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U.S. Citizenship and Immigration Services (USCIS), DHS.
Final rule.
This rule finalizes without change a 2008 interim final rule amending Department of Homeland Security (DHS) regulations governing the types of acceptable identity and employment authorization documents (EADs) and receipts that employees may present to employers for completion of Form I-9, Employment Eligibility Verification.
This final rule is effective May 16, 2011.
Letitia Coffin, Verification Division, U.S. Citizenship and Immigration Services, Department of Homeland Security, 131 M Street, NE., Suite 200, Washington, DC 20002, telephone (888) 464-4218 or e-mail at
The supplementary section is organized as follows:
All employers, agricultural recruiters and referrers for a fee
The Form I-9 has three categories of documents that employers may accept, alone or in combination, for employment authorization verification:
(1)
(2)
(3)
If the employee cannot present an acceptable document from one of the three lists, he or she may present an acceptable substitute document, referred to as a “receipt.”
On December 17, 2008, DHS published an interim rule amending DHS regulations governing the Form I-9 process.
• Prohibiting employers from accepting expired documents. Expired documents may not demonstrate the correct status of the bearer; are prone to tampering and fraudulent use; and may create confusion among employers. This change is intended to ensure that the documents accepted by employers as evidence of an employee's identity and employment authorization are valid and reliable;
• Removing Form I-688, “Temporary Resident Card,” and Forms I-688A and I-688B, “Employment Authorization Cards,” from the Lists of Acceptable Documents because USCIS no longer issues these documents and any such documents in possession of an employee would now have expired;
• Adding to the List of Acceptable Documents on List A of Form I-9: (1) The new U.S. passport card and (2) the temporary Form I-551, “Permanent Resident Card,” with a printed notation on a machine-readable immigrant visa;
• Adding documentation for certain citizens of the Federated States of Micronesia (FSM) and the Republic of the Marshall Islands (RMI) to List A to more accurately reflect their status under the Compacts of Free Association.
In addition to the amendments made by the 2008 interim rule, USCIS issued an amended Form I-9 which clarified changes, such as providing a separate box for noncitizen nationals to clearly delineate U.S. citizens from noncitizen nationals, and making minor format changes that make the form easier to use.
On January 16, 2009, DHS published a correction to the interim rule to remove extraneous language from two paragraphs of the regulation that describe a type of receipt that can be presented by lawful permanent residents to their employers in lieu of the Form I-551, “Permanent Resident Card,” for completion of Form I-9.
On February 3, 2009, DHS extended the comment period for the interim rule to March 4, 2009.
In preparing this final rule, DHS considered the comments that were received during the comment period and were within the scope of this rulemaking as well as the other materials contained in the docket. The final rule does not address comments seeking changes in United States statutes, changes in regulations or petitions unrelated to or not addressed by the interim rule, changes in procedures of other components within DHS or other agencies, or the resolution of any other issues not within the scope of the rulemaking or the authority of DHS.
All comments may be reviewed at the Federal Docket Management System (FDMS) at
The final rule adopts, without change, all of the regulatory amendments set forth in the interim rule. The rationale for the interim rule and the reasoning provided in the preamble to the interim rule remain valid with respect to these regulatory amendments, and DHS adopts such reasoning in support of the promulgation of this final rule.
Many commenters supported the improvements to the Form I-9 process made in the interim rule, such as: Prohibiting employers from accepting expired documents; removing certain documents no longer issued by USCIS; adding two new documents to List A; adding documentation for certain citizens of the FSM and RMI to List A; and making clarifying changes to Form I-9, such as providing a separate box for noncitizen nationals. Most commenters discussed the prohibition on employers from accepting expired documents and supported the change because they believe that this change would prevent unauthorized aliens from obtaining employment in the United States by using expired documents which are more susceptible to fraud and counterfeiting than unexpired documents.
Although most commenters supported one or more changes to the Form I-9 process, several commenters opposed the prohibition on the use of expired documents because they believe that many employment-authorized individuals such as asylees, refugees, and conditional residents should not be required to present an unexpired document as evidence of employment authorization. The commenters were concerned that such employees will be unable to work if processing or issuance of a new document is delayed. Several commenters also opposed the prohibition on the use of expired documents because they believe that these changes will create additional burdens and costs for employers and employees. Some of the commenters who opposed the prohibition on the use of expired documents requested a delay in implementation of the interim rule. In response to public comments requesting an extension of the effective date, DHS delayed the effective date of the interim rule from February 2, 2009, to April 3, 2009.
Many commenters pointed out the need for comprehensive immigration reform including a thorough review of the Form I-9 process. Some commenters suggested improvements to the Form I-9 process such as: Biometrics; providing the public a truly electronic Form I-9; and detailed changes to the form. Other commenters discussed document reduction or suggested changes to the acceptability of specific document types such as: School IDs; U.S. Passports; State-issued drivers' licenses including enhanced drivers' licenses; voter registration cards; Native American tribal documents; and the Certificates of Citizenship and Naturalization.
Comments that were received are addressed below and are organized by subject area. Comments related to the economic burdens of this rule are addressed in the Executive Order 12866 and Regulatory Flexibility Act sections of part III of the Supplementary Information.
DHS received 23 comments addressing the interim rule's requirement that all documents presented for Form I-9 be unexpired. Fifteen commenters supported the requirement and eight commenters opposed it. Most of the commenters who supported the requirement wrote that allowing employers to accept expired documents would lead to the inadvertent acceptance of fraudulent documents and, therefore, the employment of unauthorized aliens. Some commenters who supported the
Eight commenters opposed the requirement that documents must be unexpired for Form I-9 and stated that employers should be able to continue to accept expired documents as permitted before the interim rule went into effect. Five of these commenters proposed the continued acceptance of expired documents for varying periods between 30 days and five years after expiration of the document. Two of these commenters wrote that the cost of obtaining replacement documents was too high. One commenter wrote that refugees and asylees should be excused from this requirement because these individuals are authorized for employment incident to their status.
DHS is retaining the requirement that documents be unexpired and is not adopting the commenters' suggestions to continue accepting expired documents. Concerns about document fraud were among the most important reasons for this rulemaking. Unexpired documents are more likely to contain up-to-date security features that make them less vulnerable to counterfeiting and fraud. Because expired documents may lack security features or may have outdated security features, these documents can more easily be counterfeited.
DHS disagrees with the commenters who wrote that expired documents should be allowed within specified parameters (e.g., 30 days after expiration). Establishing a requirement that all documents be unexpired sets a clear standard that is easy for U.S. employers to apply. Such a requirement honors the time limits of validity placed on documents by their issuing authorities. In addition, precluding employers from accepting expired documents alleviates confusion when determining whether documents are valid for Form I-9 and helps to ensure that the documents relate to the person presenting them. Moreover, disallowing the acceptance of expired documents reduces document fraud and may prevent unauthorized aliens, criminals and even terrorists from evading detection.
One commenter requested that DHS allow employers to accept Employment Authorization Documents (EADs) presented by refugees and asylees that have been expired no longer than 90 days. The commenter wrote that neither group requires an EAD because both are authorized to work incident to their lawful immigration status.
DHS has not adopted the commenter's request in this final rule. DHS is aware of the many difficulties that refugees and asylees face in adapting to a new life in the United States and has carefully considered those difficulties as they relate to employment authorization. However, permitting the use of expired documents for Form I-9, even for the limited period of 90 days as suggested by the commenter, introduces vulnerabilities into the verification process that undermine the purpose of the process as a whole. The EAD is not the only acceptable document that refugees and asylees may present for Form I-9 purposes. They may satisfy Form I-9 requirements by presenting a combination of a List B and a List C document, such as a State-issued driver's license and an unrestricted Social Security Account Number card. Many refugees and asylees instead choose to present an EAD because of the simplicity of having a List A document that meets identity and employment authorization requirements. DHS acknowledges the desire for simplicity on the part of both groups; however, permitting the use of expired EADs for only refugees and asylees and for only a 90-day period after a particular document's expiration conflicts with DHS' desire to provide a consistent rule prohibiting the use of expired documents.
Five commenters wrote that expired documents should be acceptable because USCIS is unable to timely process applications for new documents demonstrating employment authorization.
DHS is not adopting the commenters' recommendations. DHS processes applications for renewal of immigration-related documents in a timely manner for applicants who apply to renew their immigration documents with sufficient planning in advance of expiration dates. In the event of a processing delay or unforeseen emergency, or for applications filed too close to the documents' expiration dates, applicants may request expedited processing. The regulations at 8 CFR 274a.13(d) impose a 90-day processing time for DHS to adjudicate applications for Form I-765, “Application for Employment Authorization Document,” and to issue an EAD. DHS records indicate that the current average cycle time for Form I-765 processing was 1.9 months as of November 2008.
Two of the five commenters also wrote that if USCIS precludes the use of expired documents, then USCIS should adopt a rule that permits employers to accept, in lieu of an acceptable Form I-9 document, a receipt for the application of replacement of an expired document, for a 240-day period. These two commenters also stated that the current 90-day period provides insufficient time to present proper documentation due to USCIS's processing delays.
DHS is not adopting the suggestion by the commenter to expand the period of time that a receipt for the application for a replacement document may be used in lieu of a document listed as acceptable for Form I-9. The commenter is referring to the “receipt rule” which allows employers to accept a document specified in the regulations as a “receipt” in lieu of a List A, B, or C document for a temporary period. Under the receipt rule, an employer may accept a receipt for the application for a replacement document for a 90-day period for Form I-9 if the List A, B, or C document that is being replaced has been lost, stolen, or damaged.
Another commenter wrote that refugees should be permitted a grace
DHS has not adopted the commenter's suggestions in this final rule. USCIS expedites applications for those refugees who choose to apply for an EAD. DHS records show that, in most instances, USCIS issues EADs to refugees within two weeks of their admission to the United States. In addition, current regulations already contain a “90-day grace period” for refugees. Until refugees receive their EADs, they may present Form I-94, “Arrival-Departure Record,” with an unexpired refugee admission stamp as temporary proof of employment authorization.
One commenter requested that DHS provide a definition of the term “unexpired.” In general, DHS considers a document to be unexpired when the expiration date on the face of the document, if any, has not passed. DHS is not, however, including a formal definition of “unexpired” in this final rule. DHS has determined that, given the wide variety of documents acceptable for Form I-9 purposes, and the fact that the term has been present in the regulations for many years, it would not be appropriate or necessary to provide an all-encompassing definition of the term in this rulemaking. DHS will provide guidance to the public in response to specific questions concerning particular documents as appropriate.
Six commenters expressed concerns about the entire Form I-9 employment verification process. Three of the six commenters requested that DHS conduct a comprehensive review of the entire Form I-9 process that carefully considers the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA).
DHS has not adopted these comments as they are outside the scope of the interim rule. The interim rule did not make changes to the verification process as a whole. Instead, the rule made limited changes to the types of documents that are acceptable for employment verification, such as eliminating outdated List A documents and precluding the presentation of expired documents.
One of the commenters wrote that DHS has not removed enough documents from the Lists of Acceptable Documents on Form I-9 to fulfill its mandate under the authorizing statute. DHS assumes that the commenter is referring to the document reduction provision of IIRIRA. IIRIRA amended section 274A(b)(1) of the INA, 8 U.S.C. 1324a(b)(1), by removing several documents from List A (
One commenter suggested that Form I-9 is not an effective tool to discourage unauthorized employment because an employer can easily discard a Form I-9 after three years under certain circumstances. The same commenter also noted that an employee's departure from the United States is not confirmed after his or her employment authorization has expired.
DHS has not addressed Form I-9's effectiveness as a means of providing employment verification or reporting the departure of aliens previously authorized to work in this rulemaking. The Form I-9 retention requirement is statutory, and, therefore, is not within DHS's authority to change. The statute requires that employers retain completed Forms I-9 for all employees for three years after the date an employee is hired, or one year after the date employment is terminated, whichever is later.
With respect to the commenter's suggestion that an employee's departure from the United States be noted on Form I-9, current rules only require reverification of employment authorization once the employment authorization noted on Form I-9 expires.
Another commenter requested that the 2008 interim rule be withdrawn because of DHS's failure to perform a comprehensive review of the Form I-9 process, noting that time and resources could be better spent on a comprehensive review.
DHS is not withdrawing the 2008 interim rule for purposes of conducting a comprehensive review. The changes made in the interim rule will lead to significant administrative benefits by reducing employer confusion and increasing compliance. Moreover, to withdraw the rule and revert to the preceding Form I-9 also would result in considerable confusion among employers. DHS continually reviews and analyzes the employment eligibility verification process and considers changes to the process as appropriate. DHS may propose additional changes in the Form I-9 verification process in the future as needed.
Two commenters discussed the 1998 notice of proposed rulemaking found at 63 FR 5287. One commenter wrote that prior to the 2008 interim rule, the former INS last requested public comments in 1998 and has not published responses to those comments. The commenter added that DHS has not promulgated a rule in the
DHS agrees with the commenter that the INS did not publish responses to the public comments received with respect to the 1998 proposed rule, and neither has DHS published responses to the comments. As stated in the Supplementary Information to the interim rule, however, the interim rule superseded the 1998 proposed rule, and the comments received as part of that rulemaking informed the development of the interim rule. DHS does not intend to publish responses to the public comments, given the time that has passed since the 1998 proposed rule. INS published a proposed rule in 1998 regarding the good faith defense against technical Form I-9 paper violations.
One commenter alerted DHS that the interim rule erroneously added the language “with an unexpired passport” to the regulation found at 8 CFR 274a.2(b)(1)(vi)(B)(
DHS published a correction to 8 CFR 274a.2(b)(1)(vi)(B)(
Ten commenters requested a delay in implementation of the interim rule. DHS did delay the initial effective date, extending the date from February 2, 2009, to April 3, 2009. DHS determined that there was no basis for any further delay in the effective date for this rule.
DHS received several comments regarding Form I-9 in response to the information collection published with the interim rule. These comments are addressed below.
Eight commenters discussed the expiration date indicated on Form I-9. Six commenters were concerned that the revised Form I-9 (Rev. 02/02/09) might expire on June 30, 2009, as indicated on the form. Four commenters suggested that because the current Form I-9 bears an expiration date of June 30, 2009, employers should be allowed to continue using the preceding Form I-9 until that time, with its allowance for accepting expired documents. Three commenters noted that the gap between the implementation date of the new form and the expiration of the old form is confusing. One commenter argued that DHS should allow the use of either Form I-9 until June 30, 2009.
Employers may use either Form I-9 with the new revision date of 08/07/09 or Form I-9 with the 02/02/09 revision date. On April 28, 2009, DHS published a 30-day notice in the
Seven commenters recommended specific changes to Form I-9. Two commenters recommended that all acceptable documents and receipts be included on Lists A, B, and C. Another commenter requested that Part 8 of the Handbook be updated to include the current Lists of Acceptable Documents. One commenter requested that DHS provide guidance about List A, Item 5, the foreign passport with Form I-94 indicating:
• Nonimmigrant status,
• Work is authorized incident to status, and that
• Work is restricted for a specific employer.
While DHS appreciates the commenters' recommendations, DHS is not making further changes to Form I-9 beyond those made based on the interim rule. DHS may consider these recommendations when undertaking future revisions to Form I-9 and the Handbook.
One commenter requested that instructions to Form I-9 be written in plain language. DHS promotes and supports the use of plain language and regrets that the commenter found the instructions difficult to understand. DHS will continue carefully to examine future changes to Form I-9 for plain language.
Another commenter recommended that the boxes to attest to U.S. citizenship and noncitizen national status should be separated on Form I-9. In the Form I-9 accompanying the interim rule, DHS added a separate check box for U.S. citizens and noncitizen nationals in the immigration/citizenship status attestation of Section 1 of Form I-9. DHS is retaining this change in Form I-9.
Two commenters requested that any future version of Form I-9 be made available at
DHS recognizes the need for employers and human resource professionals to have sufficient time to prepare for any changes to Form I-9. For this rulemaking, DHS made Form I-9 available to the public for informational
One commenter requested that DHS exercise favorable discretion for employers who unintentionally used the wrong Form I-9 after the interim rule went into effect.
Beginning April 3, 2009, employers were required to use the Form I-9 (Rev. 02/02/09) containing the revisions based on the interim rule. A subsequent Form I-9 was made available on August 7, 2009 (Rev. 8/7/09). Employers may use either form. DHS may exercise favorable discretion if an employer unintentionally used the wrong Form I-9 due to confusion regarding which form to use between February 2009 and April 2009. Employers who used the wrong form during this time period are still expected to comply with all other Form I-9 regulations applicable to the preceding form.
Three commenters requested that DHS make an electronic Form I-9 available that could be used with human resources software. Another commenter requested specific technical improvements to create a solely electronic employment authorization verification process. Four commenters noted that the Form I-9 provided on the USCIS Web site was password-protected or had security settings that prohibited them from completing and saving the form electronically. These commenters also requested that DHS provide an electronic Form I-9 that can be completed, signed electronically and saved on their computer systems.
DHS appreciates the commenters' recommendations regarding requested enhancements in electronic completion and storage of the electronic Form I-9. These comments are technical in nature and outside the scope of the changes that DHS is making to Form I-9 through this rulemaking. Changes to Form I-9 are limited to amending the Lists of Acceptable Documents and making minor clarifications to the data elements on the form.
The revised Form I-9 that DHS posted on the USCIS Web site as of January 16, 2009, can be completed online but cannot be signed and stored electronically. As such, DHS must password-protect the form to prevent the public from making any changes to it. DHS recognizes the public's desire for an electronic Form I-9. DHS is continually evaluating possible improvements to the Form I-9 process so that it is more user-friendly.
DHS received several suggested changes to the lists of documents acceptable for Form I-9. Suggested changes to List A documents include one commenter's proposal for DHS to rename the Native American tribal document and add it to List A because it is already acceptable as both a List B and List C document. Two commenters requested that Form I-797, “Notice of Action,” be made an acceptable document for permanent residents who possess an expired Form I-551 and whose conditions on status have been removed. One commenter requested that Form I-797 serve as an acceptable receipt for a List A document until the initial Form I-551 is received in the mail. Four commenters requested that Certificates of Naturalization or Citizenship be added to List A of Form I-9. One commenter wrote that it is discriminatory to allow U.S. citizens to use certified copies of birth certificates but not allow Certificates of Naturalization or Citizenship for those born outside of the United States. Two commenters requested that enhanced State-issued drivers' licenses be added to the list of documents that establish both identity and employment authorization (List A).
Suggested changes to acceptable documents on List B of Form I-9 included one commenter's suggestion that Native American tribal documents meet the same minimum requirements as State-issued driver's licenses if they are included on List B. Two commenters wrote that school ID cards should meet the same minimum requirements as State-issued driver's licenses.
With respect to changes to acceptable documents on List C of Form I-9, one commenter proposed that voter registration cards, currently under List B, be made acceptable documents on List C because such documents evidence that the bearer is 18 or older and a U.S. citizen. Concerning all documents acceptable for Form I-9, two commenters suggested the addition of biometrics to Form I-9 documents. One of the two commenters suggested that the addition of biometrics would prevent identity fraud.
DHS appreciates these commenters' concerns and suggestions. However, these comments do not address the changes made in the interim rule to the Lists of Acceptable Documents for Form I-9 and, therefore, are outside the scope of this rulemaking. In considering any future changes to the Lists of Acceptable Documents, DHS may consider commenters' suggestions.
One commenter suggested that all State and Federal agencies should accept the documents on Lists A, B, and C of Form I-9 as proof of entitlement to a benefit.
This suggestion is outside the scope of the interim rule, which is limited to documents used for the Form I-9 employment eligibility verification process. Moreover, DHS does not have the authority to mandate that State and Federal agencies accept Form I-9 documents as proof of entitlement to benefits.
DHS received several requests for additional outreach to the public and additional guidance on the Form I-9 process. Two commenters requested that DHS perform greater outreach to inform the public about their responsibilities concerning Form I-9. One of the two commenters indicated that special efforts should be made to reach refugees and asylees.
One commenter asked whether Forms I-9 that were completed a few days before the effective date of the revised Form I-9 still have to meet the requirements of the final rule.
Two commenters wrote that there is insufficient guidance for the many categories of aliens with temporary employment authorization. One commenter wrote that many of these aliens are at risk of losing or being denied employment because they are unable to meet the requirements of the interim rule. The first commenter wrote that since the notice of proposed rulemaking at 63 FR 5287 was published in 1998, Congress and USCIS have created a number of new categories of employment authorization, for which it provided only sporadic or no guidance. The first commenter also wrote that the 1997 interim rule that precedes this interim rule (
With respect to acceptable documents for Form I-9, one commenter requested that DHS provide examples of school ID cards acceptable as List B documents.
With respect to completion of Form I-9, one commenter wanted to know whether a notary public can act on behalf of an employer.
Several commenters requested that DHS provide additional guidance for employers about reverification of an employee's continued employment authorization. Six commenters requested clarification on reverifying documents that have expired after the time of hire and after Form I-9 is completed. Four commenters asked if U.S. passports or State-issued drivers' licenses had to be reverified. One commenter requested that refugees and asylees not be required to be reverified once their EADs expire because both are authorized to work incident to status. One commenter wanted to know how to complete Form I-9 for employees who are rehired by the same employer and whose documents that were used to complete the original Form I-9 have expired. The commenter also questioned whether Section 3 of Form I-9 has sufficient room to reverify two documents. Two commenters asked if they were required to reverify expired passports from FSM or RMI that were not expired at the time Form I-9 was initially completed.
DHS appreciates the commenters' requests for outreach and further guidance on the Form I-9 process. In addition to multiple written resources, including the Handbook, USCIS continually provides individualized outreach to employers. USCIS regularly provides Web-based seminars on Form I-9 and E-Verify and conducts live presentations in several states. Employers may request these seminars and live presentations at the DHS Web site. USCIS also collaborates with U.S. Immigration and Customs Enforcement (ICE) to provide additional outreach to employers regarding employment authorization requirements. Employers with specific questions related to the Form I-9 process are encouraged to call the USCIS Verification Division at 1-888-464-4218.
Nineteen commenters requested that DHS conduct a comprehensive reform of current immigration policies. Thirteen of the 19 commenters expressed opposition to the displacement of U.S citizens and/or employment-authorized persons in the workforce by undocumented workers. Two of the 19 commenters supported the legalization of undocumented workers. Three of the 19 commenters opposed continued legal immigration to the United States. Six of the 19 commenters specifically supported the use of E-Verify, and five commenters specifically opposed it.
These comments are outside the scope of the interim rule which was limited to making discrete changes to the Lists of Acceptable Documents for Form I-9.
The interim rule published by DHS on December 17, 2008, contains a complete regulatory analysis for the changes implemented under that rule.
This rule is a significant regulatory action under Executive Order 12866, section 3(f)(1), Regulatory Planning and Review. Accordingly, the Office of Management and Budget (OMB) has reviewed this rule.
DHS received three comments on the interim rule's estimated cost of renewing an expired document to comply with the rule. One commenter suggested that the costs may be too high for many individuals or may force an employee to get a new type of document. The commenter also wrote that the basis for the decision to remove expired documents is not supported by any study or statistic.
DHS appreciates the concerns of the commenters regarding the added costs that some individuals may bear to obtain unexpired documents to meet the new Form I-9 requirement. However, DHS has determined that any such costs are outweighed by the benefits of retaining the requirement that all documents be unexpired. Continuing to permit use of expired documents for Form I-9 would undermine the reliability of the verification process. Expired documents are subject to fraud. DHS experience indicates that:
• Older, invalid, expired documents are too easily converted to uses other than the purpose intended by their issuing authorities,
• Requiring documents to be unexpired establishes a clear standard for U.S. employers,
• Since an expired document is no longer useful for its original purpose as intended by the issuer, DHS should not impute validity to an expired document for purposes of Form I-9,
• As stated in the interim rule, once the transition to the new Form I-9 is complete, DHS anticipates that the costs incurred by employers will decrease because the updated Lists of Acceptable Documents, simplified design of the Form I-9, and more comprehensive instructions provided with the form, will make the verification process for employers easier than it is now.
Another commenter objected to the use of leisure time to calculate the cost of the time spent obtaining unexpired documents, noting that the time spent retrieving documents could be spent working. DHS agrees that it is possible that some of the opportunity costs associated with obtaining replacements for expired documents could be based on the value of time spent working and not solely the value of leisure time as the interim rule estimated. In the example that the commenter refers to, the interim rule stated that if 1.2 percent of the estimated 58 million annual new hires in the United States must obtain a new document, 696,000 people are affected.
As discussed in the interim rule, DHS determined that this regulatory action is exempt from notice and comment rulemaking pursuant to 5 U.S.C. 553(b)(B). Therefore, the interim rule was exempt from the provisions of the Regulatory Flexibility Act, 5 U.S.C. 601
In the December 17, 2008, interim rule DHS requested and received OMB approval to use the revised Form I-9 when the interim rule became effective until June 30, 2009. The interim rule also allowed the public to submit comments on the revised Form I-9 for 60 days. The comments to the revised Form I-9 have been addressed in the supplementary portion of this final rule, and DHS determined it would not make additional changes to Form I-9 at this time. On April 28, 2009, DHS published a 30-day notice in the
Administrative practice and procedure, Aliens, Employment, Penalties, Reporting and recordkeeping requirements.
Accordingly, the interim rule amending 8 CFR part 274a, which was published in the
Federal Aviation Administration (FAA), DOT.
Final rule.
This establishes, amends, suspends, or revokesStandard Instrument Approach Procedures (SIAPs) and associatedTakeoff Minimums and Obstacle Departure Procedures foroperations at certain airports. These regulatory actions areneeded because of the adoption of new or revised criteria, orbecause of changes occurring in the National Airspace System,such as the commissioning of new navigational facilities, addingnew obstacles, or changing air traffic requirements. Thesechanges 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 April 15, 2011. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publicationslisted in the regulations is approved by the Director of theFederal Register as of April 15, 2011.
Availability of matters incorporated by reference inthe amendment is as follows:
1. FAA Rules Docket, FAA Headquarters Building,800 Independence Avenue, SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which theaffected airport is located;
3. The National Flight Procedures Office, 6500 SouthMacArthur Blvd., Oklahoma City, OK 73169 or
4. The National Archives and Records Administration(NARA). For information on the availability of this material atNARA, call 202-741-6030, or go to:
1. FAA Public Inquiry Center (APA-200), FAA HeadquartersBuilding, 800 Independence Avenue, SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected airport is located.
Harry J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies andPrograms Divisions, Flight Standards Service, Federal AviationAdministration, Mike Monroney Aeronautical Center, 6500 SouthMacArthur 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), byestablishing, amending, suspending, or revoking SIAPS, TakeoffMinimums and/or ODPS. The complete regulators description ofeach SIAP and its associated Takeoff Minimums or ODP for anidentified airport is listed on FAA form documents which areincorporated by reference in this amendment under 5 U.S.C.552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAAForms 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, inaddition to their complex nature and the need for a special format make publication in the
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP ascontained in the transmittal. Some SIAP and Takeoff Minimums and
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 anticipatedat the affected airports. Because of the close and immediaterelationship between these SIAPs, Takeoff Minimums and ODPs, andsafety in air commerce, I find that notice and public proceduresbefore adopting these SIAPS, Takeoff Minimums and ODPs areimpracticable and contrary to the public interest and, where applicable, that 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, and Navigation (Air).
Accordingly, pursuant to the authority delegated to me,Title 14, Code of Federal Regulations, Part 97 (14CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0902 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
On March 4, 2011 (76 FR 11944) the FAA published an Amendment in Docket No. 30770, Amdt 3414 to Part 97 of the Federal Aviation Regulations under section 97.33. The following entries, published in TL 11-07 effective for 05 MAY 2011, are hereby
On March 25, 2011 (76 FR 16690) the FAA published an Amendment in Docket No. 30772, Amdt 3416 to Part 97 of the Federal Aviation Regulations under section 97.33. The following entry, published in TL 11-08 effective for 05 MAY 2011, is hereby
On March 25, 2011 (76 FR 16691) the FAA published an Amendment in Docket No. 30772, Amdt 3416 to Part 97 of the Federal Aviation Regulations under section 97.33. The following entries, published in TL 11-08 effective for 05 MAY 2011, are hereby
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or revokes 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
This rule is effective April 15, 2011. 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 April 15, 2011.
Availability of matter incorporated by reference in the amendment is as follows:
1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which the affected airport is located;
3. The National Flight Procedures Office, 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:
1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected airport is located.
Harry J. Hodges, Flight Procedure Standards Branch (AFS-420) Flight Technologies and Programs 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 (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations.
The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
The SIAPs, as modified by FDC P-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, 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 which created the need for all these SIAP amendments requires making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that 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, and 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, 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:
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is classifying the hemorrhoid prevention pressure wedge into class II (special controls). The special controls will apply to the device in order to provide a reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge provides support to the perianal region during the labor and delivery process.
This rule is effective May 16, 2011. The classification was applicable on January 13, 2011.
Glenn Bell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. G112, Silver Spring, MD 20993-0002, 301-796-6531.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act (21 U.S.C.360c(i)), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act provides that any person who submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified may, within 30 days after receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, request FDA to classify the device under the criteria set forth in section 513(a)(1) of the FD&C Act. FDA will, within 60 days of receiving this request, classify the device by written order. This classification will be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on August 5, 2009, classifying the Hem-Avert Perianal Stabilizer into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On August 17, 2009, Plexus Biomedical, Inc., submitted a petition requesting classification of the Hem-Avert Perianal Stabilizer under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II. (Ref. 1)
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the petition in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the petition, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device.
The device is assigned the generic name hemorrhoid prevention pressure wedge, and it is identified as a hemorrhoid prevention pressure wedge that provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.
FDA has identified the following risks to health associated specifically with this type of device and the recommended measures to mitigate these risks.
FDA believes that the following special controls address the risks to health and provide reasonable assurance of the safety and effectiveness of the device: (1) The sale, distribution, and use of this device are restricted to
Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a hemorrhoid prevention pressure wedge will need to address the issues covered in the special controls.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the hemorrhoid prevention pressure wedge they intend to market.
The Agency has determined under 21 CFR 25.34(b) 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.
FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 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). The Agency believes that this final rule is not a significant regulatory action under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because reclassification of this device from class III to class II will relieve manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e), and may permit small potential competitors to enter the marketplace by lowering their costs, the Agency certifies that the final rule will not have a significant economic impact on a substantial 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) in any one year.” The current threshold after adjustment for inflation is $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. (21 U.S.C. 360k);
This final rule establishes special controls that refer to previously approved collections of information found in other FDA regulations. 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. 32501-3520). The collections of information in part 807, regarding premarket notification submissions, have been approved under OMB control no. 0910-0120; the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control no. 0910-0485.
The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 884 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) The labeling must include specific instructions regarding the proper placement and use of the device.
(3) The device must be demonstrated to be biocompatible.
(4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use.
(5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.
Civil Rights Division, Department of Justice.
Final rule.
The Attorney General finds it necessary to revise the Department of Justice's “Procedures for the Administration of section 5 of the Voting Rights Act of 1965.” The revisions are needed to clarify the scope of section 5 review based on recent amendments to section 5, make technical clarifications and updates, and provide better guidance to covered jurisdictions and interested members of the public concerning current Department practices. Proposed revised Procedures were published for comment on June 11, 2010, and a 60-day comment period was provided.
The rule will be effective on April 15, 2011.
T. Christian Herren, Jr., Chief, Voting Section, Civil Rights Division, United States Department of Justice, Room 7254-NWB, 950 Pennsylvania Avenue, NW., Washington, DC 20530, or by telephone at (800) 253-3931.
Section 5 of the Voting Rights Act of 1965, as amended, 42 U.S.C. 1973c, requires certain jurisdictions (listed in the Appendix) to obtain “preclearance” from either the United States District Court for the District of Columbia or the United States Attorney General before implementing any new standard, practice, or procedure that affects voting.
Procedures for the Attorney General's Administration of section 5 were first published in 1971. Proposed Procedures were published for comment on May 28, 1971 (36 FR 9781), and the final Procedures were published on September 10, 1971 (36 FR 18186). As a result of the Department's experience under the 1971 Procedures, changes mandated by the 1975 Amendments to the Voting Rights Act, and interpretations of section 5 contained in judicial decisions, proposed revised Procedures were published for comment on March 21, 1980 (45 FR 18890), and final revised Procedures were published on January 5, 1981 (46 FR 870) (corrected at 46 FR 9571, Jan. 29, 1981). As a result of further experience under the 1981 Procedures, specifically with respect to redistricting plans adopted following the 1980 Census, changes mandated by the 1982 Amendments to the Voting Rights Act, and judicial decisions in cases involving section 5, revised Procedures were published for comment on May 6, 1985 (50 FR 19122), and final revised Procedures were published on January 6, 1987 (52 FR 486).
In the twenty-four years since the previous revisions became final, the Attorney General has had further experience in the consideration of voting changes; the courts have issued a number of important decisions in cases involving section 5, and Congress enacted the 2006 amendments to the Voting Rights Act. This new revision reflects these developments.
In response to the Notice of Proposed Rulemaking (“Notice”) published on June 11, 2010 (75 FR 33205), we received comments from or on behalf of two national public interest organizations, one research and educational institution, one national political organization composed of attorneys, and one individual. All comments received are available for inspection and copying at www.regulations.gov and at the Voting Section, Civil Rights Division, Department of Justice, Washington DC 20530.
The comments received expressed diverse views and were of great assistance in the preparation of these final revisions to the Procedures. The final revised Procedures reflect our consideration of the comments as well as further consideration of sections or topics that were not the subject of comments.
The purpose of the revision to the definition of “change affecting voting” or “change” is to clarify the definition of the benchmark standard, practice, or procedure. One commenter recommended we revise this section to reflect that the benchmark is the standard, practice, or procedure in force or effect at the time of the submission or the last legally enforceable standard, practice, or procedure in force or effect in the jurisdiction. We have concluded that no further revision of this section is warranted. The Voting Section's practice is to compare the proposed standard, practice, or procedure to the benchmark. Generally, the benchmark is the standard, practice, or procedure that has been: (1) Unchanged since the jurisdiction's coverage date; or (2) if changed since that date, found to comply with section 5 and “in force or effect.”
The purpose of the revisions to the delegation of authority is to make technical corrections to the delegation of authority from the Attorney General to the Assistant Attorney General, and from the Chief of the Voting Section to supervisory attorneys within the Voting Section, and to conform the Procedures to other parts of Title 28. Two commenters objected to the revisions, expressing concern that the delegation of the functions of the Chief to supervisory attorneys in the Voting Section results in the delegation of section 5 legal review authority to non-politically appointed attorneys subordinate to the Section Chief.
The concerns of these commenters are unfounded. The delegation of authority in these Procedures is similar to existing delegations. For example, pursuant to the appendix to 28 CFR Part 0, Subpart J, the Chief may authorize the Deputy Chief to act on his or her behalf. Moreover, under the revised Procedures, the Chief needs the concurrence of the Assistant Attorney General, who is a presidential appointee, to designate supervisory attorneys to perform section 5 functions. Accordingly, we decline to revise the section further.
The purpose of the revisions to this section is to clarify that the review period commences when a submission is received by the Department officials responsible for conducting section 5 reviews and to clarify the date of the response.
One commenter objected to the commencement of the 60-day review period upon receipt of the submission by the Voting Section or the Office of the Assistant Attorney General of the Civil Rights Division as an unwarranted extension of the 60-day review period. The Federal Rules of Civil Procedure provide for the designation of a Department clerical employee to receive summonses on behalf of the Attorney General. Fed. R. Civ. P. 4(i)(1)(A)(i). Similarly, and for the same purpose of prompt and efficient routing, the Attorney General has designated both the Voting Section and the Office of the Assistant Attorney General of the Civil Rights Division as the proper recipients for section 5 submissions.
The Department has made one additional edit to this section. As set forth in the Notice and as described below, a second paragraph is being added to § 51.37 (Obtaining information from the submitting authority). To ensure consistency, the reference to § 51.37, contained in previous versions of the Procedures, is amended to § 51.37(b),
The purpose of this revision is to clarify that the dissolution or merger of voting districts, de facto elimination of an elected office, and reallocations of authority to adopt or administer voting practices or procedures are all subject to section 5 review.
One commenter suggested that we add the extension of a term of office for an elected official as an example of a covered change in paragraph (i). We concluded that including this example would provide additional clarity. To the extent that the extension of an elected official's term is a discretionary change that affects the next regularly scheduled election for that office, there is no question that it constitutes a “change affecting voting” covered by section 5. Additionally, extending the term of a particular office affects the ability of voters to elect candidates of choice at regularly scheduled intervals.
The commenter also suggested that paragraph (k), which provides that changes affecting the right or ability of persons to participate in “political campaigns” are covered under section 5, be expanded to include “campaigns or other pre-election activity.” We agreed that the phrase “political campaigns,” without any elaboration, may carry partisan connotations not envisioned by the statute. Additionally, “political campaigns” may not include all pre-election activity related to voting, and a somewhat broader construction is consistent with the broad scope given to “changes affecting voting” covered under section 5. Such changes include any “voting qualification or prerequisite to voting or standard, practice, or procedure” related to the right to vote, 42 U.S.C. 1973(a), and the Supreme Court has recognized that voting includes “all action necessary to make a vote effective.”
Using the phrase “pre-election activity,” by itself, however, is too general and nebulous. As a result, we have revised the paragraph to reflect that any change affecting the right or ability of persons to participate in pre-election activity, such as political campaigns, is subject to review under section 5.
Another commenter objected to the inclusion of paragraph (l) as an example of changes affecting voting, stating that this change did not fall within the scope of section 5 coverage. A change in the voting-related authority of an official or governmental entity does alter election law and change rules governing voting. Thus, such changes meet the test of voting relatedness that is at the core of the Court's decision in
The purpose of the revisions to this section is to clarify the principle that section 5 review ordinarily should precede other forms of court review, that a court-ordered change that initially is not subject to section 5 may become covered through subsequent actions taken by the affected jurisdiction, and that the interim use of an covered change before it is established that such change complies with section 5 should be ordered by a court only in emergency circumstances.
One commenter opposed the changes contained in the section stating that the revisions appear to grant federal courts greater authority than the case law recognizes to implement voting changes that are subject to, but not yet reviewed under, section 5 on an emergency basis. Although that was not the intent of the revisions, we have modified § 51.18(a) to clarify that it reflects existing judicial precedent. After further consideration, we believe that, other than renumbering the paragraph as § 51.18(d), it is appropriate not to make any change to § 51.18(c) as it currently exists in the Procedures.
The proposed revision to paragraph (a) was omitted from the June 11, 2010, Notice of Proposed Rulemaking in error. The purpose of the revision is to make purely technical changes to the format in which information may be submitted to the Attorney General electronically. In addition, since the publication of the Notice, the Census Bureau has renamed the 15-character geographic identifier specified in paragraph (b); the final Procedures reflect this change in nomenclature.
The purpose of the revisions to this section is to clarify the addresses and methods by which persons may provide written comments on section 5 submissions and to clarify the circumstances in which the Department may withhold the identity of those providing comments on section 5 submissions.
One commenter objected to the nondisclosure of the identity of an individual or entity where an assurance of confidentiality may reasonably be implied from the circumstances of the communication. The Department believes, however, that communications
The purpose of the revisions to this section is to clarify the procedures for the Attorney General to make oral and written requests for additional information regarding a section 5 submission.
One commenter recommended that we revise the paragraph concerning oral requests to make clear that the Attorney General reserves the authority to restart the 60-day review period upon receipt of material provided in response to the Attorney General's first such request made with respect to a submission, and that responses to an oral request do not affect the running of the 60-day period once a written request for information is made.
We declined to amend the proposed language regarding responses to an oral request because as the Procedures currently exist the Attorney General may request further information within the new 60-day period following the receipt of a response from the submitting authority to an earlier written request, but such a request shall not suspend the running the 60-day period, nor shall the Attorney General's receipt of such further information begin a new 60-day period. Moreover, § 51.39 provides that we may determine that information supplied in response to an oral request in the initial review period materially supplements the pending request such that it does extend the 60-day period.
We did conclude, however, on the basis of the comment that we received, that a reordering of the paragraphs would add clarity to the section and make it more useful.
As described above, the paragraphs of § 51.37 are being reordered. To ensure consistency, the reference to § 51.37(a) in previous versions of the Procedures is amended to § 51.37(b).
The purpose of the revisions to this section is to clarify the manner in which the 60-day requirement applies to reconsideration requests and revise language to conform to the substantive section 5 standard in the 2006 amendments to the Act.
One commenter objected to the revisions in paragraph (a), expressing a concern that the revisions permit the Attorney General to exceed 60 days for the reconsideration of an objection. Section 51.48 provides that the 60-day reconsideration period may be extended to allow a 15-day decision period following a conference held pursuant to § 51.47. Moreover, the courts have held that when a submitting jurisdiction deems its initial submission on a reconsideration request to be inadequate and decides to supplement it, the 60-day period is commenced anew. The purpose of this interpretation is to provide the Attorney General time to give adequate consideration to materials submitted in piecemeal fashion.
The purpose of the revision to this section is to clarify the procedures regarding access to section 5 records. One commenter opposed the changes to paragraph (b) and conveyed concerns that these changes will result in the removal of record keeping with regard to objection files.
Under paragraph (a), the Voting Section continues to maintain a section 5 file for each submission, including objection files. Accordingly, all appropriate records continue to be maintained with regard to all section 5 submissions.
The purpose of the revision to this section is to clarify the substantive standard so as to reflect the 2006 amendments to the Act and the manner in which the Attorney General will evaluate submissions under section 5.
One commenter suggested that paragraph (a) be amended further to reflect the fact that the Attorney General “shall apply the same standard of review,” instead of “shall make the same determination,” that would be made by a court in an action for a declaratory judgment under section 5. The section refers to making a “determination” as the activity that both the Attorney General and the district court undertake,
Another commentator suggested we replace “purpose and effect” with “purpose or effect” in paragraph (c). Although we decided not to incorporate the commentator's exact change, we did decide that further refinement of the paragraph would provide more clarity. Therefore, the paragraph will reflect that in those situations where the evidence as to the purpose or effect of the change is conflicting and the Attorney General is unable to determine that the change is free of both the prohibited discriminatory purpose and effect, the Attorney General will interpose an objection.
One commenter suggested various minor edits to the proposed language. We declined to make these changes. The proposed language reflects our extensive experience gained over the years in our administrative review of section 5 changes, while avoiding redundancy.
We did edit the language of paragraph (c) to reflect that the statutory language refers to a change in a standard, practice, or procedure affecting voting, not only a practice or procedure.
One commenter suggested that we include “contemporaneous statements and viewpoints held by decision-makers” in the list of relevant factors. Such statements are an evidentiary source cited by the Court in its opinion in
One commenter suggested that this paragraph be revised to state that whether “election-related activities,” instead of “political activities,” are racially segregated or exclusionary constitutes important background information when making section 5 determinations. The proposed paragraph provided that the Attorney General will consider the “extent to which voting in the jurisdiction is racially polarized and political activities are racially segregated.” Courts in cases assessing whether the constitutional guarantees afforded to persons to exercise the franchise without discrimination have been infringed have often used the words “electoral” and “political” as synonyms for each other. See,
Two commenters recommended various additions or deletions to paragraph 51.59(a). Because these factors are not intended to be exhaustive, not all factors are listed. Rather, the factors that are listed are illustrative, intended to provide guidance to jurisdictions regarding redistricting plans.
Other commenters suggested we delete or revise certain previously existing factors described in the paragraph. The Attorney General has, however, repeatedly cited factors identified in the section in past objection letters. Additionally, courts have cited “traditional redistricting principles,” such as preserving recognized communities of interest and maintaining political and geographical boundaries, as relevant factors in a section 5 analysis.
One commenter suggested we amend paragraph 51.59(a)(7) to focus on whether a proposed plan is inconsistent with the jurisdiction's “long-held” redistricting standards, instead of the jurisdiction's “stated standards.” The commenter believes that by adding the term “long-held,” jurisdictions will be discouraged from adopting ad hoc redistricting principles to insulate a redistricting plan during section 5 review. The current factors, particularly with regards to discriminatory purpose, encapsulate scenarios where a jurisdiction adopts pretextual or unusual redistricting criteria. The Procedures should not be interpreted to discourage jurisdictions from considering traditional redistricting principles such as one-person, one-vote, or maintaining natural political or geographic boundaries, even if they have not done so in the past.
Several commenters suggested this paragraph be revised in the interest of clarity. After reviewing the language, we agreed that it did not clearly reflect the relevant case law on this point and that some clarification would be helpful. We revised the paragraph accordingly.
One commenter suggested the addition of several provisions related to the substantive standards to be employed during the review of redistricting plans. The proposed revisions go beyond the scope of these Procedures.
This rule amends interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice and therefore the notice requirement of 5 U.S.C. 553(b) is not mandatory. Although notice and comment was not required, we nonetheless chose to offer the proposed rule for notice and comment.
The Attorney General, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this rule and by approving it certifies that this rule will not have a significant economic impact on a substantial number of small entities because it applies only to governmental entities and jurisdictions that are already required by section 5 of the Voting Rights Act of 1965 to submit voting changes to the Department of Justice, and this rule does not change this requirement. It provides guidance to such entities to assist them in making the required submissions under section 5. Further, a Regulatory Flexibility Analysis was not required to be prepared for this rule because the Department of Justice was not required to publish a general notice of proposed rulemaking for this matter.
This rule has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review,” section 1(b), Principles of Regulation. The Department of Justice has determined that this rule is not a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by the Office of Management and Budget. The amendments made by this rule clarify the scope of section 5 review based on recent amendments to section 5, make certain technical clarifications and updates, and provide better guidance to covered jurisdictions and citizens. In many instances, the amendments describe longstanding practices of the Attorney General in his review of section 5 submissions.
This rule does not have federalism implications warranting the preparation of a Federalism Assessment under section 6 of Executive Order 13132 because the rule does not alter or modify the existing statutory requirements of section 5 of the Voting Rights Act imposed on the States, including units of local government or political subdivisions of the States.
This document meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
Administrative practice and procedure, Archives and records, Authority delegations (government agencies), Civil rights, Elections, Political committees and parties, Voting rights.
Accordingly, by virtue of the authority vested in me as Attorney General, including 5 U.S.C. 301, 28 U.S.C. 509, 510, and 42 U.S.C. 1973b, 1973c, the following amendments are made to Chapter I of Title 28 of the Code of Federal Regulations:
5 U.S.C. 301; 28 U.S.C. 509, 510.
(h) Administration of sections 3(c) and 5 of the Voting Rights Act of 1965, as amended (42 U.S.C. 1973a(c), 1973c).
5 U.S.C. 301; 28 U.S.C. 509, 510, and 42 U.S.C. 1973b, 1973c.
(a) * * *
(1) A declaratory judgment is obtained from the U.S. District Court for the District of Columbia that such qualification, prerequisite, standard, practice, or procedure neither has the purpose nor will have the effect of denying or abridging the right to vote on account of race, color, or membership in a language minority group, or
The responsibility and authority for determinations under section 5 and section 3(c) have been delegated by the Attorney General to the Assistant Attorney General, Civil Rights Division. With the exception of objections and decisions following the reconsideration of objections, the Chief of the Voting Section is authorized to perform the functions of the Assistant Attorney General. With the concurrence of the Assistant Attorney General, the Chief of the Voting Section may designate supervisory attorneys in the Voting Section to perform the functions of the Chief.
(a)
(b)
All political subunits within a covered jurisdiction (
(a) The Attorney General shall have 60 days in which to interpose an objection to a submitted change affecting voting for which a response on the merits is appropriate (
(b) The 60-day period shall commence upon receipt of a submission by the Voting Section of the Department of Justice's Civil Rights Division or upon receipt of a submission by the Office of the Assistant Attorney General, Civil Rights Division, if the submission is properly marked as specified in § 51.24(f). The 60-day period shall recommence upon the receipt in like manner of a resubmission (
(c) The 60-day period shall mean 60 calendar days, with the day of receipt of the submission not counted, and with the 60th day ending at 11:59 p.m. Eastern Time of that day. If the final day of the period should fall on a Saturday, Sunday, or any day designated as a holiday by the President or Congress of the United States, or any other day that is not a day of regular business for the Department of Justice, the next full business day shall be counted as the final day of the 60-day period. The date of the Attorney General's response shall be the date on which it is transmitted to the submitting authority by any reasonable means, including placing it in a postbox of the U.S. Postal Service or a private mail carrier, sending it by telefacsimile, email, or other electronic means, or delivering it in person to a representative of the submitting authority.
(a) Obtain a judicial determination from the U.S. District Court for the District of Columbia that the voting change neither has the purpose nor will have the effect of denying or abridging the right to vote on account of race, color, or membership in a language minority group.
Submission to the Attorney General does not affect the right of the
Except as provided in § 51.18 (Federal court-ordered changes), the section 5 requirement applies to any change affecting voting, even though it appears to be minor or indirect, returns to a prior practice or procedure, seemingly expands voting rights, or is designed to remove the elements that caused the Attorney General to object to a prior submitted change. The scope of section 5 coverage is based on whether the generic category of changes affecting voting to which the change belongs (for example, the generic categories of changes listed in § 51.13) has the potential for discrimination.
(e) Any change in the constituency of an official or the boundaries of a voting unit (
(i) Any change in the term of an elective office or an elected official, or any change in the offices that are elective (
(k) Any change affecting the right or ability of persons to participate in pre-election activities, such as political campaigns.
(l) Any change that transfers or alters the authority of any official or governmental entity regarding who may enact or seek to implement a voting qualification, prerequisite to voting, or standard, practice, or procedure with respect to voting.
(a)
(b)
(c)
(d)
A jurisdiction subject to the preclearance requirements of section 5 that becomes involved in any litigation concerning voting is requested to notify the Chief, Voting Section, Civil Rights Division, at the addresses, telefacsimile number, or email address specified in § 51.24. Such notification will not be considered a submission under section 5.
(b) The Attorney General will accept certain machine readable data in the following electronic media: 3.5 inch 1.4 megabyte disk, compact disc read-only memory (CD-ROM) formatted to the ISO-9660/Joliet standard, or digital versatile disc read-only memory (DVD-ROM). Unless requested by the Attorney General, data provided on electronic media need not be provided in hard copy.
(c) All electronic media shall be clearly labeled with the following information:
(1) Submitting authority.
(2) Name, address, title, and telephone number of contact person.
(3) Date of submission cover letter.
(4) Statement identifying the voting change(s) involved in the submission.
(d) Each magnetic medium (floppy disk or tape) provided must be accompanied by a printed description of its contents, including an identification by name or location of each data file contained on the medium, a detailed record layout for each such file, a record count for each such file, and a full description of the magnetic medium format.
(e) Text documents should be provided in a standard American Standard Code for Information Interchange (ASCII) character code; documents with graphics and complex formatting should be provided in standard Portable Document Format (PDF). The label shall be affixed to each electronic medium, and the information included on the label shall also be contained in a documentation file on the electronic medium.
(f) All data files shall be provided in a delimited text file and must include a header row as the first row with a name for each field in the data set. A separate data dictionary file documenting the fields in the data set, the field separators or delimiters, and a description of each field, including whether the field is text, date, or numeric, enumerating all possible values is required; separators and delimiters should not also be used as data in the data set. Proprietary or commercial software system data files (
Changes affecting voting should be submitted as soon as possible after they become final, except as provided in § 51.22.
(a) The Attorney General will not consider on the merits:
(1) Any proposal for a change submitted prior to final enactment or administrative decision except as provided in paragraph (b) of this section.
(2) Any submitted change directly related to another change that has not received section 5 preclearance if the Attorney General determines that the two changes cannot be substantively considered independently of one another.
(3) Any submitted change whose enforcement has ceased and been superseded by a standard, practice, or procedure that has received section 5 preclearance or that is otherwise legally enforceable under section 5.
(b) For any change requiring approval by referendum, by a State or Federal court, or by a Federal agency, the Attorney General may make a determination concerning the change prior to such approval if the change is not subject to alteration in the final approving action and if all other action necessary for approval has been taken. (
(a) Changes affecting voting shall be submitted by the chief legal officer or other appropriate official of the submitting authority or by any other authorized person on behalf of the submitting authority. A State, whether partially or fully covered, has authority to submit any voting change on behalf of its covered jurisdictions and political subunits. Where a State is covered as a whole, State legislation or other changes undertaken or required by the State shall be submitted by the State (except that legislation of local applicability may be submitted by political subunits). Where a State is partially covered, changes of statewide application may be submitted by the State. Submissions from the State, rather than from the individual covered jurisdictions, would serve the State's interest in at least two important respects: first, the State is better able to explain to the Attorney General the purpose and effect of voting changes it enacts than are the individual covered jurisdictions; second, a single submission of the voting change on behalf of all of the covered jurisdictions would reduce the possibility that some State acts will be legally enforceable in some parts of the State but not in others.
(b) A change effected by a political party (
(c) A change affecting voting that results from a State court order should be submitted by the jurisdiction or entity that is to implement or administer the change (in the manner specified by paragraphs (a) and (b) of this section).
(a)
(b)
(c)
(d)
(e)
(f)
(g) The most current information on addresses for, and methods of making, section 5 submissions is available on the Voting Section website at
(a) A jurisdiction may withdraw a submission at any time prior to a final decision by the Attorney General. Notice of the withdrawal of a submission must be made in writing addressed to the Chief, Voting Section, Civil Rights Division, to be delivered at the addresses, telefacsimile number, or email address specified in § 51.24. The submission shall be deemed withdrawn upon the Attorney General's receipt of the notice.
(a) A copy of any ordinance, enactment, order, or regulation embodying the change affecting voting for which section 5 preclearance is being requested.
(b) A copy of any ordinance, enactment, order, or regulation embodying the voting standard, practice, or procedure that is proposed to be repealed, amended, or otherwise changed.
(c) A statement that identifies with specificity each change affecting voting for which section 5 preclearance is being requested and that explains the difference between the submitted change and the prior law or practice. If the submitted change is a special referendum election and the subject of the referendum is a proposed change affecting voting, the submission should specify whether preclearance is being requested solely for the special election or for both the special election and the proposed change to be voted on in the referendum (
(d) The name, title, mailing address, and telephone number of the person making the submission. Where available, a telefacsimile number and an email address for the person making the submission also should be provided.
(a) * * *
(5) Demographic data on electronic media that are provided in conjunction
(i)
(ii)
482979501002099,1482979501002100,3482979501004301,10482975010004305,23482975010004302,101
(6) Demographic data on magnetic media that are provided in conjunction with a redistricting can be provided in shapefile (.shp) spatial data format.
(i) The shapefile shall include at a minimum the main file, index file, and dBASE table.
(ii) The dBASE table shall contain a row for each census block. Each census block will be identified by the state, county, tract and block identifier [GEOID10] as specified by the Bureau of Census. Each row shall identify the district assignment and relevant population for that specific row.
(iii) The shapefile should include a projection file (.prj).
(iv) The shapefile should be sent in NAD 83 geographic projection. If another projection is used, it should be described fully.
(c)
(1) The present and expected future use of the annexed land (
(2) An estimate of the expected population, by race and language group, when anticipated development, if any, is completed.
(3) A statement that all prior annexations (and deannexations) subject to the preclearance requirement have been submitted for review, or a statement that identifies all annexations (and deannexations) subject to the preclearance requirement that have not been submitted for review.
(4) To the extent that the jurisdiction elects some or all members of its governing body from single-member districts, it should inform the Attorney General how the newly annexed territory will be incorporated into the existing election districts.
(b) Comments should be sent to the Chief, Voting Section, Civil Rights Division, at the addresses, telefacsimile number, or email address specified in § 51.24. The first page and the envelope (if any) should be marked: “Comment under section 5 of the Voting Rights Act.” Comments should include, where available, the name of the jurisdiction and the Attorney General's file number (YYYY-NNNN) in the subject line.
(d) To the extent permitted by the Freedom of Information Act, 5 U.S.C. 552, the Attorney General shall not disclose to any person outside the Department of Justice the identity of any individual or entity providing information on a submission or the administration of section 5 where the individual or entity has requested confidentiality; an assurance of confidentiality may reasonably be implied from the circumstances of the communication; disclosure could reasonably be expected to constitute an unwarranted invasion of personal privacy under 5 U.S.C. 552; or disclosure is prohibited by any applicable provisions of federal law.
(a) When the Attorney General determines that a response on the merits of a submitted change is inappropriate, the Attorney General shall notify the submitting official in writing within the 60-day period that would have commenced for a determination on the merits and shall include an explanation of the reason why a response is not appropriate.
(b) Matters that are not appropriate for a merits response include:
(1) Changes that do not affect voting (
(2) Standards, practices, or procedures that have not been changed (
(3) Changes that previously have received preclearance;
(4) Changes that affect voting but are not subject to the requirement of section 5 (
(5) Changes that have been superseded or for which a determination is premature (
(6) Submissions by jurisdictions not subject to the preclearance requirement (
(7) Submissions by an inappropriate or unauthorized party or jurisdiction (
(8) Deficient submissions (
(c) Following such a notification by the Attorney General, a change shall be deemed resubmitted for section 5 review upon the Attorney General's receipt of a submission or other written information that renders the change appropriate for review on the merits (such as a notification from the submitting authority that a change previously determined to be premature has been formally adopted). Notice of the resubmission of a change affecting voting will be given to interested parties registered under § 51.32.
(a)
(2) An oral request for information shall not limit the authority of the Attorney General to make a written request for information.
(3) The Attorney General will notify the submitting authority in writing when the 60-day period for a submission is recalculated from the Attorney General's receipt of written information provided in response to an oral request as described in § 51.37(a)(1), above.
(4) Notice of the Attorney General's receipt of written information pursuant to an oral request will be given to interested parties registered under § 51.32.
(b)
(2) A copy of the request shall be sent to any party who has commented on the submission or has requested notice of the Attorney General's action thereon.
(3) The Attorney General shall notify the submitting authority that a new 60-day period in which the Attorney General may interpose an objection shall commence upon the Attorney General's receipt of a response from the submitting authority that provides the information requested or states that the information is unavailable. The Attorney General can request further information in writing within the new 60-day period, but such a further request shall not suspend the running of the 60-day period, nor shall the Attorney General's receipt of such further information begin a new 60-day period.
(4) Where the response from the submitting authority neither provides the information requested nor states that such information is unavailable, the response shall not commence a new 60-day period. It is the practice of the Attorney General to notify the submitting authority that its response is incomplete and to provide such notification as soon as possible within the 60-day period that would have commenced had the response been complete. Where the response includes a portion of the available information that was requested, the Attorney General will reevaluate the submission to ascertain whether a determination on the merits may be made based upon the information provided. If a merits determination is appropriate, it is the practice of the Attorney General to make that determination within the new 60-day period that would have commenced had the response been complete.
(5) If, after a request for further information is made pursuant to this section, the information requested by the Attorney General becomes available to the Attorney General from a source other than the submitting authority, the Attorney General shall promptly notify the submitting authority in writing, and the new 60-day period will commence the day after the information is received by the Attorney General.
(6) Notice of the written request for further information and the receipt of a response by the Attorney General will be given to interested parties registered under § 51.32.
(a)(1)
(2)
(b) The Attorney General will notify the submitting authority in writing when the 60-day period for a submission is recalculated due to the Attorney General's receipt of supplemental information or a related submission.
(c) Notice of the Attorney General's receipt of supplemental information or a related submission will be given to interested parties registered under § 51.32.
If after 60 days the submitting authority has not provided further information in response to a request made pursuant to § 51.37(b), the Attorney General, absent extenuating circumstances and consistent with the burden of proof under section 5 described in § 51.52(a) and (c), may object to the change, giving notice as specified in § 51.44.
It is the practice and intention of the Attorney General to respond in writing to each submission within the 60-day period. However, the failure of the Attorney General to make a written response within the 60-day period constitutes preclearance of the submitted change, provided that a 60-day review period had commenced after receipt by the Attorney General of a complete submission that is appropriate for a response on the merits. (
(a) After notification to the submitting authority of a decision not to interpose an objection to a submitted change affecting voting has been given, the Attorney General may reexamine the submission if, prior to the expiration of the 60-day period, information comes to the attention of the Attorney General that would otherwise require objection in accordance with section 5.
(b) In such circumstances, the Attorney General may by letter withdraw his decision not to interpose an objection and may by letter interpose an objection provisionally, in accordance with § 51.44, and advise the submitting authority that examination of the change in light of the newly raised issues will continue and that a final decision will be rendered as soon as possible.
(c) The submitting authority shall be advised further that notwithstanding the objection it may institute an action in the U.S. District Court for the District of Columbia for a declaratory judgment that the change objected to by the Attorney General neither has the purpose nor will have the effect of denying or abridging the right to vote on account of race, color, or membership in a language minority group.
(a) Where there appears to have been a substantial change in operative fact or relevant law, or where it appears there may have been a misinterpretation of fact or mistake in the law, an objection may be reconsidered, if it is deemed appropriate, at the instance of the Attorney General.
(a) It is the practice of the Attorney General to notify the submitting authority of the decision to continue or withdraw an objection within a 60-day period following receipt of a reconsideration request or following notice given under § 51.46(b), except that this 60-day period shall be recommenced upon receipt of any documents or written information from the submitting authority that materially supplements the reconsideration review, irrespective of whether the submitting authority provides the documents or information at its own instance or pursuant to a request (written or oral) by the Attorney General. The 60-day reconsideration period may be extended to allow a 15-day decision period following a conference held pursuant to § 51.47. The 60-day reconsideration period shall be computed in the manner specified in § 51.9. Where the reconsideration is at the instance of the Attorney General, the first day of the period shall be the day after the notice required by § 51.46(b) is transmitted to the submitting authority. The reasons for the reconsideration decision shall be stated.
(b) The objection shall be withdrawn if the Attorney General is satisfied that the change neither has the purpose nor will have the effect of denying or abridging the right to vote on account of race, color, or membership in a language minority group.
(c) If the objection is not withdrawn, the submitting authority shall be advised that notwithstanding the objection it may institute an action in the U.S. District Court for the District of Columbia for a declaratory judgment that the change objected to by the Attorney General neither has the purpose nor will have the effect of denying or abridging the right to vote on account of race, color, or membership in a language minority group.
(d) An objection remains in effect until either it is specifically withdrawn by the Attorney General or a declaratory judgment with respect to the change in question is entered by the U.S. District Court for the District of Columbia.
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(a)
(b)
(c)
(2) The Attorney General will make the comparison based on the conditions existing at the time of the submission.
(3) The implementation and use of an unprecleared voting change subject to section 5 review does not operate to make that unprecleared change a benchmark for any subsequent change submitted by the jurisdiction.
(4) Where at the time of submission of a change for section 5 review there exists no other lawful standard, practice, or procedure for use as a benchmark (
(d)
(a)
Among the factors the Attorney General will consider in making determinations with respect to the submitted changes affecting voting are the following:
(a) The extent to which a reasonable and legitimate justification for the change exists;
(b) The extent to which the jurisdiction followed objective guidelines and fair and conventional procedures in adopting the change;
(c) The extent to which the jurisdiction afforded members of racial and language minority groups an opportunity to participate in the decision to make the change;
(d) The extent to which the jurisdiction took the concerns of members of racial and language minority groups into account in making the change; and
(e) The factors set forth in
(1) Whether the impact of the official action bears more heavily on one race than another;
(2) The historical background of the decision;
(3) The specific sequence of events leading up to the decision;
(4) Whether there are departures from the normal procedural sequence;
(5) Whether there are substantive departures from the normal factors considered; and
(6) The legislative or administrative history, including contemporaneous statements made by the decision makers.
(b)
(1) The extent to which minorities have been denied an equal opportunity to participate meaningfully in the political process in the jurisdiction.
(2) The extent to which voting in the jurisdiction is racially polarized and election-related activities are racially segregated.
(3) The extent to which the voter registration and election participation of minority voters have been adversely affected by present or past discrimination.
(a)
(1) The extent to which malapportioned districts deny or abridge the right to vote of minority citizens;
(2) The extent to which minority voting strength is reduced by the proposed redistricting;
(3) The extent to which minority concentrations are fragmented among different districts;
(4) The extent to which minorities are over concentrated in one or more districts;
(5) The extent to which available alternative plans satisfying the jurisdiction's legitimate governmental interests were considered;
(6) The extent to which the plan departs from objective redistricting criteria set by the submitting jurisdiction, ignores other relevant factors such as compactness and contiguity, or displays a configuration that inexplicably disregards available natural or artificial boundaries; and
(7) The extent to which the plan is inconsistent with the jurisdiction's stated redistricting standards.
(b)
(a)
(b)
The requirements of section 5 of the Voting Rights Act, as amended, apply in the following jurisdictions. The applicable date is the date that was used to determine coverage and the date after which changes affecting voting are subject to the preclearance requirement. Some jurisdictions, for example, Yuba County, California, are included more than once because they have been determined on more than one occasion to be covered under section 4(b).
The following political subdivisions in States subject to statewide coverage are also covered individually:
The Voting Section maintains a current list of those jurisdictions that have maintained successful declaratory judgments from the United States District Court for the District of Columbia pursuant to section 4 of the Act on its Web site at
Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in May 2011. PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974.
Effective May 1, 2011.
Catherine B. Klion, Manager, Regulatory and Policy Division, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4024.)
Interest assumptions are also published on PBGC's Web site (
PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for May 2011.
The May 2011 interest assumptions under the benefit payments regulation will be 2.50 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for April 2011, these interest assumptions are unchanged.
PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.
Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during May 2011, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
In consideration of the foregoing, 29 CFR part 4022 is amended as follows:
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, Eighth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the LA 1 vertical lift span bridge across Company Canal, mile 0.4, at Lockport, Lafourche Parish, Louisiana. The deviation is necessary to perform electrical rehabilitation work on the bridge. This deviation allows the bridge to remain closed to navigation for twelve consecutive hours each day from Monday through Thursday for three weeks.
This deviation is effective from 6 a.m. on Monday, June 27, 2011 through 6 p.m. on Thursday, July 14, 2011.
Documents mentioned in this preamble as being available in the docket are part of docket USCG-2011-0252 and are available online by going to
If you have questions on this rule, call or e-mail David Frank, Bridge Administration Branch, Coast Guard; telephone 504-671-2128, e-mail
The Louisiana Department of Transportation and Development has requested a temporary deviation from the operating schedule of the vertical lift span bridge across Company Canal at mile 0.4 in Lockport, Lafourche Parish, Louisiana. The vertical clearance of the bridge is 5 feet above Mean High Water in the closed-to-navigation position and 50 feet above Mean High Water in the open-to-navigation position.
In accordance with 33 CFR 117.438(a), the vertical lift span of the bridge currently opens on signal except that, from 6 p.m. to 10 a.m. the draw opens on signal if at least 4 hours notice is given. This deviation allows the vertical lift span of the bridge to remain closed to navigation from 6 a.m. until 6 p.m. Monday through Thursday from Monday, June 27, 2011 through Thursday July 14, 2011.
The closure is necessary in order to replace electrical conductors and conduit throughout the bridge structure, including the removal and replacement of all navigation lights on the span and fender system. This maintenance is essential for the continued operation of the bridge. Temporary navigational lighting will be provided during the closure and power outage period. Notices will be published in the Eighth Coast Guard District Local Notice to Mariners and will be broadcast via the Coast Guard Broadcast Notice to Mariners System.
Navigation on the waterway consists of commercial and recreational fishing vessels, small to medium crew boats, and small tugs with and without tows. The bridge opens for the passage of navigation an average of 16 times per month. There are two alternate waterway routes available via the Gulf Intracoastal Waterway east to Bayou Lafourche and west to Navigation Canal. Small vessels may pass under the bridge while in the closed-to-navigation position provided caution is exercised.
Due to prior experience and coordination with waterway users, it has been determined that this closure will not have a significant effect on vessels that use the waterway.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The U.S. Coast Guard is extending and expanding the emergency safety zone established on the waters of the Columbia River surrounding the M/V DAVY CROCKETT at approximately river mile 117 on January 28, 2011. The safety zone is necessary to help ensure the safety of the response workers and maritime public from the hazards associated with deleterious state of and ongoing response operations involving the M/V DAVY CROCKETT. All persons and vessels are prohibited from entering or remaining in the safety zone unless authorized by the Captain of the Port, Columbia River or his designated representative.
This rule is effective from April 15, 2011 through May 17, 2011. This rule is effective with actual notice for purposes of enforcement on March 28, 2011. This rule will remain in effect through May 17, 2011.
Documents indicated in this preamble as being available in the
If you have questions on this temporary rule, call or e-mail MST1 Jaime Sayers, Waterways Management Division, Marine Safety Unit Portland, Coast Guard; telephone 503-240-9319, e-mail
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because to do so would be contrary to public interest since the safety zones are immediately necessary to help ensure the safety of the response workers and maritime public due to deleterious state of and ongoing response operations involving the M/V DAVY CROCKETT.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The M/V DAVY CROCKETT, a 431 ft barge, is anchored on the Washington State side of the Columbia River at approximately river mile 117. The vessel is in a severe state of disrepair. The Coast Guard, other State and Federal agencies, and Federal contractors are working to remove the vessel. The response operations require a minimal wake in the vicinity of the vessel to minimize the spread of contaminants and help ensure the safety of response workers on or near the vessel and in the water. In addition, due to the deleterious state of the vessel only authorized persons and/or vessels can be safely allowed on or near it.
A 300 ft safety zone is necessary to keep vessels clear of the ongoing response operations surrounding the M/V DAVY CROCKETT. The previous 200 ft zone was an inadequate distance to mitigate the wake of transiting and nearby vessels.
The Coast Guard is extending and expanding the stationary safety zone created by this rule 100 ft past the previous 200 ft safety zone. The amended safety zone will cover all waters of the Columbia River encompassed within the following four points: point one at 45°34′59.74″ N/122°28′35.00″ W on the Washington bank of the Columbia River then proceeding into the river to point two at 45°34′51.42″ N/122°28′35.47″ W, then proceeding upriver to the third point at 45°34′51.02″ N/122°28′07.32″ W, then proceeding to the shoreline to the fourth point on the Washington Bank at 45°34′56.06″ N/122°28′07.36″ W, then back along the shoreline to point one. Geographically this encompasses all the waters within an area starting at approximately 300 ft upriver from the M/V DAVY CROCKETT extending to 300 ft abreast of the M/V DAVY CROCKETT and then ending 300 ft down river of the M/V DAVY CROCKETT.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.
The Coast Guard has made this determination based on the fact that the safety zones created by this rule will not significantly affect the maritime public because the areas covered are limited in size and/or have little commercial or recreational activity. In addition, vessels may enter the safety zones with the permission of the Captain of the Port, Columbia River or his designated representative.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. 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 rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities some of which may be small entities: the owners and operators of vessels intending to operate in the areas covered by the safety zones created in this rule. The safety zones will not have a significant economic impact on a substantial number of small entities because the areas covered are limited in size. In addition, vessels may enter the safety zones with the permission of the Captain of the Port, Columbia River or his designated representative.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminates ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have Tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this 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 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the creation of safety zones. An environmental analysis checklist and a categorical exclusion determination will be available in the docket where
Harbors, Marine safety Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(1) All waters of the Columbia River encompassed within the following four points: point one at 45°34′ 59.74″ N/122°28′35.00″ W on the Washington bank of the Columbia River then proceeding into the river to point two at 45°34′51.42″ N/122°28′35.47″ W, then proceeding upriver to the third point at 45°34′51.02″ N/122°28′07.32″ W, then proceeding to the shoreline to the fourth point on the Washington Bank at 45°34′56.06″ N/122°28′07.36″ W, then back along the shoreline to point one. Geographically this encompasses all the waters within an area starting at approximately 300 ft upriver from the M/V DAVY CROCKETT extending to 300 ft abreast of the M/V DAVY CROCKETT and then ending 300 ft down river of the M/V DAVY CROCKETT.
(b)
(c)
Federal Deposit Insurance Corporation (FDIC).
Request for comment.
The FDIC seeks comment on proposed guidelines that would be used to determine how adjustments could be made to the total scores that are used in calculating the deposit insurance assessment rates of large and highly complex insured institutions. Total scores are determined according to the Assessments and Large Bank Pricing approved by the FDIC Board on February 7, 2011.
Comments must be received on or before May 31, 2011.
You may submit comments, identified by “Adjustment Guidelines,” by any of the following methods:
• Agency Web site:
• E-mail:
• Mail: Robert E. Feldman, Executive Secretary, Attention: Comments, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429.
• Hand Delivery/Courier: Guard station at the rear of the 550 17th Street Building (located on F Street) on business days between 7 a.m. and 5 p.m.
Lisa Ryu, Chief, Large Bank Pricing Section, Division of Insurance and Research, (202) 898-3538; Andrew Felton, Acting Chief, Large Bank Pricing Section, Division of Insurance and Research, (202) 898-3823; Mike Anas, Senior Financial Analyst, Division of Insurance and Research, (630) 241-0359 x 8252; and Christopher Bellotto, Counsel, Legal Division, (202) 898-3801, 550 17th Street, NW., Washington, DC 20429.
On February 7, 2011 (76 FR 10672 (Feb. 25, 2011)), the FDIC Board amended its assessment regulations (the Amended Assessment Regulations), by, among other things, adopting a new methodology for determining assessment rates for large institutions.
Tables 1 and 2 show the scorecards for large and highly complex institutions, respectively.
Scorecard measures (other than the weighted average CAMELS rating) are converted to scores between 0 and 100 based on minimum and maximum cutoff values for each measure. A score of 100 reflects the highest risk and a score of 0 reflects the lowest risk. A value reflecting lower risk than the cutoff value receives a score of 0 and a value reflecting higher risk than the cutoff value receives a score of 100. A risk measure value between the minimum and maximum cutoff values converts linearly to a score between 0 and 100, which is rounded to 3 decimal points. The weighted average CAMELS rating is converted to a score between 25 and 100, where 100 reflects the highest risk and 25 reflects the lowest risk.
In most cases, the total score produced by the applicable scorecard will correctly reflect an institution's overall risk relative to other large institutions; however, the scorecard includes assumptions that may not be appropriate for all institutions. Therefore, the FDIC believes that it is important that it have the ability to consider idiosyncratic or other relevant risk factors that are not adequately captured in the scorecards and make appropriate adjustments to an institution's total score. The Amended Assessment Regulations state that, after consultation with an institution's primary Federal regulator, the FDIC may make a limited adjustment to an institution's total score based upon risks that are not adequately captured in the scorecard. The Amended Assessment Regulations provide that no new adjustments will be made until new guidelines have been published for comment and approved by the FDIC's Board of Directors.
The proposed guidelines describe the process the FDIC would follow to determine whether to make an adjustment and to determine the size of any adjustment. This request for comments also outlines the process the FDIC would use when notifying an institution regarding an adjustment.
These proposed guidelines would supersede the large bank pricing adjustment guidelines published by the FDIC on May 14, 2007 (the 2007 Guidelines).
The FDIC seeks comments on the proposed guidelines and the procedures for making an adjustment to an institution's score. Although the FDIC has in this instance chosen to publish the proposed guidelines and solicit comment from the industry, notice and comment are not required and need not be employed to make future changes to the guidelines.
The proposed large bank adjustment process would be based on a set of guidelines designed to ensure that the adjustment process is fair and transparent and that any decision to adjust a score is well supported. The following general guidelines would govern the adjustment process, which is described in greater detail below.
• The FDIC would focus on identifying institutions for which a combination of risk measures and other information suggests either materially higher or lower risk than their total scores indicate. The FDIC would consider all available material information relating to the likelihood of failure or loss severity in the event of failure.
• The FDIC would primarily consider two types of information in determining whether to make a large bank adjustment: A scorecard ratio or measure that exceeds the maximum cutoff value for a ratio or measure or is less than the minimum cutoff value for a ratio or measure along with the degree to which the ratio or measure differs from the cutoff value (scorecard measure outliers); or information not directly captured in the scorecard, including complementary quantitative risk measures and qualitative risk considerations.
• If an institution has one or more scorecard measure outliers, the FDIC would conduct further analysis to determine whether underlying scorecard ratios are materially higher or lower than the established cutoffs for a given scorecard measure and whether other mitigating or supporting information exists.
• The FDIC would use complementary quantitative risk measures to determine whether a given scorecard measure is an appropriate measure for a particular institution.
• When qualitative risk considerations materially affect the FDIC's view of an institution's probability of failure or loss given failure, these considerations could be the primary factor supporting the adjustment. Qualitative risk considerations include, but are not limited to, underwriting practices related to material concentrations, risk management practices, strategic risk, the use and management of government support programs, and factors affecting loss severity.
• Specific risk measures would vary in importance for different types of institutions. In some cases, a single risk factor or indicator may support an adjustment if the factor suggests a significantly higher or lower likelihood of failure, or loss given failure, than the total score reflects.
• To the extent possible in comparing risk measures, the FDIC would consider the performance of similar institutions, taking into account that variations in risk measures exist among institutions with substantially different business models.
• Adjustments would be made only if the comprehensive analysis of an institution's risk, generally based on the two types of information listed above, and the institution's relative risk ranking warrant a meaningful adjustment of the institution's total score (generally, an adjustment of five points or more).
The processes for communicating with affected institutions and implementing adjustments once determined would remain largely unchanged by this proposal, except that the FDIC would now explicitly allow institutions to request an adjustment.
• The FDIC would consult with an institution's primary Federal regulator and appropriate state banking supervisor before making any decision to adjust an institution's total score (and before removing a previously implemented adjustment).
• The FDIC would give institutions advance notice of any decision to make an upward adjustment to a total score, or to remove a previously implemented downward adjustment. The notice would include the reasons for the proposed adjustment or removal, the size of the proposed adjustment or removal, specify when the adjustment or removal would take effect, and provide institutions with up to 60 days to respond.
• The FDIC would re-evaluate the need for total score adjustments on a quarterly basis.
• Institutions could make written request to the FDIC for an adjustment, but must support the request with evidence of a material risk or risk-mitigating factor that is not adequately accounted for in the scorecard.
• An institution could request review of or appeal an upward adjustment, the magnitude of an upward adjustment, removal of a previously implemented downward adjustment or an increase in a previously implemented upward adjustment pursuant to 12 CFR 327.4(c). An institution could similarly request review of or appeal a decision not to apply an adjustment following a request by the institution for an adjustment.
The FDIC believes that any adjustment should improve the rank ordering of institutions according to risk. Institutions with similar risk profiles should have similar total scores and corresponding initial assessment rates, and institutions with higher or lower risk profiles should have higher or lower total scores and initial assessment rates, respectively. The FDIC would evaluate scorecard results each quarter to identify institutions with a score that is clearly too high or too low when considered in light of risks or risk-mitigating factors that are inadequately accounted for by the scorecard. Some examples of these types of risks and risk-mitigating factors include considerations for purchased credit impaired (PCI) loans, accounting rule changes such as FAS 166/167, credit underwriting and credit administration practices, collateral and other risk mitigants, including the materiality of guarantees and franchise value. Commenters on the proposed large bank pricing rule published on November 9, 2010 (the Large Bank NPR)
In addition to considering an institution's relative risk ranking among all large institutions, the FDIC would consider how an institution compares to similar institutions. The comparison would allow the FDIC to account for variations in risk measures that may exist among institutions with differing business models. For purposes of the comparison, the FDIC would, where appropriate, assign an institution to a peer group. The proposed peer groups are:
An institution can also request that the FDIC make an adjustment to its score by submitting a written request to the FDIC's Director of the Division of Insurance and Research in Washington, DC. Similar to FDIC-initiated adjustments, an institution's request for an adjustment would be considered only if it is supported by evidence of a material risk or risk-mitigating factor that is not adequately accounted for in the scorecard. The FDIC would consider these requests as part of its ongoing effort to identify and adjust scores that require adjustment. An institution-initiated request would not preclude a subsequent request for review (12 CFR 327.4(c)) or appeal pursuant to the assessment appeals process.
Once it determines that an adjustment may be warranted, the FDIC would determine the adjustment amount necessary to bring an institution's total score into better alignment with those of other institutions that pose similar levels of risk. The FDIC would initiate adjustments only when a combination of risk measures and other information suggests either materially higher or lower risk than their total scores indicate, generally resulting in an adjustment of an institution's total score by five points or more. The FDIC believes that the adjustment process should be used to address material idiosyncratic issues in a small number of institutions rather than as a fine-tuning mechanism for a large number of institutions. If the size of the adjustment required to align an institution's total score with institutions of similar risk is not material, no adjustment would be made.
As under the 2007 Guidelines, before making an adjustment, the FDIC would consult with an institution's primary Federal regulator and state banking supervisor to obtain further information and comment.
Decisions to lower an institution's total score would not be communicated to institutions in advance. Rather, as under the 2007 Guidelines, they would be reflected in the invoices for a given assessment period along with the reasons for the adjustment.
To give an institution an opportunity to respond, the FDIC would give advance notice to an institution when proposing to make an upward adjustment to the institution's total score.
Before implementing an upward adjustment to a total score, the FDIC would review the institution's response to the advance notice, along with any subsequent changes to supervisory ratings, scorecard measures, or other relevant risk factors. Similar to the 2007 Guidelines, if the FDIC decided to implement the upward adjustment, it would notify an institution of its decision along with the invoice for the quarter in which the adjustment would become effective.
Extending the example above, if the FDIC notified an institution of a proposed upward adjustment on June 15, the institution would have 60 days from this date to respond to the notification. If, after evaluating the institution's response and updated information for the quarterly assessment period ending June 30, the FDIC decided to proceed with the adjustment, it would communicate this decision to the institution by approximately September 15, which is the invoice date for the April 1 through June 30 assessment period. In this case, the adjusted rate would be reflected in the September 15 invoice.
The time frames and example above also apply to a decision by the FDIC to remove a previously implemented downward adjustment as well as a decision to increase a previously implemented upward adjustment.
Consistent with the 2007 Guidelines, the adjustment would remain in effect for subsequent assessment periods until the FDIC determined either that the adjustment was no longer warranted or that the magnitude of the adjustment needed to be reduced or increased (subject to the 15-point limitation and the requirement for further advance notification).
An institution could request review of or appeal an upward adjustment, the magnitude of an upward adjustment, removal of a previously implemented downward adjustment or an increase in a previously implemented upward adjustment pursuant to 12 CFR 327.4(c). An institution could similarly request review of or appeal a decision not to apply an adjustment following a request by the institution for an adjustment.
As discussed above, the FDIC would primarily consider two types of information in determining whether to make a large bank adjustment: Scorecard measure outliers or information not directly captured in the scorecard, including complementary quantitative risk measures and qualitative risk considerations.
In order to convert each scorecard ratio into a score that ranges between 0 and 100, the Amended Assessment Regulations use minimum and maximum cutoff values that generally correspond to the 10th and 90th percentile values for each ratio based on data for the 2000 to 2009 period. All values less than the 10th percentile or all values greater than the 90th
The example below illustrates the analytical process the FDIC would follow in determining to propose a downward adjustment based on scorecard measure outliers. The example is merely illustrative. As shown in Chart 1, Bank A has a total score of 45 and two scorecard measures with a score of 0 (indicating lower risk).
Since at least one of the scorecard measures has a score of 0, the FDIC would further review whether the ratios underlying these measures materially differ from the cutoff value associated with a score of 0. Materiality would generally be determined by the amount that the underlying ratio differed from the relevant cutoff as a percentage of the overall scoring range (the maximum cutoff minus the minimum cutoff). Table 3 shows that Bank A's Tier 1 Leverage ratio (17 percent) far exceeds the cutoff value associated with a score of 0 (13 percent), with the difference representing 57 percent of the associated scoring range. Based on this additional information and assuming no other mitigating factors, the FDIC could determine that the Bank A's loss absorbing capacity is not fully recognized, particularly when compared with other institutions receiving the same overall score. By contrast, Bank A's Core ROA ratio is much closer to its cutoff values, suggesting that an adjustment based on consideration of those factors may not be justified.
Before initiating an adjustment, however, the FDIC would consider whether Bank A had significant risks that were not captured in the scorecard. If no information on such risks existed, the FDIC would initiate a downward adjustment to Bank A's total score.
The amount of the adjustment would be the amount needed to make the total score consistent with those of banks of comparable overall risk, with particular emphasis on institutions of the same institution type (
The next example illustrates the analytical process the FDIC would follow in determining to propose an upward adjustment based on scorecard measure outliers. As in the example above, the example is merely illustrative; an institution with less extreme values could also receive an upward adjustment. As shown in Chart 2, Bank B has a total score of 72 and three scorecard measures with a score of 100 (indicating higher risk).
Since at least one of the scorecard measures has a score of 100, the FDIC would further review whether the ratios underlying these measures materially exceed the cutoff value associated with a score of 100. Table 4 shows that Bank B's Criticized and Classified Items to Tier 1 Capital and Reserves ratio (198 percent) far exceeds the cutoff value associated with a score of 100 (100 percent), with the difference representing 105 percent of the associated scoring range. Based on this additional information and assuming no other mitigating factors, the FDIC could determine that the risk associated with Bank B's ability to withstand asset-related stress and, therefore, its overall risk, may be materially greater than its score suggests, particularly when compared with other institutions receiving the same overall score. By contrast, the Core ROA and Underperforming Assets to Tier 1 Capital and Reserves values are much closer to their respective cutoff values, suggesting that an adjustment based on these factors may not be justified.
After considering any risk-mitigating factors, the FDIC would determine the amount of adjustment needed to make the total score consistent with those of banks of comparable overall risk. For Bank B, a 5-point adjustment may be most appropriate.
Complementary risk measures are measures that are not included in the scorecard, but that can inform the appropriateness of a given scorecard measure for a particular institution. These measures are readily available for all institutions and include quantitative metrics and market indicators that provide further insights into an institution's ability to withstand financial adversity, and the severity of losses in the event of failure.
Analyzing complementary risk measures would help the FDIC determine whether the assumptions applied to a scorecard measure are appropriate for a particular institution. For example, as detailed in the Amended Assessments Regulation, the scorecard includes a loss severity measure based on the FDIC's loss severity model that applies a standard set of assumptions to all large banks to estimate potential losses to the insurance fund. These assumptions, including liability runoffs and asset recovery rates, are derived from actual bank failures; however, the FDIC recognizes that a large bank may have unique attributes that could have a bearing on the appropriateness of those assumptions. When data or quantitative metrics exist that support materially different runoff assumptions or asset recovery rates for a particular institution, the FDIC may consider an adjustment to the total score, particularly if such information is further supported by qualitative loss severity considerations as discussed below.
The example below illustrates the analytical process the FDIC would follow in determining to propose an upward adjustment based on complementary risk measures. Again, the example is merely illustrative. Chart 3 shows that Bank C has a total score of 66. Some of Bank C's risk measure scores are significantly higher than the total score, while others, including the Tier 1 leverage ratio score (42), are significantly lower.
After reviewing complementary measures for all financial ratios contained in the scorecard, in the hypothetical example, the complementary measures for Tier 1 leverage ratio showed that the level and quality of capital protection may not be correctly reflected in the Tier 1 leverage ratio score. Chart 4 shows that two other complementary capital measures for Bank C—the total equity ratio and the ratio of other comprehensive income (OCI) to Tier 1 capital—suggest higher risk than the Tier 1 leverage ratio score suggests. Additional review reveals that sizeable unrealized losses in the securities portfolio account for these differences and that Bank C's loss absorbing capacity is potentially overstated by the Tier 1 leverage ratio.
An upward adjustment to Bank C's total score may be appropriate, again assuming that no significant risk mitigants are evident. An adjustment of 5 points would be likely since the underlying level of unrealized losses is extremely high (greater than 25% of Tier 1 capital). While the adjustment in this case would likely be limited to 5 points because the bank's concentration measure and credit quality measure already receive the maximum possible score, in other cases modest unrealized losses could lead to a higher overall adjustment amount, if the concentration and credit quality measures are understated as well.
The FDIC believes that it is important to consider all relevant qualitative risk considerations in determining whether to apply a large bank adjustment. Qualitative information often provides significant insights into institution-specific or idiosyncratic risk factors that cannot be captured in the scorecard. Similar to scorecard outliers and complementary risk measures, the FDIC would use the qualitative information to consider whether potential discrepancies exist between the risk ranking of institutions based on their total score and the relative risk ranking suggested by a combination of risk measures and qualitative risk considerations. Such information includes, but is not limited to, analysis based on information obtained through the supervisory process, such as underwriting practices, interest rate risk exposure and other information obtained through public filings.
Another example of qualitative information that the FDIC would consider is available information pertaining to an institution's ability to withstand adverse events. Sources of this information are varied but may include analyses produced by the institution or supervisory authorities, such as stress test results, capital adequacy assessments, or information detailing the risk characteristics of the institution's lending portfolios and other businesses. Information pertaining to internal stress test results and internal capital adequacy assessment would be used qualitatively to help inform the relative importance of other risk measures, especially concentrations of credit exposures and other material non-lending business activities. As an example, in cases where an institution has a significant concentration of credit risk, results of internal stress tests and internal capital adequacy assessments could obviate FDIC concerns about this risk and therefore provide support for a downward adjustment, or alternatively, provide additional mitigating information to forestall a pending upward adjustment. In some cases, stress testing results may suggest greater risk than would normally be evident through the scorecard methodology alone.
Qualitative risk considerations would also include information that could have a bearing on potential loss severity, and could include, for example, the ease with which the FDIC could make quick deposit insurance determinations and depositor payments, or the availability of sufficient information on qualified financial contracts to allow the FDIC to make timely and correct determinations on these contracts in the event of failure.
In general, qualitative factors would become more important in determining whether to apply an adjustment when an institution has high performance risk
Additionally, engaging in certain business lines may warrant further consideration of qualitative factors. For instance, supervisory assessments of operational risk and controls at processing banks are likely to be important regardless of the institution's performance.
The specific example below illustrates the analytical process the FDIC would follow to determine whether to make an adjustment based on qualitative information. Chart 5 shows that Bank D has a high score of 82 that is largely driven by a high score for the ability to withstand asset-related stress component, which is, in turn, largely driven by the higher-risk asset concentration score and the underperforming asset score. The ability to withstand asset-related stress component is heavily weighted in the scorecard (50 percent weight), and, as a result, significant qualitative information that is not considered in the scorecard could lead to an adjustment to the institution's total score.
The FDIC would review qualitative information pertaining to the higher-risk asset concentration measure and the underperforming asset measure for Bank D to determine whether there are one or more important risk mitigants that are not factored into the scorecard. We assume that the further review revealed that, while Bank D has concentrations in non-traditional mortgages, its mortgage portfolio has the following characteristics that suggest lower risk:
a. Most of the loan portfolio is composed of bank-originated residential real estate loans on owner-occupied properties;
b. The portfolio has strong collateral protection (
c. Debt service coverage ratios are favorable (
d. The primary Federal regulator notes in its examination report that the institution has strong collection practices and reports no identified risk management deficiencies.
Additionally, these qualitative factors surrounding the bank's real estate portfolio suggest loss rate assumptions applied to Bank D's residential mortgage portfolio may be too severe, resulting in a loss severity score that is too high relative to its risk.
Based on the information above, the bank would be a strong candidate for a 10- to 15-point reduction in total score, primarily since the ability to withstand asset-related stress score and loss severity score do not reflect a number of significant qualitative risk mitigants that suggest lower risk.
The FDIC seeks comment on all aspects of the proposed guidelines for determining how to make potential adjustments to the initial total score of large institutions. In particular, the FDIC seeks comment on:
1. Whether the proposed guidelines governing the adjustment process are appropriate and sufficient to ensure fairness and consistency in deposit insurance pricing determinations. More specifically the FDIC seeks comment on the appropriateness of the following:
a. Reviewing outlier values on scorecard risk measures;
b. Augmenting the analysis of scorecard risk measures with a review of additional complementary and qualitative risk measures;
c. Basing adjustment decisions on considerations of multiple risk indicators;
d. Assessing financial performance risk measures relative to other institutions engaged in similar business activities; and
e. Using additional risk information, including qualitative information, to determine the magnitude of adjustment to an institution's total score that would be necessary to bring its total score into better alignment with institutions with similar risk profiles.
2. Are there additional guidelines that should govern the analytical process to ensure fairness and consistency in deposit insurance pricing determinations?
3. What qualitative information should the FDIC use to best evaluate loss severity?
4. Are the proposed guidelines for controlling the assessment rate adjustment process sufficient to ensure that adjustment decisions are justified, fully supported, and take into account the views of the primary Federal regulator and the institution?
In accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Interested parties may submit written comments to the FDIC concerning the Paperwork Reduction Act (PRA) implications of this proposal. Commenters should refer to “PRA Comments—Adjustment Guidelines” in the subject line. Comments may be submitted by any of the following methods:
• Agency Web site:
• E-mail:
• Mail: Gary A. Kuiper, Counsel, F-1086, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429.
• Hand Delivery/Courier: Guard station at the rear of the 550 17th Street Building (located on F Street) on business days between 7 a.m. and 5 p.m.
A copy of the comments may also be submitted to the OMB desk officer for the FDIC, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Comment is solicited on:
(1) 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;
(2) 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;
(3) The quality, utility, and clarity of the information to be collected;
(4) Ways to 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; e.g., permitting electronic submission of responses; and
(5) Estimates of capital or start-up costs and costs of operation, maintenance, and purchases of services to provide information.
An information collection would occur when a large or highly complex insured depository institution makes a written request that the FDIC make an adjustment to its total score. An institution's request for adjustment would be considered only if it is supported by evidence of a material risk or risk-mitigating factor that is not adequately accounted for in the scorecard.
By order of the Board of Directors.
Federal Deposit Insurance Corporation (FDIC).
Notice of proposed rulemaking (NPR) and request for comment.
Effective July 21, 2011, the statutory prohibition against the payment of interest on demand deposits will be repealed pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (the DFA).
Comments must be received on or before May 16, 2011.
You may submit comments on the notice of proposed rulemaking, identified by RIN number and the words “Interest on Deposits; Deposit Insurance Coverage NPRM,” by any of the following methods:
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Martin Becker, Senior Consumer Affairs Specialist, Division of Consumer and Depositor Protection (703) 254-2233, Mark Mellon, Counsel, Legal Division, (202) 898-3884, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429.
Section 343 of the DFA amended section 11(a)(1) of the Federal Deposit Insurance Act, 12 U.S.C. 1821(a)(1), to provide full insurance coverage for depository institution noninterest-bearing transaction accounts from December 31, 2010, through December 31, 2012. Section 627 of the DFA repealed the statutory prohibition against the payment of interest on demand deposits, effective one year from the date of the DFA's enactment, July 21, 2011.
In light of the prospective repeal of the demand deposit interest prohibition, the FDIC proposes to rescind 12 CFR Part 329, the regulation which implements that prohibition with respect to SNM banks, to be effective on the same date as the statutory repeal, July 21, 2011. At the same time, however, a regulatory definition of the term “interest” will still be useful in interpreting the requirements of section 343 of the DFA providing temporary, unlimited deposit insurance coverage for noninterest-bearing transaction accounts. For this reason, the FDIC proposes, as part of this same rulemaking, to transfer the definition of “interest” currently found at 12 CFR 329.1(c) to Part 330, specifically the definitions section at 12 CFR 330.1. The FDIC also specifically solicits comment on whether other parts of Part 329 could also prove useful and therefore should be moved into Part 330 as well. For example, section 329.103 provides an interpretive rule that defines what constitutes a “premium” which may prove useful in determining whether an account qualifies as a noninterest-bearing transaction account. The FDIC seeks comment on every aspect of this proposed rule.
Section 722 of the Gramm-Leach-Bliley Act, 1471 (Nov. 12, 1999), requires the Federal banking agencies to use plain language in all proposed and final rules published after January 1, 2000. We invite your comments on how to make this proposal easier to understand. For example:
• Have we organized the material to suit your needs? If not, how could this material be better organized?
• Are the requirements in the proposed regulation clearly stated? If not, how could the regulation be more clearly stated?
• Does the proposed regulation contain language or jargon that is not clear? If so, which language requires clarification?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the regulation easier to understand? If so, what changes to the format would make the regulation easier to understand?
• What else could we do to make the regulation easier to understand?
The Regulatory Flexibility Act (RFA) requires that each federal agency either certify that a proposed rule would not, if adopted in final form, have a significant economic impact on a substantial number of small entities or prepare an initial regulatory flexibility analysis of the rule and publish the analysis for comment. For purposes of the RFA analysis or certification, financial institutions with total assets of $175 million or less are considered to be “small entities.” The FDIC hereby certifies pursuant to 5 U.S.C. 605(b) that the NPR, if adopted, will not have a significant economic impact on a substantial number of small entities. This is because the FDIC already applies the Part 329 definition of “interest” for purposes of determining whether an account qualifies for full deposit insurance coverage as a noninterest-bearing transaction account. The FDIC is only proposing to transfer the definition from Part 329 to Part 330 because the former regulation will become moot on July 21, 2011, pursuant to section 627 of the DFA and its repeal of the statutory ban on the payment of interest on demand deposits. There will therefore be no significant economic impact on a substantial number of small entities as a result of this change.
No collections of information pursuant to the Paperwork Reduction Act (44 U.S.C. Ch. 3501
The FDIC has determined that the proposed rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 ().
Banks, banking, interest rates.
Bank deposit insurance, Banks, Banking, Reporting and recordkeeping requirements, Savings and loan associations, Trusts and trustees.
For the reasons set forth in the preamble, and under the authority of 12 U.S.C. 1813, the FDIC proposes to amend chapter III of title 12 of the Code of Federal Regulations as follows:
1. Part 329 is removed and reserved.
2. The authority for part 330 continues to read as follows: 12 U.S.C. 1813(
3. In § 330.1, paragraphs (k) through (r) are redesignated as paragraphs (l) through (s), respectively, and new paragraph (k) is added to read as follows:
(k)
By order of the Board of Directors.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E Airspace at Cocoa, FL, as
Comments must be received on or before May 31, 2011.
Send comments on this rule to: U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Ave., SE., Washington, DC 20590-0001;
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2011-0070; Airspace Docket No. 10-ASO-43) and be submitted in triplicate to the Docket Management System (
Annotators wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2011-0070; Airspace Docket No. 10-ASO-43.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded from and comments submitted through
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (
Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet above the surface to support new standard instrument approach procedures developed at Merritt Island Airport, Cocoa, FL. Airspace reconfiguration is necessary due to the decommissioning of the Merritt Island NDB and cancellation of the NDB approach, and for continued safety and management of IFR operations at the airport.
Class E airspace designations are published in Paragraph 6005 of FAA order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed 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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This proposed rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This proposed regulation is within the scope of that authority as it would amend Class E airspace at Merritt Island Airport, Cocoa, FL.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:
1. The authority citation for Part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9U, Airspace Designations and Reporting Points, dated August 18, 2010, effective September 15, 2010, is amended as follows:
That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of the Merritt Island Airport and within 2.5 miles each side of the 303° bearing from the Merritt Island Airport, extending from the 6.3-mile radius to 7 miles northwest of the airport; excluding that airspace within the Titusville, FL, and Melbourne, FL, Class E airspace areas.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Lincoln, OR. Controlled airspace is necessary to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Samaritan North Lincoln Hospital Heliport, Lincoln, OR. The FAA is proposing this action to enhance the safety and management of aircraft operations at the heliport.
Comments must be received on or before May 31, 2011.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2010-0987; Airspace Docket No. 10-ANM-14, at the beginning of your comments. You may also submit comments through the Internet at
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203-4537.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA 2010-0987 and Airspace Docket No. 10-ANM-14) and be submitted in triplicate to the Docket Management System (
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2010-0987 and AirspaceDocket No. 10-ANM-14”. The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 to establish Class E airspace extending upward from 700 feet or more above the surface at Samaritan North Lincoln Hospital Heliport, Lincoln, OR. Controlled airspace is necessary to accommodate aircraft using the new RNAV (GPS) standard instrument approach procedures at Samaritan North Lincoln Hospital Heliport. This action would enhance the safety and management of aircraft operations at Samaritan North Lincoln Hospital Heliport, Lincoln, OR.
Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR Part 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.
The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1,
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows:
1. The authority citation for 14 CFR Part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal Aviation Administration Order 7400.9U, Airspace Designations and Reporting Points, dated August 18, 2010, and effective September 15, 2010 is amended as follows:
That airspace extending upward from 700 feet above the surface within 3-mile radius of Samaritan North Lincoln Hospital Heliport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Florence Municipal Airport, Florence, OR. Controlled airspace is necessary to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Florence Municipal Airport, Florence, OR. The FAA is proposing this action to enhance the safety and management of aircraft operations at the airport.
Comments must be received on or before May 31, 2011.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2010-0986; Airspace Docket No. 10-ANM-13, at the beginning of your comments. You may also submit comments through the Internet at
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203-4537.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA 2010-0986 and Airspace Docket No. 10-ANM-13) and be submitted in triplicate to the Docket Management System (
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2010-0986 and Airspace Docket No. 10-ANM-13”. The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 700 feet or more above the surface at
Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.
The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII,Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Florence Municipal Airport, Florence, OR.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for 14 CFR part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal Aviation Administration Order 7400.9U, Airspace Designations and Reporting Points, dated August 18, 2010, and effective September 15, 2010 is amended as follows:
That airspace extending upward from 700 feet above the surface within 3-mile radius of Florence Municipal Airport.
Federal Aviation Administration (FAA), DOT.
Proposed interpretation.
This draft letter of interpretation addresses a request by the Aeronautical Repair Station Association (ARSA) to rescind a letter of interpretation issued May 18, 2010 which clarified what activities may constitute duty for maintenance personnel and the application of the rest provisions under 14 CFR 121.377. The FAA requests comment on the May 18, 2010 proposed response to United Technologies Corporation.
Send your comments on or before June 14, 2011.
You may send comments identified by Docket Number FAA-2011-0367 using any of the following methods:
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•
•
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For more information on the rulemaking process, see the
Anne Bechdolt, Attorney, Regulations Division, Office of Chief Counsel (AGC-220), Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC, 20591; e-mail:
On December 13, 2010, ARSA requested the FAA withdraw a legal interpretation issued on May 18, 2010 to United
The FAA believes that this type of schedule (
Dear Ms. McHugh: This is in response to Pratt & Whitney's letter of May 19, 2008, concerning the application of § 121.377 to maintenance personnel at Pratt's repair facility certified under Part 145 of the Federal Aviation Regulations. Based on the several factual scenarios contained in the letter and subsequent conversations between Pratt and my office, I have organized this response into three general issues. The first deals with whether Pratt can view as non-duty time the time an employee spends completing non-maintenance work or tasks while being compensated by Pratt, even while away from Pratt's facility. The second explores the extent to which Pratt may view as non-duty time the time an employee spends at other employment while off duty from Pratt, even if it is aviation related work. The last issue concerns the limit of scheduling flexibility provided by the regulation. I believe you will be able to apply the answers to these three questions to all of the specific scenarios you posited in your letter.
For repair stations certificated under Part 145 that perform maintenance work for air carriers operating under Part 121, § 121.377 establishes a maximum duty period for maintenance personnel working for that repair station. That section reads:
Within the United States, each certificate holder (or person performing maintenance or preventive maintenance functions for it) shall relieve each person performing maintenance or preventive maintenance from duty for a period of at least 24 consecutive hours during any seven consecutive days, or the equivalent thereof within any one calendar month.
Section 121.377 requires that a person performing maintenance or preventative maintenance be relieved from “duty” for, generally, one day out of every seven. One question, then, is what is considered “duty.” In other contexts, the FAA has defined duty as “actual work for the [employer] or the present responsibility for such should the occasion arise.”
Therefore, for purposes of applying § 121.377, any time for which an employee “has actual work for the employer, or the present responsibility for such work, should it arise,” constitutes “duty” time. Accordingly, the time an employee is engaged in maintenance tasks, attending a bargaining unit meeting, attending a training session, doing work related to Pratt's educational benefit, traveling from the point on Pratt's campus where the employee “clocked in” to the employee's work area, or working for another unit within Pratt's corporate
Once Pratt relieves the employee from duty, the regulation does not require Pratt to monitor the employee's activities. The scenario where an employee uses the time off from Pratt to work at another maintenance facility does not implicate Pratt's compliance with § 121.377. Unlike the regulations governing crewmember duty time, § 121.377 does not contain a limit on an employee's total accumulated working hours within a specified period of time. The FAA does not recommend this practice, however, for the reasons discussed in AC 120-72 related to fatigue. Thus, an employee relieved from duty by Pratt may perform other aviation related maintenance, even for other facilities which themselves are bound by § 121.377, provided the employee is provided the requisite time off by each facility for which the employee works. Pratt must use caution, however, not to create the appearance of requiring an employee to work during off hours for another facility that is just a corporate sister to the Pratt facility.
You also raise the question of whether a facility can schedule employees to work more than six consecutive days, thereby grouping required days off, and still remain in compliance with § 121.377. The regulatory standard requires 24 consecutive hours off duty during any seven consecutive days but also contains some flexibility in the phrase “or the equivalent thereof within any one calendar month.” The FAA intended that the regulation allow employees to work in excess of six consecutive days in the event of a national emergency or unusual occurrence in the air carrier industry.
The equivalent standard, however, does have limits. The tenants of statutory and regulatory interpretation suggest that the specific standard of one day off every week cannot be rendered completely inoperative by the more general equivalent standard. A previous interpretation allowed that a work schedule that provides for personnel to have a group of 4 days off followed by up to 24 days of work, or vice versa, would still meet the standard of being “equivalent” to one day off in every seven within a month. Legal Interpretation to Ron Webb from Donald P. Byrne, Assistant Chief Counsel, Regulations (June 21, 1991). That interpretation, however, was issued prior to the findings relating fatigue to maintenance related errors in the air carrier industry discussed in AC 120-72. Webster's dictionary defines “equivalent” as having logical equivalence, or corresponding or virtually identical in effect or function. Today, we would not view as compliant a schedule that provides over the course of eight weeks for four days off followed by 48 straight days of duty followed by four more days off. Such a work schedule that generally provides for an average of one day off over several weeks cannot be said to be “equivalent” to the more specific standard requiring one day off out of every seven days.
Lastly, you correctly note that the regulation does not address the length of the work day, only the length of the required time off work. The legal interpretation from Mr. Byrne to Mr. Webb also makes clear that the general equivalency provision in § 121.377 does not apply to the specific requirement to give 24 consecutive hours of time off. Time off may not be provided in smaller increments over several days even though the total time off over any seven day period may equal or exceed 24 hours.
We appreciate your patience and trust that the above responds to your concerns. If you need further assistance, please contact my staff at (202) 267-3073. This response was prepared by Anne Bechdolt, Attorney in the Operations Law Branch of the Regulations Division of the Office of the Chief Counsel, and coordinated with the Aircraft Maintenance and Air Transportation divisions of Flight Standards Service.
Forest Service, USDA.
Notice of proposed rulemaking.
The Forest Service, U.S. Department of Agriculture (USDA), is proposing to establish a State-specific rule to provide management direction for conserving and managing inventoried roadless areas on National Forest System (NFS) lands in Colorado. A proposed rule was published in the July 25, 2008,
The Agency is inviting public comment on this new proposed rule and accompanying revised draft environmental impact statement (RDEIS). The Agency is interested in public comments on the changes to exceptions and prohibitions on activities in roadless areas that have been developed in response to public comments on the 2008 Proposed Rule. The Agency is particularly interested in receiving public comments on the concept, management, and rationale for designation of specific areas within Colorado Roadless Areas identified as “upper tier.” In this proposed rule, these areas are provided a higher level of protection than the 2001 Roadless Rule,
Comments must be received in writing by July 14, 2011.
Comments may be sent via e-mail to
All comments, including names and addresses, are placed in the record and are available for public inspection and copying. The public may inspect comments received at
Colorado Roadless Rule Team Leader Ken Tu at (303) 275-5156. Individuals using telecommunication devices for the deaf (TDD) may call the Federal
As a leader in natural resource conservation, the Forest Service provides direction for the management and use of the Nation's forests, rangeland, and aquatic ecosystems under its jurisdiction. Similarly, the State of Colorado is committed to sustained natural resource use and conservation of State and Federal land within its borders. Furthermore, the Forest Service is charged to collaborate cooperatively with States and other interested parties regarding the use and management of the National Forest System (NFS).
Colorado's Roadless Areas are of great importance to the people of Colorado and the Nation. These magnificent landscapes provide a variety of resources and open space opportunities for all Americans. They provide the setting and backdrop for recreational experiences of all kinds, including non-motorized and/or motorized recreational trail use. They are sources of clean and safe public drinking water. They contain intact habitat for species dependent on large, undisturbed areas of land. The scenic quality of these naturally appearing landscapes is among the highest in the Nation. These areas serve as bulwarks against the spread of non-native invasive plant species and provide reference areas for study and research. The USDA, Forest Service, and State consider these areas an important component of the NFS and are committed to the conservation and protection of Colorado Roadless Areas (CRAs).
The unique perspectives and knowledge provided by the State and the public was of great assistance throughout the development of this proposed rule. Many of the CRAs form the setting and backdrop for Colorado communities and have become part of their identity. These areas help provide a high quality of life for local residents. They are also the backdrop for world-class skiing, hunting and fishing, and backcountry experiences for non-residents. Local communities are sensitive to the economic consequences of Federal land management, whether for tourism or other purposes.
The new proposed rule addresses both local and national interests in the management of Colorado Roadless Areas. Recommendations from the USDA Secretary's Roadless Area Conservation National Advisory Committee (RACNAC) and public comment on the 2008 Proposed Rule both provided a national perspective. The RACNAC was specifically designed as an advisory committee composed of national interests to provide a national perspective, and it no longer exists. The vast majority of respondents to the 2008 Proposed Rule expressed a desire for a rule that protects roadless area characteristics now and for future generations. However, some respondents suggested alternative, less restrictive roadless regulations. This proposed rule includes prohibitions on tree-cutting, sale, or removal; road construction/reconstruction; and linear construction zones, all with limited exceptions tailored to address specific issues. This proposed rule requires, in many cases, the Regional Forester to make specific determinations prior to authorizing exceptions.
In this proposed rule, substantially altered acres have been removed from the roadless inventory and new acres with high level of roadless characteristics have been added. In the standard tier, 20,000 acres are in the North Fork coal mining area, where there is an exception for temporary roads for underground coal activities such as methane drainage wells. Existing ski areas (8,300 acres) have been removed from the roadless inventory, although only 1,700 acres would be currently restricted by the 2001 Rule due to the fact that there are existing permits on the other 6,600 ski area acres.
Linear construction zones are prohibited with some exceptions. There is no prohibition of linear construction zones in the 2001 Rule.
In the proposed rule, there are exceptions for temporary roads for fuels treatment and for ecosystem maintenance and restoration, but these are restricted to locations within one half mile of communities. Road construction for these purposes is not allowed in the 2001 Rule. There is an exception for roads for authorized water conveyance structures operated according to a State water court decree in existence at the time of the promulgation of the final rule. There is no exception for roads for water conveyance structures in the 2001 Rule.
In the proposed rule, the tree cutting exceptions for fuel treatment and ecosystem maintenance and restoration are restricted spatially in this proposed rule to a maximum of one and a half miles from communities. The only condition in which tree cutting could occur outside the community protection zone (CPZ) requires a Regional Forester determination that there is a significant risk from wildfire to a municipal water supply system. The 2001 Rule exception for ecosystem maintenance and restoration allows tree cutting anywhere within roadless areas.
In the proposed rule, an upper tier of protection has been designated with fewer exceptions than the 2001 Rule for road construction and reconstruction and tree cutting. Exceptions are not allowed for road reconstruction and realignment, and temporary roads for public health and safety. The 2001 Rule tree-cutting exceptions for maintenance and restoration of ecosystem characteristics, and for habitat improvement for endangered, threatened or sensitive species are not allowed in the upper tier of the proposed rule.
On July 14, 2005, the State of Colorado announced it would submit a petition requesting specific regulatory protections for the inventoried roadless areas within the State. The State's commitment to participate was evidenced by Colorado Senate Bill 05-243, the Roadless Areas Review Task Force legislation signed into Colorado law on June 8, 2005. The law identified membership and responsibilities of a 13-member bipartisan task force to make recommendations to the Governor regarding inventoried roadless areas in Colorado. The law also identified the Federal 2001 Roadless Area Conservation Rule (2001 Roadless Rule) as the starting point for the task force. The task force held nine public meetings throughout the State, reviewed and considered over 40,000 public comments, and conducted a comprehensive review of Colorado's 4.4 million acres of inventoried roadless areas included in the 2001 Roadless Rule.
Colorado's petition (2006 Petition) was submitted by then-Governor Owens on November 13, 2006, to the Secretary of Agriculture for consideration under section 553(e) of the Administrative Procedure Act and USDA regulations at 7 CFR 1.28. On April 11, 2007, Governor Ritter resubmitted the 2006 petition with additions (2007 Petition). After reviewing the recommendation from the RACNAC, the Secretary of Agriculture accepted the 2007 Petition on August 24, 2007, and directed the Forest Service to initiate rulemaking based on the petition. The State of Colorado was granted cooperating agency status for purposes of compliance with the National Environmental Policy Act (NEPA) pursuant to 40 CFR 1501.6 of the Council on Environmental Quality regulations in a memorandum of
On July 25, 2008, the Forest Service published the 2008 Proposed Rule to establish State-specific management direction for conserving roadless areas on NFS land in Colorado in the
Information applying to the 2008 Proposed Rule was provided to the Ute Mountain Ute and Southern Ute Indian Tribes, located in Colorado, prior to the release of the NOI. An introductory letter, the NOI, background information on the 2008 Proposed Rule, and an offer for additional information or meetings were sent to the Tribes. The 2008 Proposed Rule and DEIS were sent to each Tribe and each was contacted by phone to determine interest in meeting or obtaining information. The Tribes did not request additional government to government involvement, and no formal comments from any of the Tribes were received. A letter was sent to the Tribes with a draft version of this revised proposed rule and the Forest Service met with those Tribes requesting further consultation. In accordance with Executive Order 13175, consultation efforts will continue throughout the process and preparation of a final Rule.
As a result of its July, August, and September 2008 notices, the Forest Service received approximately 106,000 responses of which 105,000 were form letters. Responses included advocacy for a particular outcome or for specific regulatory language, and calls for compliance with laws and regulations. Some responses contained suggestions on further analyses and changes to issues, alternatives, and CRA boundaries.
The RACNAC held public meetings in Washington, DC, and Salt Lake City, Utah, and submitted recommendations to the Secretary of Agriculture on December 5, 2008, to be considered in the development of the rule.
Throughout the public involvement process, the USDA, Forest Service, and State repeatedly heard comments requesting a reduction in the scope of the Colorado State Petition's proposed exceptions for tree-cutting, sale, or removal and road construction and reconstruction. Based on the comments, the State requested the USDA postpone further rulemaking efforts until the State considered revision of its 2007 Petition.
On August 3, 2009, the State of Colorado released a proposed revision of rule language to be used for its formulation of a revised petition to the public. The State received approximately 22,000 comments during the 60-day comment period, the majority of which were form letters. The State considered the public comments and submitted a revised petition to the Secretary on April 6, 2010 (2010 Petition).
Upon receipt of the revised petition and consideration of the public comments submitted on the petition, Secretary of Agriculture Thomas J. Vilsack instructed the Forest Service to “analyze the potential of adding substantially to the number of acres receiving a higher level of protection” (upper tier lands) than the 2001 Roadless Rule. The 2010 Petition contained 257,000 upper tier acres. Based on the Secretary's direction, acres were added such that there are now 562,200 upper tier acres in this proposed rule. These areas were selected to become upper tier based on their roadless characteristics, and that they were already designated for higher levels of protection in either draft or final forest plans.
The Forest Service analyzed four alternatives for managing roadless areas in this RDEIS. Alternative 1 uses provisions of the 2001 Roadless Rule and applies them to the 2001 roadless area inventory. Alternative 2 is the proposed rule, applies the rule to inventoried Colorado Roadless Areas, and includes 562,200 acres in the upper tier. Alternative 3 uses forest plan direction to manage roadless areas, and alternative 4 uses the proposed rule direction, applies the direction to Colorado Roadless Areas, and includes approximately 2.6 million acres of upper tier. The RDEIS may be found at
Finally, the proposed rule includes an updated inventory of roadless areas. The 2007 State Petition proposed using the inventories used in the 2001 Roadless Rule. In some cases, these were based on inventories from the late 70s. Those inventories used mapping technologies that are now outdated, and also roads had been constructed between the time of the original inventories and their use in the 2001 Roadless Rule. The Forest Service has reviewed and updated the 2001 inventories for the purpose of this rulemaking; making technical corrections, removing private property and making other boundary adjustments, including additions and deletions due to land exchanges. Newly congressionally-designated areas have also been removed from the CRA inventory.
During the public comment period on the 2008 Proposed Rule, comments were received on many of the boundaries of individual CRAs. The Forest Service and Colorado Department of Wildlife field staff worked jointly to identify corrections to the inventories used for the 2008 Proposed Rule. Further information on the boundary changes and a description of the uniqueness of each CRA can be found at
CRA boundaries have been adjusted where they overlap with ski areas that have special use authorizations or land use management plan allocations for ski areas that allow road construction.
The Agency is continuing land management planning efforts at the national level as well on several forests in Colorado concurrent with this rulemaking. The Rocky Mountain Region is presently conducting a revision of the San Juan National Forest land management plan and the revision schedule may be found at
The Agency is particularly interested in receiving public input regarding specific areas within the CRAs that should or should not be included in the upper tier lands including the reason for the inclusion or exclusion (see RDEIS, Appendix B and map packet); and what exceptions to the prohibitions on tree-cutting, sale, or removal, and road construction/reconstruction should apply to upper tier lands. In addition, the Agency is interested in receiving comments on effective means of managing linear facilities, such as electric power lines and telecommunications lines, within roadless areas in context of this proposed rule.
This proposed rule replaces the proposed rule published in July 2008. The section numbers of this proposed rule do not correspond with the numbering used in the 2008 Proposed Rule. Minor changes, edits, or corrections are not discussed.
The purpose remains to provide State-specific direction for the protection of roadless areas on NFS land in Colorado that sustains roadless area characteristics now and for future generations.
Several terms have been added for clarification and some terms have been removed where no longer needed.
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On lands designated as upper tier, tree-cutting, sale, or removal would be prohibited except when the Responsible Official determines that the activity is consistent with the applicable land management plan (LMP), and incidental to the implementation of a management activity not otherwise prohibited, or as needed and appropriate for personal or administrative use. Upper tier areas provide for a higher level of protection than the 2001 Roadless Rule because the exceptions in the 2001 Roadless Rule to allow tree-cutting, sale or removal for species habitat and for maintenance and restoration of ecosystem composition and structure, including the reduction of risk of uncharacteristic wildfire effects, are not applied to upper tier in this proposed rule.
On the remaining CRA lands, the proposed rule would require the Responsible Official to determine whether any proposed tree-cutting, sale, or removal project would be consistent with the applicable LMP, would maintain or improve one or more roadless area characteristic over the long-term, and would qualify as a listed exception. Tree-cutting incidental to a management activity otherwise authorized by this proposed rule or for personal or administrative use would not be required to maintain or improve one or more of the roadless area characteristics over the long-term.
The exceptions concerning tree-cutting, sale, or removal allowed to reduce fuel loadings to moderate the potential effects of a catastrophic wildland fire have been refined. The proposed rule takes into account that homes that have been constructed adjacent to Colorado's national forests and the increasing threat of fire to these at-risk communities. Treating hazardous fuels, and creating safety zones for fire crews in areas around communities can make a difference in the ability of firefighters to control wildfire moving toward an at-risk community. Such conditions have been a major consideration in developing the proposed rule language.
In Colorado, about 340 of the HFRA at-risk communities listed in the
Within the CPZ, tree-cutting, sale, or removal may occur within the first one-half mile of a CPZ only when the Regional Forester determines it is needed to reduce the wildfire hazard to either an at-risk community or a municipal water supply system, including reservoirs and dams, diversion structures, headgates, canals, ditches, tunnels, pipelines, and other surface facilities and systems.
Within the outer one mile of the CPZ, tree-cutting, sale, or removal, if determined to be needed by the Regional Forester, may only occur in an area identified in a CWPP. The CPZ would still be the maximum boundary for allowed treatments within CRAs. If the CPZ boundary exceeds the CWPP boundary, treatments would be limited to the CWPP area.
Projects within the CPZ are to be focused on small diameter trees to create fuel conditions to modify fire behavior while retaining large trees to the maximum extent practical, as appropriate to the forest type. In forest types such as lodgepole pine, trees may be dead or dying, regardless of size, and may need to be removed, both to prevent hazards to firefighters from falling and fallen trees, and for successful hazardous fuel reduction.
Tree-cutting, sale, or removal for the protection of municipal water supply systems outside of a CPZ is allowed only if the Regional Forester determines that a significant risk exists to the municipal water supply system or the maintenance of that system. This section states that a significant risk exists under conditions in which the history of fire occurrence and fire hazard and risk indicate a serious likelihood that a wildland fire disturbance event would present a high risk of threat to a municipal water supply system.
Projects outside of the CPZ are to be focused on small diameter trees to create fuel conditions to modify fire behavior, while retaining large trees to the maximum extent practical as appropriate to the forest type. It is expected such projects will be infrequent.
The requested exception that allows tree-cutting, sale, or removal to prevent or suppress an insect or disease epidemic has been replaced with an exception that allows tree-cutting, sale, or removal to restore the characteristics of ecosystem, composition, structure and processes. This exception is intended to be used infrequently.
Tree-cutting, sale or removal for the purposes of wildlife habitat improvement is limited to Federally threatened, endangered, and proposed species or those listed as a regionally designated sensitive species by the Forest Service, instead of all wildlife and plant species as was allowed in the previously proposed rule.
Tree-cutting that is incidental to a management activity that is otherwise not prohibited by the rule is allowed. Examples include, but are not limited to, trail construction or maintenance; removal of hazard trees adjacent to forest roads for public health and safety reasons; fire line construction for wildland fire suppression or control of
Tree-cutting for personal or administrative use is allowed and includes, but is not limited to, activities such as Christmas tree and firewood cutting.
The proposed rule revises the exceptions to the prohibitions on road construction or reconstruction from the previous proposal. Upper tier land designations have been added that prohibit all road construction/reconstruction, except when pursuant to reserved or outstanding rights or as provided for by statute or treaty. Even in such a situation, the Responsible Official would be required to make a series of determinations to decide whether a proposal fits the exception within the upper tier lands. The determinations would include: consideration of technically feasible options without road construction; when proposing to construct a forest road, consideration of whether a temporary road would provide reasonable access; and within a native cutthroat trout catchment or identified recovery watershed, a determination whether road construction will diminish, over the long-term, conditions in the water influence zone and in the native cutthroat habitat.
The rule provisions concerning proposed road construction or reconstruction for authorized water conveyance structures have been modified. The definition of water conveyances has been expanded to include reservoirs, and the exception is limited only to those conveyances operated pursuant to a pre-existing water court decree as of the effective date of a final rule. Water court decrees dated after the final date of the rule would not be eligible for roaded access in CRAs. Finally, the Regional Forester would be required to determine the need for the road access.
The exception for temporary road construction associated with tree-cutting, sale, or removal to reduce the wildfire hazard to an at-risk community or municipal water supply system and tree-cutting associated with maintenance and restoration of characteristics of ecosystem composition, structure and processes, is limited to the first half mile of the CPZ and would require a determination by the Regional Forester.
The road construction exception for the management of livestock grazing has been eliminated. New grazing authorizations would be limited to use of existing roads.
Temporary road construction may be authorized when associated with exploration or development of an oil and gas lease that was issued prior to the effective date of the rule and when the lease and stipulations do not prohibit surface occupancy or roading.
Approximately 9,000 acres of the Currant Creek CRA, have been removed from the North Fork Coal Mining Area exception due to public comments regarding the wildlife values of this particular CRA and the lack of existing coal leases in this area. In the remaining proposed 20,000 acres, temporary road construction would be allowed for coal exploration and coal-related surface support activities, such as the drilling of vent holes to extract methane gas to facilitate miner safety. These same temporary roads could also be used for the purpose of collecting and transporting coal mine methane to avoid venting methane into the atmosphere. The authorized road right-of-way would serve as the site for buried infrastructure, such as pipelines. The proposed rule allows for the opportunity to develop this important low-sulfur, cleaner-burning coal resource in a limited portion of the CRA inventory, with areas being returned to long term management for roadless area protection following the decommissioning of the associated temporary roads.
Under all road exceptions, projects would have to be designed and completed to reduce unnecessary or unreasonable surface disturbance. All roads constructed would be decommissioned and the affected landscape restored when a road was no longer needed for the original purpose and/or when the authorization expired, whichever was sooner. These decommissioning requirements would be included in all related contracts or permits and could not be waived.
To prevent roads from affecting the landscape longer than intended, temporary roads authorized under this subpart would not be converted to a forest road (be designated as a permanent road), unless the specific exception under which the temporary road was constructed allows for forest road construction and reconstruction. All roads would also restrict use to the purpose for the road, limiting the traffic and overall impact to the area. Motorized use by the general public including use by off-highway vehicles would be prohibited. General use restrictions would not apply to administrative use by the Forest Service, motor vehicle use that is specifically under an authorization issued under Federal law or regulation, or use for public health and safety or law enforcement reasons. Maintenance of temporary or forest roads would be permitted.
Prohibitions on linear construction zones (LCZs) have been added to the proposed rule. The 2001 Roadless Rule did not restrict the use of LCZs. LCZs would be prohibited in CRAs unless they meet one of three exceptions: water conveyance structures with a pre-existing water court decree; electrical power or telecommunication lines; and pipelines associated with oil and gas leases that allow surface use within CRAs or an oil and gas lease outside of CRA that connects to infrastructure inside of CRAs. For all three LCZ exceptions, the Regional Forester would be required to determine that motorized access is not possible without an LCZ that the LCZ is consistent with applicable LMP, and that in the long term the LCZ will not diminish conditions in native cutthroat trout habitat.
The Regional Forester may authorize a LCZ when needed for construction, reconstruction, or maintenance of an authorized water conveyance structure that was operated pursuant to a pre-existing water court decree, as of the effective date of this rule. This exception is similar to the road construction/reconstruction for water conveyance structures, but can be selected when a road is not necessary.
Colorado's petition and public comment identify that the current electrical power line system, some of which is already located in CRAs, will need to be maintained and upgraded. Additionally, demand for additional lines is expected. The rule recognizes these possibilities and would allow LCZs, when appropriate, as the method requiring the least disturbance. For the construction, reconstruction, or maintenance of existing or future electrical power lines or telecommunication lines within a CRA, the Regional Forester would determine if a LCZ is needed. The rule further clarifies that any future electrical power lines or telecommunication lines could only be authorized within a CRA if there is no opportunity for the project to be implemented outside the CRA without causing substantially greater environmental damage. The agency is inviting public comments on this exception.
The rule similarly recognizes that it may be appropriate to authorize a LCZ within CRAs to allow the movement of product to market from within a pre-existing oil and gas lease within the CRA. The proposed rule also allows an LCZ when a proponent requests to connect from outside the CRA to an existing infrastructure within a CRA in order to avoid creation of a duplicate pipeline system and unnecessary environmental harm. The Regional Forester would be required to determine that such a connection would cause substantially less environmental damage than alternative routes. An LCZ would not be allowed for new pipelines that would merely pass through a CRA.
All LCZs would be constructed in a manner that minimizes ground disturbance, and would include a reclamation plan. After installation of the linear facility, the LCZ and all areas of surface disturbance would be reclaimed according to the reclamation plan, and those requirements would not be waived.
The Forest Service will comply with NEPA for activities within CRAs. The Forest Service NEPA regulations at 36 CFR 220.5(a)(2) normally require preparation of an EIS for any proposal that would substantially alter the undeveloped character of an inventoried roadless area, including CRAs.
The Forest Service would be required to offer the State of Colorado cooperating agency status for all proposed projects and planning events within CRAs. When the Forest Service is not the lead agency and does not have the authority to offer formal cooperating agency status to the State of Colorado, the Forest Service would offer to coordinate with the State.
The proposed rule would prohibit temporary and permanent road construction and reconstruction associated with new oil and gas leases issued within a Colorado Roadless Area. Some comments suggested that the Colorado Roadless Rule establish restrictions to be applied retroactively to oil and gas leases within CRAs. The proposed rule does not implement that suggestion. Consistent with other past Department rulemakings concerning roadless area management, this proposed rule is not designed or intended to alter previously approved decisions but instead establishes prospective management direction for the protection and management of CRAs. Nevertheless, the proposed rule would establish requirements to limit future discretionary decisions concerning oil and gas leasing within CRAs. Specifically, the proposed rule would require that only temporary roads could be developed in association with pre-existing leases. In addition, the proposed rule would prohibit the Agency from authorizing the Bureau of Land Management to grant any request for a waiver, exception, or modification to any oil or gas lease, if doing so would result in any road construction within a Colorado Roadless Area beyond that authorized at the time of issuance of the lease.
Comments were also received for and against establishment of a prohibition on new oil and gas leasing or surface occupancy within CRAs. Again, like prior rules, the proposed rule does not establish such prohibitions. Instead, the proposed rule would allow only such leasing that can be accomplished without road construction or reconstruction and would require mandatory and non-waiveable stipulations prohibiting road construction. The proposed rule identifies regulatory requirements in 36 CFR 294.44 that would be imposed for any linear construction zone associated with new leases.
The proposed rule also confirms that the forest travel management processes will continue to be used for all future decisions regarding motorized and non motorized use on trails within CRAs. Motorized access not involving the construction or reconstruction of roads would continue according to existing authorizations. CRA designation would not eliminate or preclude any lands from being available for livestock grazing.
The Chief of the Forest Service would be able to modify CRA boundaries based on a changed circumstance such as, the inclusion or exclusion of lands due to land exchanges, and updated inventories. Such changes to the boundaries would require public notice and a minimum 90-day public comment period. Changes due to new congressional designations would not require a modification, and would be adjusted to conform to the applicable statute.
The Chief of the Forest Service would be able to make administrative corrections to CRA boundaries. Administrative corrections would require public notice and a 30-day comment period. Administrative corrections include adjustments such as to correct clerical errors or to reflect improved field data due to updated imagery, global positioning data, or other collected field data.
Rulemaking would be required for any modification to final rule language. The Secretary would provide for public notice and a minimum 90-day comment period, and the State would be consulted on any rulemaking proposals.
The proposed rule's applicability would be limited to authorizations for occupancy and use of NFS lands issued after the effective date of a final rule. The proposed rule's provisions would not affect project or activity decisions issued prior to the effective date of a final rule.
Components of a LMP can be more restrictive than the rule and will continue to provide guidance and direction for projects within CRAs. The proposed rule does not compel amendment or revision of a LMP. A project decision or LMP amendment or revision may not waive or supersede the provisions of this proposed rule.
The proposed rule does not waive any requirements during project analyses to consult with Tribes and other agencies, comply with applicable laws, and involve the public.
If any provision of the rule or its application were held to be invalid, the Department's intention is that the remainder of the regulation would remain in force.
After promulgation of a final rule, the rule promulgated on January 12, 2001, would have no effect within the State of Colorado.
There are 363 Colorado Roadless Areas in the proposed rule; an increase of 18 CRAs from the July 2008 Proposed Rule.
The proposed rule was reviewed under USDA procedures, Executive Order 12866 (E.O. 12866), and the major rule provisions of the Small Business Regulatory Enforcement and Fairness Act (5 U.S.C. 800). E.O. 12866 addresses regulatory planning and review and requires agencies conduct a regulatory impact assessment for economically significant regulatory actions. Economically significant regulatory actions are those that have an annual effect on the economy of $100 million or more, or adversely affect the economy or economic sectors. Total annual
A regulatory impact assessment has been prepared for this proposed rule. OMB Circular A-4 as well as guidance regarding E.O. 12866 indicate that regulatory impact analysis should include an assessment of distributional effects. The benefits, costs, and distributional effects of four alternatives are analyzed over a 15-year time period. These four alternatives referred to as follows: Alternative 1—the provisions of the 2001 Roadless Rule (2001 rule); alternative 2—the proposed Colorado Roadless Rule (proposed rule); alternative 3—Forest Plans (no action); and alternative 4 (the proposed rule with public identified upper tier acreage). The difference between alternative 2 and 4 is the number and location of upper tier acres identified within the CRAs. For the purpose of regulatory impact assessment, the forest plan alternative represents baseline conditions or goods and services provided by NFS lands in the near future in the absence of the proposed rule. In August 2008, the Wyoming District Court set aside and enjoined the 2001 Roadless Rule. Colorado is under the Wyoming Court's ruling. In the revised DEIS the baseline conditions are therefore assumed to mean that IRAs in Colorado will be managed according to direction set forth in the applicable forest plan (alternative 3).
The proposed rule is programmatic in nature and intended to guide future development of proposed actions in roadless areas. The proposed rule is intended to provide greater management flexibility under certain circumstances to address unique and local land management challenges, while continuing to conserve roadless values and characteristics. Increased management flexibility is primarily needed to reduce hazardous fuels around communities to allow access to coal reserves in the North Fork coal mining areas, and to allow access to future water conveyances.
The proposed rule does not authorize the implementation of any ground-disturbing activities, but rather it describes circumstances under which certain activities may be allowed or restricted in roadless areas. Before authorizing land use activities in roadless areas, the Forest Service must complete a more detailed and site-specific environmental analysis pursuant to the National Environmental Policy Act (NEPA) and its implementing regulations.
Because the proposed rule does not prescribe site-specific activities, it is difficult to predict changes in benefits and costs or other changes under the different alternatives. It should also be emphasized that the types of benefits derived from uses of roadless areas in Colorado are far ranging and include a number of non-market and non-use benefit categories that are difficult to measure in monetary terms. As a consequence, benefits are not monetized, nor are net present values or benefit cost ratios estimated. Instead, increases and/or losses in benefits are discussed separately for each resource area in a quantitative or qualitative manner. Benefits and costs are organized and discussed in the context of local land management challenges or concerns (`local challenges') and `roadless area characteristics' in an effort to remain consistent with the overall purpose of the proposed rule, recognizing that benefits associated with local challenges may trigger or overlap with benefits associated with roadless area characteristics in some cases (
Distributional effects or economic impacts, in terms of jobs and labor income, are quantified for the oil and gas and the coal sectors for an economic area consisting of five Colorado counties (Delta, Garfield, Mesa, Montrose, and Rio Blanco) using a regional impact model. Fiscal impacts (
Details about the environmental impacts associated with the proposed rule can be found in the RDEIS. Effects on opportunities for small entities under the proposed rule are discussed in the context of E. O. 13272 regarding proper consideration of small entities and the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), which amended the Regulatory Flexibility Act (5 U.S.C. 601
The results of the regulatory impact assessment for the proposed rule are summarized in the following tables. Table 1 provides information related to roadless area acreage, road miles, and tree-cutting. Table 2 summarizes the potential benefits and costs of alternatives 1, 2, 3 and 4. Table 3 summarizes distributional effects and economic impacts of the proposed rule and alternatives.
The proposed rule has also been considered in light of Executive Order 13272 (E. O. 13272) regarding proper consideration of small entities and the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), which amended the Regulatory Flexibility Act (5 U.S.C. 601
For small businesses affiliated with most industry sectors involved with activities in roadless areas (
There are about 1,390 recreation special use permits currently authorized within NFS lands in Colorado of which a large majority are small businesses, and 1,066 (77%) are associated with outfitter and guide permits, some of
For leasable minerals associated energy resources (coal, oil and gas), significant changes in output are projected across alternatives. More than 95 percent of the firms associated with these sectors can be classified as small as defined by Small Business Administration standards. Any changes in oil and gas, or coal development or production can therefore have an effect on small business opportunities in these sectors. A five county region has been defined to model the economic impacts associated with energy resources (Delta, Garfield, Mesa, Montrose, and Rio Blanco counties). A total of 355 firms associated with oil and gas, and coal development and extraction are estimated to be located within this region, of which 95% are likely to be small (337 firms). However, energy resource sector jobs, supported annually by projected activity within roadless areas, are estimated to increase from 1,557 under the 2001 rule alternative to 2,679 jobs under the proposed rule (as well as alternative 4), and 2,796 jobs under the no action (forest plans) alternative. Labor income increases by a similar degree from $101 million to $183.2 million and 190 million per year under all alternatives. There is slightly higher job numbers (2,796) under the forest plan alternative (alternative 3) relative to the proposed rule (2,679) alternatives (alternatives 2 and 4), but the magnitude of the difference between these alternatives does not suggest that adverse impacts will be significant if choosing between the proposed rule and forest plans. These results indicate minimal adverse impacts to small entities associated with energy resource development and extraction under the proposed rule relative to the forest plans alternative.
For all other economic sectors considered, changes in resource outputs are not projected to be significant to the extent that adverse impacts to small entities could occur in aggregate or within regions.
Among 64 counties in the State of Colorado, 36 counties (56%) are considered to be small governments (population less than 50,000). These 36 counties are considered to be small rural counties having NFS lands within IRAs/CRAs. Six counties are energy (coal, oil and gas) producing counties. These six counties (Delta, Garfield, Gunnison, Mesa, Montrose, and Pitkin) are expected to be the counties most likely to benefit from mineral lease payments and revenue sharing under the proposed rule (as well as alternative 4), and forest plans. All of these counties, with the exception of Mesa can be considered small governments (population less than 50,000), and all are forecast to receive significant increases in property tax receipts from coal, and oil and gas production, as well as State distributions of severance taxes and Federal royalties under the proposed rule and forest plans relative to the 2001 rule. There are slight increases in payments under forest plans, relative to the proposed rule (aggregate payments increase from $10.2 million to $11.1 million per year). Payments associated with the Secure Rural Schools and Self Determination Act (SRSA) and Payments in Lieu of Taxes (PILT) are not expected to change significantly, or any decreases would be largely offset by increases in Federal mineral lease payments.
Under the proposed rule, as compared to the no action alternative, the potential opportunities for fuel treatments near communities-at-risk (
Therefore, for small governments, including counties with small populations and at-risk-communities from wildfire within those counties, opportunities for revenue sharing, as well as protection of values-at-risk are not expected to significantly decrease under the proposed rule relative to forest plans. Mitigation measures associated with existing programs and laws regarding revenue sharing with counties and small business shares or set-asides will continue to apply.
This proposed rule does not call for any additional record keeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or not already approved for use and, therefore, imposes no additional paperwork burden on the public. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Department has considered this proposed rule under the requirements of Executive Order 13132 issued August 4, 1999 (E.O. 13132), Federalism. The Department has made an assessment that the proposed rule conforms with the Federalism principles set out in E.O. 13132; would not impose any compliance costs on the States; and would not have substantial direct effects on the States, on the relationship between the national government and the States, nor on the distribution of power and responsibilities among the various levels of government. Therefore, the Department concludes that this proposed rule does not have Federalism implications. This proposed rule is based on a petition submitted by the State of Colorado under the Administrative Procedure Act at 5 U.S.C. 553(e) and pursuant to Department of Agriculture regulations at 7 CFR 1.28. The State's petition was developed through a task force with the involvement of local governments. The State is a cooperating agency pursuant to 40 CFR 1501.6 of the Council on Environmental Quality regulations for the development of the supporting environmental impact statement. State and local governments are encouraged to comment on this proposed rule, in the course of this rulemaking process.
The United States has a unique relationship with Indian Tribes as provided in the Constitution of the United States, treaties, and Federal statutes. The relationship extends to the Federal government's management of public lands and the Forest Service strives to assure that its consultation with Native American Tribes is meaningful, in good faith, and entered into on a government-to-government basis.
On November 5, 2009, President Obama signed a Memorandum emphasizing his commitment to “regular and meaningful consultation and collaboration with Tribal officials in policy decisions that have Tribal implications including, as an initial step, through complete and consistent implementation of Executive Order 13175.” He charged agencies with engaging in consultation and collaboration with Indian Tribal governments; strengthening government-to-government relationship between the United States and Indian Tribes; and reducing the imposition of unfunded mandates upon Indian Tribes.
Management of roadless areas has been a topic of interest and importance to Tribal governments. During promulgation of the 2001 Roadless Rule, Forest Service line officers in the field were asked to make contact with Tribes to ensure awareness of the initiative and of the rulemaking process. Outreach to Tribes was conducted at the national forest and grassland level, which is how Forest Service government-to-government dialog with Tribes is typically conducted. Tribal representatives remained engaged concerning these issues during the subsequent litigation and rulemaking efforts.
The State's petition identifies that a vital part of its public process in developing its petition were the recommendations and comments received from Native American Tribes. The Governor's office was keenly aware of the spiritual and cultural significance some of these areas hold for the Tribes.
There are two resident Tribes in Colorado, both retaining some of their traditional land base as reservations via a series of treaties, agreements, and laws. The Ute Mountain Ute and Southern Ute Tribes (consisting originally of the Weeminuche, Capote, Tabeguache, and Mouaches Bands)—each a “domestic sovereign” nation—have reserved some specific off-reservation hunting rights in Colorado and retain inherent aboriginal rights throughout their traditional territory. Many other Tribes located outside Colorado maintain Tribal interests, including aboriginal and ceded territories, and retain inherent aboriginal rights within the State.
The Forest Service has been consulting with Colorado-affiliated Tribes regarding this proposed rulemaking action and analysis process. Tribal concerns surfaced during phone or e-mail consultations. Information applying to the proposed Colorado Roadless Rule was provided to the Ute Mountain Ute and Southern Ute Indian Tribes, located in Colorado prior to the release of the NOI. The San Juan National Forest staff held meetings with both Tribes to discuss the proposed rule as well as other Forest issues. At these meetings, the Tribes expressed concerns about hunting access, and unauthorized roads. Nothing in this rule changes access or existing rights. The management of unauthorized roads is addressed through travel management processes.
Additionally, an introductory letter and the NOI along with background information on the proposed Colorado Roadless Rule and an offer for additional information or meetings was sent to the following Tribes and committees: Hopi Tribal Council, Navajo Nation, Northern Cheyenne Tribal Council, Pueblo of Jemez, Pueblo of Nambé, Ohkay Owingeh, Pueblo of Picuris, Pueblo of Pojoaque, Pueblo of San Ildefonso, Pueblo of Santa Clara, Pueblo of Taos, Pueblo of Tesuque, Pueblo of Zuni, Jicarilla Apache Nation, Cheyenne and Arapaho Tribes of Oklahoma, Ute Business Committee, Shoshone Business Committee, and the Arapaho Business Committee. These 18 Tribes and committees were selected based on their current proximity to Colorado, their current use of lands in Colorado, and their historic use of lands within Colorado.
The 2008 Proposed Rule and DEIS were sent to each Tribe and each was contacted by phone to determine interest in meeting or obtaining information. The Tribes did not request additional government-to-government involvement, and no formal comments from any of the Tribes were received. A letter was sent outlining the key points of this revised proposed rule and the FS met with those Tribes requesting further consultation. Consultation efforts will continue throughout the process and for the final Rule.
Pursuant to Executive Order 13175 of November 6, 2000, “Consultation and Coordination with Indian Tribal Governments,” the Department has assessed the impact of this proposed rule on Indian Tribal Governments and has determined that the proposed rule does not significantly or uniquely affect Indian Tribal Government communities. The proposed rule would establish direction governing the management and protection of Colorado Roadless Areas, however, the proposed rule respects prior existing rights, and it addresses discretionary Forest Service management decisions involving road construction, timber harvest, and some mineral activities. The Department has also determined that this proposed rule does not impose substantial direct compliance costs on Indian Tribal Governments. This proposed rule does not mandate Tribal participation in roadless management of the planning of activities in Colorado Roadless Areas. Rather, the Forest Service officials are obligated by other agency policies to consult early with Tribal governments and to work cooperatively with them where planning issues affect Tribal interests.
The proposed rule has been analyzed in accordance with the principles and criteria contained in Executive Order 12630 issued March 15, 1988. It has been determined that the proposed rule does not pose the risk of a taking of private property.
The proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. After adoption of this proposed rule, (1) all State and local laws and regulations that conflict with this proposed rule or that would impede full implementation of this proposed rule will be preempted; (2) no retroactive effect would be given to this proposed rule; and (3) this proposed rule would not require the use of administrative proceedings before parties could file suit in court challenging its provisions.
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Department has assessed the effects of this proposed rule on State, local, and Tribal governments and the private sector. This proposed rule does not compel the expenditure of $100 million or more by State, local, or Tribal governments or anyone in the private sector. Therefore, a statement under section 202 of the Act is not required.
Based on guidance for implementing Executive Order 13211 (E.O. 13211) of
Projections of natural gas production are discussed in the RDEIS and the Regulatory Impact Analysis for the proposed Colorado Roadless Rule. Based on those projections, it has been determined that natural gas production varies across alternatives for only two National Forests (the Grand Mesa, Gunnison, and Uncompahgre (GMUG) and White River National Forests). It has also been determined that there is no appreciable difference in projected natural gas production between Alternatives 1 (2001 rule) and 2 (proposed rule) or alternative 4. The difference in potential natural gas production between alternatives 1, 2, or 4 (27 billion cubic feet per year) and alternative 3 (no action) (31 billion cubic feet per year) is a decrease of only 4 bcf/year, or 4 million mcf/year, which is well below the E. O. 13211 criterion for adverse effects of 25 million mcf.
Projected oil production ranges from approximately 50,000 barrels under Alternatives 1, 2, and 4 to approximately 110,000 barrels under Alternative 3 over a period of 15 to 30 years. The corresponding reduction in oil production per day under alternatives 1 or 2 or alternative 3 (no action) is inconsequential compared to the E. O. 13211 criterion of 10,000 barrels per day.
Based on
The total reduction in recoverable coal reserves from roadless areas that are made accessible under the proposed rule, relative to no action alternative, is estimated to be 210 million tons (
The estimated reductions in the production life of affected mines under the proposed rule compared to the no action alternative may be significant, particularly when considering potential increases in demand for coal from western mines
The reduction in coal production under the proposed rule (as well as alternative 4), relative to the no action alternative are not expected to have adverse effects on the productivity, competition, or prices in the energy sector regionally (or nationally) due to the following observations:
The reductions in annual production under the 2001 rule, compared to the no
There is a substantial reduction in annual production under the 2001 rule alternative compared to the no action alternative (reductions range from 5.6 million tons per year beginning as early as 2013 and increase to 11.6 million tons by 2019), and production life is anticipated to extend for only 7 to 10 years under the 2001 rule compared to a longer production life under the no action alternative. The production reductions under the 2001 rule (
Alternative 1 has the greatest reduction in production, and alternatives 2 and 4 have some reduction compared to forest plans.
No novel legal or policy issues regarding adverse effects to supply, distribution or use of energy are anticipated beyond what has already been addressed in the RDEIS, or the Regulatory Impact Analysis (RIA). None of the proposed corridors designated for oil, gas, and/or electricity under Section 368 of the Energy Policy Act of 2005 are within Colorado Roadless Areas.
The proposed rule does not disturb existing access or mineral rights, and restrictions on saleable mineral materials are narrow. The proposed rule also provides regulatory mechanism for consideration of requests for modification of restrictions if adjustments are determined to be necessary in the future. As this action is a significant energy action, the above constitutes the Statement of Energy Effects.
National Forests, Recreation areas, Navigation (air), State petitions for inventoried roadless area management.
Therefore, for the reasons set forth in the preamble, the Forest Service proposes to amend part 294 of Title 36 of the Code of Federal Regulations by adding new subpart D to read as follows:
16 U.S.C. 472, 529, 551, 1608, 1613; 23 U.S.C. 201, 205.
The purpose of this subpart is to provide, within the context of multiple use management, State-specific direction for the protection of roadless areas on National Forest System lands in Colorado. The intent of this regulation is to protect roadless values by restricting tree cutting, sale, and removal, road construction and reconstruction, and linear construction zones within CRAs, with narrowly focused exceptions. Activities must be designed to conserve the roadless area characteristics listed in § 294 .41, although applying the exceptions in § 294.42, § 294.43, and § 294.44 may have effects to some roadless area characteristics.
The following terms and definitions apply to this subpart.
(1) Has a sustained steep slope that creates the potential for wildfire behavior endangering the at-risk community;
(2) Has a geographic feature that aids in creating an effective fire break, such as a road or a ridge top; or
(3) Is in condition class 3 as defined by Healthy Forest Restoration Act (Pub. L. 108-148).
(1) Is developed within the context of the collaborative agreements and the guidance established by the Wildland Fire Leadership Council and agreed to by the applicable local government, local fire department, and State agency responsible for forest management, in consultation with interested parties and the Federal land management agencies managing land in the vicinity of the at-risk community;
(2) Identifies and prioritizes areas for hazardous fuel reduction treatments and recommends the types and methods of treatment on Federal and non-Federal land that will protect one or more at-risk communities and essential infrastructure; and
(3) Recommends measures to reduce structural ignitability throughout the at-risk community.
(1) Fire regimes on land have been significantly altered from historical ranges;
(2) There exists a high risk of losing key ecosystem components from fire;
(3) Fire frequencies have departed from historical frequencies by multiple return intervals, resulting in dramatic changes to:
(i) The size, frequency, intensity, or severity of fires; or
(ii) Landscape patterns; and
(4) Vegetation attributes have been significantly altered from the historical range of the attributes.
(1) High quality or undisturbed soil, water, and air;
(2) Sources of public drinking water;
(3) Diversity of plant and animal communities;
(4) Habitat for threatened, endangered, proposed, candidate, and sensitive species, and for those species dependent on large, undisturbed areas of land;
(5) Primitive, semi-primitive non-motorized, and semi-primitive motorized classes of dispersed recreation;
(6) Reference landscapes;
(7) Naturaly-appearing landscapes with high scenic quality;
(8) Traditional cultural properties and sacred sites; and
(9) Other locally identified unique characteristics.
(a)
(b)
(1) Tree-cutting, sale, or removal is incidental to the implementation of a management activity not otherwise prohibited by this subpart; or
(2) Tree-cutting, sale, or removal is needed and appropriate for personal or administrative use, as provided for in 36 CFR part 223, subpart A.
(c)
(1) The Regional Forester determines tree-cutting, sale, or removal is needed to reduce hazardous fuels to an at-risk community or municipal water supply system that is:
(i) Within the first one-half mile of the community protection zone, or
(ii) Within the next one-mile of the community protection zone, and is within an area identified in a Community Wildfire Protection Plan.
(iii) Projects undertaken pursuant to paragraphs (c)(1)(i) and (ii) of this section will focus on cutting and removing generally small diameter trees to create fuel conditions that modify fire behavior while retaining large trees to the maximum extent practical as appropriate to the forest type.
(2) The Regional Forester determines tree-cutting, sale, or removal is needed outside the community protection zone where there is a significant risk that a wildland fire disturbance event could adversely affect a municipal water
(i) Projects will focus on cutting and removing generally small diameter trees to create fuel conditions that modify fire behavior while retaining large trees to the maximum extent practical as appropriate to the forest type.
(ii) Projects are expected to be infrequent.
(3) Tree-cutting, sale, or removal is needed to maintain or restore the characteristics of ecosystem composition, structure and processes. These projects are expected to be infrequent.
(4) Tree-cutting, sale, or removal is needed to improve habitat for Federally threatened, endangered, proposed, or Agency designated sensitive species; in coordination with the Colorado Department of Natural Resources, including the Colorado Division of Wildlife.
(5) Tree-cutting, sale, or removal is incidental to the implementation of a management activity not otherwise prohibited by this subpart.
(6) Tree-cutting, sale, or removal is needed and appropriate for personal or administrative use, as provided for in 36 CFR part 223, subpart A.
(a)
(b)
(1) A road is needed pursuant to reserved or outstanding rights, or as provided for by statute or treaty.
(2) For any road construction/reconstruction authorized pursuant to this provision, the Responsible Official must determine:
(i) Motorized access, without road construction is not technically feasible;
(ii) When proposing to construct a forest road, that a temporary road would not provide reasonable access; and
(iii) Within a native cutthroat trout catchment or identified recovery watershed, whether road construction will diminish, over the long-term, conditions in the water influence zone and in the native cutthroat habitat.
(c)
(1) That one of the following exceptions exists:
(i) A road is needed pursuant to reserved or outstanding rights, or as provided for by statute or treaty;
(ii) Road realignment is needed to prevent irreparable resource damage that arises from the design, location, use, or deterioration of a forest road and that cannot be mitigated by road maintenance. Road realignment may occur under this paragraph only if the road is deemed essential for administrative or public access, public health and safety, or other authorized use;
(iii) Road reconstruction is needed to implement a road safety improvement project on a forest road determined to be hazardous on the basis of accident experience or accident potential on that road;
(iv) The Regional Forester determines a road is needed to allow for the construction, reconstruction, or maintenance of an authorized water conveyance structure which is operated pursuant to a pre-existing water court decree (see also § 294.44(b)(1));
(v) A temporary road is needed to protect public health and safety in cases of threat of flood, fire, or other catastrophic event that, without intervention, would cause the loss of life or property;
(vi) The Regional Forester determines a temporary road is needed to facilitate tree-cutting, sale, or removal (§ 294.42(c)(1)) within the first one-half mile of the community protection zone to reduce the wildfire hazard to an at-risk community or municipal water supply system;
(vii) The Regional Forester determines a temporary road is needed to facilitate tree-cutting, sale or removal (§ 294.42(c)(3)) within the first one-half mile of the community protection zone to maintain or restore characteristics of ecosystem composition, structure and processes;
(viii) A temporary road is needed within a Colorado Roadless Area pursuant to the exploration or development of an existing oil and gas lease that does not prohibit road construction or reconstruction, including the construction of infrastructure necessary to transport the product, on National Forest System lands that are under lease issued by the Secretary of the Interior as of [final rule effective date]. The Forest Service shall not authorize the Bureau of Land Management to grant any request for a waiver, exception, or modification to any oil or gas lease if doing so would result in any road construction or tree cutting within a Colorado Roadless Area beyond that which was authorized by the terms and conditions of the lease at the time of issuance; or
(ix) A temporary road is needed for coal exploration and coal-related surface activities for certain lands within Colorado Roadless Areas in the North Fork coal mining area of the Grand Mesa, Uncompahgre, and Gunnison National Forests as defined by the North Fork coal mining area displayed on the final Colorado Roadless Areas map. Such roads may also be used for collecting and transporting coal mine methane. Any buried infrastructure, including pipelines, needed for the capture, collection, and use of coal mine methane will be located within the rights-of-way of temporary roads that are otherwise necessary for coal-related surface activities including the installation and operation of methane venting wells.
(2) If proposed road construction/reconstruction meets one of the exceptions, subject to the legal rights identified in 36 CFR 294.43(c)(1), the following must be determined:
(i) Motorized access, without road construction is not technically feasible;
(ii) When proposing to construct a forest road, that a temporary road would not provide reasonable access;
(iii) Road construction is consistent with the applicable land management plan direction;
(iv) Within a native cutthroat trout catchment or identified recovery watershed, road construction will not diminish, over the long-term, conditions in the water influence zone and in the native cutthroat habitat; and
(d)
(1)
(2)
(3)
(4)
(i) Where specifically used for the purpose for which the road was established;
(ii) Motor vehicle use that is specifically authorized under an authorization issued under Federal law or regulation.
(5)
(a)
(b)
(1) The construction, reconstruction, or maintenance of an authorized water conveyance structure which is operated pursuant to a pre-existing water court decree (see § 294.43(c)(1)(iv));
(2) The construction, reconstruction, or maintenance of existing or future authorized electrical power lines or telecommunication lines. Authorize electrical power lines or telecommunication lines within Colorado Roadless Areas only if there is no opportunity for the project to be implemented outside of a Colorado Roadless Area without causing substantially greater environmental damage; or
(3) The construction or reconstruction of a pipeline associated with operation of an oil and gas lease that allows surface use within a Colorado Roadless Area or the construction or reconstruction of a pipeline needed to connect to infrastructure within a Colorado Roadless Area from outside a Colorado Roadless Area where such a connection would cause substantially less environmental damage than alternative routes. The construction of pipelines for the purposes of transporting oil or natural gas through a Colorado Roadless Area, where the source(s) and destination(s) of the pipeline are located exclusively outside of a Colorado Roadless Area, shall not be authorized.
(4) If a proposed linear construction zone meets one of the exceptions, then the following must be determined:
(i) Motorized access, without a linear construction zone, is not technically feasible;
(ii) A linear construction zone is consistent with the applicable land management plan direction;
(iii) Within a native cutthroat trout catchment or identified recovery watershed, a linear construction zone will not diminish, over the long-term, conditions in the water influence zone and in the native cutthroat habitat; and
(c)
(a) Environmental documentation will be prepared pursuant to Section 102 of the National Environmental Policy Act, 40 CFR 1500, and 36 CFR part 220 for any proposed action within a Colorado Roadless Area. Proposals that substantially alter the undeveloped character of a Colorado Roadless Area require an Environmental Impact Statement (EIS).
(b) The Forest Service will offer cooperating agency status to the State of Colorado, for all proposed projects and planning activities to be implemented on lands within Colorado Roadless Areas. Where the Forest Service does not have the authority to offer formal cooperating agency status, the Forest Service shall offer to coordinate with the State.
(a)
(b)
(1) Locate, to the extent possible without compromising health and safety standards, roads, well sites, and facilities on pre-existing areas of surface disturbance. Project design shall minimize the amount of necessary temporary road construction or reconstruction.
(2) Consider an alternative for proposed operations that addresses locating directional drilling of multi-well sites on pre-existing areas of surface disturbance. Such an alternative can be dismissed from detailed analysis with clear justification.
(3) Restrict road construction for leases partially within Colorado Roadless Areas, to the extent practical, to portions of the lease outside of Colorado Roadless Areas except when doing so will be substantially more environmentally damaging, compromise safety standards, or is unfeasible due to topography or surface conditions.
(4) Perform, to the extent feasible, reclamation of surface disturbances incrementally, to minimize the total area of disturbance at any given point in time during the exploration or development of a lease.
(5) Design, to the extent feasible, temporary roads and facilities to blend with the terrain to minimize visual impacts and to facilitate restoration when the road is no longer needed.
(6) Co-locate, wherever possible and consistent with health and safety standards, power lines, flow lines and pipelines within the right-of-way of roads to minimize the area of surface disturbance.
(7) Consider new and developing low impact techniques and technologies and either apply or dismiss with justification.
(8) Utilize the best available technology, to the extent possible, to minimize noise and air emissions.
(c)
(d)
(e)
Modifications and administrative corrections pursuant to this subpart, after coordination with the State, may be made under the following circumstances:
(a)
(b)
(c)
(a) This subpart does not revoke, suspend, or modify any permit, contract, lease, or other legal instrument authorizing or granting rights to the occupancy and use of National Forest system land issued prior to [final rule effective date] nor does it affect the authority or the discretion of the responsible official to reissue any such permit, contract, or other legal instrument upon its expiration or termination.
(b) This subpart does not revoke, suspend, or modify any project or activity decision made prior to [final rule effective date].
(c) The provisions set forth in this subpart provide the maximum level of tree-cutting, sale and removal, and road construction and reconstruction activity allowed within Colorado Roadless Areas. Land management plan components can be more restrictive than this subpart and will continue to provide direction and guidance for projects and activities within Colorado Roadless Areas. Nothing in this subpart shall prohibit a responsible official from further restricting activities allowed within Colorado Roadless Areas. This subpart does not compel the amendment or revision of any land management plan.
(d) The prohibitions and restrictions established in this subpart are not subject to reconsideration, revision, or rescission in subsequent project decisions or land management plan amendments or revisions undertaken pursuant to 36 CFR part 219.
(e) Nothing in this subpart waives any applicable requirements regarding site specific environmental analysis, public involvement, consultation with Tribes and other agencies, or compliance with applicable laws.
(f) If any provision in this subpart or its application to any person or to certain circumstances is held to be invalid, the remainder of the regulations in this subpart and their application remain in force.
(g) After [final rule effective date] the rule promulgated on January 12, 2001, (66 FR 3244) shall have no effect within the State of Colorado.
All National Forest System lands within the State of Colorado listed in this section are hereby designated as Colorado Roadless Areas.
Environmental Protection Agency (EPA).
Proposed rule.
As promulgated, EPA's regulations distinguish “isolates” and “strains” in a confusing and non-obvious manner. This has resulted in significant uncertainty within the regulated industry. This proposed rule addresses this problem by proposing new regulatory language that clarifies the requirements applicable to new strains that are considered to be new active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA is also soliciting comment on a draft microbial pesticide test guideline, explaining the deposition of a sample in a nationally recognized culture collection data requirement, for comment. The revisions proposed in this rule also include several other minor corrections to words and references. The changes should enhance the ability of industry to efficiently manage their microbial pesticide registration submissions.
Comments must be received on or before July 14, 2011.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-0670, by one of the following methods:
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Rose Kyprianou, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5354; fax number: (703) 305-5884; e-mail address:
You may be potentially affected by this action if you are a producer or registrant of a microbial pesticide product. This proposal also may affect any person or company who might petition the Agency for a tolerance or an exemption from the requirement of a tolerance for the residues of a microbial pesticide, holds a pesticide registration with an existing tolerance or tolerance exemption for a microbial pesticide, or is interested in obtaining or retaining a tolerance or tolerance exemption in the absence of a registration (
• Pesticide and Other Agricultural Chemical Manufacturing (NAICS code 325320),
• Crop Production (NAICS code 111).
• Animal Production (NAICS code 112).
• Food Manufacturing and Processing (NAICS 311).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. 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.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
This action is issued under the authority of sections 3, 5, 10, 12, and 25 of the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, and section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA).
EPA is proposing several changes and corrections to the Microbial Pesticides data requirements (40 CFR part 158, subpart V). Two revisions are proposed to be made to text found in the Microbial Pesticides Definition and Applicability section (40 CFR 158.2100). The first is a correction, replacing “part” with “subpart” in 40 CFR 158.2100(c)(1). The other is a clarification, involving revisions to 40 CFR 158.2100(c)(2), and is in response to recent confusion over the distinction between isolates and strains and exactly how EPA is considering both of these terms. The clarification to 40 CFR 158.2100(c)(2) also proposes to include a requirement for the use of a unique identifier, as part of the microbial pesticide active ingredient taxonomic name, to allow for improved identification of company-specific registered isolates.
In conjunction with the change detailed for 40 CFR 158.2100(c)(2), EPA is also developing a draft microbial pesticide test guideline (OCSPP Guideline 885.1250) to explain the data requirement for the deposition of a sample in a nationally recognized culture collection, which is found in the tables in 40 CFR 158.2120(c) and 40 CFR 158.2171(c); presently, there is no test guideline referenced in the tables for this requirement. A copy of this draft test guideline is in the docket for this action to solicit public comment. Additionally, to clarify this microbial deposition data requirement, EPA is proposing to add a test note to the aforementioned tables, emphasizing the need for the continuing maintenance of a culture deposit to ensure it remains available in case EPA requests a sample. Finally, EPA is proposing to remove incorrect references, in 40 CFR 158.2120 and 40 CFR 158.2171, to a paragraph (e) that does not exist.
The improved clarity and transparency of the information proposed as changes to 40 CFR part 158, subpart V should enhance the ability of industry to efficiently manage their microbial pesticide registration submissions. Applicants may save time and money by understanding the
The Agency believes that 40 CFR 158.2100(c)(1), after replacing “part” with “subpart,” should read as follows: “This subpart applies to microbial pesticides as specified in paragraphs (c)(2), (3), and (4) of this section.” This section, as currently presented, could be misconstrued or interpreted to mean that all of 40 CFR part 158 applies to microbial pesticides and conflicts with the information presented in 40 CFR 158.1(c)(3).
The preamble of the final rule (71 FR 60988, October 26, 2007), codifying the provision found at 40 CFR 158.2100(c)(2), explained that registering a new isolate of an already registered microbial strain did not necessarily increase the amount of data needed to obtain such a registration. The following language is from that preamble:
EPA carefully considered the comment raising the issue of whether an isolate occasionally could be evaluated to satisfy a subset of data requirements at a higher taxonomic level than strain level and whether an isolate might sometimes be included as part of a very similar strain. EPA believes the proposed microbial pesticide definition applicability provision is sufficiently flexible to ensure adequate consideration and data on new isolates, while allowing use of existing data to support registration if similar to an existing strain that is already registered. The wording of the provision relating to applicability of the microbial data requirements reads, “each new isolate of a microbial pesticide is treated as a new strain and must be registered independently of any similar registered microbial pesticide strain and supported by data required in this subpart.” This wording does not preclude the possibility of using data from another isolate to support the assessment if it can be shown that the two isolates are sufficiently closely related. In this way, it ensures that each isolate will be independently considered for registration purposes. The differences in taxonomy between different microorganism classifications, particularly for baculoviruses, would make any attempt to further clarify this provision very complex and potentially confusing as the systematic nomenclature of these organisms change over time. The Agency intends to use its best scientific judgment in each instance to determine if one isolate is sufficiently closely related to another isolate to allow sharing of data or waiving of data requirements.
In this action, EPA is proposing new language for 40 CFR 158.2100(c)(2) to clarify that the use of the phrase “is treated as a new strain” was intended to illustrate that a new strain is considered to be a new active ingredient. EPA believes that this interpretation is consistent with its discussion in the 2007 final rule preamble and with how EPA has been implementing this regulation. Moreover, in order to allow for improved identification of company-specific registered isolates, these modifications will include a provision requiring use of a unique identifier as part of the microbial pesticide active ingredient taxonomic name (
In conjunction with the proposed change detailed for 40 CFR 158.2100(c)(2) (see Unit IV.B.), EPA is also developing a draft microbial pesticide test guideline (OCSPP Guideline 885.1250) to explain the deposition of a sample in a nationally recognized culture collection data requirement, which is currently found in the tables in 40 CFR 158.2120(c) and 40 CFR 158.2171(c). Presently, there is no test guideline referenced in the tables for this requirement. Instead, information on this data requirement is briefly mentioned at the end of the Microbial Pesticide Test Guideline for Manufacturing Process (OPPTS Guideline 885.1200): “A sample of registered [Microbial Pest Control Agents] MPCAs is to be maintained on deposit in a nationally recognized culture collection.” In 1996, this particular statement was transferred from the 1989 revision of Subdivision M of the Pesticide Assessment Guidelines (specifically 151A-11) to the Microbial Pesticide Test Guideline for Manufacturing Process (OPPTS Guideline 885.1200). The term “maintained” was used because some culture collections will discard deposits after a certain time if they do not get subsequent requests to purchase samples from that deposit. In creating a distinct test guideline for the microbial deposition data requirement, EPA will provide a more easily found reference that can be added to the data requirement table. Furthermore, the draft test guideline will make clear that the deposition requirement is analogous to the submittal of samples data requirement (OPPTS Guideline 830.1900), which established that chemical pesticides must be deposited in the EPA National Pesticide Standard Repository. Some of this background information was explained in the preamble to the proposed rule for Data Requirements for Microbial and Biochemical Pesticides (71 FR 12072, March 8, 2006):
f.
Since the Agency does not have capacity to store the variety of microbial pesticides that may be submitted, EPA did not set up a nationally recognized culture collection. There are several nationally recognized culture collections in this country (and abroad) such as the American Type Culture Collection and a microbial collection maintained in Peoria, Ill., by the USDA. These facilities have a vast number of microbial and cell cultures that [the facilities] are dedicated to transferring, maintaining and identifying. Rather than duplicate this effort, EPA chose to refer microbial pesticide producers to these facilities who have the routine expertise to keep and distribute (or protect) microbial cultures. There is a certain element of required expertise but really the cost and small number of our microbial pesticides would make it prohibitively expensive for the Agency to do this collection rather than direct the companies to these specialized facilities.
To clarify this microbial deposition data requirement, the Agency is proposing to add a test note to the tables in 40 CFR 158.2120 and 40 CFR 158.2171, emphasizing the need for the continuing maintenance of a culture deposit to ensure it remains available in case the Agency requests a sample.
The current paragraphs (a) and (b) of both 40 CFR 158.2120 and 158.2171 incorrectly reference a paragraph (e) that does not exist. EPA proposes to remove these incorrect references. Specifically, EPA proposes to do the following in 40
Pursuant to FIFRA sections 25(a) and (d), EPA has submitted a draft of this proposed rule to the Committee on Agriculture in the House of Representatives, the Committee on Agriculture, Nutrition, and Forestry in the United States Senate, and the U.S. Department of Agriculture (USDA).
The FIFRA Scientific Advisory Panel (SAP) and the USDA waived review of this proposed rule. The FIFRA SAP waived its review of this proposed rule because the significant scientific issues involved have already been reviewed by the SAP and additional review is not necessary. The SAP waived its review of this proposed rule on August 17, 2010.
This action only proposes to clarify the existing regulatory text to allow EPA and stakeholders a clearer understanding of 40 CFR part 158, subpart V. It does not otherwise propose to amend or impose any other requirements. The proposed rule will not otherwise involve any significant policy or legal issues and will not increase existing costs. As such, this action is not subject to review by the Office of Management and Budget (OMB) as a “significant regulatory action” under Executive Order 12866, entitled
The information collection activities contained in the regulation are already approved under Information Collection Request (ICR) instruments related to the submission of data to EPA in order to establish a tolerance or an exemption from the requirement of a tolerance currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597), the activities associated with the application for a new or amended registration of a pesticide currently approved under OMB Control No. 2070-0060 (EPA ICR No. 0277), the activities associated with the application for an experimental use permit currently approved under OMB Control No. 2070-0040 (EPA ICR No. 0276), and the activities associated with the generation of data for regulatory review programs currently approved under OMB Control No. 2070-0174 (EPA ICR No. 2288). An agency 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. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
State, local, and Tribal governments are rarely pesticide applicants or registrants, so this proposed rule is not expected to affect these governments. Accordingly, pursuant to Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538), EPA has determined that this action is not subject to the requirements in sections 202 and 205 because it does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or for the private sector in any one year. In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. For the same reasons, EPA has determined that this proposed rule does not have “federalism implications” as specified in Executive Order 13132, entitled
Since this action is not economically significant under Executive Order 12866, it is not subject to Executive Order 13045, entitled
This action does not involve technical standards that would require the consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272).
This action does not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, this action does not involve special consideration of environmental justice related issues as specified in Executive Order 12898, entitled
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
1. The authority citation for part 158 continues to read as follows:
7 U.S.C. 136-136y; 21 U.S.C. 346a.
2. Amend § 158.2100 as follows:
a. Revise paragraph (c)(1).
b. Revise paragraph (c)(2).
The revised text reads as follows:
(c)
(2) Because of the potential for variation in microorganisms, each new isolate of a microbial pesticide is treated as a new active ingredient and must be registered independently of any similarly designated and already registered microbial pesticide active ingredient. Each new isolate for which registration is sought must have a unique identifier following the taxonomic name of the microorganism, and the registration application must be supported by data required in this subpart. This does not preclude the possibility of using data from another isolate, provided sufficient similarity is established, to support registration.
3. Amend § 158.2120 as follows:
a. Revise paragraph (a).
b. Revise paragraph (b).
c. Revise paragraph (c).
d. In paragraph (d), redesignate test notes 1 through 4 as 2 through 5, respectively, and add new test note 1.
The revised and added text reads as follows:
(a)
(b)
(c)
(d) * * *
1. Required for each isolate of a microbial pesticide. New isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated registration(s).
4. Amend § 158.2171 as follows:
a. Revise paragraph (a).
b. Revise paragraph (b).
c. Revise paragraph (c).
d. In paragraph (d), redesignate test notes 3 through 6 as 4 through 7, respectively and add a new test note 3.
The revised and added text reads as follows:
(a)
(b)
(c)
(d) * * *
3. Required for each isolate of a microbial pesticide. New isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated experimental use permit(s).
Environmental Protection Agency (EPA).
Proposed rule; cancellation of notice of public hearing.
This document cancels a public hearing on a proposed rulemaking relating to the State of Oregon's application for final approval of its Underground Storage Tank (UST) Program under Subtitle I of the Resource Conservation and Recovery Act (RCRA). The Environmental Protection Agency did not receive any comments or a request for a public hearing.
The public hearing originally scheduled for April 13, 2011 at 9 a.m. has been cancelled.
Katherine Griffith, U. S. Environmental Protection Agency, Region 10, 1200 Sixth Avenue, Suite 900,
A notice of proposed rulemaking and a notice of public hearing that appeared in the Federal Register on Wednesday, March 2, 2011 (76 FR 11404) announced that a public hearing was scheduled for April 13, 2011, at 9 a.m. at the United States Environmental Protection Agency, 805 SW. Broadway, Suite 500, Portland, Oregon 97205.
The public comment period for the proposed rulemaking expired on April 1, 2011. The notice of proposed rulemaking and notice of public hearing instructed those interested in testifying at the public hearing to submit a request. As of Monday, April 4, 2011, no one has requested to speak. Therefore, the public hearing scheduled for April 13, 2011, is cancelled.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to revise the manner by which the regulated community would apply the threshold planning quantities (TPQs) for those extremely hazardous substances (EHSs) that are non-reactive solid chemicals in solution form. Specifically, facilities with a solid EHS in solution would be subject to the Emergency Planning requirements if the amount of the solid chemical on-site, when multiplied by 0.2, equaled or exceeded the lower published TPQ, based on data that shows less potential for the solid chemical in solution to remain airborne in the event of an accidental release. Previously, EPA assumed that 100% of the chemical could become airborne in the event of an accidental release.
Comments must be submitted on or before June 14, 2011.
Submit your comments, identified by Docket ID No. EPA-HQ-SFUND-2010-0586, by one of the following methods:
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Kathy Franklin, Office of Emergency Management, Mail Code 5104A, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460-0002; telephone number: (202) 564-7987; fax number: (202) 564-2625; e-mail address:
Here are the contents of today's preamble.
Entities that would be affected by this proposed rule are those organizations and facilities subject to section 302 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and its implementing regulations found in 40 CFR part 355, subpart B—Emergency Planning. To determine whether your facility is affected by this action, you should carefully examine the applicability provisions at 40 CFR part 355. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding
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This proposed rule is being issued under the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), which was enacted as Title III of the Superfund Amendments and Reauthorization Act of 1986 (Pub. L. 99-499), (SARA). The Agency relies on EPCRA section 328 for general rulemaking authority.
Title III of SARA (EPCRA) establishes authorities for emergency planning and preparedness, emergency release notification reporting, community right-to-know reporting, and toxic chemical release reporting. It is intended to encourage state and local planning for, and response to releases of, hazardous substances and to provide the public, local governments, fire departments, and other emergency officials with information concerning potential chemical hazards present in their communities. The implementing regulations for emergency planning, emergency release notification and the chemicals subject to these regulations (extremely hazardous substances (EHSs)) are codified in 40 CFR part 355. The implementing regulations for community right-to-know reporting (or hazardous chemical reporting) are codified in 40 CFR part 370.
Subtitle A of EPCRA establishes the framework for local emergency planning. The statute requires that EPA publish a list of EHSs. The EHSs list was established by EPA to identify chemical substances which could cause serious irreversible health effects from accidental releases (52 FR 13378). The Agency was also directed to establish threshold planning quantities (TPQs) for each extremely hazardous substance.
Under EPCRA section 302, a facility which has an EHS in excess of its TPQ on-site must notify the State Emergency Response Commission (SERC) and Local Emergency Planning Committee (LEPC), as well as participate in local emergency planning activities. Under EPCRA section 304, the facility owner or operator must report accidental releases of EHSs and hazardous substances listed under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) listed in 40 CFR 302.4 in excess of the reportable quantity (RQ) to the LEPC and SERC. Under EPCRA section 311 and 312, facilities which have a hazardous chemical defined under the Hazard Communication Standards (HCS) of the Occupational Safety and Health Act (OSHA) at or above 10,000 pounds or an EHS at or above its TPQ or 500 pounds, whichever is lower, are required to submit an Emergency and Hazardous Chemical Inventory form and Material Safety Data Sheet (MSDS) for that chemical to their SERC, LEPC and local fire department.
The purpose of the EHSs list is to focus initial efforts in the development of state and local contingency plans. Inclusion of a chemical on the EHSs list does not mean state or local communities should ban or otherwise restrict use of a listed chemical. Rather, such identification indicates a need for the community to undertake a program to investigate and evaluate the potential for accidental exposure associated with the production, storage or handling of the chemical at a particular site and develop a chemical emergency response plan around those risks.
The list of EHSs and their TPQs are codified in 40 CFR part 355, Appendices A & B. EPA first published the EHSs list and TPQs along with the methodology for determining TPQs as an interim final rule on November 17, 1986 (51 FR 41570). In the final rule of April 22, 1987 (52 FR 13378), EPA made a number of revisions. Among other things, the final rule republished the EHSs list, added four new chemicals and revised the methodology for some TPQs. The final rule also defined TPQs for EHS solids in solution, based on comments on the interim final rule. Details of the methodology used in determining whether to list a substance as an EHS and deriving the TPQs are found in the November 1986 and April 1987
EPA has since amended the EHSs list and deleted 51 chemicals. Ten chemicals were deleted based on the request of petitioners and the remaining 41 chemicals were deleted as a result of Agency review. The chemicals were deleted because they did not meet the toxicity criteria for the list and/or were originally listed in error. Petitions requesting deletion of two chemicals, paraquat dichloride (which is discussed below) and isophorone diisocyante have been denied. Isophorone diisocyanate was not deleted from the EHSs list because its inhalation toxicity met the EHSs listing criteria.
EPA has also changed the TPQs for some of the EHSs. In the April 22, 1987 final rule, EPA reduced the TPQs for 36 substances, while it raised the TPQs for 12 substances based on updated acute toxicity data. Since then, EPA has lowered the TPQ for muscimol because of a typographical error in a prior rulemaking; EPA has raised the TPQ for isophorone diisocyanate because it was mistakenly based on a physical state of reactive solid, when it is actually a liquid; and EPA has denied a petition to raise the TPQs for azinphos methyl and fenamiphos.
After a final rule was published on November 3, 2008 (73 FR 65452) which revised the footnotes to Appendix A and B, EPA found some printing errors in the Appendix A and B tables of the CFR affecting 11 EHS listings. This November 3, 2008 rule did not add, delete or revise any of the EHS names, RQs or TPQs. For the eleven EHSs listings, their RQ and TPQ values are correct, but just appear under the wrong column heading in the table and one EHS chemical name mistakenly appears in CAS No. column. The errors do not appear in the November 3, 2008 FR notice, but only in the 2009 and 2010 versions of the CFR. These errors to the CFR will be corrected in a future effort.
Paraquat dichloride was originally listed as paraquat with a CAS No. 1910-42-5 on the final EHSs list. The lower TPQ was set at 10 pounds for paraquat dichloride with a particle size less than 100 microns in diameter, in molten form or as a solid in solution. The higher TPQ was set at 10,000 pounds for a particle size equal to or greater than 100 microns in diameter. ICI Americas submitted a petition in October 1989 that requested the Agency to remove paraquat from the EHSs list or alternatively, revise the TPQ. The TPQ for paraquat was based on an Immediately Dangerous to Life and Health (IDLH) value of 1.5 milligrams per cubic meter (mg/m
On October 12, 1994 (59 FR 51816), EPA denied the petition to delete paraquat or modify the TPQ, but changed the listed chemical name from paraquat to paraquat dichloride. The oral toxicity for paraquat dichloride met the listing criteria based on the paraquat ion only, but did not meet the listing criteria based on total paraquat dichloride weight. Therefore, EPA changed the basis of the listing from an oral LD
In November 1999, Zeneca (formerly ICI Americas) requested that EPA reconsider either removing paraquat dichloride from the EHSs list or raising its TPQ. Zeneca claimed that the form of the chemical used in inhalation toxicity tests (temporarily atomized powder under laboratory conditions) is not relevant data to use for listing paraquat dichloride. Zeneca believed that it was highly unlikely that inhalable particles or vapors of paraquat dichloride could become airborne during an accidental release. Zeneca did not agree with the rationale EPA used to assign a TPQ of 10 pounds to paraquat dichloride, which is only manufactured, processed and used in solution form. Zeneca claimed that EPA did not explain why a greater potential for airborne dispersion for solids in solution exists as opposed to liquid chemicals.
On October 11, 2000, Syngenta (formerly Zeneca) filed an action in U.S. District Court for the District of Columbia under the Administrative Procedures Act seeking judicial review of EPA's decisions regarding paraquat dichloride. In this complaint, Syngenta requested EPA to either delete paraquat dichloride from the EHSs list or raise its TPQ. On January 23, 2003, EPA filed a Motion for Voluntary Remand in order to reconsider the petition. The court granted EPA's motion and dismissed Syngenta's complaint on January 31, 2003. By order of February 24, 2003, the court denied Syngenta's Motion to Amend Judgment. EPA again reviewed the request to delete paraquat dichloride and/or to raise its TPQ. In a November 21, 2003 letter to the petitioner, EPA reaffirmed its denial to delete paraquat dichloride from the EHSs list. EPA concluded that the acute toxicity of paraquat dichloride meets the criteria for listing it as an EHS chemical. In the same letter to the petitioner, however, EPA agreed to consider a revision to the TPQ for paraquat dichloride in the context of a proposed rule to amend the TPQ for all EHS chemicals handled as solids in solution. This letter is in the docket for today's rulemaking.
The scope of this proposed rule is to revise the manner by which the regulated community would apply the TPQ for EHS chemicals that are handled as solids in solution. There are 157 EHS chemicals that are non-reactive solids at ambient temperature, which could potentially be affected by this change, if they are handled by facilities in a solution form. The affected chemicals are identified in Appendix C in the “Technical Support Document for Revised TPQ Method for Solids in Solution,” which is in the Docket to this rulemaking. These 157 chemicals appear with two TPQs, (the higher TPQ is 10,000 pounds) in Appendix A and B of 40 CFR part 355. However, this change will not apply to the 12 solid EHS chemicals that are reactive solids (noted by footnote “a” in Appendix A and B of 40 CFR part 355). Reactive solids are highly reactive with air or water or are explosive. Because of this, they are more likely than other solids to be dispersed into the air due to the energy or heat created when they react. Other reactive solids form toxic gases when they react with air or water. The explanation for not assigning a 10,000 pound TPQ to each of the reactive solids is discussed in the document, “Reactive Solids Whose Threshold Planning Quantities Should Be Less Than 10,000 Pounds,” April 7, 1987, which can be found in the docket to this rulemaking.
Additionally, the proposed methodology of applying TPQs for solids in solution does not affect the reporting requirements for Sections 311 and 312 of EPCRA (40 CFR part 370). Specifically, emergency planning notification under Section 302 helps LEPCs identify those facilities whose accidental releases pose risks to the surrounding community so they can develop emergency plans that identify the location and number of affected populations, evacuation or shelter-in-place procedures, etc. On the other hand, Sections 311 and 312 require submission of MSDSs and an on-site inventory of hazardous chemicals to help emergency responders assess how to respond to an emergency release or fire. Responders need the amounts, manner of storage and locations of the chemical on-site, not only the amount released off-site. They need information on the chemical and physical properties, hazard ratings, toxicity information and incompatibilities of the chemical, as well as measures needed to contain the spill or fire at the facility. They need to know what type of protective equipment is needed to protect them from exposure, not only airborne, but dermal.
Solid EHSs (except reactive solids) have a 10,000 pound TPQ or a specified lower TPQ for certain forms. For purposes of complying with the emergency planning notification requirements of Section 302 of EPCRA, EPA is proposing that facilities multiply the amount of EHS chemical handled as a solid in solution on-site by 0.2 and then determine if this amount equals or exceeds the established lower TPQ. If the amount of the solid EHS in solution on-site multiplied by 0.2 does not equal or exceed the lower TPQ for that solid EHS, then the facility is not subject to the EPCRA Section 302 emergency planning notification requirements for that substance. This amount includes only the weight of the chemical and not the solvent or other chemicals in solution. The amount of solid in solution may be determined by multiplying the weight percent of the solid in solution in a particular container by the weight of the solution. Solutions include aqueous or organic solutions, slurries, viscous solutions, suspensions, emulsions, and pastes. The revised TPQ methodology for solids in solution is similar to the use of the TPQ for EHS chemicals that are molten solids.
The emergency release notification requirements under EPCRA Section 304 are not affected by this proposal. Section 304 requires facilities to notify the community emergency coordinator for the LEPC of any area likely to be affected by the release and the SERC of any area likely to be affected by the release (defined in 40 CFR 355.42) at or above the reportable quantity (RQ) of
As an example, a facility has 4,000 pounds of a solution of 37% by weight paraquat dichloride on-site. Therefore, this solution contains 1,480 pounds of paraquat dichloride (0.37 × 4,000 pounds). The facility would multiply 1,480 pounds by 0.2 which equals 296 pounds. This amount is then compared to the TPQ for paraquat dichloride, which is 10 pounds. Because this amount exceeds the 10 pound TPQ, the facility is required to comply with the emergency notification requirements of Section 302 of EPCRA. As another example, a facility has 10 gallons of a solution of 37% by weight paraquat dichloride on-site. The density of the solution is 9.33 pounds per gallon. Therefore, this solution contains 34.5 pounds of paraquat dichloride (10 gal × 9.33 lb/gal × 0.37). The facility would multiply 34.5 pounds by 0.2 which equals 6.9 pounds. This amount is then compared to the TPQ for paraquat dichloride, which is 10 pounds. Because this amount is less than the 10 pound TPQ, the facility is not required to comply with the emergency notification requirements of Section 302 of EPCRA.
Facilities that handle both the powdered and solution forms of a particular solid EHS will have to consider the quantities of each form and the particle size to determine whether they exceed a TPQ. Below are several examples of how to apply the revised TPQ methods in various cases.
EPA is proposing this change based on data in the literature that shows the original assumption of 100% potential airborne release for solids in solution is inappropriate because it appears to overestimate the amount of chemical that would remain airborne after release. Review of the literature for accidental releases of liquid aerosols suggests a new methodology for applying the TPQs for solids in solution is warranted. The data shows that no more than 20% of the release is expected to remain airborne. More detailed discussion can be found in Section II.B.4.a of this preamble and in the technical support document in the docket to this proposed rule.
EPA's revised TPQ methodology for EHS solids in solution and supporting data was peer reviewed and the technical support document was revised based on peer review comments. The results of the peer review and response to peer review comments are found in a separate document, “Peer Review of Technical Support Document for Revised TPQ Method for EHS Solids in Solution,” which is available in the docket to this rulemaking. A summary of the peer reviewer's comments and EPA responses to them are presented in Section II.D of this preamble.
The TPQs were initially assigned based on a ranking scheme using a Level of Concern (LOC) based on acute toxicity and the potential for airborne dispersion. The TPQ methodology is described in detail in the “Threshold Planning Quantities Technical Support Document” dated April 7, 1987, which can be found in the docket for this rulemaking. For each chemical, a ranking index was calculated which equaled the LOC divided by an air dispersion factor (V). For gases, V = 1, while for liquids, V was based on a volatilization model using the molecular weight and boiling point of the chemical.
Solid EHS chemicals with a particle size less than 100 microns in diameter, molten solids, solids in solution, and solids with a National Fire Protection Association (NFPA) reactivity rating of 2, 3, or 4 were assigned a V equal to 1. If the EHS solid does not have a particle size less than 100 microns, is not molten or handled in solution form, and does not have an NFPA reactivity rating of 2, 3, or 4, then the EHS chemical was assigned a TPQ of 10,000 pounds, which corresponds to the highest index value. Solids with an NFPA reactivity rating of 2, 3, or 4 are noted with footnote “b” in the EHSs list.
Between one and 10,000 pounds, chemicals were assigned to the intermediate TPQ categories of 10, 100, 500 or 1,000 pounds based on the order of magnitude ranges of the index values. Also, for solids in molten form, before applying the TPQ, the amount of chemical on-site at any time is multiplied by an adjustment factor of 0.3 to conservatively account for the maximum volatilization of the spilled molten substance that is likely to take place.
In their complaint, Syngenta did not agree with EPA's rationale to assign a lower TPQ of 10 pounds to paraquat dichloride, which is only manufactured, processed and used in solution form. Syngenta claimed that EPA did not explain why it assumed a greater potential for airborne dispersion for solids in solution as opposed to liquid chemicals. In addition, Syngenta argued that Paraquat Dichloride solution is basically a non-volatile salt dissolved in water, and that the physical and chemical characteristics of many solids like paraquat dichloride limit their capacity to become airborne. Pure paraquat dichloride has a very low vapor pressure and decomposes at about 340° Celsius (C) before it reaches a boiling point. Syngenta further argued that using a liquid volatilization model to set a TPQ for paraquat dichloride is inappropriate.
In discussions with EPA, Syngenta also raised the issue of aerosol size as a factor to be considered in developing the TPQ methodology for EHS solids in solution.
In the April 7, 1987 “Threshold Planning Quantities Technical Support Document” (page 27), EPA noted that “solids may also be handled in solution and molten form and could potentially follow a liquid release scenario. However, even at molten temperatures, significant amounts of vapor are not likely to be generated.” On page 24 of the same technical support document, when discussing liquid releases, EPA assumed that a spill of a liquid could occur as a result of an accidental situation that involves heat (e.g. fire, exothermic runaway reaction, or reactions with air or water).
More specifically, when a solid chemical is in solution form, the solution can behave like a liquid during an accidental release and be dispersed into the air due to overheating, overpressure or anything that can cause a loss of containment from a vessel or piece of equipment. An accident involving a release of energy could create a liquid aerosol type of release into the air. Such liquid aerosol droplets, if small enough, can be dispersed into the air and remain airborne beyond the facility boundary, resulting in EHS exposure to the surrounding community. Environmental conditions and the properties of the specific chemical will dictate the behavior and dispersion of the chemical after a release or spill has occurred. For example, the solvent can evaporate from solution (especially at higher temperature) and small particulates of solid remaining after evaporation of the solvent can potentially be carried off-site. EPA recognized that the solid EHS (dissolved or suspended in a liquid solution) will not be dispersed into the air based on volatilization of the solid, but because of the energy released from the accident, or by wind.
At the time of the April 1987 rulemaking, EPA did not have sufficient information to determine how much of the solid EHS in solution could be dispersed airborne off-site and conservatively used V=1 for this release scenario. Furthermore, although paraquat dichloride decomposes at a temperature of 340° C (644° Fahrenheit, F), EPA believed that accidents involving aerosol releases of paraquat dichloride solution could potentially occur at temperatures less than 340° C. Boiling solutions containing non-volatile solids result in vaporization of the solvent, but not the solid. However, the turbulence of boiling the solution can entrain liquid aerosol droplets containing the solid into the air.
Based on more recent information, EPA has re-evaluated the assumption of 100% airborne releases when setting the TPQ for solids in solution, not just for paraquat dichloride solution, but for all EHS solids in solution, except for the 12 solid EHS chemicals that are reactive solids.
EPA reviewed data in the literature on releases of aerosols to evaluate their potential use for revising the application of the TPQs for EHS solids in solution. EPA was specifically looking for data on how much of a solution containing a dissolved or suspended solid would remain airborne after an accidental release. One problem encountered in reviewing the literature was some studies only involved chemicals that are pure liquids and which have vapor pressures much higher than solid chemicals. That data would likely not represent the release and dispersion of a solid chemical that normally has a very low vapor pressure. However, the U.S. Department of Energy (USDOE) used experimental liquid aerosol release data involving metal salt solutions to estimate the Airborne Release Fraction (ARF) of metal salt solutions for a wide variety of release scenarios. This information was collected in a 1994 report, which is available in the docket to this rulemaking.
Using the highest airborne release fraction rather than an average result of the scenarios is consistent with the intent of the emergency planning program to plan for a reasonable worst case scenario. This data is a good surrogate to use to predict the maximum potential aerosol release fraction of EHS solids in solution in the event of an accidental release. Water is probably the most common solvent that would be used with most of the EHS solids, whether they are dissolved, suspended or emulsified in water. Many of the EHS solids are pesticides and pesticides are commonly applied as water solutions or emulsions.
EPA also looked at experimental data collected by the Center for Chemical Process Safety (CCPS) for aerosol releases of water and cyclohexane. CCPS, a directorate of the American Institute of Chemical Engineers (AICHE), was established in 1985 to develop and disseminate technical information for use in the prevention of major chemical process incidents. CCPS develops and publishes guidelines, conducts seminars, symposia, training programs and meetings on chemical process-safety matters; CCPS also cooperates with other organizations, both internationally and domestically, to promote process safety. CCPS's activities are supported by funding and expertise from over 100 entities including, industry, consulting firms and governmental organizations. USEPA is a member of this organization.
In 1989, the CCPS Vapor Cloud Modeling Subcommittee began an “Aerosol Project” to meet some of the research objectives proposed to the U.S. National Vapor Cloud Research Committee, which included developing a superheated liquid release model and developing experimental data to validate the model. The experimental field data was the result of field controlled-release experimentation by CCPS with financial assistance by special grants from some of the CCPS sponsors and from the USEPA and USDOE. The experimental superheated liquid release data was developed, documented, peer reviewed and, where necessary, corrected. The Vapor Cloud Modeling Subcommittee contracted a review of the fundamental basis for the RELEASE model and to make model improvements to reconcile the cyclohexane, chlorine and methylamine test data. The results of the model development and the experimental field data used was published in 1999 in a CCPS concept book “RELEASE: A Model with Data to Predict Aerosol Rainout in Accidental Releases” by David W. Johnson and John L. Woodward.
EPA did not use the aerosol release fraction from the CCPS data because these liquids did not contain any solid material in solution. Specifically, the reported airborne release fraction for water varied from 0.03 to 0.54 and for cyclohexane varied from 0.36 to 0.94. Cyclohexane with a vapor pressure of 95 millimeters (mm) mercury (Hg) is more volatile than water with its vapor pressure of 24 mm Hg. It is not a good comparison to use aerosol release fractions of volatile liquids to estimate the aerosol release fractions of a solid in solution because solids generally are not very volatile. The water aerosol data might be a close surrogate for estimating a release of an aqueous solution of the solid, but it does not have the important constituent of a dissolved solid, which might influence the amount of aerosol remaining entrained in the air. However, the CCPS data for water supports EPA's belief that assuming a 100% airborne liquid aerosol release is inappropriate because the water aerosol fractions measured in the experiments were less than one. CCPS also had experimental release data for CFC-11 and chlorine (both gases) and methylamine (a highly volatile chemical with a vapor pressure of 300 mg Hg), but EPA did not consider this data for use as a good analogy because of their high volatility and they did not contain any solids.
USDOE was interested in applying the experimental aerosol release data to estimate airborne fractions of liquid aerosol releases that were below respirable size, which they defined as particles of 10 micron Aerodynamic Equivalent Diameter (AED) or less. By USDOE's definition, respirable size particles are those that can be transported through the air and inhaled into the human respiratory system.
For purposes of establishing TPQs, EPA chose a distance of 100 meters (330 feet) to represent the distance from a source inside a chemical facility to the point where the community might be exposed. This decision was based on data indicating that a particle size greater than 100 microns is not likely to be deposited more than 100 meters from the source (“Threshold Planning Quantities Technical Support Document,” USEPA April 7, 1987, Public Docket 300PQ, Document No. 300PQ-2-21). The 100-micron cutoff is also consistent with CERCLA regulations (for reportable quantities) which also uses a 100 micron particle size for powdered materials.
Most of the USDOE experimental aerosol release data had median aerosol diameters of less than 100 microns. This size is consistent with what EPA believes is the size of aerosols to which the community could be exposed. On the other hand, the water and cyclohexane aerosol release data compiled by CCPS had much larger mean aerosol diameter sizes, generally over 100 microns. For the reasons already discussed and because it is likely that aerosol releases with diameters larger than 100 microns will fall out of the air before they reach a community, the water and cylcohexane aerosol release fractions were not used in determining the TPQs for solids in solution.
Pure EHS liquids could also be released accidentally as aerosols via the same catastrophic scenarios (overpressure, superheating). It could be argued that perhaps the TPQ method for solids in solution could also apply to liquids. However, this goes against the ranking used for setting TPQs based on the extent of airborne releases by physical state as being high for gases, less for liquids and even less for solids in solution. Currently, the release scenario used for developing the liquid TPQs considers a spill of the liquid due to a loss of containment. The liquid then escapes into the air by volatilization. An airborne release of solids in solution will require more than a failure of containment to have appreciable airborne dispersion. An energy source, such as overpressure or high temperature would be required to disperse the solution into the air and create aerosol droplets. Not all of the droplets will stay airborne (unlike volatilized vapors) and affect the community, whose exposure depends on droplet size and distance from the facility fence line.
If one assumes that there is an equal potential for airborne releases for gases, liquids, small particulate solids and solids in solution, then the TPQ ranking scheme would change radically and rely
As a hypothetical scenario, EPA determined if the current TPQ method for liquids gives more conservative (or at least as conservative) TPQs (lower thresholds) as compared to the proposed TPQ methodology for solids in solution. To do this, EPA estimated the TPQs for liquids by assuming that V = 1, and then divided it by 0.2 (based on an expected 20% maximum airborne dispersion) to determine the amount of EHS on-site that would trigger emergency planning notification. These amounts or “effective TPQs” were then compared to the current listed TPQs for liquids. For 116 of the 163 EHS liquids, the current TPQs for liquids based on volatilization were equal to or lower than the new effective TPQs based on aerosolization. Most of the other 47 liquids had current TPQs that were about twice the effective TPQ. This comparison with a table of results for the EHS liquids is discussed in the technical support document for this rulemaking. Based on this analysis, EPA believes that using the volatilization model to establish V for liquid TPQs is still appropriate. The spilled liquid using a boiling point scenario is probably the most prevalent worst-case scenario that is reasonable to use for establishing TPQs for liquids.
Further examination of the 47 liquid chemicals was undertaken to see why these had TPQs greater than the effective TPQs—that is, about twice the effective TPQ. Many of these liquids had effective TPQ values of 5, 50 and 5,000 pounds. However, there are no TPQs of 5, 50 or 5,000 pounds. Rather, the use of order of magnitude index ranges assigned to various TPQ levels resulted in assigned TPQ values of 1, 10, 100, 500, 1,000 and 10,000 pounds. Thus, where the effective TPQs are either 5, 50, or 5,000 pounds, the comparison of a current TPQ versus an effective TPQ may not be valid. More discussion on this can be found in the technical support document.
Given the data in the literature available on aerosol releases of solids in solution, EPA considered various alternative approaches. One alternative was using an index ranking method with an assigned V similar to the original method of assigning TPQs. Another alternative was to apply the ARF to the existing lower TPQ for solids to develop a new TPQ for solids in solution for each solid EHS. A third alternative was similar to the approach of multiplying the maximum ARF by the amount on-site, except that the ARF would only represent aerosol sizes less than respirable size. Below we discuss these alternatives, as well as the basis for not selecting them.
This alternative would establish TPQs using a ranking approach based on each chemical's physical state, acute toxicity and, the potential for the chemical to become airborne (V). For this alternative, V would be set to 0.2 for EHS solids in solution.
For the original development of the TPQs, the ranking index was defined as the LOC divided by V, where V was set equal to 1 for gases and solids in powder form with a particle size less than 100 microns, molten solids and solids in solution. For liquid EHSs, V (the potential to become airborne) depended upon the property of volatility (evaporation of liquid into the gas phase). In the development of V for use in setting TPQs for liquids, V represented the mass per time evolved to the air per mass of the spill. This is explained in further detail in the April 1987 “Threshold Planning Quantities Technical Support Document” available in the docket.
Most of the values for V for liquids are approximately 0.1 (see Appendix B in the “Technical Support Document for Revising TPQ Method for Solids in Solution” for this rule). Using a higher V equal to 0.2 for solids in solution implies that in the event of an accidental release, more of the solution would become airborne than if it were volatilized from a liquid spill. Even if a liquid were accidentally released via aerosol form, the volatility of the liquid chemical will increase the fraction that remains dispersed in the air. Therefore, it would not be a fair representation to have a solid in solution with a V higher than that used for a volatile liquid. Also, because there are different mechanisms involved in the two types of releases, it may not be comparable to use the 0.2 as a substitute for V for solids in solution.
Another alternative is to apply the ARF to the existing lower TPQ for solids to develop a new TPQ. For example, the lower TPQ for paraquat dichloride is 10 pounds. Dividing 10 pounds by 0.2, the maximum expected aerosol release fraction for a solution would result in a new TPQ of 50 pounds for paraquat dichloride in solution form. For each of the 157 non-reactive solids on the EHSs list, a new TPQ for the solution form of the EHS solid could be determined and listed. However, for each solid non-reactive chemical, there are already two TPQs, one developed based on the ranking index methodology of (Index = Level of Concern/V) and one based on the default TPQ of 10,000 pounds for non-molten, non-reactive, non-solution solids with a particle size equal to or greater than 100 microns. Including a third set of TPQs for EHS solids in solution could be confusing to the regulated community. Thus, EPA believes that using the existing lower TPQ for solids and comparing that to the product of the amount on-site multiplied by 0.2 is a better approach, and similar to the approach used for the molten solids form.
Another approach considered is similar to the proposed approach of multiplying the maximum ARF by the amount on-site, except that the ARF would only represent the fraction of aerosols with particles less than respirable size. Through discussions with the petitioner and EPA's November 2003 response to the petition, EPA has considered whether aerosol size should be used as a factor in developing new TPQs for solids in solution. A consultant for Syngenta believes that EPA should only consider the dispersion of aerosols with particle sizes less than or equal to 4 microns because these smaller aerosols are the size that can enter the lung and because the inhalation toxicity tests used for the basis of the EHSs listing only used very small particles.
This approach would require sufficient data on the aerosol size distribution for each release scenario to develop a new ARF that would include only aerosols of 4 microns and lower. The ARFs currently cited for the scenarios used for the preferred approach include aerosol sizes of 100 microns and lower. For some of the USDOE accident scenarios, it is possible to recalculate the airborne aerosol fractions using the raw experimental data to include only aerosols less than or equal to 4 microns in diameter. This results in smaller airborne release fractions.
EPA does not believe this approach should be used for a number of reasons, including:
• Inhalation toxicity tests are designed to use small particles to ensure that the lung is exposed. However, EPA is not using the inhalation toxicity for risk assessment, but only as a screening tool.
• Although the EHSs listing for paraquat dichloride is based on inhalation toxicity, EPA also has concerns regarding dermal and ingestion exposure via swallowing for the larger aerosols.
• Solvent evaporation from larger aerosols can also create smaller aerosols which can enter the lung.
Aerosols may be defined as a suspension of solid or liquid particles in air. Inhalation acute toxicity tests are purposely designed with very small diameter particles in order to ensure that particles are small enough to enter the rodent's lungs and test the toxicity in the lungs. Larger particles may not enter deep areas of the lungs and thus, test results may be misinterpreted if little inhalation toxicity is shown. EPA is not attempting to use the airborne aerosol fraction for purposes of risk assessment, but only as a tool to set screening levels for the amount of chemicals on-site which may potentially cause harm if accidentally released. Also, the size of the aerosols used in an animal laboratory test cannot be assumed to be the same as those that people may be exposed to during an accidental release.
Inhalable size particles enter the respiratory tract, including the head airways and are generally equal to or less than 100 microns. Thoracic size particles (generally equal to or less than 10 microns) travel past the larynx and reach the lung airways and the gas-exchange regions of the lung. Respirable size particles (generally less than or equal to 4 microns) are a subset of thoracic particles that are more likely to reach the gas-exchange region of the lung.
Most particles that enter the upper airways are trapped in mucous that moves to the throat and is swallowed within a few hours. Thus, instead of inhalation exposure deep in the lungs, exposure to larger particles of chemicals may occur through dermal exposure to mucous membranes or ingestion exposure through swallowing. Emergency planning for EHS chemicals is not limited to inhalation exposure only, although many of the EHS chemical listings are based on studies which meet the EHSs listing criteria for inhalation toxicity. Although airborne exposure is the most likely route of exposure, it is not the only route of exposure. In the event of an accidental release, EPA is concerned about all routes of exposure (inhalation, dermal and ingestion) to the community. Thus, exposure to larger size aerosols (e.g. those above 4 or 10 microns) by any route, such as through the skin or mucous membranes) should not be ignored when setting TPQs.
Even after liquid aerosol droplets are released, some of the solvent may evaporate in the air. This would result in even smaller size aerosols or solid EHS particulates in the air to which a community would be exposed. One concern is that droplets of size greater than 100 microns could settle quickly, dry into a smaller particle size and then become airborne again (re-suspension). In the event of an accidental release, the responsible party should clean up chemicals deposited on the facility grounds before additional exposure to the community would take place. The USDOE report did include data on re-suspension of particulates from soil after an aerosol release. However, the amount re-suspended did not add much to the reasonable worst case aerosol release fraction of 0.2. This scenario is explained further in the technical support document for this rule.
EPA's revised TPQ methodology for EHS solids in solution and supporting data was peer reviewed and the technical support document was revised based on the peer review comments. The description of the peer review process, the results of the peer review and EPA's response to the peer review comments are found in a separate document, “Peer Review of Technical Support Document for Revised TPQ Method for EHS Solids in Solution,” which is available in the docket to this rulemaking. Below are the questions posed to the peer reviewers, a summary of the peer reviewers' comments and EPA's responses.
Two of the three reviewers agreed that the revised TPQ method was logical with a sound scientific basis using the USDOE experimental aerosol release data. However, one reviewer thought the revised TPQ method may not be based on the most sound science because the LOC is based on Immediately Dangerous to Health and Life values (IDLH) and animal lethality data that he believes may not be appropriate. Nonetheless, this reviewer did think that a cursory review of the effective TPQ list (Appendix B in technical support document) appears to have appropriately listed the ranking of chemicals by potential hazard to the public.
EPA recognizes that use of the IDLH was an imperfect measure for determining the LOC, but believes the approach provides a consistent relative ranking of the EHS. Where animal lethality data were substituted, safety factors were applied to the data to estimate the LOC. Human data were taken into account for some chemicals, such as chemical warfare agents, and adjustments were made to the TPQ initially based on index values. EPA realizes that better data are being developed that could be used for the LOC (such as AEGLs—Acute Exposure Guideline Levels). However, a re-evaluation of the LOC for all EHS chemicals would best be undertaken by a separate rulemaking effort, given the extent and complexity of this issue.
Two of the three reviewers thought that the revised method was not clear and understandable and suggested improvements. For example, it was recommended that EPA clarify the definition of a solution, as well as include a flowchart of the method or a graph to help describe the approach.
EPA agrees that improvements were needed in order to present the information in a better way for the regulated community to understand and apply, and the revised technical support document addresses those concerns. Thus, additional supporting background information, discussion about the development of TPQs, and examples and calculations of how to apply the TPQs for EHS solids in solution have been added to the technical support document and has been further
One reviewer thought that EPA had provided the right amount of detail, and thought the method is understandable, and the text is for the most part readable. However, the reviewer had several clarifications and corrections he thought EPA should make. These clarifications have been made to the technical support document, including improving a description of background on TPQ development, clarifying some terms used in the document, and adding some references and other editorial comments.
This same reviewer thought the argument against the alternative approach of using V=0.2 for developing TPQ for solids in solutions was not that convincing. EPA has revised the discussion of this alternative approach by stating that EPA believes that this approach would result in TPQs that would be too low as compared to TPQs for liquids of similar toxicity because most of the liquids have approximately V=0.1. EPA believes that liquids have a higher potential for airborne dispersion because of their inherently higher volatility. Also, the mechanism for airborne dispersion for liquids using the spill model is volatilization, whereas solids in solution will be dispersed via aerosolization, so using V=0.2 for solutions may be not comparable.
All three reviewers thought that the revised method was fairly consistent with the approach used for setting other TPQs. However, one reviewer thought that EPA should consider lowering the TPQs for 46 of 163 EHS liquids based on the comparison of using the revised TPQ method versus the current method. EPA believes that using a V of 0.2 to recalculate the TPQ indexes would result in conservatively low TPQs for solids in solution as compared to liquids of the same toxicity. Given that volatilization requires only the loss of containment of a chemical, whereas aerosolization requires the loss of containment and usually an energy release, EPA believes the higher potential for airborne dispersion should be assigned to liquids as compared to a non-volatile solid in solution. Because there are different mechanisms (volatilization versus aerosolization) involved in the two types of releases, it may not be comparable to use 0.2 as a substitute for V for solids in solution. Based on the comments, EPA has revised the discussion in the preamble to the rule and Section VI.A—Use Original Ranking Method to Develop New TPQs of the document, “Technical Support Document for Revised TPQ Method for EHS Solids in Solution.” EPA has also provided a more logical and clearer explanation for TPQs for different forms in Appendix A: Assigning Threshold Planning Quantities (TPQs) for Extremely Hazardous Substances, in the above document.
The reviewers all agreed that the method was sufficiently conservative to fulfill the accident prevention purposes of section 302 of EPCRA.
One reviewer thought that the revised method is not particularly straightforward and uncomplicated and that the regulated community will have difficulty understanding and applying it. Another reviewer suggested that examples be provided of how to apply the method when both powdered and solution form of a solid EHS is on-site. One reviewer thought a flow chart might be helpful to summarize the TPQ approach for the full spectrum of chemical forms.
To address these concerns, EPA has provided in the technical support document and the preamble to the proposed rule, a number of examples of how to apply the new TPQ method for solids in solution.
The reviewers were not able to provide any other approaches or data that should be used to revise the TPQ method for solids in solution, although one did provide other recommendations regarding the EHS chemical listing process and the toxicity values used for TPQs. Some of these comments address issues that are outside the scope of the current effort, which focuses only on TPQs for solids in solution.
To address other comments and concerns of the reviewers, EPA has clarified that the 12 reactive EHS solids are not subject to the revised TPQ method for solids in solution. EPA has also added several technical references as suggested into the technical support document.
Currently, facilities, who have an EHS present in an amount equal to or greater than the EHS's TPQ, are required to:
• Notify the SERC and LEPC that the facility is subject to emergency planning notification.
• Notify the SERC and LEPC of a facility representative to participate in the local emergency planning process.
• Notify the LEPC of any relevant facility changes that affect emergency planning.
• Provide the LEPC with the necessary information for developing a local emergency plan, as requested.
For facilities with an EHS that exists as solids in solution, emergency planning notification is required if the amount of solids by weight meets or exceeds the lower published TPQ for that chemical. Solid EHSs have another higher TPQ of 10,000 pounds that applies only if the EHS is not in solution, has a particle size equal to or greater than 100 microns, is not molten and does not have an NFPA reactivity rating of 2, 3, or 4.
The proposed rule would subject facilities with an EHS solid in solution to the emergency planning requirements if the amount of solid chemical on-site, when multiplied by 0.2, equals or exceeds the lower published TPQ. The effect would be to allow facilities to have up to five times larger amounts of EHS solids in solution on-site than before without being subject to the above emergency planning requirements.
Facilities who already had EHS solids in solution on-site above the TPQ and who have already (or should have already) completed emergency planning notification should notify their LEPC if they no longer exceed the TPQ as a result of this rulemaking. Section 303(d)(2) of EPCRA requires facilities to promptly provide to their LEPC any changes relevant to emergency planning. Regulations at 40 CFR 355.21 clarify that relevant changes to emergency planning should be reported within 30 days. EPA expects that this notification will be a minimal burden.
EPA believes that the changes proposed by this rule can benefit SERCs and LEPCs to better focus their limited resources on those amounts of EHS chemicals that will potentially cause the greatest harm and to spend fewer resources on those that pose less harm, when released. The EHSs list has a total of 355 chemicals, of which 157 are non-reactive solids. This proposed rule applies only to those 157 non-reactive solids and only when they exist in solution form. While the Agency does not collect information to quantify the number of facilities that may be impacted by this rule, we suspect it will likely be a minimal number of facilities that are impacted since we believe that many of these facilities handle other EHS chemicals that will trigger the emergency planning requirements. However, the Agency solicits comment and data on the number of facilities that may be impacted, and the extent of the impact.
Under Executive Order 12866
The proposed regulation will not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities.
This proposed rule does not impose any new information collection burden. Rather, this proposed rule, in effect, raises the amount of chemical on-site required before triggering emergency planning reporting under 40 CFR part 355 for EHS non-reactive solids in solution. Facilities with this form of EHS chemical would have already (or should have already) reported their presence to their SERC and LEPC and identified a Facility Emergency Coordinator and necessary information for development of a local emergency plan to their LEPC. If as a result of this rulemaking, facilities find that they have an EHS solid in solution on-site which no longer equals or exceeds the TPQ, the facility should notify their LEPC. Section 303(d)(2) of EPCRA requires facilities to promptly provide to their LEPC any changes relevant to emergency planning. Regulations at 40 CFR 355.21 clarify that relevant changes to emergency planning should be reported within 30 days. EPA expects that this notification will be a minimal burden. The emergency planning notification requirement is not required annually. There may be a slight burden reduction for facilities who are reporting EHS non-reactive solids in solution for the first time under the Section 302 requirements.
The Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations at 40 CFR part 355 under the provisions of the
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of today's proposed rule on small entities, small entity is defined as: (1) A small business
After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 USC 603 and 604. Thus, 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, or otherwise has a positive economic effect on all of the small entities subject to the rule.
This proposed rule changes the manner by which facilities apply the TPQs for those EHSs that are solid chemicals in solution form. Specifically, facilities with a non-reactive solid EHS in solution would be subject to the Emergency Planning requirements of 40 CFR part 355, subpart B—Emergency Planning only if the amount of non-reactive EHS solids in solution on-site, multiplied by 0.2 equals or exceeds the lower published TPQ. We have therefore concluded that today's proposed rule will relieve regulatory burden for some affected small entities. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.
This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1532-1538 for state, local, or tribal governments or the private sector. This proposed rule does not impose any new requirements on state, local or tribal governments. Facilities currently with EHS non-reactive solids in solution on-site have already (or should have already) reported these chemicals to their SERC and LEPC and identified a
This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This proposed action does not impose any new requirements on state, local or tribal governments.
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, as specified in Executive Order 13132.
This proposed rule would reduce the reporting burden on any facilities that would have an EHS non-reactive solid in solution on-site for the first time and could be subject to the emergency planning requirements for that chemical under 40 CFR part 355, subpart B—Emergency Planning. We also expect that this proposed action will neither increase nor decrease the requirements for SERCs or LEPCs. This rule does not impose any requirements on state or local governments. Thus, Executive Order 13132 does not apply to this action.
In the spirit of Executive Order 13132 and consistent with EPA policy to promote communications between EPA and state and local governments, EPA specifically solicits comment on this proposed action from state and local officials.
This action does not have tribal implications, as specified in Executive Order 13175, (65 FR 67249, November 9, 2000). This proposed rule would reduce reporting burden on any facilities that would have an EHS non-reactive solid in solution on-site for the first time and could be subject to the emergency planning requirements for that chemical under 40 CFR part 355, subpart B—Emergency Planning. This action also does not impose any new requirements on tribal governments. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in Executive Order 12866 and because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This proposed rule would reduce reporting burden on any facilities that would have an EHS non-reactive solid in solution on-site for the first time and could be subject to the emergency planning requirements for that chemical under 40 CFR part 355, subpart B—Emergency Planning.
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Rather, this proposed rule would reduce reporting burden on any facilities that would have an EHS non-reactive solid in solution on-site for the first time and could be subject to the emergency planning requirements for that chemical under 40 CFR part 355, subpart B—Emergency Planning.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or would otherwise be impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations of when the Agency decides not to use available and applicable voluntary consensus standards.
This proposed rule does not involve technical standards. Therefore, EPA does not consider the use of any voluntary consensus standards.
Executive Order (EO) 12898 (59 FR 7629 (February 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this proposed rule does not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. That is, based on new information and data, the Agency believes that amounts of EHS non-reactive solids in solution that would remain airborne from a potential release into the environment from an accident would be lower than previously considered, and thus, would have less impact on the local community. This in turn will allow SERCs and LEPCs to better focus their limited resources on the amounts of EHS chemicals that will potentially cause the greatest harm, including those affecting minority or low-income populations and to spend fewer resources on those that pose less harm, when released.
Environmental protection, Air pollution control, Chemicals, Disaster assistance, Hazardous substances, Hazardous waste, Intergovernmental relations, Natural resources, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be amended as follows:
1. The authority citation for part 355 continues to read as follows:
Sections 302, 303, 304, 325, 327, 328, and 329 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) (42 U.S.C. 11002, 11003, 11004, 11045, 11047, 11048, and 11049).
2. Section 355.16 is amended by revising paragraph (b) to read as follows:
(b)
3. Section 355.61 is amended by adding in alphabetical order the definition of “Solution” to read as follows:
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would revise the regulations implementing Medicaid home and community-based services (HCBS) waivers under section 1915(c) of the Social Security Act by providing States the option to combine the existing three waiver targeting groups as identified in § 441.301. In addition, we are proposing other changes to the HCBS waiver provisions to convey expectations regarding person-centered plans of care, to provide characteristics of settings that are not home and community-based, to clarify the timing of amendments and public input requirements when States propose modifications to HCBS waiver programs and service rates, and to describe the additional strategies available to CMS to ensure State compliance with the statutory provisions of section 1915(c) of the Act.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 14, 2011.
In commenting, please refer to file code CMS-22296-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
Kathryn Poisal, (410) 786-5940.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
Section 1915(c) of the Social Security Act (the Act) authorizes the Secretary of Health and Human Services to waive certain Medicaid statutory requirements so that a State may offer Home and Community-Based Services (HCBS) to State-specified group(s) of Medicaid beneficiaries who otherwise would require services at an institutional level of care. This provision was added to the Act by the Omnibus Budget and Reconciliation Act of 1981 (Pub. L. 97-35, enacted August 13, 1981) (OBRA'81) (with a number of subsequent amendments). Regulations were published to effectuate this statutory provision, with final regulations issued on July 25, 1994 (59 FR 37719). In the June 22, 2009
Along with our overarching interest in making improvements to the Medicaid HCBS program, we seek to ensure that Medicaid is providing needed strategies for States in their efforts to meet their obligations under the Americans with Disabilities Act (ADA) and Supreme Court's decision in
We believe that these proposed changes will have numerous benefits for individuals and States alike. In addition to providing clarity around individual and stakeholder input, these proposed changes will move the system forward by enabling services to be planned and delivered in a manner driven by individual needs rather than diagnosis. These changes will enable States to realize administrative and program design simplification, as well as improve efficiency of operation. The changes related to clarification of HCBS settings will support the use of waiver authority to maximize the opportunities for waiver participants to have access to the benefits of community living and the opportunity to receive services in the most integrated setting appropriate.
Under section 1915(c) of the Act, the Secretary is authorized to waive section 1902(a)(10)(B) of the Act, allowing States not to apply comparability requirements and target an HCBS waiver program to a specified Medicaid-eligible group or sub-group of individuals who would otherwise require institutional care. A single section 1915(c) waiver may, under current regulation, serve one of the three target groups identified in § 441.301(b)(6). As provided in the rule, these three target groups are: “Aged or disabled, or both; Mentally retarded or developmentally disabled, or both; and Mentally ill.
Through the ANPRM, we proposed to initiate rulemaking to allow States the flexibility to combine any or all of the three target groups in one HCBS waiver (74 FR 29453). We sought public comments on how we may establish criteria related to the removal of an existing regulatory barrier that currently prevents States from designing cross-disability section 1915(c) HCBS waiver programs. The comments provided on this provision were largely positive, advising CMS to consider carefully quality elements and protections needed to ensure that all target groups are protected sufficiently in such a structure. Through this proposed rule, we include expectations that each individual within the waiver, regardless of target group, has equal access to the services necessary to meet their unique needs.
Through the ANPRM, we also sought public input on strategies to define home and community-based settings where waiver participants may receive services. Additionally, the request for input was in response to isolated situations that have emerged where States or other stakeholders are expressing interest in using HCBS waivers to serve individuals in segregated settings or settings with a strong institutional nature. For example, some proposed settings are on campuses of institutional facilities, segregated from the larger community, and do not allow individuals to choose whether or with whom they share a room, limit individuals' freedom of choice on daily living experiences such as meals, visitors, activities, and limit individuals' opportunities to pursue community activities.
We received several comments to the ANPRM strongly urging CMS to clarify in regulations that HCBS funding is not intended to be used for people in segregated facilities. One comment referenced large, campus-based programs and stated “[s]uch settings clearly do not meet the basic understanding of home and community-based settings.” Another comment, expressing concern about segregated, residential campuses, added, “that HCBS funding is not intended to be used for these segregated facilities.”
More recently, we received a significant amount of correspondence from stakeholders across the country in response to a specific State proposal contemplating a campus-based, segregated setting for HCBS. One correspondent wrote “* * * congregate settings are being planned on the grounds of existing Intermediate Care Facilities for Individuals with Mental Retardation (ICF/MRs) or in other segregated settings in several States, with the intent of using Home and Community-Based (Services) Waiver (HCBW) funding. This type of effort is incompatible with the goals * * * as defined by CMS. Both ADA and
As a result of the significant comments we received and the subsequent feedback through correspondence and other stakeholder input opportunities, we propose that HCBS settings: must be integrated in the
Through the ANPRM, we received comments suggesting that we carefully consider any adverse impact that a rule change may have on American Indians and Alaska Natives who reside on Tribal lands where living settings may differ according to cultural norms. To that end, we were advised to be careful that the language of a regulation does not unintentionally prohibit normative cultural living practices. We note that this proposed rule change does not exclude from home and community-based settings culturally appropriate settings on Tribal lands when the individual is an Indian or resides on Tribal lands where culturally acceptable group living arrangements are an integral aspect of the Tribal community. Specifically, Indian means any individual defined at 25 U.S.C. 1601(c), 1603(f), or 1679(b), or who has been determined eligible as an Indian, under 42 CFR 136.12. This means the individual:
(1) Is a member of a Federally-recognized Indian Tribe;
(2) Resides in an urban center and meets one or more of the four criteria:
(a) Is a member of a Tribe, band, or other organized group of Indians, including those Tribes, bands, or groups terminated since 1940 and those recognized now or in the future by the State in which they reside, or who is a descendant, in the first or second degree, of any such member;
(b) Is an Eskimo or Aleut or other Alaska Native;
(c) Is considered by the Secretary of the Interior to be an Indian for any purpose; or
(d) Is determined to be an Indian under regulations promulgated by the Secretary.
(3) Is considered by the Secretary of the Interior to be an Indian for any purpose; or
(4) Is considered by the Secretary of Health and Human Services to be an Indian for purposes of eligibility for Indian health care services, including as a California Indian, Eskimo, Aleut, or other Alaska Native.
The comments noted that persons who are older with and without disabilities may choose to live together in assisted living facilities and urged CMS to allow them to exercise this preference and receive waiver services. Similarly, some persons who are older may desire to live in retirement communities, such as continuing care retirement communities. As a result, in accordance with a person-centered plan, we will allow such settings to be permissible under the section 1915(c) HCBS program for older persons under certain circumstances, which are noted below.
However, as previously noted, the Medicaid program's rules do not define or limit other obligations States may have under the ADA and section 504 of the Rehabilitation Act for individuals who seek more integrated settings than assisted living settings (ALS) or other settings not covered by this regulation.
For the purposes of this regulation, we note that ALS for persons who are older, without regard to disability, would not be excluded from home and community-based settings when the following conditions are met:
• Individual has a lease.
• Setting is an apartment with individual living, sleeping, bathing and cooking areas, and individuals can choose whether to share a living arrangement and with whom.
• Individuals have lockable access to and egress from their own apartments.
• Individuals are free to receive visitors and leave the setting at times and for durations of their own choosing.
• Aging in place, or allowing individuals to remain where they live as they age and/or support needs change, must be a common practice of the ALS.
• Leases may not reserve the right to assign apartments or change apartment assignments.
• Access to the greater community is easily facilitated based on the individual's needs and preferences.
• An individual's compliance with their person-centered plan (in the event that the individual has shared his/her plan or the landlord is also the provider of services) is not in and of itself a condition of the lease.
We are particularly interested in gaining comments on these aspects of the proposed rule. In addition, we note that this proposal in no way preempts broad Medicaid requirements, such as an individual's right to obtain services from any willing and qualified provider of a service.
Recognizing the imperative to provide clear guidance to States and in consideration of recent proposals that have clearly exceeded reasonable standards for HCBS, we are proposing to clarify now that certain settings are not home and community-based because they are not integrated in the community. A setting that is integrated in the community is a setting that enables individuals with disabilities to interact with individuals without disabilities to the fullest extent possible. Further, we believe that such settings do not preclude individuals' ability to access community activities at times, frequencies and with persons of their choosing. Such settings are not segregated based on disability, either physically or because of setting characteristics, from the larger community. In addition, such settings will afford individuals choice in their daily life activities, such as eating, bathing, sleeping, visiting and other typical daily activities. We will continue our dialogue with a wide variety of stakeholders on other issues related to the characteristics of HCBS settings.
Underpinning all aspects of successful HCBS is the importance of a complete and inclusive person-centered planning process that addresses health and long-term services and support needs in a manner that reflects individual preferences. To fully meet individual needs and ensure meaningful access to their surrounding community, systems that deliver HCBS must be based upon a strong foundation of person-centered planning and approaches to service delivery. Through the ANPRM process, we received favorable comments regarding our interest in ensuring a person-centered approach to services and support plan development, with recommendations that we articulate expectations for such an approach.
The person-centered approach is a process, directed by the individual with long-term support needs, and may also include a representative whom the individual has freely chosen. The person-centered plan shall identify the strengths, preferences, needs (clinical and support), and desired outcomes of the individual. The person-centered process enables the individual to choose others to serve as important contributors and members of the team in the planning process.
These participants in the person-centered planning process enable and
In addition to being driven by the individual receiving services, the person-centered planning process would—
• Include people chosen by the individual;
• Provide necessary support to ensure that the individual has a meaningful role in directing the process;
• Occur at times and locations of convenience to the individual;
• Reflect cultural considerations of the individual;
• Include strategies for solving conflict or disagreement within the process, including strategies to address any conflict of interest concerns among planning participants;
• Include opportunities for periodic and ongoing plan updates as needed and/or requested by the individual; and,
• Offer choices to the individual regarding the services and supports they receive and from whom.
The plan resulting from this process should reflect the individual strengths and preferences, as well as clinical and support needs (as identified through a person-centered functional assessment). The plan should include individually identified goals, which may include goals and preferences related to relationships, community participation, employment, income and savings, health care and wellness, education, and others. The plan should reflect the services and supports (paid and unpaid) that will assist the individual to achieve identified goals and who provides them. The plan should reflect risk factors and measures in place to minimize them. The plan must be signed by all individuals and providers responsible for its implementation, and should reflect the approach in place to ensure that it is implemented as intended. A copy of the plan must be provided to the individual and their representative(s). We invite comment on the person-centered process and planning elements of this proposed rule.
It is in this context and with the valuable input from the ANPRM that we propose modifications and additions to the regulations governing section 1915(c) HCBS waiver programs. We further seek to use this opportunity to clarify expectations regarding timing of amendments and public input requirements when States propose modifications to HCBS waiver programs and service rates, and strategies available to CMS to ensure State compliance with the statutory assurances of section 1915(c) of the Act.
Our primary concern in the oversight of the section 1915(c) waivers is the health and welfare of the individuals served within the programs. Section 1915(f) of the Act requires the Secretary to monitor implementation of waivers to assure compliance with all requirements and provides for termination of waivers where the Secretary has found noncompliance. This authority and the process for termination of waivers is currently addressed in the regulations at § 441.304(d), § 441.307, and § 441.308. We seek to add provisions describing other strategies CMS may employ only after all other efforts have not yielded necessary results, to ensure compliance, short of termination or nonrenewal. At present, when we identify serious quality issues, such as potential harm to individual health and welfare or significant financial concerns, and States fail to take appropriate remedial action, the only enforcement options addressed in the regulations are for CMS to refuse to renew the waiver or terminate the waiver, as described at current § 441.304(d). Such action could have a significant detrimental impact on the individuals served (for example, loss of waiver services or Medicaid eligibility). We are interested in specifying a broader array of approaches CMS may take to achieve and maintain full State compliance with the requirements specified in or under section 1915(c) of the Act in addition to waiver termination. We invite comment on the discussion of compliance strategies in this proposed rule.
CMS issues these proposed rules to address issues that are pressing in the design, operation, and oversight of the section 1915(c) waiver program. However, we are committed to continuing a dialogue with all interested stakeholders on issues related to designing services and supports that meet individual needs, and that offer meaningful community participation opportunities.
The provisions of this proposed rule would apply to all States offering Medicaid HCBS waivers under section 1915(c) of the Act.
As noted above, our ANPRM encompassed three main areas: Removal of regulatory barriers to serve more than one target group in a single waiver; definition of home and community characteristics; and, underpinning each of those areas, requirements for person-centered planning. Comments were supportive of our interest in setting forth our expectations regarding person-centered service and support plans that reflect what is important for the individual and to the individual. The proposed revisions to § 441.301(b)(1)(i) would require that a written services and support plan be based on the person-centered approach. This provision includes minimum requirements for this approach.
In new paragraph, § 441.301(b)(1)(iv), we would include clarifying language regarding settings that would not be considered home and community-based under section 1915(c) of the Act. We clarify that HCBS settings are integrated in the community and may not include: facilities located in a building that is also a publicly or privately-operated facility that provides inpatient institutional treatment or custodial care; or in a building on the grounds of, or immediately adjacent to, a public or private institution; or a disability-specific housing complex designed expressly around an individual's diagnosis, that is segregated from the larger community, as determined by the Secretary.
We note that this proposed rule change does not exclude living settings on Tribal lands that reflect cultural norms, or ALS for persons who are older
The proposed revisions to § 441.301(b)(6) would allow States to combine target groups. We recognize that some States and stakeholders want additional flexibility to combine target groups in order to provide services based upon needs rather than diagnosis or condition, and for administrative relief from operating and managing multiple section 1915(c) waiver programs. Under this proposal, States must still determine that without the waiver, participants would require institutional level of care, in accordance with section 1915(c) of the Act. The proposal will not affect the cost neutrality requirement for section 1915(c) waivers, which requires the State to assure that the average per capita expenditure under the waiver for each waiver year not exceed 100 percent of the average per capita expenditures that would have been made during the same year for the level of care provided in a hospital, nursing facility, or ICF/MR under the State plan had the waiver not been granted. We will provide States with guidance on how to demonstrate cost neutrality for a waiver serving multiple target groups.
In an effort to ensure that safeguards are in place to protect the health and welfare of each waiver participant, we are proposing in a new paragraph § 441.302(a)(4) that to choose the option of more than one target group under a single waiver, States must assure CMS that they are able to meet the unique service needs that each individual may have regardless of target group, and that each individual in the waiver has equal access to all needed services. In addition, to ensure that services are provided in settings that are home and community-based, we are proposing in a new paragraph § 441.302(a)(5) that States provide assurance that the settings where services are provided are home and community based, and comport with new paragraph § 441.301(b)(1)(iv). While we are not changing the existing quality assurances through this rule, we are proposing to clarify that States must continue to assure health and welfare of all participants when target groups are combined under one waiver, and assure that they have the mechanisms in place to demonstrate compliance with that assurance.
At § 441.304, we would make minor revisions to the heading to indicate the rules addressed under this section.
We are proposing to revise § 441.304(d) and redesignate current § 441.304(d) as new § 441.304(g). The new § 441.304(d) would codify and clarify our guidance (
Additionally, given the important requirement at § 447.205, which describes States' responsibilities to provide public notice when States propose significant changes to their methods and standards for setting payment rates for services, we propose to add a new paragraph § 441.304(e) to remind States of their obligations under § 447.205. We would further include a requirement at a new proposed paragraph § 441.304(f) that States establish public input processes specifically for HCBS changes. These processes, commensurate with the proposed change, could include formalized information dissemination approaches, conducting focus groups with affected parties, and establishing a standing advisory group to assist in waiver policy development. These processes must be identified expressly within the waiver document and utilized for waiver policy development. The input process must be accessible to the public (including individuals with disabilities) and States must make significant efforts to ensure that those who want to participate in the process are able to do so. These processes must include consultation with Federally-recognized Indian Tribes in accordance with Federal requirements and the State must seek advice from Indian health programs or Urban Indian Organizations prior to submission of a waiver request, renewal, amendment or action that would have a direct effect on Indians or Indian health providers or Urban Indian Organizations in accordance with section 5006(e) of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5, enacted on February 17, 2009). We would be interested in comments on this proposed addition to strengthen the public input process on changes proposed to services and other changes to the structure and operation of the section 1915(c) waivers.
In new paragraph, § 441.304(g), we propose to add language describing additional strategies CMS may employ to ensure State compliance with the requirements of a waiver, short of termination or non-renewal. Our proposed regulation at the new § 441.304(g) reflects an approach to encourage State compliance. We are interested in working with States to achieve full compliance without having to resort to termination of a waiver. Therefore, we are proposing strategies to ensure compliance in serious situations short of termination. These strategies include use of a moratorium on waiver enrollments or withholding of a portion of Federal payment for waiver services or for administration of waiver services in accordance with the seriousness and nature of the State's noncompliance (that is, health and welfare concerns and significant financial issues). These strategies could continue, if necessary, as the Secretary determines whether termination is warranted. Our primary objective is to use such strategies rarely, only after other efforts to resolve issues have not succeeded as necessary to ensure the health and welfare of individuals served.
Once CMS employs a strategy to ensure compliance, the State must submit an acceptable corrective action plan in order to resolve all areas of noncompliance. The corrective action plan must include detail on the actions and timeframe the State will take to correct each area of noncompliance, including necessary changes to the quality improvement strategy and a detailed timeline for the completion and implementation of corrective actions. CMS will determine if the corrective action plan is acceptable.
In consideration of whether and which strategies will be used to ensure compliance, and in accordance with the seriousness and nature of the State's noncompliance (that is, health and welfare concerns and significant financial issues), we will consider such areas as the following:
• The areas of noncompliance and whether they pose immediate concerns or otherwise compromise the State's ability to assure participant's health and welfare.
• The nature and duration of the identified area of serious noncompliance.
• The State's history of noncompliance in general, and specifically with reference to the cited area of serious noncompliance.
• The significance of the deficiencies and whether they indicate a system-wide failure to provide quality services.
This proposed rule does not contain any new information collection requirements; however, it does make reference to information collection requirements currently approved by OMB. Specifically, the burden associated with the information collection requirements contained in this proposed rule (HCBS Waivers) is currently approved under OMB control number 0938-0499 with a July 31, 2012, expiration date.
If you comment on these information collection and recordkeeping requirements, please do either of the following:
1. Submit your comments electronically as specified in the
2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, [CMS-2296-P] Fax: (202) 395-6974; or E-mail:
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 directs 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). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.
The RFA requires agencies to analyze options for regulatory relief for small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $7.0 million to $34.5 million in any 1 year. Individuals and States are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This rule will have no consequential effect on State, local, or Tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Aged, Family planning, Grant programs-health, Infants and children, Medicaid, Penalties and Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services would amend 42 CFR chapter IV as set forth below:
1. The authority citation continues to read as follows:
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
2. Section 441.301 is amended by—
A. Revising paragraphs (b)(1)(i) and (b)(6).
B. Adding new paragraph (b)(1)(iv).
The revisions and addition read as follows:
(b) * * *
(1) * * *
(i) Under a written services and support plan (also called plan of care) that is based on a person-centered approach and is subject to approval by the Medicaid agency.
(A)
(
(
(
(
(
(
(
(B)
(
(
(
(
(
(
(
(
(
(
(
(
(iv) Only in settings that are home and community based, integrated in the community, provide meaningful access to the community and community activities, and choice about providers, individuals with whom to interact, and daily life activities. A setting is not integrated in the community if it is:
(A) Located in a building that is also a publicly or privately operated facility that provides inpatient institutional treatment or custodial care; in a building on the grounds of, or immediately adjacent to, a public institution; or a housing complex designed expressly around an individual's diagnosis or disability, as determined by the Secretary; or
(B) Has qualities of an institutional setting, as determined by the Secretary.
(6) Be limited to one or more of the following target groups or any subgroup thereof that the State may define:
(i) Aged or disabled, or both.
(ii) Individuals with Intellectual or Developmental Disabilities, or both.
(iii) Mentally ill.
3. Section 441.302 is amended by adding paragraphs (a)(4) and (a)(5) to read as follows:
(a) * * *
(4) Assurance that the State is able to meet the unique service needs that particular target groups may present when the State selects to serve more than one target group under a single waiver, as specified in § 441.301(b)(6) of this subpart.
(5) Assurance that services are provided in home and community based settings, as specified in § 441.301(b)(1)(iv) of this subpart.
4. Section 441.304 is amended by—
A. Revising the section heading as set forth below.
B. Redesignating paragraph (d) as new paragraph (g).
C. Adding new paragraphs (d), (e), and (f).
D. Revising newly designated paragraph (g).
The additions and revisions read as follows:
(d) The agency may request that waiver modifications be made effective retroactive to the first day of a waiver year, or another date after the first day of a waiver year, in which the amendment is submitted, unless the amendment involves substantive changes as determined by CMS.
(1) Substantive changes may include, but are not limited to, revisions to services available under the waiver including elimination or reduction in services, and changes in the scope, amount, and duration of the services. Substantive changes may also include a change in the qualifications of service providers, changes in rate methodology or a change in the eligible population.
(2) A request for an amendment that involves a substantive change as determined by CMS, may only take effect on or after the date when the amendment is approved by CMS, and must be accompanied by information on how the State has assured smooth transitions and minimal adverse impact on individuals impacted by the change.
(e) The agency must provide public notice of any significant proposed change in its methods and standards for setting payment rates for services in accordance with § 447.205 of this chapter.
(f) The agency must establish and use a public input process, for any changes in the services or operations of the waiver.
(1) This process must be described fully in the State's approved waiver application and be sufficient in light of the scope of the changes proposed, to ensure meaningful opportunities for input for individuals served, or eligible to be served, in the waiver.
(2) This process must include consultation with Federally recognized Tribes, and in accordance with section 5006(e) of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), Indian health programs and Urban Indian Organizations.
(g)(1) If CMS finds that the Medicaid agency is not meeting one or more of the requirements for a waiver contained in this subpart, the agency is given a notice of CMS' findings and an opportunity for a hearing to rebut the findings.
(2) If CMS determines that the agency is substantively out of compliance with this subpart after the notice and any hearing, CMS may employ strategies to ensure compliance as described in § 441.304(g)(1) of this paragraph or terminate the waiver.
(3)(i) Strategies to ensure compliance may include the imposition of a moratorium on waiver enrollments, other corrective strategies as appropriate to ensure the health and welfare of waiver participants, or the withholding of a portion of Federal payment for waiver services until such time that compliance is achieved, or, ultimately, termination. When a waiver is terminated, the State must comport with § 441.307 of this subpart.
(ii) CMS will provide States with a written notice of the impending strategies to ensure compliance for a waiver program. The notice of CMS' intent to utilize strategies to ensure compliance would include the nature of the noncompliance, the strategy to be employed, the effective date of the compliance strategy, the criteria for removing the compliance strategy and the opportunity for a hearing.
Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program.
The Commodity Credit Corporation (CCC) announces it is inviting proposals for the 2012 Quality Samples Program (QSP). The intended effect of this notice is to solicit applications from eligible applicants and to award funds in October 2011. QSP is administered by personnel of the Foreign Agricultural Service (FAS).
To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, May 16, 2011. Any applications received after this time will be considered only if funds are still available.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
QSP is authorized under Section 5(f) of the CCC Charter Act, 15 U.S.C. 714c(f).
QSP participants will be responsible for procuring (or arranging for the procurement of) commodity samples, exporting the samples, and providing the on-site technical assistance necessary to facilitate successful use of the samples by importers. Participants that are funded under this announcement may seek reimbursement from QSP for the sample purchase price, the cost of transporting the samples domestically to the port of export, and then to the foreign port or point of entry. Transportation costs from the foreign port or point of entry to the final destination will not be eligible for reimbursement. CCC will not reimburse the costs incidental to purchasing and transporting samples, for example, inspection or documentation fees. Although providing technical assistance is required for all projects, QSP will not reimburse the costs of providing technical assistance. A QSP participant will be reimbursed after CCC reviews its reimbursement claim and determines that the claim is complete.
As a general matter, QSP projects should conform to the following guidelines:
• Projects should benefit the represented U.S. industry and not a specific company or brand;
• Projects should develop a new market for a U.S. product, promote a new U.S. product, or promote a new use for a U.S. product, rather than promote the substitution of one established U.S. product for another;
• Sample commodities provided under a QSP project must be in sufficient supply and available on a commercial basis;
• The QSP project must either subject the commodity sample to further processing or substantial transformation in the importing country, or the sample must be used in technical seminars in the importing country designed to demonstrate to an appropriate target audience the proper preparation or use of the sample in the creation of an end product;
• Samples provided in a QSP project shall not be directly used as part of a retail promotion or supplied directly to consumers. However, the end product, that is, the product resulting from further processing, substantial transformation, or a technical seminar, may be provided to end-use consumers to demonstrate to importers consumer preference for that end product; and
• Samples shall be in quantities less than a typical commercial sale and limited to the amount sufficient to achieve the project goal (
QSP projects shall target foreign importers and audiences who:
• Have not previously purchased the U.S. commodity that will be transported under QSP;
• Are unfamiliar with the variety, quality attribute, or end-use characteristic of the U.S. commodity;
• Have been unsuccessful in previous attempts to import, process, and market the U.S. commodity (
• Are interested in testing or demonstrating the benefits of the U.S. commodity; or
• Need technical assistance in processing or using the U.S. commodity.
Under this announcement, the number of projects per participant will not be limited. However, individual projects will be limited to $75,000 of QSP reimbursement. Projects comprised of technical preparation seminars, that is, projects that do not include further processing or substantial transformation, will be limited to $15,000 of QSP reimbursement as these projects require smaller samples. Financial assistance will be made available on a reimbursement basis only; cash advances will not be made available to any QSP participant.
All proposals will be reviewed against the evaluation criteria contained herein and funds will be awarded on a competitive basis. Funding for
1.
2.
3. Proposals should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance. Applicants may submit more than one proposal.
1.
Applicants planning to use the Internet-based system must contact the FAS/Program Operations Division to obtain Web site access information. The Internet-based application may be found at the following URL address:
Although FAS highly recommends applying via the Internet-based application, as this format virtually eliminates paperwork and expedites the FAS processing and review cycle, applicants also have the option of submitting an electronic version of their application to FAS at
2.
FAS recommends that proposals contain, at a minimum, the following:
(a) Organizational information, including:
• Organization's name, address, Chief Executive Officer (or designee), Federal Tax Identification Number (TIN), and DUNS number;
• Type of organization;
• Name, telephone number, fax number, and e-mail address of the primary contact person;
• A description of the organization and its membership;
• A description of the organization's prior export promotion experience; and
• A description of the organization's experience in implementing an appropriate trade/technical assistance component;
(b) Market information, including:
• An assessment of the market;
• A long-term strategy in the market; and
• U.S. export value/volume and market share (historic and goals) for 2005-2011;
(c) Project information, including:
• A brief project title;
• Amount of funding requested;
• A brief description of the specific market development trade constraint or opportunity to be addressed by the project, performance measures for the years 2012-2014 which will be used to measure the effectiveness of the project, a benchmark performance measure for 2010, the viability of long-term sales to this market, the goals of the project, and the expected benefits to the represented industry;
• A description of the activities planned to address the constraint or opportunity, including how the sample will be used in the end-use performance trial, the attributes of the sample to be demonstrated and its end-use benefit, and details of the trade/technical servicing component (including who will provide and who will fund this component);
• A sample description (
• An itemized list of all estimated costs associated with the project for which reimbursement will be sought;
• Beginning and end dates for the proposed project; and
• The importer's role in the project regarding handling and processing the commodity sample.
• Explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance
(d) Information indicating all funding sources and amounts to be contributed by each entity that will supplement implementation of the proposed project. This may include the organization that submitted the proposal, private industry entities, host governments, foreign third parties, CCC, FAS, or other Federal agencies. Contributed resources may include cash, goods or services.
3.
• Proposals received by, but not later than 5 p.m. Eastern Daylight Time, May 16, 2011, will be considered for funding with other proposals received by that date;
• Proposals not approved for funding during the review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;
• Proposals received after 5 p.m. Eastern Daylight Time, May 16, 2011, will be considered for funding only if funding remains available.
4.
1.
FAS will use the following criteria in evaluating proposals:
• The ability of the organization to provide an experienced staff with the requisite technical and trade experience to execute the proposal;
• The extent to which the proposal is targeted to a market in which the United States is generally competitive;
• The potential for expanding commercial sales in the proposed market;
• The nature of the specific market constraint or opportunity involved and how well it is addressed by the proposal;
• The extent to which the importer's contribution in terms of handling and processing enhances the potential outcome of the project;
• The amount of reimbursement requested and the organization's willingness to contribute resources, including cash, goods and services of the U.S. industry, and foreign third parties; and
• How well the proposed technical assistance component assures that performance trials will effectively demonstrate the intended end-use benefit.
Proposals will be evaluated by the Commodity Branch offices in the FAS' Cooperator Programs Division. The Commodity Branches will review each proposal against the factors described above. The purpose of this review is to identify meritorious proposals, recommend an appropriate funding level for each proposal based upon these factors, and submit proposals and funding recommendations to the Deputy Administrator, Office of Trade Programs.
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2.
QSP projects are subject to review and verification by FAS' Compliance, Security and Emergency Planning Division. Upon request, a QSP participant shall provide to CCC the original documents that support the participant's reimbursement claims. CCC may deny a claim for reimbursement if the claim is not supported by adequate documentation.
3.
For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2012 Emerging Markets Program (EMP). The intended effect of this notice is to solicit applications from the private sector and from government agencies for FY 2012 and to award funds in October 2011. The EMP is administered by personnel of the Foreign Agricultural Service (FAS).
To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, May 16, 2011. Any applications received after this time will be considered only if funds are still available.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
The EMP is authorized by section 1542(d)(1) of the Food, Agriculture, Conservation and Trade Act of 1990 (The Act), as amended. The EMP regulations appear at 7 CFR part 1486.
1.
All U.S. agricultural commodities, except tobacco, are eligible for consideration. Agricultural product(s) should be comprised of at least 50 percent U.S. origin content by weight,
2.
(a) Assistance to teams consisting primarily of U.S. individuals expert in assessing the food and rural business systems of other countries. This type of EMP project must include all three of the following:
• Conduct an assessment of the food and rural business system needs of an emerging market;
• Make recommendations on measures necessary to enhance the effectiveness of these systems; and
• Identify opportunities and projects to enhance the effectiveness of the emerging market's food and rural business systems.
To be eligible, such proposals must clearly demonstrate that experts are primarily agricultural consultants, farmers, other persons from the private sector, and government officials, and that they have expertise in assessing the food and rural business systems of other countries.
(b) Assistance to enable individuals from emerging markets to travel to the United States so that these individuals can, for the purpose of enhancing the food and rural business systems in their countries, become familiar with U.S. technology and agribusiness and rural enterprise operations by consulting with food and rural business system experts in the United States.
(c) Assistance to enable U.S. agricultural producers and other individuals knowledgeable in agricultural and agribusiness matters to travel to emerging markets to assist in transferring their knowledge and expertise to entities in emerging markets. Such travel must be to emerging markets. Travel to developed markets is not eligible under the program even if the traveler's targeted market is an emerging market.
(d) Technical assistance to implement the recommendations, projects, and/or opportunities identified under 2(a) above. Technical assistance that does not implement the recommendations, projects, and/or opportunities identified by assistance under 2(a) above is not eligible under the EMP.
Proposals that do not fall into one or more of the four categories above, regardless of previous guidance provided regarding the EMP, are not eligible for consideration under the program.
EMP funds may not be used to support normal operating costs of individual organizations, nor as a source to recover pre-award costs or prior expenses from previous or ongoing projects. Proposals that counter national strategies or duplicate activities planned or already underway by U.S. non-profit agricultural commodity or trade associations (“cooperators”) will not be considered. Other ineligible expenditures include: branded product promotions (in-store, restaurant advertising, labeling,
3.
Secretary of Agriculture determines:
(a) Is taking steps toward developing a market-oriented economy through the food, agriculture, or rural business sectors of the economy of the country; and
(b) Has the potential to provide a viable and significant market for U.S. agricultural commodities or products of U.S. agricultural commodities.
Because EMP funds are limited and the range of potential emerging market countries is worldwide, consideration will be given only to proposals that target countries or regional groups with per capita income of less than $12,195 (the current ceiling on upper middle income economies as determined by the World Bank [World Development Indicators; December 2010,
Income limits and their calculation can change from year to year with the result that a given country may qualify under the legislative and administrative criteria one year but not the next. Therefore, CCC has not established a fixed list of emerging market countries.
A few countries technically qualify as emerging markets but may require a separate determination before funding can be considered because of political sensitivities.
In general, all qualified proposals received before the application deadline will compete for EMP funding. Priority consideration will be given to proposals that directly support or address at least one of the goals and objectives in the USDA and FAS Strategic Plans. The USDA Strategic Plan can be accessed at the following link:
The limited funds and the range of eligible emerging markets worldwide generally preclude CCC from approving large budgets for individual projects. While there is no minimum or maximum amount set for EMP-funded projects, most projects are funded at a level of less than $500,000 and for a duration of approximately one year. Private entities may submit multi-year proposals requesting higher levels of funding that may be considered in the context of a detailed strategic implementation plan. Funding in such cases is generally limited to three years and provided one year at a time with commitments beyond the first year subject to interim evaluations and funding availability. Government entities are not eligible for multi-year funding.
Funding for successful proposals will be provided through specific agreements. The CCC, through FAS, will be kept informed of the implementation of approved projects through the requirement to provide interim progress reports and final performance reports. Changes in the original project timelines and adjustments within project budgets must be approved in advance by FAS.
EMP funds awarded to government agencies must be expended or otherwise obligated by close of business, September 30, 2012.
1.
U.S. export market development cooperators and SRTGs may seek funding to address priority, market specific issues and to undertake activities not suitable for funding under other CCC market development programs,
2.
Cost-sharing is not required for proposals from government agencies, but is mandatory for all other eligible entities, even when they may be party to a joint proposal with a government agency. Contributions from USDA or other government agencies or programs may not be counted toward the stated cost-share requirement of other applicants. Similarly, contributions from foreign (non-U.S.) organizations may not be counted toward the cost-share requirement, but may be counted in the total cost of the project.
3.
1.
Applicants are strongly encouraged to submit their applications to FAS through the UES application Internet Web site. The Internet-based format reduces paperwork and expedites the FAS processing and review cycle. Applicants planning to use the on-line UES system must contact the Program Operations Division to obtain site access information. The Internet-based application is located at the following URL address:
Although FAS highly recommends applying via the Internet-based application, applicants also have the option of submitting an electronic version to FAS at
2.
In addition, in accordance with the Office of Management and Budget's issuance of a final policy (68 FR 38402 (June 27, 2003)) regarding the need to identify entities that are receiving government awards, all applicants must submit a Dun and Bradstreet Data Universal Numbering System (DUNS) number. An applicant may request a DUNS number at no cost by calling the dedicated toll-free DUNS number request line on 1-866-705-5711.
Applications should be no longer than ten (10) pages and include the following information:
(a) Date of proposal;
(b) Name of organization submitting proposal;
(c) Organization address, telephone and fax numbers;
(d) Tax ID number;
(e) DUNS number;
(f) Primary contact person;
(g) Full title of proposal;
(h) Target market(s);
(i) Current conditions in the target market(s) affecting the intended commodity or product;
(j) Description of problem(s) (
(k) Project objectives;
(l) Performance measures: Benchmarks for quantifying progress in meeting the objectives;
(m) Rationale: Explanation of the underlying reasons for the project proposal and its approach, the anticipated benefits, and any additional pertinent analysis;
(n) Clear demonstration that successful implementation will benefit an emerging market's food and rural business system and/or reduce potential trade barriers, and will benefit a particular industry as a whole, not just the applicant(s);
(o) Explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance;
(p) Specific description of activity/activities to be undertaken;
(q) Timeline(s) for implementation of activity, including start and end dates;
(r) Information on whether similar activities are or have previously been funded with USDA resources in the target country or countries (
and
(s) Detailed line item activity budget:
• Cost items should be allocated separately to each participating organization; and
• Expense items constituting a proposed activity's overall budget (
(1) Which items are to be covered by EMP funding;
(2) Which by the participating U.S. organization(s); and
(3) Which by foreign third parties (if applicable).
Cost items for individual consultant fees should show calculation of daily rate and number of days. Cost items for travel expenses should show number of trips, destinations, cost, and objective for each trip.
Qualifications of applicant(s) should be included as an attachment.
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• Proposals received by, but not later than, 5 p.m. Eastern Daylight Time, May 16, 2011, will be considered for funding with other proposals received by that date;
• Proposals not approved for funding during the review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;
• Proposals received after 5 p.m. Eastern Daylight Time, May 16, 2011, will be considered for funding only if funding remains available.
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• The objective of the activities is to develop, maintain, or expand markets for U.S. agricultural exports by improving the effectiveness of the food and rural business systems in emerging markets;
• Appropriateness of the activities for the targeted market(s) and the extent to which the project identifies market barriers (
• Potential of the project to expand U.S. market share, increase U.S. exports or sales;
• Quality of the project's performance measures, and the degree to which they relate to the objectives, deliverables, and proposed approach and activities;
• Justification for Federal funding;
• Overall cost of the project and the amount of funding provided by the applicant and any partners; and
• Evidence that the organization has the knowledge, expertise, ability, and resources to successfully implement the project, including timeliness and quality of reporting on past EMP activities.
Please see 7 CFR part 1486 for additional evaluation criteria.
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For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2012 Technical Assistance for Specialty Crops (TASC) program. The intended effect of this notice is to solicit applications from the private sector and from government agencies for FY 2012 and to award funds in October 2011. The TASC program is administered by personnel of the Foreign Agricultural Service (FAS).
To be considered for funding, applications must be received by 5 p.m. Eastern Daylight Time, May 16, 2011. Any applications received after this time will be considered only if funds are still available.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
As a general matter, TASC program projects should be designed to address the following criteria:
• Projects should identify and address a sanitary, phytosanitary, or related technical barrier that prohibits or threatens the export of U.S. specialty crops;
• Projects should demonstrably benefit the represented industry rather than a specific company or brand;
• Projects must address barriers to exports of commercially-available U.S. specialty crops for which barrier removal would predominantly benefit U.S. exports; and
• Projects should include an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance.
Examples of expenses that CCC may agree to reimburse under the TASC program include, but are not limited to: initial pre-clearance programs, export protocol and work plan support, seminars and workshops, study tours, field surveys, development of pest lists, pest and disease research, database development, reasonable logistical and administrative support, and travel and per diem expenses.
In general, all qualified proposals received before the specified application deadline will compete for funding. The limited funds and the range of barriers affecting the exports of U.S. specialty crops worldwide preclude CCC from approving large budgets for individual projects. Proposals requesting more than $500,000 in any given year will not be considered. Additionally, the maximum duration of an activity is 5 years. In order to validate funding eligibility, proposals must specify previous years of TASC funding for each proposed activity/title/market/constraint combination.
Applicants may submit multiple proposals, and applicants with previously approved TASC proposals may apply for additional funding. The number of approved projects that a TASC participant can have underway at any given time is five. Please see 7 CFR part 1487 for additional restrictions.
FAS will consider providing either grant funds as direct assistance to U.S. organizations or technical assistance on behalf of U.S. organizations, provided that the organization submits timely and qualified proposals. FAS will review all proposals against the evaluation criteria contained in the program regulations.
Funding for successful proposals will be provided through specific agreements. These agreements will incorporate the proposal as approved by FAS. FAS must approve in advance any subsequent changes to the project. FAS or another Federal agency may be involved in the implementation of approved projects.
Foreign organizations, whether government or private, may participate as third parties in activities carried out by U.S. organizations, but are not eligible for funding assistance from the program.
3. Proposals should include a justification for funding assistance from the program—an explanation as to what specifically could not be accomplished without Federal funding assistance and why the participating organization(s) would be unlikely to carry out the project without such assistance.
Although FAS highly recommends applying via the Internet-based UES application, as this format virtually eliminates paperwork and expedites the FAS processing and review cycle, applicants also have the option of submitting an electronic version to FAS at
• Proposals received by, but not later than, 5 p.m. Eastern Daylight Time, May 16, 2011, will be considered for funding with other proposals received by that date;
• Proposals not approved for funding during the review period will be reconsidered for funding after the review period only if the applicant specifically requests such reconsideration in writing, and only if funding remains available;
• Proposals received after 5 p.m. Eastern Daylight Time, May 16, 2011, will be considered for funding only if funding remains available.
Notwithstanding the foregoing, a proposal may be submitted for expedited consideration under the TASC Quick Response process if, in addition to meeting all requirements of the TASC program, a proposal clearly identifies a time-sensitive activity. In these cases, a proposal may be submitted at any time for an expedited evaluation. Such a proposal must include a specific request for expedited evaluation.
FAS will track the time and date of receipt of all proposals.
Certain types of expenses are not eligible for reimbursement by the program, such as the costs of market research, advertising, or other promotional expenses, as set forth in the written program agreement between CCC and the participant. CCC will also not reimburse unreasonable expenditures or any expenditure made prior to approval of a proposal.
For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2012 Market Access Program (MAP). The intended effect of this notice is to solicit applications from eligible applicants and to award funds in October 2011. The MAP is administered by personnel of the Foreign Agricultural Service (FAS).
All applications must be received by 5 p.m. Eastern Daylight Time, May 16, 2011. Applications received after this date will not be considered.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
The MAP is authorized under Section 203 of the Agricultural Trade Act of 1978, as amended. MAP regulations appear at 7 CFR part 1485.
The FAS allocates funds in a manner that effectively supports the strategic decision-making initiatives of the Government Performance and Results Act (GPRA) of 1993. In deciding whether a proposed project will contribute to the effective creation, expansion, or maintenance of foreign markets, the FAS considers whether the applicant provides a clear, long-term agricultural trade strategy and a program effectiveness time line against which results can be measured at specific intervals using quantifiable product or country goals. The FAS also considers the extent to which a proposed project targets markets with the greatest growth potential. These factors are part of the FAS resource allocation strategy to fund applicants who can demonstrate performance and address the objectives of the GPRA.
Under the MAP, the CCC enters into agreements with eligible participants to share the cost of certain overseas marketing and promotion activities. MAP participants may receive assistance for generic or brand promotion activities. For generic activities, funding priority is given to organizations that have the broadest possible producer representation of the commodity being promoted and that are nationwide in membership and scope. Only non-profit U.S. agricultural trade organizations, nonprofit State regional
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The degree of commitment of an applicant to the promotional strategies contained in its application, as represented by the agreed cost-share contributions specified therein, is considered by FAS when determining which applications will be approved for funding. Cost-share may be actual cash invested or in-kind contributions, such as professional staff time spent on design and execution of activities. The MAP regulations, in section 1485.13(c), provide detailed discussion of eligible and ineligible cost-share contributions.
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The FAS highly recommends applying via the Internet-based application, as this format virtually eliminates paperwork and expedites the FAS processing and review cycle. However, applicants also have the option of submitting an electronic version of their application to FAS at
2.
The FAS administers various other agricultural export assistance programs including the Foreign Market Development Cooperator (Cooperator) program, the Emerging Markets Program, the Quality Samples Program, and the Technical Assistance for Specialty Crops program. Any organization that is not interested in applying for the MAP, but would like to request assistance through one of the other programs mentioned should contact the Program Operations Division.
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(1) Phase 1—Sufficiency Review and FAS Divisional Review:
Applications received by the closing date will be reviewed by FAS to determine the eligibility of the applicants and the completeness of the applications. These requirements appear in sections 1485.12 and 1485.13 of the MAP regulations. Applications that meet the requirements then will be further evaluated by the appropriate Commodity Branch office of the FAS/Cooperator Programs Division. The Commodity Branch will review each application against the criteria listed in section 1485.14 of the MAP regulations. The purpose of this review is to identify meritorious proposals and to recommend an appropriate funding level for each application based upon these criteria.
(2) Phase 2—Competitive Review: Meritorious applications then will be passed on to the Office of the Deputy Administrator, Office of Trade Programs, for the purpose of allocating available funds among the applicants. Applicants will compete for funds on the basis of the following allocation criteria (the number in parentheses represents a percentage weight factor):
• The applicant's 4-year average share (2009-2012) of all contributions (cash and goods and services provided by U.S. entities in support of overseas marketing and promotion activities) compared to;
• The applicant's 4-year average share (2009-2012) of the funding level for all MAP participants.
• The 3-year average share (2008-2010) of the value of exports promoted by the applicant compared to;
• The applicant's 2-year average share (2010-2011) of the funding level for all
• The total dollar value of projected exports promoted by the applicant for 2012 compared to;
• The applicant's requested funding level;
• Actual exports for 2010 as reported in the 2012 MAP application compared to;
• Past projections of exports for 2010 as specified in the 2010 MAP application.
The Commodity Branches' recommended funding levels for each applicant are converted to percentages of the total MAP funds available and then multiplied by each weight factor as described above to determine the amount of funds allocated to each applicant.
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For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U.S. Department of Agriculture at: Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or by phone: (202) 720-4327, or by fax: (202) 720-9361, or by e-mail:
The Commodity Credit Corporation (CCC) announces that it is inviting proposals for the 2012 Foreign Market Development Cooperator (Cooperator) program. The intended effect of this notice is to solicit applications from eligible applicants for 2012 and to award funds in October 2011. The Cooperator program is administered by personnel of the Foreign Agricultural Service (FAS).
All applications must be received by 5 p.m. Eastern Daylight Time, May 16, 2011. Applications received after this date will not be considered.
Entities wishing to apply for funding assistance should contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, Portals Office Building, Suite 400, 1250 Maryland Avenue, SW., Washington, DC 20024, or
The FAS allocates funds in a manner that effectively supports the strategic decision-making initiatives of the Government Performance and Results Act (GPRA) of 1993. In deciding whether a proposed project will contribute to the effective creation, expansion, or maintenance of foreign markets, the FAS considers whether the applicant provides a clear, long-term agricultural trade strategy, and a program effectiveness time line against which results can be measured at specific intervals using quantifiable product or country goals. The FAS also considers the extent to which a proposed project targets markets with the greatest growth potential. These factors are part of the FAS resource allocation strategy to fund applicants who can demonstrate performance and address the objectives of the GPRA.
Under the Cooperator program, the FAS enters into agreements with eligible nonprofit U.S. trade organizations to share the cost of certain overseas marketing and promotion activities. Funding priority is given to organizations that have the broadest possible producer representation of the commodity being promoted and that are nationwide in membership and scope. Cooperators may receive assistance only for generic activities that do not involve promotions targeted directly to consumers. The program generally operates on a reimbursement basis.
1.
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The degree of commitment of an applicant to the promotional strategies contained in its application, as represented by the agreed cost-share contributions specified therein, is considered by the FAS when determining which applications will be approved for funding. Cost-share may be
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Applicants planning to use the Internet-based system must contact the FAS/Program Operations Division to obtain site access information. The Internet-based application may be found at the following URL address:
The FAS highly recommends applying via the Internet-based application as this format virtually eliminates paperwork and expedites the FAS processing and review cycle. However, applicants also have the option of submitting an electronic version of their application to FAS at
2.
Incomplete applications and applications that do not otherwise conform to this announcement will not be accepted for review.
The FAS administers various other agricultural export assistance programs, including the Market Access Program (MAP), the Emerging Markets Program, the Quality Samples Program, and the Technical Assistance for Specialty Crops Program. Any organization that is not interested in applying for the Cooperator program but would like to request assistance through one of the other programs mentioned should contact the Program Operations Division.
3.
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Applications received by the closing date will be reviewed by FAS to determine the eligibility of the applicants and the completeness of the applications. These requirements appear in sections 1484.14 and 1484.20 of the Cooperator program regulations. Applications that meet the requirements then will be further evaluated by the appropriate Commodity Branch office of the FAS/Cooperator Programs Division. The Commodity Branch will review each application against the criteria listed in sections 1484.21 and 1484.22 of the Cooperator program regulations. The purpose of this review is to identify meritorious proposals and to recommend an appropriate funding level for each application based upon these criteria.
Meritorious applications then will be passed on to the Office of the Deputy Administrator, Office of Trade Programs, for the purpose of allocating available funds among the applicants. Applicants will compete for funds on the basis of the following allocation criteria (the number in parentheses represents a percentage weight factor):
• The applicant's 6-year average share (2007-2012) of all contributions (contributions may include cash and goods and services provided by U.S. entities in support of foreign market development activities) compared to;
• The applicant's 6-year average share (2007-2012) of all Cooperator marketing plan expenditures.
• The 6-year average share (2006-2011) of the value of exports promoted by the applicant compared to;
• The applicant's 6-year average share (2006-2011) of all Cooperator marketing plan expenditures plus a 6-year average share (2006-2011) of MAP expenditures, if any.
• The 6-year average share (2006-2011) of the total value of world trade of the commodities promoted by the applicant compared to;
• The applicant's 6-year average share (2006-2011) of all Cooperator marketing plan expenditures plus a 6-year average share (2006-2011) of MAP expenditures, if any.
• The projected total dollar value of world trade of the commodities being promoted by the applicant for the year 2017 compared to;
• The applicant's requested funding level.
• The actual dollar value share of world trade of the commodities being promoted by the applicant for the year 2010 compared to;
• The applicant's past projected share of world trade of the commodities being
The Commodity Branches' recommended funding levels for each applicant are converted to percentages of the total Cooperator program funds available and then multiplied by each weight factor to determine the amount of funds allocated to each applicant.
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For additional information and assistance, contact the Program Operations Division, Office of Trade Programs, Foreign Agricultural Service, U. S. Department of Agriculture.
Forest Service, USDA.
Notice of Intent to prepare an environmental impact statement.
The Humboldt-Toiyabe National Forest (HTNF) will prepare an environmental impact statement (EIS) to evaluate certain National Forest System (NFS) lands for geothermal leasing availability. The project area includes NFS lands on the HTNF in Douglas, Lyon, Mineral, Lander, Nye and White Pine County, NV.
Comments concerning the scope of the analysis must be received by May 16, 2011. The draft environmental impact statement is expected in October 2011 and the final environmental impact statement is expected in March 2012.
Send written comments to Keith Whaley, Project Manager, Humboldt-Toiyabe National Forest, Bridgeport Ranger District, HC 62 Box 1000, Bridgeport, CA 93517. Comments may also be sent via e-mail to
Keith Whaley, Project Manager, Bridgeport Ranger District, HC 62 Box 1000, Bridgeport, CA 93517;
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.
The purpose of the proposed action is to determine if certain lands within the HTNF may be made available for geothermal leasing, and if so, to identify reasonable and necessary conditions to protect surface resources. The need for the proposed action is to allow the FS to satisfy their respective statutory and policy mandates in responding to requests for the environmentally responsible development of energy resources; to address provisions of the Energy Policy Act of 2005 (Sections 211 and 222[d][1]); respond to other policy directives calling for clean and renewable energy; and to meet the increasing energy demands of the nation while reducing reliance on foreign energy imports, reducing greenhouse gas emissions, and improving national security.
The HTNF would make approximately 662,700 acres of NFS lands administratively available for geothermal leasing. The lands to be made available encompass the Nevada portion of the Bridgeport Ranger District (approximately 659,000 acres), one area on the Austin Ranger District (approximately 3,200 acres), one area (approximately 160 acres) on the Tonopah District and one area on the Ely Ranger District (approximately 3,574 acres). Leasing would include stipulations from Chapter 2 of the Geothermal Leasing Programmatic Environmental Impact Statement (BLM, October 2008) and other stipulations determined to be reasonable and necessary to protect surface resources.
The Decision resulting from this analysis would not affect any prior decisions on: (1) Geothermal leases in effect (2) Regional Forester Consent Decisions for specific geothermal leases or (3) lands made available under previous Forest-Level Availability Determination Decisions at the time said Decision is made. In addition, this analysis does not make any leasing determination decisions on any lands being analyzed under a separate environmental analysis at the time of this EIS.
The Bureau of Land Management Nevada State office, located at 1340 Financial Blvd, Reno, NV 89502, is a cooperating agency for this NEPA analysis.
Jeanne M. Higgins, Forest Supervisor, Humboldt-Toiyabe National Forest, 1200 Franklin Way, Sparks, Nevada 89431.
Based on the environmental analysis and disclosure in the EIS, the Forest Supervisor will decide whether or not to make available for geothermal leasing the lands analyzed in this EIS.
Preliminary issues identified based on our experience with similar projects includes, but is not limited to, cultural resources, wildlife, vegetation, air, water, Native American concerns, visuals, land use, hazardous materials, inventoried roadless areas, social, and economic conditions. Other issues may be identified during the scoping period.
This NOI initiates the scoping process, which guides the development of the environmental impact statement. The scoping period for this EIS will run 30 days from the published date of this NOI.
It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions.
Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered, however.
Forest Service, USDA.
Notice of meeting.
The Lynn Canal/Icy Straits Resource Advisory Committee will meet in Juneau, Alaska, April 25, 2011. The purpose of this meeting is to orient the new appointees as to the Secure Rural Schools and Community Self-Determination Act of 2008, provide operational guidelines, discuss and adopt specific bylaws for the RAC, and elect a RAC Chairperson.
The meeting will be held April 25, 2011 from 8:30-3:30.
The meeting will be held at the Juneau Ranger District/Admiralty National Monument Office, 8510 Mendenhall Loop Road, Juneau, Alaska. Send written comments to Lynn Canal/Icy Straits Resource Advisory Committee, c/o Admiralty National Monument Ranger, 8510 Mendenhall Loop Road, Juneau, Alaska 99801, or electronically to Debra Robinson, RAC Coordinator at
Debra Robinson, RAC Coordinator Juneau Ranger District/Admiralty National Monument, Tongass National Forest, (907) 789-0209.
The meeting is open to the public. Committee discussion is limited to Forest Service staff and Committee members. However, public input opportunity will be provided and individuals will have the opportunity to address the Committee at that time.
Forest Service, USDA.
Notice of meeting.
The Glenn/Colusa Resource Advisory Committee will meet in Willows, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L 110-343) (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. The meeting is open to the public. The purpose of the meeting is to review and discuss existing projects, and review new proposals for additional projects.
The meeting will be held May 16, 2011 at 1:30 p.m.
The meeting will be held at Mendocino National Forest, Grindstone Ranger District Office, Black Butte and Snow Mountain Conference Rooms, located at 825 N. Humboldt, Willows, CA 95988. Written comments may be submitted as described under
Laurie L. Pearson, Visitor Information Assistant, and Glenn/Colusa R.A.C. Coordinator, Grindstone Ranger District, 530-963-3128,
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday. Requests for reasonable accomodation for access to the facility or procedings may be made by contacting the person listed
The following business will be conducted:1. Introductions, 2. Approval of Minutes, 3. RAC Admin. Updates, 4. Public Comment,5. New Project Proposals, 6. Presenters, 7. Project Reviews FY 08/09/10, 8. ScheduleMonitoring Field Trip, 9. General Discussion, 10. Meeting Schedule, 11. Adjourn.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. 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 May 3, 2011 to be scheduled on the agenda. Written comments and requests for time for oral comments must be sent
The Materials Technical Advisory Committee will meet on May 12, 2011, 10 a.m.,Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues, NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials and related technology.
1. Opening Remarks by the Chairman and Introduction.
2. Remarks form Bureau of Industry and Security Senior Management.
3. Report of the Composite Working Group (CWG) and Export Control Classification Number Review Subgroup.
4. Update on Regime-Based Activities.
5. Comments from the Public and New Business.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. Written statements may be submitted at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the materials should be forwarded prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on September 27, 2010, pursuant to Section 10(d) of the FederalAdvisory Committee Act, as amended, that the portion of the meeting dealing with matters the premature disclosure of which would likely frustrate the implementation of a proposed agencyaction as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating topublic meetings found in 5 U.S.C. app. 2 § § 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
Import Administration, International Trade Administration, Department of Commerce.
On October 1, 2010, the Department of Commerce (the Department) initiated the third sunset reviews of the antidumping duty orders on carbon steel butt-weld pipe fittings from Brazil, Japan, Taiwan, Thailand, and the People's Republic of China (PRC), pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).
Catherine Cartsos or Minoo Hatten, AD/CVD Operations, Office 5, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230;
On October 1, 2010, the Department initiated and the ITC instituted sunset reviews of the antidumping duty orders
As a result of these sunset reviews, the Department determined that revocation of the antidumping duty orders on carbon steel butt-weld pipe fittings from Brazil, Japan, Taiwan, Thailand, and the PRC would likely lead to continuation or recurrence of dumping and notified the ITC of the magnitude of the margins likely to prevail should the orders be revoked.
On April 8, 2011, the ITC published its determination in the
The merchandise covered by the order consists of certain carbon steel butt-weld type fittings, other than couplings, under 14 inches in diameter, whether finished or unfinished, that have been formed in the shape of elbows, tees, reducers, caps, etc., and, if forged, have been advanced after forging. These advancements may include any one or more of the following: coining, heat treatment, shot blasting, grinding, die stamping or painting. Such merchandise was classifiable under Tariff Schedules of the United States Annotated (TSUSA) item number 610.8800. These imports are currently classified under subheading 7307.93.30 of the Harmonized Tariff Schedule of the United States (HTSUS). The HTSUS subheading is provided for convenience and customs purposes. The written product description remains dispositive.
The merchandise covered by the order consists of certain carbon steel butt-weld type fittings, other than couplings, under 14 inches in inside diameter, whether finished or unfinished, that have been formed in the shape of elbows, tees, reducers, caps,
The merchandise covered by the order consists of certain carbon steel butt-weld type fittings, other than couplings, under 14 inches in inside diameter, whether finished or unfinished, that have been formed in the shape of elbows, tees, reducers, and caps, and if forged, have been advanced after forging. These advancements may include one or more of the following: coining, heat treatment, shot blasting, grinding, die stamping or painting. The Department clarified that the so-called sprink-let is within the scope of the order (57 FR 19602). Such merchandise was classifiable under TSUSA item number 610.8800. These imports are currently classifiable under the HTSUS item number 7307.93.3000. The HTSUS subheading is provided for convenience and for customs purposes. The written product description remains dispositive.
The merchandise covered by the orders consists of certain carbon steel butt-weld pipe fittings, having an inside diameter of less than 14 inches, imported in either finished or unfinished form. These formed or forged pipe fittings are used to join sections in piping systems where conditions require permanent, welded connections, as distinguished from fittings based on other fastening methods (e.g., threaded, grooved, or bolted fittings). Carbon steel butt-weld pipe fittings are currently classified under subheading 7307.93.30 of the HTSUS. The HTSUS subheading is provided for convenience and customs purposes. The written product description remains dispositive.
As a result of the determinations by the Department and the ITC that revocation of the antidumping duty orders would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty orders on carbon steel butt-weld pipe fittings from Brazil, Japan, Taiwan, Thailand, and the PRC.
U.S. Customs and Border Protection will continue to collect antidumping cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of the continuation of the orders will be the date of publication of this notice of continuation in the
These five-year sunset reviews and this notice are in accordance with section 751(c) of the Act and is published pursuant to section 777(i) of the Act and 19 CFR 351.218(f)(4).
Import Administration, International Trade Administration, Department of Commerce.
Victoria Cho, AD/CVD Operations, Office 3, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Ave., NW., Washington, DC 20230; telephone: (202) 482-5075.
On September 29, 2010, the U.S. Department of Commerce (“Department”) published a notice of initiation of the administrative review of the antidumping duty order on corrosion-resistant carbon steel flat products from the Republic of Korea, covering the period August 1, 2009, to July 31, 2010.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires that the Department make a preliminary determination within 245 days after the last day of the anniversary month of an order for which a review is requested. Section 751(a)(3)(A) of the Act further states that if it is not practicable to complete the review within the time period specified, the administering authority may extend the 245-day period to issue its preliminary results to up to 365 days.
We determine that completion of the preliminary results of this review within the 245-day period is not practicable.
This notice is published pursuant to sections 751(a)(3)(A) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On December 27, 2010, the Department of Commerce (“Department”) published in the
Jamie Blair-Walker, AD/CVD Operations, Office 9, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230;
On September 29, 2010, the Department initiated this review with respect to one company.
In the
All issues raised in the case and rebuttal briefs by parties to these reviews are addressed in the “Laminated Woven Sacks from the People's Republic of China: Issues and Decision Memorandum for the Final Results of the Second Antidumping Duty Administrative Review” (“Decision Memo”), which is dated concurrently with this notice. A list of the issues which parties raised and to which we respond in the Decision Memo is attached to this notice as an Appendix. The Decision Memo is a public document and is on file in the Central Records Unit, Main Commerce Building, Room 7046, and is accessible on the Department's Web site at
The merchandise covered by the order is laminated woven sacks. Laminated woven sacks are bags or sacks consisting of one or more plies of fabric consisting of woven polypropylene strip and/or woven polyethylene strip, regardless of the width of the strip; with or without an extrusion coating of polypropylene and/or polyethylene on one or both sides of the fabric; laminated by any method either to an exterior ply of plastic film such as biaxially-oriented polypropylene (“BOPP”) or to an exterior ply of paper that is suitable for high quality print graphics;
Effective July 1, 2007, laminated woven sacks are classifiable under Harmonized Tariff Schedule of the United States (“HTSUS”) subheadings 6305.33.0050 and 6305.33.0080. Laminated woven sacks were previously classifiable under HTSUS subheading 6305.33.0020. If entered with plastic coating on both sides of the fabric consisting of woven polypropylene strip and/or woven polyethylene strip, laminated woven sacks may be classifiable under HTSUS subheadings 3923.21.0080, 3923.21.0095, and 3923.29.0000. If entered not closed on one end or in roll form (including sheets, lay-flat tubing, and sleeves), laminated woven sacks may be classifiable under other HTSUS subheadings including 3917.39.0050, 3921.90.1100, 3921.90.1500, and 5903.90.2500. If the polypropylene
In the
In accordance with section 776(b) of the Act, we determine that the use of AFA as the basis for the weighted-average dumping margin is appropriate for the PRC-wide entity. As explained in the
Because we have determined that Aifudi is part of the PRC-wide entity, the PRC-wide entity is under review. Pursuant to section 776(a)(2)(A) and (C) of the Act, we find that Aifudi failed to respond to the Department's questionnaires, withheld information requested by the Department, and impeded the conduct of this review. Accordingly, the Department continues to find that it is appropriate to base the dumping margin of the PRC-wide entity on the facts otherwise available on the record. Further, because Aifudi's failure to provide the requested information constitutes circumstances under which it is reasonable to conclude that less than full cooperation has been shown, pursuant to section 776(b) of the Act, the Department has determined that, when selecting from among the facts otherwise available, an adverse inference is warranted with respect to the PRC-wide entity.
As AFA, we have applied the highest dumping margin on the record of any segment of this proceeding, which is 91.73 percent.
The weighted-average dumping margins for the POR are as follows:
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b), the Department will determine, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. For assessment purposes, we calculated importer (or customer)-specific assessment rates for merchandise subject to this review. Where appropriate, we calculated an
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For Aifudi, the cash deposit rate will be the rate as listed above in the “Final Results of Review” section of this notice; (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (3) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate of 91.73 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporters that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial
We are issuing and publishing this administrative review and notice in accordance with sections 751(a)(1) and 777(i) of the Act.
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of public meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the NOAA Science Advisory Board. The members will discuss and provide advice on issues outlined in the agenda below.
The meeting is scheduled for: Monday, May 16, from 3-5 p.m. Eastern Daylight Time.
Conference call. Public access is available at: NOAA, SSMC 3, Room 12836, 1315 East-West Highway, Silver Spring, MD.
Dr. Cynthia Decker, Executive Director, Science Advisory Board, NOAA, Rm. 11230, 1315 East-West Highway, Silver Spring, Maryland 20910. (Phone: 301-734-1156, Fax: 301-713-1459, E-mail:
The Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.
1. Recommendations on Coastal and Marine Spatial Planning from the Ecosystem Sciences and Management Working Group.
2. Discussion of a Revised Concept of Operations Document for SAB Working Groups and Task Forces.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from the procurement list.
This action adds products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
Barry S. Lineback,
On 1/14/2011 (76 FR 2673-2674); 1/28/2011 (76 FR 5142-5143); 2/4/2011 (76 FR 6451-6452); and 2/11/2011 (76 FR 7824-7825), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and services and impact of the additions on the current or most recent contractors, the Committee has determined that the products and services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and services to the Government.
2. The action will result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and services proposed for addition to the Procurement List.
Accordingly, the following products and services are added to the Procurement List:
On 2/4/2011 (76 FR 6451-6452) and 2/18/2011 (76 FR 9555), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the products and services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and services deleted from the Procurement List.
Accordingly, the following products and services are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Additions to and Deletions from the Procurement List.
The Committee is proposing to add products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and a service previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia, 22202-3259.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or e-mail
This notice is published pursuant to 41 U.S.C 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products and services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and services to the Government.
2. If approved, the action will result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and services proposed for addition to the Procurement List.
Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.
The following products and services are proposed for addition to Procurement List for production by the nonprofit agencies listed:
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. If approved, the action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. If approved, the action may result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and service proposed for deletion from the Procurement List.
The following products and service are proposed for deletion from the Procurement List:
Citation of Previous Announcement:
Vol. 76, No. 68, Friday, April 8, 2011, page 19752.
Wednesday, April 13, 2011, 10 a.m.-11 a.m.
Decisional Matter: Toddler Beds—Final Rule Meeting Canceled.
For a recorded message containing the latest agenda information, call (301) 504-7948.
Todd A. Stevenson, Office of the Secretary, 4330 East West Highway, Bethesda, MD 20814 (301) 504-7923.
Department of Education.
Comment request.
The Department of Education (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and helps the public understand the Department's information collection
Interested persons are invited to submit comments on or before June 14, 2011.
Comments regarding burden and/or the collection activity requirements should be electronically mailed to
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that Federal agencies provide interested parties an early opportunity to comment on information collection requests. The Director, Information Collection Clearance Division, Information Management and Privacy Services, Office of Management, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might
the Department minimize the burden of this collection on the respondents, including through the use of information technology.
Copies of the proposed information collection request may be accessed from
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Department of Energy.
Reopening of scoping period.
The U.S. Department of Energy (DOE) is reopening the public scoping period for the Northern Pass Transmission Line Project Environmental Impact Statement (EIS) (DOE/EIS-0463). The scoping period now ends on June 14, 2011.
DOE announced on February 11, 2011 (76 FR 7828), its intention to prepare an EIS to assess the potential environmental impacts from its proposal to grant a Presidential Permit to Northern Pass Transmission, LLC, to construct, operate, maintain, and connect a new electric transmission line across the U.S.-Canada border in northern New Hampshire. The EIS will address potential environmental impacts from the proposed action and the range of reasonable alternatives. The U.S. Forest Service, White Mountain National Forest, and the Army Corps of Engineers, New England District, are cooperating agencies.
DOE held seven public scoping meetings from March 14 to 20 in Pembroke, Franklin, Lincoln, Whitefield, Plymouth, Colebrook, and Haverhill, New Hampshire. The public scoping period closed on April 12, 2011. DOE is reopening the public scoping period in response to public requests and to ensure that the public has ample opportunity to provide comments.
The reopened public scoping period starts with the publication of this Notice in the
Comments on the scope of the EIS and requests to be added to the document mailing list should be addressed to: Brian Mills, Office of Electricity Delivery and Energy Reliability (OE-20), U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585; by electronic mail to
For information on DOE's proposed action, contact Brian Mills by one of the methods listed in
Environmental Protection Agency (EPA).
Notice.
Section 5 of the Toxic Substances Control Act (TSCA) requires any person who intends to manufacture (defined by statute to include import) a new chemical (
Comments identified by the specific PMN or TME number, must be received on or before May 16, 2011.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0313, and the specific PMN number or TME number for the chemical related to your comment, by one of the following methods:
•
•
•
This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the particular PMN or TME addressed in this document. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. 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.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
EPA classifies chemical substances as either “existing” chemicals or “new” chemicals. Any substance that is not on EPA's TSCA Chemical Substances Inventory, commonly referred to as the TSCA Inventory, is classified as a “new chemical,” while those that are on the TSCA Inventory are classified as an “existing chemical.” For more information about the TSCA Inventory go to:
Under TSCA sections 5(d)(2) and 5(d)(3) of TSCA, EPA is required to publish in the
In Table I. of this Unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the PMNs received by EPA during this period: The EPA case number assigned to the PMN, the date the PMN was received by EPA, the projected end date for EPA's review of the PMN, the submitting manufacturer; the potential uses identified by the manufacturer/importer in the PMN, and the chemical identity.
In Table II. of this Unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the TMEs received by EPA during this period: The EPA case number assigned to the TME, the date the TME was received by EPA, the projected end date for EPA's review of the TME, the submitting manufacturer/importer, the potential uses identified by the manufacturer/importer in the TME, and the chemical identity.
In Table III. of this Unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs received by EPA during this period: The EPA case number assigned to the NOC, the date the NOC was received by EPA, the projected end date for EPA's review of the NOC, and the chemical identity.
If you are interested in information that is not included in these tables, you may contact the person listed under
Environmental protection, Chemicals, Hazardous substances, Imports, Notice of commencement, Premanufacturer, Reporting and recordkeeping requirements, Test marketing exemptions.
Notice of Availability
In accordance with Section 309(a) of the Clean Air Act, EPA is required to make its comments on EISs issued by other Federal agencies public. Historically, EPA met this mandate by publishing weekly notices of availability of EPA comments, which includes a brief summary of EPA's comment letters, in the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA or Agency) Science
Two public teleconference calls will be held on Monday, May 16, 2011 from 12:30 p.m. to 4:30 p.m. and on Tuesday, May 17, 2011 from 12:30 p.m. to 4:30 p.m. (Eastern Time).
The public teleconferences will be conducted by telephone only.
Any member of the public wishing further information regarding this Notice and public teleconference may contact Mr. Edward Hanlon, Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice mail at (202) 564-2134; by fax at (202) 565-2098 or via e-mail at
Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for EPA. Input from the public to the CASAC will have the most impact if it provides specific scientific or technical information or analysis for CASAC to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the Designated Federal Officer for the relevant advisory committee directly.
Environmental Protection Agency (EPA).
Notice.
The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the Clean Air Scientific Advisory Committee (CASAC) Lead Review Panel to provide consultative advice on EPA's draft
The public teleconference will be held on Thursday, May 5, 2011 from 1 p.m. to 5 p.m. (Eastern Time).
Any member of the public wishing to obtain information concerning the public
Section 109(d)(1) of the CAA requires that the Agency periodically review and revise, as appropriate, the air quality criteria and the National Ambient Air Quality Standards (NAAQS) for the six “criteria” air pollutants, including lead. EPA is currently reviewing the primary (health-based) and secondary (welfare-based) NAAQS for lead. Accordingly, the SAB Staff Office solicited nominations for the CASAC Lead Review Panel on October 28, 2009 (74 FR 55548-55549). Membership of the Panel is listed at
EPA's Integrated Review Plan (IRP) will serve as the framework for its review of the lead NAAQS. The draft IRP presents the current plan and specifies the schedule for the entire review, the process for conducting the review, and the key policy-relevant science issues that will guide the review. The draft document also describes the different phases of the review, including the science assessment, risk/exposure assessment, and policy assessment/rulemaking, for which EPA will prepare documents which will be submitted for later CASAC review and public comment. The purpose of this teleconference is for the CASAC Panel to provide consultative advice on the draft
Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for EPA. Input from the public to the CASAC will have the most impact if it provides specific scientific or technical information or analysis for CASAC panels to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the Designated Federal Officer directly.
Environmental Protection Agency (EPA).
Notice.
EPA's Office of Pesticide Programs (OPP) is publishing for comment a proposed Pilot Fragrance Notification Program (PFNP) for registrants seeking to add new or modify existing fragrances in new or currently registered pesticide products. The Agency intends to implement the proposed PFNP for two years as a process improvement effort to streamline the current 90-day process used to amend registrations to a 30-day notification process when fragrance ingredients are added, removed, or modified.
Comments must be received on or before May 16, 2011.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-1046, by one of the following methods:
•
•
•
SanYvette Williams, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7702; fax number: (703) 305-7484; e-mail address:
You may be potentially affected by this action if you are a registrant wishing to add or modify fragrances in registered products or fragrance suppliers. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. 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.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
The Agency is taking this action as a follow up to the 2007 Fragrance Notification Pilot Program and it is very similar in conduct. The proposed PFNP incorporates the ability to self certify and rely on the Fragrance Ingredient List (FIL). The FIL is comprised of more than 1,500 fragrance component ingredients contained in pesticide products previously reviewed and registered by the Agency and have undergone an evaluation to determine their suitability for safe use as components of fragrances used in nonfood use pesticide product formulations. Only fragrances in which all of the components in the fragrance are on the FIL are eligible to participate in the proposed PFNP.
The objectives of the current pilot are to improve public transparency, reduce the amount of paperwork required of registrants and decrease tracking. The number of fragrance documents needing to be tracked would be decreased because they would be submitted twice a year versus with every application. These efficiencies will allow resources to be focused on other regulatory work without compromise to public health or the environment.
This is a voluntary program where interested entities have an opportunity to participate. The Agency is publishing this for comment by registrants as part of process improvement. Comments on the proposed process for this pilot are welcomed.
Environmental protection.
Environmental Protection Agency.
Notice.
The U.S. Environmental Protection Agency (EPA) invites nominations of scientific experts from a diverse range of disciplinary areas to be considered for appointment to the Advisory Council on Clean Air Compliance Analysis (Council), Clean Air Scientific Advisory Committee (CASAC), the Science Advisory Board (SAB), or SAB Committees described in this notice. Appointments are anticipated to be filled by the start of Fiscal Year 2012. Sources in addition to this
Nominations should be submitted in time to arrive no later than May 16, 2011.
Nominators unable to submit nominations electronically as described below may submit a paper copy by the Designated Federal Officers for the committees, as identified below. General inquiries regarding the work of the Council, CASAC and SAB or SAB Standing Committees may also be directed to them.
Members of the Council, CASAC, and the SAB, constitute a distinguished body of non-EPA scientists, engineers, economists, and social scientists that are nationally and internationally recognized experts in their respective fields. Members are appointed by the EPA Administrator for a period of three years. This notice specifically requests nominations for the Council, CASAC, the SAB, and SAB Committees from academia, industry, state, and tribal governments, research institutes, and non-governmental organizations throughout the United States.
Established in 1977 under the Clean Air Act (CAA) Amendments, the chartered CASAC reviews and offers scientific advice to the EPA Administrator on technical aspects of national ambient air quality standards for criteria pollutants. As required under the CAA section 109(d), CASAC will be composed of seven members, with at least one member of the National Academy of Sciences, one physician, and one person representing State air pollution control agencies. The SAB Staff Office is seeking nominations of experts to serve on the CASAC with demonstrated experience in:
The chartered SAB was established in 1978 by the Environmental Research, Development and Demonstration Act to provide independent advice to the Administrator on general scientific and technical matters underlying the Agency' policies and actions. All the work of the SAB is under the direction of the Board. The chartered Board provides strategic advice to the EPA Administrator on a variety of EPA science and research programs and reviews and approves all SAB subcommittee and panel reports. The SAB Staff Office is seeking nominations of experts to serve on the chartered SAB in the following disciplines:
The SAB Drinking Water Committee (DWC) provides advice on the technical aspects of EPA's national drinking water standards program. The SAB Staff Office is seeking nominations of experts to serve on the DWC in the following disciplines:
The SAB Environmental Economics Advisory Committee (EEAC) provides advice on methods and analyses related to economics, costs, and benefits of EPA environmental programs. The SAB Staff office is seeking nominations of experts in environmental
The SAB Exposure and Human Health Committee (EHHC) provides advice on the development and use of guidelines for human health effects, exposure assessment, and human health risk assessment of chemical contaminants. The SAB Staff Office is seeking nominations of experts to serve on the EHHC in the following disciplines:
The SAB Ecological Processes and Effects Committee (EPEC) provides advice on technical issues related to the science and research to protect and restore the health of ecosystems. The SAB Staff Office is seeking nominations of experts to serve on EPEC with demonstrated expertise in the following disciplines:
The Radiation Advisory Committee (RAC) provides advice on radiation protection, radiation science, and radiation risk assessment. The SAB Staff Office is seeking nominations of experts to serve on RAC with demonstrated expertise in the following disciplines:
Selection criteria include:
Nominators are asked to identify the specific committee(s) for which nominees would like to be considered. The Web site requests contact information about: The person making the nomination; contact information about the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee's curriculum vita; and a biographical sketch of the nominee indicating current position, educational background; research activities; and recent service on other national advisory committees or national professional organizations. Persons having questions about the nomination procedures, or who are unable to submit nominations through the SAB Web site, should contact the Designated Federal Officer for the committee, as identified above. Non-electronic submissions must follow the same format and contain the same information as the electronic form. The SAB Staff Office will acknowledge receipt of nominations.
Candidates invited to serve will be asked to submit the “Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency” (EPA Form 3110-48). This confidential form allows EPA to determine whether there is a statutory conflict between that person's public responsibilities as a Special Government Employee and private interests and activities, or the appearance of a lack of impartiality, as defined by Federal regulation. The form may be viewed and downloaded through the “Ethics Requirements for Advisors” link on the blue navigational bar on the SAB Web site at
To help the Agency in evaluating the effectiveness of its outreach efforts, please tell us how you learned of this opportunity.
Federal Communications Commission.
Notice.
This document announces the procedures and minimum opening bids for the upcoming auction of 16 licenses in the 698-806 MHz band (700 MHz band), designated as Auction 92, and is intended to familiarize prospective bidders with these procedures, minimum opening bid amounts, and deadlines for the auction.
Applications to participate in Auction 92 and required upfront payments must be filed prior to 6:00 p.m. Eastern Time (ET) on May 11, 2011. Bidding for construction permits in Auction 92 is scheduled to begin on July 19, 2011.
This is a summary of the
On December 15, 2010, the Wireless Telecommunications Bureau (Bureau) released a public notice seeking comment on competitive bidding procedures to be used in Auction 92. A summary of this public notice was published in the
The 16 licenses in Auction 92 were offered in Auction 73 and remained unsold or were licenses on which a winning bidder defaulted. A complete list of licenses offered in Auction 92 is available in Attachment A to the
Prospective applicants must familiarize themselves thoroughly with the Commission's general competitive bidding rules, rules relating to the 700 MHz band and emerging technologies, and rules relating to applications, environmental requirements, practice and procedure. Prospective applicants must also be thoroughly familiar with the procedures, terms and conditions contained in the
To ensure the competitiveness of the auction process, 47 CFR 1.2105(c) prohibits auction applicants for licenses in any of the same geographic license areas from communicating with each other about bids, bidding strategies, or settlements unless such applicants have identified each other on their short-form applications (FCC Form 175) as parties with whom they have entered into agreements pursuant to 47 CFR 1.2105(a)(2)(viii).
5. 47 CFR 1.2105(c)'s prohibition on certain communications will apply to any applicants that submit short-form applications seeking to participate in a Commission auction for licenses in the same or overlapping markets. Thus, unless they have identified each other on their short-form applications as parties with whom they have entered into agreements under 47 CFR 1.2105(a)(2)(viii), applicants for any of the same or overlapping markets must affirmatively avoid all communications with or disclosures to each other that affect or have the potential to affect bids or bidding strategy. In some instances, this prohibition extends to communications regarding the post-auction market structure. This prohibition applies to all applicants regardless of whether such applicants become qualified bidders or actually bid. In Auction 92, this rule would apply to applicants designating on the short-form application any of the same licenses. The rule would also prohibit, for example, an applicant bidding for a CMA license and another applicant bidding for an EA license that covers any of the same geographic area from communicating, absent a disclosed agreement.
6. Applicants are also reminded that, for purposes of this prohibition on certain communications, 47 CFR 1.2105(c)(7)(i) defines applicant as including all officers and directors of the entity submitting a short-form application to participate in the auction, all controlling interests of that entity, as well as all holders of partnership and other ownership interests and any stock interest amounting to 10 percent or more of the entity, or outstanding stock, or outstanding voting stock of the entity submitting a short-form application. For example, where an individual served as an officer for two or more applicants, the Bureau has found that the bids and bidding strategies of one applicant are necessarily conveyed to the other applicant, and, absent a disclosed bidding agreement, an apparent violation of 47 CFR 1.2105(c) occurs.
7. Information concerning Auction 92 applicants' license selections will not be available to the public. Therefore, the Commission will inform each applicant by letter of the identity of each of the other applicants that has applied for licenses covering any of the same geographic areas as the licenses that it has selected in its short-form application.
8. Individuals and entities subject to 47 CFR 1.2105(c) should take special care in circumstances where their employees may receive information directly or indirectly from a competing applicant relating to any competing applicant's bids or bidding strategies. An exception to the prohibition on certain communications allows non-controlling interest holders to obtain interests in more than one competing applicant without violating 47 CFR 1.2105(c), provided specified conditions are met (including a certification that no prohibited communications have occurred or will occur), but that exception does not extend to controlling interest holders.
9. Auction 92 applicants selecting licenses for any of the same geographic license areas are encouraged not to use the same individual as an authorized bidder. A violation of 47 CFR 1.2105(c) could occur if an individual acts as the authorized bidder for two or more competing applicants, and conveys information concerning the substance of bids or bidding strategies between such applicants. Also, if the authorized bidders are different individuals employed by the same organization (
10. 47 CFR 1.2105(c)'s prohibition on certain communications begins at the short-form application filing deadline and ends at the down payment deadline after the auction, which will be announced in a future public notice.
11. Applicants should note that they must not communicate directly or indirectly about bids or bidding strategy to other applicants in this auction. 47 CFR 1.2105(c) prohibits not only a communication about an applicant's own bids or bidding strategy, but also a communication of another applicant's bids or bidding strategy. While 47 CFR 1.2105(c) does not prohibit non-auction-
12. Applicants are cautioned that the Commission remains vigilant about prohibited communications taking place in other situations. For example, the Commission has warned that prohibited communications concerning bids and bidding strategies may include communications regarding capital calls or requests for additional funds in support of bids or bidding strategies to the extent such communications convey information concerning bids and bidding strategies directly or indirectly. Moreover, the Commission has found a violation of 47 CFR 1.2105(c) where a bidder used the Commission's bidding system to disclose its bidding strategy in a manner that explicitly invited other auction participants to cooperate and collaborate in specific markets, and has placed auction participants on notice that the use of its bidding system to disclose market information to competitors will not be tolerated and will subject bidders to sanctions. Accordingly, applicants should use caution in their dealings with other parties, such as members of the press, financial analysts, or others who might become conduits for the communication of prohibited bidding information. For example, where limited information disclosure procedures are in place, as is the case for Auction 92, a qualified bidder's statement to the press that it has lost bidding eligibility and stopped bidding in the auction could give rise to a finding of a 47 CFR 1.2105(c) violation. Similarly, an applicant's public statement of intent not to participate in Auction 92 bidding could also violate the rule.
13. Applicants are also hereby placed on notice that disclosure of information relating to bidder interests and bidder identities that has not yet been made public by the Commission at the time of disclosure may violate the provisions of 47 CFR 1.2105(c) that prohibit certain communications. This is so even though similar types of information were revealed prior to and during other Commission auctions subject to different information procedures. Thus, communication by an applicant of its license selections to another applicant for one or more of the same licenses, or communication of the fact that an applicant does nor does not hold provisionally winning bids on particular licenses, may well violate 47 CFR 1.2105(c).
14. In addition, when completing short-form applications, applicants should avoid any statements or disclosures that may violate 47 CFR 1.2105(c), particularly in light of the limited information procedures in effect for Auction 92. Specifically, applicants should avoid including any information in their short-form applications that might convey information regarding their license selection, such as using applicant names that refer to licenses being offered, referring to certain licenses or markets in describing bidding agreements, or including any information in attachments that may otherwise disclose applicants' license selections.
15. The Commission's rules do not prohibit applicants from entering into otherwise lawful bidding agreements before filing their short-form applications, as long as they disclose the existence of the agreement(s) in their short-form applications. If parties agree in principle on all material terms prior to the short-form application filing deadline, each party to the agreement must identify the other party or parties to the agreement on its short-form application under 47 CFR 1.2105(c), even if the agreement has not been reduced to writing. If the parties have not agreed in principle by the short-form filing deadline, they should not include the names of parties to discussions on their applications, and they may not continue negotiation, discussion, or communication with any other applicants for licenses covering any of the same or overlapping geographic areas after the short-form application filing deadline.
16. By electronically submitting a short-form application, each applicant in Auction 92 certifies its compliance with 47 CFR 1.2105(c). However, the Bureau cautions that merely filing a certifying statement as part of an application will not outweigh specific evidence that a prohibited communication has occurred, nor will it preclude the initiation of an investigation when warranted. The Commission has stated that it intends to scrutinize carefully any instances in which bidding patterns suggest that collusion may be occurring. Any applicant found to have violated 47 CFR 1.2105(c) may be subject to sanctions.
17. 47 CFR 1.2105(c)(6) provides that any applicant that makes or receives a communication that appears to violate 47 CFR 1.2105(c) must report such communication in writing to the Commission immediately, and in no case later than five business days after the communication occurs. The Commission has clarified that each applicant's obligation to report any such communication continues beyond the five-day period after the communication is made, even if the report is not made within the five day period.
18. 47 CFR 1.65 requires an applicant to maintain the accuracy and completeness of information furnished in its pending application and to notify the Commission of any substantial change that may be of decisional significance to that application. Thus, 47 CFR 1.65 requires an auction applicant to notify the Commission of any substantial change to the information or certifications included in its pending short-form application. An applicant is therefore required by 47 CFR 1.65 to report to the Commission any communication the applicant has made to or received from another applicant after the short-form application filing deadline that affects or has the potential to affect bids or bidding strategy, unless such communication is made to or received from a party to an agreement identified under 47 CFR 1.2105(a)(2)(viii).
19. 47 CFR 1.65(a) and 1.2105(c) requires applicants in competitive bidding proceedings to furnish additional or corrected information within five days of a significant occurrence, or to amend their short-form applications no more than five days after the applicant becomes aware of the need for amendment. These rules are intended to facilitate the auction process by making the information available promptly to all participants and to enable the Bureau to act expeditiously on those changes when such action is necessary.
20. A party reporting any communication pursuant to 47 CFR 1.65, 1.2105(a)(2), or 1.2105(c)(6) must take care to ensure that any report of a prohibited communication does not itself give rise to a violation of 47 CFR 1.2105(c). For example, a party's report of a prohibited communication could violate the rule by communicating prohibited information to other applicants through the use of Commission filing procedures that would allow such materials to be made available for public inspection.
21. 47 CFR 1.2105(c) requires parties to file only a single report concerning such communications and to file that report with Commission personnel expressly charged with administering the Commission's auctions. This rule is designed to minimize the risk of inadvertent dissemination of information in such reports. Pursuant to the amended rule, any reports required by 47 CFR 1.2105(c) must be filed consistent with the instructions set forth in the
22. A party seeking to report such a prohibited communication should consider submitting its report with a request that the report or portions of the submission be withheld from public inspection pursuant to 47 CFR 0.459. If requesting that a report be withheld from public inspection, the cover page of the filing must prominently display that the report seeks confidential treatment, and cover all of the material to which the request applies. Such parties also are encouraged to coordinate with the Auctions and Spectrum Access Division staff if they have any questions about the procedures for submitting such reports. The
23. Applicants that are winning bidders will be required to disclose in their long-form applications the specific terms, conditions, and parties involved in any bidding consortia, joint venture, partnership, or agreement, understanding, or other arrangement entered into relating to the competitive bidding process, including any agreement relating to the post-auction market structure. Applicants must be aware that failure to comply with the Commission's rules can result in enforcement action.
24. Applicants are also reminded that, regardless of compliance with the Commission's rules, they remain subject to the antitrust laws, which are designed to prevent anticompetitive behavior in the marketplace. Compliance with the disclosure requirements of 47 CFR 1.2105(c) will not insulate a party from enforcement of the antitrust laws. For instance, a violation of the antitrust laws could arise out of actions taking place well before any party submitted a short-form application. The Commission has cited a number of examples of potentially anticompetitive actions that would be prohibited under antitrust laws: For example, actual or potential competitors may not agree to divide territories in order to minimize competition, regardless of whether they split a market in which they both do business, or whether they merely reserve one market for one and another market for the other. Similarly, the Bureau previously reminded potential applicants and others that even where the applicant discloses parties with whom it has reached an agreement on the short-form application, thereby permitting discussions with those parties, the applicant is nevertheless subject to existing antitrust laws.
25. To the extent the Commission becomes aware of specific allegations that suggest that violations of the federal antitrust laws may have occurred, the Commission may refer such allegations to the United States Department of Justice for investigation. If an applicant is found to have violated the antitrust laws or the Commission's rules in connection with its participation in the competitive bidding process, it may be subject to forfeiture of its upfront payment, down payment, or full bid amount and may be prohibited from participating in future auctions, among other sanctions.
26. 700 MHz Band licensees must operate in accordance with Commission rules to reduce the potential for interference to public reception of the signals of digital television (DTV) broadcast stations transmitting on DTV Channel 51. These limitations may restrict the ability of such geographic area licensees to use certain portions of the electromagnetic spectrum or provide service to some parts of their geographic license areas.
27. Potential bidders seeking licenses for geographic areas that are near the Canadian or Mexican borders are subject to international agreements with Canada and Mexico. Pursuant to these agreements, the U.S. must protect the signals of Canadian and Mexican television broadcast stations located in the border area. Unless otherwise modified by international treaty, licensees must not cause interference to, and must accept harmful interference from, television broadcast operations in Mexico and Canada. Further, until such time as existing agreements are replaced or modified to reflect the new uses, licensees in the band will be subject to existing agreements.
28. 700 MHz band licensees must protect the radio quiet zones specified at 47 CFR 1.924. Licensees are cautioned that they must receive the appropriate approvals directly from the relevant quiet zone entity prior to operating within the areas described in 47 CFR 1.924.
29. To avoid anti-competitive spectrum aggregation, the Commission in 2008 announced its intention to apply prospectively a competitive analysis to spectrum acquired through auctions, just as the Commission has done previously to spectrum acquired through transactions. Accordingly, the Bureau will apply a competitive analysis to spectrum acquired through this auction when evaluating the winning bidder's long-form application. The Commission's competitive analysis includes an examination of the appropriate market definitions including a determination of the product market, geographic markets, market participants, and the input market for spectrum available for the provision of mobile telephony/broadband services.
30. Each applicant must take seriously its duties and responsibilities and carefully determine before filing an application that the applicant has the legal, technical and financial resources to participate in Auction 92, as well as construct and operate a 700 MHz facility if the auction applicant becomes a licensee as a result of its participation in this auction.
31. The Bureau cautions potential applicants formulating their bidding strategies to investigate and consider the extent to which these frequencies are occupied, and how such occupancy may affect their business plans. For example, there are incumbent operations already licensed and operating in these bands that must be protected. These limitations may restrict the ability of licensees to use certain portions of the electromagnetic spectrum or provide
32. Potential applicants are reminded that they are solely responsible for investigating and evaluating all technical and marketplace factors that may have a bearing on the value of the licenses being offered in this auction. Bidders are responsible for assuring themselves that, if they win a license, they will be able to build and operate facilities in accordance with the Commission's rules. The Commission makes no representations or warranties about the use of this spectrum for particular services. Applicants should be aware that an FCC auction represents an opportunity to become a licensee subject to certain conditions and regulations. An FCC auction does not constitute an endorsement by the FCC of any particular service, technology, or product, nor does an FCC license constitute a guarantee of business success.
33. Applicants should perform their individual due diligence before proceeding, as they would with any new business venture. In particular, potential applicants are strongly encouraged to conduct their own research prior to the beginning of bidding in Auction 92 in order to determine the existence of any pending legislative, administrative, or judicial proceedings that might affect their decisions regarding participation in the auction. Participants in Auction 92 are strongly encouraged to continue such research throughout the auction. In addition, potential bidders should perform technical analyses sufficient to assure themselves that, should they be a winning bidder in competitive bidding for a specific license, they will be able to build and operate facilities that will fully comply with the Commission's technical and legal requirements as well as other applicable Federal, state, and local laws.
34. Applicants should also be aware that certain pending and future proceedings, including rulemaking proceedings or petitions for rulemaking, applications (including those for modification), requests for special temporary authority, waiver requests, petitions to deny, petitions for reconsideration, informal oppositions, and applications for review, before the Commission may relate to particular applicants or incumbent licensees or the licenses available in Auction 92. In addition, pending and future judicial proceedings may also relate to particular applicants or incumbent licensees, or to the licenses available in Auction 92. Prospective applicants are responsible for assessing the likelihood of the various possible outcomes and for considering their potential impact on spectrum licenses available in this auction.
35. Applicants should perform due diligence to identify and consider all proceedings that may affect the spectrum licenses being auctioned and that could have an impact on the availability of spectrum for Auction 92. In addition, although the Commission may continue to act on various pending applications, informal objections, petitions, and other requests for Commission relief, some of these matters may not be resolved by the beginning of bidding in the auction. Applicants are solely responsible for identifying associated risks and for investigating and evaluating the degree to which such matters may affect their ability to bid on, otherwise acquire, or make use of licenses being offered in this auction.
36. Applicants may research the Bureau's licensing database on the Internet in order to determine which frequencies are already licensed to incumbent licensees. Applicants may obtain information about licenses available in Auction 92 through the Bureau's online licensing databases at
37. The Commission makes no representations or guarantees regarding the accuracy or completeness of information in its databases or any third party databases, including, for example, court docketing systems. To the extent the Commission's databases may not include all information deemed necessary or desirable by an applicant, applicants may obtain or verify such information from independent sources or assume the risk of any incompleteness or inaccuracy in said databases. Furthermore, the Commission makes no representations or guarantees regarding the accuracy or completeness of information that has been provided by incumbent licensees and incorporated into its databases.
38. Potential applicants are strongly encouraged to physically inspect any prospective sites located in, or near, the geographic area for which they plan to bid, and also to familiarize themselves with the relevant environmental review obligations.
39. The Commission will make available a browser-based bidding system to allow bidders to participate in Auction 92 over the Internet using the Commission's Integrated Spectrum Auction System (ISAS or FCC Auction System). The Commission makes no warranty whatsoever with respect to the FCC Auction System. In no event shall the Commission, or any of its officers, employees, or agents, be liable for any damages whatsoever (including, but not limited to, loss of business profits, business interruption, loss of business information, or any other loss) arising out of or relating to the existence, furnishing, functioning, or use of the FCC Auction System that is accessible to qualified bidders in connection with this auction. Moreover, no obligation or liability will arise out of the Commission's technical, programming, or other advice or service provided in connection with the FCC Auction System.
40. Licensees must comply with the Commission's rules regarding implementation of the National Environmental Policy Act and other federal environmental statutes. The construction of a wireless antenna facility is a federal action and the licensee must comply with the Commission's environmental rules for each such facility. Further information about such environmental review requirements is provided in the
41. Bidding in Auction 92 will begin on Tuesday, July 19, 2011. The initial schedule for bidding will be announced by public notice at least one week before the start of the auction. Unless otherwise announced, bidding on all licenses will be conducted on each business day until bidding has stopped on all licenses.
42. As discussed in more detail in the
43. The following dates and deadlines apply:
44. Those wishing to participate in this auction must: (1) submit a short-form application (FCC Form 175) electronically prior to 6:00 p.m. ET, May 11, 2011, following the electronic filing procedures set forth in Attachment C to the
45. An application to participate in an FCC auction, referred to as a short-form application or FCC Form 175, provides information used in determining whether the applicant is legally, technically, and financially qualified to participate in Commission auctions for licenses or permits. The short-form application is the first part of the Commission's two-phased auction application process. In the first phase of this process, parties desiring to participate in the auction must file streamlined, short-form applications in which they certify under penalty of perjury as to their qualifications. Eligibility to participate in bidding is based on the applicants' short-form applications and certifications as well as their upfront payments. In the second phase of the process, winning bidders must file a more comprehensive long-form application (FCC Form 601) and have a complete and accurate ownership disclosure information report (FCC Form 602) on file with the Commission.
46. Entities and individuals seeking licenses available in Auction 92 must file a short-form application electronically via the FCC Auction System prior to 6 p.m. ET on May 11, 2011, following the procedures prescribed in Attachment C to the
47. Applicants bear full responsibility for submitting accurate, complete and timely short-form applications. All applicants must certify on their short-form applications under penalty of perjury that they are legally, technically, financially and otherwise qualified to hold a license. Applicants should read carefully the instructions set forth in Attachment C to the
48. An individual or entity may not submit more than one short-form application for a single auction. If a party submits multiple short-form applications, only one application may be accepted for filing.
49. Applicants also should note that submission of a short-form application (and any amendments thereto) constitutes a representation by the certifying official that he or she is an authorized representative of the applicant, that he or she has read the form's instructions and certifications, and that the contents of the application, its certifications, and any attachments are true and correct. Applicants are not permitted to make major modifications to their applications; such impermissible changes include a change of the certifying official to the application. Submission of a false certification to the Commission may result in penalties, including monetary forfeitures, license forfeitures, ineligibility to participate in future auctions, and/or criminal prosecution.
50. An applicant must select the licenses on which it wants to bid from the Eligible Licenses list on its short-form application. Applicants interested in participating in Auction 92 must have selected license(s) available in this auction by the short-form application filing deadline. Applicants must review and verify their license selections before the deadline for submitting short-form applications. Applicants will not be able to change their license selections after the short-form application filing deadline. The FCC Auction System will not accept bids from an applicant on licenses that the applicant has not selected on its short-form application.
51. Applicants will be required to identify in their short-form application all parties with whom they have entered into any agreements, arrangements, or understandings of any kind relating to the licenses being auctioned, including any agreements relating to post-auction market structure.
52. After the filing of short-form applications, the Commission's rules do not prohibit a party holding a non-controlling, attributable interest in one applicant from acquiring an ownership interest in or entering into a joint bidding arrangement with other applicants, provided that: (1) The attributable interest holder certifies that it has not and will not communicate with any party concerning the bids or bidding strategies of more than one of the applicants in which it holds an attributable interest, or with which it has entered into a joint bidding arrangement; and (2) the arrangements do not result in a change in control of any of the applicants.
53. All applicants must comply with the uniform Part 1 ownership disclosure standards and provide information
54. In certain circumstances, an applicant's most current ownership information on file with the Commission, if in an electronic format compatible with the short-form application (such as information submitted in an on-line FCC Form 602 or in an FCC Form 175 filed for a previous auction using ISAS) will automatically be entered into the applicant's short-form application. Each applicant is responsible for ensuring that the information submitted in their short-form application for Auction 92 is complete and accurate. Accordingly, applicants should carefully review any information automatically entered to confirm that it is complete and accurate as of the deadline for filing the short-form application. Applicants can update directly in the short-form application any information that was entered automatically and needs to be changed.
55. Eligible applicants in Auction 92 may claim small business bidding credits. In addition to the information provided below, applicants should review carefully the Commission's decisions regarding the designated entity provisions.
56. A bidding credit represents an amount by which a bidder's winning bid will be discounted. For Auction 92, bidding credits will be available to small businesses and very small businesses, and consortia thereof.
57. The level of bidding credit is determined as follows: (1) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) will receive a 15 percent discount on its winning bid; and (2) a bidder with attributed average annual gross revenues that do not exceed $15 million for the preceding three years (very small business) will receive a 25 percent discount on its winning bid.
58. Bidding credits are not cumulative. A qualifying applicant may claim either a 15 percent or 25 percent bidding credit on its winning bid.
59. An entity applying as a small or very small business must provide gross revenues for the preceding three years of each of the following: (1) The applicant, (2) its affiliates, (3) its controlling interests, (4) the affiliates of its controlling interests, and (5) the entities with which it has an attributable material relationship. Certification that the average annual gross revenues of such entities and individuals for the preceding three years do not exceed the applicable limit is not sufficient. Additionally, if an applicant is applying as a consortium of small businesses or very small businesses, this information must be provided for each consortium member.
60. Controlling interests of an applicant include individuals and entities with either
61. Applicants should refer to 47 CFR 1.2110(c)(2) and Attachment C of the
62. Affiliates of an applicant or controlling interest include an individual or entity that: (1) Directly or indirectly controls or has the power to control the applicant; (2) is directly or indirectly controlled by the applicant; (3) is directly or indirectly controlled by a third party that also controls or has the power to control the applicant; or (4) has an “identity of interest” with the applicant. The Commission's definition of an affiliate of the applicant encompasses both controlling interests of the applicant and affiliates of controlling interests of the applicant. For more information regarding affiliates, applicants should refer to 47 CFR 1.2110(c)(5) and Attachment C to the
63. The Commission requires the consideration of certain leasing and resale (including wholesale) relationships—referred to as attributable material relationships—in determining designated entity eligibility for bidding credits. An applicant or licensee has an attributable material relationship when it has one or more agreements with any individual entity for the lease or resale (including under a wholesale agreement) of, on a cumulative basis, more than 25 percent of the spectrum capacity of any individual license held by the applicant or licensee. The attributable material relationship will cause the gross revenues of that entity and its attributable interest holders to be attributed to the applicant or licensee for the purposes of determining the applicant's or licensee's (i) eligibility for designated entity benefits and (ii) liability for unjust enrichment on a license-by-license basis.
64. The Commission grandfathered material relationships in existence before the release of the
65. The Commission has clarified that, in calculating an applicant's gross revenues under the controlling interest standard, it will not attribute to the applicant the personal net worth, including personal income, of its officers and directors. However, to the
66. The Commission has also exempted from attribution to the applicant the gross revenues of the affiliates of a rural telephone cooperative's officers and directors, if certain conditions specified in 47 CFR 1.2110(b)(3)(iii) are met. An applicant claiming this exemption must provide, in an attachment, an affirmative statement that the applicant, affiliate and/or controlling interest is an eligible rural telephone cooperative within the meaning of 47 CFR 1.2110(b)(3)(iii), and the applicant must supply any additional information as may be required to demonstrate eligibility for the exemption from the attribution rule. Applicants seeking to claim this exemption must meet all of the conditions. Additional guidance on claiming this exemption may be found in Attachment C to the
67. A consortium of small businesses or very small businesses is a conglomerate organization composed of two or more entities, each of which individually satisfies the definition of a small business or very small business. Thus, each member of a consortium of small businesses or very small businesses that applies to participate in Auction 92 must individually meet the criteria for small businesses or very small businesses. Each consortium member must disclose its gross revenues along with those of its affiliates, its controlling interests, the affiliates of its controlling interests, and any entities having an attributable material relationship with the member. Although the gross revenues of the consortium members will not be aggregated for purposes of determining the consortium's eligibility as a small business or very small business, this information must be provided to ensure that each individual consortium member qualifies for any bidding credit awarded to the consortium.
68. Applicants do not provide information regarding tribal lands bidding credits on their short-form applications. Instead, winning bidders may apply for the tribal lands bidding credit after the auction when they file their more detailed, long-form applications.
69. Current defaulters or delinquents are not eligible to participate in Auction 92, but former defaulters can participate so long as they are otherwise qualified and make upfront payments that are fifty percent more than the normal upfront payment amounts. An applicant is considered a current defaulter or a current delinquent when it, any of its affiliates, any of its controlling interests, or any of the affiliates of its controlling interests, is in default on any payment for any Commission license (including a down payment) or is delinquent on any non-tax debt owed to any Federal agency as of the filing deadline for short-form applications. An applicant is considered a former defaulter or a former delinquent when it, any of its affiliates, any of its controlling interests, or any of the affiliates of its controlling interests, have defaulted on any Commission license or been delinquent on any non-tax debt owed to any Federal agency, but have since remedied all such defaults and cured all of the outstanding non-tax delinquencies.
70. On the short-form application, an applicant must certify under penalty of perjury that it, its affiliates, its controlling interests, and the affiliates of its controlling interests, as defined by 47 CFR 1.2110, are not in default on any payment for a Commission license (including down payments) and that it is not delinquent on any non-tax debt owed to any Federal agency. Each applicant must also state under penalty of perjury whether it, its affiliates, its controlling interests, and the affiliates of its controlling interests, have ever been in default on any Commission license or have ever been delinquent on any non-tax debt owed to any Federal agency. Prospective applicants are reminded that submission of a false certification to the Commission is a serious matter that may result in severe penalties, including monetary forfeitures, license revocations, exclusion from participation in future auctions, and/or criminal prosecution. These statements and certifications are prerequisites to submitting an application to participate in an FCC auction.
71. Applicants are encouraged to review the Bureau's previous guidance on default and delinquency disclosure requirements in the context of the short-form application process. For example, to the extent that Commission rules permit late payment of regulatory or application fees accompanied by late fees, such debts will become delinquent for purposes of 47 CFR 1.2105(a) and 1.2106(a) only after the expiration of a final payment deadline. Therefore, with respect to regulatory or application fees, the provisions of 47 CFR 1.2105(a) and 1.2106(a) regarding default and delinquency in connection with competitive bidding are limited to circumstances in which the relevant party has not complied with a final Commission payment deadline. Parties are also encouraged to consult with the Bureau's Auctions and Spectrum Access Division staff if they have any questions about default and delinquency disclosure requirements.
72. The Commission considers outstanding debts owed to the United States Government, in any amount, to be a serious matter. The Commission adopted rules, including a provision referred to as the red light rule, that implement the Commission's obligations under the Debt Collection Improvement Act of 1996, which governs the collection of claims owed to the United States. Under the red light rule, the Commission will not process applications and other requests for benefits filed by parties that have outstanding debts owed to the Commission. In the same rulemaking order, the Commission explicitly declared, however, that the Commission's competitive bidding rules are not affected by the red light rule. As a consequence, the Commission's adoption of the red light rule does not alter the applicability of any of the Commission's competitive bidding rules, including the provisions and certifications of 47 CFR 1.2105 and 1.2106, with regard to current and former defaults or delinquencies.
73. Applicants are reminded, however, that the Commission's Red Light Display System, which provides information regarding debts currently owed to the Commission, may not be determinative of an auction applicant's ability to comply with the default and delinquency disclosure requirements of 47 CFR 1.2105. Thus, while the red light rule ultimately may prevent the processing of long-form applications by auction winners, an auction applicant's lack of current red light status is not necessarily determinative of its eligibility to participate in an auction or of its upfront payment obligation.
74. Moreover, prospective applicants in Auction 92 should note that any long-form applications filed after the close of bidding will be reviewed for compliance with the Commission's red light rule, and such review may result in the
75. Applicants owned by members of minority groups and/or women, as defined in 47 CFR 1.2110(c)(3), and rural telephone companies, as defined in 47 CFR 1.2110(c)(4), may identify themselves regarding this status in filling out their short-form applications. This applicant status information is collected for statistical purposes only and assists the Commission in monitoring the participation of designated entities in its auctions.
76. After the deadline for filing initial applications, an Auction 92 applicant is permitted to make only minor changes to its application. Permissible minor changes include, among other things, deletion and addition of authorized bidders (to a maximum of three) and revision of addresses and telephone numbers of the applicant and its contact person. An applicant is not permitted to make a major modification to its application (
77. If an applicant wishes to make permissible minor changes to its short-form application, such changes should be made electronically to its short-form application using the FCC Auction System whenever possible. Applicants are reminded to click on the SUBMIT button in the FCC Auction System for the change to be submitted and considered by the Commission. After the revised application has been submitted, a confirmation page will be displayed that states the submission time, submission date and a unique file number. The Bureau advises applicant to print and retain a copy of this confirmation page.
78. An applicant cannot use the FCC Auction System outside of the initial and resubmission filing windows to make changes to its short-form application other than administrative changes (
79. Any letter describing changes to an applicant's short-form application should be submitted by e-mail to
80. Any application amendment and related statements of fact must be certified by (1) the applicant, if the applicant is an individual; (2) one of the partners if the applicant is a partnership; (3) an officer, director, or duly authorized employee, if the applicant is a corporation; (4) a member who is an officer, if the applicant is an unincorporated association; (5) the trustee, if the applicant is an amateur radio service club; or (6) a duly elected or appointed official who is authorized to make such certifications under the laws of the applicable jurisdiction, if the applicant is a governmental entity.
81. Applicants must not submit application-specific material through the Commission's Electronic Comment Filing System (ECFS), which was used for submitting comments regarding Auction 92. Parties submitting information related to their applications should use caution to ensure that their submissions do not contain confidential information or communicate information that would violate 47 CFR 1.2105(c) or the limited information procedures adopted for Auction 92. A party seeking to submit information that might reflect non-public information, such as an applicant's license selections, upfront payment amount, or bidding eligibility, should consider submitting any such information along with a request that the filing or portions of the filing be withheld from public inspection until the end of the prohibition of certain communications pursuant to 47 CFR 1.2105(c).
82. 47 CFR 1.65 and 1.2105(b) require an applicant to maintain the accuracy and completeness of information furnished in its pending application and in competitive bidding proceedings to furnish additional or corrected information to the Commission within five days of a significant occurrence, or to amend a short form application no more than five days after the applicant becomes aware of the need for the amendment. Changes that cause a loss of or reduction in the percentage of bidding credit specified on the originally submitted application must be reported immediately, and no later than five business days after the change occurs. If an amendment reporting substantial changes is a major amendment, as defined by 47 CFR 1.2105, the major amendment will not be accepted and may result in the dismissal of the application. As explained previously, after the application filing deadline, applicants may make only minor changes to their applications. Applicants must click on the SUBMIT button in the FCC Auction System for the changes to be submitted and considered by the Commission. In addition, an applicant cannot update its short-form application using the FCC Auction System after the initial and resubmission filing windows close. If 47 CFR 1.65 submissions are needed after these windows close, applicants must submit a letter, briefly summarizing the changes, by e-mail to
83. No later than Monday, May 2, 2011, the Commission will post an educational auction tutorial on the Auction 92 web page for prospective bidders to familiarize themselves with the auction process. This online tutorial will provide information about pre-auction procedures, completing short-form applications, auction conduct, the FCC Auction Bidding System, auction rules, and 700 MHz Band service rules. The tutorial will also provide an avenue to ask FCC staff questions about the auction, auction procedures, filing requirements, and other matters related to this auction.
84. The auction tutorial will be accessible through a web browser from the FCC's Auction 92 web page at
85. In order to be eligible to bid in this auction, applicants must first follow the procedures set forth in Attachment C to the
86. Applications may generally be filed at any time beginning at noon ET on May 2, 2011, until the filing window closes at 6 p.m. ET on May 11, 2011. Applicants are strongly encouraged to file early and are responsible for allowing adequate time for filing their applications. Applicants may update or amend their applications multiple times until the filing deadline on May 11, 2011.
87. An applicant must always click on the SUBMIT button on the Certify & Submit screen to successfully submit its FCC Form 175 and any modifications; otherwise the application or changes to the application will not be received or reviewed. Additional information about accessing, completing, and viewing the FCC Form 175 is included in Attachment C of the
88. After the deadline for filing FCC Form 175 applications, the Commission will process all timely submitted applications to determine which are complete, and subsequently will issue a public notice identifying (1) those applications that are complete; (2) those applications that are rejected; and (3) those applications that are incomplete because of minor defects that may be corrected. The public notice will include the deadline for resubmitting corrected applications.
89. After the application filing deadline on May 11, 2011, applicants continue to be able to make only minor corrections to their applications. Applicants will not be permitted to make major modifications to their applications (
90. Commission staff will communicate only with an applicant's contact person or certifying official, as designated on the applicant's short-form application, unless the applicant's certifying official or contact person notifies the Commission in writing that applicant's counsel or other representative is authorized to speak on its behalf. Authorizations may be sent by e-mail to
91. In order to be eligible to bid in this auction, applicants must submit an upfront payment accompanied by an FCC Remittance Advice Form (FCC Form 159). After completing its short-form application, an applicant will have access to an electronic version of the FCC Form 159 that can be printed and sent by fax to U.S. Bank in St. Louis, Missouri. All upfront payments must be made as instructed in the
92. Wire transfer payments must be received before 6 p.m. ET on June 17, 2011. No other payment method is acceptable. The Commission will not accept checks, credit cards, or automated clearing house (ACH) payments to satisfy this upfront payment requirement. To avoid untimely payments, applicants should discuss arrangements (including bank closing schedules) with their bankers several days before they plan to make the wire transfer, and allow sufficient time for the transfer to be initiated and completed before the deadline. Information required for this wire transfer is specified in the
93. At least one hour before placing the order for the wire transfer (but on the same business day), applicants must fax a completed FCC Form 159 (Revised 2/03) to U.S. Bank at (314) 418-4232. On the fax cover sheet, applicants should write Wire Transfer—Auction Payment for Auction 92. In order to meet the Commission's upfront payment deadline, an applicant's payment must be credited to the Commission's account for Auction 92 before the deadline.
94. Each applicant is responsible for ensuring timely submission of its upfront payment and for timely filing of an accurate and complete FCC Remittance Advice Form (FCC Form 159). An applicant should coordinate with its financial institution well ahead of the due date regarding its wire transfer and allow sufficient time for the wire transfer to be initiated and completed prior to the deadline. The Commission repeatedly has cautioned auction participants about the importance of planning ahead to prepare for unforeseen last-minute difficulties in making payments by wire transfer. Each applicant also is responsible for obtaining confirmation from its financial institution that its wire transfer to U.S. Bank was successful and from Commission staff that the Commission has timely received the applicant's upfront payment and deposited it into the proper account. For confirmation that the Commission has timely received the applicant's upfront payment and deposited it into the proper account, an applicant may contact Gail Glasser of the Office of Managing Director's Auctions Accounting Group at (202) 418-0578, or alternatively, Theresa Meeks at (202) 418-2945.
95. Please note the following information regarding upfront payments: (1) All payments must be made in U.S. dollars; (2) all payments must be made by wire transfer; (3) upfront payments for Auction 92 go to a lockbox number different from the lockboxes used in previous FCC auctions, and (4) failure to deliver a sufficient upfront payment as instructed by the June 17, 2011, deadline will result in dismissal of the short-form
96. A completed FCC Remittance Advice Form (FCC Form 159, Revised 2/03) must be faxed to U.S. Bank to accompany each upfront payment. Proper completion of FCC Form 159 is critical to ensuring correct crediting of upfront payments. Detailed instructions for completion of FCC Form 159 are included in Attachment D to the
97. Applicants that are former defaulters, as described above, must pay upfront payments 50 percent greater than non-former defaulters. For purposes of this calculation, the applicant includes the applicant itself, its affiliates, its controlling interests, and affiliates of its controlling interests, as defined by 47 CFR 1.2110.
98. Applicants must make upfront payments sufficient to obtain bidding eligibility on the licenses on which they will bid. The amount of the upfront payment determines a bidder's initial bidding eligibility, the maximum number of bidding units on which a bidder may place bids. In order to bid on a particular license, a qualified bidder must have selected the license on its FCC Form 175 and must have a current eligibility level that meets or exceeds the number of bidding units assigned to that license. At a minimum, therefore, an applicant's total upfront payment must be enough to establish eligibility to bid on at least one of the licenses selected on its FCC Form 175, or else the applicant will not be eligible to participate in the auction. A bidder's total upfront payment does not affect the total dollar amount the bidder may bid on any given license. An applicant does not have to make an upfront payment to cover all licenses the applicant selected on its FCC Form 175, but only enough to cover the maximum number of bidding units that are associated with licenses on which the bidder wishes to place bids and hold provisionally winning bids in any given round. Provisionally winning bids are bids that would become final winning bids if the auction were to close after the given round.
99. Each license in Auction 92 is assigned a specific number of bidding units equal to the upfront payment listed for the license, on a bidding unit for dollar basis. The bidding unit level for each license will remain constant throughout the auction.
100. The upfront payment amount submitted by each applicant determines a bidder's initial bidding eligibility. The upfront payments and bidding units for each license in Auction 92 are set forth in Attachment A of the
101. In calculating its upfront payment amount, an applicant should determine the maximum number of bidding units on which it may wish to be active (bid on or hold provisionally winning bids on) in any single round, and submit an upfront payment amount covering that number of bidding units. In order to make this calculation, an applicant should add together the bidding units for all licenses on which it seeks to be active in any given round. Applicants should check their calculations carefully, as there is no provision for increasing a bidder's eligibility after the upfront payment deadline.
102. If an applicant is a former defaulter, it must calculate its upfront payment for all of its identified licenses by multiplying the number of bidding units on which it wishes to be active by 1.5. In order to calculate the number of bidding units to assign to former defaulters, the Commission will divide the upfront payment received by 1.5 and round the result up to the nearest bidding unit. If a former defaulter fails to submit a sufficient upfront payment to establish eligibility to bid on at least one of the licenses selected on its FCC Form 175, the applicant will not be eligible to participate in the auction.
103. To ensure that refunds of upfront payments are processed in an expeditious manner, the Commission is requesting that all pertinent refund information specified in the
104. Approximately ten days before the auction, the Bureau will issue a public notice announcing all qualified bidders for the auction. Qualified bidders are those applicants with submitted FCC Form 175 applications that are deemed timely-filed, accurate, and complete, provided that such applicants have timely submitted an upfront payment that is sufficient to qualify them to bid.
105. All qualified bidders are automatically registered for the auction. Registration materials will be distributed prior to the auction by overnight mail. The mailing will be sent only to the contact person at the contact address listed in the FCC Form 175 and will include the SecurID® tokens that will be required to place bids, the Integrated Spectrum Auction System (ISAS) Bidder's Guide, and the Auction Bidder Line phone number.
106. Qualified bidders that do not receive this registration mailing will not be able to submit bids. Therefore, any qualified bidder that has not received this mailing by noon on Wednesday, July 13, 2011, should call (717) 338-2868. Receipt of this registration mailing is critical to participating in the auction, and each applicant is responsible for ensuring it has received all of the registration material.
107. In the event that SecurID® tokens are lost or damaged, only a person who has been designated as an authorized bidder, the contact person, or the certifying official on the applicant's short-form application may request replacements. Qualified bidders requiring the replacement of these items must call Technical Support at (877) 480-3201, option nine; (202) 414-1250; or (202) 414-1255 (TTY).
108. The Commission will conduct this auction over the Internet, and telephonic bidding will be available as well. Only qualified bidders are permitted to bid. Each applicant should indicate its bidding preference—electronic or telephonic—on its FCC Form 175. In either case, each authorized bidder must have its own SecurID® token, which the Commission
109. Please note that the SecurID® tokens can be recycled, and the Bureau encourages bidders to return the tokens to the FCC. The Bureau will provide pre-addressed envelopes that bidders may use to return the tokens once the auction has ended.
110. All qualified bidders will be eligible to participate in a mock auction on Friday, July 15, 2011. The mock auction will enable qualified bidders to become familiar with the FCC Auction System prior to the auction. Participation by all bidders is strongly recommended. Details will be announced by public notice.
111. The first round of bidding for Auction 92 will begin on Tuesday, July 19, 2011. The initial bidding schedule will be announced in a public notice listing the qualified bidders, which is to be released approximately 10 days before the start of the auction.
112. All licenses in Auction 92 will be offered in a single auction using the Commission's standard simultaneous multiple-round (SMR) auction format. This type of auction offers every license for bid at the same time and consists of successive bidding rounds in which eligible bidders may place bids on individual licenses. A bidder may bid on, and potentially win, any number of licenses. Unless otherwise announced, bids will be accepted on all licenses in each round of the auction until bidding stops on every license.
113. After consideration of the comments submitted on this issue, the Bureau decided to restrict the information available to bidders in this auction. Pursuant to the anonymous bidding procedures adopted for Auction 92, the Bureau will withhold, until after the close of bidding, public release of (1) bidders' license selections on their short-form applications (FCC Form 175), (2) the amounts of bidders' upfront payments and bidding eligibility, and (3) information that may reveal the identities of bidders placing bids and taking other bidding-related actions.
114. After the conclusion of each round, the Bureau will disclose all relevant information about the bids placed and/or withdrawn except the identities of the bidders performing the actions and the net amounts of the bids placed or withdrawn. As in past auctions conducted with limited information procedures, the Bureau will indicate, for each license, the minimum acceptable bid amount for the next round and whether the license has a provisionally winning bid. After each round, the Bureau will also release, for each license, the number of bidders that placed a bid on the license. Furthermore, the Bureau will indicate whether any proactive waivers were submitted in each round, and the Bureau will release the stage transition percentage—the percentages of licenses (as measured in bidding units) on which there were new bids—for the round. In addition, bidders can log in to the FCC Auction System to see, after each round, whether their own bids are provisionally winning. The Bureau will provide descriptions and/or samples of publicly-available and bidder-specific (non-public) results files prior to the start of the auction.
115. The Bureau, however, retains the discretion not to use limited information procedures if the Bureau, after examining the level of potential competition as expressed in the license selection on the short-form applications filed for Auction 92, determines that the circumstances indicate that limited information procedures would not be an effective tool for deterring anti-competitive behavior. For example, if only two applicants become qualified to participate in the bidding, limited information procedures would be ineffective in preventing bidders from knowing the identity of the competing bidder and, therefore, limited information procedures would not serve to deter attempts at signaling and retaliatory bidding behavior.
116.
117. In Auction 92, the Commission will not disclose information regarding license selection or the amounts of bidders' upfront payments and bidding eligibility. As in the past, the Commission will disclose the other portions of applicants' short-form applications through its online database, and certain application-based information through public notices.
118. To assist applicants in identifying other parties subject to 47 CFR 1.2105(c), the Bureau will notify separately each applicant in Auction 92 whether applicants with short-form applications to participate in pending auctions, including but not limited to Auction 92, have applied for licenses in any of the same geographic areas as that applicant. Specifically, after the Bureau conducts its initial review of applications to participate in Auction 92, it will send to each applicant in Auction 92 a letter that lists the other applicants that have pending short-form applications for licenses in any of the same geographic areas. The list will identify the other applicants by name but will not list their license selections. As in past auctions, additional information regarding other applicants that is needed to comply with 47 CFR 1.2105(c)—such as the identities of other applicants' controlling interests and entities with a greater than ten percent ownership interest—will be available through the publicly accessible online short-form application database. For purposes of 47 CFR 1.2105(c), the term applicant includes all officers and directors of the applicant and all other controlling interests, as well as all parties with ownership interests greater than ten percent.
119. When completing short-form applications, applicants should avoid any statements or disclosures that may violate the prohibition of certain communications pursuant to 47 CFR 1.2105(c), particularly in light of the Commission's procedures regarding the availability of certain information in Auction 92. While applicants' license selections will not be disclosed until after Auction 92 closes, the Commission will disclose other portions of short-form applications through its online database and public notices. Accordingly, applicants must avoid including any information in their short-form applications that might
120. If an applicant is found to have violated the Commission's rules or antitrust laws in connection with its participation in the competitive bidding process, the applicant may be subject to various sanctions, including forfeiture of its upfront payment, down payment, or full bid amount and prohibition from participating in future auctions.
121. Direct or indirect communication to other applicants or the public disclosure of non-public information (
122. The Bureau will use upfront payments to determine initial (maximum) eligibility (as measured in bidding units) for Auction 92. The amount of the upfront payment submitted by a bidder determines initial bidding eligibility, the maximum number of bidding units on which a bidder may be active. Each license is assigned the specific number of bidding units listed in Attachment A of the
123. In order to ensure that an auction closes within a reasonable period of time, an activity rule requires bidders to bid actively throughout the auction, rather than wait until late in the auction before participating. Bidders are required to be active on a specific percentage of their current bidding eligibility during each round of the auction.
124. A bidder's activity level in a round is the sum of the bidding units associated with any licenses covered by new and provisionally winning bids. A bidder is considered active on a license in the current round if it is either the provisionally winning bidder at the end of the previous bidding round and does not withdraw the provisionally winning bid in the current round, or if it submits a bid in the current round.
125. The minimum required activity is expressed as a percentage of the bidder's current eligibility, and increases by stage as the auction progresses. Failure to maintain the requisite activity level will result in the use of an activity rule waiver, if any remain, or a reduction in the bidder's eligibility, possibly curtailing or eliminating the bidder's ability to place additional bids in the auction.
126. For now, the Bureau will conduct the auction in two stages and employ an activity rule. A bidder desiring to maintain its current bidding eligibility would be required to be active on licenses representing at least 80 percent of its current bidding eligibility, during each round of Stage One, and at least 95 percent of its current bidding eligibility in Stage Two.
127.
128.
129.
130. The Bureau has the discretion to further alter the activity requirements before and/or during the auction as circumstances warrant, and also has other mechanisms by which it may influence the speed of an auction.
131. The auction will start in Stage One. The Bureau will regulate the pace of the auction by announcement. The Bureau retains the discretion to change the activity requirements during the auction. For example, the Bureau could transition the auction to Stage Two, to add an additional stage with a higher activity requirement, not to transition to Stage Two, and to transition to Stage Two with an activity requirement that is higher or lower than 95 percent. This determination will be based on a variety of measures of auction activity, including, but not limited to, the number of new bids and the percentages of licenses (as measured in bidding units) on which there are new bids. Potential bidders should note that the stage of the auction does not affect the auction stopping rules. The auction may conclude in Stage One.
132. Each bidder in the auction will be provided with three activity rule
133. The FCC Auction System assumes that bidders with insufficient activity would prefer to apply an activity rule waiver (if available) rather than lose bidding eligibility. Therefore, the system will automatically apply a waiver at the end of any bidding round where a bidder's activity level is below the minimum required unless (1) there are no activity rule waivers available or (2) the bidder overrides the automatic application of a waiver by reducing eligibility. If a bidder has no waivers remaining and does not satisfy the activity requirement, the FCC Auction System will permanently reduce the bidder's eligibility, possibly curtailing or eliminating the bidder's ability to place additional bids in the auction.
134. A bidder with insufficient activity that wants to reduce its bidding eligibility rather than use an activity rule waiver must affirmatively override the automatic waiver mechanism during the bidding round by using the reduce eligibility function in the FCC Auction System. In this case, the bidder's eligibility is permanently reduced to bring the bidder into compliance with the activity rule. Once eligibility has been reduced, a bidder will not be permitted to regain its lost bidding eligibility even if the round has not yet ended.
135. Finally, a bidder may apply an activity rule waiver proactively as a means to keep the auction open without placing a bid. If a bidder proactively applies an activity waiver (using the apply waiver function in the FCC Auction System) during a bidding round in which no bids are placed or withdrawn, the auction will remain open and the bidder's eligibility will be preserved. However, an automatic waiver applied by the FCC Auction System in a round in which there are no new bids, withdrawals, or proactive waivers will not keep the auction open. A bidder cannot submit a proactive waiver after submitting a bid in a round, and submitting a proactive waiver will preclude a bidder from placing any bids in that round. It is important for bidders to understand that applying a waiver is irreversible. Once a bidder submits a proactive waiver, the bidder cannot unsubmit the waiver even if the round has not yet ended.
136. For Auction 92, the Bureau will employ a simultaneous stopping rule approach. A simultaneous stopping rule means that all licenses remain available for bidding until bidding closes simultaneously on all licenses. More specifically, bidding will close simultaneously on all licenses after the first round in which no bidder submits any new bids, applies a proactive waiver, or withdraws any provisionally winning bids.
137. As explained in the Auction 92 Procedures Public Notice, the Bureau retains the discretion to exercise alternative stopping rules, with or without prior announcement in the auction. For example, under Option 1, the auction would close for all licenses after the first round in which no bidder applies a waiver, withdraws a provisionally winning bid, or places any new bids on any license on which it is not the provisionally winning bidder. Thus, absent any other bidding activity, a bidder placing a new bid on a license for which it is the provisionally winning bidder would not keep the auction open under this modified stopping rule. Under Option 2, the auction would close for all licenses after the first round in which no bidder applies a waiver, withdraws a provisionally winning bid, or places any new bids on any license that is not FCC held. Thus, absent any other bidding activity, a bidder placing a new bid on a license that does not already have a provisionally winning bid (an FCC-held license) would not keep the auction open under this modified stopping rule. Under Option 3, the auction would close using a modified version of the simultaneous stopping rule that combines Option 1 and Option 2. Under Option 4, the auction would end after a specified number of additional rounds. If the Bureau invokes this special stopping rule, it will accept bids in the specified final round(s) and the auction will close. Under Option 5, the auction would remain open even if no bidder places any new bids, applies a waiver, or withdraws any provisionally winning bids. In this event, the effect will be the same as if a bidder had applied a waiver. Thus, the activity rule will apply as usual, and a bidder with insufficient activity will either lose bidding eligibility or use a waiver.
138. By public notice or by announcement during the auction, the Bureau may delay, suspend, or cancel the auction in the event of natural disaster, technical obstacle, administrative or weather necessity, evidence of an auction security breach or unlawful bidding activity, or for any other reason that affects the fair and efficient conduct of competitive bidding. In such cases, the Bureau, in its sole discretion, may elect to resume the auction starting from the beginning of the current round, resume the auction starting from some previous round, or cancel the auction in its entirety. Network interruption may cause the Bureau to delay or suspend the auction. The Bureau emphasizes that exercise of this authority is solely within the discretion of the Bureau, and its use is not intended to be a substitute for situations in which bidders may wish to apply their activity rule waivers.
139. The initial schedule of bidding rounds will be announced in the public notice listing the qualified bidders, which is released approximately 10 days before the start of the auction. Each bidding round is followed by the release of round results. Multiple bidding rounds may be conducted in a given day. Details regarding round results formats and locations will also be included in the qualified bidders public notice.
140. The Bureau has the discretion to change the bidding schedule in order to foster an auction pace that reasonably balances speed with the bidders' need to study round results and adjust their bidding strategies. The Bureau may increase or decrease the amount of time for the bidding rounds, the amount of time between rounds, or the number of rounds per day, depending upon bidding activity and other factors.
141. There will be no reserve prices for the licenses to be offered in Auction 92. After consideration of comments submitted, the Bureau adopted the specific minimum opening bid amounts for each license available in Auction 92 listed in Attachment A of the
142. In each round, eligible bidders will be able to place a bid on a given license using one or more pre-defined
143. The first of the acceptable bid amounts is called the minimum acceptable bid amount. The minimum acceptable bid amount for a license will be equal to its minimum opening bid amount until there is a provisionally winning bid on the license. After there is a provisionally winning bid for a license, the minimum acceptable bid amount for that license will be equal to the amount of the provisionally winning bid plus a percentage of that bid amount calculated using the formula specified in the
144. The percentage of the provisionally winning bid used to establish the minimum acceptable bid amount (the additional percentage) is calculated at the end of each round, based on an activity index. The activity index is a weighted average of (a) the number of distinct bidders placing a bid on the license, and (b) the activity index from the prior round. Specifically, the activity index is equal to a weighting factor times the number of bidders placing a bid covering the license in the most recent bidding round plus one minus the weighting factor times the activity index from the prior round. The additional percentage is determined as one plus the activity index times a minimum percentage amount, with the result not to exceed a given maximum. The additional percentage is then multiplied by the provisionally winning bid amount to obtain the minimum acceptable bid for the next round. For round 1 calculations, however, the index from the prior round is set at 0, because there is no prior round (i.e. no round 0).
145. The weighting factor is set at 0.5, the minimum percentage (floor) at 0.1 (10%), and the maximum percentage (ceiling) at 0.3 (30%). At these initial settings, the minimum acceptable bid for a license will generally be between ten percent and thirty percent higher than the provisionally winning bid, depending upon the bidding activity for the license. Equations and examples were provided in Attachment B of the
146. Any additional bid amounts are calculated using the minimum acceptable bid amount and a bid increment percentage, which need not be the same as the percentage used to calculate the minimum acceptable bid amount. The first additional acceptable bid amount equals the minimum acceptable bid amount times one plus the bid increment percentage. The Bureau will begin the auction with eight additional bid amounts per license. The Bureau will use a bid increment percentage of 5 percent. With a bid increment percentage of 5 percent, the calculation is (minimum acceptable bid amount) * (1 + 0.05), or (minimum acceptable bid amount) * 1.05; the second additional acceptable bid amount equals the minimum acceptable bid amount times one plus two times the bid increment percentage, or (minimum acceptable bid amount) * 1.1, etc. The Bureau will start the auction without a limit on the dollar amount by which minimum acceptable bids and additional bid amounts may increase. The Bureau retains the discretion to change the minimum acceptable bid amounts, the additional bid amounts, the number of acceptable bid amounts, and the parameters of the formulas used to calculate minimum acceptable bid amounts and additional bid amounts, and impose a limit on bid amounts if it determines that circumstances so dictate. Further, the Bureau retains the discretion to do so on a license-by-license basis. If the Bureau exercises this discretion, it will alert bidders by announcement in the FCC Auction System during the auction.
147. At the end of each bidding round, a provisionally winning bid will be determined based on the highest bid amount received for each license. A provisionally winning bid will remain the provisionally winning bid until there is a higher bid on the same license at the close of a subsequent round. Provisionally winning bids at the end of the auction become the winning bids. Bidders are reminded that provisionally winning bids count toward activity for purposes of the activity rule.
148. The Bureau will use a random number generator to select a single provisionally winning bid in the event of identical high bid amounts being submitted on a license in a given round (
149. All bidding will take place remotely either through the FCC Auction System or by telephonic bidding. There will be no on-site bidding during Auction 92. Please note that telephonic bid assistants are required to use a script when entering bids placed by telephone. Telephonic bidders are therefore reminded to allow sufficient time to bid by placing their calls well in advance of the close of a round. The length of a call to place a telephonic bid may vary; please allow a minimum of ten minutes.
150. A bidder's ability to bid on specific licenses is determined by two factors: (1) The licenses selected on the bidder's FCC Form 175 and (2) the bidder's eligibility. The bid submission screens will allow bidders to submit bids on only those licenses the bidder selected on its FCC Form 175.
151. In order to access the bidding function of the FCC Auction System, bidders must be logged in during the bidding round using the passcode generated by the SecurID® token and a personal identification number (PIN) created by the bidder. Bidders are strongly encouraged to print a round summary for each round after they have completed all of their activity for that round.
152. In each round, an eligible bidder will be able to place bids on a given license in any of up to nine pre-defined bid amounts, if the bidder has sufficient eligibility to place a bid on a particular license. For each license, the FCC Auction System will list the acceptable bid amounts in a drop-down box. Bidders use the drop-down box to select from among the acceptable bid amounts. The FCC Auction System also includes an upload function that allows bidders to upload text files containing bid information.
153. Until a bid has been placed on a license, the minimum acceptable bid amount for that license will be equal to its minimum opening bid amount. Once there are bids on a license, minimum acceptable bids for a license for the following round will be determined.
154. During a round, an eligible bidder may submit bids for as many licenses as it wishes (provided that it is eligible to bid), remove bids placed in the current bidding round, withdraw provisionally winning bids from previous rounds, or permanently reduce eligibility. If a bidder submits multiple bids for the exact same license in the same round, the system takes the last bid entered as that bidder's bid for the round. Bidders should note that the bidding units associated with licenses for which the bidder has removed or withdrawn bids do not count towards the bidder's current activity.
155. Finally, bidders are cautioned to select their bid amounts carefully because bidders that withdraw a provisionally winning bid from a previous round, even if the bid was mistakenly or erroneously made, are subject to bid withdrawal payments.
156.
157.
158. If a provisionally winning bid is withdrawn, the minimum acceptable bid amount will equal the amount of the second highest bid received for the license, which may be less than, or in the case of tied bids, equal to, the amount of the withdrawn bid. The Commission will serve as a placeholder provisionally winning bidder on the license until a new bid is submitted on that license. The Bureau retains the discretion to lower the minimum acceptable bid on such licenses in the next round or in later rounds.
159.
160. 47 CFR 1.2104(g)(1) sets forth the payment obligations of a bidder that withdraws a provisionally winning bid on a license during the course of an auction, and provides for the assessment of interim bid withdrawal payments. The Commission will assess an interim withdrawal payment equal to fifteen percent of the amount of the withdrawn bid. The fifteen percent interim payment will be applied toward any final bid withdrawal payment that will be assessed after subsequent auction of the license. Assessing an interim bid withdrawal payment ensures that the Commission receives a minimal withdrawal payment pending assessment of any final withdrawal payment. 47 CFR 1.2104(g) provides specific examples showing application of the bid withdrawal payment rule.
161. Limited information about the results of a round will be made public after the conclusion of the round. Specifically, after a round closes, the Bureau will make available for each license, its current provisionally winning bid amount, the minimum acceptable bid amount for the following round, the amounts of all bids placed on the license during the round, and whether the license is FCC held. The system will also provide an entire license history detailing all activity that has taken place on a license with the ability to sort by round number. The reports will be publicly accessible. Moreover, after the auction closes, the Bureau will make available complete reports of all bids placed during each round of the auction, including bidder identities.
162. The Commission will use auction announcements to report necessary information such as schedule changes and stage transitions. All auction announcements will be available by clicking a link in the FCC Auction System.
163. Shortly after bidding has ended, the Commission will issue a public notice declaring the auction closed, identifying the winning bidders, and establishing the deadlines for submitting down payments, long-form applications, final payments, and ownership disclosure information reports.
164. Within ten business days after release of the auction closing public notice, each winning bidder must submit sufficient funds (in addition to its upfront payment) to bring its total amount of money on deposit with the Commission for Auction 92 to 20 percent of the net amount of its winning bids (gross bids less any applicable small business bidding credit).
165. Each winning bidder will be required to submit the balance of the net amount of its winning bids within ten business days after the applicable deadline for submitting down payments.
166. Within ten business days after release of the auction closing notice, winning bidders must electronically submit a properly completed long-form application (FCC Form 601) for the license(s) they won through Auction 92. Winning bidders claiming eligibility for a small business or very small business bidding credit must demonstrate their eligibility for the bidding credit. Further instructions on these and other filing requirements will be provided to winning bidders in the auction closing public notice.
167. Winning bidders organized as bidding consortia must comply with applicable long-form application procedures as described in the
168. Within ten business days after release of the auction closing public notice, each winning bidder must also comply with the ownership reporting requirements in 47 CFR 1.913, 1.919, and 1.2112 by submitting an ownership disclosure information report for wireless telecommunications services (FCC Form 602) with its long-form application.
169. If an applicant already has a complete and accurate FCC Form 602 on file in ULS, it is not necessary to file a new report, but applicants must verify that the information on file with the Commission is complete and accurate. If the applicant does not have an FCC Form 602 on file, or if it is not complete and accurate, the applicant must submit one.
170. When an applicant submits a short-form application, ULS automatically creates an ownership record. This record is not an FCC Form 602, but may be used to pre-fill the FCC Form 602 with the ownership information submitted on the applicant's short-form application. Applicants must review the pre-filled information and confirm that it is complete and accurate as of the filing date of the long-form application before certifying and submitting the FCC Form 602. Further instructions will be provided to winning bidders in the auction closing public notice.
171. A winning bidder that intends to use its license(s) to deploy facilities and provide services to federally recognized tribal lands that are unserved by any telecommunications carrier or that have a wireline penetration rate equal to or below 85 percent is eligible to receive a tribal lands bidding credit as set forth in 47 CFR 1.2107 and 1.2110(f). A tribal lands bidding credit is in addition to, and separate from, any other bidding credit for which a winning bidder may qualify.
172. Unlike other bidding credits that are requested prior to the auction, a winning bidder applies for the tribal lands bidding credit after the auction when it files its long-form application (FCC Form 601). When initially filing the long-form application, the winning bidder will be required to advise the Commission whether it intends to seek a tribal lands bidding credit, for each license won in the auction, by checking the designated box(es). After stating its intent to seek a tribal lands bidding credit, the applicant will have 180 days from the close of the long-form application filing window to amend its application to select the specific tribal lands to be served and provide the required tribal government certifications. Licensees receiving a tribal lands bidding credit are subject to performance criteria as set forth in 47 CFR 1.2110(f)(3)(vii).
173. For additional information on the tribal lands bidding credit, including how the amount of the credit is calculated, applicants should review the Commission's rulemaking proceeding regarding tribal lands bidding credits and related public notices. Relevant documents can be viewed on the Commission's Web site by going to
174. Any winning bidder that defaults or is disqualified after the close of the auction (i.e., fails to remit the required down payment within the prescribed period of time, fails to submit a timely long-form application, fails to make full payment, or is otherwise disqualified) will be subject to the payments described in 47 CFR 1.2104(g)(2). The payments include both a deficiency payment, equal to the difference between the amount of the bidder's bid and the amount of the winning bid the next time a license covering the same spectrum is won in an auction, plus an additional payment equal to a percentage of the defaulter's bid or of the subsequent winning bid, whichever is less. The Bureau set the additional default payment for this auction at fifteen percent of the applicable bid.
175. Finally, in the event of a default, the Commission has the discretion to re-auction the license or offer it to the next highest bidder (in descending order) at its final bid amount. In addition, if a default or disqualification involves gross misconduct, misrepresentation, or bad faith by an applicant, the Commission may declare the applicant and its principals ineligible to bid in future auctions, and may take any other action that it deems necessary, including institution of proceedings to revoke any existing authorizations held by the applicant.
176. After the auction, applicants that are not winning bidders or are winning bidders whose upfront payment exceeded the total net amount of their winning bids may be entitled to a refund of some or all of their upfront payment. All refunds will be returned to the payer of record, as identified on the FCC Form 159, unless the payer submits written authorization instructing otherwise. Bidders should not request a refund of their upfront payments before the Commission releases a public notice declaring the auction closed, identifying the winning bidders, and establishing the deadlines for submitting down payments, long-form applications, and final payments. Bidders must comply with the specific instructions provided in the
Based on the foregoing, the Receiver has determined that the continued existence of the receiverships will serve no useful purpose. Consequently, notice is given that the receiverships shall be terminated, to be effective no sooner
No comments concerning the termination of these receiverships will be considered which are not sent within this time frame.
Federal Deposit Insurance Corporation.
Update Listing of Financial Institutions in Liquidation.
Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the
Federal Deposit Insurance Corporation.
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 May 2, 2011.
A. Federal Reserve Bank of Atlanta (Clifford Stanford, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309:
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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 application also will 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 May 12, 2011.
A. Federal Reserve Bank of New York (Ivan Hurwitz, Vice President) 33 Liberty Street, New York, New York 10045-0001:
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National Institute of Environmental Health Sciences (NIEHS); National Toxicology Program; National Institutes of Health (NIH), HHS.
Call for information and nomination of scientific experts.
CERHR is evaluating the scientific evidence regarding the potential developmental effects of cancer chemotherapy during pregnancy. CERHR invites the submission of information about ongoing studies or upcoming publications on the pregnancy outcomes and long-term health of offspring exposed to cancer chemotherapy agents during pregnancy and associated topics that might be considered for inclusion in the evaluation. CERHR also invites the nomination of scientific experts to potentially serve as technical advisors in conducting the evaluation or as members of an
All information and nominations should be received by May 16, 2011.
Information and nominations may be submitted to Dr. Kembra Howdeshell, CERHR, NTP, NIEHS, P.O. Box 12233, MD K2-04, Research Triangle Park, NC 27709 (mail), 919-316-4708 (telephone), or
A significant number of pregnant women are diagnosed with cancer each year. The frequency of such diagnoses is difficult to determine, but has been estimated to be between 1 in 1000 to 1 in 6000 pregnancies. Treatment for cancer most often involves some form of chemotherapy. The United States Food and Drug Administration has categorized nearly all chemotherapy agents as Pregnancy Category D,
While some reviews have been published in the medical literature on pregnancy outcomes following chemotherapy during pregnancy, the majority of these reviews focus on specific cancer types or specific chemotherapeutic agents. Thus, CERHR proposes to conduct a comprehensive survey of the literature and systematically evaluate the scientific evidence regarding the developmental toxicity of cancer chemotherapy during pregnancy in humans for the six most frequently diagnosed cancers in pregnant women,
CERHR invites the public and other interested parties to submit information on cancer chemotherapy during pregnancy, including data on pregnancy outcomes, long-term health reports of human offspring, and laboratory animal toxicology information from completed, ongoing, or planned studies. This information will be considered in evaluating the potential developmental effects of exposure to cancer chemotherapy during pregnancy. Information should be submitted to CERHR (see
CERHR invites nominations of qualified scientists (
The NTP established CERHR in 1998 (63 FR 68782). CERHR is a publicly accessible resource for information about adverse reproductive and/or developmental health effects associated with exposure to environmental and/or occupational exposures. CERHR publishes monographs that assess the evidence regarding whether
Presidential Commission for the Study of Bioethical Issues, Office of the Assistant Secretary for Health, Department of Health and Human Services.
Notice of meeting.
The Presidential Commission for the Study of Bioethical Issues will conduct its fifth meeting in May. At this meeting, the Commission will discuss the topic of Federal standards regarding human subjects protection in Federally funded scientific studies.
The meeting will take place Wednesday, May 18, 2011, from 9 a.m. to approximately 4:45 p.m., and Thursday, May 19, 2011, from 9 a.m. to approximately 1:15 p.m.
The Warwick New York Hotel, 65 West 54th Street, New York, NY 10019. Phone 212-247-2700.
Hillary Wicai Viers, Communications Director, Presidential Commission for the Study of Bioethical Issues, 1425 New York Avenue, NW., Suite C-100, Washington, DC 20005. Telephone: 202-233-3963. E-mail:
Pursuant to the Federal Advisory Committee Act of 1972, Public Law 92-463, 5 U.S.C. app. 2, notice is hereby given of the fifth meeting of the Presidential Commission for the Study of Bioethical Issues (PCSBI). The meeting will be held from 9 a.m. to approximately 4:45 p.m. on Wednesday, May 18, 2011, and from 9 a.m. to approximately 1:15 p.m. on Thursday, May 19, 2011, at the Warwick New York Hotel, New York, NY. The meeting will be open to the public with attendance limited to space available. The meeting will also be webcast at
Under authority of Executive Order 13521, dated November 24, 2009, the President established PCSBI to serve as a public forum and advise him on bioethical issues generated by novel and emerging research in biomedicine and related areas of science and technology. The Commission is charged to identify and promote policies and practices that assure ethically responsible conduct of scientific research, healthcare delivery, and technological innovation. In undertaking these duties, the Commission will examine specific bioethical, legal, and social issues related to potential scientific and technological advances; examine diverse perspectives and possibilities for useful international collaboration on these issues; and recommend legal, regulatory, or policy actions as appropriate.
The main agenda item for this fifth meeting is to review Federal as well as transnational standards of human subjects protections in scientific studies supported by the Federal government as requested by President Obama on November 24, 2010.
The draft meeting agenda and other information about PCSBI, including information about access to the webcast, will be available at
The Commission welcomes input from anyone wishing to provide public comment on any issue before it. There will be a public comment session in the afternoon on May 18, 2011. Individuals who would like to provide public comment at that time should notify Esther Yoo by telephone at 202-233-3960, or e-mail at
Anyone planning to attend the meeting who needs special assistance, such as sign language interpretation or other reasonable accommodations, should also notify Esther Yoo (contact information above) in advance of the meeting. The Commission will make every effort to accommodate persons who need special assistance.
Written comments will also be accepted and are especially welcome. Please address written comments by e-mail to
Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.
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To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site at
In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by
1. Electronically. You may submit your comments electronically to
2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency's function; (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.
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To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on
OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer,
Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment.
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To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site at
In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by
1. Electronically. You may submit your comments electronically to
2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.
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The Affordable Care Act provides each State with the option to set up a State-operated Health Benefits
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To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site at
In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by
1. Electronically. You may submit your comments electronically to
2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice informs interested parties of an opportunity to apply to participate in the Medicare Community-based Care Transitions Program, which was authorized by section 3026 of the Affordable Care Act.
Proposals will be accepted on a rolling basis. Acceptable applicants will be awarded on an ongoing basis as funds permit.
Juliana Tiongson, (410) 786-0342 or by e-mail at
Proposals should be mailed to the following address:
Section 3026 of the Patient Protection and Affordable Care Act (Pub. L. 111-148, enacted on March 23, 2010) (Affordable Care Act) authorized the Medicare Community-based Care Transitions Program (CCTP). The goals of the CCTP are to improve the quality of care transitions, reduce readmissions for high risk Medicare beneficiaries, and document measurable savings to the Medicare program by reducing unnecessary readmissions. The CCTP is part of Partnership for Patients, a national patient safety initiative through which the Administration is supporting broad-based efforts to reduce harm caused to patients in hospitals and improve care transitions.
We are seeking eligible organizations which are a subsection (d) hospital, as defined in section 1886(d)(1)(B) of the Social Security Act (the Act), with high readmission rates that partner with community-based organizations (CBOs) or CBOs that provide care transition services. CBOs are defined as community-based organizations that provide care transition services across the continuum of care through arrangements with subsection (d) hospitals and whose governing bodies include sufficient representation of multiple health care stakeholders, including consumers.
This program creates a source of funding for care transition services that effectively manage transitions from acute to community-based settings and report specified process and outcome measures on their results. CBOs will be paid on a per eligible discharge basis for eligible Medicare beneficiaries at high risk for readmission, including those with multiple chronic conditions, depression, or cognitive impairments.
In selecting CBOs to participate in the program, preference will be given to eligible entities that are Administration on Aging (AoA) grantees that provide concurrent care transition interventions with multiple hospitals and practitioners or entities that provide services to medically-underserved populations, small communities, and rural areas. The program will run for 5 years beginning April 11, 2011; however, participants will be awarded 2-year agreements that may be extended on an annual basis for the remaining 3 years based on performance.
Applicants must identify root causes of readmissions and define their target population and strategies for identifying high risk patients. Applicants must also specify care transition interventions including strategies for improving provider communications in care transitions and improving patient activation. Lastly, applicants will be required to provide a budget including a per eligible discharge rate for care transition services, provide an implementation plan with milestones, and demonstrate prior experience with effectively managing care transition services and reducing readmissions.
A competitive process will be used to select eligible organizations. We will accept proposals on a rolling basis. The program will continue through 2015.
For specific details regarding the CCTP and the application process, please refer to the solicitation on the CMS Web site at
Please refer to file code [CMS-5055-N2] on the application. Proposals (an unbound original and 3 copies plus an electronic copy on CD-ROM) must be typed for clarity and should not exceed 30 double-spaced pages, exclusive of cover letter, the executive summary, resumes, forms, and supporting documentation. Because of staffing and resource limitations, we cannot accept proposals by facsimile (FAX) transmission. Applicants may, but are not required to, submit a total of 10 copies to assure that each reviewer receive a proposal in the manner intended by the applicant (for example, collated, tabulated color copies). Hard copies and electronic copies must be identical.
As discussed above, subsection (d) hospitals with high readmission rates that partner with CBOs or CBOs that provide care transition services are eligible to participate in the CCTP. We anticipate that a wide variety of interested parties may be eligible to form a CBO in order to apply in collaboration with other organizations to perform the responsibilities specified. CBOs may be characterized as physician practices, particularly primary care practices, a corporate entity that has a separate quality improvement organization (QIO) contract with CMS under Part B of title XI of the Act, in situations that will not result in or create the appearance of a conflict of interest between the QIO's review tasks under title XI and the corporate entity's role as a CBO, an Aging and Disability Resource Center, Area Agency on Aging, or other appropriate organization that meets the statutory definition at section 3026(b)(1)(B) of the Act.
Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program.
Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS).
Notice of a new Privacy Act system of records.
In accordance with the requirements of the Privacy Act of 1974, the Centers for Medicare and Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight (CCIIO) is establishing a new system of records (SOR) titled the “Health Insurance Assistance Database (HIAD),” System No. 09-70-0586. This SOR is established under the authority of Sections 2719, 2723, and 2761 of the Public Health Service Act (PHS Act) (Public Law (Pub. L.) 97-35) and § 1321(c) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148). Section 1321(c) of the Affordable Care Act authorizes HHS (1) to ensure that States with Exchanges are substantially enforcing the Federal standards to be set for the Exchanges and (2) to set up Exchanges in States that elect not to do so or are not substantially enforcing related provisions. Sections 2723 and 2761 of the PHS Act authorize HHS to enforce provisions that apply to non-Federal governmental plans and to enforce PHS Act provisions that apply to other health insurance coverage in States that HHS has determined are not substantially enforcing those provisions. The HIAD database will be maintained by the Office of Consumer Support Health Insurance Assistance Team (the Team) to assist the Office of Oversight with its compliance activities. HIAD is the primary tool through which the Team will track information for the purposes of oversight.
The primary purpose of this system is to collect and maintain information on consumer inquiries and complaints regarding insurance issuers that will permit CCIIO to exercise its direct enforcement authority over non-Federal governmental health plans, investigate any inquiries or complaints from enrollees of those plans, to determine which States may not be substantially enforcing the Affordable Care Act and PHS Act provisions and to determine whether complaints that indicate
The public should address comments to: CMS Privacy Officer, Division of Information Security and Privacy Management, Enterprise Architecture and Strategy Group, Office of Information Services, CMS, Room N1-24-08, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern time zone.
Mr. Paul Tibbits, Team Leader, Health Insurance Assistance Team, Office of Consumer Support, Center for Consumer Information and Insurance Oversight, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244. His telephone number is 301-492-4229 or via e-mail at
CCIIO has direct enforcement authority over non-Federal governmental health plans, and any inquiries or complaints from enrollees of those plans will be logged into this database for the purpose of following up to determine whether complaints that indicate possible noncompliance with Federal law are resolved by the plans. In addition, consumer inquiries and complaints regarding insurance issuers will be logged into the database in order to help CCIIO determine which States may not be substantially enforcing Affordable Care Act and PHS Act provisions, and, in the event Federal enforcement is necessary, in order to follow up to determine whether complaints that indicate possible noncompliance with Federal law are resolved by the issuers.
Section 1321(c) of the Affordable Care Act authorizes HHS (1) to ensure that States with Exchanges are substantially enforcing the Federal standards to be set for the Exchanges and (2) to set up Exchanges in States that elect not to do so or are not substantially enforcing related provisions. Sections 2723 and 2761 of the PHS Act authorize HHS to enforce PHS Act provisions that apply to non-Federal governmental plans and to enforce PHS Act provisions that apply to other health insurance coverage in States that HHS has determined are not substantially enforcing those provisions.
The database will be maintained by the Team to help CCIIO Office of Oversight with its compliance activities under the Affordable Care Act and PHS Act. Consumer inquiries and complaints addressed by the Team will help CCIIO conduct direct enforcement over non-Federal governmental health plans; the database will also help CCIIO determine which States are not substantially enforcing PHS Act provisions under HHS's Federal fallback authority in sections 2723 and 2761 of the PHS Act.
In the course of its work, the Team will: (1) Receive consumer inquiries; (2) respond to consumer inquiries in order to obtain the necessary information to determine the best course of action; (3) refer consumers to appropriate entities; and (4) when appropriate, gather information about consumers in order to assist CCIIO oversight capacity.
When responding to consumer contacts, the Team will pursue one of the following courses of action: (1) If it is determined that the consumer is covered by a non-Federal governmental plan, the Team will obtain enough information to determine whether the case merits referral to the Office of Oversight; (2) if it is determined that jurisdiction over a consumer's case lies with another entity, the Team will refer consumers to that entity, such as a State insurance department, the U.S. Department of Labor, or a State Consumer Assistance Program; or (3) if it is determined that the consumer seeks to file an appeal in a State or territory without an external appeals process in place, the Team will refer the consumer to the appropriate entity carrying out the Federal external appeals process.
As mentioned, the system will be used to create reports regarding the types of consumer inquiries and Affordable Care Act and PHS Act compliance issues that are brought to the attention of CCIIO by consumers. These reports will assist the Office of Oversight in identifying areas where compliance concerns may arise, and will be stripped of any information in identifiable form (IIF) and personal health information when written and prepared.
Authority for the collection, maintenance, and disclosures from this system is provided under provisions of §§ 2719, 2723, and 2761 of the Public Health Service Act (PHS Act) (Pub. L. 97-35) and § 1321(c) of the Patient Protection and Affordable Care Act (AFFORABLE CARE ACT) (Pub. L. 111—148).
The Health Insurance Assistance Database (HIAD) contains information on individuals who contact CCIIO's Health Insurance Assistance Team, complainants or other individuals with health insurance issues. The HIAD contains the name, address, State of residence and zip code; contact information such as telephone numbers, e-mail address, demographic information such as age, gender, ethnicity, family status, employment status, income level and veteran's status; and health insurance identification number, health insurance status, background, recent history and available options.
A. The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release information collected in the HIAD that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Identifiable data may be disclosed under a routine use.
CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. In general, disclosure of information from the system will be approved only for the minimum information necessary to accomplish the purpose of the disclosure and only after CMS:
1. Determines that the use or disclosure is consistent with the reason that the data is being collected,
2. Determines that:
a. the purpose of the disclosure can only be accomplished if the record is provided in an individually identifiable form;
b. the purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual provider that additional exposure of the record might bring; and
c. there is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s).
3. Requires the information recipient to:
a. establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record;
b. remove or destroy at the earliest time all individually identifiable information; and
c. agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed.
4. Determines that the data are valid and reliable.
These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, under which CMS may release information from the HIAD without the consent of the individual to whom such information pertains. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected. We propose to establish the following routine use disclosures of information maintained in the system:
1. To support Agency contractors, consultants, CMS grantees, student volunteers, interns and other workers who do not have the status of Federal employees, and who have been engaged by the Agency to assist in accomplishment of a CMS function relating to the purposes for this SOR and who need to have access to the records in order to assist CMS.
We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing a CMS function relating to purposes for this SOR.
CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant, CMS grantees, student volunteers, interns and other workers who do not have the status of Federal employees whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant, CMS grantees, student volunteers, interns and other workers who do not have the status of Federal employees from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant, CMS grantees, student volunteers, interns and other workers who do not have the status of Federal employees to return or destroy all information at the completion of the contract.
2. To assist another Federal or State agency, agency of a State government, or an agency established by State law pursuant to agreements with CMS to:
a. Increase consumer assistance and accessibility to health care coverage by identifying insurer noncompliance with Federal, State and other applicable law, and
b. Assist Federally funded health insurance programs in administering functions tasked to them pursuant to the Affordable Care Act and other relevant Federal and State laws which may require CCIIO Program information related to this system.
c. Assist other Federal/State agencies that have the authority to perform collection of debts owed to the Federal government.
State Departments of Insurance can achieve greater regulation and oversight of the health insurance industry and strengthen enforcement in areas where problems arise by identifying trends and patterns in consumer inquiries and complaints.
The Internal Revenue Service (IRS), Department of the Treasury, can use CCIIO information for the purpose of resolving difficulties with obtaining premium tax credits under 36B of the Internal Revenue Code (IRC) of 1986 and to understand the consumer needs leading to the State health insurance Exchanges starting in 2014.
Federal, State, and local law enforcement agencies and private security contractors, may require CCIIO information to protect CCIIO employees and customers, provide security for CCIIO facilities or to assist investigations or prosecutions with respect to activities that affect such safety and security or activities that disrupts the operation of CCIIO operations and facilities.
3. To support the Department of Justice (DOJ), court, or adjudicatory body when:
a. the Agency or any component thereof, or
b. any employee of the Agency in his or her official capacity, or
c. any employee of the Agency in his or her individual capacity where the DOJ has agreed to represent the employee, or
d. the United States Government,
Whenever HHS is involved in litigation, or occasionally when another party is involved in litigation and HHS's policies or operations could be affected
4. To assist a CMS contractor (including, but not limited to Medicare Administrative Contractors, fiscal intermediaries, and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such program.
We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contract or grant with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste or abuse.
CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor or grantee whatever information is necessary for the contractor or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor or grantee from using or disclosing the information for any purpose other than that described in the contract and requiring the contractor or grantee to return or destroy all information.
5. To assist another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste or abuse in a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such programs.
Other agencies may require CCIIO Program information for the purpose of combating fraud, waste or abuse in such Federally-funded programs.
6. To assist appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, and the information disclosed is relevant and unnecessary for the assistance.
Other Federal agencies and contractors may require CCIIO Program information for the purpose of assisting in a respond to a suspected or confirmed breach of the security or confidentiality of information.
CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access.
This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook.
CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. We will only disclose the minimum personal data necessary to achieve the purpose of the data collection and the routine uses contained in this notice. Disclosure of information from the system will be approved only to the extent necessary to accomplish the purpose of the disclosure. CMS has assigned a higher level of security clearance for the information maintained in this system in an effort to provide added security and protection of data in this system.
CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of the disclosure of information relating to individuals.
09-70-0586.
“Health Insurance Assistance Database” (HIAD), HHS/CMS/CCIIO.
Level Three Privacy Act Sensitive.
CMS Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various contractor sites.
Center for Consumer Information and Insurance Oversight, Centers for Medicare and Medicaid Services, U.S. Department of Health & Human Services, Triple-I Core Site, 12100 Sunrise Valley Drive, Reston, Virginia 20191.
Information in this system is maintained on individuals who contact the CCIIO Health Insurance Assistance Team, complainants or other individuals with health insurance issues.
The HIAD contains the name, address, State of residence and zip code; contact information such as telephone numbers, e-mail address, demographic information such as age, gender, ethnicity, family status, employment status, income level and veteran's
Authority for the collection, maintenance, and disclosures from this system is provided under provisions of §§ 2719, 2723, and 2761 of the Public Health Service Act (PHS Act) (Public Law (Pub. L.) 97-35) and § 1321(c) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148).
The primary purposes of this system is to collect and maintain information on consumer inquiries and complaints regarding insurance issuers that will permit CCIIO to exercise its direct enforcement authority over non-Federal governmental health plans, investigate any inquiries or complaints from enrollees of those plans, to determine which States may not be substantially enforcing the Affordable Care Act and PHS Act provisions and to determine whether complaints that indicate possible noncompliance with Federal law are resolved by the plans. In addition, information maintained will enable CCIIO to develop aggregate reports that will inform CMS and HHS about compliance issues. Information in this system will also be disclosed to: (1) Support regulatory and programmatic activities such as investigations and reporting activities performed by an Agency contractor, consultants, CMS grantees, student volunteers, interns and other workers who do not have the status of Federal employees; (2) assist another Federal and/or State agency, agency of a State government, or an agency established by State law; (3) support litigation involving the Agency; (4) combat fraud, waste, and abuse in certain health benefits programs, and (5) assist in a response to a suspected or confirmed breach of the security or confidentiality of information.
B. Entities Who May Receive Disclosure Under Routine Use
These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, under which CMS may release information from the HIAD without the consent of the individual to whom such information pertains. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected. We propose to establish the following routine use disclosures of information maintained in the system:
3. To support Agency contractors, consultants, CMS grantees, student, volunteers, interns and other workers who do not have the status of Federal employees, who have been engaged by the Agency to assist in accomplishment of a CMS function relating to the purposes for this SOR and who need to have access to the records in order to assist CMS.
4. To assist another Federal or State agency, agency of a State government, or an agency established by State law pursuant to agreements with CMS to:
a. Increase consumer assistance and accessibility to health care coverage by identifying insurer noncompliance with Federal, State and other applicable law, and
b. Assist Federally funded health insurance programs in administering functions tasked to them pursuant to the Affordable Care Act and other relevant Federal and State laws which may require CCIIO Program information related to this system.
c. Assist other Federal/State agencies that have the authority to perform collection of debts owed to the Federal government.
5. To support the Department of Justice (DOJ), court, or adjudicatory body when:
e. The Agency or any component thereof, or
f. Any employee of the Agency in his or her official capacity, or
g. Any employee of the Agency in his or her individual capacity where the DOJ has agreed to represent the employee, or
h. The United States Government,
is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records.
6. To assist a CMS contractor (including, but not limited to Medicare Administrative Contractors, fiscal intermediaries, and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such program.
7. To assist another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste or abuse in a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such programs.
8. To assist appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, and the information disclosed is relevant and unnecessary for the assistance.
CMS has safeguards in place for authorized users and monitors such users to ensure against unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access.
This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also
Records are maintained electronically in the CCIIO developed database for collection, tracking and storage of casework information and for reporting purposes. Any manually maintained records will be kept in locked cabinets or otherwise secured areas.
The records are retrieved electronically by a variety of fields, including but not limited to name, State, zip code, and health insurance identification number issued to the individual.
Records are maintained with identifiers for all transactions after they are entered into the system for a period of 10 years. Records are housed in both active and archival files. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from the Department of Justice.
Team Lead, Health Insurance Assistance Team, Office of Consumer Support, Center for Consumer Information and Insurance Oversight, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244.
For purpose of notification, the subject individual should write to the system manager who will require the system name and the retrieval selection criteria (
For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)).
The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7).
The identifying information contained in these records is provided voluntarily by the individual consumers, confidential informants, or by reports received from other sources . Additional case-relevant information may also be provided by the individual's employer or insurer to assist in achieving resolution of the specific case.
None.
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 June 14, 2011.
Submit electronic comments on the collection of information to
Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
Section 801(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(a)) provides requirements with regard to imported food and cosmetics and provides for refusal of admission into the United States of human food and cosmetics that appear to be adulterated. Section 701(b) of the FD&C Act (21 U.S.C. 371(b)) authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act. To address the potential risk of BSE in human food and cosmetics, FDA regulations in §§ 189.5 and 700.27 (21 CFR 189.5 and 700.27) designate certain materials from cattle as “prohibited cattle materials,” including specified risk materials, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, and mechanically separated (MS) (Beef). Under the regulations no human food or cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials. However, the Agency may designate a country from which cattle materials inspected and passed for human consumption are not considered prohibited cattle materials and their use does not render a human food or cosmetic adulterated.
Sections 189.5(e) and 700.27(e) provide that a country seeking to be so designated must send a written request to the Director, Center for Food Safety and Applied Nutrition (CFSAN). The information the country is required to submit includes information about a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and other information relevant to determining whether specified risk materials, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, or MS (Beef) from the country seeking designation should be considered prohibited cattle materials. FDA uses the information to determine whether to grant a request for designation, and whether to impose conditions if a request is granted.
Sections 189.5 and 700.27 further state that countries that have been designated under §§ 189.5(e) and 700.27(e) will be subject to future review by FDA to determine whether designation remains appropriate. As part of this process, FDA may ask designated countries to confirm that their BSE situation and the information submitted by them in support of their original application remain unchanged. FDA may revoke a country's designation if FDA determines that it is no longer appropriate. Therefore, designated countries may respond to periodic requests by FDA by submitting information to confirm that their designation remains appropriate. FDA uses the information to ensure that their designation remains appropriate.
FDA estimates the burden of this collection of information as follows:
This estimate is based on FDA's experience and the average number of requests for designation under §§ 189.5 and 700.27 received in the past 3 years. FDA received one request for designation in 2009 and one in 2010. Based on this experience, FDA estimates the annual number of new requests for designation will be 1. FDA estimates that preparing the information required by §§ 189.5 and 700.27 and submitting it to the Agency in the form of a written request to the Director, CFSAN will require a burden of approximately 80 hours per request. Thus, the annual burden for new requests for designation is estimated to be 80 hours, as shown in table 1, row 1 of this document.
Under §§ 189.5(e) and 700.27(e), designated countries are subject to future review by FDA and may respond to periodic requests by FDA by submitting information to confirm that their designation remains appropriate. In the last 3 years, FDA has not requested any reviews. Thus, the Agency estimates that one or fewer will occur annually in the future. We estimate that the designated country undergoing a review in the future will need one third the time it took preparing its request for designation to respond to FDA's request for review, or 26 hours (80 hours x 0.33 = 26.4 hours, rounded to 26). The annual burden for reviews is estimated to be 26 hours, as shown in table 1, row 2 of this document. The total annual burden for this information collection is estimated to be 106 hours.
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
Submit either electronic or written comments on the collection of information by June 14, 2011.
Submit electronic comments on the collection of information to
Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.
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.
This proposed collection of information entitled “Experiment to Evaluate Risk Perceptions of Produce Growers, Food Retailers, and Consumers After a Food Recall Resulting From a Foodborne Illness Outbreak” will be conducted under a cooperative agreement between the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) and the Center for Risk Communication Research (CRCR) at the University of Maryland. JIFSAN was established in 1996 and is a public and private partnership between FDA and the University of Maryland. The CRCR will design and administer the study.
FDA is requesting OMB approval under the PRA for the CRCR to conduct research with produce growers, food retailers, and consumers to gain information about these groups' risk perceptions associated with produce that has recently been subject to a food recall resulting from a foodborne illness outbreak. The purpose of this research is to help FDA better understand whether the magnitude and duration of the decline in commodity consumption following food recalls can be partly explained by grower and retailer speculations and projections about consumers' attitudes toward food recalls resulting from foodborne illness outbreaks. This research will be used to assess how grower, retailer, and consumer perceptions, attitudes, knowledge, and beliefs affect market recovery after a hypothetical fresh spinach recall.
Epidemiologists define foodborne illness outbreaks as two or more cases of a similar illness resulting from the ingestion of a common food (Ref. 1). Because many foodborne illness cases are mild, most outbreaks are never recognized or brought to the attention of public health authorities. When the outbreaks are large in scale or cause hospitalization, serious illness, or death, public health officials will inform the public in order to try to stop the spread of disease. A food recall can occur when a particular food in the marketplace is found to have a known contaminant, because either people have become sickened by it or pathogen testing has revealed contamination (Ref. 2). The purpose of a food recall is to rid retail establishments of the product and to inform consumers that they should discard the product if they have it in their homes. Although the purpose of a food recall is to keep consumers from becoming ill, food recalls can be costly to all sectors of the food distribution chain (Ref. 3). The goal of the proposed project is to test, by experimental study, whether the psychological tendency called “attribution error,” contributes to unnecessarily prolonging the economic effects of a food recall. “Attribution error” is the tendency people have of overestimating others' negative response to situations compared to their own response. If industry decisionmakers' measures of consumer response are biased by “attribution error,” industry could be contributing to its own slow recovery after a food recall.
When a widespread foodborne illness outbreak results in a food recall, the product can be out of the marketplace for an extended period of time; this occurred when fresh, bagged spinach was recalled in 2006 (Ref. 3). Tomatoes were also less available following the
The CRCR plans to conduct an experiment using a Web-based questionnaire. The center will use a convenience sample of 900 participants (180 growers, 180 retailers, 540 consumers) drawn from industry networks (for the growers and retailers), and a Web-based panel of U.S. households (for the consumers). Participation in the study is voluntary.
This study will help FDA better understand the reasons for the time between a food recall resulting from a foodborne illness outbreak and market recovery. In order to understand the complexities of market recovery process, the CRCR will compare understandings and reactions of growers, retailers, and consumers to a hypothetical food recall resulting from a hypothetical foodborne illness outbreak. To make this comparison, individuals in each group will be assigned to one of the following experimental conditions (consisting of vignettes in the form of news articles on a hypothetical food recall): An “anger” scenario, a “fear” scenario, or a “control” scenario. After
To help design and refine the questionnaire, we will recruit 25 participants in order to conduct 10 cognitive interviews. We estimate cognitive interview recruitment will take 5 minutes (0.083 hours), for a total of 2 hours. The cognitive interviews are estimated at 1 hour per response for a total of 10 hours for the cognitive interview activities. We expect to send screeners to 800 members of a consumer panel, each taking 2 minutes (0.03 hours) to complete, for a total of 24 hours for the consumer panel screener activity. We also expect to administer 360 screeners to growers and retailers, each taking 2 minutes (0.033 hours) to complete, for a total of 24 hours (11 + 11 = 22). Twenty-four participants (20 consumers, 2 growers, 2 retailers) will complete the pre-test. Each pre-test will take 10 minutes (0.17 hours) for a total of 5 hours for the pre-test activity. We estimate that 900 individuals (540 consumers, 180 growers, and 180 retailers) will complete the questionnaire for the experiment, each taking 10 minutes (0.17 hours) for a total of 153 hours for the experimental study activities. The estimated total hour burden of the collection of information is 215 hours.
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Joyce Strong, Office of Policy, Planning and Budget, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 3208, Silver Spring, MD 20993-0002,301-796-9138.
In FR Doc. 2011-6509, appearing on page 15323, in the
1. On page 15323, in the first column, in the Docket No. heading, “[Docket No. FDA-2010-E-0241]” is corrected to read “[Docket No. FDA-2009-E-0241]”.
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
The Pediatric Advisory Committee will hear and discuss the recommendation of the Pediatric Ethics Subcommittee from its meeting on May 11, 2011, regarding the Institutional Review Board process for clinical investigations that involve both an FDA regulated product and research involving children as subjects that is conducted or supported by HHS. The announcement of the May 11, 2011, Pediatric Ethics Subcommittee of the Pediatric Advisory Committee meeting can be found elsewhere in this issue of the
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA 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 Walter Ellenberg at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
The meeting will be held on Wednesday, May 11, 2011, from 8 a.m. to 3 p.m.
FDA is opening a docket to allow for additional public comments to be submitted to the Agency on the issues before the Pediatric Ethics Subcommittee. Submit either electronic or written comments by May 5, 2011.
The meeting will be held at the North Marriott Hotel & Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852.
Submit electronic comments to
The subcommittee's recommendations will then be presented to the FDA Pediatric Advisory Committee on Monday, May 16, 2011. The announcement of the May 16, 2011, Pediatric Advisory Committee meeting can be found elsewhere in this issue of the
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA 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 Walter Ellenberg at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
To request more information on the proposed project or to obtain a copy of the data collection plans, contact Frances E. Thompson, PhD, Project Officer, National Cancer Institute, NIH, EPN 4095A, 6130 Executive Boulevard MSC 7335, Bethesda, Maryland 20892-7335, or call non-toll-free number 301-594-4410, or FAX your request to 301-435-3710, or e-mail your request, including your address, to
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 Council of Councils.
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. Information is also available on the Council of Council's home page at
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,
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.
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 Deafness and Other Communication Disorders Advisory Council.
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 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, 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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Notice of Closed Meetings
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 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.
Notice of Closed Meetings
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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 7266, Washington, DC 20410; telephone (202) 708-1234; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Theresa Rita, Division of Property Management, Program Support Center, HHS, room 5B-17, 5600 Fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Bureau of Ocean Energy Management, Regulation and Enforcement (BOEMRE), Interior.
Notice of an extension of an information collection (1010-0082).
To comply with the Paperwork Reduction Act of 1995 (PRA), BOEMRE is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns the paperwork requirements related to leasing for minerals other than oil, gas and sulphur in the Outer Continental Shelf.
Submit written comments by June 14, 2011.
Cheryl Blundon, Regulations and Standards Branch at (703) 787-1607. You may also contact Cheryl Blundon to obtain a copy, at no cost, of the regulation that requires the subject collection of information.
You may submit comments by either of the following methods listed below.
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Regulations at 30 CFR 281 implement these statutory requirements. The regulations at 30 CFR 281 concern leasing activities of minerals other than oil, gas or sulphur and are the subject of this collection.
BOEMRE uses the information required by 30 CFR 281 to determine if statutory requirements are met prior to the issuance of a lease. Specifically, BOEMRE uses the information to:
• Evaluate the area and minerals requested by the lessee to assess the viability of offering leases for sale.
• Allow the State(s) to initiate the establishment of a joint group.
• Ensure excessive overriding royalty interests are not created that would put economic constraints on all parties involved.
• Document that a leasehold or geographical subdivision has been surrendered by the record title holder.
We protect proprietary information according to the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR 2), and 30 CFR parts 280 and 282. No items of a sensitive nature are collected. Responses are mandatory.
Agencies must also estimate the non-hour cost burdens to respondents or recordkeepers resulting from the collection of information. Therefore, if you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information, monitoring, and record storage facilities. You should not include estimates for equipment or services purchased: (i) Before October 1, 1995; (ii) to comply with requirements not associated with the information collection; (iii) for reasons other than to provide information or keep records for the Government; or (iv) as part of customary and usual business or private practices.
We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB.
Bureau of Ocean Energy Management, Regulation and Enforcement (BOEMRE), Interior.
Notice of extension of an information collection (1010-0141).
To comply with the Paperwork Reduction Act of 1995 (PRA), BOEMRE is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. The information collection request (ICR) concerns the paperwork requirements related to oil and gas drilling operations, and related forms.
Submit written comments by June 14, 2011.
Cheryl Blundon, Regulations and Standards Branch at (703) 787-1607. You may also contact Cheryl Blundon to obtain a copy, at no cost, of the regulations and the forms that require the subject collection of information.
You may submit comments by either of the following methods listed below.
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• E-mail
The Independent Offices Appropriations Act (31 U.S.C. 9701), the Omnibus Appropriations Bill (Pub. L. 104-133, 110 Stat. 1321, April 26, 1996), and OMB Circular A-25, authorize Federal agencies to recover the full cost of services that confer special benefits. Under the Department of the Interior's implementing policy, BOEMRE is required to charge fees for services that provide special benefits or privileges to an identifiable non-Federal recipient above and beyond those which accrue to the public at large. Applications for permits to drill and modification approvals are subject to cost recovery, and BOEMRE regulations specify service fees for these requests.
This authority and responsibility are among those delegated to BOEMRE. The regulations at 30 CFR 250, subpart D, concern oil and gas drilling operations and are the subject of this collection. This request also covers the related Notices to Lessees and Operators (NTLs) that BOEMRE issues to clarify, supplement, or provide additional guidance on some aspects of our regulations.
Regulations at 30 CFR 250, subpart D, implement these statutory requirements. We use the information to ensure safe drilling operations and to protect the human, marine, and coastal environment. Among other things, BOEMRE specifically uses the information to ensure: The drilling unit is fit for the intended purpose; the lessee or operator will not encounter geologic conditions that present a hazard to operations; equipment is maintained in a state of readiness and meets safety standards; each drilling crew is properly trained and able to promptly perform well-control activities at any time during well operations; compliance with safety standards; and the current regulations will provide for safe and proper field or reservoir development, resource evaluation, conservation, protection of correlative rights, safety, and environmental protection. We also review well records to ascertain whether drilling operations have encountered hydrocarbons or H
The following forms are also submitted to BOEMRE under subpart D. The forms and their purposes are:
BOEMRE uses the information from these forms to determine the conditions of a drilling site to avoid hazards inherent in drilling operations. Specifically, we use the information to evaluate the adequacy of a lessee's plan and equipment for drilling, sidetracking or bypass operations. This includes the adequacy of the proposed casing design, casing setting depths, drilling fluid (mud), and cementing programs to ascertain that the proposed operations will be conducted in an operationally safe manner that provides adequate protection for the environment. BOEMRE also reviews the information to ensure conformance with specific provisions of the lease. In addition, except for proprietary data, BOEMRE is required by the OCS Lands Act to make available to the public certain
The information on this form is used to evaluate and approve the adequacy of the equipment, materials, and/or procedures that the lessee plans to use during such post APD modifications or operations as plugging back or temporary abandonment where the well bore will be reentered and completed or permanently plugged. In addition, except for proprietary data, BOEMRE is required by the OCS Lands Act to make available to the public certain information submitted on form MMS-124.
BOEMRE uses this information to ensure that we have accurate and up-to-date data and information on wells and leasehold activities under our jurisdiction and to ensure compliance with approved plans and any conditions placed upon a suspension or temporary prohibition. It is also used to evaluate the remedial action in the event of well equipment failure or well control loss. Form MMS-125 is updated and resubmitted in the event the well status changes. The information keeps us aware of the status of drilling and completion operations. In addition, except for proprietary data, BOEMRE is required by the OCS Lands Act to make available to the public certain information submitted on form MMS-125.
BOEMRE uses this information to monitor the conditions of a well and status of drilling operations. We review the information to be aware of the well conditions and current drilling activity (i.e., well depth, drilling fluid weight, casing types and setting depths, completed well logs, and recent safety equipment tests and drills). The engineer uses this information to determine how accurately the lessee anticipated well conditions and if the lessee is following the approved APD. The information is also used for review of an APM (form MMS-124). With the information collected on form MMS-133 available, the reviewers can analyze the proposed revisions (i.e., revised grade of casing or deeper casing setting depth) and make a quick and informed decision on the request. In addition, except for proprietary data, BOEMRE is required by the OCS Lands Act to make available to the public certain information submitted on forms MMS-133 and MMS-133S.
As activity increased over the years in the Gulf of Mexico (GOM), the rig notification requirement became essential for BOEMRE inspection scheduling and has become a standard condition of approval for certain permits. BOEMRE needs the information on Form MMS-144 to schedule inspections and verify that the equipment being used complies with approved permits. In reporting rig movements respondents have the option of submitting the form or using a Web-based system for electronic data submissions. The information on this form is used primarily in the GOM to ascertain the precise arrival and departure of all rigs in OCS waters in the GOM. The accurate location of these rigs is necessary to facilitate the scheduling of inspections by BOEMRE personnel.
It is noted that the U.S. Coast Guard (USCG) also requires notification of rig movement and that there is some duplication of information reported. Therefore, there are some data elements in the form that are “optional” for BOEMRE reporting purposes, since we do not need this information. These optional data elements in the form satisfy any concerns in reporting rig movement information to both BOEMRE and the USCG.
Out of the seven forms associated with this collection, we have made some minor editorial changes for clarity purposes to forms MMS-123 and MMS-123S and we have added plug information to be submitted via form MMS-125. The information is on the schematic that is submitted as an attachment to the form.
We will protect proprietary information according to 30 CFR 250.197, “Data and information to be made available to the public or for limited inspection,” 30 CFR part 252, “OCS Oil and Gas Information Program,” and the Freedom of Information Act (5 U.S.C. 552) and its implementing regulations (43 CFR 2). No items of a sensitive nature are collected. Responses are mandatory.
Agencies must also estimate the non-hour paperwork cost burdens to respondents or recordkeepers resulting from the collection of information. Therefore, if you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods you use to estimate major cost factors, including system and technology acquisition, expected useful life of capital equipment, discount rate(s), and the period over which you incur costs. Capital and startup costs include, among other items, computers and software you purchase to prepare for collecting information, monitoring, and record storage facilities. You should not include estimates for equipment or services purchased: (i) Before October 1, 1995; (ii) to comply with requirements not associated with the information collection; (iii) for reasons other than to provide information or keep records for the Government; or (iv) as part of customary and usual business or private practices.
We will summarize written responses to this notice and address them in our submission for OMB approval. As a result of your comments, we will make any necessary adjustments to the burden in our submission to OMB.
Fish and Wildlife Service, Interior.
Notice of availability of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered and threatened species unless a Federal permit allows such activity. The Act requires that we invite public comment before issuing these permits.
We must receive any written comments on or before May 16, 2011.
Send written comments by U.S. mail to the Regional Director, Attn: Lisa Mandell, U.S. Fish and Wildlife Service, Ecological Services, 1 Federal Drive, Fort Snelling, MN 55111-4056; or by electronic mail to
Lisa Mandell,(612) 713-5343.
We invite public comment on the following permit applications for certain activities with endangered species authorized by section 10(a)(1)(A) of the Act (16 U.S.C. 1531
The applicant requests a permit renewal to take (capture and release) Indiana bats (
The applicant requests a permit renewal to take (capture and release) Indiana bats within Indiana, Kentucky, Ohio, Pennsylvania, and West Virginia. Proposed activities are for enhancement of survival of the species in the wild.
The applicant requests a permit renewal to take (capture and release) Indiana bats and gray bats throughout the range of the species (within IL, IN, IA, MI, MO, OH, KY, TN, AL, GA, AR, MS, NC, SC, FL, PA, and NY). Permit renewal is also requested for threatened and endangered mussel species within AZ, NM, OK, TX, IL, IN, IA, MI, MN, MO, OH, WI, AL, AR, FL, GA, KY, LA, MS, NC, SC, TN, CT, DE, ME, MD, MA, NH, NJ, NY, PA, RI, VT, VA, and WV and threatened and endangered fish species within those States and CO, KS, MT, NE, ND, SD, UT, and WY. Proposed activities are for enhancement of survival of the species in the wild through studies to monitor habitat use, surveys to document presence of the species, and through population assessments.
The applicant requests a permit renewal to take (capture and release of larvae; collection of excuviae) Hine's emerald dragonfly (
The applicant requests a permit renewal/amendment to take (capture and release) Indiana bats, gray bats, Ozark big-eared bats (
The applicant requests a permit renewal/amendment to take (habitat management; presence/absence surveys; prescribed fire) Karner blue butterfly (
The applicant requests a permit renewal/amendment to take (capture and release) Indiana bats and gray bats within Kentucky, Illinois, Indiana, Iowa, Michigan, Missouri, Ohio, and Wisconsin. The applicant requests a permit amendment to include Virginia big-eared bats and to expand the geographic scope of the permit to include the range of all three species within States above and Alabama, Arkansas, Connecticut, Florida, Georgia, Maryland, Mississippi, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Tennessee, Vermont, Virginia, and West Virginia. Proposed activities are for enhancement of survival of the species in the wild.
The applicant requests a permit renewal to take (capture and release) Federally listed mussels within Ohio. Species included on Dr. Hoggarth's existing permit are: purple catspaw pearlymussel (
The applicant requests a permit renewal/amendment to take (capture; radio-tag; release) Indiana bats within Illinois, Indiana, Iowa, Michigan, Missouri, Ohio, and Wisconsin. The applicant requests a permit amendment to include gray bats and to expand the geographic scope of the permit to include the range of both species within the States above and Alabama, Arkansas, Florida, Georgia, Kentucky, Mississippi, North Carolina, and Tennessee. Proposed activities are for enhancement of survival of the species in the wild.
The applicant requests a permit renewal/amendment to take (capture and release) Higgins' eye pearlymussel (
The applicant requests a permit to take (capture and release) Indiana bats and Virginia big-eared bats throughout the range of the species within Illinois, Indiana, Iowa, Michigan, Missouri, Ohio, Arkansas, Georgia, Kentucky, Mississippi, North Carolina, Tennessee, Connecticut, Maryland, New Jersey, New York, Pennsylvania, Vermont,
The applicant requests a permit to take (survey and collect seed) Houghton's goldenrod (
The applicant requests a permit to take (conduct habitat surveys; monitor nesting sites; erect nesting enclosures) Piping plover (
The applicant requests a permit to take (capture and release) Topeka shiners (
The applicant requests a permit to take (capture, radio-tag, use chemical immobilization, assess and treat health conditions, implant isotopes, salvage, and release) gray wolf (
We seek public review and comments on these permit applications. Please refer to the permit number when you submit comments. Comments and materials we receive are available for public inspection, by appointment, during normal business hours at the address shown in the
In compliance with NEPA (42 U.S.C. 4321
Bureau of Land Management, Interior.
Notice of Availability.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), the Bureau of Land Management (BLM) has prepared a Draft Environmental Impact Statement (EIS) for the HB In-Situ Solution Mine Project, and by this Notice is announcing the opening of the comment period.
To ensure comments will be considered, the BLM must receive written comments on the HB In-Situ Solution Mine Project Draft EIS within 60 days following the date of publication of this Notice of Availability in the
You may submit comments related to the HB In-Situ Solution Mine Project by any of the following methods:
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Copies of the HB In-Situ Solution Mine Project proposal are available in the Carlsbad Field Office at the above address.
Contact David Alderman, Assistant Project Manager; telephone 575-234-6232; address 620 E. Greene St., Carlsbad, New Mexico 88220; e-mail
Intrepid Potash, Inc. (Intrepid) is proposing to extract potash, a potassium compound commonly used for fertilizer, remaining in inactive underground mine workings using solution mining methods. Intrepid proposes to construct and operate a solution mining project in an existing deep mine located approximately 20 miles northeast of Carlsbad in Eddy County, New Mexico, in the Secretary's Potash Area.
The potash left in the pillars and walls of the inactive underground mine workings is not accessible through conventional methods. The proposed action is to inject saline water into the mine workings, dissolve potash, and extract the mineral solution. This mineral-rich solution would be pumped to the surface and transported through a series of surface pipelines to evaporation ponds. Once the solution evaporates in the ponds, the potassium-bearing salts would be harvested from the ponds and transported to a newly constructed mill for ore refinement.
The project area is located in portions of Township 19 South, Range 30 and 31 East, Township 20 South, Ranges 29, 30 and 31 East and Township 21 South, Ranges 29 and 30 East, New Mexico Principal Meridian. The project area, which encompasses the proposed facilities and inactive workings under consideration, includes a total of 38,453 acres, of which 82 percent is on public lands managed by the U.S. Department of the Interior, Bureau of Land Management. Four thousand three hundred and thirty acres of open mine workings are targeted for flooding but the total surface footprint of the project would be 822 acres.
The BLM initiated the NEPA process for the HB In-Situ Solution Mine Project by preparing an environmental assessment (EA) in 2008. Two public scoping meetings were held on September 16, 2008, to receive public input and comments on the proposed project. During development of the EA and prior to publication, the BLM determined that the preparation of an EIS would be required for the proposed project. The Notice of Intent to prepare an EIS for the HB In-Situ Solution Mine Project was published in the
Alternatives developed include the proposed action (Alternative A) which uses non-potable water supplied by seven wells in the Rustler formation. Alternative B includes six of the seven wells from the proposed action but also considers that a substantial portion of the water needed for the project would be supplied from fresh water wells in the Caprock formation (Ogallala Aquifer) 30 miles northeast of the project area. Alternative C buries the pipelines to reduce surface impacts. An alternate routing of pipelines to the Caprock is also being considered under Alternative B.
Currently, a preferred alternative has not been selected. Alternative A uses a greater quantity of non-potable saline water; however, this has impacts to the environment from the drawdown of the aquifer. Alternative B uses a greater quantity of potable fresh water but impacts from drawdown of the aquifers would be reduced.
Please note that public comments and information submitted including names, street addresses, and email addresses of persons who submit comments will be available for public review and disclosure at the above address during regular business hours (8 a.m. to 4 p.m.), Monday through Friday, except holidays.
Before including your address, phone number, e-mail 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.
40 CFR 1506.6 and 1506.10.
Bureau of Land Management, Interior.
Notice of Availability.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) has prepared a Proposed California Desert Conservation Area (CDCA) Plan Amendment/Final Environmental Impact Statement (EIS) for the Desert Sunlight Solar Farm (DSSF) project and by this notice is announcing its availability.
The BLM planning regulations state that any person who meets the conditions as described in the regulations may protest the BLM's Proposed CDCA Plan Amendment/Final EIS. A person who meets the conditions and files a protest must file the protest within 30 days of the date that the Environmental Protection Agency (EPA) publishes its notice in the
Copies of the DSSF Proposed CDCA Plan Amendment/Final EIS have been sent to affected Federal, state, and local government agencies and to other stakeholders. Copies are available for public inspection at the Palms Springs South Coast Field Office, 1201 Bird Center Drive, Palm Springs, California 92262. Interested persons may also review the document at the following Web site:
For further information contact Allison Shaffer, BLM Project Manager, telephone (760) 833-7100; address (
Desert Sunlight Holdings, LLC has submitted a right of way (ROW) application to the BLM to construct the proposed DSSF which includes a 550-megawatt (MW) solar photovoltaic (PV) facility and associated 220- kilovolt (kV) interconnection line (gen-tie line), and to facilitate the construction and operation by Southern California Edison (SCE) of the new 500/220-kV Red Bluff Substation, where the project would interconnect with the SCE regional transmission system. The total project footprint consists of approximately 4,165 acres of BLM-managed lands with a proposed ROW encompassing approximately 4,317 acres. The power generation site would consist of several components: A main generation area which includes PV arrays, combining switchgear, overhead lines, and access corridors; an operations and maintenance facility; a solar energy visitor center; an on-site substation; and site security and fencing. The gen-tie line ROW from the project to the proposed Red Bluff Substation would cover 256 acres with a 12-mile long, 160-foot wide corridor. The gen-tie line would transmit power to SCE's existing Devers-Palo Verde 1 (DPV1) 500-kV transmission line.
The Red Bluff Substation would consist of a 500/220-kV substation on approximately 76 acres, with an additional 73 acres for related features including access roads and drainage control. Substation features would include: connection of the project transmission line into the substation; transmission lines to connect the substation to the DPV1 line; modification of DPV1 towers near the substation; construction of an electric
The project site is located approximately 6 miles north of Interstate 10 and the rural community of Desert Center in Riverside County. The project area is within 2 miles of Joshua Tree National Park.
The BLM's purpose and need for the DSSF project is to respond to an application for a ROW grant to construct, operate, maintain, and decommission a solar photovoltaic facility on public lands in compliance with FLPMA, BLM ROW regulations, and other applicable Federal laws. The BLM will decide whether to approve, approve with modification, or deny the ROW for the proposed DSSF project. The BLM will also consider amending the CDCA Plan in this analysis. The CDCA Plan (1980, as amended), while recognizing the potential compatibility of solar generation facilities on public lands, requires that all sites associated with power generation or transmission not identified in that plan be considered through the plan amendment process. If the BLM decides to grant a ROW, the BLM would also amend the CDCA Plan as required.
In the Final EIS, the proposed action is to authorize the DSSF project and approve a CDCA Plan amendment in response to the application received from Desert Sunlight Holdings, LLC. The BLM's preferred alternative is the proposed action, which consists of the power generation site (Solar Farm Layout B), Gen-Tie Line GT-A-1 (which parallels Kaiser Road), Substation A, and Access Road 2, aggregating 4,165 acres of permanent ground disturbance. Other alternatives to authorizing the proposed DSSF project include: (1) Authorize the Solar Farm Layout B, Gen-Tie Line GT-B-2, and Red Bluff Substation B, aggregating 4,100 acres of permanent ground disturbance; and (2) authorize a reduced footprint alternative with a reduced output including Solar Farm Layout C (413 MW), Gen-Tie Line GT-A-2, Red Bluff Substation A, and Access Road 1, aggregating 3,292 acres of permanent ground disturbance. Additionally, the Final EIS analyzes two no project alternatives: (1) Deny the project but amend the CDCA Plan to allow other solar energy power generation projects on the project site; and (2) deny the project and amend the CDCA Plan to prohibit solar energy projects on the project site. As required under NEPA, the Final EIS analyzes a no action alternative (no ROW grant and no CDCA Plan amendment).
The Final EIS evaluates the potential impacts of the proposed DSSF and CDCA Plan Amendment on air quality, biological resources, cultural resources, water resources, geological resources and hazards, land use, noise, paleontological resources, public health, socioeconomics, soils, traffic and transportation, visual resources, wilderness characteristics, and other resources.
A Notice of Availability for the DSSF Draft CDCA Plan Amendment/Draft EIS was published by the EPA in the
Instructions for filing a protest with the Director of the BLM regarding the DSSF project may be found in the “Dear Reader” letter of the Proposed CDCA Plan Amendment/Final EIS and at 43 CFR 1610.5-2. E-mail and faxed protests will not be accepted as valid protests unless the protesting party also provides the original letter by either regular or overnight mail postmarked by the close of the protest period. Under these conditions, the BLM will consider the e-mail or faxed protest as an advance copy and it will receive full consideration. If you wish to provide the BLM with such advance notification, please direct faxed protests to the attention of the BLM protest coordinator at 202-912-7212, and e-mails to
Before including your phone number, e-mail address, or other personal identifying information in your protest, you should be aware that your entire protest-including your personal identifying information-may be made publicly available at any time. While you can ask us in your protest to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
40 CFR 1506.6 and 1506.10; 43 CFR 1610.2 and1610.5.
Bureau of Land Management, Interior.
Notice of Availability.
In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM), Elko District Office has prepared a Final Environmental Impact Statement (EIS) for the Newmont Mining Corporation's proposed Genesis Project and by this notice is announcing its availability.
The BLM will not issue a final decision on the proposal for a minimum of 30 days following the date the Environmental Protection Agency publishes its notice in the
Printed copies of the Genesis Project Final EIS are available for public inspection at the BLM Elko District Office, 3900 E. Idaho Street, Elko, Nevada during regular business hours of 7:30 a.m. to 4:30 p.m., Monday through Friday, except holidays. The Final EIS is also available on-line at:
Kirk Laird, Project Manager, (775) 753-0200, address: 3900 E. Idaho, Elko, NV 89801, or e-mail:
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
Newmont Mining Corporation's Genesis-Bluestar mining operations area is located in northeastern Nevada on the Carlin Trend, a 50-mile-long by 10-mile-wide geologic area that has produced more than 60 million ounces of gold from numerous mines over the last 30 years. The proposed action is to expand the Genesis Pit, develop the new Bluestar Ridge Pit, backfill the Beast and Bluestar pits and partially backfill the Genesis
The proposed action includes an adaptive management plan which was analyzed in the Draft EIS and included as an appendix to the Draft EIS. The Draft EIS was released for public review on April 23, 2010, for a 45-day comment period. A public comment meeting was held in Elko, Nevada on May 19, 2010.
The Final EIS has been prepared in an abbreviated format, and includes comments on the Draft EIS and the BLM's responses along with minor modifications and corrections to the Draft EIS.
40 CFR 1506.6 and 1506.10.
National Park Service, Interior.
[Notice of Availability] Notice of Availability of a Record of Decision on the Final Environmental Impact Statement for the Long Draw Reservoir Special Use Authorization, Rocky Mountain National Park.
Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332(2)(C), the National Park Service announces the availability of the Record of Decision for the Long Draw Reservoir Special Use Authorization, Rocky Mountain National Park, Colorado. On September 17, 2010, the Regional Director, Intermountain Region approved the Record of Decision for the project. As soon as practicable, the National Park Service will begin to implement the Preferred Alternative contained in the FEIS issued on March 27, 2009.
Lawrence Gamble, Chief of Planning and Compliance, Rocky Mountain National Park, Estes Park, CO 80517, telephone 970-586-1320, e-mail
The United States Department of Agriculture, Forest Service, is the lead agency for this project and was responsible for preparation of the EIS because Long Draw Reservoir is located on National Forest System lands. The NPS is a cooperating agency on this project because the operations of Long Draw Reservoir affect lands within Rocky Mountain National Park managed by the NPS, and two alternatives considered in the EIS propose actions within the park. A total of four alternatives were considered: A no-action alternative and three action alternatives.
With the Record of Decision, the National Park Service approves the implementation of Alternative 3 within the park. This decision is being made in conjunction with the Forest Service's decision to apply terms and conditions to the 30-year authorization for Long Draw Reservoir and is necessary for the Forest Service to implement the selected alternative. The National Park Service is approving implementation of native greenback cutthroat trout restoration in the headwaters of the Cache la Poudre River within Rocky Mountain National Park by the Forest Service, Water Supply and Storage Company of Fort Collins, Colorado, and their project partners, with oversight provided by the National Park Service. In addition to the activities associated with implementation of the terms and conditions for the Long Draw reservoir authorization, the NPS will implement native fish restoration in Cascade Creek.
The Record of Decision includes a description of the background of the project; a statement of the decision made including key actions and mitigating measures/monitoring to minimize environmental harm; the basis for the decision; an overview of public involvement and agency consultation in the decision-making process; a description of other alternatives considered; a description of the environmentally preferred alternative; and a findings on impairment of park resources and values.
Copies of the Record of Decision may be obtained from the contact listed above or online at
National Park Service, Interior.
Notice of public meeting for the National Park Service Alaska Region's Subsistence Resource Commission (SRC) program.
The Gates of the Arctic National Park SRC will meet to develop and continue work on National Park Service (NPS) subsistence hunting program recommendations and other related subsistence management issues. The NPS SRC program is authorized under Title VIII, Section 808 of the Alaska National Interest Lands Conservation Act, Public Law 96-487, to operate in accordance with the provisions of the Federal Advisory Committee Act.
The proposed meeting agenda includes the following:
Notice is hereby given that on April 6, 2011, a proposed Consent Decree (the “Consent Decree”) in
In settlement of the claims for injury to, destruction of, or loss of natural resources, the Defendants have agreed to preserve the site of a former marine dock at the mouth of Middle Waterway in perpetuity for use as a habitat restoration site, and will pay $7,802,081.29 in cash. In addition, the Defendants will pay $300,000.00 toward the Trustees' long-term restoration project oversight and stewardship activities and $700,000.00 to reimburse Trustee damage assessment costs.
During the public comment period, the Consent Decree may be examined on the following Department of Justice Web site,
The Department of Justice will receive, for a period of thirty (30) days from the date of this publication, comments relating to the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to
In requesting a copy from the Consent Decree Library, please enclose a check in the amount of $10.75 (25 cents per page reproduction cost) payable to the U.S. Treasury or, if by e-mail or fax, forward a check in that amount to the Consent Decree Library at the stated address.
Notice is hereby given that, on March 16, 2011, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, EDISOFT S.A., Caparica, Setubal, PORTUGAL; COMCARE, Washington, DC; ASELASAN Elektronik Sanayi ve Ticaret A.S., Ankara, TURKEY; MilSOFT ICT-Iletisim Teknolojileri A.S., Ankara TURKEY; Terrestar Networks, Inc,. Reston, VA;
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Network Centric Operations Industry Consortium, Inc. intends to file additional written notifications disclosing all changes in membership.
On November 19, 2004, NCOIC filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on December 20, 2010. A notice was filed with the Department on December 20, 2010. A notice was published in the
Correction.
On Thursday, April 7, 2011, the Drug Enforcement Administration published the above-titled Decision and Order, as well as the Decision of the Administrative Law Judge (76 FR 19420). In preparing the document for publication, the files were merged resulting in the footnotes of the Administrative Law Judge's Decision being numbered sequentially to follow the footnote numbers of the Decision and Order rather than beginning with the number 1 as they did in the ALJ's slip opinion.
Therefore, this notice corrects footnotes 4 through 69 appearing in the Decision signed by the U.S. Administrative Law Judge to be footnotes 1 through 66 beginning at 76 FR 19420 under the third column.
Correction.
On Thursday, April 7, 2011, the Drug Enforcement Administration published the above-titled Decision and Order, as well as the Decision of the Administrative Law Judge (76 FR 19401). In preparing the document for publication, the files were merged resulting in the footnotes of the Administrative Law Judge's Decision being numbered sequentially to follow the footnote numbers of the Decision and Order rather than beginning with the number 1 as they did in the ALJ's slip opinion.
Therefore, this notice corrects footnotes 10 through 84 appearing in the Decision signed by the U.S. Administrative Law Judge to be footnotes 1 through 75 beginning at 76 FR 19404 under the third column.
Correction.
On Thursday, April 7, 2011, the Drug Enforcement Administration published the above-titled Decision and Order, as well as the Decision of the Administrative Law Judge (76 FR 19450). In preparing the document for publication, the files were merged resulting in the footnotes of the Administrative Law Judge's Decision being numbered sequentially to follow the footnote numbers of the Decision and Order rather than beginning with the number 1 as they did in the ALJ's slip opinion.
Therefore, this notice corrects footnotes 4 through 67 appearing in the Decision signed by the U.S. Administrative Law Judge to be footnotes 1 through 64 beginning at 76 FR 19451 under the second column.
Correction.
On Thursday, April 7, 2011, the Drug Enforcement Administration published the above-titled Decision and Order, as well as the Decision of the Administrative Law Judge (76 FR 19434). In preparing the document for publication, the files were merged resulting in the footnotes of the Administrative Law Judge's Decision being numbered sequentially to follow the footnote numbers of the Decision and Order rather than beginning with the number 1 as they did in the ALJ's slip opinion.
Therefore, this notice corrects footnotes 11 through 71 appearing in the Decision signed by the U.S. Administrative Law Judge to be footnotes 1 through 61 beginning at 76 FR 19437 under the second column.
Correction.
On Thursday, April 7, 2011, the Drug Enforcement Administration published the above-titled Decision and Order, as well as the Decision of the Administrative Law Judge (76 FR 19386). In preparing the document for publication, the files were merged resulting in the footnotes of the Administrative Law Judge's Decision
Therefore, this notice corrects footnotes 12 through 67 appearing in the Decision signed by the U.S. Administrative Law Judge to be footnotes 1 through 56 beginning at 76 FR 19390 under the first column.
By Notice dated November 19, 2010, and published in the
The company plans to manufacture small quantities of the listed controlled substance in bulk for distribution to its customers for use as reference standards.
No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Siegfried (USA), Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Siegfried (USA), Inc. to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed.
Notice.
The Department of Labor (DOL) is submitting the Bureau of Labor Statistics (BLS) sponsored information collection request (ICR) titled, “Current Population Survey—Basic Labor Force,” to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).
Submit comments on or before May 16, 2011.
A copy of this ICR, with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site,
Submit comments about this request to the Office of Information and Regulatory Affairs,
Michel Smyth by telephone at 202-693-4129 (this is not a toll-free number) or by e-mail at
The labor force data collected in the Current Population Survey (CPS) help to determine the employment situation of specific population groups as well as general trends in employment and unemployment. The survey is the only source of monthly data on total employment and unemployment. The
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid OMB control number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• 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;
• Enhance the quality, utility, and clarity of the information to be collected; 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,
In accordance with Section 223 of the Trade Act of 1974, as amended (19 U.S.C. 2273) the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers by (TA-W) number issued during the period of March 28, 2011 through April 1, 2011.
In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met.
I. Under Section 222(a)(2)(A), the following must be satisfied:
(1) A significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The sales or production, or both, of such firm have decreased absolutely; and
(3) One of the following must be satisfied:
(A) Imports of articles or services like or directly competitive with articles produced or services supplied by such firm have increased;
(B) Imports of articles like or directly competitive with articles into which one or more component parts produced by such firm are directly incorporated, have increased;
(C) Imports of articles directly incorporating one or more component parts produced outside the United States that are like or directly competitive with imports of articles incorporating one or more component parts produced by such firm have increased;
(D) Imports of articles like or directly competitive with articles which are produced directly using services supplied by such firm, have increased; and
(4) The increase in imports contributed importantly to such workers' separation or threat of separation and to the decline in the sales or production of such firm; or
II. Section 222(a)(2)(B) all of the following must be satisfied:
(1) A significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) One of the following must be satisfied:
(A) There has been a shift by the workers' firm to a foreign country in the production of articles or supply of services like or directly competitive with those produced/supplied by the workers' firm;
(B) There has been an acquisition from a foreign country by the workers' firm of articles/services that are like or directly competitive with those produced/supplied by the workers' firm; and
(3) The shift/acquisition contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected workers in public agencies and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(b) of the Act must be met.
(1) A significant number or proportion of the workers in the public agency have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The public agency has acquired from a foreign country services like or directly competitive with services which are supplied by such agency; and
(3) The acquisition of services contributed importantly to such workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected secondary workers of a firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(c) of the Act must be met.
(1) A significant number or proportion of the workers in the workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The workers' firm is a Supplier or Downstream Producer to a firm that employed a group of workers who received a certification of eligibility under Section 222(a) of the Act, and such supply or production is related to the article or service that was the basis for such certification; and
(3) Either—
(A) The workers' firm is a supplier and the component parts it supplied to the firm described in paragraph (2) accounted for at least 20 percent of the production or sales of the workers' firm; or
(B) A loss of business by the workers' firm with the firm described in paragraph (2) contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected workers in firms identified by the International Trade Commission and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(f) of the Act must be met.
(1) The workers' firm is publicly identified by name by the International Trade Commission as a member of a domestic industry in an investigation resulting in—
(A) An affirmative determination of serious injury or threat thereof under section 202(b)(1);
(B) An affirmative determination of market disruption or threat thereof under section 421(b)(1); or
(C) An affirmative final determination of material injury or threat thereof under section 705(b)(1)(A) or 735(b)(1)(A) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)(1)(A) and 1673d(b)(1)(A));
(2) The petition is filed during the 1-year period beginning on the date on which—
(A) A summary of the report submitted to the President by the International Trade Commission under section 202(f)(1) with respect to the affirmative determination described in paragraph (1)(A) is published in the
(B) Notice of an affirmative determination described in subparagraph (1) is published in the
(3) The workers have become totally or partially separated from the workers' firm within—
(A) The 1-year period described in paragraph (2); or
(B) Notwithstanding section 223(b)(1), the 1-year period preceding the 1-year period described in paragraph (2).
The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production or services) of the Trade Act have been met.
In the following cases, the investigation revealed that the eligibility criteria for worker adjustment assistance have not been met for the reasons specified.
The investigation revealed that the criterion under paragraph (a)(1), or (b)(1), or (c)(1)(employment decline or threat of separation) of section 222 has not been met.
The investigation revealed that the criteria under paragraphs(a)(2)(A) (increased imports) and (a)(2)(B) (shift in production or services to a foreign country) of section 222 have not been met.
I hereby certify that the aforementioned determinations were issued during the period of March 28, 2011 through April 1, 2011. Copies of these determinations may be requested under the Freedom of Information Act. Requests may be submitted by fax, courier services, or mail to FOIA Disclosure Officer, Office of Trade Adjustment Assistance (ETA), U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210 or
Mine Safety and Health Administration, Department of Labor.
Notice of request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments concerning the extension of the information collection for 30 CFR part 47.
All comments must be postmarked or received by midnight Eastern Standard Time on June 14, 2011.
Comments must be clearly identified with the rule title and may be submitted to MSHA by any of the following methods:
(1)
(2)
(3)
(4)
Mario Distasio, Chief of the Economic Analysis Division, Office of Standards, Regulations, and Variances, MSHA, at
Section 101(a)(7) of the Federal Mine Safety and Health Act of 1977, as amended (Mine Act) requires, in part, that mandatory standards prescribe the use of labels or other appropriate forms of warning as are necessary to insure that miners are apprised of all hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and proper conditions and precautions for safe use or exposure.
MSHA collected evidence from the National Institute for Occupational Safety and Health's (NIOSH) Occupational Health Survey of Mining and other sources indicating that there were chemical exposures occurring in every type of mine, although every miner may not have been exposed. MSHA became concerned that miners were being exposed to chemicals and may not have known the hazards of those chemicals or the appropriate precautions to prevent injury or illness caused by exposure to a hazardous chemical.
MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
A copy of the information collection request can be obtained by contacting the person listed in the
This notice contains the request for an extension of the existing collection of information in 30 CFR Part 47. MSHA does not intend to publish the results from this information collection and is not seeking approval to either display or not display the expiration date for the OMB approval of this information collection.
There are no certification exceptions identified with this information collection and the collection of this information does not employ statistical methods.
Comments submitted in response to this notice will be summarized and included in the request for Office of
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Protection Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The Meeting will be held for the purpose of soliciting from the scientific community and other persons scientific and technical information relevant to program planning.
Tuesday, May 10, 2011, 9 a.m. to 5 p.m., and Wednesday, May 11, 2011, 9 a.m. to 1 p.m., Local Time.
NASA Headquarters, 300 E Street, SW., Rooms 5H45 and 9H40 consecutively, Washington, DC 20546.
Ms. Marian Norris, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-4452, fax (202) 358-4118, or
The meeting will be open to the public up to the capacity of the room. The agenda for the meeting includes the following topics:
It is imperative that the meeting be held on these dates to accommodate the scheduling priorities of the key participants. Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID, before receiving an access badge. Foreign nationals attending this meeting will be required to provide a copy of their passport, visa, or green card in addition to providing the following information no less than 10 working days prior to the meeting: Full name; gender; date/place of birth; citizenship; visa/green card information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position of attendee. To expedite admittance, attendees with U.S. citizenship can provide identifying information 3 working days in advance by contacting Marian Norris via e-mail at
U.S. Office of Personnel Management (OPM).
Notice.
This gives notice of OPM decisions granting authority to make appointments under Schedules A, B, and C in the excepted service as required by 5 CFR 213.103.
Roland Edwards, Senior Executive Resource Services, Executive Resources and Employee Development, Employee Services, 202-606-2246.
Appearing in the listing below are the individual authorities established under Schedules A, B, and C between February 1, 2011, and February 28, 2011. These notices are published monthly in the
No Schedule A authorities to report during February 2011.
No Schedule B authorities to report during February 2011.
The following Schedule C appointments were approved during February 2011.
5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR 1954-1958 Comp., p. 218.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recently-filed Postal Service notice of two classification changes concerning certain competitive mail services. This notice informs the public of the filing, addresses preliminary procedural matters, and invites public comment.
Submit comments electronically by accessing the “Filing Online” link in the banner at the top of the Commission's Web site (
Stephen L. Sharfman, General Counsel, at 202-789-6820 (case-related information) or
On April 8, 2011, the Postal Service filed a notice of two classification changes pursuant to 39 CFR 3020.90 and 3020.91 concerning certain competitive mail services.
The second change adds another dimensional option to the large Flat Rate Box for Priority Mail and Outbound Priority Mail International services.
The Postal Service asserts these classification changes are consistent with the requirements of 39 U.S.C. 3642, and further proposes conforming MCS language.
The Commission establishes Docket No. MC2011-24 for consideration of matters related to the proposed classification change identified in the Postal Service's Notice.
Interested persons may submit comments on whether the Postal Service's request is consistent with the policies of 39 U.S.C. 3642 and generally with the provisions of title 39. Comments are due no later than April 22, 2011. The Postal Service's Notice can be accessed via the Commission's Web site (
The Commission appoints Jeremy Simmons to serve as Public Representative in the captioned proceeding.
1. The Commission establishes Docket No. MC2011-24 for consideration of matters raised by the Postal Service's Notice.
2. Comments by interested persons are due no later than April 22, 2011.
3. Pursuant to 39 U.S.C. 505, Jeremy Simmons is appointed to serve as the officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
4. The Secretary shall arrange for publication of this Order in the
By the Commission.
Summary: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB) to request an extension without change of a currently approved collection of information: 3220-0176, Representative Payee Parental Custody Report. Out ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens.
The RRB invites comments on the proposed collection of information to determine (1) the ractical utility of the collection; (2) the accuracy of the estimated burden of the collection; (3) ways to enhance the quality, utility and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of publication date.
Under Section 12(a) of the Railroad Retirement Act (RRA), the RRB is authorized to select, make payments to, and to conduct transactions with, a beneficiary's relative or some other person willing to act on behalf of the beneficiary as a representative payee. The RRB is responsible for determining if direct payment to the beneficiary or payment to a representative payee would best serve the beneficiary's interest. Inherent in the RRB's authorization to select a representative payee is the responsibility to monitor the payee to assure that the beneficiary's interests are protected. The RRB utilizes Form G-99D, Parental Custody Report, to obtain information needed to verify that a parent-for-child representative payee still has custody of the child. One response is required from each respondent. The RRB proposes no changes to Form G-99D.
Comments regarding the information collection should be addressed to Patricia Henaghan, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-2092 or
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 101 prohibits distribution participants from purchasing activities at specified times during a distribution of securities. Persons otherwise covered by these rules may seek to use several applicable exceptions such as a calculation of the average daily trading volume of the securities in distribution, the maintenance of policies regarding information barriers between their affiliates, and the maintenance a written policy regarding general compliance with Regulation M for de minimus transactions.
There are approximately 1588 respondents per year that require an aggregate total of 31,309 hours to comply with this rule. Each respondent makes an estimated 1 annual response. Each response takes approximately 20 hours to complete. Thus, the total compliance burden per year is 31,309 burden hours. The total estimated internal labor compliance cost for the respondents is approximately $1,783,673.73, resulting in a cost of compliance for the respondent per response of approximately $1123.22 (i.e., $1,783,673.73/1588 responses).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 103 permits passive market-making in Nasdaq securities during a distribution. A distribution participant that seeks use of this exception would be required to disclose to third parties its intention to engage in passive market making.
There are approximately 298 respondents per year that require an aggregate total of 298 hours to comply with this rule. Each respondent makes an estimated 1 response annually. Each response takes approximately 1 hour to complete. Thus, the total hourly burden per year is 298 hours. The total estimated internal labor cost for the respondents is approximately $19,966.00, resulting in an estimated internal labor cost per response of approximately $67.00 (
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number. Background documentation for this information collection may be viewed at the following link,
Comments should be directed to (i) Desk Officer for the Securities and Exchange Commission, Office of
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Section 17(d) (15 U.S.C. 80a-17(d)) of the Investment Company Act of 1940 (15 U.S.C. 80a
Rule 17d-1 also contains a number of exceptions to the requirement that a fund must obtain Commission approval prior to entering into joint transactions or arrangements with affiliates. For example, funds do not have to obtain Commission approval for certain employee compensation plans, certain tax-deferred employee benefit plans, certain transactions involving small business investment companies, the receipt of securities or cash by certain affiliates pursuant to a plan of reorganization, certain arrangements regarding liability insurance policies and transactions with “portfolio affiliates” (companies that are affiliated with the fund solely as a result of the fund (or an affiliated fund) controlling them or owning more than five percent of their voting securities) so long as certain other affiliated persons of the fund (
Thus, the rule contains two filing and recordkeeping requirements that constitute collections of information. First, rule 17d-1 requires funds that wish to engage in a joint transaction or arrangement with affiliates to meet the procedural requirements for obtaining exemptive relief from the rule's prohibition on joint transactions or arrangements involving first- or second-tier affiliates. Second, rule 17d-1 permits a portfolio affiliate to enter into a joint transaction or arrangement with the fund if a prohibited participant has a financial interest that the fund's board determines is not material and records the basis for this finding in their meeting minutes. These requirements of rule 17d-1 are designed to prevent fund insiders from managing funds for their own benefit, rather than for the benefit of the funds' shareholders.
Based on an analysis of past filings, Commission staff estimates that 8 funds file applications under section 17(d) and rule 17d-1 per year. The staff understands that funds that file an application generally obtain assistance from outside counsel to prepare the application. The cost burden of using outside counsel is discussed below. Based on a limited survey of persons in the mutual fund industry, the Commission staff estimates that each applicant will spend an average of 154 hours to comply with the Commission's applications process. The Commission staff therefore estimates the annual burden hours per year for all funds under rule 17d-1's application process to be 1,232 hours at a cost of $445,328.
As noted above, the Commission staff understands that funds that file an application under rule 17d-1 generally use outside counsel to assist in preparing the application.
Based on these calculations, the total annual hour burden is estimated to be 1,232 hours and the total annual cost burden is estimated to be $745,048.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act. The estimate is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules. Complying with these collections of information requirements is necessary to obtain the benefit of relying on rule 17d-1. Responses will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 104 permits stabilizing by a distribution participant during a distribution so long as the distribution participant discloses information to the market and investors. This rule requires disclosure in offering materials of the potential stabilizing transactions and that the distribution participant inform the market when a stabilizing bid is made. It also requires the distribution participants (
There are approximately 745 respondents per year that require an aggregate total of 149 hours to comply with this rule. Each respondent makes an estimated 1 annual response. Each response takes approximately 0.20 hours (12 minutes) to complete. Thus, the total compliance burden per year is 149 burden hours. The total internal labor compliance cost for the respondents is approximately $9,983.00, resulting in an estimate of $13.40 (
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number. Background documentation for this information collection may be viewed at the following link,
Comments should be directed to (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503 or by sending an e-mail to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The ISE is proposing to adopt fees for a 10 Gigabit network connection. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The self-regulatory organization has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.
The purpose of this proposed rule change is to amend the Exchange's Schedule of Fees to adopt fees for a 10 Gigabit (GB) network connection. The Exchange currently has a tiered
An Ethernet/Managed Service Provider connection enables users to acquire bandwidth in megabit increments. The Exchange currently charges Members $100 per month for a member's purchase of up to 10 Megabits (MBs) of connection speed, $250 per month for the purchase of 11-100 MBs of connection speed and $500 per month for the purchase of 101 MBs— 1 GB of connection speed. These fees are charged on a per connection basis.
The Exchange is scheduled to launch an enhanced trading platform called Optimise on April 11, 2011. Upon transitioning to the Optimise trading platform, ISE will offer a new network connectivity option for Members. One of the many perceived advantages that the Optimise trading platform will offer is greatly improved capacity and throughput. To allow Members to maximize Optimise's low latency, ISE will offer a connectivity option of 10 GBs. ISE proposes to charge Members a fee of $4,000 per month for this 10 GB connection. ISE will retain the current Ethernet connectivity options that are available to Members today.
Once Optimise is rolled out, and until the Exchange has fully transitioned from the current trading platform to the Optimise trading platform, market makers will be required to maintain connections to both trading systems. Therefore, ISE proposes to waive the new 10 GB fee for all members until the migration is entirely completed. The Exchange notes that the fees proposed herein are intended to cover and are reasonably related to ISE's costs of rolling out and supporting the new service.
The Exchange has designated this proposal to be operative on April 11, 2011.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The proposed rule change does not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
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 e-mail to
• Send paper comments in triplicate to Elizabeth Murphy, 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.
Office of the United States Trade Representative.
Notice.
The Office of the United States Trade Representative (USTR) is providing notice of country-by-country allocations of additional Fiscal Year (FY) 2011 in-quota quantity of the tariff-rate quota (TRQ) for imported raw cane sugar and of country-by-country reallocations of the FY 2011 in-quota quantity of the tariff-rate quota for imported raw cane sugar.
Effective Date: April 15, 2011.
Inquiries may be mailed or delivered to Ann Heilman-Dahl, Director of Agricultural Affairs, Office of Agricultural Affairs, Office of the United States Trade Representative, 600 17th Street, NW., Washington, DC 20508.
Ann Heilman-Dahl, Office of Agricultural Affairs, 202-395-6127.
Pursuant to Additional U.S. Note 5 to Chapter 17 of the Harmonized Tariff Schedule of the United States (HTS), the United States maintains TRQs for imports of raw cane and refined sugar.
Section 404(d)(3) of the Uruguay Round Agreements Act (19 U.S.C. 3601(d)(3)) authorizes the President to allocate the in-quota quantity of a TRQ for any agricultural product among supplying countries or customs areas. The President delegated this authority to the United States Trade Representative under Presidential Proclamation 6763 (60 FR 1007).
On April 11, 2011, The Secretary of Agriculture announced an additional in-quota quantity of the TRQ for raw cane sugar for the remainder of FY 2011 (ending September 30, 2011) in the amount of 294,835 metric tons, raw value (MTRV). This quantity is in addition to the minimum amount to which the United States has already committed to pursuant to the World Trade Organization (WTO) Uruguay Round Agreements (1,117,195 MTRV as announced by
These allocations are based on the countries' historical shipments to the United States. The allocations of the raw cane sugar TRQ to countries that are net importers of sugar are conditioned on receipt of the appropriate verifications of origin and certificates for quota eligibility must accompany imports from any country for which an allocation has been provided.
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (See 14 CFR 301.201
The following Agreements were filed with the Department of Transportation under the Sections 412 and 414 of the Federal Aviation Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing proceedings to enforce these provisions. Answers may be filed within 21 days after the filing of the application.
(b) TC23 Middle East/Africa—TC3 (except South West Pacific) Flex Fare Resolution 111tt, Mail Vote 673 (Memo 0458/0454), Intended Effective Date: 1 April 2011.
Federal Aviation Administration, DOT.
Notice.
The Federal Aviation Administration (FAA) announces its determination that the Noise Exposure Maps submitted by Louisville Regional Airport Authority for Louisville International Airport under the provisions of 49 U.S.C. 47501
Phillip J. Braden, Federal Aviation Administration, Memphis Airports District Office, 2862 Business Park Drive, Building G, Memphis, Tennessee 38118, 901-322-8181.
This notice announces that the FAA finds that the Noise Exposure Maps submitted for Louisville International Airport are in compliance with applicable requirements of Title 14 Code of Federal Regulations (CFR) part 150, effective April 7, 2011. Under 49 U.S.C. section 47503 of the Aviation Safety and Noise Abatement Act (the Act), an airport operator may submit to the FAA Noise Exposure Maps which meet applicable regulations and which depict noncompatible land uses as of the date of submission of such maps, a description of projected aircraft operations, and the ways in which such operations will affect such maps. The Act requires such maps to be developed in consultation with interested and affected parties in the local community, government agencies, and persons using the airport. An airport operator who has submitted Noise Exposure Maps that are found by FAA to be in compliance with the requirements of 14 CFR part 150, promulgated pursuant to the Act, may submit a Noise Compatibility Program for FAA approval which sets forth the measures the airport operator has taken or proposes to take to reduce existing noncompatible uses and prevent the introduction of additional noncompatible uses.
The FAA has completed its review of the Noise Exposure Maps and accompanying documentation submitted by Louisville Regional Airport Authority. The documentation that constitutes the “Noise Exposure Maps” as defined in Section 150.7 of 14 CFR part 150 includes: Figure 11, “Existing Condition 2011 Noise Exposure Map”; Figure 12, “Forecast Condition 2012 Noise Exposure Map”; Figure 4, “Existing 2011 North Flow Arrival and Departure Tracks”; Figure 5, “Existing 2011 South Flow Arrival and Departure Tracks”; Figure 6, “Forecast 2016 North Flow Arrival and Departure RNAV Tracks”; Figure 7, “Forecast 2016 South Flow Arrival and Departure RNAV Tracks”; Figure 8, “Military Arrival and Departure Tracks”; Figure 13, “Comparison of Existing 2011 and Forecast 2016 Noise Exposure Maps”; Table 4, “2011 Operations Summary”; Table 5, “Modeled Average Daily Aircraft Operations for 2011”; Table 6, “2016 Operations Summary”; Table 7, “Modeled Average Daily Aircraft Operations for 2016”; Table 9, “Overall Runway Use Percentages for 2011”; Table 10, “Modeled Average Daily Runway Use for 2011”; Table 14, “Overall Runway Use Percentages for 2016”; Table 15, “Modeled Average Daily Runway Use for 2016”; Table 21, “Military Helicopter Flight Tracks and Use”; Table 25, “Estimated Residential Population within 2011 and 2016 DNL Contours”. The FAA has determined that these Noise Exposure Maps and accompanying documentation are in compliance with applicable requirements. This determination is effective on April 7, 2011.
FAA's determination on the airport operator's Noise Exposure Maps is limited to a finding that the maps were developed in accordance with the
Therefore, the responsibility for the detailed overlaying of noise exposure contours onto the map depicting properties on the surface rests exclusively with the airport operator that submitted those maps, or with those public agencies and planning agencies with which consultation is required under Section 47503 of the Act. The FAA has relied on the certification by the airport operator, under Section 150.21 of 14 CFR part 150, that the statutorily required consultation has been accomplished.
Copies of the full Noise Exposure Maps documentation and of the FAA's evaluation of the maps are available for examination at the following locations:
Questions may be directed to the individual named above under the heading,
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of petition; request for comments.
This notice requests comments on a petition to accept an air service incentive program at McCarran International Airport (Airport) as consistent with Federal law and policies on the use of airport revenue and on airport rates and charges. The petitioner Clark County Department of Aviation is the owner and operator of the Airport. The petitioner is the recipient of Federal grants under the Airport Improvement Program (AIP), and is subject to obligations under AIP grant agreements, including Federal law and policy on the use of airport revenue and on airport rates and charges. The FAA has interpreted these policies, and the underlying Federal statutes, to permit a temporary waiver of standard airport fees for carriers that provide new air service at an airport, as an incentive to begin or expand air service. The agency recently issued the Air Carrier Incentive Program Guidebook to provide specific guidance to airport operators on the use of air service incentive programs. That guidance restates FAA's previously issued opinions regarding what constitutes new service as characterized in the FAA's
Send your comments on or before May 31, 2011.
You may send comments [identified by Docket Number FAA-2011-0361] using any of the following methods:
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Stacy Swigart, Airport Compliance Division, ACO-100, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591, telephone (202) 267-8725; facsimile: (202) 267-5257; e-mail:
An air service incentive program is a temporary reduction in the fees that an airport operator charges air carriers at the airport, or other temporary benefits for carriers, for the purpose of promoting new or additional air service.
On February 14, 2011, the Federal Aviation Administration (FAA) received a letter from counsel for the Clark County Department of Aviation, the owner and operator of McCarran International Airport in Las Vegas, Nevada, requesting a determination from the FAA that the Department of Aviation's proposed air service incentive program does not conflict with Federal obligations. As a matter of process, the agency has elected to treat the request as a petition to amend agency policy, and is publishing notice of the request for public comment before making a determination. However, the agency has made no determination on whether granting the Department of Aviation's request would or would not actually require amendment of any existing agency policy statements.
Background: FAA policy on use of airport revenue and airport rates and charges.
Airport sponsors that accept grants under the Airport Improvement Program agree to a set of standard grant assurances, as required by 49 U.S.C. 47107. These include an assurance that airport revenue will be used for the capital and operating costs of the airport or airport system, or certain other purposes. They also include assurances that fees charged air carriers will be reasonable, not unjustly discriminatory, and substantially comparable to fees charged other carriers making similar use of the airport. The FAA has issued comprehensive policies on each of these assurances.
The Department of Transportation published the Policy Regarding Airport Rates and Charges on June 21, 1996 (61 FR 31994). Portions of the policy were subsequently vacated by the United States Court of Appeals for the District of Columbia Circuit in
3. Aeronautical fees may not unjustly discriminate against aeronautical users or user groups.
3.1 The airport proprietor must apply a consistent methodology in establishing fees for comparable aeronautical users of the airport. When the airport proprietor uses a cost-based methodology, aeronautical fees imposed on any aeronautical user or group of aeronautical users may not exceed the costs allocated to that user or user group under a cost allocation methodology adopted by the airport proprietor that is consistent with this guidance, unless aeronautical users otherwise agree.
3.1.1 The prohibition on unjust discrimination does not prevent an airport proprietor from making reasonable distinctions among aeronautical users (such as signatory and non-signatory carriers) and assessing higher fees on certain categories of aeronautical users based on those distinctions (such as higher fees for non-signatory carriers, as compared to signatory carriers).
The Department of Transportation and the FAA published the Policy and Procedures for the Use of Airport Revenue on February 16, 1999 (64 FR 7696). That policy, in paragraph VI.B.12,
Prohibited direct subsidies do not include waivers of fees or discounted landing or other fees during a promotional period. Any fee waiver or discount must be offered to all users of the airport, and provided to all users that are willing to provide the same type and level of new services consistent with the promotional offering. [64 FR 7720]
In September 2010, the FAA published the
Specifically, for example, the Guidebook states that promotional incentives are limited to
FAA defines new service as (a) service to an airport destination not currently served, (b) nonstop service where no nonstop service is currently offered, (c) new entrant carrier, and/or (d) increased frequency of flights to a specific destination. (In the last case, the incentive would be available only on the added flights.) FAA does not recognize repeated seasonal service, upgrade of equipment type, or increased number of seats on existing flights as new service.
The summary of prohibited practices reaffirms that incentives are not available for an increase in aircraft weight or seating not associated with an added flight:
Your Incentive Program may NOT:
• Offer incremental discounts based on weight for existing service
• Offer incentives based on incremental weight or increased number of seats on existing flights.
The February 14, 2011, letter from counsel for the Clark County Department of Aviation requests that FAA determine that the Department's proposed air service incentive program does not conflict with Federal obligations, and attaches a 13-page memorandum in support of that request. The letter and memorandum are available for review on the FAA Airports
In brief, the Department of Aviation states that the “objective of the proposed Incentives Program is to provide an incentive at the margin to promote additions to scheduled air service seat capacity.” The program provides, subject to certain terms and exceptions, that:
* * * all monthly scheduled service landed weight, by airline, in excess of that operated in the same month of the prior year, would receive a credit of up to 100% of the landing fee (currently $2.26 per 1,000 pounds of landed weight) paid on the incremental landed weight.
In addition to new flights, the credit would apply to existing flights for which an increase in aircraft size resulted in an increase in landing weight.
The FAA requests comments on whether the petition can be considered consistent with agency policy on use of airport revenue and airport rates and charges, including policy statements contained in the
Federal Highway Administration (FHWA), DOT.
Notice to Rescind a Notice of Intent to Prepare a Tiered Environmental Impact Statement.
The FHWA is issuing this notice to advise the public and other agencies that the Notice of Intent published January 16, 2009, DOCID: fr16ja09-155, to prepare a tiered EIS for the Northwest Loop in Sandoval and Bernalillo Counties, New Mexico, is being rescinded.
Mr. Greg Heitmann, Environmental Specialist, Federal Highway Administration, New Mexico Division Office, 4001 Office Court Drive, Suite 801, Santa Fe, NM 87507 Telephone (505) 820-2027.
The scope of the project has been adjusted to include only the construction of a 2-lane all-weather roadway within existing right-of-way owned by Sandoval County.
The project will begin 3.06 miles north of the Bernalillo County line and extend north for 2.12 miles to Alice King Way. The proposed roadway will consist of two 12-ft driving lanes and 3.7-ft shoulders. The roadway will have a gravel surface and will be designed to meet a design speed of 50 miles per hour. Drainage improvements will be provided where the roadway crosses existing water flows.
Pursuant to the National Environmental Policy Act, as amended, FHWA, in cooperation with the NMDOT, is preparing a categorical exclusion for the proposed improvements. While hard copy comments are preferred, comments by electronic mail may be sent to
National Highway Traffic Safety Administration (NHTSA), DOT.
Request for public comment on proposed collection of information.
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
This document describes an Information Collection Request (ICR) for which NHTSA intends to seek OMB approval.
Comments must be submitted on or before June 14, 2011.
Direct all written comments to the U.S. Department of Transportation Dockets, 1200 New Jersey Ave., SE., Washington, DC 20590. You may also submit comments electronically at
Jessica Cicchino, PhD, Contracting Officer's Technical Representative, Office of Behavioral Safety Research (NTI-131), National Highway Traffic Safety Administration, 1200 New Jersey Ave., SE., W46-491, Washington, DC, 20590. Dr. Cicchino's phone number is 202-366-2752 and her e-mail address is
Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must publish a document in the
(i) 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;
(ii) 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;
(iii) How to enhance the quality, utility, and clarity of the information to be collected; and
(iv) How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
In compliance with these requirements, NHTSA asks public comment on the following proposed collection of information:
The interviews will follow a pre-post design where they are administered prior to the implementation of the intervention and after its conclusion. Up
For interventions where a pre-post design would not be possible (
The heavy toll that impaired driving exacts on the Nation in fatalities, injuries, and economic costs is well documented. Impaired motorcycle riding has also been an increasing concern on our Nation's roads. Motorcycle fatalities in the US decreased in 2009 for the first time after steadily increasing for 11 years; however, even with this decline, the number of motorcycle fatalities in 2009 was nearly double that from a decade earlier. Alcohol impairment is a factor that contributes to a substantial proportion of fatal motorcycle crashes. In 2009, 30% of motorcycle riders fatally injured in crashes had a blood alcohol concentration (BAC) at or above .08 g/dL, which is
In 2012, NHTSA anticipates sponsoring demonstration projects in multiple sites to conduct interventions with the purpose of reducing impaired motorcycle riding. NHTSA plans to evaluate these interventions to determine their effectiveness. A key component of this evaluation effort will use brief interviews to assess motorcycle riders' knowledge of the intervention, self-reported drinking and riding behavior, and belief that alcohol-impaired driving laws are enforced for all motorists, including motorcycle riders in the areas in which the interventions will occur.
The findings from this proposed collection of information will assist NHTSA in addressing the problem of alcohol-impaired motorcycle riding. NHTSA will use the findings to help focus current programs and activities to achieve the greatest benefit, to develop new programs to decrease the likelihood of impaired riding, and to provide informational support to States, localities, and law enforcement agencies that will aid them in their efforts to reduce impaired motorcycle crashes.
44 U.S.C. 3506(c)(2)(A).
Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT.
Notice.
Pursuant to the Federal pipeline safety laws, PHMSA is publishing this notice of special permit requests we have received from several pipeline operators, seeking relief from compliance with certain requirements in the Federal pipeline safety regulations. This notice seeks public comments on these requests, including comments on any safety or environmental impacts. At the conclusion of the 30-day comment period, PHMSA will evaluate the requests and determine whether to grant or deny a special permit.
Submit any comments regarding these special permit requests by May 16, 2011.
Comments should reference the docket numbers for the specific special permit request and may be submitted in the following ways:
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Comments are posted without changes or edits to
PHMSA has received requests for special permits from several pipeline operators who seek relief from compliance with certain pipeline safety regulations. Each request includes a technical analysis provided by the respective operator. Each request has been filed at www.Regulations.gov and assigned a separate docket number. We invite interested persons to participate by reviewing these special permit requests at
Before acting on these special permit requests, PHMSA will evaluate all comments received on or before the comments closing date. Comments will be evaluated after this date if it is possible to do so without incurring additional expense or delay. PHMSA will consider each relevant comment we receive in making our decision to grant or deny a request.
PHMSA has received the following special permit requests:
49 U.S.C. 60118 (c)(1) and 49 CFR 1.53.
On March 28, 2011, Montreal, Maine & Atlantic Railway, Ltd. (MMA) filed with the Surface Transportation Board (Board) a petition under 49 U.S.C. 10502 for exemption from the provisions of 49 U.S.C. 10903 to abandon a .4-mile rail line extending between milepost V 23.72 at Bridge Street and milepost V 24.12 at Main Street, in Van Buren, Aroostook County, Me. The line traverses United States Postal Service Zip Code 04785.
In addition to an exemption from the provisions of 49 U.S.C. 10903, MMA seeks exemption from 49 U.S.C. 10904 (offer of financial assistance (OFA) procedures) and 49 U.S.C. 10905 (public use conditions). MMA also seeks relief from the trail use provisions of the Board's regulations at 49 CFR 1152.29. In support, MMA states that, upon receipt of abandonment authority, it plans to sell the .4-mile rail line and its transloading yard to the United States General Services Administration (GSA). In turn, GSA plans to use the property, together with other property that GSA has acquired, to construct a new land port of entry facility for the U.S. Customs and Border Protection Agency. MMA also seeks expedited action in this proceeding. These requests will be addressed in the final decision.
The line does not contain federally granted rights-of-way. Any documentation in MMA's possession will be made available promptly to those requesting it.
The interest of railroad employees will be protected by the conditions set forth in
By issuing this notice, the Board is instituting an exemption proceeding pursuant to 49 U.S.C. 10502(b). A final decision will be issued by July 15, 2011.
Any OFA under 49 CFR 1152.27(b)(2) will be due no later than 10 days after service of a decision granting the petition for exemption. Each OFA must be accompanied by a $1,500 filing fee.
All interested persons should be aware that, following abandonment of rail service and salvage of the line, the line may be suitable for other public use, including interim trail use. Any request for a public use condition under 49 CFR 1152.28 or for trail use/rail banking under 49 CFR 1152.29 will be due no later than May 5, 2011. Each trail use request must be accompanied by a $250 filing fee.
All filings in response to this notice must refer to Docket No. AB 1043 (Sub-No. 2X), and must be sent to: (1) Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001; and (2) James E. Howard, 1 Thompson Square, Suite 201, Charlestown, MA 02129. Replies to MMA's petition are due on or before May 5, 2011.
Persons seeking further information concerning abandonment procedures may contact the Board's Office of Public Assistance, Governmental Affairs, and Compliance at (202) 245-0238 or refer to the full abandonment or discontinuance regulations at 49 CFR pt. 1152. Questions concerning environmental issues may be directed to the Board's Office of Environmental Analysis (OEA) at (202) 245-0305. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.
An environmental assessment (EA) (or environmental impact statement (EIS), if necessary) prepared by OEA will be served upon all parties of record and upon any agencies or other persons who commented during its preparation. Other interested persons may contact OEA to obtain a copy of the EA (or EIS). EAs in these abandonment proceedings normally will be made available within 60 days of the filing of the petition. The deadline for submission of comments on the EA will generally be within 30 days of its service.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Rocky Mountain Railcar and Repair, Inc. (Rocky Mountain), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to acquire from Utah Industrial Depot and operate 11.5 miles of rail line, located inside an existing industrial facility in Tooele County, Utah.
According to Rocky Mountain, the transaction is expected to be consummated on or after September 28, 2011 (180 days after the exemption was filed); this is after the May 1, 2011 effective date of the exemption (30 days after the exemption was filed).
Rocky Mountain certifies that its projected annual revenues as a result of this transaction will not result in Rocky Mountain becoming a Class II or Class I rail carrier. Rocky Mountain further certifies that its projected annual revenues upon becoming a Class III carrier will not exceed $5 million.
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to Docket No. FD 35478, must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Trent D. Stirling, Rocky Mountain Railcar and Repair, Inc., 1485 W. James Way, Tooele, UT 84074.
Board decisions and notices are available on our Web site at “
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Surface Transportation Board, DOT.
Partial Revocation of Exemption.
Under 49 U.S.C. 10502, the Board revokes the class exemption as it pertains to the trackage rights described in Docket No. FD 34554 (Sub-No. 14)
This decision is effective on May 15, 2011. Petitions to stay must be filed by April 25, 2011. Petitions for reconsideration must be filed by May 5, 2011.
Send an original and 10 copies of all pleadings, referring to Docket No. FD 34554 (Sub-No. 15) to: Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on UP's representative: Elisa B. Davies, General Attorney, Union Pacific Railroad Company, 1400 Douglas Street, Mail Stop 1580, Omaha, NE 68179.
Julia Farr, (202) 245-0359. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.]
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 and Commissioner Mulvey.
Notice and request for comments.
The U.S. 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 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 Community Development Financial Institutions (CDFI) Fund, Department of the Treasury, is soliciting comments concerning the Capital Magnet Fund (CMF) Environmental Review Notification Report (ERNR).
Written comments should be received on or before June 14, 2011 to be assured of consideration.
Direct all comments to David Dworkin, Program Manager, Community Development Financial Institutions Fund, U.S. Department of the Treasury, 601 13th Street, NW., Suite 200 South, Washington, DC 20005, by e-mail to
The CMF Environmental Review Notification Report may be obtained from the CMF page of the CDFI Fund's Web site at
Pub. L. 110-289.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its effort to reduce paperwork and respondent burden, invites the general public and 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)). The IRS is soliciting comments concerning information collection requirements related to the treatment of gain from the disposition of interest in certain natural resource recapture property by S corporations and their shareholders.
Written comments should be received on or before June 14, 2011 to be assured of consideration.
Direct all written comments to Yvette B. Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the information collection should be directed to Joel Goldberger, at (202) 927-9368, or at 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 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 information collection requirements related to manufacturers excise taxes on sporting goods and firearms and other administrative provisions of special application to manufacturers and retailers excise taxes.
Written comments should be received on or before June 14, 2011 to be assured of consideration.
Direct all written comments to, Yvette B. Lawrence, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to, Joel Goldberger (202) 927-9368, 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 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)). The IRS is soliciting comments concerning information collection requirements related to manufacturers excise taxes on sporting goods and firearms and other administrative provisions of special application to manufacturers and retailers excise taxes.
Written comments should be received on or before June 14, 2011 to be assured of consideration.
Direct all written comments to Yvette B. Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to Joel Goldberger (202) 927-9368, 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 and request for comments.
The Department of the Treasury, as part of its 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)). The IRS is soliciting comments concerning information collection requirements related to changes with respect to prizes and awards and employee achievement awards.
Written comments should be received on or before June 14, 2011 to be assured of consideration.
Direct all written comments to Yvette B. Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of regulation should be directed to Joel Goldberger, (202) 927-9368, 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.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 14, 2011.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 461-9769 or FAX (202) 275-5947.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility;
a. Central Nervous System and Neuromusculo Diseases, Disability Benefits Questionnaire, VA Form 21-0960C-5.
b. Headaches (Including Migraine Headaches), Disability Benefits Questionnaire, VA Form 21-0960C-8.
c. Multiple Sclerosis (MS), Disability Benefits Questionnaire, VA Form 21-0960C-9.
d. Esophageal Disorders (Including GERD), Disability Benefits Questionnaire, VA Form 21-0960G-1.
e. Gallbladder and Pancreas Conditions, Disability Benefits Questionnaire, VA Form 21-0960G-2.
f. Intestinal Disorders (Other Than Surgical or Infectious) (Including Irritable Bowel Syndrome, Crohn's Disease, Ulcerative Colitis, and Diverticulitis) Disability Benefits Questionnaire, VA Form 21-0960G-3.
g. Intestines Surgical and/or Infectious Intestinal Disorders (Bowel Resection, Colostomy, Ileostomy, Bacterial and Parasitic Infections) Disability Benefits Questionnaire, VA Form 21-0960G-4.
h. Hepatitis, Cirrhosis and Other Liver Conditions, Disability Benefits Questionnaire, VA Form 21-0960G-5.
i. Peritoneal Adhesions Disability Benefits Questionnaire, VA Form 21-0960G-6.
j. Stomach and Duodenal Conditions (Not Including GERD or Esophageal Disorders) Disability Benefits Questionnaire, VA Form 21-0960G-7.
k. Rectum and Anus Disability Benefits Questionnaire, VA Form 21-0960H-2.
l. Breast Conditions and Disorders Disability Benefits Questionnaire, VA Form 21-0960K-1.
m. Gynecological Conditions Disability Benefits Questionnaire, VA Form 21-0960K-2.
n. Sleep Apnea Disability Benefits Questionnaire, VA Form 21-0960L-2.
o. Arthritis Disability Benefits Questionnaire, VA Form 21-0960M-3.
p. Osteomyelitis Disability Benefits Questionnaire, VA Form 21-0960M-11.
q. Ear Conditions (Including Vestibular and Infectious) Disability Benefits Questionnaire, VA Form 21-0960N-1.
a. VA Form 21-0960C-5—5,000.
b. VA Form 21-0960C-8—3,750.
c. VA Form 21-0960C-9—7,500.
d. VA Form 21-0960G-1—10,000.
e. VA Form 21-0960G-2—1,250.
f. VA Form 21-0960G-3—1,250.
g. VA Form 21-0960G-4—1,250.
h. VA Form 21-0960G-5—5,000.
i. VA Form 21-0960G-6—1,250.
j. VA Form 21-0960G-7—2,500.
k. VA Form 21-0960H-2—2,500.
l. VA Form 21-0960K-1—7,500.
m. VA Form 21-0960K-2—10,000.
n. VA Form 21-0960L-2—1,250.
o. VA Form 21-0960M-3—25,000.
p. VA Form 21-0960M-11—10,000.
q. VA Form 21-0960N-1—6,250.
a. VA Form 21-0960C-5—30 minutes.
b. VA Form 21-0960C-8—15 minutes.
c. VA Form 21-0960C-9—45 minutes.
d. VA Form 21-0960G-1—15 minutes.
e. VA Form 21-0960G-2—15 minutes.
f. VA Form 21-0960G-3—15 minutes.
g. VA Form 21-0960G-4—15 minutes.
h. VA Form 21-0960G-5—30 minutes.
i. VA Form 21-0960G-6—15 minutes.
j. VA Form 21-0960G-7—15 minutes.
k. VA Form 21-0960H-2—15 minutes.
l. VA Form 21-0960K-1—15 minutes.
m. VA Form 21-0960K-2—30 minutes.
n. VA Form 21-0960L-2—15 minutes.
o. VA Form 21-0960M-3—15 minutes.
p. VA Form 21-0960M-11—15 minutes.
q. VA Form 21-0960N-1—15 minutes.
a. VA Form 21-0960C-5—10,000.
b. VA Form 21-0960C-8—15,000.
c. VA Form 21-0960C-9—10,000.
d. VA Form 21-0960G-1—40,000.
e. VA Form 21-0960G-2—5,000.
f. VA Form 21-0960G-3—5,000.
g. VA Form 21-0960G-4—5,000.
h. VA Form 21-0960G-5—10,000.
i. VA Form 21-0960G-6—5,000.
j. VA Form 21-0960G-7—10,000.
k. VA Form 21-0960H-2—10,000.
l. VA Form 21-0960K-1—30,000.
m. VA Form 21-0960K-2—20,000.
n. VA Form 21-0960L2—5,000.
o. VA Form 21-0960M-3—100,000.
p. VA Form 21-0960N-11—40,000.
q. VA Form 21-0960N-1—25,000.
By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule makes revisions to the Medicare Advantage (MA) program (Part C) and Prescription Drug Benefit Program (Part D) to implement provisions specified in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) (ACA) and make other changes to the regulations based on our experience in the administration of the Part C and Part D programs. These latter revisions clarify various program participation requirements; make changes to strengthen beneficiary protections; strengthen our ability to identify strong applicants for Part C and Part D program participation and remove consistently poor performers; and make other clarifications and technical changes.
Vanessa Duran, (410) 786-8697, Christopher McClintick, (410) 786-4682, and Sabrina Ahmed, (410) 786-7499, General information.
Heather Rudo, (410) 786-7627 and Christopher McClintick, (410) 786-4682, Part C issues.
Deborah Larwood, (410) 786-9500, Part D issues.
Kristy Nishimoto, (410) 786-8517, Part C and Part D enrollment and appeals issues.
Deondra Moseley, (410) 786-4577, Part C payment issues.
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) established a new “Part C” in the Medicare statute (sections 1851 through 1859 of the Social Security Act (the Act) which established the current MA program (known as Medicare+Choice under the BBA). The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) established the Part D program and made significant revisions to Part C provisions governing the Medicare Advantage (MA) program. The MMA directed that important aspects of the Part D program be similar to, and coordinated with, regulations for the MA program. Generally, the provisions enacted in the MMA took effect January 1, 2006. The final rules implementing the MMA for the MA and Part D prescription drug programs appeared in the
As we have gained experience with the MA program and the prescription drug benefit program, we periodically have revised the Part C and Part D regulations to continue to improve or clarify existing policies and/or codify current guidance for both programs. In December 2007, we published a final rule with comment on contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors (72 FR 68700). In April 2008, we published a final rule to address policy and technical changes to the Part D program (73 FR 20486). In September 2008 and January 2009, we finalized revisions to both the Medicare Advantage and Medicare prescription drug benefit programs (73 FR 54226 and 74 FR 1494, respectively) to implement provisions in the Medicare Improvement for Patients and Providers Act (MIPPA) (Pub. L. 110-275), which contained provisions affecting both the Medicare Part C and Part D programs, and to make other policy changes and clarifications based on experience with both programs (73 FR 54208, 73 FR 54226, and 74 FR 2881). We also clarified the MIPPA marketing provisions in a November 2008 interim final rule (73 FR 67407).
Proposed and final rules addressing additional policy clarifications under the Part C and Part D programs appeared in the October 22, 2009 (74 FR 54634) and April 15, 2010
Indeed, one of the primary reasons set forth in support of issuing our April 2010 final rule was to address beneficiary concerns associated with the annual task of selecting a Part C or Part D plan from so many options. We noted that while it was clear that the Medicare Part C and Part D programs have been successful in providing additional health care options for beneficiaries, a significant number of beneficiaries have been confused by the array of choices provided and have found it difficult to make enrollment decisions that are best for them. Moreover, experience had shown that organizations submitting multiple bids under Part C and Part D had not consistently submitted benefit designs significantly different from each other, which we believed added to beneficiary confusion. For this reason, the April 2010 rule required that multiple plan submissions in the same area have significant differences from each other. Other changes set forth in the April 2010 final rule were aimed at strengthening existing beneficiary protections, improving payment rules and processes, enhancing our ability to pursue data collection for oversight and quality assessment, strengthening formulary policy, and finalizing a number of clarifications and technical corrections to existing policy.
On November 22, 2010, a proposed rule (hereinafter referred to as the November 2010 proposed rule) appeared in the
In the sections that follow, we discuss the changes made in the final rule to regulations in 42 CFR parts 417, 422, and 423 governing the MA and prescription drug benefit programs. To better frame the discussion of the specific regulatory provisions, we have structured the preamble narrative by topic area rather than in subpart order. Accordingly, we address the following five specific goals:
• Implementing the provisions of the ACA.
• Clarifying various program participation requirements.
• Strengthening beneficiary protections.
• Strengthening our ability to distinguish stronger applicants for Part C and Part D program participation and to remove consistently poor performers.
• Implementing other clarifications and technical changes.
A number of the revisions and clarifications in this final rule affect both the MA and prescription drug programs, and some affect section 1876 cost contracts. Within each section, we have provided a chart listing all subject areas containing provisions affecting the Part C, Part D, and section 1876 cost contract programs, and the associated regulatory citations that are being revised.
We note that these regulations are effective 60 days after the date of display of the final rule. Table 1 lists key changes that have an applicability date other than 60 days after the date of display of this final rule. The applicability dates are discussed in the preamble for each of these items.
We are implementing several changes to the regulations to reflect provisions in the ACA which are already in effect. Table 2 lists the key changes. While these ACA provisions became effective on the statutory effective date, the regulations implementing these provisions will be effective 60 days after the date of display of the final rule.
We received approximately 261 timely public comments on the November 2010 proposed rule. These public comments addressed issues on multiple topics. Commenters included health and drug plan organizations, insurance industry trade groups, pharmacy associations, pharmaceutical benefit manager (PBM) organizations, provider associations, representatives of hospital and long term care institutions, drug manufacturers, mental health and disease specific advocacy groups, beneficiary advocacy groups, researchers, and others.
In this final rule, we address all comments and concerns on the policies included in the proposed rule. We also reference comments that were outside the scope of the proposals set forth in the proposed rule, in the comment and response sections of this final rule.
We present a summary of the public comments and our responses to them in the applicable subject-matter sections of this final rule.
The ACA includes significant reforms of both the private health insurance industry and the Medicare and Medicaid programs. Provisions in the ACA that concern the Part C and Part D programs largely focus on beneficiary protections, MA payments, and simplification of MA and Part D program processes. The changes based on provisions in the ACA are detailed in Table 3.
Section 3202 of the ACA amended section 1852 of the Act to establish new standards for MA plans' cost sharing. Specifically, section 1852(a)(1)(B) of the Act was amended by the addition of a new clause (iii) that limits cost sharing under MA plans so that it cannot exceed the cost sharing imposed under Original Medicare for specific services identified in a new clause (iv). New section 1852(a)(1)(B)(iv) of the Act lists the three service categories for which cost sharing in MA plans may not exceed that required in Original Medicare (chemotherapy administration services, renal dialysis services, skilled nursing care) and section 1852(a)(1)(B)(iv)(IV) of the Act specifies that this limit on cost sharing also applies to such other services that the Secretary determines appropriate, including services that the Secretary determines require a high level of predictability and transparency for beneficiaries. The limits on cost sharing in clause (iii) are “subject to” an exception in clause (v) which provides that, “[i]n the case of services described in clause (iv) for which there is no cost sharing required under Parts A and B, cost sharing may be required for those services” under the clause (i) standard in place prior to the amendments made by section 3202 of the ACA. This section requires that overall cost sharing for Medicare Part A and B services be actuarially equivalent to that imposed under Original Medicare. As noted in the April 2010 final rule (75 FR 19712) and clarified in our April 16, 2010 policy guidance, the provisions of section 3202 of the ACA apply to MA plans offered in CY 2011. To codify these provisions, we proposed to amend § 422.100 by adding new paragraph (j). In addition, under our authority in section 1876(i)(3)(D) of the Act to impose “other terms and conditions” deemed “necessary and appropriate,” we proposed to add new paragraph (e) in § 417.101 to extend the requirements in section 3202 of the ACA to section 1876 cost contracts. In this rule we explain that our proposed addition to § 417.101 was technically incorrect and have corrected the regulation citation so that our proposed addition is new paragraph (e) to § 417.454 to extend the requirements in section 3202 of the ACA to section 1876 cost contracts. We believe that this extension is necessary in order to ensure that all Medicare beneficiaries have the benefit of the cost sharing protections enacted in the ACA, regardless of whether they receive their Part A and B benefits through Original Medicare, an MA plan, or under a section 1876 cost contract.
In our April 16, 2010 guidance issued via the Health Plan Management System (HPMS) (“Benefits Policy and Operations Guidance Regarding Bid Submissions; Duplicative and Low
In our proposed additions to § 417.454 and § 422.100, we proposed to incorporate these definitions for the two service categories. We welcomed comments on these proposed cost sharing standards.
We also proposed to limit cost sharing for home health services under MA plans to that charged under Original Medicare and noted that, although we can generally rely on our authority at 1852(a)(1)(B)(iv)(IV) of the Act to apply Original Medicare cost sharing limits to other services that the Secretary determines appropriate, because there is no cost sharing under Original Medicare for home health services, as in the case of the first 20 days of skilled nursing facility services, the exception in clause (v) of section 1852(a)(1)(B) of the Act would apply, and the limit on cost sharing under section 1852(a)(1)(B)(iii) of the Act would not apply. Thus, in proposing to apply Original Medicare cost sharing amounts to home health services or any other service with zero cost sharing, we instead indicated that we would rely on our authority in section 1856(b)(1) of the Act to establish MA standards by regulation, and in section 1857(e)(1) of the Act to impose additional “terms and conditions” found “necessary and appropriate” to require that cost sharing for these services under MA plans conform to that under Original Medicare, meaning that no cost sharing could be imposed for these services.
We solicited public comment on our proposal to limit cost sharing for home health services to that charged for those services under Original Medicare.
MedPAC strongly opposed our proposal to limit home health cost sharing to $0 for several reasons including: Home health is a less well-defined benefit in Medicare and its appropriate use is more difficult to monitor and the proposed prohibition on cost sharing for home health is unduly restrictive. They also argued that CMS' proposal is based on weak rationale. The comment included a statement of MedPAC's belief that cost sharing should be one of the tools that plans can use at their discretion as a means of ensuring appropriate utilization. The comment informed us that MedPAC was currently considering these kinds of issues as a part of their deliberations on whether or not to recommend that traditional FFS Medicare should have cost sharing for home health services, along with the level of such cost sharing and the circumstances in which the cost sharing would apply.
CMS limits the cost sharing that may be charged for SNF care so that it does not exceed what the beneficiary would pay under Original Medicare, including the minimal cost sharing we allow during the first 20 days in a covered SNF stay. We believe that minimal cost sharing is more than offset by other savings and protections offered under plans' benefit packages. One very important protection that all plans are required to offer is the maximum out-of-pocket (MOOP) limit on enrolled beneficiaries' out-of-pocket costs for covered in-network services. The maximum amount an enrolled beneficiary can be required to pay for those services is $6,700. In addition, most plans that charge cost sharing in the first 20 days of SNF care, waive the Original Medicare requirement for a 3-day qualifying inpatient hospital stay which saves beneficiaries enrolled in those plans from having to pay the costs for an inpatient stay.
We have considered all of the comments on this proposal and will finalize, as revised, the addition of a new paragraph and (j) to § 422.100 to implement section 3202 of the ACA requiring that MA plans' in-network cost sharing charges for chemotherapy, SNF care and dialysis will be no greater than that charged under Original Medicare, and a new paragraph (e) to § 417.454 to extend these protections to section 1876 cost contracts. However, we will not finalize our proposal to add new paragraph (4) to § 417.454(e) or new paragraph (4) to § 422.100(j) to prohibit plans from charging cost sharing for home health services.
Section 3204 of the ACA modified section 1851(e)(3)(B) of the Act such that, beginning with plan year 2012, the annual coordinated election period (AEP) under Parts C and D will be held from October 15 to December 7. We proposed to amend 0§ 422.62(a)(2) and § 423.38(b) to codify this change.
Section 3204 of the ACA also revised section 1851(e)(2)(C) of the Act to establish, beginning in 2011, a 45-day period at the beginning of the year (January 1 through February 14) that allows beneficiaries enrolled in MA plans the opportunity to disenroll and join Original Medicare, with the option to enroll in a Medicare prescription drug plan. This 45-day period, also referred to as the Medicare Advantage Disenrollment Period (MADP), replaces the open enrollment period (OEP) that previously occurred annually from January 1st through March 31st. To codify this provision, we proposed the following changes:
• § 422.62(a) was amended to provide for this new disenrollment opportunity and clarify that the OEP ended after 2010;
• § 422.68(f) was amended to specify the effective date for disenrollment
• § 423.38(d) was amended to allow individuals who disenrolled from an MA plan between January 1 through February 14th to enroll in a standalone PDP; and
• § 423.40(d) was amended to specify the enrollment effective dates for individuals who enroll in a standalone Medicare prescription drug plan after disenrolling from MA during the 45-day period.
In our proposed rule, we defined a fully integrated dual eligible special needs plan (SNP) as specified by the ACA, and set forth proposed regulations implementing changes made by the ACA. These changes would extend the authority to offer SNPs, extend provisions permitting existing D-SNPs that are not expanding their service areas to continue operating without contracts with State Medicaid agencies through 2012, and establish a required NCQA quality approval process for SNPs.
Section 3205 of the ACA revised section 1853(a)(1)(B) of the Act to provide authority to apply a frailty payment under PACE payment rules for certain individuals enrolled in fully integrated dual eligible special needs plans described in section 3205(b) of the ACA. In order to implement this provision, we proposed a definition of fully integrated dual eligible special needs plan to § 422.2 that will apply for these purposes. Under our proposed definition, the D-SNP must meet the following criteria in order to be considered a fully integrated dual eligible special needs plan:
• Enroll special needs individuals entitled to medical assistance under a Medicaid State plan, as defined in section 1859(b)(6)(B)(ii) of the Act and § 422.2.
• Provide dual eligible beneficiaries access to Medicare and Medicaid benefits under a single managed care organization (MCO).
• Have a capitated contract with a State Medicaid agency that includes coverage of specified primary, acute and long-term care benefits and services, consistent with State policy.
• Coordinate the delivery of covered Medicare and Medicaid health and long-term care services, using aligned care management and specialty care network methods for high-risk beneficiaries.
• Employ policies and procedures approved by CMS and the State to coordinate or integrate member materials, including enrollment, communications, grievance and appeals, and quality assurance.
In this final rule, we adopt our proposed definition of a fully integrated dual eligible special needs plan with some modification. For reasons discussed below, we have in this final rule revised the definition by removing the word “including” and have replaced the word “assurance” with “improvement.”
Based on section 3205(a) of the ACA, which revised section 1859(f)(1) of the Act, we proposed in our November 2010 proposed rule (75 FR 71198) to extend the authority for SNPs to restrict enrollment to special needs individuals, thereby permitting SNPs to continue to limit enrollment to special needs individuals through the 2013 contract year. This extension applies to all SNP categories defined at § 422.2, with the exception of dual eligible SNPs (D-SNPs) that do not have a contract with the State in which they operate in contract year 2013, as described in section II.B.3.c of this final rule.
This provision was effective upon enactment of the ACA. However, we proposed that the regulations implementing this provision would be effective 60 days after the publication of this final rule.
After considering comments, we are finalizing this provision without modification.
Section 164(c)(2) of MIPPA required all new D-SNPs and all existing D-SNPs that are seeking to expand their service areas to have contracts with the State Medicaid agencies in the States in which they operate. The provision allowed existing D-SNPs that were not seeking to expand their service areas to continue to operate without a State contract through the 2010 contract year as long as they met all other statutory requirements. Section 3205 of the ACA, which revised section 164(c)(2) of MIPPA, extends the date that D-SNPs not seeking to expand their service areas can continue to operate without a State contract to December 31, 2012. In order to implement this provision, we proposed to revise § 422.107(d)(ii) to specify the new deadline.
This provision was effective upon enactment of the ACA. However, we proposed that the regulations implementing this provision would be effective 60 days after the publication of the final rule.
The ACA amended section 1859(f) of the Act to require that all SNPs, existing, new, and those wishing to expand their service areas, be approved by the National Committee for Quality Assurance (NCQA) effective January 1, 2012 and subsequent years. Section 1859(f) of the Act further specified that the NCQA approval process shall be based on the standards established by the Secretary.
In our November 2010 proposed rule (75 FR 71199), we stated that both the quality improvement (QI) program plan description and the model of care (MOC) are critical clinical elements that represent the potential for the SNP to provide integrated care for Medicare enrollees. We proposed that NCQA review both the QI program plan description and the MOC submitted during the application process for all SNPs using standards developed by CMS. Specifically, we proposed to add a new paragraph (iv) to § 422.4(a) to require MA plans wishing to offer a SNP, whether new or current, to be approved by NCQA, effective January 1, 2012, by submitting their quality QI program plan and MOC to CMS for NCQA evaluation and approval, per CMS guidance. We also proposed to codify the new requirement at § 422.101(f), which specifies MOC requirements, by adding a new paragraph (vi). Finally, we proposed to codify the new requirement by revising § 422.152(g), which specifies QI program requirements.
In the proposed rule, we also clarified that CMS would not participate in the scoring and review of the MOC and QI program plans. We also stated in our proposed rule that we would release specific instructions and guidance to organizations, including the specific criteria that NCQA would use to evaluate the QI program plan description and MOC, information about technical assistance training that would be available to the SNPs as they prepared their QI program plan and MOC submissions, as well as details on the frequency of the SNP approval process. We also expressed concern that an annual approval process could be burdensome for plans and solicited comments on how to determine the appropriate frequency for the SNP approval process.
Based on the comments we received on the proposed rule, we are modifying § 422.4(a)(iv), § 422.101(f), and § 422.152(g), as described below.
In accordance with section 3206 of the ACA, which revised section 1876(h)(5)(C) of the Act, we proposed in our November 2010 proposed rule (FR 75 71199) to extend implementation of the section 1876 cost contract competition provisions until January 1, 2013. Previously, MIPPA had specified that section 1876 cost contractors operating in service areas or portions of service areas with two or more local or two or more regional Medicare coordinated care plans meeting minimum enrollment requirements (5,000 enrollees for urban areas and 1,500 enrollees for non urban areas) would be non-renewed beginning in 2010.
In implementing the new contract non-renewal date, we specified in our November 2010 proposed rule that we would evaluate enrollment of competing MA coordinated care plans beginning in 2012, send out non-renewal notices to affected section 1876 cost contracts in 2013, and that affected section 1876 cost contractors would first be unable to offer a plan beginning contract year 2014. We proposed to codify the statutory change in § 417.402(c).
We received no comments on this provision and are finalizing the provision as proposed.
Section 3208 of the ACA established (at section 1859(g) of the Act) that as of January 1, 2010, senior housing facility plans participating as of December 31, 2009 “in a demonstration project established by the Secretary under which such a plan was offered for not less than 1 year” may continue participation as Medicare Advantage senior housing facility plans. In implementing this provision of the ACA, we proposed in our November 2010 proposed rule (75 FR 71199 and 71200) to amend the definitions at § 422.2 to include “senior housing facility plan” as a new coordinated care plan type. Our proposed definition of the term was consistent with the statutory requirements for such plans at section 1859(g) of the Act: that such a plan restrict enrollment to individuals who reside in a continuing care retirement community as defined in § 422.133(b)(2); provide primary care services onsite and have a ratio of accessible physicians to beneficiaries that we determine is adequate consistent with prevailing patterns of community health care as provided under § 422.112(a)(10); provide transportation services for beneficiaries to specialty providers outside of the facility; and was participating as of December 31, 2009 in a demonstration established by us for not less than 1 year. We also noted that a senior housing facility plan must otherwise meet all requirements applicable to MA organizations under this part.
In addition, we proposed to add a new § 422.53 to subpart B of Part 422 to address the eligibility and enrollment policies applicable to senior housing facility plans. We proposed specifying at § 422.53 that MA senior housing facility plans must restrict enrollment in these plans to residents of continuing care retirement communities, and that individuals enrolled in such plans must meet all other MA eligibility requirements in order to be eligible to enroll. In addition, we proposed specifying at § 422.53(c) that an MA senior housing facility plan must verify the eligibility of each individual enrolling in its plan using a CMS-approved process. We proposed that the regulations implementing this provision would be effective 60 days after the publication of the final rule.
We are finalizing our proposed provisions regarding senior housing facility plans without modification.
Section 3209 of the ACA amends section 1854(a)(5) of the Act by adding subsection (C) (ii) to stipulate and expressly provide that the Secretary may deny a bid submitted by an MA organization for an MA plan if it proposes significant increases in cost sharing or decreases in benefits offered under the plan. Section 3209 of the ACA also extends this provision to apply to the review of bids from Part D sponsors by amending section 1860D-11(d) of the Act to add a new paragraph (3). This statutory authority applies to bids submitted for contract years beginning on or after January 1, 2011. However, as indicated in section II.A. of this final rule, the regulations codifying this provision will be effective 60 days after the date of display of the final rule.
In the proposed rule, we stated that we believe these amendments clarify the Secretary's authority to deny bids
Because these policies have been implemented so recently, we concluded that it was premature to propose additional regulatory restrictions limiting MA organizations' or PDP sponsors' flexibility in developing plan bids until we are able to evaluate the effectiveness and impact on the market of those current policies. However, in the preamble to the proposed rule, we requested comments on the criteria outlined in our April 16, 2010 guidance issued via HPMS and whether we should establish additional requirements to limit plan offerings in a service area and whether there are other measures we should consider as part of future rulemaking that may help us in our efforts to protect beneficiaries and promote the provision of high quality, affordable health plans. We also invited comments on whether we should adopt other substantive criteria for exercising our authority under 3209 of the ACA by implementing caps or limits on the number of plans offered in a region, or on the number of sponsors participating in the program. Finally, we solicited comments on the best way to ensure fair notice and equal treatment for all plan bids in the absence of specific non-acceptance and denial policies. While we indicated that we would not propose additional specific regulatory criteria for CY 2012, we noted that our decision should not be interpreted as an indication that we would not adopt specific policies in future rulemaking. We will consider the suggestions and comments we received from the public on the proposed rule to guide our future policy.
We proposed to codify the amendments made to sections 1854(a)(5) and 1860D-11(d) of the Act by adding paragraph (a)(5) to § 422.254, revising § 422.256(a), adding paragraph (b)(3) to § 423.265 and by adding paragraph (b)(4) to § 423.272.
A detailed discussion regarding the thresholds that CMS will be using for CY 2012 meaningful differences policies are included in the Final Rate Announcement and Call Letter for CY 2012.
A few commenters indicated that CMS did not provide sufficiently detailed information as to how plan benefits as part of the OOPC calculation were projected and estimated for 2011. A number of sponsors discovered during bid negotiations that estimates they had produced to guide their benefit designs were significantly different than CMS recommendations. Commenters recommended CMS reevaluate use of the tool to analyze plan bids and engage in detailed discussion with MA and Part D plan sponsors to identify alternatives.
One commenter believes the OOPC tool, which is used by CMS to provide out-of-pocket costs information through the
The ACA amends the statute governing the calculation of the LIS benchmark premium amount (see section 3302 of the ACA, as amended by section 1102 of HCERA). As amended, section 1860D-14(b)(3)(B)(iii) of the Act requires us to calculate the LIS benchmarks using MA-PD basic Part D premiums before the application of Part C rebates each year, beginning with 2011. We proposed to update the regulations at § 423.780(b)(2)(ii)(C) to incorporate this change. We also proposed that the regulations implementing this provision would be effective 60 days after the publication of the final rule.
Section 3303(a) of the ACA modifies section 1860D-14(a) of the Act by creating a new subsection (5) that permits PDPs and MA-PD plans to waive a
Section 3303(b) of the ACA modifies section 1860D-1(b)(1) of the Act by inserting new language in subparagraph (C) and adding a new subparagraph (D) that permits the Secretary to include PDPs and MA-PD plans that waive the
Section 423.34(c) specifies that CMS may reassign certain LIS-eligible individuals if CMS determines that further enrollment is warranted. We have used this authority to reassign LIS-eligible individuals annually when a PDP's monthly beneficiary premium amount will exceed the low income benchmark, as calculated in § 423.780(b)(2). As noted previously, the ACA prohibits the Secretary from reassigning a plan's LIS eligible enrollees based on the fact that the plan's monthly beneficiary premium exceeds the LIS benchmark premium amount, so long as the amount of premium that exceeds the LIS benchmark is
Section 423.34(d) specifies that CMS will automatically enroll LIS-eligible individuals who fail to enroll in a PDP. The pool of PDPs into which we auto-enroll these individuals includes those plans with monthly beneficiary premiums for LIS-eligible individuals that do not exceed the low income benchmark as calculated in § 423.780(b)(2). We proposed to amend § 423.34(d) regarding auto-enrollment of LIS-eligible individuals to be consistent with section 1860D-1(b)(1) of the Act, as modified by section 3303(b) of the ACA, which expands the Secretary's discretionary authority to include PDPs or MA-PD plans that voluntarily waive the de minimis amount in the pool of Part D plans qualified to receive auto-enrollees and reassignees, if the Secretary determines that such inclusion is warranted.
For the reasons stated previously, we are amending § 423.34(d) to codify the Secretary's authority only with respect to including PDPs that voluntarily waive the
We also proposed to amend § 423.780(f) to reflect section 1860D-14(a)(5) of the Act, permitting a Part D plan to waive a
Section 3308 of the ACA amended section 1860D-13(a) of the Act by establishing an income related monthly adjustment amount (hereafter referred to as Part D—IRMAA) that is added to the monthly Part D premium for individuals whose modified adjusted gross income exceeds the same income threshold amounts established under section 1839(i) of the Act with respect to the Medicare Part B income related monthly adjustment amount (Part B—IRMAA).
In CY 2007, the income ranges set forth in section 1839(i) of the Act required that individual and joint tax filers enrolled in Part B whose modified adjusted gross income exceeded $80,000 and $160,000, respectively, would be assessed the Part B—IRMAA on a sliding scale. As specified in section 1839(i)(5) of the Act, since the implementation of the Part B—IRMAA, each dollar amount within the income threshold tiers has been adjusted annually based on the Consumer Price Index. As a result of the annual adjustment, for calendar year 2010, the income threshold amounts were increased to reflect the four income threshold amount tiers shown below:
In accordance with section 3308 of the ACA, effective January 1, 2011, any individual enrolled in the Medicare prescription drug program whose modified adjusted gross income exceeds the same income threshold amount tiers established under Part B will have an income related increase to his/her Part D monthly premium. Section 3308 of the ACA provides that the Part D—IRMAA will be calculated using the Part D national base beneficiary premium and the premium percentages in the above chart as follows: BBP × [(P percent −25.5 percent)/25.5 percent]. The BBP is the base beneficiary premium and P is the applicable premium percentage (35 percent, 50 percent, 65 percent, or 80 percent). The premium percentage used in the calculation will depend on the level of the Part D enrollee's modified adjusted gross income.
Section 3308 of the ACA requires CMS to provide the Social Security Administration (SSA) with the national base beneficiary premium amount used to calculate the Part D—IRMAA no later than September 15 of every year, beginning in 2010. Beginning in 2010, we must also provide SSA, no later than October 15 of each year, with: (1) The modified adjusted gross income threshold ranges; (2) the applicable percentages established for Part D—IRMAA in accordance with section 1839(i) of the Act; (3) the corresponding monthly adjustment amounts; and (4) any other information SSA deems necessary to carry out the Part D—IRMAA. With respect to the final item, we previously provided SSA with an initial list of all individuals enrolled in the Part D program.
In accordance with section 3308 of the ACA and the interim final rule with request for comments entitled “Regulations Regarding Income-Related Monthly Adjustment Amounts to Medicare Beneficiaries' Prescription Drug Coverage Premiums” (75 FR 75884), SSA used this initial list of Part D enrollees to request beneficiary-specific tax payer information from the Internal Revenue Service in order to determine: (1) Which Part D enrollees exceed the income threshold amounts established under section 1839(i) of the Act; and (2) the income related monthly adjustment amount that these enrollees must pay. This exchange of information between CMS and SSA occurred in 2010 so that individuals identified were billed the correct Part D—IRMAA beginning January 1, 2011. Following this initial data exchange with SSA, CMS will routinely provide SSA with the names of all individuals newly enrolling in the Part D program so that SSA can repeat the process of identifying individuals who must pay the Part D—IRMAA and the specific income-related amount. We will also routinely provide the names of individuals who have disenrolled from the Part D program so that such individuals will no longer be assessed the Part D—IRMAA. In cases where an individual disagrees with a determination that he/she is subject to the Part D—IRMAA, such individual may appeal as provided in the SSA regulations under 20 CFR part 418.
Section 3308 of the ACA also stipulates that the Part D—IRMAA must be withheld from benefit payments in accordance with section 1840 of the Act. Therefore, in cases where an individual is receiving benefit payments from SSA, the Railroad Retirement Board (RRB), or the Office of Personnel Management (OPM), the Part D—IRMAA must be withheld from such benefit payments. However, if the benefit payment is insufficient to allow the Part D—IRMAA withholding, or an individual is not receiving benefit payments as described in section 1840 of the Act, section 3308 of the ACA requires SSA to enter into agreements with CMS, RRB, and OPM, as necessary, in order to allow the Part D—IRMAA to be collected directly from these beneficiaries.
To implement section 3308 of the ACA, we proposed to revise § 423.286 (rules regarding premiums), § 423.293 (collection of monthly beneficiary premium), and § 423.44 (involuntary disenrollment by PDP).
Currently, § 423.286(a) provides that the monthly beneficiary premium for a Part D plan in a PDP region is the same for all Part D-eligible individuals enrolled in the plan with the exception of employer group waivers, the assessment of the Part D late enrollment penalty, or an enrollee receiving low-income assistance. We proposed to revise the following:
• Section 423.286(a) to include the assessment of the income related monthly adjustment amount as another exception to the requirement for a uniform monthly beneficiary premium for a Part D plan in a PDP region;
• Section 423.286(d)(4) to define the increase for the income related monthly adjustment amount for Part D;
• Section 423.286(d)(4)(i) to specify that SSA would determine the individuals that are subject to the Part D—IRMAA and the amount of the adjustment;
• Section 423.286(d)(4)(ii) to provide the formula used to calculate the monthly adjustment amount; and
• Section 423.286(d)(4) to provide appeals rights to individuals who disagree with SSA's determination that they are subject to the Part D—IRMAA or the threshold amount of the adjustment they must pay.
On December 10, 2010, we released to Part D plan sponsors a memorandum entitled, “Part D—Income Related Monthly Adjustment Amount—Frequently Asked Questions & Answers,” which included plain-language, beneficiary-friendly questions and answers specifically addressing inquiries plans may receive from beneficiaries. These FAQs include information such as how the Part D—IRMAA is collected, the responsible entity for determining who should be assessed the amount, as well as the appropriate government agency a beneficiary should contact with additional questions.
We have provided clear instructions to plans regarding the appropriate referral agency for specific questions regarding an individual's Part D—IRMAA determination and billing. We will continue to work with Part D plan sponsors to determine what specific additional guidance they need in answering beneficiary inquiries related to the Part D—IRMAA.
Consistent with section 1860D-15(a)(1) of the Act, we will not apply Part D—IRMAA to the base beneficiary premium used to calculate the Part D direct subsidy payments. In addition, no other Part D—IRMAA related adjustments will be made to the Part D payments received by Part D sponsors. As a result, the Part D—IRMAA is expected to have no impact on the Part D bids or Federal payments received by Part D sponsors.
We would also like to note that in the preamble of the proposed rule we inadvertently referenced the wrong citation in describing our proposal to add provisions regarding a beneficiary's right to file an appeal of SSA's Part D—IRMAA determination. We referenced § 423.286(d)(4)(iii) and (iv), but should have referred to § 423.286(d)(4)(i) which is where these provisions were
We proposed establishing a new § 423.293(d)(1) to describe how the Part D—IRMAA would be collected. First, we addressed the process for collecting the Part D—IRMAA from SSA, RRB, or OPM benefit payments. In cases where SSA determines that a Part D enrollee must pay a Part D—IRMAA, such amount must be paid through withholding from the enrollee's Social Security benefit payments, or benefit payments by the RRB or OPM in the manner that the Part B premium is withheld. Additionally, we proposed at § 423.293(d)(2) that in cases where premium withholding is not possible because the monthly benefit check is insufficient to allow the withholding, or the enrollee is not receiving any monthly benefit payment, the individual must be directly billed for the Part D—IRMAA through an electronic funds transfer mechanism (such as automatic charges of an account at a financial institution or a credit or debit card account) or according to other means that we may specify.
Section 3308 of the ACA provides that the Part D—IRMAA is an increase to the monthly beneficiary premium for certain individuals. Section 1851(g)(B)(i) of the Act, as incorporated by section 1860D-1(b)(5) of the Act, establishes that a beneficiary may be terminated for failing to pay his/her Part D premiums. At § 423.293(d)(3), we proposed that CMS will terminate Part D coverage for any individual who fails to pay the income related monthly adjustment amount in accordance with proposed § 423.44 (see discussion below).
Section 3308 of the ACA provides that the Part D—IRMAA increases the monthly beneficiary premium for individuals who are subject to the assessment. Therefore, we proposed to apply provisions similar to the existing Part D premium rules to terminate Part D coverage (provided for by Section 1860D-13(c) of the Act) for any individual who fails to pay the Part D—IRMAA. Specifically, we proposed the following:
• Section 423.44(e)(1) provides that CMS will disenroll individuals who do not pay their Part D—IRMAA.
• Section 423.44(e)(2) provides individuals a 3-month grace period to pay outstanding Part D—IRMAA amounts before they are involuntarily disenrolled.
• Section 423.44(e)(3) provides an opportunity for a disenrolled beneficiary to establish “good cause” for failure to pay their Part D—IRMAA and have their plan enrollment reinstated if Part D—IRMAA arrearages are paid.
• Section 423.44(e)(4) requires PDPs, after notification by CMS, to notify enrollees of the termination of their enrollment in the Part D plan in a form and manner determined by CMS.
• Section 423.44(e)(5) establishes that the effective date of disenrollment is the first day following the initial grace period.
• Finally, we proposed modifying the title of § 423.44 from “Involuntary Disenrollment by the PDP” to “Involuntary Disenrollment from Part D Coverage.”
Commenters also requested that we take into consideration the potential
In addition, one commenter recommended that CMS delay implementation of the grace period specific to the Part D—IRMAA in light of the other CMS provisions that require process and system changes. According to this commenter, CMS should consider this recommendation since the Part D—IRMAA affects only a small percentage of the total Part D population.
With respect to synchronizing the Part D—IRMAA with plan premium grace periods, our regulations at § 423.44(d)(1)(iii) stipulate that plans choosing to implement a policy of involuntary disenrollment for failure to pay the Part D plan premium must provide a minimum 2-month grace period. A Part D plan sponsor with an established 2-month minimum grace period may disenroll a beneficiary for failing to pay the plan's premium, if such grace period ends prior to the 3-month grace period allotted for payment of the Part D—IRMAA. Current guidance (Medicare Prescription Drug Benefit Manual, Chapter 3, § 50.3.1) allows plans to implement a longer grace period or forgo involuntary disenrollments for failure to pay premiums entirely. Therefore, plans already have the ability to modify their respective grace periods and are encouraged to do so if they believe the existence of two different grace periods will create conflict or confusion.
As noted previously, the vast majority of individuals subject to the Part D—IRMAA are paying the income-based amount through a deduction from their Social Security checks, and thus the grace period associated specifically with payment of the Part D—IRMAA is not a factor. However, to the extent that individuals fail to pay only the Part D—IRMAA, we believe it is appropriate to use the same procedures and time frames that apply to the Part B-IRMAA. Note that individuals who fail to pay the Part D premium that is owed to a plan may be disenrolled by the plan after the expiration of the 2-month grace period, regardless of the payment status of their Part D—IRMAA.
If a plan chooses to retain a grace period that is shorter than the one specific to the Part D—IRMAA, once the beneficiary is disenrolled from the plan, the assessment of the Part D—IRMAA will cease. Therefore, the beneficiary will receive the disenrollment notice as a result of not paying the plan's premium and there will be no need to issue the involuntary notice for failing to pay the Part D—IRMAA. For example, if the beneficiary fails to pay the plan premium within the plan's grace period but the grace period specific to the Part D—IRMAA has not lapsed, the Part D plan sponsor will, in accordance with CMS rules, send us a plan transaction to disenroll the beneficiary. Following confirmation from us that the disenrollment transaction has been accepted, the Part D plan sponsor must send the beneficiary the disenrollment notice no later than 3 business days following the last day of the grace period. (See Chapter 3, Section 50.3.1 of the Medicare Prescription Drug Benefit Manual.) Once the beneficiary has been disenrolled from the plan, the withholding and/or billing of the Part D—IRMAA will cease. Lastly, in those cases where the Part D—IRMAA and the plan premium grace periods are different, but end on the same date, the beneficiary will receive two disenrollment notifications—Notice of Failure to Pay Plan Premiums and the Notification of Involuntary Disenrollment by the Centers for Medicare and Medicaid Services for Failure to Pay the Part D—IRMAA since the former conveys information about requesting the plan to reconsider its decision and the latter provides information about requesting a “good cause” determination.
For these reasons, we are finalizing the regulatory provisions as proposed. However, we will carefully consider these comments and potential system impacts as it develops its program instructions to plans regarding the procedures for disenrolling beneficiaries who fail to pay their Part D—IRMAA and the timing of when plans will convey the notice. In addition, we will closely monitor the disenrollment process and make adjustments to the process to ensure optimum coordination between the timing of the grace period and the issuance of the beneficiary disenrollment notice.
We recognize that Part D plan sponsors may receive questions from their members regarding the disenrollment. As such, the notification used by Part D plan sponsors will explicitly state that the disenrollment is being effectuated by the plan at CMS' direction. This notice further instructs the beneficiary to contact us, not the plan, about questions pertaining to the notice. As noted previously, the December 10, 2010 CMS memorandum mentioned previously provides plans with language they can use in responding to members' Part D—IRMAA inquiries. We will continually develop and release information to Part D plan sponsors, partners, and beneficiaries via the CMS information channels (1-800-MEDICARE,
• Establish a special enrollment period (SEP) for disenrolled individuals to re-enroll into another MA-only (or a cost plan).
• Allow for passive enrollment into an MA-only plan within the same organization if an individual is disenrolled from their MA-PD plan for failure to pay Part D—IRMAA.
• Grant employer group waiver plans a waiver from the disenrollment process.
Individuals in employer group waiver plans and employer group health plans will also be disenrolled for failure to pay Part D—IRMAA. Employer groups that want to assure that their members retain coverage are not prohibited from informing their retirees that they will be reimbursed by their employer group for any Part D—IRMAA they are required to pay.
We appreciate the comments on our proposals and, for the reasons contained in the discussion previously, are finalizing these provisions as proposed. We have, however, made technical revisions to § 423.286(d)(4) and§ 423.293(d) to incorporate references to the new SSA regulations regarding the Part D IRMAA, which were published after the issuance of our proposed rule.
The MMA, as reflected in § 423.782, established that full-benefit dual eligible institutionalized individuals have no cost-sharing for covered Part D drugs under their PDP or MA-PD plan. Section 3309 of the ACA eliminates cost-sharing for full-benefit dual eligible individuals who are receiving home and community-based services (HCBS) under a home and community-based waiver authorized for a State under section 1115 or subsection (c) or (d) of section 1915 of the Act, or under a State Plan Amendment under section 1915(i) of the Act, or if such services are
Section 3309 of the ACA provides the Secretary with discretion regarding the effective date of this provision, with the stipulation that it shall be effective no earlier than January 1, 2012. We proposed that this provision would take effect on January 1, 2012, because we believed it was important to provide this benefit at the earliest possible date to an estimated 600,000 beneficiaries a year.
We appreciate the strong support we received from commenters for our proposal to amend § 423.772 to establish the definition of an “individual receiving home and community-based services” and § 423.782(a)(2)(ii) to reflect that these individuals will have no cost-sharing. We are finalizing these regulations as proposed.
We appreciate the comments that were submitted on these provisions and will be finalizing these proposals.
In our proposed rule, we proposed to implement section 3310 of the ACA by adding a new regulation at § 423.154 to govern how plan sponsors (all organizations and sponsors offering Part D including stand-alone Part D plans, MA organizations, EGWP contracts, and PACE plans) direct network pharmacy dispensing of covered Part D drugs in LTC facilities. Under § 423.154 (a)(1)(i) of the proposed rule, we require all sponsors to contract with network pharmacies servicing LTC facilities, as defined in § 423.100, to dispense brand medications, as defined in § 423.4, to enrollees in such facilities in no greater than 7-day increments at a time. In an effort to target the drugs resulting in the most financial waste and to lessen the burden for facilities transitioning from 30-day supplies to 7-day-or-less supplies, we proposed initially limiting the requirement for 7-day-or-less dispensing to brand drugs as defined in § 423.4. We noted in the proposed rule that as a result of consultation with industry representatives, a transitional approach would ease the initial burden on nursing and pharmacist staff by reducing the number of products for which a pharmacy would have to transition from dispensing one 30-day supply per month to dispensing at least four 7-day supplies per month. We also acknowledged that we are not aware of any objective data that demonstrate the cost effectiveness of full versus partial implementation, but welcomed comments from the public presenting such data and also solicited comments on how soon the industry can transition to include generic drugs in the 7-day-or-less requirement.
Under § 423.154(a)(1)(ii) of the proposed rule, we require Part D sponsors to permit the use of uniform dispensing techniques defined by each of the LTC facilities being serviced. We proposed to define uniform techniques to mean that dispensing methodologies will be uniform with respect to the type of packaging used to dispense Part D drugs within a LTC facility, but may vary by the quantity of medication (days' supply) dispensed at a time. We explained that it is the LTC facilities that are in the best position to identify uniform dispensing techniques to be used throughout their LTC facility. Therefore, we proposed that Part D sponsors must permit their contracted pharmacies to implement the uniform dispensing techniques selected by each LTC facility, and may not require the use of a different packaging system or technology than that selected by the facility through its contracted LTC pharmacy.
We noted in the proposed rule that we do not expect pharmacy delivery schedules to change as a result of the 7-day-or-less dispensing requirement since deliveries are generally made daily to accommodate new admissions and first doses. We do recognize, however, that there may be changes in the way some pharmacies make deliveries. We stated in the preamble of the proposed rule that, subject to State restrictions, pharmacies, and LTC facilities may agree to use a common carrier for some deliveries to LTC facilities. We would not consider a contractual agreement for a pharmacy to deliver a portion of Part D drugs to Part D enrollees residing in LTC facilities via common carrier as causing the pharmacy to be considered a mail order pharmacy. We solicited comments on our interpretation.
We proposed to exclude from the requirements of § 423.154(a), those drugs that are difficult to dispense in a 7-day-or-less supply and those drugs that are dispensed for acute illnesses. We expressed our belief that requiring these types of drugs to be dispensed in 7-day-or-less increments could result in safety or efficacy concerns or could have the counterproductive effect of increasing drug waste. For medications that we proposed to exclude from the requirement, we encouraged use of smaller size containers, when available, to reduce the potential for waste. We proposed to codify these exclusions at § 423.154(b) and solicited comments on the types of dosage forms and drugs that should be excluded from the requirements under § 423.154(a).
We explained that we considered “return for credit and reuse” as a possible solution to reduce waste in LTC facilities. Although “return for credit and reuse” is not prohibited by CMS, we recognized limitations to this approach since “return for credit and
Although we did not propose “return for credit and reuse” as an alternative to 7-day-or-less dispensing, we understand that it may be a supplement to reduce the minimal pharmaceutical waste associated with 7-day-or-less dispensing, particularly in circumstances where a Part D drug can be safely returned to stock for reuse. We proposed to explicitly allow “return for credit and reuse” in LTC pharmacies, when “return for credit and reuse” is permitted under the State law and is explicitly allowed under the contract between the Part D sponsor and the pharmacy. In addition, when permitted or required contractually, we noted that pharmacy dispensing fees paid to pharmacies may take into account restocking fees consistent with the modification to dispensing fees under § 423.100, “Dispensing Fees” discussed in section II. F. of this final rule (Other Clarifications and Technical Changes).
We explained in our proposed rule that only when data has been systematically collected will the extent of waste of Part D drugs be quantifiable on other than an anecdotal basis. Therefore, we proposed to add a provision at § 423.154(f) to require that Part D sponsors include terms in their LTC pharmacy contracts that require any unused drugs originally dispensed to the Part D sponsor's enrollees to be returned to the pharmacy (not necessarily for reuse) and reported to the sponsor. Such contracts would also address contractual obligations for disposal in accordance with Federal and State regulations. We solicited comments on whether there are DEA or state technical issues that may be barriers to the implementation of this provision.
We noted that options for billing to accommodate 7-day-or-less dispensing are being discussed in a National Council for Prescription Drug Programs (NCPDP) workgroup, and unless the industry voluntarily adopts a single billing standard, we believe that Part D sponsors should generally allow pharmacies to use be currently accepted transactions to minimize burden in transitioning to more frequent dispensing of smaller amounts.
Pursuant to our authority under section 1860D-12(b)(3)(D) of the Act, which incorporates by reference section 1857(e)(1) of the Act, we proposed a new requirement under § 423.154(a)(2) in which Part D sponsors must collect and report to CMS the dispensing methodology used for each dispensing event described by § 423.154(a)(1)(i) and (ii) and on the nature and quantity of unused drugs returned to the pharmacy. This data collection would be done in an effort to help us estimate the relative efficiencies of dispensing methodologies and determine the residual waste to estimate additional savings.
We stated in the proposed rule that this provision would likely lead to a change in copayment methodology. We noted that we anticipate the implementation of particular copayment methodologies will be dependent on the billing and dispensing methodologies used, and as a result, we acknowledged that copayment methodologies within the same plan may vary depending on the LTC facility where the beneficiary resides. Copayment may be collected at the first dispensing event in a month, the last dispensing event in a month, or prorated based on the number of days a Part D drug was dispensed in a month. However, due to the relatively small copayments for low-income subsidy (LIS) beneficiaries, copayments for LIS beneficiaries should be billed with the first or last dispensing event of the month.
Under § 423.154(c) of the proposed rule, we would waive the requirements under paragraph (a) for pharmacies when they dispense brand Part D drugs to Part D enrollees residing in intermediate care facilities for the mentally retarded (ICFMR) and institutes for mental disease (IMDs) due to specific problems with medication delivery and dispensing to closed (and often locked) facilities. We explained that waiving the requirements in this instance would be consistent with the statute when done on a uniform basis (that is, all similarly situated LTC facilities) and when there is a demonstration that applying the dispensing requirements to pharmacies servicing enrollees residing in that type of LTC facility would not serve to reduce waste. We solicited comments on whether other types of facilities (such as LTC facilities utilizing Indian Health Service (IHS) facilities to provide Part D drugs or utilizing Tribal facilities providing pharmacy services for the IHS under Pub. L. 93-638 compacts or contracts) should also be waived from the requirement and on the specific reasons as to why those facilities should be waived from the requirement. In addition, we solicited specific comments on the waiver criteria for LTC pharmacies.
Under § 423.154(d) of the proposed rule and pursuant to section 3310 of the ACA, the requirements of this section would be effective January 1, 2012. However, under § 423.154(e) of the proposed rule, we proposed to allow an independent community pharmacy (such as, not a closed door pharmacy dedicated to servicing LTC facilities only) that is the primary provider of the Part D drugs to a small LTC facility (less than 80 beds) located in a rural community (as defined by the Bureau of the Census) to dispense no more than a 14-day supply through December 31, 2012, assuming that the pharmacy is not already dispensing a 7-day supply to any patient population in the LTC facility. We explained that we expected that Part D sponsors contracting with these pharmacies would find solutions to their significant challenges and work toward full compliance with § 423.154(a) during this extension. Under the proposed rule, these pharmacies would be required to come into full compliance with § 423.154(a) by January 1, 2013. We solicited comments on this matter.
Based on the preceding, we proposed revising § 423.150 by renumbering paragraphs (b) through (g) as paragraphs (c) through (h) and adding a new paragraph (b) to address appropriate dispensing of covered Part D drugs to enrollees in LTC facilities. We proposed adding new requirements, as discussed previously, at § 423.154 to require Part D sponsors to ensure that all pharmacies servicing LTC facilities dispense no more than a 7-day supply of brand medications and use uniform dispensing methodologies as defined by each of the LTC facilities being serviced. In addition, under § 423.154(a)(2), we proposed requiring Part D sponsors to collect and report, as CMS specifies, the dispensing methodology used for each dispensing event described by paragraphs (a)(1)(i) and (ii) of § 423.154. We proposed identifying exceptions to this requirement at § 423.154(b)(1) and (2) relative to specific drugs and waivers of this requirement for specific pharmacies under § 423.154(c). Pursuant to section 3310 of the ACA, we proposed an effective date of January 1, 2012 for these requirements at § 423.154(d), with a limited extension through December 31, 2012 for pharmacies meeting the requirements under § 423.154(e). We also proposed that Part D sponsors require any unused Part D drugs originally dispensed to
We agree with the commenters that the statute does not mandate 7-day-or-less dispensing. Section 3310 of ACA, which is implemented by § 423.154, states “[t]he Secretary shall require PDP sponsors of prescription drug plans to utilize specific uniform dispensing techniques, as determined by the Secretary, in consultation with relevant stakeholders, * * * such as weekly, daily, or automated dose dispensing * * *” Because the dispensing frequencies are illustrative examples (as indicated by the use of the phrase “such as”), we interpret this language as an indicator of Congress' preference to give the Secretary flexibility in determining the dispensing increments based on information received from the relevant stakeholders. Based on comments, we believe that 14-day-or-less dispensing is a more prudent approach to initially implementing section 3310 of ACA. A 14-day-or-less dispensing requirement will place less of a burden on pharmacies and LTC facilities than a 7-day-or-less dispensing requirement while allowing CMS to collect data to determine the impact of 14-day-or-less dispensing on unused drugs in LTC facilities.
For purposes of scoring this final rule, we project that the current aggregate level of dispensing fees will double. Obviously, the negotiations between LTC pharmacies and Part D sponsors or PBMs that would determine any changes in dispensing fees have not yet taken place and the actual level of dispensing fees is not knowable. Historically, we believe dispensing fees on LTC claims have been relatively low and not directly related to pharmacy costs, reflecting the economies of scale and dominant competitive strategy of long-term care pharmacies in a highly concentrated industry and the negotiating leverage of large PBMs. Therefore, pharmacy costs have not been recovered solely through dispensing fees, but also through other revenue sources, such as mark-up of negotiated prices for drug sales over acquisition costs and receipt of rebates from drug manufacturers. Since these other revenue sources are expected to remain, it is not at all clear that negotiated dispensing fees must or will increase directly in proportion to the number of dispensing events per month as some, but not all, commenters assert. Although the way we are finalizing this rule will result in only minimal additional costs (for example, only one additional dispensing event per month with 14-day dispensing and a substantial reduction in burden associated with the reporting requirements as compared to the proposed rule), we believe that there will be some upward pressure on dispensing fees to incentivize the use of more efficient and cost effective systems in some pharmacies. Therefore, in order to be as conservative as possible in projecting cost increases, we have assumed a doubling of the current aggregate level of dispensing fees.
The comments that follow refer to the 7-day-or-less dispensing requirement reflecting our requirement in the proposed rule. We believe that the comments also apply to 14-day-or-less dispensing, as it is a shorter dispensing increment than traditional 30-day dispensing used in LTC facilities today. Although all of the comments apply to 14-day-or-less dispensing, we believe that some of the burden and costs described in the comments are decreased as a result of less frequent dispensing events per month associated with 14-day-dispensing versus 7-day-dispensing.
In fact, we believe that the original 7-day-or-less dispensing requirement, and to a somewhat lesser extent, the new 14-day-or-less dispensing requirement, incentivizes the use of the most effective and efficient dispensing technologies, such as automated dose dispensing, which we believe based on conversations with LTC facility and pharmacy staff who have implemented such systems, will actually result in fewer medication errors. We learned from multiple industry representatives that automated dose dispensing systems reduce medication errors by ensuring the accuracy of the medication dispensed to the patient by eliminating many manual steps involved in removing doses from multiple blister packs and collecting them in paper cups prior to the medication pass. In addition, these systems free up nursing time allowing nursing staff to focus more on patient care.
We believe that facilities and pharmacies evaluating the optimal systems to employ in meeting the required change from 30-day dispensing will seriously consider all alternatives, and many will find that the confluence of improvements in dispensing equipment technology and developments in health information technology standards, combined with changes in dispensing fees represent an excellent opportunity to upgrade their dispensing systems to the most efficient methodologies to further both cost-effective operations and competitive advantage.
As stated in the proposed rule, we have learned from many industry representatives that delivery schedules will not be expected to change significantly to accommodate 14-day-or-less dispensing. We received a few comments on the proposed rule asserting that there might be delays in therapy as a result of changes to delivery schedules to accommodate shorter dispensing increments. However, no commenters provided details that contradict what we heard from most industry representatives during consultation. In most LTC facilities deliveries are already made on a daily basis to accommodate new admissions and first doses. We did not receive any comments with substantiating detail that lead us to believe delivery schedules will have to significantly change as a result of this requirement. Nor do we believe that bad weather will impact deliveries to any greater extent than it does today. We did, however, state in the proposed rule that the way in which some deliveries are made may have to change. We stated that, when allowed by State law, common carriers may be used to make some deliveries from the pharmacy to the LTC facility. So in rare circumstances when a delivery cannot be made by the pharmacy, deliveries by common carrier may supplement the delivery schedule. In summary, the comments we received did not persuade us that the information we received during our pre-rulemaking consultation with the industry was incorrect or insufficient, and for this reason, we continue to believe that the parties are capable of handling various dispensing methodologies and frequent deliveries, and thus the 14-day-or-less dispensing requirement will not interfere with patient care.
We agree with the environmental groups that extending the requirement to generic drugs would result in fewer unused drugs. However, we must weigh the effect of our proposal against the costs to the Part D program that may arise and the burden on LTC pharmacies and facilities. As such, we believe that the phased-in approach—which focuses first on reducing the amount of unused
However, we agree with the commenter that dispensing fees will likely increase with 14-day-or-less dispensing. Although we are prohibited from intervening between negotiations between Part D plans and pharmacies, we do expect that dispensing fees will increase with the increased number of dispensing events in a billing cycle up to a point. Consistent with feedback from the LTC industry and comments on the proposed rule, we believe that drugs dispensed in shorter dispensing increments will result in fewer unused drugs. We also believe that appropriate dispensing fees that differentiate among the various dispensing methodologies could incentivize more rapid adoption of the most cost-effective technologies and effectively align facility, plan sponsor, and public interest in minimizing costs associated with unused drugs.
We disagree with commenters that requested that we exclude controlled drugs. As stated in the proposed rule, the Drug Enforcement Agency rules do not preclude dispensing controlled drugs in 14-day-or-less increments. Further, we believe that 14-day-or-less dispensing of controlled drugs will result in less unused controlled drugs in the LTC facilities, and therefore, will be less of a disposal burden on LTC facilities or a diversion risk. But unlike antibiotics and drugs that must be dispensed in their original packaging, we do not find a similar basis for excluding controlled substances from the dispensing requirements (unless they are excluded for another reason) because there is no clinical or patient safety reason to do so.
However, for pharmacies that voluntarily adopt 7-day-or-less dispensing for all solid oral doses (that is, both brand name drugs and generic drugs), we will waive the requirement that Part D sponsors report on the unused drugs. All other pharmacies must report on the amount of unused brand and generic drugs as of implementation of this provision, January 1, 2013. We continue to believe that reporting is essential in order to acquire data from which to evaluate the potential savings from extending the dispensing requirement to generic drugs. Only when data has been systematically collected will the extent of the volume of unused Part D drugs be quantifiable. However, we will eliminate the reporting requirement for those pharmacies that immediately adopt 7-day-or-less dispensing for
The 14-day-or-less dispensing requirements will generally not apply to PACE organizations because PACE programs provide community-based care. When PACE enrollees are in SNFs, we would expect that pharmacies servicing those facilities adhere to the 14-day-or-less dispensing requirement. Therefore, we are waiving these requirements for I/T/U pharmacies, but not for pharmacies when they serve PACE programs.
This delay will give LTC facilities and pharmacies more time to evaluate dispensing methodologies and make decisions regarding the most effective and efficient systems. In particular, we are persuaded by the comments that indicate that more pharmacies will convert to the more efficient dispensing systems if given more time to make arrangements for those systems. We also believe, based on the comments, that if the affected parties have more time to make measured and fully considered decisions about capital investments in dispensing technologies, they will be more likely to immediately extend shorter cycle dispensing to both brand and generic drugs in order to maximize the return upon their investment. We believe that these decisions will increase program savings in the long run and lead to greater savings than if, because of an earlier implementation date, the parties did the minimum necessary and merely made minor adjustments to their current systems to meet the requirements.
We also are persuaded by the comments suggesting that the delay will give Part D sponsors sufficient time to negotiate contractual changes and finalize dispensing fees with LTC pharmacies in advance of the 2013 bid deadline, thereby allowing Part D sponsors to submit accurate bids. We would be concerned that bids that could not accurately account for yet-to-be renegotiated dispensing fees would increase program costs in other ways and could potentially offset savings resulting from implementing the requirement for 2012, potentially defeating the purpose of section 3310 of the ACA.
We further are persuaded that, given that we do not have concrete data about the amount of savings that could be achieved, and consistent with our
As a result of comments, in our final rule, we modify § 423.154(a)(1)(i) to dispense solid oral brand name drugs, as defined in § 423.4, to enrollees in LTC facilities in no greater than 14-day increments at a time. We modify § 423.154(a)(2) to collect and report information, in a form and manner specified by CMS, on the dispensing methodology used for each dispensing event described by paragraph (a)(1) of this section and on the quantity of unused brand and generic drugs, as defined in § 423.4. Reporting on unused brand and generic drugs is waived for Part D sponsors' when their pharmacies dispense both brand and generic drugs, as defined in § 423.4, in no greater than 7-day increments. We modify § 423.154(b) to exclude from the requirements under paragraph (a) of this section: (1) Solid oral doses of antibiotics; and (2) solid oral doses that are dispensed in their original container as indicated in the Food and Drug Administration Prescribing Information or are customarily dispensed in their original packaging to assist patients with compliance (for example, oral contraceptives). We modify § 423.154(c) to include a waiver for I/T/U pharmacies. We modify § 423.154(d) to change the effective date from January 1, 2012 to January 1, 2013. We modify § 423.154(e) by eliminating the extension for certain pharmacies and adding a requirement that regardless of the number of incremental dispensing events, the total cost sharing for a Part D drug to which the dispensing requirements under this paragraph (a) apply must be no greater than the total cost sharing that would be imposed for such Part D drug if the requirements under paragraph (a) of this section did not apply. Finally, we modify § 423.154(f) by eliminating paragraph (f)(1) and combining paragraph (f)(2) with the introductory clause of paragraph (f).
In our November 2010 proposed rule, we proposed to implement a new requirement under the authority of section 3311 of the ACA to require MA organizations and Part D sponsors to respond to complaints. Specifically, we proposed to require that MA organizations and Part D sponsors use our existing Health Plan Management System (HPMS) Complaints Tracking Module (CTM) to document the closure of complaints and provide a detailed complaint resolution summary when the complaint is resolved. That is, we proposed to require an MA organization or Part D sponsor to provide an explanation of the way in which the complaint was closed, rather than simply providing the words “complaint closed” in the CTM.
In our proposed rule, we proposed applying these requirements to both MA organizations and Part D sponsors ensure beneficiary access to medical services and drugs under the MA and Part D programs. We also indicated that we were considering adding a drop down checklist to CTM for MA organizations, and Part D sponsors to use as the documentation method when closing complaints, as opposed to requiring free text descriptions of complaint closure, and we invited comments on this approach.
As provided under section 3311 of ACA, we developed a model electronic complaint form on the Medicare.gov Internet Web site and on the Internet Web site of the Medicare Beneficiary Ombudsman. We proposed that plans be required to prominently display the CMS-developed complaint form on their Web site and directly link to the CMS Medicare.gov Web site and the Web site of the Medicare Ombudsman. As we explained in the proposed rule, when we completed our development of the model electronic complaint form was made available on the internet Web sites as in December 2010.
In our proposed rule, we stated the new requirement for plans to prominently display the electronic model on their Web sites would be effective January 1, 2012 and indicated that following the issuance of this final rule, we would be developing guidance to instruct MA organizations and Part D sponsors on how to comply with this new requirement.
We agree with the commenters that a text box in addition to the drop-down menu in the CTM would be helpful for capturing information on the MA organization's or PDP sponsor's resolution of a complaint. Therefore, we are adding a text box to the complaint form. We will clarify in instructions that CMS and plan users must select at least one item in the drop down box or use the text box in CTM to resolve a complaint. Thus, the system will not permit the complaint to be resolved if at least one of the available options is not selected.
Regarding the commenters' request that we define a complaint, we note that the Frequently Asked Questions section of CTM describes the difference between a complaint and grievance. It states that grievances are received directly by the plan from beneficiaries and that plans are required to report
We do not agree with those who claimed that having a direct link on the plan's Web site to the Medicare.gov Web site and the Web site of the Medicare Ombudsman would discourage use of plan resources for resolving issues, confuse beneficiaries or create additional administrative costs. It has been our experience that beneficiaries go directly to their MA organization or PDP sponsor with issues of concern, including complaints, prior to contacting CMS for assistance. We have no cause to believe that requiring sponsors to directly link to the Medicare.gov Web site and the Web site of the Medicare Ombudsman would alter the beneficiaries' practice of seeking to resolve their issues by first contacting their plan. We also do not believe that requiring a link from the sponsor's Web site to the Medicare Web sites will add significant administrative costs. Since the proposed requirement is similar to existing requirements regarding a plan's Web site, we expect that any costs related to this requirement are currently reflected in the organization's bid.
We appreciate the commenter's interest in commenting on the new electronic complaint form prior to its implementation, but as we noted previously, we have already posted the model electronic complaint form which is available at
For the reasons discussed previously, we are finalizing these requirements as proposed with an effective date of January 1, 2012 for the requirement that MA organizations and Part D plans create a link from their main Web page to the CMS-developed electronic complaint form on the
Section 3312 of the ACA amends section 1860D-4(b)(3) of the Act by adding a new section (H) that requires, effective January 1, 2012, each PDP sponsor to use a single, uniform exceptions and appeals process (including, to the extent the Secretary determines feasible, a single uniform model form for use under such process) with respect to the determination of prescription drug coverage for an enrollee under the plan; and to provide instant access to such processes through a toll-free telephone number and an Internet Web site.
In accordance with the new section 1860D-4(b)(3)(H) of the Act, we proposed in the November 2010 proposed regulation to revise the regulation at § 423.562(a) to require Part D plans to use a single, uniform exceptions and appeals process that includes procedures for accepting oral and written requests for coverage determinations and redeterminations. In addition, we proposed to revise the regulation at § 423.128 paragraphs (b)(7) and (d) to identify specific mechanisms that plan sponsors must have in place in order to meet the uniform appeals requirements of section 1860D-4(b)(3)(H) of the Act. Most notably, at § 423.128(b)(7), we proposed adding paragraph (i) to require that plan sponsors make available a standard form to request a coverage determination and a standard form to request a redetermination, to the extent such standard request forms have been approved for use by CMS. (Note that in the context of appeals, the term “standard form” or “standardized form” is generally used to refer to a form that would be the only permissible vehicle for requesting a coverage determination or redetermination.)
Section 3312 of the ACA also requires plan sponsors to provide instant access to the coverage determination and appeals process through an internet Web site. Consistent with the requirement, we also proposed to add paragraph (ii) to § 423.128(b)(7), which would require sponsors to provide immediate access to the coverage determination and redetermination processes via an Internet Web site. We requested comments and ideas regarding how this should work and any issues that needed to be addressed before operationalizing this requirement. Section 3312 of the ACA also specifies that plan sponsors must establish a toll-free telephone line that provides instant access to the coverage determination and appeals processes. Because plan sponsors are currently required to offer a toll-free customer call center as part of the provision of information requirement at § 423.128(d), we proposed to revise § 423.128(d)(1) to include a requirement that sponsors provide enrollees with access to the coverage determination and redetermination processes through their toll-free customer call center.
To codify the proposals that plans make available standard forms for requesting coverage determinations and redeterminations (to the extent that standard request forms have been approved for use by CMS), and establish a toll-free telephone number and Web site for accepting requests for coverage determinations and redeterminations, we proposed to amend § 423.562 by adding a new paragraph (a)(1)(ii) which cross-references the requirements in § 423.128 paragraphs (b)(7) and (d)(1)(iii), and redesignating paragraphs (a)(1)(ii) and (a)(1)(iii) as paragraphs (a)(1)(iii) and (a)(1)(iv), respectively. Finally, we proposed that Part D sponsors modify their electronic response transactions to pharmacies so that they can transmit codes instructing the pharmacy to provide a standardized point-of-sale (POS) notice to enrollees when a prescription cannot be filled. Specifically, we proposed at § 423.128(b)(7)(iii) to require that Part D sponsors modify their systems so that the plan sponsors are capable of transmitting codes to their in-network
Our current regulations permit either written or oral requests for a coverage determination (§ 423.568), with the exception of requests for payment, which must be made in writing unless the sponsor has a voluntary policy of accepting oral payment requests. Standard redetermination requests generally are made in writing, under § 423.582; plans may also accept oral requests for standard redeterminations but are not required to do so. Plans must accept oral requests for expedited redeterminations (§ 423.584). Currently, we have developed model forms for requesting a coverage determination—one for beneficiaries and one for prescribers—but there are no comparable model forms for requesting redeterminations. It is also important to note that our existing subregulatory guidance specifies that
Therefore, we are modifying the proposed regulatory language at § 423.128(b)(7)(i) by replacing the proposed reference to a “standard” form with the statutory language referencing use of a “uniform model form.” In support of this requirement, we will work with plans, prescribers, and beneficiary advocates to revise the existing model coverage determination request form, including combining the existing enrollee and prescriber request forms into a single model form. We will also develop a separate model redetermination request form for use by enrollees and their prescribers and representatives. Plans will be required to make these model forms available to their enrollees via their websites, and to include the model redetermination request form with any coverage determination denial notice, consistent with the requirement under § 423.568(g)(4) that denial notices comply with notice requirements established by CMS.
The introduction of uniform model forms is not intended to interfere with the current requirements regarding acceptance of oral or written requests, nor does it preclude plans from developing and making available drug-specific coverage determination request forms to supplement the model forms to the extent such forms can enhance access to the exceptions and appeals process. Given that plan formularies, utilization management tools and step therapy requirements can vary widely, we believe that not allowing plans to continue making drug-specific forms available or precluding enrollees from making coverage determination requests through other written vehicles, may actually delay decision-making and/or result in additional unfavorable decisions based on a lack of adequate documentation. Thus, although we acknowledge that making multiple forms available for use may cause some confusion for enrollees, we believe that continuing to permit such variation is in the best interests of Medicare beneficiaries. Plans must comply with the appropriate marketing procedures for approval of forms, including CMS-approved model forms.
Almost all commenters, whether they opposed or supported the proposal, raised questions about systems specifications and functionality, including whether plan systems for accepting electronic requests must: (1) Accept electronic attachments such as clinical documentation, prescriber supporting statements, enrollee receipts for out-of-pocket expenses, and Appointment of Representative (AOR) forms or, alternatively, be equipped to generate a bar code or other receipt to allow for the separate submission of supporting documents via fax; (2) generate an auto-reply acknowledging receipt of the request; (3) have a user authentication feature; and (4) include mandatory fields or other specifications (for example, font type/size).
However, after reviewing all of the comments on this provision, we agree that requiring plans to develop an interactive Web-based system by the 2012 plan year would impose significant costs and operational difficulties on many Part D plans. Therefore, although we are finalizing the regulatory language as proposed, we are clarifying that “immediate access” to the coverage determination and appeals processes can be satisfied through a variety of means. We strongly encourage plans to establish interactive, web-based systems to meet this requirement. At a minimum, however, plans must have a process for allowing an enrollee to initiate a coverage determination or appeal request by sending a secure e-mail to an e-mail address that is prominently displayed on the plan's Web site. In response to such requests, plans must provide notice of decisions in a timely manner, consistent with all existing requirements in Subpart M of our regulations. We believe that this approach takes into consideration the plans' differing technological capabilities, while implementing the statutory requirement that plans provide access to the coverage determination and appeals processes via plan Web sites. Although plans that have the capability to deploy a more robust and sophisticated Web-based system are encouraged to do so, we do not intend to specify systems functionality for plan Web sites, beyond the requirement that an enrollee (and an enrollee's prescriber or representative) be able to initiate a request by sending a secure e-mail via the plan's Web site.
Finally, we note that enrollees (and their prescribers and representatives) will retain the right to make requests for oral coverage determinations and expedited appeals which serve as another means of obtaining instant access to the coverage determination and appeals processes.
We also do not agree that the distribution of the POS notice is an additional burden on pharmacies. It is likely the POS notice will relieve pharmacy staff from being queried by enrollees as to why their prescriptions could not be filled as written, because the notice refers the enrollee directly to their plan to obtain a coverage determination. Furthermore, we believe that eliminating the current option of directing enrollees to a posted notice and requiring that they receive a printed notice strengthens enrollee access to the coverage determination process because the enrollee will leave the pharmacy with printed instructions about contacting the plan to request a coverage determination.
We are finalizing the proposed language in § 423.128(b)(7) and § 423.562, with the modifications to § 423.128(b)(7)(i) described previously. Consistent with section 3312 of the ACA, these new requirements will be effective January 1, 2012.
Section 1860D-2(b)(4)(C) of the Act provides protection against high out-of-pocket expenditures for Part D eligible individuals. Under the standard Part D benefit, a beneficiary is entitled to reductions in cost sharing under the catastrophic phase of the benefit once his or her true out-of-pocket (TrOOP) expenditures reach the annual Part D out-of-pocket threshold. Prior to enactment of the ACA, TrOOP expenditures represented costs actually paid by the beneficiary, another person on behalf of the beneficiary, or a qualified State Pharmaceutical Assistance Program (SPAP).
Thus, prior to the passage of the ACA, supplemental drug coverage provided by the Indian Health Service (IHS), Indian tribes and organizations, and urban Indian organization facilities (as defined in section 4 of the Indian Health Care Improvement Act) were not considered to be TrOOP eligible because these entities fell under our definition of “government-funded health program,” under § 423.100. Similarly, the Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS Program-funded AIDS Drug Assistance Programs (ADAPs) cost sharing were not counted toward TrOOP for the purpose of meeting the out-of-pocket threshold at which catastrophic coverage under the Part D benefit begins. As explained in the preamble in the January 2005 final rule (see 70 FR 4240 and 4241) implementing the Part D program, ADAPs were not considered SPAPs because these programs received Federal funding. With the passage of the ACA, CMS regulations, as they relate to IHS/Tribes and ADAPs, have been superseded effective January 1, 2011. Section 3314 of the ACA amends section 1860D-2(b)(4)(C) of the Act to specify that costs borne or paid for by IHS, an Indian tribe or tribal organization, or an urban Indian organization, and costs borne or paid for by an ADAP will be treated as incurred costs for the purpose of meeting the annual out-of-pocket threshold. Based on these amendments, we proposed to revise the definition of incurred cost at § 423.100(2)(ii) to include payments by the IHS (as defined in section 4 of the Indian Health Care Improvement Act), an Indian tribe or tribal organization, or an urban Indian organization (referred to as I/T/U pharmacy in § 423.100) or under an AIDS Drug Assistance Program (as defined in part B of title XXVI of the Public Health Service). We also proposed to amend § 423.464(f)(2) to specifically exclude expenditures made by IHS, an Indian tribe or tribal organization, or an urban Indian organization (referred to as I/T/U pharmacy in § 423.100) or under an AIDS Drug Assistance Program (as defined in part B of title XXVI of the Public Health Service) from the requirement to exclude such expenditures for the purpose of determining whether a Part D enrollee has satisfied the out-of-pocket threshold.
Except for the technical amendments to the proposed regulations text noted previously, we are finalizing the regulation as proposed.
Effective January 1, 2011, sections 4103 and 4104 of the ACA revised sections 1833 and 1861 of the Act to create new coverage of Personalized Prevention Plan Services (PPPS) or “annual wellness visits” and establish a requirement that no cost sharing may be charged to beneficiaries under Original Medicare for the annual wellness visit, the initial preventive physical exam (IPPE) and Medicare-covered preventive services graded as an A or B by the U.S. Preventive Services Task Force (USPSTF).
In light of the new legislative requirements for Original Medicare, and the importance of preventive services in managed and coordinated care, we included information related to coverage and cost sharing for preventive services in guidance issued via the Health Plan Management System (HPMS) on April 16, 2010 (“Benefits Policy and Operations Guidance Regarding Bid Submissions; Duplicative and Low Enrollment Plans; Cost Sharing Standards; General Benefits Policy Issues; and Plan Benefits Package (PBP) Reminders for Contract Year (CY) 2011”) and May 20, 2010 (“Supplemental 2011 Benefits Policy and Operations Guidance on Application of the Mandatory Maximum Out-of-Pocket (MOOP) for Dual Eligible SNPs, and Cost Sharing for Preventive Services”). In this guidance, we strongly encouraged MA organizations to provide all in-network Medicare-covered preventive services without cost sharing charges under their MA plans in contract year 2011, indicated our intention to consider rulemaking to require that such preventive services be provided with no cost sharing, and provided instructions on how to reflect the zero cost sharing in their plan benefit package (PBP) submissions for contract year 2011.
As required at section 1852(a)(1)(A) of the Act (except as provided in section 1859(b)(3) of the Act for MSA plans and in section 1852(a)(6) of the Act for MA regional plans), each MA plan must provide to its members all Parts A and B benefits included under the Original Medicare fee-for-service program as defined at section 1852(a)(1)(B) of the Act. We agree that the utilization of preventive services should be encouraged by providing such services without cost sharing. Therefore, we believe it is necessary, and appropriate, to provide this same incentive to all Medicare beneficiaries, whether they receive their benefits through Original Medicare, under an MA plan, or under a section 1876 cost contract.
Therefore, under our authority in section 1856(b)(1) of the Act to establish MA standards by regulation, and our authority in section 1857(e)(1) of the Act to establish requirements we find “necessary and appropriate,” we proposed to add a new paragraph (k) to § 422.100, and under our authority in section 1876(i)(3)(D) of the Act to impose “other terms and conditions” deemed “necessary and appropriate,” new paragraph (f) to § 417.101, to require MA organizations and section 1876 cost plans to provide in-network Medicare-covered preventive benefits at zero cost sharing, consistent with the new regulations for Original Medicare-covered preventive benefits.
For specific information about the list of preventive services covered under Original Medicare without cost sharing and information about what is included in the annual wellness visit, we directed plans to go to the following Medicare Web sites:
We have considered all of the comments received on this proposal and will finalize our proposed policy to amend § 422.100 by adding new paragraph (k) to require that there be no cost sharing for in-network Medicare-covered preventive services, as specified by CMS annually. In addition, we are adding new paragraph (d) to § 417.454 as previously specified.
Section 221(c) of the MMA added section 1858 of the Act to establish rules for MA Regional Plans. Section 1858(e) established an MA Regional Plan Stabilization Fund (the Fund) for the purpose of providing financial incentives to MA organizations that offered new MA Regional Plans nationally, or in each MA region without one.
Section 10327(c) of the ACA repealed section 1858(e) of the Act, eliminating the Stabilization Fund. Therefore, we proposed to delete paragraph (f) from § 422.458, since the statutory basis for the Fund no longer exists. We received no comments on this proposal and therefore are finalizing this provision without modification. We are also adopting § 422.258(f) as proposed in this final rule.
As required by section 1860D-4(c)(1)(C) of the Act, Part D sponsors must establish Medication Therapy Management Programs (MTMPs). Section 1860D-4(c)(2) of the Act requires MTMPs to be designed to ensure that, with respect to targeted beneficiaries described in section 1860D-4(c)(2)(A)(ii) of the Act, covered Part D drugs are appropriately used to optimize therapeutic outcomes through improved medication use and to reduce the risk of adverse events. As noted in our November 2010 proposed rule, these requirements are codified in § 423.153(d) of the Part D regulations.
Effective January 1, 2013, section 10328 of the ACA amends section 1860D-4(c)(2) of the Act to require prescription drug plan sponsors to perform a quarterly assessment of all “at risk” individuals who are not already enrolled in an MTMP, establish opt-out enrollment for MTM, and offer medication therapy management services to targeted beneficiaries. These MTM services must include, at a minimum, an annual comprehensive medication review (CMR) that may be furnished person-to-person or via telehealth technologies and a review of the individual's medications, which may result in the creation of a recommended medication action plan, with a written or printed summary of the results of the review provided to the targeted individual. The law also requires that the action plan and summary resulting from the CMR be written in a standardized format.
In our November 2010 proposed rule, we noted that prior to the passage of the new legislation, we had already made several improvements to the MTM program. We also indicated that in comparing the requirements in section 10328 of the ACA to those codified in the April 2011 final rule containing policy and technical changes under the Part C and Part D programs (see 75 FR 19772 through 19776 and 19818 and 19819), we found that a number of the provisions are consistent. Specifically, the April 2011 final rule requires the use of an opt-out method of enrollment for targeted beneficiaries, an annual comprehensive medication review (CMR) with a written summary, quarterly targeting of beneficiaries for enrollment into the MTMP, and quarterly targeted medication reviews for individuals enrolled in the MTMP with follow-up interventions when necessary. However, to ensure that our policies are fully consistent with the new requirements added by section 10328 of the ACA, we proposed to amend the current regulations to clarify the Part D MTMP requirements relating to the required use of a standardized format for the written summary and action plan that may result from the CMR. Thus, in our November 2010 proposed rule, we proposed to amend § 423.153(d)(1)(vii) to add the requirement that Part D sponsors use a standardized format for the action plan and summary resulting from a review of the targeted beneficiary's individual medications, and to provide the individual with a written or printed copy of the summary. We also noted our plan to award a contract to an outside entity, pending the availability of funding, to work in consultation with stakeholders in order to develop a standardized format for the action plan and summary which may result from annual or quarterly targeted medication reviews.
In our November 2010 proposed rule, we also proposed to amend the MTMP requirements at § 423.153(d)(1)(vii) to explicitly permit the use of telehealth technologies to conduct the required annual CMR as referenced under the ACA, to allow the sponsors to attempt innovative techniques that provide care at a distance in order to better serve the beneficiary, especially beneficiaries who cannot travel to the provider's location, or who reside in a remote location or in a different time zone. We emphasized as well that when using telehealth technologies, personal health information privacy and security must be ensured. This would involve the establishment of appropriate administrative, technical, and physical safeguards to protect the confidentiality of data and to prevent unauthorized use of, or access to, it. The safeguards must provide a level and scope of security that is not less than the level and scope of security requirements established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III—Security of Federal Automated Information Systems) as well as Federal Information Processing Standard 200 entitled “Minimum Security Requirements for Federal Information and Information Systems”; and Special Publication 800-53 “Recommended Security Controls for Federal Information Systems.” The use of unsecured telecommunications, including the Internet, to transmit individually identifiable information would, therefore, be prohibited.
In addition to the proposed regulatory changes required to implement the ACA provisions, in our November 2010 proposed rule, we proposed to amend the MTMP requirements related specifically to MTM services furnished in LTC facilities. As provided under sections 1819(b)(4) and 1919(b)(4) of the Act, LTC facilities must provide, either directly or under arrangements with others, for the provision of pharmaceutical services to meet the
• Live videoconferencing: Audio and video feeds used to connect two or more geographically dispersed health care facilities to enable patients and physicians to consult in real time; and
• E-visits/e-consults: Evolved from secure email or phone based encounters, e-visits can be offered by health insurers through a secure Web portal.
Based on the comments received, we are finalizing this provision with the amendments previously noted. This provision will be effective January 1, 2013.
In our November 2010 proposed rule, we noted that paragraphs (b)(3) and (d) of section 1101 of the ACA amended section 1860D-2(b) of the Act by adding provisions that revise the Part D benefit structure to close the gap in coverage that occurs between the initial coverage limit for the year and the out-of-pocket threshold. We noted that the new provisions not only will revise the amount of coinsurance for costs of covered drugs above the initial coverage limit and below the out-of-pocket threshold (that is, within the Part D coverage gap) for applicable beneficiaries, but also will reduce the growth in the annual out-of-pocket threshold from 2014 to 2019.
As stipulated under the new provisions in section 1860D-2(b)(2)(C) and (D) of the Act, effective January 1, 2011, cost sharing in the coverage gap for “applicable beneficiaries” will be determined on the basis of whether the covered Part D drug is considered an “applicable drug” under the Medicare coverage gap discount program as defined at section 1860D-14A(g)(2). Section 1860D-14A(g)(2)(A) defines an applicable drug under the Medicare coverage gap discount program as a covered Part D drug that is either approved under a new drug application (NDA) under section 505(b) of the Federal Food, Drug, and Cosmetic Act or, in the case of a biologic product, licensed under section 351 of the Public Health Service Act (BLA) (other than under section 351(k)). Under standard
We proposed to codify these new requirements in § 423.104(d)(4). Additionally, since the terms applicable drug, applicable beneficiary, and coverage gap have not been previously defined in regulation, we proposed new definitions for these terms at § 423.100. Consistent with section 1101 of the ACA, these reductions in cost sharing during the coverage gap will apply only to applicable beneficiaries. In defined standard coverage, cost sharing during the coverage gap will remain unchanged at 100 percent coinsurance for all other Part D beneficiaries (prior to application of any low-income cost sharing subsidy).
As provided under the new provisions in section 1860D-2(b)(4)(B)(i) of the Act, the rate of growth of the annual out-of-pocket threshold will be reduced from 2014 to 2019. In our November 2010 proposed rule, we proposed to amend § 423.104(d)(5)(iii) to state that the annual out-of-pocket threshold for years 2014 and 2015 will be the amount specified for the previous year, increased by the “annual percentage increase” in the average expenditures for Part D drugs per eligible beneficiary currently specified in § 423.104(d)(5)(iv), minus 0.25 percentage point. Further, we proposed to amend § 423.104(d)(5)(iii) and (v) to reflect that for years 2016 through 2019, the annual out-of-pocket threshold will be the amount specified for the previous year, increased by the lesser of: (1) the annual percentage increase in the consumer price index specified in § 423.104(d)(5)(v) for the year involved plus 2 percentage points; or (2) the “annual percentage increase” specified in § 423.104(d)(5)(iv), rounded to the nearest $50. We also noted that the new provisions in section 1860D-2(b)(4)(B)(i) of the Act require us to calculate the annual out-of-pocket threshold for 2020 and later as if no change had been made to the calculation of the out-of-pocket threshold for 2014 through 2019 under the ACA. Thus, we proposed to amend § 423.104(d)(5)(iii) to reflect this requirement.
In our November 2010 proposed rule, we noted the ACA also amended section 1860D-22(a)(2)(A) of the Act by adding a provision with regard to the actuarial equivalence of retiree prescription drug plan coverage to standard coverage. Specifically, the new provision requires that when attesting to the actuarial equivalence of the plan's prescription drug coverage to defined standard coverage, qualified retiree prescription drug plans not take into account the value of any discount or coverage provided during the gap in coverage that occurs between the initial coverage limit during the year and the out-of-pocket threshold for defined standard coverage under Part D. We proposed to codify this new requirement in § 423.884(d).
As indicated in section II.A. of this final rule, the regulations implementing these provisions are effective 60 days after the date of display of the final rule.
We agree with the commenter requesting that we specify that drugs provided through an exception or appeal are applicable drugs only for that particular beneficiary. As a result, we are revising the final clause in the definition to state that the drug “is provided to a particular applicable beneficiary through an exception or appeal for that particular applicable beneficiary.”
Therefore, in finalizing the proposed rule, we will also exclude the vaccine administration fee from the cost sharing reductions and revise the regulatory language in § 423.104(d)(4)(ii) to specify coinsurance in the coverage gap is based on actual cost minus the dispensing fee and any vaccine administration fee.
We also clarify that the reductions to cost sharing in the coverage gap specified in § 423.104(d)(4) apply only to “applicable beneficiaries” by revising the title of this paragraph to “Cost-sharing in the coverage gap for applicable beneficiaries.”
We believe that the risk associated with permitting actuarially equivalent co-payments will be mitigated once coverage for generic drugs in the coverage gap reaches a reasonable coverage level for actuarial equivalence. We note that Chapter 4 of the Medicare Managed Care Manual Section 50.1 provides that for an Original Medicare item or service to be considered a reasonable benefit, cost-sharing for that service cannot exceed 50 percent of the plan's financial liability for the benefit. Consistent with this policy, we believe that 50 percent would be a reasonable benefit level at which to permit actuarial equivalence. Therefore, we anticipate permitting actuarially equivalent co-payments in the coverage gap for drugs that are not applicable (that is, generic drugs) starting in 2018 when beneficiary cost sharing for these drugs will be below 50 percent.
For these reasons, we will continue our current policy of not accepting actuarially equivalent co-payments in the coverage gap for drugs that are not applicable (that is, generic drugs) until 2018.
We are finalizing this provision with the amendments previously noted.
In our November 2010 proposed rule, we proposed the revisions to the regulations described below in order to reflect changes in payment rules specified in statute and implemented in the Annual Announcement of MA Capitation Rates and MA and Part D Payment Policies.
In our November 2010 proposed rule, we noted that section 3205 of the ACA provides the Secretary with the authority to apply a frailty adjustment to payments to certain Special Needs Plans (SNPs) that meet our definition of a fully integrated dual-eligible special needs plan at § 422.2, and have a similar average level of frailty as the PACE program, starting with plan year 2011. The statute permits the Secretary to apply the payment rules under section 1894(d) of the Act (other than paragraph (3) of such section), rather than the
We proposed that payments to Fully Integrated Dual Eligible SNPs that qualify for frailty adjusted payment continue to be calculated using the existing MA payment rules under which all SNPs are paid, with the sole exception of the application of a frailty adjustment. Further, we stated that the new law continued to allow us to use the same methodology to adjust payment to take into account the frailty of SNP enrollees as we use for the PACE program.
As the Secretary determines the adjustment methodology for frailty, which frailty scores will be considered “similar” to PACE program, and how to measure the “average level of frailty of the PACE program,” we noted that we will announce any changes to the methodology used to pay for frailty, as well as how we determine PACE program averages, and which SNPs have similar levels of frailty to the PACE program, in the Advance Notice and Rate Announcement for the plan year in question.
In order to have a frailty score that can be compared to the PACE program, we proposed requiring MA organizations sponsoring a dual eligible SNP that meets our definition of a fully integrated dual-eligible SNP to fund any survey used by us to support the calculation of frailty scores. Moreover, we proposed requiring the survey to be fielded such that we can calculate a frailty score at the plan benefit package level for each SNP in question (currently the counts of limitations on activities of daily living (ADLs) used to calculate frailty scores are taken from the HOS or HOS-M), and to adhere to the methodological requirements of any such survey.