        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 229
        [Docket No. 150122067-5229-01]
        RIN 0648-BE83
        Taking of Marine Mammals Incidental to Commercial Fishing Operations; Atlantic Large Whale Take Reduction Plan Regulations; Correction

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Proposed rule; request for comments; correction.

          SUMMARY:
          NMFS published a proposed rule in the Federal Register on March 19, 2015, to amend the regulations implementing the Atlantic Large Whale Take Reduction Plan. This action proposed to change the minimum number of traps per trawl to allow fishing with a single trap in certain Massachusetts and Rhode Island state waters; and proposed to modify the requirement to use one endline on trawls within certain areas in Massachusetts state waters. NMFS also proposed a 1/4 mile buffer in waters surrounding certain islands in Maine to allow fishing with a single trap. In addition, NMFS proposed additional gear marking requirements for those waters allowing single traps as well as two new high use areas for humpback whales (Megaptera novaeangliae) and North Atlantic right whales (Eubalaena glacialis). In that proposal, NMFS provided the wrong address for the submission of electronic comments. With this document, we correct our error by publishing the correct ADDRESSES section in its entirety.

          DATES:
          We will accept comments on the March 19, 2015, (80 FR 14345) proposed rule that are received or postmarked on or before April 20, 2015.

          ADDRESSES:
          You may submit comments on the March 19, 2015, proposed rule, identified by NOAA-NMFS-2015-0012, by either of the following methods:
          • Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal.

            1. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2015-0012.

          2. Click the “Comment Now!” icon, complete the required fields.
          3. Enter or attach your comments.
          • Mail: Submit written comments to Kim Damon-Randall, Assistant Regional Administrator for Protected Resources, NMFS Greater Atlantic Region, 55 Great Republic Dr., Gloucester, MA 01930, Attn: Large Whale Proposed Rule.

          Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

          FOR FURTHER INFORMATION CONTACT:

          Kate Swails, NMFS Greater Atlantic Regional Fisheries Office, 978-282-8481, Kate.Swails@noaa.gov; or, Kristy Long, NMFS Office of Protected Resources, 206-526-4792, Kristy.Long@noaa.gov.

        SUPPLEMENTARY INFORMATION:
        Correction
        In a proposed rule that published in the Federal Register on March 19, 2015 (FR Doc. 2015-06272), (80 FR 14345) the ADDRESSES section provided the wrong address for the submission of electronic comments. The corrected ADDRESSES section appears above. All other information in the proposed rule, other than the ADDRESSES section, remains exactly the same as previously published.

          Dated: March 27, 2015.
          Samuel D. Rauch III,
          Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

      [FR Doc. 2015-08003 Filed 4-6-15; 8:45 am]
      BILLING CODE 3510-22-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Office of the Secretary
        45 CFR Part 13
        Implementation of the Equal Access to Justice Act in Agency Proceedings

          AGENCY:
          Office of the Secretary, HHS.

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:
          This proposed rule would extend the coverage of the Department's regulation implementing the Equal Access to Justice Act to include adversary administrative adjudications commenced after September 30, 1984. It would also amend the eligibility criteria and certain other aspects of that regulation to conform with amendments to the Act. Finally, it would reflect the separation of the Social Security Administration from HHS, and that component's establishment as an independent agency in 1995.

          DATE:
          HHS will accept comments on this proposed rule through October 12, 2002. The Office of Management and Budget will accept comments on the amendments to §§ 13.10 through 13.12 through the same date.

          ADDRESSES:

          Comments must be in writing. Please send them to: Katherine M. Drews, Acting Associate General Counsel, Business and Administrative Law Division, Room 5362, 330 Independence Ave., SW., Cohen Building, Room 5362, Washington, DC 20201. Please send comments on the amendments to subpart B to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, Attention: Desk Officer for HHS.

          FOR FURTHER INFORMATION CONTACT:
          Katherine M. Drews, Acting Associate General Counsel. Telephone: (202) 619-0150.

        SUPPLEMENTARY INFORMATION:
        Background
        The Equal Access to Justice Act (EAJA), enacted in 1980, requires the Government to pay attorney fees to parties prevailing against it in litigation where the Government's position is not substantially justified. The Act applies to certain types of adversary administrative proceedings and to certain court litigation where attorney fees are not otherwise available.
        The EAJA requires each agency to issue rules implementing the Act as it applies to administrative proceedings. The current rule of the Department of Health and Human Services (HHS) was published on October 4, 1983, and is codified at 45 CFR part 13. (All citations below to section 13 are to sections of 45 CFR part 13.)
        The original Act had a sunset provision, causing it to expiring on September 30, 1984 (although it would continue to cover proceedings pending on that date). The HHS regulation presently in effect contains a similar sunset provision. A subsequent statutory change eliminated the sunset provision, revised the eligibility criteria for parties, and amended the Act in certain other respects. Public Law No. 99-80, 99 Stat. 183 (1985).

        HHS  published a Notice of Proposed Rulemaking to revise its EAJA regulation on June 19, 1987 (52 FR 23311). Pursuant to the notice, we received only one set of comments, from the Office of the Chairman of the Administrative Conference of the United States (ACUS), an agency that no longer exists. Since then, the Social Security Administration, certain proceedings of which were addressed in the proposed rule, became an independent agency. See Pub. L. No. 103-296, § 101 (codified at 42 U.S.C. 901). Also since  than, the EAJA has been amended by section 231 of the Contract with America Advancement Act of 1996, Pub. L. No. 104-121, 110 Stat. 847 (1996). Because of those changes because substantial time has passed since the initial Notice of Proposed Rulemaking, we are publishing a new Notice of Proposed Rulemaking; this notice replaces the earlier notice. We considered the ACUS comments carefully, and this notice reflects some of those comments. This notice also reflects the changes effected by Pub. L. 104-121. Since the statutory change, we have been processing fee applications under the current regulation except to the extent that the amended statute requires changes.
        This proposed rule would amend the existing rule in the following ways:
        1. The Act provided for fee shifting only where the agency's position was not substantially justified. Pub. L.; 1-4-121 added a provision of fee shifting where the agency's demand was substantially in excess of the ultimate decision and was unreasonable when compared with decision. The proposed regulation would amend section 13.1, and would revise sections 13.5 and 13.10 (a)(2), to incorporate this new basis for fee awards. Pub. L. 104-121 also added a new category of party that would be eligible for a fee award, though only for awards made based on this excessive and unreasonable demand criterion. The proposed regulation would amend sections 13.4; 13.10(a)(3), (5); and 13.11(a) to the same effect.
        2. The Act included a sunset clause, section 203(c), providing that the Act would not apply to administrative adjudications initiated after September 30, 1984. HHS's regulation includes a similar provisions, 45 CFR 13.2. Section 6(b)(1) of Pub. L. 99-80 repealed the sunset provision in the Act. The proposed regulation would similarly amend Section 13.2.
        3. Section 13.3 generally provides that we have listed the covered proceedings in the Appendix to the rule. We propose revision this section to provide for situations involving proceedings not listed in the Appendix.  The new provision would automatically cover proceedings where the procedural rights are incorporated by reference from certain statutes that we  have already determined invoke the Act. It  would also allow a party in any other administrative proceeding to file an EAJA application and claim coverage, and have the issue resolved in the resulting proceeding on the fee application.
        4. Section 1(c)(1) of Pub. L. 99-80 increased the net worth limitations on parties eligible to recover fees under EAJA. It also added local government units to the categories of eligible entities. Section 7 of Pub. L. 99-80 makes these expanded eligibility criteria applicable to proceedings pending on or after August 5, 1985 (the effective date of that statute), and to proceedings commenced after September 30, 1984 (the sunset date of the original EAJA), even if finally disposed of before August 5, 1985. The proposed regulation would amend Sections 13.3(b) and 13.10(a)(5) to make the same changes with respect to the same categories of cases. The passage of time has made it unnecessary to provide explicitly for older cases. However, for proceedings commenced before October 1, 1984, and finally decided before August 5, 1985, the older eligibility criteria would govern, as follows: Individuals with a net worth of not more than $1 million; sole owners of unincorporated businesses if the owner has a net worth of not more than $5 million, including both personal and business interests, and if the business has no more than 500 employees; and all other partnerships, corporations, associations, or public or private organizations with a net worth of not more than $5 million and with not more than 500 employees.
        5. Section 1(c)(3) of Pub. L. 99-80 defines the “position of the agency” to include the action or omission that was the basis for the proceeding, and section 1(a)(1) restricts the analysis of whether that position was substantially justified to the administrative record. The proposed regulation would revise sections 13.5(a) and 13.10(a)(2) likewise, and it would also amend section 13.25(a) to the same end.
        6. We no longer take the position that the applicant must have actually paid (or must have actually become obligated to pay) the attorney fees and expenses in order to recover those fees and expenses under EAJA. Accordingly, the proposed regulation would delete the sentence in section 13.6(a) that stated this position.
        7. Pub. L. 104-121 increased the allowable hourly rate for fees from $75 to $125. The proposed regulation would amend section 13.6(b) to the same effect.
        8. The proposed regulation would amend section 13.12(d) to make clear that the adjudicative officer may require further substantiation of fees as well as expenses.

        9. The EAJA and the HHS regulation require the prevailing party to file the fee application within 30 days of the final disposition of the administrative proceeding. 5 U.S.C. 504(a)(2); 45 CFR 13.22(a). Section 7(b) of Pub. L. 99-80 provides that, in cases commenced after September 30, 1984 (the sunset date of the original EAJA), and finally disposed of before August 5, 1985 (the effective date of the new law), this 30-day period runs from the latter date. The proposed regulation would amend section 13.22(a) to this effect.
        10. Section 1(B) of Pub. L. 99-80 provides that when the Government appeals the merits of a proceeding, any fee application is stayed until the appeal is finally resolved, and it specifies that a court decision is deemed to finally dispose of such an appeal only when that decision is final and unreviewable. There is a similar, but more inclusive, stay provision in section 13.22(d). The proposed regulation would amend sections 13.22(b) and (d) to conform with the statute. The proposed regulation would also revise section 13.23(a) to make clear that, when a fee proceeding is stayed in these circumstances, the agency need answer the fee application only after the final disposition of the underlying controversy.
        11. The proposed rule would revise section 13.27 to designate as the review authority on fee decisions the same person or component that would have jurisdiction over an appeal of the merits of the adjudication. It would eliminate as unnecessary the requirement that the appellate authority review fee awards where neither party appeals. It would also revise section 13.27(b) to provide for cross-exceptions to be filed from an initial decision on a fee application.
        12. Appendix A to the regulation lists the HHS proceedings that are covered by the regulation if the agency's litigating party enters an appearance and participates. The proposed regulation would revise the appendix to correct descriptions of categories of proceedings, to correct statutory citations for  categories of proceedings, to add regulatory citations for categories, and to add new categories of proceedings that are covered.

        13. The legislative history of Pub. L. 99-80 contains several references to the Social Security Administration Representation Project, under which SSA representatives participated in certain disability hearings involving Social Security benefits or Supplemental Security Income benefits. That project was discontinued in 1987. See 52 FR 17285 (May 7, 1987). We have taken the position that proceedings in that project were not within the scope of the EAJA as originally enacted, and thus Appendix A to the current regulation does not list them. The legislative history of Pub. L. 99-80 evidences the intent of some members of Congress that the EAJA as revised and amended should apply to cases in this project. As noted above, the project has been discontinued, and, in any case, the Social Security Administration is now an independent agency. However, we have determined that the EAJA should be applied to other HHS proceedings for which the statutory entitlement to a hearing rests either on a statute tracking the language of the provision underlying the disability hearings (section 205(b) of the Social Security Act, 42 U.S.C. 405(b)), or on a statute incorporating that provision by reference. Thus, the proposed regulation would add these proceedings to Appendix A.
        Economic Impact
        We have examined the impacts of this proposed rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980 Pub. L. 96-354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 96-354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 (Federalism).
        Executive Order 12866 (the Order) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for major rules with economically significant affects ($100 million or more in any 1 year).
        We have determined that the proposed rule is consistent with the principles set forth in the Order, and we also find that the proposed rule would not have economically significant effects. In addition, the rule is not a major rule as defined at 5 USC 804(2). In accordance with the provisions of the Order, this regulation was reviewed by the Office of Management and Budget.
        The Secretary certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The basis for the Secretary's certification is that, although small entities are eligible to apply for awards, the regulation will apply only to a small number of the proceedings held by the Department each year, and, in many of those proceedings, there will not be any fee award because the Department's position will be substantially justified or its demand will be reasonable. Also, most of the changes reflected in the regulation are mandated by the statue, so it is the statute rather than the regulation that would have any impact. Finally, the procedures prescribed by the regulation are no more onerous than those imposed by the current rule. In sum, the regulation will have negligible effect on such entities.
        The Secretary states, in accordance with section 3(c) of Executive Order 12988 (Civil Justice Reform), that the Department has reviewed this regulatory proposal in light of section 3 of that Order and that the proposal meets the applicable standards in subsections (a) and (b) of that Order.
        Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million. As noted above, we find that this proposal would not have an effect of this magnitude on the economy.
        Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this proposed rule under the threshold criteria of Executive order 13132, and we find that there would be no substantial direct effect on the States, on the relationship between the States and the national Government, or on the distribution of power between the levels of government on our federal system. Thus, a federalism impact statement is not required.
        Information Collection

        Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide a 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. Subpart B of the proposed 45 CFR part 13 contains collection of information requirements. These collection of information requirements are necessary to carry out the provisions of the EAJA. In order to fairly evaluate whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:

        —Whether the information collection is necessary and useful to carry out the proper functions of the agency;
        —The accuracy of the agency's estimate of the information collection burden;
        —The quality, utility, and clarity of the information to be collected; and

        —Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

        Section 13.10 of the proposed rule contains the requirements for the application for an award of fees and expenses. The burden associated with these requirements is the time and effort necessary for an applicant to prepare and submit the application. On an annual basis it is estimated that it will take 10 applicants 20 hours each to prepare and submit an application. The total annual burden associated with this requirement is 200 hours.
        Section 13.11 of the proposed rule contains the requirements for the submission of the applicant's net worth exhibits. The burden associated with these requirements is the time and effort necessary for an applicant to prepare and submit the net worth exhibits. On an annual basis it is estimated that it will take 10 applicants 10 hours each to prepare and submit net worth exhibits. The total annual burden associated with this requirement is 100 hours.
        Section 131.12 of the proposed rules contains the requirements for submission of the applicant's documentation of fees and expenses. The burden associated with these requirements is the time and effort necessary for an applicant to prepare and submit the fee and expense documentation. On an annual basis it is estimated that it will take 10 applicants 5 hours each to prepare and submit fee and expense documentation. The total annual burden associated with this requirement is 50 hours.
        The Department will submit a copy of this proposed Rule to OMB for its review of the information collection requirements described above. These requirements are not effective until they have been approved by OMB.
        If you comment on any of these information collection requirements, please mail copies directly to the following:

        Cynthia Agens Bauer, OS Reports Clearance Officer, Room 503H, Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201; and
        Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, ATTN: Allison Eydt, HHS Desk Officer.

          List of Subjects in 45 CFR Part 13
          Administrative practice and procedure, Claims, Equal access to justice.

        For the reasons set out in the preamble, the Secretary proposes to amend 45 CFR part 13 as follows:
        1. The authority citation for part 13 is revised to read as follows:

          Authority:
          5 U.S.C. 504(c)(1).

        2. In § 13.1, the third sentence is revised to read as follows:

          § 13.1
          Purpose of these rules.
          * * * the Department may reimburse parties for expenses incurred in adversary adjudications if the party prevails in the proceeding and if the Department's position in the proceeding was not substantially justified or if the action is one to enforce compliance with a statutory or regulatory requirement and the Department's demand is substantially in excess of the ultimate decision and is unreasonable when compared with that decision. * * *
          3. Section 13.2 is revised to read as follows:

          § 13.2
          When these rules apply.
          These rules apply to adversary adjudications before the Department.
          4. Section 13.3 is amended by removing the last sentence in paragraph (a), by redesignating paragraph (b) as paragraph (c), and by adding a new paragraph (b) as follows:

          § 13.3
          Proceedings covered.

          (b) If the agency's litigating party enters an appearance, Department proceedings listed in Appendix A to this part are covered by these rules. Also covered are any other proceedings under statutes that incorporate by reference the procedures of sections 1128(f), 1128A(c)(2), or 1842(j)(2) of the Social Security Act, 42 U.S.C. 1320a-7(f), 1320a-7a(c)(2), or 1395u(j)(2). If a proceeding is not covered under either of the two previous sentences, a party may file a free application as otherwise required by this part and may argue that the act covers the proceeding. Any coverage issue shall be determined by the adjudicative officer and, if necessary, by the appellate authority on review.

          5. Section 13.4(b) is revised to read as follows:

          § 13.4
          Eligibility of applicants.

          (b) The categories of eligible applicants are as follows:
          (1) Charitable or other tax-exempt organizations described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) with not more than 500 employees;
          (2) Cooperative associations as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)) with not more than 500 employees;
          (3) Individuals with a net worth of not more than $2 million;
          (4) Sole owners of unincorporated businesses if the owner has a net worth of not more than $7 million, including both personal and business interests, and if the business has not more than 500 employees;
          (5) All other partnerships, corporations, associations, local governmental units, and public and private organizations with a net worth of not more than $7 million and with not more than 500 employees; and
          (6) Where an award is sought on the basis stated in § 13.5(c) of this part, small entities as defined in 5 U.S.C. 601.

          6. Section 13.5 is amended by redesignating paragraphs (a) through (d) as paragraphs (b)(1) through (b)(4), respectively; adding new paragraph (a) and a paragraph (b) heading; revising newly designated paragraph (b)(1); and adding a new paragraph (c) to read as follows:

          § 13.5
          Standards for awards.
          (a) An award of fees and expenses may be made either on the basis that the Department's position in the proceeding was not substantially justified or on the basis that, in a proceeding to enforce compliance with a statutory or regulatory requirement, the Department's demand substantially exceeded the ultimate decision and was unreasonable when compared with that decision. These two bases are explained in greater detail in paragraphs (b) and (c) of this section.
          (b) Awards where the Department's position was not substantially justified. (1) Awards will be made on this basis only where the Department's position in the proceeding was not substantially justified. The Department's position includes, in addition to the position taken by the agency in the proceeding, the agency action or failure to act that was the basis for the proceeding. Whether the Department's position was substantially justified is to be determined on the basis of the administrative record as a whole. The fact that a party has prevailed in a proceeding does not create a presumption that the Department's position was not substantially justified. The burden of proof as to substantial justification is on the agency's litigating party, which may avoid an award by showing that its position was reasonable in law and fact.

          (c) Awards where the Department's demand was substantially excessive and unreasonable. (1) Awards will be made on this basis only where the adversary adjudication arises from the Department's action to enforce a party's compliance with a statutory or regulatory requirement. An award may be made on this basis only if the Department's demand that led to the proceeding was substantially in excess of the ultimate decision in the proceeding, and that demand is unreasonable when compared with that decision, given all the facts and circumstances of the case.
          (2) Any award made on this basis shall be limited to the fees and expenses that are primarily related to defending against the excessive nature of the demand. An award shall not include fees and expenses that are primarily related to defending against the merits of charges, or fees and expenses that are primarily related to defending against the portion of the demand that was not excessive, to the extent that these fees and expenses are distinguishable from the fees and expenses primarily related to defending against the excessive nature of the demand.
          (3) Awards will be denied if the party has committed a willful violation of law or otherwise acted in bad faith, or if special circumstances make an award unjust.
          7. In § 13.6, the second sentence of paragraph (a) is removed and the first sentence of paragraph (b) is amended by removing “$75.00” and adding in its place “$125.00”.
          8.-9. In § 13.10, paragraphs (a)(2) and (a)(3) and the first sentence of paragraph (a)(5) introductory text are revised; paragraph (a)(5)(i) is amended by removing the word “or” at the end and paragraph (a)(5)(ii) is amended by adding the word “or” at the end; and paragraph (a)(5)(iii) is added to read as follows:

          § 13.10
          Contents of application.
          (a) * * *
          (2) Where an award is sought on the basis stated in § 13.5(b) of this part, a declaration that the applicant believes it has prevailed, and an identification of the position of the Department that the applicant alleges was not substantially justified. Where an award is sought on the basis stated in § 13.5(c) of this part, an identification of the statutory or regulatory requirement that the applicant alleges the Department was seeking to enforce, and an identification of the Department's demand and of the document or documents containing that demand;
          (3) Unless the applicant is an individual, a statement of the number of its employees on the date on which the proceeding was initiated, and a brief description of the type and purpose of its organization or business. However, where an award is sought solely on the basis stated in § 13.5(c) of this part, the applicant need not state the number of its employees;

          (5) A statement that the applicant's net worth as of the date on which the proceeding was initiated did not exceed the appropriate limits as stated in § 13.4(b) of this part. * * *

          (iii) It states that it is applying for an award solely on the basis stated in § 13.5(c) of this part, and that it is a small entity as defined in 5 U.S.C. 601, and it describes the basis for its belief that it qualifies as a small entity under that section.

          10.-12. Section 13.11(a) is amended by removing the first sentence and adding in its place the sentences reading as follows:

          § 13.11
          Net worth exhibits.
          (a) Each applicant must provide with its application a detailed exhibit showing the net worth of the applicant and any affiliates (as defined in § 13.4(f) of this part) when the proceeding was initiated. This requirement does not apply to a qualified tax-exempt organization or cooperative association. Nor does it apply to a party that states that it is applying for an award solely on the basis stated in § 13.5(c) of this part. * * *

          13. Section 13.12(d) is revised to read as follows:

          § 13.12
          Documentation of fees and expenses.

          (d) The adjudicative officer may require the applicant to provide vouchers, receipts, or other substantiation for any fees or expenses claimed, pursuant to § 13.25 of this part.
          14. Section 13.22 is amended by revising paragraphs (b) and (d), as follows:

          § 13.22
          When an application may be filed.

          (b) For purposes of this rule, final disposition means the date on which a decision or order disposing of the merits of the proceeding or any other complete resolution of the proceeding, such as a settlement or voluntary dismissal, becomes final and unappealable, both within the agency and to the courts.

          (d) If review or reconsideration is sought or taken, whether within the agency or to the courts, of a decision as to which an applicant believes it has prevailed, proceedings on the application shall be stayed pending final disposition of the underlying controversy.
          15. In § 13.23(a), the first sentence is removed and two sentences are added in its place to read as follows:

          § 13.23
          Responsive pleadings.
          (a) The agency's litigating party shall file an answer within 30 calendar days after service of the application or, where the proceeding is stayed as provided in § 13.22(d) of this part, within 30 calendar days after the final disposition of the underlying controversy. The answer shall either consent to the award or explain in detail any objections to the award requested and identify the facts relied on in support of the agency's position. * * *

          16. Section 13.25(a) is amended by adding the following sentence at the end:

          § 13.25
          Further proceedings.
          (a) * * * In no such further proceeding shall evidence be introduced from outside the administrative record in order to prove that the Department's position was, or was not, substantially justified.

          17. Section 13.27 is revised to read as follows:

          § 13.27
          Agency review.
          (a) The appellate authority for any proceedings shall be the official or component that would have jurisdiction over an appeal of the merits.
          (b) If either the applicant or the agency's litigating party seeks review of the adjudicative officer's decision on the fee application, it shall file and serve exceptions within 30 days after issuance of the initial decision. Within another 30 days after receipt of such exceptions, the opposing party, if it has not done so previously, may file its own exceptions to the adjudicative officer's decision. The appellate authority shall issue a final decision on the application as soon as possible or remand the application to the adjudicative officer for further proceedings. Any party that does not file and serve exceptions within the stated time limit loses the opportunity to do so.
          18. Appendix A to part 13 is revised to read as follows:

            Appendix A To Part 13

                Proceedings covered
                Statutory authority
                Applicable regulations

                  Office of Inspector General

                1. Proceedings to impose civil monetary penalties, assessments, or exclusions from Medicare and State health care program

                42 U.S.C. 1320a-7a(c)(2); 1320b-10(c); 1395l-3(b)(3)(B)(ii), (g)(2)(A)(i); 1395l(h)(5)(D), (i)(6); 1395m(a)(11)(A), (a)(18), (b)(5)(C), (j)(2)(A)(iii); 1395u(j)(2), (k), (l)(3), (m)(3), (n)(3), (p)(3)(A); 1395y(b)(3)(C), (b)(6)(B); 1395cc(g); 1395dd(d)(1)(A), (B); 1395mm(i)(6)(B); 1395nn(g)(3), (4); 1395ss(d); 1395bbb(c)(1); 1396b(m)(5)(B); 1396r(b)(3)(B)(ii), (g)(2)(A)(i); 1396t(i)(3); 11131(c); 11137(b)(2)
                42 CFR Part 1003; 42 CFR Part 1005.

                2. Appeals of exclusions from Medicare and State health care programs and/or other programs under the Social Security Act
                42 U.S.C. 1320a-7(f); 13951(h)(5)(D); 1395m(a)(11)(A), (b)(5)(C); 1395u(j)(2), (k), (l)(3), (m)(3), (n)(3), (p)(3)(B)
                42 CFR Part 1001; 42 CFR Part 1005.

                3. Appeal of exclusions from programs under the Social Security Act, for which services may be provided on the recommendation of a Peer Review Organization
                42 U.S.C. 1320c-5(b)(4), (5)
                42 CFR Part 1004; 42 CFR Parts 1005.

                4. Proceedings to impose civil penalties and assessments for false claims and statements
                31 U.S.C. 3803
                45 CFR Part 79.

                  Centers for Medicare and Medicaid Services

                1. Proceedings to suspend or revoke licenses of clinical laboratories
                42 U.S.C. 263a(i); 1395w-2
                42 CFR Part 493, Subpart R.

                2. Proceedings provided to a fiscal intermediary before assigning or reassigning Medicare providers to a different fiscal intermediary
                42 U.S.C. 1395h(e)(1)-(3)
                42 CFR 421.114, 421.128.

                3. Appeals of determinations that an institution or agency is not a Medicare provider of services, and appeals of terminations or nonrenewals of Medicare provider agreements
                42 U.S.C. 1395cc(h); 1395dd(d)(1)(A)
                42 CFR 489.53(d); 42 CFR Part 498.

                4. Proceedings before the Provider Reimbursement Review Board when Department employees appear as counsel for the intermediary
                42 U.S.C. 1395oo
                42 CFR Part 405, Subpart R.

                5. Appeals of CMS determinations that an intermediate care facility for the mentally retarded (ICFMR) no longer qualifies as an ICFMR for Medicaid purposes
                42 U.S.C. 1396i
                42 CFR Part 498.

                6. Proceedings to impose civil monetary penalties, assessments, or exclusions from Medicare and State health care programs
                42 U.S.C. 1395l-3(h)(2)(B)(ii); 13951-(q)(2)(B)(i); 1395m(a)(11)(A), (c)(4)(C); 1395w-2(b)(2)(A); 1395w-4(g)(1), (g)(3)(B), (g)(4)(B)(ii); 1395nn-(g)(5); 1395ss-(a)(2), (p)(8), (p)(9)(C), (q)(5)(C), (r)(6)(A), (s)(3), (t)(2); 1395bbb(f)(2)(A); 1396r(h)(3)(C)(ii); 1396r-8(b)(3)(B), (C)(ii); 1396t(j)(2)(C); 1396u(h)(2)
                42 CFR Part 1003.

                7. Appeals of exclusions from Medicare and State health care programs and/or other programs under the Social Security Act
                42 U.S.C. 1395l(q)(2)(B)(ii); 1395m(a)(11)(A), (c)(5)(C); 1395w-4(g)(1), (g)(3)(B), (g)(4)(B)(ii)
                42 CFR Part 498; 42 CFR 1001.107.

                  Food and Drug Administration

                1. Proceedings to withdraw approval of new drug applications
                21 U.S.C. 355(e)
                21 CFR Part 12: 21 CFR 314.200.

                2. Proceedings to withdraw approval of new animal drug applications and medicated feed applications
                21 U.S.C. 360b(e), (m)
                21 CFR Part 12; 21 CFR Part 514, Subpart B.

                3. Proceedings to withdraw approval of medical device premarket approval applications
                21 U.S.C. 306e(e), (g)
                21 CFR Part 12.

                  Office for Civil Rights

                1. Proceedings to enforce Title VI of the Civil Rights Act of 1964, which prohibits discrimination on the basis of race, color or national origin by recipients of Federal financial assistance
                42 U.S.C. 2000d-1
                45 CFR 80.9.

                2. Proceedings to enforce section 504 of the Rehabilitation Act of 1973, which prohibits discrimination on the basis of handicap by recipients of Federal financial assistance
                29 U.S.C. 794a; 42 U.S.C. 2000d-1
                45 CFR 84.61.

                3. Proceedings to enforce the Age Discrimination Act of 1975, which prohibits discrimination on the basis of age by recipients of Federal financial assistance
                42 U.S.C. 6104(a)
                45 CFR 91.47.

                4. Proceedings to enforce Title IX of the Education Amendments of 1972, which prohibits discrimination on the basis of sex in certain education programs by recipients of Federal financial assistance
                20 U.S.C. 1682
                45 CFR 86.71.

              Dated: May 10, 2002.
              Tommy G. Thompson,
              Secretary.

      [FR Doc. 02-20307 Filed 8-12-02; 8:45 am]
      BILLING CODE 4150-26-M


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 30
        [EPA-HQ-OA-2018-0259; FRL-9977-40-ORD]
        RIN 2080-AA14
        Strengthening Transparency in Regulatory Science

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          This document proposes a regulation intended to strengthen the transparency of EPA regulatory science. The proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation. In this notice, EPA solicits comment on this proposal and how it can best be promulgated and implemented in light of existing law and prior Federal policies that already require increasing public access to data and influential scientific information used to inform federal regulation.

          DATES:
          Comments must be received on or before May 30, 2018.

          ADDRESSES:

          Submit your comments, identified by Docket ID No. EPA-HQ-OA-2018-0259, at https://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

          FOR FURTHER INFORMATION CONTACT:

          Tom Sinks, Office of the Science Advisor, Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; (202) 564-0221; email address: staff_osa@epa.gov.

        SUPPLEMENTARY INFORMATION:

          Submitting CBI. Do not submit information that you consider to be CBI electronically through https://www.regulations.gov or email. Send or deliver information identified as CBI to only the following address using U.S. Postal Service: U.S. Environmental Protection Agency, EPA Docket Center, EPA-HQ-OA-2018-0259, Mail Code 28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460. For other methods of delivery, see https://www.epa.gov/dockets/where-send-comments-epa-dockets.

        Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. If you submit a CD-ROM or disk that does not contain CBI, mark the outside of the disk or CD-ROM clearly that it does not contain CBI. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

          Organization of This Document. The following outline is provided to aid in locating information in this preamble.

          I. General Information
          A. Does this action apply to me?
          B. What action is the Agency taking?
          C. What is the Agency's authority for taking this action?
          II. Background
          III. Request for Comment
          IV. Statutory and Executive Orders

        I. General Information
        A. Does this action apply to me?
        This proposed regulation does not directly regulate any entity outside the federal government. However, any entity interested in EPA's regulations may be interested in this proposal. This proposal may be of particular interest to entities that conduct research and other scientific activity that is likely to be relevant to EPA's regulatory activity.
        B. What action is the Agency taking?
        This notice solicits information and comment from the public on a proposed regulation intended to strengthen the transparency of EPA regulatory science. The proposed regulation provides that, for the science pivotal to its significant regulatory actions, EPA will ensure that the data and models underlying the science is publicly available in a manner sufficient for validation and analysis. In this notice, EPA solicits comment on this proposal and how it can best be implemented in light of existing law and prior statements of policy that have called for increasing public access to data and influential scientific information used to inform federal regulation. EPA has not previously implemented these policies and guidance in a robust and consistent manner. This proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.
        C. What is the Agency's authority for taking this action?
        The Agency proposes to take this action under authority of the statutes it administers, including provisions providing general authority to promulgate regulations necessary to carry out the Agency's functions under these statutes and provisions specifically addressing the Agency's conducting of and reliance on scientific activity to inform those functions, including Clean Air Act sections 103, 301(a), 42 U.S.C. 7403, 7601(a); Clean Water Act sections 104, 501, 33 U.S.C. 1254, 1361; Safe Drinking Water Act sections 1442, 1450(a)(1), 42 U.S.C. 300j-1, 300j-9(a)(1); Resource Conservation and Recovery Act sections 2002(a)(1), 7009, 42 U.S.C. 6912(a)(1), 6979; Comprehensive Environmental Response, Compensation, and Liability Act (as delegated to the Administrator via Executive Order 12580) sections 115, 311, 42 U.S.C. 9616, 9660; Emergency Planning and Community Right-To-Know Act section 328, 42 U.S.C. 11048; Federal Insecticide, Fungicide, and Rodenticide Act sections 25(a)(1), 136r(a), 7 U.S.C. 136r(a), 136w; and Toxic Substances Control Act, as amended, section 10, 15 U.S.C. 2609. This action is also consistent with requirements in the Administrative Procedure Act to ensure public participation in the rulemaking process. As noted in Section III below, EPA solicits comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation.
        II. Background
        The best available science must serve as the foundation of EPA's regulatory actions.1
           Enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA's regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions. By better informing the public, the Agency in enhancing the public's ability to understand and meaningfully participate in the regulatory process.2
           In applying the best available science to its regulatory decision-making, EPA must comply with federal transparency and data integrity laws, and must also ensure that its decision-making is marked by independence, objectivity, transparency, clarity, and reproducibility. Although these standards are important in all scientific endeavors, they are of paramount importance when the government relies on science to inform its significant regulatory decisions that will affect the public. When EPA develops significant regulations using public resources, including regulations for which the public is likely to bear the cost of compliance, EPA should ensure that the data and models underlying scientific studies that are pivotal to the regulatory action are available to the public. This proposed rule is designed to increase transparency in the preparation, identification, and use of science in policymaking.

            1 See Exec. Order No. 13563, 76 FR 3821 (Jan. 21, 2011). “Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation. It must be based on the best available science.”

            2 See Memorandum for the Heads of Executive Department and Agencies on Scientific Integrity (Mar. 9, 2009). “If scientific and technological information is developed and used by the Federal Government, it should ordinarily be made available to the public. To the extent permitted by law, there should be transparency in the preparation, identification, and use of scientific and technological information in policymaking.”

        This proposed rule is consistent with the principles underlying the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.3
           This proposed rule is also consistent with Executive Orders 13777 4
           and 13783,5
           and the focus on transparency in OMB's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information Disseminated by Federal Agencies 6
           (the Guidelines) and OMB
          Memorandum 13-13: Open Data Policy—Managing Information as an Asset.7
           It builds upon prior EPA actions 8
           in response to government-wide data access and sharing policies, as well as the experience of other federal agencies in this space.9
           In particular, this proposal applies concepts and lessons learned from its ongoing implementation of the 2016 Plan to Increase Access to Results of EPA-Funded Scientific Research to significant regulatory decisions. The proposed rule takes into consideration the policies or recommendations of third party organizations who advocated for open science.10
           These policies are informed by the policies recently adopted by some major scientific journals,11
           spurred in some part by the “replication crisis.” 12

            3 EPA has the authority to establish policies governing its reliance on science in the administration of its regulatory functions. Historically, EPA has not consistently observed the policies underlying this proposal, and courts have at times upheld EPA's use non-public data in support of its regulatory actions. See Coalition of Battery Recyclers Ass'n v. EPA, 604 F.3d 613, 623 (D.C. Cir. 2010); American Trucking Ass'ns v. EPA, 283 F.3d 355, 372 (D.C. Cir. 2002). EPA is proposing to exercise its discretionary authority to establish a policy that would preclude it from using such data in future regulatory actions.

            4 Exec. Order No. 13777, 82 FR 12285 (Mar. 1, 2017). Regulatory reform efforts shall attempt to identify “those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility.”

            5 Exec. Order No. 13783, 82 FR 16093 (Mar. 31, 2017). “It is also the policy of the United States that necessary and appropriate environmental regulations comply with the law, are of greater benefit than cost, when permissible, achieve environmental improvements for the American people, and are developed through transparent processes that employ the best available peer-reviewed science and economics.”

            6 February 22, 2002 (67 FR 8453) OMB's Guidelines Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information (2002) https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-and-maximizing-the-quality-objectivity-utility-and-integrity-of-information.

            7 Memorandum for the Heads of Executive Departments and Agencies on Open Data Policy—Managing Information as an Asset (https://project-open-data.cio.gov/policy-memo/). “Specifically, this Memorandum requires agencies to collect or create information in a way that supports downstream information processing and dissemination activities. This includes using machine-readable and open formats, data standards, and common core and extensible metadata for all new information creation and collection efforts. It also includes agencies ensuring information stewardship through the use of open licenses and review of information for privacy, confidentiality, security, or other restrictions to release.”

            8 Plan to Increase Access to Results of EPA-Funded Scientific Research; EPA Open Government Plan 4.0; Open Data Implementation Plan; EPA's Scientific Integrity Policy; Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency.

            9 For example, see related policies from the National Science Foundation, National Institute of Science and Technology, the National Institutes of Health; and the U.S. Census Bureau, which provides secure access to data from several agencies in an environment that protects against unauthorized disclosure (https://www.census.gov/fsrdc).

            10 These include policies and recommendations from: The Administrative Conference of the United States' Science in the Administrative Process Project; National Academies' reports on Improving Access to and Confidentiality of Research Data, Expanding Access to Research Data, and Access to Research Data in the 21st Century; the Health Effects Institute; Center for Open Science; members of the Risk Assessment Specialty Section of the Society of Toxicology, the Dose Response Section of the Society for Risk Analysis, and the International Society for Regulatory Toxicology and Pharmacology; and the Bipartisan Policy Center's Science for Policy Project.

            11 For example, see related policies from the Proceedings of the National Academy of Sciences, PLOS ONE,
            Science, and Nature.

            12 See: https://www.nature.com/articles/s41562-016-0021; http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124;
            http://science.sciencemag.org/content/343/6168/229.long; https://www.economist.com/news/leaders/21588069-scientific-research-has-changed-world-now-it-needs-change-itself-how-science-goes-wrong.; http://stm.sciencemag.org/content/8/341/341ps12.full.

        Today, EPA is proposing to establish a clear policy for the transparency of the scientific information used for significant regulations: Specifically, the dose response data and models that underlie what we are calling “pivotal regulatory science.” “Pivotal regulatory science” is the studies, models, and analyses that drive the magnitude of the benefit-cost calculation, the level of a standard, or point-of-departure from which a reference value is calculated. In other words, they are critical to the calculation of a final regulatory standard or level, or to the quantified costs, benefits, risks and other impacts on which a final regulation is based.
        With this notice, EPA is soliciting public comment on a proposed regulation designed to provide a mechanism to increase access to dose response data and models underlying pivotal regulatory science in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests. The proposal takes comment on how to ensure that, over time, more of the data and models underlying the science that informs regulatory decisions (over and above the dose response data and models underlying “pivotal regulatory science”) is available to the public for validation 13
           in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification. As such this proposed regulation is designed to change agency culture and practices regarding data access so that the scientific justification for regulatory actions is truly available for validation and analysis.

            13 EPA has not consistently followed previous EPA policy (e.g, EPA's Scientific Integrity Guidance, referenced above) that encouraged the use of non-proprietary data and models.

        Regulatory determinations based on science should describe and document any assumptions and methods used, and should address variability and uncertainty. Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments. EPA's regulatory science should be consistent with the Office of Management and Budget's Final Information Quality Bulletin for Peer Review.14
           Robust peer review plays a critical role in independently validating key findings and ensuring that the quality of published information meets the standards of the scientific and technical community.

            14 https://www.whitehouse.gov/wp-content/uploads/2017/11/2005-M-05-03-Issuance-of-OMBs-Final-Information-Quality-Bulletin-for-Peer-Review-December-16-2004.pdf.

        In addition, this proposed regulation is designed to increase transparency of the assumptions underlying dose response models. As a case in point, there is growing empirical evidence of non-linearity in the concentration-response function for specific pollutants and health effects. The use of default models, without consideration of alternatives or model uncertainty, can obscure the scientific justification for EPA actions. To be even more transparent about these complex relationships, EPA should give appropriate consideration to high quality studies that explore: A broad class of parametric concentration-response models with a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the exposure range; and spatial heterogeneity. EPA should also incorporate the concept of model uncertainty when needed as a default to optimize low dose risk estimation based on major competing models, including linear, threshold, and U-shaped, J-shaped, and bell-shaped models.
        Across EPA programs, much of the science that informs regulatory actions is developed outside the Agency. It is the charge of regulators to ensure that key findings are valid and credible, as required by OMB's Guidelines 15
           (which apply to “third party” information—e.g., non-government scientific research—if the agency use of that information provides the appearance of representing agency views). Using scientific information that can be independently validated will lead to better outcomes, and strengthen public confidence in the health and environmental protections underpinning EPA's regulatory actions.

            15 February 22, 2002 (67 FR 8453) OMB's Guidelines Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information (2002) https://www.federalregister.gov/documents/2002/02/22/R2-59/guidelines-for-ensuring-and-maximizing-the-quality-objectivity-utility-and-integrity-of-information.

        EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government.16
           Nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines.17
           The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that “Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach.” 18
           More recently, both the National Academies and the Bipartisan Commission on Evidence Based Policy 19
           have discussed the challenges and opportunities for facilitating to secure access to confidential data for non-government analysts.

            16 See examples from the U.S. Department of Health and Human Services, National Institute of Standards and Technology, U.S. Department of Education, and the U.S. Census Bureau.

            17 https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html.

            18 https://www.nap.edu/catalog/11434/expanding-access-to-research-data-reconciling-risks-and-opportunities.

            19 https://www.cep.gov/content/dam/cep/report/cep-final-report.pdf; https://www.nap.edu/catalog/24652/innovations-in-federal-statistics-combining-data-sources-while-protecting-privacy; https://www.nap.edu/catalog/24893/federal-statistics-multiple-data-sources-and-privacy-protection-next-steps.

        Considering the breadth of dose response data and models used in the development of significant EPA regulations, the requirements for availability may differ. These mechanisms may range from deposition in public data repositories, consistent with requirements for many scientific journals,20
           to, for certain types of information, controlled access in federal research data centers that facilitate secondary research use by the public.21
           EPA should collaborate with other federal agencies to identify strategies to protect confidential and private information in any circumstance in which it is making information publicly available. These strategies should be cost-effective and may also include: Requiring applications for access; restricting access to data for the purposes of replication, validation, and sensitivity evaluation; establishing physical controls on data storage; online training for researchers; and nondisclosure agreements.22

            20 For example, see policies or recommendations of publishers Taylor & Francis, Elsevier, PLOS, and Springer Nature.

            21 For example: https://osp.od.nih.gov/scientific-sharing/requesting-access-to-controlled-access-data-maintained-in-nih-designated-data-repositories-e-g-dbgap/; https://www.census.gov/fsrdc.

            22 These recommendations are consistent with those of Lutter and Zorn (2016). https://www.mercatus.org/system/files/Mercatus-Lutter-Public-Access-Data-v3.pdf.we re.

        Implementation of this proposed rule will be consistent with the definition of “research data” in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in Public Law 89-487, and other applicable federal laws.
        This proposed regulation is intended to apply prospectively to final regulations that are determined to be “significant regulatory actions” pursuant to E.O. 12866. The Agency's offices should be guided by this policy to the maximum extent practicable during ongoing regulatory action, even where such research has already been generated, solicited, or obtained.
        III. Request for Comment
        EPA solicits comment on all aspects of the proposed regulation and the bases articulated for it above. Specifically, EPA believes that it has identified appropriate sources of statutory authority for this proposed regulation in Section I(c) above, and solicits public comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation. EPA further believes that a generally applicable regulatory provision of the type proposed here is the appropriate vehicle to establish and implement the policies articulated in Section II above, in the interests of consistency, predictability, and transparency across the functions that EPA performs.
        EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II above.
        EPA solicits comment on the effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted or if other requirements would affect implementation. EPA also seeks comments on which criteria the Agency should use to base any exceptions, including whether case-by-case exceptions may be appropriate.
        Although the proposed regulatory text would impose requirements specifically on final regulations determined to be “significant regulatory actions” under E.O. 12866, EPA solicits comment on whether and to what extent these requirements, or other provisions and policies, should apply to other stages of the rulemaking process, including proposed rules, as well as to other types of agency actions and promulgations, such as guidance. EPA also solicits comment on whether a narrower scope of coverage would be appropriate, such as only final regulations that are determined to be “major” under the Congressional Review Act, or “economically significant” under E.O. 12866. EPA also requests comment on whether certain categories of regulations should be excluded from coverage, such as those that merely reaffirm an existing standard, or some other category. For instance, we request comment on whether the provisions of the proposed rule should apply to individual party adjudications, enforcement activities, or permit proceedings when EPA determines that these provisions are practical and appropriate and that the actions are scientifically or technically novel or likely to have precedent-setting influence on future actions. EPA seeks comment on whether the Agency should apply the provisions of the proposed rule to these actions or to specific types of actions within these categories. The Agency also seeks comment on whether other agency actions, beyond significant final regulatory actions under E.O. 12866, should be included, such as site-specific permitting actions or non-binding regulatory determinations.
        EPA solicits comment on the definitions of “pivotal regulatory science,” and “dose response data and models” and how to implement such definitions.

        EPA also solicits comment on how to incorporate stronger data and model access requirements into the terms and conditions of cooperative agreements and grants. EPA solicits comments on how it can build upon other federal agencies' policies regarding grantee and cooperator requirements for data access and data sharing. EPA also solicits suggestions for a platform that would enable the Agency to implement the provisions of this proposal related to increasing public access to EPA-funded data. EPA also seeks comment on methodologies and technologies designed to provide protected access to identifiable and sensitive data, such as individual health data, and on commenters experience with the use of such methodologies and technologies and their strengths and limitations. Similarly, EPA seeks comment on how to balance appropriate protection for copyrighted or confidential business information, including where protected by law, with requirements for increased transparency of pivotal regulatory science. EPA also requests comment on whether there are other compelling interests besides privacy, confidentiality, national and homeland security that may require special consideration when data is being released.
        EPA solicits comment on implementation of the proposed regulation, including which parts of the Agency should be responsible for carrying out these requirements. EPA seeks comment on the effective date of a rule as well as on whether the Agency should seek to phase-in the requirements for certain significant regulatory actions or seek to prioritize specific actions. For regulatory programs, like the National Ambient Air Quality Standards program, in which future significant regulatory actions may be based on the administrative record from previous reviews—particularly where the governing statute requires repeated review on a fixed, date-certain cycle—EPA seeks comment on the manner in which this proposed rule should apply to that previous record. EPA also solicits comments on whether and how the proposed rule should apply to dose response data and models underlying pivotal regulatory science if those data and models were developed prior to the effective date. In addition, EPA seeks comment on how the prospective or retrospective application of the provisions for dose response data and models or pivotal regulatory science could inadvertently introduce bias regarding the timeliness and quality of the scientific information available. EPA seeks comment on how to address a circumstance in which EPA has a statutory requirement to make a determination for which scientific information publicly available in a manner sufficient for independent validation does not exist. EPA also seeks comment on any additional implementation challenges not discussed in this notice that commenters may be aware of as well as suggestions for addressing them.
        The proposed rule includes a provision allowing the Administrator to exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB's Information Quality Bulletin for Peer Review provides for an exemption (Section IX). The agency requests comment on whether these exemptions are appropriate, and on whether there are other situations in which specific significant regulatory actions, or specific categories of significant regulatory actions should be exempted.
        EPA also requests comment on whether the disclosure requirements applicable to dose response data and models in the proposed rule should be expanded to cover other types of data and information, such as for example economic and environmental impact data and models that are designed to predict the costs, benefits, market impacts and/or environmental effects of specific regulatory interventions on complex economic or environmental systems.
        IV. Statutory and Executive Orders Reviews
        A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
        This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.
        EPA believes the benefits of this proposed rule justify the costs. The benefits of EPA ensuring that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation are that it will improve the data and scientific quality of the Agency's actions and facilitate expanded data sharing and exploration of key data sets; this is consistent with the conclusions of the National Academies 23
           This action should be implemented in a cost-effective way and is consistent with recent activities of the scientific community and other federal agencies, which will help to lower costs of implementation. The proposed rule directs EPA to make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making dose response models and data underlying pivotal regulatory science used in significant regulatory decisions available to the public in a manner sufficient for independent validation, consistent with law and protection of privacy, confidentiality, and national and homeland security. However, it does not compel the Agency to make that information available where it concludes after all such reasonable efforts that doing so in way that complies with the law and appropriate protections is not possible.

            23 https://www.nap.edu/catalog/11434/expanding-access-to-research-data-reconciling-risks-and-opportunities.

        By limiting the proposed rule to pivotal regulatory science for final significant regulatory actions pursuant to E.O. 12866, the proposed rule ensures that this standard for transparency affects a smaller subset of regulations which are economically significant, create inconsistency for other federal agencies, alter budgetary impacts, or raise novel legal or policy issues. One recent analysis found that: “Improvements in reproducibility can be thought of as increasing the net benefits of regulation because they would avoid situations in which costs or benefits are wrongly estimated to occur or in which regulatory costs are imposed without corresponding benefits. . . .” They concluded that “an increase in existing net benefits from greater reproducibility, which, if it occurred, would cover the costs of obtaining the data and making the data available.” 24

            24 https://www.mercatus.org/system/files/Mercatus-Lutter-Public-Access-Data-v3.pdf.

        B. Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs
        This action is not expected to be an Executive Order 13771 regulatory action because it relates to “agency organization, management or personnel.”
        C. Paperwork Reduction Act (PRA)
        This action does not contain any information collection activities and therefore does not impose an information collection burden under the PRA.
        D. Regulatory Flexibility Act (RFA)
        I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities.
        E. Unfunded Mandates Reform Act (UMRA)
        This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
        F. Executive Order 13132: Federalism

        This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
        G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
        This action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
        H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
        The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
        I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
        This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.
        J. National Technology Transfer and Advancement Act (NTTAA)
        This rulemaking does not involve technical standards.
        K. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
        The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard.

          List of Subjects in 40 CFR Part 30
          Environmental protection, Administrative practice and procedure, Reporting and recordkeeping requirements.

          Dated: April 24, 2018.
          E. Scott Pruitt,
          Administrator.

        For the reasons set forth in the preamble, EPA proposes to add 40 CFR part 30 as follows:

          PART 30—TRANSPARENCY IN REGULATORY DECISIONMAKING

        1. Add part 30 to read as follows:

          PART 30—TRANSPARENCY IN REGULATORY DECISIONMAKING

            Sec.
            30.1
            What is the purpose of this subpart?
            30.2
            What definitions apply to this subpart?
            30.3
            How do the provisions of this subpart apply?
            30.4
            What requirements apply to EPA's use of studies in taking final action?
            30.5
            What requirements apply to EPA's use of dose response data and models underlying pivotal regulatory science?
            30.6
            What additional requirements pertain to the use of dose response data and models underlying pivotal regulatory science?
            30.7
            What role does independent peer review play in this section?
            30.8
            How is EPA to account for cost under this subpart?
            30.9
            May the EPA Administrator grant exemptions to this subpart?
            30.10
            What other requirements apply under this subpart?

            Authority:
             Clean Air Act sections 103, 301(a), 42 U.S.C. 7403, 7601(a); Clean Water Act sections 104, 501, 33 U.S.C. 1254, 1361; Safe Drinking Water Act sections 1442, 1450(a)(1), 42 U.S.C. 300j-1, 300j-9(a)(1); Resource Conservation and Recovery Act sections 2002(a)(1), 7009, 42 U.S.C. 6912(a)(1), 6979; Comprehensive Environmental Response, Compensation, and Liability Act (as delegated to the Administrator via Executive Order 12580) sections 115, 311, 42 U.S.C. 9616, 9660; Emergency Planning and Community Right-To-Know Act section 328, 42 U.S.C. 11048; Federal Insecticide, Fungicide, and Rodenticide Act sections 25(a)(1), 136r(a), 7 U.S.C. 136r(a), 136w; and Toxic Substances Control Act, as amended, section 10, 15 U.S.C. 2609.

            § 30.1
            What is the purpose of this subpart?
            This subpart directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation.

            § 30.2
            What definitions apply to this subpart?
            As used in this subpart, all terms not defined herein shall have the meaning given them in the Act or in subpart A; and the following terms shall have the specific meanings given them.

              Dose response data and models means the data and models used to characterize the quantitative relationship between the amount of dose or exposure to a pollutant, contaminant, or substance and the magnitude of a predicted health or environmental impact. Such functions typically underlie pivotal regulatory science that drives the size of benefit-cost calculations, the level of a standard, and/or the points of departure from which reference values (reference doses or reference concentrations) are calculated.

              Pivotal regulatory science means the specific scientific studies or analyses that drive the requirements and/or quantitative analysis of EPA final significant regulatory decisions.

              Regulatory decisions mean final regulations determined to be “significant regulatory actions” by the Office of Management and Budget pursuant to Executive Order 12866.

              Regulatory science means scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final significant regulatory decisions.

              Research data means “research data” as that term is defined in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

            § 30.3
            How do the provisions of this subpart apply?
            The provisions of this subpart apply to dose response data and models underlying pivotal regulatory science that are used to justify significant regulatory decisions regardless of the source of funding or identity of the party conducting the regulatory science. The provisions of this section do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses. Except where explicitly stated otherwise, the provisions of this subpart do not apply to any other type of agency action, including individual party adjudications, enforcement activities, or permit proceedings.

            § 30.4
            What requirements apply to EPA's use of studies in taking final action?
            EPA shall clearly identify all studies (or other regulatory science) relied upon when it takes any final agency action. EPA should make all such studies available to the public to the extent practicable.

            § 30.5
            What requirements apply to EPA's use of dose response data and models underlying pivotal regulatory science?

            When promulgating significant regulatory actions, the Agency shall ensure that dose response data and models underlying pivotal regulatory science are publicly available in a manner sufficient for independent validation. Where the Agency is making data or models publicly available, it shall do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security. Information is considered “publicly available in a manner sufficient for independent validation” when it includes the information necessary for the public to understand, assess, and replicate findings. This may include, for example:
            (a) Data (where necessary, data would be made available subject to access and use restrictions).
            (b) Associated protocols necessary to understand, assess, and extend conclusions;
            (c) Computer codes and models involved in the creation and analysis of such information;
            (d) Recorded factual materials; and
            (e) Detailed descriptions of how to access and use such information.
            The provisions of this section apply to dose response data and models underlying pivotal regulatory science regardless of who funded or conducted the underlying data, models, or other regulatory science. The agency shall make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making such data available before it concludes that doing so in a manner consistent with law and protection of privacy, confidentiality, national and homeland security is not possible. Where data is controlled by third parties, EPA shall work with those parties to endeavor to make the data available in a manner that complies with this section.

            § 30.6
            What additional requirements pertain to the use of dose response data and models underlying pivotal regulatory science?
            EPA shall describe and document any assumptions and methods used, and should describe variability and uncertainty. EPA shall evaluate the appropriateness of using default assumptions, including assumptions of a linear, no-threshold dose response, on a case-by-case basis. EPA shall clearly explain the scientific basis for each model assumption used and present analyses showing the sensitivity of the modeled results to alternative assumptions. When available, EPA shall give explicit consideration to high quality studies that explore: A broad class of parametric dose-response or concentration-response models; a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the dose or exposure range; and models that investigate factors that might account for spatial heterogeneity.

            § 30.7
            What role does independent peer review in this section?
            EPA shall conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions, consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664) and the exemptions described therein.
            Because transparency in regulatory science includes addressing issues associated with assumptions used in models, EPA shall ask peer reviewers to articulate the strengths and weaknesses of EPA's justification for the assumptions applied and the implications of those assumptions for the results.

            § 30.8
            How is EPA to account for cost under this subpart?
            EPA shall implement the provisions of this subpart in a manner that minimizes costs.

            § 30.9
            May the EPA Administrator grant exemptions to this subpart?
            Yes. The Administrator may grant an exemption to this subpart on a case-by-case basis if he or she determines that compliance is impracticable because:
            (a) It is not feasible to ensure that all dose response data and models underlying pivotal regulatory science is publicly available in a manner sufficient for independent validation, in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national and homeland security; or
            (b) It is not feasible to conduct independent peer review on all pivotal regulatory science used to justify regulatory decisions for reasons outlined in OMB Final Information Quality Bulletin for Peer Review (70 FR 2664), Section IX.

            § 30.10
            What other requirements apply under this subpart?
            EPA shall implement the provisions of this section consistent with the definition of “research data” in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in Public Law 89-487, and other applicable federal laws. Where appropriate, data sharing agreements and state-of-the-art data-masking techniques may be employed to facilitate access to information.

      [FR Doc. 2018-09078 Filed 4-27-18; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF THE INTERIOR
        Fish and Wildlife Service
        50 CFR Part 17
        [Docket No. FWS-R2-ES-2012-0071; 4500030113]
        RIN 1018-AY21
        Endangered and Threatened Wildlife and Plants; 6-Month Extension of Final Determination for the Proposed Listing of the Lesser Prairie-Chicken as a Threatened Species

          AGENCY:
          Fish and Wildlife Service, Interior.

          ACTION:
          Proposed rule; reopening of comment period.

          SUMMARY:

          We, the U.S. Fish and Wildlife Service (Service), announce a 6-month extension of the final determination of whether to list the lesser prairie-chicken (Tympanuchus pallidicinctus) as a threatened species and reopen the comment period on the proposed rule to list the species. We are taking this action based on our finding that there is substantial disagreement regarding the sufficiency or accuracy of the available data relevant to our determination regarding the proposed listing rule, making it necessary to solicit additional information by reopening the comment period for 30 days.

          DATES:

          The comment period end date is August 8, 2013. If you comment using the Federal eRulemaking Portal (see ADDRESSES), you must submit your comment by 11:59 p.m. Eastern Time on the closing date.

          ADDRESSES:
          You may submit written comments by one of the following methods:
          (1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-R2-ES-2012-0071, which is the docket number for the proposed rule to list the lesser prairie-chicken as threatened. Then, in the Search panel on the left side of the screen, under the Document Type heading, check on the Proposed Rules link to located the proposed rule. You may submit a comment by clicking on “Comment Now!”
          (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-R2-ES-2012-0071; Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, MS 2042-PDM; Arlington, VA 22203.

          We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Public Comments section below for more information).

          FOR FURTHER INFORMATION CONTACT:
          Jontie Aldrich, Acting Field Supervisor, Oklahoma Ecological Services Field Office, 9014 East 21st Street, Tulsa, OK 74129; by telephone 918-581-7458; or by facsimile 918-581-7467. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.

        SUPPLEMENTARY INFORMATION:
        Background
        On December 11, 2012, we published in the Federal Register a proposed rule (77 FR 73828) to list the lesser prairie-chicken (Tympanuchus pallidicinctus), a grassland bird known from southeastern Colorado, western Kansas, eastern New Mexico, western Oklahoma, and the Texas Panhandle, as a threatened species under the Endangered Species Act of 1973, as amended (Act) (16 U.S.C. 1531 et seq.). For a description of previous Federal actions concerning the lesser prairie-chicken, please refer to the proposed rule. The proposed listing rule had a 90-day comment period, ending March 11, 2013. We held a public meeting and hearing in Woodward, Oklahoma, on February 5, 2013; in Garden City, Kansas, on February 7, 2013; in Lubbock, Texas, on February 11, 2013; and in Roswell, New Mexico, on February 12, 2013. On May 6, 2013, we reopened the comment period on the proposed listing rule and proposed a special rule under the authority of section 4(d) of the Act that provides measures that are necessary and advisable to provide for the conservation of the lesser prairie-chicken (78 FR 26302). The reopening of the comment period closed June 20, 2013.
        Section 4(b)(6) of the Act and its implementing regulation, 50 C.F.R. 424.17(a), requires that we take one of three actions within 1 year of a proposed listing: (1) Finalize the proposed listing; (2) withdraw the proposed listing; or (3) extend the final determination by not more than 6 months, if there is substantial disagreement among scientists knowledgeable about the species regarding the sufficiency or accuracy of the available data relevant to the determination, for the purposes of soliciting additional data.
        During the public comment periods, we received multiple comments on the proposed listing and the sufficiency or accuracy of the available data used to support the proposed listing. In particular, commenters raised questions regarding:
        (1) The interpretation of scientific literature in the proposed rulemaking and scientific literature that we may have overlooked in our analysis. Specifically, commenters were concerned with the appropriateness of our interpretation of habitat fragmentation, grassland conversion, and collision mortality.
        (2) Whether the Service considered the effectiveness of conservation practices of the oil and gas industry, and of agricultural practices, including grazing management, brush management, and water development, in relation to reducing threats. In particular, the U.S. Department of Agriculture provided a letter that questioned the adequacy of our evaluation of conservation measures associated with agricultural practices.
        (3) The accuracy of short-term and long-term population trends of the lesser prairie-chicken, particularly as it relates to climate change. Specifically, commenters recommended a more thorough analysis of the U.S. Geological Survey's Great Plains modeling effort.
        As a result of the public comments we have received, we find that there is substantial disagreement regarding the sufficiency or accuracy of the available data that is relevant to our determination of the proposed listing. Therefore, in consideration of these disagreements, we have determined that a 6-month extension of final determination of this rulemaking is warranted, and we are hereby extending the final determination for up to 6 months in order to solicit information that will help to clarify these issues and to fully analyze this information.
        As noted in the proposed listing rule (77 FR 73828), we were previously required by the terms of judicially approved settlement agreement to make a final determination on the lesser prairie-chicken proposed listing rule no later than September 30, 2013. Therefore, with this 6-month extension, we will make a final determination on the proposed rule no later than March 30, 2014.
        Public Comments

        We will accept written comments and information during this reopened comment period on our proposed listing for the lesser prairie-chicken that was published in the Federal Register on December 11, 2012 (77 FR 73828), and on our proposed 4(d) special rule for the species that was published in the Federal Register on May 6, 2013 (78 FR 26302). We will consider information and recommendations from all interested parties. We intend that any final action resulting from the proposals be as accurate as possible and based on the best available scientific and commercial data.
        In consideration of the disagreements surrounding the data used to support the proposed rulemaking, we are extending the final determination for 6 months in order to solicit information that will help to clarify these issues. We are particularly interested in new information and comments regarding:
        (1) The historical and current status and distribution of the lesser prairie-chicken, its biology and ecology, specific threats (or lack thereof) and regulations that may be addressing those threats, and ongoing conservation measures for the species and its habitat.
        (2) Information relevant to the factors that are the basis for making a listing determination for a species under section 4(a) of the Act, which are:
        (a) The present or threatened destruction, modification, or curtailment of the species' habitat or range;
        (b) Overutilization for commercial, recreational, scientific, or educational purposes;
        (c) Disease or predation;
        (d) The inadequacy of existing regulatory mechanisms; or
        (e) Other natural or manmade factors affecting its continued existence.
        (3) Application of the Lesser Prairie-Chicken Interstate Working Group's draft rangewide conservation plan to our determination of status under section 4(a)(1) of the Act; we particularly request comments or information to help us assess the certainty that the rangewide conservation plan will be effective in conserving the lesser prairie-chicken and will be implemented.
        (4) Which areas would be appropriate as critical habitat for the species and why areas should or should not be proposed for designation as critical habitat, including whether any threats to the species from human activity would be expected to increase due to the designation and whether that increase in threat would outweigh the benefit of designation such that the designation of critical habitat may not be prudent.
        (5) Specific information on:
        (a) The amount and distribution of habitat for the lesser prairie-chicken;
        (b) What may constitute “physical or biological features essential to the conservation of the species,” within the geographical range currently occupied by the species;
        (c) Where these features are currently found;
        (d) Whether any of these features may require special management considerations or protection;
        (e) What areas, that were occupied at the time of listing (or are currently occupied) and that contain features essential to the conservation of the species, should be included in the designation and why; and
        (f) What areas not occupied at the time of listing are essential for the conservation of the species and why.
        (6) Information on the projected and reasonably likely impacts of climate change on the lesser prairie-chicken and its habitat.
        (7) Whether measures outlined in the proposed 4(d) special rule are necessary and advisable for the conservation and management of the lesser prairie-chicken.

        (8) Additional provisions the Service may wish to consider for the proposed 4(d) special rule in order to conserve, recover, and manage the lesser prairie-chicken.

        If you previously submitted comments or information on the proposed listing rule or proposed special 4(d) rule, please do not resubmit them. We have incorporated them into the public record, and we will fully consider them in the preparation of our final determination. Our final determination concerning this proposed listing will take into consideration all written comments and any additional information we receive.

        You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.
        If you submit a comment via http://www.regulations.gov, your entire comment—including any personal identifying information—will be posted on the Web site. We will post all hardcopy comments on http://www.regulations.gov as well. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

        Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on http://www.regulations.gov at Docket No. FWS-R2-ES-2012-0071, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Oklahoma Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT). You may obtain copies of the proposed rule on the Internet at http://www.regulations.gov at Docket No. FWS-R2-ES-2012-0071, or by mail from the Oklahoma Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).
        Authority

        The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

          Dated: June 26, 2013.
          Stephen Guertin,
          Acting Director, Fish and Wildlife Service.

      [FR Doc. 2013-16111 Filed 7-8-13; 8:45 am]
      BILLING CODE 4310-55-P