On December 16, 2011, the FAA published in the Federal Register a notice of proposed rulemaking to amend controlled airspace at Douglas, AZ (76 FR 78180). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Subsequent to publication, the FAA found a typographical error in a bearing of the 1,200 foot airspace description and makes the correction in the rule.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface at Douglas, AZ. Additional controlled airspace is necessary to accommodate aircraft using VHF Omni-Directional Radio Range/Distance Measuring Equipment, Global Positioning System standard instrument approach procedures at Bisbee Douglas International Airport, Douglas, AZ. Decommissioning of the Cochise VORTAC has made this action necessary and enhances the safety and management of aircraft operations at the airport. The geographic coordinates of the airport is also updated to coincide with the FAA's aeronautical database. In the 700 foot/1,200 foot airspace description, the 20-mile radius bearing 076° is corrected to 075° bearing of the airport.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies controlled airspace at Bisbee Douglas International Airport, Douglas, AZ.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows:

Document Availability: In addition to publishing the full text of this document in the Federal Register , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page ( http://www.ferc.gov ) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5 p.m. Eastern time) at 888 First Street NE., Room 2A, Washington, DC 20426.

From FERC's Web site on the Internet, this information is available in the eLibrary (formerly FERRIS). The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field and follow other directions on the search page.

User assistance is available for eLibrary and other aspects of FERC's Web site during normal business hours. For assistance, contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659.

The Federal Energy Regulatory Commission (Commission) is issuing this notice to update filing fees that the Commission assesses for specific services and benefits provided to identifiable beneficiaries. Pursuant to 18 CFR 381.104, the Commission is establishing updated fees on the basis of the Commission's Fiscal Year 2011 costs. The adjusted fees announced in this notice are effective March 26, 2012. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, that this final rule is not a major rule within the meaning of section 251 of Subtitle E of Small Business Regulatory Enforcement Fairness Act, 5 U.S.C. 804(2). The Commission is submitting this final rule to both houses of the United States Congress and to the Comptroller General of the United States.

The new fee schedule is as follows:

In consideration of the foregoing, the Commission amends Part 381, Chapter I, Title 18, Code of Federal Regulations, as set forth below.

Background

We are making final the proposed changes to our rules regarding when we will recontact your medical source(s) to resolve an inconsistency or insufficiency in the evidence he or she provided. We proposed these changes in a Notice of Proposed Rulemaking (NPRM) we published in the Federal Register on April 12, 2011 (76 FR 20282). The preamble to the NPRM discussed the changes from the current rules and our reasons for proposing those changes. 1 Because we are adopting the proposed rules as published, we are not repeating that information here.

In the NPRM, we provided the public a 60-day comment period, which ended on June 13, 2011. We received 59 public comments. The comments came from a member of the public, members of the disability advocacy community, and several national groups of Social Security claimants' representatives.

We provide below summaries of the significant comments that were relevant to this rulemaking and our responses to those comments. We have tried to present the commenters' concerns and suggestions accurately and completely.

Comment: All of the commenters recommended that we keep our current requirement to recontact a person's medical source(s) first when we need to resolve an inconsistency or insufficiency in the evidence he or she provided. Some of these commenters believed that the proposed modification of this requirement was inconsistent with sections 223(d)(5)(B) and 1614(a)(3)(H) of the Social Security Act (Act), which require us to make “every reasonable effort to obtain from the individual's treating physician (or other treating health care provider) all medical evidence, including diagnostic tests, necessary in order to properly make [a] determination, prior to evaluating medical evidence obtained from any other source on a consultative basis.” Other commenters believed that any modification of the current requirement would make it less likely that adjudicators would obtain evidence from a person's medical source(s), and more likely that they would try and obtain evidence from a consultative examination (CE) instead. These commenters speculated that some adjudicators may even purchase CEs to undermine evidence provided by treating sources and to circumvent our rules on how we weigh medical opinions from these sources. 2 These commenters said that treating sources are usually the most knowledgeable about a person's condition, and therefore, can provide the best evidence regarding disability. One of these commenters also said that recontacting treating sources is simpler and more effective than purchasing a CE, and another commenter noted that it is more convenient for claimants to see their treating sources than it is for them to attend CEs.

Response: We did not adopt the comments. We disagree with the commenters' concerns for several reasons. First, we disagree that modification of the requirement to recontact a person's medical source(s) first when we need to resolve an inconsistency or insufficiency in the evidence he or she provided violates sections 223(d)(5)(B) and 1614(a)(3)(H) of the Act or our regulations. As we explained in the NPRM, the proposed change “would not alter our rules in §§ 404.1512(d) and 416.912(d) that require us to make every reasonable effort to help you get medical reports from your medical sources when you give us permission to request the reports. Rather, the proposed change would apply only after we have made those reasonable efforts.”  3

As we noted in the NPRM, the rules in §§ 404.1512(d) and 416.912(d) first require us to “make every reasonable effort” to develop “your complete medical history for at least the 12 months preceding the month in which you file your application unless there is a reason to believe that development of an earlier period is necessary or unless you say that your disability began less than 12 months before you filed your application.”  4 Our regulations define “every reasonable effort” to include “an initial request for evidence from your medical source” and “one follow-up request” at anytime “between 10 and 20 calendar days after the initial request” if we did not receive the evidence. 5 The recontact requirement applies only when we have already received evidence from a person's medical source; therefore, the revisions we are making to our rules here do not change the adjudicator's initial obligation to obtain medical evidence.

Because these final rules do not alter an adjudicator's obligations under §§ 404.1512(d) and 416.912(d), they are consistent with sections 223(d)(5)(B) and 1614(a)(3)(H) of the Act. Contrary to what some of the commenters seemed to assume, when Congress enacted sections 223(d)(5)(B) and 1614(a)(3)(H) of the Act in 1984, it did not intend to alter in any way the relative weight that we place on reports received from treating sources and consultative examiners or preclude us from obtaining consultative examinations when we find it necessary to obtain additional information or resolve conflicting evidence. 6

Second, we disagree that these rules would permit adjudicators to purchase CEs rather than develop evidence from a person's medical source(s). We have regulations that govern the purchase of CEs, and those regulations provide, in part, that “Generally, we will not request a consultative examination until we have made every reasonable effort to obtain evidence from your own medical sources.”  7 Other CE regulations underscore this point by providing that “If your medical sources cannot or will not give us sufficient medical evidence about your impairment, we may ask you to have one or more physical or mental examinations. 8 Our CE regulations also provide that before purchasing a CE, we will consider your “existing medical reports.”  9 It is also important to note that, subject to certain requirements, “your treating source will be the preferred source to do the purchased examination.”  10 We believe these regulations provide sufficient safeguards against any potential abuse of the CE process.

We agree with the commenters who stated that the treating source can be a valuable source of evidence about a person's condition. As we explained in the NPRM, there are times when we would still expect adjudicators to recontact a person's medical source first; that is, when recontact is the most effective and efficient way to obtain the information needed to resolve an inconsistency or insufficiency in the evidence received from that source. In the NPRM, we also gave two examples of situations where we would expect adjudicators to contact the medical source first, because the additional information needed is directly related to that source's medical opinion. 11 In fact, we expect that adjudicators will often contact a person's medical source(s) first whenever the additional information sought pertains to findings, treatment, and functional capacity, because the treating source may be the best source regarding these issues.

In further response to the commenters' concerns, we plan to conduct training on these final rules and will provide additional guidance on when adjudicators should recontact a person's medical source(s) first for additional information. In addition, we are currently conducting comprehensive training regarding the development of evidence from a person's medical source(s) and related rules regarding the purchase of CEs. These training efforts are ongoing and for adjudicators at all levels of the disability determination process.

Comment: Several commenters believed that the proposed modification to the recontact requirement will sacrifice the best evidence from a person's medical source(s) for the sake of efficiency, and will, therefore, result in less accurate decision making by adjudicators.

Response: We disagree with the commenters. As we pointed out in response to the comments above, modifying the recontact requirement does not alter how we comply with the provisions of the Act that require us to make “every reasonable effort” to obtain medical evidence from the individual's treating physician “prior to evaluating medical evidence obtained from any other source on a consultative basis.” Therefore, the efficiencies we expect to achieve by the changes we are making in these rules will not come at the expense of those statutory provisions. As we also noted in response to previous comments, we expect adjudicators will often recontact treating sources first in some situations because they may be the best sources of information about a person's medical condition. Accordingly, we do not believe the modification to our recontact requirement will cause a qualitative change in the medical evidence we consider or produce less accurate disability determinations and decisions.

Comment: One commenter noted that in the preamble to the NPRM, we gave two examples of when we believed it would be “inefficient and ineffective” to require recontact with a person's medical source. In one example, the person's medical source did not specialize in the area of the impairment alleged and we needed more evidence about its current severity. 12 We indicated that we may supplement the evidence “by obtaining a CE with a specialist (such as a pulmonologist) who can perform the type of examination we need to determine disability under our rules.”  13 In the other example, the medical records received contain a reference that the claimant has returned to work; we explained that it may be more appropriate to verify this information with the claimant and obtain related information rather than recontact the medical source. 14 The commenter suggested that we include some examples in the regulations, but believed the first example appears to absolve adjudicators of their obligation to recontact the medical source if that source is not a specialist.

Response: We did not adopt this comment because whether to obtain additional evidence often depends on specific case facts, and because we believe it is better to present examples in training and other instructions. As we indicated in response to the comments above, we plan to conduct training on these final rules and will provide additional guidance on when adjudicators should recontact a person's medical source(s) first for additional information. We disagree with the commenter that the first example about obtaining a CE with a specialist would absolve adjudicators of any recontact obligation if a person's medical source is not a specialist. Depending on the nature of the impairment or the additional information we need, it may be more appropriate for us to recontact the person's medical source(s) first before considering the purchase of a CE with a specialist. Because the situations when we need to obtain additional information are so variable, the type of guidance the commenter asked us to include would be too extensive to put in the regulation.

Comment: Several commenters said the proposed modification to the recontact requirement eliminates the “treating physician rule,” which relates to our regulations on how we weigh medical opinions from treating sources and the deference we give these opinions under certain circumstances. 15 These commenters also said that the proposed modification would diminish the role and weight of medical opinion evidence we receive from treating sources in our determination of disability.

Response: We did not propose any changes to our regulations on how we weigh treating source opinions in the NPRM. In addition, we disagree that modification of our recontact requirement diminishes the importance of medical evidence we receive from treating sources. As we described in response to the comments above, we have rules regarding how we obtain and consider evidence from a person's medical source(s) and rules that govern the purchase and use of CEs. These rules explain how we apply the provisions of the Act that require us to make “every reasonable effort” to obtain medical evidence from the individual's treating physician before we consider purchase of a CE. We believe these rules provide adequate safeguards against possible attempts to undermine the evidence received from a person's medical source(s), and we expect our adjudicators to follow these rules.

Comment: One commenter expressed concern about the impact our proposed modification of the recontact requirement could have at the hearings level. The commenter believed that giving administrative law judges the option of contacting someone other than a person's treating source(s) for additional information would make the proceeding adversarial. The commenter pointed out that our judges have a duty to develop the record fully and fairly and should seek out the most reliable evidence which, the commenter said, is “presumptively” from a treating source.

Response: We do not believe that modifying the recontact requirement will change the non-adversarial format of our administrative hearings. We agree that our judges have a duty to develop the record fully and fairly. Our rules regarding the development of medical evidence from a person's medical source(s) and the purchase of CEs apply equally to the judges. As we have discussed at length in our prior responses to comments, we believe these rules prevent both abuse of the CE process and any attempt to undermine the evidence received from treating sources at all levels of the disability determination process, including the hearings level.

Comment: Several commenters said the proposed modification to our recontact requirement is unnecessary because there is already an exception to this requirement in our current regulations that will permit adjudicators to contact someone other than the person's medical source first.

Response: We disagree with the commenters. Currently, the only exception to the recontact requirement is if we know from past experience that the medical source either cannot or will not provide the additional information we need. 16 We believe, however, that this exception is not always broad enough to cover other situations when contact with a different source first would be more appropriate. In the NPRM, we gave the example of evidence received from a medical source referencing a claimant's return to work. 17 Although the medical source may know something about this issue, the claimant would usually be a more appropriate source to contact first, because the claimant would be more likely to have all of the related information we need regarding work issues. Under our current rules, however, the adjudicator would first have to recontact the medical source for additional information, which could delay adjudicating the case. Therefore, we have found that our current requirement, even with its one exception, is simply too rigid at a time when our adjudicators need more flexibility in developing evidence as quickly and efficiently as possible.

Comment: One commenter said that the proposed regulation does not require us to document the case record when we know from past experience that a medical source either cannot or will not provide the additional information we need. This commenter also said it is unfair for us to assume that a medical source will not respond to an inquiry just because that source has been uncooperative in the past.

Response: Our current instructions require adjudicators to document the case development summary whenever they do not attempt to recontact a medical source because of past experience with that source. 18 Although these instructions are sub-regulatory, we expect our adjudicators to follow them, and we do not expect to change this procedure when we publish these final rules. In response to the commenter's other concern, we do not believe it is reasonable to require our adjudicators to attempt to recontact a medical source when we know from past experience that this source either cannot or will not provide the information we need. Of course, adjudicators may recontact such a source whenever they have reason to believe that the source may provide information for a particular claimant. To require recontact in all cases, however, on the chance that the source might be cooperative, would not promote efficient claims adjudication.

Comment: Several commenters said that rather than modifying our recontact requirement, we should instead find better ways to develop the evidence we need from a person's medical source(s). Some of these commenters recommended that we send a medical source statement form to elicit information targeted to our specific disability criteria or templates of condition-specific questions at the same time we send our general request for records to a person's medical source(s). Other commenters suggested that we establish even more requirements for recontacting medical sources. For example, they suggested that we require adjudicators to contact the claimant, a family member, or the claimant's representative for assistance in recontacting the medical source(s), or that we require adjudicators to make at least three attempts to recontact a medical source(s) before ordering a CE. One of these commenters also suggested that we wait 45 days for feedback from the claimant or claimant's representative after requesting assistance in recontacting a medical source(s). Several commenters said that claimants' representatives can assist our adjudicators in getting the information they need and said we should develop better lines of communication between them. Another commenter suggested that we might be able to improve our ability to obtain additional information from a person's medical source(s) by finding out whether the claimant is receiving services or support from another source that could assist us in getting information from treating sources, or by establishing a telephone dictation system for medical sources that may not have clerical support, or by paying treating sources that are unwilling to provide additional information without some financial compensation.

Response: We did not adopt the comments. We believe our adjudicators need more flexibility to conduct case development in the most efficient way possible. Requiring them to repeatedly contact the medical source(s), or requiring them to wait for feedback or to contact another source for assistance in recontacting the medical source(s), regardless of the nature of the inconsistency or insufficiency in the evidence received, would not serve these goals. As we explained in the NPRM, “[d]epending on the nature of the inconsistency or insufficiency, there may be other, more appropriate sources from whom we could obtain the information we need.”  19 Therefore, adjudicators need more, not less, discretion than our current recontact requirement provides to obtain the needed information from the most appropriate source. In addition, we are confident that we will be able to identify and correct any problems in the exercise of that discretion, should they occur, through our quality review process.

In further response to the commenters' suggestions, it is important to note that we are always striving to find better methods of collecting medical evidence, such as using Health Information Technology (HIT). As we explained in the NPRM, using HIT will enable our adjudicators to access a person's complete medical records upon receipt of a claim and reduce the number of CEs. 20 In addition, our adjudicators already use a variety of methods to obtain the evidence we need to determine disability, including the use of forms and tailored requests for information from treating sources, which several commenters suggested. Our adjudicators also routinely contact claimants, representatives, and third parties designated by claimants for assistance in obtaining evidence. We will continue to explore ways of improving the medical evidence collection process, but there are many factors, especially cost, which we must consider before we can require any particular method of obtaining medical evidence.

Moreover, we believe there should be a variety of methods available to our adjudicators, and that they should have the flexibility to determine which method of development would be the most appropriate given the facts in each case. We do not believe there is any one method that is always the most suitable or efficient, and therefore, do not believe we should require any of the suggestions made by the commenters in all cases.

Comment: Several commenters noted our reference to HIT in the NPRM and said that using HIT cannot justify modifying the recontact requirement, because HIT is not yet widespread.

Response: We did not intend our reference to HIT in the NPRM to be a justification for the proposed change to the recontact requirement. Instead, we mentioned HIT simply to point out that we are engaging in other efforts to improve the medical evidence collection process. Many of the commenters encouraged such efforts, and several of these commenters agreed with our view that increased use of HIT will speed our review of medical evidence, reduce the need to recontact treating sources, and reduce the number of CEs we might otherwise need to purchase. 21 Although HIT is still in the early phases, we are positioning our agency to take full advantage of this technology as it becomes more widespread in the medical community.

Comment: One commenter thought the organization of the proposed changes to our regulations on how we collect and consider evidence of disability was confusing and would be clearer if we reorganized those changes.

Response: We did not adopt the comment. We received many comments on the NPRM, and it appears that the commenters generally had a good understanding of how we proposed to modify the recontact requirement. In addition, as we noted in the NPRM, we combined our rules on how we collect and consider evidence into one new section (final §§ 404.1520b and 416.1520b), “so that these rules are easier to understand and apply.”  22 We believe the consolidation of our rules into one section will achieve these goals.

We have consulted with the Office of Management and Budget (OMB) and determined that this final rule meets the requirements for a significant regulatory action under Executive Order 12866 as supplemented by Executive Order 13563. Thus, OMB reviewed the final rule.

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it only affects individuals. Accordingly, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required.

This rule does not create any new or affect any existing collections and, therefore, does not require Office of Management Budget approval under the Paperwork Reduction Act.

For the reasons set out in the preamble, we are amending subpart P of part 404 and subpart I of part 416 of chapter III of title 20 Code of Federal Regulations as set forth below:

With one minor change, we are making final the rules protecting the public and our employees in our hearing process that we published as interim final rules in the Federal Register on March 14, 2011 (76 FR 13506). The preamble to the interim final rules discussed the new rules and our reasons for proposing those additions. Interested readers may refer to the preamble to the interim final rules. 1

We are revising our regulations at §§ 404.937 and 416.1437 to further describe when the Hearing Office Chief Administrative Law Judge will find a claimant or other individual poses a reasonable threat to the safety of our employees or other participants in the hearing. We are making these changes to respond to public comments we received.

In the interim final rules, we provided the public a 60-day comment period, which ended on May 13, 2011. We received three public comments. Since the comments were long, we have condensed, summarized, and paraphrased them. We summarized the commenters' views and responded to the significant issues raised by the commenters that were within the scope of this rule.

Comment: Two commenters wanted to make sure that the regulation consistently used the term “poses a threat” instead of any reference to “has made a threat” as the grounds for applying the regulation.

Response: We expanded this section to clarify that the Hearing Office Chief Administrative Judge will find that an individual poses a threat if the individual either has made a threat and there is reasonable likelihood that the claimant or other individual could act on the threat, or if evidence suggests that the claimant or other individual poses a threat.

Comment: Another commenter agreed with the goal of our interim final rules, but wanted to make sure that the regulation will not result in discrimination against claimants based on their disabilities, national origin, or primary language.

Response: These regulations are designed to protect our employees and the public we serve regardless of their disabilities, national origin or primary language. Nothing in these regulations increases the likelihood of discrimination against any claimant or other individual based disability, national origin or primary language. Rather, the regulations focus solely on the conduct of the individual posing a threat and the consequences of such activity.

We consulted with the Office of Management and Budget (OMB) and determined that these final rules meet the criteria for a significant regulatory action under Executive Order 12866 as supplemented by Executive Order 13563. Thus, OMB reviewed these final rules.

We certify that these final rules will not have a significant economic impact on a substantial number of small entities as they affect individuals only. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.

These rules do not create any new or affect any existing collections and, therefore, do not require OMB approval under the Paperwork Reduction Act.

For the reasons stated in the preamble, we are amending subpart J of part 404 and subpart N of part 416 of title 20 of the Code of Federal Regulations as set forth below:

Each year about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die from food borne diseases, according to recent data from the Centers for Disease Control and Prevention (CDC) (Estimates of Foodborne Illness in the United States—CDC 2011 Estimates, available at http://www.cdc.gov/foodborneburden ). This is a significant public health burden that is largely preventable.

FSMA (Pub. L. 111-353), signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities to help it achieve higher rates of compliance with prevention and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to better ensure the safety of imported foods and directs FDA to build an integrated national food safety system in partnership with State and local authorities.

Section 101 of FSMA amends section 414(a) of the FD&C Act (21 U.S.C. 350c(a)). Section 414 was added to the FD&C Act by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). As amended section 414(a) of the FD&C Act expands FDA's access to records. Specifically, FDA's access to records was expanded beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary (by delegation FDA) reasonably believes is likely to be affected in a similar manner. In addition, FDA can now access records if FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. Decisions regarding whether FDA “reasonably believes” a food is affected in a similar manner to cause serious adverse health consequences or death to humans or animals would be made on a case-by-case basis because such decisions are fact-specific. Section 414(a) of the FD&C Act further provides that, at the request of an officer or employee duly designated by FDA, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall permit such officer or employee to have access to and copy all records relating to such article and any other article of food that FDA reasonably believes is likely to be affected in a similar manner. FDA shall have access to the records that are needed to assist FDA in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. To gain access to these records, the officer or employee must present appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner. The Bioterrorism Act also amended section 704(a)(1)(B) of the FD&C Act (21 U.S.C. 374(a)(1)(B)) to include a cross-reference to section 414 of the FD&C Act. Section 101 of FSMA amends this section by updating the cross-reference to refer to the amended version of section 414(a).

The amendments made by section 101 of FSMA to the FD&C Act were effective upon enactment of the law (January 4, 2011).

Among other things, section 306(a) of the Bioterrorism Act amended the FD&C Act by adding section 414(a) to the FD&C Act, which provided FDA with the authority to access records if FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, persons who manufacture, process, pack, distribute, receive, hold, or import food must provide access to records related to the food that are needed to assist FDA in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The statute provided for such records to be provided under certain conditions, including at reasonable times.

In addition, section 306(a) of the Bioterrorism Act added a new section 414(b) to the FD&C Act that provided, in part, that FDA may by regulation establish requirements regarding establishment and maintenance, for not longer than 2 years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that are required to be kept by these regulations are those needed by FDA for inspection to allow FDA to identify the immediate previous sources and immediate subsequent recipients of food.

Section 306(b) of the Bioterrorism Act also amended section 704(a) of the FD&C Act to authorize FDA inspections of all records and other information described in section 414 of the FD&C Act, when FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.

Further, section 306(c) of the Bioterrorism Act amended section 301 of the FD&C Act (21 U.S.C. 331) to make it a prohibited act to refuse to permit access to, or copying of, any record as required by section 414 or 704(a) of the FD&C Act; or to fail to establish or maintain any record as required by section 414(b) of the FD&C Act; or to refuse to permit access to, or verification or copying of, any such required record; or for any person to use to his own advantage, or to reveal, other than to FDA or officers or employees of the Department of Health and Human Services, or to the courts when relevant in any judicial proceeding under the FD&C Act, any information acquired under authority of section 414 of the FD&C Act.

In accordance with the Bioterrorism Act, FDA issued a proposed rule in the Federal Register on May 9, 2003 (68 FR 25188) (the 2003 proposed rule), proposing to require the establishment and maintenance of records to identify the immediate previous sources and immediate subsequent recipients of food and the record availability requirements. On December 9, 2004, FDA issued a final rule in the Federal Register (69 FR 71562) (the 2004 final rule) specifying the requirements for the establishment and maintenance of records, including among other provisions the record availability requirements. The establishment, maintenance, and availability of records regulations have been codified at part 1, subpart J (21 CFR part 1, subpart J).

The current regulation at § 1.361 primarily tracks the language of section 414(a) of the FD&C Act prior to the amendments made by FSMA. However, the regulation does specify the timeframe in which the records must be provided in that requested records and information must be made available as soon as possible, not to exceed 24 hours, from the time of receipt of an official request. As specified by the statute, the request must be from an officer or employee designated by the Secretary who presents appropriate credentials and a written notice.

This IFR amends § 1.361 by replacing the current text with language that reflects the language of section 414 of the FD&C Act as amended by section 101 of FSMA. This amendment conforms the regulation to the statute that is now in effect. Upon publication of this IFR, records requested by FDA under amended section 414(a)(1) and (a)(2) of the FD&C Act will fall within the scope of the availability requirements in the regulation.

In accordance with the provisions of the Administrative Procedure Act at 5 U.S.C. 553(b)(3)(B) and FDA's administrative practices and procedures regulations at § 10.40(e)(1) (21 CFR 10.40(e)(1)), FDA finds for good cause that use of prior notice and comment procedures for issuing this IFR is contrary to the public interest. This IFR modifies § 1.361 to be consistent with the current statutory language in section 414(a) of the FD&C Act and to require that records and other information be provided as soon as possible, but no later than 24 hours from the receipt of an official records request. Because FDA's expanded records access authority was effective upon the enactment of FSMA, it is contrary to the public interest to require those members of the public whose records are requested under FDA's expanded authority to produce records without regulations explaining how to comply with FDA's new authority. Thus, in the interest of protecting the public health and eliminating any possible confusion about how to comply with FDA's expanded authority, FDA is dispensing with the need for prior notice and comment and is issuing this IFR.

Further, under 5 U.S.C. 553(d)(3) and § 10.40(d), we find good cause to make this IFR effective immediately. As stated previously in this document, to protect the public health it is necessary that we act quickly to make the regulation at issue consistent with the current statutory provisions in order to eliminate any possible confusion that may arise during the time that the regulation and statute are inconsistent. As discussed later in this document, FDA invites public comment on this IFR.

FDA has examined the impacts of this IFR under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Office of Management and Budget (OMB) has determined that this IFR is a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the additional costs per entity of this IFR are negligible if any, the Agency also concludes that this IFR 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 (Pub. L. 104-4) 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 $136 million, using the most current (2010) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this IFR to result in any 1-year expenditure that would meet or exceed this amount.

In the 2003 proposed rule, FDA analyzed the economic impact of the proposed rule to require the establishment and maintenance of records and record availability requirements under the Bioterrorism Act (68 FR 25188). The Economic Impact Analysis of the 2004 final rule (69 FR 71562 at 71611) revised the analysis set forth in the 2003 proposed rule in response to comments on the proposed rule and to account for the changes between the proposed and final rules. The Economic Impact Analysis in this IFR explains and further revises the analysis set forth in the 2004 final rule by addressing the economic impact of the amendments made by section 101 of FSMA.

The need for this IFR arises from section 101 of FSMA which expands FDA's access to records beyond records relating to the specific suspect article of food to records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment provides FDA additional access to records relating to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This amendment will further help the Agency prevent potentially harmful food from reaching consumers and thereby improve the safety of the food supply in the United States. This IFR amends the record availability requirements in § 1.361 in accordance with the new records access authority in section 414(a) of the FD&C Act, which became effective immediately upon the enactment of FSMA.

FDA expects the costs related to this IFR to be negligible. According to the 2004 final rule analysis, the final rule covered more than 1 million entities, and this IFR covers those same entities.

Because, as a standard business practice, most firms were already capable of providing records access within 24 hours of a request, records access planning costs and records retention (which include storage and retrieval) costs were estimated to be zero in the 2004 final rule and were not reported in the total costs estimate.

As this IFR only affects FDA's authority to access already existing records, most records management procedures will not change. As stated in the 2004 final rule (69 FR 71562 at 71635), the estimated records access costs are based on the private costs of planning for a records access request. The costs to plan for a records access request are the same under this IFR as they were under the 2004 final rule, regardless of the number of records requested. FDA does not estimate the probability of a records access request. To the extent that FDA would have access to additional records that we previously could not access, the following potential costs could be incurred by both FDA and businesses:

1. Costs to FDA: Costs incurred by FDA could result from the additional time it would take to analyze records in order to complete an investigative visit. On average, records access times depend, in part, on how records are stored and maintained; average travel times, length of overnight stays required for completing an investigative visit; and average records analysis times. According to the 2004 final rule, the time required to analyze records depends on the quality of the records (69 FR 71562 at 71616). Potential costs to the Agency from this IFR in terms of additional time needed to analyze more records than under the 2004 final rule are expected to be small.

2. Costs to businesses: Costs incurred by businesses could result from an FDA access request requiring them to retrieve a larger number of records than they would have otherwise retrieved under the current authority. Similar to the costs of planning for a records access request, the 2004 final rule estimated records retrieval costs are also based on the private costs of retrieving records (69 FR 71562 at 71635). This IFR does not require firms to make any changes in records retention practices beyond the requirement in the 2004 final rule (69 FR 71562 at 71654), and thus the marginal cost is estimated to be negligible.

Since neither the FDA nor firms are able to predict the number of records requested to complete an investigation under the current authority or the new authority, additional costs to retrieve any number of additional records are estimated to be the same under this IFR as they were under the 2004 final rule, regardless of the number of records requested.

FDA would use this new authority in a targeted fashion and it is unlikely that FDA would request all records from a suspect facility. The records FDA will access and copy will be focused on addressing the immediate needs of the inspection.

To the extent that FDA requests access to more records than it was previously allowed to access under similar circumstances, businesses may incur additional retrieval costs per record. However, the costs of retrieving one or more additional records from any number of records still remain part of the private costs for records retention which are determined by a firm's business plan. Thus, any potential costs to businesses from this IFR in terms of retrieving more records than under the 2004 final rule are also expected to be small.

In the 2004 final rule analysis, FDA estimated the number of illnesses prevented (excluding those associated with food security) to be approximately 1,204 (69 FR 71562 at 71616). Averted illnesses in the 2004 final rule were attributed to having quicker access to records (24-hour time period) to initiate an investigation and also due to an increased ability to complete investigations that previously would have been prematurely terminated due to poor records quality (69 FR 71562 at 71614).

Similarly, the expected benefits from this IFR will be from minimizing consumer exposure to potentially dangerous foods. These benefits will be achieved by FDA having access to records beyond those relating only to the specifically suspect article of food. By expanding the current records access authority to include records relating to any other article of food that FDA reasonably believes is likely to be affected in a similar manner, FDA can now access additional information that can enhance FDA's food safety efforts.

FDA has not quantified any additional benefits from this IFR, but because this IFR enhances food safety and security efforts, we reason that any benefits resulting from this IFR are likely to be in addition to benefits already estimated in the 2004 final rule.

FDA examined the economic implications of this IFR as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options that would lessen the economic effect of the rule on small entities.

The Regulatory Flexibility Act requires analyzing options for regulatory relief for small businesses. In compliance with the Regulatory Flexibility Act this IFR will not have a significant impact on a substantial number of small businesses.

This interim final rule contains information collection provisions that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We conclude that these information collection provisions are exempt from OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections of information obtained during the conduct of a civil action to which the United States or any official or agency thereof is a party, or during the conduct of an administrative action, investigation, or audit involving an agency against specific individuals or entities. The regulations in 5 CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies during the entire course of the investigation, audit or action, but only after a case file or equivalent is opened with respect to a particular party. Such a case file would be opened as part of the request to access records under § 1.361.

The Agency has carefully considered the potential environmental effects of this action. FDA 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.

FDA has analyzed this IFR in accordance with the principles set forth in Executive Order 13132. FDA has determined that the IFR 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 concludes that the IFR 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 requirements in this IFR will be in effect immediately upon publication in the Federal Register. FDA invites public comment on this IFR and will consider modifications to it based on comments made during the comment period when FDA issues the final rule. FDA intends to finalize this IFR 1 year from the close of the comment period.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 1 is amended as follows:

FDA is announcing the availability of a guidance entitled “Questions and Answers Establishment and Maintenance of Records by Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5),” which replaces the fourth edition of a guidance of the same title issued in September 2006. The guidance is intended for persons who manufacture, process, pack, hold, or import human or animal foods intended for distribution to consumers, institutions, or food processors.

In the Federal Register of December 9, 2004 (69 FR 71562), FDA published a final rule implementing sections 414 and 704 of FD&C Act (21 U.S.C. 350c and 374) as amended by section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The final rule requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food. FSMA, signed into law on January 4, 2011 (Pub. L. 111-353), amended sections 414 and 704 of the FD&C Act by expanding FDA's access to records relating to foods that may cause serious adverse health consequences or death to humans or animals. In February 2012, FDA issued an interim final rule that revises § 1.361 (21 CFR 1.361) to reflect the FSMA amendments to the FD&C Act. This guidance document has been updated to reflect these changes.

On September 12, 2005, FDA issued the first edition of a guidance entitled “Questions and Answers Regarding the Establishment and Maintenance of Records.” This document is the fifth edition of that guidance and is updated to reflect changes to the FD&C Act made by FSMA. This guidance is intended to provide individuals in the human and animal food industries with an updated overview of FDA's access to records. It provides practical information by answering common questions that cover a range of topics, including who is subject to records requirements, the scope of records retention and availability requirements, and the consequences of failing to establish and maintain required records or failing to make required records available to FDA. This guidance is being issued consistent with FDA's good guidance practices regulation § 10.115 (21 CFR 10.115) as a level 1 guidance. The Agency will accept comments, but it is implementing this document immediately, in accordance with § 10.115(g)(2) because the Agency has determined that prior public participation is not feasible or appropriate. The Agency made this determination because this guidance simply reflects the statutory changes made by section 101 of FSMA to sections 414 and 704 of the FD&C Act and seeks to remove any confusion that might arise due to the existence of a guidance document that is inconsistent with the FD&C Act and its implementing regulations. In addition, much of this guidance remains the same as the guidance issued in September 2006.

This guidance represents the Agency's current thinking on its authority to access and copy records. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

This guidance refers to information collection provisions found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We conclude that the collection of information in § 1.361 is exempt from OMB review under 44 U.S.C. 18(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as collections of information obtained during the conduct of a civil action to which the United States or any official or Agency thereof is a party, or during the conduct of an administrative action, investigation, or audit involving an Agency against specific individuals or entities. The regulations in 5 CFR 1320.3(c) provide that the exception in 5 CFR 1320.4(a)(2) applies during the entire course of the investigation, audit or action, but only after a case file or equivalent is opened with respect to a particular party. Such a case file would be opened as part of the request to access records under § 1.361.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Always access an FDA guidance document by using the Web sites listed previously to find the most current version of the guidance.

Under 38 U.S.C. 8131 through 8138, VA is authorized to award grants to assist States in constructing, remodeling, altering, or expanding State home facilities that will furnish specified types of care to veterans. VA has implemented this statutory authority at 38 CFR part 59.

Under 38 U.S.C. 8135, States that wish to receive assistance for a State home construction project (or acquisition of an existing facility to be used as a State home facility) must submit an application that includes certain information and documentation described in the statute. VA has implemented the application requirement in current § 59.20(a), which requires that applicants seeking inclusion on the priority list for grants awarded during the next fiscal year submit to VA an original and one copy of a completed VA Form 10-0388-1 and all information, documentation, and other forms specified by VA Form 10-0388-1. Under current § 59.20(c), VA encourages the submission of the application by April 15 but considers any application submitted before August 16 for inclusion on the priority list. VA maintains the “priority list” pursuant to current 38 CFR 59.50. Additionally, under current § 59.70(b), VA requires a State to commit funds for a project before August 16 in order for that project to be eligible for inclusion in priority group 1 of the priority list for the next fiscal year.

On March 1, 2011, VA published a proposed rule to improve the clarity and efficacy of the application process and to address certain administrative challenges presented by the current rules. 76 FR 11187 (Mar. 1, 2011). We proposed adopting April 15 as the due date for applications, including matching funding. We provided a 60-day comment period during which we received eight comments from State departments of veterans affairs and State veterans homes and a comment from the National Association of State Veterans Homes. All of the commenters raised similar or identical concerns, which we address below. We are grateful for their submissions and, after careful deliberation, make one change to the final rule based on these comments.

First, several commenters assert that they have consistently treated the April 15 date as a “preapplication” date and acknowledge that they complete as much of the application as possible on or before that date. However, they argue that it is impossible to meet an April 15 deadline for matching funds because the fiscal year for most States begins on July 1, which is after that deadline. To address this concern, the final rule adopts a separate, later, deadline for the official certification of matching funds. Under the final rule, the application must be received no later than April 15. If official certification of the matching funds is received on or before August 1, the State may be included in priority group 1.

This will allow VA to review the submissions and establish each application in priority groups 2 through 7 (which mirror the sub-priorities in priority group 1 with the distinction that projects in priority group 1 have State matching funds while those in priority groups 2 through 7 lack these resources). When a State is able to provide documentation of State matching funds, the application will be placed in the appropriate position in priority group 1. Should a State be unable to document matching funds by the new August 1 deadline, the project will be placed in one of groups 2 through 7 for the following fiscal year.

Some commenters argue that the burden of filing the application itself, not just the matching-funds requirement, would be impossible to meet before April 15. Previous experience is that most States already submit preapplication materials on or before April 15, as acknowledged by the commenters themselves, and thus, we do not think that there will be a new significant burden. The items required on the VA Form 10-0388-1 are generally administrative information (such as identifier numbers) and the schematics of the project. Schematics generally require an aerial view of the site of the project, a floor plan, and a rendering of the exterior of the building. Although these may require some financial expense, we believe that the cost is usually between $6,000 and $10,000. In any event, it is never a significant expense in relation to the cost of the project itself, which is usually over $30 million. We do not believe that it should be necessary to wait for a State legislature to authorize the expense or time for producing these application materials.

The commenters challenged VA's need for the additional review time, citing the impact of the American Recovery and Reinvestment Act of 2009 (ARRA) on the previous grant cycle asserting that it resulted in an anomalously high number of applications. We acknowledge that the ARRA increased the 2010 workload but maintain that there is a need for additional review time in general, based on the uniqueness of each fiscal year, the complexity of the projects, and the need for extensive detailed and careful review of each application. In fact, we had begun reassessing the August 15 due date before Fiscal Year 2010. Adoption of the proposed April 15 application due date, while allowing States to submit documentation of matching funds by August 1, will allow VA to provide due diligence in the review and prioritization process, while maximizing the States' opportunity to obtain and document matching funds to secure a position in priority group 1.

Several commenters recommended delaying publication of the priority list rather than altering the due date. We appreciate the flexibility recommended by these parties but note that release of the priority list is determined by the time federal budget funds are appropriated. Regardless of the ultimate date the budget is finalized, VA strives to publish the priority list in a timely manner and will continue to do so in an effort to provide quick, efficient distribution of and maximum access to available funds.

The commenters also argue administrative inconvenience. However, the initial application materials are not overly burdensome, and requiring the earlier deadlines will help VA ensure the timely delivery of funds to worthy State projects. Because most applications are already received by April 15, this date is reasonable, and allowing for the August 1 date for the certification of matching funds addresses the administrative needs of the States.

Finally, commenters objected to VA's rulemaking as being based solely on the administrative needs of VA staff, at the expense of America's veterans. VA strives diligently to remain veteran-centric in all of its programs. Clarification of the due date and the technical changes proposed in this amendment are designed to mirror current practice and to facilitate a thorough and complete review of grant applications prior to funding, in an effort to minimize program delays and make space in the State homes available to our veterans as quickly as possible. VA has always initiated review of proposals upon receipt, which in most cases has been by the April 15 date cited in § 59.20. However, VA's review of these grants and their construction plans necessitates numerous internal concurrences; communications with the States for clarification of the application materials; development and adoption of memorandums of understanding for each project; and other significant, time-consuming, relevant processes. Each proposal is unique and may have special issues, including terrain, access, potential for natural disaster, facility measures, varying codes and local requirements, etc. VA staff assesses new construction as well as renovations to facilities of various ages, under an assortment of State and national construction and safety standards, to ascertain that each element of the application is thorough, complete, and current. Requiring this detailed review prior to prioritization and funding ensures that the project is “shovel ready” when funds become available. This, in turn, helps ensure that VA funds projects that will be ready, on time, for waiting veterans.

Acknowledging the effort the States have historically made to submit applications by the April 15 date to secure their position on the priority list, we believe formal adoption of an April 15 deadline, with the August 1 date for documentation of matching funds for placement in priority group 1, will help VA and the States and, most importantly, serve the needs of veterans by improving existing space and making new space available for eligible veterans at the earliest possible moment.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule would have no such effect on State, local, and tribal governments, or on the private sector.

Although this document contains provisions constituting collections of information, at 38 CFR 59.20, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ), no new or revised collections of information are associated with this rule. The information collection requirements for § 59.20 are currently approved by OMB and have been assigned OMB control number 2900-0661.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” which requires review by the Office of Management and Budget (OMB), as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, 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 set forth in this Executive Order.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined and it has been determined to be a significant regulatory action under Executive Order 12866 because it is likely to result in a rule that may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The Secretary hereby certifies that this final rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The rule affects States and has no impact on any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Catalog of Federal Domestic Assistance program numbers and titles for this rule are as follows: 64.005, Grants to States for Construction of State Home Facilities; 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on November 14, 2011, for publication.

For the reasons set forth in the preamble, VA amends 38 CFR part 59 as follows:

The General Services Administration is amending the GSAR to comply with changes made to acquisition-related thresholds by Federal Acquisition Circular 2005-45 (Federal Acquisition Regulation (FAR) Case 2008-024), published in the Federal Register at 75 FR 53129, August 30, 2010, with an effective date of October 1, 2010. FAR Case 2008-024 implements Section 807 of the National Defense Authorization Act for Fiscal Year 2005 (Pub. L. 108-375). Section 807 provides for adjustment every 5 years of acquisition-related thresholds, except for Davis-Bacon Act, Service Contract Act, and trade agreements thresholds.

As a result of changes made to the acquisition-related thresholds, the GSAR clause at 552.219-71, Notice to Offerors of Subcontracting Plan Requirements, is revised by removing “$500,000” and “$1,000,000” and replacing the GSAR text with “$650,000” and “$1,500,000”, respectively. The GSAR clause at 552.219-72, Preparation, Submission, and Negotiation of Subcontracting Plans, is revised by removing “$500,000” and “$1,000,000” and replacing the GSAR text with “$650,000” and “$1,500,000”, respectively.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

The General Services Administration certify that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because FAR Case 2008-024, which addresses the acquisition-related thresholds, was published in the Federal Register at 75 FR 53129, August 30, 2010, with an effective date of October 1, 2010. Further, Acquisition Letter MV-11-01, Adjustment of GSAM Acquisition-Related Thresholds due to Federal Acquisition Circular 2005-45 (Item I, Inflation Adjustment of Acquisition-Related Thresholds), was effective immediately upon the publishing of Acquisition Letter (October 8, 2010). All other revisions to the GSAM are non-regulatory.

The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

Therefore, GSA amends 48 CFR parts 519 and 552 as set forth below:

I. Background

On September 9, 2010, a 30-inch-diameter segment of an intrastate natural gas transmission pipeline owned and operated by the Pacific Gas and Electric Company ruptured in a residential area in San Bruno, California. As a result of an NTSB investigation of this event, one of its recommendations to PHMSA was to issue guidance clarifying the need to conduct post-accident drug and alcohol testing of all potentially involved personnel despite uncertainty about the circumstances of the accident. This advisory bulletin fulfills the NTSB recommendation and PHMSA's ongoing commitment to pipeline safety.

To: Operators of Gas, Hazardous Liquid, and Carbon Dioxide Pipelines and Liquefied Natural Gas Facilities.

Subject: Post-Accident Drug and Alcohol Testing.

Advisory: “The need to conduct post-accident drug and alcohol testing of all potentially involved personnel despite uncertainty about the circumstances of the accident” is an important reminder and recommendation in the final report of the NTSB— Pacific Gas and Electric Company Natural Gas Transmission Pipeline Rupture and Fire, San Bruno, California, September 9, 2010, Pipeline Accident Report [NTSB/PAR-11/01; Washington, DC]. The term “accident” in Part 199 includes both “incidents” reportable under Part 191 and “accidents” reportable under Part 195. Covered employees include both operator employees and contractor employees performing operations, maintenance, or emergency response functions. Operators and contractors are encouraged to review and update, where necessary, plans and procedures governing post-accident substance abuse/misuse testing and train all those involved with ensuring that such testing is performed promptly and in an effective manner.

Operators are reminded that covered functions encompass a broad range of employee and contractor positions, including, but not limited to, contract emergency responders, pressure control technicians, temp-agency covered employees, and control room operators. If a covered employee's performance cannot be completely discounted as a contributing factor to the accident or incident, the employee must be tested for the potential substance abuse or misuse of both drugs and alcohol. In order to meet the testing timelines, do not delay testing in order to determine the circumstances surrounding the accident or incident. However, the accident or incident circumstances and events must be assessed promptly and documented, especially the reasons for not drug or alcohol testing an accident-related covered employee.

The following are key regulatory sections addressing post-accident drug and alcohol testing that should be reviewed, along with other applicable sections of Part 199:

• Under § 199.105, post-accident drug tests of covered employees whose performance cannot be completely discounted as a contributing factor to the accident must be completed no later than 32 hours after the accident.

• Under § 199.225(a), if an operator does not complete post-accident alcohol testing of covered employees whose performance cannot be completely discounted as a contributing factor to the accident within two hours of the accident, the operator must prepare and maintain on file a record stating the reasons the test was not promptly administered. If post-accident alcohol testing is not administered within eight hours following the accident, the operator must cease attempts to administer an alcohol test and must state in the record the reasons for not administering the test. Covered employees must remain available for post-accident testing, but emergency response or medical care of the employee are never to be delayed for alcohol testing.

• Under § 199.221, each operator shall prohibit a covered employee who has actual knowledge of an accident in which his or her performance of covered functions has not been discounted by the operator as a contributing factor to the accident from using alcohol for eight hours following the accident, unless he or she has been given a post-accident test under § 199.225(a), or the operator has determined that the employee's performance could not have contributed to the accident.

• Under § 199.103(a) an operator may not knowingly use as an employee any person who (1) Fails a drug test required by this part and the Medical Review Officer makes a determination under DOT Procedures Part 40; or (2) refuses to take a drug test required by this part.

• Under § 199.223, each operator shall require a covered employee to submit to a post-accident alcohol test required under § 199.225(a). No operator shall permit an employee who refuses to submit to such a test to perform or continue to perform covered functions.

• Under § 199.233, no operator shall permit any covered employee to perform covered functions if the employee has engaged in conduct prohibited by §§ 199.215 through 199.223.

Regulations governing the herring fishery are found at 50 CFR part 648. The regulations require annual specification of the overfishing limit, acceptable biological catch, annual catch limit (ACL), optimum yield, domestic harvest and processing, U.S. at-sea processing, border transfer, and sub-ACLs for each management area. The 2012 Domestic Annual Harvest is 91,200 metric tons (mt); the 2012 sub-ACL allocated to Area 2 is 22,146 mt, and 0 mt of the sub-ACL is set aside for research (75 FR 48874, August 12, 2010).

Section 648.201 requires the Administrator, Northeast Region, NMFS (Regional Administrator), to monitor the herring fishery in each of the four management areas designated in the Fishery Management Plan for the herring fishery and, based on dealer reports, state data, and other available information, to determine when the harvest of herring is projected to reach 95 percent of the management area sub-ACL. When such a determination is made, NMFS must publish notification in the Federal Register and prohibit herring vessel permit holders from fishing for, catching, possessing, transferring, or landing more than 2,000 lb (907.2 kg) of herring per calendar day in or from the specified management area for the remainder of the closure period. Transiting of Area 2 with more than 2,000 lb (907.2 kg) of herring on board is allowed under the conditions described below.

The Regional Administrator has determined, based upon dealer reports and other available information that 95 percent of the total herring sub-ACL allocated to Area 2 for 2012 is projected to be harvested. Therefore, effective 0001 hr local time, February 20, 2012, federally permitted vessels may not fish for, catch, possess, transfer, or land more than 2,000 lb (907.2 kg) of herring in or from Area 2 per calendar day through December 31, 2012. Vessels may transit through Area 2 with more than 2,000 lb (907.2 kg) of herring on board, provided such herring was not caught in Area 2 and provided all fishing gear aboard is stowed and not available for immediate use as required by § 648.23(b). Effective 0001 hr, February 20, 2012, federally permitted dealers are also advised that they may not purchase herring from federally permitted herring vessels that harvest more than 2,000 lb (907.2 kg) of herring from Area 2 through 2400 hr local time, December 31, 2012.

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

NMFS finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest and impracticable. This action closes the herring fishery for Management Area 2 until January 1, 2013, under current regulations. The regulations at § 648.201(a) require such action to ensure that herring vessels do not exceed the 2012 sub-ACL allocated to Area 2. The herring fishery opened for the 2012 fishing year on January 1, 2012. Data indicating the herring fleet will have landed at least 95 percent of the 2012 sub-ACL allocated to Area 2 have only recently become available. If implementation of this closure is delayed to solicit prior public comment, the sub-ACL for Area 2 for this fishing year can be exceeded, thereby undermining the conservation objectives of the FMP. NMFS further finds, pursuant to 5 U.S.C 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reasons stated above.

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The A season allowance of the 2012 Pacific cod TAC specified for AFA trawl catcher-processors in the BSAI is 4,021 metric tons as established by the final 2011 and 2012 harvest specifications for groundfish in the BSAI (76 FR 11139, March 1, 2011) and inseason adjustment (76 FR 81875, December 29, 2011).

In accordance with § 679.20(d)(1)(i) and (d)(1)(ii)(B), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the A season allowance of the 2012 Pacific cod TAC allocated to AFA trawl catcher processors in the BSAI will be taken as incidental catch in the directed fishing for other species. Therefore, the Regional Administrator is establishing a directed fishing allowance for Pacific cod allocated to AFA trawl catcher processors in the BSAI of 0 mt. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by AFA trawl catcher processors in the BSAI.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod by AFA trawl catcher/processors in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of February 16, 2012.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

Federal regulations at 50 CFR part 679 implement the FMP and govern the groundfish fisheries in the BSAI. The Council prepared the FMP, and NMFS approved it under the Magnuson-Stevens Act. General regulations governing U.S. fisheries also appear at 50 CFR part 600.

The FMP and its implementing regulations require NMFS, after consultation with the Council, to specify the total allowable catch (TAC) for each target species; the sum TAC for all groundfish species must be within the optimum yield (OY) range of 1.4 million to 2.0 million metric tons (mt) (see § 679.20(a)(1)(i)). This final rule specifies the TAC at 2.0 million mt for both 2012 and 2013. NMFS also must specify apportionments of TACs, prohibited species catch (PSC) allowances, and prohibited species quota (PSQ) reserves established by § 679.21; seasonal allowances of pollock, Pacific cod, and Atka mackerel TAC; Amendment 80 allocations; and Community Development Quota (CDQ) reserve amounts established by § 679.20(b)(1)(ii). The final harvest specifications set forth in Tables 1 through 16 of this action satisfy these requirements.

Section 679.20(c)(3)(i) further requires NMFS to consider public comment on the proposed annual TACs (and apportionments thereof) and PSC allowances, and to publish final harvest specifications in the Federal Register . The proposed 2012 and 2013 harvest specifications and PSC allowances for the groundfish fishery of the BSAI were published in the Federal Register on December 27, 2011 (76 FR 80782). Comments were invited and accepted through January 26, 2012. NMFS received 1 letter with 1 comment on the proposed harvest specifications. This comment is summarized and responded to in the “Response to Comments” section of this rule. NMFS consulted with the Council on the final 2012 and 2013 harvest specifications during the December 2011 Council meeting in Anchorage, AK. After considering public comments, as well as biological and economic data that were available at the Council's December meeting, NMFS is implementing the final 2012 and 2013 harvest specifications as recommended by the Council.

The final ABC levels for Alaska groundfish are based on the best available biological and socioeconomic information, including projected biomass trends, information on assumed distribution of stock biomass, and revised technical methods used to calculate stock biomass. In general, the development of ABCs and overfishing levels (OFLs) involves sophisticated statistical analyses of fish populations. The FMP specifies a series of six tiers to define OFL and ABC amounts based on the level of reliable information available to fishery scientists. Tier 1 represents the highest level of information quality available while Tier 6 represents the lowest.

In December 2011, the Scientific and Statistical Committee (SSC), Advisory Panel (AP), and Council reviewed current biological information about the condition of the BSAI groundfish stocks. The Council's Plan Team compiled and presented this information in the 2011 SAFE report for the BSAI groundfish fisheries, dated November 2011. The SAFE report contains a review of the latest scientific analyses and estimates of each species' biomass and other biological parameters, as well as summaries of the available information on the BSAI ecosystem and the economic condition of groundfish fisheries off Alaska. NMFS notified the public and asked for review of the SAFE report in the notice of proposed harvest specifications; the report is still available (see ADDRESSES ). From these data and analyses, the Plan Team estimated an OFL and ABC for each species or species category.

In December 2011, the SSC, AP, and Council reviewed the Plan Team's recommendations. The SSC concurred with the Plan Team's recommendations, and the Council adopted the OFL and ABC amounts recommended by the SSC (Table 1). The final TAC recommendations were based on the ABCs as adjusted for other biological and socioeconomic considerations, including maintaining the sum of the TACs within the required OY range of 1.4 million to 2.0 million mt. As required by annual catch limit rules for all fisheries (74 FR 3178, January 16, 2009), none of the Council's recommended TACs for 2012 or 2013 exceeds the final 2012 or 2013 ABCs for any species category. The final 2012 and 2013 harvest specifications approved by the Secretary of Commerce are unchanged from those recommended by the Council and are consistent with the preferred harvest strategy alternative in the EIS (see ADDRESSES ). NMFS finds that the Council's recommended OFLs, ABCs, and TACs are consistent with the biological condition of groundfish stocks as described in the 2011 SAFE report that was approved by the Council.

The Council is currently considering implementing management measures in the event that Pacific cod is split from a BSAI-wide fishery into separate OFLs, ABCs, and TACs for the Bering Sea subarea and the Aleutian Island subarea. This split depends on NMFS developing an age-structured model for the Aleutian Islands Pacific cod stock assessment that will be reviewed by the Plan Team and SSC in 2012 or 2013. This split could impact the OFLs, ABCs, and TACs for Pacific cod on Table 1 for 2013.

In October 2011, the Council proposed its recommendations for the 2012 and 2013 harvest specifications (76 FR 80782, December 27, 2011), based largely on information contained in the 2010 SAFE report for the BSAI groundfish fisheries. Through the proposed harvest specifications, NMFS notified the public that these harvest specifications could change, as the Council would consider information contained in the 2011 SAFE report, recommendations from the SSC, Plan Team, and AP committees, and public testimony when making its recommendations for final harvest specification levels at the December Council meeting. NMFS further notified the public that, as required by the FMP and its implementing regulations, the sum of the TACs must be within the OY range of 1.4 million and 2.0 million mt.

Information contained in the 2011 SAFE reports indicates biomass changes for several groundfish species from the 2010 SAFE reports. At the December 2011 Council meeting, the SSC recommended the ABCs for many species in 2012 and 2013 based on the best and most recent information contained in the 2011 SAFE reports. This recommendation resulted in an ABC sum total for all BSAI groundfish species that exceeds 2 million mt for both 2012 and 2013. Based on the SSC ABC recommendations and the 2011 SAFE reports, the AP recommended raising the TACs for more economically valuable species that have increasing biomasses, such as Pacific cod and Greenland turbot. Conversely, the SSC reduced the OFL and ABC of Bering Sea pollock from the proposed OFL and ABC, and these reductions led to the largest decrease in TAC in terms of tonnage. In terms of percentage change from the proposed TACs, octopuses and sharks had the largest increases in TAC. This is due to model changes for the calculation of octopuses OFL and ABC, and recommendations by the AP and the Council of TACs that are more realistic of incidental harvest of these species in other fisheries. The Bogoslof pollock TAC also had a large percentage increase, because the SSC discontinued the target biomass of 2 million mt and adopted a traditional OFL and ABC estimate under the Tier 5 approach of the FMP. The Council recommended a TAC to account for incidental catch in other fisheries. However, under § 679.22(a)(7)(i)(B), directed fishing for pollock in the Bogoslof area is prohibited, so changes in TAC will have little effect upon fisheries. The changes to TAC between the proposed and final harvest specifications are based on the most recent scientific and economic information and are consistent with the FMP and regulatory obligations and harvest strategy as described in the proposed harvest specifications. These changes are compared in the following table.

Table 1 lists the Council's recommended final 2012 and 2013 OFL, ABC, TAC, initial TAC (ITAC), and CDQ reserve amounts of the BSAI groundfish. NMFS concurs in these recommendations. The final 2012 and 2013 TAC recommendations for the BSAI are within the OY range established for the BSAI and do not exceed the ABC for any single species or complex. The apportionment of TAC amounts among fisheries and seasons is discussed below.

Section 679.20(b)(1)(i) requires NMFS to reserve 15 percent of the TAC for each target species, except for pollock, the hook-and-line and pot gear allocation of sablefish, and the Amendment 80 species, in a non-specified reserve. Section 679.20(b)(1)(ii)(B) requires that 20 percent of the hook-and-line and pot gear allocation of sablefish be set aside for the fixed gear sablefish CDQ reserve. Section 679.20(b)(1)(ii)(D) requires NMFS to allocate 7.5 percent of the trawl gear allocations of sablefish and 10.7 percent of the Bering Sea Greenland turbot and arrowtooth flounder TACs to the respective CDQ reserves. Under section 679.20(b)(1)(ii)(C), NMFS must allocate 10.7 percent of the TACs for Atka mackerel, Aleutian Islands Pacific ocean perch, yellowfin sole, rock sole, flathead sole, and Pacific cod to the CDQ reserves. Sections 679.20(a)(5)(i)(A) and 679.31(a) also require that 10 percent of the BSAI pollock TACs be allocated to the pollock CDQ directed fishing allowance (DFA). The entire Bogoslof District pollock TAC is allocated as an ICA (see § 679.20(a)(5)(ii)). With the exception of the hook-and-line and pot gear sablefish CDQ reserve, the regulations do not further apportion the CDQ allocations by gear.

Pursuant to § 679.20(a)(5)(i)(A)( 1 ), NMFS allocates a pollock ICA of 3 percent of the BS subarea pollock TAC after subtracting the 10 percent CDQ reserve. This allowance is based on NMFS' examination of the pollock incidental catch, including the incidental catch by CDQ vessels, in target fisheries other than pollock from 1999 through 2011. During this 13-year period, the pollock incidental catch ranged from a low of 2.4 percent in 2006 to a high of 5 percent in 1999, with a 13-year average of 3.2 percent. Pursuant to § 679.20(a)(5)(iii)(B)( 2 )( i ) and ( ii ), NMFS establishes a pollock ICA of 1,600 mt of the AI subarea TAC after subtracting the 10 percent CDQ DFA. This allowance is based on NMFS' examination of the pollock incidental catch, including the incidental catch by CDQ vessels, in target fisheries other than pollock from 2003 through 2011. During this 9-year period, the incidental catch of pollock ranged from a low of 5 percent in 2006 to a high of 10 percent in 2003, with a 9-year average of 7 percent.

Pursuant to § 679.20(a)(8) and (10), NMFS allocates ICAs of 5,000 mt of flathead sole, 10,000 mt of rock sole, 2,000 mt of yellowfin sole, 10 mt of Western Aleutian District Pacific (WAI) ocean perch, 75 mt of Central Aleutian District (CAI) Pacific ocean perch, 100 mt of Eastern Aleutian District (EAI) Pacific ocean perch, 40 mt of WAI Atka mackerel, 100 mt of CAI Atka mackerel, and 1,000 mt of EAI and BS subarea Atka mackerel TAC after subtracting the 10.7 percent CDQ reserve. These ICA allowances are based on NMFS' examination of the incidental catch in other target fisheries from 2003 through 2011.

The regulations do not designate the remainder of the non-specified reserve by species or species group. Any amount of the reserve may be apportioned to a target species category during the year, providing that such apportionments do not result in overfishing (see § 679.20(b)(1)(i)). The Regional Administrator has determined that the ITACs specified for the species listed in Table 2 need to be supplemented from the non-specified reserve because U.S. fishing vessels have demonstrated the capacity to catch the full TAC allocations. Therefore, in accordance with § 679.20(b)(3), NMFS is apportioning the amounts shown in Table 2 from the non-specified reserve to increase the ITAC for northern rockfish, shortraker rockfish, rougheye rockfish, Bering Sea “other rockfish,” skates, sharks, octopuses, and sculpins by 15 percent of the TAC in 2012 and 2013.

Section 679.20(a)(5)(i)(A) requires that the BS subarea pollock TAC be apportioned, after subtracting the 10 percent for the CDQ program and the 3 percent for the ICA, as a DFA as follows: 50 percent to the inshore sector, 40 percent to the catcher/processor (C/P) sector, and 10 percent to the mothership sector. In the BS subarea, 40 percent of the DFA is allocated to the A season (January 20-June 10), and 60 percent of the DFA is allocated to the B season (June 10-November 1) (§ 679.20(a)(5)(i)(A)). The AI directed pollock fishery allocation to the Aleut Corporation is the amount of pollock remaining in the AI subarea after subtracting 1,900 mt for the CDQ DFA (10 percent) and 1,600 mt for the ICA (§ 679.20(a)(5)(iii)(B)( 2 )( ii )). In the AI subarea, 40 percent of the DFA is allocated to the A season and the remainder of the directed pollock fishery is allocated to the B season. Table 3 lists these 2012 and 2013 amounts.

Section 679.20(a)(5)(i)(A)( 4 ) also includes several specific requirements regarding BS subarea pollock allocations. First, it requires that 8.5 percent of the pollock allocated to the C/P sector be available for harvest by AFA catcher vessels (CVs) with C/P sector endorsements, unless the Regional Administrator receives a cooperative contract that allows the distribution of harvest among AFA C/Ps and AFA CVs in a manner agreed to by all members. Second, AFA C/Ps not listed in the AFA are limited to harvesting not more than 0.5 percent of the pollock allocated to the C/P sector. Table 3 lists the 2012 and 2013 allocations of pollock TAC. Tables 11 through 16 list the AFA C/P and CV harvesting sideboard limits. The tables for the pollock allocations to the BS subarea inshore pollock cooperatives and open access sector will be posted on the Alaska Region Web site at http://alaskafisheries.noaa.gov.

Table 3 also lists seasonal apportionments of pollock and harvest limits within the Steller Sea Lion Conservation Area (SCA). The harvest within the SCA, as defined at § 679.22(a)(7)(vii), is limited to 28 percent of the annual DFA until 12 noon, April 1 as provided in § 679.20(a)(5)(i)(C). The remaining 12 percent of the 40 percent annual DFA allocated to the A season may be taken outside the SCA before 12 noon, April 1 or inside the SCA after 12 noon, April 1. If less than 28 percent of the annual DFA is taken inside the SCA before 12 noon, April 1, the remainder will be available to be taken inside the SCA after 12 noon, April 1. The A season pollock SCA harvest limit will be apportioned to each sector in proportion to each sector's allocated percentage of the DFA. Table 3 lists these 2012 and 2013 amounts by sector.

Section 679.20(a)(8) allocates the Atka mackerel TACs to the Amendment 80 and BSAI trawl limited access sectors, after subtracting the CDQ reserves, jig gear allocation, and ICAs for the BSAI trawl limited access sector and non-trawl gear sector (Table 4). The process for allocating the ITAC for Atka mackerel to the Amendment 80 and BSAI trawl limited access sectors is listed in Table 33 to part 679 and § 679.91. Pursuant to § 679.20(a)(8)(i), up to 2 percent of the EAI and the BS subarea Atka mackerel ITAC may be allocated to the jig gear sector. This allocation is determined annually by the Council based on several criteria, including the anticipated harvest capacity of the jig gear fleet. The Council recommended, and NMFS approves, a 0.5 percent allocation of the Atka mackerel ITAC in the EAI and BS subarea to the jig gear sector in 2012 and 2013. This percentage is applied to the Atka mackerel TAC after subtracting the CDQ reserve and the ICA.

Section 679.20(a)(8)(ii)(C)( 3 ) limits the annual Atka mackerel TAC for Area 542 (the CAI) to no more than 47 percent of the Area 542 ABC. Section 679.7(a)(19) prohibits retention of Atka mackerel in Area 543 (the WAI), and the amount set here accounts for discards in other fisheries.

Section 679.20(a)(8)(ii)(A) apportions the Atka mackerel ITAC into two equal seasonal allowances. Section 679.23(e)(3) sets the first seasonal allowance for directed fishing with trawl gear from January 20 through June 10 (A season), and the second seasonal allowance from June 10 through November 1 (B season). Section 679.23(e)(4)(iii) applies Atka mackerel seasons to CDQ Atka mackerel fishing. The jig gear allocation is not apportioned by season.

Section 679.20(a)(8)(ii)(C) requires the Amendment 80 cooperatives and CDQ groups to limit harvest to 10 percent of their Central Aleutian District Atka mackerel allocation equally divided between the A and B seasons, within waters 10 nm to 20 nm of Gramp Rock and Tag Island, as described on Table 12 to part 679. Vessels not fishing under the authority of an Amendment 80 cooperative quota or CDQ allocation are prohibited from conducting directed fishing for Atka mackerel inside Steller sea lion critical habitat in the Central Aleutian District.

Table 4 lists these 2012 and 2013 Atka mackerel season and area allowances, as well as the sector allocations. The 2013 allocations for Atka mackerel between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2012.

Section 679.20(a)(7)(i) and (ii) requires NMFS to allocate the Pacific cod TAC in the BSAI, after subtracting 10.7 percent for the CDQ reserve, as follows: 1.4 percent to vessels using jig gear; 2.0 percent to hook-and-line and pot CVs less than 60 ft (18.3 m) length overall (LOA); 0.2 percent to hook-and-line CVs greater than or equal to 60 ft (18.3 m) LOA; 48.7 percent to hook-and-line C/P; 8.4 percent to pot CVs greater than or equal to 60 ft (18.3 m) LOA; 1.5 percent to pot C/Ps; 2.3 percent to AFA trawl C/Ps; 13.4 percent to non-AFA trawl C/Ps; and 22.1 percent to trawl CVs. The ICA for the hook-and-line and pot sectors will be deducted from the aggregate portion of Pacific cod TAC allocated to the hook-and-line and pot sectors. For 2012 and 2013, the Regional Administrator establishes an ICA of 500 mt based on anticipated incidental catch by these sectors in other fisheries. The ITAC allocation of Pacific cod to the Amendment 80 sector is established in Table 33 to part 679 and § 679.91. The 2013 allocations for Pacific cod between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until November 1, 2012, the date by which the applicants eligible to apply for participation in the Amendment 80 program must file their application. Amendment 80 applications for 2013 have not yet been submitted to NMFS, thereby preventing NMFS from calculating 2013 allocations. NMFS will post 2013 Amendment 80 allocations when they become available in December 2012.

The Pacific cod ITAC is apportioned into seasonal allowances to disperse the Pacific cod fisheries over the fishing year (see §§ 679.20(a)(7) and 679.23(e)(5)). In accordance with § 679.20(a)(7)(iv)(B) and (C), any unused portion of a seasonal Pacific cod allowance will become available at the beginning of the next seasonal allowance.

The CDQ and non-CDQ season allowances by gear based on the 2012 and 2013 Pacific cod TACs are listed in Tables 5a and 5b, and are based on the sector allocation percentages of Pacific cod set forth at §§ 679.20(a)(7)(i)(B) and 679.20(a)(7)(iv)(A); and the seasonal allowances of Pacific cod set forth at § 679.23(e)(5).

Section 679.7(a)(19) prohibits retaining Pacific cod in Area 543, and § 679.7(a)(23) prohibits directed fishing for Pacific cod with hook-and-line, pot, or jig gear in the Aleutian Islands subarea November 1 through December 31.

Sections 679.20(a)(4)(iii) and (iv) require that sablefish TACs for the BS and AI subareas be allocated between trawl and hook-and-line or pot gear sectors. Of the TAC for the BS subarea, 50 percent is allocated to vessels using trawl gear, and 50 percent to hook-and-line or pot gear vessels. TACs for the AI subarea are divided 25 percent to the trawl gear vessels, and 75 percent to hook-and-line or pot gear sector. Section 679.20(b)(1)(ii)(B) requires NMFS to allot 20 percent of the hook-and-line and pot gear allocation of sablefish to the CDQ reserve. Additionally, § 679.20(b)(1)(ii)(D) requires that 7.5 percent of the trawl gear allocation of sablefish from the nonspecified reserves, established under § 679.20(b)(1)(i), be assigned to the CDQ reserve. The Council recommended that only trawl sablefish TAC be established biennially, because the harvest specifications for the hook-and-line gear and pot gear sablefish Individual Fishing Quota (IFQ) fisheries will be limited to the 2012 fishing year to ensure those fisheries are conducted concurrently with the halibut IFQ fishery. Concurrent sablefish and halibut IFQ fisheries reduce the potential for discards of halibut and sablefish in those fisheries. The sablefish IFQ fisheries will remain closed at the beginning of each fishing year until the final specifications for the sablefish IFQ fisheries are in effect. Table 6 lists the 2012 and 2013 gear allocations of the sablefish TAC and CDQ reserve amounts.