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Commodity Futures Trading Commission.
Final rule.
The Commodity Futures Trading Commission (“Commission”) is amending its Rules of Practice, Rules Relating to Reparation Proceedings, and its Rules Relating to Review of National Futures Association (“NFA”) Decisions in Disciplinary, Membership Denial, Registration and Membership Responsibility Actions, to simplify and clarify service, filing and formatting requirements, particularly those requirements applicable to electronic service and filing. The Commission is also amending its Rules Relating to Reparations Proceedings to clarify the authority of its Judgment Officers.
Effective February 26, 2013.
Jason Gizzarelli, Director, Office of Proceedings, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581. Telephone: (202) 418-5395.
In 2008, the Commission amended its rules to allow for service via electronic mail (“email”) for 17 CFR parts 10 and 12, and via facsimile (“fax”) for Part 12 (service by fax under Part 10 had been permitted by the Commission since 1998.) At that time, the Commission approved these additional means of service to take advantage of technological developments that would be faster and less costly than regular mail. Today, the Commission has amended 17 CFR Parts 10, 12 and 171 to simplify and refine the rules for service, filing and formatting. Additionally, the Commission has amended 17 CFR Parts 10 and 12 to clarify the role and authority of its Judgment Officers. The Commission believes these rule amendments will increase efficiencies and lower costs for parties and for the Commission in administrative enforcement proceedings, in reparations proceedings, and in the appellate review of NFA decisions. Also, the Commission has designed the amendments to the reparations rules to make the reparations forum less legalistic and more user-friendly for
To ease the burden on parties in reparations cases, many of whom appear
The amendments to the service rules in 17 CFR parts 10 and 12 reflect the Commission's experience with electronic filing since 2008, which generally has been positive. First, the amendments specifically provide that a party who consents to service by email must specify the email address to be used. Consent is required because it is not yet possible to assume universal access to electronic communication. Second, under these amendments, actual notice that an email or fax transmission was not received will defeat the presumption of receipt that service is complete on transmission and will compel the sender to take additional steps to affect service. Finally, consistent with 17 CFR 12.1(a), which provides that the reparations rules “shall be construed liberally so as to secure the just, speedy and inexpensive determination of the issues,” the Commission expects that as electronic technology continues to advance, its Proceedings Clerk and its presiding officials will provide guidance to parties on standards governing such technical specifications as data formatting, speed of transmission, means to transmit attachments, and security of communication.
The amended rules simplify and harmonize the filing and formatting requirements contained in 17 CFR parts 10 and 12. First, the amended rules provide that parties filing by personal delivery, mail or commercial delivery service are no longer required to file any copies of an original. Second, the amended rules explicitly provide that parties filing electronically should not also send paper copies of the same documents to the Proceedings Clerk. Third, the amended rules reduce the maximum length of briefs in administrative proceedings from 60 to 50 pages and in reparations proceedings from 35 to 25 pages. Fourth, the amended rules simplify the formatting of filed documents, such as font size, spacing and related issues. Fifth, the amendments clarify that documents that are delivered in person, or delivered by first-class mail, by a more expeditious form of United States mail, or by overnight or similar commercial delivery service will be considered timely filed if they are delivered in person or mailed to the Proceedings Clerk within the time prescribed for filing. Finally, the Commission is also amending 17 CFR 171.8 to allow filing and service by fax and email.
On October 12, 2011, to promote the efficient use of the Commission's budget and personnel resources, the Commission amended 17 CFR part 12 to authorize its Judgment Officers to conduct formal decisional proceedings. The new 17 CFR part 12 amendments issued today conform the definition of “Judgment Officer” to the authority of Judgment Officers to conduct formal decisional proceedings. These new amendments also provide that Judgment Officers may conduct
The amendment to 17 CFR 10.8, which authorizes the Commission to appoint a Presiding Officer other than an administrative law judge (“ALJ”) to conduct proceedings within the scope of 17 CFR part 10, unless some other provision of law requires the use of an ALJ in a particular category of proceeding,
Prior to this amendment, the second sentence of 17 CFR 10.8 stated:
If the Commission determines that a proceeding within the scope of this subpart shall be conducted before a Presiding Officer who is not an Administrative Law Judge, all provisions of this part that refer to and grant authority to or impose obligations upon an Administrative Law Judge shall be read as referring to and granting authority to and imposing obligations upon the designated Presiding Officer.
This amendment adds the phrase “or of Part 3 of this title” following the words “this part” in this sentence.
The Commission has determined that these amendments are exempt from the provisions of the Administrative Procedure Act, 5 U.S.C. 553, which generally require notice of proposed rulemaking and provide other opportunities for public participation. According to the exemptive language of 5 U.S.C. 553, these amendments pertain to “rules of agency organization, procedure, or practice,” as to which there exists agency discretion not to provide notice. In addition, notice and public procedure are unnecessary in this case because the proposed amendments are self-explanatory. If made effective immediately, they will promote efficiency and facilitate the Commission's core mission without imposing a new burden. For the above reasons, the notice requirements under 5 U.S.C. 553 are inapplicable.
The Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601
The amendments to 17 CFR parts 10, 12 and 171 do not impose a burden within the meaning and intent of the Paperwork Reduction Act of 1980, 44 U.S.C. 3501,
Section 15(a) of the CEA, 7 U.S.C. 19(a), requires the Commission to consider the costs and benefits of its action before issuing a new regulation. CEA section 15(a) further specifies that costs and benefits shall be evaluated in light of five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency, competitiveness, and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations.
The amendments to 17 CFR parts 10, 12 and 171 will not create any significant change in the Commission's adjudicatory process. In fact, the amendments will enhance the protection of market participants and the public by making filing and service more certain, faster and cheaper. The amendments do not bear directly upon the risk-benefit factors, but reduce costs and increase the efficiency of litigation that arises pursuant to the operation of futures markets.
Administrative practice and procedure, Authority delegations (Government agencies), Commodity futures.
Administrative practice and procedure, Commodity futures, Consumer protection.
Administrative practice and procedure, Commodity futures.
For the reasons discussed in the preamble, the Commodity Futures Trading Commission amends 17 CFR parts 10, 12 and 171 as follows:
Pub. L. 93-463, sec. 101(a)(11), 88 Stat. 1391; 7 U.S.C. 2(a)(12).
Section 10.102 also issued under 7 U.S.C. 4a, 12a; 5 U.S.C. 10.
The Office of Proceedings is located at Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581. Faxes must be sent to (202) 418-5532, and emails must be sent to
Unless otherwise determined by the Commission, all proceedings within the scope of this Part shall be assigned to an Administrative Law Judge for hearing. If the Commission determines that a proceeding within the scope of this Part shall be conducted before a Presiding Officer who is not an Administrative Law Judge, all provisions of this part or
The revisions and additions read as follows:
(a)
(2) * * *
(ii) First-class or a more expeditious form of United States mail or an overnight or similar commercial delivery service;
(iii) Facsimile (“fax”); or
(iv) Electronic mail (“email”).
(3) Service by email or fax shall be permitted at the discretion of the Presiding Officer, with the parties' consent. The consent of a party must specify the email address or fax number to be used. Signed documents that are served by email must be in PDF or other non-alterable form.
(4) Service will be complete at the time of personal service; upon deposit in the mail or with an overnight or similar commercial delivery service of a properly addressed document for which all postage or delivery service fees have been paid; or upon transmission by fax or email. Service by email or by fax will not be effective if the party making service learns that the attempted service did not reach the person to be served.
(5) Where service is effected by mail or a commercial delivery service (but not by fax or email), the time within which the person being served may respond shall be extended by five (5) days.
(6)
(i) Confirms that service has been made,
(ii) Identifies each person served,
(iii) Sets forth the date of service, and
(iv) Recites the manner of service.
(b)
(c)
(d)
(2) To be timely filed under this part, a document must be delivered in person; mailed by first-class or a more expeditious form of United States mail or by an overnight or similar commercial delivery service; or faxed or emailed to the Proceedings Clerk within the time prescribed for filing.
(e)
(2)
(3)
(4)
(ii)
(A) He has read the document and knows the contents thereof;
(B) If executed in any representative capacity, it was done with full power and authority to do so;
(C) To the best of his knowledge, information, and belief, every statement contained in the document is true and not misleading; and
(D) The document is not being interposed for delay.
(5)
(f)
(c)
7 U.S.C. 2(a)(12), 12a(5), and 18.
The Office of Proceedings is located at Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581. Faxes must be sent to (202) 418-5532, and emails must be sent to
(a)
(2)
(i) Personal service;
(ii) First-class or a more expeditious form of United States mail or an overnight or similar commercial delivery service;
(iii) Facsimile (“fax”); or
(iv) Electronic mail (“email”).
(3) Service by fax or email shall be permitted at the discretion of the Presiding Officer, with the parties' consent. The consent of a party must specify the email address or fax number to be used. Signed documents that are served by email attachment must be in PDF or other non-alterable form.
(4) Service will be complete at the time of personal service; upon deposit in the mail or with an overnight or similar commercial delivery service of a properly addressed document for which all postage or delivery service fees have been paid; or upon transmission by fax or email. Service by email or by fax will not be effective if the party making service learns that the attempted service did not reach the person to be served.
(5) Where service is effected by mail or commercial delivery service (but not by fax or email), the time within which the person served may respond thereto shall be extended by five (5) days.
(6)
(i) Confirms that service has been made;
(ii) Identifies each person served;
(iii) Sets forth the date of service; and
(iv) Recites the manner of service.
(b)
(c)
(a) If a party files by personal delivery or mail, an original of all documents shall be filed with the Proceedings Clerk. If a party files a document by fax or email in accordance with § 12.10(a)(2), they should not also send paper copies.
(b)
(c)
(d)
(2)
(i) He has read the document and knows the contents thereof;
(ii) If executed in any representative capacity, it was done with full power and authority to do so;
(iii) To the best of his knowledge, information, and belief, every statement contained in the document is true and not misleading; and
(iv) The document has been filed in good faith and has not been filed to cause delay.
(e)
(f) All documents which are required to be served upon a party shall be filed concurrently with the Proceedings Clerk. A document shall be filed by delivering it in person or by first-class mail or a more expeditious form of United States mail or by overnight or similar commercial delivery service to Proceedings Clerk, Office of Proceedings, Three Lafayette Centre,
(g) To be timely filed under this part, a document must be delivered in person; mailed by first-class or a more expeditious form of United States mail or by an overnight or similar commercial delivery service; or faxed or emailed to the Proceedings Clerk within the time prescribed for filing.
(a)
(a) To rule upon discovery-related motions, and to take such action pursuant to § 12.35 as is appropriate if a party fails to comply with a discovery order;
(b) To issue orders for the production of documents and tangible things and orders for written testimony, as provided in § 12.34;
(c) To issue subpoenas pursuant to § 12.34 and § 12.36;
7 U.S.C. 4a, 12a, and 21, unless otherwise noted.
(a)
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.
This rule is effective March 28, 2013.
Robert M. Nelson,Office of Pediatric Therapeutics,Food and Drug Administration,10903 New Hampshire Ave.Bldg. 32, rm. 5126,Silver Spring, MD 20993-0002,301-796-8659.
In the
FDA is finalizing its interim final rule both to comply with the congressional mandate in the Children's Health Act and because of increases in the enrollment of children in clinical investigations, in part as a result of ongoing pediatric initiatives. Some of these pediatric initiatives were described in detail in the interim rule (66 FR 20589), including the Food and Drug Administration Modernization Act of 1997 (FDAMA) and FDA's 1998 pediatric rule (63 FR 66632, December 2, 1998).
FDAMA established economic incentives for manufacturers to conduct pediatric studies on drugs for which exclusivity or patent protection is
Under FDA's 1998 pediatric rule, drug and biological product approvals issued, or applications submitted, on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration, were required to include pediatric assessments for all indications for which applicants were receiving or seeking approval, unless the requirement was waived or deferred. Although the pediatric rule was suspended by court order on October 17, 2002, the Pediatric Research Equity Act (PREA) of 2003 (Pub. L. 108-155) codified many of its elements. The Pediatric Research Equity Act of 2007 (Title IV of Pub. L. 110-85) re-authorized and expanded PREA 2003, continuing these pediatric requirements. FDASIA also made permanent this requirement for pediatric assessments.
Additionally, as noted in the interim final rule, FDA initiated other actions to encourage the development of adequate pediatric use information for FDA-regulated products, for example, through issuance in 2000 of pediatric guidance titled “E11 Clinical Investigation of Medicinal Products in the Pediatric Population” (ICH E11) (December 2000) (Ref. 1). This guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as part of the ICH effort to harmonize such requirements among the European Union, Japan, and the United States. ICH E11 addresses issues in pediatric drug development including ethical considerations in pediatric studies. It states that pediatric populations represent a vulnerable subgroup and special measures therefore are needed to protect the rights of pediatric study participants. Section 2.6 of ICH E11 addresses relevant issues including: the roles and responsibilities of institutional review boards (IRBs) and independent ethics committees (IECs), recruitment of study participants, consent and assent, and minimizing risk and distress in pediatric studies.
Additional examples of pediatric specific guidance include: (1) A final guidance entitled “Acute Bacterial Otitis Media: Developing Drugs for Treatment” (September 2012) (Ref. 2), which includes a section on the ethical considerations under part 50, subpart D in designing a clinical trial for acute bacterial otitis media; and (2) a final guidance entitled “Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children” (March 2007) (Ref. 3), which includes a section on the ethical concerns raised by the choice of a comparator or control group for allergic rhinitis and asthma studies.
These (and other) regulatory actions, combined with the statutory initiatives described previously, have resulted in increases in the enrollment of children in clinical investigations (see information provided at
This final rule adopts the safeguards described in HHS subpart D for children participating in clinical investigations regulated by FDA under sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C 355(i) and 360j(g)), as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including human drug and biological products; medical devices for human use; foods, including dietary supplements, that bear a nutrient content claim or health claim; infant formula; food and color additives; and electronic products. (See § 50.1) These safeguards are intended to ensure that the rights and welfare of children who participate in clinical investigations are adequately protected. Nothing in these regulations is intended to preempt any applicable Federal, State, or local laws that require additional safeguards for children participating in clinical investigations.
The final rule brings FDA's regulations into compliance with HHS subpart D, as directed by Congress, with some changes reflecting differences between FDA's and HHS's regulatory authority and other changes made for clarification. In the preamble to the interim rule, we provided a detailed explanation of the provisions of the rule. In the final rule, we respond to comments received on the interim rule. Four substantive changes have been made to the codified section of the final rule: (1) The definition of guardian has been modified, (2) the definition of permission has been modified, (3) paragraph (a) has been added to § 50.51 to require, consistent with § 46.404 of HHS subpart D, that IRBs assess the level of risk to children in clinical investigations subject to § 50.51, and (4) a phrase has been added to § 50.55(e) to make it clear that the exception for emergency research described in § 50.24 applies to research in children. In addition, we have made changes on our own initiative for the purposes of clarity and consistency. In addition to modifying the definitions of guardian and permission, changes to the following sections were made in order to be more consistent with HHS 45 CFR part 46, subpart D: 1) Changing “may” to “should” in the definition of assent (§ 50.3(n)); (2) deleting “and documents” from §§ 50.51 to 50.54; and (3) deleting “if consistent with State law” from § 50.55(e)(1).
The Agency received a total of 18 comments on the April 24, 2001, interim rule. Five of those comments were from pharmaceutical companies, four were from health care professionals, four were from national membership organizations, three were from Federal Government agencies, one was from a State legislator, and one was from a private citizen. The majority of comments supported the rule. Most commenters provided comment on specific provisions, including the areas on which FDA solicited comment.
(Comment 1) We received one comment stating that our modification of definitions creates several regulatory documents that are using slightly different terms and definitions. The comment stated that these differences would create challenges for sponsors as they try to meet the requirements under one document but, due to slightly modified terms and definitions, fail to meet requirements under another document.
As we stated in the preamble to the interim rule, we are aware that dissimilar or inconsistent Federal
(Comment 2) Two comments supported our definition of “permission” at § 50.3(r) and agreed that it was necessary to adopt this term. We agree with those comments. However, we have decided to simplify the definition by deleting the statement that permission must be obtained in compliance with part 50, subpart B and must include the elements of informed consent described in § 50.25. As required under § 50.55(f), permission by parents or guardians must be documented in accordance with, and to the extent required by, § 50.27, and thus must include the elements of informed consent required by § 50.25. The identified language is therefore unnecessary. As a result of this change, this definition and the definition of parental permission found in 45 CFR 46.402(c) are the same.
We defined “guardian” at § 50.3(s). In the preamble to the interim rule, we explained that we were adopting the term because it is currently used in HHS subpart D and is familiar to IRBs. Our regulations at § 50.3(l) use the term “legally authorized representative” to describe an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. Our definition of the term guardian was intended to make it clear that, for purposes of FDA subpart D, a guardian must be an individual who is legally authorized to consent to a child's participation in research. We invited comment on our definition and any implications under State or local law.
(Comment 3) We received five comments on our definition of guardian. All five comments raised concerns about our inclusion of language stating that a guardian is an individual who is authorized to consent on behalf of a child to participate in research.
Two comments recommended that the definition of guardian at § 50.3(s) should be the same as, or consistent with, the definition of guardian at 45 CFR 46.402(e) of HHS subpart D. One comment noted that under HHS subpart D, IRBs have been and continue to be responsible for ensuring that HHS-sponsored or HHS-conducted studies involving children comply with Federal, State, and local legal standards regarding permission. The comment stated that it was unclear why a revised definition was necessary in our regulation when no change is proposed for the existing definition in the HHS regulation. The comment stated that when HHS-sponsored research is also subject to FDA regulation, the conflicting definitions will lead to confusion. The second comment stated that our definition of guardian may result in unanticipated consequences, since many State laws do not specifically authorize legal guardians to provide consent to research. The comment stated that this requirement would unnecessarily prevent some children with guardians from participating in research from which they could benefit directly.
Another comment stated that the additional language we suggested represented a departure from the HHS definition and that it was unclear whether State laws specifically authorize guardians to consent to children's participation in clinical research. The comment stated that FDA's change may represent a serious, unintended obstacle to children's participation in research. The comment suggested defining a guardian as an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care and whose consenting on behalf of the child to research participation is consistent with applicable laws, if any.
Two comments stated that our definition leaves open the possibility that a guardian could be a person who is authorized to consent to a child's participation in research, but not authorized to consent to general medical care. These comments stated that this would be wholly undesirable for the child and that the language should be clarified to require that no one may consent to a child's participation in research who is not also authorized to consent to the child's general medical care. These comments also stated that it appears that many State laws do not specifically authorize a guardian to permit a child's involvement in research, so the definition may be very restrictive in practice. These comments concluded that adequate protection for children would result from the requirement that guardians should be authorized to consent to general medical care and that they should be in loco parentis, with a legally enforceable duty to care for the totality of the child's interests.
We appreciate the comments we received on State and local laws of guardianship and the likelihood that many of these laws do not specifically grant guardians the authority to consent to research. We did not intend to create an obstacle to children's participation in research or to prevent children under guardianship from participating in beneficial research when we included authorization to consent to research in the definition of guardian. We also did not intend to suggest that it would be appropriate to allow a person who is authorized to consent to research only, but not authorized to consent to general medical care, to grant permission for a child to participate in FDA-regulated research. We note, however, that we are not aware of any State or local laws which authorize a guardian to consent to research where the guardian does not have the authority to consent to general medical care as well.
After reviewing the comments submitted, we have decided to delete the phrase “when general medical care includes participation in research,” as State and local laws may be silent on whether general medical care includes research participation. We have also deleted the language stating that “a guardian also means an individual who is authorized to consent on behalf of a child to participate in research.” This revised definition makes it clear that under FDA regulations a legally authorized guardian for general medical care may consent on behalf of a child to participate in research in the absence of specific laws granting (or restricting) that authority. It remains the responsibility of an IRB to determine if there are any applicable State or local laws that either grant or restrict that authority. This revised definition of guardian is the same as the definition of guardian in HHS 45 CFR 46.402(e) of HHS subpart D.
(Comment 4) Two comments stated that IRB membership should include professionals and lay persons with demonstrated competence working with children, including pediatricians,
FDA supports the intent of these comments to ensure IRB members are adequately trained to make decisions on the unique aspects of conducting clinical trials in children. Part 56 (21 CFR part 56) of our regulations addresses IRBs generally. Section 56.107 requires IRBs to have members with varying backgrounds to promote complete and adequate review of research activities. This section requires the IRB to be sufficiently qualified through the experience and expertise of its members, the diversity of its members, and their sensitivity to issues such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. Section 56.107(a) specifically states that if an IRB regularly reviews research that involves “a vulnerable category of subjects, such as children * * *, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with those subjects.” Section 56.107(b) states that no IRB may consist entirely of members of one profession. Section 56.107(c) requires that each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas. FDA Guidance (ICH E11) on “Clinical Investigation of Medicinal Products in the Pediatric Population” advises that “when protocols involving the pediatric population are reviewed, there should be IRB/IEC members or experts consulted by the IRB/IEC who are knowledgeable in pediatric ethical, clinical, and psychosocial issues” (§ 2.6.1, Ref. 1). In our view, these provisions and guidance are adequate to ensure the appropriate composition of members on IRBs reviewing clinical trials in children.
We agree that it is important for members of an IRB reviewing such trials to be educated and trained in appropriate areas. Although these regulations do not require any specific training or continuing education for IRB members, we discuss the programming and educational needs for the IRB and investigator community with OHRP and others on an ongoing basis. As part of our efforts, we will consider the need to develop specific educational programs focusing on research involving children.
With regard to the comment requesting establishment of an advisory committee for IRBs, we note that § 56.107(f) provides that an IRB, at its discretion, may invite individuals with competence in special areas to assist in the review of complex issues that require expertise beyond or in addition to that available on the IRB. These individuals serve in an advisory capacity and do not vote with the IRB. We have published extensive guidance for IRBs and clinical investigators to use in conducting their reviews. This guidance is available on FDA's Web site at
As stated in the preamble to the interim rule, we adopted HHS subpart D, as directed by Congress, with those changes necessary because of differences between FDA's and HHS's regulatory authority. Sections § 50.51 through § 50.53 describe the criteria under which IRBs may approve clinical investigations of FDA-regulated products in children. Section 50.54 describes the criteria under which a clinical investigation that is otherwise not approvable by an IRB under sections § 50.51 through § 50.53 may be referred to FDA for review and consultation with a panel of experts.
We received three comments on § 50.51.
(Comment 5) One comment requested a clearer definition of “greater than minimal risk.” Although it noted that FDA provided examples of types of procedures that fit the category of no more than minimal risk, the comment stated that the term is vague and the definition is open to interpretation.
Another comment stated that the language of this provision deviated in an important way from 45 CFR 46.404 of HHS subpart D, which places responsibility for determining the level of risk with the IRB. The comment stated that FDA only requires the IRB to find and document adequate provisions for soliciting assent and permission, which may create circumstances in which the investigator and the IRB disagree on the level of risk. The comment acknowledged that any disagreement will be resolved by the decision of the IRB, but the provision might cause unnecessary conflict and confusion. The comment also stated that this section appears internally inconsistent with §§ 50.52 and 50.53 in which the IRB assesses the nature and level of risk and suggested that the language of this provision should be consistent with 45 CFR 46.404 of HHS subpart D.
Another comment stated that the rule should include a well-defined scale system for risk assessment that would allow the IRB to classify procedures and help in identifying the degree of minimal risk. As an example, the comment stated that collecting a clean-catch urine sample via a catheter has a potential to cause tissue injury and/or infection and therefore has a higher degree of risk than testing devices involving temperature readings orally or in the ear. The comment stated that this type of scale would help IRBs in granting an approval for a procedure by providing a specific “distinction” of the potential risk.
As stated in the preamble to the interim rule (66 FR 20589 at 20593), we previously adopted HHS's definition of minimal risk without change in § 50.3(k). The definition of minimal risk states that “minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” As one comment noted, in the preamble to the interim rule we provided examples of procedures and clinical investigations that may present no greater than minimal risk to children.
While we acknowledge that there is no specific definition of “greater than minimal risk” in these regulations, IRBs
The Children's Health Act also required a substantive review of HHS subpart D, and required the Secretary to consider any necessary modifications to ensure adequate and appropriate protection of children participating in research. This review was conducted by OHRP and a report was submitted to Congress in May 2001 entitled “Protections for Children in Research: A Report to Congress in Accord with Section 1003 of Public Law 106-310, Children's Health Act of 2000” (2001 OHRP report) (Ref. 4). While the 2001 OHRP report concluded that the current HHS regulations under subpart D are sound, effective, and well-crafted, the report identified terms and concepts for which further guidance is needed. Among the terms and concepts identified in this report as needing clarification are the terms “minimal risk” and “minor increase over minimal risk.”
On January 4, 2002, the President signed BPCA 2002 into law. BPCA 2002 required HHS to contract with the Institute of Medicine (IOM) to conduct a review of Federal regulations relating to research involving children and report its findings to Congress. In the conduct of this review, the IOM was required to consider the definition of minimal risk with respect to children. The IOM published its report, “Ethical Conduct of Clinical Research Involving Children” in 2004 (2004 IOM report) (Ref. 5). The 2004 IOM report recommended that the Secretary's Advisory Committee on Human Research Protections continue the work of its predecessor committee (the National Human Research Protections Advisory Committee) by developing additional consensus descriptions of procedures or interventions that present minimal risk and no more than a minor increase over minimal risk. The 2004 IOM report also recommended that OHRP and FDA cooperate to develop and disseminate guidance and examples for investigators and IRBs to clarify definitions, including the definitions of minimal risk and minor increase over minimal risk (2004 IOM report, p. 136) (Ref. 5).
While both the 2001 OHRP report and the 2004 IOM report recommended that further guidance may be appropriate to clarify the meaning of minimal risk, neither report recommended changes to the current regulatory definition of minimal risk. Although we will not change FDA's definition of minimal risk at this time, we will consider developing guidance to assist in determining whether a research intervention poses minimal or more than minimal risk to children.
We agree with the comment regarding the fact that § 50.51 does not specifically require IRBs to assess the level of risk in order to approve a study under that provision. We have modified § 50.51 to make clear that it applies to clinical investigations involving children as subjects where the IRB finds that no greater than minimal risk to children is presented. This change is consistent with § 46.404 of HHS subpart D and §§ 50.52 and 50.53 of our regulations, and clarifies that the IRB is responsible for reviewing, assessing, and documenting the nature and level of risk in this category. Furthermore, because an IRB is required to document its findings under § 56.115(a)(2), we also have deleted the phrase “and documents” as unnecessary, and have made the same change to §§ 50.51 through 50.54.
While we appreciate the intent of the comment requesting a scale system for assessing risk, attempting to identify and classify every procedure that might be used in a clinical investigation as to its appropriate risk category would be a difficult, if not impossible, task. Rather, the broad categories laid out in the regulation will assist IRBs in assessing the risk level for any specific intervention and/or procedure in a clinical investigation on a case-by-case basis. IRBs have been using this system of classification for many years. However, if HHS proposes to change these risk categories, we will review and consider modifying the corresponding provisions of our regulations as appropriate.
In our discussion of § 50.52 in the preamble to the interim rule (66 FR 20589 at 20593), we recognized that the requirement for the prospect of direct benefit might create ambiguity as to whether placebo-controlled clinical investigations may be conducted in children under this section. We stated that placebo-controlled clinical investigations in children may be conducted in accord with § 50.52. FDA invited comment on the issue of conducting placebo-controlled investigations in children. We also noted that there is evidence of direct benefit to children from participating in placebo-controlled trials, including increased monitoring and care of subjects, even though a child may not actually receive the test product. This statement has been misinterpreted, and we provide clarification in the paragraphs that follow.
(Comment 6) Eight comments responded to FDA's request for comments on the issue of placebo-controlled clinical investigations in children. Five of the eight comments agreed with FDA that placebo-controlled trials in children may be appropriate in certain circumstances. Two comments opposed the conduct of placebo-controlled trials in healthy children, and one comment opposed the conduct of placebo-controlled trials in children with the active disease.
Of the five comments that supported the use of placebo-controlled clinical trials in children, four cited specific circumstances under which placebo-controlled trials would be appropriate in children. One comment stated that placebo-controlled trials should not be used in serious diseases where the absence of an “active substance” might put a child at undue risk. This comment stated that placebos should be used only in “benign” diseases such as the common cold or mild to moderate allergies because the absence of an active drug would not lead to a permanent handicap. The comment also stated a belief that in a controlled clinical trial, the active substance should be compared to the best standard therapy for the disease, so that children with a disease in a control group would be given the best standard therapy and not a placebo.
Another comment agreed with us that placebo-controlled trials may be conducted in accord with the terms of § 50.52. This comment stated that certain vaccines and a number of drug trials for certain non-life-threatening medical conditions may require use of placebo designs in which the placebo does not provide a medical benefit. This comment suggested that FDA evaluate specific circumstances on a study-by-study basis.
One comment noted that a prohibition or limitation on the use of placebo-controlled trials in children would not assist us in our goals of improving labeling and encouraging studies for children. This comment also suggested that IRBs should retain broad latitude in determining whether or not a particular placebo-controlled trial holds out the prospect of direct benefit to the proposed subjects. This comment cited guidelines established by the research community (ICH E 10 (Ref. 6); American Academy of Pediatrics (Ref. 7)) as support for its position.
One comment agreed with FDA that placebo-controlled trials in children may be conducted if they are in accord with § 50.51 or § 50.52; however, this comment suggested that an IRB's determination of a prospect of direct benefit should be based primarily on the potential benefit of the research intervention itself. The comment suggested that FDA and HHS should develop guidance on what benefits should be taken into account when determining whether a protocol offers the prospect of direct benefit.
Two comments expressed specific support for the view, which they ascribed to the American Academy of Pediatrics, that placebos may be used ethically in children only if their use does not place children at increased risk. According to the comments, such increased risk includes not only risk of mortality or increased or irreversible morbidity, but also physical pain or other distress, including fear and inconvenience. These comments suggested codifying these points in the rule.
One comment was concerned with language in the preamble to the interim rule stating that clinical investigations under § 50.52 “
One comment was opposed to the use of placebo-controlled trials in children. This comment stated that a child's development could be affected by the use of placebos in Phase 1 trials. The comment also stated that the use of placebos in Phase 2 trials could result in negative outcomes. This comment stated that the rule should clearly indicate that an investigational medicine would be compared against another “active medicine” in the same class.
We appreciate the numerous comments we received on this difficult area. Our position on the conduct of placebo-controlled trials in children takes into account the general guidance on the choice of control groups found in FDA's guidance entitled “International Conference on Harmonisation E 10 Choice of Control Group and Related Issues in Clinical Trials” (May 2001) (Ref. 6) and the advice of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee (Pediatric Subcommittee) and the Pediatric Ethics Subcommittee (PES) of FDA's Pediatric Advisory Committee (PAC). The PES and the PAC, and previously the Pediatric Subcommittee, are charged with providing advice and guidance on pediatric ethical issues.
In general, the Pediatric Subcommittee has agreed that placebo-controlled trials are acceptable in situations where there are no approved or adequately studied therapies for children with the condition under study. A Consensus Statement on the Pediatric Subcommittee's September 11, 2000, meeting is available on FDA's Web site at
The PES met in June 2008 to address the interpretation of prospect of direct benefit as it relates to investigations conducted under the FDA subpart D regulations, including placebo-controlled trials (Ref. 9). The PES specifically addressed the question of what benefits may be considered “direct” under the FDA subpart D regulations, and whether the benefits need to accrue to children in both the control and treatment arms of a clinical trial. The general consensus of the PES was that the placebo arm of a trial cannot be considered to confer the prospect of direct benefit under § 50.52 of the FDA subpart D regulations. In general, the PES advised that the so-called “inclusion” benefit is not a “direct” benefit, and that children enrolled in the placebo arm of a trial should be exposed to no more than minimal risk or a minor increase over minimal risk (Ref. 9).
FDA agrees with this position. Because we do not consider the administration of a placebo to offer a prospect of direct benefit, part 50, subpart D, therefore requires that the placebo arm must present no more than minimal risk (§ 50.51) or a minor increase over minimal risk (§ 50.53), unless the clinical investigation is referred for review under § 50.54. As stated in ICH E10, in certain circumstances a placebo-controlled study of an investigational drug or biologic may involve the withholding of known effective treatment (section 2.1.3., Ref. 6). In such situations, however, the risks of such withholding of known effective treatment in the placebo control group should present no more than minimal risk or a minor increase over minimal risk, i.e. the placebo control arm of such a clinical trial must be approvable under either § 50.51 or § 50.53. The arm that receives the investigational product often would be approvable under § 50.52. With respect to the criteria that must be met for approval under§ 50.53, we note that the inclusion of children without the disorder or condition under study would not meet the requirement of § 50.53(c) that “the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition.”
With respect to the concern raised about physical pain or other distress, including fear and inconvenience, we recognize that children with a disorder or condition who are assigned to a placebo group might experience physical pain or discomfort (although no serious risk). It would usually be possible to design a trial to take this concern into account (for example by introducing “escape” or withdrawal provisions, such as defining an early escape as a treatment failure). Regardless of the trial design, however, for such a clinical trial to proceed, the risk of experiencing transient pain and/or discomfort would need to represent no more than a minor increase over minimal risk.
This approach to the analysis of placebo-controlled trials is consistent with the recommendation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (created under the 1974 National Research Act, Public Law 93-348) that the interventions that do and do not offer a prospect of direct benefit in any given protocol must be analyzed separately (often called a component analysis of risk) (43 FR 2084 at 2086 (January 13, 1978)). This approach is applied to, for example, antimicrobial studies for the treatment of acute bacterial otitis media in the FDA guidance entitled “Acute Bacterial Otitis Media: Developing Drugs for Treatment” (September 2012) (Ref. 2).
(Comment 7) In the preamble to the interim rule, FDA discussed strategies for mitigating risk in clinical investigations, including exit strategies in the case of adverse events or a lack of efficacy or establishing a data monitoring committee (DMC) to review ongoing data collection and recommend
Since we published the interim rule, we have issued a final guidance for clinical trial sponsors on the establishment and operation of clinical trial DMCs entitled “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees” (March 2006) (Ref. 10). This document discusses the role of DMCs and other oversight groups, including IRBs, and the relationship between sponsors and DMCs. As part of its initial evaluation, an IRB may appropriately inquire as to whether a DMC has been established and, if so, seek information about its scope and composition. For ongoing trials, an IRB is responsible for considering information arising from the trial that may bear on the continued acceptability of the trial at the study site(s) it oversees. A DMC generally has access to much more data than the IRB during the trial, including interim efficacy and safety outcomes by treatment arm, and makes recommendations with regard to the entire trial. Given its obligation to minimize the risks to patients, an IRB may take action based on information from any appropriate source, including recommendations from a DMC to the sponsor. A trial may have multiple IRBs, each responsible for the patients at a single site, but only one DMC. Individual investigators (or the sponsor of investigational devices) are responsible for assuring that IRBs are made aware of significant new information that arises about a clinical trial. Such information may include DMC recommendations to the sponsor that are communicated to IRB(s), either directly or through individual investigators or sponsors. Additionally, it may be useful for sponsors to ensure that IRBs are informed when DMCs have met, even when no problems have been identified and the DMC has recommended continuation of the trial as designed.
We solicited comments on § 50.53, particularly on whether further definitional criteria should be provided to aid IRBs in understanding certain concepts, including: (1) How to measure a minor increase in risk, (2) at what point a minimal risk develops into a major risk, and (3) whether IRBs have the expertise necessary to determine minor increases over minimal risk. We received four comments on this section.
(Comment 8) One comment expressed support for this provision, stating that the regulations provide adequate protections for children in research with more than minimal risk and provide IRBs with sufficient criteria for review. The comment stated that IRBs have been assessing “increases over minimal risk and the balance between the prospects of benefit to the individual participant or generalizable knowledge and can continue to make these assessments on a case-by-case basis.” Citing documents currently available to guide IRBs, the comment stated that there is no need for further definition or elaboration of criteria in the regulations. The comment concluded that additional criteria or definitions in the regulation would not provide greater protections for research participants.
In contrast, another comment expressed great concern regarding “the power that has been bestowed upon IRBs.” This comment stated that protection of pediatric populations requires a high degree of competency on the part of IRBs and pointed out that inappropriate practices have been detected in the past. The comment stated that only FDA should determine adequate guidelines for the procedures and that we should be the only authority that decides whether a clinical investigation in this category goes forward.
Two comments on this section responded to our solicitation of comments on appropriate criteria for an IRB to use in assessing more than minimal risk. Both comments listed the critical factors as: (1) Age and degree of physiological maturity of the child, (2) nature and natural history of the clinical condition to be treated, (3) presence of complicating clinical conditions, (4) efficacy and safety of the treatment that may have been demonstrated in older patients, or that is expected on the basis of other clinical or preclinical investigations, and (5) likely duration of treatment and its impact upon the growth and development of the child.
We do not agree that only FDA should determine whether research in this category proceeds. Further, IRBs are required to comply with all applicable federal requirements, including those set forth in subpart D, in their review of clinical investigations. To the extent concerns have arisen, or may arise, concerning their compliance with Federal requirements, both OHRP and FDA have taken regulatory action against non-compliant IRBs and/or institutions and have worked to help eliminate non-compliant procedures used by IRBs.
Although there are many documents to guide IRBs in their decisionmaking, we recognize that further elaboration of the criteria set out in these final regulations may prove helpful. This may involve a long-term process of coordination with other Agencies, including OHRP. We appreciate comments received on the appropriate criteria for an IRB to use in assessing more than minimal risk and, although we are not incorporating these suggestions into the regulations at this time, we will consider these suggestions in the future. As previously stated, OHRP identified in its 2001 report to Congress the need for guidance on terms and concepts in HHS subpart D, including the terms “minimal risk,” “the prospect of direct benefit for the individual subject,” “condition,” and “disorder” (Ref. 4) Should HHS propose changes to HHS subpart D, we will review and consider modifying the corresponding provisions of our regulations as appropriate.
(Comment 9) We received five comments on this provision. One comment stated that the requirement for public review and comment on study proposals from private industry under§ 50.54 “should be reconsidered in view of the commercial confidential nature of clinical drug development studies.” This comment suggested that a closed advisory committee meeting in which the committee would be supplemented with invited guests should permit full consideration of the issues and would satisfy the requirement for public review and comment. Three comments supported the requirement for public review and comment, with two of these comments recommending that FDA “suspend” a clinical trial referred under § 50.54 absent a sponsor's willingness to
Another comment requested that we clarify the requirements for the review of research under § 50.54. This comment stated that in cases where a research study involving children is subject to both FDA and HHS regulations, it is unclear which entity will make the determination that the research can proceed, and that requiring a determination by both entities might be unnecessarily duplicative. The comment also noted that the preamble to the interim rule stated that FDA may not be able to provide public review and comment if the sponsor is unwilling to publicly disclose necessary information. The comment suggested that the text of the regulation state explicitly that public review and comment may not be possible in all cases given the FDA regulations relevant to sponsor confidentiality.
From the comments we received, it appears that confusion exists as to the intent of our statements in the preamble to the interim rule about the necessity of public review and comment. In the preamble we stated “Because FDA believes full public review and comment is critical in determining whether a clinical investigation should proceed under these circumstances, if a sponsor is unwilling to waive this privilege, FDA may not be able to satisfy the public review and comment requirement and any such clinical investigation could not proceed” (66 FR 20589 at 20594). The intent of this statement was to make it clear that if the public review and comment requirement could not be met because some or all of the information necessary for that public review and comment was trade secret and/or confidential commercial information, and therefore could not be discussed publicly unless the sponsor gave consent to have that information discussed publicly, the criteria under § 50.54 could not be met and thus the investigation could not go forward.
Because closed advisory committee meetings do not allow for public participation or review of issues under discussion, we do not agree that a closed advisory committee meeting satisfies the requirement for public review and comment. The Agency would be unable to proceed with a referral of a clinical investigation involving children under § 50.54 unless there is full opportunity for public review and comment as provided in this section.
In December 2006, FDA published a final guidance document entitled “Guidance for Clinical Investigators, Institutional Review Boards and Sponsors; Process for Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for Children in Clinical Investigations” (Ref. 11). This final guidance describes the procedures FDA generally will follow in handling clinical investigations referred for review under § 50.54 and in reaching final determinations under this regulation. The guidance is based in part on FDA's experience to date with such referrals. This guidance also addresses situations in which a clinical investigation being referred involves an FDA-regulated product and is conducted or supported by HHS, and therefore is subject to both FDA's regulations (§ 50.54) and HHS regulations (45 CFR 46.407). If there is a referral of a clinical investigation subject to both FDA and HHS regulations, FDA's PAC is chartered to advise both the Commissioner of FDA and the Secretary of HHS on referrals under § 50.54 of FDA subpart D and § 46.407 of HHS subpart D.
OHRP's guidance on the review process under 45 CFR 46.407, issued in May 2005, is available on OHRP's Web page at
We defined “assent” at § 50.3(n). In § 50.55 we listed our requirements for assent by children, and in the preamble to the interim rule we solicited comments on how to ensure that age-appropriate explanations are provided to children. We received three comments on soliciting and documenting assent and three comments on ensuring age-appropriate explanations.
(Comment 10) One comment suggested that the consent/assent of a child or family member should be witnessed by an independent person at the research facility and/or videotaped to ensure that proper and truthful information has been provided in an understandable fashion to children. A second comment requested that FDA define a minimum standard for documentation of assent similar to that of informed consent. The comment stated that a minimum standard would assist sponsors in monitoring and other quality assurance efforts and would facilitate increased consistency across clinical sites. The comment expressed concern that if an IRB determined that pediatric assent was warranted for a trial, but decided that documentation of the assent was unnecessary, both sponsors and FDA would be unable to determine that assent actually occurred. A third comment suggested that persons with demonstrated competence in dealing with children be added to the assent process to evaluate the cognitive levels of understanding for children in various age groups.
The requirements for assent listed at § 50.55 are the same as those in 45 CFR 46.408 of HHS subpart D. Because of the unique issues raised when soliciting assent from children, permission (i.e., consent) from one or both parents is required. This permission must be documented in accordance with and to the extent required by § 50.27. We do not agree that requiring an independent witness and/or videotape of the process of soliciting parental permission or child assent would, in every study, be necessary or would act as a safeguard. We conclude that the procedures in § 50.27 for documenting consent are sufficient for an adult providing parental or guardian permission. Additionally, in certain circumstances the use of videotape or the presence of an independent witness might intimidate a child being asked to provide assent. Under § 50.55(g), the IRB determines whether and how assent must be documented. If an IRB determines that videotaping the assent process is appropriate or that an independent witness is warranted, the IRB can require such procedures at its discretion as a condition of study approval. We do not agree that adding a formal evaluation of the cognitive levels of understanding for children in various age groups is routinely warranted.
FDA's guidance entitled “E6 Good Clinical Practice: Consolidated Guidance” (ICH E6) (Ref. 13) recommends that a child “should be informed about the trial to the extent compatible with the [child]'s understanding and, if capable, the [child] should assent, sign and personally date the written informed consent” (§ 4.8.12, ICH E6, Ref. 13). In addition, the “language used in the oral and written information about the trial * * * should be understandable” to the child or the child's parent or guardian (§ 4.8.6, ICH E6, Ref. 13). If a child is
(Comment 11) Three comments responded to our solicitation on ensuring age-appropriate explanations to children. The first comment stated that age-appropriate assent has long been a part of the HHS regulations and that current, available guidance is sufficient to assist IRBs in meeting their responsibilities. This comment stated that there is no need for further definition or elaboration of criteria to aid IRBs in ensuring age-appropriate explanations. A second comment stated that FDA should encourage the study and publication of techniques for securing the assent of pediatric patients. A third comment stated that ensuring that children are provided with age-appropriate explanations is both important and difficult. The comment supported the factors listed in the regulation and added the following factors: The environment in which the research will be conducted, the expertise of the researchers, and the risks and benefits of the specific protocol. The comment concluded that since these are matters of informed judgment, the assessment of the appropriateness of the explanation to children at a particular research site is best made by a duly constituted IRB that, as necessary, consults with individuals with expertise and experience in age-appropriate explanations.
We agree with the comment that ensuring that children are provided with age-appropriate explanations is important and difficult. We also agree that the assessment of appropriateness is best left to the IRB responsible for review of any specific protocol. However, if child assent is required, persons who are knowledgeable and skilled in dealing with children should be involved in the assent process to detect and/or minimize child distress (§ 2.6.3 and 2.6.5; ICH E 11, Ref. 1). While we acknowledge that age-appropriate assent has long been a part of HHS regulations, we support the continued study and publication of techniques for securing the assent of pediatric patients in the best ways possible.
Consistent with the interim rule, we are not adopting the provisions of HHS subpart D at 45 CFR 46.408(c) that allow IRBs to waive the requirements for obtaining permission in certain circumstances. The policy decision not to adopt the waiver of parental or guardian permission found in 45 CFR 46.408(c) stems from FDA's specific regulatory scheme. We explained in the preamble to the interim rule that the only exceptions to our requirements for informed consent are found in the emergency exceptions listed in part 50 of our regulations.
(Comment 12) We received six comments on this provision. Four comments supported our decision not to adopt the waiver provision for permission by parents or guardians. Two comments objected to our decision not to adopt the waiver provision.
Of the two comments that objected to our decision not to adopt the waiver provision, one comment suggested that the waiver provision for parental permission in HHS subpart D is appropriate in certain, unusual circumstances and suggested that we adopt it in limited, appropriate circumstances. The comment provided two possible examples of circumstances it considered unusual: (1) The development of a new test kit for a sexually transmitted disease or (2) studies involving children who have been the victims of sexual abuse. The comment also asked that FDA clarify that the option to waive informed consent in emergency settings applies to pediatric research and that FDA specifically state that the possible exceptions in § 50.24 apply to children as well.
The other comment that objected to our decision not to adopt the provision for waiver of parental permission asked us to interpret the FD&C Act to enable mature adolescents to consent to involvement in certain types of clinical studies without parental permission. The comment stressed that if such an interpretation of the law is not possible, we should seek to change the law to allow FDA and HHS regulations to be consistent in this area. The comment stated that if the waiver provision is not adopted, vital research involving mature adolescents for whom seeking parental permission is not in their best interest will not be conducted.
The comment cited the example of research studies using new therapeutic modalities for the human immunodeficiency virus (HIV) and the acquired immunodeficiency virus (AIDS) in the HIV epidemic in the late 1980s and early 1990s and stated that many adolescents who sought treatment for HIV requested that their diagnosis be kept confidential from their parents. The comment stated that such confidential treatment was provided to these adolescents based on State laws allowing physicians to treat adolescents for sexually transmitted diseases without parental involvement. The comment continued that when new drugs became available only under research protocols, these adolescents would not have been afforded the potential benefits from participation in such clinical trials if parental permission were required. The comment stated that clinicians responded to this problem by asking IRBs to invoke 45 CFR 46.408(c) of HHS subpart D to allow the research to proceed without informing the parents of adolescents who requested confidentiality. This comment also urged the development of guidance to protect the interests of adolescents and children who are research subjects.
We have reviewed this issue and have decided not to adopt the waiver of parental or guardian permission. We acknowledge that FDA and HHS regulations are not harmonized on this point; however, as discussed in the paragraphs that follow, we consider this difference to be necessary and appropriate in light of FDA's existing
We recognize that mature adolescents may contract diseases such as HIV-AIDS and other sexually transmissible diseases, and that there are important issues relating to the confidentiality of treatment sought. We note that in some situations a State may grant certain classes of mature adolescents of a specific age the right to consent to treatments or procedures involved in a clinical investigation. These mature minors would not meet the definition of children under § 50.3(o) and thus would not be subject to the requirements of this subpart. Similarly, minors deemed “emancipated” by state law also would not meet the definition of children under § 50.3(o) and would not be subject to the requirements of this subpart. Mature or emancipated minors would be allowed to consent to participation in FDA-regulated research without the need for parental or guardian permission. Thus, we consider reliance on established state and/or local laws that establish an adolescent as mature and/or emancipated to be appropriate in this context. Furthermore, it would be difficult to limit the interpretation and application of a waiver provision to narrowly apply to a limited set of circumstances or appropriate conditions, as suggested by one comment.
In FDA's view, adopting the waiver provision in 45 CFR 46.408(c) would be prohibited by the FD&C Act in certain circumstances, and would be inconsistent with FDA's implementing regulations. Specifically, section 520(g)(3) of the FD&C Act, which was added to the FD&C Act as part of the Medical Device Amendments of 1976 (Pub. L. 94-295), requires that informed consent be obtained from each human subject in a clinical trial of a device, except when an exception is granted in certain narrow emergency situations. Thus, the circumstances in which an exception from the requirement for informed consent can be granted in a clinical investigation of a medical device are specifically set forth in FDA's statute. When FDA issued its informed consent regulations (46 FR 8942, January 27, 1981), the agency sought to create a single set of informed consent regulations (part 50), including provisions for an exception from the requirement for informed consent, that would provide consistent protections for subjects in trials subject to FDA jurisdiction, regardless of the type of product being investigated. Accordingly, the provisions in part 50 pertaining to exceptions from the requirement for informed consent are based on those in section 520(g)(3) of the FD&C Act, and apply to all FDA-regulated clinical investigations.
Because parental or guardian permission takes the place of informed consent when the human subject is a child, a waiver of permission (as in 45 CFR 46.408(c) of the HHS regulations) is equivalent to a waiver of or exception from the requirement for informed consent, regardless of whether child assent is obtained. If we were to amend our regulations to allow for IRB waiver of or exception from the requirement to obtain permission in certain clinical investigations involving children, we would be prohibited from doing so by section 520(g)(3) of the FD&C Act with regard to medical device trials. Thus, we would have two disparate standards of human subject protection (one for clinical trials of devices and one for other trials regulated by FDA) based not on ethical considerations, but rather based solely on the type of product being studied. We conclude that this result would not be in the interest of public health and safety, and that public health and safety is best served by having uniform informed consent requirements across medical product categories and that the informed consent requirements should not vary depending on whether a clinical trial regulated by FDA involves a drug, biological product, device, or other product subject to FDA jurisdiction.
We note that § 50.23 sets forth an exception from the general requirement to obtain informed consent in certain situations when a human subject is confronted by a life-threatening situation necessitating the use of a test article when there is not sufficient time to obtain consent from the subject or the subject's legal representative. FDA interprets this provision to apply to children when there is not sufficient time to obtain parental or guardian permission. The regulation therefore allows a test article to be administered to a child if the investigator and an independent physician who is not otherwise participating in the clinical investigation certify in writing, before use of the test article, that certain conditions are met, including that there is no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the child. However, § 50.23 also provides that, if immediate use of the test article is, in the investigator's opinion, required to preserve the life of the subject (in this context, the child), and time is not sufficient to obtain the required independent determination in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. In either situation, the written documentation must be submitted to the IRB within 5 working days after the use of the test article.
With regard to the concerns in the comment about emergency research involving children, we wish to clarify that the emergency research provisions in § 50.24 apply, and always were intended to apply, to clinical investigations involving children. We have added language to § 50.55(e) that originates from § 46.408(b) of HHS subpart D and was inadvertently omitted from the interim rule, indicating that the exceptions from informed consent for emergency research described in § 50.24 apply to research in children. Section 50.55(e) now reads, “In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine,
(Comment 13) We received five comments on the participation of children who are wards in clinical investigations. One comment supported the appointment of an advocate for children who are wards. One comment asked for clarification about the appointment process, noting that the preamble to the interim rule states that the IRB itself must appoint the advocate rather than assure that an advocate has been appointed. Two comments asked for clarification about the role and responsibilities of an advocate, and the obligations of a central IRB and sponsor in monitoring the appointment of
We agree with the comment that the preamble overstated the requirement, as set forth in § 50.56, for the appointment of an advocate. As § 50.56 states, the IRB must require appointment of an advocate for each child who is a ward, not appoint the advocate itself. This advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis and will act in the best interest of the child for the duration of the child's participation in the clinical investigation. We note that § 50.56 only addresses the circumstances in which wards can be included in clinical investigations approved under § 50.53 or § 50.54, and therefore only requires the appointment of an advocate in such clinical investigations. It does not address the appointment of an advocate in clinical investigations approved under § 50.51 or § 50.52; however, the regulations do not preclude an IRB from considering the appointment of an advocate in such clinical investigations in order to assure that there is someone who will act in the best interest of the child for the duration of the child's participation in the clinical investigation. Before enrolling any child who is a ward in a clinical investigation, IRBs should ensure that each child has a guardian and/or advocate with the background, experience and commitment to act in the best interest of the child.
We do not consider it necessary to codify a provision specifically empowering the IRB to reject the selection of an advocate if the IRB finds that individual to be unsuitable. Other regulatory provisions, including § 56.113, provide the IRB with authority to suspend or terminate research if it determines that any aspect of the research is not in conformance with the regulations. This would include any noncompliance with § 50.56.
(Comment 14) One comment requested that we clarify that the regulations apply to biological products. Section 50.1 of part 50—Protection of Human Subjects, and § 56.101 of part 56—Institutional Review Boards, clearly state that they apply to clinical investigations regulated by FDA under sections 505(i) and 520(g) of the FD&C Act, as well as clinical investigations that support applications for research or marketing permits for products regulated by FDA, including human drug and biological products; medical devices for human use; foods, including dietary supplements, that bear a nutrient content claim or health claim; infant formula; food and color additives; and electronic products. Because §§ 50.1 and 56.101 apply to this final rule, it is unnecessary for us to include specific language in this final rule indicating that it applies to biological products.
We received three comments on the economic analysis in the interim rule.
(Comment 15) One comment stated that the estimate of additional time to be spent by IRBs to review and document the level of risk may be underestimated at one person-hour. The comment also raised concern that the additional IRB responsibilities, including ensuring age-appropriate explanations for assent and assessing strategies for the appointment of advocates, will add to the time spent by IRBs to ensure the safe conduct of pediatric clinical trials. The comment requested clarification on the nature and scope of the documentation necessary.
Under current regulations and guidance, IRBs are already required to make several determinations concerning risk to participants and to document those risks. The additional requirements of this rule state that IRBs must specifically identify which of the four risk categories applies to children in a clinical trial. We expect that this determination will require some additional effort, but take at most one person-hour of additional time. This estimate includes time for the documentation required to identify the selected risk category.
(Comment 16) Two comments stated that they did not agree with our assumption that there would be no costs associated with clinical holds. These comments noted that we did not calculate the potential impact of the widespread accreditation of IRBs. These comments stated that inspection of studies will be common as IRBs go through the accreditation process and that, particularly in the pediatric area, IRBs themselves may increase their inspection of studies to avoid findings of “noncompliance” by accrediting bodies. The comments concluded that increased inspections will probably uncover more circumstances in which studies will be put on clinical hold.
This rule does not require IRBs to undergo any accreditation process. We do not know of any plans to require federally mandated accreditation of IRBs, nor do we endorse any particular accreditation body. Therefore, there are no costs from accreditation related to this rule. While IRB reviews of pediatric clinical trials may become more comprehensive if there are concerns about noncompliance, any increase in IRB reviews because of noncompliance would not be attributable to this rule, but to problems with noncompliance generally.
(Comment 17) Two comments raised concerns that ethical standards were not codified in the regulation. One comment called on us to ensure that the pharmaceutical industry focuses on the ethical conduct of clinical trials in children and not financial gain. The other comment raised concern that the regulations do not include standards for conflict of interest or require that such conflicts by investigators or institutions be revealed on informed consent documents to parents or guardians. The comment also noted that the regulations do not mention rules for recruitment. This comment suggested that there should be prohibitions against “bribing” parents with high payments to offer their children for research and that compensation should cover only direct expenses such as travel, meals and lodging costs, and daycare for other children.
FDA's regulations under 21 CFR part 54 govern financial disclosure by clinical investigators and requires disclosure of certain financial relationships between the sponsors of covered studies and the clinical investigators, including interests of the clinical investigators in the product under study or in the sponsor of the covered studies. We use this information in conjunction with information about the design and purpose of the study, as well as information obtained through onsite inspections, in our assessment of the reliability of data presented.
In August 2000, HHS held a conference on human subject protection and financial conflicts of interest. As a result of this conference, HHS issued a
Additionally, we note that ethical considerations for IRBs are covered under several provisions of our regulations. Sections 56.107(a) and 56.111 require IRBs to ensure that appropriate safeguards exist to protect the rights and welfare of research subjects. In fulfilling these responsibilities, an IRB is expected to review all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The protocol, the consent document and, for studies conducted under the Investigational New Drug (IND) regulations, the investigator's brochure are examples of documents that the IRB should review. The IRB should also review the methods and material that investigators propose to use to recruit subjects (see “Recruiting Study Subjects—Information Sheet,” Ref. 17). Section 56.107 on IRB membership contains several provisions designed to prevent conflicts of interest. Section 56.107(e) states that no IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
Regulatory requirements for recordkeeping and retention of records provide one means for FDA oversight of IRBs. Section 56.115(c) states that we may refuse to consider a clinical investigation in support of an application for a research or marketing permit if the institution or the IRB that reviewed the investigation refuses to allow inspections of its records or reports. Similarly, subpart E of part 56 outlines various actions we may take against IRBs if we observe during an inspection that an IRB is not complying with the regulations. These actions include disqualification of an IRB, referral for civil or criminal judicial proceedings, and any other appropriate regulatory action. We may also refer matters to another Federal, State, or local government Agency for any action that the Agency determines to be appropriate.
Although it is always possible that an IRB will not be in compliance with all of our regulations, our current IRB regulations, along with other human subject protection regulations, provide us with multiple tools to ensure ethical conduct by IRBs, clinical investigators, and sponsors. The 2001 OHRP report identified the need for guidance on payment (financial or otherwise) that may be provided either to children involved in research as subjects or to their parents, under circumstances that minimize the possibility of coercion or undue influence (Ref. 4). While the 2004 IOM report concluded that payments related to research participation have a role to play in reducing barriers and equalizing access to research participation, it recommended that IRBs should develop written guidance and policies on payments to children or parents related to research participation (Ref. 5). Should HHS propose changes to its regulations pertaining to IRB oversight, we will review our regulations and consider revising them as appropriate.
This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act (Pub. L. 103-310). Title XXVII, section 2701 of the Children's Health Act required that within 6 months of enactment all research involving children that is conducted, supported, or regulated by HHS be in compliance with HHS regulations providing additional protections for children involved as subjects in research. The HHS regulations are codified at 45 CFR part 46 subpart D. FDA interprets the Children's Health Act to require FDA to issue regulations to ensure that clinical investigations of FDA-regulated products are conducted in compliance with HHS subpart D.
Additional authority for this rule derives from sections 505(i) and 520(g) of the FD&C Act regarding clinical investigations of FDA-regulated drugs, biological products, and devices for human use. These provisions direct the Commissioner to issue regulations for exempting such investigational products from the general requirements for preapproval or presubmission review. Among other stated objectives, this final rule fulfills that mandate by enhancing protections for children involved as subjects in clinical research of FDA-regulated drugs, biological products, and devices for human use.
A further source of authority for this rule is section 701 of the FD&C Act (21 U.S.C. 371), which authorizes the Commissioner to issue regulations for the efficient enforcement of the FD&C Act. This final rule helps the efficient enforcement of the FD&C Act by enhancing clarity and certainty in FDA's oversight of clinical investigations involving children as subjects.
The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final rule contains no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), and therefore review by the Office of Management and Budget (OMB) is not required. The information requested for clinical investigations in children of FDA-regulated products is already covered by the collections of information in the IND regulations (21 CFR part 312), the investigational device exemption (IDE) regulations (21 CFR part 812), the IRB regulations (§ 56.115), the food additive petition and nutrient content claim petition regulations (21 CFR 101.69 and 101.70), and the infant formula regulations (21 CFR parts 106 and 107), all of which are approved by OMB. Specifically, the information collected under the IND regulations is currently approved under OMB control number 0910-0014. The information collected under the IDE regulations is currently approved under OMB control number 0910-0078. The information collected under the IRB regulations is currently approved under OMB control number 0910-0130. The information collected in food additive and nutrient content claim petitions is currently approved under OMB control number 0910-0381 (general requirements) and 0910-0016 (FDA Form 3503). The information collected under the infant formula regulations is currently approved under OMB control number 0910-0256 (general requirements) and 0910-0188 (infant formula recalls).
FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. 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 $139 million, using the most current (2011) 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.
The interim final rule (66 FR 20589 at 20596, April 24, 2001) imposed an additional burden on IRBs reviewing investigations which involve children. The estimated costs of the interim final rule were estimated to be small ($933,000 in year 2001 and $23,550 per year in years 2002 through 2009). As the interim final rule has been in effect since April 2001, the publication of this final rule will have little additional impact. However, we update the estimated costs of the interim rule for the post-2001 period to adjust for inflation and availability of more recent data. The total annual cost of reviewing pediatric clinical trials remains at $933,000 (this includes a one-time cost of $900,000 to conduct a one-time review and update standard operating procedures plus $33,000 for annual reviews) for the year 2001. The revised annual review cost for the post-2001 period ranges between $79,817 and $112,357 per year (see table 1 in this document).
The revised post-2001 costs per year are revised as follows. First, the annual IRB costs per year are in inflation-adjusted (2010) dollars. Second, we use recent data from the various FDA centers reviewing protocols involving pediatrics, and update the total number of studies affected by the rule to be between 872 and 1,227 per year. We note that given data limitations we are unable to use the same period of analysis across centers. To the extent that there has been an increase in the number of protocols involving children since 2001, then using the most recently available data would provide an upper bound estimate on the average number of protocols received after 2001. However, over the past few years, most offices within FDA's Center for Drug Evaluation and Research (CDER) did not observe a significant increase in the percentage change of protocols received. Thus, we believe that the impact of using different periods of data is negligible. The data and methodology used are discussed in more detail in the paragraphs that follow.
The estimated number of drug- and biologics-related protocols involving pediatrics ranges from 561 to 637. The number of drug-related or biologics-related protocols (553 to 610) provided by CDER was based on data from fiscal year 2011. The range of protocols related to biological products regulated by FDA's Center for Biologics Evaluation and Research (CBER) represents the minimum (8 in fiscal year 2004) and maximum (27 in fiscal year 2011) number of pediatric protocols received by CBER during fiscal years 2002-2011. The count is adjusted up 30 percent
We estimate that 305 to 572 medical device protocols involve pediatrics. This is calculated by using the average number of applications or submissions (including supplements) reviewed by FDA's Center for Devices and Radiological Health per year and an estimate on the percent of medical device applications involving children. We estimate that, using the number of approved IDE pediatric studies as reported by FDA's Center Tracking System (7 to 13), and the average number of original IDE submissions (219) in fiscal years 2008-2009, 3 percent to 6 percent of medical device protocols involve pediatrics. We note that there could be some high-risk medical devices which might not be included in our estimated number of protocols for medical devices; however, data limitations do not permit us to quantify the extent to which our estimates would have to be adjusted up.
Finally, the estimated number of protocols for food additives and infant formula are extrapolated using the average High-to-Low ratio (3-to-1) across the other products and the initial estimates in the final rule. For instance, to determine the upper-bound estimate for infant formula we multiply the 2001 estimate by the High-to-Low ratio (5 × 3).
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that 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. Accordingly, the Agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references have been placed on display in the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at
1. FDA “Guidance for Industry: ICH E11 Clinical Investigation of Medicinal Products in the Pediatric Population,” December 2000, available at
2. FDA “Guidance for Industry: Acute Bacterial Otitis Media: Developing Drugs for Treatment,” September 2012, available at
3. FDA “Guidance for Industry: Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children,” March 2007, available at
4. OHRP “Protections for Children in Research: A Report to Congress in Accord with Section 1003 of P.L. 106-310, Children's Health Act of 2000,” May 2001, available at:
5. Committee on Clinical Research Involving Children, Board on Health Sciences Policy, Institute of Medicine of the National Academies, “Ethical Conduct of Clinical Research Involving Children,” Marilyn J. Field and Richard E. Behrman, Eds., The National Academies Press, 2004, available at
6. FDA “Guidance for Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials,” May 2001, available at
7. Committee on Drugs, American Academy of Pediatrics, “Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations,”
8. FDA “FDA Pediatric Ethics Working Group Consensus Statement on Pediatric Advisory Subcommittee's September 11, 2000,” available at
9. FDA Pediatric Ethics Subcommittee of the Pediatric Advisory Committee, June 9-10, 2008 meeting. The agenda, briefing information, slides, minutes and transcripts can be found at
10. FDA “Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees,” March 2006, available at
11. FDA “Guidance for Clinical Investigators, Institutional Review Boards and Sponsors; Process for Handling Referrals to FDA Under 21 CFR 50.4: Additional Safeguards for Children in Clinical Investigations, ” December 2006, available at
12. HHS Office of Human Research Protections “Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 (“407”) Review Process,” May 2005, available at
13. FDA “Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance,” April 1996, available at
14. Department of Health and Human Services, “Final Guidance Document: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection” May 2004, available at
15. FDA “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators,” May 2011, available at
16. FDA “Guidance for Industry: Investigator Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects,” October 2009, available at
17. FDA “Recruiting Study Subjects—Information Sheet. Guidance for Institutional Review Boards and Clinical Investigators,” page last updated: 10/18/2010, available at
Human research subjects, Prisoners, Reporting and recordkeeping requirements, Safety.
Human research subjects, Report and recordkeeping requirements, Safety.
Accordingly, the interim rule amending 21 CFR parts 50 and 56 which was published at 66 FR 20589, on April 24, 2001, is adopted as a final rule with the following changes:
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.
(n)
(r)
(s)
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:
(a) No greater than minimal risk to children is presented; and
(b) Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in § 50.55.
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, may involve children as subjects only if the IRB finds that:
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well-being of the subject, may involve children as subjects only if the IRB finds that:
(a) The IRB finds that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
(e) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine, in accordance with and to the extent that consent is required under part 50, that the permission of each child's parents or guardian is granted.
(1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for clinical investigations to be conducted under § 50.51 or § 50.52.
(2) Where clinical investigations are covered by § 50.53 or § 50.54 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.
(h) * * * When some or all of the subjects in a study that was ongoing on April 30, 2001, are children, an IRB must conduct a review of the research to determine compliance with part 50, subpart D of this chapter, either at the time of continuing review or, at the discretion of the IRB, at an earlier date.
Office of the Secretary, Department of Defense.
Final rule.
This final rule eliminates the requirement that states a NAS is needed for non-emergency inpatient mental health care in order for a TRICARE Standard beneficiary's claim to be paid. Currently, NAS are required for non-emergency inpatient mental health care for TRICARE Standard beneficiaries who live within a military treatment facility catchment area. At this time, the number of NASs issued is negligible as most mental health admissions are emergency admissions. Requiring a NAS for a relatively few non-emergency inpatient mental health admissions is disproportionate to the cost of maintaining the systems necessary to process and coordinate the NAS.
Effective March 28, 2013.
Mr. Richard Hart, TRICARE Policy and Operations, TRICARE Management Activity, 5111 Leesburg Pike, Suite 810, Falls Church, VA 22041, 703-681-0047.
a. Currently, NAS are required for non-emergency inpatient mental health care for TRICARE Standard beneficiaries who live within a military treatment facility catchment area. Pursuant to section 1080(c)(2) of title 10, United States Code, the Secretary can waive the requirement to obtain NASs following an evaluation of the effectiveness of such statements in optimizing the use of
b. Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
This final rule eliminates the requirement for a NAS for non-emergency inpatient mental health care in order for the TRICARE Standard beneficiary's claim to be paid.
The elimination of the requirement for a NAS for non-emergency inpatient mental health care for TRICARE Standard beneficiaries is separate and distinct from the ongoing right of first refusal for specialty services requested by a civilian provider under TRICARE Prime, if the services are available at the MTF, or the ongoing statutory requirement for preadmission authorization before inpatient mental health services may be provided. This final rule does not eliminate the right of first refusal or requirement for preadmission authorization.
In reviewing the proposed rule, we discovered that we had inadvertently deleted not only the requirement to obtain a NAS for non-emergency inpatient mental health services for TRICARE Standard beneficiaries living within the 40-mile catchment area of a military treatment facility, but also the Department's general implementation of section 721 of Public Law 106-398, as amended by section 735 of Public Law 107-107, regarding the Secretary's statutory authority to require a NAS. We have remedied that oversight in this final rule, thereby preserving the option to impose the requirement to obtain NASs in the future, consistent with existing statutory authority, should circumstances change and a demonstration be made that, by performing specific procedures at affected military medical treatment facilities, use of such facilities would be optimized and significant costs avoided. Section 199.4(a)(9) is thereby amended to retain this general authority while still eliminating the current requirement to obtain a NAS for non-emergency inpatient mental health services.
There are no anticipated budgetary health care cost increases. Requiring a NAS for a relatively few non-emergency inpatient mental health admissions is disproportionate to the cost of maintaining the systems necessary to process and coordinate the NAS.
The proposed rule was published in the
Executive Order 12866 requires that a comprehensive regulatory impact analysis be performed on any economically significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. This final rule is not economically significant nor a significant regulatory action as defined under these executives orders.
This rule does not contain unfunded mandates. It does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any 1 year.
The Regulatory Flexibility Act (RFA) requires that each Federal Agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This final rule will not have a significant impact on a substantial number of small entities for purposes of the RFA. Thus this final rule is not subject to this requirement.
This final rule will not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.
We have examined the impacts of the rule under Executive Order 13132 and it does not have policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, therefore, consultation with State and local officials is not required.
Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Military personnel.
Accordingly, 32 CFR part 199 is amended as follows:
5 U.S.C. 301; 10 U.S.C. chapter 55.
(a) * * *
(9)
(i) With the exception of maternity services, the ASD(HA) may require an NAS prior to TRICARE cost-sharing for additional services from civilian sources if such services are to be provided to a beneficiary who lives within a 40-mile catchment area of an MTF where such services are available and the ASD(HA):
(A) Demonstrates that significant costs would be avoided by performing specific procedures at the affected MTF or MTFs; or
(B) Determines that a specific procedure must be provided at the
(C) Determines that the lack of NAS data would significantly interfere with TRICARE contract administration; and
(D) Provides notification of the ASD(HA)'s intent to require an NAS under this authority to covered beneficiaries who receive care at the MTF or MTFs that will be affected by the decision to require an NAS under this authority; and
(E) Provides at least 60-day notification to the Committees on Armed Services of the House of Representatives and the Senate of the ASD(HA)'s intent to require an NAS under this authority, the reason for the NAS requirement, and the date that an NAS will be required.
(ii) Rules in effect at the time civilian medical care is provided apply. The applicable rules and regulations regarding Nonavailability Statements in effect at the time the civilian care is rendered apply in determining whether a NAS is required.
(iii) The Director, TMA is responsible for issuing the procedural rules and regulations regarding Nonavailability Statements. Such rules and regulations should address:
(A) When and for what services a NAS is required. However, a NAS may not be required for services otherwise available at an MTF located within a 40-mile radius of the beneficiary's residence when another insurance plan or program provides the beneficiary's primary coverage for the services. This requirement for an NAS does not apply to beneficiaries enrolled in TRICARE Prime, even when those beneficiaries use the point-of-service option under § 199.17(n)(3) of this part; and
(B) When and how notifications will be made to a beneficiary who is not enrolled in TRICARE Prime as to whether or not he or she resides in a geographic area that requires obtaining a NAS; and
(C) What information relating to claims submissions, including the documentation, if any, that is required to document that a valid NAS was issued. However, when documentation of a NAS is required, then that documentation shall be valid for the adjudication of CHAMPUS claims for all related care otherwise authorized by this part which is received from a civilian source while the beneficiary resided within the Uniformed Service facility catchment area which issued the NAS.
(iv) In the case of any service subject to a NAS requirement under this paragraph (a)(9) and also subject to a preadmission (or other pre-service) authorization requirement under § 199.4 or § 199.15 of this part, the administrative processes for the NAS and pre-service authorization may be combined.
Office of the Secretary, Department of Defense.
Final rule.
This final rule will provide the Director, TRICARE Management Activity (TMA), or designee, with the authority to sanction third-party billing agents by invoking the administrative remedy of exclusion or suspension from the TRICARE program. Such sanctions may be invoked in situations involving fraud or abuse on the part of third-party billing agents that prepare or submit claims presented to TRICARE for payment.
Ms. Ann N. Fazzini, Medical Benefits and Reimbursement Branch, TMA, telephone, (303) 676-3803.
As stated in the proposed rule, TRICARE has regulatory authority under 32 Code of Federal Regulations (CFR) 199.9 to invoke sanctions in situations involving fraud or abuse on the part of providers of TRICARE services. A provider is defined in 32 CFR 199.2 as, “A hospital or other institutional provider, a physician, or other individual professional provider, or other provider of services or supplies as specified in § 199.6 of this part.” Third-party billing agents do not meet the definition of a provider as stated in 32 CFR 199.2, nor do TRICARE regulations currently define third-party billing agents.
Title 42 of the CFR subpart C—Exclusions at 42 CFR 402.200(b)(1) provides for the imposition of an exclusion from the Medicare and Medicaid programs (and, where applicable, other Federal health care programs) against persons that violate the provisions provided in § 402.1(e) (and further described in § 402.1(c)). However, TRICARE had no independent regulatory authority to sanction or exclude third-party billing agents. This final rule provides that authority.
This final rule establishes that such entities, when acting on behalf of a provider, are held to an equal standard in regard to accuracy and honesty when filing claims for services and supplies under the TRICARE program. As such, these entities should be subject to the same administrative controls applied to providers in ensuring that funds are disbursed appropriately. This rule will allow TRICARE to sanction third-party billing agents to prevent the payment of false or improper billings.
By expanding the scope of sanctioning authority to include third-party billing agents, TRICARE costs are not anticipated to increase in this area. Rather, by expanding the sanctioning authority to include third-party billing agents in situations of fraud or abuse, the program is safeguarding benefit dollars from being expended for fraudulent or abusive charges. The anticipated result of this final rule is a savings benefit to the program.
The Department of Defense, Office of Inspector General (DoD IG) initiated an audit in February 2008 to review TRICARE controls over claims submitted by third-party billing agents (Department of Defense Inspector General Report No. D-2009-037—“TRICARE Controls Over Claims Prepared by Third-Party Billing Agencies”). The DoD IG published a report on December 31, 2008. The report included a recommendation that the Director, TMA strengthen internal controls by initiating action to obtain statutory or regulatory authority to sanction billing agencies or any entities that prepare or submit improper health care claims to TRICARE contractors.
In the
We received one comment on the proposed rule. The commenter recommended that the Code of Federal Regulations (CFR) rule be expanded to prohibit sanctioned providers or third party billing agents from pursing collection activities against patients in the event that sanctions are implemented. We appreciate this comment and note that there is presently policy and regulations that address this issue. By their very nature, third-party billing agents have a contractual relationship with the health care provider that requires them to file claims on behalf of the provider. This should normally require that the third-party billing agreement meet the claims filing requirements of the entity or agency that would be paying the claim. In the case of a DoD beneficiary, claims must be filed in accordance with the Code of Federal Regulations, including the requirements relating to the maximum allowable payments and any balance billing limitations. Additionally, TRICARE benefit payments are payable directly to the provider, not the third-party billing agent, as federal regulations prohibit the general assignment of claims. The agent has no independent right to payment from either TRICARE or the beneficiary.
Per 32 CFR 199.9(h)(4)(i)(c), participating providers are considered to have forfeited or waived any right or entitlement to bill TRICARE beneficiaries for care involved in claims for services furnished on or after the effective date of the provider's exclusion or suspension. As a result, any third-party billing agent purporting to act on behalf of a sanctioned provider would also be prohibited from billing TRICARE beneficiaries on behalf of that provider. Additionally, if the proposed authority to sanction third-party billing agents is invoked, a suspended or excluded third-party billing agent would also be prohibited from submitting a claim to TRICARE on behalf of any authorized provider or to bill any TRICARE beneficiary directly. Any claim received from an excluded third-party billing agent would be returned to the provider with instructions to resubmit the claim directly or through another third-party billing agent. As long as the provider of services has not been sanctioned and remains an authorized TRICARE provider pursuant to the requirements in 32 CFR 199.6, the provider remains entitled to reimbursement for covered services. Under either of these scenarios, TRICARE beneficiaries should not be subject to collection actions.
It is also important to note that the authority sought under the proposed rule to sanction third-party billing agents by invoking administrative remedies under 32 CFR 199.9 is in addition to, and not in lieu of, any other remedies or sanctions authorized by law or regulation, including potential criminal convictions and civil judgments for fraud and abuse.
Sec. 801 of Title 5, United States Code (U.S.C.), and Executive Orders 12866 and 13563 require certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy of which would have other substantial impacts. This final rule is not a significant regulatory action.
Section 202 of Public Law 104-4, “Unfunded Mandates Reform Act,” requires that an analysis be performed to determine whether any Federal mandate may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector of $100 million in any one year. It has been certified that this final rule does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector of $100 million or more in any one year, and thus this rule is not subject to this requirement.
Public Law 96-351, “Regulatory Flexibility Act” (RFA) (5 U.S.C. 601), requires each Federal agency to prepare a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This final rule is not an economically significant regulatory action, and it has been certified that it will not have a significant impact on a substantial number of small entities. Therefore, this final rule is not subject to the requirements of RFA.
This final rule does not contain a “collection of information” requirement, and will not impose additional information collection requirement on the public under Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35).
E.O. 13132, “Federalism,” requires that an impact analysis be performed to determine whether the rule has federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. It has been certified that this final rule does not have federalism implications, as set forth in E.O. 13132.
Claims, Dental health, Health care, Health insurance, Individuals with disabilities, Military personnel.
Accordingly, DoD amends 32 CFR part 199 as follows:
5 U.S.C. 301; 10 U.S.C. chapter 55.
(b) * * *
(n) Third-party billing agents as defined in § 199.2(b) of this part, while not considered providers, are subject to the provisions of this section to the same extent as such provisions apply to providers.
Office of Vocational and Adult Education, Department of Education.
Final requirements, definitions, and selection criteria.
The Assistant Secretary for Vocational and Adult Education announces requirements, definitions, and selection criteria under the Native American Career and Technical Education Program (NACTEP). The Assistant Secretary may use these requirements, definitions, and selection criteria for a competition in fiscal year (FY) 2013 and possibly in later years. We take this action to notify all interested parties and eligible applicants in particular, of the requirements, definitions, and selection criteria that we may use in upcoming competitions under section 116 of the Carl D. Perkins Career and Technical Education Act of 2006 (the Act).
Gwen Washington, by telephone: (202) 245-7790, or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
We published a notice of proposed requirements, definitions, and selection criteria for this program in the
Analysis of Comments:
The commenter also requested that the Department not impose a page limit for applications in the next competition so as to allow applicants the greatest flexibility in their applications.
The commenter requested that we not impose application page limitations. We do not do so through these requirements, definitions, or selection criteria.
Therefore, we require that NACTEP programs meet all of the elements of the Act's definition of “career and technical education.” In addition, we require
By identifying these program elements in detail, we intend to clearly identify those programmatic elements that NACTEP applicants would be required to include and address in their applications and in their proposed projects, to fully reflect NACTEP program requirements of section 116 and, where appropriate, of the broader Act.
As to the commenter's second request for clarification, in addition to the elements we are requiring for all NACTEP-funded programs, we are requiring that NACTEP programs with CTE at the secondary level, provide individuals with coherent and rigorous academic curriculum aligned with challenging academic content standards and student academic achievement standards in reading or language arts and in mathematics that the State in which the applicant is located has established under the ESEA.
Based on the Act's definition of “career and technical education,”, we are requiring that all programs, activities, or services funded under NACTEP provide coherent sequences of courses including organized educational activities that include competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical skills, and occupation-specific skills, and knowledge of all aspects of an industry, including entrepreneurship, of an individual. Contrary to the commenter's conclusion on this point, our proposed requirement for competency-based applied learning referred broadly to authorized activities and included career and technical education activities at postsecondary level.
As to the commenter's third request for clarification, we did not define the term “special populations” in our November 20, 2012 Notice because this term is defined in the section 3(29) of the Act. As we indicated in the Notice, we did not intend to include in our November 20, 2012 Notice, nor were seeking public comment on, statutory requirements or definitions.
Note that we changed the introductory paragraph in section II of the requirements to more accurately reflect the definition of “career and technical education” in section 3(5) of the Act.
(a) The Assistant Secretary for Vocational and Adult Education announces that an eligible applicant (as determined by the Act) must include documentation in its application showing that it and, if appropriate, its consortium members, are eligible to apply.
(b) As defined in the Indian Self-Determination and Education Assistance Act (ISDEA) (25 U.S.C. 450b(l)), the term “tribal organization” means the recognized governing body of any Indian tribe; any legally established organization of Indians which is controlled, sanctioned, or chartered by such governing body or which is democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of Indians in all phases of its activities: provided, that in any case where a contract is let or grant made to an organization to perform services benefiting more than one Indian tribe, the approval of each such Indian tribe shall be a prerequisite to the letting or making of such contract or grant. In accordance with this statutory definition, any tribal organization proposing to provide NACTEP services for the benefit of more than one Indian tribe must first obtain the approval of each Indian tribe it proposes to serve and must submit documentation of such approval with its NACTEP application and that documentation of tribal approval is a prerequisite to the awarding of a NACTEP grant to any tribal organization proposing to serve more than one Indian tribe.
Consistent with the Act, the Assistant Secretary for Vocational and Adult Education announces the following requirements, to align NACTEP with other authorized programs that require recipients of funds under the Act to provide coherent and rigorous content aligned with challenging academic standards and improve career and technical education programs.
(a)
(1) Propose organized educational activities offering a sequence of courses that—
(i) Provide individuals with coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions;
(ii) Provide technical skill proficiency, an industry-recognized credential, a certificate, or an associate degree; and
(iii) Include competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills,
(2) Develop new programs, services, or activities or improve or expand existing programs, services, or activities that are consistent with the purposes of the Act. In other words, the Department will support “expansions” or “improvements” that include, but are not limited to, the expansion of effective programs or practices; upgrading of activities, equipment, or materials; increasing staff capacity; adoption of new technology; modification of curriculum; or implementation of new policies to improve program effectiveness and outcomes.
(3) Fund a career and technical education program, service, or activity that—
(i) Is a new program, service, or activity that was not provided by the applicant during the instructional term (a defined period, such as a semester, trimester, or quarter, within the academic year) that preceded the request for funding under NACTEP;
(ii) Will improve or expand an existing career and technical education program; or
(iii) Inherently improves career and technical education.
(a) Develops new career and technical education programs of study that will be approved by the appropriate accreditation agency;
(b) Strengthens the rigor of the academic and career and technical components of funded programs;
(c) Uses curriculum that is aligned with industry-recognized standards and will result in students attaining industry-recognized credentials, certificates, or degrees;
(d) Integrates academics (other than remedial courses) with career and technical education programs through a coherent sequence of courses to ensure learning in the core academic and career and technical subjects;
(e) Links career and technical education at the secondary level with career and technical education at the postsecondary level and facilitates students' pursuit of a baccalaureate degree;
(f) Expands the scope, depth, and relevance of curriculum, especially content that provides students with a comprehensive understanding of all aspects of an industry and a variety of hands-on, job-specific experiences; and
(g) Offers—
(1) Work-related experience, internships, cooperative education, school-based enterprises, entrepreneurship, community service learning, and job shadowing that are related to career and technical education programs;
(2) Coaching/mentoring, support services, and extra help for students after school, on weekends and/or during the summers, so they can meet higher standards;
(3) Career guidance and academic counseling for students participating in career and technical education programs;
(4) Placement services for students who have successfully completed career and technical education programs and attained a technical skill proficiency that is aligned with industry-recognized standards;
(5) Professional development programs for teachers, counselors, and administrators;
(6) Strong partnerships among grantees and local educational agencies, postsecondary institutions, community leaders, adult education providers, and, as appropriate, other entities, such as employers, labor organizations, parents, and local partnerships, to enable students to achieve State academic standards and career and technical skills;
(7) The use of student assessment and evaluation data to improve continually instruction and staff development with the goal of increasing student achievement in career and technical education programs; or
(8) Research, development, demonstration, dissemination, evaluation and assessment, capacity-building, and technical assistance, related to career and technical education programs.
(b)
(1) To be eligible for a stipend a student must—
(i) Be enrolled in a career and technical education project funded under this program;
(ii) Be in regular attendance in a NACTEP project and meet the training institution's attendance requirement;
(iii) Maintain satisfactory progress in his or her program of study according to the training institution's published standards for satisfactory progress; and
(iv) Have an acute economic need that—
(A) Prevents participation in a project funded under this program without a stipend; and
(B) Cannot be met through a work-study program.
(2) The amount of a stipend is the greater of either the minimum hourly wage prescribed by State or local law or the minimum hourly wage established under the Fair Labor Standards Act.
(3) A grantee may only award a stipend if the stipend combined with other resources the student receives does not exceed the student's financial need. A student's financial need is the difference between the student's cost of attendance and the financial aid or other resources available to defray the student's cost of participating in a NACTEP project.
(4) To calculate the amount of a student's stipend, a grantee would multiply the number of hours a student actually attends career and technical education instruction by the amount of the minimum hourly wage that is prescribed by State or local law, or by the minimum hourly wage that is established under the Fair Labor Standards Act.
In accordance with applicable Department statutory requirements and administrative regulations, grantees must maintain records that fully support their decisions to award stipends and the amounts that are paid, such as proof of a student's enrollment in a NACTEP project, stipend applications, timesheets showing the number of attendance hours confirmed in writing by an instructor, student financial status information, and evidence that a student would not be able to participate in the
(5) An eligible student may receive a stipend when taking a course for the first time. However, generally a stipend may not be provided to a student who has already taken, completed, and had the opportunity to benefit from a course and is merely repeating the course.
(6) An applicant must include in its application the procedure it intends to use to determine student eligibility for stipends and stipend amounts, and its oversight procedures for the awarding and payment of stipends.
(c)
(1) The recipient of the direct assistance is an individual who is a member of a special population and who is participating in the grantee's NACTEP project.
(2) The direct assistance is needed to address barriers to the individual's successful participation in that project.
(3) The direct assistance is part of a broader, more generally focused program or activity to address the needs of an individual who is a member of a special population.
Direct assistance to individuals who are members of special populations is not, by itself, a “program or activity for special populations.”
(4) The grant funds used for direct assistance must be expended to supplement, and not supplant, assistance that is otherwise available from non-Federal sources. (20 U.S.C. 2391(a)) For example, generally, a postsecondary educational institution could not use NACTEP funds to provide child care for single parents if non-Federal funds previously were made available for this purpose, or if non-Federal funds are used to provide child care services for single parents participating in non-career and technical education programs and these services otherwise would have been available to career and technical education students in the absence of NACTEP funds.
(5) In determining how much of the NACTEP grant funds it will use for direct assistance to an eligible student, a grantee must consider whether the specific services to be provided are a reasonable and necessary cost of providing career and technical education programs for special populations. However, the Assistant Secretary does not envision a circumstance in which it would be a reasonable and necessary expenditure of NACTEP project funds for a grantee to use a majority of a project's budget to pay direct assistance to students, in lieu of providing the students served by the project with career and technical education.
(a)
(b)
(1) Be appropriate for the project and be both formative and summative in nature;
(2) Include—
(i) Applicable performance measures for NACTEP;
(ii) Qualitative and quantitative data with respect to—
(A) Academic and career and technical competencies demonstrated by the participants and the number and kinds of academic and work credentials acquired by individuals, including participation in programs providing skill proficiency assessments, industry certifications, or training at the associate degree level that is articulated with an advanced degree option;
(B) Enrollment, completion, and placement of participants by gender for each occupation for which training was provided;
(C) Job or work skill attainment or enhancement, including participation in apprenticeship and work-based learning programs, and student progress in achieving technical skill proficiencies necessary to obtain employment in the field for which the student has been prepared, including attainment or enhancement of technical skills in the industry the student is preparing to enter;
(D) Activities during the formative stages of the project to help guide and improve the project, as well as a summative evaluation that includes recommendations for disseminating information on project activities and results;
(E) The number and percentage of students who obtained industry-recognized credentials, certificates, or degrees;
(F) If available, the outcomes of students' technical assessments, by type and scores; and
(G) The rates of attainment of a proficiency credential or certificate, in conjunction with a secondary school diploma.
(3) Measure the effectiveness of the project, including—
(i) A comparison between the intended and observed results; and
(ii) A demonstration of a clear link between the observed results and the specific treatment given to project participants;
(4) Measure the extent to which information about or resulting from the project was disseminated at other sites, such as through the grantee's development and use of guides or manuals that provide step-by-step directions for practitioners to follow when initiating similar efforts; and
(5) Measure the long-term impact of the project, such as, follow-up data on students' employment, sustained employment, promotions, and further/continuing education or training, or the impact the project had on tribal economic development or career and technical education activities offered by tribes.
The Assistant Secretary for Vocational and Adult Education announces the following definitions for program terms not defined in the Act, by cross-references in the Act to other Federal statutes, or in the Education Department General Administrative Regulations:
The Assistant Secretary for Vocational and Adult Education announces the following selection criteria for evaluating an application under this program. We may apply one or more of these criteria in any year in which this program is in effect. We will announce the maximum possible points assigned to each criterion in the notice inviting applications, in the application package, or both.
(a)
(b)
(1) The potential contribution of the proposed project toward increasing the understanding of educational needs, issues, or strategies for providing career and technical education to American Indians and Alaska Natives.
(2) The likelihood that the proposed project will result in system change or improvement in the applicant's educational program as evidenced by the types of training and activities identified in the project application.
(3) The extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the career and technical needs of the target population.
(c)
(1) The extent to which goals, objectives, and outcomes are clearly specified and measurable (e.g., identification of the requirements for each course of study to be provided under the project, the technical skill proficiencies to be taught and the industry-recognized standards or competency assessments to be used, including related training areas and a description of the industry certifications, credentials, certificates, or degrees that students may earn; expected enrollments, completions, and student placements in jobs, military specialties, and continuing education/training opportunities in each career training area; the number of teachers, counselors, and administrators to be trained).
(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs, as evidenced by the applicant's description of programs and activities that align with the target population's needs.
(3) The extent to which the design for implementing and evaluating the proposed project plans for and is likely to result in the development of information that will guide possible dissemination of information on project practices, activities, or strategies, including information about the effectiveness of the approach or strategies employed by the project, planned dissemination activities, the kind of practices, activities, or strategies to be disseminated, the target audience for the dissemination of such practices, activities, or strategies, and the proposed uses for such disseminated practices, activities, or strategies.
(4) The extent to which the proposed project will establish linkages with or will be coordinated with similar or related efforts, and with community, State, or Federal resources, where such opportunities and resources exist.
(d)
(1) The extent to which the training or professional development services to be provided by the proposed project would be of sufficient quality, intensity, and duration to lead to improvements in practice among the project staff and instructors, including the extent to which the proposed training and professional development plans address ways in which learning gaps will be addressed and how continuous review of performance will be conducted to identify training needs.
(2) The extent to which the services to be provided by the proposed project will create opportunities for students to receive an industry-recognized credential; become employed in high-skill, high-wage, and high-demand occupations; or both.
(3) The extent to which the services proposed in the project will create opportunities for students to acquire technical skill proficiencies, industry certifications, or the skills identified by State or industry-recognized career and technical education programs or professions. In describing the services, there must be a clear link between the services and the skill proficiencies, industry certifications, credentials, certificates, or degrees that students may earn.
(e)
(1) The extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability.
(2) The qualifications, including relevant training, expertise, and experience, of the project director, key personnel, and project consultants.
(3) The extent to which the project will use instructors who are certified to teach in the field in which they will provide instruction.
(f)
(1) The adequacy of support, including facilities, equipment, supplies, and other resources, from the applicant organization(s) and the tribal entity or entities to be served.
(2) The extent to which the budget is adequate and costs are reasonable in relation to the objectives of the proposed project.
(3) The relevance and demonstrated commitment (e.g., through written career and technical education agreements, memoranda of understanding, letters of support and commitment, or commitments to employ project participants, as appropriate) of the applicant, members of the consortium, local employers, or tribal entities to be served by the project.
(4) The potential for continued support of the project after Federal funding ends.
(g)
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and the milestones and performance standards for accomplishing project tasks.
(2) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.
(3) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project.
(h)
(1) The extent to which the methods of evaluation proposed by the grantee are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project.
(2) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and the Government Performance and Results Act of 1993 (GPRA) performance measures, and will produce quantitative and qualitative data, to the extent possible.
(3) The extent to which the methods of the evaluation include processes that consider the validity and integrity of data collection and analysis; accessibility of appropriate and timely data; accurate descriptions of performance; collection processes that yield unbiased, unprejudiced, and impartial data results; and the extent to which representation of the data clearly communicates an accurate picture of performance.
(4) The extent to which the methods of evaluation will provide performance feedback and continuous improvement toward achieving intended outcomes.
(5) The quality of the evaluation to be conducted by an external evaluator with the necessary background and technical expertise to carry out the evaluation.
In accordance with the requirement in section 116(e) of the Act, we have included the following additional selection factors and will award additional points to any application addressing the following factors, as indicated.
We will award—
(a) Up to 10 additional points to applications that propose exemplary approaches that involve, coordinate with, or encourage tribal economic development plans; and
(b) Five points to applications from tribally controlled colleges or universities that—
(1) Are accredited or are candidates for accreditation by a nationally recognized accreditation organization as an institution of postsecondary career and technical education; or
(2) Operate career and technical education programs that are accredited or are candidates for accreditation by a nationally recognized accreditation organization and issue certificates for completion of career and technical education programs (20 U.S.C. 2326(e)).
This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.
This notice does
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing these final requirements, definitions, and selection criteria only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action does not unduly interfere with tribal governments in the exercise of their governmental functions.
In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
You may also access documents of the Department published in the
Environmental Protection Agency (EPA).
Final rule.
The EPA is finding that seven states have not made complete state implementation plan (SIP) submissions to address certain SIP elements, as required by the Clean Air Act (CAA). Specifically, the EPA is determining that these seven states have not submitted complete SIPs that provide the basic CAA program elements necessary to implement the 2008 lead national ambient air quality standards (NAAQS). The EPA refers to these SIP submissions as “infrastructure” SIPs. Of the seven states, three are incomplete only due to prevention of significant deterioration (PSD)-related elements, for which a federal implementation plan (FIP) is in place. The remaining 43 states have made complete submissions. Each finding of failure to submit establishes a 24-month deadline for the EPA to promulgate FIPs to address the outstanding SIP elements unless prior to the EPA promulgating a FIP an affected state submits, and the EPA approves, a SIP that corrects the deficiency.
The effective date of this rule is March 28, 2013.
General questions concerning this notice should be addressed to Ms. Mia South: telephone (919) 541-5550, email
Section 553 of the Administrative Procedures Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this rule final without prior proposal and opportunity for comment because no significant EPA judgment is involved in making a finding of failure to submit SIPs, or elements of SIPs, required by the CAA, where states have made no submissions, or incomplete submissions, to meet the requirement. Thus, notice and public procedure are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).
For questions related to specific states mentioned in this notice, please contact the appropriate EPA Regional Office:
On October 15, 2008, the EPA promulgated revised NAAQS for lead.
The CAA section 110(a) imposes an obligation upon states to make a SIP submission with respect to the 2008 lead NAAQS. CAA section 110(a)(1) requires states to submit SIPs that provide for the implementation, maintenance and enforcement of a new or revised NAAQS within 3 years following the promulgation of the new or revised NAAQS. The EPA has not prescribed a shorter deadline; therefore, October 15, 2011, was the statutory deadline. Section 110(a)(2) lists specific requirements that states must meet in these SIP submissions, as applicable. The EPA refers to this type of SIP submission as the “infrastructure” SIP. The requirements for infrastructure SIPs include basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. The contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS necessarily affect the content of the submission. The content of such a SIP submission may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 2008 lead NAAQS, the EPA believes that many states have met many of the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with previous NAAQS.
Two elements identified in section 110(a)(2) are not governed by the 3-year submission deadline of section 110(a)(1) because SIPs incorporating necessary local nonattainment area requirements are not due within 3 years after promulgation of a new or revised NAAQS, but rather are due at the time the nonattainment area plan requirements are due pursuant to section 191.
The EPA is also not, in this notice, issuing any findings of failure to submit SIPs addressing section 110(a)(2)(D)(i)(I) of the CAA. The EPA has historically interpreted section 110(a)(1) of the CAA as establishing the required submittal date for SIPs addressing all of the “interstate transport” requirements in section 110(a)(2)(D) including the provisions in section 110(a)(2)(D)(i)(I) regarding significant contribution to nonattainment and interference with maintenance. The D.C. Circuit's recent opinion in
On September 24, 2012, litigants sued the EPA for failure to perform certain mandatory duties under the CAA, including a failure to find that the following states had failed to submit infrastructure SIPs for the 2008 lead NAAQS: Colorado, Hawaii, Illinois, Maryland, Massachusetts, New Jersey, Oklahoma, Oregon, Pennsylvania, South Dakota, Vermont and Washington.
After excluding SIP elements required by CAA sections 110(a)(2)(C) to the extent that subsection refers to a nonattainment area new source review permit program for major sources as required in part D of title I of the CAA, 110(a)(2)(I) regarding plans for nonattainment areas, and 110(a)(2)(D)(i)(I) regarding interstate transport affecting attainment and maintenance of the NAAQS, as explained above, the remaining elements that are relevant to this action are the requirements of CAA sections 110(a)(2)(A), (B), (C) (but not with respect to the permitting program required by CAA title I subpart D), (D)(i)(II), (D)(ii), (E)-(H) and (J)-(M).
For those states cited in this litigation that have not yet made an infrastructure SIP submittal and those states that have made a submittal that was not complete with respect to each relevant element of section 110(a)(2), as applicable, the EPA is making a finding of failure to submit. Four states have not made any submittal, and for these states the EPA is making a finding with respect to all of the relevant section 110(a)(2) SIP elements. Three states made a SIP submittal that was found complete with respect to all required elements except those elements that are related to PSD in sections 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J).
These findings establish a 24-month deadline for the promulgation by the EPA of a FIP, in accordance with section 110(c)(1) for those states for which the EPA is making a finding unless the EPA has approved a final SIP by that date. These findings of failure to submit do not impose sanctions, or set deadlines for imposing sanctions as described in section 179 of the CAA, because these findings do not pertain to the elements of a part D, title I plan for nonattainment areas as required under section 110(a)(2)(I), and because these states have not failed to make submissions in response to a SIP call pursuant to section 110(k)(5). Moreover, the EPA has already promulgated a FIP that
To summarize, the EPA is finding that seven states, as identified in section II of this notice, have not made a complete infrastructure SIP submission to meet certain requirements of section 110(a)(2) that are relevant to this action, as applicable, for the 2008 lead NAAQS. The EPA is committed to working with these states to expedite submissions as necessary, and to working with all the states to review and act on their infrastructure SIP submissions in accordance with the requirements of the CAA.
The EPA is making findings that certain states identified below have failed to submit a complete infrastructure SIP that provides certain basic program elements of section 110(a)(2) necessary to implement the 2008 lead NAAQS, by February 14, 2013. The EPA is establishing a 24-month deadline by which time the EPA must promulgate a FIP for each affected state to address the identified section 110(a)(2) requirements, unless the state submits and the EPA approves a SIP revision that corrects the deficiency before the EPA promulgates a FIP for the state, in accordance with section 110(c)(1). This action will be effective 30 days after publication, on March 28, 2013.
As of February 14, 2013, New Jersey, Oregon, Vermont and Washington failed to make a submittal to address the requirements of section 110(a)(2)(A), (B), (C) (but not with respect to the permitting program required by CAA title I subpart D), (D)(i)(II), (D)(ii), (E)-(H) and (J)-(M).
The effective date of this action starts a 24-month FIP clock for the EPA to approve a SIP for the affected states that addresses those requirements of section 110(a)(2), or for the EPA to finalize a FIP. The EPA notes that it has already promulgated FIPs to address PSD-related requirements for New Jersey and Washington and therefore this action will not trigger additional PSD FIP obligations for these states.
Hawaii, Illinois and Massachusetts made submittals as of February 14, 2013, that address all of the section 110(a)(2) requirements, with the exception of the PSD-related requirements in sections 110(a)(2)(C), (D)(i)(II), (D)(ii), and (J). The EPA notes that it has already promulgated a FIP to address PSD-related requirements for each of these states and therefore this action will not trigger any additional FIP obligations for these states.
This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under EO 12866 and 13563 (76 FR 3821, January 21, 2011).
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
Burden means the total time, effort or financial resources expended by persons to generate, maintain, retain or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. 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 the EPA's regulations in the CFR are listed in 40 CFR Part 9.
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 Procedures Act (APA) 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 the purpose of assessing the impacts of this final rule on small entities, small entity is defined as: (1) A small business that is a small industry entity as defined in the U.S. Small Business Administration (SBA) size standards
After considering the economic impacts of this final rule on small entities, I certify that this rule will not have a significant economic impact on a substantial number of small entities. This final rule will not impose any requirements on small entities. This action relates to the requirement in the CAA for states to submit SIPs under section 110(a) to satisfy certain infrastructure and general authority-related elements required under section 110(a)(2) of the CAA for the 2008 lead NAAQS. Section 110(a)(1) of the CAA requires that states submit SIPs that implement, maintain and enforce a new or revised NAAQS which satisfies the requirements of section 110(a)(2) within 3 years of promulgation of such standard, or such shorter period as the EPA may provide.
This action contains no federal mandate under the provisions of Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538 for state, local and tribal governments and the private sector. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. Therefore, this action is not subject to the requirements of section 202 and 205 of the UMRA.
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 action relates to the requirement in the CAA for states to submit SIPs under section 110(a) to satisfy certain infrastructure and general authority-related elements required under section 110(a)(2) of the CAA for the 2008 lead NAAQS. Section 110(a)(1) of the CAA requires that states submit SIPs that implement, maintain and enforce a new or revised NAAQS which satisfies the requirements of section 110(a)(2) within 3 years of promulgation of such standard, or such shorter period as the EPA may provide.
EO 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires the EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the EO to include regulations that have “substantial direct effects on the states, or the relationship between the national government and the states or on the distribution of power and responsibilities among the various levels of government.” This final rule 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 EO 13132. The CAA establishes the scheme whereby states take the lead in developing plans to meet the NAAQS. This rule will not modify the relationship of the states and the EPA for purposes of developing programs to implement the NAAQS. Thus, EO 13132 does not apply to this rule.
EO 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires the EPA to develop an accountable process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.” This final rule does not have tribal implications, as specified in EO 13175. This rule responds to the requirement in the CAA for states to submit SIPs under section 110(a) to satisfy certain elements required under section 110(a)(2) of the CAA for the 2008 lead NAAQS. Section 110(a)(1) of the CAA requires that states submit SIPs that provide for implementation, maintenance and enforcement of a new or revised NAAQS, and which satisfy the applicable requirements of section 110(a)(2), within 3 years of promulgation of such standard, or within such shorter period as the EPA may provide. No tribe is subject to the requirement to submit an implementation plan under section 110(a) within 3 years of promulgation of a new or revised NAAQS.
The EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it is not an action that concerns health or safety risks. This action is finding that certain states have failed to submit a complete SIP that provides certain basic program elements of section 110(a)(2) necessary to implement the 2008 lead NAAQS.
This rule is not a “significant energy action” as defined in EO 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (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.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note), directs the EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impracticable. VCS are technical standards (
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. The EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not directly affect the level of protection provided to human health or the environment. This notice is making a finding that certain states have failed to submit a complete SIP that provides certain basic program elements of section 110(a)(2) necessary to implement the 2008 lead NAAQS.
The Congressional Review Act, 5 U.S.C. 801
Section 307(b)(1) of the CAA indicates which federal Courts of Appeal have venue for petitions of review of final agency actions by the EPA under the CAA. This section provides, in part, that petitions for review must be filed in the Court of Appeals for the District of Columbia Circuit (i) when the agency action consists of “nationally applicable regulations promulgated, or final actions taken, by the Administrator,” or (ii) when such action is locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”
This final rule consisting of findings of failure to submit certain of the required infrastructure SIP provisions is “nationally applicable” within the meaning of section 307(b)(1). This rule affects seven states across the country that are located in five of the ten EPA Regions, five different federal circuits, and multiple time zones. In addition, the rule addresses a common core of knowledge and analysis involved in formulating the decision and a common interpretation of the requirements of 40 CFR 51 appendix V applied to determining the completeness of SIPs in states across the country.
This determination is appropriate because in the 1977 CAA Amendments that revised CAA section 307(b)(1), Congress noted that the Administrator's determination that an action is of “nationwide scope or effect” would be appropriate for any action that has “scope or effect beyond a single judicial circuit.” H.R. Rep. No. 95-294 at 323-324, reprinted in 1977 U.S.C.C.A.N. 1402-03. Here, the scope and effect of this action extends to the five judicial circuits that include the states across the country affected by this action. In these circumstances, section 307(b)(1) and its legislative history authorize the Administrator to find the rule to be of “nationwide scope or effect” and thus to indicate that venue for challenges lies in the D.C. Circuit. Accordingly, the EPA is determining that this is a rule of nationwide scope or effect. Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court ofAppeals for the District of Columbia Circuit within 60 days from the date final action is published in the
Approval and promulgation of implementation plans, Environmental protection, Administrative practice and procedures, Air pollution control, Incorporation by reference, Intergovernmental relations, and Reporting and recordkeeping requirements.
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact David Stearrett, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2953.
The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR Part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
Accordingly, 44 CFR Part 64 is amended as follows:
42 U.S.C. 4001
Federal Communications Commission.
Final rule; announcement of effective date.
This document announces the effective date of rules published in the
The amendment to 47 CFR 73.3526(e)(11)(iii) published in the
For additional information contact John Norton, 202-418-2120, Media Bureau, Policy Division.
In a Third Report and Order in Report and Order inMM Docket No. 00-167, FCC 04-103, published in the
Federal Communications Commission.
Final rule; clarification and announcement of effective dates.
The Federal Communications Commission published requirements related to Establishment of Class A TV Service and Cable Television Rate Regulation; Cost of Service Rules, which were determined to contain information collection requirements that were subject to OMB review. After further review, we have found OMB approval is not required. This document intends to provide clarification that these rules are effective and that it has been determined that these provisions are not subject to OMB review.
47 CFR 73.1545(e) and 47 CFR 76.922(i)(6)(i) and (i)(7) are effective February 26, 2013.
John Norton, 202-418-2120, Media Bureau, Policy Division.
The Commission published documents in the
The following regulations are no longer pending OMB approval for the sections listed:73.1545(e)-66 FR 21681, May 1, 200176.922(i)(6)(i) and (i)(7)-61 FR 9367, March 8, 1996.
Office of Energy Efficiency and Renewable Energy, DOE.
Notice of proposed rulemaking and announcement of public meeting.
The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential water heaters. EPCA also requires the U.S. Department of Energy (DOE) to determine whether more stringent amended standards would be technologically feasible and economically justified, and would save a significant amount of energy. Accordingly, DOE established amended energy conservation standards for several classes of residential water heaters in an April 2010 final rule. Subsequent to the publication of that final rule, a number of utility companies brought forth concerns regarding the amended energy conservation standard levels for electric storage water heaters and the impact of these standards on electric thermal storage programs that utility companies administer to manage peak load. In this document, DOE proposes to establish a waiver process that will mitigate the concerns of utility companies regarding the implementation of the April 2010 standard levels by allowing for the manufacture of certain large-volume electric storage water heaters provided that they meet a set of conditions discussed in this proposed rule. The document also announces a public meeting to receive comment on the proposed waiver process and criteria for obtaining a waiver.
The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585. To attend, please notify Ms. Brenda Edwards at (202) 586-2945. For more information, refer to section 0, “Public Participation.”
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
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2.
3.
4.
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to Office of Energy Efficiency and Renewable Energy through the methods listed above and by email to
Ms. Ashley Armstrong, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies, EE-2J, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-6590. Email:
Mr. Ari Altman, U.S. Department of Energy, Office of the General Counsel, GC-71, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 287-6307. Email:
DOE believes that electric thermal storage (ETS) programs involving water heaters provide numerous benefits to consumers, utilities, and the Nation, and that an alternative approach to energy conservation standards for certain, limited electric water heaters appears to be warranted in order to ensure the viability of these programs. After considering several options, DOE determined that a waiver process is the most appropriate, and thus, is proposing to adopt such a process in this notice of proposed rulemaking (NPRM). The proposed process would allow any manufacturer of electric water heaters, any electric utility company, or a combination of the two, to request a waiver granting exemption from the energy conservation standards established in an April 16, 2010 final rule (75 FR 20112; referred to hereinafter as the “April 2010 final rule”) for certain electric water heaters with rated storage volumes greater than 55 gallons. Each waiver granted by the U.S. Department of Energy (DOE), would allow, for a one-year period, manufacturers to produce limited numbers of electric water heaters with rated storage volumes above 55 gallons exclusively for the purpose of installation in residences enrolled in a specific utility company ETS program. Parties would be allowed to apply for additional one-year waivers in subsequent years. This proposed rule, if adopted, or the granting of a waiver under this rule, would not amend the energy conservation standard otherwise applicable to electric water heaters with rated storage volumes above 55 gallons.
The following sections include: (1) A description of DOE's statutory authority for setting energy conservation standards for residential water heaters; (2) a discussion of the standards promulgated in the April 2010 final rule and concerns of utility companies regarding those standards; (3) a summary of the comments received in response to DOE's June 13, 2012 request for information (RFI) on this topic (77 FR 35299; hereinafter referred to as the “June 2012 RFI”) and DOE's responses to those comments, including a discussion of the appropriate mechanism to address the concerns of utility companies; and (4) a description of the waiver process that DOE proposes to establish.
The following section briefly discusses the statutory authority underlying DOE's standards for residential water heaters and this NPRM, as well as some of the relevant historical background regarding the establishment of standards for residential water heaters.
Title III, Part B
Under EPCA, this program generally consists of four parts: (1) Testing; (2) labeling; (3) establishing Federal energy conservation standards; and (4) certification and enforcement procedures. The Federal Trade Commission (FTC) is primarily responsible for labeling consumer products, and DOE implements the remainder of the program. Subject to certain criteria and conditions, DOE is required to develop test procedures to measure the energy efficiency, energy use, or estimated annual operating cost of each covered product. (42 U.S.C. 6293) Manufacturers of covered products must use the prescribed DOE test procedure as the basis for certifying to DOE that their products comply with the applicable energy conservation standards adopted under EPCA and when making representations to the public regarding the energy use or efficiency of those products. (42 U.S.C. 6293(c) and 6295(s)) Similarly, DOE must use these test procedures to determine whether the products comply with standards adopted pursuant to EPCA.
EPCA, as codified, contains what is known as an “anti-backsliding” provision, which prevents the Secretary from prescribing any amended standard that either increases the maximum allowable energy use or decreases the minimum required energy efficiency of a covered product. (42 U.S.C. 6295(o)(1)) Also, the Secretary may not prescribe an amended or new standard if interested persons have established by a preponderance of the evidence that the standard is likely to result in the unavailability in the United States of any covered product type (or class) of performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States. (42 U.S.C. 6295(o)(4)).
Before being amended by the National Appliance Energy Conservation Act of 1987 (NAECA; Pub. L. 100-12), Title III of EPCA included residential water heaters as covered products. NAECA's amendments to EPCA established energy conservation standards for
The energy conservation standards for residential water heaters in the April 2010 Final Rule will apply to products manufactured on or after April 16, 2015. 75 FR 20112. The amended energy conservation standards consist of minimum energy factors
Subsequent to the publication of the April 2010 Final Rule, several stakeholders (
As shown in Table II.1 and noted above, the April 2010 Final Rule established an energy conservation standard that would effectively require the use of heat pump technology to meet the minimum energy conservation standard for large-volume electric storage water heaters. Utility companies presented concerns about the feasibility of continuing ETS programs without the use of large-volume electric resistance water heaters (ERWHs). Utilities believe the practicability of heat pump water heaters (HPWHs) are such that HPWHs may not be able to fill the same role as large-volume ERWHs in ETS programs. (The capability of HPWHs or multiple small-volume (
To seek feedback from interested parties related to the issues raised by utility companies, DOE published the June 2012 RFI. 77 FR 35299, June 13, 2012. The RFI described utility ETS programs for water heaters and the utility's concerns over the amended standard levels for electric storage water heaters with storage volumes above 55 gallons, and sought comment on these topics as well as a number of related issues. Specifically, DOE requested comment on (1) the penetration of ETS programs and the impacts of such programs on consumers and the Nation; (2) the impacts of the April 2010 standard levels on utility ETS programs; (3) information on any feature or features for residential water heaters used in ETS programs that are unique to those water heaters and whether such feature(s) would justify a separate standard from other residential water heaters; and (4) information on potential solutions that would resolve the concerns of utilities that administer ETS programs for residential water heaters and require the use of large-volume electric storage water heaters, including several potential approaches identified in the RFI. 77 FR 35304.
DOE received 127
As noted, DOE received 127 unique comments in response to the June 2012 RFI. The comments focused on four main issues: (1) whether DOE should take action to address the utility company concerns and the benefits of ETS programs; (2) the technological capability of alternatives to large-volume ERWHs to be utilized in ETS programs; (3) the potential for implementing a waiver program to allow the manufacture of certain water heaters specifically for use in ETS programs; and 4) the potential for implementing a separate product class for water heaters used in ETS programs (
Of the 127 comments received by DOE, 120 recommended that DOE should take some action to mitigate the issue that the April 2010 standard would potentially cause for utility ETS programs. (See section 2 for a brief description of the utility concerns.) (Buckeye Power, Inc. (Buckeye), No. 3 at p. 1; Codington-Clark Electric Cooperative (Codington-Clark), No. 4 at pp. 1-3; Rappahannock Electric Cooperative (Rappahannock), No. 5 at pp. 1-3; Northern Plains Electric Cooperative (Northern Plains), No. 6 at p. 1; Itasca-Mantrap Cooperative Electrical Association (Itasca-Mantrap), No. 7 at pp. 1-2; Northwest Iowa Power Cooperative (Northwest Iowa Power), No. 8 at p. 1; PowerSouth Energy Cooperative (Powersouth), No. 10 at pp. 1-3; Barron Electric Cooperative (Barron), No. 11 at p. 2; Clark Electric Cooperative (Clark), No. 13 at p. 1; Woodbury County Rural Electric Cooperative (Woodbury), No. 14 at p. 1; North West Rural Electric Cooperative (North West), No. 15 at p. 1; Bayfield Electric Cooperative (Bayfield), No. 16 at p. 2; Union County Electric Cooperative (Union County), Inc., No. 17 at p. 1; Allamakee-Clayton Electric Cooperative (Allamakee-Clayton), No. 18 at p. 1; Lower Valley Energy, No. 19 at p. 1; AO Smith, No. 20 at p. 1; Wabash Valley Power (Wabash), No. 21 at p. 1; Heartland Power Cooperative (Heartland), No. 22 at p. 1; South Central Electric Association (South Central), No. 23 at p. 1; Cass County Electric Cooperative (Cass County), No. 24 at p. 1; East River Electric Power Cooperative (East River), No. 25 at p. 1;
The Northwest Advocates stated that action should be taken, but only if analysis concludes that the net benefits of resistance-only water heaters including load shifting and ancillary service benefits are greater than those of HPWHs. (Northwest Advocates, No. 89 at p. 2)
Only two commenters—one manufacturer, General Electric (GE), and one utility company, Farmers Electric Cooperative—recommended that DOE take no action to address the utility company concerns regarding the April 2010 final rule energy conservation standard for large-volume electric water heaters. (GE, No. 85 at pp. 1-4; Farmers Electric Cooperative, No. 2 at p. 1) Farmers Electric Cooperative cited the considerable energy conservation benefits and cost savings to consumers from heat pump water heaters as a reason for supporting the April 2010 standard. Farmers Electric Cooperative emphasized that HPWHs reduce electricity demand up to three times. GE argued that viable alternatives are available (including heat pump water heaters) to meet the needs of ETS programs (see additional discussion of alternatives in section 0 below). GE also stated that there is no basis for creating a new product class for grid interactive water heaters and that doing so would impede the development of the market for HPWHs (see additional discussion of the potential for a new product class in section 3). GE contended that such an approach would also create a loophole that would erase some of the consumer and national benefits achieved by the April 2010 standards, which would be contrary to DOE's goals. (GE, No. 85 at p. 2)
EPRI took no position on whether DOE should take action, but rather noted that large-volume grid interactive
The majority of the comments received in support of DOE action described the benefits of ETS programs for consumers, utilities, and the Nation as the main reason that DOE should take action to preserve utility ETS programs. Generally these commenters believe that DOE should take some action (generally either establishing a new product class or establishing a waiver program) to preserve the ability of manufacturers to produce and utility companies to use large-volume electric resistance storage water heaters. These stakeholders supported action due to the considerable benefits that they believe ETS programs provide to consumers, utilities and the electric grid, and due to the perceived lack of alternative products capable of meeting the needs of ETS programs for electric water heaters. In total, the utility respondents indicated that they realize a combined peak load reduction of approximately 145 MW,
The joint utility commenters cited a survey conducted by NRECA of its cooperatively owned utility members which found that the average bill credit for participating customers per water heater is $58 a year. In addition to the bill credit, customers are often eligible to receive an upfront rebate to offset a portion of the purchase cost of certain eligible types of electric water heaters when the customer agrees to participate in the direct load control program. The average rebate among survey respondents that also offered the bill credits is $230. (Joint Utilities, No. 58 at p. 8)
Through ETS programs for electric water heaters, utilities can require customers to heat and store hot water in times when overall electric demand and power-supply costs are low, thus lowering peak demand when costs are highest. Utilities contended that eliminating large volume electric resistance water heaters would reduce or eliminate ETS programs and would in turn result in higher electricity prices to consumers. (Buckeye, No. 3 at p. 2; Codington-Clark, No. 4 at p. 2; Rappahannock, No. 5 at p. 1; Itasca-Mantrap, No. 7 at p. 1; Northwest Iowa Power, No. 8 at p. 1; PowerSouth, No. 10 at p. 1; Barron, No. 11 at p. 1; Clark, No. 13 at p. 1; Woodbury, No. 14 at p. 2; North West, No. 15 at p. 1; Bayfield, No. 16 at p. 2; Union County, No. 17 at p. 1; Allamakee-Clayton, No. 18 at p. 1; Lower Valley Energy, No. 19 at p. 2; AO Smith, No. 20 at p. 1; Wabash, No. 21 at pp.1-2; Heartland, No. 22 at p. 1; South Central, No. 23 at p. 2; Cass County, No. 24 at p. 1; East River, No. 25 at p. 1; Richland, No. 26 at p. 3; Lyon-Lincoln Electric Cooperative, No. 27 at pp. 1-3; Central, No. 28 at p. 1; Tri-County, No. 29 at p. 1; Price, No. 30 at pp. 1-2; Bristol, No. 31 at p. 2; FEM, No. 32 at p. 1; BEC, No. 33 at p. 1; Powell Valley, No. 34 at p. 2; Humboldt, No. 35 at p. 1; Dakota Electric, No. 36 at p. 1; Nishnabotna Valley REC, No. 37 at p. 1; Corn Belt, No. 39 at p. 1; Clay-Union, No. 40 at p. 1; Great River, No. 41 at p. 1; Central Georgia EMC, No. 42 at p. 1; Otter Tail, No. 44 at p. 1; ECSC, No. 45 at p. 1; Aiken, No. 46 at p. 1; Connexus, No. 47 at p. 1; Dairyland, No. 48 at p. 1; Pee Dee, No. 49 at p. 1; Oconto, No. 50 at p. 1; Wright-Hennepin, No. 51 at p. 1; Midland, No. 52 at p. 1; Lynches, No. 53 at p. 1; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 1; Palmetto, No. 56 at p. 1; Horry, No. 57 at p. 1; Joint Utility Commenters, No. 58 at p. 4; Fairfield, No. 59 at p. 1; Tri-State, No. 61 at p. 1; Santee, No. 62 at p. 1; Newberry, No. 64 at p. 1; People's Energy, No. 66 at p. 2; MECA, No. 67 at p. 1; Eau Claire, No. 69 at p. 2; Edisto, No. 70 at p. 1; Coastal, No. 71 at p. 1; York, No. 73 at p. 1; Black River, No. 76 at p. 1; MCEC, No. 77 at p. 1; Prairie, No. 78 at p. 1; Blue Ridge, No. 82 at p. 1; Freeborn-Mower, No. 83 at p. 2; APPA, No. 84 at p. 3; Nebraska Public Power, No. 88 at p. 1; Clark Public Utilities, No. 90 at p. 1; NOVEC, No. 91 at p. 1; Black Hills, No. 96 at p. 1;
Many utilities stated that ETS water heating programs have become a popular low-cost option for their members who do not have access to natural gas, as it allows them to heat water using electricity at lower cost. (Itasca-Mantrap, No. 7 at p. 2; Northwest Iowa Power, No. 8 at p. 2; Barron, No. 11 at p. 1; Clark, No. 13 at p. 2; Woodbury, No. 14 at p. 2; North West, No. 15 at p. 1; Bayfield, No. 16 at p. 2; Cass County, No. 24 at p. 2. Price, No. 30 at p. 2; Dakota Electric, No. 36 at p. 5; Nishnabotna Valley REC, No. 37 at p. 2; Great River, No. 41 at p. 2; Otter Tail, No. 44 at p. 2; Dairyland, No. 48 at p. 2; Wright-Hennepin, No. 51 at p. 2; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 2; People's Energy, No. 66 at p. 2; Eau Claire, No. 69 at p. 1; Freeborn-Mower, No. 83 at p. 2; Minnesota Rural, No. 99 at p. 1; Minnesota Valley, No. 101 at p. 1; McLeod, No. 102 at p. 1; Riverland, No. 111 at p. 2; Meeker, No. 112 at p. 2; Federated, No. 113 at p. 2; Lake Region, No. 120 at p. 1; Goodhue, No. 130 at p. 1; Stearns, No. 134 at p. 1; Kandiyohi, No. 138 at p. 1)
Some utilities also stated that their ETS programs provide energy savings benefits because they serve as a tool to educate their members to help them understand and participate in programs that save energy and money for all members. (Union County, No. 17 at p. 1; Humboldt, No. 35 at p. 1; Dakota Electric, No. 36 at p. 2; Corn Belt, No. 39 at p. 2; Oconto, No. 50 at p. 2; Lake Country, No. 108 at p. 1; Jackson County, No. 126 at p. 2; Duck River, No. 127 at p. 2) Utilities stated that their ETS programs promote energy conservation because the amount of energy used for domestic hot water needs is determined more by the amount of water used than by the efficiency of the water heater, and customers who know they have limits on their hot water capacity tend to conserve hot water. (Rappahannock, No. 5 at p. 2; Northwest Iowa Power, No. 8 at p. 2; Woodbury, No. 14 at p. 2; North West, No. 15 at p. 1; Dakota Electric, No. 36 at p. 2; Nishnabotna Valley REC, No. 37 at p. 2;Otter Tail, No. 44 at p. 3; Dairyland, No. 48 at p. 6, Minnesota Valley, No. 101 at p. 2; McLeod, No. 102 at p. 2; Meeker, No. 112 at p. 1; South Central Indiana REC, No. 117 at p. 1; Lake Region, No. 120 at p. 2; Goodhue, No. 130 at p. 1; Stearns, No. 134 at p. 2; Kandiyohi, No. 138 at p. 2; Aurelia, No. 151 at p. 2)
Dairyland commented that studies indicate that participation in certain demand response programs can also result in an energy conservation effect. Specifically, Dairyland cited a 2005 study
Utilities also described how the utilities themselves benefit from an increased ability to manage peak load. Many utility companies indicated that the reduction or elimination of ETS programs would force utilities to spend more money on meeting increased peak generation needs. (Rappahannock, No. 5 at p. 2; PowerSouth, No. 10 at p. 1; Clark, No. 13 at p. 2; Bayfield, No. 16 at p. 2; Union County, No. 17 at p. 3; Lower Valley Energy, No. 19 at p. 2; Wabash, No. 21 at p. 2; Heartland, No. 22 at p. 2; Cass County, No. 24 at p. 3; East River, No. 25 at p. 1; Central, No. 28 at p. 2; Tri-County, No. 29 at p. 2; Price, No. 30 at p. 2; Bristol, No. 31 at p. 2; FEM, No. 32 at p. 2; BEC, No. 33 at p. 2; Central Georgia EMC, No. 42 at p. 2; ECSC, No. 45 at p. 2; Aiken, No. 46 at p. 2; Dairyland, No. 48 at pp. 2-3; Oconto, No. 50 at p. 2; Wright-Hennepin, No. 51 at p. 2; Lynches, No. 53 at p. 2; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 2; Palmetto, No. 56 at p. 2; Horry, No. 57 at p. 1; Fairfield, No. 59 at p. 2; Tri-State, No. 61 at p. 5; Santee, No. 62 at p. 2; Newberry, No. 64 at p. 2; People's Energy, No. 66 at p. 2; Eau Claire, No. 69 at p. 2; Edisto, No. 70 at p. 2; Coastal, No. 71 at p. 2; York, No. 73 at p. 2; Black River, No. 76 at p. 2; MCEC, No. 77 at p. 2; Blue Ridge, No. 82 at p. 2; Freeborn-Mower, No. 83 at p. 2; APPA, No. 84 at p. 2; Clark Public Utilities, No. 90 at p. 1; Mountain Electric, No. 109 at p. 1; Tri-County Electric, No. 118 at p. 2; Sioux Valley, No. 123 at p. 2; East Central, No. 124 at p. 1; Jackson County, No. 126 at p. 2; Habersham, No. 146 at p. 1; Flint, No. 147 at p. 3)
A number of utility companies also argued that ETS programs benefit the electric grid by improving reliability and reducing system losses. Commenters stated that these effects are the result of improved utilization of the generation and transmission system infrastructure and improved system load factors. (Buckeye, No. 3 at pp. 1-3; Codington-Clark, No. 4 at p. 1; Itasca-Mantrap, No. 7 at p. 1; PowerSouth, No. 10 at p. 2; Union County, No. 17 at p. 3; Allamakee-Clayton, No. 18 at p. 2, Lower Valley Energy, No. 19 at p. 1-2; Wabash, No. 21 at p. 2; Heartland, No. 22 at p. 1; South Central, No. 23 at p. 1; Cass County, No. 24 at p. 2; East River, No. 25 at p. 2; Lyon-Lincoln, No. 27 at p. 1-2; Central, No. 28 at p. 1; Tri-County, No. 29 at p. 2; Bristol, No. 31 at p. 2; FEM, No. 32 at p. 1; BEC, No. 33 at p. 1; Powell Valley, No. 34 at p. 2; Dakota Electric, No. 36 at p. 3; Corn Belt, No. 39 at p. 2; Dairyland, No. 48 at p. 2; Clay-Union, No. 40 at p. 1; Great River, No. 41 at p. 1; No. 48 at p. 3; Central Georgia EMC, No. 42 at p. 1; Otter Tail, No. 44 at p. 2; ECSC, No. 45 at p. 1; Aiken, No. 46 at p. 1; Connexus, No. 47 at p. 2; Pee Dee, No. 49 at p. 1; Oconto, No. 50 at p. 2; Lynches, No. 53 at p. 1; Palmetto, No. 56 at p. 2; Horry, No. 57 at p. 1; Joint Utility Commenters, No. 58 at p. 17; Fairfield, No. 59 at p. 2; NEMA, No. 60 at p. 2; Tri-State, No. 61 at p. 5; Santee, No. 62 at p. 2; Newberry, No. 64 at p. 1; MECA, No. 67 at p. 1; Edisto, No. 70 at p. 1; Coastal, No. 71 at p. 1; York, No. 73 at p. 1; Black River, No. 76 at p. 1; MCEC, No. 77 at p. 2; Prairie, No. 78 at p. 1; ALP, No. 79 at p. 1; Blue Ridge, No. 82 at p. 2; NOVEC, No. 91 at p. 1; Wright-Hennepin, No. 51 at p. 2; Black Hills, No. 96 at p. 1; Verendrye, No. 97 at p. 1; Dakota Energy, No. 98 at p. 1; Lake Country, No. 108 at p. 1; Mountain
According to utility companies, the reduction in energy usage during peak times from ETS programs allows the utilities to increase utilization of more efficient generation facilities while simultaneously providing a method of integrating intermittent renewable energy sources into the electric grid. (Central Georgia EMC, No. 42 at p. 2; Codington-Clark, No. 4 at p. 2; Itasca-Mantrap, No. 7 at p. 1; Northwest Iowa Power, No. 8 at p. 2; Barron, No. 11 at p. 1; Clark, No. 13 at p. 1; Woodbury, No. 14 at p. 2; North West, No. 15 at p. 2; Bayfield, No. 16 at p. 1; Allamakee-Clayton, No. 18 at p. 2; Lower Valley Energy, No. 19 at p. 2; AO Smith, No. 20 at p. 1; Wabash, No. 21 at p. 2; South Central, No. 23 at p. 2; East River, No. 25 at p. 2; Richland, No. 26 at p. 3; Lyon-Lincoln Electric Cooperative, No. 27 at p. 2; Price, No. 30 at p. 1; BEC, No. 33 at p. 3; Humboldt, No. 35 at p. 1; Dakota Electric, No. 36 at p. 2; Nishnabotna Valley REC, No. 37 at p. 2; Great River, No. 41 at p. 3; Otter Tail, No. 44 at p. 3; Connexus, No. 47 at p. 1; Dairyland, No. 48 at p. 3; Midland, No. 52 at p. 2; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 2; Tri-State, No. 61 at p. 2; People's Energy, No. 66 at p. 2; MECA, No. 67 at p. 1; Eau Claire, No. 69 at p. 1; EPRI, No. 74 at p 2-4; Prairie, No. 78 at p. 2; Freeborn-Mower, No. 83 at p. 2; Nebraska Public Power, No. 88 at p. 1; Corn Belt, No. 39 at p. 2; Clay-Union, No. 40 at p. 2; Wright-Hennepin, No. 51 at p. 2; HTP, No. 87 at p. 1; NOVEC, No. 91 at p. 4; Black Hills, No. 96 at p. 2; Minnesota Rural, No. 99 at p. 1; Minnesota Valley, No. 101 at p. 1; McLeod, No. 102 at p. 1; Lake Country, No. 108 at p. 1; Riverland, No. 111 at p. 1; Meeker, No. 112 at p. 2; Federated, No. 113 at p. 2; Nobles, No. 119 at p. 1; Lake Region, No. 120 at p. 1; Congressman Dan Burton, No. 122 at p. 1; East Central, No. 124 at p. 2; Goodhue, No. 130 at p. 2; Stearns, No. 134 at p. 2; Senator John Thune, No. 137 at p. 1; Beltrami, No. 145 at p. 1; Habersham, No. 146 at p. 3; Aurelia, No. 151 at p. 2)
After considering the information presented by stakeholders regarding the benefits of ETS programs to consumers, utilities, and the Nation, DOE is persuaded by the information submitted by the utility companies given their expertise in administering demand response programs, regarding the benefits of ETS programs. DOE believes that the evidence presented indicates that these programs provide a number of valuable benefits to consumers, utilities, and the Nation. As a result, DOE agrees with the majority of commenters that action should be taken to mitigate the impacts of the April 2010 final rule standard levels on utility ETS programs in order to help preserve these benefits, if no practical alternatives exist to allow for the continuation of ETS programs in the absence of large-volume ERWHs. Accordingly, DOE considered whether practical alternatives exist that would allow the existing ETS programs to continue to be effective despite the potential unavailability of large volume ERWHs. DOE's consideration of this issue, as well as comments received, are discussed in section 0.
DOE recognizes that participants in ETS programs need more hot water storage capacity than they would require absent their participation in such programs. However, as noted in the June 2012 RFI, DOE believes that there are potential alternatives that may be able to provide a comparable amount of water storage capacity required for these programs. These potential alternatives include large-volume HPWHs and multiple (two or more) small-volume ERWHs. A number of stakeholders argued that heat pump water heaters and multiple small-volume water heaters are not well-suited for ETS programs and would not be a viable replacement for large-volume ERWHs in these applications. The points that the commenters raised are discussed below.
Many utility company commenters emphasized that managing a load control program is a balance of controlling load while maintaining customer satisfaction. Utilities stated that large volume ERWHs are required to ensure ETS program participants have enough hot water and remain satisfied with the program. These commenters asserted that smaller tanks reduce the amount of storage capacity and thus require more recharge time between control periods to ensure customers have enough hot water. Conversely, large capacity water heaters allow consumers to have enough hot water during control periods. (Buckeye, Inc. No. 3 at p. 1; Codington-Clark, No. 4 at p. 2; Northwest Iowa Power, No. 8 at p. 2; PowerSouth, No. 10 at p. 2; Barron, No. 11 at p. 1; Clark, No. 13 at p. 1; Woodbury, No. 14 at p. 1; North West, No. 15 at p. 2; Bayfield, No. 16 at p. 2; Union County, No. 17 at p. 1; South Central, No. 23 at p. 1; Cass County, No. 24 at p. 3; East River, No. 25 at p. 2; Richland, No. 26 at p. 1; Lyon-Lincoln Electric Cooperative, No. 27 at p. 2; Price, No. 30 at p. 1; Bristol, No. 31 at p. 2; FEM, No. 32 at p. 2; Nishnabotna Valley REC, No. 37 at p. 2; Corn Belt, No. 39 at pp. 2-3; Clay-Union, No. 40 at p. 2; Great River, No. 41 at p. 1; Central Georgia EMC, No. 42 at p. 2; Otter Tail, No. 44 at p. 2; Wright-Hennepin, No. 51 at p. 1; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 1; Horry, No. 57 at p. 2; Fairfield, No. 59 at p. 2; Tri-State, No. 61 at p. 3; People's Energy, No. 66 at p. 2; Eau Claire, No. 69 at p. 1; Prairie, No. 78 at p. 2; Freeborn-Mower, No. 83 at p. 2; Black Hills, No. 96 at p. 2; Riverland, No. 111 at p. 1; Meeker, No. 112 at p. 1; Tri-County Electric, No. 118 at p. 2; Nobles, No. 119 at p. 2; Sioux Valley, No. 123 at p. 2; East Central, No. 124 at p. 2; Jackson County, No. 126 at p. 1; Goodhue, No. 130 at p. 1;Aurelia, No. 151 at p. 2; United Electric, No. 153 at p. 2)
A number of parties stated that the heat pump unit is, by itself, incapable of heating water to the temperatures needed for ETS programs. (PowerSouth, No. 10 at p. 3; Barron, No. 11 at p. 2; Clark, No. 13 at p. 2; Bayfield, No. 16 at p. 2; Allamakee-Clayton, No. 18 at p. 2; A. O. Smith, No. 20 at p. 2; Richland, No. 26 at p. 3; Price, No. 30 at p. 2; Bristol, No. 31 at p. 1; Great River, No. 41 at p. 4; Dairyland, No. 48 at p. 4; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 2; Joint Utilities, No. 58 at p. 13; People's Energy, No. 66 at p. 2; Eau Claire, No. 69 at p. 2; Vaughn, No. 72 at p. 6; ALP, No. 79 at p. 1; Freeborn-Mower, No. 83 at p. 2; APPA, No. 84 at p. 2; Clark Public Utilities, No. 90 at p. 1; NOVEC, No. 91 at p. 4; Riverland, No. 111 at p. 2; Adams-Columbia, No. 132 at p. 2; Habersham, No. 146 at p. 3)
GE and the Northwest Advocates comment noted that using the electric resistance elements of an HPWH, it is possible to reach higher temperatures as
DOE believes that most HPWHs are technically capable of heating water to the temperatures needed for ETS programs, but would need to use the electric resistance elements in order to heat the tank to temperatures above the maximum temperature limits of current HPWH refrigerants. The need to use the electric resistance element would lower overall efficiency and reduce the energy and cost savings that would otherwise result from the use of a HPWH. DOE has not attempted to quantify such energy and cost savings differences in this NPRM, but could do so in evaluating specific waiver requests.
Several interested parties noted that use of HPWHs in ETS programs would lead to deterioration of the compressor due to frequent on/off cycling for demand response purposes, and the frequent on/off cycle would also reduce the efficiency of the HPWH. (PowerSouth, No. 10 at p. 3; Barron, No. 11 at p. 2; Clark, No. 13 at p. 2; Bayfield, No. 16 at p. 2; Allamakee-Clayton, No. 18 at p. 2; Richland, No. 26 at p. 3; Tri-Country, No. 29 at p. 2; Price, No. 30 at p. 2; Powell Valley, No. 34 at p. 3; Great River, No. 41 at p. 3; Dairyland, No. 48 at p. 4; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 2; Joint Utilities, No. 58 at p. 14; NEMA, No. 60 at p. 3; People's Energy, No. 66 at p. 2; Eau Claire, No. 69 at p. 2; EPRI, No. 74 at p. 3; ALP, No. 79 at p. 1; Freeborn-Mower, No. 83 at p. 2; APPA, No. 84 at p. 2; Clark Public Utilities, No. 90 at p. 1; NOVEC, No. 91 at p. 4; Riverland, No. 111 at p. 2; Federated, No. 113 at p. 2; Habersham, No. 146 at p. 3) EPRI stated that using variable speed compressors in HPWHs is a solution to the start-stop operation problem, but additional research is needed in order to understand whether this HPWH design can yield efficiency gains and emerge as a cost-effective solution for customers and the grid. (EPRI, No. 74 at p. 3)
DOE understands that while a HPWH might cycle frequently in some ETS applications, the minimum run times for existing HPWHs are sufficiently long (30 minutes) that on/off cycling is unlikely to lead to deterioration of the compressor. DOE agrees that variable speed compressors may be useful, but notes that the benefits of this technology have not yet been demonstrated and the cost of this option is still uncertain.
Several stakeholders stated that using a vapor-compression cycle to heat water increases operating time compared to electric resistance heating, so there would be a smaller time window for load reduction and less opportunity for load shifting. (Buckeye, No. 3 at p. 2; Codington-Clark, No. 4 at p. 2; Bayfield, No. 16 at p. 2; Union County, No. 17 at p. 3; A. O. Smith, No. 20 at p. 4; Cass County, No. 24 at p. 4; East River, No. 25 at p. 2; Richland, No. 26 at p. 3; Lyon-Lincoln, No. 27 at p. 2; Corn Belt, No. 39 at p. 3; Clay-Union, No. 40 at p. 2; Great River, No. 41 at p. 3; ECSC, No. 45 at p. 3; Dairyland, No. 48 at p. 4; Pee Dee, No. 49 at p. 2; Lynches, No. 53 at p. 3; Pierce Pepin, No. 54 at p. 2; Palmetto, No. 56 at p. 2; Joint Utilities, No. 58 at p. 16; Fairfield, No. 59 at p. 3; NEMA, No. 60 at p. 3; York, No. 73 at p. 4; EPRI, No. 74 at p. 4; Black River, No. 76 at p. 2; Prairie, No. 78 at p. 2; ALP, No. 79 at p. 1; Blue Ridge, No. 82 at p. 2; Freeborn-Mower, No. 83 at p. 2; APPA, No. 84 at p. 2; Clark Public Utilities, No. 90 at p. 1; NOVEC, No. 91 at p. 4; Nobles, No. 119 at p. 2; Adams-Columbia, No. 132 at p. 2; Habersham, No. 146 at p. 3; ECE, No. 124 at p. 2; FEM, No. 32 at p. 2; Iowa Lakes, No. 114 at p. 3; Aiken, No. 46 at p. 2; Itasca-Mantrap, No. 7 at p. 2)
DOE agrees that HPWHs have slower recovery when operating in heat pump only mode, but believes that this issue could be overcome by utilizing the backup electric resistance elements or by using water heaters with even larger rated volumes than currently used in ETS programs. However, DOE notes that if prolonged operation using electric resistance elements is required, the overall efficiency of the water heater will be lowered.
Several parties stated that HPWHs have additional total installed cost, which makes them less economically feasible for ETS programs. (PowerSouth, No. 10 at p. 3; Bayfield, No. 16 at p. 2; Cass County, No. 24 at p. 5; East River, No. 25 at p. 2; Richland, No. 26 at p. 2; Tri-Country, No. 29 at p. 3; BEC, No. 33 at p. 3; Dakota Electric, No. 36 at p. 4; Otter Tail, No. 44 at p. 3; ECSC, No. 45 at p. 3; Connexus, No. 47 at p. 1; Dairyland, No. 48 at p. 5; Pee Dee, No. 49 at p. 2; Wright-Hennepin, No. 51 at p. 1; Lynches, No. 53 at p. 3; Palmetto, No. 56 at p. 2; Horry, No. 57 at p. 4; Joint Utilities, No. 58 at p. 14; Fairfield, No. 59 at p. 3; Newberry, No. 64 at p. 3; Edisto, No. 70 at p. 3; Coastal, No.71 at p. 3; Vaughn, No. 72 at p. 2 to 3; York, No. 73 at p. 2; Black River, No.76 at p. 3; MCEC, No. 77 at p. 2; Blue Ridge, No. 82 at p. 2; Clark Public Utilities, No. 90 at p. 1; NOVEC, No. 91 at p. 4; Verendrye, No. 97 at p. 1; Dakota Energy, No. 98 at p. 1; Minnesota Rural, No. 99 at p. 1; Mountain Electric, No. 109 at p. 1; Leavenworth-Jefferson, No. 110 at p. 1; Meeker, No. 112 at p. 2; Iowa Lakes, No. 114 at p. 2; Federated, No. 115 at p. 2; Thumb Electric, No. 115 at p. 1; SCI REMC, No. 117 at p. 1; Tri-County, No. 118 at p. 1; Nobles, No. 119 at p. 1; LREC, No. 120 at p. 1; Sioux Valley, No. 123 at p. 1; Jackson County, No. 126 at p. 2; Adams-Columbia, No. 132 at p. 2; People's Energy, No. 142 at p. 1; Beltrami, No. 145 at p. 1; Habersham, No. 146 at p. 3; Flint, No. 147 at p. 1; Aurelia, No. 151 at p. 1; United Electric, No. 153 at p. 1; ECE, No. 124 at p. 2; Iowa Lakes, No. 114 at p. 3; Aiken, No. 46 at p. 2; Santee, No. 62 at p. 1)
DOE agrees that a large HPWH would have much higher installed cost than a large ERWH. The extent to which this would be balanced by lower operating costs would vary among ETS programs. DOE notes this increase in first installed cost could have an adverse impact on utility ETS programs, in which customer participation is voluntary, because a utility customer may be less willing to take on the additional installed cost of a HPWH to participate in the program.
Several of the interested parties stated that HPWHs require larger installation space and larger surrounding air volume. Some of the parties also stated that such requirements could force the consumer to switch to two smaller ERWHs, which would lead to increased costs for purchase and maintenance (as compared to a large-volume ERWH) and lower efficiency. (Rappahannock, No. 5 at p. 2; PowerSouth, No. 10 at p. 3; Woodbury, No. 14 at p. 1; North West, No. 15 at p. 1; Bayfield, No. 16 at p. 2; Union County, No. 17 at p. 3; Cass County, No. 24 at p. 3; Lyon-Lincoln, No. 27 at p. 2; Tri-Country, No. 29 at p. 4; Price, No. 30 at p. 2; Bristol, No. 31 at p. 1; BEC, No. 33 at p. 2; Dakota Electric, No. 36 at p. 2; Corn Belt, No. 39 at p. 3; Clay-Union, No. 40 at p. 2; Otter Tail, No. 44 at p. 3; ECSC, No. 45 at p. 3; Connexus, No. 47 at p. 1; Pee Dee, No. 49 at p. 2; Lynches, No. 53 at p. 3; Dunn, No. 55 at p. 2; Palmetto, No.
DOE believes that the use of two smaller water heaters in place of one large water heater for ETS programs could be a viable option in some cases. However, DOE agrees that there are situations where a consumer in an ETS program would have difficulty physically accommodating a HPWH or multiple smaller water heaters, resulting in higher installation expenses.
The Northwest Advocates commented that HPWHs can provide the same load shifting and ancillary services (load following and regulation) and benefits that are provided by ERWHs. They also stated that with additional programming (and no additional material costs) the HPWH controls can be adapted to provide ETS capabilities and the same functionality as resistance-only grid-interactive water heaters. (Northwest Advocates, No. 89, at p. 2) Similarly, GE argued that because all HPWHs use electronic controls as opposed to the electromechanical controls found on most standard electric water heaters, these products can much more easily interact with the grid and provide simpler ETS capability. (GE, No. 85 at p. 2) GE stated that the concerns that HPWHs will not be able to fill the same role as large volume resistance water heaters are not technologically justified. GE added that new larger capacity HPWH models may need to be produced, but there is no inherent reason why that cannot be done. (GE, No. 85 at p. 3)
DOE believes that from a technical perspective HPWHs could substitute for ERWHs in ETS programs. Future improvements in HPWH design such as variable speed compressors, use of higher temperature refrigerants and refinements to controls may improve HPWHs' suitability for use in ETS programs. DOE also believes that multiple smaller ERWHs are a feasible alternative to a large-volume ERWH, but may lower the system efficiency of the water heating process and may not be an option in space constrained installations. Additionally, DOE believes that the installed cost of currently available HPWH models or multiple small-volume ERWHs instead of a single large-volume ERWH and the need to often operate HPWHs in electric resistance mode to serve the demands of ETS programs could limit the attractiveness of participation in ETS programs. Additional analysis and data would be needed to determine the precise effect of unavailability of large-volume ERWHs on participation in ETS programs.
Based on the above considerations, DOE concludes that products that are currently available on the market that meet the April 2010 standard levels may not be practical to fulfill the needs of utility ETS programs. Therefore, as discussed immediately below, DOE considered two approaches—establishing a separate product class and establishing a waiver process. See sections 3 and 0, respectively.
Twenty-three utility companies and associations, four manufacturers, one trade association (NEMA), and three U.S. Congressmen recommended that DOE establish a separate product class for grid interactive water heaters. (Itasca-Mantrap No. 7 at p. 2; Barron, No. 11 at p. 2; Clark, No. 13 at p. 2; Bayfield, No. 16 at p. 2; East River, No. 25 at p. 3; Richland, No. 26 at p. 3; Lyon-Lincoln Electric Cooperative, No. 27 at p. 3; Price, No. 30 at p. 2; Dakota Electric, No. 36 at p. 5; Corn Belt, No. 39 at p. 3; Otter Tail, No. 44 at p. 4; Dairyland, No. 48 at p. 6; Pierce Pepin, No. 54 at p. 2; Dunn, No. 55 at p. 2; Joint Utilities, No. 58 at p. 4; People's Energy, No. 66 at p. 2; MECA, No. 67 at p. 1; Eau Claire, No. 69 at p. 3; ALP, No. 79 at p. 1; Freeborn-Mower, No. 83 at pp. 2-3; APPA, No. 84 at p. 3; HTP, No. 87 at p. 1; Nebraska Public Power, No. 88 at p. 1; Rheem, No. 86 at p. 2; Giant Factories, No. 65 at p. 2; AO Smith
The Joint Utilities urged the Secretary to use the authority granted pursuant to 42 U.S.C. 6295(o)(2)(A) to develop a new standard for large-volume electric resistance water heaters that interact with the grid. Specifically, the Joint Utilities believe that the grid connectivity feature of certain large volume ERWHs differentiates them from the broader ERWH product class and warrants a separate classification and standard. (Joint Utilities, No. 58 at p. 4) The Joint Utilities further argued that grid-interactive water heaters are clearly distinguishable from water heaters that are not responsive to grid signals, and proposed a definition (discussed below) that would distinguish those products from other water heaters. The Joint Utilities also stated that grid-interactive water heaters provide uninterrupted hot water to consumers, large amounts of energy storage during times when there is an excess of unused, available renewable energy, the ability to reduce load on the grid to enhance reliability or reduce congestion on the transmission grid, and reliability services in the form of frequency regulation or other grid ancillary services, all of which make this specific group of water heaters different from the general class of electric water heaters, and thus deserving of a new classification pursuant to Section 6295 (o)(2)(A). (Joint Utilities, No. 58 at p. 17)
The Joint Utilities proposed that a “Grid-Interactive Water Heater” be defined as a separate product class consisting of products with the following characteristics: (1) A storage
Further, the Joint Utilities supplemental comment suggested that if “grid interactive water heaters” were established as a separate product class and required ongoing reporting from utilities in order to track manufacturer sales versus utility installations, this should be done through the addition of a single question onto the Energy Information Administration (EIA) forms EIA-861 and EIA-861S in order to minimize burdens on utilities and DOE/EIA. The Joint Utility commenters proposed adding the following question: “If you have a demand side management (DSM) program for grid-interactive water heaters (as defined by DOE), how many grid-interactive water heaters were added to your program this/last year?” The Joint Utilities commented that the information collected by EIA could be made available to DOE for tracking purposes. (Joint Utilities Supplemental, No. 156 at pp. 1-2)
Rheem commented on the four criteria of the proposed product class for “grid-interactive water heater.” Rheem expressed support for the first requirement proposed by the Joint Utilities in the definition of “grid-interactive water heater” requiring such water heaters to have a storage volume of greater than 55 gallons, but noted this requirement may have a limiting effect on the potential application and associated benefits in the field. Rheem also supported the second criterion proposed by the Joint Utilities that a control device must be present with the understanding that these control devices are provided in the field by the utility to the consumer in support of their ETS program, giving the utility the ability to turn the water heater on or off. Rheem also agreed with the third criterion proposed by utilities (
AO Smith also commented on the four criteria for defining a “grid-interactive water heater” product class, as proposed by the Joint Utilities. AO Smith supported the first and third criteria listed above (
Contrary to the Joint Utilities' and manufacturers' position, the Joint Efficiency Advocates stated that a separate product class for grid-interactive water heaters is not appropriate. (Joint Efficiency Advocates, No. 68 at p. 1) The Joint Efficiency Advocates stated that given the novelty of grid-interactive water heaters, the variety of possible applications, and the variety of possible product designs and features, it would be unclear how to meaningfully define such a product class to enable the benefits while reducing risk and minimizing costs. (Joint Efficiency Advocates, No. 68 at p. 3) The Joint Efficiency Advocates were also concerned that there would be a significant risk that a new product class may be abused as a loophole to bypass the efficiency standards, rather than to deliver grid benefits. The Joint Efficiency Advocates pointed out that the benefits remain unquantified and generally unassessed, making it impossible to consider whether the benefits outweigh the risks and costs. Lastly, the Joint Efficiency Advocates stated that creating a new product class would likely run afoul of the “anti-backsliding” provision. The Joint Efficiency Advocates argued that all water heaters, including those that include grid interactive controls, are now subject to the 2010 standards, which prevents DOE from creating a new class with lower standards for a grid interactive water heater. (Joint Efficiency Advocates, No. 68 at p. 3)
GE also argued against the creation of a product class for grid interactive water heaters, stating that it is not justified under DOE's criteria for establishing product classes since it would not preserve a utility that would otherwise be eliminated by the standard. (GE, No. 85 at p. 3) GE stated that even if a certain consumer utility is at risk, that concern should have been raised during the rulemaking when it could have been thoroughly evaluated by DOE and all interested parties. (GE, No. 85 at p. 3) Further, GE commented that grid interactive water heaters do not have capacity or other performance related features that HPWHs do not, or could not, have, and opined that creating a separate product class would impede development of the market for high-performing HPWH products. (GE, No. 85 at p. 3) GE also argued that DOE is prevented under the “anti-backsliding” provision at 42 U.S.C. 6295(o)(1) from amending the standard to waive its requirements as applicable to a subset of covered products, especially if doing so increases maximum allowable energy use or decreases minimum energy efficiency. (GE, No. 85 at pp. 4)
After considering the comments regarding the potential for establishing a separate product class for “grid-
In the June 2012 RFI, DOE also requested comment on the potential for establishing a waiver process that would allow for production of limited number of large-volume ERWHs solely for ETS programs. Both the joint comment received from Joint Efficiency Advocates, ACEEE, NRDC, and ASAP, and the joint comment received from the Northwest Advocates, NEEA, NPCC, and BPA, generally supported a waiver system. (Joint Efficiency Advocates, No. 68 at p. 1; Northwest Advocates, No. 89 at p. 2) Several utility companies also indicated that the waiver option could potentially be a viable alternative, but most of the utility company commenters preferred the product class approach discussed above. (East River, No. 25 at p. 3; Lyon-Lincoln, No. 27 at p. 3; Bristol, No. 31 at p. 2; Corn Belt, No. 39 at p. 3; Otter Tail, No. 44 at p. 5)
The Joint Efficiency Advocates argued that a waiver approach is legal under 42 U.S.C. 7194(a) and could allow manufacturers to produce small quantities of large-volume ERWHs and sell them directly to utilities that operate such programs. (Joint Efficiency Advocates, No. 68 at p. 4) The Joint Efficiency Advocates stated that a waiver program has precedent and cited the waivers granted for small-duct, high-velocity central air conditioners from the standards for residential central air conditioners as an example. The Joint Efficiency Advocates stated that a waiver system would add flexibility and reduce the likelihood of loopholes, and would facilitate ongoing creativity and dynamism from the utility and manufacturing industries, given the ability to revisit waiver conditions. The Joint Efficiency Advocates argued that a waiver system would also encourage and facilitate ongoing assessment by DOE, industry, and other stakeholders, leading to greatly improved understanding of the benefits and costs of grid-interactive water heaters, and form the basis for well-informed future decisions of a more permanent nature. (Joint Efficiency Advocates, No. 68 at p. 4)
The Joint Efficiency Advocates stated that any waiver would need to be limited to cover units sold to utilities that actually have demand response programs, and the utilities must be required to sell or provide grid-interactive water heaters only to customers who agree to participate in the demand response program. In addition, the Joint Efficiency Advocates suggested that any application for waiver should have to demonstrate that it is impossible to operate a demand response program with water heaters that meet the standard. The Joint Efficiency Advocates also argued that waiver applications should be made jointly by a manufacturer and a utility. (Joint Efficiency Advocates, No. 68 at p. 4)
The Northwest Advocates stated that prior to determining whether to grant a waiver, DOE should determine the net economic benefits of such an action. (Northwest Advocates, No. 89 at p. 2) The Northwest Advocates also stated that the mechanism enforcing the conditions of any program waiver that may be established should be given very careful consideration because binding new homeowners to agreements made by previous homeowners has significant legal complications. The commenters also noted that the required level of program oversight and cost of enforcement should be considered. (Northwest Advocates, No. 89 at pp. 4-5) Similarly, Otter Tail stated that when customers move the water heater stays with the home, but the new homeowner may or may not want to have a controlled water heater that is part of an ETS program. (Otter Tail, No. 44 at p. 5)
The Joint Utilities, Rheem, and AO Smith generally opposed the option of establishing a waiver process. Opposition was primarily due to concerns about how distribution would be affected if the waiver were to require some control or direct distribution from a manufacturer to a utility program. AO Smith stated that not all water heater manufacturers sell directly to utilities, meaning the level of control DOE assumes the manufacturers possess may not exist. (AO Smith, No. 20 at p.3) Similarly, Rheem stated that a waiver type system concept cannot be managed effectively by a manufacturer, since a manufacturer has little to no distribution control over the intended application of its product. (Rheem, No. 86 at p. 3) Further, AO Smith argued that using a waiver system would introduce a very high degree of uncertainty to the manufacturer (and the utility) as to their business planning for such water heaters and has the potential to slow down the manufacturing process if a waiver must be granted each time a water heater is to be manufactured. AO Smith added that if the intent is to allow a “blanket waiver,” DOE should establish a standing program instead as both actions achieve the same end. (AO Smith, No. 20 at p.3)
The Joint Utilities comment pointed out that a number of regulatory proceedings at the state level led to utilities being required under state regulation to terminate programs where the utility was active in the sale of an appliance to the consumer. (Joint Utilities, No. 58 at p. 18) The Joint Utilities comment stated that if DOE appears to be reinstating utility appliance programs, it would be running afoul of years of state regulations and legislation, which would inevitably lead to litigation. (Joint Utilities, No. 58 at p. 18)
As noted above, several utility company commenters, while preferring the product class approach discussed in section III.A.3, indicated that the waiver option could potentially be a viable solution. (East River, No. 25 at p. 3; Lyon-Lincoln, No. 27 at p. 3; Bristol, No. 31 at p. 2; Corn Belt, No. 39 at p. 3; Otter Tail, No. 44 at p. 5) Otter Tail stated that although they are open to the concept of the waiver option, not all utilities' business models support the business of selling appliances and for the most part utilities do not compete with other retail businesses. (Otter Tail, No. 44 at p. 3) Two utilities stated that they sell water heaters directly to their participants. (Eau Claire, No. 69 at p. 2; Bristol, No. 31 at p. 2) Dakota Electric commented
After considering the comments on the waiver process, DOE has tentatively concluded that a waiver system would achieve DOE's goal of mitigating the impacts of the April 2010 final rule on utility ETS programs, while also being allowable under EPCA. A waiver process will address the concerns raised by utility companies and has the added benefit of having the potential for frequent evaluation. Thus, DOE is proposing in this NPRM to establish a waiver system for large-volume electric storage water heaters. The waiver, if granted, would allow, for a one-year period, manufacturers to produce limited numbers of electric water heaters with storage volumes above 55 gallons exclusively for the purpose of installation in residences enrolled in a utility company electric thermal storage (ETS) program. Parties would be allowed to apply for additional one-year waivers in subsequent years. The proposed criteria and method for petitioning for a waiver, and the proposed requirements that any granted waivers will impose are discussed in section 0.
DOE recognizes the concerns of certain stakeholders with regard to the establishment of a waiver program. In particular, DOE believes that manufacturers, the Joint Utilities, and other utility companies made compelling arguments regarding the lack of control of the distribution chain, as well as local regulations that may prevent certain utilities from selling water heaters directly to consumers. For these reasons, DOE's proposed waiver program will not include any requirements that the manufacturer sell directly to the utility, or that the utility sell the units covered under waiver directly to the consumer. Also, recognizing that situations may occur where new homeowners move into a residence with a grid-interactive water heater installed but do not wish to participate in an ETS program or where a consumer purchases a water heater for use an ETS program but later decides not to participate, DOE is not including in its waiver program any criterion that the homeowner have an agreement to be enrolled in a utility ETS program. Rather, DOE is including other requirements to ensure that the waiver program is targeted, including an annual limit on the number of units to which the waiver will apply and a requirement that the water heater be shipped with the control device that will be used for the ETS program. These requirements are discussed further in section III.B.2.
In response to the comment from NEEA, NPCC, and BPA stating that DOE must consider the economic impacts of any waiver that is granted, DOE agrees that an economic analysis may provide helpful information in determining whether to grant a waiver, but also believes it may be infeasible to individually calculate the economic benefits for every waiver request received depending on the volume of requests.
Any waiver process established by DOE must include a clear procedure for obtaining a waiver, with guidelines for circumstances under which the waiver will be granted, instructions regarding how to apply for and document the waiver, and a description of conditions that must be met for the waiver to be granted. The following sections describe the waiver process that DOE proposes to establish, including the criteria necessary to obtain a waiver, the requirements that must be met to comply with the waiver, and a process for reviewing the waiver to ensure its effectiveness in addressing the issue at hand.
In order to obtain a waiver that would allow for the manufacture and sale of limited numbers of electric water heaters with storage volumes above 55 gallons for a one year period exclusively for the purpose of installation in residences enrolled in a utility company ETS program, DOE proposes that manufacturers and/or utility companies, or a utility company and a manufacturer jointly, must request such a waiver from DOE. Further, the request must come from a manufacturer of water heaters and/or a utility company that administers an electric thermal storage program utilizing large-volume electric water heaters. No other parties may apply for a waiver. If the request is made individually by a manufacturer, it must identify each of the utility ETS programs for which the water heaters are intended to participate. Similarly, if the request is made by a utility, it must identify the manufacturer that would be responsible for producing the units.
To request an exception from the DOE energy conservation standards for residential water heaters, a manufacturer and/or utility company must submit a letter to the Assistant Secretary for Energy Efficiency and Renewable Energy detailing the waiver request. Descriptions of how to petition for the waiver, the information that should be contained in the request, and additional requirements that must be met if the waiver is granted are discussed in section 0.
DOE proposes that, if a manufacturer and/or utility company believes that it (they) can meet these requirements, in order to receive a waiver it (they) must first submit a letter to the Assistant Secretary for Energy Efficiency and Renewable Energy requesting that a waiver be granted. The waiver request should include the petitioning company contact information. If the application is filed jointly, it must contain contact information for all parties. If not filed jointly, the request must contain information about any additional entity (
Second, the waiver should include the model information (manufacturer, brand, basic model number, rated storage volumes and energy factor for each basic model that the manufacturer plans to produce and the utility plans to use in an ETS program coinciding with the DOE certification record). In addition, the application must include a list of the utility names that administer each of the ETS programs for which the basic models subject to the waiver application will be utilized and the specific number of units for each ETS program which exemption from the standards is requested. The utility company that is a party to the request must submit information on the current stock of ERWHs in their ETS programs and any planned expansion of the programs that would justify the number of units requested to be covered by waiver. DOE proposes to limit the number of units for which the waiver would apply annually to reduce the likelihood of significant numbers of large-volume ERWHs being used in applications without ETS programs.
The waiver request must also include a description of the control device that will be used to control any potentially waiver-covered water heaters for the ETS program. The control device must be capable of receiving communication from a grid operator, electric utility, or other energy services company that provides real-time control of the heating element.
Upon reviewing the application, DOE will determine whether to grant the waiver. If such determination is positive, DOE will specify the residential water heater basic model (or models) that the waiver applies to and the number of units that are covered under the waiver, as well as the expiration date of that waiver. DOE will also specify an alternative minimum energy conservation standard that would apply to any models covered under waiver. DOE will notify the petitioner(s) in writing and the public through publication of a
In addition, DOE believes that in order to effectively enforce this waiver program, DOE must have some means of physically distinguishing between water heaters for ETS programs and other electric resistance water heaters. In order to ensure that water heaters manufactured under a waiver are intended for use in ETS programs and encourage their use in ETS programs, DOE proposes to require that the units for which a waiver is granted are shipped from the manufacturer with the ETS control device installed on the water heater or packaged with the water heater. DOE is aware that currently the control mechanism is typically provided by a third party manufacturer (
In summary, to apply for a waiver, DOE proposes that a manufacturer and/or utility must submit a request to DOE that includes the following information: (1) Contact and company information for all parties involved in the waiver request (including both the manufacturer of the water heaters and the utilities administering the ETS program); (2) number of units of a given basic model broken down by utility for which the waiver is requested; (3) specific information about the water heaters, including manufacturer, brand, basic model number, rated storage volume, and energy factor; and (4) a description of the control device to be used on the water heaters and documentation of the integration of that control device into the water heater design if the waiver is granted. If DOE grants the waiver, as a condition of the waiver, DOE proposes that the covered water heaters leave the manufacturer with the ETS control device installed on the water heater or packaged with the water heater.
DOE believes that a critical component of the waiver process proposed in this NPRM will be periodic reviews of the waiver mechanism to ensure that it is achieving its goals of serving its intended purpose while limiting the potential for circumvention of the April 2010 energy conservation standards for products not used in ETS programs. Periodic reviews will allow DOE to assess any new technologies that are available on the market and to evaluate whether the concerns of utility companies are still valid in light of any new information or products on the market that may become available. In addition, periodic reviews would account for any new technologies that make products meeting DOE's energy conservation standards appropriate for use in ETS programs.
DOE believes that its proposal that each granted waiver will be applicable for only one year creates a de facto review period. As waivers expire and manufacturers and/or utility companies must apply for new waivers, DOE will re-evaluate any previous decisions made under this process. DOE also plans to review the waiver process each year. In order to conduct these evaluations, DOE is proposing to implement the suggestion contained in the Joint Utilities supplemental comment (discussed previously in section 3) that a question be added to forms EIA-861 and EIA-861S that tracks the number of models that are actually installed in utility ETS applications. (Joint Utilities Supplemental, No.156 at p.1) This information would allow DOE to compare the number of units for which a waiver is granted to the number actually installed in ETS applications each year to ensure that this process achieves its goals. DOE proposes to include with minor modifications the additional question on forms EIA-861 and EIA-861S suggested by the Joint Utilities. Rather than ask how many grid-interactive water heaters were added to each program this/last year, as proposed by the Joint Utilities, DOE proposes to include a question that asks for the total number of water heaters enrolled in a given ETS program. The question DOE proposes to add would read as follows: “If you have a demand side management (DSM) program for electric storage water heaters, how many electric storage water heaters with storage volumes above 55 gallons were utilized in your program this/last year?” DOE seeks comment on its proposal to add this question to forms EIA-861 and EIA-861S, and this is identified as issue 2 in section V.E, “Issues on Which DOE Seeks Comment.”
At the time of each review, DOE can update the waiver process, if necessary, through a notice and comment rulemaking to amend the criteria and requirements to comply with the waiver. Similarly, if new technologies come to market or new information comes to light that mitigate the concerns raised by utility companies to date (
Section 1(b)(1) of Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993), requires each agency to identify the problem that it intends to address, including, where applicable, the failures of private markets or public institutions that warrant new agency action, as well as to assess the significance of that
(1) There is a lack of consumer information and/or information processing capability about energy efficiency opportunities in the home appliance market.
(2) There is asymmetric information (one party to a transaction has more and better information than the other) and/or high transactions costs (costs of gathering information and effecting exchanges of goods and services).
(3) There are external benefits resulting from improved energy efficiency of residential water heaters that are not captured by the users of such equipment. These benefits include externalities related to environmental protection and energy security that are not reflected in energy prices, such as reduced emissions of greenhouse gases.
In addition, this regulatory action is not an “economically significant regulatory action” under section 3(f)(1) of Executive Order 12866. Accordingly, DOE is not required under section 6(a)(3) of the Executive Order to prepare a regulatory impact analysis (RIA) on this NPRM and the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) is not required to review this rule.
DOE has also reviewed this regulation pursuant to Executive Order 13563, issued on January 18, 2011 (76 FR 3281, Jan. 21, 2011). EO 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, agencies are required by Executive Order 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.
DOE emphasizes as well that Executive Order 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. For the reasons stated in the preamble, DOE believes that this NPRM is consistent with these principles, including the requirement that, to the extent permitted by law, benefits justify costs and that net benefits are maximized.
The Regulatory Flexibility Act (5 U.S.C. 601
In this notice, DOE is not proposing to amend the existing energy conservation standards for residential water heaters to adopt more stringent levels, but rather is proposing a waiver process that would allow, for a one-year period, manufacturers to produce limited numbers of electric water heaters with storage volumes above 55 gallons exclusively for the purpose of installation in residences enrolled in a utility company electric thermal storage (ETS) program.
For manufacturers of residential water heaters, the Small Business Administration (SBA) has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule. 13 CFR part 121.The size standards are listed by North American Industry Classification System (NAICS) code and industry description and are available at
DOE does not expect that this proposed rule, if adopted, would have a significant impact on any small business manufacturers. The proposed waiver process does impose several requirements, including that manufacturers may have to apply for the waiver (unless they are part of a joint application in which a utility company is submitting the application), and will be responsible for ensuring that the control device is installed on any water heaters that are manufactured under a waiver. DOE expects the impact of both of these requirements to be minimal for all manufacturers. In addition, DOE believes it is reasonable to assume that because the waiver process is optional, these potential benefits outweigh the small burdens of obtaining a waiver, as manufacturers would otherwise not opt to participate in the waiver process. Thus, DOE certifies that waiver process set forth in this proposed rule, if promulgated, would not have a significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this rulemaking. DOE will transmit the certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).
DOE requests comment on its above conclusions, as well as any information concerning small businesses that could be impacted by this rulemaking and the nature and extent of those potential impacts of the proposed waiver process on small residential water heater manufacturers. This is identified as issue 3 in section V.E, “Issues on Which DOE Seeks Comment.”
Manufacturers of residential water heaters must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
Pursuant to the National Environmental Policy Act (NEPA) of 1969, DOE has determined that the proposed rule fits within the category of actions included in Categorical Exclusion (CX) B5.1 and otherwise meets the requirements for application of a CX. See 10 CFR Part 1021, App. B, B5.1(b); 1021.410(b) and Appendix B, B(1)-(5). The proposed rule fits within the category of actions because it is a rulemaking that establishes a waiver process that would allow, for a one-year period, manufacturers to produce limited numbers of electric water heaters with storage volumes above 55 gallons exclusively for the purpose of installation in residences enrolled in a utility company electric thermal storage (ETS) program. DOE has determined that none of the exceptions identified in CX B5.1(b) apply. Therefore, DOE has made a CX determination for this rulemaking, and DOE does not need to prepare an Environmental Assessment or Environmental Impact Statement for this proposed rule. DOE's CX determination for this proposed rule is available at
Executive Order 13132, “Federalism.” 64 FR 43255 (Aug. 10, 1999) imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297) No further action is required by Executive Order 13132.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. 61 FR 4729 (Feb. 7, 1996). Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at
This proposed rule does not contain a Federal intergovernmental mandate, and it will not require expenditures of $100 million or more by State, local, and Tribal governments, in the aggregate, or by the private sector. Accordingly, no further action is required under the UMRA.
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
DOE has determined, under Executive Order 12630, “Governmental Actions
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for Federal agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this NPRM under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
DOE has tentatively concluded that this regulatory action, which sets forth a waiver process for energy conservation standards for residential water heaters, is not a significant energy action because the proposed waiver process is not likely to have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as such by the Administrator at OIRA. Accordingly, DOE has not prepared a Statement of Energy Effects on the proposed rule.
On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (OSTP), issued its Final Information Quality Bulletin for Peer Review (the Bulletin). 70 FR 2664 (Jan. 14, 2005). The Bulletin establishes that certain scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal Government, including influential scientific information related to agency regulatory actions. The purpose of the bulletin is to enhance the quality and credibility of the Government's scientific information. Under the Bulletin, the energy conservation standards rulemaking analyses are “influential scientific information,” which the Bulletin defines as scientific information the agency reasonably can determine will have, or does have, a clear and substantial impact on important public policies or private sector decisions. 70 FR 2667.
In response to OMB's Bulletin, DOE conducted formal in-progress peer reviews of the energy conservation standards development process and analyses and has prepared a Peer Review Report pertaining to the energy conservation standards rulemaking analyses. Generation of this report involved a rigorous, formal, and documented evaluation using objective criteria and qualified and independent reviewers to make a judgment as to the technical/scientific/business merit, the actual or anticipated results, and the productivity and management effectiveness of programs and/or projects. The “Energy Conservation Standards Rulemaking Peer Review Report” dated February 2007 has been disseminated and is available at the following Web site:
The time, date, and location of the public meeting are listed in the
In addition, you can attend the public meeting via webinar. Webinar registration information, participant instructions, and information about the capabilities available to webinar participants will be published on DOE's Web site at:
Any person who has an interest in the topics addressed in this notice, or who is representative of a group or class of persons that has an interest in these issues, may request an opportunity to make an oral presentation at the public meeting. Such persons may hand-deliver requests to speak to the address shown in the
DOE requests persons scheduled to make an oral presentation to submit an advance copy of their statements at least one week before the public meeting. DOE may permit persons who cannot supply an advance copy of their statement to participate, if those persons have made advance alternative arrangements with the Building Technologies Program. As necessary, requests to give an oral presentation should ask for such alternative arrangements.
DOE will designate a DOE official to preside at the public meeting and may also use a professional facilitator to aid discussion. The meeting will not be a judicial or evidentiary-type public hearing, but DOE will conduct it in
The public meeting will be conducted in an informal, conference style. DOE will present summaries of comments received before the public meeting, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will allow, as time permits, other participants to comment briefly on any general statements.
At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly and comment on statements made by others. Participants should be prepared to answer questions by DOE and by other participants concerning these issues. DOE representatives may also ask questions of participants concerning other matters relevant to this rulemaking. The official conducting the public meeting will accept additional comments or questions from those attending, as time permits. The presiding official will announce any further procedural rules or modification of the above procedures that may be needed for the proper conduct of the public meeting.
A transcript of the public meeting will be included in the docket, which can be viewed as described in the
DOE will accept comments, data, and information regarding this proposed rule before or after the public meeting, but no later than the date provided in the
Submitting comments via regulations.gov. The regulations.gov web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.
However, your contact information will be publicly viewable if you include it in the comment itself or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Otherwise, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
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Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
1. DOE's proposal to require that the units for which a waiver is granted are shipped from the manufacturer with the ETS control device installed on the water heater.
2. DOE's proposal to add a question to forms EIA-861 and EIA-861S that would read as follows: “If you have a demand side management (DSM) program for electric storage water heaters, how many electric storage water heaters with storage volumes above 55 gallons were utilized in your program this/last year?”
3. DOE's conclusion that the proposed waiver process will not have significant adverse impacts on a substantial number of small business manufacturers. DOE also seeks any information concerning small businesses that could be impacted by this rulemaking and the nature and extent of those potential impacts of the proposed waiver process on small residential water heater manufacturers.
The Secretary of Energy has approved publication of this notice of proposed rulemaking.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Intergovernmental relations, Reporting and recordkeeping requirements, and Small businesses.
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(a) Any manufacturer of residential water heaters or utility company that administers an electric thermal storage program for electric water heaters, or combination of these two, may submit a petition to allow, for a one-year period, manufacturers to produce limited numbers of electric water heaters with rated storage volumes above 55 gallons exclusively for the purpose of installation in residences enrolled in a utility company electric thermal storage (ETS) program.
(b) A petition for waiver shall be submitted to the Assistant Secretary for Energy Efficiency and Renewable Energy, United States Department of Energy by email. Each petition for waiver shall:
(1) Identify the company or companies, whether manufacturer or utility company or combination of the two, requesting the waiver, and provide contact information (
(2) Identify the particular manufacturer, brand, basic model(s), rated storage volume, and energy factor for which a waiver is requested.
(3) Identify the number of units per utility program on an annual basis for each of the basic models for which a waiver is requested (
(4) Provide information from the utility company regarding the current stock of electric water heaters used in the electric thermal storage programs at the time the waiver is submitted and any planned expansion of the programs for the annual period the waiver will cover that would justify the number of units requested to be covered by waiver.
(5) Identify and describe the control device that will be installed on the unit. The control device must be capable of receiving communication from a grid operator, electric utility, or other energy services company that provides real-time control of the heating element. Provide documentation that the control device is integrated into the water heater design at the point of manufacture, including but not limited to any marketing and labeling material from the manufacturer describing the basic model(s) for which the waiver is requested.
(6) Be signed by a company official. In accordance with the provisions set forth in 10 CFR 1004.11, any request for confidential treatment of any information contained in a petition for waiver or in supporting documentation must be accompanied by a copy of the petition, application or supporting documentation from which the information claimed to be confidential has been deleted. DOE shall publish in the
(c) The Assistant Secretary for Energy Efficiency and Renewable Energy shall issue a decision on the petition as soon as is practicable following receipt and review of the petition for waiver and other applicable documents. The Assistant Secretary for Energy Efficiency and Renewable Energy will grant a waiver upon determining that the basic model for which the waiver was requested is particularly well suited for use in the electric thermal storage program, the requester or combination of requesters is an appropriate party to be granted such a waiver, the quantity of units to be manufactured under the waiver is sufficiently limited, and that an appropriate control device will be present on any water heaters manufactured and shipped pursuant to a waiver. Manufacture of units authorized by a waiver granted under this section will not constitute violations of an applicable energy conservation standard, provided that the units are distributed and installed in accordance with the terms of the waiver.
(d) Any granted waiver will specify the manufacturer, utilities, brand, basic model number, number of units of a particular basic model and the applicable energy conservation standard for units authorized by the waiver. Any
(e) Any basic model for which a waiver has been granted shall be shipped from the water heater original equipment manufacturer with a control device that is compatible with the utility company administered electric thermal storage program. Any changes to the basic model design which results in the unit consuming more energy or alters the control device from which the waiver was granted shall require a new waiver application. The control device must be installed on the water heater before it leaves the original equipment manufacturer. The control device must be capable of receiving communication from a grid operator, electric utility, or other energy services company that provides real-time control of the heating element. The water heater must be clearly labeled and marketed for use exclusively in ETS programs, including a description of the control device integrated into the water heater, before it leaves the original equipment manufacturer.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A318, A319, A320, and A321 series airplanes. This proposed AD was prompted by reports that certain trimmable horizontal stabilizer actuators (THSA) were found with corrosion that affected the ballscrew lower splines between the tie-bar and screw-jack. This proposed AD would require repetitive inspections of the THSA; ballscrew integrity tests, if necessary; and replacement of affected THSAs. We are proposing this AD to detect and correct corrosion in the ballscrew lower splines, which, if the ballscrew ruptured, could lead to transmission of THSA torque loads from the ballscrew to the tie-bar, prompting THSA blowback, and possible loss of control of the airplane.
We must receive comments on this proposed AD by April 12, 2013.
You may send comments by any of the following methods:
•
•
•
•
For Airbus service information identified in this proposed AD, contact Airbus, Airworthiness Office—EAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone (425) 227-1405; fax (425) 227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2012-0175, dated September 7, 2012 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
Some Trimmable Horizontal Stabilizer Actuators (THSA), Part Number (P/N) 47147-500 fitted on A330/A340 aeroplanes have been found with corrosion, affecting the ballscrew lower splines between the tie bar and the screw-jack. The affected ballscrew is made of steel and anti-corrosion protection is ensured, except on both extremities (upper and lower splines) where Molykote is applied.
The results of the technical investigations have identified that the corrosion was caused by a combination of:
The results of the technical investigations have also concluded that A320 family THSA P/N 47145-XXX (where XXX stands for any numerical
This condition, if not detected and corrected, may lead, in case of ballscrew rupture, to loss of transmission of THSA torque loads from the ballscrew to the tie-bar, prompting THSA blowback, possibly resulting in loss of control of the aeroplane.
For the reasons described above, this [EASA] AD requires repetitive detailed inspections of the ballscrew lower splines of THSAs having P/N 47145-XXX to detect corrosion and, depending on findings, the accomplishment of applicable corrective actions.
Airbus has issued Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012; and Goodrich has issued Service Bulletin 47145-27-16, dated November 7, 2011. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
Based on the service information, we estimate that this proposed AD would affect about 755 products of U.S. registry. We also estimate that it would take about 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $256,700, or $340 per product.
In addition, we estimate that any necessary follow-on actions would take about 15 work-hours and require parts costing $2,203, for a cost of $3,478 per product. We have no way of determining the number of products that may need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. 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.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by April 12, 2013.
None.
This AD applies to all Airbus Model A318-111, -112, -121, and -122 airplanes; Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Airbus Model A320-111, -211, -212, -214, -231, -232, and -233 airplanes; and Airbus Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes; certificated in any category.
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by reports that certain trimmable horizontal stabilizer actuators (THSA) were found with corrosion that affected the ballscrew lower splines between the tie-bar and screw-jack. We are issuing this AD to detect and correct corrosion in the ballscrew lower splines, which, if the ballscrew ruptured, could lead to transmission of THSA torque loads from the ballscrew to the tie-bar, prompting THSA blowback, and possible loss of control of the airplane.
You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
For the purposes of this AD, the definition of THSA first flight is the THSA “entry into service date,” as identified in Goodrich Service Bulletin 47145-27-16, dated November 7, 2011. If the THSA part number (P/N) is not identified in Goodrich Service Bulletin 47145-27-16, dated November 7, 2011, the THSA first flight is the manufacturing date engraved on the THSA identification plate.
At the later of the times in paragraphs (h)(1) and (h)(2) of this AD: Do a detailed inspection of the gaps between the ballscrew shaft and tie-rod splines on any THSA having P/N 47145-XXX (where XXX stands for any numerical value) to determine if the corrosion category is Type I, Type II, or Type III, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012; and the Accomplishment Instructions and the flowchart following the Accomplishment Instructions of Goodrich Service Bulletin 47145-27-16, dated November 7, 2011. Repeat the inspection thereafter at intervals not to exceed 24 months.
(1) Within 22 years accumulated by the THSA since the THSA's first flight, but no earlier than 20 years accumulated by the THSA since its first flight.
(2) Within three months after the effective date of this AD.
If, during any inspection required by paragraph (h) of this AD, it is determined that a THSA has Type II or Type III corrosion: Before further flight, do a ballscrew integrity test, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012; and the Accomplishment Instructions and the flowchart following the Accomplishment Instructions of Goodrich Service Bulletin 47145-27-16, dated November 7, 2011. If Type I corrosion is found, no action is required by this paragraph.
(1) For THSAs having Type II or Type III corrosion and for which the results of the ballscrew integrity test are not correct, as specified in Airbus Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012: Before further flight, replace the affected THSA with a new THSA, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012.
(2) For THSAs having Type III corrosion and on which the results of the ballscrew integrity test are correct, as specified in Airbus Service Bulletin A320 27-1214, including Appendix 01, dated February 23, 2012: Within 10 days after the most recent inspection, replace the THSA with a new THSA, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012.
(3) For THSAs having Type II corrosion and on which the results of the ballscrew integrity test are correct, as specified in Airbus Service Bulletin A320 27-1214, including Appendix 01, dated February 23, 2012: Within 24 months or 5,000 flight cycles after the most recent inspection, whichever occurs first, replace the THSA with a new THSA, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012.
Replacement of a THSA, as required by paragraph (i) of this AD, does not constitute terminating action for the repetitive inspections required by paragraph (h) of this AD.
If any corrosion type is found during any inspection required by paragraph (h) of this AD, at the applicable time in paragraph (k)(1) or (k)(2) of this AD, report the findings to Airbus, Customer Services Engineering—SEEL5, Flight Control Systems A320 Family, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; fax +33 5 61 93 44 25. The report must include the information specified in Appendix 01 of Airbus Service Bulletin A320-27-1214, dated February 23, 2012.
(1) If the inspection was done on or after the effective date of this AD: Within 90 days after that inspection.
(2) If the inspection was done before the effective date of this AD: Within 90 days after the effective date of this AD.
As of the effective date of this AD, no person may install a THSA having P/N 47145-XXX (where XXX stands for any numerical value), on any airplane, unless that THSA meets the criteria specified in paragraphs (l)(1) and (l)(2) of this AD.
(1) The THSA has not accumulated 20 years since the THSA's first flight, or the THSA has been inspected as required by paragraph (h) of this AD and it has been determined that the THSA had Type I corrosion (no corrosion) at the time of installation; and
(2) The THSA is thereafter inspected as required by paragraph (h) of this AD, and any applicable actions specified in paragraph (i) of this AD are accomplished.
The following provisions also apply to this AD:
(1)
(2)
(3)
Special flight permits may be issued in accordance with sections 21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199) to operate the airplane to a location where the airplane can be modified (if the operator elects to do so), provided that, if any THSA corrosion is found during any action required by paragraph (h) of this AD, that corrosion is classified as Type I or Type II, as defined in Goodrich Service Bulletin 47145-27-16, dated November 7, 2011.
(1) Refer to Mandatory Continuing Airworthiness Information European Aviation Safety Agency Airworthiness Directive 2012-0175, dated September 7, 2012, and the service information specified in paragraphs (o)(1)(i) and (o)(1)(ii) of this AD, for related information.
(i) Airbus Service Bulletin A320-27-1214, including Appendix 01, dated February 23, 2012.
(ii) Goodrich Service Bulletin 47145-27-16, dated November 7, 2011.
(2) For Airbus service information identified in this AD, contact Airbus, Airworthiness Office—EAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede two existing airworthiness directives (AD) that apply to all The Boeing Company Model 767 airplanes. One AD currently requires a functional check of the shear rivets in all six elevator power control actuator (PCA) bellcrank assemblies to determine the condition of the shear rivets, and replacement or rework of the bellcrank assemblies if necessary. The other AD currently requires repetitive testing of the elevator control system to determine if an elevator PCA is rigged incorrectly, and follow-on actions if necessary. Since we issued those ADs, a terminating modification has been designed. This proposed AD would require an inspection to determine the part numbers and condition of the bellcrank assemblies; modification or replacement of the PCA bellcrank assembly, if necessary; and a repetitive functional test and mis-rig check, and corrective actions if necessary. We are proposing this AD to prevent continued operation with yielded or failed shear rivets in the elevator PCA bellcrank assemblies, and to prevent certain failures or jams in the elevator system from causing a hardover of the elevator surface, resulting in a significant pitch upset and possible loss of control of the airplane.
We must receive comments on this proposed AD by April 12, 2013.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Marie Hogestad, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6418; fax: 425-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On August 18, 2000, we issued AD 2000-17-05, Amendment 39-11879 (65 FR 51754, August 25, 2000), for certain The Boeing Company Model 767-200, -300, and -300F series airplanes. That AD requires a one-time functional check of the shear rivets in all six PCA bellcrank assemblies to determine the condition of the shear rivets; and replacement or rework of the bellcrank assemblies, if necessary. That AD resulted from reports that elevator bellcrank assemblies with failed shear rivets had been found on three Model 767 airplanes. We issued that AD to detect and correct any failed or partially yielded shear rivets of the elevator PCA bellcrank assemblies. Failure of two bellcrank assemblies on one side can result in that single elevator surface moving to a hardover position, independent of pilot command, resulting in a significant pitch upset recoverable by the crew. Failure of three bellcrank assemblies on one side could result in loss of control of the airplane.
On February 21, 2001, we issued AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001), for all The Boeing Company Model 767 airplanes. That AD requires repetitive testing of the elevator control system to determine if an elevator PCA is rigged incorrectly due to yielded or failed shear rivets in a bellcrank assembly of the elevator PCA, and follow-on actions if necessary. That AD resulted from reports that several Model 767 airplanes failed the one-time functional check of the shear rivets in the bellcrank assemblies of the elevator PCA required by AD 2000-17-05, Amendment 39-11879 (65 FR 51754, August 25, 2000). We issued AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001), to prevent continued operation with yielded or failed shear rivets in a bellcrank assembly of the elevator PCA, which could result in loss of control of the airplane.
The preambles to AD 2000-17-05, Amendment 39-11879 (65 FR 51754, August 25, 2000); and AD 2001-04-09, Amendment 39-12128 (66 FR 13227,
We reviewed Boeing Service Bulletins 767-27-0186, dated June 25, 2007 (for Model 767-200, -300, and -300F series airplanes); and 767-27-0187, dated June 25, 2007 (for Model 767-400ER series airplanes). This service information describes procedures for doing a general visual inspection of the PCA bellcrank assemblies on each elevator to determine if the bellcrank assembly has shear rivets; and installing a solid elevator PCA bellcrank assembly or reworking the bellcrank assembly to replace the shear rivets with solid rivets, if necessary. This service information also describes procedures for the initial test of the elevator PCA input rod assemblies (pogo check), and replacement or overhaul if necessary; and an elevator PCA rigging check.
We also reviewed Boeing Service Bulletins 767-27-0200, dated June 25, 2007 (for Model 767-200, -300, and -300F series airplanes); and 767-27-0201, dated June 27, 2007 (for Model 767-400ER series airplanes). This service information describes procedures for repetitive testing of the elevator PCA input rod assemblies (pogo check), and replacing or overhauling the elevator PCA input rod assembly, if necessary.
We reviewed Boeing Service Bulletins 767-27-0202, Revision 1, dated February 21, 2008 (for Model 767-200, -300, and -300F series airplanes); and 767-27-0203, Revision 1, dated February 21, 2008 (for Model 767-400ER series airplanes). This service information describes procedures for doing repetitive checks of the elevator PCA rigging, and adjusting the PCA input rod assemblies and structural inspection, if necessary.
AD 2007-24-08, Amendment 39-15274 (72 FR 67236, November 28, 2007), was issued for Model 767 airplanes. That AD requires repetitive measurements of the rudder and elevator freeplay, related investigative and corrective actions if necessary, and repetitive lubrications of the rudder and elevator components. For certain airplanes, we require concurrent actions.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain certain requirements of AD 2000-17-05, Amendment 39-11879 (65 FR 51754, August 25, 2000); and AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001). This proposed AD would require an inspection to determine the part numbers and condition of the bellcrank assemblies; modification or replacement of the PCA bellcrank assembly, if necessary; and repetitive post-modification testing and corrective actions, if necessary. This proposed AD would also require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between the Proposed AD and the Service Information.”
Boeing Commercial Airplanes has received an Organization Designation Authorization (ODA). We have revised this proposed AD to delegate the authority to approve an alternative method of compliance for any repair required by this proposed AD to the Boeing Commercial Airplanes ODA rather than a Designated Engineering Representative (DER).
Since AD 2000-17-05, Amendment 39-11879 (65 FR 51754, August 25, 2000); and AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001); were issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following table:
In addition, we have revised certain headings pertaining to restated material throughout this AD.
This proposed AD will allow for an alternate grease (BMS 3-33) when accomplishing the actions specified in Boeing Service Bulletins 767-27-0186 and 767-27-0187, both dated June 25, 2007.
Although Boeing Service Bulletins 767-27-0202 and 767-27-0203, both Revision 1, both dated February 21, 2008, do not specify a corrective action following a structural inspection, this proposed AD would require operators to repair conditions using a method approved by the FAA.
We estimate that this proposed AD affects 415 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary repairs or replacements that would be required based on the results of the proposed inspection, tests, and checks. We have no way of determining the number of aircraft that might need these repairs or replacements.
We estimate that reworking the bellcrank assembly would take about 6 work-hours, for a labor cost of $510 per airplane; however, we have no definitive data to determine the cost of parts required. We have received no definitive data that would enable us to provide a cost estimate for replacing or overhauling the elevator PCA input rod assembly, adjusting the elevator PCA input rod assemblies, and doing structural inspections specified in this proposed AD.
According to the manufacturer, some of the costs of this proposed AD might be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. 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.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this AD action by April 12, 2013.
This AD supersedes AD 2000-17-05, Amendment 39-11879 (65 FR 51754, August 25, 2000); and AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001). This AD affects AD 2007-24-08, Amendment 39-15274 (72 FR 67236, November 28, 2007).
This AD applies to all The Boeing Company Model 767-200, -300, -300F, and -400ER series airplanes, certificated in any category.
Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by reports of failed shear rivets in the bellcrank assemblies of the elevator power control actuator (PCA). We are issuing this AD to prevent continued operation with yielded or failed shear rivets in the elevator PCA bellcrank assemblies, and to prevent certain failures or jams in the elevator system from causing a hardover of the elevator surface, resulting in a significant pitch upset and possible loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (a) of AD 2000-17-05, Amendment 39-11879 (65 FR 51754, August 25, 2000). For Model 767-200, -300, and -300F series airplanes, line numbers 1 through 800 inclusive: Within 30 days after September 11, 2000 (the effective date AD 2000-17-05), perform a functional check of one shear rivet in all six elevator PCA bellcrank assemblies to determine the condition of the shear rivets, in accordance with Paragraph 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000. Doing the actions required by paragraphs (j), (k), and (l) of this AD terminates the requirements of paragraph (g) of this AD.
(1) If all penetration depths, when measured per Figure 2 of Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000, are 0.50 inch or more, no further action is required by paragraph (g) of this AD.
(2) If any penetration depth, when measured per Figure 2 of Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000, is 0.35 inch or more, but less than 0.50 inch, rework or replace the bellcrank assembly with a new or serviceable bellcrank assembly within 400 flight hours after accomplishing the functional check. After installation of a new or serviceable bellcrank assembly, and prior to further flight, repeat the functional check of all the bellcrank assemblies to make sure the rivets are still in good condition (as specified in Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000) after installation, in accordance with Figure 2 of Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000.
(3) If any penetration depth, when measured per Figure 2 of Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000, is less than 0.35 inch, prior to further flight, rework or replace the bellcrank assembly with a new or serviceable bellcrank assembly. After installation of a new or serviceable bellcrank assembly, and prior to further flight, repeat the functional check of all the bellcrank assemblies to make sure the rivets are still in good condition (as specified in Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000) after installation, in accordance with Figure 2 of Boeing Alert Service Bulletin 767-27A0166, dated August 17, 2000.
This paragraph restates the requirements of paragraph (a) of AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001), with revised provisions for repetitive tests. For all airplanes: Within 90 days after March 20, 2001 (the effective date of AD 2001-04-09), perform a test of the elevator PCA bellcranks to determine if an elevator PCA is rigged incorrectly due to yielded or failed shear rivets in a bellcrank assembly, in accordance with Boeing Alert Service Bulletin 767-27A0168 (for Model 767-200, -300, and -300F series airplanes) or 767-27A0169 (for Model 767-400ER series airplanes), both dated November 21, 2000. Repeat the test thereafter at least every 400 flight hours. As of March 20, 2001 (the effective date of AD 2001-04-09), and until the accomplishment of the actions required by paragraphs (j), (k), and (l) of this AD, as applicable. Accomplishment of the repetitive tests required by paragraph (h) of this AD are acceptable for compliance with the functional check of the elevator system required by a certification maintenance requirement (CMR) that is documented as Item Number 27-31-00-5B in the Boeing 767 Maintenance Planning Document (MPD). Doing the actions required by paragraphs (j), (k), and (l) of this AD terminates the requirements of paragraph (h) of this AD. After accomplishment of the actions required by paragraphs (j), (k), and (l) of this AD, accomplishment of the repetitive tests required by paragraph (h) of this AD are not acceptable for compliance with the functional check of the elevator system required by a CMR that is documented as Item Number 27-31-00-5B in the Boeing 767 MPD.
This paragraph restates the requirements of paragraph (b) of AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001). For all airplanes: If an elevator PCA is determined to be rigged incorrectly during any test required by paragraph (h) of this AD, before further flight, do a one-time inspection to measure penetration depth of the shear rivets of all three elevator bellcrank assemblies of the affected elevator surface, in accordance with Boeing Alert Service Bulletin 767-27A0168 (for Model 767-200, -300, and -300F series airplanes) or 767-27A0169 (for Model 767-400ER series airplanes), both dated November 21, 2000. Doing the actions required by paragraphs (j), (k), and (l) of this AD terminates the requirements of paragraph (i) of this AD.
(1) If the measured penetration depth of the shear rivets on all bellcrank assemblies is 0.50 inch or more: Before further flight, re-rig the elevator PCA correctly, in accordance with Boeing Alert Service Bulletin 767-27A0168 (for Model 767-200, -300, and -300F series airplanes) or 767-27A0169 (for Model 767-400ER series airplanes), both dated November 21, 2000.
(2) If the measured shear rivet penetration depth on any single bellcrank assembly is less than 0.50 inch: Before further flight, repair the bellcrank assembly by replacing the shear rivets or replace the bellcrank assembly, and reassemble and re-rig the elevator control system, in accordance with Boeing Alert Service Bulletin 767-27A0168 (for Model 767-200, -300, and -300F series airplanes) or 767-27A0169 (for Model 767-400ER series airplanes), both dated November 21, 2000.
For airplanes having line numbers 1 through 901 inclusive: Within 72 months after the effective date of this AD, do a general visual inspection of the three PCA bellcrank assemblies on each elevator to determine the part numbers (P/Ns) of the bellcrank assemblies and to determine whether the bellcrank assembly has shear rivets, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-27-0186, dated June 25, 2007 (for Model 767-200, -300, and -300F series airplanes); or 767-27-0187, dated June 25, 2007 (for Model 767-400ER series airplanes).
(1) If the bellcrank assembly has P/N 252T2118-4 or 252T2118-5, and has solid rivets, no further action is required by this paragraph.
(2) If the bellcrank is a solid one-piece bellcrank with no rivets, no further action is required by this paragraph.
(3) If the bellcrank assembly has P/N 252T2118-1, 252T2118-2, or 252T2118-3, and has shear rivets, before further flight, do the action specified in either paragraph (j)(3)(i) or (j)(3)(ii) of this AD, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-27-0186, dated June 25, 2007 (for Model 767-200, -300, and -300F series airplanes); or 767-27-0187, dated June 25, 2007 (for Model 767-400ER series airplanes); except as provided by paragraph (n) of this AD.
(i) Rework the existing bellcrank to replace the shear rivets with solid rivets.
(ii) Install a new, solid one-piece (no rivets) bellcrank assembly having P/N 252T2118-6.
(1) For airplanes having line numbers 1 through 901 inclusive: Before further flight after doing the inspection and applicable corrective actions required by paragraph (j) of this AD, do a functional test (pogo check) on each of the six elevator PCA input rod assemblies, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-27-0186, dated June 25, 2007 (for Model 767-200, -300, and -300F series airplanes); or 767-27-0187, dated June 25, 2007 (for Model 767-400ER series airplanes).
(2) For all airplanes: At the latest of the times specified in paragraphs (k)(2)(i), (k)(2)(ii), and (k)(2)(iii) of this AD, do a
(i) Before the accumulation of 12,000 total flight hours.
(ii) Within 12,000 flight hours after completion of the most recent pogo check.
(iii) Within 6,000 flight hours after the effective date of this AD.
(3) If any elevator PCA input rod assembly fails to meet any functional test requirement of this AD, before further flight, replace the elevator PCA input rod assembly with a new or serviceable assembly, or overhaul the elevator PCA input rod assembly, in accordance with the applicable service information identified in paragraphs (k)(3)(i) and (k)(3)(ii) of this AD, except as provided by paragraph (n) of this AD.
(i) For replacing or overhauling the assembly on Model 767-200, -300, and -300F airplanes: Use Boeing Service Bulletin 767-27-0186, dated June 25, 2007; or 767-27-0200, dated June 25, 2007; as applicable.
(ii) For replacing or overhauling the assembly on Model 767-400ER airplanes: Use Boeing Service Bulletin 767-27-0187, dated June 25, 2007; or 767-27-0201, dated June 27, 2007; as applicable.
(1) For airplanes having line numbers 1 through 901 inclusive: Before further flight after doing the actions required by paragraphs (j) and (k) of this AD, do a check of the elevator PCA rigging, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-27-0186, dated June 25, 2007 (for Model 767-200, -300, and -300F series airplanes); or 767-27-0187, dated June 25, 2007 (for Model 767-400ER series airplanes).
(2) For all airplanes: At the latest of the times specified in paragraphs (l)(2)(i), (l)(2)(ii), and (l)(2)(iii) of this AD, do a check of the elevator PCA rigging, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-27-0202, Revision 1, dated February 21, 2008 (for Model 767-200, -300, and -300F series airplanes); or 767-27-0203, Revision 1, dated February 21, 2008 (for Model 767-400ER series airplanes). Repeat the mis-rig check thereafter at intervals not to exceed 6,000 flight hours.
(i) Before the accumulation 6,000 total flight hours.
(ii) Within 6,000 flight hours after the completion of the most recent mis-rig check, or after completion of the most recent bellcrank repetitive check, as specified in Boeing Alert Service Bulletin 767-27A0168.
(iii) Within 6,000 flight hours after the effective date of this AD.
(3) If a mis-rig condition is found, before further flight, adjust the PCA input rod assemblies and do a structural inspection for damage, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 767-27-0202, Revision 1, dated February 21, 2008 (for Model 767-200, -300, and -300F airplanes); or 767-27-0203, Revision 1, dated February 21, 2008 (for Model 767-400ER airplanes). If any damage is found during any structural inspection, before further flight, repair in accordance with a method approved by the Manager, Seattle Aircraft Certification Office (ACO), FAA. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
Accomplishment of the requirements of paragraphs (j), (k), and (l) of this AD terminates the requirements of paragraphs (g), (h), and (i) of this AD.
Where Boeing Service Bulletins 767-27-0186 and 767-27-0187, both dated June 25, 2007, specify the use of grease BMS 3-24, this AD allows the alternate use of grease BMS 3-33.
For airplanes identified in paragraphs (o)(1) and (o)(2) of this AD: Doing the actions required by paragraphs (j), (k), and (l) of this AD is acceptable for compliance with the actions required by paragraph (k) of AD 2007-24-08, Amendment 39-15274 (72 FR 67236, November 28, 2007).
(1) Group 1, Configuration 2, airplanes identified in Boeing Special Attention Service Bulletin 767-27-0197, Revision 1, dated July 19, 2007.
(2) Group 1, Configuration 1, airplanes identified in Boeing Special Attention Service Bulletin 767-27-0198, Revision 1, dated July 19, 2007.
As of the effective date of this AD, no person may install a bellcrank assembly, P/N 252T2118-1, 252T2118-2, or 252T2118-3, on any airplane.
This paragraph provides credit for the actions required by paragraph (l) of this AD, if those actions were performed before the effective date of this AD using Boeing Service Bulletin 767-27-0202 (for Model 767-200, -300, and -300F airplanes) or 767-27-0203, (for Model 767-400ER airplanes), both dated June 25, 2007.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane and the approval must specifically refer to this AD.
(4) AMOCs approved previously in accordance with AD 2001-04-09, Amendment 39-12128 (66 FR 13227, March 5, 2001), are approved as AMOCs for the corresponding requirements of this AD.
(1) For more information about this AD, contact Marie Hogestad, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6418; fax: (425) 917-6590; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede an existing airworthiness directive (AD) that applies to all Gulfstream Aerospace
We must receive comments on this proposed AD by April 12, 2013.
You may send comments by any of the following methods:
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For service information identified in this proposed AD, contact Gulfstream Aerospace Corporation, P.O. Box 2206, Mail Station D-25, Savannah, Georgia 31402-2206; telephone 800-810-4853; fax 912-965-3520; email
You may examine the AD docket on the Internet at
Tom Stafford, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-227-1622; fax: 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On May 7, 2010, we issued AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010), which superseded AD 2007-03-05, Amendment 39-14916 (72 FR 4414, January 31, 2007). That AD required actions intended to address an unsafe condition on the products listed above.
Since we issued AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010), we have determined that the compliance time must be revised to ensure the unsafe condition is addressed on low utilization airplanes. We have also removed one airplane from the applicability. The Civil Aviation Authority of Israel (CAAI), which is the aviation authority for Israel, has issued Israeli Airworthiness Directive 31-06-11-05R1, dated May 18, 2011 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
To increase pilots' awareness to the possibility of incomplete closure of the Main Entry Door (MED) by the following means:
1. Splitting the common caution light
2. Converting the separated
Incomplete closure of the MED may be followed by in-flight opening and possible separation of the door. As a result, the MED, the adjacent fuselage structure and other parts of the aircraft may be damaged due to opening forces and landing impact.
Damage to the aircraft structure and to the left engine by flying debris and objects may also occur.
Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) has issued Service Bulletin 100-31-284, Revision 1, dated May 27, 2011. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
The new requirements of this AD add no additional economic burden. The current costs for this AD are repeated for the convenience of affected operators, as follows:
Based on the service information, we estimate that this proposed AD would
The actions that are required by AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010) and retained in this proposed AD take about 60 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost about $600 per product. Based on these figures, the estimated cost of the currently required actions is $5,700 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. 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.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by April 12, 2013.
This AD supersedes AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010).
This AD applies to Gulfstream Aerospace LP (Type Certificate previously held by Israel Aircraft Industries, Ltd.) Model Gulfstream 100 airplanes, and Model Astra SPX and 1125 Westwind Astra airplanes; certificated in any category; all serial numbers except serial number 158.
Air Transport Association (ATA) of America Code 31: Indicating/Recording Systems.
This AD was prompted by a report of a main entry door (MED) opening in flight on an unmodified airplane. We are issuing this AD to prevent incomplete closure of the main entry door, which may result in the door opening in flight and possible separation of the door, causing damage to the airplane structure and left engine by flying debris and objects.
You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
This paragraph restates the requirements of paragraph (f) of AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010). Within 10 days after February 15, 2007 (the effective date of AD 2007-03-05, Amendment 39-14916 (72 FR 4414, January 31, 2007)), amend Section IV, Normal Procedures, of the following Gulfstream airplane flight manuals (AFMs): Model 1125 Astra, 25W-1001-1; Model Astra SPX, SPX-1001-1; and Model G100, G100-1001-1; as applicable; to include the following statement. Insertion of copies of this AD at the appropriate places of the AFMs is acceptable. The actions required by this paragraph may be accomplished by a holder of a Private Pilot's License.
Insert between the POSITION lights switch and the THRUST LEVERS procedures:
Mod 20052 is equivalent to Gulfstream Service Bulletin 100-31-284, dated August 17, 2006.
This paragraph restates the requirements of paragraph (g) of AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010), with reduced compliance time and new service information.
(1) Within 250 flight hours after June 25, 2010 (the effective date of AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010)), but no later than within 6 months after the effective date of this AD: Modify the warning and caution lights panel (WACLP), in accordance with the Accomplishment Instructions of the applicable service bulletin identified in table 1 of this AD.
(2) Within 250 flight hours after June 25, 2010 (the effective date of AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010)), but no later than within 6 months after the effective date of this AD: Change the
(3) Within 250 flight hours after June 25, 2010 (the effective date of AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010)), but no later than within 6 months after the effective date of this AD: Change the wiring harness connecting the MED to the WACLP, in accordance with the Accomplishment Instructions of Gulfstream Service Bulletin 100-31-284, dated August 17, 2006; or Gulfstream Service Bulletin 100-31-284, Revision 1, dated May 27, 2011. As of the effective date of this AD, Gulfstream Service Bulletin 100-31-284, Revision 1, dated May 27, 2011, must be used to accomplish the actions required by this paragraph.
(4) Within 250 flight hours after June 25, 2010 (the effective date of AD 2010-11-02, Amendment 39-16307 (75 FR 28485, May 21, 2010)), but no later than within 6 months after the effective date of this AD: Verify that the log of modification of the relevant AFM includes reference to MOD G1-20052, and, if no reference is found, revise the log of modification of the AFM to include reference to the modification.
(5) Doing the modifications specified in paragraphs (h)(1), (h)(2), (h)(3), and (h)(4) of this AD terminates the requirements of paragraph (g) of this AD, and after the modifications have been done, the AFM limitation required by paragraph (g) of this AD may be removed from the AFM.
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI Israeli Airworthiness Directive 31-06-11-05R1, dated May 18, 2011; and the applicable service information identified in paragraphs (j)(1) through (j)(5) of this AD; for related information.
(1) Gulfstream Service Bulletin 100-31-284, Revision 1, dated May 27, 2011.
(2) Gulfstream Service Bulletin 100-31-284, dated August 17, 2006.
(3) Honeywell Service Bulletin 80-0548-31-0001, dated April 1, 2006.
(4) Honeywell Service Bulletin 80-0548-31-0002, dated March 1, 2006.
(5) Honeywell Service Bulletin 80-5090-31-0001, dated March 1, 2006.
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Notice of proposed rulemaking.
This document proposes to amend the U.S. Customs and Border Protection (CBP) regulations to set forth due process procedures for CBP to follow before suspending or revoking assigned entry filer codes, immediate delivery privileges or remote location filing privileges. These proposed changes will codify in the regulations due process procedures consistent with the Administrative Procedure Act before CBP takes actions on these programs depriving an importer of these privileges.
Comments must be received on or before April 29, 2013.
You may submit comments, identified by
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For operational questions, Laurie Dempsey, Trade Policy and Programs, Office of International Trade, Tel. (202) 863-6509. For legal questions, Blake Harden, Trade and Finance, Office of Chief Counsel, Tel. (202) 344-2972.
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. U.S. Customs and Border Protection (CBP) also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rule. If appropriate to a specific comment, the commenter should reference the specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change.
When an agency acts to deprive a person of a property interest, the Constitution of the United States requires procedures that appropriately
The APA (Section 558 of title 5 of the United States Code) provides, in relevant part, that except in cases of willfulness or those in which public health, interest, or safety requires otherwise, the withdrawal, suspension, revocation, or annulment of a license is lawful only if, before the institution of agency proceedings, the licensee has been given—(1) Notice by the agency in writing of the facts or conduct which may warrant the action; and (2) opportunity to demonstrate or achieve compliance with all lawful requirements. 5 U.S.C. 558(c).
Since participation in CBP programs involving entry filer codes, immediate delivery, and remote location filing all require the satisfaction of certain eligibility requirements, they are akin to licenses for the purpose of the APA. To comply with the due process requirements, CBP proposes to amend 19 CFR parts 142 and 143 by adding notice requirements and appeal procedures for the suspension or revocation of an assigned entry filer code and for the discontinuance of immediate delivery and remote location filing procedures before CBP takes action on these programs depriving an importer or broker of these privileges.
An entry filer code is a unique three character (alphabetic, numeric, or alpha numeric) number assigned by CBP to all licensed brokers filing CBP consumption entries and all importers filing CBP entries through the Automated Broker Interface (ABI) system.
In order to file electronically, an importer or broker must have an active entry filer code and be approved to use the ABI system. The ABI is a module of CBP's automated systems that permits qualified participants to electronically file required import data with CBP.
Current CBP regulations provide that the Assistant Commissioner, Office of International Trade, or his designee may refuse to allow use of an assigned entry filer code if it is misused by the importer or broker.
In this document, CBP is proposing to amend the CBP regulations by limiting its ability to invalidate an entry filer code in order to provide due process protections to approved ABI entry filers with regard to the suspension or revocation of entry filer codes. More specifically, this document proposes to revise § 142.3a(d) of title 19 of the CFR to provide notice requirements and appeal procedures for suspending or revoking an entry filer code.
CBP proposes to add new subsection (1) to paragraph (d) in § 142.3a to provide that, in the event a port director finds that an assigned entry filer code has been misused by the importer or broker, CBP will provide the importer or broker with written notice proposing the suspension or revocation of the entry filer code, including a description of the facts or conduct warranting the action. The importer or broker will have the opportunity to appeal the port director's decision in writing within 10 calendar days of receiving the written notice. Within 30 working days after receiving a timely filed appeal, the Assistant Commissioner, Office of International Trade, or his designee, will issue a decision in writing on the proposed action. If the importer or broker does not timely appeal the written notice, the notice proposing the suspension or revocation of the entry filer code becomes CBP's final decision as of the date that the appeal period expires. This section provides that the importer or broker may continue to use the entry filer code during the appeal period and that the entry filer code will not be suspended or revoked unless the appeal process has been concluded with a decision adverse to the importer or broker.
CBP also proposes to add § 142.3a(d)(2) to title 19 of the CFR to allow the port director to immediately suspend an entry filer code upon written notice to the importer or broker in the case of willfulness or in those cases in which public health, interest, or safety so requires. The written notice provided to the importer or broker will contain a description of the facts or conduct warranting the immediate action. The importer or broker will be offered the opportunity to appeal the port director's decision within 10 calendar days of receiving the written notice providing for immediate discontinuance. Within 15 working days after receiving a timely filed appeal from the importer or broker, the Assistant Commissioner, Office of International Trade, or his designee, will issue a decision in writing on the discontinuance. If no timely appeal is received, the notice becomes the final decision of CBP as of the date that the appeal period expires. This section provides that the entry filer code remains suspended or revoked unless the appeal is resolved in favor of the importer or broker.
CBP also proposes to amend the procedures for discontinuing immediate delivery and remote location filing privileges.
Section 448(b) of the Tariff Act of 1930, as amended, authorizes the Secretary of the Treasury to promulgate regulations allowing the issuance of special permits for delivery, prior to formal entry, of perishable articles and other articles for which immediate delivery is necessary. 19 U.S.C. 1448(b).
Accordingly, under certain circumstances merchandise may be released under a special permit for immediate delivery.
Currently, the port director has the authority to discontinue immediate delivery privileges under certain circumstances.
Specifically, CBP proposes to add § 142.25(c)(1) to title 19 of the CFR to require CBP to provide the importer with written notice proposing the discontinuation of the immediate delivery privileges, including a description of the facts or conduct warranting the action. The importer will have the opportunity to appeal the port director's decision in writing within 10 calendar days of receiving the written notice. Within 30 working days after receiving a timely filed appeal from the importer, the Assistant Commissioner, Office of International Trade, or his designee, will issue a decision in writing on the proposed action. If the importer does not timely appeal the written notice, the notice proposing the discontinuation of the immediate delivery privilege becomes the final decision of CBP as of the date that the appeal period expires. This section provides that in the case of a proposed discontinuance, the importer may continue to use immediate delivery during the appeal period and immediate delivery privileges will not be discontinued unless the appeal process has been concluded with a decision adverse to the importer or broker.
CBP also proposes to add § 142.25(c)(2) to title 19 of the CFR to allow the port director to immediately discontinue immediate delivery privileges upon written notice to the importer in the case of willfulness or those in which public health, interest, or safety so requires. The written notice provided to the importer will contain a description of the facts or conduct warranting the immediate action. The importer will be offered the opportunity to appeal the port director's decision within 10 calendar days of receiving the written notice providing for immediate discontinuance. Within 15 working days after receiving a timely filed appeal from the importer, the Assistant Commissioner, Office of International Trade, or his designee, will issue a decision in writing on the discontinuance. If no timely appeal is received, the notice becomes the final decision of CBP as of the date that the appeal period expires. This section provides that in the case of an immediate discontinuance, immediate delivery privileges remain discontinued unless the appeal is resolved in favor of the importer or broker.
Remote location filing is an elective method of making entry by which a customs broker with a national permit electronically transmits all data associated with an entry that CBP can process in a completely electronic data interchange, filed from a location other than where the goods are being entered.
Section 1414(a)(2) of title 19 of the U.S. Code sets forth the requirements for a program participant to file from a remote location. Program participant is defined as any party entitled to enter merchandise under 19 U.S.C. 1484(a)(2)(B).
Currently, so long as a remote location filer meets all of the compliance requirements and operational standards for remote location filing and adheres to all applicable laws and regulations, it qualifies for filing from a remote location.
Specifically, this document proposes to amend subpart E of Part 143 of 19 CFR by adding a new § 143.46, entitled
CBP proposes to add § 143.46(b)(1) to 19 CFR to require CBP to provide the remote location filer with written notice proposing the discontinuance of the remote location filing privileges, including a description of the facts or conduct warranting the action. The remote location filer will have the opportunity to appeal the port director's decision in writing within 10 calendar days of receiving the written notice. Within 30 working days after receiving a timely filed appeal from the remote location filer, the Assistant Commissioner, Office of International Trade, or his designee, will issue a decision in writing on the proposed action. If an appeal is not timely received, the notice proposing the discontinuance of the remote location filing privilege becomes the final decision of CBP as of the date that the appeal period expires. This section provides that in the case of a proposed discontinuance, the remote location filer may continue to file remotely during the appeal period and remote location filing privileges will not be discontinued unless the appeal process has been concluded with a decision adverse to the filer.
CBP also proposes to add § 143.46(b)(2) to 19 CFR to allow the port director to immediately discontinue remote location filing privileges upon written notice to the remote location filer in the case of willfulness or those in which public health, interest, or safety so requires. The written notice provided to the remote location filer will contain a description of the facts or conduct warranting the immediate action. The remote location filer will be offered the
This rule is not a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563, and has not been reviewed by the Office of Management and Budget (OMB) under that order.
This section examines the impact of the rule on small entities as required by the Regulatory Flexibility Act (5 U.S.C. 603), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people).
As stated above, CBP exercises its authority to suspend or revoke entry filer codes, immediate delivery privileges, or remote location filing privileges fewer than ten times a year for each type of authority. It is unknown how many of the affected parties, primarily customs brokers, are small businesses, but the number will be very small. In addition, the impact to these parties is expected to be low (cost to prepare and submit the appeal to CBP) and beneficial (establishment of due process). CBP will certify, therefore, that this rule will not have a significant impact on a substantial number of small entities if it does not receive any comments to the contrary.
As the collection of information proposed in this document applies to fewer than ten respondents annually, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) do not apply.
This proposed regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.
Canada, Customs duties and inspection, Mexico, Reporting and recordkeepingrequirements.
Customs duties and inspection, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, parts 142 and 143 of title 19 of the CFR (19 CFR parts 142 and 143) are proposed to be amended as set forth below.
19 U.S.C. 66, 1448, 1484, 1624.
(d)
(1)
(2)
(c)
(1)
(2)
19 U.S.C. 66, 1414, 1481, 1484, 1498, 1624, 1641.
(a)
(1) No longer meets the eligibility criteria set forth in § 143.43,
(2) Fails to file all additional information required by CBP pursuant to § 143.45; or
(3) Fails to adhere to all applicable laws and regulations.
(b)
(1)
(2)
Office of Surface Mining Reclamation and Enforcement (“OSM”), Interior.
Proposed rule; public comment period and opportunity for public hearing.
OSM announces receipt of a proposed amendment to the Pennsylvania regulatory program under the Surface Mining Control and Reclamation Act of 1977 (“SMCRA” or the “Act”). Pennsylvania's proposed amendment consists of the addition of new definitions and revisions to Pennsylvania's regulations on the use of the Coal Refuse Disposal Control Fund (“CRDCF”) and permit and reclamation fees.
This document provides the times and locations that the Pennsylvania program and proposed amendment are available for public inspection, the comment period during which you may submit written comments, and the public hearing procedures if a hearing is requested.
We will accept written comments on these amendments until 4:00 p.m., Eastern Standard Time (“EST”) March 28, 2013. If requested, we will hold a public hearing on the amendment on March 25, 2013. We will accept requests to speak at a hearing until 4:00 p.m., EST on March 13, 2013.
You may submit comments, identified by SATS No. PA-162-FOR by any of the following methods:
•
•
•
In addition, you may review a copy of the amendment during regular business hours at one of the following locations:
Ben Owens, Chief, Pittsburgh Field Division; Telephone: (412) 937-2827. Email:
Section 503(a) of the SMCRA permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, “a State law which provides for the regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act * * * ; and rules and regulations consistent with regulations issued by the Secretary pursuant to this Act.” 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Pennsylvania program, effective July 30, 1982. You can find background information on the Pennsylvania program, including the Secretary's findings, the disposition of comments, and the conditions of approval of the Pennsylvania program in the July 30, 1982,
By letter dated December 19, 2012, (Administrative Record Number PA 895.00), Pennsylvania sent OSM a request to approve regulations related to Pennsylvania coal fees. Pennsylvania is requesting approval of regulations found at 25 Pa. Code Chapter 86, sections 1, 3, and 17.
Pennsylvania proposes the addition of two terms to the “Definitions” section of Chapter 86, of the Pennsylvania regulations dealing with general aspects of surface and underground coal mining. Pennsylvania proposes to add the terms “major permit revision” and “permit application fee” to this section. The definition of “major permit revision” is proposed to be, a revision to a coal mining permit that requires public notice. The definition of “permit application fee” is proposed to be, a nonrefundable filing fee due at the time of submission of an application. The permit application fee is required for an application to be considered complete.
Additionally, Pennsylvania proposes to add a subsection to section 86.3, regarding the use of the CRDCF. The new subsection (b) will, if approved, require permit application fees submitted under the Coal Refuse and Disposal Act to be used to finance the costs of review of the applications.
Further, Pennsylvania proposes to increase the permit application fees. Currently, a permit application for coal mining activities or an application for a coal preparation plant is required to be submitted with an application fee of $250. Currently, coal refuse disposal activities require a fee of $500 plus an additional $10 per acre for acreage in excess of 50 acres. The proposed amendment increases the fees and creates new categories of permits with differing fees. Surface mining and coal refuse disposal permits will be assessed a fee of $3,250; coal refuse reprocessing permits will be assessed a fee of $1,900; coal preparation plant, anthracite underground mining, and incidental extraction permits will be assessed a fee of $1,650; bituminous underground mining permits will be assessed a fee of $5,750; and post-mining activity permits will be assessed a fee of $300. Under subsection (b)(2) of the proposed amendment, a new fee is imposed for major permit revisions. This fee is either $300 or $1,250, dependent upon the permit type. The proposed subsection (b)(3) introduces a new fee of $250 for permit transfers. The renewal fee assessed under the current regulation still exists at the rate of $250. The details of this fee are detailed in proposed subsection (b)(4). Additionally, a new fee for auger safety and bond liability revisions is proposed to be assessed in the amount of $200 and $100, respectively.
The proposed subsection (c) describes how the collected fees will be allocated. Permit application fees collected for surface coal mine facilities, coal refuse reprocessing facilities, and coal mining activity facilities will be deposited in the Surface Mining Conservation and Reclamation Fund. Permit application fees for bituminous underground mines will be deposited in the Bituminous Mine Subsidence and Land Reclamation Fund. The fees collected for coal refuse disposal facilities are to be deposited in the CRDCF.The proposed amendment also proposes adding a new component at subsection (d). This subsection requires the Department of Environmental Protection to review the adequacy of the permit application fees at least once every three years. The results of this review must be submitted in writing to the Environmental Quality Board. Specifically, the proposed report will identify and reconcile any disparity between the amount of income generated by the fees and the costs to administer these programs as well as recommend a fee increase, if necessary.
Subsection (e) of the current regulation will remain unaltered.
Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether Pennsylvania's proposed amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of Pennsylvania's State Program.
If you submit written comments, they should be specific, confined to issues pertinent to the proposed regulations, and explain the reason for any recommended change(s). We appreciate any and all comments, but those most useful and likely to influence decisions on the final regulations will be those that either involve personal experience or include citations to and analysis of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications.
We cannot ensure that comments received after the close of the comment period (see
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment including your personal identifying information may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
If you wish to speak at the public hearing, contact the person listed under
To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at the public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak and others present in the audience who wish to speak, have been heard.
If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under
This rule is exempted from review by the Office of Management and Budget (“OMB”) under Executive Order 12866.
When a State submits a program amendment to OSM for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the
Intergovernmental relations, Surface mining, Underground mining.
Office of Surface Mining Reclamation and Enforcement, Interior.
Proposed rule; public comment period and opportunity for public hearing on proposed amendment.
We are announcing receipt of a proposed amendment to the Wyoming regulatory program (hereinafter, the “Wyoming program”) under the Surface Mining Control and Reclamation Act of 1977 (“SMCRA” or “the Act”). Wyoming proposes both revisions of and additions to its coal rules and regulations concerning ownership and control, adds a provision concerning variable topsoil depths during reclamation, and addresses four deficiencies that were identified by OSM during the review of a previous program amendment (WY-038-FOR; Docket ID No. OSM-2009-0012). Wyoming intends to revise its program to be consistent with the corresponding Federal regulations and SMCRA, clarify ambiguities, and improve operational efficiency.
This document gives the times and locations that the Wyoming program and proposed amendment to that program are available for your inspection, the comment period during which you may submit written comments on the amendment, and the procedures that we will follow for the public hearing, if one is requested.
We will accept written comments on this amendment until 4:00 p.m., m.d.t. March 28, 2013. If requested, we will hold a public hearing on the amendment on March 25, 2013. We will accept requests to speak until 4:00 p.m., m.d.t. on March 13, 2013.
You may submit comments by either of the following two methods:
•
•
For detailed instructions on submitting comments and additional information on the rulemaking process, see the “III. Public Comment Procedures” in the
In addition to viewing the docket and obtaining copies of documents at
Jeffrey Fleischman, Telephone: (307) 261-6547. Internet:
Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal
By letter dated January 8, 2013, Wyoming sent us a proposed amendment to its approved regulatory program (Administrative Record Docket ID No. OSM-2013-0002) under SMCRA (30 U.S.C. 1201
Specifically, Wyoming proposes to amend the Land Quality Division Coal Rules and Regulations at Chapter 1, Section 2 (definitions related to ownership and control including “Applicant violator system or AVS,” “Control or controller,” “Notice of violation,” and “Own, owner or ownership”); Chapter 2, Section 2(a)(i) and (ii) (ownership and control permit application information including identification of interests and a complete statement of compliance); Chapter 12, Section 1(a)(viii)-(xiv) (the review process, procedures, and requirements for making permit eligibility determinations including: Review of applicant and operator information, review of permit history, review of compliance history, and related AVS entry requirements); and Chapter 16, Section 2(h) and (j) (notification requirements related to Wyoming's enforcement regulations and AVS entry requirements). Wyoming also proposes to add a provision which allows for variable replacement depths for topsoil during reclamation at Chapter 4, Section 2(c)(v). Lastly, Wyoming addresses four deficiencies that OSM identified in response to Wyoming's formally submitted revegetation rule package (WY-038-FOR; Docket ID No. OSM-2009-0012)) including: Adding the term “surface” back into Wyoming's rules where it had been deleted and reinstating the definition of “Surface coal mining and reclamation operations” at Chapter 1, Section 2(ez) that had been removed from Wyoming's rules; adding the 1:24,000 scale requirement for maps that are submitted with permit applications back into Wyoming's rules at Chapter 2, Section 1(c); adding language to clarify that wildlife enhancement is not limited to revegetation efforts at Chapter 2, Section 5(a)(viii); and correcting numerous inaccurate citations to other sections of Wyoming's rules and regulations. The full text of the program amendment is available for you to read at the locations listed above under
Under the provisions of 30 CFR 732.17(h), we are seeking your comments on whether the amendment satisfies the applicable program approval criteria of 30 CFR 732.15. If we approve the amendment, it will become part of the Wyoming program.
If you submit written comments, they should be specific, confined to issues pertinent to the proposed regulations, and explain the reason for any recommended change(s). We appreciate any and all comments, but those most useful and likely to influence decisions on the final regulations will be those that either involve personal experience or include citations to and analyses of SMCRA, its legislative history, its implementing regulations, case law, other pertinent State or Federal laws or regulations, technical literature, or other relevant publications.
We cannot ensure that comments received after the close of the comment period (see
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available in the electronic docket for this rulemaking at
If you wish to speak at the public hearing, contact the person listed under
To assist the transcriber and ensure an accurate record, we request, if possible, that each person who speaks at a public hearing provide us with a written copy of his or her comments. The public hearing will continue on the specified date until everyone scheduled to speak has been given an opportunity to be heard. If you are in the audience and have not been scheduled to speak and wish to do so, you will be allowed to speak after those who have been scheduled. We will end the hearing after everyone scheduled to speak and others present in the audience who wish to speak, have been heard.
If only one person requests an opportunity to speak, we may hold a public meeting rather than a public hearing. If you wish to meet with us to discuss the amendment, please request a meeting by contacting the person listed under
This rule is exempted from review by the Office of Management and Budget (OMB) under Executive Order 12866 (Regulatory Planning and Review).
When a State submits a program amendment to OSM for review, our regulations at 30 CFR 732.17(h) require us to publish a notice in the
Intergovernmental relations, Surface mining, Underground mining.
Postal Service
Request for comments.
The Postal Service is exploring the advisability of requiring the use of Intelligent Mail® package barcodes (IMpb) or unique tracking Intelligent Mail barcodes (IMb
Comments are due on March 28, 2013.
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 4446, Washington, DC 20260-5015. You may inspect and photocopy all written comments at USPS® Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor North, Washington, DC, by appointment only between the hours of 9 a.m. and 4 p.m., Monday through Friday. Call 1-202-268-2906 in advance for an appointment. Email comments, containing the name and address of the commenter, may be sent to:
Jeffrey L. Freeman at 202-268-2922 or Kevin Gunther at 202-268-7208.
The Postal Service continues to enhance its operational capability to provide scanning data of IMpb and other tracking barcodes through the use of automated processing equipment and Intelligent Mail scanning devices. The tracking data provided by IMpb, including acceptance, enroute, and delivery status data, will provide value to the Postal Service, to mailers and to their shared customer base.
IMpb can offer a number of additional benefits by providing mailers with access to piece-level visibility throughout the Postal Service's processing and delivery operations. The basic structure of IMpb includes:
• A routing code to facilitate the processing of parcels on automated sorting equipment.
• A channel-specific Application Identifier (AI) that associates the barcode to the payment method, supporting revenue assurance.
• A 3-digit service type code, which identifies the exact mail class and service combination, eliminating the need for multiple barcodes on a parcel.
• An option to use a 6-digit or 9-digit numeric Mailer ID (MID), to accommodate all mailers.
• A serial number that enables uniqueness and supports piece-level visibility.
These features contribute to the data-stream efficiency within USPS® mail processing, delivery, payment, and reporting. Intelligent Mail package barcodes also include specific “mail class only” service type codes that may be used for parcels without extra services.
The mailing industry was first provided notice of the intent of the Postal Service to require the mandatory use of IMpb on all domestic packages via an advanced notice of proposed rulemaking,
The Postal Service is now considering the addition, at a future date, of a new requirement for all remaining commercial parcels to bear an IMpb. Mailers of these parcels will also be required to transmit electronic documentation to the Postal Service using version 1.6 (or a newer version) of the Shipping Services Manifest File. If this requirement is adopted, it would apply to all commercial parcels, without regard to presort or entry level, and would generally include commercial parcels of all classes with the exception of Express Mail entered through Express Mail Corporate Account. The Postal Service would expect to implement these new standards on or about July 28, 2013.
Additionally, the Postal Service is investigating alternative processes that would permit some categories of Standard Mail to bear a unique IMb instead of an IMpb. If the Postal Service determines that the use of an IMb is a viable option in these limited circumstances, those mailers using this option will be required to transmit piece-level data to the Postal Service in a Mail.dat or Mail.XML format. Mailers who use the IMb format will not receive delivery scans on their pieces unless they comply with Postal Service requirements for additional identifying marks indicating that confirmation services are requested. The Postal Service is also exploring options to accommodate a modified tracking process for some categories of Standard mail parcels, such as Simple Samples
Mailers will benefit from the tracking services provided with IMpb, both from improved service performance and from more efficient postal operations. The Postal Service anticipates that the enhancements to parcel visibility following these changes in standards will produce the following benefits:
• Enable customer-level service reporting;
• Support accurate customer volume reporting;
• Provide data for identifying, diagnosing, and correcting service issues;
• Enable the use of scanning technology to reduce distribution costs in delivery units by allowing non-scheme-trained employees to perform parcel distribution to carrier routes, resulting in greater flexibility in staffing and savings on training expenses;
• Provide advance notice of workload to improve planning in processing and delivery operations;
• Support improved understanding of, and opportunities to reduce, postal costs;
If these new standards are adopted, the Postal Service also expects to provide support to its smaller and mid-sized mailers in applying IMpb-compliant labels to every commercial parcel. The Postal Service intends to provide pre-printed IMpb-compliant tracking barcodes to permit imprint and postage meter mailers for use with non-presorted mailings, and to provide tools for Merchandise Return Service (MRS) permit holders to enable their customers to print IMpb-compliant MRS labels online.
To improve piece-level visibility within USPS processing, the Postal Service is investigating the operational feasibility of electronically associating individual parcel tracking numbers with specific sacks, trays, pallets, or similar containers. Depending on the results, the Postal Service may, at a future date, establish a requirement for all commercial parcel mailers to electronically transmit Intelligent Mail tray barcode (IMtb) and Intelligent Mail container barcode (IMcb) nesting data to the Postal Service. Nesting data would be required to be included in the shipment manifest or to be transmitted through another approved electronic documentation method. Recognizing that package mailers have not previously been required to use these barcodes, if this requirement is adopted, the Postal Service will work with the industry to support transitioning to the use of these barcodes, and to determine the proper timing for its implementation.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania for Allegheny County Health Department (ACHD). This SIP revision consists of a demonstration that Allegheny County's portion of the Pennsylvania requirements of reasonably available control technology (RACT) for nitrogen oxides (NOx) and volatile organic compounds (VOCs) satisfies the RACT requirements set forth by the Clean Air Act (CAA). This SIP revision demonstrates that all requirements for RACT are met either through Certification that previously adopted RACT controls in Allegheny County's SIP that were approved by EPA under the 1-hour ozone national ambient air quality standards (NAAQS) are based on the currently available technically and economically feasible controls, and continue to represent RACT for the 8-hour ozone NAAQS, a negative declaration demonstrating that no facilities exist in Allegheny County for certain control technology guideline (CTG) categories; and a new RACT determination for a specific source. This action is being taken under the CAA.
Written comments must be received on or before March 28, 2013.
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2013-0055 by one of the following methods:
A.
B.
C.
D.
Emlyn Velez-Rosa, (215) 814-2038, or by email at
Ozone is formed in the atmosphere by photochemical reactions between VOC, NOx, and carbon monoxide (CO) in the presence of sunlight. In order to reduce ozone concentrations in the ambient air, the CAA requires all nonattainment
Since the 1970s, EPA has consistently interpreted RACT to mean the lowest emission limit that a particular source is capable of meeting by the application of the control technology that is reasonably available considering technological and economic feasibility.
The second requirement, set forth in section 182(b)(2) of the CAA, applies to moderate (or worse) ozone nonattainment areas and attainment areas in the ozone transport region (OTR) established pursuant to section 184 of the CAA. These areas are required to implement RACT controls on all major VOC and NOx emission sources and on all sources and source categories covered by a CTG issued by EPA. Allegheny County has adopted all CTGs and they are listed in Section II of this notice. Further details of Allegheny County's RACT requirements can be found in a Technical Support Document (TSD) prepared for this rulemaking and included in the docket at EPA-R03-OAR-2013-0055.
Section 182(b)(2) of the CAA required Allegheny County to implement RACT on all sources and source categories covered by a CTG issued by EPA. Stationary sources with the potential to emit 50 tons per year or more of VOCs or 100 tons per year or more of NOx that were not covered by a CTG were also required to implement RACT.
The ozone transport region (OTR) is established by section 184 of the CAA. Areas in the OTR are subject to OTR-specific RACT requirements. Section 184(b)(1)(B) of the CAA requires the implementation of RACT with respect to all sources of VOC covered by a CTG. Additionally, section 184(b)(2) of the CAA requires the implementation of major stationary source requirements as if the area was a moderate nonattainment area on any stationary source with a potential to emit at least 50 tons per year of VOC or 100 tons per year of NOx. Because Allegheny County is in Pennsylvania which is in the OTR, Allegheny County must comply with section 184(b)(1)(B) and (2) of the CAA.
EPA requires for the 8-hour ozone NAAQS that states meet the CAA RACT requirements, either through a certification that previously adopted RACT controls in their SIP approved by EPA under the 1-hour ozone NAAQS represent adequate RACT control levels for 8-hour ozone NAAQS attainment purposes or through the establishment of new or more stringent requirements that represent RACT control levels.
As set forth in the preamble to the Phase 2 Rule, a certification must be accompanied by appropriate supporting information such as consideration of information received during the public comment period and consideration of new data (70 FR 71612, 71655). This information may supplement existing RACT guidance documents that were developed for the 1-hour ozone standard, such that the state's SIP accurately reflects RACT for the 8-hour ozone standard based on the current availability of technically and economically feasible controls. Establishment of new RACT requirements will occur when states have new stationary sources not covered by existing RACT regulations, or when new data or technical information indicates that a previously adopted RACT measure does not represent a newly available RACT control level. Another 8-hour ozone NAAQS requirement for RACT is to submit a negative declaration if there are no CTG sources or major sources of VOC and NOx emissions in lieu of or in addition to a certification.
On May 5, 2009, the Pennsylvania Department of Environmental Protection (PADEP) submitted a revision on behalf of ACHD for its SIP that addresses the requirements of RACT under the 8-hour ozone NAAQS set forth by the CAA. Allegheny County's SIP revision is consistent with the process in the Phase 2 Rule preamble and satisfies the requirements of RACT set forth by the CAA under the 8-hour ozone NAAQS through: (1) Certification that previously adopted RACT controls in Allegheny County's SIP, which were approved by EPA under the 1-hour ozone NAAQS, are based on the currently available, technically and economically feasible controls and continue to represent RACT for the 8-hour ozone NAAQS; (2) a negative declaration demonstrating that no facilities exist in Allegheny County for the applicable CTG categories; and (3) a new RACT determination for a single source based upon reliance on the Maximum Achievable Control Technology (MACT) standard as allowed in the Phase 2 Rule.
Allegheny County's Regulations, codified at Article XXI, contain the County's CTG VOC RACT controls that were implemented and approved in the Allegheny County SIP under the 1-hour ozone NAAQS. Table 1 lists Allegheny County's VOC RACT controls for which Allegheny County has provided the required evaluation and is certifying as meeting the 8-hour ozone NAAQS RACT requirements. Revisions to Article XXI section 2105.10 for surface coating processes and related definitions found in Article XXI section 2101.20 were made after this May 5, 2009 SIP submittal and approved by EPA into the Pennsylvania SIP on December 28, 2010 (75 FR 81480) and supersede the May 5, 2009 submittal. EPA approved new regulations in the December 28, 2010 rulemaking action including emission limits for Large Appliance and Metal Surface Coatings, Article XXI section 2105.77 and emission limits for Paper, Film, and Foil Surface Coatings, Article XXI section 2105.79. Allegheny County also incorporated by reference Pennsylvania's Consumer Products Rule that amended Article XXI section 2105.88, which was finalized by EPA on
ACHD also submitted a negative declaration certifying that the following VOC CTG sources listed in table 2 do not exist in Allegheny County, and therefore ACHD does not need to adopt CTGs for these sources. Table 2 lists VOC CTG sources in Allegheny County's negative declaration.
Table 3 lists Allegheny County's source-specific RACT controls, which were implemented and approved into the SIP under the 1-hour ozone NAAQS, for which Allegheny County is certifying as meeting the 8-hr ozone NAAQS RACT requirements for VOC and/or NO
Finally, the Laurel Mountain Whirlpool facility did not have a 1-hour ozone NAAQS RACT determination, but is subject to the MACT standards of 40 CFR 63 subpart WWWW, which has been determined sufficient for VOC 8-hour ozone NAAQS RACT in accordance with the Phase 2 Rule. Further details of ACHD's RACT re-evaluations can be found in the TSD prepared for this rulemaking.
EPA is proposing to approve the ACHD SIP revision that addresses the requirements of RACT under the 8-hour ozone NAAQS, which was submitted on May 5, 2009. This SIP revision includes a combination of: (1) Certifications that previously adopted RACT controls in Pennsylvania's SIP which were approved by EPA under the 1-hour ozone NAAQS are based on the currently available, technically and economically feasible controls and continue to represent RACT for the 8-hour ozone NAAQS; (2) a negative declaration demonstrating that no facilities exist in Allegheny County for the applicable CTG categories; and (3) a new RACT determination for a single source. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using
In addition, this proposed rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the Allegheny County RACT SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Federal Maritime Commission.
Notice of proposed rulemaking.
The Federal Maritime Commission proposes to impose registration requirements on foreign-based unlicensed non-vessel-operating common carriers (NVOCCs) and to extend an exemption from certain provisions and requirements of the Shipping Act of 1984 and the Commission regulations to foreign-based unlicensed non-vessel-operating common carriers that agree to negotiated rate arrangements (NRAs). The extension of the exemption is to make NRAs more useful and to enhance competition among all NVOCCs.
Comments or suggestions due on or before: April 29, 2013.
Submit all comments concerning this proposed rule to: Karen V. Gregory, Secretary, Federal Maritime Commission, 800 North Capitol Street NW., Washington, DC 20573-0001, Phone: (202) 523-5725, Email:
Rebecca A. Fenneman, General Counsel, Federal Maritime Commission, 800 North Capitol Street NW., Washington, DC 20573-0001, Phone: (202) 523-5740, Email:
On March 2, 2011, the Commission published a final rule promulgating 46 CFR part 532, Docket No. 10-03,
However, concerns about extending the exemption to foreign-based unlicensed NVOCCs were raised by staff.
The Commission later issued a Notice of Inquiry, Docket No. 11-22,
The Commission may exempt any specified future activity from any requirements of the Shipping Act of 1984 “if the Commission finds that the exemption will not result in substantial reduction in competition or be detrimental to commerce.” 46 U.S.C. 40103. The Commission may attach conditions to an exemption and may, by order, revoke an exemption.
Commission staff, however, raised concerns that extending the exemption to foreign-based unlicensed NVOCCs could hamper the Commission's ability to protect the shipping public, as the exemption is predicated, among other things, on the prompt availability of records.
Those discussions brought to light the need for a registration process for foreign-based unlicensed NVOCCs. The registration process requires such NVOCCs submit a registration form to the Commission that identifies the NVOCCs' legal name, trade name(s), principal address, contact information including name of a contact person, and name, address, and contact person for a
A strong majority of comments received by the Commission in Docket No. 10-03
Without the registration requirements and other conditions, extending the exemption to foreign-based unlicensed NVOCCs may be detrimental to commerce by reducing the Commission's ability to protect the shipping public. Therefore, to address those concerns, the Commission proposes extending the exemption subject to the following:
• Foreign-based unlicensed NVOCCs must be registered with the Commission in accordance with § 515.19 of this proposed rule.
• Such registrations are effective for 3 years, as stated in § 515.19(d) of this proposed rule.
• Such registrations may be terminated or suspended pursuant to § 515.19(g) of this proposed rule, which includes failure to comply with 46 CFR 515.24 Agent for service of process.
• As stated in § 532.7 of this proposed rule, all NVOCCs that enter into NRAs are subject to the Commission's inspection and reproduction requests and must produce the requested NRAs promptly in response to a Commission request. All records produced must be in English or be accompanied by a certified English translation.
The collection of information requirements contained in this proposed 46 CFR parts 515 and 532 have been submitted to the Office of Management and Budget for review under section 3504(h) of the Paperwork Reduction Act of 1980, as amended. 44 U.S.C. 3501
According to the Small Business Administration's regulation, “a small business is a business entity organized for profit, with a place of business located in the United States, and which operates primarily within the United States or which makes a significant contribution to the U.S. economy through payment of taxes or use of American products, materials or labor.” 13 CFR 121.105(a)(1). As foreign-based unlicensed NVOCCs have their principal place of business in foreign countries and operate primarily in foreign countries, they are not small businesses as defined by the regulation and, thus, are not small entities under the Regulatory Flexibility Act (RFA). 5 U.S.C. 601-612. Therefore, this rulemaking is not subject to the RFA.
This proposed rule is not a “major rule” under 5 U.S.C. 804(2).
Freight, Freight forwarders, Maritime carriers, Reporting and recordkeeping requirements.
Freight, Intermodal transportation, Maritime carriers, Reporting and recordkeeping requirements.
Exports, Non-vessel-operating common carriers, Ocean transportation intermediary.
For the reasons stated in the
5 U.S.C. 553; 31 U.S.C. 9701; 46 U.S.C. 305, 40102, 40104, 40501-40503, 40901-40904. 41101-41109, 41301-41302, 41305-41307; Pub. L. 105-383, 112 Stat. 3411; 21 U.S.C. 862.
(a) Any person whose primary place of business is located outside the United States that elects to operate as a registered NVOCC in the United States foreign trade shall register with the Commission by submitting to the Director of the Bureau of Certification and Licensing (BCL) a completed registration form, Form FMC-65 (Foreign-based Unlicensed NVOCC Registration/Renewal). A notice of each registration shall be published on the Commission's Web site www.fmc.gov. It is a violation of the Commission's regulations implementing the Shipping Act for a foreign-based unlicensed non-vessel-operating common carrier to provide NVOCC services in the U.S. foreign trade without a valid registration and an effective tariff.
(b) A registration form which appears, upon submission, to be substantially incomplete may be rejected. If rejected, a notice, together with the reasons therefore, shall be sent to the foreign-based unlicensed NVOCC and the filing fee shall be refunded. Persons who have had a registration rejected may submit a new registration at any time together with the applicable fee.
(c) Registrations are complete upon receipt of a registration form which meets the requirements of this section and upon evidence of financial responsibility being furnished pursuant to § 515.21.
(d) Registrations shall be effective for a period of three (3) years. Thereafter, registrations will be renewed for sequential three year periods upon submission of an updated registration form.
(e) A tariff shall not be published and NVOCC service shall not commence until the Commission receives valid proof of financial responsibility from the registrant and a Form FMC-1 has been filed.
(f) Any changes to legal name(s) or trade name(s), principal place of business address (including telephone number, facsimile number), contact
(g)
(1)
(i) Violation of any provision of the Act, or any other statute or Commission order or regulation related to carrying on the business of an ocean transportation intermediary;
(ii) Failure to respond to any lawful order or inquiry by the Commission or an authorized Commission representative;
(iii) Making a materially false or misleading statement to the Commission in connection with a registration or renewal thereof;
(iv) Failure to honor financial obligations to the Commission;
(v) Failure to timely renew a registration;
(vi) Failure to maintain a Form FMC-1 and a tariff in compliance with 46 CFR Part 520;
(vii) Knowingly and willfully processing, booking, or accepting cargo from, or transporting cargo for the account of, an NVOCC that is not licensed or registered, or has not provided proof of financial responsibility or published an effective tariff; and
(viii) Failure to designate and maintain a person in the United States as legal agent for the receipt of judicial and administrative process, including subpoenas, as required by § 515.24.
(2) [Reserved].
(3)
(b) Service of administrative process, other than subpoenas, may be effected upon the legal agent by dispatching a copy of the document to be served by mail or courier service. Administrative subpoenas shall be served in accordance with § 502.134 of this chapter.
(c) If the designated legal agent cannot be served because of death, disability, unavailability, termination or expiration of the designation, or if a legal agent authorized to receive such service is not designated in compliance with this section, the Secretary of the Federal Maritime Commission will be deemed to be the legal agent for service of process. Any person serving the Secretary must also send to the ocean transportation intermediary, or group or association of ocean transportation intermediaries which provide financial coverage for the financial responsibilities of a member ocean transportation intermediary, by mail or courier service at the ocean transportation intermediary's, or group's, address published in its tariff, a copy of each document served upon the Secretary, and shall attest to that service at the time service is made upon the Secretary. For purposes of this paragraph, it is sufficient that a person seeking to serve process on an ocean transportation intermediary, or group of such intermediaries, affirm to the Commission's Secretary that: They have contacted, or attempted to contact, the designated agent to confirm whether it remained authorized to accept service of process; or, if no legal agent is designated in the tariff, that it has no knowledge of the identity of the ocean transportation intermediary's legal agent. Designation of the Commission's Secretary as the legal agent shall survive any cancellation of the OTI's license or tariff and shall continue for the entire period during which claims may be made under the OTI's financial responsibility instrument.
(d) Designations of legal agent under paragraphs (a) and (b) of this section and provisions relating to service of process under paragraph (c) of this section shall be published in the ocean transportation intermediary's tariff, when required, in accordance with part 520 of this chapter.
5 U.S.C. 553; 46 U.S.C. 305, 40101-40102, 40501-40503, 40701-40706, 41101-41109.
(e)
46 U.S.C. 40103.
The purpose of this Part, pursuant to the Commission's statutory authority, is to exempt non-vessel-operating common carriers (NVOCCs) from the tariff rate publication and adherence requirements of the Shipping Act of 1984, as enumerated herein.
This Part exempts NVOCCs duly licensed pursuant to 46 CFR 515.3 or registered pursuant to 46 CFR 515.19, holding adequate proof of financial responsibility pursuant to 46 CFR 515.21, and meeting the requirements of 46 CFR 532.4 through 532.7, from the following requirements and prohibitions of the Shipping Act and the Commission's regulations:
(g) * * * Any NVOCC failing to maintain its bond or license or registration as set forth above, or who has had its tariff suspended by the Commission, shall not be eligible to invoke this exemption.
(b) NRAs are subject to inspection and reproduction requests by the Commission. An NVOCC shall produce the requested NRAs promptly in response to a Commission request. All records produced must be in English or be accompanied by a certified English translation.
By the Commission.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on 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.
Comments regarding this information collection received by March 28, 2013 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
GIPSA is announcing the designation of Titus Grain Inspection, Inc. (Titus) to provide Class X or Class Y weighing services under the United States Grain Standards Act (USGSA), as amended.
Eric J. Jabs, Chief, USDA, GIPSA, FGIS, QACD, QADB, 10383 North Ambassador Drive, Kansas City, MO 64153.
Eric J. Jabs, 816-659-8408 or Eric.J.Jabs@usda.gov.
In the May 25, 2010
Titus's present designation is amended to include Class X or Class Y weighing within their assigned geographic area, effective November 20, 2012 to June 30, 2013.
Interested persons may obtain official services by contacting Titus at 765-497-2202.
7 U.S.C. 71-87k.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
GIPSA is announcing the designation of Detroit Grain Inspection Service, Inc. (Detroit); Eastern Iowa Grain Inspection and Weighing Service, Inc. (Eastern Iowa); Enid Grain Inspection Company, Inc. (Enid); Keokuk Grain Inspection Service (Keokuk); Michigan Grain Inspection Services, Inc. (Michigan); and Omaha Grain Inspection Service, Inc. (Omaha) to provide official services under the United States Grain Standards Act (USGSA), as amended.
Eric J. Jabs, Chief, USDA, GIPSA, FGIS, QACD, QADB, 10383 North Ambassador Drive, Kansas City, MO 64153.
Eric J. Jabs, 816-659-8408 or
In the September 13, 2012
Detroit, Eastern Iowa, Enid, Keokuk, Michigan, and Omaha were the sole applicants for designation to provide official services in these areas. As a result, GIPSA did not ask for additional comments.
GIPSA evaluated all available information regarding the designation criteria in section 79(f) of the USGSA (7 U.S.C. 79(f)) and determined that Detroit, Eastern Iowa, Enid, Keokuk, Michigan, and Omaha are qualified to provide official services in the geographic area specified in the
Interested persons may obtain official services by contacting these agencies at the following telephone numbers:
Section 79(f) of the USGSA authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79 (f)).
Under section 79(g) of the USGSA, designations of official agencies are effective for no longer than three years unless terminated by the Secretary; however, designations may be renewed according to the criteria and procedures prescribed in section 79(f) of the USGSA.
7 U.S.C. 71-87k.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Port of Corpus Christi Authority, grantee of FTZ 122, requesting authority to reorganize the zone under the alternative site framework (ASF) adopted by the Board (15 CFR 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the Board's standard 2,000-acre activation limit for a zone. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on February 20, 2013.
FTZ 122 was approved by the Board on September 5, 1985 (Board Order 310, 50 FR 38020, 9/19/1985) and expanded on December 6, 1991 (Board Order 545, 56 FR 65884, 12/19/1991), and on September 1, 1995 (Board Order 764, 60 FR 47149, 9/11/1995). The current zone includes the following sites in Corpus Christi:
The grantee's proposed service area under the ASF would be the Counties of Nueces, San Patricio, Aransas, Jim Wells, Kleberg and Bee, Texas, as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The proposed service area is within and adjacent to the Corpus Christi Customs and Border Protection port of entry.
The applicant is requesting authority to reorganize its existing zone project to include existing Site 1 as a “magnet” site and existing Sites 3, 7 and 8 as “usage-driven” sites. The ASF allows for the possible exemption of one magnet site from the “sunset” time limits that generally apply to sites under the ASF, and the applicant proposes that Site 1 be so exempted. The applicant is also requesting to remove Site 4 from the zone. No additional subzones/usage-driven sites are being requested at this time. The application would have no impact on FTZ 122's previously authorized subzones.
In accordance with the Board's regulations, Camille Evans of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is April 29, 2013. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to May 13, 2013.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
Import Administration, International Trade Administration, Department of Commerce.
Patricia Tran, AD/CVD Operations, Office 8, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1009.
On September 4, 2012, the Department of Commerce (the Department) published a notice of opportunity to request an administrative review of the countervailing duty order on certain lined paper products from India.
Pursuant to requests from interested parties, the Department published in the
Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. The Department published the
The Department will instruct U.S. Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries. For the company for which this review is rescinded countervailing duties shall be assessed at rates equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2011, through December 31, 2011, in accordance with 19 CFR 351.212(c)(1)(i).
The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.
This notice serves as a final reminder to parties subject to administrative protective orders (APOs) of their responsibility concerning the disposition of proprietary information disclosed under an APO in accordance
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) determines that countervailable subsidies are being provided to producers and exporters of drawn stainless steel sinks (“SS sinks”) from the People's Republic of China (“PRC”). For information on the estimated subsidy rates,
Shane Subler or Austin Redington, AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0189 or (202) 482-1664, respectively.
The petitioner in this investigation is Elkay Manufacturing Company (“Petitioner”).
The period for which we are measuring subsidies, or period of investigation, is January 1, 2011, through December 31, 2011.
The following events have occurred since the
On August 7, 2012, the Department initiated its investigation of new subsidy allegations.
On September 20, 2012, the Department published a notice aligning the deadline for this final countervailing duty (“CVD”) determination with the deadline for the final determination in the antidumping duty (“AD”) investigation.
We conducted verification of Yingao's, Superte's and the GOC's questionnaire responses from November 5, to November 16, 2012, and subsequently issued verification reports.
On January 8, 2013, the Department issued post-preliminary analyses for Yingao and Superte on January 8, 2013.
The GOC, Yingao, Superte, and Petitioner submitted case briefs on January 17, 2013, and rebuttal briefs on January 25, 2013.
In accordance with the preamble to the Department's regulations,
The products covered by the scope of this investigation are SS sinks with single or multiple drawn bowls, with or without drain boards, whether finished or unfinished, regardless of type of finish, gauge, or grade of stainless steel. Mounting clips, fasteners, seals, and sound-deadening pads are also covered by the scope of this investigation if they are included within the sales price of the SS sinks.
Excluded from the scope of the investigation are SS sinks with fabricated bowls. Fabricated bowls do not have seamless corners, but rather are made by notching and bending the stainless steel, and then welding and finishing the vertical corners to form the bowls. SS sinks with fabricated bowls
The products covered by this investigation are currently classified in the Harmonized Tariff Schedule of the United States (“HTSUS”) under statistical reporting number 7324.10.0000 and 7324.10.0010. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the products under investigation is dispositive of its inclusion as subject merchandise.
The subsidy programs under investigation and all issues raised in the case and rebuttal briefs by parties to this investigation are addressed in the Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Import Administration, titled “Issues and Decision Memorandum for the Final Determination in the Countervailing Duty Investigation of Drawn Stainless Steel Sinks from the People's Republic of China” (February 19, 2013) (hereafter, “Decision Memorandum”), which is hereby adopted by this notice. Attached to this notice as an Appendix is a list of the issues that parties have raised and to which we have responded in the Decision Memorandum. The Decision Memorandum is a public document and is on file electronically
In accordance with section 705(c)(1)(B)(i)(I) of the Tariff Act of 1930, as amended (“Act”), we have calculated an individual countervailable subsidy rate for each respondent. Section 705(c)(5)(A)(i) of the Act states that for companies not individually investigated, we will determine an all others rate equal to the weighted average of the countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and
We determine the total estimated net countervailable subsidy rates to be:
As a result of our
If the International Trade Commission (“ITC”) issues a final affirmative injury determination, we will issue a CVD order and reinstate the suspension of liquidation under section 706(a) of the Act, and we will require a cash deposit of estimated CVDs for such entries of merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (“APO”), without the written consent of the Assistant Secretary for Import Administration.
In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This determination is published pursuant to sections 705(d) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On October 4, 2012, the Department of Commerce (“Department”) published its preliminary determination of sales at less than fair value (“LTFV”) and postponement of final determination in the antidumping (“AD”) investigation of drawn stainless steel sinks (“drawn sinks”) from the People's Republic of China (“PRC”).
Frances Veith or Eve Wang, AD/CVD Operations, Office 8, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4295 or (202) 482-6231, respectively.
The Department published its
On November 15, 2012, in response to a request filed by Dongyuan, the Department extended the deadline for submission of publicly available information to November 26, 2012, and the due date for rebuttal information to December 6, 2012. On November 26, 2012, Petitioner and Dongyuan submitted surrogate value (“SV”) information for the record, and Petitioner, Dongyuan, and Superte submitted rebuttal comments to this information on December 6, 2012. On November 28, 2012, the Department extended the deadline for submission of case briefs to December 10, 2012, and the due date for rebuttals briefs to December 17, 2012. On December 7, 2012, in response to a request filed by Dongyuan, the Department again extended the deadline for submission of case briefs to December 13, 2012, and the due date for rebuttals briefs to December 18, 2012. On December 13, 2012, case briefs were filed by Petitioner, Dongyuan, Superte/Zhaoshun, and Kehuaxing.
On December 18, 2012, Petitioner, Dongyuan, Superte/Zhaoshun and the Government of China (“GOC”), each filed their rebuttal briefs, and on December 19, 2012, in its request to replace its case brief, the GOC submitted a corrected version of its case brief. On December 20, 2012, the Department rejected the GOC's original case brief and granted the GOC's request to correct and replace their case brief filed as an attachment to its December 19, 2012, request. We did not receive briefs or rebuttal briefs from any other interested party to the investigation. On January 30, 2013, the Department held a public hearing limited to issues raised in case and rebuttal briefs.
The Department postponed the deadline for the final determination to not later than 135 days after publication of the
The period of investigation (“POI”) is July 1, 2011, through December 31, 2011. This period corresponds to the two most recent fiscal quarters prior to the month of the filing of the petition, which was March 2012.
As provided in section 782(i) of the Act, we verified the information submitted by Dongyuan and Superte/Zhaoshun for use in our final determination.
All issues raised in the case and rebuttal briefs by parties to this investigation are addressed in the “Investigation of Drawn Stainless Steel Sinks from the People's Republic of China: Issues and Decision Memorandum,” dated concurrently with this notice and hereby adopted by this notice (“Issues and Decision Memorandum”). A list of the issues which parties raised and to which we respond in the Issues and Decision Memorandum is attached to this notice as an Appendix. The Issues and Decision Memorandum is a public document on file in the CRU and accessible on the Web at
• Updated the SV used to value sound deadening pads.
• Valued the labor SV using Thailand 2007 National Statistics Office (“NSO”) data.
• Revised the treatment of labor in the financial ratios calculations to accord with the costs captured in the Thailand 2007 NSO data.
• Revised the SV calculation for stainless steel.
• Adjusted Superte/Zhaoshun's electricity consumption to reflect usage during the POI.
• Adjusted Superte/Zhaoshun's consumption of wooden boxes and polystyrene based on verification findings.
• Revised the SV used to value Dongyuan's paint input.
For detailed information concerning all of the changes made, including those listed above,
The products covered by the scope of this investigation are drawn stainless steel sinks with single or multiple drawn bowls, with or without drain boards, whether finished or unfinished, regardless of type of finish, gauge, or grade of stainless steel. Mounting clips, fasteners, seals, and sound-deadening pads are also covered by the scope of this investigation if they are included within the sales price of the drawn stainless steel sinks.
Excluded from the scope of the investigation are stainless steel sinks with fabricated bowls. Fabricated bowls do not have seamless corners, but rather are made by notching and bending the stainless steel, and then welding and finishing the vertical corners to form the bowls. Stainless steel sinks with fabricated bowls may sometimes be referred to as “zero radius” or “near zero radius” sinks.
The products covered by this investigation are currently classified in the Harmonized Tariff Schedule of the United States (“HTSUS”) under statistical reporting number 7324.10.0000 and 7324.10.00.10. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope is dispositive.
The Department considers the PRC to be a nonmarket economy (“NME”) country. In accordance with section 771(18)(C)(i) of the Act, any determination that a foreign country is an NME country shall remain in effect until revoked by the administering authority. The Department continues to treat the PRC as an NME for purposes of this final determination.
In the
In proceedings involving NME countries, the Department holds a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assessed a single antidumping duty rate. It is the Department's policy to assign all exporters of the subject merchandise in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
In the
The Department continues to find that the evidence placed on the record of this investigation by the Separate Rate Applicants that were granted separate rate status in the
The separate rate is normally determined based on the weighted-average of the estimated AD margins established for exporters and producers individually investigated, excluding zero and
The statute does not preclude adopting a uniform application of the average-to-transaction method (“A-to-T”) under the following circumstances: (1) There is a pattern of export prices that differ significantly among purchasers, regions, or periods of time; and (2) the Department explains why such differences cannot be taken into account using the average-to-average (“A-to-A”) method or transaction-to-transaction (“T-to-T”) method.
In the
For the final determination, for Superte, we have found that there is a pattern of prices for U.S. sales of comparable merchandise that differ significantly among purchasers, regions, and time periods. With respect to Dongyuan, we find that a pattern of export prices (or constructed export prices) for comparable merchandise that differ significantly among purchasers, regions, or time periods does not exist. As in the
In our
After verifying Dongyuan's and Superte's sales and costs, we continue to find that electricity and stainless steel coil subsidies impacted both Superte's and Dongyuan's cost of manufacturing (“COM”), and that the other subsidy programs under investigation (
The Department has determined that record evidence does not support the calculation of a company-specific pass-through rate for Dongyuan. Although Dongyuan's calculation of an estimated pass-through rate provides probative evidence that some pass-through occurred, the estimate is based only on certain sales
The Department has determined to continue to grant Dongyuan's and Superte's claimed scrap offset in the final determination. It is the Department's practice to allow respondents an offset to the reported FOPs for scrap generated during the production of the merchandise under consideration if evidence is provided that such scrap has commercial value.
Section 776(a) of the Act provides that the Department shall apply facts available (“FA”) if (1) necessary information is not on the record, or (2) an interested party or any other person (A) withholds information that has been requested, (B) fails to provide information within the deadlines established, or in the form and manner requested by the Department, subject to subsections (c)(1) and (e) of section 782 of the Act, (C) significantly impedes a proceeding, or (D) provides information that cannot be verified as provided by section 782(i) of the Act.
Section 776(b) of the Act further provides that the Department may use an adverse inference in applying FA when a party has failed to cooperate by not acting to the best of its ability to comply with a request for information. Such an adverse inference may include reliance on information derived from the petition, the final determination, a previous administrative review, or other information placed on the record.
In the
The Department determines that, because the PRC-wide entity did not respond to our request for information, the PRC-wide entity has failed to cooperate to the best of its ability. Therefore, pursuant to section 776(b) of the Act, the Department finds that, in selecting from among the FA, an adverse inference is appropriate for the PRC-wide entity. Because the Department begins with the presumption that all companies within an NME country are subject to government control, and because only the mandatory respondents and certain Separate Rate Applicants have overcome that presumption, the Department is applying a single AD rate to all other exporters of subject merchandise from the PRC. Such companies have not demonstrated entitlement to a separate rate.
In determining a rate for AFA, the Department's practice is to select a rate that is sufficiently adverse “as to effectuate the purpose of the adverse facts available rule to induce respondents to provide the Department with complete and accurate information in a timely manner.”
Section 776(c) of the Act requires the Department to corroborate, to the extent practicable, secondary information used as facts available. Secondary information is defined as “information derived from the petition that gave rise to the investigation or review, the final determination concerning the subject merchandise, or any previous review under section 751 of the Act concerning the subject merchandise.”
The SAA clarifies that “corroborate” means that the Department will satisfy itself that the secondary information to be used has probative value.
In order to determine the probative value of the margins in the petition for use as AFA for purposes of this preliminary determination, we compared the petition margins to the margins we calculated for the individually examined respondents. We determined that the petition margin of 76.53 percent is reliable and relevant because it is within the range of the control number specific margins on the record for one of the individually examined exporters of subject merchandise.
In the
The Department determines that the following weighted-average dumping margins exist for the period July 1, 2011, through December 31, 2011.
We intend to disclose to parties the calculations performed in this proceeding within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
In accordance with section 735(c)(1)(B) of the Act, the Department will instruct U.S. Customs and Border Protection (“CBP”) to continue to suspend liquidation of all appropriate entries of drawn sinks from the PRC as described in the “Scope of the Investigation” section, entered, or withdrawn from warehouse, for consumption on or after October 4,
In accordance with section 735(d) of the Act, we have notified the International Trade Commission (“ITC”) of the final affirmative determination of sales at LTFV. As the Department's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will determine, within 45 days, whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of subject merchandise, or sales (or the likelihood of sales) for importation, of the subject merchandise. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice also serves as a reminder to the parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of BPI disclosed under APO in accordance with 19 CFR 351.305. Timely notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act.
National Institute of Standards and Technology, U.S. Department of Commerce.
Notice; Request for Information (RFI).
The National Institute of Standards and Technology (NIST) is conducting a comprehensive review to develop a framework to reduce cyber risks to critical infrastructure
This RFI requests information to help identify, refine, and guide the many interrelated considerations, challenges, and efforts needed to develop the Framework. In developing the Cybersecurity Framework, NIST will consult with the Secretary of Homeland Security, the National Security Agency, Sector-Specific Agencies and other interested agencies including the Office of Management and Budget, owners and operators of critical infrastructure, and other stakeholders including other relevant agencies, independent regulatory agencies, State, local, territorial and tribal governments. The Framework will be developed through an open public review and comment process that will include workshops and other opportunities to provide input.
Comments must be received by 5:00 p.m. Eastern time on Monday, April 8, 2013.
Written comments may be submitted by mail to Diane Honeycutt, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899. Submissions may be in any of the following formats: HTML, ASCII, Word, RTF, or PDF. Online submissions in electronic form may be sent to
For questions about this RFI contact: Adam Sedgewick, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230, telephone (202) 482-0788, email
The national and economic security of the United States depends on the reliable functioning of critical infrastructure, which has become increasingly dependent on information technology. Recent trends demonstrate the need for improved capabilities for defending against malicious cyber activity. Such activity is increasing and its consequences can range from theft through disruption to destruction. Steps must be taken to enhance existing efforts to increase the protection and resilience of this infrastructure, while maintaining a cyber environment that encourages efficiency, innovation, and economic prosperity, while protecting privacy and civil liberties.
Under Executive Order 13636
Given the diversity of sectors in critical infrastructure, the Framework development process is designed to initially identify cross-sector security standards and guidelines that are immediately applicable or likely to be applicable to critical infrastructure, to increase visibility and adoption of those standards and guidelines, and to find potential gaps (i.e., where standards/guidelines are nonexistent or where existing standards/guidelines are inadequate) that need to be addressed through collaboration with industry and industry-led standards bodies. The Framework will incorporate voluntary consensus standards and industry best practices to the fullest extent possible and will be consistent with voluntary international consensus-based standards when such international standards will advance the objectives of the Executive Order. The Framework would be designed to be compatible with existing regulatory authorities and regulations.
The Cybersecurity Framework will provide a prioritized, flexible, repeatable, performance-based, and cost-effective approach, including information security measures and controls to help owners and operators of critical infrastructure and other interested entities to identify, assess, and manage cybersecurity-related risk while protecting business confidentiality, individual privacy and civil liberties. To enable technical innovation and account for organizational differences, the Cybersecurity Framework will not prescribe particular technological solutions or specifications. It will include guidance for measuring the performance of an entity in implementing the Cybersecurity Framework and will include methodologies to identify and mitigate impacts of the Framework and associated information security measures and controls on business confidentiality and to protect individual privacy and civil liberties.
As a non-regulatory Federal agency, NIST will develop the Framework in a manner that is consistent with its mission to promote U.S. innovation and industrial competitiveness through the development of standards and guidelines in consultation with stakeholders in both government and industry. While the focus will be on the Nation's critical infrastructure, the Framework will be developed in a manner to promote wide adoption of practices to increase cybersecurity across all sectors and industry types. In its first year, the emphasis will be on finding commonality within and across the affected sectors. It will seek to provide owners and operators the ability to implement security practices in the most effective manner while allowing organizations to express requirements to multiple authorities and regulators. Issues relating to harmonization of existing relevant standards and integration with existing frameworks will also be considered in this initial stage.
In accordance with the Executive Order, the Secretary of Commerce has directed the Director of the National Institute of Standards and Technology (the Director) to coordinate the development of a Framework to reduce the cyber risks to critical infrastructure. The Cybersecurity Framework will incorporate existing consensus-based standards to the fullest extent possible, consistent with requirements of the National Technology Transfer and Advancement Act of 1995,
The goals of the Framework development process will be: (i) To identify existing cybersecurity standards, guidelines, frameworks, and best practices that are applicable to increase the security of critical infrastructure sectors and other interested entities; (ii) to specify high-priority gaps for which new or revised standards are needed; and (iii) to collaboratively develop action plans by which these gaps can be addressed. It is contemplated that the development process will have requisite stages to allow for continuing engagement with the owners and operators of critical infrastructure, and other industry, academic, and government stakeholders.
In December 2011, the United States Government Accountability Office (GAO) issued a report titled “CRITICAL INFRASTRUCTURE PROTECTION: Cybersecurity Guidance Is Available, but More Can Be Done to Promote Its Use.”
NIST believes the diversity of business and mission needs notwithstanding, there are core cybersecurity practices that can be identified and that will be applicable to a diversity of sectors and a spectrum of quickly evolving threats. Identifying such core practices will be a focus of the Framework development process.
In order to be effective in protecting the information and information systems that are a part of the U.S. critical infrastructure, NIST believes the Framework should have a number of general properties or characteristics. The Framework should include flexible, extensible, scalable, and technology-independent standards, guidelines, and best practices, that provide:
• A consultative process to assess the cybersecurity-related risks to organizational missions and business functions;
• A menu of management, operational, and technical security controls, including policies and processes, available to address a range of threats and protect privacy and civil liberties;
• A consultative process to identify the security controls that would adequately address risks
• Metrics, methods, and procedures that can be used to assess and monitor, on an ongoing or continuous basis, the effectiveness of security controls that are selected and deployed in organizational information systems and environments in which those systems operate and available processes that can be used to facilitate continuous improvement in such controls;
• A comprehensive risk management approach that provides the ability to assess, respond to, and monitor information security-related risks and provide senior leaders/executives with the kinds of necessary information sets that help them to make ongoing risk-based decisions;
• A menu of privacy controls necessary to protect privacy and civil liberties.
Within eight months, the Executive Order requires NIST to publish for additional comment a draft Framework that clearly outlines areas of focus and provides preliminary lists of standards, guidelines and best practices that fall within that outline. The draft will also include initial conclusions for additional public comment. The draft Framework will build on NIST's ongoing work with cybersecurity standards and guidelines for the Smart Grid, Identity Management, Federal Information Security Management Act (FISMA) implementation, the Electricity Subsector Cybersecurity Capability Maturity Model, and related projects.
NIST intends to engage with critical infrastructure stakeholders, through a voluntary consensus-based process, to develop the standards, guidelines and best practices that will comprise the Framework. This will include interactive workshops with industry and academia, along with other forms of outreach. NIST believes that the Framework cannot be static, but must be a living document that allows for ongoing consultation in order to address constantly evolving risks to critical infrastructure cybersecurity. A voluntary consensus standards-based approach will facilitate the ability of critical infrastructure owners and operators to manage such risks, and to implement alternate solutions from the bottom up with interoperability, scalability, and reliability as key attributes.
A standards-based Framework will also help provide some of the measures necessary to understand the effectiveness of critical infrastructure protection, and track changes over time. DHS and Sector Specific Agencies will provide input in this area based on their engagement with sector stakeholders. This standards-based approach is necessary in order to be able to provide and analyze data from different sources that can directly support risk-based decision-making. A Framework without sufficient standards and associated conformity assessment programs could impede future innovation in security efforts for critical infrastructure by potentially creating a false sense of security.
The use of widely-accepted standards is also necessary to enable economies of scale and scope to help create competitive markets in which competition is driven by market need and products that meet that market need through combinations of price, quality, performance, and value to consumers. Market competition then promotes faster diffusion of these technologies and realization of many benefits throughout these sectors.
It is anticipated that the Framework will: (i) Include consideration of sustainable approaches for assessing conformity to identified standards and guidelines; (ii) assist in the selection and development of an optimal conformity assessment approach; and (iii) facilitate the implementation of selected approach(es) that could cover technology varying in scope from individual devices or components to large-scale organizational operations. The decisions on the type, independence and technical rigor of these conformity assessment approaches should be risk-based. The need for confidence in conformity must be balanced with cost to the public and private sectors, including their international operations and legal obligations. Successful conformity assessment programs provide the needed level of confidence, are efficient and have a sustainable and scalable business case.
This RFI is looking for current adoption rates and related information for particular standards, guidelines, best practices, and frameworks to determine applicability throughout the critical infrastructure sectors. The RFI asks for stakeholders to submit ideas, based on their experience and mission/business needs, to assist in prioritizing the work of the Framework, as well as highlighting relevant performance needs of their respective sectors.
For the purposes of this notice and the Framework, the term “standards” and the phrase “standards setting” are used in a generic manner to include both standards development and conformity assessment development. In addition to critical infrastructure owners and operators, NIST invites Federal agencies, state, local, territorial and tribal governments, standard-setting organizations,
The following questions cover the major areas about which NIST seeks comment. The questions are not intended to limit the topics that may be addressed. Responses may include any topic believed to have implications for the development of the Framework
While the Framework will be focused on critical infrastructure, given the broad diversity of sectors that may include parts of critical infrastructure, the evolving nature of the classification of critical infrastructure based on risk, and the intention to involve a broad set of stakeholders in development of the Framework, the RFI will generally use the broader term “organizations” when seeking information.
Comments containing references, studies, research, and other empirical data that are not widely published should include copies of the referenced materials. Do not include in comments or otherwise submit proprietary or confidential information, as all comments received by the deadline will be made available publically at
NIST solicits information about how organizations assess risk; how cybersecurity factors into that risk assessment; the current usage of existing cybersecurity frameworks, standards, and guidelines; and other management practices related to cybersecurity. In addition, NIST is interested in understanding whether particular frameworks, standards, guidelines, and/or best practices are mandated by legal or regulatory requirements and the challenges organizations perceive in meeting such requirements. This will assist in NIST's goal of developing a Framework that includes and identifies common practices across sectors.
1. What do organizations see as the greatest challenges in improving cybersecurity practices across critical infrastructure?
2. What do organizations see as the greatest challenges in developing a cross-sector standards-based Framework for critical infrastructure?
3. Describe your organization's policies and procedures governing risk generally and cybersecurity risk specifically. How does senior management communicate and oversee these policies and procedures?
4. Where do organizations locate their cybersecurity risk management program/office?
5. How do organizations define and assess risk generally and cybersecurity risk specifically?
6. To what extent is cybersecurity risk incorporated into organizations' overarching enterprise risk management?
7. What standards, guidelines, best practices, and tools are organizations using to understand, measure, and manage risk at the management, operational, and technical levels?
8. What are the current regulatory and regulatory reporting requirements in the United States (e.g. local, state, national, and other) for organizations relating to cybersecurity?
9. What organizational critical assets are interdependent upon other critical physical and information infrastructures, including telecommunications, energy, financial services, water, and transportation sectors?
10. What performance goals do organizations adopt to ensure their ability to provide essential services while managing cybersecurity risk?
11. If your organization is required to report to more than one regulatory body, what information does your organization report and what has been your organization's reporting experience?
12. What role(s) do or should national/international standards and organizations that develop national/international standards play in critical infrastructure cybersecurity conformity assessment?
As set forth in the Executive Order, the Framework will consist of standards, guidelines, and/or best practices that promote the protection of information and information systems supporting organizational missions and business functions.
NIST seeks comments on the applicability of existing publications to address cybersecurity needs, including, but not limited to the documents developed by: international standards organizations; U.S. Government Agencies and organizations; State regulators or Public Utility Commissions; Industry and industry associations; other Governments, and non-profits and other non-government organizations.
NIST is seeking information on the current usage of these existing approaches throughout industry, the robustness and applicability of these frameworks and standards, and what would encourage their increased usage. Please provide information related to the following:
1. What additional approaches already exist?
2. Which of these approaches apply across sectors?
3. Which organizations use these approaches?
4. What, if any, are the limitations of using such approaches?
5. What, if any, modifications could make these approaches more useful?
6. How do these approaches take into account sector-specific needs?
7. When using an existing framework, should there be a related sector-specific standards development process or voluntary program?
8. What can the role of sector-specific agencies and related sector coordinating councils be in developing and promoting the use of these approaches?
9. What other outreach efforts would be helpful?
In addition to the approaches above, NIST is interested in identifying core practices that are broadly applicable across sectors and throughout industry.
NIST is interested in information on the adoption of the following practices as they pertain to critical infrastructure components:
• Separation of business from operational systems;
• Use of encryption and key management;
• Identification and authorization of users accessing systems;
• Asset identification and management;
• Monitoring and incident detection tools and capabilities;
• Incident handling policies and procedures;
• Mission/system resiliency practices;
• Security engineering practices;
• Privacy and civil liberties protection.
1. Are these practices widely used throughout critical infrastructure and industry?
2. How do these practices relate to existing international standards and practices?
3. Which of these practices do commenters see as being the most critical for the secure operation of critical infrastructure?
4. Are some of these practices not applicable for business or mission needs within particular sectors?
5. Which of these practices pose the most significant implementation challenge?
6. How are standards or guidelines utilized by organizations in the implementation of these practices?
7. Do organizations have a methodology in place for the proper allocation of business resources to invest in, create, and maintain IT standards?
8. Do organizations have a formal escalation process to address cybersecurity risks that suddenly increase in severity?
9. What risks to privacy and civil liberties do commenters perceive in the application of these practices?
10. What are the international implications of this Framework on your global business or in policymaking in other countries?
11. How should any risks to privacy and civil liberties be managed?
12. In addition to the practices noted above, are there other core practices that should be considered for inclusion in the Framework?
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; notification of quota for bowhead whales.
NMFS notifies the public of the aboriginal subsistence whaling quota for bowhead whales that it has assigned to the Alaska Eskimo Whaling Commission (AEWC), and of limitations on the use of the quota deriving from regulations of the International Whaling Commission (IWC). For 2013, the quota is 75 bowhead whales struck. This quota and other applicable limitations govern the harvest of bowhead whales by members of the AEWC.
Effective February 26, 2013.
Office of International Affairs, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910.
Melissa Andersen, (301) 427-8385.
Aboriginal subsistence whaling in the United States is governed by the Whaling Convention Act (WCA) (16 U.S.C. 916
At the 64th Annual Meeting of the IWC, the Commission set catch limits for aboriginal subsistence use of bowhead whales from the Bering-Chukchi-Beaufort Seas stock. The bowhead catch limits were based on a joint request by the United States and the Russian Federation, accompanied by documentation concerning the needs of two Native groups: Alaska Eskimos and Chukotka Natives in the Russian Far East.
The IWC set a 6-year block catch limit of 336 bowhead whales landed. For each of the years 2013 through 2018, the number of bowhead whales struck may not exceed 67, except that any unused portion of a strike quota from any prior year, including 15 unused strikes from the 2008 through 2012 quota, may be carried forward. No more than 15 strikes may be added to the strike quota for any one year. At the end of the 2012 harvest, there were 15 unused strikes available for carry-forward, so the combined strike quota set by the IWC for 2013 is 82 (67 + 15).
An arrangement between the United States and the Russian Federation ensures that the total quota of bowhead whales landed and struck in 2013 will not exceed the limits set by the IWC. Under this arrangement, the Russian natives may use no more than seven strikes, and the Alaska Eskimos may use no more than 75 strikes.
Through its cooperative agreement with the AEWC, NOAA has assigned 75 strikes to the Alaska Eskimos. The AEWC will in turn allocate these strikes among the 11 villages whose cultural and subsistence needs have been documented, and will ensure that its hunters use no more than 75 strikes.
The IWC regulations, as well as the NOAA regulation at 50 CFR 230.4(c), forbid the taking of calves or any whale accompanied by a calf.
NOAA regulations (at 50 CFR 230.4) contain a number of other prohibitions relating to aboriginal subsistence whaling, some of which are summarized here:
• Only licensed whaling captains or crew under the control of those captains may engage in whaling.
• Captains and crew must follow the provisions of the relevant cooperative agreement between NOAA and a Native American whaling organization.
• The aboriginal hunters must have adequate crew, supplies, and equipment to engage in an efficient operation.
• Crew may not receive money for participating in the hunt.
• No person may sell or offer for sale whale products from whales taken in the hunt, except for authentic articles of Native American handicrafts.
• Captains may not continue to whale after the relevant quota is taken, after the season has been closed, or if their licenses have been suspended. They may not engage in whaling in a wasteful manner.
Commodity Futures Trading Commission.
10:00 a.m., Friday, March 15, 2013.
: 1155 21st St. NW., Washington, DC, 9th Floor Commission Conference Room.
Closed.
Surveillance and Enforcement Matters. In the event that the times or dates of this or any future meetings change, an announcement of the change, along with the new time and place of the meeting will be posted on the Commission's Web site at
Melissa D. Jurgens, 202-418-5516.
Commodity Futures Trading Commission.
10:00 a.m., Friday, March 1, 2013.
1155 21st St. NW., Washington, DC, 9th Floor Commission Conference Room.
Closed.
Surveillance and Enforcement Matters. In the event that the times or dates of this or any future meetings change, an announcement of the change, along with the new time and place of the meeting
Melissa D. Jurgens, 202-418-5516.
Commodity Futures Trading Commission.
10:00 a.m., Friday, March 22, 2013.
1155 21st St. NW., Washington, DC, 9th Floor Commission Conference Room.
Closed.
Surveillance and Enforcement Matters. In the event that the times or dates of this or any future meetings change, an announcement of the change, along with the new time and place of the meeting will be posted on the Commission's Web site at
Melissa D. Jurgens, 202-418-5516.
Commodity Futures Trading Commission.
10:00 a.m., Friday, March 8, 2013.
1155 21st St. NW., Washington, DC, 9th Floor Commission Conference Room.
Closed.
Surveillance and Enforcement Matters. In the event that the times or dates of this or any future meetings change, an announcement of the change, along with the new time and place of the meeting will be posted on the Commission's Web site at
Melissa D. Jurgens, 202-418-5516.
Commodity Futures Trading Commission.
10:00 a.m., Friday, March 29, 2013.
1155 21st St. NW., Washington, DC, 9th Floor Commission Conference Room.
Closed.
Surveillance and Enforcement Matters. In the event that the times or dates of this or any future meetings change, an announcement of the change, along with the new time and place of the meeting will be posted on the Commission's Web site at
Melissa D. Jurgens, 202-418-5516.
Department of Defense.
Notice.
Pursuant to Section 10(a), Public Law 92-463, as amended, notice is hereby given of a forthcoming meeting of the Defense Advisory Committee on Women in the Services (DACOWITS). The purpose of the meeting is to introduce and swear in six new members to the Committee. Also, the Committee will receive briefings from the Services on representation of women at the Service Academies, and receive an update from the Joint Staff on the Women in Service Review. Additionally, the Navy will provide a briefing on the Sexual Assault Prevention Program at Naval Station Great Lakes, and the Sexual Assault and Prevention Office will brief on the Annual Report on Sexual Harassment and Violence at the Military Service Academies. The meeting is open to the public, subject to the availability of space.
March 14, 2013, from 8:00 a.m. to 2:30 p.m.; March 15, 2013, from 8:00 a.m. to 11:30 a.m.
Embassy Suites Hotel, 1300 Jefferson Davis Hwy, Arlington, VA 22202.
Mr. Robert Bowling or DACOWITS Staff at 4000 Defense Pentagon, Room 5A734, Washington, DC 20301-4000.
Interested persons may submit a written statement for consideration by the Defense Advisory Committee on Women in the Services. Individuals submitting a written statement must submit their statement to the Point of Contact listed at the address detailed in
Department of the Army, DoD.
Meeting notice.
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that the following Federal advisory committee meeting will take place:
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Any member of the public is permitted to file a written statement with the USMA Board of Visitors. Written statements should be sent to the Designated Federal Officer (DFO) at: United States Military Academy, Office of the Secretary of the General Staff (MASG), 646 Swift Road, West Point, NY 10996-1905 or faxed to the Designated Federal Officer (DFO) at (845) 938-3214. Written statements must be received no later than five working days prior to the next meeting in order to provide time for member consideration. By rule, no member of the public attending open meetings will be allowed to present questions from the floor or speak to any issue under consideration by the Board.
The Committee's Designated Federal Officer or Point of Contact is Ms. Deadra Ghostlaw, (845) 938-4200,
Department of the Army, DoD.
Notice of meeting.
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), announcement is made of the following committee meeting:
Inquiries and notice of intent to attend the meeting may be addressed to COL Kevin J. Wilson, Executive Secretary, U.S. Army Engineer Research and Development Center, Waterways Experiment Station, 3909 Halls Ferry Road, Vicksburg, MS 39180-6199.
The Board provides broad policy guidance and review of plans and fund requirements for the conduct of research and development of research projects in consonance with the needs of the coastal engineering field and the objectives of the Chief of Engineers.
On Tuesday morning, March 19, the Board will discuss coastal engineering in the United States, including industry and the CHL goals and plans. The Board will also hear and discuss the CHL Numerical Model strategy, comments from the civilian members on their site visit to CHL, pending action items, and the next annual meeting.
The meeting is open to the public, but since seating capacity of the meeting room is limited and the meeting is located on a government facility, advance notice of intent to attend is required.
Office of Vocational and Adult Education, Department of Education.
Notice.
Native American Career and Technical Education Program (NACTEP).
Notice inviting applications for new awards for fiscal year (FY) 2013.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.101A.
Under this competition we are particularly interested in applications that address the following priorities.
Under this priority, we invite applications that propose projects that are designed to improve student achievement (as defined in this notice) or teacher effectiveness through the use of high-quality digital tools or materials, which may include preparing teachers to use the technology to improve instruction, as well as developing, implementing, or evaluating digital tools or materials.
Under this priority, we invite applications that propose projects that are designed to address one or more of the following priority areas:
(a) Providing students with increased access to rigorous and engaging coursework in STEM.
(b) Increasing the number and proportion of students prepared for postsecondary or graduate study and careers in STEM.
(c) Increasing the opportunities for high-quality preparation of, or professional development for, teachers or other educators of STEM subjects.
(a) Any Native, as so defined, either or both of whose adoptive parents are not Natives; and
(b) In the absence of proof of a minimum blood quantum, any citizen of the United States who is regarded as an Alaska Native by the Native village or Native group of which he or she claims to be a member and whose father or mother is (or, if deceased, was) regarded as Native by any village or group. Any decision of the Secretary of the Interior regarding eligibility for enrollment will be final. (20 U.S.C. 2326(a)(1); 43 U.S.C. 1602(b))
(a) Listed in sections 1610 and 1615 of the Alaska Native Claims Settlement Act; or
(b) That meets the requirements of chapter 33 of the Alaska Native Claims Settlement Act; and
(c) That the Secretary of the Interior determines was, on the 1970 census enumeration date (as shown by the census or other evidence satisfactory to the Secretary of the Interior, who shall make findings of fact in each instance), composed of twenty-five or more Natives. (43 U.S.C. 1602(c))
(a) A Bureau-operated elementary or secondary day or boarding school or Bureau-operated dormitory for students attending a school other than a Bureau school. (25 U.S.C. 2021(3) and (4));
(b) An elementary school, secondary school, or dormitory, that receives financial assistance for its operation under a contract, grant, or agreement with the Bureau under section 102, 103(a), or 208 of ISDEA (25 U.S.C. 450f, 450h(a), or 458d) or under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2504
(c) A school for which assistance is provided under the Tribally Controlled Schools Act of 1988 (25 U.S.C. 2501
(a) Offer a sequence of courses that—
(1) Provides individuals with coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions;
(2) Provides technical skills proficiency, an industry-recognized credential, a certificate, or an associate degree; and
(3) May include prerequisite courses (other than remedial courses) that meet the requirements of this definition; and
(b) Include competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical skills, and occupation-specific skills, and knowledge of all aspects of an industry, including entrepreneurship, of the individual. (20 U.S.C. 2302(5))
(a) An educational institution in any State that—
(1) Admits as regular students only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such a certificate;
(2) Is legally authorized within such State to provide a program of education beyond secondary education;
(3) Provides an educational program for which the institution awards a bachelor's degree or provides not less than a 2-year program that is acceptable for full credit toward such a degree;
(4) Is a public or other nonprofit institution; and
(5) Is accredited by a nationally recognized accrediting agency or association or, if not so accredited, is an institution that has been granted pre-accreditation status by such an agency or association that has been recognized by the Secretary of the Education for the granting of pre-accreditation status, and the Secretary of Education has determined that there is satisfactory assurance that the institution will meet the accreditation standards of such an agency or association within a reasonable time.
(b) The term also includes—
(1) Any school that provides not less than a 1-year program of training to prepare students for gainful employment in a recognized occupation and that meets the provisions of paragraphs (a)(1), (2), (4), and (5) of this definition.
(2) A public or nonprofit private educational institution in any State that, in lieu of the requirement in paragraph (a)(1) of this definition, admits as regular students persons who are beyond the age of compulsory school attendance in the State in which the institution is located. (20 U.S.C. 1001 and 2302(18))
(a) Individuals with disabilities;
(b) Individuals from economically disadvantaged families, including foster children;
(c) Individuals preparing for nontraditional training fields;
(d) Single parents, including single pregnant women;
(e) Displaced homemakers; and
(f) Individuals with limited English proficiency. (20 U.S.C. 2302(29))
(a) For tested grades and subjects: (1) A student's score on the State's assessments under the Elementary and Secondary Education Act, as amended. (20 U.S.C. 6301 et seq.) (ESEA); and, as appropriate, (2) other measures of student learning, such as those described in paragraph (b) of this definition, provided they are rigorous and comparable across schools.
(b) For non-tested grades and subjects: alternative measures of student learning and performance, such as student scores on pre-tests and end-of-course texts; student performance on English language proficiency assessments; and other measures of student achievement that are rigorous and comparable across schools.
See the notice of final supplemental priorities and definitions for discretionary grant programs, published in the
Authorized Programs, Services, and Activities
(a)
Therefore, under NACTEP the Assistant Secretary will award grants to carry out projects that—
(1) Propose organized educational activities offering a sequence of courses that—
(i) Provide individuals with coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions;
(ii) Provide technical skill proficiency, an industry-recognized credential, a certificate, or an associate degree; and
(iii) Include competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical skills, and occupation-specific skills, and knowledge of all aspects of an industry, including entrepreneurship, of an individual. Projects may include prerequisite courses (other than remedial courses) that meet the definitional requirements of section 3(5) of the Act. (20 U.S.C. 2302(5)) In addition, at the secondary level, coherent and rigorous academic curriculum must be aligned with challenging academic content standards and student academic achievement standards in reading or language arts and in mathematics that the State in which the applicant is located has established under the ESEA. Contacts for State ESEA programs may be found on the Internet at:
(2) Develop new programs, services, or activities or improve or expand existing programs, services, or activities that are consistent with the purposes of the Act. In other words, the Department will support “expansions” or “improvements” that include, but are not limited to, the expansion of effective programs or practices; upgrading of activities, equipment, or materials; increasing staff capacity; adoption of new technology; modification of curriculum; or implementation of new policies to improve program effectiveness and outcomes.
(3) Fund a career and technical education program, service, or activity that—
(i) Is a new program, service, or activity that was not provided by the applicant during the instructional term (a defined period, such as a semester, trimester, or quarter, within the academic year) that preceded the request for funding under NACTEP;
(ii) Will improve or expand an existing career and technical education program; or
(iii) Inherently improves career and technical education.
A program, service, or activity “inherently improves career and technical education” if it—
(a) Develops new career and technical education programs of study that will be approved by the appropriate accreditation agency;
(b) Strengthens the rigor of the academic and career and technical components of funded programs;
(c) Uses curriculum that is aligned with industry-recognized standards and will result in students attaining industry-recognized credentials, certificates, or degrees;
(d) Integrates academics (other than remedial courses) with career and technical education programs through a coherent sequence of courses to ensure learning in the core academic and career and technical subjects;
(e) Links career and technical education at the secondary level with career and technical education at the postsecondary level and facilitates students' pursuit of a baccalaureate degree;
(f) Expands the scope, depth, and relevance of curriculum, especially content that provides students with a comprehensive understanding of all aspects of an industry and a variety of hands-on, job-specific experiences; and
(g) Offers—
(1) Work-related experience, internships, cooperative education, school-based enterprises, entrepreneurship, community service learning, and job shadowing that are related to career and technical education programs;
(2) Coaching/mentoring, support services, and extra help for students after school, on weekends, and/or during the summers, so they can meet higher standards;
(3) Career guidance and academic counseling for students participating in career and technical education programs;
(4) Placement services for students who have successfully completed career and technical education programs and attained a technical skill proficiency that is aligned with industry-recognized standards;
(5) Professional development programs for teachers, counselors, and administrators;
(6) Strong partnerships among grantees and local educational agencies, postsecondary institutions, community leaders, adult education providers, and, as appropriate, other entities, such as employers, labor organizations, parents, and local partnerships, to enable students to achieve State academic standards and career and technical skills;
(7) The use of student assessment and evaluation data to improve continually instruction and staff development with the goal of increasing student achievement in career and technical education programs; or
(8) Research, development, demonstration, dissemination, evaluation and assessment, capacity-building, and technical assistance, related to career and technical education programs.
(b) Assistance to Bureau-funded secondary schools. An Indian tribe, a tribal organization, or an Alaska Native entity, that receives funds through a NACTEP grant or contract may use the funds to provide assistance to a secondary school operated or supported by the U.S. Department of the Interior to enable such school to carry out career and technical education programs.
(c) Student stipends. In accordance with section 116(c)(2) of the Act, a portion of an award under this program may be used to provide stipends (as defined in the Definitions section of this notice) to one or more students to help meet the students' costs of participation in a NACTEP project. A grantee must apply the following procedures for determining student eligibility for stipends and appropriate amounts to be awarded as stipends:
(1) To be eligible for a stipend a student must—
(i) Be enrolled in a career and technical education project funded under this program;
(ii) Be in regular attendance in a NACTEP project and meet the training institution's attendance requirement;
(iii) Maintain satisfactory progress in his or her program of study according to the training institution's published standards for satisfactory progress; and
(iv) Have an acute economic need that—
(A) Prevents participation in a project funded under this program without a stipend; and
(B) Cannot be met through a work-study program.
(2) The amount of a stipend is the greater of either the minimum hourly wage prescribed by State or local law or the minimum hourly wage established under the Fair Labor Standards Act.
(3) A grantee may only award a stipend if the stipend combined with other resources the student receives does not exceed the student's financial need. A student's financial need is the difference between the student's cost of attendance and the financial aid or other resources available to defray the student's cost of participating in a NACTEP project.
(4) To calculate the amount of a student's stipend, a grantee would multiply the number of hours a student actually attends career and technical education instruction by the amount of the minimum hourly wage that is prescribed by State or local law, or by the minimum hourly wage that is established under the Fair Labor Standards Act.
If a grantee uses the Fair Labor Standards Act minimum hourly wage of $7.25 and a student attends classes for 20 hours a week, the student's stipend would be $145 for the week during which the student attends classes ($7.25 × 20 = $145.00).
In accordance with applicable Department statutory requirements and administrative regulations, grantees must maintain records that fully support their decisions to award stipends and the amounts that are paid, such as proof of a student's enrollment in a NACTEP project, stipend applications, timesheets showing the number of attendance hours confirmed in writing by an instructor, student financial status information, and evidence that a student would not be able to participate in the NACTEP project without a stipend. (20 U.S.C. 1232f; 34 CFR 75.700-75.702; 75.730; and 75.731)
(5) An eligible student may receive a stipend when taking a course for the first time. However, generally a stipend may not be provided to a student who has already taken, completed, and had the opportunity to benefit from a course and is merely repeating the course.
(6) An applicant must include in its application the procedure it intends to use to determine student eligibility for stipends and stipend amounts, and its oversight procedures for the awarding and payment of stipends.
(d) Direct assistance to students. A grantee may provide direct assistance to students if the following conditions are met:
(1) The recipient of the direct assistance is an individual who is a member of a special population and who is participating in the grantee's NACTEP project.
(2) The direct assistance is needed to address barriers to the individual's successful participation in that project.
(3) The direct assistance is part of a broader, more generally focused program or activity to address the needs of an individual who is a member of a special population.
Direct assistance to individuals who are members of special populations is not, by itself, a “program or activity for special populations.”
(4) The grant funds used for direct assistance must be expended to supplement, and not supplant, assistance that is otherwise available from non-Federal sources. (20 U.S.C. 2391(a)) For example, generally, a postsecondary educational institution could not use NACTEP funds to provide child care for single parents if non-Federal funds previously were made available for this purpose, or if non-Federal funds are used to provide child care services for single parents participating in non-career and technical education programs and these services otherwise would have been available to career and technical education students in the absence of NACTEP funds.
(5) In determining how much of the NACTEP grant funds it will use for direct assistance to an eligible student, a grantee must consider whether the specific services to be provided are a reasonable and necessary cost of providing career and technical education programs for special populations. However, the Assistant Secretary does not envision a circumstance in which it would be a reasonable and necessary expenditure of NACTEP project funds for a grantee to use a majority of a project's budget to pay direct assistance to students, in lieu of providing the students served by the project with career and technical education.
(a) Appeal process. Any applicant denied funding under this NACTEP competition may request a hearing to review the Secretary's decision not to make the award. The Secretary will implement the appeal process in accordance with the procedures set forth in 34 CFR 401.23. In accordance with those procedures, any applicant denied funding will have 30 calendar days to make a written request to the Secretary for a hearing to review the Secretary's decision.
(b) Career and technical education agreement. Any applicant that is not proposing to provide career and technical education directly to its students and proposes instead to use NACTEP funds to pay one or more qualified educational entities to provide education to its students must include with its application a written career and technical education agreement between the applicant and that entity. The written agreement must describe the commitment between the applicant and each educational entity and must include, at a minimum, a statement of the responsibilities of the applicant and the entity. The agreement must be signed by the appropriate individuals on behalf of each party, such as the authorizing official or president of a tribe or tribal organization, a college president, or a college dean.
(c) Limitation on services. Section 315 of the Act prohibits the use of funds received under the Act to provide career and technical education programs to students prior to the seventh grade.
(d) Supplement-Not-Supplant. In accordance with section 311(a) of the Act, funds under this program may not be used to supplant non-Federal funds used to carry out career and technical education activities and tech-prep activities. Further, the prohibition against supplanting also means that grantees are required to use their negotiated restricted indirect cost rates under this program. (34 CFR 75.563)
The Secretary cautions applicants not to plan to use funds under NACTEP to replace otherwise available non-Federal funding for direct assistance to students and family assistance programs. For example, NACTEP funds must not be used to supplant tribal and other non-Federal funds with Federal funds in order to pay the costs of students' tuition, dependent care, transportation, books, supplies, and other costs associated with participation in a career and technical education program.
Further, the Secretary is concerned that funds under NACTEP may be used to replace Federal student financial aid. The Secretary wishes to highlight that the Act does not authorize the Secretary to fund projects that serve primarily as entities through which students may apply for and receive tuition and other financial assistance.
(a) A tribe, tribal organization, or Alaska Native entity receiving financial assistance under this program may integrate those funds with assistance received from related programs in
(b) A tribe, tribal organization, or Alaska Native entity wishing to integrate funds must have a plan that meets the requirements of the Indian Employment, Training and Related Services Demonstration Act and is acceptable to the Secretary of the Interior and the Secretary of Education.
For further information on the integration of grant funds under this and related programs contact Jack Stevens the Division of Workforce Development, Office of Indian Energy and Economic Development, U.S. Department of the Interior, 1951 Constitution Avenue NW., Mailstop 20 SIB, Washington, DC 20245. Telephone: (202) 208-6764. Email address:
Section 116(b)(2) of the Act provides that grants or contracts awarded under section 116 of the Act are subject to the terms and conditions of section 102 of the ISDEA (25 U.S.C. 450f) and must be conducted in accordance with the provisions of sections 4, 5, and 6 of the Act of April 16, 1934 (25 U.S.C. 455-457), that are relevant to the programs administered under section 116(b) of the Act. Section 102 of the ISDEA authorizes Indian tribes to request self-determination contracts. Accordingly, an Indian tribe or tribal organization that has applied to the Secretary for financial assistance under NACTEP and has been notified of its selection to be a recipient of financial assistance may submit a request to operate its NACTEP project through a section 102 Indian self-determination contract.
In accordance with section 102(a) of the ISDEA, any Indian tribe or tribal organization requesting to operate its project under an Indian self-determination contract must do so by tribal resolution. After successful applicants are selected under this NACTEP competition, the Secretary will review any requests to operate a project under an Indian self-determination contract pursuant to the ISDEA. If a request for an Indian self-determination contract is approved, the Indian tribe or tribal organization submitting the request will be required, to the extent possible, to operate its project in accordance with the ISDEA, the Act, and the non-statutory program requirements established in the notice of final requirements, definitions, and selection criteria for this program, published elsewhere in this issue of the
The career and technical education programs, services, and activities provided through an Indian self-determination contract would have to be essentially the same as were proposed in the initial application and approved by the Department. Any Indian tribe or tribal organization that is selected to receive funding under this competition, but whose request for an Indian self-determination contract is denied, may appeal the denial to the Secretary. If you have questions about ISDEA self-determination contracts, please contact the persons listed in the
The regulations in 34 CFR part 86 apply to institutions of higher education only.
Estimated Number of Awards: 30.
The Department is not bound by any estimates in this notice.
1.
(1) A federally recognized Indian tribe.
(2) A tribal organization.
(3) An Alaska Native entity.
(4) A Bureau-funded school, except for a Bureau-funded school proposing to use its award to support secondary school career and technical education programs.
(b) Any tribe, tribal organization, Alaska Native entity, or eligible Bureau-funded school may apply individually or as part of a consortium with one or more eligible tribes, tribal organizations, Alaska Native entities, or eligible Bureau-funded schools. (Eligible applicants seeking to apply for funds as a consortium must meet the requirements in 34 CFR 75.127-75.129, which apply to group applications.)
2.
(a) An eligible applicant (as determined by the Act) must include documentation in its application showing that it and, if appropriate, its consortium members are eligible to apply.
(b) As defined in the Indian Self-Determination and Education Assistance Act (ISDEA) (25 U.S.C. 450b(l)), the term “tribal organization” means the recognized governing body of any Indian tribe; any legally established organization of Indians which is controlled, sanctioned, or chartered by such governing body or which is democratically elected by the adult members of the Indian community to be served by such organization and which includes the maximum participation of Indians in all phases of its activities: Provided, that in any case where a contract is let or grant made to an organization to perform services benefiting more than one Indian tribe, the approval of each such Indian tribe shall be a prerequisite to the letting or making of such contract or grant. In accordance with this statutory definition, any tribal organization proposing to provide NACTEP services for the benefit of more than one Indian tribe must first obtain the approval of each Indian tribe it proposes to serve and must submit documentation of such approval with its NACTEP application and that documentation of tribal approval is a prerequisite to the awarding of a NACTEP grant to any tribal organization proposing to serve more than one Indian tribe.
3. (a)
(b)
4.
(a) Background Information
This notice invites applications for a NACTEP competition that implements section 116 of the Act, enacted August 12, 2006. Section 116 of the Act continues to authorize the Secretary to award grants, cooperative agreements, or enter into contracts with Indian tribes, tribal organizations, and Alaska Native entities to operate career and technical education projects that improve career and technical education for Native American and Alaska Native students.
Under section 116 of the Act, Bureau-funded schools proposing to fund secondary programs are not eligible to receive an award directly from the Secretary. However, an Indian tribe, tribal organization, Alaska Native entity, or Bureau-funded school may use its award to assist a secondary school operated or supported by the U.S. Department of the Interior to carry out career and technical education programs. A Bureau-funded school that is not proposing a secondary program is eligible for assistance under NACTEP.
(b) Under the statutory definition of “career and technical education”, the sequence of courses provided as part of a career and technical education program must provide students with coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions. (20 U.S.C. 2302(5)(A)(i))
(c) Special Populations. Paragraph (F) of the definition of “Special Populations” in section 3(29) of the Act uses the phrase “individuals with limited English proficiency”. Under section 324 of the Act, NACTEP students with other barriers to educational achievement may receive assistance such as tuition and fees, dependent care, transportation, books, and supplies, that are necessary for a student to participate in a project funded under this program. (20 U.S.C. 2414(b))
Refer to the Direct assistance to students and Student Stipends sections of this notice for guidance on providing financial assistance for tuition, dependent care, transportation, books, supplies, and stipends.
1.
You may also obtain an application package via the Internet from the following address:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the program contact persons listed in this section.
2.
Requirements concerning the content of the application, together with the forms you must submit, are in the application package for this program.
3.
Applications for grants under this program may be submitted electronically using the Grants.gov Apply site (Grants.gov), or in paper format by mail or hand delivery. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery, please refer to section IV. 7.
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the persons listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR)—and, after July 24, 2012, with the System for Award Management (SAM), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active CCR and SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one business day.
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2-5 weeks for your TIN to become active.
The CCR or SAM registration process may take five or more business days to complete. If you are currently registered with the CCR, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days to complete. Information about SAM is available at SAM.gov.
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
Applications for grants under this program may be submitted electronically or in paper format by mail or hand delivery.
a.
We are participating as a partner in the Governmentwide Grants.gov Apply
If you choose to submit your application electronically, you must use the Governmentwide Grants.gov Apply site at
You may access the electronic grant application for NACTEP at
Please note the following:
• Your participation in Grants.gov is voluntary.
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you submit your application in paper format.
• If you submit your application electronically, you must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• If you submit your application electronically, you must upload any narrative sections and all other attachments to your application as files in a PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material.
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award Number (an ED-specified identifying number unique to your application.)
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the persons listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
b.
If you submit your application in paper format by mail (through the U.S. Postal Service of a commercial carrier), you must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education,Application Control Center,Attention: (CFDA Number 84.101A),LBJ Basement Level 1,400 Maryland Avenue SW.,Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
c.
If you submit your application in paper format by hand delivery, you (or a courier service) must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education,Application Control Center,Attention: (CFDA Number 84.101A)550 12th Street SW.,Room 7041, Potomac Center Plaza,Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
(a)
(b)
(1) The potential contribution of the proposed project toward increasing the understanding of educational needs, issues, or strategies for providing career and technical education to American Indians and Alaska Natives. (5 points)
(2) The likelihood that the proposed project will result in system change or improvement in the applicant's educational program as evidenced by the types of training and activities identified in the project application. (5 points)
(3) The extent to which the proposed project is likely to build local capacity to provide, improve, or expand services that address the career and technical needs of the target population. (5 points)
(c)
(1) The extent to which goals, objectives, and outcomes are clearly specified and measurable (e.g., identification of the requirements for each course of study to be provided under the project, the technical skill proficiencies to be taught and the industry-recognized standards or competency assessments to be used, including related training areas and a description of the industry certifications, credentials, certificates, or degrees that students may earn; expected enrollments, completions, and student placements in jobs, military specialties, and continuing education/training opportunities in each career training area; the number of teachers, counselors, and administrators to be trained). (10 points)
(2) The extent to which the design of the proposed project is appropriate to, and will successfully address, the needs of the target population or other identified needs, as evidenced by the applicant's description of programs and activities that align with the target population's needs. (5 points)
(3) The extent to which the design for implementing and evaluating the proposed project plans for and is likely to result in the development of information that will guide possible dissemination of information on project practices, activities, or strategies, including information about the effectiveness of the approach or strategies employed by the project, planned dissemination activities, the kind of practices, activities, or strategies to be disseminated, the target audience for the dissemination of such practices, activities, or strategies, and the proposed uses for such disseminated practices, activities, or strategies. (5 points)
(4) The extent to which the proposed project will establish linkages with or will be coordinated with similar or related efforts, and with community, State, or Federal resources, where such opportunities and resources exist. (5 points)
(d)
(1) The extent to which the training or professional development services to be provided by the proposed project would be of sufficient quality, intensity, and duration to lead to improvements in practice among the project staff and instructors, including the extent to which the proposed training and professional development plans address ways in which learning gaps will be addressed and how continuous review of performance will be conducted to identify training needs. (5 points)
(2) The extent to which the services to be provided by the proposed project will create opportunities for students to receive an industry-recognized credential; become employed in high-skill, high-wage, and high-demand occupations; or both. (5 points)
(3) The extent to which the services proposed in the project will create opportunities for students to acquire technical skill proficiencies, industry certifications, or the skills identified by State or industry-recognized career and technical education programs or professions. In describing the services, there must be a clear link between the services and the skill proficiencies, industry certifications, credentials, certificates, or degrees that students may earn. (10 points)
(e)
(1) The extent to which the applicant encourages applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. (5 points)
(2) The qualifications, including relevant training, expertise, and experience, of the project director, key personnel, and project consultants. (5 points)
(3) The extent to which the project will use instructors who are certified to teach in the field in which they will provide instruction. (5 points)
(f)
(1) The adequacy of support, including facilities, equipment, supplies, and other resources, from the
(2) The extent to which the budget is adequate and costs are reasonable in relation to the objectives of the proposed project. (5 points)
(3) The relevance and demonstrated commitment (e.g., through written career and technical education agreements, memoranda of understanding, letters of support and commitment, or commitments to employ project participants, as appropriate) of the applicant, members of the consortium, local employers, or tribal entities to be served by the project. (5 points)
(4) The potential for continued support of the project after Federal funding ends. (5 points)
(g)
(1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and the milestones and performance standards for accomplishing project tasks. (5 points)
(2) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project. (5 points)
(3) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project. (5 points)
(h)
(1) The extent to which the methods of evaluation proposed by the grantee are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project. (5 points)
(2) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and the Government Performance and Results Act of 1993 (GPRA) performance measures, and will produce quantitative and qualitative data, to the extent possible. (5 points)
(3) The extent to which the methods of the evaluation include processes that consider the validity and integrity of data collection and analysis; accessibility of appropriate and timely data; accurate descriptions of performance; collection processes that yield unbiased, unprejudiced, and impartial data results; and the extent to which representation of the data clearly communicates an accurate picture of performance. (5 points)
(4) The extent to which the methods of evaluation will provide performance feedback and continuous improvement toward achieving intended outcomes. (5 points)
(5) The quality of the evaluation to be conducted by an external evaluator with the necessary background and technical expertise to carry out the evaluation. (5 points)
2.
(a) Up to 10 additional points to applications that propose exemplary approaches that involve, coordinate with, or encourage tribal economic development plans; and
(b) Five points to applications from tribally controlled colleges or universities that—
(1) Are accredited or are candidates for accreditation by a nationally recognized accreditation organization as an institution of postsecondary career and technical education; or
(2) Operate career and technical education programs that are accredited or are candidates for accreditation by a nationally recognized accreditation organization and issue certificates for completion of career and technical education programs (20 U.S.C. 2326(e)).
3.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
4.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
4.
(a) At the secondary level: An increase in the percentage of career and technical education students who—
(1) Attain academic proficiency, as demonstrated by meeting academic content standards and student academic achievement standards that meet challenging State defined academic standards for reading/language arts and mathematics;
(2) Attain career and technical skill proficiencies, including student achievement on technical assessments that are aligned with industry-recognized standards;
(3) Attain a secondary school diploma;
(4) If a credential, certificate, or degree is offered by the State in which the project operates, in conjunction with a secondary school diploma, attain a proficiency credential, certificate, or degree in conjunction with a secondary school diploma; and
(5) Are placed in—
(i) Postsecondary education or advanced training;
(ii) Military service; or
(iii) Employment.
(b) At the postsecondary level: An increase in the percentage of career and technical education students who—
(1) Attain challenging career and technical skill proficiencies, including student achievement on technical assessments that are aligned with industry-recognized standards;
(2) Attain an industry-recognized credential, a certificate, or a degree;
(3) Are retained in postsecondary education or transfer to a baccalaureate degree program;
(4) Are placed in—
(i) Military service; or
(ii) Apprenticeship programs; and
(5) Are placed or have been retained in employment, including in high-skill, high-wage, or high-demand occupations or professions.
(c) At the adult education level: An increase in the percentage of participating adult career and technical education students who—
(1) Enroll in a postsecondary education or training program;
(2) Attain career and technical education skill proficiencies aligned with industry-recognized standards;
(3) Receive industry-recognized credentials or certificates; and
(4) Are placed in a job, upgraded in a job, or retain employment.
All grantees will be expected to submit an annual performance report addressing these performance measures, to the extent feasible and to the extent that they apply to each grantee's NACTEP project.
5.
(a) Be appropriate for the project and be both formative and summative in nature;
(b) Include—
(1) Applicable performance measures for NACTEP;
(2) Qualitative and quantitative data with respect to—
(i) Academic and career and technical competencies demonstrated by the participants and the number and kinds of academic and work credentials acquired by individuals, including participation in programs providing skill proficiency assessments, industry certifications, or training at the associate degree level that is articulated with an advanced degree option;
(ii) Enrollment, completion, and placement of participants by gender for each occupation for which training was provided;
(iii) Job or work skill attainment or enhancement, including participation in apprenticeship and work-based learning programs, and student progress in achieving technical skill proficiencies necessary to obtain employment in the field for which the student has been prepared, including attainment or enhancement of technical skills in the industry the student is preparing to enter;
(iv) Activities during the formative stages of the project to help guide and improve the project, as well as a summative evaluation that includes recommendations for disseminating information on project activities and results;
(v) The number and percentage of students who obtained industry-recognized credentials, certificates, or degrees;
(vi) If available, the outcomes of students' technical assessments, by type and scores; and
(vii) The rates of attainment of a proficiency credential or certificate, in conjunction with a secondary school diploma;
(c) Measure the effectiveness of the project, including—
(1) A comparison between the intended and observed results; and
(2) A demonstration of a clear link between the observed results and the specific treatment given to project participants;
(d) Measure the extent to which information about or resulting from the project was disseminated at other sites, such as through the grantee's development and use of guides or manuals that provide step-by-step directions for practitioners to follow when initiating similar efforts; and
(e) Measure the long-term impact of the project, such as, follow-up data on students' employment, sustained employment, promotions, and further/continuing education or training, or the impact the project had on tribal economic development or career and technical education activities offered by tribes.
6.
If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Office of Elementary and Secondary Education, Department of Education.
Notice.
Carol M. White Physical Education Program.
Notice inviting applications for new awards for fiscal year (FY) 2013.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.215F.
The priority is:
Under this priority, an applicant is required to develop, expand, or improve its physical education program and address its State's physical education standards by undertaking the following activities: (1) Instruction in healthy eating habits and good nutrition and (2) physical fitness activities that must include at least one of the following: (a) Fitness education and assessment to help students understand, improve, or maintain their physical well-being; (b) instruction in a variety of motor skills and physical activities designed to enhance the physical, mental, and social or emotional development of every student; (c) development of, and instruction in, cognitive concepts about motor skills and physical fitness that support a lifelong healthy lifestyle; (d) opportunities to develop positive social and cooperative skills through physical activity participation; or (e) opportunities for professional development for teachers of physical education to stay abreast of the latest research, issues, and trends in the field of physical education.
These priorities are:
Under this priority we give competitive preference to projects that are designed to address the following priority area:
(a) Providing services to students enrolled in persistently lowest-achieving schools (as defined in this notice).
For the purposes of this priority, the Department considers schools that are identified as Tier I or Tier II schools under the School Improvement Grants Program (see 75 FR 66363) as part of a State's approved FY 2009, FY 2010, or FY 2011 application to be persistently lowest-achieving schools. A list of these Tier I and Tier II schools can be found on the Department's Web site at
We will give a competitive preference priority to an applicant that includes in its application an agreement that details the participation of required partners, as defined in this notice. The agreement must include a description of: (1) Each partner's roles and responsibilities in the project; (2) how each partner will contribute to the project, including any contribution to the local match; (3) an assurance that the application was developed after timely and meaningful consultation between the required parties, as defined in this notice; and (4) a commitment to work together to reach the desired goals and outcomes of the project. The partner agreement must be signed by the Authorized Representative of each of the required partners and by other partners as appropriate.
For an LEA applicant, this partnership agreement must include: (1) The LEA; (2) at least one CBO; (3) a local public health entity, as defined in this notice; (4) the LEA's food service or child nutrition director; and (5) the head of the local government, as defined in this notice.
For a CBO applicant, the partnership agreement must include: (1) The CBO; (2) a local public health entity, as defined in this notice; (3) a local organization supporting nutrition or healthy eating, as defined in this notice; (4) the head of the local government, as defined in this notice; and (5) the LEA from which the largest number of students expected to participate in the CBO's project attend. If the CBO applicant is a school, such as a parochial or other private school, the applicant must describe its school as part of the partnership agreement but is not required to provide an additional signature from an LEA or another school. A CBO applicant that is a school and serves its own population of students is required to include another CBO as part of its partnership and include the head of that CBO as a signatory on the partnership agreement.
Although partnerships with other parties are required for this priority, the eligible applicant must retain the administrative and fiscal control of the project.
These priorities are:
We believe that the seven design filters complement the priorities and requirements in this notice. Additional information about the seven design filters is available at:
This priority is:
Projects that propose to align their programs with the following design filters. Programs should:
1. Strive for universal access;
2. Include a range of age appropriate activities;
3. Aim to reach the recommended guidelines on dosage and duration;
4. Be engaging and fun for kids;
5. Be led by well-trained coaches and mentors;
6. Track progress, both individually and for the group; and
7. Provide consistent motivation and incentives.
In general, priority schools represent the lowest-achieving five percent of a State's Title I schools and also may include Title I-participating or Title I-eligible high schools with graduation rates below 60 percent. A State's priority schools list typically includes at least some persistently lowest-achieving schools in which LEAs are implementing comprehensive interventions under the School Improvement Grants program, but most States' lists include additional schools as well. Some priority schools, then, are not persistently lowest-achieving schools.
Consequently, for most States that have received waivers under ESEA flexibility, the list of priority schools represents a more complete and up-to-date list of its lowest-performing schools than its list of persistently lowest-achieving schools. In addition, States that have received ESEA flexibility are required to begin, over the next three years, implementation of comprehensive interventions that are designed to turn around the performance of each of their priority schools.
For these reasons, we encourage applicants from States approved for ESEA flexibility to include in their project design an emphasis on providing services to students enrolled in priority schools, both those that are and those that are not persistently lowest-achieving schools. An applicant may address this priority and Competitive Preference Priority 1 by serving priority schools that are also persistently lowest-achieving schools.
This priority is:
Projects that provide services to students enrolled in priority schools (as defined in this notice).
The following requirements, which are from the notice of final priorities, requirements, and definitions published in the
Applicants must complete the physical activity and nutrition questions in Modules 1-4 of the Center for Disease Control's (CDC's) SHI self-assessment tool and develop project goals and plans that address the identified needs. Modules 1-4 are School Health and Safety Policies and Environment, Health Education, Physical Activity and Other Physical Activity Programs, and Nutrition Services. LEA applicants must use the SHI self-assessment to develop a School Health Improvement Plan focused on improving these issues, and design an initiative that addresses their identified gaps and weaknesses. Applicants must include their Overall Score Card for the questions answered in Modules 1-4 in their application, and correlate their School Health Improvement Plan to their project design. Grantees must also complete the same modules of the SHI at the end of the project period and submit the Overall Score Card from the second assessment in their final reports to demonstrate SHI completion and program improvement as a result of PEP funding.
If a CBO applicant (unless the CBO is a school) is in a partner agreement with an LEA or school, it must collaborate with its partner or partners to complete Modules 1-4 of the SHI.
Alternatively, if the CBO has not identified a school or LEA partner, the CBO is not required to do Modules 1-4 of the SHI but must use an alternative needs assessment tool to assess the nutrition and physical activity environment in the community for children. CBO applicants are required to include their overall findings from the community needs assessment and correlate their findings with their project design. Grantees will be required to complete the same needs assessment at the end of their project and submit their findings in their final reports to demonstrate the completion of the assessment and program involvement as a result of PEP funding.
Grantees must develop, update, or enhance physical activity policies and
Applicants must sign a Program-Specific Assurance that commits them to developing, updating, or enhancing these policies during the project period. Applicants that do not submit such a Program-Specific Assurance signed by the applicant's Authorized Representative are ineligible for the competition.
Applicants that are participating in a program authorized by the Richard B. Russell National School Lunch Act or the Child Nutrition Act of 1966
If an applicant or a member of its partnership group does not participate in a program authorized by the Richard B. Russell National School Lunch Act or the Child Nutrition Act of 1966, it will not necessarily have a local wellness policy and, thus, is not required to meet this requirement or adopt a local wellness policy. However, we encourage those applicants to develop and adopt a local wellness policy, consistent with the provisions in the Richard B. Russell National School Lunch Act or the Child Nutrition Act of 1966 in conjunction with its PEP project.
Applicants must sign a Program-Specific Assurance that commits them to align their PEP project with the district's Local Wellness Policy, if applicable. Applicants to whom this requirement applies that do not submit a Program-Specific Assurance signed by the applicant's Authorized Representative are ineligible for the competition.
If an applicant is implementing the CDC's Coordinated School Health program, it must coordinate project activities with that initiative and describe in its application how the proposed PEP project would be coordinated and integrated with the program.
If an applicant receives funding under the United States Department of Agriculture's (USDA's) Team Nutrition initiative (Team Nutrition Training Grants), the applicant must describe in its application how the proposed PEP project supports the efforts of this initiative.
An applicant for a PEP project in a community that receives a grant under the Recovery Act Communities Putting Prevention to Work—Community Initiative must agree to coordinate its PEP project efforts with those under the Recovery Act Communities Putting Prevention to Work-Community Initiative.
Applicants and PEP-funded projects must complement, rather than duplicate, existing, ongoing or new efforts whose goals and objectives are to promote physical activity and healthy eating or help students meet their State standards for physical education.
Applicants must sign a Program-Specific Assurance that commits them to align their PEP project with the Coordinated School Health program, Team Nutrition Training Grant, Recovery Act Communities Putting Prevention to Work—Community Initiative, or any other similar Federal, State, or local initiatives. Applicants that do not submit a Program-Specific Assurance signed by the applicant's Authorized Representative are ineligible for the competition.
Applicants that plan to use grant-related funds, including Federal and non-Federal matching funds, to create, update, or enhance their physical education or nutrition education curricula are required to use the Physical Education Curriculum Analysis Tool (PECAT) and submit their overall PECAT scorecard, and the curriculum improvement plan from PECAT. Also, those applicants that plan to use grant-related funds, including Federal and non-Federal matching funds to create, update, or enhance their nutrition instruction in health education must complete the healthy eating module of the Health Education Curriculum Analysis Tool (HECAT). Applicants must use the curriculum improvement plan from the HECAT to identify curricular changes to be addressed during the funding period. Applicants must also describe how the HECAT assessment would be used to guide nutrition instruction curricular changes. If an applicant is not proposing to use grant-related funds for physical education or nutrition instruction curricula, it would not need to use these tools.
Purchases of equipment with PEP funds or with funds used to meet the program's matching requirement must be aligned with the curricular components of the proposed physical education and nutrition program. Applicants must commit to aligning the students' use of the equipment with PEP elements applicable to their projects, identified in the absolute priority in this notice, and any applicable curricula by signing a Program-Specific Assurance. Applicants that do not submit a Program-Specific Assurance signed by the applicant's Authorized Representative are ineligible for the competition.
Grantees must create or use existing reporting mechanisms to provide information on students' progress, in the aggregate, on the key program indicators, as described in this notice and required under the Government Performance and Results Act, as well as on any unique project-level measures proposed in the application. Grantees that are educational agencies or institutions are subject to applicable Federal, State, and local privacy provisions, including the Family Educational Rights and Privacy Act—a law that generally prohibits the non-consensual disclosure of personally identifiable information in a student's education record. All grantees must comply with applicable Federal, State, and local privacy provisions. The aggregate-level information should be easily accessible by the public, such as posted on the grantee's or a partner's Web site. Applicants must describe in
Applicants must commit to reporting information to the public by signing a Program-Specific Assurance. Applicants that do not submit a Program-Specific Assurance signed by the applicant's Authorized Representative are ineligible for the competition.
(a) Is representative of a community or significant segments of a community; and
(b) Provides educational or related services to individuals in the community. (ESEA section 9101(6)).
(1) A public board of education or other public authority legally constituted within a State for either administrative control or direction of, or to perform a service function for, public elementary schools or secondary schools in a city, county, township, school district, or other political subdivision of a State, or of or for a combination of school districts or counties that is recognized in a State as an administrative agency for its public elementary schools or secondary schools.
(2) The term includes any other public institution or agency having administrative control and direction of a public elementary school or secondary school.
(3) The term includes an elementary school or secondary school funded by the Bureau of Indian Affairs but only to the extent that including the school makes the school eligible for programs for which specific eligibility is not provided to the school in another provision of law and the school does not have a student population that is smaller than the student population of the local educational agency receiving assistance under this Act with the smallest student population, except that the school shall not be subject to the jurisdiction of any State educational agency other than the Bureau of Indian Affairs.
(4) The term includes educational service agencies and consortia of those agencies.
(5) The term includes the State educational agency in a State in which the State educational agency is the sole educational agency for all public schools. (ESEA section 9101(26)).
To identify the persistently lowest achieving schools, a State must take into account both: (i) The academic achievement of the “all students” group in a school in terms of proficiency on the State's assessments under section 1111(b)(3) of the ESEA in reading/language arts and mathematics combined; and (ii) the school's lack of progress on those assessments over a number of years in the “all students” group. (76 FR 27637, 27640).
For the purposes of Competitive Preference Priority 1 in this notice, the Department considers schools that are identified as Tier I or Tier II schools under the School Improvement Grants Program (see 75 FR 66363) as part of a State's approved FY 2009, FY 2010, or FY 2011 application to be persistently lowest-achieving schools. A list of these Tier I and Tier II schools can be found on the Department's Web site at
A list of priority schools in each State approved for ESEA flexibility may be found on the SEA's Web site. The following States have been approved for ESEA flexibility: Arkansas, Arizona, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Washington, and Wisconsin. In addition, the District of Columbia has been approved for ESEA flexibility.
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to institutions of higher education only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards later in FY 2013 and in subsequent years from the list of unfunded applicants from this competition.
The Department is not bound by any estimates in this notice.
1.
(b) The Secretary limits eligibility under this discretionary grant competition to LEAs or CBOs that do not currently have an active grant under PEP. For the purpose of this eligibility requirement, a grant is considered active until the end of the grant's project or funding period, including any extensions of those periods that extend the grantee's authority to obligate funds.
2. (a)
(b)
3.
1.
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the program contact person listed in this section.
2.
Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the application narrative to no more than 25 pages, using the following standards:
• A “page” is 8.5″ x 11″, on one side only, with 1″margins at the top, bottom, and both sides.
• Double space (no more than three lines per verticalinch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger or nosmaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman,Courier, Courier New, or Arial.
The page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the page limit does apply to all of the application narrative section.
Our reviewers will not read any pages of your application that exceed the page limit.
3.
Applications for grants under this program must be submitted electronically using the Grants.gov
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
In accordance with section 5505(b) of the ESEA, not more than five percent of grant funds provided under this program to an LEA or CBO for any fiscal year may be used for administrative expenses.
We reference additional regulations outlining funding restrictions in the
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the Central Contractor Registry (CCR))—and, after July 24, 2012, with the System for Award Management (SAM), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active CCR or SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one business day.
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2-5 weeks for your TIN to become active.
The CCR or SAM registration process may take five or more business days to complete. If you are currently registered with the CCR, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days to complete. Information about SAM is available at
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.
a.
Applications for grants under the Carol M. White Physical Education Program, CFDA number 84.215F, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
You may access the electronic grant application for the Carol M. White Physical Education Program at
Please note the following:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this program to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF or submit a password-protected file, we will not review that material.
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system;
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Carlette KyserPegram, U.S. Department of Education, 400 Maryland Avenue SW., room 10007, PCP, Washington, DC 20202-6450. FAX: (202)245-7166.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address:
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
2.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
An additional factor we consider in selecting applications for an award is equitable distribution of awards among LEAs and CBOs serving urban and rural areas. (See 20 U.S.C. 7261e(b).)
3.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) There are reporting requirements under this program, including under section 5505(a) of the ESEA and 34 CFR 75.118 and 75.720. In accordance with section 5505(a) of the ESEA, grantees under this program are required to submit an annual report that—
(1) Describes the activities conducted during the preceding year; and
(2) Demonstrates that progress has been made toward meeting State standards for physical education.
This annual report must also address progress toward meeting the performance and efficiency measures established by the Secretary for this program and described in the next section of this notice.
(c) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
4.
(a) The percentage of students served by the grant who engage in 60 minutes of daily physical activity measured by using pedometers for students in grades K-12 and an additional 3-Day Physical Activity Recall (3DPAR) instrument to collect data on students in grades 5-12.
(b) The percentage of students served by the grant who meet the standard of a healthy fitness zone as established by the assessment for the Presidential Youth Fitness Program (PYFP) in at least five of the six fitness areas of that assessment.
(c) The percentage of students served by the grant who consume fruit two or more times per day and vegetables three or more times per day as measured in programs serving high school students using the nutrition-related questions from the Youth Risk Behavior Survey and in programs serving elementary and middle school students using an appropriate assessment tool for their populations.
For each measure, grantees should collect and aggregate data from two discrete data collection periods throughout each year. During the first year, grantees have an additional data collection period prior to program implementation to collect baseline data.
(d) The cost (based on the amount of the grant award) per student who achieves the level of physical activity required to meet the physical activity measure above (i.e., 60 minutes of daily physical activity).
These measures constitute the Department's measures of success for this program. Consequently, applicants for a grant under this program are advised to give careful consideration to these measures in conceptualizing the approach and evaluation of their proposed project. If funded, applicants will be asked to collect and report data in their performance and final reports about progress toward these measures.
5.
Carlette KyserPegram, U.S. Department of Education, 550 12th Street SW., room 10007, PCP, Washington, DC 20202-6450. Telephone: 202-245-7871 or by email:
If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.
Electronic Access to This Document: The official version of this document is the document published in the
You may also access documents of the Department published in the
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Take notice that the Commission received the following land acquisition reports:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, and service can be found at:
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 28, 2013.
Submit your comments, referencing docket ID number EPA-HQ-OECA-2012-0693, to: (1) EPA online, using
Learia Williams, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 564-4113; fax number: (202) 564-0050; email address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On October 17, 2012 (77
EPA has established a public docket for this ICR under docket ID number EPA-HQ-OECA-2012-0693, which is available for either public viewing online at
Use EPA's electronic docket and comment system at
Owners or operators of the affected facilities must submit initial notification report, performance tests, and periodic reports and results. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. Reports, at a minimum, are required semiannually.
There is an increase in labor rates for both the respondents and the Agency from the most- recently approved ICR. This ICR uses updated labor rates from the Bureau of Labor Statistics to calculate burden costs for respondents, and uses updated labor rates from OPM to calculate burden costs for the Agency.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 28, 2013.
Submit your comments, referencing docket ID number EPA-HQ-OECA-2012-0653, to: (1) EPA online, using
Learia Williams, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 564-4113; fax number: (202) 564-0050; email address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On October 17, 2012 (77 FR 63813), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional comments on this ICR should be submitted to both EPA and OMB within 30 days of this notice.
EPA has established a public docket for this ICR under docket ID number EPA-HQ-OECA-2012-0653, which is available for either public viewing online at
Use EPA's electronic docket and comment system at
Owners or operators of the affected facilities must submit initial notification report, performance tests, and periodic reports and results. Owners or operators are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. Reports, at a minimum, are required semiannually.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “Information Requirements for Locomotives and Locomotive Engines (Renewal)” (EPA ICR No. 1800.07, OMB Control No. 2060-0392) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before March 28, 2013.
Submit your comments, referencing Docket ID Number Docket ID No. EPA-HQ-OAR-2007-1184, to (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Nydia Yanira Reyes-Morales, Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Mail Code 6403J, Washington, DC 20460; telephone number: 202-343-9264; fax number: 202-343-2804; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
The CAA also mandates EPA to verify that manufacturers have successfully translated their certified prototypes into mass produced engines, and that these engines comply with emission standards throughout their useful lives. Under the Production Line Testing (PLT) Program, manufacturers are required to test a sample of engines as they leave the assembly line. This self-audit program allows manufacturers to monitor compliance with statistical certainty and minimize the cost of correcting errors through early detection. A similar audit program exists for the installation of locomotive remanufacturing kits. In-use testing allows manufacturers and EPA to verify compliance with emission standards throughout the locomotive's useful life. Through Selected Enforcement Audits (SEAs), EPA verifies that test data submitted by engine manufacturers is reliable and testing is performed according to EPA regulations.
The information requested is collected by the Diesel Engine Compliance Center (DECC), Compliance Division (CD), Office of Transportation and Air Quality, Office of Air and Radiation, EPA. Besides DECC and CD, this information could be used by the Office of Enforcement and Compliance Assurance and the Department of Justice for enforcement purposes. Non-confidential business information submitted by respondents to this information collection may be disclosed over the Internet. That information is used by trade associations, environmental groups, and the public. Under this ICR, most of the information is collected in electronic format and stored in CD's databases.
Confidential business information (CBI) is kept confidential in accordance with the Freedom of Information Act, EPA regulations at 40 CFR Part 2, and class determinations issued by EPA's Office of General Counsel. Non-proprietary information submitted by manufacturers is held as confidential until the specific locomotive or locomotive engine to which it pertains is available for purchase.
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Office of External Affairs and Environmental Education, Environmental Protection Agency.
Notice.
The National Environmental Education Foundation (NEEF) was created by Section 10 of Public Law #101-619, the National Environmental Education Act of 1990. It is a private 501 (c)(3) non-profit organization established to promote and support education and training as necessary tools to further environmental protection and sustainable, environmentally sound development. It provides the common ground upon which leaders from business and industry, all levels of government, public interest groups, and others can work cooperatively to expand the reach of environmental education and training programs beyond the traditional classroom. The Foundation supports a grant program that promotes innovative environmental education and training programs; it also develops partnerships with government and other organizations to administer projects that promote the development of an environmentally literal public. The Administrator of the U.S. Environmental Protection Agency, as required by the terms of the Act, announces the following appointment to the National Environmental Education Foundation Board of Trustees. The appointee is Megan Reilly Cayten, Co-Founder and Chief Executive Officer of Catrinka, LLC.
For information regarding this Notice of Appointment, please contact Mrs. Stephanie Owens, Deputy Associate Administrator, Office of External Affairs and Environmental Education (1701A) U.S. EPA 1200 Pennsylvania Ave., NW., Washington, DC 20460. General information concerning NEEF can be found on their Web site at:
This appointee will join the current Board members which include:
• JL Armstrong (NEEF Vice Chair), National Manger, Toyota Motor Sales, USA, Inc.
• Raymond Ban, Executive Vice President, The Weather Channel
• Holly Cannon, Principal, Beveridge and Diamond, P.C.
• Phillipe Cousteau, Co-Founder and CEO, EarthEcho International
• Manuel Alberto Diaz, Partner, Lydecker Diaz, L.L.P.
• Arthur Gibson (NEEF Chair), Vice President, Environment, Health and Safety, Baxter Healthcare Corporation
• Trish Silber, President, Aliniad Consulting Partners, Inc.
• Bradley Smith, Dean, Huxley College of the Environment, Western Washington University
• Kenneth Strassner (NEEF Treasurer), Vice President, Global Environment, Safety, Regulatory and Scientific Affairs, Kimberly-Clark Corporation
• Diane Wood (NEEF Secretary), President, National Environmental Education Foundation
• Decker Anstrom, Former CEO, The Weather Channel Companies
• Wonya Lucas, Former CEO, TV One
The Foundation is a charitable and nonprofit corporation whose income is exempt from tax, and donations to which are tax deductible to the same extent as those organizations listed pursuant to section 501(c) of the Internal Revenue Code of 1986. The Foundation is not an agency or establishment of the United States. The purposes of the Foundation are—
(A) Subject to the limitation contained in the final sentence of subsection (d) herein, to encourage, accept, leverage, and administer private gifts for the benefit of, or in connection with, the environmental education and training activities and services of the United States Environmental Protection Agency;
(B) To conduct such other environmental education activities as will further the development of an environmentally conscious and responsible public, a well-trained and environmentally literate workforce, and an environmentally advanced educational system;
(C) To participate with foreign entities and individuals in the conduct and coordination of activities that will further opportunities for environmental education and training to address environmental issues and problems involving the United States and Canada or Mexico.
The Foundation develops, supports, and/or operates programs and projects to educate and train educational and environmental professionals, and to assist them in the development and delivery of environmental education and training programs and studies.
The Foundation has a governing Board of Directors (hereafter referred to in this section as `the Board'), which consists of 13 directors, each of whom shall be knowledgeable or experienced in the environment, education and/or training. The Board oversees the activities of the Foundation and assures that the activities of the Foundation are consistent with the environmental and education goals and policies of the Environmental Protection Agency and with the intents and purposes of the Act. The membership of the Board, to the extent practicable, represents diverse points of view relating to environmental education and training. Members of the Board are appointed by the Administrator of the Environmental Protection Agency.
Within 90 days of the date of the enactment of the National Environmental Education Act, and as appropriate thereafter, the Administrator will publish in the
Ms. Cayten has been Co-Founder and Chief Executive Officer of CATRINKA, LLC since 2012.
Ms. Cayten was Vice President of Alinda Capital Partners since 2011, Consultant of Global Water Challenge since 2008, Vice President of Citigroup since 2007, Associate of Endesa Internacional since 2003, Vice President of AES Honduras since 2002, Development Manager of AES Corporation since 2000, Policy Director and Assistant to the Chairwoman of Citizens Party since 1998 and Legislative Aide to Margaret Ng Ngoi-yee since 1997.
Moderator, Clinton Global Initiative. She is a passionate believer in the power of public-private partnerships to effect change. She serves as a term member of the Council on Foreign Relations.
Ms. Cayten earned a master's degree in business administration from Harvard Business School and a bachelor's degree in History from Yale University. She speaks Spanish, French and Mandarin Chinese.
Lives with husband, Christopher, in New York City and mother of two young children.
Environmental Protection Agency (EPA).
Notice of final order on petition to object to Clean Air Act (CAA or Act) operating permit.
This document announces that the EPA Administrator has responded to a citizen petition asking EPA to object to an operating permit (Permit Number O3025) issued by the Texas Commission on Environmental Quality (TCEQ). Specifically, the Administrator has denied the October 5, 2011 petition, submitted by the Environmental Integrity Project (EIP), Sierra Club, Public Citizen, Texas Campaign for the Environment, Environment Texas, and the SEED Coalition (Petitioners), to object to the operating permit issued on August 18, 2011, to Luminant Generation Company, for the operation of the Sandow 5 Generating Plant located near Rockdale, Milam County, Texas. Sections 307(b) and 505(b)(2) of the Act provide that a petitioner may ask for judicial review of those portions of the petition which EPA denies in the United States Court of Appeals for the appropriate circuit. Any petition for review shall be filed within 60 days from the date this notice appears in the
You may review copies of the final Order, the petition, and other supporting information at EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733.
EPA requests that if at all possible, you contact the individual listed in the
Dinesh Senghani at (214) 665-7221, email address:
The CAA affords EPA a 45-day period to review, and object to as appropriate, a title V operating permit proposed by State permitting authorities. Section 505(b)(2) of the CAA authorizes any person to petition the EPA Administrator, within 60 days after the expiration of this review period, to object to a title V operating permit if EPA has not done so. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the State, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or the grounds for the issue arose after this period.
EPA received a petition from the Petitioners dated October 4, 2011, requesting that EPA object to the issuance of the title V operating permit to Luminant Generation Company—Sandow 5 Generating Plant located near Rockdale, Milam County, Texas based on the following contentions: (1) The Sandow 5 title V permit impermissibly incorporates by reference emission limitations established in a major New Source Review permit, (2) the Sandow 5 title V permit impermissibly incorporates by reference the EPA-disapproved Pollution Control Project Standard Permit, (3) the permit impermissibly incorporates permit by rules (this claim is divided into 7 sub-claims), and (4) the permit lacks a Maximum Achievable Control Technology determination as required by CAA section 112(g).
On January 15, 2013, the Administrator issued an Order denying the petition. The Order explains the reasons behind EPA's conclusion to deny the petition.
Environmental Protection Agency (EPA).
Notice; extension of comment period.
The Environmental Protection Agency published a document in the
Comments must be submitted on or before March 29, 2013.
John Warren, Environmental Protection Agency; 1200 Pennsylvania Avenue, MC 2811R; Washington, DC 20460; Phone: 202-564-6876; email address:
U.S. Environmental Protection Agency (EPA).
Notice of proposed settlement; request for public comment.
In accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement for recovery of response costs under CERCLA Section 122(h)(1) concerning the Factory H Superfund Site in Meriden, Connecticut (“Site”) with the following settling party: MidState Medical Center, Inc. The settlement requires the settling party to pay $100,000 to the Hazardous Substance Superfund. The settlement includes a covenant not to sue the settling party pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a), relating to the Site. The settlement has been approved by the Environment and Natural Resources Division of the United States Department of Justice. For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at 5 Post Office Square, Boston, Massachusetts 02109-3912.
Comments must be submitted on or before March 28, 2013.
Comments should be addressed to Hugh W. Martinez, Senior Enforcement Counsel, U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Suite 100 (OES 04-3), Boston, MA 02109-3912 (telephone (617) 918-1867) and should refer to the Factory H Superfund Site, U.S. EPA Docket No. CERCLA-01-2012-0112.
A copy of the proposed settlement may be obtained from Hugh W. Martinez, Senior Enforcement Counsel, U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Suite 100 (OES 04-3), Boston, MA 02109-3912 (telephone no. (617) 918-1867; email
Federal Communications Commission.
Notice and request for comments.
The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before April 29, 2013. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to the Federal Communications Commission via email to
For additional information about the informatio