certain health programs and activities on the grounds prohibited under Title VI, Title IX, the Age Act, and Section 504, which together prohibit discrimination on the basis of race, color, national origin, sex, age, or disability.
Section 92.1 also establishes that the effective date of the Section 1557 implementing regulation shall be 60 days after the publication of the final rule in the
Section 1557 applies to all health programs and activities, any part of which receives Federal financial assistance from any Federal agency. In addition, Section 1557 applies to all programs and activities that are administered by an Executive Agency or any entity established under Title I of the ACA.
OCR proposes in § 92.2(a) to apply the rule, except as otherwise provided in this part, to: (1) All health programs and activities, any part of which receives Federal financial assistance administered by HHS;
Section 92.2(b) provides limitations to the application of the proposed rule. In this section, addressing limitations in the statutes referenced in Section 1557, and in Subpart B, which incorporates exceptions in the regulations implementing the statutes referenced in Section 1557, we have adopted the existing limitations and exceptions that already govern the health programs and activities subject to Section 1557. These limitations and exceptions are found in the Age Act and in the regulations implementing the Age Act, Section 504, and Title VI, which apply to all programs and activities that receive Federal financial assistance.
Thus, § 92.2(b)(1) incorporates the exclusions found in the Age Act, such that the provisions of this proposed rule do not apply to any age distinction contained in that part of a Federal, State, or local statute or ordinance adopted by an elected, general purpose legislative body which provides any benefits or assistance to persons based on age, establishes criteria for participation in age-related terms, or describes intended beneficiaries to target groups in age-related terms.
By contrast, we are requesting comment on whether the exemptions found in Title IX and its implementing regulation should be incorporated into this proposed rule. Unlike the Age Act, Section 504, and Title VI, which apply to all programs and activities that receive Federal financial assistance, Title IX applies only in the context of education programs and not to the health programs and activities subject to this proposed rule. In addition, many of Title IX's limitations and exceptions do not readily apply in a context that is grounded in health care, rather than education. For example, Title IX exempts from its prohibitions on sex discrimination certain institutions of undergraduate higher education, military and merchant marine educational institutions, and membership practices of social fraternities and sororities and voluntary youth service organizations.
In the RFI, OCR specifically inquired as to what exceptions, if any, should apply in the context of sex discrimination in health programs and activities. Nearly all commenters who provided a response to this inquiry indicated that Section 1557 includes only one exception—that the statute applies except as otherwise provided in Title I of the ACA. To this end, commenters argued that nothing in the language or legislative history of Section 1557 allows for any other limitations or exceptions regarding its application, highlighting that exceptions to general rules like Section 1557's antidiscrimination provision must be read strictly and narrowly.
We continue to seek comment on whether the regulation should include any specific exemptions for health providers, health plans, or other covered entities with respect to requirements of the proposed rule related to sex discrimination, including the particular requirements that are discussed in this proposed rule.
At the same time, a fundamental purpose of the ACA is to ensure that vital health care services are broadly and nondiscriminatorily available to individuals throughout the country. As a result, we seek comment on any health care consequences that would ensue were the regulation to provide additional exemptions.
Finally, we seek comment on the scope of additional exemptions, if any, that should be included and the processes for claiming them, including whether those processes should track those used under Title IX, at 45 CFR 86.12.
Proposed § 92.3 explains the relationship of this part to existing laws. Paragraph (a) provides that Section 1557 is not intended to apply lesser standards for the protection of individuals from discrimination than the standards under Title VI, Title IX, Section 504, the Age Act, or the regulations issued pursuant to those laws. Consistent with the statute, paragraph (b) states that nothing in this part shall be interpreted to invalidate or limit the existing rights, remedies, procedures, or legal standards available to individuals aggrieved under other Federal civil rights laws or to supersede State or local laws that provide greater or equal protection against discrimination on the basis of race, color, national origin, sex, age, or disability. This intent is derived from Section 1557(b) of the ACA. In addition to the statutory references cited directly in Section 1557(b), the proposed rule includes the Architectural Barriers Act of 1968, 42 U.S.C. 4151–4157 (2012), the Americans with Disabilities Act of 1990, 42 U.S.C. 12101
Section 92.4 contains proposed definitions. Definitions of particular note are set out below.
With regard to the Health Insurance Marketplaces, covered entities include, for example, Navigators that receive Federal financial assistance as defined in this rule. Navigators are entities that carry out the duties identified in the ACA and its implementing regulations, such as informing the public about the health coverage options available through the Health Insurance Marketplaces and facilitating enrollment in health coverage programs.
However, consistent with OCR's enforcement of other civil rights authorities, the definition of Federal financial assistance does not include Medicare Part B.
An additional clause is added to the proposed regulatory provision, modeled on the definition of “Federal financial assistance” in the regulation implementing Title IX at 45 CFR 86.2(g). That Title IX regulatory provision clarifies that Federal financial assistance includes wages, loans, grants, scholarships and other monies that are given to any entity for payment to or on behalf of students who are admitted to that entity or that are given directly to these students for payment to that entity.
OCR intends the plural “health programs or activities” used in this proposed part to have the same meaning as the term “health program or activity” in the singular. Similarly, this proposed part's use of “health programs and activities,” a variation of “health program or activity,” does not reflect a change in the substance of the definition of “health program or activity.”
Commenters responding to the request in the RFI for examples of programs and activities that should be considered “health programs or activities” generally supported a broad interpretation of the term. We propose to interpret “health programs and activities” to include programs such as health education and health research programs. However, OCR recognizes that health research is conducted to answer scientific questions and advance health through the advancement of knowledge; it is not designed to result in direct health benefits to participants, though individuals may in fact receive health benefits from participation. In addition, and consistent with basic nondiscrimination principles applied in other contexts, OCR notes that individuals have a right to nondiscriminatory consideration for inclusion in a research project but are not entitled to be selected to participate.
Because Federal civil rights laws already prohibit discrimination on the basis of race, color, national origin, disability, or age in all health research programs and activities that receive Federal financial assistance and prohibit discrimination on the basis of sex in all health research programs conducted by colleges and universities, application of Section 1557 to health research should impose limited additional burden on covered entities. But including health research under Section 1557 would extend the prohibition against discrimination on the basis of sex to Federally assisted health research programs and activities in non-educational institutions, complementing existing initiatives to increase diversity and inclusion in health research. Moreover, applying the requirements of Section 1557 to Department-conducted health programs and activities, including health research, would hold HHS components to the same standards as recipients of Federal financial assistance, prohibiting discrimination on all bases covered by Section 1557.
OCR also recognizes that research projects are often limited in scope for many reasons, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other nondiscriminatory considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. OCR does not intend for inclusion of health research within the definition of health program or activity to alter the fundamental manner in which research projects are designed, conducted, or funded; nor is OCR proposing to systematically review health research protocols. For example, a medical research institution that is a covered entity may exclude individuals who are a deaf from a clinical trial to investigate a new brain imaging technology for assessing cognitive functioning that relies on auditory stimulation as the test stimulus. This research design would not be discriminatory on the basis of disability because there is a nondiscriminatory justification for excluding individuals who are deaf.
OCR continues to seek comment on programs and activities that should be considered health programs or activities.
Section 1557 extends the grounds for discrimination found in nondiscrimination laws (
The proposed inclusion of sex stereotyping reflects the Supreme Court's holding in
We propose that discrimination on the basis of sex further includes discrimination on the basis of gender identity. OCR has previously interpreted sex discrimination to include discrimination on the basis of gender identity.
As a matter of policy, we support banning discrimination in health programs and activities not only on the bases identified previously, but also on the basis of sexual orientation. Current law is mixed on whether existing Federal nondiscrimination laws prohibit discrimination on the basis of sexual orientation as a part of their prohibitions of sex discrimination. To date, no Federal appellate court has concluded that Title IX's prohibition of discrimination “on the basis of sex”—or Federal laws prohibiting sex discrimination more generally—prohibits sexual orientation discrimination, and some appellate courts previously reached the opposite conclusion.
However, a recent EEOC decision concluded that Title VII's prohibition of discrimination “on the basis of sex” precludes sexual orientation discrimination because discrimination on the basis of sexual orientation necessarily involves sex-based considerations. The EEOC relied on several theories to reach this conclusion: A plain interpretation of the term “sex” in the statutory language, an associational theory of discrimination based on “sex,” and the gender-stereotype theory announced in
The final rule should reflect the current state of nondiscrimination law, including with respect to prohibited bases of discrimination. We seek comment on the best way of ensuring that this rule includes the most robust set of protections supported by the courts on an ongoing basis.
The definition of “qualified interpreter” includes criteria regarding interpreter ethics, including client confidentiality. Because the definition of a qualified interpreter includes adherence to generally accepted interpreter ethics principles, bilingual or multilingual staff who are competent to communicate directly with individuals with limited English proficiency nonetheless may not satisfy a requirement to adhere to such principles. For instance, a bilingual nurse who is competent to communicate in Spanish directly with Spanish-speaking individuals with limited English proficiency may not be a “qualified interpreter” if serving as an interpreter would pose a conflict of interest with the nurse's treatment of the patient.
Section 92.5 proposes that each entity applying for Federal financial assistance, each issuer seeking certification to participate in a Health Insurance Marketplace, and each State seeking approval to operate a State-based Marketplace be required to submit an assurance that its health programs and activities will be operated in compliance with Section 1557 and this part. The regulations implementing Title VI, Title IX, Section 504, and the Age Act all require similar assurances. We modeled the assurance, duration of obligation, and covenants language on the Section 504 regulation, at 45 CFR 84.5. To reduce burden on covered entities, OCR is revising the Assurance of Compliance HHS–690 Form to include all civil rights laws, including Section 1557, with which covered entities must comply.
Section 92.6 proposes provisions addressing remedial action and voluntary action by covered entities. Paragraph (a) proposes that a recipient or State-based Marketplace that has been found to have discriminated on any of the bases prohibited by Section 1557 be required to take remedial action as required by the Director to overcome the effects of that discrimination. The Department, including the Federally-facilitated Marketplaces, like recipients and State-based Marketplaces, is also obligated to address discrimination, but is subject to a different remedial process than recipients and State-based Marketplaces.
Proposed paragraph (b) permits, but does not require, all covered entities to take voluntary action in the absence of a finding of discrimination to overcome the effects of conditions that result or
Proposed § 92.7 outlines the requirement for covered entities that employ 15 or more persons to designate a responsible employee and adopt grievance procedures. The implementing regulations for Section 504 and Title IX contain such requirements. Moreover, through its case investigative experience, OCR has observed that the presence of a coordinator and a grievance procedure help to bring concerns to prompt resolution within the entity, leading to lower compliance costs and more efficient outcomes. We thus propose in this provision to apply these requirements to all bases of prohibited discrimination.
Paragraph (a) proposes that covered entities that employ 15 or more persons designate at least one employee to coordinate compliance with the requirements of the rule. A covered entity that has already designated a responsible employee pursuant to the regulations implementing Section 504 or Title IX may use that individual to coordinate its efforts to comply with Section 1557 or this part, provided that the scope of the individual's responsibilities is modified to include all prohibited bases of discrimination included in Section 1557 and other duties as required by Section 1557 or this part. For the Department, including Federally-facilitated Marketplaces, OCR will be deemed the responsible employee.
Paragraph (b) proposes that covered entities that employ 15 or more persons be required to adopt grievance procedures and appropriate due process standards that would allow for the prompt and equitable resolution of complaints concerning actions prohibited by Section 1557 and this part. Covered entities that already have a grievance procedure in place pursuant to the regulation implementing Section 504 may use that procedure to address claims under Section 1557 or this part, provided that the existing procedure meets the standards established under the Section 504 regulation. In addition, covered entities may use that procedure to address all other Section 1557 claims, provided that that procedure meets the standards under the Section 504 regulation and that the procedure is modified to apply to race, color, national origin, sex, and age discrimination claims. For the Department, including Federally-facilitated Marketplaces, the procedures for addressing complaints of discrimination on the grounds covered under Section 1557 will be deemed grievance procedures.
OCR is considering requiring that all covered entities, not just those that employ 15 or more persons, designate a responsible employee and establish grievance procedures. While Section 504 limits these requirements to recipients with 15 or more employees, Title IX applies them to all recipients that operate educational programs or activities, regardless of the size of the recipient. Following the approach of Title IX would lead to a broader application under Section 1557 that would benefit more individuals by reaching more covered entities and allowing covered entities to address any potential compliance issues at an earlier stage and in a less formal manner than an OCR investigation. We invite comment on this proposal, including any associated costs and benefits.
Section 92.8 proposes that each covered entity take initial and continuing steps to notify beneficiaries, enrollees, applicants, or members of the public of certain important information. We modeled this section generally after the notice requirements found in regulations implementing Title VI, Title IX, Section 504, and the Age Act, which require covered entities to have a notice in place.
Paragraphs (a)(1)–(7) of § 92.8 propose the components of the notice that each covered entity is required by § 92.8(b) and (f) to post.
Paragraph (a)(1) proposes that the notice include that the covered entity does not discriminate on the basis of race, color, national origin, sex, age, or disability.
Paragraphs (a)(2) and (a)(3) propose that the notice include a statement that the covered entity provides auxiliary aids and services, free of charge, in a timely manner, to individuals with disabilities, when such aids and services are necessary to provide an individual with a disability an equal opportunity to benefit from the entity's health programs or activities; and language assistance services, free of charge, in a timely manner, to individuals with limited English proficiency, when those services are necessary to provide an individual with limited English proficiency meaningful access to a covered entity's health programs or activities. These provisions are necessary to ensure that individuals are aware of their rights under the law, and are grounded in OCR's experience that failures of communication based on the absence of auxiliary aids and services and language assistance services raise particularly significant compliance concerns. In addition, such failures of communication often are a primary contributor to limitations in access to health programs and activities for individuals with disabilities and individuals with limited English proficiency. Apprising individuals of the availability of communication assistance under Section 1557 will promote both compliance with the law and better health outcomes.
Paragraph (a)(4) proposes that the notice include information on how an individual can access the aids and services referenced in (a)(2) and (a)(3).
Paragraph (a)(5) proposes that the notice provide contact information for the responsible employee, where such a responsible employee is required by § 92.7(a).
Paragraph (a)(6) proposes that the notice include the availability of the grievance procedure, where such a grievance procedure is required by § 92.7(b), and information on how to file a grievance.
Paragraph (a)(7) proposes that the notice provide information on how to file a complaint with OCR. Inclusion of this requirement ensures that covered entities inform individuals about the enforcement mechanisms outside of the covered entity's internal process.
Paragraph (b) provides that within 90 days of the effective date of this part, each covered entity shall post the notice, consistent with paragraph (f) of this section, that conveys the information in English in paragraph (a)(1) through (7) of this section.
Paragraph (c) provides that the Director shall make available an electronic sample notice in English that contains the content listed in, and meets the requirements of, paragraphs (a)(1) through (7). Covered entities may use this sample notice or may develop their own notices that meet the requirements of paragraphs (a)(1) through (7). We request comment on the sample notice included in Appendix A to this proposed rule.
OCR also invites comment on whether this proposed rule should permit covered entities to combine the content of the notice required under the proposed rule with the content of other notices that covered entities may be required to disseminate or post under Federal laws and, if so, what steps covered entities may or should take to
Paragraph (c) also proposes that the Director shall translate the sample notice into the top 15 languages
Under our proposed approach, covered entities are encouraged, but not required, to post one or more of the translated notices, particularly in the most prevalent languages spoken by individuals with limited English proficiency in the covered entities' geographic service areas, as determined by the covered entities. Covered entities also may make the notice available in non-English languages other than the top 15 languages for which translated notices are provided by the Director. We encourage covered entities to make the content of the notice available in additional non-English languages to inform national origin groups within covered entities' geographic service areas of their rights under Section 1557 and this proposed rule.
In lieu of this approach, OCR considered requiring, rather than merely encouraging, covered entities to post one or more of the notices in the most prevalent non-English languages frequently encountered by covered entities in their geographic service areas, such as Spanish. This option would leverage the OCR-translated notices and improve, for certain national origin populations, access to the information in the notice in a language that those individuals with limited English proficiency could understand. The main disadvantage of this option is the burden of using physical wall space to post notices and using information technology staff/resources for web posting of notices and printing of notices. For the purposes of this proposed rule, we believe the availability of the taglines that § 92.8(d) of this proposed rule requires covered entities to post strikes an appropriate balance. We seek comment on the alternate approach.
With regard to the proposal that the Director provide translations of the sample notice, we selected the top 15 languages spoken by individuals with limited English proficiency nationally as a data driven policy. This scope reaches nearly 90 percent of individuals with limited English proficiency in the United States based on the U.S. Census Bureau's 2011 to 2013 data—the most recent three-year data available—that estimates the prevalence of foreign-language speakers who speak English less than “very well.” We will review U.S. Census Bureau data more recent than 2011 to 2013, as the data becomes available, to determine if and when the top 15 languages spoken nationally by individuals with limited English proficiency change, warranting the Director to make available notices translated in additional non-English languages.
Paragraph (d) proposes that within 90 days of the effective date of this part, each covered entity shall post, consistent with paragraph (f) of this section, taglines in the top 15 languages spoken nationally by individuals with limited English proficiency.
Paragraph (e) proposes that the Director shall make available taglines in the top 15 languages spoken nationally by individuals with limited English proficiency for use by covered entities. Taglines have a high utility as a gateway to language assistance services: They are written in non-English languages that individuals with limited English proficiency can understand, inform those individuals how to access language assistance services, and encourage those individuals to identify themselves and the languages in which they communicate.
We request comment on the content of the sample tagline included in Appendix B to this proposed rule. As with our approach to making available translated notices, assigning to OCR the responsibility to provide translated taglines maximizes efficiency and economies of scale. This approach means that covered entities will receive the benefits of having multi-language taglines available without incurring the associated translation costs. For this reason, we anticipate covered entities will use the translated taglines that the Director makes available. Covered entities are not limited to posting taglines in the 15 languages made available by the Director; covered entities may provide taglines in as many other non-English languages as appropriate to alert national origin groups in the covered entity's geographic service area of language assistance services that may be available.
Paragraph (f) of this section prescribes the location for posting both notices and taglines. Specifically, the proposed rule requires that covered entities post the English-language notice required by § 92.8(a) and (b) and the taglines required by § 92.8(d) in a conspicuously-visible font size in: Significant publications or significant communications targeted to beneficiaries, enrollees, applicants, or members of the public, which may include patient handbooks, outreach publications, or written notices pertaining to rights or benefits or requiring a response from an individual; in conspicuous physical locations; and in a conspicuous location on the home page of a covered entity's Web site. Section 92.8(f) specifically states that a
We propose to require the notice and taglines on a covered entity's Web site to be located conspicuously on the home page so that individuals, generally, are aware of their rights, and individuals with limited English proficiency do not have to navigate English-only text to find information in the individual's language. Covered entities may satisfy the requirement to post the notice on the covered entity's Web site by including a link in a conspicuous location on the covered entity's home page that immediately directs the individual to the content of the notice on the covered entity's Web site. Covered entities may satisfy the requirement to post taglines on the covered entity's Web site by including web links conspicuously on the home page that identify each of the 15 non-English languages, written “in language,” and that direct the individual to the full text of the tagline indicating how the individual may obtain language assistance services. For instance, a tagline web link directing a Spanish-speaking individual with LEP to a Spanish-language tagline should appear as “Español” rather than “Spanish.” Similarly, a tagline directing an individual to a Web site with the full text of a tagline written in Haitian Creole should appear as “Kreyòl Ayisien” rather than “Haitian Creole.” Providing tagline web links and the text of taglines in their respective non-English languages is of particular importance for languages that do not use a Latin script.
Covered entities that distribute general or major publications targeted to beneficiaries, enrollees, applicants, or members of the public will need to update these publications to include the new notice. However, we propose allowing entities to exhaust their current stock of hard copy publications, rather than requiring a special printing of the publications to include the new notice. When covered entities restock their printed materials, they will be expected to include in those printed materials the notice that we are promulgating with the final rule.
Because the top 15 languages spoken by individuals with limited English proficiency nationally may be over-inclusive or under-inclusive of the languages spoken by individuals with limited English proficiency within the areas served by covered entities' health programs and activities, OCR considered a State-based methodology for identifying the languages in which covered entities would be required to post taglines. For instance, we considered proposing a requirement for entities to make available taglines in the top 15 languages spoken statewide, rather than nationwide, by individuals with limited English proficiency. Identifying a State-based threshold aligns with Federal regulations governing the Health Insurance Marketplaces and qualified health plan
To reduce the burden on covered entities, proposed subsection (g) of this section states that a covered entity's compliance with § 92.8 satisfies the notice requirements under HHS' Title VI, Section 504, Title IX, and Age Act regulations. We request comment on OCR's proposal to treat compliance with § 92.8 as satisfying the notice requirements under the regulations implementing Title VI, Section 504, Title IX, and the Age Act.
Subpart B of the proposed rule incorporates regulatory provisions implementing the civil rights statutes referenced in Section 1557(a): Title VI, Title IX, the Age Act, and Section 504.
Proposed § 92.101 of subpart B prohibits discrimination on the basis of race, color, national origin, sex, age, or disability under any health program or activity to which Section 1557 or this part applies. Paragraphs (a) and (b) of § 92.101 follow the structure of the implementing regulations for Title VI, Section 504, Title IX, and the Age Act by including a general nondiscrimination provision in paragraph (a) followed by a provision identifying specific discrimination prohibited in paragraph (b). Exceptions to discrimination prohibited under the Title VI, Section 504, and Age Act regulations are addressed in paragraph (c). Paragraph (d) effectuates technical changes in terminology to apply the provisions incorporated from other regulations to the covered entities obligated to comply with this proposed rule.
In paragraph (a)(1) of § 92.101, we restate the core objective of Section 1557(a), which prohibits discrimination on the grounds prohibited under Title VI (race, color, or national origin), Title IX (sex), the Age Act (age), or Section 504 (disability) in any health program or activity to which this part applies.
In paragraph (a)(2), we propose to limit the ways in which the proposed rule applies to employment. Except as provided in § 92.208, which addresses employee health benefit programs, this proposed rule does not apply to discrimination by a covered entity against its own employees. Thus, this proposed rule would not extend to hiring, firing, promotions, or terms and conditions of employment outside of those identified in § 92.208; such claims would continue to be brought under other laws, including Title VII of the Civil Rights Act of 1964,
Proposed paragraph (b) incorporates into this proposed regulation the specific discriminatory actions prohibited by each civil rights statute which Section 1557 references. We considered harmonizing each of the specific discriminatory actions prohibited across each civil rights law addressed by Section 1557. Although harmonization could reduce redundancy in the specific discriminatory actions incorporated that are similar to one another, harmonization would likely lead to confusion and unintended differences in interpretation that are subtle yet significant. For example, with respect to the separate or different treatment prohibited under the Title VI regulation, such as at 45 CFR 80.3(b)(1)(iii) and (vi), the Section 504 regulation at 45 CFR 84.4(b)(1)(iv), 85.21(b)(1)(iv) requires separate or different treatment in some instances where it is necessary to provide persons with disabilities with aids, benefits or services that are as effective as those provided to others. To avoid confusion and unintended differences in interpretation, therefore, paragraphs (b)(1)–(4) incorporate into this proposed regulation the specific discriminatory actions prohibited under each civil rights law on which Section 1557 is grounded. Thus, for example, the specific discriminatory actions listed under Title VI are incorporated here to govern the obligations of covered entities not to discriminate based on race, color, or national origin. We seek comments on this proposed approach.
Proposed paragraph (b)(1) of § 92.101 adopts the specific discriminatory actions prohibited by the Title VI implementing regulation, which appear in 45 CFR 80.3(b)(1) through (6).
Proposed paragraph (b)(2)(i) of § 92.101 addresses the specific prohibition of discrimination on the basis of disability with which recipients and State-based Marketplaces must comply. This paragraph adopts relevant provisions in the Section 504 implementing regulation for Federally assisted programs and activities at 45 CFR part 84. The provisions incorporated are the specific discriminatory actions prohibited at § 84.4(b); the program accessibility provisions at §§ 84.21 through 84.23(b); and the provisions governing education, health, welfare, and social services at §§ 84.31, 84.34, 84.37, 84.38, and 84.41–84.55. We do not propose adopting the program accessibility provision at § 84.23(c), addressing conformance with the Uniform Federal Accessibility Standards for the construction and alteration of facilities, because these standards are outdated. Section 92.203 of this proposed rule requires compliance with more contemporary standards.
Paragraph (b)(2)(ii) of § 92.101 addresses the specific prohibitions of discrimination on the basis of disability with which the Department, including the Federally-facilitated Marketplaces, must comply. This paragraph adopts relevant provisions in the Section 504 implementing regulation for Federally administered programs and activities at 45 CFR part 85. The provisions adopted are the specific discriminatory actions prohibited at § 85.21(b) and the program accessibility provisions at §§ 85.41 through 85.42 and 84.44 through 84.51.
Paragraph (b)(3) of § 92.101 adopts the specific discriminatory actions prohibited by the Title IX implementing regulation, which appear at 45 CFR 86.3(b)(1) through (8).
Paragraph (b)(4) of § 92.101 adopts the specific discriminatory actions prohibited by the Age Act implementing regulation, which appear at 45 CFR 91.11(b).
Paragraph (b)(5) of § 92.101 states that the specific discriminatory actions prohibited in § 92.101(b)(1) through (4) do not limit the general prohibition of discrimination in § 92.101(a). This statement is consistent with regulatory provisions in the implementing regulations for Title VI at 45 CFR 80.3(b)(5) and the Age Act at 45 CFR 91.11(c).
Paragraph (c) of § 92.101 incorporates the exceptions to the general prohibition of discrimination that appear in the implementing regulations for Title VI, Section 504, and the Age Act, as these exceptions have applied to health programs and activities for nearly 40 years. Generally, the exceptions in the Title VI, Section 504, and Age Act implementing regulations provide that it is not discriminatory to exclude a person from the benefits of a program that Federal law or executive order limits to a protected class. For instance, we incorporate the exceptions in the Age Act implementing regulation which address, among other things, age distinctions in Departmental regulations, and actions based on age where age is a factor necessary to the normal operation or achievement of a statutory objective of a program or activity. This would include allowable age rating under the ACA where issuers may vary premium rates based on age within a 3:1 ratio.
Paragraph (c) of § 92.101 does not address the sex-based distinctions authorized in Title IX and its implementing regulation in the context of education programs or activities. As discussed previously, given Title IX's limitation to education programs and activities, these distinctions do not necessarily apply in the health care context.
Title IX and its implementing regulation allow some single-sex education programs (
HHS does not propose to prohibit separate toilet, locker room, and shower facilities where comparable facilities are provided to individuals, regardless of sex. However, we continue to seek comment on what other sex-based distinctions, if any, should be permitted in the context of health programs and activities and the standards for permitting the distinctions (see also the previous discussion of § 92.2 regarding the application of this proposed rule). Examples of sex-based distinctions include a women's health clinic or a counseling program limited to male victims of domestic violence.
Finally, paragraph (d) of § 92.101 effectuates technical changes to apply the provisions incorporated in § 92.101(b) and (c) to covered entities obligated to comply with this proposed rule by, among other things, replacing references to “recipient” in the incorporated provisions with “covered entity.”
Section 1557 is unique among Federal civil rights laws in that it specifically addresses discrimination in health programs and activities. To provide additional specificity regarding nondiscrimination requirements in this setting, Subpart C builds upon pre-existing civil rights regulations referenced in Subpart B. Due to the nature and importance of health care, health-related insurance, and other health-related coverage to individuals and communities, OCR is proposing these additional specific requirements to ensure that covered entities have clear instruction in areas where OCR, through its enforcement work, has seen significant discrimination issues and complaints. We believe that these specific requirements will best assist covered entities in meeting their obligations and explain to individuals the scope of some of the protections afforded by Section 1557. We seek comment on this approach.
Proposed § 92.201 effectuates Section 1557's prohibition of national origin discrimination as it affects individuals with limited English proficiency in health programs and activities of covered entities. About 25 million individuals in the United States, or about 8.5 percent, have limited proficiency in English.
For individuals with limited English proficiency, lack of proficiency in English—and the use of non-English languages—is a direct outgrowth of, and is integrally tied to, their national origins.
It is thus well-established under Title VI and its implementing regulation that a prohibition on national origin discrimination requires covered entities to take reasonable steps to provide meaningful access to individuals with limited English proficiency.
[T]here is no equality of treatment merely by providing [limited English proficient] students with the same facilities, textbooks, teachers, and curriculum [as their English speaking peers]; for students who do not understand English are effectively foreclosed from any meaningful education. . . . We know that those who do not understand English are certain to find their classroom experiences wholly incomprehensible and in no way meaningful.
Based on these principles, OCR proposes § 92.201 to require covered entities to take reasonable steps to provide meaningful access to health programs and activities for all persons regardless of national origin. Specifically, proposed paragraph (a) of § 92.201 incorporates the Title VI standard, and paragraph (b) identifies requirements for the Director's evaluation of a covered entity's compliance with paragraph (a). Proposed paragraph (c) contains requirements for language assistance services, and proposed paragraph (d) includes specific requirements for oral interpretation. Proposed paragraph (e) sets forth restrictions on covered entities' use of certain persons to interpret for, or facilitate communication with, individuals with limited English proficiency. Proposed paragraph (f) provides that no individual with limited English proficiency shall be required to accept language assistance services. Each paragraph is described further as follows.
Proposed § 92.201(a) adopts the well-established principle that covered entities must take reasonable steps to provide meaningful access to health programs and activities for all individuals with limited English proficiency that they serve or encounter in their health programs or activities.
Because it incorporates long-standing principles under Title VI, the standard we propose in paragraph (a) provides familiarity and consistency for covered entities about the scope of their obligations. As we stated in the Department's initial policy guidance released in 2000 on the Title VI prohibition of national origin discrimination with respect to persons with limited English proficiency:
The key to providing meaningful access for LEP persons is to ensure that the recipient/covered entity and LEP person can communicate effectively. The steps taken by a covered entity must ensure that the LEP person is given adequate information, is able to understand the services and benefits available, and is able to receive those for which he or she is eligible. The covered entity must also ensure that the LEP person can effectively communicate the relevant circumstances of his or her situation to the service provider.
Further, the standard balances two core principles critical in effectuating Section 1557's prohibition of national origin discrimination.
The first principle is that the Department must “ensure that [health programs and activities] aimed at the American public do not leave some behind simply because they face challenges communicating in English.”
The second principle is that the level, type and manner of language assistance services required under paragraph (a) should vary based on the relevant facts, which may include the operations and capacity of the covered entity.
For these reasons, proposed § 92.201(b) identifies how the Director will evaluate whether a covered entity has met the requirement in paragraph (a).
Section 92.201(b)(2)(i) and (ii) identify the length, complexity, and context of the communication as potentially relevant factors in a particular case. Where a communication is particularly long or complex, for example, a covered entity might be required to provide a means for an individual with limited English proficiency to be able to refer back to the information communicated through, for instance, a document written in the individual's primary language or an audio file of the information conveyed orally in the individual's primary language.
The prevalence of the primary language, among those eligible to be served or likely to be encountered by the health program or activity, in which the individual with limited English proficiency communicates, identified in paragraph (b)(2)(iii) of § 92.201, might also be relevant in a particular case. Where an individual with limited English proficiency speaks a language that has a low prevalence among those eligible to be served or likely to be encountered by the health program or activity, the covered entity might, for example and depending on other relevant factors, satisfy its obligations by providing, rather than a written document translated verbatim, a qualified interpreter who reads the brochure and provides an oral interpretation of the brochure into the non-English language.
The resources available to the covered entity and the costs of language assistance services might also be relevant in a particular case. Where the Director considers an entity's resources, he or she will evaluate all available resources, including the entity's capacity to leverage resources among its partners or to use its negotiating power to lower the costs at which language assistance services could be obtained.
Proposed § 92.201(c) makes clear that language assistance services required under paragraph (a) must be provided free of charge, be accurate and timely, and protect the privacy and independence of the individual with limited English proficiency.
Proposed § 92.201(d) addresses standards applicable to oral interpretation. In particular, this paragraph provides that when a covered entity is required by proposed § 92.201(a) to provide oral interpretation as a reasonable step to provide meaningful access to an individual with limited English proficiency, the covered entity must offer that individual a qualified interpreter. As defined in § 92.4, a qualified interpreter for an individual with limited English proficiency possesses certain characteristics and skills necessary for him or her to interpret competently and effectively under the circumstances and
Proposed § 92.201(e) identifies restrictions on the use of certain persons to provide language assistance services for an individual with limited English proficiency. This paragraph applies in addition to, and regardless of, the appropriate level, type or manner of language assistance services a covered entity is required to provide. As some RFI commenters shared, the use of incompetent or ad hoc interpreters, such as family members, friends, and children, is not uncommon and can have negative implications. Thus, proposed paragraph (e)(1) of § 92.201 prohibits a covered entity from requiring an individual with limited English proficiency to provide his or her own interpreter. Proposed paragraphs (e)(2)(i) and (ii), however, identify narrow and finite situations in which a covered entity may rely on an adult accompanying an individual with limited English proficiency to interpret. Proposed paragraph (e)(3) prohibits a covered entity from relying on a minor child to interpret or facilitate communication and identifies an exception to this prohibition that is narrower in scope than the exception identified in (e)(2)(i) and (ii).
The provisions of § 92.201(d) and (e) codify standards described in the Department's LEP Guidance regarding the use of family members or friends as interpreters or to facilitate communication.
In lieu of the approach we propose in § 92.201(d) and (e), OCR considered proposing that all covered entities have the capacity to provide, in their health programs or activities, qualified interpreters for individuals with limited English proficiency through telephonic oral interpretation services available in at least 150 non-English languages. We considered proposing this requirement to ensure that every covered entity could provide a base level of cost-effective language assistance services to the nation's increasingly linguistically diverse populations. This alternate approach, relative to the approach we propose in § 92.201(d) and (e), likely would improve access to health programs and activities for individuals with limited English proficiency; would improve the clarity of covered entities' obligations when communicating orally with individuals; and would mirror the requirement for Health Insurance Marketplaces and qualified health plan issuers to provide telephonic oral interpretation services described further below.
Despite these benefits, we were concerned with proposing an overly prescriptive approach that regulated the manner in which covered entities take reasonable steps to provide meaningful access to individuals with limited English proficiency, given the range in the types, sizes, and service areas of covered entities' health programs and activities regulated by Section 1557 and this proposed rule. We seek comment on what oral interpretation services, if any, we should require and how such approaches appropriately balance the provision of meaningful access to individuals with limited English proficiency while preserving covered entities' flexibilities to identify the means of providing such access.
Even without a requirement in this proposed rule to provide telephonic oral interpretation services, OCR expects that most entities will, at a minimum, have the capacity to provide individuals with limited English proficiency with qualified interpreters remotely, given the widespread commercial availability of relatively low-cost language assistance services such as remote oral interpretation via telephone, as well as the nature and importance of covered entities' health programs or activities.
Proposed paragraph (f) provides that no individual with limited English proficiency shall be required to accept language assistance services, consistent with an individual's right to self-determination. Paragraph (f) also demonstrates the corollary that a covered entity cannot coerce an individual to decline language assistance services. If an individual with LEP voluntarily declines an offer of language assistance services from the covered entity, a covered entity could denote, in the individual's file or records, the language assistance services offered and the declination.
Covered entities, including Health Insurance Marketplaces, Medicaid programs, and qualified health plan issuers, are reminded that independent of proposed § 92.201, they must comply with any applicable language access requirements in other laws and regulations.
Although we believe that the approach of the proposed rule best serves the purposes of the law, we considered a regulatory scheme requiring covered entities to provide meaningful access to each individual with limited English proficiency by providing effective language assistance services, at no cost, unless such action would result in an undue burden or a fundamental alteration of the health program or activity. Under this approach, a covered entity would be able to raise an undue burden or fundamental alteration defense but would be required, if it made this showing successfully, to take another action to provide meaningful access if there was one that was less burdensome or that did not fundamentally alter the nature of the health program or activity.
We also considered a regulatory scheme that would require a predetermined range of language assistance services in certain non-English languages. The language assistance services required and the languages required would vary based on certain factors, such as whether the covered entity is of a certain type or size, has frequent contact with individuals with limited English proficiency, or operates particularly important health programs or activities, among other potential factors. Under this approach, instead of requiring the Director to evaluate each case on its particular facts, the Director would evaluate a covered entity's compliance based on whether the entity provided the range of language assistance services in the non-English languages specified. Potential categories of covered entities that could have enhanced obligations to provide language assistance services under this alternative approach could include State agencies administering Medicaid or CHIP, Health Insurance Marketplaces, or the Department in its operation of its health programs or activities. Other potential categories could include the following types of covered entities that have a minimum number of beds, employees, or locations: Hospitals, nursing homes or skilled nursing facilities, home health agencies, and retail pharmacies (including mail-order pharmacies). We seek comment on whether certain categories of covered entities should have enhanced obligations to provide language assistance services and, if so, what characteristics of covered entities should define these categories.
We also considered a regulatory scheme requiring covered entities to provide a range of language assistance services in the non-English languages spoken by State-wide populations with limited English proficiency that meet defined thresholds. Such thresholds would provide a minimum number of non-English languages covered entities would be required to provide in delivering oral interpretation services; requirements for written translation of vital documents and Web site content; and requirements for including taglines on vital documents and on Web sites. For instance, we considered thresholds triggering a requirement to translate standardized vital documents based on number of languages (
We seek comment on whether OCR should require thresholds, and if so, what thresholds should be required, and to what geographic areas or service areas the thresholds should apply. If thresholds should be required, we seek comment on the time that should be allowed for covered entities to come into compliance with the thresholds, including whether this proposed rule should permit covered entities to implement their obligations with a phased-in approach. We also seek comment on other methodologies for formulating language access thresholds that would result in meaningful access for individuals regardless of national origin, while being mindful of the potential burden on covered entities.
We further considered adopting a requirement for covered entities to be systematically prepared to provide language assistance services in their health programs or activities, such as through the establishment of policies and procedures or through other advanced planning mechanisms. In OCR's experience, covered entities are in a better position to meet their obligations to provide language assistance services in a timely manner to individuals with limited English proficiency when those entities identify, in advance, the types and levels of services that will be provided in each of the contexts in which the covered entity encounters individuals with limited English proficiency. Thus, the Department's LEP guidance encourages covered entities to conduct advanced planning through the establishment and implementation of language access plans.
An advanced planning requirement could require each covered entity to identify all resources for providing language assistance services; to annually assess the frequently-encountered or highly prevalent languages in the
OCR solicited information in its Request for Information about covered entities' experience with one mechanism for advanced planning—developing and implementing language access plans. Nearly all of the commenters who responded to the question regarding language access plans had experience developing and implementing plans themselves or providing technical assistance to other organizations that were doing so. Commenters identified benefits, such as: Increasing the likelihood of ensuring nondiscrimination on the basis of national origin with respect to individuals with LEP; facilitating consistent and appropriate language assistance services; and defining clear staff obligations and roles. Most commenters who responded to this question described language access plans or the institution of organizational policies and procedures as simple and non-burdensome. We seek comment on whether § 92.201 should include a requirement for covered entities to be systematically prepared to provide language assistance services in their health programs or activities, and if so what advanced planning mechanisms should be required and why.
Covered entities that are already developing or implementing language access plans, or otherwise assessing their language assistance needs, are encouraged to continue such efforts. Covered entities should be aware, however, that engaging in such planning is not a defense for failing to provide language assistance services to any particular individual, at all or in an untimely manner, if such services are reasonable steps to provide meaningful access. Covered entities that are conducting advanced planning should consider how they can ensure that language assistance services are available in their health programs and activities as they simultaneously improve their operational capacities to provide effective language assistance services into the future.
Proposed § 92.202 incorporates the provisions governing effective communication with individuals with disabilities found in the regulation implementing Title II of the ADA, which applies to State and local government entities.
The amended regulations incorporate longstanding Department of Justice interpretations regarding effective communication with individuals with disabilities under the ADA, which are consistent with OCR's enforcement of Section 504 and are a sound set of standards for incorporation into the Section 1557 regulation.
OCR considered whether to incorporate the standards in the regulation implementing Title II of the ADA or in the regulation implementing Title III of the ADA, or the standards in both regulations. As summarized by the Department of Justice,
OCR proposes to apply the Title II standards to entities covered under the proposed rule. First, State or local government entities that are covered under the proposed rule are already subject to the Title II standards. Second, the other entities covered under the proposed rule are health programs and activities that either receive Federal financial assistance from HHS or are conducted directly by HHS. Although OCR could apply Title II standards to States and local entities and Title III standards to private entities, we believe it is appropriate to hold all recipients of Federal financial assistance from HHS to the higher Title II standards as a condition of their receipt of that assistance. OCR also believes it appropriate to hold HHS itself to the same standards to which the Department subjects the recipients of its financial assistance.
Where the regulatory provisions referenced in § 92.202 use the term “public entity,” that term shall be replaced with “covered entity.”
The Section 504 regulatory provisions incorporated into Subpart B in this proposed regulation contain program accessibility requirements that apply to existing facilities as well as new construction and alterations. This proposed provision establishes specific accessibility standards for new construction and alterations. OCR notes that these standards are consistent with existing standards under the ADA.
Under § 92.203(a) of the proposed rule, each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based marketplace shall comply with the 2010 ADA Standards for Accessible Design (2010 Standards), as defined in 28 CFR 35.104, if construction or alteration was commenced on or after [18 MONTHS FROM DATE OF PUBLICATION OF FINAL RULE]. All newly constructed or altered buildings or facilities subject to this section shall comply with the requirements for a “public building or facility” as defined in Section 106.5 of the 2010 Standards.
Under § 92.101(b)(2)(i) of the proposed rule, new construction and alterations of such facilities are also subject to the new construction standards found in the Section 504 implementing regulation at 45 CFR 84.23(a) and (b). OCR is not incorporating 45 CFR 84.23(c), which treats compliance with the Uniform Federal Accessibility Standards as compliance with 45 CFR 84.23(a) and (b) because the 2010 Standards are more current than the Uniform Federal Accessibility Standards. Moreover, nearly all of the facilities covered under the proposed rule are already subject to the 2010 Standards. This provision will require facilities subject to the ADA and Section 1557 to comply with the same accessibility standards for new construction or alterations.
However, under § 92.203(b) of the proposed rule, each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based Marketplace before [18 MONTHS FROM DATE OF PUBLICATION OF FINAL RULE] in conformance with the Uniform Federal Accessibility Standards, the 1991 Standards, or the 2010 Standards shall be deemed to comply with the requirements of this section and with 45 CFR 84.23 (a) and (b), cross referenced in § 92.101(b)(2)(i) with respect to those facilities. Thus, if the construction or alteration of facilities began prior to the effective date of paragraph (a) of this section, the facilities shall be deemed in compliance if they were constructed or altered in conformance with applicable standards at the time of their construction or alteration.
Under § 92.203(c) of the proposed rule, each building or part of a building that is constructed or altered by or on behalf of, or for the use of, the Department must be designed, constructed, or altered so as to be readily accessible to and usable by individuals with disabilities. The definitions, requirements, and standards of the Architectural Barriers Act, as established in Appendices C and D to 36 CFR part 1191, apply to buildings and facilities covered by this section.
OCR considered adding specific language regarding accessibility standards for medical diagnostic equipment. However, we are aware that the United States Access Board is currently developing standards for accessible medical diagnostic equipment and, therefore, are deferring on proposing specific accessibility standards for medical equipment at this time. Once the United States Access Board standards are promulgated, OCR intends to issue regulations or policies that require covered entities to conform to those standards. We request comment on this proposal. We note that a health program or activity's use of medical diagnostic equipment is covered by Section 1557 and this proposed rule under the general prohibition of discrimination on the basis of disability in § 92.101.
Section 92.204(a) of the proposed rule requires covered entities to ensure that their health programs or activities provided through electronic and information technology are accessible to individuals with disabilities, unless doing so would impose undue financial and administrative burdens or would result in a fundamental alteration in the nature of an entity's health program or activity.
This provision is consistent with existing standards applicable to covered entities. Specifically, Section 508 of the Rehabilitation Act requires that electronic and information technology developed, procured, maintained, or used by Federal agencies be accessible for individuals with disabilities. Section 508 applies to HHS administered health programs or activities, including the Federally-facilitated Marketplaces. Section 504 and the ADA, which apply to recipients of Federal financial assistance, and to State and local government entities and places of public accommodation, respectively, similarly have been interpreted to require that covered entities' programs, services, and benefits provided through electronic and information technology be accessible to individuals with disabilities.
Section 92.204(b) proposes to require State-based Marketplaces and recipients of Federal financial assistance to ensure that their health programs and activities provided through Web sites comply with the accessibility requirements of Title II of the ADA. OCR has decided to adopt Title II requirements for a number of reasons. First, State-based Marketplaces, as State entities, are already subject to the ADA Title II requirements. Second, even though recipients of Federal financial assistance from HHS include both entities covered by Title II of the ADA, as State and local government entities, and entities covered by Title III of the ADA, as places of public accommodation and commercial facilities, we believe it is appropriate to apply one uniform standard to all recipients of Federal financial assistance from HHS under the proposed rule. Further, it is reasonable to hold recipients of Federal financial assistance from HHS to the Title II ADA requirements (rather than those of Title III of the ADA), since Title II is modeled on Section 504, which applies to recipients of Federal financial assistance. Our proposed regulatory text cross-references the Title II regulations as a whole, which would therefore incorporate any future changes to the Title II regulations.
These requirements are informed by this Department's extensive experience with web-based technology through Federal grant-making programs, including programs that provide funds for State infrastructure changes to allow electronic applications for participation in the Medicaid program and the Health Insurance Marketplaces, provider adoption of electronic health records, and the development of web-based curricula for health care professionals.
Based on the Department's prior experience in this field, we believe that including an explicit requirement for electronic and information technology is necessary to clarify the obligations of covered entities to make this technology accessible. In addition, we are concerned that without an explicit requirement for accessible electronic and information technology, people with disabilities will not have opportunities to participate in services, programs, and activities that are equal to and as effective as those provided to others, further exacerbating existing health disparities for persons with disabilities. The RFI yielded numerous comments and concerns about the lack of accessibility of electronic and information technology and the incidents of and potential for discrimination, for example with respect to health information.
OCR initially considered whether to limit the explicit accessibility requirements to a covered entity's Web site only, rather than all of a covered entity's electronic and information technology. However, given the existing requirements under Section 504, Section 508, and the ADA applicable to information provided through electronic and information technology as a whole, and given the importance of such technologies, such as kiosks and applications, to access to health care, health-related insurance and other health-related coverage, we have decided to include an explicit accessibility requirement that applies to all of a covered entity's electronic and information technology. We seek comment on this proposal.
In addition to proposing that Web sites of recipients of Federal financial assistance and State-based Marketplaces comply with the accessibility requirements of Title II of the ADA, OCR also considered requiring all covered entities to ensure that all their electronic and information technology comply with specific accessibility standards, such as standards developed pursuant to Section 508 by the Access Board at 36 CFR part 1194, the Worldwide Web Consortium's Web Accessibility Initiative's WCAG 2.0 AA, or other standards that provide equal or greater accessibility to individuals with disabilities. As part of this alternative, OCR considered whether a phased-in approach to accessibility similar to the one recently taken by the Department of Transportation might be appropriate.
However, this alternative could potentially place a greater burden on recipients of Federal financial assistance and Title I entities. In addition, we are aware that the Access Board is in the process of amending and updating the Section 508 standards applicable to electronic and information technology. Given these developments and circumstances, we are proposing a general accessibility performance standard for electronic and information technology, rather than a requirement for conformance to a specific set of accessibility standards. The application of this general accessibility performance standard will be informed by future rulemaking by the Access Board and the Department of Justice. We seek comment on whether the regulation should impose a general accessibility performance standard for electronic and information technology or require that electronic and information technology comply with a specific set of standards, such as the Section 508 or WCAG standards.
As noted, under the proposed rule, covered entities must make their health programs and activities provided through electronic and information technology accessible, unless doing so would impose undue financial and administrative burdens or would result in a fundamental alteration in the nature of the health program or activity. In determining whether an action would be an undue burden, a covered entity must consider all resources available for use in the funding or operation of the health program or activity.
When undue financial and administrative burdens or a fundamental alteration are determined to exist, the covered entity is still required to provide information in a format other than an accessible electronic format that would not result in such undue financial and administrative burdens or a fundamental alteration, but would ensure, to the maximum extent possible, that individuals with disabilities receive the benefits or services of the health program or activity that are provided through electronic and information technology.
Section 92.205 of the proposed rule provides that a covered entity shall make reasonable modifications in policies, practices, or procedures when necessary to avoid discrimination on the basis of disability, unless the covered entity can demonstrate that the modification would fundamentally alter the nature of the health program or activity. This provision is consistent with the U.S. Supreme Court's decision interpreting Section 504 in
Section 92.206 proposes that covered entities be required to provide individuals equal access to their health programs or activities without discrimination on the basis of sex and proposes that covered entities treat individuals consistent with their gender identity. This provision applies to all health programs and activities, and prohibits, among other forms of adverse treatment, the denial of access to facilities administered by the covered entity. This proposed approach is consistent with the principle that discrimination on the basis of sex includes discrimination on the basis of gender identity and that failure to treat individuals in accordance with their gender identity may constitute prohibited discrimination. It is also consistent with recent guidance issued and enforcement actions taken by the U.S. Department of Education, the U.S. Department of Justice, and the Equal Employment Opportunity Commission.
The limited exception to the requirement that covered entities treat individuals consistent with their gender identity is that a covered entity may not deny or limit health services that are ordinarily or exclusively available to individuals of one gender based on the fact that the individual's sex assigned at birth, gender identity, or gender otherwise recorded in a medical record or by a health insurance plan is different from the one to which such health services are ordinarily or exclusively available. The exception applies only in limited circumstances. For example, a covered entity may not deny an individual treatment for ovarian cancer where the individual could benefit medically from the treatment, based on the individual's identification as a transgender male.
Section 92.207 of the proposed rule emphasizes and provides specific details regarding the prohibition of discrimination on the basis of race, color, national origin, sex, age, or disability in the provision and administration of health-related insurance or other health-related coverage. This prohibition applies to all covered entities that provide or administer health-related insurance or other health-related coverage, including health insurance issuers and group health plans that are recipients of Federal financial assistance and the Department in the administration of its health-related coverage programs. This section is independent of, but complements, the nondiscrimination provisions at 45 CFR 155.120(c)(1) and (2) that apply to the Health Insurance Marketplaces and 45 CFR 156.200(e) that apply to issuers of qualified health plans through the Health Insurance Marketplaces with respect to their qualified health plans. These provisions prohibit discrimination on the basis of race, color, national origin, disability, age, sex, gender identity or sexual orientation, and entities covered under them and Section 1557 are obligated to comply with both sets of requirements.
Based on the longstanding civil rights principles discussed in connection with the definition of “health program or activity” in § 92.4 of this proposed rule, we propose to apply this part to all issuers that receive Federal financial assistance, whether those issuers' products are offered through the Marketplace, outside the Marketplace, in the individual or group health insurance markets, or as an employee health benefit program through an employer-sponsored group health plan. Thus, for example, an issuer that participates in the Marketplace and thereby receives Federal financial assistance, and that also offers plans outside the Marketplace, will be covered by the proposed regulation for all of its health plans, as well as when it acts as a third party administrator for an employer-sponsored group health plan.
Paragraph (a) of the proposed rule provides a general nondiscrimination requirement, and paragraph (b) provides specific examples of prohibited actions. Paragraphs (b)(1) and (2) address the prohibition on denying, cancelling, limiting, or refusing to issue or renew a health-related insurance plan or policy or other health-related coverage on the basis of an enrollee's or prospective enrollee's race, color, national origin, sex, age, or disability, and the use of marketing practices or benefit designs that discriminate on these bases.
The proposed rule does not require plans to cover any particular benefit or service, but a covered entity cannot have a coverage policy that operates in a discriminatory manner. For example, a plan that covers inpatient treatment for eating disorders in men but not women would not be in compliance with the prohibition of discrimination based on sex. Similarly, a plan that covers bariatric surgery in adults, but excludes such coverage for adults with particular developmental disabilities would not be in compliance with the prohibition on discrimination based on disability.
Paragraphs (b)(3) through (5) of the proposed rule specifically address discrimination faced by transgender individuals in accessing coverage of health services. We propose in paragraph (b)(3) that to deny or limit coverage, deny a claim, or impose additional cost sharing or other limitations or restrictions, on any health service is impermissible discrimination when the denial or limitation is due to the fact that the individual's sex assigned at birth, gender identity, or gender otherwise recorded by the plan or issuer is different from the one to which such services are ordinarily or exclusively available.
In addition, many health-related insurance plans or other health-related coverage, including Medicaid programs, currently have explicit exclusions of coverage for all care for beneficiaries related to gender dysphoria or associated with gender transition. Historically, covered entities have justified these blanket exclusions by categorizing transition-related treatment as cosmetic or experimental.
For similar reasons, an increasing number of states, including, California,
OCR proposes to apply basic nondiscrimination principles in evaluating whether a covered entity's denial of a claim for coverage of treatment related to transition-related care is the product of discrimination. Based on these principles, an explicit, categorical (or automatic) exclusion of coverage for all health services related to gender transition is unlawful on its face under paragraph (b)(4); in singling out the entire category of services and treatments for transition-related care, such an exclusion systematically denies services and treatments for transgender individuals and is prohibited discrimination on the basis of sex.
Moreover, we propose in § 92.207(b)(5) to bar a covered entity from denying or limiting coverage, or denying a claim for coverage, for specific health services related to gender transition where such a denial or limitation results in discrimination against a transgender individual. In evaluating whether it is discriminatory to deny or limit a request for coverage of a particular service for an individual seeking the service as part of transition-related care, OCR will start by inquiring whether and to what extent coverage is available when the same service is not related to gender transition. If, for example, a health plan or State Medicaid agency denies a claim for coverage of a hysterectomy that a patient's provider says is medically necessary to treat gender dysphoria, OCR will evaluate the extent of the plan's coverage of hysterectomies under other circumstances. OCR will also carefully scrutinize whether the covered entity's explanation for the denial or limitation of coverage for transition-related care is legitimate and not a pretext for discrimination.
These provisions do not, however, affirmatively require covered entities to cover any particular procedure or treatment for transition-related care; nor do they preclude a covered entity from applying neutral standards that govern the circumstances in which it will offer coverage to all its enrollees in a nondiscriminatory manner.
We invite comment as to whether the approach of § 92.207(b)(1)–(5) is over or under inclusive of the types of potentially discriminatory claim denials experienced by transgender individuals in their attempts to access coverage and care, as well as on how nondiscrimination principles apply in this context.
Paragraph (c) of § 92.207 provides that the enumeration of specific forms of discrimination in paragraph (b) does not limit the general applicability of the prohibition in paragraph (a) of this section. Paragraph (d) of the proposed rule provides that nothing in § 92.207 is intended to determine, or restrict a covered entity from determining, whether a particular health care service is medically necessary or otherwise meets applicable coverage requirements in any individual case.
Proposed Section 92.208 addresses the application of Section 1557 to employers that offer health benefit programs to their employees. Under our proposed approach, where an entity that receives Federal financial assistance provides an employee health benefit program to its employees, it will be liable for discrimination in that employee health benefit program under this part only in the following circumstances:
(a) The entity is principally engaged in providing or administering health services or health insurance coverage;
(b) The entity receives Federal financial assistance the primary objective of which is to fund the entity's employee health benefit program; or
(c) The entity is not principally engaged in providing or administering health services or health insurance coverage but operates a health program or activity (which is not an employee health benefit program) that receives Federal financial assistance; except that in such cases, the entity is accountable under this part with regard to the provision or administration of employee health benefits only to the employees in that health program or activity.
Under § 92.208(a) of the proposed rule, where an employer is principally engaged in providing or administering health services or health coverage and receives Federal financial assistance, the employer will be subject to Section 1557 in its provision or administration of employee health benefit programs to its employees. Thus, if a hospital provides health benefits to its employees, it will be covered by Section 1557 not only for the services it offers to its patients or other beneficiaries but also for the health benefits it provides to its employees.
Under proposed § 92.208(b), where an entity receives Federal financial assistance the primary objective of which is to fund an employee health benefit program, that entity's provision or administration of the health benefit program will be covered by Section 1557 regardless of the business in which the entity is engaged. Where, for example, an entity receives Federal financial assistance that is specifically designated to support its employee wellness program, this part will apply to the entity's administration of that wellness program.
Proposed § 92.208(c) seeks to clarify that an employer that is not principally
In summary, unless the primary purpose of the Federal financial assistance is to fund employee health benefits, we propose to not apply Section 1557 to an employer's provision of employee health benefits where the provision of those benefits is the only health program or activity operated by the employer. If, for example, a community organization that exclusively offers a legal clinic receives Federal financial assistance, and the organization uses grant funds to support personnel costs, including employee health benefits, Section 1557 would not apply to the organization's provision of employee health benefits.
Absent the limitations this rule proposes in § 92.208, employers that receive Federal financial assistance for any purpose could be held liable for discrimination in the employee health benefit programs they provide or administer, where those employers are not otherwise engaged in a health program or activity and where the use of Federal funds for employee health benefits is merely incidental to the purpose of the assistance. We believe that claims of discrimination in such benefits, brought against employers that do not operate other health programs or activities, are better addressed under other applicable laws.
We propose to apply the same analysis of employer liability under Section 1557 whether the employee health benefit program is self-insured or fully-insured by the employer. Where an employer that would otherwise be covered under this section creates a separate legal entity to administer its employee health benefit plan, the employer continues to be liable for the nondiscriminatory provision of employee health benefits to its employees; the employer, as a recipient, may not, through contractual or other arrangements, discriminate on a prohibited basis against its employees.
Section 92.209 of the proposed rule specifically addresses discrimination faced by an individual or an entity on the basis of the race, color, national origin, age, disability, or sex of an individual with whom the individual or entity is known or is believed to have a relationship or association. The language of Section 1557 makes clear that individuals may not be subject to any form of discrimination “on the grounds prohibited by” Title VI and other civil rights laws; the statute does not restrict that prohibition to discrimination based on the individual's
Associational discrimination prohibited by this rule can arise in multiple contexts. For example, a primary care physician could not refuse to accept a new patient because the physician disapproves of this individual's family relationships;
Similarly, a physician could not deny a medical appointment to a patient who is an individual without a disability on the basis that the patient will be accompanied by a family member who is deaf and who will require a sign language interpreter; § 92.202 of this proposed rule requires effective communication with individuals with disabilities, including companions with disabilities, and denying an appointment based on the patient's association with an individual with a disability who needs an interpreter thus would constitute associational discrimination based on disability.
This proposed section restates the language of Section 1557 regarding enforcement, which provides that the enforcement mechanisms under Title VI, Title IX, the Age Act, or Section 504 apply for violations of Section 1557. These existing enforcement mechanisms include requiring covered entities to
Proposed § 92.302 specifies the regulatory procedures that will apply to claims under Section 1557 for health programs and activities conducted by recipients and State-based Marketplaces. The administrative procedures provided for and available under Title VI are found in the regulation implementing Title VI, at 45 CFR 80.6–80.11 and 45 CFR part 81. These administrative procedures are incorporated into the regulation implementing Title IX at 45 CFR 86.71 and the regulation implementing Section 504 with respect to recipients at 45 CFR 84.61. Section 92.302(a) incorporates these procedures into the proposed rule with respect to race, color, national origin, sex, and disability discrimination. The administrative procedures provided for and available under the Age Act are found in the regulation implementing the Age Act at 45 CFR 91.41 through 91.50. Section 92.302(b) incorporates these procedures into the proposed rule with respect to age discrimination.
Section 92.302(c) also provides that an individual may bring a civil action in a United States District Court in which a recipient or State-based Marketplace is located, as provided for and available under Section 1557.
As noted, Section 1557 expressly states that the enforcement mechanisms provided for and available under Title VI, Title IX, Section 504, or the Age Act shall apply for purposes of violations of Section 1557. The administrative procedures provided for and available under Section 504—which is the only one of these statutes that applies to Federally conducted, as well as Federally assisted, programs—for programs and activities administered by the Department are found in the regulation implementing Section 504 at 45 CFR 85.61 and 85.62. These procedures shall apply with respect to complaints and compliance reviews of health programs or activities administered by the Department, including the Federally-facilitated Marketplaces, concerning discrimination on the basis of race, color, national origin, sex, age, or disability.
The proposed rule adds two provisions that are not found in 45 CFR 85.61 and 85.62. The first provision relates to OCR's access to information. This provision, which is in accordance with OCR's practice under Section 504, is designed to ensure that OCR has the ability to obtain all of the relevant information needed to investigate a complaint or determine compliance in a particular health program or activity administered by the Department, and mirrors similar requirements for recipients under the Title VI regulation.
The second provision prohibits the Department, including the Federally-facilitated Marketplaces, from retaliating against any individual for the purpose of interfering with any right or privilege under Section 1557 or the proposed rule or because the individual has made a complaint, testified, assisted, or participated in any manner in an investigation, proceeding, or hearing under Section 1557 or this proposed rule. Section 504 of the Rehabilitation Act, to which the Department is already subject, provides that the procedures, rights, and remedies under Title VI are available to any individual aggrieved by an act or failure to act by any recipient of Federal financial assistance or Federal provider of such financial assistance under Section 504. Thus, the prohibition of retaliation under Title VI applies to the Department under Section 504. The retaliation provision in the proposed rule is simply an extension of this existing prohibition. This provision is also in accordance with a similar requirement for recipients under the Title VI regulation at 45 CFR 80.7(e); the Department should hold itself to the same standards to which it holds recipients of Federal financial assistance.
This notice of proposed rulemaking would call for new collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling and other similar actions. The title and description of those entities that must collect the information and an estimate of the total annual burden follow. The estimate covers the time for reviewing and posting the collections required.
Title: Notice on Nondiscrimination in Health Programs and Activities.
OMB Control Number: XXXX–XXXX.
In addition, each covered entity subject to the proposed rule would be required to post a notice of certain important information, including that the covered entity provides auxiliary aids and services, free of charge, in a timely manner, to individuals with disabilities, when such aids and services are necessary to provide an individual with a disability an equal opportunity to benefit from the entity's health programs or activities; and language assistance services, free of charge, in a timely manner, to individuals with limited English proficiency, when those services are necessary to provide an individual with limited English proficiency meaningful access to a covered entity's health programs or activities. Furthermore, each covered entity would be required to post taglines in the top 15 languages spoken by individuals with limited English proficiency nationally,
Additionally, each covered entity that employs 15 or more persons would be required to adopt grievance procedures that incorporate appropriate due process standards and that provide for the prompt and equitable resolution of grievances alleging any action that would be prohibited by Section 1557. Each such entity would also be required to designate at least one individual to coordinate its efforts to comply with and carry out its responsibilities under Section 1557, including the investigation of any grievance communicated to it alleging noncompliance with Section 1557.
The posting of a notice of certain important information and the posting of taglines in the top 15 languages spoken by individuals with limited English proficiency nationally are necessary to ensure that individuals are aware of their protections under the law, and are grounded in OCR's experience that failures of communication based on the absence of auxiliary aids and services and language assistance services raise particularly significant compliance concerns under Section 1557, as well as Section 504 and Title VI.
The requirements that every covered entity that employs 15 or more persons adopt a grievance procedure and designate at least one individual to coordinate its efforts to comply with and carry out its responsibilities under Section 1557 are similar to requirements included in the Title IX and Section 504 implementing regulations. Through its case investigation experience, OCR has observed that the presence of a coordinator and grievance procedure helps to bring concerns to prompt resolution within an entity, leading to lower compliance costs and more efficient outcomes.
While the requirement to submit an assurance of compliance is subject to the Paperwork Reduction Act (PRA), OCR believes the burden associated with this requirement is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). OCR believes that the time, effort, and financial resources necessary to comply with this requirement should be considered a usual and customary business practice and would be incurred by covered entities during their ordinary course of business.
OCR estimates the burden for responding to the proposed notice requirement would be 17 minutes to download/print and post the notice of important information and that the burden to download/print and post taglines in the top 15 languages nationally would also be 17 minutes, for a burden total of 34 minutes. We estimate that administrative or clerical support personnel would perform these functions. Based on the wage rate for a Clerical Support Worker ($22.94) we estimate the annual burden cost for these two requirements to be approximately $4.8 million.
Regarding the requirement that every covered entity that employs 15 or more persons adopt grievance procedures and designate at least one individual to coordinate its efforts to comply with and carry out its responsibilities under Section 1557, based on OCR's compliant workload increase since the passage of Section 1557, we anticipate that within the first five years following the rule's enactment, complaints will increase approximately 1%, but eventually will drop off as covered entities modify their policies and practices in response to the proposed rule. We estimate that medical and health service managers would handle the grievances. Taking 1% of the annual wage rate for medical and health service managers ($101,340) and increasing that amount by 100% to account for fringe benefits and overhead, we estimate the total annual burden cost for this requirement to be approximately $118.7 million.
Thus, the total estimated annual burden cost for the proposed information collection requirements will be approximately $123.5 million.
We ask for public comment on the proposed information collection to help us determine:
1. Whether the proposed collection of information is necessary for the proper performance of the functions of OCR, including whether the information will have practical utility;
2. The accuracy of the estimated burden associated with the proposed collection of information;
3. How the quality, utility, and clarity of the information to be collected may be enhanced; and
4. How the burden of complying with the proposed collection of information may be minimized, including through the application of automated collection techniques or other forms of information technology.
Comments regarding the collection of information proposed in this rule must refer to the proposed rule by name and docket number and must be submitted to both OMB and the Docket Management Facility where indicated under
Executive Order 12866
Section 1557 of the ACA prohibits an individual from being excluded from participation in, denied the benefits of, or otherwise subjected to discrimination on the basis of race, color, national origin, sex, age or disability in certain health programs and activities. It applies the protections available under Title VI, Title IX, the Age Act, and Section 504 to any health program or activity, any part of which is receiving Federal financial assistance, and to any program or activity that is administered by an Executive Agency or any entity established under Title I of the ACA.
One of the central aims of the ACA is to expand access to health care and health coverage for all individuals. Equal access for all individuals without discrimination is essential to achieving this goal. Discrimination in the health care context can often lead to poor and inadequate health care or health insurance or other coverage for individuals and exacerbate existing health disparities in underserved communities. Individuals who have experienced discrimination in the health care context often postpone or do not seek needed health care; individuals who are subject to discrimination are denied opportunities to obtain health care services provided to others, with resulting adverse effects on their health status. Moreover, discrimination in health care can lead to poor and ineffective distribution of health care resources, as needed resources fail to reach many who need them. The result is a marketplace comprised of higher medical costs due to delayed treatment, lost wages, lost productivity, and the misuse of people's talent and energy.
To help address these issues, this regulation seeks to clarify the application of the nondiscrimination provision in the ACA to any health program or activity receiving Federal financial assistance or administered by HHS or any entity established under Title I. Such clarity will promote understanding of and compliance with Section 1557 by covered entities and the ability of individuals to assert and protect their rights under the law.
In addition, Executive Order 13563 directs Federal agencies to improve regulations and regulatory review by promoting the simplification and harmonization of regulations and to ensure that regulations are accessible, consistent and easy to understand. Regulations implementing the civil rights laws referenced in Section 1557 contain certain inconsistencies across common areas and subject matters, reflecting, among other things, differences in time and experience when the regulations were issued. The approach taken in the proposed rule is to simplify and make uniform, consistent, and easy to understand the various nondiscrimination requirements and rights available under Section 1557, as appropriate.
This proposed rule would apply to any entity that has a health program or activity, any part of which receives Federal financial assistance from the Department, any health program or activity administered by the Department, or any health program or activity administered by an entity created under Title I of the ACA. The following are examples of covered entities as well as health programs or activities under the proposed rule.
This Department, through agencies such as the Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare & Medicaid Services (CMS), provides Federal financial assistance through various mechanisms to health programs and activities of local governments, State governments, and the private sector. An entity may receive Federal financial assistance from more than one component in the Department. For instance, Federally qualified health centers receive Federal financial assistance from CMS by participating in the Medicare or Medicaid programs and also receive Federal financial assistance from HRSA through grant awards. Because more than one funding stream may provide Federal financial assistance to an entity, the examples we provide may not uniquely receive Federal financial assistance from only one HHS component.
(1) Entities receiving Federal financial assistance through their participation in Medicare or Medicaid (about 133,343 facilities).
(2) Laboratories that are hospital-based, office-based, or freestanding that receive Federal financial assistance through Medicare or Medicaid payments for covered laboratory tests (about 445,657 laboratories with Clinical Laboratory Improvement Act certification).
(3) Community health centers receiving Federal financial assistance
(4) Health-related schools in the United States and other health education entities receiving Federal financial assistance through grant awards to support 40 health professional training programs that include oral health, behavioral health, medicine, geriatric, and physician's assistant programs (171 health-related schools and other health education entities).
(5) State Medicaid agencies receiving Federal financial assistance from CMS to operate Medicaid and CHIP programs (includes every State, the District of Columbia, Puerto Rico, Guam, the Northern Marianas, U.S. Virgin Islands, and American Samoa).
(6) State public health agencies receiving Federal financial assistance from CDC, SAMHSA, and other HHS components (includes each State, the District of Columbia, Puerto Rico, Guam, the Northern Marianas, U.S. Virgin Islands, and American Samoa).
(7) Qualified health plan issuers receiving Federal financial assistance through premium tax credits or cost-sharing reductions (which include at least the 169 health insurance issuers receiving Federal financial assistance through premium tax credits and cost sharing reductions and at least 11 issuers operating in the State Based Marketplaces that we were able to identify).
(8) Physicians receiving Federal financial assistance through Medicaid payments, “meaningful use” payments, and other sources, but not Medicare Part B payments, as the Department does not consider Medicare Part B payments to physicians to be Federal financial assistance.
In regard to the eighth category of entities that may be covered by this proposed rule—physicians—we estimate that this proposed rule likely covers almost all licensed physicians because they accept Federal financial assistance from sources other than Medicare Part B. Most physicians participate in more than one Federal, State, and local health program that receives Federal financial assistance, and many practice in several different settings,
In spite of the difficulty in obtaining an unduplicated physician count, we provide our best estimate of the number of physicians receiving Federal financial assistance by analyzing and comparing different data sources and drawing conclusions from this analysis. Based on 2010 Medicaid Statistical Information System data (the latest available), about 614,000 physicians accept Medicaid payments and are covered under Section 1557 as a result.
Earlier, we identified several grant programs from various Department agencies that fund a variety of health care programs in which physicians participate and thus come under Section 1557, such as the National Health Service Corps, HRSA-funded community health centers, programs receiving NIH research grants, and SAMHSA-funded programs. Furthermore, physicians participating in a CMS gain-sharing demonstration project who receive gain-sharing payments would be covered under Section 1557 even if they did not participate in Medicare and Medicaid or any other health program or activity that receives Federal financial assistance. Again, there will be duplication and overlap with physicians who accept Medicaid or Medicare meaningful use payments, or other payments apart from Medicare Part B payments. Nevertheless, at least some of these physicians add to the total number of physicians reached under Section 1557 because some of them are not duplicates and do not accept Medicaid or Medicare meaningful use payments. We do not have an exact number, but adding these physicians may bring the total participating in Federal programs other than Part B to over 900,000.
When we compare the upper bound estimated number of physicians participating in Federal programs other than Medicare Part B (over 900,000) to the number of licensed physicians counted in HRSA's Area Health Resource File (approximately 890,000), we conclude that almost all practicing physicians in the United States are reached by Section 1557 because they accept some form of Federal remuneration or reimbursement apart from Medicare Part B.
This proposed rule applies to the Department's health programs and activities, such as those administered by CMS, HRSA, CDC, IHS, and SAMHSA. Examples include the Indian Health Service tribal hospitals and clinics operated by the Department (about 876 hospitals and clinics) and the National Health Service Corps.
This proposed rule applies to entities established under Title I of the ACA. According to the CMS Center for Consumer Information and Insurance Oversight (CCIIO), there are Health Insurance Marketplaces covering 51 jurisdictions: (14 State-based-Marketplaces and 37 Federally-facilitated Marketplaces).
As discussed above, it is important to recognize that the NPRM—except in the area of sex discrimination—applies pre-existing requirements in Federal civil rights laws to various entities, nearly all of which have been covered by these requirements for many years. Because the NPRM restates existing requirements, we do not anticipate that covered entities will undertake new actions or bear any additional costs in response to the issuance of the regulation with respect to the prohibition of race, color, national origin, age, or disability discrimination.
However, the prohibition of sex discrimination is new for many of the covered entities, and we do anticipate that the enactment of the regulation will result in changes in action and behavior by covered entities to comply with this new prohibition. Some of these actions will impose costs and others will not.
In addition, as noted above, Section 1557 applies to the Health Insurance Marketplaces, as entities newly created under Title I of the ACA. However, these entities, along with the qualified health plans issuers participating in the Health Insurance Marketplaces, are already covered by regulations issued by CMS that prohibit discrimination on the basis of race, color, national origin, sex, including sex stereotyping and gender identity, sexual orientation, age, or disability, and the Federally-facilitated Marketplaces are already covered by Section 504, which prohibits disability discrimination. Thus the impact of Section 1557 on these entities is limited.
The following regulatory analysis examines the costs and benefits that are attributable to this regulation only. While we make assumptions about possible behavioral responses to the regulation, we acknowledge that more information may be available to inform these assumptions and we welcome comment.
We first analyze the costs we expect the proposed rule to create for covered entities. Then we examine the potential benefits the rule is likely to produce. In the subsequent analyses of costs in this RIA and the Regulatory Flexibility Act (RFA), we use data sets from the Census Bureau and Bureau of Labor Statistics for estimating burdens.
The following cost assessment rests on certain key assumptions that include: (1) Voluntary activity on the part of covered entities that is triggered by the enactment of this regulation—and that would not have occurred absent the enactment of the regulation—which generates both costs and corresponding benefits; (2) to the extent that actions are required under the proposed rule where the same actions are already required by prior existing civil rights regulations, we assume that the actions are already taking place and thus that they are not a burden imposed by the proposed rule; (3) although the regulation does not require training at any time, we anticipate that covered entities may voluntarily provide one-time training to some employees on the requirements of the regulation at the time that the regulation is published; and (4) employers are most likely to train employees who interact with the public. Based on this assumption, we also assume employers likely will train between 40 and 60% of their employees, as the percentage of employees that interact with patients and the public varies by covered entity. For purposes of the analysis, we assume that 50% of the covered entity's staff will receive one-time training on the requirements of the regulation. We use the 50% estimate as a proxy, given the lack of certain information as described below. For the purposes of the analysis, we do not distinguish between employees whom covered entities will train and those who obtain training independently of a covered entity.
We assume covered entities will provide some workers a one-time awareness or familiarization training regarding the requirements in the regulation at the time of its issuance. We are counting the cost of training on all aspects of the regulation, not only on the new responsibilities under the regulation, as we believe covered entities will want to offer comprehensive training to employees, recognizing that refresher training can provide value. We invite comment on whether we should count only the cost of training on new responsibilities under the regulation.
We know that many employees work “behind the scenes” at large entities, and may not have contact with patients or the general public or otherwise have duties impacted by the requirements we are proposing and therefore may have little need for training. However, we are uncertain which employees those are. Furthermore, we do not know whether an entity rotates employees into different positions that may have patient contact or relevant duties, or whether, over time, an employee will switch to a position that places him or her in such a position, which may create a need for training.
We also lack information on State and local regulations that may require employees to receive training on civil rights provisions and whether those provisions are more or less rigorous than the ones we propose. Thus, workers in covered entities in States and local jurisdictions with civil rights provisions more robust than the ones we propose may need only minimal training. In State and local jurisdictions where civil rights provisions are not more robust, workers may need more training. As stated above, because we lack data on covered entities' training practices we are assuming that covered entities will voluntarily provide training on the final rule for between 40% and 60% of their staffs.
We welcome public comment and information that will help us focus our analyses on the specific entities and workers who likely will receive training.
In the following section, we identify the pool of workers and staff that we anticipate may need knowledge of the proposed rule. Next, we identify the covered entities that may choose to train their staffs to provide this knowledge. Last, we estimate the costs of presenting the training materials and the worker time that will be spent in training.
The Bureau of Labor Statistics
The first category of health care staff that may receive training is comprised of health diagnosing and treating practitioners. This category includes physicians, dentists, optometrists, physician assistants, occupational, physical, speech and other therapists, audiologists, pharmacists, registered nurses, and nurse practitioners. The Bureau of Labor Statistics occupational code for this grouping is 29–1000 and the 2013 reported count is 4,833,840. We note that the Bureau of Labor Statistics reports the number of physicians as 623,380 in contrast to the 888,947 physicians reported in the HRSA Area Health Resource File.
Because the Area Health Resource File's count is based on licensure, it includes physicians who may hold licenses in more than one State. There are a number of metropolitan areas that cross State boundaries and physicians practicing in these areas may be licensed in the adjoining States and, thus, will be counted more than once in the Area Health Resource File. On the other hand, the Bureau of Labor Statistics data, which report physician employment and income, may be an inaccurate count of physicians because of sampling error. We note that the sampling error reported for one physician specialty category is 6.1% and five out of seven specialty categories reported have sampling errors of 3% or greater. To resolve the difference between the Bureau of Labor Statistics and Area Health Resource File sources, we propose to take the midpoint of the difference between the two files.
The difference in the number of physicians in the Bureau of Labor Statistics and Area Health Resource File tables equals 265,567. Taking the midpoint yields 132,784 and adding this to the Bureau of Labor Statistics physician count gives us 756,164. Thus, the total count for Occupational code 29–1000—Healthcare Diagnostic and Treating Practitioners, after adjusting for the number of physicians, is 4.8 million.
The second category of health care staff that we assume will receive training is comprised of degreed technical staff (Occupation code 29–2000) and accounts for 2.8 million workers. Technicians work in almost every area of health care: From x-ray to physical, speech, psychiatric, dietetic, laboratory, nursing, and records technicians, to name but a few areas.
The third category of health care staff that we assume will receive training is comprised of non-degreed medical assistants (Occupation code 31–0000), and includes psychiatric and home health aides, orderlies, dental assistants, and phlebotomists. Health care support staffs (technical assistants) operate in the same medical disciplines as technicians, but often lack professional degrees or certificates. We refer to this workforce as non-degreed compared to medical technicians who generally have degrees or certificates. There are 3.9 million individuals employed in these occupations.
The fourth category of health care staff that we assume will receive training is health care managers (approximately 300,000 based on Bureau of Labor Statistics data for occupation code 11–9111).
The fifth category of health care staff that we assume will receive training is office and administrative assistants—Office and Administrative Support Occupation (Occupation code 43–0000). These workers are often the first staff patients encounter in a health facility and, because of this, covered entities might find it important that staff, such as receptionists and assistants, receive training on the proposed regulatory requirements. Approximately 2.7 million individuals were employed in these occupations in health facilities in 2013.
Below is a summary table of individuals employed in the health care sector.
We have data from CMS/CCIIO on the number of issuers offering qualified health plans in the Federally-facilitated Marketplaces. We assume that many issuers that operate in the Federally-facilitated Marketplaces also operate in the State-based Marketplaces. However, to the extent there are issuers who operate in a State-based Marketplace only, an estimate of their employees will not be included in our count of issuers (derived from the CCIIO tables of issuers participating only in the 37 jurisdictions with Federally-facilitated Marketplaces). We propose to determine the number of employees working for those issuers participating in the Federally-facilitated Marketplaces and we assume, as noted above, that some of the same issuers and employees serve the State-based Marketplaces. Determining the number of employees working for issuers participating in the Health Insurance Marketplaces is problematic because we have no data directly linking the number of
We perform this imputation by first identifying the number of issuers offering qualified health plans in the Federally-facilitated Marketplaces. To determine the number of issuers offering qualified health plans in the Federally-facilitated Marketplaces, we looked at the 2015 Qualified Health Plan Landscape Individual and Small Business Health Options Program Market Medical files.
In addition to 169 issuers participating in Federally-facilitated Marketplace, we are aware of 11 issuers participating only in the State-based Marketplaces. Thus, we calculate that the total number of issuers included in the analysis of covered issuers equals 180.
We next analyzed the number of employees working in the health insurance industry in the following way. Using Census Bureau 2011 payroll and employment data (the latest data available) for North American Industry Classification System 524114—Direct Health Insurance
The Census data shows 805 small issuers and 180 large issuers. The ratio of small to large issuers is about 4.5 small issuers for every large issuer. We assumed the ratio of small to large issuers in the Health Insurance Marketplaces would be approximately the same as the ratio in the Census table. We ask for public comment on this assumption.
Applying this ratio to the issuers in the Federally-facilitated Marketplaces, we get 131 small issuers and 38 large issuers. We assume that the 11 issuers (for which we have data and have thus identified) operating in the State-based Marketplaces are likely to be classified as small, based on Census workforce data. Therefore, we are adding them to the 131 small issuers identified above, bringing the total number of small issuers to 142. We ask for public comment on this assumption.
Based on the Census data, the average number of employees in a small issuer is 34 and the average number of employees in a large issuer is 2,300. Multiplying the number of small issuers by the number of employees equals 4,828 employees in the 142 small issuers and 87,400 employees in the 38 large issuers. The combined total number of employees for small and large issuers in the Federally-facilitated Marketplaces is estimated to be 92,228 employees.
With respect to the majority of issuers operating in a State-based Marketplace that we have not been able to identify but would also be subject to the regulation, we do not have any direct data. However, the workforce data we have from the Census tables covers employees regardless of their work site. If any of the 169 issuers identified above operating in the Federally-facilitated Marketplaces also operate in the State-based Marketplaces, then some portion of the nearly 92,000 employees imputed to be working for the issuers in the Federally-facilitated Marketplaces may also be working for issuers operating in the State-based Marketplaces. Thus, in effect, we are including employees working for issuers that operate in both the State-based Marketplaces and the Federally-facilitated Marketplaces in our count of employees who likely will receive training on the regulation.
At the same time that we include employees who work for issuers operating in both the Federally-facilitated Marketplaces and State-based Marketplaces, we lack direct data on issuers participating only in State-based Marketplaces. We are not able to include employees that work for insurance issuers that operate only in State-based Marketplaces, such as New York or California, which would be subject to the proposed rule. We invite public comment on ways we can identify issuers that participate only in State-based Marketplaces and the number of employees they employ.
A third category of workers who may need to be trained are Navigators receiving Federal financial assistance to support the functions they perform in assisting applicants to enroll in qualified health plans. CCIIO has awarded grant funding to 92 Navigator entities, and CCIIO estimates that 2,797 Navigators work for these 92 entities.
We invite public comment on our approach to estimating the number of employees per issuer based on the Census data and seek any public information on issuers who operate only in State-based Marketplaces.
The Census Bureau State government payroll and employment data for 2013 shows the number of full-time employees working in State hospitals and departments of health as 531,251.
Using the Bureau of Labor Statistics industry data for North American Industry Classification System code 999201: State government, including schools and hospitals, we identified 446,210 medical personnel employed by State governments.
The method for identifying and removing duplicate State medical personnel from the count of State employees in the health and Medicaid programs may remove too many covered State employees. We assume that most State medical personnel work in health departments and Medicaid agencies, but some medical personnel work in other units of State government such as environmental protection or schools that are not included in the State agencies subject to the rule. We invite public comment and data on this point.
The 2013 Census data for all US industries identifies 18,852 pharmacy establishments. The number of employees presented in the Census data includes both pharmacists and non-pharmacist personnel. At this point, we must refer back to the Bureau of Labor Statistics data on the number of health care workers reported for 2013 because the Bureau of Labor Statistics data divides the pharmacy workforce by occupation. The number of employees that Bureau of Labor Statistics reports were employed in pharmacies for 2013 is 706,000. The number of health care workers discussed in subsection II.C.1.a. above includes 348,381 pharmacists and other health care staff in occupation codes 29–0000 and 31–0000 reported to be working in pharmacies.
The following table shows the total number of employees who may receive training; that is, the table shows the 50% of total workers whom we expect will receive training. The table does not include HHS employees conducting HHS health programs or activities because there are roughly 65,000 HHS total employees and many of these employees do not work in health programs or activities administered by HHS. For those employees who do work in health programs or activities administered by HHS, many may not have direct beneficiary contact. Given these limitations, we estimate the number of employees added would be very small and have little impact on overall cost.
Just as there are a number of data sources for counting workforce, there are various sources for counting the number of health care entities. Many covered entities are controlled or owned by a single corporate entity and one can count each individual entity separately or count only the single corporate enterprise. For example, a multi-campus facility or vertically integrated entity that owns a hospital, a nursing home, and a home health agency and also operates an accountable care organization could count each of these entities separately—as does Medicare—or count them only once, with each entity treated as part of the corporate entity. At this point, we make two assumptions: (1) Albeit not required to do so by the regulation, each covered entity will provide some training to its staff on the requirements of the regulation; and (2) when entities are controlled or owned by a corporate entity, the corporate entity will supplement or make any desired modification to the OCR training materials and distribute the training materials. We believe this last point to be especially true because rather than have each entity prepare its own training materials, the corporate entity is more likely to prepare one set of training materials and distribute the materials to its individual entities. This is because the corporate entity saves money by preparing a limited set of training materials and assures uniform quality and consistency in its policies across all its entities. It is also possible that some local health centers in a State may be managed from a central location that handles logistics and training materials. Therefore, we propose using the 2012 Census table that presents the number of firms and establishments. In the Census data, a corporate entity is referred to as a “firm” and the corporation's facilities are “establishments.” When a firm has one establishment, the establishment is the firm. The difficulty we face in using these data sources is that the Census data captures all entity types that fit the definition of a health care service entity, including entities such as private retirement communities that are unlikely to receive Federal financial assistance and thus would not be covered by Section 1557. In our use of the Census data, we attempted to exclude types of entities that are not likely to receive Federal financial assistance by excluding retirement communities and other similar type entities in the file but have included entities that may receive Federal financial assistance, for example, community health centers and residential centers for individuals with intellectual disabilities.
To test our success in producing a list of covered entities from the Census data, we compared the number of entities we selected from the Census data and the number of entities included in the CMS Provider of Service file. However, to make the lists comparable, we have to remove the count of Clinical Laboratory Improvement Act laboratories from the CMS Provider of Service data files. There are close to 450,000 Clinical Laboratory Improvement Act laboratories located in hospitals, clinics, outpatient centers, and doctors' offices.
If we add the entities in the Provider of Service file (excluding Clinical Laboratory Improvement Act laboratories) and the number of community health centers to our list of affected entities that are not included in the Provider of Service file, we get a total of 134,543 entities. Using the Census data, minus the categories for medical laboratories, we obtain a total of 139,164 establishments. It is evident that these numbers are very similar. However, as discussed earlier, we propose using only the number of firms for the analysis of the number of entities possibly conducting training, that is, 70,384 firms. As, noted, we believe firms and not establishments will modify or supplement materials and train employees.
In addition to the firms we include from the Census file, we must add physicians' office firms and pharmacy firms because they may also need to train some workers. Physicians' office firms and pharmacy firms are generally referred to as physician group practices and pharmacy chains.
Below we present the types and number of firms that we estimate will take part in the training for the regulation.
There are two components to the cost of training the workers we identified in the previous section: (1) The cost of training materials that is based on the number of covered entities identified in the previous section; and (2) the cost of employee time spent in training.
OCR estimates, based on its experience of training employees on other regulations it enforces, that training employees on this regulation will take about one hour of an employee's time. Based on discussions with firms that develop training materials, we estimate that developing or presenting materials for a one-hour course would cost about $500. However, OCR proposes to provide covered entities with training materials that will cover the key provisions of the regulation that can be used by entities in conjunction with their own training materials. We estimate that OCR preparing the training materials on the regulation will substantially reduce the material preparation burden to covered entities and reduce the cost by about three quarters or about $375 per entity. Therefore, the costs to entities will equal $125 multiplied by the number of entities that will prepare and present training materials. Based on its experience in preparing training materials for Health Insurance Portability and Accountability Act regulations and other civil rights regulations, OCR expects to spend $10,000 to develop training materials that will prepare health care workers and managers to effectively implement the Section 1557 regulation.
Training materials can be presented in a number of ways. A common method for offering training materials is through e-courses that are distributed over an entity's computer network. Another method is to offer lectures to selected employees/staff and then have attendees present the materials to their co-workers as part of train-the-trainer programs. For small entities, one lecture session may be given to all employees. Regardless of presentation mode, we estimate that preparing the materials or having a lecturer will cost about the same amount.
Applying the $125 per course materials to the number of firms (125 × 278,565)—including the 169 health insurance issuers—equals $34.8 million for the cost of developing training materials.
The next step is to compute the cost of employee time for training. This involves taking the hourly wage rate times one hour, times the number of employees expected to take the training. The problem we face is only the Bureau of Labor Statistics data provides employee median wage rates.
The occupation code 29–1000 (health care practitioners) applies to the 4.8 million professional staff and degreed technical staffs we discussed above. The Bureau of Labor Statistics reports the median hourly wage for this code as $35.76. We estimate one hour of a worker's time would be required for training. To this amount we must add 100% for fringe benefits and overhead, which yields an adjusted hourly wage per employee of $71.52. Assuming that half of the 4.8 million health care practitioners identified earlier receive or obtain training (2.4 million workers), and multiplying this number by the hourly employee wage plus fringe benefits and overhead for one hour equals slightly more than $170 million in one-time training costs for practitioners.
For the degreed health care work force in occupation 29–2000, the median hourly wage is $19.65. Adding 100% for fringe benefits and overhead equals $39.30. The total training cost for one hour of training for half of the 2.8 million degreed technical staff (1.42 million workers) is about $56.0 million. In addition, we must add the cost of training non-degreed staff (reported in occupation 31–0000) who earn a median hourly wage of $12.54. Adding 100% for fringe benefits and overhead to the $12.54 median hourly wage rate yields an adjusted wage of $25.08. Multiplying this amount by half of the 3.9 million workforce yields a one-time cost of $49.2 million.
To these amounts we must add the cost of training the medical and health service managerial staff in occupation 11–9111: 300,180 individuals with a median hourly pay rate of $43.72. Adding 100% for fringe benefits and overhead gives us an adjusted hourly wage of $87.44, and assuming that half of the managers would seek or receive training results in a one-time cost of $13.1 million.
The cost of training occupation code 43–0000, office and administrative support workers employed in covered health care entities, is the product of the median hourly rate of $15.26 adjusted for fringe benefits and overhead multiplied by the 2.7 million workers reported for North American Industry Classification System code 62: Health Care and Social Assistance (including private, State, and local government hospitals). Adding 100% for fringe benefits and overhead to the $15.26 equals $30.52. Multiplying the pay rate by half the number of support and administrative personnel equals $41.8 million.
For the remaining entities for which we cannot use Bureau of Labor Statistics data, we must use the industry payroll and employment Census data. To arrive at an estimate of the cost of time for training employees of health insurance issuers and State health and Medicaid agencies, we must divide the total annual payroll reported for these entities by the total number of employees and divide that number by the annual hours paid (2,080 hours), adjusted for fringe benefits and overhead.
For workers employed by the issuers participating in the Health Insurance Marketplaces, we must determine the hourly wage rate for workers employed in small and large issuers as we have described them above. The total number of workers in small entities (fewer than 500 workers) is 27,269 and the annual payroll is $1.68 billion. The average wage per employee is $61,895. Using the 2,080 hours for the annual number of work hours, we obtain an hourly rate of $29.76. Assuming that the payroll amounts reported in the Census data do not include fringe benefits and overhead, we add 100% to the hourly rate to yield $59.51 per hour. Multiplying this amount by half of the 4,454 employees in small issuers equals $132,540 in one-time training costs.
The total number of employees employed by large issuers (500 or more) is 415,017 and the annual payroll is $30.8 billion. The average annual wage is $74,219. Dividing this figure by 2,080 hours yields an hourly wage rate of $35.68. Multiplying by 100% for fringe benefits and overhead yields $71.36. Multiplying this amount by 50% of the 87,400 workers equals slightly more than $3.12 million in one-time training costs.
For State government workers employed in welfare, health, and hospital services, we divided the total number of workers the 2013 Annual Census Bureau reported (755,993 employees) into the annual payroll reported for the period ($3,275,595,529). On an annual basis, the average salary per employee equals $52,123. The hourly rate equals $25.06 and multiplied by 100% for fringe benefits and overhead yields $50.12 per worker for training costs.
In the
Although we removed the cost of training the 446,210 medical personnel from the State training cost analysis to avoid double counting training costs, the cost of training half the medical staff may still fall to the States where they are employed. We estimate the cost to train State medical personnel to be approximately $10.5 million.
The 2013 Bureau of Labor Statistics data for North American Industry Classification System pharmacies and drugstores reports a total workforce of 706,000 workers. As with the analysis for State employees, we must remove health care workers that are already counted in our training costs analysis of the health care workforce. To avoid double counting training costs for these occupations, we removed them from the count of the pharmacy workforce. However, the entities that employ these workers will still bear the cost for training them. At a median weighted wage of $47.22, if employers trained half of the medical staff they employ, they would be responsible for $8.2 million in training costs for the employees we excluded from the analysis to avoid double counting.
For the 357,620 non-medical pharmacy personnel, the cost of training half the employees equals the median hourly rate for pharmacy employees ($13.37), or $26.74 after adding 100% for fringe benefits and overhead. Total
The following table summarizes the training costs we estimate for the proposed rule.
Pursuant to the regulations implementing Section 504, recipients of Federal financial assistance with 15 or more employees are required to designate a responsible employee to coordinate compliance with respect to nondiscrimination requirements and to have a grievance procedure to address complaints of discrimination under this law. Of the 279,000 covered health care entities, approximately 15% employ more than 15 employees, resulting in approximately only slightly more than 58,500 covered health care entities being required to have a grievance procedure and designate a responsible official. Thus, all recipients of Federal financial assistance with 15 or more employees are already expected to have in place a grievance procedure and a designated employee to coordinate their compliance responsibilities. The proposed rule standardizes the requirement to designate a responsible employee and adopt grievance procedures across all bases of discrimination prohibited under Section 1557.
To implement the proposed rule, a recipient of Federal financial assistance could increase the responsibilities of an already-designated employee to handle compliance with the proposed rule's nondiscrimination requirements. In addition, a recipient of Federal financial assistance could increase the scope of existing grievance procedures to accommodate complaints of discrimination under all bases prohibited under Section 1557. The costs associated with these requirements are the costs of training the designated employee on his or her increased responsibilities and the costs associated with modifying the existing grievance procedures to reflect the additional bases of race, color, national origin, sex, and age. Here we are referring to employee training to perform their specific enforcement responsibilities, not one-time training in the provisions of the rule described in the training section above. We also note that grievance officials will probably receive specific training on their new responsibilities and that covered entities will probably provide this additional training and absorb the costs, which are expected to be minimal. Many covered entities already may be using their existing grievance procedures to address the additional cases covered under Section 1557.
State-based Marketplaces are required to designate an employee to handle compliance responsibilities and to adopt a grievance procedure under the ADA. The duties of the employee and the grievance procedure could be modified to reflect all the bases covered under Section 1557. We have not estimated the additional costs of training grievance officials on their individual enforcement responsibilities, but believe such cost would be absorbed in general training costs of all employees on their job responsibilities. Costs associated with modifying existing grievance procedures are covered in the section of the analysis on enforcement.
The implementing regulations of Title VI, Section 504, Title IX, and the Age Act require recipients of Federal financial assistance and, in the case of Section 504, the Department, to notify individuals that recipients (and, under Section 504, the Department) do not discriminate. The content of the nondiscrimination notices varies based on the applicable civil rights law.
The proposed rule harmonizes notification requirements under Title VI, Section 504, Title IX and the Age Act, and standardizes the minimum information for a notice. The proposed rule also requires initial and continuing notification of individuals. The proposed rule provides that OCR will draft a sample notice in English that meets the requirements and will translate that notice into 15 additional languages. Covered entities have discretion to use the OCR sample notice or their own notice, if preferred, and to post the notice in non-English languages.
As all Section 1557 covered entities will need to create or update an existing notice of nondiscrimination, all covered entities can discharge their responsibilities under § 92.8(a) by replacing their current notices with the sample notice OCR will make available to all covered entities pursuant to § 92.8(c). Using the sample OCR notice means that covered entities will not have to compose their own notices; we expect nearly all covered entities will use the sample OCR notice.
All covered entities will incur costs, however, to implement § 92.8(a) of the proposed rule, which requires “initial and continuing” notification. Such notification is expected to involve:
• Downloading the notice from the OCR Web site;
• Printing copies of the notice for posting;
• Posting hard copies of the notice in public spaces of the office or facility; and
• Posting the notice on the entity's Web site, if it has one.
Approximately 278,500 covered entities would spend one minute downloading the notice from the OCR
• Downloading the OCR notice—1 minute at $30.52 per hour equals $0.51;
• Printing 2 hard copies of the notice—1 minute at $30.52 per hour equals $0.51;
• Posting the notice in an average of two areas—5 minutes, at $30.52 per hour equals $2.54; and
• Preparing the OCR notice for posting on the facility's Web site and posting the notice on the Web site—ten minutes of a clerical worker's time adjusted for fringe benefits and overhead equaling $5.08.
For each entity, the cost of downloading the notice, posting it in a public place and posting it to the entity's Web site is $8.64. The total cost for the 279,000 covered entities is $2,411,000.
Covered entities that distribute general or major publications targeted to patients, consumers, or members of the public will need to update these publications to include the new notice. However, as noted above, we are allowing entities to exhaust their current publications, rather than do a special printing of the publications to include the new notice. When covered entities restock their printed materials, they will be expected to include in those printed materials the notice that OCR will provide with the final rule.
Because we are permitting covered entities to exhaust their existing stock of publications with the current notices before using the new notice, we conclude that the notice requirement imposes no resource costs related to including updated notices in the publications. We invite public comment on our analysis. Section 92.8 provides covered entities discretion to post the OCR sample notice of nondiscrimination in 15 non-English languages, which can include languages that differ from OCR's list. The 15 languages cover over 90 percent of non-English language speakers. In addition, covered entities can draft and translate their own notice in however many languages they choose, if they prefer.
We examined CMS contractual cost for translating a one page notice into 13 languages which was $1,000. Based on this figure, if we were providing notices to approximately 300,000 entities and used the same contractor, the costs to the Federal government would be a maximum of approximately $1.4 million dollars. However, because the Federal government would be posting the notice onto its Web site, rather than printing it, covered entities would have to bear the cost of downloading and printing the notice from OCR's Web site and then posting it.
We expect total costs to the government to be limited to $1,000 to translate the notice into 15 languages and place the translated notices on OCR's Web site.
Although not required, we expect that many covered entities would choose to post the OCR-provided notice in one or more non-English languages on their Web sites, in their physical office space, and in certain publications they may have. We do not know how many covered entities would take this action or how many non-English language versions of the notice they would choose to post, or where they would make the non-English versions of the notice available. We invite comment on these issues.
Section 92.8 requires covered entities to publish taglines indicating the availability of language assistance services in the top 15 languages nationally. OCR will make these taglines available electronically in the 15 languages; therefore, there will be no burden to the covered entity other than the cost of printing and posting these taglines, as described above with respect to the notice. We are uncertain of the exact volume of taglines that will be printed or posted, but we estimate that covered entities will print and post the same number of tag lines as notices and therefore the costs would be comparable to the cost for printing and disseminating the notice, or $2,411,000. The costs to the federal government for translating the taglines will approximately be the same as for printing the notices or $1,000. We estimate that the combined costs of printing and distributing notices and tag lines will be $4,822,000 for entities and $2,000 for the Federal government. We seek public comment on this estimate.
Proposed § 92.201, which effectuates Section 1557's prohibition of national origin discrimination as it affects individuals with limited English proficiency, does not pose any new burden on covered entities. With regard to recipients of Federal financial assistance, the proposed rule adopts recipients' existing obligations under Title VI to take reasonable steps to provide meaningful access to individuals with limited English proficiency and codifies standards consistent with long-standing principles from the HHS LEP Guidance regarding the provision of oral interpretation and written translation services. Because the proposed rule does not impose duties beyond recipients' legal obligations under Title VI, the proposed rule imposes no new burden.
Although Title VI does not apply to the Department, Executive Order 13166 “Improving Access to Services for Persons with Limited English Proficiency,” has applied to HHS for nearly 15 years.
Title VI applies to Title I entities that receive Federal financial assistance, including State-based Marketplaces. Executive Order 13166 applies to the Federally-facilitated Marketplaces as an HHS-conducted health program. Additionally, both Federally-facilitated Marketplaces and State-based Marketplaces must already comply with language access provisions of the Federal regulations governing Health Insurance Marketplaces.
Section 1557 prohibits discrimination on the basis of sex, including sex stereotyping and gender identity, in certain health programs and activities. When providing services, including access to facilities, covered entities must provide individuals with equal program access on the basis of sex, and are required to treat individuals in a manner consistent with their gender identity.
Prior to the enactment of Section 1557, Title IX applied to educational institutions. Therefore, medical schools, nursing programs, and other health education programs were already prohibited from discriminating on the basis of sex. Under Section 1557 and this proposed regulation, health insurance issuers receiving Federal financial assistance, hospitals, clinics and other health facilities, HHS health programs and activities, and Title I entities, along with the staff and practitioners working in these health programs, are now similarly prohibited from discriminating on the basis of sex.
Covered entities that provide or administer health services or health insurance coverage are covered by the prohibition of discrimination on the basis of sex, including sex stereotyping and gender identity. The costs that we anticipate that covered entities would incur relate to: (1) Training; (2) enforcement; (3) the posting of the notice; (4) the revision of policies and procedures; and (5) some costs associated with changes in discriminatory practices. The costs related to training, enforcement, and the posting of the notice have already been discussed in this analysis. This section discusses costs related to changes in policy and procedures and potential changes in discriminatory practices.
The NPRM would not invalidate specialties that focus on men or women,
Under the sex discrimination prohibition, however, providers of health services may no longer deny or limit services based on an individual's sex, without a legitimate nondiscriminatory reason. Although a large number of providers may already be subject to state laws or institutional policies that prohibit discrimination on the basis of sex in the provision of health services, the clarification of the prohibition of sex discrimination in this regulation, particularly as it relates to discrimination on the basis of sex stereotyping and gender identity, may be new. We anticipate that a large number of providers may need to develop or revise policies or procedures to incorporate this prohibition. For example, if a hospital or other provider has specific protocols in place for domestic violence victims, but only engages that protocol for women, the provider would have to revise its procedures to require that protocol for all individuals regardless of sex. A provider specializing in gynecological services that previously declined to provide a medically necessary hysterectomy for a transgender man would have to revise its policy to perform the procedure on transgender individuals in the same manner it provides the procedure for other individuals.
We assume that it will take, on average, 3–5 hours for a provider to develop or modify policies and procedures concerning sex discrimination. We are selecting four hours, or the midpoint of this range, for our analysis. We further assume that three of the hours will be spent by a mid-level manager equivalent to a front-line supervisor (Occupation code 43–1011), at a salary, with fringe benefits and overhead of $48.52 per hour, and one hour will be spent by executive staff equivalent to a general and operations manager (Occupation code 11–1021), at a salary, with fringe benefits and overhead of $81.84 per hour. We further assume that 75% of covered health providers will need to develop or modify policies and procedures, given that some proportion of health care providers already prohibit sex discrimination based on State law or institutional policies prohibiting discrimination generally. The total cost for the estimated 208,700 providers to make their policies and procedures consistent with the regulatory prohibition on discrimination on the basis of sex is estimated to be a one-time cost of approximately $47.5 million, which we assume is divided evenly between the first two years of compliance.
The above estimates of time and number of entities that would have to revise their policies under the regulation is an approximate estimate based on general BLS data. Due to the wide range of types and sizes of covered entities, from complex multi-divisional hospitals to small neighborhood clinics and physician offices, the above estimates of time and number of entities that would have to revise their policies under the regulation is difficult to calculate. We invite the public to submit data and comments on our estimate.
For providers that discriminate on the basis of sex in violation of the proposed rule, some changes in behavior or action would be necessary to come into compliance. We anticipate some change in the patient population for which a particular provider provides care or the extent of services provided. However, the infrastructure and protocols for providing services or treatment are already in place; providers would simply have to start providing those existing services in a nondiscriminatory manner to individuals regardless of sex. For example, a provider could not refuse to treat a patient for a cold or a broken arm based on the patient's gender identity. Similarly, if the provider is accepting new patients, it must accept a new patient request from a transgender individual and cannot decline to accept a transgender person in favor of a person who is not transgender.
However, the proposed rule does not impose a burden on covered entities with respect to the number of patients treated. The proposed rule does not
Moreover, costs associated with administering care or treating a new patient generally would be offset by the reimbursement received by the provider for providing the care, in the same way the provider gets paid for existing care or treatment of patients. Thus, for example, for the hospital or other provider that needs to revise its protocol for domestic violence to require that protocol for all individuals regardless of sex, rather than just women, there would be little to no net increase in costs for treating men because the hospital or provider would be paid for its services in the same way it would be paid to treat a woman for the same care. We welcome comments on this assumption and information about costs.
The ACA, including Section 1557, changed the health care landscape for millions of people by instituting protections against sex discrimination in the provision of health care and health insurance coverage. Prior to the ACA, it was standard health insurance practice to treat women differently in premium pricing and coverage of benefits,
The ACA addresses inequitable treatment by health plans based on sex in multiple ways. CMS regulations implementing the ACA prohibit Title I entities
In addition, the Affordable Care Act prohibits many health insurance issuers from charging higher premiums based on sex;
Section 92.207 (Nondiscrimination in health insurance and other health coverage) of the proposed rule prohibits discrimination on the basis of sex, including sex stereotyping and gender identity, by a covered entity providing or administering health insurance or other health coverage. As noted, many of the same covered entities subject to Section 1557, including Health Insurance Marketplaces and health insurance issuers that are recipients of Federal financial assistance, are also subject to existing nondiscrimination provisions in CMS regulations. While the CMS regulations complement and do not replace Section 1557, the existing nondiscrimination requirements applicable to health insurance issuers and Health Insurance Marketplaces mean that these entities are aware that they are not permitted to discriminate on the basis of sex, including sex stereotyping and gender identity, and thus they are familiar with their nondiscrimination obligations under the law. We assume that these covered entities have already taken steps to comply with CMS regulations and so instituted changes in their policies and actions. To the extent these existing obligations overlap with Section 1557 and covered entities have taken steps required under the CMS regulations, this proposed rule will impose little or no burden on health insurance issuers and Title I entities to comply with Section 1557's prohibition on sex discrimination because these covered entities should already be in compliance with regulations that prohibit discrimination on the basis of sex, including sex stereotyping and gender identity.
There may be some incremental burden on issuers and Title I entities in terms of the additional guidance that this proposed rule provides related to sex discrimination, since, in some circumstances, it provides more detail than CMS regulations or guidance. Therefore, covered entities may have an increased burden when incorporating this rule into their existing nondiscrimination policies and procedures. For example, this rule specifies that an explicit categorical exclusion of coverage for health care
However, we note that the number of major U.S. employers providing transgender-inclusive health care coverage has been increasing dramatically, from 0 in 2002, to 49 in 2009, 278 in 2013, 336 in 2014, and finally 418 in 2015.
Similar to the estimate for providers of health services, we assume that it will take, on average, three to five hours for issuers of health insurance coverage to develop or modify policies and procedures concerning sex discrimination. We are selecting four hours, or the midpoint of this range, for our analysis. We further assume that three of the hours will be spent by a mid-level manager, at a salary, with fringe benefits and overhead of $57.60 per hour,
In addition to the cost some covered health insurance providers may have for revising policies and procedures to comply with the proposed rule, such providers may also incur a minimal cost related to the cost of coverage. In this regard, we note that the April 2012 California Department of Insurance Economic Impact Assessment on Gender Nondiscrimination in Health Insurance found that covering transgender individuals under California's private and public health insurance plans would have an “insignificant and immaterial economic impact” on costs.
This conclusion was based on evidence of low utilization and the estimated number of transgender individuals in California. The transgender population of California was estimated to range between 0.0022% and 0.0173%.
Based on the California study, we believe that providing transgender individuals non-discriminatory insurance coverage and treatment will impact a very small segment of the population due to the fact that the number of transgender individuals (and particularly those who seek surgical procedures in connection with their gender transition) in the general population is small, and will have minimal impact on the overall cost of care and on health insurance premiums.
Although Section 1557 requires covered entities to ensure that the health programs, services, and activities provided through electronic and information technology are accessible to individuals with disabilities, all covered entities affected by Section 1557 already have these obligations under Section 508, Section 504 or the ADA.
Section 508 requires that electronic and information technology developed, procured, maintained, or used by Federal agencies be accessible for individuals with disabilities (both members of the public and Federal employees). Section 504 also establishes general obligations for Federal agencies to make their programs that are provided through electronic and information technology accessible to individuals with disabilities. Both Section 504 and Section 508 were in place before the passage of the ACA. There is, therefore, no additional burden under Section 1557 for HHS health programs, including the Federally-facilitated Marketplaces, as the Section 1557 requirements are consistent with the obligations these programs already have under Section 504 and Section 508.
Section 504 also establishes general obligations for entities receiving Federal financial assistance to make their programs, services, and activities provided through electronic and information technology accessible to individuals with disabilities. The ADA imposes similar accessibility requirements on covered entities. The proposed regulation thus imposes no additional burden on recipients of Federal financial assistance from HHS because Section 1557 is consistent with existing standards these entities are already obligated to meet under the ADA and Section 504. Title I entities have no Section 1557 burden with respect to this proposed requirement, as the Title I entities must already be compliant with the ADA, which is consistent with the Section 1557 accessibility standards.
After grievances are filed with covered entities or complaints are filed with OCR, there are associated costs to investigate and resolve those grievances and complaints. We believe the following costs result from enforcement of the Section 1557 regulation:
• Costs to covered entities for modifying and implementing existing grievance procedures to cover grievances filed under Section 1557.
• Costs to OCR for reviewing and investigating complaints, monitoring
We now proceed to estimate the aggregate costs of these enforcement procedures. In the analysis below, we analyze the costs to covered entities separately from the costs to OCR.
Federal civil rights laws that were in place before Section 1557 became effective apply to entities that receive Federal financial assistance. Entities subject to those laws are already required to have in place an established grievance procedure to address disability discrimination complaints and complaints of sex discrimination in education programs. It is anticipated that any additional costs that may be imposed by this regulation would potentially arise because of the expansion of the grievance process to cover all bases covered under Section 1557, including race, color, national origin, and age, as well as sex discrimination in health care. It is expected that this may lead to a slight increase in additional grievances being filed, and require increased time to investigate and resolve these additional grievances.
To compute the anticipated costs for covered entities to enforce the proposed regulation, we looked to OCR data. The current number of civil rights complaints filed annually with OCR is approximately 3,000. Since the passage of Section 1557, OCR's complaint workload has increased slightly; with somewhere in the range of 15–20 unique Section 1557 cases filed each year. Stemming from the sentinel effects from the enactment of the regulation, if we include another ten cases per year, we calculate an increase of 30 cases per year or 1% of the annual caseload of 3,000. We assume the incremental workload will be similar for affected entities and thus will be approximately 1%. We anticipate that within the first five years following the rule's enactment, complaints will increase, but eventually will drop off as covered entities modify their policies and practices in response to the proposed rule. Although we have data on OCR's caseload, we have no data on the caseload of affected covered entities. We ask for public comment on the assumption regarding increased caseload.
If we assume that as a result of promulgating the proposed regulation, a designated grievance official for the 58,550 covered entities with 15 or more employees had to devote an additional 1% of his or her time to investigating discrimination grievances, incremental costs (including fringe benefits and overhead) would be $118.7 million.
To arrive at this number we used the annual mean wage of $101,340 for medical and health service managers (occupation code 11–9111) and took 1%. We increased the amount by 100% to account for fringe benefits and overhead, and multiplied the value by the number of covered health entities that we estimate have 15 or more entities using 2012 US business census data.
It is important to consider the assumptions we made in estimating the costs to covered entities. We assumed that all entities would experience the same proportional increase in complaints filed. This may not be accurate. We expect most covered entities will comply with the regulation and not see an increase in complaints. However, because we lack data to enable us to pinpoint which entities will experience an increase, we are required to make a general assumption about all covered entities. As such, we anticipate the resultant cost estimate to be an overestimation of the new costs for addressing grievances filed against covered health entities. We ask for public comment on these costs and estimates.
The same incremental calculations apply to the workloads of State agencies and the officials working in these agencies. If we assume the same 1% increase in caseload and the average mid-level State official salary is $94,580 (including fringe benefits and overhead), we must multiply $94,580 by the number of State covered entities.
• We assume that there are 53 Medicaid State agencies;
• We assume that there are 53 State health departments;
• We assume that each State and the District of Columbia has two State-run hospitals; and
• We assume that each of 3,143 counties has a county health department that provides direct health services (
The total number of State covered entities is 3,351. Multiplying $94,580 by 3,351 equals $316.9 million. One percent of this value equals $3.17 million.
We considered the various OCR enforcement costs together, based on OCR average salary data presented in its annual budgets. According to the FY 2016 President's Budget, $28,400,000 and 137 Full Time Equivalents (FTEs) were requested for Enforcement and Regional Operations, at a cost of approximately $201,000 per FTE. Of the 137 FTEs, approximately 40 FTEs spend 100% of their investigative time enforcing the civil rights laws.
The table below summarizes the costs attributable to the proposed regulation that covered entities may incur following enactment of the final regulation. We assume that half of the training costs and changes to policies and procedures on the prohibition of discrimination on the basis of sex will be incurred in the first year and the second half will be expended in the second year. For covered entities that will be printing and distributing notices to their patients and policy holders, we assume that all of the estimated printing and distribution costs will be expended in the first year after the effective date of the rule. Due to the likelihood that applicable changes will need to be phased in, we assume one half of the annual projected costs for investigating discrimination complaints will be incurred during the first year and three quarters of the annual projected enforcement costs will be spent in the second year and the full amounts in the third through fifth years. Information collection requirements and paperwork burden costs would be incurred within the first year after the effective date of the final regulation.
With this summary, we have completed our analysis the costs of the rule. Next, we examine the benefits that can be expected to accrue as a result of the proposed rule.
In enacting Section 1557 of the ACA, Congress recognized the benefits of equal access to health services and health insurance that all individuals should have, regardless of their race, color, national origin, age, or disability. Section 1557 brought together the rights to equal access that had been guaranteed under Title VI, the Age Act and Section 504. At the same time, Congress extended these protections and rights to individuals seeking access to health services and health insurance without discrimination on the basis of sex.
This proposed rule would implement the provisions of Section 1557. In most respects, the proposed rule clarifies existing obligations under existing authorities and we have noted in the cost analysis that we do not expect that covered entities would incur costs related to the clarification of those existing obligations in the proposed rule. However, we also noted that we expected that the prohibition of sex discrimination in the proposed rule would generate certain actions and other changes in behavior by covered entities and that these actions and changes would impose costs. These actions and other changes in behavior would also result in benefits.
The provisions prohibiting sex discrimination in the ACA increase the affordability and accessibility of health care for women and transgender individuals. However, despite the ACA improving access to health services and health insurance, many women and transgender individuals continue to experience discrimination in the health care context. This continued discrimination demonstrates the need for further clarification regarding the prohibition of discrimination on the basis of sex.
Prior to the enactment of the ACA, insurance companies were allowed to impose higher premiums on women or deny women coverage altogether. If issuers did cover women, they frequently did not cover many women's health services, including routine preventive and wellness services, such as pap smears or mammograms. Insurance premiums previously differed by sex, based on additional actuarial risk for females relative to males; with the ACA's requirement of equal premiums for both sexes, the payments associated with that risk are transferred from impacted females (who previously paid for that risk through higher premiums) to entities in society.
In the transgender community, a major barrier to receiving care is a concern over being refused medical treatment based on bias against them.
Covered entities' patient nondiscrimination policies often do not include gender identity. The 2014 Human Rights Campaign Healthcare Equality Index, which evaluates health care facilities' LGBT policies and practices, found that among the 640 hospitals it evaluated, 501 had patient nondiscrimination policies but of those only 257 had a patient nondiscrimination policy that included both the terms “sexual orientation” and “gender identity.”
With respect to access to nondiscriminatory health insurance coverage, Durso, Baker and Cray cite interviews from their survey of the difficulties that LGBT individuals have experienced seeking insurance.
Discrimination in the health care context leads to denials of adequate health care for individuals and increases in existing health disparities in underserved communities.
By prohibiting discrimination on the basis of sex, including sex stereotyping and gender identity, Section 1557 would result in more women and transgender individuals feeling secure in obtaining coverage and accessing health services. Since 2013, the uninsured rate for women has declined by 7.7 percentage points, resulting in nearly 7.7 million women gaining health insurance as of 2015.
The State of California, in an economic impact assessment of State practices prohibiting gender discrimination in health care, cites the following benefits:
1. Reduced violence against affected individuals;
2. Improved worker safety and improved productivity at work for affected individuals;
3. Reduced depression and suicide attempts among the affected population; and
4. Overall declines in substance abuse, smoking and alcohol abuse rates, and improvements in mental health among treated individuals in LGBT populations who receive appropriate medical treatment.
Moreover, because discrimination contributes to health disparities, the prohibition of sex discrimination in health care under Section 1557 can help reduce health disparities. While it is not possible to quantify the benefits of the reduction in health disparities, the benefits would include more people receiving adequate health care, regardless of their sex, including gender identity.
The health and longevity benefits discussed above as potential effects of this rule can only occur if additional or higher-quality medical services are provided to affected individuals. These services would be associated with costs (which we lack data to estimate). As discussed in the earlier discussion of actuarial risk, to the extent that changes in insurance premiums do not alter how society uses its resources, then effects of the rule would be transfers between members of society, rather than social costs or benefits. In addition to women and transgender individuals, health service providers and the Federal government could also be recipients of these transfers. For example, in 2013, hospitals provided over $50 billion in uncompensated care to the uninsured, and the Federal government pays approximately 62% of uncompensated care.
Aside from the specific benefits and transfers that women, transgender individuals, and the health care community can be expected to gain from the enactment of the regulation, there are more general benefits that are intangible and unquantifiable. These benefits derive from having a society that provides equal access to health care for all.
In the course of developing this regulation, the Department considered various alternatives. Some of those alternatives still under consideration are discussed in the preamble, and the Department invites public comment on those options. A discussion of alternatives considered cannot cover all alternatives considered by the Department. The following alternatives are meant to be a representative sample to show how burden reduction was a major consideration in constructing the standards in this regulation.
OCR considered requiring covered entities to provide separate notices, covering separate content,
OCR decided to further reduce the burden imposed on covered entities by the notice requirement by providing that it would develop and provide covered entities with a sample notice. OCR allows covered entities flexibility in complying with the proposed notice requirement by giving covered entities the option of using the sample notice or developing their own notice. Although OCR considered requiring covered entities to post the notice in 15 languages (Spanish (or Spanish Creole), Chinese, Vietnamese, Korean, Tagalog, Russian, Arabic, French Creole, French (including Patois, Cajun), Portuguese (or Portuguese Creole), Polish, Japanese, Italian, German, and Persian (Farsi)), it rejected that option. Instead, it will translate the notice into 15 languages and provide covered entities the discretion to post one or more of the translated notices, should they so choose. We believe that making translated notices readily available to covered entities maximizes efficiency and economies of scale, provides flexibility while minimizing burden, and helps provide greater access for beneficiaries and consumers. Additionally, although OCR considered requiring covered entities to create their own taglines in the top 15 national languages spoken by individuals with LEP, it rejected that option. Instead, OCR will provide covered entities the 15 translated taglines. As the tagline requirement for the covered entities only requires the cost of printing and posting, this burden is expected to be minimal.
OCR considered not providing training materials to covered entities on the requirements of the regulation. However, in order to reduce costs and burden, OCR is providing these materials which will reduce covered entities' costs of developing training materials from $500 per entity to $125 per entity, saving an estimated $106 million. Entities are assumed to bear one quarter of the total costs. These costs result from paying the presenters who will run the training sessions, providing classroom space, and supplementing the OCR provided training materials (should they choose to do so).
OCR considered remaining silent on covered entities' obligations to comply with Section 1557's prohibition of national origin discrimination as it affects individuals with LEP. We rejected this approach because we were concerned that the Department's silence would create ambiguity about covered entities' obligations to individuals with LEP and could jeopardize the access of individuals with LEP to covered entities' health programs and activities. Options for addressing the prohibition of national origin discrimination as it affects individuals with LEP are discussed in the preamble to the proposed rule.
OCR considered a regulatory scheme requiring covered entities to provide meaningful access to each individual with LEP by providing effective language assistance services, at no cost, unless such action would result in an undue burden or fundamental alteration. OCR also considered requiring covered entities of a certain type or size to have enhanced obligations to provide language assistance services. Such enhanced obligations could include providing a predetermined range of language assistance services in certain non-English languages that met defined thresholds. A covered entity that was not of a certain type or size still would be required to provide meaningful access to each individual with LEP in its health programs and activities, but the covered entity would not have to provide a predetermined range of language assistance services in certain non-English languages. OCR also explored applying the threshold requirement to standardized vital documents on a national, State, or county level as well as specific to a covered entity's geographic service area.
The strengths of these alternate regulatory schemes include limited obligations for small businesses providing health programs or activities and defined standards for larger entities. The costs of these approaches include the complexity of the regulatory scheme and the potential burden on the covered entities of a certain type or size that would have enhanced applications. OCR determined these costs outweighed the benefits at this time. As stated in the preamble, the Department invites public comment on these options.
OCR considered drafting new provisions addressing effective communication (apart from communication through electronic and information technology) with individuals with disabilities, but instead is incorporating provisions of the regulation implementing Title II of the ADA to ensure consistency for covered entities and potentially reduce burden by limiting resources spent on training and modification of policies and procedures.
Options regarding communication through electronic and information technology are discussed in the preamble to the regulation. Regarding the accessibility requirements under the proposed regulation, OCR considered two alternatives: (1) Clarifying the scope of the requirements by defining whether the standards adopted apply only to access to covered entities' Web sites or other means of electronic and information technology; and (2) updating the NPRM's current standards for determining accessibility to include newer functional standards such as the Web Content Accessibility Guidelines adopted by the World Wide Web Consortium or standards under Section 508. While these alternatives could potentially increase the burden on recipients of Federal financial assistance and State-based Marketplaces, they also would offer clarity to covered entities and would help enhance access for individuals with disabilities.
In the area of compliance, OCR considered having one set of procedures for all compliance activities involving recipients of Federal financial assistance and State-based Marketplace entities. Instead, OCR decided to adopt the unique Age Act procedures
With regard to other areas of compliance, OCR considered developing a separate set of procedures for Section 1557 compliance activities involving HHS health programs and activities, but decided to largely adopt the existing procedures for disability compliance activities involving HHS health programs and activities (with some enhancement) to improve efficiencies for OCR and the HHS health programs and activities covered by Section 1557.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule that includes a Federal mandate that could result in expenditure in any one year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. In 2015, that
The Unfunded Mandates Reform Act does not address the total cost of a final rule. Rather, it focuses on certain categories of cost, mainly those “Federal mandate” costs resulting from: (1) Imposing enforceable duties on State, local, or tribal governments, or on the private sector; or (2) increasing the stringency of conditions in, or decreasing the funding of, State, local, or tribal governments under entitlement programs.
Our impact analysis shows that burden associated with training staff working for covered entities will be spread widely across health care entities, State and local governmental entities and a substantial number of health insurance issuers. The analysis estimates the unfunded burden will be about $383 million in one-time training costs. We project that for the first few years following enactment of the final rule, private sector costs for investigating discrimination complaints may amount to $119 million per year. Within the first five years following the rule's enactment, we anticipate complaints to increase, but eventually to drop off as covered entities modify their policies and practices in response to the proposed rule.
As we explain in the RIA, we believe there will be benefits gained from the enactment of this regulation in the form of reduction in discrimination based on race, color, national origin, sex, age, and disability, the improvement in the quality of care underserved communities will receive.
As required by Executive Order 13132 on Federalism, the Department has examined the effects of provisions in the proposed regulation on the relationship between the Federal government and the States. The Department has concluded that the proposed regulation does have Federalism implications but preempts State law only where the exercise of State authority directly conflicts with the exercise of Federal authority under the Federal statute.
The proposed regulation attempts to balance State autonomy with the necessity to create a Federal benchmark that will provide a uniform level of nondiscrimination protection across the country. The proposed regulation restricts regulatory preemption of State law to the minimum level necessary to achieve the objectives of the underlying Federal statute, Section 1557 of the ACA.
It is recognized that the States generally have laws that relate to nondiscrimination against individuals on a variety of bases. State laws continue to be enforceable, unless they prevent application of the proposed rule. The proposed rule explicitly provides that it is not to be construed to supersede State or local laws that provide additional protections against discrimination on any basis articulated under the regulation. Provisions of State law relating to nondiscrimination that are “more stringent” than the proposed Federal regulatory requirements or implementation specifications will continue to be enforceable.
Section 3(b) of Executive Order 13132 recognizes that national action limiting the policymaking discretion of States will be imposed only where there is constitutional and statutory authority for the action and the national activity is appropriate in light of the presence of a problem of national significance. Discrimination issues in relation to health care are of national concern by virtue of the scope of interstate health commerce. The ACA's provisions reflect this position.
Section 3(d)(2) of the Executive Order 13132 requires that where possible, the Federal Government defer to the States to establish standards. Title I of the ACA authorized the Secretary to promulgate regulations to implement Section 1557, and we have done so accordingly.
Section 4(a) of Executive Order 13132 expressly contemplates preemption when there is a conflict between exercising State and Federal authority under a Federal statute. Section 4(b) of the Executive Order authorizes preemption of State law in the Federal rule making context when “the exercise of State authority directly conflicts with the exercise of Federal authority under the Federal statute.” The approach in this regulation is consistent with these standards in the Executive Order in superseding State authority only when such authority is inconsistent with standards established pursuant to the grant of Federal authority under the statute.
Section 6(b) of Executive Order 13132 includes some qualitative discussion of substantial direct compliance costs that State and local governments would incur as a result of a proposed regulation. We have determined that the costs of the proposed rule would not impose substantial direct compliance costs on State or local governments. We have considered the cost burden that this proposed rule would impose on State and local health care and benefit programs, and estimate State and local government costs will be in the order of $18.5 million in the first two years of implementation. The $18.5 million represents the sum of the costs of training State workers and enforcement costs attributable to State agencies analyzed above.
The RFA requires agencies that issue a regulation to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The RFA generally defines a “small entity” as:
(1) A proprietary firm meeting the size standards of the Small Business Administration (SBA);
(2) A nonprofit organization that is not dominant in its field; or
(3) A small government jurisdiction with a population of less than 50,000 (States and individuals are not included in the definition of “small entity”).
HHS uses as its measure of significant economic impact on a substantial number of small entities a change in revenues of more than 3% for 5% or more of affected small entities.
If we judge that a rule would have a significant impact on a substantial number of small entities, we will consider alternatives to reduce the burden. To accomplish our task, we must first identify all the small entities that may be impacted, and then evaluate whether the economic burden we determined in the RIA represents a significant economic impact.
HHS has traditionally classified most health care providers as small entities even though some nonprofit providers would not meet the definition of “small entity” were they proprietary firms. Nonprofit entities are small if they are independently owned and operated and are not dominant in their fields.
The CMS Provider of Service file has indicators for profit and nonprofit entities, but these have proven to be unreliable. The Census data identifies firms' tax status by profit and non-profit status but only reports revenues and does not report them by the profit and non-profit status of the entity.
One class of providers we do not automatically classify as small businesses is physician practices. Physician practices are businesses and therefore are “small” if they meet the SBA's definition. The current size standard for physicians (excluding mental health specialists)—North American Industry Classification System code 62111—is annual receipts
Pharmacies also are businesses, and the size standard for them is annual receipts of less than $27.5 million. According to U.S. Census Statistics of U.S. Businesses, there are 18,852 pharmacy and drug store firms (North American Industry Classification System code 44611). Because of the lack of revenue or receipt data for pharmacies, we are unable to estimate the number of small pharmacies based on the SBA size standard. However, using the number of employees taken from the Statistics of U.S. Businesses as a proxy for revenues, the data is divided by number of employees per firm and shows the number of employers with fewer than 20 employees and those with more than 20 employees.
Another class of covered entities that are business enterprises is health insurance issuers. The SBA size standard for health insurance issuers is annual receipts of $38.5 million. Although the Blue Cross/Blue Shield companies that operate in some markets are organized as nonprofit entities, they often are large enough so as to not meet the definition of “small entity.”
Unfortunately, we cannot use the Census revenue data for estimating the number of small health insurance issuers because the Census data combines life and health insurance. Substituting costs for revenues allows us to obtain a rough estimate of the number of large insurance issuers, realizing that cost will probably be less than revenues, thus giving us a lower count of large issuers. Using the National Health Expenditure for 2013, net cost of health insurance equaled $173.6 billion. However, the 2012 Census data report a total of 815 health insurance issuers. Dividing the $174 billion in costs by the number of insurance issuers reported in the census tables yields average costs of over $213 million, which means that average annual revenues per issuer exceeds $213 million. We conclude, therefore, that there are almost no small insurance issuers. The above analysis comports with the conclusion CMS published in the Health Insurance Web Portal Requirements (75 FR 24481, May 5, 2010).
We also exclude local governmental entities from our count of small entities because we lack the data to classify them by populations of fewer than 50,000. The following table shows the number of small covered entities we estimate may be affected by the proposed rule.
To determine the economic impact of the proposed rule, we divide the costs that small entities will bear by the number of small affected entities. We examine the costs we identified for training, enforcement, and complying with the notice requirement and adjust those costs to reflect only the costs that small entities will incur.
To remove the costs for training for large entities, we must remove both the large entities and their associated workforce. We removed 17,855 physician firms with associated training costs of $60.8 million and 2,332 pharmacies with associated training costs of $11.4 million. Also, we removed costs borne by the 180 health insurance issuers we identified as
The total cost burden of the “large” entities we can identify (including cost of preparing materials and employee time) amounts to $89.4 million.
We also identified costs for investigating discrimination complaints that covered entities may incur following enactment of the final rule in the enforcement section in this analysis. The total amount ascribed to investigating discrimination complaints for covered health care entities with 15 or more employees is estimated to be $118.7 million per year over five years following final rule enactment. As we noted in the enforcement analysis, for purposes of the analysis, we assumed a uniform distribution of complaints across all covered entities.
To determine costs for investigating discrimination complaints for small entities, we divided the cost attributed to health care covered entities. Dividing health care covered entity investigation costs of $118.7 million by the approximately 58,500 health care covered entities with 15 or more employees who are required to have grievance procedures under the proposed rule, yielding a cost per entity of $2,029.
We also examined the cost for covered entities of printing, translating, and posting new notices as required under this proposed regulation. The estimated cost for printing and distributing notice and tag lines for health care providers is approximately $4.8 million. Dividing this amount by the 278,565 total health care providers equals $17 per entity.
In the analysis of the cost for providers to revise their policies and procedures to conform to the prohibition of discrimination on the basis of sex, we estimate that 75% of total health care entities, or 208,700, would incur a cost of approximately $47.5 million. To arrive at the cost per entity, we divide the cost by the 208,700 health care entities, which equals $227 per entity.
To estimate the overall burden cost on small entities, we must add training costs ($1,135), the cost to an entity to investigate a complaint of discrimination ($2,029), the costs for printing and distributing notices and tag lines ($17), and the cost for providers to revise their policy and procedures for prohibiting sex discrimination ($227). The total estimated overall burden of the proposed rule on small entities is approximately $3,409.
The definition of a small entity varies with its North American Industry Classification System code; for physicians, the SBA defines the threshold revenues as up to $11 million, for pharmacies up to $25 million, and for health issuers up to $38.5 million. An average cost of $3,409 represents a de minimis percentage of their revenues and clearly less than the 3% standard that is set up under the RFA standards for significant impact. Furthermore we believe that fewer than 5% of all small entities will experience a burden of greater than 3% of their revenues. Ambulatory health care services facilities (North American Industry Classification System 621), for example, are small entities with an average of 13 employees and revenue of $1.7 million based on 2012 reported data for employees of 6.4 million and total revenues of $825.7 million for 485,235 firms.
For the most part, because this regulation is consistent with existing standards applicable to the covered entities, the new burdens created by its issuance are minimal. The major impacts are in the areas of voluntary training and enforcement where increased caseloads pose incremental costs on covered entities. It is possible, if broader options that extend existing civil rights requirements beyond their current scope were adopted after public comment in a final rule, that the burdens estimated in this RIA would increase. However, the rule as currently written does not include such expansions and therefore minimizes the imposition of new burdens. Nevertheless, it is still a major rule with approximately $383 million in training costs over a two-year period and another $122 million in increased annual enforcement costs. We also account for printing notice and tagline costs of $5 million, and costs to revise policies and procedures of $48 million, for a total of $558 million. This RIA was organized and designed to explain the origin of these cost impacts to allow for meaningful public comment.
Administrative practice and procedure, Civil rights, Discrimination, Elderly, Health care, Health facilities, Health insurance, Health programs and activities, Individuals with disabilities, Nondiscrimination, Reporting and recordkeeping requirements, Sex discrimination.
For the reasons set forth in the preamble, the Department of Health and Human Services proposes to add 45 CFR part 92 as follows:
42 U.S.C. 18116, 5 U.S.C. 301.
The purpose of this part is to implement Section 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. 18116), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557 provides that, except as provided in Title I of the Patient Protection and Affordable Care Act (ACA), an individual shall not, on the grounds prohibited under Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, the Age Discrimination Act of 1975, or Section 504 of the Rehabilitation Act of 1973, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any
(a) Except as provided otherwise in this part, this part applies to every health program or activity, any part of which receives Federal financial assistance administered by the Department; every health program or activity administered by the Department; and every health program or activity administered by a Title I entity.
(b) Limitations:
(1) Exclusions to the application of the Age Discrimination Act of 1975, as set forth at 45 CFR 91.3(b)(1), apply to claims of discrimination based on age under Section 1557 or this part.
(2) [Reserved]
(a)
(b)
As used in this part, the term—
(1) Qualified interpreters on-site or through video remote interpreting (VRI) services, as defined in 28 CFR 35.104, 36.303(b); note takers; real-time computer-aided transcription services; written materials; exchange of written notes; telephone handset amplifiers; assistive listening devices; assistive listening systems; telephones compatible with hearing aids; closed caption decoders; open and closed captioning, including real-time captioning; voice, text, and video-based telecommunication products and systems, text telephones (TTYs), videophones, and captioned telephones, or equally effective telecommunications devices; videotext displays; accessible electronic and information technology; or other effective methods of making aurally delivered information available to individuals who are deaf or hard of hearing;
(2) Qualified readers; taped texts; audio recordings; Braille materials and displays; screen reader software; magnification software; optical readers; secondary auditory programs; large print materials; accessible electronic and information technology; or other effective methods of making visually delivered materials available to individuals who are blind or have low vision;
(3) Acquisition or modification of equipment and devices; and
(4) Other similar services and actions.
(1) An entity that operates a health program or activity, any part of which receives Federal financial assistance;
(2) An entity established under Title I of the ACA that administers a health program or activity; and
(3) The Department.
(1) The term electronic and information technology includes, but is not limited to, telecommunications products (such as telephones), information kiosks and transaction machines, internet sites, multimedia, and office equipment such as copiers and fax machines.
(2) The term does not include any equipment that contains embedded information technology that is used as an integral part of the product, but the principal function of which is not the acquisition, storage, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information. For example, HVAC (heating, ventilation, and air conditioning) equipment such as thermostats or temperature control devices, and medical equipment where information technology is integral to its operation, are not electronic and information technology as defined in this part.
(1) Health benefits coverage or health insurance provided to employees and/or their dependents established, operated, sponsored or administered by, for, or on
(2) An employer provided or sponsored wellness program;
(3) An employer-provided health clinic; or
(4) Long term care coverage or insurance provided or administered by an employer, group health plan, third party administrator, or health insurance issuer.
(i) Funds;
(ii) Services of Federal personnel; or
(iii) Real and personal property or any interest in or use of such property, including:
(A) Transfers or leases of such property for less than fair market value or for reduced consideration; and
(B) Proceeds from a subsequent transfer or lease of such property if the Federal share of its fair market value is not returned to the Federal government.
(2) Federal financial assistance provided or administered by the Department includes all tax credits under Title I of the ACA, as well as payments, subsidies, or other funds extended by the Department to any entity providing health insurance coverage for payment to or on behalf of an individual obtaining health insurance coverage from that entity or extended by the Department directly to such individual for payment to any entity providing health insurance coverage.
(1) Oral language assistance, including interpretation in non-English languages provided in-person or remotely by a qualified interpreter, and bilingual or multilingual staff competent to communicate, in non-English languages using any necessary specialized vocabulary, directly with individuals with limited English proficiency;
(2) Written translation of documents and Web sites into languages other than English; and
(3) Taglines.
(i) Is able, for an individual with a disability, to interpret effectively, accurately, and impartially, both receptively and expressively, using any necessary specialized vocabulary, and/or;
(ii) Has demonstrated proficiency in, and has above average familiarity with speaking or understanding, both spoken English and at least one other spoken language; and is able, for an individual with limited English proficiency, to interpret effectively, accurately, and impartially, both receptively and expressly, to and from such language(s) and English, using any necessary specialized vocabulary.
(2) For an individual with a disability, qualified interpreters can include, for example, sign language interpreters, oral transliterators (individuals who represent or spell in the characters of another alphabet), and cued-language transliterators (individuals who represent or spell by using a small number of handshapes).
(1) A Health Insurance Marketplace that facilitates the purchase of health insurance coverage through qualified health plans in the individual market and that provides for the establishment of a Small Business Health Options Program; or
(2) A Health Insurance Marketplace that provides only for the establishment of a Small Business Health Options Program.
(a)
(b)
(c)
(a)
(2) Where a recipient is found to have discriminated against an individual on the basis of race, color, national origin, sex, age, or disability, in violation of Section 1557 or this part, and where another recipient exercises control over the recipient that has discriminated, the Director, where appropriate, may require either or both entities to take remedial action.
(3) The Director may, where necessary to overcome the effects of discrimination in violation of Section 1557 or this part, require a recipient or State-based Marketplace to take remedial action with respect to:
(i) Individuals who are no longer participants in the recipient's or State-based Marketplace's health program or activity but who were participants in the health program or activity when such discrimination occurred; or
(ii) Individuals who would have been participants in the health program or activity had the discrimination not occurred.
(b)
(a)
(b)
(a) Each covered entity shall take appropriate initial and continuing steps to notify beneficiaries, enrollees, applicants, or members of the public of the following:
(1) The covered entity does not discriminate on the basis of race, color, national origin, sex, age, or disability;
(2) The covered entity provides appropriate auxiliary aids and services, including qualified interpreters and information in alternate formats, free of charge and in a timely manner, when such aids and services are necessary to ensure an equal opportunity to participate to individuals with disabilities;
(3) The covered entity provides language assistance services, free of charge and in a timely manner, when such services are necessary to provide meaningful access to individuals with limited English proficiency;
(4) How to obtain the aids and services in paragraphs (a)(2) and (3) of this section;
(5) An identification of and contact information for the responsible employee designated pursuant to § 92.7(a), if applicable;
(6) The availability of the grievance procedure and how to file a grievance, pursuant to § 92.7(b), if applicable; and
(7) How to file a discrimination complaint with OCR in the Department.
(b) Within 90 days of the effective date of this part, each covered entity shall post, consistent with paragraph (f) of this section, an English-language notice that conveys the information in paragraphs (a)(1) through (7) of this section.
(c) For use by covered entities, the Director shall make available, electronically and in any other manner that the Director determines appropriate, the content of a sample notice that conveys the information in paragraphs (a)(1) through (7) of this section in English and in the top 15 languages spoken by individuals with limited English proficiency nationally.
(d) Within 90 days of the effective date of this part, each covered entity shall post taglines in the top 15 languages spoken by individuals with limited English proficiency nationally.
(e) For use by covered entities, the Director shall make available, electronically and in any other manner that the Director determines appropriate, taglines in the top 15 languages spoken by individuals with limited English proficiency nationally.
(f)(1) Each covered entity shall post the English-language notice required by paragraphs (a) and (b) of this section and the taglines required by paragraph (d) of this section in a conspicuously-visible font size:
(i) In significant publications and significant communications targeted to beneficiaries, enrollees, applicants, or members of the public;
(ii) In conspicuous physical locations where the entity interacts with the public; and
(iii) In a conspicuous location accessible from the home page of the covered entity's Web site.
(2) A covered entity may also post the notice and taglines in additional publications and communications.
(g) A covered entity that complies with paragraphs (a), (b), (d), and (f) of this section meets the requirements of the regulation implementing Title VI, at § 80.6(d) of this subchapter, the regulation implementing Section 504, at §§ 84.8(a) and 85.12 of this subchapter, the regulation implementing Title IX, at §§ 86.8(b) and 86.9(a)(1) of this subchapter, and the regulation implementing the Age Act, at § 91.32(b) of this subchapter, as applicable.
(a)
(2) Except as provided in § 92.208, this part does not apply to discrimination by a covered entity against its own employees.
(b)
(1) Each covered entity must comply with the regulation implementing Title VI, at § 80.3(b)(1) through (6) of this subchapter.
(2)(i) Each recipient and State-based Marketplace must comply with the regulation implementing Section 504, at §§ 84.4(b), 84.21 through 84.23(b), 84.31, 84.34, 84.37, 84.38, and 84.41 through 84.55 of this subchapter. Where this paragraph cross-references regulatory provisions that use the term “recipient,” the term “recipient or State-based Marketplace” shall apply in its place.
(ii) The Department, including the Federally-facilitated Marketplaces, must comply with the regulation implementing Section 504, at §§ 85.21(b), 85.41 through 85.42, and 85.44 through 85.51 of this subchapter.
(3) Each covered entity must comply with the regulation implementing Title IX, at § 86.31(b)(1) through (8) of this subchapter. Where this paragraph cross-references regulatory provisions that use the term “student,” “employee,” or “applicant,” the terms “individual” shall apply in its place.
(4) Each covered entity must comply with the regulation implementing the Age Act, at § 91.11(b) of this subchapter.
(5) The enumeration of specific forms of discrimination in this paragraph does not limit the generality of the prohibition in paragraph (a) of this section.
(c) The exceptions applicable to Title VI apply to discrimination on the basis of race, color, or national origin under this part. The exceptions applicable to Section 504 apply to discrimination on the basis of disability under this part. The exceptions applicable to the Age Act apply to discrimination on the basis of age under this part. These provisions are found at §§ 80.3(d), 84.4(c), 85.21(c), 91.12 through 91.15, and 91.17 through 91.18 of this subchapter.
(d) Where the regulatory provisions referenced in paragraphs (b)(1), (b)(3), (b)(4), and (c) of this section use the term “recipient,” the term “covered entity” shall apply in its place. Where the regulatory provisions referenced in paragraphs (b)(1), (b)(3), (b)(4), and (c) of this section use the terms “program or activity” or “program” or “education program,” the term “health program or activity” shall apply in its place.
(a)
(b)
(1) Evaluate, and give substantial weight to, the nature and importance of the health program or activity, including the particular communication at issue, to the individual with limited English proficiency; and
(2) Take other relevant factors into account. Such factors may include:
(i) The length and complexity of the communication involved;
(ii) The context in which the communication is taking place;
(iii) The prevalence of the language in which the individual communicates among those eligible to be served or likely to be encountered by the health program or activity;
(iv) All resources available to the covered entity; and
(v) The cost of language assistance services.
(c)
(d)
(e)
(1) Require an individual with limited English proficiency to provide his or her own interpreter;
(2) Rely on an adult accompanying an individual with limited English proficiency to interpret or facilitate communication, except:
(i) In an emergency involving an imminent threat to the safety or welfare of an individual or the public where there is no qualified interpreter immediately available; or
(ii) Where the individual with limited English proficiency specifically requests that the accompanying adult interpret or facilitate communication, the accompanying adult agrees to provide such assistance, and reliance on that adult for such assistance is appropriate under the circumstances; or
(3) Rely on a minor child to interpret or facilitate communication, except in an emergency involving an imminent threat to the safety or welfare of an individual or the public where there is no qualified interpreter immediately available.
(f)
A covered entity shall take appropriate steps to ensure that communications with individuals with disabilities are as effective as communications with others in health programs and activities, in accordance with the standards found at 28 CFR 35.160 through 35.164. Where the regulatory provisions referenced in this section use the term “public entity,” the term “covered entity” shall apply in its place.
(a) Each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based Marketplace shall comply with the 2010 Standards as defined in § 92.4, if the construction or alteration was commenced on or after [18 MONTHS FROM DATE OF PUBLICATION OF FINAL RULE]. Departures from particular technical and scoping requirements by the use of other methods are permitted where substantially equivalent or greater access to and usability of the facility is provided. All newly constructed or altered buildings or facilities subject to this section shall comply with the requirements for a “public building or facility” as defined in Section 106.5 of the 2010 Standards.
(b) Each facility or part of a facility in which health programs or activities are conducted that is constructed or altered by or on behalf of, or for the use of, a recipient or State-based Marketplace in conformance with the Uniform Federal Accessibility Standards, the 1991 Standards, or the 2010 Standards as defined in § 92.4 shall be deemed to comply with the requirements of this section and with 45 CFR 84.23(a) and (b), cross-referenced in § 92.101(b)(2)(i) with respect to those facilities, if the construction or alteration was commenced before [18 MONTHS FROM DATE OF PUBLICATION OF FINAL RULE] .
(c) Each building or part of a building that is constructed or altered by or on behalf of, or for the use of, the Department must be designed, constructed, or altered so as to be readily accessible to and usable by individuals with disabilities. The definitions, requirements, and standards of the Architectural Barriers Act, as established in Appendices C and D to 36 CFR part 1191, apply to buildings and facilities covered by this section.
(a) Covered entities shall ensure that their health programs or activities provided through electronic and information technology are accessible to individuals with disabilities, unless doing so would result in undue financial and administrative burdens or a fundamental alteration in the nature of the health programs or activities. When undue financial and administrative burdens or a fundamental alteration exist, the covered entity shall provide information in a format other than an electronic format that would not result in such undue financial and administrative burdens or a fundamental alteration but would ensure, to the maximum extent possible, that individuals with disabilities receive the benefits or services of the health program or activity that are provided through electronic and information technology.
(b) State-based Marketplaces and recipients shall ensure that their health programs and activities provided through Web sites comply with the requirements of Title II of the ADA.
A covered entity shall make reasonable modifications to policies, practices, or procedures when such modifications are necessary to avoid discrimination on the basis of disability, unless the covered entity can demonstrate that making the modifications would fundamentally alter the nature of the health program or activity. For the purposes of this section, the term “reasonable modifications” shall be interpreted in a manner consistent with the term as set forth in the ADA Title II regulation at 28 CFR 35.130(b)(7).
A covered entity shall provide individuals equal access to its health programs or activities without discrimination on the basis of sex, and shall treat individuals consistent with their gender identity, except that any health services that are ordinarily or exclusively available to individuals of one gender may not be denied or limited based on the fact that an individual's sex assigned at birth, gender identity, or gender otherwise recorded in a medical record is different from the one to which such health services are ordinarily or exclusively available.
(a)
(b)
(1) Deny, cancel, limit, or refuse to issue or renew a health insurance plan or policy, or other health coverage, or deny or limit coverage of a claim, or impose additional cost sharing or other limitations or restrictions, on the basis of an enrollee's or prospective enrollee's race, color, national origin, sex, age, or disability;
(2) Employ marketing practices or benefit designs that discriminate on the basis of race, color, national origin, sex, age, or disability in a health-related insurance plan or policy, or other health-related coverage;
(3) Deny or limit coverage, deny a claim, or impose additional cost sharing or other limitations or restrictions, on any health services that are ordinarily or exclusively available to individuals of one sex, based on the fact that an individual's sex assigned at birth, gender identity, or gender otherwise recorded by the plan or issuer is
(4) Categorically or automatically exclude from coverage, or limit coverage for, all health services related to gender transition; or
(5) Otherwise deny or limit coverage, or deny a claim, for specific health services related to gender transition if such denial or limitation results in discrimination against a transgender individual.
(c) The enumeration of specific forms of discrimination in paragraph (b) does not limit the general applicability of the prohibition in paragraph (a) of this section.
(d) Nothing in this section is intended to determine, or restrict a covered entity from determining, whether a particular health service is medically necessary or otherwise meets applicable coverage requirements in any individual case.
A covered entity that provides an employee health benefit program to its employees and/or their dependents shall be liable for violations of this part in that employee health benefit program only when:
(a) The entity is principally engaged in providing or administering health services or health insurance coverage;
(b) The entity receives Federal financial assistance a primary objective of which is to fund the entity's employee health benefit program; or
(c) The entity is not principally engaged in providing or administering health services or health insurance coverage but operates a health program or activity, which is not an employee health benefit program, that receives Federal financial assistance; except that the entity is liable under this part with regard to the provision or administration of employee health benefits only to the employees in that health program or activity.
A covered entity shall not exclude from participation in, deny the benefits of, or otherwise discriminate against an individual or entity in its health programs or activities on the basis of the race, color, national origin, age, disability, or sex of an individual with whom the individual or entity is known or believed to have a relationship or association.
The enforcement mechanisms available for and provided under Title VI, Title IX, Section 504, or the Age Act shall apply for purposes of Section 1557 and this part with respect to covered entities.
(a) The procedural provisions applicable to Title VI apply with respect to enforcement actions concerning discrimination on the basis of race, color, national, origin, sex, and disability discrimination under Section 1557 or this part. These procedures are found at §§ 80.6 through 80.11 of this subchapter and part 81 of this subchapter.
(b) The procedural provisions applicable to the Age Act apply with respect to enforcement actions concerning age discrimination under Section 1557 or this part. These procedures are found at §§ 91.41 through 91.50 of this subchapter.
(c) An individual or entity may bring a civil action to challenge a violation of Section 1557 or this part in a United States District Court in which the recipient or State-based Marketplace is found or transacts business.
(a) This section applies to discrimination on the basis of race, color, national origin, sex, age, or disability in health programs or activities administered by the Department, including the Federally-facilitated Marketplaces.
(b) The procedural provisions applicable to Section 504 at §§ 85.61 through 85.62 of this subchapter shall apply with respect to enforcement actions against the Department concerning discrimination on the basis of race, color, national origin, sex, age, or disability under Section 1557 or this part. Where this section cross-references regulatory provisions that use the term “handicap,” this term shall be replaced with “race, color, national origin, sex, age, or disability.”
(c)
(d)
[Name of covered entity] complies with applicable federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex, including sex stereotypes and gender identity[. [Name of covered entity] does not exclude people or treat them worse because of their race, color, national origin, age, disability, or sex.
[Name of covered entity]:
• Provides free aids and services to people with disabilities to communicate effectively with us, such as:
○ Qualified sign language interpreters
○ written information in other formats (large print, audio, accessible electronic formats, other formats)
• Provides free language services to people whose first language is not English when needed to communicate effectively with us, such as:
○ Interpreters
○ information translated into other languages
If you believe that [Name of covered entity] has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: [
ATTENTION: If you speak [insert language], language assistance services, free of charge, may be available to you. Contact 1–xxx–xxx–xxxx (TTY: 1–xxx–xxx–xxxx).