Vol. 79 Thursday, No. 233 December 4, 2014
Pages 71955–72106
OFFICE OF THE FEDERAL REGISTER
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Contents Federal Register Vol. 79, No. 233
Thursday, December 4, 2014
Agriculture Department Charter Renewals: See Animal and Plant Health Inspection Service Commercial Space Transportation Advisory Committee, 72057 Animal and Plant Health Inspection Service Passenger Facility Charge Approvals and Disapprovals, PROPOSED RULES 72057–72060 Establishing a Performance Standard for Authorizing the User Fees: Importation and Interstate Movement of Fruits and Passenger Facility Charges, 72060–72061 Vegetables, 71973 Federal Communications Commission Bonneville Power Administration NOTICES NOTICES Agency Information Collection Activities; Proposals, Meetings: Submissions, and Approvals, 71999–72001 Power and Transmission Rate Adjustments, Fiscal Year 2016–2017; Public Hearing, 71984–71990 Federal Election Commission Bureau of Consumer Financial Protection NOTICES NOTICES Meetings; Sunshine Act, 72001 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 71984 Federal Energy Regulatory Commission NOTICES Children and Families Administration Applications: NOTICES Yuba County Water Agency, Yuba River Project, 71990– Delegations of Authority: 71991 Statement of Organization, Functions, and Delegations of Combined Filings, 71991–71993 Authority, 72002–72003 Combined Filings: AltaGas Power Holdings (U.S.) Inc., Veresen U.S. Power Commerce Department Inc., et al., 71993 See International Trade Administration Catalina Solar 2, LLC, et al., 71994–71995 See National Oceanic and Atmospheric Administration Southwest Power Pool, Inc., et al., 71993–71994 Environmental Impact Statements; Availability, etc.: Commodity Futures Trading Commission Dominion Transmission, Inc., Lebanon West II Project, PROPOSED RULES 71995–71998 Position Limits for Derivatives and Aggregation of Meetings: Positions, 71973–71975 Entergy Regional State Committee; Staff Attendances, 71998–71999 Defense Department PROPOSED RULES Federal Reserve System Federal Acquisition Regulations: NOTICES Information on Corporate Contractor Performance and Meetings; Sunshine Act, 72001–72002 Integrity, 71975–71979 Education Department Fish and Wildlife Service RULES NOTICES Program Integrity: Permit Applications: Gainful Employment; Correction, 71957–71959 Endangered Species; Marine Mammals, 72007–72009 Energy Department Food and Drug Administration See Bonneville Power Administration RULES See Federal Energy Regulatory Commission Content and Format of Labeling for Human Prescription Drug and Biological Products: Federal Aviation Administration Pregnancy and Lactation Labeling Requirements, 72064– NOTICES 72103 Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals: Guidance for Industry and Staff: Airport Noise Compatibility Planning, 72055–72056 Pregnancy, Lactation, and Reproductive Potential–– Aviation Insurance, 72055 Labeling for Human Prescription Drug and Biological Certification Procedures for Products and Parts, 72055 Products––Content and Format, 72104–72105 Criteria for Internet Communications of Aviation Weather, Notices to Airmen, and Aeronautical Data, General Services Administration 72056–72057 PROPOSED RULES Fractional Aircraft Ownership Programs, 72056 Federal Acquisition Regulations: Report of Inspections Required by Airworthiness Information on Corporate Contractor Performance and Directives, 72054 Integrity, 71975–71979
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Government Ethics Office NOTICES RULES Agency Information Collection Activities; Proposals, Revision of Departmental Component Designations: Submissions, and Approvals: Post-Employment Conflict of Interest Restrictions, 71955– Economic Value of Puerto Rico’s Coral Reef Ecosystems 71957 for Recreation/Tourism Uses, 71982 Meetings: Health and Human Services Department Atlantic Shark and Protected Species Safe Handling, See Children and Families Administration Release, and Identification Workshops, 71982–71984 See Food and Drug Administration See National Institutes of Health Occupational Safety and Health Administration See Substance Abuse and Mental Health Services NOTICES Administration Agency Information Collection Activities; Proposals, Submissions, and Approvals: Indian Affairs Bureau Methylene Chloride Standard, 72030–72031 NOTICES Vinyl Chloride Standard, 72031–72033 Designated Tribal Agents for Service of Notice under the Indian Child Welfare Act, 72009–72030 Overseas Private Investment Corporation NOTICES Interior Department Meetings; Sunshine Act, 72034 See Fish and Wildlife Service See Indian Affairs Bureau Railroad Retirement Board NOTICES NOTICES Permits: Agency Information Collection Activities; Proposals, Endangered Species; Marine Mammals, 72006–72007 Submissions, and Approvals, 72034–72035
International Trade Administration Securities and Exchange Commission NOTICES NOTICES Antidumping or Countervailing Duty Investigations, Orders, Self-Regulatory Organizations; Proposed Rule Changes: or Reviews: Chicago Board Options Exchange, Inc., 72044–72049 Diamond Sawblades and Parts Thereof from the People’s NASDAQ OMX BX, Inc., 72049–72054 Republic of China: Preliminary Results of New York Stock Exchange LLC, 72039–72043 Antidumping Duty Administrative Review; 2012– NYSE Arca, Inc., 72036–72039 2013, 71980–71982 State Department Labor Department NOTICES See Occupational Safety and Health Administration Determinations by the Secretary of State Relating to Iran Sanctions, 72054 National Aeronautics and Space Administration Substance Abuse and Mental Health Services PROPOSED RULES Administration Federal Acquisition Regulations: Information on Corporate Contractor Performance and NOTICES Integrity, 71975–71979 Certified Laboratories and Instrumented Initial Testing Facilities: National Archives and Records Administration Urine Drug Testing for Federal Agencies, 72005–72006 NOTICES Agency Information Collection Activities; Proposals, Surface Transportation Board Submissions, and Approvals, 72033–72034 NOTICES Release of Waybill Data, 72061 National Institutes of Health NOTICES Transportation Department Agency Information Collection Activities; Proposals, See Federal Aviation Administration Submissions, and Approvals: See Surface Transportation Board Health Information National Trends Survey, 72003–72004 Surveys and Interviews to Support an Evaluation of the Innovative Molecular Analysis Technologies Program, 72004–72005 Separate Parts In This Issue
National Oceanic and Atmospheric Administration Part II RULES Health and Human Services Department, Food and Drug Fisheries of the Caribbean, Gulf of Mexico, and South Administration, 72064–72105 Atlantic: Atlantic Migratory Group Cobia; 2014 Commercial Accountability Measure and Closure, 71959–71960 Reader Aids Fisheries of the Northeastern United States: Consult the Reader Aids section at the end of this page for Atlantic Herring Fishery; Framework Adjustment 3, phone numbers, online resources, finding aids, reminders, 71960–71972 and notice of recently enacted public laws.
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CFR PARTS AFFECTED IN THIS ISSUE
A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.
5 CFR 2641...... 71955 7 CFR Proposed Rules: 318...... 71973 319...... 71973 17 CFR Proposed Rules: 1...... 71973 15...... 71973 17...... 71973 19...... 71973 32...... 71973 37...... 71973 38...... 71973 140...... 71973 150...... 71973 21 CFR 201...... 72064 34 CFR 600...... 71957 668...... 71957 48 CFR Proposed Rules: 1...... 71975 4...... 71975 9...... 71975 22...... 71975 52...... 71975 50 CFR 622...... 71959 648...... 71960
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Rules and Regulations Federal Register Vol. 79, No. 233
Thursday, December 4, 2014
This section of the FEDERAL REGISTER U.S.C. 207(c). The representational bar component is an agency or bureau, contains regulatory documents having general of 18 U.S.C. 207(c) usually extends to within a parent agency, that exercises applicability and legal effect, most of which the whole of any department or agency functions which are distinct and are keyed to and codified in the Code of in which a former senior employee separate from the functions of the parent Federal Regulations, which is published under served in any capacity during the year agency and from the functions of other 50 titles pursuant to 44 U.S.C. 1510. prior to termination from a senior components of that parent. 5 CFR The Code of Federal Regulations is sold by employee position. However, 18 U.S.C. 2641.302(c)(1). the Superintendent of Documents. Prices of 207(h) provides that whenever the Pursuant to the procedures prescribed new books are listed in the first FEDERAL Director of OGE determines that an in 5 CFR 2641.302(e), two departments REGISTER issue of each week. agency or bureau within a department forwarded written requests to OGE to or agency in the executive branch amend their listings in appendix B. On exercises functions which are distinct June 10, 2014, OGE published for OFFICE OF GOVERNMENT ETHICS and separate from the remaining comment a proposed rule that modified functions of the department or agency the component designations for the two 5 CFR Part 2641 and there exists no potential for use of departments. See 79 FR 33138–33140 RIN 3209–AA14 undue influence or unfair advantage (June 10, 2014). OGE did not receive any based on past Government service, the responses to the proposed rule. After Post-Employment Conflict of Interest Director shall by rule designate such carefully reviewing the requested Restrictions; Revision of Departmental agency or bureau as a separate changes in light of the criteria in 18 Component Designations component of that department or U.S.C. 207(h) as implemented in 5 CFR agency. As a result, a former senior 2641.302(c), the Director of OGE has AGENCY: Office of Government Ethics. employee who served in a ‘‘parent’’ determined to grant these requests and ACTION: Final rule. department or agency is not barred by amend appendix B to 5 CFR part 2641 18 U.S.C. 207(c) from making as explained below. SUMMARY: The Office of Government communications to or appearances The Department of Health and Human Ethics (OGE) is issuing this final rule to before any employees of any designated Services has requested that OGE remove revoke the designation of one component of that parent, but is barred the Administration on Aging (AoA) departmental component of one agency as to employees of that parent or of from its list of component designations and designate a new bureau as a other components that have not been and designate in its place the departmental component for purposes separately designated. Moreover, a Administration for Community Living of the one-year post-employment former senior employee who served in as a distinct and separate component of conflict of interest restriction in the a designated component of a parent the Department of Health and Human United States Code; to revoke the department or agency is barred from Services for purposes of 18 U.S.C. designation of two departmental communicating to or making an 207(c). On April 18, 2012, the AoA components of another agency and appearance before any employee of that ceased to be an operating division designate their successor bureau as a component, but is not barred as to any within the Department of Health and departmental component; to change the employee of the parent or of any other Human Services and became a name of an existing departmental component. subcomponent of a new operating component; and to revoke the Under 18 U.S.C. 207(h)(2), component division within the Department, the designation of a departmental designations do not apply to persons Administration for Community Living. component that was abolished. employed at a rate of pay specified in The mission of the Administration for DATES: This rule is effective December 4, or fixed according to subchapter II of 5 Community Living is to maximize the 2014, except for the amendments to U.S.C. chapter 53 (the Executive self-determination, well-being, and Appendix B to part 2641 set forth in Schedule). Component designations are health of older adults, people with amendatory instruction 3, which are listed in appendix B to 5 CFR part 2641. disabilities, and their families and effective March 4, 2015. The Director of OGE regularly reviews caregivers. The Administration for FOR FURTHER INFORMATION CONTACT: the component designations and Community Living is the primary entity Amy E. Braud, Associate Counsel, determinations and, in consultation within the Department to direct General Counsel and Legal Policy with the department or agency development, administration, and Division, Office of Government Ethics, concerned, makes such additions and advancement of aging and disability Telephone: 202–482–9300; TTY: 800– deletions as are necessary. Specifically, programs. 877–8339; FAX: 202–482–9237. the Director ‘‘shall, by rule, make or In addition to the AoA, the SUPPLEMENTARY INFORMATION: revoke a component designation after Administration for Community Living is considering the recommendation of the composed of the Administration on A. Substantive Discussion: Revocation designated agency ethics official.’’ 5 Intellectual and Developmental and Addition of Departmental CFR 2641.302(e)(3). Before designating Disabilities and the Center for Disability Components an agency component as distinct and and Aging Policy. The Administration The Director of OGE (Director) is separate for purposes of 18 U.S.C. on Intellectual and Developmental authorized by 18 U.S.C. 207(h) to 207(c), the Director must find that there Disabilities advises the Secretary of the designate distinct and separate exists no potential for use of undue Department of Health and Human departmental or agency components in influence or unfair advantage based on Services on issues that relate to the executive branch for purposes of 18 past Government service, and that the individuals who have intellectual and
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developmental disabilities. It provides The Department of the Treasury has underlying component designation support to the States and to local also requested that OGE revise the name date), is effective December 4, 2014. communities for programs that increase of one component currently listed in As also indicated in 5 CFR the independence and productivity of appendix B to part 2641, the Bureau of 2641.302(f), revocation is effective 90 these individuals. The Center for the Mint. According to the Department, days after the effective date of the rule Disability and Aging Policy plans and since the 1992 amendments to 31 U.S.C. that revokes the designation. oversees the implementation of policies, 304, the statutory name, and the name Accordingly, the component programs, and special initiatives that used in all official publications, of this designation revocations made in this address the needs of older Americans bureau is the ‘‘United States Mint.’’ The rulemaking will take effect March 4, and persons with disabilities. Director is therefore amending the 2015. Revocations are not effective as to According to the Department of Department of the Treasury listing in any individual terminating senior Health and Human Services, the appendix B to reflect the current name service prior to the expiration of the 90- Administration for Community Living of this component. day period. exercises functions that are distinct and Additionally, the Department of the B. Matters of Regulatory Procedure separate from the functions of the parent Treasury has requested that OGE Department and from every other remove the Office of Thrift Supervision Regulatory Flexibility Act agency within the Department. (OTS) from its list of component As Director of OGE, I certify under the Accordingly, the Director is granting designations. Under the Dodd-Frank Regulatory Flexibility Act (5 U.S.C. the request of the Department of Health Wall Street Reform and Consumer chapter 6) that this final rule will not and Human Services and is amending Protection Act (Dodd-Frank Act), Pub. have a significant economic impact on the Department of Health and Human L. 111–203, 124 Stat. 1376, all OTS a substantial number of small entities Services listing in appendix B to part functions were distributed to the Office because it affects only Federal 2641 to remove the AoA from the of the Comptroller of the Currency, the departments and agencies and current component designation list and to Federal Deposit Insurance Corporation, and former Federal employees. designate the Administration for the Federal Reserve Board, and the Community Living as a new component Bureau of Consumer Financial Paperwork Reduction Act as discussed. Protection. Under Title III of the Dodd- The Paperwork Reduction Act (44 The Department of the Treasury has Frank Act, all OTS functions relating to U.S.C. chapter 35) does not apply to this requested that OGE remove the Federal savings and loan associations final rule because it does not contain Financial Management Service (FMS) and the rulemaking authority of OTS information collection requirements that and the Bureau of Public Debt (BPD) relating to all savings associations, both require the approval of the Office of from its list of component designations Federal and State, were transferred to Management and Budget. and in their place designate the Bureau the Office of the Comptroller of the of the Fiscal Service as a distinct and Currency as of July 21, 2011. Also as of Unfunded Mandates Reform Act separate component of the Department July 21, 2011, the other functions of For purposes of the Unfunded of the Treasury for purposes of 18 U.S.C. OTS were transferred to the Federal Mandates Reform Act of 1995 (2 U.S.C. 207(c). The Department of the Treasury Deposit Insurance Corporation, the chapter 25, subchapter II), this final rule consolidated FMS and BPD into a new Federal Reserve Board, and the Bureau will not significantly or uniquely affect entity, the Bureau of the Fiscal Service. of Consumer Financial Protection. small governments and will not result in This consolidation was effective on Pursuant to Section 313 of the Dodd- increased expenditures by State, local October 7, 2012. See Treas. Order 136– Frank Act, OTS was abolished 90 days and tribal governments, in the aggregate, 01 (October 7, 2012). The new bureau after the date of the transfer of its or by the private sector, of $100 million will carry out the functions of the FMS functions to other agencies. or more (as adjusted for inflation) in any and the BPD, which include borrowing Because OTS has been abolished, the one year. the money needed to operate the Director is granting the request of the Federal Government, administering the Department of the Treasury and is Congressional Review Act public debt, receiving and disbursing amending the Department of the OGE has determined that this public monies, and maintaining Treasury listing in appendix B to part rulemaking involves a non-major rule Government accounts. 2641 to remove OTS from the under the Congressional Review Act (5 According to the Department of the component designation list. The Office U.S.C. chapter 8) and will submit a Treasury, the functions of the Bureau of of the Comptroller of the Currency has report thereon to the U.S. Senate, House the Fiscal Service are distinct and been designated as a component since of Representatives and Government separate from the functions of the parent January 1, 1991 and remains designated Accountability Office in accordance Department and from every other as a component. with that law at the same time this agency within the Department. This As indicated in 5 CFR 2641.302(f), a rulemaking document is sent to the distinction was previously recognized designation ‘‘shall be effective on the Office of the Federal Register for when OGE designated its predecessor date the rule creating the designation is publication in the Federal Register. bureaus, the FMS and the BPD, as published in the Federal Register and components for purposes of 18 U.S.C. shall be effective as to individuals who Executive Order 12866 207(c). terminated senior service either before, In promulgating this final rule, OGE Accordingly, the Director is granting on or after that date.’’ Initial has adhered to the regulatory the request of the Department of the designations were effective as of January philosophy and the applicable Treasury and is amending the 1, 1991. The effective date of subsequent principles of regulation set forth in Department of the Treasury listing in designations is indicated by means of section 1 of Executive Order 12866, appendix B to part 2641 to remove the parenthetical entries in appendix B. The Regulatory Planning and Review. This FMS and the BPD from the component new component designations made by rule has not been reviewed by the Office designation list and to designate the this rulemaking document, as well as of Management and Budget under Bureau of the Fiscal Service as a new the name corrections being reflected Executive Order 12866 because it deals component as discussed. herein (which do not affect the with agency organization, management,
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and personnel matters and is not Substance Abuse and Mental Health can view this document, as well as all ‘‘significant’’ under the order. Services Administration (effective May 16, other documents of this Department 1997). published in the Federal Register, in Executive Order 12988 * * * * * text or Adobe Portable Document As Director of OGE, I have reviewed Parent: Department of the Treasury Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is this final rule in light of section 3 of Components: Executive Order 12988, Civil Justice available free at the site. Alcohol and Tobacco Tax and Trade You may also access documents of the Reform, and certify that it meets the Bureau (effective November 23, 2004). applicable standards provided therein. Bureau of Engraving and Printing. Department published in the Federal Bureau of the Public Debt. Register by using the article search List of Subjects in 5 CFR Part 2641 Bureau of the Fiscal Service (effective feature at: www.federalregister.gov. December 4, 2014). Specifically, through the advanced Conflict of interests, Government Comptroller of the Currency. search feature at this site, you can limit employees. Financial Crimes Enforcement Center your search to documents published by Approved: November 4, 2014. (FinCEN) (effective January 30, 2003). the Department. Financial Management Service. Walter M. Shaub, Jr. FOR FURTHER INFORMATION CONTACT: John Internal Revenue Service. Director, Office of Government Ethics. Office of Thrift Supervision. Kolotos, U.S. Department of Education, United States Mint (formerly listed as 1990 K Street NW., Room 8018, Accordingly, for the reasons set forth Bureau of the Mint). Washington, DC 20006–8502. in the preamble, OGE is amending 5 ■ Telephone: (202) 502–7762 or by email CFR part 2641 as follows: 3. Appendix B to part 2641 is further amended by removing the at: gainfulemploymentregulations@ Administration on Aging from the ed.gov. PART 2641—POST-EMPLOYMENT If you use a telecommunications listing for the Department of Health and CONFLICT OF INTEREST device for the deaf (TDD) or a text Human Services and by removing the RESTRICTIONS telephone (TTY), call the Federal Relay Bureau of the Public Debt, the Financial Service, toll free, at 1–800–877–8339. ■ Management Service, and the Office of 1. The authority citation for part 2641 SUPPLEMENTARY INFORMATION: This continues to read as follows: Thrift Supervision from the listing for the Department of the Treasury. document corrects: (1) Footnote text that Authority: 5 U.S.C. app. (Ethics in was omitted from the Gainful Government Act of 1978); 18 U.S.C. 207; E.O. [FR Doc. 2014–27284 Filed 12–3–14; 8:45 am] Employment rule; (2) § 668.412 of the 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. BILLING CODE 6345–03–P regulations to include the 215, as modified by E.O. 12731, 55 FR 42547, implementation date for the disclosure 3 CFR, 1990 Comp., p. 306. requirements; (3) the equations for DEPARTMENT OF EDUCATION ■ 2. Appendix B to part 2641 is calculating completion rates for full- time students in § 668.413(b)(1)(i) of the amended by revising the listings for the 34 CFR Parts 600 and 668 Department of Health and Human regulations; (4) § 668.413 to add mean Services and the Department of the RIN 1840–AD15 earnings in addition to median earnings; Treasury to read as follows: and (5) the notification provisions in [Docket ID ED–2014–OPE–0039] § 668.413(c)(2) of the regulations. Appendix B to Part 2641—Agency Program Integrity: Gainful In the Gainful Employment rule: Components for Purposes of 18 U.S.C. • The text of certain footnotes was Employment; Correction 207(c) omitted; • We discussed that institutions must * * * * * AGENCY: Department of Education. begin complying with the requirements ACTION: Final regulations; correction. Parent: Department of Health and Human in § 668.412 of the regulations beginning Services SUMMARY: On October 31, 2014, we January 1, 2017. However, that language Components: published in the Federal Register final was inadvertently omitted from the Administration on Aging (effective May 16, regulations for Program Integrity: regulatory text; • 1997). Gainful Employment (Gainful Dividing lines were omitted from Administration for Children and Families the chart on page 64954 that would (effective January 28, 1992). Employment rule). This document corrects regulatory text, footnotes, and a enhance the data presentation; Administration for Community Living • We revised § 668.412(a)(11) of the (effective December 4, 2014). chart in the Gainful Employment rule. proposed regulations to add mean Agency for Healthcare Research and DATES: Effective July 1, 2015. Quality (formerly Agency for Health Care earnings, in addition to median ADDRESSES: Accessible Format: Policy and Research) (effective May 16, earnings, as a possible disclosure item 1997). Individuals with disabilities can obtain to be included on the disclosure Agency for Toxic Substances and Disease this document in an accessible format template, but we did not revise Registry (effective May 16, 1997). (e.g., braille, large print, audiotape, or § 668.413 of the regulations to reflect Centers for Disease Control and Prevention compact disc) on request to the program this addition; and (effective May 16, 1997). contact person listed under FOR FURTHER • Section 668.413(c)(2) referred Centers for Medicare and Medicaid INFORMATION CONTACT. incorrectly to the cohort period with Services (formerly Health Care Financing Electronic Access to This Document: respect to the calculation of median Administration). The official version of this document is loan debt. Food and Drug Administration. the document published in the Federal Health Resources and Services Corrections Administration (effective May 16, 1997). Register. Free Internet access to the Indian Health Service (effective May 16, official edition of the Federal Register In FR Doc. No. 2014–25594, in the 1997). and the Code of Federal Regulations is Federal Register of October 31, 2014 (79 National Institutes of Health (effective May available via the Federal Digital System FR 64890), make the following 16, 1997). at: www.gpo.gov/fdsys. At this site you corrections:
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■ 1. On page 64905, in the left-hand characteristics: United States, academic years 47 NCES, ‘‘Transferability of Postsecondary column, add footnote 22 to read as 2010–11 and 2012–13. Credit Following Student Transfer or follows: Coenrollment,’’ NCES 2014–163, table 3. ■ 2. On page 64906, in the right-hand 22 IPEDS First-Look (July 2013), table 2. column, revise footnotes 46 and 47 to ■ 3. On page 64907, in the middle Average costs (in constant 2012–13 dollars) read as follows: column, revise footnote 54 to read as associated with attendance for full-time, first- follows: time degree/certificate-seeking 46 NCES, ‘‘Transferability of Postsecondary undergraduates at Title IV institutions Credit Following Student Transfer or 54 Id. operating on an academic year calendar Coenrollment,’’ NCES 2014–163. Available system, and percentage change, by level of at: http://nces.ed.gov/pubsearch/ ■ 4. On page 64954, the table is revised institution, type of cost, and other selected pubsinfo.asp?pubid=2014163. to read as follows:
Date received Number ED Number SSA Number SSA Number with Number with zero from SSA sent to SSA verified did not verify earnings earnings
2011 GE informational 3/5/12 811,718 797,070 14,708 699,024 98,046 [12.3% of verified]. rates—includes non-Title IV. 2012 GE informational rates 7/18/13 255,168 252,328 2,845 232,006 20,317 [7.96% of verified]. for reg neg Title IV only. 2012 GE post reg neg—Title 8/14/13 923,399 917,912 8,487 798,952 115,960 [12.6% of IV only. verified]. For College Scorecard—Title 9/13/13 900,419 892,796 7,623 809,204 83,592. IV only derived from ED 901,719 894,260 7,459 819,542 74,718. data on borrowers in FY 902,380 892,840 9,540 787,223 105,617. 2007 iCDR cohort for se- 921,749 909,613 12,136 772,574 137,039. lected institutions of higher education.
Totals ...... 3,626,267 3,589,509 36,758 3,188,543 400,966 [11.1% of verified]. For College Scorecard—Title 12/13/13 969,145 954,728 14,417 857,539 97,189. IV only derived from ED 985,742 970,742 15,000 865,060 105,682. data on borrowers in FY 490,305 480,421 9,884 411,917 68,504. 2008 iCDR cohort for se- lected institutions of higher education.
Totals ...... 2,445,192 2,405,891 39,301 2,134,516 271,375 [11.3% of verified]. Grand Totals ...... 8,061,744 7,959,705 102,099 7,053,041 906,664 [11.4% of verified].
§ 668.412 [Corrected] § 668.413 [Corrected] in each place in which the phrase ■ ■ 5. On page 65015, in the middle 6. In the table of contents for subpart ‘‘median earnings’’ appears, including in the heading of § 668.413, revise the column, add paragraph (h) to § 668.412 Q, on page 65007, in the second line in phrase to read ‘‘mean and median to read as follows: the middle column, we revise the phrase ‘‘median earnings’’ to read earnings’’. (h) Implementation date. Institutions ‘‘mean and median earnings’’. ■ 8. On page 65015, revise the two, must comply with the requirements of ■ 7. Beginning in the middle column on three-column equations in this section beginning January 1, 2017. page 65015 and ending on page 65018, § 668.413(b)(1)(i) to read as follows:
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■ 9. On page 65018, in the left-hand limit (ACL) on December 11, 2014. Florida Keys, and between the Florida column, revise § 668.413(c)(2) by Therefore, NMFS closes the commercial Keys and the mainland, are within the removing the phrase ‘‘, in each case sector for Atlantic migratory group cobia Gulf of Mexico. The northern boundary during the cohort period’’. on December 11, 2014, and it will for Atlantic migratory group cobia is at ■ 10. On page 65033, in the right-hand remain closed throughout the remainder the jurisdictional boundary between the column, add footnotes 259 and 260 to of the fishing year, through December Mid-Atlantic and New England read as follows: 31, 2014. This closure is necessary to Councils. As specified in 50 CFR 259 NCES, ‘‘Transferability of protect the resource of Atlantic 600.105(a), the northern boundary Postsecondary Credit Following Student migratory group cobia. begins at the intersection point of Transfer or Coenrollment,’’ NCES 2014–163. DATES: This rule is effective 12:01 a.m., Connecticut, Rhode Island, and New Available at: http://nces.ed.gov/pubsearch/ local time, December 11, 2014, until York at 41°18′16.249″ N. latitude and pubsinfo.asp?pubid=2014163. 12:01 a.m., local time, January 1, 2015. 71°54′28.477″ W. longitude and 260 NCES, ‘‘Transferability of FOR FURTHER INFORMATION CONTACT: proceeds south along 37°22′32.75″ E. Postsecondary Credit Following Student Britni LaVine, telephone: 727–824– longitude to the point of intersection Transfer or Coenrollment,’’ NCES 2014–163, 5305, email: [email protected]. with the outward boundary of the EEZ table 3. SUPPLEMENTARY INFORMATION: The as specified in the Magnuson-Stevens Program Authority: 20 U.S.C. 1001, 1002, fishery for coastal migratory pelagic fish Act. 1088. (king mackerel, Spanish mackerel, and The commercial ACL or commercial Dated: November 25, 2014. cobia) is managed under the Fishery quota (quota) for Atlantic migratory Arne Duncan, Management Plan for Coastal Migratory group cobia is 125,712 lb (57,022 kg), round weight, for the current fishing Secretary of Education. Pelagic Resources in the Gulf of Mexico year, January 1 through December 31, [FR Doc. 2014–28284 Filed 12–3–14; 8:45 am] and Atlantic Region (FMP). The FMP was prepared by the Gulf of Mexico and 2014, as specified in 50 CFR BILLING CODE 4000–01–P South Atlantic Fishery Management 622.384(d)(2). Councils (Councils) and is implemented The AMs specified at 50 CFR under the authority of the Magnuson- 622.388(f)(1)(i) require NMFS to close DEPARTMENT OF COMMERCE Stevens Fishery Conservation and the commercial sector for Atlantic Management Act (Magnuson-Stevens migratory group cobia when its quota is National Oceanic and Atmospheric reached or is projected to be reached, by Administration Act) by regulations at 50 CFR part 622. Separate migratory groups of cobia filing a notification with the Office of were established in Amendment 18 to the Federal Register to close the 50 CFR Part 622 the FMP. The southern boundary for commercial sector for the remainder of [Docket No. 101206604–1758–02] Atlantic migratory group cobia occurs at the fishing year. NMFS has determined the division between Gulf of Mexico that the quota for Atlantic migratory RIN 0648–XD601 and Atlantic migratory groups, which is group cobia will have been reached by Fisheries of the Caribbean, Gulf of set at the intercouncil jurisdictional December 11, 2014. Accordingly, the Mexico, and South Atlantic; 2014 boundary, off the Florida Keys. As commercial sector for Atlantic migratory Commercial Accountability Measure specified in 50 CFR 600.105(c), the group cobia is closed effective 12:01 and Closure for Atlantic Migratory South Atlantic and Gulf of Mexico a.m., local time, December 11, 2014, Group Cobia intercouncil boundary coincides with until 12:01 a.m., local time, January 1, the line of demarcation between the 2015. AGENCY: National Marine Fisheries Atlantic Ocean and the Gulf of Mexico, The possession limit for cobia located Service (NMFS), National Oceanic and which begins at the intersection of the at 50 CFR 622.383(b), specifies that no Atmospheric Administration (NOAA), outer boundary of the EEZ, as specified person may possess more than two Commerce. in the Magnuson-Stevens Act, and cobia per day in or from the EEZ in the ° ′ ACTION: Temporary rule; closure. 83 00 W. longitude, proceeds Gulf of Mexico, Mid-Atlantic, or South northward along that meridian to 24°35′ Atlantic, regardless of the number of SUMMARY: NMFS implements N. latitude, (near the Dry Tortugas trips or duration of a trip. In addition, accountability measures (AMs) for Islands), then eastward along that a person who fishes in the EEZ may not commercial Atlantic migratory group parallel, through Rebecca Shoal and the combine this harvest limitation with a cobia in the exclusive economic zone Quicksand Shoal, to the Marquesas harvest limitation applicable to state (EEZ) of the South Atlantic. Commercial Keys, and then through the Florida Keys waters. Atlantic migratory group cobia landings for Atlantic migratory group to the mainland at the eastern end of taken in the EEZ may not be transferred cobia, as estimated by the Science Florida Bay, the line so running that the at sea, regardless of where such transfer Research Director (SRD), are projected narrow waters within the Dry Tortugas takes place, and may not be transferred to reach the commercial annual catch Islands, the Marquesas Keys and the in the EEZ.
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During the closure, the possession Dated: November 28, 2014. Copies of the small entity compliance limit for cobia remains in effect, Alan D. Risenhoover, guide are available from John K. however, in accordance with regulations Director, Office of Sustainable Fisheries, Bullard, Regional Administrator, NMFS, at 50 CFR 622.384(e)(3), the sale or National Marine Fisheries Service. Greater Atlantic Regional Fisheries purchase of Atlantic migratory group [FR Doc. 2014–28468 Filed 12–3–14; 8:45 am] Office, 55 Great Republic Drive, cobia taken under the possession limit BILLING CODE 3510–22–P Gloucester, MA 01930–2298, or is prohibited. The prohibition on sale available on the Internet at http://www. and purchase does not apply to the sale greateratlantic.fisheries.noaa.gov/ or purchase of Atlantic migratory group DEPARTMENT OF COMMERCE sustainable/species/atlherring/ cobia that were harvested, landed index.html. ashore, and sold prior to 12:01 a.m., National Oceanic and Atmospheric FOR FURTHER INFORMATION CONTACT: Administration local time, December 11, 2014, and were Carrie Nordeen, Fishery Policy Analyst, held in cold storage by a dealer or 978–281–9272, fax 978–281–9135. processor. 50 CFR Part 648 SUPPLEMENTARY INFORMATION: Classification [Docket No. 140221166–4963–02] Background The Regional Administrator, Southeast Region, NMFS, has RIN 0648–BE01 The New England Fishery determined this temporary rule is Management Council adopted necessary for the conservation and Fisheries of the Northeastern United Framework Adjustment 3 to the Atlantic management of Atlantic migratory group States; Atlantic Herring Fishery; Herring Fishery Management Plan cobia and is consistent with the Framework Adjustment 3 (FMP) at its September 24, 2013, meeting. The Council submitted Magnuson-Stevens Act and other AGENCY: National Marine Fisheries Framework 3 to NMFS for review on applicable laws. Service (NMFS), National Oceanic and This action is taken under 50 CFR January 3, 2014, and resubmitted it to Atmospheric Administration (NOAA), NMFS on March 26, 2014. The Council 622.8(b) and is exempt from review Commerce. under Executive Order 12866. reviewed the Framework 3 proposed These measures are exempt from the ACTION: Final rule. rule regulations as drafted by NMFS, and deemed them to be necessary and procedures of the Regulatory Flexibility SUMMARY: NMFS implements final appropriate as specified in section Act because the temporary rule is issued regulations to establish a process for 303(c) of the Magnuson-Stevens Fishery without opportunity for prior notice and setting river herring (alewife and Conservation and Management Act. The comment. blueback) and shad (American and This action responds to the best proposed rule for Framework 3 hickory) catch caps for the herring scientific information available. The published in the Federal Register on fishery. This action also sets these catch Assistant Administrator for Fisheries, June 13, 2014 (79 FR 33879), with a 30- caps for the 2014 and 2015 fishing NOAA (AA), finds good cause to waive day public comment period that ended years. The river herring and shad caps the requirements to provide prior notice July 14, 2014. NMFS received four in the herring fishery will limit how and opportunity for public comment, comments on the proposed measures. much of these species will be caught in pursuant to the authority set forth at 5 Framework 3 establishes a process for the herring fishery. This action will U.S.C. 553(b)(B), as such prior notice setting and modifying catch caps for allow the New England Fishery and opportunity for public comment is river herring (alewife and blueback) and Management Council to set river herring unnecessary and contrary to the public shad (American and hickory) catch caps and shad catch caps and associated interest. Such procedures are in the Atlantic herring fishery (herring measures in future years through unnecessary and contrary to the public fishery), and sets specific river herring specifications or frameworks, whichever interest because the AMs for Atlantic and shad catch caps for the 2014 and is appropriate. The measures in this migratory group cobia established by 2015 fishing years. Catch of river action are a positive step in Amendment 18 to the FMP (76 FR herring and shad for 2014 will count conservation efforts for river herring and 82058, December 29, 2011), and located against the cap in 2014 after the shad. at 50 CFR 622.388(f)(1)(i), have already effective date of this final rule. been subject to notice and comment, DATES: Effective December 4, 2014. River herring and shad are and all that remains is to notify the ADDRESSES: The New England Fishery anadromous species that may co-occur public of the commercial closure for the Management Council developed an seasonally with Atlantic herring and are remainder of the 2014 fishing year. environmental assessment (EA) for this harvested as a non-target species in the Additionally, there is a need to action that describes the action and fishery. When river herring are immediately implement the closure to other considered alternatives and encountered in the herring fishery, they prevent further commercial harvest and provides a thorough analysis of the are either discarded at sea (bycatch) or, prevent the ACL from being exceeded, impacts of these final measures and because they closely resemble herring, which will protect the cobia resource. alternatives. Copies of the framework, they are retained and sold as part of the Prior notice and opportunity for public the EA, and the Regulatory Impact herring catch (incidental catch). comment on this action would be Review (RIR)/Initial Regulatory According to the most recent river contrary to the public interest, because Flexibility Analysis (IRFA), are herring stock assessment (May 2012) those affected by the closure need as available upon request from Thomas A. conducted by the Atlantic States Marine much advance notice as NMFS is able Nies, Executive Director, New England Fisheries Commission (ASMFC), river to provide. Fishery Management Council, 50 Water herring populations have declined from For the aforementioned reasons, the Street, Newburyport, MA 01950. The historic levels and many factors will AA also finds good cause to waive the EA/RIR/IRFA is accessible via the need to be addressed to allow their 30-day delay in the effectiveness of this Internet at http://www.greateratlantic. recovery, including: Fishing in both action under 5 U.S.C. 553(d)(3). fisheries.noaa.gov/sustainable/species/ state and Federal waters; improvement Authority: 16 U.S.C. 1801 et seq. atlherring/index.html. of river passageways and water quality;
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reduced predation; and understanding TABLE 1—RIVER HERRING AND SHAD the 2,000-lb (0.9-mt) possession limit the effects of climate change. The CATCH CAP AREAS and could continue directed fishing for Council has been working on addressing herring in those areas with other gear types. Vessels participating in the river herring and shad catch issues in Catch cap Statistical areas the herring fishery, most recently in areas herring fishery outside of the catch cap Amendment 5 to the FMP (79 FR 8786; closure area(s) will be able to use any GOM ...... 464, 465, 467, 511–515. gear type (consistent with other February 13, 2014) (Amendment 5). CC ...... 521. Amendment 5 allowed for river herring GB ...... 522, 525–526, 541–543, regulations) until the applicable herring and shad catch caps to be implemented 561–562, 640. annual catch limits/sub-annual catch through a framework adjustment. SNE/MA ...... 533–534, 537–539, 611– limits are harvested. This 95-percent Framework 3 allows the Council to set 616, 621–629, 631–639, catch trigger is consistent with the river herring and shad catch caps and 700–705, 707–711. trigger implemented for the river herring and shad catch cap in the mackerel associated measures in future years fishery (79 FR 18834; April 4, 2014). through specifications or frameworks, Reporting Requirements and Monitoring the River Herring and Shad Catch Caps The Catch Cap Closure Areas are whichever is appropriate. This action adjusts current Vessel identical to the Catch Cap Areas for GB, Framework 3 outlines a process for Monitoring System (VMS) trip GOM, and CC. For SNE/MA, the catch setting and modifying the river herring notification requirements in order for cap closure area is the inshore portion and shad catch caps that includes: NMFS to monitor the catch caps. Vessel of the SNE/MA Catch Cap Area (Table Identification of gears, areas, and trips operators will have to report kept catch 2). that would be subject to the catch caps; of all species by statistical area daily via TABLE 2—RIVER HERRING AND SHAD changes to reporting requirements for VMS catch reports. The Council may vessels issued limited access and consider adjustments to trip notification CATCH CAP CLOSURE AREAS Herring Management Areas 2/3 open requirements in the future as necessary access herring permits; criteria that Catch cap to ensure the effectiveness of the catch closure areas Statistical areas would trigger the closure of an area to caps. directed herring fishing for a particular The Greater Atlantic Regional GOM ...... 464, 465, 467, 511–515. gear type; and a list of management Fisheries Office will monitor the catch CC ...... 521. measures related to setting catch caps cap by estimating the total river herring GB ...... 522, 525–526, 541–543, that can be modified through the herring and shad catch in the herring fishery 561–562, 640. specifications process and/or framework using data from observed hauls on SNE/MA ...... 537–539, 611–616, 621– herring trips and extrapolating this data 623, 625–627, 631–632, adjustment process. 635–636. to unobserved herring trips. The rate of Area and Gear Provisions of the River river herring and shad catch will be Herring and Shad Catch Caps estimated as the ratio of observed river Modifying Future River Herring and herring and shad catch (including Shad Catch Cap Management Measures Framework 3 establishes four distinct discards) to the kept catch of all species This action specifies the mechanisms Catch Cap Areas that could have on observed trips that land greater than to modify measures related to the catch associated catch caps: Gulf of Maine 6,600 lb (3 mt) of herring. Total river caps. Measures related to the catch cap (GOM); Cape Cod (CC); Southern New herring and shad catch (in weight) will process that could be established in this England/Mid-Atlantic (SNE/MA); and then be derived by multiplying the framework may be modified in the Georges Bank (GB) (Table 1). During a catch rate by total pounds of all kept future through the specifications or given fishing year, catch of river herring species on all trips that land greater framework adjustment process, and shad from all herring trips landing than 6,600 lb (3 mt) of herring. This depending on whether the modification more than 6,600 lb (3 mt) of herring will methodology is identical to that used for is suitable for either specifications or apply against the catch caps for specific catch cap accounting in the mackerel framework adjustment. New or fishing gears and areas. The Council fishery. More information about our additional measures (e.g., new considered alternatives for catch caps monitoring methodology for the river accountability measures to become for all gear types used in the herring herring and shad catch can be found at effective when a catch cap is reached), fishery, but ultimately decided to adopt http://www.greateratlantic.fisheries. or measures outside the scope already catch caps for midwater trawl gear in noaa.gov/aps/monitoring/riverherrings analyzed, could be implemented the GOM, CC, and SNE/MA, as well as had.html. through another framework action or an amendment. bottom trawl gear in SNE/MA. The River Herring and Shad Catch Triggers selection of these gear types in these and Closure Areas River Herring and Shad Catch Caps for areas is based on recent fishery data that Fishing Years 2014–2015 indicate where river herring and shad This action specifies that when 95 percent of the river herring and shad This action sets river herring and shad interactions are occurring, and to what catch for a gear-specific catch cap is catch caps for the 2014–2015 fishing extent they may be occurring by each projected to be reached in a Catch Cap years (January 1–December 31) (Table gear type used in the herring fishery. Area, all vessels fishing with that gear 3). Catch of river herring and shad for Because current catch data indicate that type in the respective closure area will 2014 will only be counted from the river herring and shad are not caught by be subject to a reduced herring effective date of this action until the herring fishery in GB, the Council possession limit of 2,000 lb (0.9 mt) per December 31, 2014. All the catch caps did not specify catch caps for GB during trip, per calendar day, in or from that in the GOM, CC, and SNE/MA Catch 2014–2015. The Council may consider area for the remainder of the fishing Cap Areas are based on the median adjustments to the selected gears and year. Vessels using other gear types in value of estimated river herring and areas that have associated catch caps in the closure area will not be affected in shad catch from 2008–2012. Current a future management action. that those vessels will not be subject to data are not sufficient to definitively
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determine the magnitude of potential incentive for the industry to continue to while still providing the opportunity to biological effects of such a cap on river avoid river herring and shad and help fully utilize the herring annual catch herring and shad stocks. Using the to minimize overall river herring and limit if the fleet can avoid river herring median values is expected to provide an shad catch to the extent practicable, and shad.
TABLE 3—RIVER HERRING AND SHAD CATCH CAPS BY AREA AND GEAR TYPE FOR 2014 AND 2015
Catch cap Catch cap area Gear type (mt)
GOM ...... Midwater Trawl ...... 86 CC ...... Midwater Trawl ...... 13 SNE/MA ...... Midwater Trawl ...... 124 Bottom Trawl ...... 89 GB ...... N/A ...... N/A
Due to very low observed river possession limit requirements of the individual states, prohibited state herring and shad catch in GB, the Herring Management Areas 2/3 Open waters commercial and recreational Council did not recommend a catch cap Access Permit. This regulation was fisheries that did not have approved in the GB Catch Cap Area for the 2014– overlooked during rulemaking for sustainable fisheries management plans, 2015 fishing years. If the catch of river Herring Amendment 5 and is consistent effective January 1, 2012. NMFS herring and shad increases in this area, with the intent of that action. considers river herring to be a species of the Council could consider setting a cap Comments and Responses concern, but recently (78 FR 48944, for this area in a future herring August 12, 2013) determined that listing specifications. NMFS received four comment letters river herring, as either threatened or in response to the proposed rule from Corrections endangered, under the Endangered The Herring Alliance; Wild Oceans; the Species Act was not warranted. NMFS This rule also contains minor Coalition for the Atlantic Herring established a technical working group corrections to existing regulations. Fishery’s Orderly, Informed and and will continue to work closely with NMFS makes these adjustments under Responsible Long Term Development the ASMFC and others to develop a the authority of section 305(d) to the (CHOIR); and an individual. The long-term, dynamic conservation plan Magnuson-Stevens Act, which provides following summarizes the comments for river herring from Canada to Florida. that the Secretary of Commerce may and provides our responses. The working group will evaluate the promulgate regulations necessary to Comment 1: An individual impact of ongoing restoration and ensure that amendments to a fishery commented that depleted runs of conservation efforts, as well as new management plan are carried out in blueback herring and alewife in rivers fisheries management measures, which accordance with the FMP and the and streams of Massachusetts suggest should benefit the species. It will also Magnuson-Stevens Act. These that conservation and management review new information produced from adjustments, which are identified and measures have not achieved sustainable ongoing research, including genetic described below, are necessary to clarify levels of these fish. He urged NMFS to analyses, ocean migration pattern current regulations or the intent of the use precautionary management research, and climate change impact FMP and would not change the intent measures for the herring fishery to allow studies, to assess whether recent of any regulations. us to evaluate the benefits that reports, showing higher river herring restrictive and conservative measures NMFS clarifies the coordinates for the counts in the last 2 years, represent herring management areas, modified would have on populations of river sustained trends. NMFS intends to haddock stock areas, and river herring herring. The Herring Alliance noted that revisit its river herring status monitoring/avoidance areas at river herring and shad populations are determination within the next 5 years. § 648.200(f) to more accurately define near historic lows and that without In addition to the these actions, various areas. For example, some areas sufficient federal management to Amendment 5 to the FMP established were intended to be based on statistical complement state conservation river herring monitoring and avoidance areas, but the previous coordinates were measures, river herring and shad areas for the herring fishery. NMFS unintentionally misaligned with those populations will not recover and asserts that setting river herring and statistical areas. This action updates fisheries for these species are unlikely to shad catch caps in the herring fishery is those coordinates to correctly align reopen. an additional positive step toward them with the statistical areas upon Response: River herring are managed which they were based. In addition, by the ASMFC and the individual reducing the impacts of herring fishing some area boundaries are being revised Atlantic coastal states. According to the on river herring and shad. The caps to correctly incorporate coastal bodies of most recent ASMFC river herring stock should further help minimize river water, as well as the legally defined U.S. assessment (May 2012), river herring herring and shad catch in the herring Canada Maritime boundary. This action populations have declined from historic fishery to the extent practicable and also moves the coordinates for the GOM levels and many factors will need to be increase the incentive for the herring and GB modified haddock stock areas in addressed to allow their recovery, fishery to avoid river herring and shad the regulations from § 648.10 to including fishing (in both state and catch when possible. § 648.200(f) so that all the herring- Federal waters), river passageways, Comment 2: Wild Oceans, CHOIR, related management areas are in a single water quality, predation, and climate and the Herring Alliance urged NMFS to location for easy reference. Finally, this change. In an effort to aid in the approve and implement Framework 3, action adds a possession limit recovery of depleted or declining stocks, including the process for setting river regulation to § 648.204(a) to describe the the ASMFC, in cooperation with herring and shad caps, applicable areas
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and gears, and the caps and for 2014 river herring and shad catch against the Alliance commented that NMFS should and 2015. cap for all of 2014. The Council’s approve the cap designated for George Response: NMFS is implementing the timeline for submission provided for Bank, ensure sufficient observer measures as recommended by the implementation late in the 2014 fishing coverage in that area to accurately Council. year. Although the herring fishing fleets monitor catch, and establish a limit in Comment 3: Wild Oceans, CHOIR, likely knew that the Council the next appropriate action. and the Herring Alliance urged NMFS to recommended this action, it also likely Response: NMFS and the Council will quickly implement the measures in knew that implementation is dependent work together to examine catch on Framework 3. Wild Oceans commented upon NMFS review and approval. Georges Bank and all other herring that swift implementation is necessary Counting all river herring and shad management areas to determine whether in part because it believes that the catch since January 1, 2014, would to establish caps on Georges Bank or measures to limit river herring and shad unfairly penalize the herring fleet for adjust the caps through the herring catch in the herring fishery are overdue. measures that were not effective for the fishery specifications process. The Herring Alliance, Wild Oceans, and majority of their fishing year in 2014. Comment 6: The Herring Alliance, CHOIR urged NMFS to waive the 30-day Comment 4: The Herring Alliance, Wild Oceans, and CHOIR all stressed delay in effectiveness required by the Wild Oceans, and CHOIR all expressed the importance of coordinating river Administrative Procedure Act. CHOIR concern that NMFS could have herring and shad catch caps between the and the Herring Alliance requested that difficulty monitoring the catch caps Mid-Atlantic and New England NMFS retroactively apply the river with a 95-percent closure threshold. Councils. Commenters suggest that this herring and shad catch caps to catch of They commented that difficulty in would ensure that the Councils and herring, river herring, and shad, monitoring the herring fishery could NMFS sufficiently address river herring beginning January 1, 2014. The Herring result in late closure, causing the and shad catch in areas where the Alliance believes that the herring herring fishery to exceed the applicable herring and mackerel fisheries overlap, fishing fleets had sufficient notice that river herring and shad caps. The Herring and where vessels catch substantial this rule would take effect in 2014, and Alliance commented that it is concerned amounts of both herring and mackerel that the rule will not result in costs that the measures in Framework 3 are on the same trip. Comments urged the related to on-board changes to fishing not enough to account for scientific and creation of a single river herring and vessels or changes to bycatch estimation management uncertainty surrounding shad cap to address herring and methodologies. river herring and shad. The Herring mackerel fishery overlap. Comments Response: NMFS has determined that Alliance commented that the 95-percent recognized that the Councils and NMFS good cause exists to waive the 30-day closure threshold is not conservative could develop joint caps for the 2016 delay in effectiveness for this action on enough in light of a recent catch overage fishing year, but not for 2014 and 2015. the basis that it is important to in Herring Management Area 1B and Response: NMFS agrees that the New implement the catch caps for the frequent historical overages of the area- England and Mid-Atlantic Councils remainder of 2014 and it is in the based quotas in the herring fishery. should work cooperatively to establish public’s interest to do so. The Council CHOIR urged NMFS to be highly river herring and shad caps for the submitted its final version of vigilant in monitoring the caps, and the herring and mackerel fisheries that do Framework 3 for NMFS review in March Herring Alliance commented that a not cause management inconsistency in 2014, meaning that final NMFS action lower cap is warranted until NMFS is the two fisheries, in particular where would occur well after the herring able to provide observer coverage they overlap. The Council has indicated fishery was underway. As a result, necessary to accurately monitor these its intent in the Framework 3 document NMFS intended from the outset to catch caps. to work with the Mid-Atlantic Council implement these measures upon Response: NMFS has a monitoring in establishing a joint cap. publication due to the need and the program in place for the herring fishery Comment 7: The Herring Alliance public interest. Even though it is near that enables it to project a closure date commented that the river herring and the end of 2014 and only one area based on daily catch and weekly dealer shad caps are a first step in management remains open (Area 2) to the herring data. NMFS is vigilant in monitoring of river herring and shad, but ultimately fishery, NMFS believes that it is still this fishery and has effectively closed insufficient, to prevent further important to implement the measures herring management areas before the population declines and rebuild these upon publication. To further delay area allocations the majority of the time. species. It commented that the implementation would reduce the NMFS asserts that the 95-percent Magnuson-Stevens Act requires all benefits of the caps as the herring threshold is sufficient, but will advise stocks in need of conservation and fishery will likely have harvested the the Council to reassess this threshold if management to be added to an FMP, vast majority of its catch allocated for it does not provide a sufficient buffer in and therefore believes that river herring 2014. The Council intended that the the event the herring fishery has a very and shad must be added to the FMP as caps apply to as much as the 2014 rapid harvest rate. NMFS cannot a federally managed species, as well as herring fishery as possible, but it did not implement a lower closure threshold any other fishery FMP that manage recommend a retroactive application of because one was not recommended by fisheries that catch river herring and the cap. The analysis to support this the Council. NMFS cannot implement shad. action does not describe retroactive different measures than what the Response: Measures to help minimize catch caps nor does it analyze Council recommended; it can only the catch of any species may be added retroactive catch caps. Therefore, NMFS approve or disapprove the measures to a Federal FMP without also including cannot retroactively apply the catch recommended by the Council. that species in that FMP’s stock in the caps to the beginning of 2014. NMFS Comment 5: CHOIR commented that fishery definition. Many measures have did retroactively apply catch against the NMFS should pay close attention to been implemented in the FMP to river herring and shad cap for the new data from herring fishing activity minimize bycatch to the extent mackerel fishery implemented in April on Georges Bank and should support the practicable, most recently in 2014 because the Mid-Atlantic Council development and implementation of a Amendment 5 to the FMP. In addition recomended and analyzed applying cap on Georges Bank. The Herring to those measures, implementing river
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herring and shad catch caps in the FMP U.S.C. 1851(a)(7)). Stocks in the fishery past, when the ASMFC believed that is an additional way to minimize river classifications must be monitored ‘‘on a management in Federal waters was herring and shad catch to the extent regular basis’’ to determine whether warranted, it requested the development practicable in Federal waters while the reclassification through and of a Federal FMP, as in the case of effects of various threats (e.g., water Amendment to the FMP is necessary (50 lobster, striped bass, weakfish, and quality, fish passage, predation, habitat CFR 600.310(d)(6)). horseshoe crab. loss, fishing mortality, and climate We considered whether the FMP’s Information currently available change) on river herring and shad definition of stocks in the fishery supports a conclusion that it is continue to be evaluated. NMFS and the complied with the Magnuson-Stevens impracticable to treat shad and river Council continue to monitor and Act in relation to Amendment 4 to the herring as a ‘‘unit’’ on a regional or evaluate whether further management FMP in response to a court order in coast-wide scale as contemplated by measures to address river herring and Flaherty v. Pritzker, 2014 WL 642658 National Standard 3. ASMFC stock shad catch are necessary, including (D.D.C. Feb. 19, 2014), and we found assessments evaluated individual rivers. whether to include river herring and that it complied with the Magnuson- The best available information suggests shad as stocks in the fishery. Stevens Act. The best available that river herring and shad from There are many factors that must be information at that time supported a different natal rivers co-occur in the considered when determining whether a conclusion that: It is impracticable to ocean, but the full extent and rate of species will be included as a stock in a treat river herring and shad throughout mixing are uncertain. Catch data do not their range in federal waters as a unit; always differentiate between river fishery in a fishery management plan. there is insufficient information to herring and shad species and have not Each Fishery Management Council is support a finding that they are in need been determined to sufficiently link fish required by the Magnuson-Stevens Act of conservation and management under caught in the ocean with individual to develop FMPs ‘‘for each fishery under the Magnuson-Stevens Act; and it source rivers or stocks. its authority that requires conservation would be impracticable and The best available science is and management’’ (16 U.S.C. unnecessarily duplicative to undertake insufficient to support a finding that 1852(h)(1)). If a stock in a fishery is management and conservation of them conservation and management of these determined to be overfished or subject in Federal waters at that time. stocks in Federal waters is necessary. to overfishing, it must be included in an The states have historically managed The best available science for river FMP. Section 303(a)(2) of the shad and river herring in state waters herring was a 2012 benchmark Magnuson-Stevens Act requires that under the ASMFC’s Interstate Fishery assessment. This assessment found that each FMP contain, among other things, Management Plan (ISFMP) for Shad and of the 52 stocks of alewife and blueback a description of the species of fish River Herring. In 1998, Amendment 1 to herring for which data were available involved in the fishery, and a ‘‘fishery’’ the ASMFC’s ISFMP for Shad and River for use in the assessment, 23 were is defined as ‘‘one or more stocks of fish Herring prohibited a commercial ocean depleted from historic levels, 1 stock that can be treated as a unit for purposes fishery for American shad, established was increasing, and the status of 28 of conservation and management and fishing mortality targets for specific other stocks could not be determined that are identified on the basis of American shad river fisheries, and because of insufficient data. The geographic, scientific, technical, established a daily fish limit in assessment was insufficient to conclude recreational, or economic recreational fisheries for American shad overfishing was occurring or that the characteristics’’ (16 U.S.C. 1802(13)). and hickory shad. In 2009, Amendment stocks were overfished. Depletion was The National Standard 1 Guidelines 2 to the ISFMP for Shad and River used instead of overfished because of provide further guidance that Councils Herring required each state to close its the many factors (e.g., water quality, fish should determine ‘‘which specific target rivers to river herring fishing unless that passage, predation, habitat loss, and stocks and/or non-target stocks to state could develop a plan that ensured climate change) contributing to river include in the fishery,’’ as well as that such fishing could be maintained at herring’s declining abundance. Also, the whether it would be appropriate to sustainable levels. Any such plans had river herring assessment provided only designate any ‘‘ecosystem component to first be submitted to the ASMFC’s river-by-river information, and did not species’’ (50 CFR 600.310(d)(l)). When Shad and River Herring Management include information about stocks considering which stocks ‘‘can be Board for approval before a state could regionally or coast-wide. Likewise, the treated as a unit for purposes of open the river to fishing. State river 2007 shad stock assessment addressed conservation and management,’’ and herring fisheries without such plans stocks in 32 rivers. Of the 32 rivers, over therefore constitute a ‘‘fishery,’’ were required to close by January 1, half (19) were either stable or could not National Standard 3 requires that, ‘‘[t]o 2012. In 2010, Amendment 3 to the be determined. The assessments are the extent practicable, an individual ISFMP for Shad and River Herring available at: http://www.asmfc.org. The stock of fish shall be managed as a unit established requirements for states to lack of adequate data prevented the throughout its range, and interrelated develop sustainable fishery plans in ASMFC from developing estimates of stocks of fish shall be managed as a unit order to maintain a commercial abundance and fishing mortality in or in close coordination’’ (16 U.S.C. American shad fishery. American shad either assessment. The best scientific 1851(a)(3)). The National Standard 3 fisheries without such plans were information currently available shows Guidelines further instruct that the required to close by January 1, 2013. that encounters between the herring choice of a management unit ‘‘depends The ASMFC’s Shad and River Herring fishery in Federal waters and river on the focus of the FMP’s objectives, Management Board recommends river herring are relatively rare (75 percent of and may be organized around biological, herring and shad management sampled trips had no encounters), and geographic, economic, technical, social, measures. At no time has the Shad and that estimates about river herring catch or ecological perspectives’’ (50 CFR River Herring Management Board in the herring fishery in Federal waters 600.320(d)(l)). Additionally, recommended that we create an FMP for are highly variable and depend on gear, conservation and management measures river herring and shad in federal waters area, and season. Additionally, data shall, where practicable, minimize costs or designate river herring and/or shad as suggest that vessels using small-mesh and avoid unnecessary duplication (16 a stock in any Federal fishery. In the bottom trawl, and targeting species
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other than Atlantic herring, are also shad catch caps and/or the potential by National Standard 2, and helps the encountering river herring. Because of impacts of such catch caps on the river FMP minimize bycatch and bycatch the variability in encounters with river herring and shad stocks. Setting a cap mortality to the extent practicable, as herring, there is a need for adequate on the catch of these species in the required by National Standard 9. sampling of the herring fishery by herring fishery is a proactive action The Council considered the most observers before any conclusions could intended to manage and minimize catch recent assessments for river herring and be made based on the available to the extent practicable while allowing shad when developing these catch caps. information. In light of these significant the herring fishery to continue to These assessments are the best available data limitations, there is insufficient operate and fully utilize optimum yield science for river herring and shad. Data information to support a finding that in the upcoming fishing years, if river do not appear to be robust enough to river herring and shad are overfished or herring and shad can be avoided. The determine a biologically based catch cap subject to overfishing. Further, given the catch of river herring and shad in the for these species or the potential effects scale and uncertainty associated with herring fishery would likely be less on these populations of a coastwide this information, including interactions under a catch cap. Additionally, there catch cap. Nevertheless, the Council between the herring fishery and river would be further incentive for the fleet determined that capping the allowed herring, there is insufficient information to avoid river herring and shad to avoid level of river herring and shad in the to support a finding that the river triggering area closures resulting from herring fishery should provide a further herring or shad stocks coast-wide the catch caps being fully harvested. incentive for the industry to avoid river otherwise require conservation and Establishing river herring and shad as herring and shad and will help management. stocks in FMP and implementing all of minimize encounters with these species. Information currently available the MSA required provisions would National Standard 9 Guidelines demonstrates that conservation and require an amendment and is not advise taking into account the net management of river herring and/or appropriate for this framework benefits to the nation of any proposed shad in Federal waters would be adjustment. The river herring and shad conservation and management measure, impracticable and unnecessarily catch caps implemented in this action including: Negative impacts on affected duplicative. The limited available stock provide further incentive for the herring stocks; incomes to fishery participants status information is primarily related to industry to avoid river herring and shad in directed fisheries; incomes accruing state waters. Data on the incidental catch and minimize the FMP’s impact to to those targeting the bycatch species; catch of river herring and shad in the extent practicable. In light of the environmental consequences; non- Federal waters are uncertain. Given existing management of directed market values of bycatch species (e.g., these limitations, relying on the fisheries for river herring and shad in recreational values); and impacts on ASMFC’s management of river herring state waters through the ASMFC’s other marine organisms. River herring and shad is reasonable. As more ISFMP, and the information currently and shad are caught incidentally in the information is gathered about the available, we conclude that the herring fishery. River herring and shad incidental catch of river herring and Council’s decision to implement these are forage species that play an important shad in Federal waters, and as stock catch caps while continuing the FMP’s role in the ecosystem, providing a status information is generated on a designation of Atlantic herring as the benefit to recreational fishermen, and regional and/or coast-wide scale, the only stock in the fishery is reasonable are of great interest to numerous potential benefits of Federal and complies with the Magnuson- stakeholders. While they do occur in management to these stocks, the Stevens Act. Further, the Council has Federal waters and are encountered in regional economy, and competing added the consideration of whether it the herring fishery, river herring and stakeholder groups may outweigh the should include river herring and shad as shad are not target species in the costs and duplication with ASMFC stocks in the fishery in the FMP as one fishery, and their rate of bycatch is very management. of several management priorities that it low overall. Even the rate of incidental While this comment reflects public expects to address in the upcoming catch of river herring and shad is interest in river herring and shad, it is year. We have urged the Council to relatively low. Available information not objective, science-based information consider this issue and plan to and analysis have not shown a strong that would satisfy NMFS’s obligation to encourage them to make this a priority connection between the effects of rely on the best available science. action. If the Council finds that river bycatch—either in the herring fishery or Typically, when new science is herring and shad should be included as in other fisheries subject to Federal considered, it takes the form of a peer- stocks in the FMP, it will initiate an management—and the stocks of these reviewed journal article or a peer- amendment to do so. species. reviewed stock assessment. Currently, Comment 8: The Herring Alliance Because discarding of river herring, the best available science on river commented that NMFS must ensure that shad, and other species does not herring and shad is the ASMFC’s stock the methodology to set catch caps generally occur after the fish is brought assessments. Amendment 5 to the FMP adheres to National Standard 2, on board a vessel, the FMP and related implemented bycatch measures to National Standard 9, and the goals and measures in the Northeast Multispecies address the FMP’s impact on river objectives of Framework 3 (which the FMP use measures aimed at directly herring and shad and minimize bycatch Herring Alliance stated is to reduce all avoiding incidental catch of these of these species to the extent catch—bycatch and incidental catch—of species, thereby avoiding any possibility practicable. Those measures included river herring and shad from recent of bycatch or bycatch mortality. The increased at-sea sampling, bycatch levels). Herring FMP also seeks to gather further accounting, promoting cooperative Response: NMFS has determined that information that may help design future efforts with the industry to minimize the measures in Framework 3 are avoidance measures while taking into bycatch, and set the foundation for consistent with the Magnuson-Stevens account the net benefits to the nation of implementing river herring and shad Act, the FMP, and applicable laws. Part the herring fishery and its effect on catch caps in this action. Data are not of this decision includes NMFS’s other species, consistent with the robust enough at this time to determine determination that the action is based National Standard Guidelines. A catch biologically-based river herring and on the best available science as required cap falls under the concept of reducing
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bycatch by providing an incentive to on various aspects of the FMP that are clarifications to the proposed rule. avoid the incidental catch of river related to this action but are not within These changes do not modify the intent herring and shad by triggering a low the scope of measures considered and or the substance of the regulations. herring possession limit once the cap is approved as part of Framework 3. These Clarifications are in sections and reached. Amendment 5 included the include improvements to fishery paragraphs: 648.7(b)(3)(i); measure to allow implementing a river observer provisions for the FMP, 648.14(r)(1)(ii)(B); 648.200(f)(6) and herring catch cap through a framework consideration of adding river herring (f)(7)(ii); 648.201(a)(2), (a)(4)(i) and (ii); or the specifications process as well as and shad as stocks in the herring and 648.204(a)(1) through (5). improvements in monitoring and fishery, development of more robust Classification avoidance measures. Monitoring and catch monitoring provisions (not avoidance are critical steps to a better specific to river herring and shad), and The Assistant Administrator for understanding of the nature and extent development of consequences for Fisheries, NOAA, has determined that of incidental catch and bycatch in the vessels that dump catch at sea before it this rule is consistent with the national herring fishery in order to sufficiently can be sampled by at-sea observers on standards and other provisions of the analyze and, if necessary, address herring vessels. Specifically, the MSA and other applicable laws. bycatch issues. Because the seasonal commenters stated or implied that the The Assistant Administrator also and inter-annual distribution of river measures that NMFS disapproved as finds that the need to immediately limit herring and shad is highly variable in part of Amendment 5 are integral to the the amount of river herring and shad time and space, the most effective effective monitoring and management of catch in the herring fishery constitutes measures to address river herring and river herring and shad catch in the good cause under authority contained in shad bycatch and bycatch mortality are herring fishery. 5 U.S.C. 553(d)(3) to waive the 30-day those that increase catch monitoring and Response: NMFS is working with the delay in effective date. There is good incidental catch and bycatch Council to develop measures related to cause to implement the river herring accounting, promote cooperative efforts these issues. Some of these issues are and shad catch caps upon publication of with the industry, and reduce economic currently being considered in this final rule The Council intended for impacts to minimize incidental catch, Framework 4 to the FMP. Other issues, the caps to be in place for as much of bycatch, and bycatch mortality to the such as considering whether to add the 2014 herring fishing year as extent practicable. We have concluded river herring and shad as stocks in the possible. Delaying the effectiveness of that these catch caps, in addition to fishery may be addressed in future the river herring and shad catch caps other measures in the FMP, reduce actions. Although NMFS understands may cause the caps to be implemented bycatch and bycatch mortality to the the connection between these measures after the herring fishery has already extent practicable. and the river herring and shad catch harvested the herring catch allocated to Comment 9: The Herring Alliance caps, these additional issues and it for 2014, thereby undermining the commented that the best available measures are not within the scope of benefits of implementing the catch caps science demonstrates that there are a this action. that were specified by the Council to number of approaches used to set catch take effect in 2014. The herring fishery Changes From Proposed Rule to Final limits in data poor species that are more opened for the 2014 fishing year on Rule appropriate than the methodology January 1, 2014, and the herring fishery implemented in Framework 3, which is In § 648.2, NMFS is clarifying the has already harvested more than 80 scaled up to achieve maximum herring definitions for herring and blueback percent of the allocated catch for the catch. The Herring Alliance, Wild herring by including a definition for year. The cap must be in place upon Oceans, and CHOIR commented that the blueback herring and removing publication of this final rule in order to cap should be biologically based, should blueback herring from the definition of constrain river herring and shad catch be focused on the conservation of river ‘‘Herring.’’ The proposed rule only on as much of the herring fishery in herring and shad, and should reduce included a definition for ‘‘river herring 2014 as possible. If the herring fishery river herring and shad mortality. The and shad’’ to include the four species of continues to operate without a cap Herring Alliance, Wild Oceans, and river herring and shad and their genus through the rest of 2014 in Area 2 CHOIR recommended that the New and species names. primarily, the benefit of the caps in England Council should request that the In § 648.7(b)(3)(i), NMFS clarifies that 2014 will be forgone altogether if the SSC review cap limits and the the requirement for herring vessels to herring fishery catches its remaining methodology used to set them. report total catch retained by statistical allocation before the final rule makes Response: Data do not appear robust area only applies to herring vessels that the river herring and shad caps enough to determine a biologically- are fishing with midwater trawl or effective. The Council submitted its based cap at this time. Based on the best bottom trawl gear. The proposed rule final version of Framework 3 for NMFS scientific information available, the would have required all herring vessels review in March 2014, meaning that Council determined, and NMFS agrees, issued a limited access herring permit or final NMFS action would occur well that caps based on past performance of an Areas 2/3 open access herring permit after the herring fishery was underway. the herring fishery, scaled to the herring to report total catch retained regardless As a result, NMFS intended from the annual catch limit of 107,800 mt for of the gear type they use. NMFS will use outset to implement these measures 2013–2015, is an acceptable limit on the the ‘‘total catch retained’’ portion of the upon publication due to the need and amount of catch in the herring fishery. report to monitor catch caps for river the public interest. Even though it is As the Council considers additional herring and shad, and haddock, which near the end of 2014 and only one area information on the biology of river only apply to vessels using midwater remains open (Area 2) to the herring herring and shad, it can use that trawl or bottom trawl gear. NMFS does fishery, NMFS believes that it is still information to try to establish catch not need the total catch retained important to implement the measures caps directly tied to river herring and information for other gear types and is upon publication. These species have a shad biology. therefore not requiring them to report it. high level of importance in the Comment 10: The Herring Alliance, NMFS has also made some changes to ecosytems, the public is extremely CHOIR, and Wild Oceans commented the regulatory text in paragraphs as interested in measures to protect them,
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and this final rule implements measures increased the size standard from $19.0 in some cases may be more costly for all that provide possible protection of these to $20.5 million for finfish fishing, from entities regardless of whether they are species from excessive catch in the $5 to $5.5 million for shellfish fishing, classified as small or large under SBA herring fishery. and from $7.0 million to $7.5 million for standards. Therefore, the addition of no The Office of Management and Budget other marine fishing, for-hire more than six small entities would not has determined that this rule is not businesses, and marinas. change the assessment of impacts significant according to Executive Order This action will affect all limited described in the IRFA and supported in 12866. access herring vessels (i.e., category A, this FRFA. This final rule does not contain B, or C permit). In 2012, there were 94 policies with federalism or ‘‘takings’’ fishing vessels that had a limited access Description of the Steps the Agency Has implications, as those terms are defined herring permit. Vessels and/or permits Taken To Minimize the Significant in E.O. 13132 and E.O. 12630, may be owned by entities affiliated by Economic Impact on Small Entities respectively. stock ownership, common management, Consistent With the Stated Objectives of NMFS, pursuant to section 604 of the identity of interest, contractual Applicable Statutes, Including a Regulatory Flexibility Act (RFA), has relationships, or economic dependency. Statement of the Factual, Policy, and completed a final regulatory flexibility For the purposes of this analysis, Legal Reasons for Selecting the analysis (FRFA) in support of affiliated ownership entities are Alternative Adopted in the Final Rule Framework 3 in this final rule. The determined by those entities with and Why Each One of the Other FRFA incorporates the IRFA, a summary common ownership personnel as listed Significant Alternatives to the Rule of the significant issues raised by the on permit application documentation. Considered by the Agency Which Affect public comments in response to the Only permits with identical ownership the Impact on Small Entities Was IRFA, NMFS responses to those personnel are categorized as an Rejected comments, a summary of the analyses ownership entity. For example, if five During the development of completed in the Framework 3 EA, and permits have the same seven personnel Framework 3, NMFS and the Council this portion of the preamble. A listed as co-owners on their application considered ways to reduce the summary of the IRFA was published in paperwork, those seven personnel form regulatory burden on, and provide the proposed rule for this action and is one ownership entity, covering those flexibility for, the regulated entities in not repeated here. A description of why five permits. If one or several of the this action. Proposed actions and this action was considered, the seven owners also own additional alternatives are described in detail in objectives of, and the legal basis for this vessels, with different co-owners (i.e., Framework 3, which includes an EA, rule is contained in Framework 3 and in either sub-sets of the original seven RIR, and IRFA (available at ADDRESSES). the preamble to the proposed and this personnel or new co-owners), those The measures implemented by this final final rule, and is not repeated here. All ownership arrangements are deemed to rule minimize the economic impacts on of the documents that constitute the be separate ownership entities for the small entities to the extent practicable. FRFA are available from NMFS and a purpose of this analysis. Overall, this rule minimizes economic copy of the IRFA, the RIR, and the EA Pursuant to the Regulatory Flexibility impacts (i.e., directed fishery closures) are available upon request (see Act, and prior to SBA’s June 12, 2014, by dividing catch caps across various ADDRESSES). interim final rule, NMFS prepared an areas. If a catch cap in a given area for IRFA for this action using SBA’s former a specific gear is reached, the measures Summary of the Significant Issues size standards. Based on ownership implemented by this action will close Raised by the Public Comments in criterion explained above and NMFS only that area to that gear type. Thus, Response to the IRFA, a Summary of the dealer-reported landings data for 3 years the catch cap measures avoid closing Assessment of the Agency of Such ending in 2012, and the July 2013 size the directed herring fishery in all areas Issues, and a Statement of Any Changes standards for finfish and shellfish firms, due to a single catch cap overage. This Made in the Proposed Rule as a Result the Council and NMFS determined that seeks to minimize negative impacts on of Such Comments there are 72 directly regulated small fishing businesses reliant on gear types NMFS received no comments in entities and 6 large entities, as defined subject to directed herring fishery response to the IRFA. in section 601 of the RFA. Not all of closures in terms of forgone profits. The these permitted firms were active: Only extent of these impacts depends on Description and Estimate of Number of 25 directly regulated small entities and when an area is closed to directed Small Entities To Which the Final Rule 4 large entities were actively fishing for fishing relative to nearby areas available Will Apply herring during the last 3 years. NMFS for directed herring fishing. Further, the On June 20, 2013, the Small Business has reviewed the analyses prepared for catch caps are not likely to preclude Administration (SBA) issued a final rule this action in light of the new size herring fishing in all areas and will revising the small business size standards effective July 14, 2014. The provide midwater trawl vessels an standards for several industries effective new standards could result in no more opportunity to fish in Herring July 22, 2013 (78 FR 37398). The rule than six additional entities being Management Area 3 (Georges Bank) increased the size standard for finfish considered small. without a catch cap, thereby potentially fishing from $4.0 to $19.0 million, Taking this change into consideration, mitigating some of the negative impacts. shellfish fishing from $4.0 to $5.0 NMFS has identified no additional million, and other marine fishing from significant alternatives that accomplish Small Entity Compliance Guide $4.0 to $7.0 million. The IRFA that the statutory objectives and minimize any Section 212 of the Small Business Council and NMFS developed for this significant economic impacts of this Regulatory Enforcement Fairness Act of action used the SBA size standards that action on small entities. Further, the 1996 states that, for each rule or group became effective in July 2013. On June new size standards do not affect the of related rules for which an agency is 12, 2014, SBA issued an interim final decision to prepare a FRFA for this required to prepare a FRFA, the agency rule revising the small business size action. The IRFA described that the will publish one or more guides to assist standards for several industries effective alternatives to the proposed action small entities in complying with the July 14, 2014 (79 FR 33467). The rule would have no economic benefits, and rule, and will designate such
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publications as ‘‘small entity § 648.7 Recordkeeping and reporting vessel has been issued and holds a valid compliance guides.’’ The agency will requirements. herring permit. explain the actions a small entity is * * * * * * * * * * required to take to comply with a rule (b) * * * ■ 6. In § 648.200, paragraph (a) or group of rules. As part of this (3) * * * introductory text is revised, paragraph rulemaking process, a letter to permit (i) Atlantic herring owners or (b)(6) is added, and paragraphs (f) and holders that also serves as a small entity operators issued a limited access permit (g) are revised to read as follows: compliance guide (the guide) was or Areas 2/3 open access permit. The prepared. Copies of this final rule are § 648.200 Specifications. owner or operator of a vessel issued a available from the Greater Atlantic (a) The Atlantic Herring Plan limited access permit or Areas 2/3 open Regional Fisheries Office, and the guide Development Team (PDT) shall meet at access permit to fish for herring must (i.e., permit holder letter) will be sent to least every 3 years, but no later than July report catch (retained and discarded) of all holders of permits for the herring of the year before new specifications are herring daily via VMS, unless exempted fishery. The guide and this final rule implemented, with the Atlantic States by the Regional Administrator. The will be available upon request. Marine Fisheries Commission’s report shall include at least the (Commission) Atlantic Herring Plan Description of Projected Reporting, following information, and any other Review Team (PRT) to develop and Recordkeeping, and Other Compliance information required by the Regional recommend the following specifications Requirements Administrator: Fishing Vessel Trip for a period of 3 years for consideration Report serial number; month and day This action does not contain any new by the New England Fishery herring was caught; pounds retained for collection-of-information, reporting, Management Council’s Atlantic Herring each herring management area; and recordkeeping, or other compliance Oversight Committee: Overfishing Limit pounds discarded for each herring requirements. This action does not (OFL), Acceptable Biological Catch management area. Additionally, the duplicate, overlap, or conflict with any (ABC), Annual Catch Limit (ACL), owner or operator of a vessel issued a other Federal rules. Optimum yield (OY), domestic annual limited access permit or Areas 2/3 open harvest (DAH), domestic annual List of Subjects in 50 CFR Part 648 access permit to fish for herring using processing (DAP), U.S. at-sea processing midwater trawl or bottom trawl gear Fisheries, Fishing, Recordkeeping and (USAP), border transfer (BT), the sub- must report daily via VMS the estimated reporting requirements. ACL for each management area, total amount of all species retained (in including seasonal periods as specified Dated: November 21, 2014. pounds, landed weight) by statistical at § 648.201(d) and modifications to Samuel D. Rauch III, area for use in tracking catch against sub-ACLs as specified at § 648.201(f), Deputy Assistant Administrator for catch caps (haddock, river herring and the amount to be set aside for the RSA Regulatory Programs, National Marine shad) in the herring fishery. Daily (from 0 to 3 percent of the sub-ACL from Fisheries Service. Atlantic herring VMS catch reports must any management area), and river herring be submitted in 24-hr intervals for each For the reasons set out in the and shad catch caps, as specified in day and must be submitted by 0900 hr preamble, 50 CFR part 648 is amended § 648.201(a)(4). Recommended (9:00 a.m.) of the following day. Reports as follows: specifications shall be presented to the are required even if herring caught that New England Fishery Management PART 648—FISHERIES OF THE day has not yet been landed. This report Council. NORTHEASTERN UNITED STATES does not exempt the owner or operator from other applicable reporting * * * * * ■ 1. The authority citation for part 648 requirements of this section. (b) * * * continues to read as follows: (6) River herring and shad catch caps * * * * * may be allocated to the herring fishery Authority: 16 U.S.C. 1801 et seq. § 648.10 [Amended] by the following: Species, as defined in ■ 2. In § 648.2, the definition for § 648.2, either separately or combined; ■ ‘‘herring’’ is removed and the 4. In § 648.10, paragraph (l) is area as specified in paragraph (f)(7) of definitions for ‘‘Blueback herring,’’ removed and reserved. this section; vessel permit; gear type; or any combination of these. ‘‘River herring,’’ and ‘‘Shad,’’ are added ■ 5. In § 648.14, paragraph (r)(1)(ii)(B) is in alphabetical order to read as follows: revised to read as follows: * * * * * (f) Management areas. The § 648.2 Definitions. § 648.14 Prohibitions. specifications process establishes sub- * * * * * * * * * * ACLs and other management measures Blueback herring means Alosa (r) * * * for the three management areas, which aestivalis. may have different management (1) * * * * * * * * measures. Management Area 1 is River herring means alewife (Alosa (ii) * * * subdivided into inshore and offshore pseudoharengus) and blueback herring (B) Fish for, possess, transfer, receive, sub-areas. The management areas are (Alosa aestivalis). or sell; or attempt to fish for, possess, defined as follows: transfer, receive, or sell; more than (1) Management Area 1 (Gulf of * * * * * 2,000 lb (907.2 kg) of herring per trip; Maine): All U.S. waters of the Gulf of Shad means American shad (Alosa or land, or attempt to land more than Maine (GOM) north of a line extending sapidissima) and hickory shad (Alosa 2,000 lb (907.2 kg) of herring per day in from a point at 41°39′ N. lat, 70°00′ W. mediocris). or from a management area closed long. to 42°53′ 14.32125″ N. lat., 67° 44′ * * * * * pursuant to § 648.201(a), or from a river 33.01613″ W. long., thence northerly ■ 3. In § 648.7, paragraph (b)(3)(i) herring and shad catch cap closure area along the U.S.-Canada Maritime introductory text is revised to read as that has been closed to specified gear Boundary to the U.S.-Canadian border, follows: pursuant to § 648.201(a)(4)(ii), if the to include state and Federal waters
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adjacent to the states of Maine, New Point Latitude Longitude Point Latitude Longitude Hampshire, and Massachusetts. Management Area 1 is divided into Area JF2A .... 42°00′ N 70°00′ W MA2A ... 42°00′ N 70°00′ W 1A (inshore) and Area 1B (offshore). The JF2B .... 42°00′ N 69°30′ W JF2C .... 41°30′ N 69°30′ W line dividing these areas is described by ° ′ ° ′ (C) March–April River Herring the following coordinates: JF2D .... 41 30 N 70 00 W JF2A .... 42°00′ N 70°00′ W Monitoring/Avoidance Sub-Area 3. Point Latitude Longitude Note (C) January–February River Herring Point Latitude Longitude Note 1 ...... 41°58′ N 70° 00′ W Monitoring/Avoidance Sub-Area 3. ° ′ 1 2 ...... 42°38′ N 70° 00′ W MA3A ... 41 00 N ( ) 3 ...... 42°53′ N 69° 40′ W MA3B ... 41°00′ N 71°00′ W Point Latitude Longitude Note 4 ...... 43°12′ N 69° 00′ W MA3C .. 40°30′ N 71°00′ W 5 ...... 43°40′ N 68° 00′ W MA3D .. 40°30′ N 71°30′ W 1 JF3A .... 41°30′ N 72°00′ W 6 ...... 43°58′16.0314″ 67° 21′26.157″ ( ) MA3E ... 40°00′ N 71°30′ W JF3B .... 41°30′ N 71°00′ W N W MA3F ... 40°00′ N 72°30′ W JF3C .... 40°30′ N 71°00′ W 1 MA3G .. (2) 72°30′ W (3) Point 6 falls on the U.S.-Canada Maritime JF3D .... 40°30′ N 72°30′ W Boundary. MA3A ... 41°00′ N (1) (3) JF3E .... (1) 72°30′ W (3) JF3F .... (2) 72°00′ W (3) 1 The easternmost shoreline of Long Island, (2) Management Area 2 (South ° ′ ° ′ Coastal Area): All state and Federal JF3A .... 41 30 N 72 00 W New York. 2 The southernmost shoreline of Long Is- waters inclusive of sounds and bays, 1 The southernmost shoreline of Long Is- land, New York. bounded on the east by 70°00′ W. long. land, New York. 3 Points MA3G and MA3A are connected 2 and the outer limit of the U.S. Exclusive The north-facing shoreline of Long Island, following the southern shoreline of Long Is- New York. land, New York. Economic Zone; bounded on the north 3 Points JF3E and JF3F are connected fol- and west by the southern coastline of lowing the coastline of the south fork of east- (D) March–April River Herring ern Long Island, New York. Cape Cod, Massachusetts, and the Monitoring/Avoidance Sub-Area 4. coastlines of Rhode Island, Connecticut, (D) January–February River Herring New York, New Jersey, Delaware, Monitoring/Avoidance Sub-Area 4. Point Latitude Longitude Maryland, Virginia, and North Carolina; and bounded on the south by a line Point Latitude Longitude Note MA4A ... 40°00′ N 73°30′ W following the lateral seaward boundary MA4B ... 40°00′ N 72°30′ W between North Carolina and South JF4A .... 40°30′ N 74°00′ W MA4C ... 39°00′ N 72°30′ W ° ′ ° ′ ° ′ ° ′ Carolina from the coast to the JF4B .... 40 30 N 72 30 W MA4D ... 39 00 N 73 30 W JF4C .... 40°00′ N 72°30′ W MA4A ... 40°00′ N 73°30′ W Submerged Lands Act line, ° ′ ° ′ ° ′ ″ JF4D .... 40 00 N 72 00 W approximately 33 48 46.37 N. lat, JF4E .... 39°30′ N 72°00′ W 78°29′46.46″ W. long., and then heading JF4F .... 39°30′ N 73°30′ W (E) March–April River Herring due east along 38°48′46.37″ N. lat. to the JF4G .... 40°00′ N 73°30′ W Monitoring/Avoidance Sub-Area 5. outer limit of the US Exclusive JF4H .... 40°00′ N 74°00′ W (1) Economic Zone. JF4A .... 40°30′ N 74°00′ W (1) Point Latitude Longitude Note (3) Management Area 3 (Georges 1 Points JF4H and JF4A are connected fol- MA5A ... 40°30′ N 74°00′ W Bank): All U.S. waters east of 70°00′ W. lowing 74 °W longitude and the easternmost MA5B ... 40°30′ N 73°30′ W shoreline of New Jersey, whichever is furthest MA5C .. 40°00′ N 73°30′ W long. and southeast of the line that runs east. from a point at 41°39′ N. lat. and 70°00′ MA5D .. 40°00′ N 74°00′ W (1) ° ′ ° ′ 1 W. long., northeasterly to U.S.-Canada (ii) March–April River Herring MA5A ... 40 30 N 74 00 W ( ) Maritime Boundary at 42°53′14.32125″ Monitoring/Avoidance Areas. The 1 Points MA5D and MA5A are connected fol- N. lat., 67°44′33.01613″ W. long. March–April River Herring Monitoring/ lowing 74 °W longitude and the easternmost Avoidance Areas include five sub-areas. shoreline of New Jersey, whichever is furthest (4) River Herring Monitoring/ Each sub-area includes the waters east. Avoidance Areas—(i) January–February bounded by the coordinates below, River Herring Monitoring/Avoidance (iii) May–June River Herring connected in the order listed by straight Areas. The January–February River Monitoring/Avoidance Areas. The May– lines unless otherwise noted. Herring Monitoring/Avoidance Areas (A) March–April River Herring June River Herring Monitoring/ include four sub-areas. Each sub-area Monitoring/Avoidance Sub-Area 1. Avoidance Areas include two sub-areas. includes the waters bounded by the Each sub-area includes the waters coordinates below, connected in the Point Latitude Longitude bounded by the coordinates below, order listed by straight lines unless connected in the order listed by straight otherwise noted. MA1A ... 43°00′ N 71°00′ W lines unless otherwise noted. ° ′ ° ′ MA1B ... 43 00 N 70 30 W (A) May–June River Herring (A) January–February River Herring MA1C ... 42°30′ N 70°30′ W Monitoring/Avoidance Sub-Area 1. MA1D ... 42°30′ N 71°00′ W Monitoring/Avoidance Sub-Area 1. MA1A ... 43°00′ N 71°00′ W Point Latitude Longitude Point Latitude Longitude (B) March–April River Herring JF1A .... 43°00′ N 71°00′ W MJ1A ... 44°00′ N 69°30′ W JF1B .... 43°00′ N 70°30′ W Monitoring/Avoidance Sub-Area 2. MJ1B ... 44°00′ N 69°00′ W JF1C .... 42°30′ N 70°30′ W MJ1C ... 43°30′ N 69°00′ W JF1D .... 42°30′ N 71°00′ W Point Latitude Longitude MJ1D ... 43°30′ N 69°30′ W JF1A .... 43°00′ N 71°00′ W MJ1A ... 44°00′ N 69°30′ W MA2A ... 42°00′ N 70°00′ W MA2B ... 42°00′ N 69°30′ W (B) January–February River Herring MA2C ... 41°30′ N 69°30′ W (B) May–June River Herring Monitoring/Avoidance Sub-Area 2. MA2D ... 41°30′ N 70°00′ W Monitoring/Avoidance Sub-Area 2.
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Point Latitude Longitude Point Latitude Longitude Point Latitude Longitude Note
MJ2A ... 42°00′ N 70°00′ W SO2C ... 42°30′ N 70°30′ W A ...... (1) 67°00′ W (6) MJ2B ... 42°00′ N 69°30′ W SO2D ... 42°30′ N 71°00′ W 1 ° ′ MJ2C ... 41°30′ N 69°30′ W SO2A ... 43°00′ N 71°00′ W The intersection of 67 00 W longitude and ° ′ ° ′ the southern coast of Maine. MJ2D ... 41 30 N 70 00 W 2 The intersection of 67°00′ W longitude and MJ2A ... 42°00′ N 70°00′ W (vi) November–December River the U.S.-Canada Maritime Boundary. 3 From POINT B to POINT C along the (iv) July–August River Herring Herring Monitoring/Avoidance Areas. U.S.-Canada Maritime Boundary. Monitoring/Avoidance Areas. The July– The November–December River Herring 4 The intersection of 42°20′ N latitude and Monitoring/Avoidance Areas include the U.S.-Canada Maritime Boundary. August River Herring Monitoring/ 5 The intersection of 70°00′ W longitude and Avoidance Areas include two sub-areas. two sub-areas. Each sub-area includes the northeast-facing shoreline of Cape Cod, Each sub-area includes the waters the waters bounded by the coordinates Massachusetts. bounded by the coordinates below, below, connected in the order listed by 6 From POINT E back to POINT A along the coastline of the United States. connected in the order listed by straight straight lines unless otherwise noted. lines unless otherwise noted. (A) November–December River (6) Georges Bank Modified Haddock (A) July–August River Herring Herring Monitoring/Avoidance Sub- Stock Area. The Georges Bank Modified Monitoring/Avoidance Sub-Area 1. Area 1. Haddock Stock Area is composed of Greater Atlantic Region Statistical Areas Point Latitude Longitude Note Point Latitude Longitude Note #521, #522, #525, #526, #561, and #562, and is defined by the following points JA1A .... 44°00′ N 70°00′ W ND1A ... 43°00′ N 71°00′ W connected in the order listed by straight JA1B .... 44°00′ N 69°30′ W ND1B ... 43°00′ N 70°00′ W ° ′ ° ′ lines unless otherwise noted: JA1C .... 43 00 N 69 30 W ND1C ... 42°00′ N 70°00′ W ° ′ ° ′ 1 JA1D .... 43 00 N 70 00 W ( ) ND1D ... 42°00′ N 69°30′ W ° ′ ° ′ 1 Point Latitude Longitude Note JA1A .... 44 00 N 70 00 W ( ) ND1E ... 41°30′ N 69°30′ W ° ′ ° ′ 1 The boundary from Points JA1D to JA1A ND1F ... 41 30 N 70 00 W A ...... 42°20′ N 70°00′ W excludes the portions Maquoit Bay and Middle ND1G .. (1) 70°00′ W (3) B ...... 42°20′ N (1) (2) Bay (Brunswick, ME) east of 70°00′ W. ND1H ... 42°00′ N (2) (3) C ...... 40°30′ N (3) (2) ° ′ ° ′ D ...... 40°30′ N 66°40′ W (B) July–August River Herring ND1I .... 42 00 N 70 30 W ND1J ... 42°30′ N 70°30′ W E ...... 39°50′ N 66°40′ W Monitoring/Avoidance Sub-Area 2. ND1K ... 42°30′ N 71°00′ W F ...... 39°50′ N 70°00′ W (4) ND1A ... 43°00′ N 71°00′ W A ...... 42°20′ N 70°00′ W (4) Point Latitude Longitude 1 The south-facing shoreline of Cape Cod, 1 The intersection of 42°20′ N latitude and JA2A .... 44°00′ N 69°00′ W Massachusetts. the U.S.-Canada Maritime Boundary. 2 JA2B .... 44°00′ N 68°30′ W 2 The west-facing shoreline of Cape Cod, From POINT B to POINT C following the ° ′ ° ′ Massachusetts. U.S.-Canada Maritime Boundary. JA2C .... 43 30 N 68 30 W 3 ° ′ ° ′ ° ′ 3 Point ND1G and ND1H are connected fol- The intersection of 40 30 N latitude and JA2D .... 43 30 N 69 00 W the U.S.-Canada Maritime Boundary. JA2A .... 44°00′ N 69°00′ W lowing the coastline of Cape Cod, 4 Massachusetts. From POINT F back to POINT A along 70°00′ W longitude and the coastlines of Nan- (v) September–October River Herring tucket Island and mainland Cape Cod, Massa- (B) November–December River chusetts, whichever is further east. Monitoring/Avoidance Areas. The Herring Monitoring/Avoidance Sub- September–October River Herring Area 2. (7) River herring and shad catch cap Monitoring/Avoidance Areas include areas—(i) Gulf of Maine Catch Cap two sub-areas. Each sub-area includes Point Latitude Longitude Area. The Gulf of Maine Catch Cap Area the waters bounded by the coordinates is composed of the portions of Greater below, connected in the order listed by ND2A ... 41°30′ N 72°00′ W Atlantic Region Statistical Areas #464, straight lines unless otherwise noted. ND2B ... 41°30′ N 70°00′ W #465, #467, #511, #512, #513, #514, and (A) September–October River Herring ND2C ... 40°30′ N 70°00′ W #515 in U.S. waters. The Gulf of Maine Monitoring/Avoidance Sub-Area 1. ND2D ... 40°30′ N 70°30′ W Catch Cap Area is bounded on the west ND2E ... 41°00′ N 70°30′ W by the coastline of the United States, Point Latitude Longitude Note ND2F ... 41°00′ N 72°00′ W ° ′ ° ′ bounded on the east by the U.S.-Canada ND2A ... 41 30 N 72 00 W Maritime Boundary, and bounded on SO1A ... 44°30′ N 68°00′ W ° ′ 1 2 the south by the following coordinates SO1B ... 44 30 N ( ) ( ) (5) Gulf of Maine Modified Haddock SO1C ... 44°00′ N (3) (2) connected by straight lines in the order SO1D ... 44°00′ N 68°00′ W Stock Area. The Gulf of Maine Modified listed: SO1A ... 44°30′ N 68°00′ W Haddock Stock Area is composed of the portions of Greater Atlantic Region Point Latitude Longitude 1 ° ′ The intersection of 44 30 N and the U.S.- Statistical Areas #464, #465, #511, #512, Canada Maritime Boundary. A ...... (1) 70°00′ W 2 #513, #514, and #515 in U.S. waters, Point SO1B and Point SO1C are con- B ...... 42°20′ N 70°00′ W nected along the U.S.-Canada Maritime and is defined by the following points C ...... 42°20′ N (2) Boundary. connected in the order listed by straight 3 ° ′ The intersection of 44 00 N and the U.S.- lines unless otherwise noted: 1 The intersection of 70°00′ W longitude and Canada Maritime Boundary. the northwest facing shoreline of Cape Cod, Massachusetts (B) September–October River Herring Point Latitude Longitude Note 2 The intersection of 42°00′ N latitude and Monitoring/Avoidance Sub-Area 2. the U.S.-Canada Maritime Boundary. A ...... (1) 67°00′ W Point Latitude Longitude B ...... (2) 67°00′ W (3) (ii) Cape Cod Catch Cap Area. The C ...... 42°20′ N (4) (3) Cape Cod Catch Cap Area is composed SO2A ... 43°00′ N 71°00′ W D ...... 42°20′ N 70°00′ W of Greater Atlantic Region Statistical SO2B ... 43°00′ N 70°30′ W E ...... (5) 70°00′ W (6) Area #521, and is defined by the
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following points connected in the order coordinates of this area are the same as incidental catch cap for haddock in listed by straight lines unless otherwise Management Area 2 (South Coastal § 648.85(d) has been caught, no vessel noted: Area), as specified in paragraph (f)(2) of issued a Federal Atlantic herring permit this section. and fishing with midwater trawl gear in Point Latitude Longitude Note (8) River herring and shad catch cap the applicable Accountability Measure closure areas—(i) Gulf of Maine Catch (AM) Area, i.e., the Herring GOM 1 ° ′ A ...... ( ) 70 00 W Cap Closure Area. The coordinates of B ...... 42°20′ N 70°00′ W Haddock AM Area or Herring GB C ...... 42°20′ N 68°50′ W this area are the same as the Gulf of Haddock AM Area, as defined in D ...... 41°00′ N 68°50′ W Maine Catch Cap Area, as specified in § 648.86(a)(3)(ii)(A)(2) and (3) of this E ...... 41°00′ N 69°30′ W paragraph (f)(7)(i) of this section. part, may fish for, possess, or land F ...... 41°10′ N 69°30′ W (ii) Cape Cod Catch Cap Closure Area. herring in excess of 2,000 lb (907.2 kg) G ...... 41°10′ N 69°50′ W The coordinates of this area are the per trip in or from the applicable AM H ...... 41°20′ N 69°50′ W same as the Cape Cod Catch Cap Area, Area, and from landing herring more ° ′ 2 3 I ...... 41 20 N ( ) ( ) as specified in paragraph (f)(7)(ii) of this than once per calendar day, unless all 4 ° ′ 3 J ...... ( ) 70 00 W ( ) section. 5 ° ′ 6 herring possessed and landed by a K ...... ( ) 70 00 W ( ) (iii) Georges Bank Catch Cap Closure A ...... (1) 70°00′ W (6) vessel were caught outside the Area. The coordinates of this area are applicable AM Area and the vessel’s 1 The intersection of 70°00′ W longitude and the same as the Georges Bank Catch Cap gear is not available for immediate use the northeast-facing shoreline of Cape Cod, Area, as specified in paragraph (f)(7)(iii) Massachusetts as defined in § 648.2 while transiting 2 The intersection of 41°20′ N latitude and of this section. the applicable AM Area. Upon this the northeast-facing shoreline of Nantucket Is- (iv) Southern New England/Mid- determination, the haddock possession land. Atlantic Catch Cap Closure Area. The 3 limit is reduced to 0 lb (0 kg) in the From Point I to Point J along the north- Southern New England/Mid-Atlantic applicable AM area for a vessel issued east-facing shoreline of Nantucket Island. Catch Cap Closure Area is composed of 4 The intersection of 70°00′ W longitude and a Federal Atlantic herring permit and the northeast-facing shoreline of Nantucket Is- the portions of Greater Atlantic Region fishing with midwater trawl gear or for land. Statistical Areas #537, #538, #539, #611, a vessel issued an All Areas Limited 5 ° ′ The intersection of 70 00 W longitude and #612, #613, #614, #615, #616, #621, Access Herring Permit and/or an Areas the south-facing shoreline of mainland Cape #622, #623, #625, #626, #627, #631, Cod, Massachusetts. 2 and 3 Limited Access Herring Permit 6 From Point K back to Point A along the #632, #635, and #636 in US waters, and fishing on a declared herring trip, east-facing shoreline of Cape Cod, is defined by the following coordinates, regardless of area fished or gear used, in Massachusetts. connected by straight lines in the order the applicable AM area, unless the (iii) Georges Bank Catch Cap Area. listed unless otherwise noted: vessel also possesses a Northeast The Georges Bank Catch Cap Area is multispecies permit and is operating on Point Latitude Longitude Note composed of the portions of Greater a declared (consistent with § 648.10(g)) Atlantic Region Statistical Areas #522, A ...... 35°00′ N (1) Northeast multispecies trip. #525, #526, #541, #542, #543, #561, B ...... 35°00′ N 74°00′ W * * * * * #562, and #640 in U.S. waters, and is C ...... 37°00′ N 74°00′ W (4) River herring and shad catch cap. defined by the following points, D ...... 37°00′ N 73°00′ W (i) The catch from all trips that land connected in the order listed by straight E ...... 38°00′ N 73°00′ W ° ′ ° ′ more than 6,600 lb (3 mt) of herring lines unless otherwise noted: F ...... 38 00 N 72 00 W shall apply to the river herring and shad G ...... 39°00′ N 72°00′ W catch cap in the herring fishery. Caps by Point Latitude Longitude Note H ...... 39°00′ N 71°40′ W I ...... 39°50′ N 71°40′ W gear and by area shall be established A ...... (1) 70°00′ W J ...... 39°50′ N 70°00′ W through the specifications process B ...... (2) 70°00′ W (3) K ...... (2) 70°00′ W (3) described in § 648.201. C ...... 41°20′ N (4) (3) A ...... 35°00′ N (1) (3) (ii) Beginning on the date that NMFS D ...... 41°20′ N 69°50′ W projects that river herring and shad 1 The intersection of 35°00′ N latitude and E ...... 41°10′ N 69°50′ W catch will reach 95 percent of a catch ° ′ ° ′ the mainland shoreline of North Carolina. F ...... 41 10 N 69 30 W 2 The intersection of 70°00′ W longitude and cap for specified gear applicable to an G ...... 41°00′ N 69°30′ W the south-facing shoreline of mainland Cape area specified in § 648.200(f)(7) for the ° ′ ° ′ H ...... 41 00 N 68 50 W Cod, Massachusetts. remainder of the fishing year, NMFS I ...... 42°20′ N 68°50′ W 3 From Point K back to Point A along the J ...... 42°20′ N (5) (6) mainland shoreline of the United States. shall prohibit vessels from fishing for, A ...... (1) 70°00′ W (6) possessing, catching, transferring, or (g) All aspects of the following landing more than 2,000 lb (907.2 kg) of 1 The intersection of 70°00′ W longitude and measures can be modified through the Atlantic herring per trip using the the outer limit of the U.S. Exclusive Economic specifications process: applicable gear in the applicable catch Zone. (1) AMs; 2 ° ′ cap closure area, specified in The intersection of 70 00 W longitude and (2) Possession limits; the south-facing shoreline of Nantucket Island. (3) River Herring Monitoring/ § 648.200(f)(8), and from landing herring 3 From Point B to Point C along the south- more than once per calendar day, except and east-facing shorelines of Nantucket Is- Avoidance Areas; and land. (4) River herring and shad catch caps. as provided in paragraphs (b) and (c) of 4 ° ′ this section. NMFS shall implement The intersection of 41 20 N latitude and ■ 7. In § 648.201, paragraphs (a)(2) is the northeast-facing shoreline of Nantucket Is- these restrictions in accordance with the revised, paragraph (a)(4) is added, and land. APA. 5 The intersection of 42°20′ N latitude and paragraph (e) is revised to read as the U.S.-Canada Maritime Boundary. follows: * * * * * 6 From Point J back to Point A along the (e) Up to 500 mt of the Area 1A sub- U.S.-Canada Maritime Boundary and the outer § 648.201 AMs and harvest controls. ACL shall be allocated for the fixed gear limit of the U.S. Exclusive Economic Zone. (a) * * * fisheries in Area 1A (weirs and stop (iv) Southern New England/Mid- (2) When the Regional Administrator seines) that occur west of 67°16.8′ W. Atlantic Catch Cap Area. The has determined that the GOM and/or GB long (Cutler, Maine). This set-aside shall
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be available for harvest by fixed gear only from Area 2 or Area 3, as defined land up to, but no more than, 20,000 lb within the specified area until in § 648.200(f), provided none of the (9 mt) of Atlantic herring from only November 1 of each fishing year. Any accountability measures or harvest Area 2 or Area 3, as defined in portion of this allocation that has not restrictions specified in § 648.201 have § 648.200(f), per trip, and is limited to been utilized by November 1 shall be been implemented. Such a vessel may one landing of herring per calendar day, restored to the sub-ACL allocation for fish in Area 1 only if issued an open provided none of the accountability Area 1A. access herring permit or a Limited measures or harvest restrictions * * * * * Access Incidental Catch Herring Permit, specified in § 648.201 have been ■ 8. In § 648.204, paragraph (a) is and only as authorized by the respective implemented. revised to read as follows: permit. (6) A vessel issued a herring permit (3) A vessel issued a Limited Access may possess herring roe provided that § 648.204 Possession restrictions. Incidental Catch Herring Permit may the carcasses of the herring from which (a) A vessel must be issued and fish for, possess, or land up to, but no it came are not discarded at sea. possess a valid limited access herring more than, 55,000 lb (25 mt) of Atlantic * * * * * permit to fish for, possess, or land more herring in any calendar day, and is ■ 9. In § 648.206, paragraphs (b)(36) and than 6,600 lb (3 mt) of Atlantic herring limited to one landing of herring per (37) are revised and (b)(38) is added to from any herring management area in calendar day, from any management read as follows: the EEZ, provided none of the harvest area defined in § 648.200(f), provided restrictions specified in § 648.201 has none of the accountability measures or § 648.206 Framework provisions. been implemented. harvest restrictions specified in * * * * * (1) A vessel issued an All Areas § 648.201 have been implemented. (b) * * * Limited Access Herring Permit may fish (4) A vessel issued an All Areas Open for, possess, or land Atlantic herring Access Permit may fish for, possess, or (36) River herring and shad catch with no possession restriction from any land up to, but no more than, 6,600 lb caps, including species-specific caps, of the herring management areas (3 mt) of Atlantic herring from any and vessels, permits, trips, gears, and defined in § 648.200(f), provided none herring management area per trip, and areas to which caps apply; of the accountability measures or is limited to one landing of herring per (37) River herring and shad Catch Cap harvest restrictions specified in calendar day, provided none of the Areas and Catch Cap Closure Areas; and § 648.201 have been implemented. accountability measures or harvest (38) Any other measure currently (2) A vessel issued only an Areas 2 restrictions specified in § 648.201 have included in the FMP. and 3 Limited Access Herring Permit been implemented. * * * * * may fish for, possess, or land Atlantic (5) A vessel issued an Areas 2/3 Open [FR Doc. 2014–28131 Filed 12–2–14; 8:45 am] herring with no possession restriction Access Permit may fish for, possess, or BILLING CODE 3510–22–P
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Proposed Rules Federal Register Vol. 79, No. 233
Thursday, December 4, 2014
This section of the FEDERAL REGISTER room, which is located in Room 1141 of notice. This action will allow interested contains notices to the public of the proposed the USDA South Building, 14th Street persons additional time to prepare and issuance of rules and regulations. The and Independence Avenue SW., submit comments. purpose of these notices is to give interested Washington, DC. Normal reading room Authority: 7 U.S.C. 450, 7701–7772, and persons an opportunity to participate in the hours are 8 a.m. to 4:30 p.m., Monday rule making prior to the adoption of the final 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR rules. through Friday, except holidays. To be 2.22, 2.80, and 371.3. sure someone is there to help you, Done in Washington, DC, this 1st day of please call (202) 799–7039 before December 2014. coming. DEPARTMENT OF AGRICULTURE Kevin Shea, FOR FURTHER INFORMATION CONTACT: Ms. Administrator, Animal and Plant Health Animal and Plant Health Inspection Nicole L. Russo, Assistant Director, Inspection Service. Service Regulatory Coordination and [FR Doc. 2014–28488 Filed 12–3–14; 8:45 am] Compliance, PPQ, APHIS, 4700 River BILLING CODE 3410–34–P 7 CFR Parts 318 and 319 Road Unit 133, Riverdale, MD 20737– [Docket No. APHIS–2010–0082] 1231; (301) 851–2159. SUPPLEMENTARY INFORMATION: On RIN 0579–AD71 COMMODITY FUTURES TRADING September 9, 2014, we published in the COMMISSION Establishing a Performance Standard Federal Register (79 FR 53346–53352) a for Authorizing the Importation and proposal to amend our regulations 17 CFR Parts 1, 15, 17, 19, 32, 37, 38, Interstate Movement of Fruits and governing the importations of fruits and 140, and 150 Vegetables vegetables by broadening our existing performance standard to provide for RIN 3038–AD99; 3038–AD82 AGENCY: Animal and Plant Health approval of all new fruits and vegetables Position Limits for Derivatives and Inspection Service, USDA. for importation into the United States Aggregation of Positions ACTION: Proposed rule; reopening of using a notice-based process. We also comment period. proposed to remove the region- or AGENCY: Commodity Futures Trading commodity-specific phytosanitary Commission. SUMMARY: We are reopening the requirements currently found in these ACTION: Notice of proposed rulemaking; comment period for our proposed rule regulations. Likewise, we proposed an reopening of comment periods. that would amend our regulations equivalent revision of the performance governing the importation and interstate standard in our regulations governing SUMMARY: On December 12, 2013, the movement of fruits and vegetables by the interstate movement of fruits and Commodity Futures Trading broadening our existing performance vegetables from Hawaii and the U.S. Commission (‘‘Commission’’) published standard to provide for approval of all territories (Guam, Northern Mariana in the Federal Register a notice of new fruits and vegetables for Islands, Puerto Rico, and the U.S. Virgin proposed rulemaking (the ‘‘Position importation or interstate movement into Islands) and the removal of commodity- Limits Proposal’’) to establish or within the United States using a specific phytosanitary requirements speculative position limits for 28 notice-based process. This action will from those regulations. This proposal exempt and agricultural commodity allow interested persons additional time would allow for the approval of requests futures and options contracts and the to prepare and submit comments. to authorize the importation or physical commodity swaps that are DATES: The comment period for the interstate movement of new fruits and economically equivalent to such proposed rule published on September vegetables in a manner that enables a contracts. On November 15, 2013, the 9, 2014 (79 FR 53346–53352) is more flexible and responsive regulatory Commission published in the Federal reopened. We will consider all approach to evolving pest situations in Register a notice of proposed comments that we receive on or before both the United States and exporting rulemaking (the ‘‘Aggregation January 9, 2015. countries. It would not however, alter Proposal’’) to amend existing ADDRESSES: You may submit comments the science-based process in which the regulations setting out the Commission’s by either of the following methods: risk associated with importation or policy for aggregation under its position • Federal eRulemaking Portal: Go to interstate movement of a given fruit or limits regime. The Commission’s http://www.regulations.gov/#!docket vegetable is evaluated or the manner in Agricultural Advisory Committee has Detail;D=APHIS-2010-0082. which risks associated with the scheduled a public meeting to be held • Postal Mail/Commercial Delivery: importation or interstate movement of a on December 9, 2014, which will Send your comment to Docket No. fruit or vegetable are mitigated. consider, among other matters, APHIS–2010–0082, Regulatory Analysis Comments on the proposed rule were deliverable supply and exemptions for and Development, PPD, APHIS, Station required to be received on or before bona fide hedging positions. To provide 3A–03.8, 4700 River Road Unit 118, November 10, 2014. We are reopening commenters with a sufficient period of Riverdale, MD 20737–1238. the comment period on Docket No. time to respond to questions raised and Supporting documents and any APHIS–2010–0082 for an additional 60 points made at the Agricultural comments we receive on this docket days. We will also accept all comments Advisory Committee meeting, the may be viewed at http://www. received between November 11, 2014 Commission is reopening the comment regulations.gov/#!docketDetail;D= (the day after the close of the original periods for an additional 45 days. APHIS-2010-0082 or in our reading comment period) and the date of this Comments should be limited to the
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following issues as they pertain to 5494, [email protected]; Commodity modifications in the Aggregation agricultural commodities: Hedges of a Futures Trading Commission, Three Proposal would apply to the position physical commodity by a commercial Lafayette Centre, 1155 21st Street NW., limits regime for 28 exempt and enterprise; and the process for Washington, DC 20581. agricultural commodity futures and estimating deliverable supplies used in SUPPLEMENTARY INFORMATION: options contracts and the physical the setting of spot month limits. commodity swaps that are economically I. Background DATES: The comment periods for the equivalent to such contracts. Aggregation Proposal published The Commission has long established In order to provide interested parties November 15, 2013, at 78 FR 68946, and and enforced speculative position limits with an opportunity to comment on the for the Position Limits Proposal for futures and options contracts on Aggregation Proposal during the published December 12, 2013, at 78 FR various agricultural commodities as comment period on the Position Limits 75680, will reopen on December 9, authorized by the Commodity Exchange Proposal, the Commission extended the 2014, and close on January 22, 2015. Act (‘‘CEA’’).1 The part 150 position comment period for the Aggregation 2 Proposal to February 10, 2014, the same ADDRESSES: You may submit comments, limits regime generally includes three end date as the comment period for the identified by RIN 3038–AD99 for the components: (1) The level of the limits, Position Limits Proposal.9 Position Limits Proposal or RIN 3038– which set a threshold that restricts the number of speculative positions that a Subsequent to publication of the AD82 for the Aggregation Proposal, by Position Limits Proposal and the any of the following methods: person may hold in the spot-month, • individual month, and all months Aggregation Proposal, the Commission Agency Web site: http:// directed staff to schedule a June 19, comments.cftc.gov; combined,3 (2) exemptions for positions • that constitute bona fide hedging 2014, public roundtable to consider Mail: Christopher Kirkpatrick, certain issues regarding position limits Secretary of the Commission, transactions and certain other types of transactions,4 and (3) rules to determine for physical commodity derivatives. The Commodity Futures Trading roundtable focused on hedges of a Commission, Three Lafayette Centre, which accounts and positions a person must aggregate for the purpose of physical commodity by a commercial 1155 21st Street NW., Washington, DC enterprise, including gross hedging, 20581; determining compliance with the • position limit levels.5 The Position cross-commodity hedging, anticipatory Hand Delivery/Courier: Same as hedging, and the process for obtaining a Mail, above; or Limits Proposal generally sets out • proposed changes to the first and non-enumerated exemption. Discussion Federal eRulemaking Portal: http:// included the setting of spot month www.regulations.gov. Follow second components of the position limits regime and would establish limits in physical-delivery and cash- instructions for submitting comments. settled contracts and a conditional spot- Please submit your comments using speculative position limits for 28 month limit exemption. Further, the exempt and agricultural commodity only one method. All comments must be roundtable included discussion of: The futures and option contracts, and submitted in English, or if not, aggregation exemption for certain physical commodity swaps that are accompanied by an English translation. ownership interests of greater than 50 ‘‘economically equivalent’’ to such Comments will be posted as received to percent in an owned entity; and contracts (as such term is used in CEA http://www.cftc.gov. You should submit aggregation based on substantially section 4a(a)(5)).6 The Aggregation only information that you wish to make identical trading strategies. As well, the Proposal generally sets out proposed available publicly. If you wish the Commission invited comment on changes to the third component of the Commission to consider information whether to provide parity for wheat position limits regime.7 that may be exempt from disclosure contracts in non-spot month limits. In The Commission published the under the Freedom of Information Act, conjunction with the roundtable, staff Position Limits Proposal and the a petition for confidential treatment of questions regarding these topics were Aggregation Proposal separately because the exempt information may be posted on the Commission’s Web site. submitted under § 145.9 of the it believes that the proposed To provide commenters with a Commission’s regulations (17 CFR amendments regarding aggregation of sufficient period of time to respond to 145.9). positions could be appropriate questions raised and points made at the The Commission reserves the right, regardless of whether the Position roundtable, the Commission published a 8 but shall have no obligation, to review, Limits Proposal is finalized. If the notice in the Federal Register on May pre-screen, filter, redact, refuse or Aggregation Proposal is finalized first, 29, 2014, reopening the comment remove any or all of your submission the modifications would apply to the periods for the Position Limit Proposal from http://www.cftc.gov that it may current position limits regime for and the Aggregation Proposal for three deem to be inappropriate for futures and option contracts on nine weeks, from June 12, 2014 to July 3, publication, such as obscene language. enumerated agricultural commodities. If 2014. The Commission published notice All submissions that have been redacted the Position Limits Proposal is in the Federal Register on July 3, 2014, or removed that contain comments on subsequently finalized, the further extending the comment periods the merits of the rulemaking will be to August 4, 2014. retained in the public comment file and 1 7 U.S.C. 1 et seq. Comment letters received on the will be considered as required under the 2 See 17 CFR part 150. Part 150 of the Commission’s regulations establishes federal Position Limits Proposal are available at Administrative Procedure Act and other position limits on futures and option contracts in http://comments.cftc.gov/ applicable laws, and may be accessible nine enumerated agricultural commodities. PublicComments/ under the Freedom of Information Act. 3 See 17 CFR 150.2. CommentList.aspx?id=1436. Comment FOR FURTHER INFORMATION CONTACT: 4 See 17 CFR 150.3. letters received on the Aggregation Stephen Sherrod, Senior Economist, 5 See 17 CFR 150.4. Proposal are available at http:// 6 See Position Limits for Derivatives, 78 FR 75680 Division of Market Oversight, (202) 418– (Dec. 12, 2013). comments.cftc.gov/PublicComments/ 5452, [email protected]; or Riva Spear 7 See Aggregation of Positions, 78 FR 68946 (Nov. CommentList.aspx?id=1427. Adriance, Senior Special Counsel, 15, 2013). Division of Market Oversight, (202) 418– 8 See Aggregation Proposal, 78 FR at 68947. 9 See 79 FR 2394 (Jan. 14, 2014).
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II. Reopening of Comment Period Sometimes that may mean making the rules corresponds with ‘‘FAR Case 2013– more cost-effective and leaner, but at other 020.’’ Follow the instructions provided The Commission’s Agricultural times that will mean making them stronger Advisory Committee has scheduled a at the ‘‘Comment Now’’ screen. Please than before. Enhancing a rule can mean include your name, company name (if meeting to be held on December 9, 2014, reducing burdens to business while and adopted an agenda that includes strengthening protections for the public. I any), and ‘‘FAR Case 2013–020’’ on your consideration, among other matters, of believe our position limits proposal is exactly attached document. • two issues associated with the Position the sort of rule that needs to be enhanced, Fax: 202–501–4067. • Limits rulemaking: Deliverable supply and I look forward to working with my fellow Mail: General Services and exemptions for bona fide hedging Commissioners to finish and release this rule Administration, Regulatory Secretariat positions. To provide interested persons in a timely fashion. (MVCB), ATTN: Ms. Hada Flowers, with a sufficient period of time to [FR Doc. 2014–28482 Filed 12–3–14; 8:45 am] 1800 F Street NW., 2nd floor, respond to questions raised and points BILLING CODE 6351–01–P Washington, DC 20405. made at the Agricultural Advisory Instructions: Please submit comments Committee meeting, the Commission is only and cite ‘‘FAR Case 2013–020’’ in reopening both the Position Limit DEPARTMENT OF DEFENSE all correspondence related to this case. Proposal and the Aggregation Proposal All comments received will be posted for an additional 45-day comment GENERAL SERVICES without change to http:// period. Comments should be limited to ADMINISTRATION www.regulations.gov, including any the following issues as they pertain to personal and/or business confidential agricultural commodities: Hedges of a NATIONAL AERONAUTICS AND information provided. physical commodity by a commercial SPACE ADMINISTRATION FOR FURTHER INFORMATION CONTACT: Ms. enterprise; and the process for Cecelia L. Davis, Procurement Analyst, estimating deliverable supplies used in 48 CFR Parts 1, 4, 9, 22, and 52 at 202–219–0202 for clarification of the setting of spot month limits, as each [FAR Case: 2013–020; Docket No. 2013– content. For information pertaining to pertains to agricultural commodities. 0020; Sequence No. 1] status or publication schedules, contact Both comment periods will reopen on the Regulatory Secretariat Division at December 9, 2014, and close on January RIN 9000–AM74 202–501–4755. Please cite FAR Case 22, 2015. 2013–020. Federal Acquisition Regulation: Issued in Washington, DC, on December 1, Information on Corporate Contractor SUPPLEMENTARY INFORMATION: 2014, by the Commission. Performance and Integrity I. Background Christopher J. Kirkpatrick, Secretary of the Commission. AGENCIES: Department of Defense (DoD), DoD, GSA, and NASA are proposing General Services Administration (GSA), to revise the FAR to implement section Note: The following appendices will not and National Aeronautics and Space 852 of the National Defense appear in the Code of Federal Regulations. Administration (NASA). Authorization Act for Fiscal Year 2013 ACTION: (Pub. L. 112–239) with regard to Federal Appendices to Position Limits for Proposed rule. contracts. Section 852 requires that the Derivatives and Aggregation of SUMMARY: DoD, GSA, and NASA are FAPIIS include, to the extent Positions Reopening of Comment proposing to amend the Federal practicable, information on any parent, Periods—Commission Voting Summary Acquisition Regulation (FAR) to subsidiary, or successor entities to a and Commissioner’s Statement implement a section of the National corporation in a manner designed to Appendix 1—Commission Voting Defense Authorization Act (NDAA) for give the acquisition officials using the Summary Fiscal Year (FY) 2013 to include in the database a comprehensive Federal Awardee Performance and understanding of the performance and On this matter, Chairman Massad and Integrity Information System (FAPIIS), integrity of the corporation in carrying Commissioners Wetjen, Bowen, and to the extent practicable, identification out Federal contracts and grants. This Giancarlo voted in the affirmative. No of any immediate owner or subsidiary, Commissioner voted in the negative. proposed rule addresses the collection and all predecessors of an offeror that of information with regard to offerors Appendix 2—Statement of held a Federal contract or grant within that are responding to a solicitation for Commissioner Sharon Y. Bowen the last three years. The objective is to a Federal contract. The data on provide a more comprehensive immediate owner and direct I support this reopening of the comment understanding of the performance and subsidiaries of an entity will be period for our position limits rule. As I’ve integrity of the corporation before available through FAPIIS, based on the previously said, this is a key rule and we are awarding a Federal contract. data obtained from offerors in response well-served by giving stakeholders another DATES: Interested parties should submit to the FAR provision 52.204–17, chance to comment. written comments to the Regulatory However, we cannot allow this rule to Ownership or Control of Offeror, which linger indefinitely on our docket. It has been Secretariat at one of the addresses was published in the Federal Register at over a year since we re-proposed this rule shown below on or before February 2, 79 FR 31187, on May 30, 2014, as a final and nearly four years since it was first 2015 to be considered in the formation rule under FAR Case 2012–024. proposed. We need to finish this rule next of the final rule. II. Discussion and Analysis year, and I believe we can release a final rule ADDRESSES: Submit comments in by spring 2015. response to FAR Case 2013–020 by any A. Information Required As we continue to finalize and fine-tune of the following methods: our Dodd-Frank rulemakings, we have to • Regulations.gov: http:// 1. Owner/Subsidiary (Proposed FAR avoid the temptation to simply ratchet back 9.104–6(a)(2)(i)) or weaken prior versions of those rules. In www.regulations.gov. Submit comments fact, I think the best way of viewing changes via the Federal eRulemaking portal by After reviewing section 852, the to our rules is not that we are tweaking them, searching for ‘‘FAR Case 2013–020’’. Defense Acquisition Regulation Council but rather that we are enhancing them. Select the link ‘‘Comment Now’’ that and the Civilian Agency Acquisition
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Council (the Councils) determined that B. Source of Information on Ownership will be identified in FAPIIS, based on the further the distance between the and Predecessor of Offeror the identified immediate owners. entities, the less relevant the By obtaining the information on Therefore, it is unnecessary to define information is likely to be for ownership directly from each offeror, ‘‘subsidiary.’’ establishing responsibility of the offeror. the Government can define exactly what 3. ‘‘Predecessor’’ and ‘‘successor.’’ Furthermore, the cost and complexity information it is seeking. Furthermore, The Councils have proposed definitions maintaining a system that monitors the there is already a final FAR rule (FAR of ‘‘predecessor’’ and ‘‘successor’’ to be interrelationships of companies and case 2012–024, Commercial and included in paragraph (a) of the their changes in ownership, and direct Government Entity Code (CAGE), proposed provision 52.204–WW, and indirect subsidiaries that could published in the Federal Register at 79 Predecessor of Offeror. The term ‘‘successor’’ does not include new occur may be resource intensive for both FR 3118, on May 30, 2014; effective offices/divisions of the same company. the Government and the contractor and November 1, 2014) that provides An entity that has only changed its outweigh the benefits. Therefore, the information on owners of each offeror. It is not necessary to request name will not be considered to be a Councils have determined that it is not successor. Identification of changes in practicable to establish information on subsidiaries from the offeror, because if the subsidiary is in name is not necessary for purposes of interrelationships beyond the this case, because as long as the CAGE immediate owner and the direct the SAM database, the subsidiary will provide the information on its Code is still the same, FAPIIS will subsidiary. The data on the immediate provide the prior information relating to owner of an entity will be available immediate owner, which would then be shared with FAPIIS. If the subsidiary the entity. A ‘‘predecessor’’ means an through FAPIIS, based on the data entity that is replaced by a successor has not received any Government obtained from offerors in response to the and includes any predecessors of the awards, the subsidiary will have no FAR provision 52.204–17, Ownership or predecessor. A ‘‘successor’’ means an information available in FAPIIS, making Control of Offeror, which was published entity that has replaced a predecessor by it unnecessary for the owner to identify in the Federal Register at 79 FR 31187, acquiring the assets and carrying out the such a relationship. The following on May 30, 2014, as a final rule under affairs of the predecessor under a new example demonstrates how FAPIIS will name (often through acquisition or FAR Case 2012–024, effective November link owners with subsidiaries: 1, 2014. This proposed rule 2013–020 merger). The term ‘‘successor’’ does not will not be finalized until after the final If companies B, C, and D have reported include new offices/divisions of the rule under FAR Case 2012–024 becomes that— same company or a company that only B is owned by A; changes its name. The extent of the effective. For discussion of subsidiaries, C is owned by A; and see the information below in paragraph D is owned by C, responsibility of the successor for the B. Then FAPIIS will identify— liabilities of the predecessor may vary, Subsidiaries B and C for offeror A; depending on State law and specific 2. Predecessor/Successor (Proposed Owner A for offeror B; circumstances. FAR 9.1046(a)(2)(ii)) Owner A and subsidiary D for offeror C; and D. Use of Information on Other Entities Although the law requested Immediate owner C (not higher-level FAR 9.104–3(c) already sets forth the information on successor entities, the owner A) for offeror D. FAR policy on consideration of the Councils concluded that any entity The Councils propose a new integrity and past performance of making an offer would have to be the provision 52.204–WW, entitled affiliates, which as defined in the FAR successor, because by definition the ‘‘Predecessor of Offeror’’ to gather includes owners and subsidiaries, when predecessor no longer exists, having information on all predecessors of the they may adversely affect the been replaced by the successor. offeror that held a Federal contract or prospective contractor’s responsibility. Therefore, the proposed provision grant within the last three years. The Councils have not proposed any requests offerors to provide information change to this policy because it is C. Definitions (Proposed FAR 52.204– about all predecessors of the offeror that adequate to protect the interests of the WW and FAR 52.204–17(a)) received a Federal contract or grant Government. 1. ‘‘Owner.’’ The proposed definition within the last three years. The E. Availability to the Public information on predecessors of the of the term ‘‘owner’’ is consistent with offeror provided from the proposed the definition in the provision 52.204– The statute specifically requires the provision at FAR 52.204–WW will be 17, Ownership or Control of Offeror (see additional information on corporate shown with the entity’s record in the final rule for FAR Case 2012–024, structure to be available ‘‘in a manner System for Award Management (SAM) Commercial and Government Entity designed to give the acquisition officials and in FAPIIS. Code, published in the Federal Register using the database a comprehensive at 79 FR 31187, on May 30, 2014 and understanding of the performance and With regard to identification of effective November 1, 2014). integrity of the corporation in carrying predecessors, the Councils have limited 2. ‘‘Subsidiary.’’ The term out Federal contracts and grants.’’ the identification of predecessor entities ‘‘subsidiary’’ is used throughout the However, section 3010 of the to within the last three years. This FAR without definition, except as used Supplemental Appropriations Act, 2010 timeframe is consistent with the period with regard to inverted domestic (Pub. L. 111–212) added the required by FAR 42.1503(g) for corporations (FAR 9.108–1). The requirement that all the information in consideration of most past performance Councils have not defined ‘‘subsidiary’’ FAPIIS, except for past performance information, and the timeframe in this case, because it is necessary for information, shall be posted on a generally used when reviewing the term ‘‘subsidiary’’ to be the exact publicly available Internet Web site. prospective contractor’s integrity and reverse of the term ‘‘immediate owner.’’ Therefore, any information in FAPIIS past performance information within Any offeror that identifies an entity as with regard to immediate owner, the last three years to make a its immediate owner is the subsidiary of subsidiaries, and predecessors, will be responsibility determination. that other entity. These relationships available to the public.
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F. Applicability to provide the CAGE Code and the name separately and should cite 5 U.S.C. 610 This rule applies to commercial items, of all predecessors that held a Federal (FAR Case 2013–020), in including commercially available off- contract or grant within the last three correspondence. years. However, an Initial Regulatory the-shelf items, as well as acquisitions V. Paperwork Reduction Act below the simplified acquisition Flexibility Analysis (IRFA) has been threshold. performed and is summarized as The Paperwork Reduction Act (44 The information on predecessors is follows: U.S.C. chapter 35) applies. The needed for all offerors for which a CAGE The objective of this rule is to provide proposed rule contains information code is required. The information will acquisition officials using FAPIIS a collection requirements. Accordingly, be stored in the SAM database. comprehensive understanding of the the Regulatory Secretariat has submitted Determinations and findings were performance and integrity of the corporation a request for approval of a new in carrying out Federal contracts. The legal information collection requirement signed in February 2010 under FAR basis for the rule is section 852 of the Case 2008–027, that section 872 of the concerning Identification of Predecessor National Defense Authorization Act for Fiscal Entities to the Office of Management NDAA for FY 2009, which established Year 2013 (Pub. L. 112–239). the FAPIIS database, applies to the The proposed provision in this rule would and Budget. acquisition of commercial items, require each offeror to represent whether the A. Public reporting burden for this including commercially available off- offeror is or is not, within the last three years, collection of information is estimated to the-shelf (COTS) items. That a successor to a predecessor that held a average .1 hours per response, including determination stated that an exemption Federal contract or grant within the last three the time for reviewing instructions, years. If the offeror has indicated that it is for commercial item acquisitions searching existing data sources, such a successor, then the offeror must gathering and maintaining the data (including COTS items) would exclude provide the CAGE code and legal name of all a significant portion of Federal predecessors that held a Federal contract or needed, and completing and reviewing contractors, thereby undermining an grant within the last three years. The data on the collection of information. overarching public policy to achieve immediate owner and direct subsidiaries of The annual reporting burden greater integrity and performance an entity will be available through FAPIIS, estimated as follows: quality in contracting. We should apply based on the data obtained from offerors in Respondents: 413,800. extensions of information to be used in response to the FAR provision 52.204–17, Ownership or Control of Offeror, that Responses per respondent: 1. FAPIIS to acquisitions of commercial requires this information for the CAGE code. Total annual responses: 413,800. items, including COTS items, for the The Federal Government received offers from Preparation hours per response: .1. same reasons we stated with regard to approximately 413,800 unique vendors in FY Total response Burden Hours: 41,380. the original statute that established 2011. Approximately 275,900 of these offers B. Request for Comments Regarding FAPIIS. were by unique small businesses, which will Paperwork Burden. The representation will also apply to be required to respond to the proposed solicitations that do not exceed the provision. Submit comments, including simplified acquisition threshold. The proposed rule requires approximately suggestions for reducing this burden, one submission per year, with an estimated Determinations and findings will be not later than February 2, 2015 to: FAR average of .1 preparation hours per response. Desk Officer, OMB, Room 10102, NEOB, approved by the appropriate authorities The response time will be less for most prior to publication of the final rule. Washington, DC 20503, and a copy to respondents, only required to check a box. the General Services Administration, Only those respondents that check ‘‘is’’ will III. Executive Orders 12866 and 13563 have to provide a minimal amount of Regulatory Secretariat Division (MVCB), Executive Orders (E.O.s) 12866 and information (CAGE Code and legal name of ATTN: Ms. Hada Flowers, 1800 F Street 13563 direct agencies to assess all costs all predecessors that held a Federal contract NW., 2nd floor, Washington, DC 20405. and benefits of available regulatory or grant within the last three years). A mid- Public comments are particularly alternatives and, if regulation is level professional skill would be required in invited on: whether this collection of some instances to know whether the entity is necessary, to select regulatory information is necessary for the proper a successor, as defined in the proposed rule. performance of functions of the FAR, approaches that maximize net benefits The rule does not duplicate, overlap, or (including potential economic, conflict with any other Federal rules. and will have practical utility; Whether environmental, public health and safety There are no exemptions from the rule for our estimate of the public burden of this effects, distributive impacts, and small entities, because the law does not collection of information is accurate, equity). E.O. 13563 emphasizes the provide for any such exemption. However, and based on valid assumptions and importance of quantifying both costs the proposed rule limits the review of methodology; ways to enhance the and benefits, of reducing costs, of predecessor entities to three years. quality, utility, and clarity of the harmonizing rules, and of promoting The Regulatory Secretariat has information to be collected; and ways in flexibility. This is not a significant submitted a copy of the IRFA to the which we can minimize the burden of regulatory action and, therefore, was not Chief Counsel for Advocacy of the Small the collection of information on those subject to review under Section 6(b) of Business Administration. A copy of the who are to respond, through the use of E.O. 12866, Regulatory Planning and IRFA may be obtained from the appropriate technological collection Review, dated September 30, 1993. This Regulatory Secretariat. DoD, GSA and techniques or other forms of information rule is not a major rule under 5 U.S.C. NASA invite comments from small technology. 804. business concerns and other interested Requesters may obtain a copy of the parties on the expected impact of this supporting statement from the General IV. Regulatory Flexibility Act rule on small entities. Services Administration, Regulatory DoD, GSA, and NASA do not expect DoD, GSA, and NASA will also Secretariat Division (MVCB), ATTN: Ms. this rule to have a significant economic consider comments from small entities Hada Flowers, 1800 F Street NW., 2nd impact on a substantial number of small concerning the existing regulations in floor, Washington, DC 20405. Please cite entities within the meaning of the subparts affected by the rule in ‘‘OMB Control Number 9000–00XX; Regulatory Flexibility Act, 5 U.S.C. 601, accordance with 5 U.S.C. 610. Interested Identification of Predecessors,’’ in all et seq., because the burden is minimal parties must submit such comments correspondence.
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List of Subjects in 48 CFR Parts 1, 4, 9, at www.ppirs.gov, then select FAPIIS, following sources of information to 22, and 52 including FAPIIS information from the support such determinations: Government procurement. System for Award Management * * * * * Exclusions and the Past Performance Dated: November 25, 2014. Information Retrieval System (PPIRS). PART 22—APPLICATION OF LABOR William Clark, (2) In accordance with 41 U.S.C. LAWS TO GOVERNMENT Acting Director, Office of Government-wide 2313(d)(3), FAPIIS also identifies— ACQUISITIONS Acquisition Policy, Office of Acquisition (i) An affiliate that is an immediate 22.1006 [Amended] Policy, Office of Government-wide Policy. owner or subsidiary of the offeror, if any ■ Therefore, the DoD, GSA, and NASA (see 52.204–17, Ownership or Control of 7. Amend section 22.1006 by propose amending 48 CFR parts 1, 4, 9, Offeror); and removing from paragraph (a)(2)(i)(C) the 22, and 52 as set forth below: (ii) All predecessors of the offeror that words ‘‘52.204–8(c)(2)(iii) or (iv)’’ and adding ‘‘52.204–8(c)(2)’’ in its place; ■ 1. The authority citation for 48 CFR held a Federal contract or grant within the last three years (see 52.204–WW, and removing from paragraph (e)(4)(i) parts 1, 4, 9, 22, and 52 continues to the words ‘‘52.204–8(c)(2)(iv)’’ and read as follows: Predecessor of Offeror). (b) When making a responsibility adding ‘‘52.204–8(c)(2)’’ in its place. Authority: 40 U.S.C. 121(c); 10 U.S.C. determination, the contracting officer chapter 137; and 51 U.S.C. 20113. PART 52—SOLICITATION PROVISIONS shall consider all the information AND CONTRACT CLAUSES PART 1—FEDERAL ACQUISITION available through FAPIIS with regard to REGULATIONS SYSTEM the offeror and any immediate owner, ■ 8. Amend section 52.204–8 by— predecessor, or subsidiary identified for ■ a. Revising the date of the clause; 1.106 [Amended] that offeror in FAPIIS, as well as other ■ b. Redesignating paragraphs (c)(2)(ii) ■ 2. Amend section 1.106, in the table past performance information on the thru (vii) as paragraphs (c)(2)(iii) thru following the introductory text, by offeror (see subpart 42.15). (viii), respectively; and adding in numerical sequence, FAR (1) For evaluation of information ■ c. Adding new paragraph (c)(2)(ii). segment ‘‘52.204–WW’’ and its available through FAPIIS relating to an The revised and added text reads as corresponding OMB Control No. ‘‘9000– affiliate of the offeror, see 9.104–3(c). follows: 00XX’’. (2) For source selection evaluations of 52.204–8 Annual Representations and past performance, see 15.305(a)(2). Certifications. PART 4—ADMINISTRATIVE MATTERS Contracting officers shall use sound * * * * * ■ 3. Amend section 4.1202 by judgment in determining the weight and redesignating paragraphs (a)(6) through relevance of the information contained Annual Representations and (29) as paragraphs (a)(7) through (30), in FAPIIS and how it relates to the Certifications (Date) present acquisition. Since FAPIIS may respectively; and adding a new * * * * * contain information on any of the paragraph (6) to read as follows; (c) * * * offeror’s previous contracts and (2) * * * 4.1202 Solicitation provision and contract information covering a five-year period, ll (ii) 52.204–WW, Predecessor of clause. some of that information may not be Offeror. (a) * * * relevant to a determination of present (6) 52.204–WW, Predecessor of responsibility, e.g., a prior * * * * * ■ Offeror. administrative action such as debarment 9. Add section 52.204–WW, to read as follows: * * * * * or suspension that has expired or ■ 4. Amend section 4.1804 by adding otherwise been resolved, or information 52.204–WW Predecessor of Offeror. paragraph (d) to read as follows: relating to contracts for completely As prescribed in 4.1804(d), insert the different products or services. following provision: 4.1804 Solicitation provisions and * * * * * contract clause. ■ 6. Amend section 9.105–1 by revising Predecessor of Offeror (Date) * * * * * introductory paragraph (c) to read as (a) Definitions. As used in this provision— (d) Insert the provision at 52.204– follows: Commercial and Government Entity WW, Predecessor of Offeror, in all (CAGE) code means— solicitations that include the provision 9.105–1 Obtaining information. (1) An identifier assigned to entities at 52.204–16, Commercial and * * * * * located in the United States and its outlying Government Entity Code Reporting. (c) In making the determination of areas by the Defense Logistics Agency (DLA) responsibility, the contracting officer Logistics Information Service to identify a commercial or government entity, or PART 9—CONTRACTOR shall consider information available QUALIFICATIONS (2) An identifier assigned by a member of through FAPIIS (see 9.104–6) with the North Atlantic Treaty Organization ■ 5. Amend section 9.104–6 by revising regard to the offeror and any immediate (NATO) or by NATO’s Maintenance and paragraphs (a) and (b) to read as follows: owner, predecessor, or subsidiary Supply Agency (NAMSA) to entities located identified for that offeror in FAPIIS, outside the United States and its outlying 9.104–6 Federal Awardee Performance including information that is linked to areas that DLA Logistics Information Service and Integrity Information System. FAPIIS such as from the System for records and maintains in the CAGE master (a)(1) Before awarding a contract in Award Management Exclusions, and the file. This type of code is known as an NCAGE excess of the simplified acquisition Past Performance Information Retrieval code. Predecessor means an entity that is threshold, the contracting officer shall System (PPIRS), as well as any other replaced by a successor and includes any review the integrity and performance relevant past performance information predecessors of the predecessor. information available in the Federal on the offeror (see 9.104–1(c) and Successor means an entity that has Awardee Performance and Integrity subpart 42.15). In addition, the replaced a predecessor by acquiring the Information System (FAPIIS), available contracting officer should use the assets and carrying out the affairs of the
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predecessor under a new name (often through (p)’’ and adding ‘‘paragraphs (c) divisions of the same company or a company through acquisition or merger). The term through (q)’’ in its place; that only changes its name. The extent of the ‘‘successor’’ does not include new offices/ ■ c. Adding to paragraph (a), in responsibility of the successor for the divisions of the same company or a company alphabetical order, the definitions liabilities of the predecessor may vary, that only changes its name. The extent of the ‘‘predecessor’’ and ‘‘successor’’; depending on State law and specific responsibility of the successor for the ■ circumstances. liabilities of the predecessor may vary, d. Removing from paragraph (b)(2) the depending on State law and specific words ‘‘paragraphs at (c) through (p)’’ * * * * * circumstances. and adding ‘‘paragraphs at (c) through (q) Predecessor of Offeror. (Applies in all (b) The offeror represents that it ❏ is or ❏ (q)’’ in its place; and solicitations that include the provision at is not a successor to a predecessor that held ■ e. Adding paragraph (q). 52.204–16, Commercial and Government a Federal contract or grant within the last The revised text reads as follows: Entity Code Reporting.) three years. (1) The offeror represents that it ❏ is or ❏ (c) If the offeror has indicated ‘‘is’’ in 52.212–3 Offeror Representations and is not a successor to a predecessor that held paragraph (b) of this provision, enter the Certifications—Commercial Items. a Federal contract or grant within the last following information for all predecessors of * * * * * three years. the offeror that held a Federal contract or (2) If the offeror has indicated ‘‘is’’ in grant within the last three years (If more than Offeror Representations and Certifications— paragraph (q)(1) of this provision, enter the one predecessor list in reverse chronological Commercial Items (Date) following information for all predecessors order): * * * * * that held a Federal contract or grant within Predecessor CAGE code: llll (or mark (a) * * * the last three years (If more than one ‘‘Unknown’’). Predecessor means an entity that is predecessor, list in reverse chronological Predecessor legal name: llll. replaced by a successor and includes any order): (Do not use a ‘‘doing business as’’ name.) predecessors of the predecessor. Predecessor CAGE code: llll (or mark (End of provision) * * * * * ‘‘Unknown’’). Successor means an entity that has llll * * * * * Predecessor legal name: . replaced a predecessor by acquiring the (Do not use a ‘‘doing business as’’ name) ■ 10. Amend section 52.212–3 by— assets and carrying out the affairs of the ■ a. Revising the date of the clause; predecessor under a new name (often * * * * * ■ b. Removing from the introductory through acquisition or merger). The term [FR Doc. 2014–28484 Filed 12–3–14; 8:45 am] paragraph the words ‘‘paragraphs (c) ‘‘successor’’ does not include new offices/ BILLING CODE 6820–EP–P
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Notices Federal Register Vol. 79, No. 233
Thursday, December 4, 2014
This section of the FEDERAL REGISTER written description is dispositive. A full Methodology contains documents other than rules or description of the scope of the order is The Department has conducted this proposed rules that are applicable to the contained in the Preliminary Decision review in accordance with section public. Notices of hearings and investigations, Memorandum.1 committee meetings, agency decisions and 751(a)(1)(B) of the Tariff Act of 1930, as rulings, delegations of authority, filing of Rescission of Review in Part amended (the Act). Export price and petitions and applications and agency constructed export price have been statements of organization and functions are We are rescinding the review in part calculated in accordance with section examples of documents appearing in this with respect to Husqvarna (Hebei) Co., 772 of the Act. Because the PRC is a section. Ltd., and Hebei Husqvarna-Jikai NME within the meaning of section 2 Diamond Tools Co., Ltd. 771(18) of the Act, normal value has Preliminary Determination of No been calculated in accordance with DEPARTMENT OF COMMERCE Shipments section 773(c) of the Act. For a full description of the International Trade Administration Qingdao Shinhan Diamond Industrial methodology underlying our [A–570–900] Co., Ltd., which received a separate rate conclusions, see the Preliminary in previous segments of the proceeding Decision Memorandum. The Diamond Sawblades and Parts Thereof and is subject to this review, reported Preliminary Decision Memorandum is a From the People’s Republic of China: that it did not have any exports of public document and is on file Preliminary Results of Antidumping subject merchandise during the POR.3 electronically via Enforcement and Duty Administrative Review; 2012– U.S. Customs and Border Protection Compliance’s Antidumping and 2013 (CBP) data for the POR corroborated this Countervailing Duty Centralized company’s no-shipment claim.4 Electronic Service System (ACCESS). AGENCY: Enforcement and Compliance, Additionally, we requested that CBP ACCESS is available to registered users International Trade Administration, report any contrary information.5 To at http://access.trade.gov and to all Department of Commerce. date, CBP has not responded to our parties in the Central Records Unit, SUMMARY: The Department of Commerce inquiry with any contrary information room 7046 of the main Department of (the Department) is conducting an and we have not received any evidence Commerce building.8 In addition, a administrative review of the that this company had any shipments of complete version of the Preliminary antidumping duty order on diamond the subject merchandise sold to the Decision Memorandum can be accessed sawblades and parts thereof (diamond United States during the POR.6 directly on the Internet at http:// sawblades) from the People’s Republic Consistent with the Department’s enforcement.trade.gov/frn/index.html. of China (the PRC). The period of review refinement to its assessment practice in (POR) is November 1, 2012, through non-market economy (NME) cases Preliminary Results of Review October 31, 2013. The Department has regarding no shipment claims, we are The Department preliminarily preliminarily determined that certain completing the review with respect to determines that the following weighted- companies covered by this review made this company and will issue appropriate average dumping margins exist: sales of subject merchandise at less than instructions to CBP based on the final normal value. Interested parties are results of the review.7 Exporter Margin invited to comment on these (percent) 1 preliminary results. See the Memorandum from Deputy Assistant Bosun Tools Co., Ltd ...... 11.21 DATES: Effective Date: December 4, 2014. Secretary Christian Marsh to Acting Assistant Chengdu Huifeng Diamond Secretary Ronald K. Lorentzen entitled ‘‘Decision FOR FURTHER INFORMATION CONTACT: Memorandum for Preliminary Results of 2012–2013 Tools Co., Ltd ...... 7.87 Yang Jin Chun or Michael Romani, AD/ Antidumping Duty Administrative Review: Danyang City Ou Di Ma Tools CVD Operations, Office I, Enforcement Diamond Sawblades and Parts Thereof from the Co., Ltd ...... 7.87 People’s Republic of China’’ dated concurrently Danyang NYCL Tools Manufac- and Compliance, International Trade with and hereby adopted by this notice turing Co., Ltd ...... 7.87 Administration, U.S. Department of (Preliminary Decision Memorandum). Danyang Tsunda Diamond Tools Commerce, 14th Street and Constitution 2 See Preliminary Decision Memorandum at 4–5 Co., Ltd ...... 7.87 Avenue NW., Washington, DC 20230; for more details on this rescission in part. Danyang Weiwang Tools Manu- telephone: (202) 482–5760 and (202) 3 See Qingdao Shinhan Diamond Industrial Co., facturing Co., Ltd ...... 7.87 Ltd.’s no shipment letter dated Febuary 28, 2014. Guilin Tebon Superhard Material 482–0198, respectively. 4 See the CBP data attached to the letter to all Co., Ltd ...... 7.87 Scope of the Order interested parties dated January 24, 2014. Hangzhou Deer King Industrial 5 See CBP message number 4261305 dated and Trading Co., Ltd ...... 7.87 The merchandise subject to the order September 18, 2014. Hangzhou Kingburg Import & 6 CBP only responds to the Department’s inquiry is diamond sawblades and parts thereof. Export Co., Ltd ...... 7.87 The diamond sawblades subject to the when there are records of shipments from the company in question. See, e.g., Certain Hot-Rolled order are currently classifiable under Flat-Rolled Carbon Quality Steel Flat Products 8 ACCESS is the new acronym for Enforcement subheadings 8202 to 8206 of the From Brazil: Notice of Rescission of Antidumping and Compliance’s Antidumping and Countervailing Harmonized Tariff Schedule of the Duty Administrative Review, 75 FR 65453, 65454 Duty Centralized Electronic Service System (IA United States (HTSUS), and may also (October 25, 2010). ACCESS). We changed the Web site location from 7 See Non-Market Economy Antidumping http://iaaccess.trade.gov to http://access.trade.gov. enter under 6804.21.00. While the Proceedings: Assessment of Antidumping Duties, 76 See 19 CFR 351.303, as amended in Enforcement HTSUS subheadings are provided for FR 65694 (October 24, 2011), and the ‘‘Assessment and Compliance; Change of Electronic Filing convenience and customs purposes, the Rates’’ section below. System Name, 79 FR 69046 (November 20, 2014).
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Margin preliminary results to the parties within above de minimis (i.e., 0.5 percent) in Exporter (percent) five days of the date of publication of the final results of this review, we will this notice in accordance with 19 CFR calculate an importer-specific Huzhou Gu’s Import & Export 351.224(b). Pursuant to 19 CFR assessment rate on the basis of the ratio 9 Co., Ltd ...... 7.87 351.309(c), interested parties may of the total amount of dumping Jiangsu Fengtai Diamond Tool submit case briefs no later than 30 days calculated for the importer’s examined Manufacture Co., Ltd ...... 7.87 Jiangsu Inter-China Group Cor- after the date of publication of these sales and the total entered value of those 12 poration ...... 7.87 preliminary results of review. Parties sales in accordance with 19 CFR Jiangsu Youhe Tool Manufac- who submit case briefs or rebuttal briefs 351.212(b)(1). Specifically, the turer Co., Ltd ...... 7.87 in this proceeding are encouraged to Department will apply the assessment Pujiang Talent Diamond Tools submit with each argument: (1) A rate calculation method adopted in Co., Ltd ...... 7.87 statement of the issue; (2) a brief Final Modification for Reviews.16 Where Qingdao Hyosung Diamond summary of the argument; and (3) a an importer- (or customer-) specific ad Tools Co., Ltd ...... 7.87 table of authorities.13 Rebuttal briefs, valorem rate is zero or de minimis, we Qingyuan Shangtai Diamond limited to issues raised in the case will instruct CBP to liquidate Tools Co., Ltd ...... 7.87 briefs, may be filed no later than five appropriate entries without regard to Quanzhou Zhongzhi Diamond 17 Tool Co. Ltd ...... 7.87 days after the cases briefs are filed. antidumping duties. Rizhao Hein Saw Co., Ltd ...... 7.87 Interested parties who wish to request For Husqvarna (Hebei) Co., Ltd., for Saint-Gobain Abrasives (Shang- a hearing, or to participate if one is which the review is rescinded, the hai) Co., Ltd ...... 7.87 requested, must submit a written antidumping duty shall be assessed at Shanghai Jingquan Ind. Trade request to the Assistant Secretary for the rate equal to the cash deposit of the Co., Ltd ...... 7.87 Enforcement and Compliance, U.S. estimated antidumping duty required at Weihai Xiangguang Mechanical Department of Commerce, filed the time of entry, or withdrawal from Industrial Co., Ltd ...... 3.79 electronically using ACCESS. An warehouse, for consumption, in Xiamen ZL Diamond Technology electronically filed document must be accordance with 19 CFR 351.212(c)(2). Co., Ltd 10 ...... 7.87 received successfully in its entirety by We will instruct CBP accordingly. Zhejiang Wanli Tools Group Co., Pursuant to a refinement to the Ltd ...... 7.87 the Department’s ACCESS by 5:00 p.m. PRC-Wide Entity 11 ...... 164.09 Eastern Time within 30 days after the Department’s assessment practice in date of publication of this notice.14 NME cases,18 for entries that were not reported in the U.S. sales databases Disclosure and Public Comment Hearing requests should contain (1) the party’s name, address, and telephone submitted by companies individually The Department will disclose number; (2) the number of participants; examined during this review, the calculations performed for these and (3) a list of issues to be discussed. Department will instruct CBP to Issues raised in the hearing will be liquidate such entries at the PRC-wide 9 Huzhou Gu’s Import & Export Co., Ltd., uses the limited to those raised in the respective rate. In addition, if the Department name Huzhou Gu’s Imp. & Exp. Co., Ltd., determines that an exporter under interchangeably. See Diamond Sawblades and Parts case briefs. The Department intends to Thereof From the People’s Republic of China: issue the final results of this review, review had no shipments of the subject Preliminary Results of Antidumping Duty including the results of its analysis of merchandise, any suspended entries Administrative Review; 2011–2012, 78 FR 77098, that entered under that exporter’s case 77100 n.14 (December 20, 2013) (3rd Review issues raised by parties in their comments, within 120 days after the number (i.e., at that exporter’s rate) will Prelim), unchanged in Diamond Sawblades and 19 Parts Thereof From the People’s Republic of China: publication of these preliminary results, be liquidated at the PRC-wide rate. Final Results of Antidumping Duty Administrative pursuant to section 751(a)(3)(A) of the The Department intends to issue Review; 2011–2012, 79 FR 35723 (June 24, 2014) Act and 19 CFR 351.213(h)(2). appropriate assessment instructions (3rd Review Final). directly to CBP 15 days after publication 10 Xiamen ZL Diamond Technology Co., Ltd., Assessment Rates of the final results of review. stated in its separate rate application that its name before the POR was Xiamen ZL Diamond Tools Co., Upon issuing the final results of Cash Deposit Requirements Ltd., for which we initiated this review in Initiation review, the Department will determine, of Antidumping and Countervailing Duty and CBP shall assess, antidumping The following cash deposit Administrative Reviews and Request for Revocation duties on all appropriate entries covered requirements will be effective upon in Part, 78 FR 79392, 79395 (December 30, 2013). publication of the final results of this See Xiamen ZL Diamond Technology Co., Ltd.’s by this review.15 If a respondent’s administrative review for shipments of February 26, 2014, separate rate application at 2. weighted-average dumping margin is 11 The PRC-wide entity includes the following the subject merchandise from the PRC companies: ATM Single Entity, Central Iron and entered, or withdrawn from warehouse, Superhard Material Tools Co., Ltd., Zhejiang Tea Steel Research Institute Group, China Iron and Steel Import & Export Co., Ltd., Zhejiang Wanda Import for consumption on or after the Research Institute Group, Danyang Aurui Hardware and Export Co., Zhejiang Wanda Tools Group Corp., publication date, as provided by section Products Co., Ltd., Danyang Dida Diamond Tools and Zhejiang Wanli Super-hard Materials Co., Ltd. Manufacturing Co., Ltd., Danyang Huachang 751(a)(2)(C) of the Act: (1) For subject ATM Single Entity includes Advanced Technology Diamond Tools Manufacturing Co., Ltd., Electrolux merchandise exported by the companies & Materials Co., Ltd., Beijing Gang Yan Diamond Construction Products (Xiamen) Co. Ltd., Fujian Products Co., Yichang HXF Circular Saw Industrial listed above that have separate rates, the Quanzhou Wanlong Stone Co., Ltd., Hebei Jikai Co., Ltd. (currently HXF Saw Co., Ltd.) (HXF), Cliff Industrial Group Co., Ltd., Huachang Diamond (Tianjin) International Ltd (Cliff), and AT&M 16 Tools Manufacturing Co., Ltd., Hua Da See Antidumping Proceeding: Calculation of International Trading Co., Ltd. Cliff also used the Superabrasive Tools Technology Co., Ltd., Jiangsu the Weighted-Average Dumping Margin and company name Cliff International Ltd. See 3rd Fengyu Tools Co., Ltd., Jiangyin Likn Industry Co., Assessment Rate in Certain Antidumping Duty Review Prelim, 78 FR at 77099, n.4, and the Ltd., Protech Diamond Tools, Quanzhou Proceedings; Final Modification, 77 FR 8103 accompanying Preliminary Decision Memorandum Shuangyang Diamond Tools Co., Ltd., Quanzhou (February 14, 2012) (Final Modification for at 5, n.24, unchanged in 3rd Review Final for HXF’s Zongzhi Diamond Tool Co. Ltd., Shanghai Deda Reviews). name change and Cliff’s use of another company 17 Industry & Trading Co., Ltd., Shanghai Robtol Tool See 19 CFR 351.106(c)(2). name. Manufacturing Co., Ltd., Shanghai Starcraft Tools 18 For a full discussion of this practice, see Non- 12 Company Limited, Shijiazhuang Global New See 19 CFR 351.309(c). Market Economy Antidumping Proceedings: Century Tools Co., Ltd., Sichuan Huili Tools Co., 13 See 19 CFR 351.309(c)(2). Assessment of Antidumping Duties, 76 FR 65694 Task Tools & Abrasives, Wanli Tools Group, Wuhan 14 See 19 CFR 351.310(c). (October 24, 2011). Wanbang Laser Diamond Tools Co., Wuxi Lianhua 15 See 19 CFR 351.212(b)(1). 19 Id.
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cash deposit rate will be that established J. Recommendation information collection should be sent in the final results of review (except, if [FR Doc. 2014–28531 Filed 12–3–14; 8:45 am] within 30 days of publication of this _ the rate is zero or de minimis, then zero BILLING CODE 3510–DS–P notice to OIRA Submission@ cash deposit will be required); (2) for omb.eop.gov or fax to (202) 395–5806. previously investigated or reviewed PRC Dated: November 28, 2014. and non-PRC exporters not listed above DEPARTMENT OF COMMERCE Glenna Mickelson, that received a separate rate in a prior Submission for OMB Review; Management Analyst, Office of the Chief segment of this proceeding, the cash Information Officer. deposit rate will continue to be the Comment Request existing exporter-specific rate; (3) for all [FR Doc. 2014–28469 Filed 12–3–14; 8:45 am] The Department of Commerce will BILLING CODE 3510–NK–P PRC exporters of subject merchandise submit to the Office of Management and that have not been found to be entitled Budget (OMB) for clearance the to a separate rate, the cash deposit rate following proposal for collection of DEPARTMENT OF COMMERCE will be that for the PRC-wide entity; and information under the provisions of the (4) for all non-PRC exporters of subject Paperwork Reduction Act (44 U.S.C. National Oceanic and Atmospheric merchandise which have not received Chapter 35). Administration their own rate, the cash deposit rate will Agency: National Oceanic and RIN 0648–XD605 be the rate applicable to the PRC Atmospheric Administration (NOAA). exporter that supplied that non-PRC Title: Economic Value of Puerto Rico’s Schedules for Atlantic Shark exporter. These deposit requirements, Coral Reef Ecosystems for Recreation/ Identification Workshops and when imposed, shall remain in effect Tourism Uses. Protected Species Safe Handling, until further notice. OMB Control Number: 0648–xxxx. Release, and Identification Workshops Notification to Importers Form Number(s): None. Type of Request: Regular (request for AGENCY: National Marine Fisheries This notice serves as a preliminary a new information collection). Service (NMFS), National Oceanic and reminder to importers of their Number of Respondents: 4,600. Atmospheric Administration (NOAA), responsibility under 19 CFR Average Hours per Response: Commerce. 351.402(f)(2) to file a certificate Resident interviews, 1 hour; visitor ACTION: Notice of public workshops. regarding the reimbursement of screening surveys, 5 minutes; visitor antidumping duties prior to liquidation interviews, 35 minutes, expenditure SUMMARY: Free Atlantic Shark of the relevant entries during this mail-back surveys for residents and Identification Workshops and Protected review period. Failure to comply with visitors, 20 minutes. Species Safe Handling, Release, and this requirement could result in the Burden Hours: 2,550. Identification Workshops will be held in Department’s presumption that Needs and Uses: This request is for a January, February, and March of 2015. reimbursement of antidumping duties new information collection. Certain fishermen and shark dealers are occurred and the subsequent assessment NOAA and the U.S. Environmental required to attend a workshop to meet of double antidumping duties. Protection Agency (EPA) have entered a regulatory requirements and to maintain partnership to estimate the market and valid permits. Specifically, the Atlantic We are issuing and publishing these Shark Identification Workshop is results in accordance with sections non-market economic values of Puerto Rico’s coral reef ecosystems. Estimates mandatory for all federally permitted 751(a)(1) and 777(i)(1) of the Act and 19 Atlantic shark dealers. The Protected CFR 351.213. will be made for all ecosystem services for the Guanica Bay Watershed and for Species Safe Handling, Release, and Dated: November 26, 2014. recreation-tourism for all of Puerto Identification Workshop is mandatory Ronald K. Lorentzen, Rico’s coral reef ecosystems. for vessel owners and operators who use Acting Assistant Secretary for Enforcement We will conduct surveys of visitors to bottom longline, pelagic longline, or and Compliance. Puerto Rico and residents of Puerto Rico gillnet gear, and who have also been issued shark or swordfish limited access Appendix who use the coral reef ecosystems to estimate the amount and type of use, permits. Additional free workshops will List of Topics Discussed in the Preliminary their spending while undertaking coral be conducted during 2015 and will be Decision Memorandum reef use activities, the economic value of announced in a future notice. A. Summary reef attributes (e.g. water clarity/ DATES: The Atlantic Shark Identification B. Background visibility, coral abundance and Workshops will be held on January 22, C. Scope of the Order diversity, fish and invertebrate February 26, and March 19, 2015. D. Request To Modify the Physical abundance and diversity, and The Protected Species Safe Handling, Characteristics Release, and Identification Workshops E. Rescission of Review in Part opportunity to see large wildlife) and F. Preliminary Determination of No how economic value changes with will be held on January 14, January 21, Shipments changes in reef attributes. February 12, February 19, March 10, G. Discussion of the Methodology Affected Public: Individuals or and March 12, 2015. 1. Non-Market Economy Country Status households. See SUPPLEMENTARY INFORMATION for 2. Separate Rates Frequency: One time. further details. 3. Surrogate Country Respondent’s Obligation: Voluntary. ADDRESSES: The Atlantic Shark H. Fair Value Comparisons This information collection request Identification Workshops will be held in 1. Determination of Comparison Method may be viewed at reginfo.gov. Follow Kenner, LA; Norfolk, VA; and Fort 2. Results of the Differential Pricing Analysis the instructions to view Department of Pierce, FL. 3. U.S. Price Commerce collections currently under The Protected Species Safe Handling, 4. Normal Value review by OMB. Release, and Identification Workshops 5. Factor Valuations Written comments and will be held in Panama City, FL; I. Currency Conversion recommendations for the proposed Portsmouth, NH; Manahawkin, NJ;
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Wilmington, NC; Largo, FL; and 2. February 26, 2015, 12 p.m.–4 p.m., limited-access permits. Additionally, Houston, TX. LaQuinta Inn & Suites, 1387 North new shark and swordfish limited-access See SUPPLEMENTARY INFORMATION for Military Highway, Norfolk, VA 23502. permit applicants who intend to fish further details on workshop locations. 3. March 19, 2015, 12 p.m.–4 p.m., with longline or gillnet gear must attend LaQuinta Inn & Suites, 2655 Crossroads a Protected Species Safe Handling, FOR FURTHER INFORMATION CONTACT: Rick Parkway, Fort Pierce, FL 34945. Release, and Identification Workshop Pearson by phone: (727) 824–5399, or by Registration and submit a copy of their workshop fax: (727) 824–5398. certificate before either of the permits SUPPLEMENTARY INFORMATION: The To register for a scheduled Atlantic will be issued. Approximately 190 free workshop schedules, registration Shark Identification Workshop, please Protected Species Safe Handling, information, and a list of frequently contact Eric Sander at esander@ Release, and Identification Workshops asked questions regarding these peoplepc.com or at (386) 852–8588. have been conducted since 2006. workshops are posted on the Internet at: Registration Materials In addition to certifying vessel http://www.nmfs.noaa.gov/sfa/hms/ owners, at least one operator on board workshops/. To ensure that workshop certificates vessels issued a limited-access are linked to the correct permits, swordfish or shark permit that uses Atlantic Shark Identification participants will need to bring the longline or gillnet gear is required to Workshops following specific items to the attend a Protected Species Safe workshop: Since January 1, 2008, Atlantic shark • Handling, Release, and Identification dealers have been prohibited from Atlantic shark dealer permit holders Workshop and receive a certificate. receiving, purchasing, trading, or must bring proof that the attendee is an Vessels that have been issued a limited- bartering for Atlantic sharks unless a owner or agent of the business (such as access swordfish or shark permit and valid Atlantic Shark Identification articles of incorporation), a copy of the that use longline or gillnet gear may not Workshop certificate is on the premises applicable permit, and proof of fish unless both the vessel owner and of each business listed under the shark identification. operator have valid workshop • Atlantic shark dealer proxies must dealer permit that first receives Atlantic certificates onboard at all times. Vessel bring documentation from the permitted sharks (71 FR 58057; October 2, 2006). operators who have not already dealer acknowledging that the proxy is Dealers who attend and successfully attended a workshop and received a attending the workshop on behalf of the complete a workshop are issued a NMFS certificate, or vessel operators permitted Atlantic shark dealer for a certificate for each place of business that whose certificate(s) will expire prior to specific business location, a copy of the is permitted to receive sharks. These their next fishing trip, must attend a appropriate valid permit, and proof of certificate(s) are valid for 3 years. workshop to operate a vessel with identification. Approximately 104 free Atlantic Shark swordfish and shark limited-access Identification Workshops have been Workshop Objectives permits that uses longline or gillnet conducted since January 2007. The Atlantic Shark Identification gear. Currently, permitted dealers may send Workshops are designed to reduce the Workshop Dates, Times, and Locations a proxy to an Atlantic Shark number of unknown and improperly 1. January 14, 2015, 9 a.m.–5 p.m., Identification Workshop. However, if a identified sharks reported in the dealer dealer opts to send a proxy, the dealer Hilton Garden Inn, 1101 US Highway reporting form and increase the 231, Panama City, FL 32405. must designate a proxy for each place of accuracy of species-specific dealer- business covered by the dealer’s permit 2. January 21, 2015, 9 a.m.–5 p.m., reported information. Reducing the Holiday Inn, 300 Woodbury Avenue, which first receives Atlantic sharks. number of unknown and improperly Only one certificate will be issued to Portsmouth, NH 03878. identified sharks will improve quota 3. February 12, 2015, 9 a.m.–5 p.m., each proxy. A proxy must be a person monitoring and the data used in stock Holiday Inn, 151 Route 72 East, who is currently employed by a place of assessments. These workshops will train Manahawkin, NJ 08050. business covered by the dealer’s permit; shark dealer permit holders or their 4. February 19, 2015, 9 a.m.–5 p.m., is a primary participant in the proxies to properly identify Atlantic Hilton Garden Inn, 6745 Rock Spring identification, weighing, and/or first shark carcasses. Road, Wilmington, NC 28405. receipt of fish as they are offloaded from 5. March 10, 2015, 9 a.m.–5 p.m., a vessel; and who fills out dealer Protected Species Safe Handling, Release, and Identification Workshops Holiday Inn Express, 210 Seminole reports. Atlantic shark dealers are Boulevard, Largo, FL 33770. prohibited from renewing a Federal Since January 1, 2007, shark limited- 6. March 12, 2015, 9 a.m.–5 p.m., shark dealer permit unless a valid access and swordfish limited-access Holiday Inn Express, 8080 Main Street, Atlantic Shark Identification Workshop permit holders who fish with longline Houston, TX 77025. certificate for each business location or gillnet gear have been required to that first receives Atlantic sharks has submit a copy of their Protected Species Registration been submitted with the permit renewal Safe Handling, Release, and To register for a scheduled Protected application. Additionally, trucks or Identification Workshop certificate in Species Safe Handling, Release, and other conveyances that are extensions of order to renew either permit (71 FR Identification Workshop, please contact a dealer’s place of business must 58057; October 2, 2006). These Angler Conservation Education at (386) possess a copy of a valid dealer or proxy certificate(s) are valid for 3 years. As 682–0158. Atlantic Shark Identification Workshop such, vessel owners who have not certificate. already attended a workshop and Registration Materials To ensure that workshop certificates Workshop Dates, Times, and Locations received a NMFS certificate, or vessel owners whose certificate(s) will expire are linked to the correct permits, 1. January 22, 2015, 12 p.m.–4 p.m., prior to the next permit renewal, must participants will need to bring the LaQuinta Inn & Suites, 2610 Williams attend a workshop to fish with, or following specific items with them to Boulevard, Kenner, LA 70062. renew, their swordfish and shark the workshop:
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• Individual vessel owners must before February 2, 2015 to be assured of based interface between the Bureau’s bring a copy of the appropriate consideration. Office of Consumer Response swordfish and/or shark permit(s), a copy ADDRESSES: You may submit comments, (Consumer Response) and companies. of the vessel registration or identified by the title of the information The Company Portal allows companies documentation, and proof of collection, OMB Control Number (see to view and respond to complaints identification. below), and docket number (see above), submitted through the Bureau’s • Representatives of a business- by any of the following methods: complaint handling system. Many owned or co-owned vessel must bring • Electronic: http:// companies have sought to register with proof that the individual is an agent of www.regulations.gov. Follow the the Company Portal before consumer the business (such as articles of instructions for submitting comments. complaints have been submitted to the incorporation), a copy of the applicable • Mail: Consumer Financial Bureau about their companies to ensure swordfish and/or shark permit(s), and Protection Bureau (Attention: PRA early notice of potential complaints and proof of identification. Office), 1700 G Street NW., Washington, allow companies’ users to acclimate to • Vessel operators must bring proof of DC 20552. the software and security protocols identification. • Hand Delivery/Courier: Consumer needed to access the Company Portal. Workshop Objectives Financial Protection Bureau (Attention: The Bureau’s proposed form, the PRA Office), 1275 First Street NE., Company Portal Boarding Form The Protected Species Safe Handling, Washington, DC 20002. (Boarding Form), will serve to Release, and Identification Workshops Please note that comments submitted streamline information collection from are designed to teach longline and after the comment period will not be these companies, result in a greatly gillnet fishermen the required accepted. In general, all comments enhanced and efficient experience from techniques for the safe handling and received will become public records, both the consumers and companies’ release of entangled and/or hooked including any personal information perspectives. protected species, such as sea turtles, provided. Sensitive personal Request for Comments: Comments are marine mammals, and smalltooth information, such as account numbers invited on: (a) Whether the collection of sawfish. In an effort to improve or social security numbers, should not information is necessary for the proper reporting, the proper identification of be included. performance of the functions of the protected species will also be taught at FOR FURTHER INFORMATION CONTACT: Bureau, including whether the these workshops. Additionally, information will have practical utility; individuals attending these workshops Documentation prepared in support of this information collection request is (b) The accuracy of the Bureau’s will gain a better understanding of the estimate of the burden of the collection requirements for participating in these available at www.regulations.gov. Requests for additional information of information, including the validity of fisheries. The overall goal of these the methods and the assumptions used; workshops is to provide participants should be directed to the Consumer Financial Protection Bureau, (Attention: (c) Ways to enhance the quality, utility, with the skills needed to reduce the and clarity of the information to be mortality of protected species, which PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435–9575, collected; and (d) Ways to minimize the may prevent additional regulations on burden of the collection of information these fisheries in the future. or email: [email protected]. Please do not submit comments to this mailbox. on respondents, including through the Authority: 16 U.S.C. 1801 et seq. use of automated collection techniques SUPPLEMENTARY INFORMATION: Dated: December 1, 2014. Title of Collection: CFPB’S Consumer or other forms of information Emily H. Menashes, Complaint Intake System Company technology. Comments submitted in response to this notice will be Acting Director, Office of Sustainable Portal Boarding Form Information Fisheries, National Marine Fisheries Service. Collection System. summarized and/or included in the request for Office of Management and [FR Doc. 2014–28502 Filed 12–3–14; 8:45 am] OMB Control Number: 3170–XXXX. Budget (OMB) approval. All comments BILLING CODE 3510–22–P Type of Review: New collection (Request for a new OMB control will become a matter of public record. number. Dated: November 19, 2014. BUREAU OF CONSUMER FINANCIAL Affected Public: Private sector. Nellisha Ramdass, PROTECTION Estimated Number of Respondents: Acting Chief Information Officer, Bureau of 50,000. Consumer Financial Protection. [Docket No. CFPB–2014–0032] Estimated Total Annual Burden [FR Doc. 2014–28511 Filed 12–3–14; 8:45 am] Hours: 12,500. BILLING CODE 4810–AM–P Agency Information Collection Abstract: The Dodd-Frank Wall Street Activities: Comment Request Reform and Consumer Protection Act, AGENCY: Bureau of Consumer Financial Public Law 111–203, Title X, provides DEPARTMENT OF ENERGY Protection. for the Bureau’s consumer complaint ACTION: Notice and request for comment. handling function. Among other things, Bonneville Power Administration the Bureau is to facilitate the centralized SUMMARY: In accordance with the collection of, monitoring of, and [BPA File No.: BP–16] Paperwork Reduction Act of 1995 response to complaints concerning Fiscal Year (FY) 2016–2017 Proposed (PRA), the Consumer Financial consumer financial products and Power and Transmission Rate Protection Bureau (Bureau) is proposing services. The support the appropriate Adjustments Public Hearing and a new information collection titled, routing of complaints to the companies Opportunities for Public Review and ‘‘CFPB’S Consumer Complaint Intake that are the subjects of the complaints, Comment System Company Portal Boarding Form the Bureau is developing a form which Information Collection System.’’ will allow companies to proactively AGENCY: Bonneville Power DATES: Written comments are participate in the Bureau’s Company Administration (BPA or Bonneville), encouraged and must be received on or Portal (Company Portal), a secure, Web- Department of Energy (DOE).
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ACTIONS: Notice of FY 2016–2017 2. Written comments by participants Prehearing Conference/BPA Initial Proposed Power and Transmission Rate should be submitted to the Public Proposal—December 10, 2014 Adjustments. Engagement Office, DKE–7, Bonneville Parties File Petitions to Intervene— Power Administration, P.O. Box 14428, December 12, 2014 SUMMARY: BPA is holding a consolidated Portland, Oregon 97293. Participants Clarification—December 17–19, 2014 rate proceeding, Docket No. BP–16, to may also submit comments by email at: Motions to Strike—January 13, 2015 establish power and transmission rates www.bpa.gov/comment. BPA requests Data Request Deadline—January 13, for FY 2016–2017. that all comments and documents 2015 The Pacific Northwest Electric Power intended to be part of the Official Answers to Motions to Strike—January Planning and Conservation Act Record in this rate proceeding contain 21, 2015 (Northwest Power Act) provides that the designation BP–16 in the subject Data Response Deadline—January 21, BPA must establish and periodically line. 2015 review and revise its rates so that they Parties file Direct Case—February 4, FOR FURTHER INFORMATION CONTACT: Ms. recover, in accordance with sound 2015 Michelle Whalen, DKC–7, Public Affairs business principles, the costs associated Clarification—February 11–13, 2015 Specialist, Bonneville Power Motions to Strike—February 17, 2015 with the acquisition, conservation, and Administration, P.O. Box 3621, transmission of electric power, Data Request Deadline—February 17, Portland, Oregon 97208; by phone toll 2015 including amortization of the Federal free at 1–800–622–4520; or via email to investment in the Federal Columbia Answers to Motions to Strike—February [email protected]. Responsible 24, 2015 River Power System (FCRPS) over a Officials: Mr. Raymond D. Bliven, reasonable number of years, and BPA’s Data Response Deadline—February 24, Power Rates Manager, is the official 2015 other costs and expenses. The responsible for the development of Northwest Power Act also requires that Close of Participant Comments— BPA’s power rates, and Ms. Rebecca E. February 26, 2015 BPA’s rates be established based on the Fredrickson, Transmission Rates record of a formal hearing, and for Litigants file Rebuttal—March 16, 2015 Manager, is the official responsible for Clarification—March 19–20, 2015 transmission rates only, that the costs of the development of BPA’s transmission, Motions to Strike—March 24, 2015 the Federal transmission system be ancillary, and control area services Data Request Deadline—March 24, 2015 equitably allocated between Federal and rates. Answers to Motions to Strike—March non-Federal power utilizing the system. SUPPLEMENTARY INFORMATION: 31, 2015 By this notice, BPA announces the Data Response Deadline—March 31, commencement of a power and Table of Contents 2015 transmission rate adjustment proceeding Part I. Introduction and Procedural Cross-Examination—April 1–3 and 6–7, for power, transmission, control area Background 2015 services, and ancillary services rates to Part II. Scope of BP–16 Rate Proceeding Initial Briefs Filed—May 1, 2015 be effective on October 1, 2015. Part III. Public Participation in BP–16 Oral Argument—May 8, 2015 DATES: Anyone wishing to become a Part IV. Summary of Rate Proposals Draft ROD issued—June 12, 2015 party to the BP–16 proceeding must Part V. Proposed BP–16 Rate Schedules Briefs on Exceptions—July 1, 2015 provide written notice, via U.S. Mail or Part I—Introduction and Procedural Final ROD—Final Studies—July 24, electronic mail, which must be received Background 2015 by BPA no later than 3:00 p.m. on Section 7(i) of the Northwest Power Section 1010.7 of BPA’s Procedures December 12, 2014. Act, 16 U.S.C. 839e(i), requires that prohibits ex parte communications. The The BP–16 rate adjustment BPA’s rates be established according to ex parte rule applies to all BPA and proceeding begins with a prehearing certain procedures, including DOE employees and contractors. Except conference at 9:00 a.m. on December 10, publication in the Federal Register of as provided below, any outside 2014, in the BPA Rates Hearing Room, this notice of the proposed rates; one or communications with BPA and/or DOE 1201 NE Lloyd Boulevard, Suite 200, more hearings conducted as personnel regarding the merits of any Portland, Oregon 97232. expeditiously as practicable by a issue in BPA’s rate proceeding by other Written comments by non-party Hearing Officer; opportunity for both Executive Branch agencies, Congress, participants must be received by oral presentation and written existing or potential BPA customers February 26, 2015, to be considered in submission of views, data, questions, (including tribes), or nonprofit or public the Administrator’s Record of Decision and arguments related to the proposed interest groups are considered outside (ROD). rates; and a decision by the communications and are subject to the ADDRESSES: Administrator based on the record. ex parte rule. The rule does not apply 1. Petitions to intervene should be BPA’s rate proceedings are further to communications relating to: (1) directed to: Hearing Clerk—L–7, governed by BPA’s Procedures Matters of procedure only (the status of Bonneville Power Administration, 905 Governing Bonneville Power the rate proceeding, for example); (2) NE 11th Avenue, Portland, Oregon Administration Rate Hearings, 51 exchanges of data in the course of 97232, or may be emailed to rateclerk@ Federal Register 7611 (1986), which business or under the Freedom of bpa.gov. In addition, copies of the implement and expand the statutory Information Act; (3) requests for factual petition must be served concurrently on requirements. information; (4) matters for which BPA BPA’s General Counsel and directed to This proceeding is being conducted is responsible under statutes other than both Mr. Kurt Casad, LP–7, and Mr. under the rule for general rate the ratemaking provisions; or (5) matters Barry Bennett, LT–7, Office of General proceedings, section 1010.4 of BPA’s which all parties agree may be made on Counsel, 905 NE 11th Avenue, Portland, Procedures. A proposed schedule for the an ex parte basis. The ex parte rule Oregon 97232, or via email to krcasad@ proceeding is provided below. A final remains in effect until the bpa.gov and [email protected] (see schedule will be established by the Administrator’s Final ROD is issued, section III.A. for more information Hearing Officer at the prehearing which is scheduled to occur on or about regarding interventions). conference. July 24, 2015.
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Part II—Scope of BP–16 Rate actions resulting from the expense and transmission system, dispatcher Proceeding revenue uncertainties included in the standing orders, e-Tag requirements and risk analysis. The Administrator also definitions, open access transmission A. Joint Rate Proceeding directs the Hearing Officer to exclude tariff (OATT) provisions, and business BPA is holding one power and argument and evidence regarding BPA’s practices. These non-rates issues are transmission rate proceeding with one debt management practices and policies. generally addressed by BPA in procedural schedule, one record, and See section II.C.5. accordance with industry, reliability, one ROD. and other compliance standards and 2. Tiered Rate Methodology (TRM) B. 2014 Integrated Program Review criteria and are not matters appropriate The TRM restricts BPA and customers for the rate proceeding. BPA began its 2014 Integrated with Contract High Water Mark Program Review (IPR) process in May (CHWM) contracts from proposing 5. Federal and Non-Federal Debt Service 2014. The IPR process is designed to changes to the TRM’s ratesetting and Debt Management allow an opportunity to review and guidelines unless certain procedures During the 2014 IPR and in other comment on BPA’s expense and capital have been successfully concluded. No forums, BPA provided the public with spending level estimates before the proposed changes have been subjected background information on BPA’s estimates are used to set rates. On to the required procedures. internal Federal and non-Federal debt October 2, 2014, BPA issued the Final Pursuant to § 1010.3(f) of BPA’s management policies and practices. Close-Out Report for the IPR. In the Procedures, the Administrator hereby While these policies and practices are Final Close-Out Report, BPA established directs the Hearing Officer to exclude not decided in the IPR forum, these the program level cost estimates that are from the record all argument, testimony, discussions were intended to inform used in the Initial Proposal to establish or other evidence that seeks in any way interested parties about these matters so both the power and transmission rates. to propose revisions to the TRM made that they would better understand C. Scope of the Rate Proceeding by BPA, customers with a CHWM BPA’s debt structure. BPA’s debt contract, or their representatives, unless management policies and practices This section provides guidance to the it can be established that the TRM remain outside the scope of the rate Hearing Officer as to those matters that procedures for proposing a change to proceeding. are within the scope of the rate the TRM have been concluded. This Pursuant to § 1010.3(f) of BPA’s proceeding and those that are outside restriction does not extend to a party or Procedures, the Administrator hereby the scope. In addition to the items listed customer that does not have a CHWM directs the Hearing Officer to exclude below, any other issue that is not a rates contract. from the record all argument, testimony, issue is outside the scope of this or other evidence that seeks in any way 3. Service to the Direct Service proceeding. to address the appropriateness or Industries (DSIs) 1. Program Cost Estimates reasonableness of BPA’s debt BPA’s decisions to serve Alcoa and management policies and practices. Some of the decisions that determine Port Townsend along with the method This exclusion does not encompass how program costs and spending levels have and level of service to be provided DSIs debt management actions are reflected been made in the IPR public review in the FY 2016–2017 rate period will in ratemaking. process outside the rate proceeding. See not be determined in this proceeding. section II.B. BPA’s spending levels for The decision to serve the DSIs was 6. Potential Environmental Impacts investments and expenses are not made in the record of decision on the Environmental impacts are addressed determined or subject to review in rate Alcoa and Port Townsend contracts. in a concurrent National Environmental proceedings. The decision was not challenged in the Policy Act (NEPA) process. See section Pursuant to section 1010.3(f) of BPA’s Ninth Circuit Court of Appeals. II.D. Procedures, the Administrator directs Pursuant to § 1010.3(f) of BPA’s Pursuant to § 1010.3(f) of BPA’s the Hearing Officer to exclude from the Procedures, the Administrator directs Procedures, the Administrator directs record all argument, testimony, or other the Hearing Officer to exclude from the the Hearing Officer to exclude from the evidence that challenges the record all argument, testimony, or other record all argument, testimony, or other appropriateness or reasonableness of the evidence that seeks in any way to revisit evidence that seeks in any way to Administrator’s decisions on cost and the appropriateness or reasonableness of address the potential environmental spending levels. If any re-examination BPA’s decisions regarding service to the impacts of the rates being developed in of spending levels is necessary, such re- DSIs, including BPA’s decision to offer this rate proceeding. examination will occur outside of the contracts to the DSIs and the method or 7. 2008 Average System Cost rate proceeding. The above exclusion level of service. does not extend to those portions of the Methodology (2008 ASCM) and Average revenue requirements related to interest 4. Generation Inputs System Cost Determinations rate forecasts, interest expense and BPA provides a portion of the Section 5(c) of the Northwest Power credit, Treasury repayment schedules, available generation from the FCRPS to Act established the Residential forecasts of depreciation and enable Transmission Services to meet its Exchange Program, which provides amortization expense, forecasts of various requirements. Transmission benefits to residential and farm system replacements used in repayment Services uses these generation inputs to consumers of Pacific Northwest utilities studies, Residential Exchange Program provide ancillary and control area based, in part, on a utility’s ‘‘average benefits, purchased power expenses, services. system cost’’ (ASC) of resources. On transmission acquisition expense Pursuant to § 1010.3(f) of BPA’s September 4, 2009, the Federal Energy incurred by Power Services, generation Procedures, the Administrator directs Regulatory Commission (Commission) acquisition expense incurred by the Hearing Officer to exclude from the granted final approval of BPA’s 2008 Transmission Services, minimum record all argument, testimony, or other ASCM. The 2008 ASCM is not subject required net revenue, use of financial evidence that seeks in any way to revisit to challenge or review in a section 7(i) reserves, and the costs of risk mitigation issues regarding reliability of the proceeding. Determinations of the ASCs
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of participating utilities are made in Public Agency Customers v. Bonneville combination of alternative policy separate processes conducted pursuant Power Administration, 733 F.3d 939 modules should allow BPA to balance to the ASCM. Those processes began (9th Cir. 2013). its costs and revenues. The Business with ASC filings on June 2, 2014, and Because the 2012 REP Settlement was Plan EIS also includes response are continuing through July 2015. The part of the REP–12 ROD, and approved strategies, such as adjustments to rates, determinations of ASCs are not subject by the Court, challenges to BPA’s that BPA could implement if BPA’s to challenge or review in a section 7(i) decision to adopt the 2012 REP costs exceed its revenues. proceeding. Settlement and implement its terms in In August 1995, the BPA Pursuant to § 1010.3(f) of BPA’s BPA’s rate proceedings are not within Administrator issued a ROD (Business Procedures, the Administrator hereby the scope of this proceeding. Pursuant Plan ROD) that adopted the Market- directs the Hearing Officer to exclude to § 1010.3(f) of BPA’s Procedures, the Driven Alternative from the Business from the record all argument, testimony, Administrator hereby directs the Plan EIS. This alternative was selected or other evidence that seeks in any way Hearing Officer to exclude from the because, among other reasons, it allows to visit or revisit the appropriateness or record all argument, testimony, or other BPA to: (1) Recover costs through rates; reasonableness of the 2008 ASCM or evidence that seeks in any way to visit (2) competitively market BPA’s products that seeks in any way to visit or revisit or revisit BPA’s determination to adopt and services; (3) develop rates that meet the appropriateness or reasonableness of the 2012 REP Settlement or its terms in customer needs for clarity and any of the ongoing ASC determinations. this rate proceeding. simplicity; (4) continue to meet BPA’s legal mandates; and (5) avoid adverse 8. Rate Period High Water Mark 10. Transfer Service for Southeast Idaho environmental impacts. BPA also (RHWM) Process Load Service committed to apply as many response Under the Tiered Rate Methodology Because of the termination of strategies as necessary when BPA’s costs (TRM), BPA has established FY 2016– grandfathered contracts, BPA is and revenues do not balance. 2017 RHWMs for Public customers that developing a new transmission service In April 2007, BPA completed and signed contracts for firm requirements plan for its preference customers located issued a Supplement Analysis to the power service providing for tiered rates, in Southeast Idaho. The cost allocation Business Plan EIS. This Supplement referred to as CHWM contracts. In this issue related to this plan is an Analysis found that the Business Plan RHWM Process, which preceded the appropriate issue in this rate EIS’s relationship-based and policy- BP–16 rate proceeding, BPA established proceeding. However, all decisions level analysis of potential the maximum planned amount of power regarding the development of the new environmental impacts from BPA’s a customer is eligible to purchase at Tier plan of service itself are outside the business practices remains valid, and 1 rates during the rate period, the scope of the rate proceeding. that BPA’s current business practices Above-RHWM Loads for each customer, Pursuant to § 1010.3(f) of BPA’s remain consistent with BPA’s Market- the System Shaped Load for each Procedures, the Administrator directs Driven Alternative approach. The customer, the Tier 1 System Firm the Hearing Officer to exclude from the Business Plan EIS and ROD thus Critical Output, RHWM Augmentation, record all argument, testimony, or other continue to provide a sound basis for the Rate Period Tier 1 System Capability evidence that seeks in any way to visit making determinations under NEPA (RT1SC), and the monthly/diurnal or revisit BPA’s strategy or acquisition concerning BPA’s policy-level shape of RT1SC. The RHWM Process decisions for Southeast Idaho Load decisions, including rates. provided customers an opportunity to Service. Because the proposed rates likely review, comment, and, if necessary, would assist BPA in accomplishing the D. The National Environmental Policy challenge BPA’s RHWM determinations. goals identified in the Business Plan Pursuant to § 1010.3(f) of BPA’s Act (NEPA) ROD, the proposal appears consistent Procedures, the Administrator hereby BPA is in the process of assessing the with these aspects of the Market-Driven directs the Hearing Officer to exclude potential environmental effects of its Alternative. In addition, this rate from the record all argument, testimony, proposed power and transmission rates, proposal is similar to the type of rate or other evidence that seeks in any way consistent with NEPA. The NEPA designs evaluated in the Business Plan to visit or revisit BPA’s determination of process is conducted separately from EIS; thus, implementation of this rate a customer’s FY 2016–2017 RHWM or the rate proceeding. As discussed in proposal would not be expected to other RHWM Process determinations. section II.C.6., all evidence and result in environmental impacts argument addressing potential significantly different from those 9. 2012 Residential Exchange Program environmental impacts of rates being examined in the Business Plan EIS. Settlement Agreement (2012 REP developed in the BP–16 rate proceeding Therefore, BPA expects that this rate Settlement) are excluded from the rate proceeding proposal will likely fall within the On July 26, 2011, the Administrator hearing record. Instead, comments on scope of the Market-Driven Alternative executed the 2012 REP Settlement environmental effects should be that was evaluated in the Business Plan resolving longstanding litigation over directed to the NEPA process. EIS and adopted in the Business Plan BPA’s implementation of the Because this proposal involves BPA’s ROD. Residential Exchange Program (REP) ongoing business practices related to As part of the Administrator’s ROD under section 5(c) of the Northwest rates, BPA is reviewing the proposal for that will be prepared for the BP–16 rate Power Act, 16 U.S.C. 839c(c). The consistency with BPA’s Business Plan proceeding, BPA may tier its decision Administrator’s findings regarding the Environmental Impact Statement under NEPA to the Business Plan ROD. legal, factual, and policy challenges to (Business Plan EIS), completed in June However, depending upon the ongoing the 2012 REP Settlement are thoroughly 1995 (BOE/EIS–0183). This policy-level environmental review, BPA may instead explained in the REP–12 Record of EIS evaluates the environmental issue another appropriate NEPA Decision (REP–12 ROD). The 2012 REP impacts of a range of business plan document. Comments regarding the Settlement and REP–12 ROD were alternatives for BPA that could be varied potential environmental effects of the approved by U.S. Court of Appeals for by applying various policy modules, proposal may be submitted to Katherine the Ninth Circuit in Association of including one for rates. Any Pierce, NEPA Compliance Officer, KEC–
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4, Bonneville Power Administration, filed and served 24 hours before the Tier 2 rates, corresponding to contract 905 NE 11th Avenue, Portland, OR prehearing conference. The time limit options, are applied to customers that 97232. Any such comments received by for opposing a timely intervention will have elected to purchase power from the comment deadline for Participant be established at the prehearing BPA for service to their Above-RHWM Comments identified in section III.A. conference. Any party, including BPA, Load. below will be considered by BPA’s may oppose a petition for intervention. The PF rate is a collection of rates NEPA compliance staff in the NEPA All petitions will be ruled on by the charged on the basis of percentage of process that will be conducted for this Hearing Officer. Late interventions are cost responsibility, marginal changes in proposal. strongly disfavored. Opposition to an demand and energy usage, customer untimely petition to intervene must be purchase elections for BPA service to Part III—Public Participation in BP–16 filed and received by BPA within two loads in excess of power purchased at A. Distinguishing Between days after service of the petition. Tier 1 rates, product and service ‘‘Participants’’ and ‘‘Parties’’ choices, transfer load delivery and B. Developing the Record operating reserves, and applicability of BPA distinguishes between The hearing record will include, rate discounts. Very few of BPA’s ‘‘participants in’’ and ‘‘parties to’’ the among other things, the transcripts of customers have exactly the same mix of hearings. Separate from the formal the hearing, written evidence and PF rate components in common. hearing process, BPA will receive argument entered into the record by Therefore, BPA has developed a written comments, views, opinions, and BPA and the parties, written comments quantification of the PF rate that information from participants, who may from participants, and other material measures the impact on an average submit comments without being subject accepted into the record by the Hearing customer purchasing at Tier 1 rates. to the duties of, or having the privileges Officer. The Hearing Officer will review This quantification, the Tier 1 Average of, parties. Participants’ written the record and certify the record to the Net Cost, is increasing 6.7 percent in comments will be made part of the Administrator for final decision. this proposal, from $31.50/MWh for the official record and considered by the The Administrator will develop final PF–14 rate to $33.60/MWh for the PF– Administrator. Participants are not rates based on the record and such other 16 rate. entitled to participate in the prehearing materials and information as may have The Base PF Exchange rate and its conference; may not cross-examine been submitted to or developed by the associated surcharges apply to the sale parties’ witnesses, seek discovery, or Administrator. The Administrator will of power to regional utilities that serve or be served with documents; and serve copies of the Final ROD on all participate in the REP established under are not subject to the same procedural parties. BPA will file its rates with the section 5(c) of the Northwest Power Act. requirements as parties. BPA customers Commission for confirmation and 16 U.S.C. 839c(c). The Base PF whose rates are subject to this approval after issuance of the Final Exchange rate establishes the threshold proceeding, or their affiliated customer ROD. for participation in the REP; only groups, may not submit participant utilities with ASCs above the Part IV—Summary of Rate Proposals comments. Members or employees of appropriate Base PF Exchange rate may organizations that have intervened in A. Summary of the Power Rate Proposal receive REP benefits. If a utility meets the rate proceeding may submit the threshold, a utility-specific PF 1. Power Rates participant comments as private Exchange rate will be established in this individuals (that is, not speaking for BPA is proposing four different rates proceeding for each eligible utility. The their organizations) but may not use the for Federal power sales and services. utility-specific PF Exchange rate is used comment procedures to address specific The General Transfer Agreement Service in calculating the REP benefits each issues raised by their intervenor (GTA) rate schedule, currently included participant will receive during FY organizations. as a power rate schedule, is being 2016–2017. Written comments by participants moved to the General Rate Schedule In addition, the proposed PF–16 rate will be included in the record if they are Provisions. The proposed GTA charges schedule includes rates for customers received by February 26, 2015. Written are expanded to recover Western with non-Federal resources that have views, supporting information, Electricity Coordinating Council elected to take Diurnal Flattening questions, and arguments should be (WECC) and Peak Reliability (Peak) Service or Secondary Crediting Service, submitted to the address listed in the costs BPA incurs based on transfer and a melded PF rate for any Public ADDRESSES section of this notice. customer loads outside of the BPA customer that elects a power sales Entities or persons become parties to balancing authority area. contract other than a CHWM Contract the proceeding by filing petitions to Priority Firm Power Rate (PF–16)— for firm requirements service. intervene, which must state the name The PF rate schedule applies to net New Resource Firm Power Rate (NR– and address of the entity or person requirements power sales to public 16)—The NR–16 rate applies to net requesting party status and the entity’s body, cooperative, and Federal agency requirements power sales to investor- or person’s interest in the hearing. BPA customers made pursuant to section 5(b) owned utilities (IOUs) made pursuant to customers and affiliated customer of the Northwest Power Act and section 5(b) of the Northwest Power Act groups will be granted intervention includes the PF Public rates for the sale for resale to ultimate consumers, direct based on petitions filed in conformance of firm requirements power under consumption, construction, testing and with BPA’s Procedures. Other CHWM Contracts and the PF Exchange start-up, and station service. The NR–16 petitioners must explain their interests rates for sales under Residential rate is also applied to sales of firm in sufficient detail to permit the Hearing Purchase and Sale Agreements. The PF power to Public customers when this Officer to determine whether the Public rate applies to customers taking power is used to serve new large single petitioners have a relevant interest in load following or Slice/block service. loads. In addition, BPA is proposing NR the hearing. Pursuant to Rule 1010.1(d) Consistent with the TRM, Tier 1 rates rates for services to support Public of BPA’s Procedures, BPA waives the include three charges: (1) Customer customers serving new large single requirement in Rule 1010.4(d) that an charges; (2) a demand charge; and (3) a loads with non-Federal resources. In the opposition to an intervention petition be load shaping charge. In addition, four Initial Proposal BPA is forecasting no
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sales at the NR rate. The average NR–16 3. Risk Mitigation Tools Network, similar to Point-to-Point (PTP) rate in the Initial Proposal is $76.60/ The main financial risk mitigation service (see below), and includes MWh, a decrease of 1.4 percent from the tool BPA relies upon is financial Scheduling, System Control, and NR–14 rate. liquidity, which consists of cash, other Dispatch Service. Industrial Firm Power Rate (IP–16)— Network Integration Transmission investments in the Bonneville Fund at The IP rate is applicable to firm power Rate (NT–16)—The NT rate applies to the U.S. Treasury, and a short-term sales to DSI customers authorized by customers taking network integration liquidity facility with the U.S. Treasury. section 5(d)(1)(A) of the Northwest service under the Open Access BPA proposes to include provisions for Power Act. 16 U.S.C. § 839c(d)(1)(A). In Transmission Tariff (OATT) and allows two rate adjustments in the power rate the Initial Proposal BPA is forecasting customers to flexibly serve their retail schedules and in certain ancillary and annual sales of 316 average megawatts load. control area services rate schedules: The (aMW) to DSIs. See section IV.A.2c. The Point-to-Point Rate (PTP–16)—The Cost Recovery Adjustment Clause average IP–16 rate in the Initial Proposal PTP rate is a contract demand rate that (CRAC), which can generate additional is $41.53/MWh, an increase of 6.6 applies to customers taking Point-to- cash within the rate period, and the percent over the IP–14 rate. Point service on BPA’s network Dividend Distribution Clause (DDC), Firm Power and Surplus Products and facilities under the OATT. It provides which can return cash to customers Services Rate (FPS–16)—The FPS rate customers with flexible service from when BPA’s financial reserves schedule is applicable to sales of identified Points of Receipt to identified attributed to power are larger than various surplus power products and Points of Delivery. There are separate needed to meet its Treasury Payment surplus transmission capacity, for use PTP rates for long-term firm service; Probability (TPP) standard. When inside and outside the Pacific daily firm and non-firm service; and available liquidity and the CRAC are Northwest. The rates for these products hourly firm and non-firm service. are negotiated between BPA and the insufficient to meet the TPP standard, BPA is proposing four rates for purchasers. In addition, the FPS–16 rate BPA includes Planned Net Revenues for intertie use: schedule includes rates for customers Risk (PNRR) in its rates. The Southern Intertie Rate (IS–16) is with non-Federal resources, the In the Initial Proposal, BPA proposes a contract demand rate that applies to Unanticipated Load Service rate, rates to include no PNRR and to cap the customers taking Point-to-Point service for other capacity, energy, and maximum revenue recoverable through under the OATT on the Southern scheduling products and services, and the CRAC at $300 million per year. BPA Intertie. rates for reserve services for use outside is proposing some minor changes to the The Montana Intertie Rate (IM–16) the BPA balancing authority area. risk mitigation tools in the BP–16 Initial applies to customers taking Point-to- Proposal, including a revision to the Point service on the Eastern Intertie. 2. Ancillary Service and Control Area metric used to determine whether a Service Rates The Townsend-Garrison Transmission CRAC or DDC triggers. The thresholds Rate (TGT–16) is a rate for firm service Beginning in May 2014, BPA held rate for triggering the CRAC and DDC remain over BPA’s section of the Montana case workshops and solicited unchanged from the BP–14 rate case Intertie and is available to parties to the stakeholder comments concerning (equivalent reserve levels of $0 and Montana Intertie Agreement. generation inputs issues that form the $750 million, respectively, in financial The Eastern Intertie Rate (IE–16) is a foundation of most ancillary service and reserves attributed to Power). BPA also rate for non-firm service on the portion control area service rates. Over the proposes to continue the National of the Eastern Intertie capacity that following months, BPA and Marine Fisheries Service FCRPS exceeds BPA’s firm transmission rights stakeholders developed a settlement Biological Opinion Adjustment (NFB and is available to parties to the agreement that covers most ancillary Adjustment) and the Emergency NFB Montana Intertie Agreement. and control area service rates. The Surcharge, given that litigation Other proposed transmission rates settlement agreement rates are at the regarding the Biological Opinion are: same level as current rates except for a continues. The Use-of-Facilities Rate (UFT–16) five percent increase for the Operating B. Summary of the Transmission Rate establishes a formula rate for the use of Reserves rates. The settlement Proposal a specific facility based on the annual agreement also provides for other cost of that facility. changes to the rate schedules, and BPA is proposing an overall 5.6 The Advance Funding Rate (AF–16) specifies the amount of balancing percent increase in transmission rates. allows BPA to collect the capital and reserve capacity to be provided during BPA is also proposing to develop a related costs of specific facilities the rate period as well as an acquisition WECC and Peak rate. through an advance-funding budget for balancing reserve capacity. BPA is proposing four different rates mechanism. BPA asked all entities that intended to for the use of its Network segment, four The Scheduling, System Control, and be parties to the BP–16 rate proceeding different rates for use of intertie Dispatch Service Rate and the Reactive to either sign the agreement or declare segments, and several other rates for Supply and Voltage Control from their intention to contest the agreement various purposes. Generation Sources Service Rate are for by September 25, 2014. By that The four rates for use of the Network required ancillary services for deadline, 29 parties signed or agreed not segment are: transmission service on the Network, to contest the settlement agreement. No Formula Power Transmission Rate the Southern Intertie, and the Montana party declared an intent to contest the (FPT–16)—The FPT rate is based on the Intertie. agreement. cost of using specific types of facilities, The WECC and Peak rates recover BPA will file the BP–16 generation including a distance component for the WECC and Peak costs assessed to BPA inputs settlement agreement as part of use of transmission lines, and is charged to cover WECC and Peak reliability the BP–16 Initial Proposal. Parties will on a contract demand basis. functions. be given an opportunity to contest the Integration of Resources Rate (IR– The Oversupply Rate (OS–16) agreement pursuant to a timeline 16)—The IR rate is a postage stamp, recovers the costs BPA incurs to established by the Hearing Officer. contract demand rate for the use of the displace generation under the
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oversupply management protocol, Water Agency, 1200 F Street, http://www.ferc.gov/docs-filing/ Attachment P to BPA’s OATT. Marysville, CA 95901–4740, (530) 741– elibrary.asp. Enter the docket number Other charges that may apply include 5015. excluding the last three digits in the a Delivery Charge for the use of low- i. FERC Contact: Mr. John Aedo, (415) docket number field to access the voltage delivery substations; a 369–3335, or [email protected]. document. You may also register online Reservation Fee for customers that j. Deadline for filing comments, at http://www.ferc.gov/docs-filing/ postpone their service commencement motions to intervene, protests, and esubscription.asp to be notified via dates; incremental rates for transmission recommendations is 30 days from the email of new filings and issuances requests that require new facilities; a issuance date of this notice by the related to this or other pending projects. penalty charge for failure to comply Commission (December 26, 2014). The For assistance, call 1–866–208–3676 or with dispatch, curtailment, redispatch, Commission strongly encourages email [email protected], for or load shedding orders; and an electronic filing. Please file motions to TTY, call (202) 502–8659. A copy is also Unauthorized Increase Charge for intervene, protests, comments, or available for inspection and customers that exceed their contracted recommendations using the reproduction at the address in item (h) amounts. BPA is proposing to eliminate Commission’s eFiling system at http:// above. the Power Factor Penalty Charge. www.ferc.gov/docs-filing/efiling.asp. m. Individuals desiring to be included Commenters can submit brief comments on the Commission’s mailing list should Part V—Proposed BP–16 Rate up to 6,000 characters, without prior so indicate by writing to the Secretary Schedules registration, using the eComment system of the Commission. BPA’s proposed BP–16 Power Rate at http://www.ferc.gov/docs-filing/ n. Comments, Protests, or Motions to Schedules and Transmission Rate ecomment.asp. You must include your Intervene: Anyone may submit Schedules are a part of this notice and name and contact information at the end comments, a protest, or a motion to are available for viewing and of your comments. For assistance, intervene in accordance with the downloading on BPA’s Web site at please contact FERC Online Support at requirements of Rules of Practice and http://www.bpa.gov/goto/BP16. Copies [email protected], (866) Procedure, 18 CFR 385.210, .211, .214. of the proposed rate schedules also are 208–3676 (toll free), or (202) 502–8659 In determining the appropriate action to available for viewing in BPA’s Public (TTY). In lieu of electronic filing, please take, the Commission will consider all Reference Room at the BPA send a paper copy to: Secretary, Federal protests or other comments filed, but Headquarters, 1st Floor, 905 NE 11th Energy Regulatory Commission, 888 only those who file a motion to Avenue, Portland, OR 97232. First Street NE., Washington, DC 20426. intervene in accordance with the Please include the project number (P– Commission’s Rules may become a Issued this 19th day of November, 2014. 2246–069) on any comments, motions to party to the proceeding. Any comments, Elliot E. Mainzer, intervene, protests, or recommendations protests, or motions to intervene must Administrator and Chief Executive Officer. filed. be received on or before the specified [FR Doc. 2014–28463 Filed 12–3–14; 8:45 am] k. Description of Request: The comment date for the particular BILLING CODE 6450–01–P licensee requests a temporary variance application. of the minimum flow requirements in o. Filing and Service of Responsive the lower Yuba River below Englebright Documents: Any filing must (1) bear in DEPARTMENT OF ENERGY Dam, which requires a minimum flow of all capital letters the title 1,000 cubic feet per second (cfs) from ‘‘COMMENTS’’, ‘‘PROTEST’’, or Federal Energy Regulatory January 1 to 15. In order to conserve ‘‘MOTION TO INTERVENE’’ as Commission water resources during the current applicable; (2) set forth in the heading [Project No. 2246–069] drought and make best biological use of the name of the applicant and the a limited water supply, the licensee project number of the application to Yuba County Water Agency; Notice of proposes to instead release 550 cfs from which the filing responds; (3) furnish Application Accepted for Filing, January 1 to January 16, 2015. In the name, address, and telephone Soliciting Comments, Motions To addition, the licensee requests that number of the person protesting or Intervene, and Protests minimum flow compliance during this intervening; and (4) otherwise comply period be based on a 5-day running with the requirements of 18 CFR Take notice that the following average of average daily streamflows, 385.2001 through 385.2005. All hydroelectric application has been filed with instantaneous flows never less comments, motions to intervene, or with the Commission and is available than 90 percent of the specified 550 cfs protests must set forth their evidentiary for public inspection: minimum flow and never less than 550 basis and otherwise comply with the a. Type of Application: Application cfs for more than 48 hours. The requirements of 18 CFR 4.34(b). All for Temporary Variance of Minimum proposed variance would be in addition comments, motions to intervene, or Flow Requirement. to the one already requested variance for protests should relate to project works b. Project No.: 2246–069. December 1–31, 2014 and January 16 to which are the subject of the variance. c. Date Filed: November 25, 2014. March 31, 2015 period. Take note that Agencies may obtain copies of the d. Applicant: Yuba County Water the December 1–31 variance was application directly from the applicant. Agency (licensee). granted by Commission order dated A copy of any protest or motion to e. Name of Project: Yuba River November 25, 2014. intervene must be served upon each Project. l. Locations of the Application: A representative of the applicant specified f. Location: North Yuba River, Middle copy of the application is available for in the particular application. If an Yuba River, and Oregon Creek in Yuba, inspection and reproduction at the intervener files comments or documents Nevada, and Sierra counties, CA. Commission’s Public Reference Room, with the Commission relating to the g. Filed Pursuant to: Federal Power located at 888 First Street NE., Room merits of an issue that may affect the Act, 16 U.S.C. 791(a)–825(r). 2A, Washington, DC 20426, or by calling responsibilities of a particular resource h. Applicant Contact: Mr. Curt (202) 502–8371. This filing may also be agency, they must also serve a copy of Aikens, General Manager, Yuba County viewed on the Commission’s Web site at the document on that resource agency.
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A copy of all other filings in reference Docket Numbers: ER15–142–000. Docket Numbers: ER15–487–000; to this application must be accompanied Applicants: Midcontinent ER15–488–000; ER15–489–000. by proof of service on all persons listed Independent System Operator, Inc. Applicants: Peetz Logan Interconnect, in the service list prepared by the Description: Report Filing: 2014–11– LLC, Sagebrush, a California Commission in this proceeding, in 26_Marshall—MRES Attachment O partnership, Sky River LLC. accordance with 18 CFR 4.34(b) and Supplement to be effective N/A. Description: Request for Waiver of 385.2010. Filed Date: 11/26/14. Order No. 676–H Compliance Dated: November 26, 2014. Accession Number: 20141126–5143. Requirements of Peetz Logan Kimberly D. Bose, Comments Due: 5 p.m. ET 12/17/14. Interconnect, LLC, Sagebrush, a California partnership, and Sky River Secretary. Docket Numbers: ER15–359–001. Applicants: Samchully Power & LLC. [FR Doc. 2014–28492 Filed 12–3–14; 8:45 am] Utilities 1 LLC. Filed Date: 11/25/14. BILLING CODE 6717–01–P Description: Tariff Amendment per Accession Number: 20141125–5383. 35.17(b): Supplement to MBR Comments Due: 5 p.m. ET 12/16/14. DEPARTMENT OF ENERGY Application to be effective 12/15/2014. Docket Numbers: ER15–490–000. Filed Date: 11/25/14. Applicants: Southwest Power Pool, Federal Energy Regulatory Accession Number: 20141125–5335. Inc. Commission Comments Due: 5 p.m. ET 12/16/14. Description: § 205(d) rate filing per Docket Numbers: ER15–482–000. 35.13(a)(2)(iii): 1892R3 Westar Energy, Combined Notice of Filings #1 Applicants: South Carolina Electric & Inc. NITSA and NOA to be effective 8/ 1/2014. Take notice that the Commission Gas Company. Filed Date: 11/26/14. received the following electric corporate Description: Compliance filing per 35: Accession Number: 20141126–5040. filings: Order 676 H Compliance filing to be effective 2/2/2015. Comments Due: 5 p.m. ET 12/17/14. Docket Numbers: EC15–36–000. Applicants: Verso Androscoggin Filed Date: 11/25/14. Docket Numbers: ER15–491–000. Power LLC. Accession Number: 20141125–5285. Applicants: Southwest Power Pool, Description: Application for Approval Comments Due: 5 p.m. ET 12/16/14. Inc. under Section 203 of the Federal Power Docket Numbers: ER15–483–000. Description: § 205(d) rate filing per Act of Verso Androscoggin Power LLC. Applicants: New York Independent 35.13(a)(2)(iii): 1893R3 Westar Energy, Filed Date: 11/25/14. System Operator, Inc. Inc. (Savonburg) NITSA and NOA to be Accession Number: 20141125–5397. Description: § 205(d) rate filing per effective 8/1/2014. Comments Due: 5 p.m. ET 12/16/14. 35.13(a)(2)(iii): 205 filing MST revision Filed Date: 11/26/14. Accession Number: 20141126–5043. Take notice that the Commission to clarify eligibility for DAMAP and Comments Due: 5 p.m. ET 12/17/14. received the following exempt BPCG payments to be effective 1/25/ wholesale generator filings: 2015. Docket Numbers: ER15–493–000. Filed Date: 11/25/14. Applicants: Duke Energy Conesville, Docket Numbers: EG15–18–000. Applicants: Spinning Spur Wind Accession Number: 20141125–5306. LLC. Three, LLC. Comments Due: 5 p.m. ET 12/16/14. Description: § 205(d) rate filing per Description: Notice of Self- Docket Numbers: ER15–484–000. 35.13(a)(2)(iii): Amendment to Reactive Certification of Exempt Wholesale Applicants: Southwest Power Pool, Rate Schedule to be effective 12/1/2014. Generator Status of Spinning Spur Wind Inc. Filed Date: 11/26/14. Three, LLC. Description: § 205(d) rate filing per Accession Number: 20141126–5063. Filed Date: 11/26/14. 35.13(a)(2)(iii): 1891R3 Westar Energy, Comments Due: 5 p.m. ET 12/17/14. Accession Number: 20141126–5093. Inc. NITSA and NOA to be effective 8/ Docket Numbers: ER15–494–000. Comments Due: 5 p.m. ET 12/17/14. 1/2014. Applicants: Duke Energy Dicks Creek, Take notice that the Commission Filed Date: 11/25/14. LLC. received the following electric rate Accession Number: 20141125–5312. Description: § 205(d) rate filing per filings: Comments Due: 5 p.m. ET 12/16/14. 35.13(a)(2)(iii): Amendment to Reactive Rate Schedule to be effective 12/1/2014. Docket Numbers: ER14–2574–003. Docket Numbers: ER15–485–000. Applicants: California Independent Applicants: New York Independent Filed Date: 11/26/14. System Operator Corporation. System Operator, Inc. Accession Number: 20141126–5064. Description: Compliance filing per 35: Description: § 205(d) rate filing per Comments Due: 5 p.m. ET 12/17/14. 2014–11–25_Errata_FRAC–MOO to be 35.13(a)(2)(iii): 205 filing re: graduated Docket Numbers: ER15–495–000. effective 11/1/2014. transmission demand curve— Applicants: Duke Energy Killen, LLC. Filed Date: 11/25/14. transmission shortage costs to be Description: § 205(d) rate filing per Accession Number: 20141125–5338. effective 12/31/9998. 35.13(a)(2)(iii): Amendment to Reactive Comments Due: 5 p.m. ET 12/16/14. Filed Date: 11/25/14. Rate Schedule to be effective 12/1/2014. Docket Numbers: ER15–15–001. Accession Number: 20141125–5334. Filed Date: 11/26/14. Applicants: California Independent Comments Due: 5 p.m. ET 12/16/14. Accession Number: 20141126–5068. System Operator Corporation. Docket Numbers: ER15–486–000. Comments Due: 5 p.m. ET 12/17/14. Description: Tariff Amendment per Applicants: Peninsula Power, LLC. Docket Numbers: ER15–496–000. 35.17(b): 2014–11–25_ Description: Initial rate filing per Applicants: Duke Energy Zimmer, DeficiencyResponse_CommitmentCosts 35.12 Peninsula Power,LLC (FERC LLC. to be effective 12/1/2014. Electric Tariff) to be effective 1/1/2015. Description: § 205(d) rate filing per Filed Date: 11/25/14. Filed Date: 11/26/14. 35.13(a)(2)(iii): Amendment to Reactive Accession Number: 20141125–5313. Accession Number: 20141126–5001. Rate Schedule to be effective 12/1/2014. Comments Due: 5 p.m. ET 12/5/14. Comments Due: 5 p.m. ET 12/17/14. Filed Date: 11/26/14.
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Accession Number: 20141126–5082. other information, call (866) 208–3676 Description: § 205(d) rate filing per Comments Due: 5 p.m. ET 12/17/14. (toll free). For TTY, call (202) 502–8659. 35.13(a)(2)(iii): Original Service Docket Numbers: ER15–497–000. Dated: November 26, 2014. Agreement No. 4035; Queue No. U2– _ Applicants: Duke Energy Ohio, Inc. Nathaniel J. Davis, Sr., 028A AT1 to be effective 10/27/2014. Description: Tariff Withdrawal per Deputy Secretary. Filed Date: 11/26/14. 35.15: Cancellation of Rate Schedule 66 Accession Number: 20141126–5215. [FR Doc. 2014–28465 Filed 12–3–14; 8:45 am] to be effective 11/30/2014. Comments Due: 5 p.m. ET 12/17/14. BILLING CODE 6717–01–P Filed Date: 11/26/14. Docket Numbers: ER15–505–000. Accession Number: 20141126–5084. Applicants: Portland General Electric Comments Due: 5 p.m. ET 12/17/14. DEPARTMENT OF ENERGY Company. Docket Numbers: ER15–498–000. Description: Compliance filing per 35: Applicants: Duke Energy Miami Fort, Federal Energy Regulatory NAESB Standards Compliance Filing to LLC. Commission be effective 2/1/2015. Description: § 205(d) rate filing per Combined Notice of Filings #2 Filed Date: 11/26/14. 35.13(a)(2)(iii): Amendment to Reactive Accession Number: 20141126–5216. Rate Schedule to be effective 12/1/2014. Take notice that the Commission Comments Due: 5 p.m. ET 12/17/14. Filed Date: 11/26/14. received the following electric rate Docket Numbers: ER15–506–000. Accession Number: 20141126–5091. filings: Applicants: DeSoto County Comments Due: 5 p.m. ET 12/17/14. Docket Numbers: ER14–2658–001. Generating Company, LLC. Docket Numbers: ER15–499–000. Applicants: NV Energy, Inc. Applicants: Southern California Description: Compliance filing per 35: Description: § 205(d) rate filing per Edison Company. OATT Order No. 792 Compliance 35.13(a)(2)(iii): Revised Reactive Rate Description: § 205(d) rate filing per Filing-Revisions to Attachment O to be Schedule to be effective 12/1/2014. 35.13(a)(2)(iii): LGIA with Alta effective 8/4/2014. Filed Date: 11/26/14. Windpower Development, LLC to be Filed Date: 11/26/14. Accession Number: 20141126–5218. effective 1/26/2015. Accession Number: 20141126–5244. Comments Due: 5 p.m. ET 12/17/14. Filed Date: 11/26/14. Comments Due: 5 p.m. ET 12/17/14. Docket Numbers: ER15–507–000. Accession Number: 20141126–5096. Docket Numbers: ER15–52–002. Applicants: NorthWestern Comments Due: 5 p.m. ET 12/17/14. Applicants: Midcontinent Corporation. Docket Numbers: ER15–500–000. Independent System Operator, Inc. Description: Compliance filing per 35: Applicants: Southwest Power Pool, Description: Tariff Amendment per OATT Order No. 676–H Compliance Inc. 35.17(b): 2014–11–26 GVTC Clean up Filing and Request for Partial Waiver Description: § 205(d) rate filing per Amendment Filing to be effective (Montana) to be effective 2/2/2015. 12/6/2014. 35.13(a)(2)(iii): 1889R3 Westar Energy, Filed Date: 11/26/14. Inc. NITSA and NOA to be effective 8/ Filed Date: 11/26/14. Accession Number: 20141126–5200. Accession Number: 20141126–5243. 1/2014. Comments Due: 5 p.m. ET 12/17/14. Filed Date: 11/26/14. Comments Due: 5 p.m. ET 12/17/14. Accession Number: 20141126–5139. Docket Numbers: ER15–118–001. Docket Numbers: ER15–508–000. Comments Due: 5 p.m. ET 12/17/14. Applicants: Morris Cogeneration, Applicants: Southwest Power Pool, LLC. Inc. Docket Numbers: ER15–501–000. Description: Compliance filing per 35: Applicants: Trans Bay Cable LLC. Description: § 205(d) rate filing per Amendment Refile to be effective 10/17/ Description: Compliance filing per 35: 35.13(a)(2)(iii): 1887R3 Westar Energy, 2014. Inc. NITSA and NOA to be effective Revised Appendix I to the TO tariff to Filed Date: 11/26/14. be effective 10/29/2014. 8/1/2014. Accession Number: 20141126–5153. Filed Date: 11/26/14. Filed Date: 11/26/14. Comments Due: 5 p.m. ET 12/17/14. Accession Number: 20141126–5145. Accession Number: 20141126–5246. Docket Numbers: ER15–502–000. Comments Due: 5 p.m. ET 12/17/14. Comments Due: 5 p.m. ET 12/17/14. Applicants: Bayou Cove Peaking The filings are accessible in the Power, LLC. The filings are accessible in the Commission’s eLibrary system by Description: § 205(d) rate filing per Commission’s eLibrary system by clicking on the links or querying the 35.13(a)(2)(iii): Reactive Service Rate clicking on the links or querying the docket number. Filing to be effective 2/1/2015. docket number. Any person desiring to intervene or Filed Date: 11/26/14. Any person desiring to intervene or protest in any of the above proceedings Accession Number: 20141126–5213. protest in any of the above proceedings must file in accordance with Rules 211 Comments Due: 5 p.m. ET 12/17/14. must file in accordance with Rules 211 and 214 of the Commission’s Docket Numbers: ER15–503–000. and 214 of the Commission’s Regulations (18 CFR 385.211 and Applicants: Midcontinent Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern Independent System Operator, Inc. 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Description: § 205(d) rate filing per time on the specified comment date. Protests may be considered, but 35.13(a)(2)(iii): 2014–11–26_Rattlesnake Protests may be considered, but intervention is necessary to become a SA 847-Wind Belt SA 852 Termination intervention is necessary to become a party to the proceeding. to be effective 11/27/2014. party to the proceeding. eFiling is encouraged. More detailed Filed Date: 11/26/14. eFiling is encouraged. More detailed information relating to filing Accession Number: 20141126–5214. information relating to filing requirements, interventions, protests, Comments Due: 5 p.m. ET 12/17/14. requirements, interventions, protests, service, and qualifying facilities filings Docket Numbers: ER15–504–000. service, and qualifying facilities filings can be found at: http://www.ferc.gov/ Applicants: PJM Interconnection, can be found at: http://www.ferc.gov/ docs-filing/efiling/filing-req.pdf. For L.L.C. docs-filing/efiling/filing-req.pdf. For
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other information, call (866) 208–3676 Description: Initial rate filing per Municipal Energy Agency NITSA NOA (toll free). For TTY, call (202) 502–8659. 35.12, MBR Application to be effective to be effective 8/1/2014. 1/9/2015. Filed Date: 11/24/14. Nathaniel J. Davis, Sr., Filed Date: 11/21/14. Accession Number: 20141124–5118. Deputy Secretary. Accession Number: 20141121–5202. Comments Due: 5 p.m. ET 12/15/14. [FR Doc. 2014–28466 Filed 12–3–14; 8:45 am] Comments Due: 5 p.m. ET 12/12/14. Docket Numbers: ER15–232–001. BILLING CODE 6717–01–P Docket Numbers: ER15–464–000. Applicants: Southwest Power Pool, Applicants: Idaho Power Company. Inc. Description: § 205(d) rate filing per Description: Tariff Amendment per DEPARTMENT OF ENERGY 35.13(a)(2)(iii): Order No. 676–H Waiver 35.17(b): 2415R3 Substitute Kansas Federal Energy Regulatory Request and Compliance Filing to be Municipal Energy Agency NITSA & Commission effective 2/1/2015. NOA to be effective 8/1/2014. Filed Date: 11/24/14. Filed Date: 11/24/14. Combined Notice of Filings #1 Accession Number: 20141124–5008. Accession Number: 20141124–5158. Comments Due: 5 p.m. ET 12/15/14. Comments Due: 5 p.m. ET 12/15/14. Take notice that the Commission Docket Numbers: ER15–465–000. Docket Numbers: ER15–466–000. received the following electric corporate Applicants: Midcontinent Applicants: Midcontinent filings: Independent System Operator, Inc. Independent System Operator, Inc. Docket Numbers: EC15–35–000. Description: Request for Waiver of Description: § 205(d) rate filing per Applicants: AltaGas Power Holdings Midcontinent Independent System 35.13(a)(2)(iii): 2014–11–24 City of (U.S.) Inc., Veresen U.S. Power Inc. Operator, Inc. Alexandria to Schedules 7,8,9 to be Description: Joint Application for Filed Date: 11/21/14. effective 12/1/2014. Authorization Under Section 203 of the Accession Number: 20141121–5245. Filed Date: 11/24/14. Federal Power Act, Request for Comments Due: 5 p.m. ET 12/12/14. Accession Number: 20141124–5120. Expedited Consideration and The filings are accessible in the Comments Due: 5 p.m. ET 12/15/14. Confidential Treatment of AltaGas Commission’s eLibrary system by Docket Numbers: ER15–467–000. Power Holdings (U.S.) Inc., et al. clicking on the links or querying the Applicants: Midcontinent Filed Date: 11/21/14. docket number. Accession Number: 20141121–5261 Independent System Operator, Inc. Any person desiring to intervene or Comments Due: 5 p.m. ET 12/12/14. Description: § 205(d) rate filing per protest in any of the above proceedings 35.13(a)(2)(iii): 2014–11–24 SA 2414 Take notice that the Commission must file in accordance with Rules 211 ATC-Dairyland T–T 1st Rev. to be received the following electric rate and 214 of the Commission’s effective 10/25/2014. filings: Regulations (18 CFR 385.211 and Filed Date: 11/24/14. Docket Numbers: ER12–162–009; 385.214) on or before 5:00 p.m. Eastern Accession Number: 20141124–5135. ER11–3876–012; ER11–2044–012; ER10– time on the specified comment date. Comments Due: 5 p.m. ET 12/15/14. 2611–010. Protests may be considered, but Docket Numbers: ER15–468–000. Applicants: Bishop Hill Energy II intervention is necessary to become a Applicants: Bayonne Plant Holding, LLC, Cordova Energy Company LLC, party to the proceeding. L.L.C. MidAmerican Energy Company, Saranac eFiling is encouraged. More detailed Description: Request for Limited Power Partners, L.P. information relating to filing Waiver of Bayonne Plant Holding, L.L.C. Description: Notification of Change in requirements, interventions, protests, Filed Date: 11/24/14. Status of the Berkshire Hathaway service, and qualifying facilities filings Accession Number: 20141124–5155. Parties. can be found at: http://www.ferc.gov/ Comments Due: 5 p.m. ET 12/15/14. Filed Date: 11/21/14. docs-filing/efiling/filing-req.pdf. For Docket Numbers: ER15–469–000. Accession Number: 20141121–5248. other information, call (866) 208–3676 Applicants: Duke Energy Carolinas, Comments Due: 5 p.m. ET 12/12/14. (toll free). For TTY, call (202) 502–8659. Docket Numbers: ER15–162–001. LLC. Dated: November 24, 2014. Applicants: Southwest Power Pool, Description: § 205(d) rate filing per Inc. Nathaniel J. Davis, Sr., 35.13(a)(2)(iii): NCMPA1 RS 318 Description: Tariff Amendment per Deputy Secretary. Amendment (2014) to be effective 12/ 35.17(b): 2881R1 Substitute City of [FR Doc. 2014–28470 Filed 12–3–14; 8:45 am] 31/2014. Chanute, KS NITSA NOA to be effective BILLING CODE 6717–01–P Filed Date: 11/24/14. 8/1/2014. Accession Number: 20141124–5201. Filed Date: 11/24/14. Comments Due: 5 p.m. ET 12/15/14. Accession Number: 20141124–5101. DEPARTMENT OF ENERGY Take notice that the Commission Comments Due: 5 p.m. ET 12/15/14. received the following PURPA Federal Energy Regulatory 210(m)(3) filings: Docket Numbers: ER15–428–001. Commission Applicants: Nevada Power Company. Docket Numbers: QM14–3–000. Description: Compliance filing per 35: Combined Notice of Filings #2 Applicants: Entergy Arkansas, Inc., Errata to Order No. 1000 Third Regional Entergy Gulf States Louisiana, L.L.C., Compliance Filing to be effective 1/1/ Take notice that the Commission Entergy Louisiana, LLC, Entergy 2015. received the following electric rate Mississippi, Inc., Entergy New Orleans, Filed Date: 11/21/14. filings: Inc., Entergy Services, Inc., Entergy Accession Number: 20141121–5218. Docket Numbers: ER15–212–001. Texas, Inc., Entergy Services, Inc. Comments Due: 5 p.m. ET 12/12/14. Applicants: Southwest Power Pool, Description: Motion for Leave to Docket Numbers: ER15–463–000. Inc. Answer and Answer to Protests of Applicants: San Gorgonio Westwinds Description: Tariff Amendment per Entergy Services, Inc., et al. II, LLC. 35.17(b): 2900R1 Substitute Kansas Filed Date: 11/21/14.
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Accession Number: 20141121–5265. Filed Date: 11/25/14. Filed Date: 11/24/14. Comments Due: 5 p.m. ET 12/19/14. Accession Number: 20141125–5208. Accession Number: 20141124–5224. The filings are accessible in the Comments Due: 5 p.m. ET 12/16/14. Comments Due: 5 p.m. ET 12/15/14. Commission’s eLibrary system by Docket Numbers: ER12–2178–010; Docket Numbers: ER14–2399–003. clicking on the links or querying the ER14–1524–002; ER13–1536–004; Applicants: Southwest Power Pool, docket number. ER12–2528–009; ER12–2311–009; Inc. Any person desiring to intervene or ER12–2201–009; ER12–1829–009; Description: Tariff Amendment per protest in any of the above proceedings ER12–1223–014; ER11–3989–014; 35.17(b): Amendment in ER14–2399— must file in accordance with Rules 211 ER11–2016–016; ER11–2014–018; Attachment AE (MPL) Section 7.1.1 to and 214 of the Commission’s ER11–2013–018; ER11–2011–017; be effective 9/8/2014. Regulations (18 CFR 385.211 and ER11–2010–018; ER11–2009–017; Filed Date: 11/25/14. 385.214) on or before 5:00 p.m. Eastern ER11–2007–016; ER11–2005–018; Accession Number: 20141125–5261. time on the specified comment date. ER10–3308–020; ER10–3027–002; Comments Due: 5 p.m. ET 12/16/14. Protests may be considered, but ER10–3025–004; ER10–2192–021; Docket Numbers: ER14–2982–001. intervention is necessary to become a ER10–2184–021; ER10–2183–018; Applicants: Millennium Power party to the proceeding. ER10–2182–025; ER10–2181–025; Partners, L.P. eFiling is encouraged. More detailed ER10–2180–021; ER10–2179–025; Description: Compliance filing per 35: information relating to filing ER10–2178–021; ER10–2172–021; Additional Revisions to Change in requirements, interventions, protests, ER14–2144–002; ER11–2056–002; Stations to be effective 11/26/2014. service, and qualifying facilities filings ER10–1143–017; ER10–1080–017; Filed Date: 11/25/14. can be found at: http://www.ferc.gov/ ER10–1081–017; ER10–1078–017; Accession Number: 20141125–5055. docs-filing/efiling/filing-req.pdf. For ER10–1048–018; ER10–1020–017; Comments Due: 5 p.m. ET 12/16/14. other information, call (866) 208–3676 ER14–2145–001. (toll free). For TTY, call (202) 502–8659. Docket Numbers: ER15–27–001. Applicants: AV Solar Ranch 1, LLC, Applicants: New Athens Generating Dated: November 24, 2014. Baltimore Gas and Electric Company, Company, LLC. Nathaniel J. Davis, Sr., Beebe 1B Renewable Energy, LLC, Beebe Description: Tariff Amendment per Deputy Secretary. Renewable Energy, LLC, Calvert Cliffs 35.17(b): Additional Revisions to MBR [FR Doc. 2014–28471 Filed 12–3–14; 8:45 am] Nuclear Power Plant LLC, Cassia Gulch Tariff to be effective 11/24/2014. Wind Park, LLC, CER Generation, BILLING CODE 6717–01–P Filed Date: 11/25/14. LLC,CER Generation II, LLC, Accession Number: 20141125–5171. Commonwealth Edison Company, Comments Due: 5 p.m. ET 12/16/14. Constellation Energy Commodities DEPARTMENT OF ENERGY Docket Numbers: ER15–255–000. Group Maine, LLC, Constellation Mystic Applicants: Duke Energy Beckjord Power, LLC, Constellation NewEnergy, Federal Energy Regulatory Storage, LLC. Inc., Constellation Power Source Commission Description: Amendment to October Generation, LLC, Cow Branch Wind 31, 2014 Duke Energy Beckjord Storage, Combined Notice of Filings #1 Power LLC, CR Clearing, LLC, Criterion LLC tariff filing. Power Partners, LLC, Exelon Take notice that the Commission Filed Date: 11/21/14. Framingham, LLC, Exelon Generation received the following electric corporate Accession Number: 20141121–5160. Company, LLC, Exelon New Boston, filings: Comments Due: 5 p.m. ET 12/12/14. LLC, Exelon West Medway, LLC, Exelon Docket Numbers: EC15–12–000. Docket Numbers: ER15–470–000. Wind 4, LLC, Exelon Wyman, LLC, Applicants: Catalina Solar 2, LLC. Applicants: New York Independent Description: Supplement to October Fourmile Wind Energy, LLC, Handsome Lake Energy, LLC, Harvest WindFarm, System Operator, Inc. 17, 2014 Application of Catalina Solar 2, Description: § 205(d) rate filing per LLC for Authorization under Section LLC, Harvest II Windfarm, LLC, High Mesa Energy, LLC, Integrys Energy 35.13(a)(2)(iii): NYISO 205 filing: tariff 203 of the Federal Power Act. revisions credit requirement for external Filed Date: 11/25/14. Services, Inc., Integrys Energy Services of New York, Inc., Michigan Wind 1, transactions to be effective 2/18/2015. Accession Number: 20141125–5222. Filed Date: 11/24/14. Comments Due: 5 p.m. ET 12/5/14. LLC, Michigan Wind 2, LLC, Nine Mile Point Nuclear Station, LLC, PECO Accession Number: 20141124–5225. Take notice that the Commission Comments Due: 5 p.m. ET 12/15/14. received the following electric rate Energy Company, R.E. Ginna Nuclear filings: Power Plant, LLC, Shooting Star Wind Docket Numbers: ER15–470–001. Project, LLC, Tuana Springs Energy, Applicants: New York Independent Docket Numbers: ER10–3097–003. System Operator, Inc. Applicants: Bruce Power Inc. LLC, Wildcat Wind, LLC, Wind Capital Description: Supplement to June 27, Holdings, LLC. Description: Tariff Amendment per 2014 Updated Market Power Analysis Description: Notice of Non-Material 35.17(b): NYISO amendment errata for the Northeast Region of Bruce Power Change in Status of the Integrys and filing to 11/24/14 tariff revision filing to Inc. Exelon MBR Entities under ER12–2178, be effective 2/18/2015. Filed Date: 11/25/14. et. al. Filed Date: 11/25/14. Accession Number: 20141125–5211. Filed Date: 11/24/14. Accession Number: 20141125–5201. Comments Due: 5 p.m. ET 12/16/14. Accession Number: 20141124–5286. Comments Due: 5 p.m. ET 12/16/14. Docket Numbers: ER11–3697–000. Comments Due: 5 p.m. ET 12/15/14. Docket Numbers: ER15–471–000. Applicants: Southern California Docket Numbers: ER14–1224–002. Applicants: Southwest Power Pool, Edison Company. Applicants: Duke Energy Carolinas, Inc. Description: Informational Filing of LLC. Description: § 205(d) rate filing per Notice of Revision to Formula Description: Tariff Amendment per 35.13(a)(2)(iii): 1884R3 Westar Energy, Transmission Rate Annual Update of 35.17(b): Amendment to PMPA NITSA Inc. NITSA and NOA to be effective Southern California Edison Company. OATT SA 355 to be effective 1/1/2014. 8/1/2014.
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Filed Date: 11/25/14. Comments Due: 5 p.m. ET 12/16/14. Dated: November 25, 2014. Accession Number: 20141125–5069. Docket Numbers: ER15–479–000. Nathaniel J. Davis, Sr., Comments Due: 5 p.m. ET 12/16/14. Applicants: Southwest Power Pool, Deputy Secretary. Docket Numbers: ER15–472–000. Inc. [FR Doc. 2014–28472 Filed 12–3–14; 8:45 am] Applicants: Southwest Power Pool, Description: § 205(d) rate filing per BILLING CODE 6717–01–P Inc. 35.13(a)(2)(iii): 1890R3 Westar Energy, Description: § 205(d) rate filing per Inc. NITSA and NOA to be effective 35.13(a)(2)(iii): 1885R3 Westar Energy, 8/1/2014. DEPARTMENT OF ENERGY Inc. (City of Bronson) NITSA and NOA Filed Date: 11/25/14. to be effective 8/1/2014. Accession Number: 20141125–5194. Federal Energy Regulatory Filed Date: 11/25/14. Comments Due: 5 p.m. ET 12/16/14. Commission Accession Number: 20141125–5070. Docket Numbers: ER15–480–000. [Docket No. CP14–555–000] Comments Due: 5 p.m. ET 12/16/14. Applicants: Pacific Gas and Electric Docket Numbers: ER15–473–000. Company. Dominion Transmission, Inc.; Notice of Applicants: Southwest Power Pool, Description: § 205(d) rate filing per Intent To Prepare an Environmental Inc. 35.13(a)(2)(iii): Shelter Cover Extension Assessment for the Proposed Lebanon Description: § 205(d) rate filing per Amendment Filing to be effective West II Project and Request for 35.13(a)(2)(iii): 1886R3 Westar Energy, 12/1/2014. Comments on Environmental Issues Filed Date: 11/25/14. Inc. (Doniphan) NITSA and NOA to be The staff of the Federal Energy effective 8/1/2014. Accession Number: 20141125–5204. Comments Due: 5 p.m. ET 12/16/14. Regulatory Commission (FERC or Filed Date: 11/25/14. Commission) will prepare an Accession Number: 20141125–5086. Docket Numbers: ER15–481–000. environmental assessment (EA) that will Comments Due: 5 p.m. ET 12/16/14. Applicants: AEP Texas Central discuss the environmental impacts of Docket Numbers: ER15–474–000. Company. the Lebanon West II Project (Project) Description: § 205(d) rate filing per Applicants: Ocean State Power LLC. involving construction, operation, and Description: Tariff Withdrawal per 35.13(a)(2)(iii): TCC–EC&R Development abandonment of facilities by Dominion 35.15: Ocean State Power II Notice of PDA to be effective 11/3/2014. Transmission, Inc. (DTI) in Armstrong, Filed Date: 11/25/14. Cancellation to be effective 11/25/2014. Allegheny, and Beaver Counties, Accession Number: 20141125–5248. Filed Date: 11/25/14. Pennsylvania, and Licking, Fayette, Comments Due: 5 p.m. ET 12/16/14. Accession Number: 20141125–5120. Coshocton, Tuscarawas, Harrison, Comments Due: 5 p.m. ET 12/16/14. Take notice that the Commission Carroll, and Columbiana Counties, received the following electric Docket Numbers: ER15–475–000. Ohio. The Commission will use this EA reliability filings: Applicants: Public Service Company in its decision-making process to of New Mexico. Docket Numbers: RR14–8–000. determine whether the project is in the Description: § 205(d) rate filing per Applicants: North American Electric public convenience and necessity. 35.13(a)(2)(iii): Certificate of Reliability Corp. This notice announces the opening of Concurrence with TEP’s Rate Schedule Description: Errata to September 16, the scoping process the Commission No. 104 to be effective 12/29/2014. 2014 Petition of the North American will use to gather input from the public Filed Date: 11/25/14. Electric Reliability Corporation for and interested agencies on the project. Accession Number: 20141125–5133. Approval of the Bylaws and Reliability Your input will help the Commission Comments Due: 5 p.m. ET 12/16/14. Standards Development Procedures of staff determine what issues they need to the Western Electricity Coordinating Docket Numbers: ER15–476–000. evaluate in the EA. Please note that the Council. scoping period will close on December Applicants: Louisville Gas and Filed Date: 11/21/14. Electric Company. 26, 2014. Accession Number: 20141121–5269. This notice is being sent to the Description: Compliance filing per 35: Comments Due: 5 p.m. ET 12/1/14. Commission’s current environmental Order 676_H Section 4 Rev to be The filings are accessible in the mailing list for this project. State and effective 2/2/2015. Commission’s eLibrary system by local government representatives should Filed Date: 11/25/14. clicking on the links or querying the notify their constituents of this Accession Number: 20141125–5136. docket number. proposed project and encourage them to Comments Due: 5 p.m. ET 12/16/14. Any person desiring to intervene or comment on their areas of concern. Docket Numbers: ER15–477–000. protest in any of the above proceedings If you are a landowner receiving this Applicants: Southwest Power Pool, must file in accordance with Rules 211 notice, a pipeline company Inc. and 214 of the Commission’s representative may contact you about Description: § 205(d) rate filing per Regulations (18 CFR 385.211 and the acquisition of an easement to 35.13(a)(2)(iii): 1888R3 Westar Energy, 385.214) on or before 5:00 p.m. Eastern construct, operate, and maintain the Inc. NITSA and NOA to be effective 8/ time on the specified comment date. proposed facilities. The company would 1/2014. Protests may be considered, but seek to negotiate a mutually acceptable Filed Date: 11/25/14. intervention is necessary to become a agreement. However, if the Commission Accession Number: 20141125–5153. party to the proceeding. approves the project, that approval Comments Due: 5 p.m. ET 12/16/14. eFiling is encouraged. More detailed conveys with it the right of eminent Docket Numbers: ER15–478–000. information relating to filing domain. Therefore, if easement Applicants: MATL LLP. requirements, interventions, protests, negotiations fail to produce an Description: Compliance filing per 35: service, and qualifying facilities filings agreement, the pipeline company could NAESB Compliance Filing to be can be found at: http://www.ferc.gov/ initiate condemnation proceedings effective 2/2/2015. docs-filing/efiling/filing-req.pdf. For where compensation would be Filed Date: 11/25/14. other information, call (866) 208–3676 determined in accordance with state Accession Number: 20141125–5164. (toll free). For TTY, call (202) 502–8659. law.
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DTI provided landowners with a fact replacement pipeline in Columbiana The general location of the project sheet prepared by the FERC entitled County, Ohio. facilities is shown in appendix 1.1 ‘‘An Interstate Natural Gas Facility On • Segment 22—abandon in-place Land Requirements for Construction My Land? What Do I Need To Know?’’ about 920 feet, abandon by removal This fact sheet addresses a number of about 3,277 feet, and construct about DTI’s replacement activities would typically-asked questions, including the 4,197 feet of 30-inch-diameter disturb a total of about 196.4 acres, use of eminent domain and how to replacement pipeline in Columbiana including 128.6 acres for abandonment participate in the Commission’s County. of existing pipeline segments and installation of new pipeline, 10.9 acres proceedings. It is also available for • Segment 24—abandon in-place for 63 additional temporary work viewing on the FERC Web site about 897 feet, abandon by removal spaces, 14.6 acres for use of 28 access (www.ferc.gov). about 2,714 feet, and construct about roads, 18.7 acres for 10 pipe storage and 3,611 feet of 30-inch-diameter Summary of the Proposed Project contractor yards, and 23.6 acres for replacement pipeline in Columbiana DTI proposes to replace 11 segments installation of aboveground facilities. County. of 26- and 30-inch-diameter pipeline Following construction DTI would • and install compressor station facilities Segment 25—abandon in-place maintain a total of about 109.4 acres for to transport 130,000 dekatherms per day about 151 feet, abandon by removal permanent operation of the projects on behalf of R. E. Gas Development, LLC about 951 feet, and construct about facilities, and the remaining acreage from DTI’s MarkWest Liberty Bluestone 1,102 feet of 30-inch-diameter would be restored and revert to former Interconnect in Butler County, replacement pipeline in Columbiana uses. Pennsylvania to DTI’s Lebanon-Texas County. The EA Process Gas Interconnect in Warren County, • Segment 27—abandon by removal Ohio. DTI also proposes to increase the about 986 feet, and construct about 986 The National Environmental Policy maximum allowable operating pressure feet of 30-inch-diameter replacement Act (NEPA) requires the Commission to of these pipeline segments from 745 pipeline in Beaver County, take into account the environmental pounds per square inch gauge (psig) to Pennsylvania. impacts that could result from an action 848 psig. 2. Aboveground Facilities—DTI whenever it considers the issuance of a The Project would consist of the proposes to undertake the following Certificate of Public Convenience and following facilities: activities on its existing facilities as Necessity. NEPA also requires us 2 to 1. Pipeline Facilities—DTI would described below: discover and address concerns the undertake the following activities on its public may have about proposals. This • Rural Valley Compressor Station— existing TL–400 Pipeline: process is referred to as ‘‘scoping.’’ The Install a new 10,915-horsepower Solar • Segment 14—abandon in-place main goal of the scoping process is to Taurus 70S combustion turbine and a about 2,647 feet, abandon by removal focus the analysis in the EA on the 3.5 million British thermal units per about 8,420 feet, and construct about important environmental issues. By this hour (MMBtu/hr) boiler that would 11,067 feet of 26-inch-diameter notice, the Commission requests public replace an existing 2.1 MMBtu/hr boiler replacement pipeline in Coshocton and comments on the scope of the issues to at the Rural Valley Compressor Station, Tuscarawas Counties, Ohio. address in the EA. We will consider all in Armstrong County, Pennsylvania. In • Segment 15—abandon in-place filed comments during the preparation addition, DTI would install one new gas about 664 feet, abandon by removal of the EA. cooler, one new filter separator, a about 1,434 feet, and construct about In the EA we will discuss impacts that blowdown separator/silencer, new 2,098 feet of 26-inch-diameter could occur as a result of the suction/discharge tie-ins, and expand replacement pipeline in Tuscarawas construction and operation of the the existing compressor building to County. proposed project under these general accommodate the new compressor unit. • Segment 16—abandon in-place headings: • about 1,654 feet, abandon by removal Newark Compressor Station— • Geology and soils; about 4,159 feet, and construct about Install additional regulation at the • land use; 5,813 feet of 30-inch-diameter existing Newark Compressor Station in • water resources, fisheries, and replacement pipeline in Tuscarawas Licking County, Ohio to reduce the wetlands; County. pressure in the TL–400 Pipeline as the • cultural resources; • Segment 17—abandon in-place gas flows west from the compressor • vegetation and wildlife; about 6,664 feet, abandon by removal station. • air quality and noise; about 3,418 feet, and construction of • Beaver Compressor Station—Install • endangered and threatened species; about 10,082 feet of 30-inch-diameter additional regulation at the existing • public safety; and replacement pipeline in Harrison Beaver Compressor Station in Beaver • cumulative impacts. County, Ohio. County, Pennsylvania to allow We will also evaluate reasonable • Segment 19—abandon in-place additional gas to flow from the TL–400 alternatives to the proposed project or about 1,805 feet, abandon by removal Extension 1 Pipeline into the TL–400 portions of the project, and make about 6,243 feet, and construct about Pipeline. 8,048 feet of 30-inch-diameter 1 The appendices referenced in this notice will • Washington Compressor Station— replacement pipeline in Carroll County. not appear in the Federal Register. Copies of Install four new valves and 30-inch • Segment 20—abandon in-place appendices were sent to all those receiving this diameter steel crossover piping at the notice in the mail and are available at www.ferc.gov about 1,413 feet, abandon by removal existing Washington Compressor Station using the link called ‘‘eLibrary’’ or from the about 3,708 feet, and construct about Commission’s Public Reference Room, 888 First in Fayette County, Ohio. 5,121 feet of 30-inch-diameter Street NE., Washington, DC 20426, or call (202) • replacement pipeline in Carroll County. Coxcomb Gate Assembly—Install a 502–8371. For instructions on connecting to • new relief valve on the existing LN–25 eLibrary, refer to the last page of this notice. Segment 21—abandon by removal 2 Pipeline at the existing Coxcomb Gate ‘‘We,’’ ‘‘us,’’ and ‘‘our’’ refer to the about 1,709 feet, and construct about environmental staff of the Commission’s Office of 1,709 feet of 30-inch-diameter Site in Allegheny County, Pennsylvania. Energy Projects.
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recommendations on how to lessen or Currently Identified Environmental Environmental Mailing List avoid impacts on the various resource Issues The environmental mailing list areas. We have already identified several includes federal, state, and local The EA will present our independent issues that we think deserve attention government representatives and analysis of the issues. The EA will be based on a preliminary review of the agencies; elected officials; available in the public record through proposed facilities and the environmental and public interest eLibrary. Depending on the comments environmental information provided by groups; Native American Tribes; other received during the scoping process, we DTI. This preliminary list of issues may interested parties; and local libraries may also publish and distribute the EA be changed based on your comments and newspapers. This list also includes to the public for an allotted comment and our analysis. all affected landowners (as defined in period. We will consider all comments • Impacts on federally listed threatened the Commission’s regulations) who are on the EA before making our potential right-of-way grantors, whose recommendations to the Commission. and endangered species • impacts on wetlands property may be used temporarily for To ensure we have the opportunity to project purposes, or who own homes • impacts on perennial waterbodies consider and address your comments, within certain distances of aboveground please carefully follow the instructions Public Participation facilities, and anyone who submits in the Public Participation section comments on the project. We will You can make a difference by beginning on page 6. update the environmental mailing list as providing us with your specific With this notice, we are asking the analysis proceeds to ensure that we comments or concerns about the project. agencies with jurisdiction by law and/ send the information related to this Your comments should focus on the or special expertise with respect to the environmental review to all individuals, potential environmental effects, environmental issues of this project to organizations, and government entities reasonable alternatives, and measures to formally cooperate with us in the interested in and/or potentially affected 3 avoid or lessen environmental impacts. preparation of the EA. Agencies that by the proposed project. The more specific your comments, the would like to request cooperating If we publish and distribute the EA, more useful they will be. To ensure that agency status should follow the copies will be sent to the environmental your comments are timely and properly instructions for filing comments mailing list for public review and recorded, please send your comments so provided under the Public Participation comment. If you would prefer to receive that the Commission receives them in section of this notice. a paper copy of the document instead of Washington, DC on or before December the CD version or would like to remove Consultations Under Section 106 of the 26, 2014. National Historic Preservation Act your name from the mailing list, please For your convenience, there are three return the attached Information Request In accordance with the Advisory methods which you can use to submit (appendix 2). Council on Historic Preservation’s your comments to the Commission. In implementing regulations for section all instances please reference the project Becoming an Intervenor 106 of the National Historic docket number (CP14–555–000) with In addition to involvement in the EA Preservation Act, we are using this your submission. The Commission scoping process, you may want to notice to initiate consultation with the encourages electronic filing of become an ‘‘intervenor’’ which is an applicable State Historic Preservation comments and has expert staff available official party to the Commission’s Offices (SHPOs), and to solicit their to assist you at (202) 502–8258 or proceeding. Intervenors play a more views and those of other government [email protected]. formal role in the process and are able agencies, interested Indian tribes, and (1) You can file your comments to file briefs, appear at hearings, and be the public on the project’s potential electronically using the eComment heard by the courts if they choose to 4 effects on historic properties. feature on the Commission’s Web site appeal the Commission’s final ruling. We will define the project-specific (www.ferc.gov) under the link to An intervenor formally participates in Area of Potential Effects (APE) in Documents and Filings. This is an easy the proceeding by filing a request to consultation with the SHPOs as the method for interested persons to submit intervene. Instructions for becoming an project develops. On natural gas facility brief, text-only comments on a project; intervenor are in the User’s Guide under projects, the APE at a minimum (2) You can file your comments the ‘‘e-filing’’ link on the Commission’s encompasses all areas subject to ground electronically using the eFiling feature Web site. disturbance (examples include on the Commission’s Web site construction right-of-way, contractor/ (www.ferc.gov) under the link to Additional Information pipe storage yards, compressor stations, Documents and Filings. With eFiling, Additional information about the and access roads). Our EA for this you can provide comments in a variety project is available from the project will document our findings on of formats by attaching them as a file Commission’s Office of External Affairs, the impacts on historic properties and with your submission. New eFiling at (866) 208–FERC, or on the FERC Web summarize the status of consultations users must first create an account by site at www.ferc.gov using the under section 106. clicking on ‘‘eRegister.’’ You must select ‘‘eLibrary’’ link. Click on the eLibrary the type of filing you are making. If you link, click on ‘‘General Search’’ and 3 The Council on Environmental Quality are filing a comment on a particular enter the docket number, excluding the regulations addressing cooperating agency project, please select ‘‘Comment on a last three digits in the Docket Number responsibilities are at Title 40, Code of Federal Regulations, Part 1501.6. Filing’’; or field (i.e., CP14–555). Be sure you have 4 The Advisory Council on Historic Preservation’s (3) You can file a paper copy of your selected an appropriate date range. For regulations are at Title 36, Code of Federal comments by mailing them to the assistance, please contact FERC Online Regulations, Part 800. Those regulations define following address: Kimberly D. Bose, Support at [email protected] historic properties as any prehistoric or historic or toll free at (866) 208–3676, or for district, site, building, structure, or object included Secretary, Federal Energy Regulatory in or eligible for inclusion in the National Register Commission, 888 First Street NE., Room TTY, contact (202) 502–8659. The of Historic Places. 1A, Washington, DC 20426. eLibrary link also provides access to the
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texts of formal documents issued by the Docket No. EL11–34, Midwest Docket No. ER13–1317, Entergy Commission, such as orders, notices, Independent Transmission System Arkansas, Inc. and rulemakings. Operator, Inc. v. Southwest Power Docket No. ER13–1508, Entergy In addition, the Commission now Pool, Inc. Arkansas, Inc. offers a free service called eSubscription Docket No. EL11–57, Louisiana Public Docket No. ER13–1509, Entergy Gulf which allows you to keep track of all Service Commission v. Entergy States Louisiana, L.L.C. formal issuances and submittals in Services, Inc., et al. Docket No. ER13–1510, Entergy specific dockets. This can reduce the Docket No. EL11–63, Louisiana Public Louisiana, LLC amount of time you spend researching Service Commission v. Entergy Docket No. ER13–1511, Entergy proceedings by automatically providing Services, Inc. Mississippi, Inc. you with notification of these filings, Docket No. EL11–65, Louisiana Public Docket No. ER13–1512, Entergy New document summaries, and direct links Service Commission v. Entergy Orleans, Inc. to the documents. Go to www.ferc.gov/ Services, Inc. Docket No. ER13–1513, Entergy Texas, docs-filing/esubscription.asp. Docket No. EL13–41, Occidental Inc. Finally, public meetings or site visits Chemical Company v. Midwest Docket No. ER13–1595, Entergy will be posted on the Commission’s Independent System Transmission Services, Inc. calendar located at www.ferc.gov/ Operator, Inc. Docket No. ER13–1623, Entergy EventCalendar/EventsList.aspx along Docket No. EL14–19, Midcontinent Services, Inc. with other related information. Independent System Operator and Docket No. ER14–73, Entergy Services, Inc. Dated: November 25, 2014. Entergy Services, Inc. Docket No. EL14–21, Southwest Power Docket No. ER14–75, Entergy Arkansas, Kimberly D. Bose, Pool, Inc. v. Midcontinent Inc. Secretary. Independent System Operator, Inc. Docket No. ER14–76, Entergy Gulf [FR Doc. 2014–28490 Filed 12–3–14; 8:45 am] Docket No. EL14–46, Ameren Services States Louisiana, L.L.C. BILLING CODE 6717–01–P Co. Docket No. ER14–77, Entergy Louisiana, Docket No. ER07–956, Entergy Services, LLC Inc. Docket No. ER14–78, Entergy DEPARTMENT OF ENERGY Docket No. ER08–1056, Entergy Mississippi, Inc. Services, Inc. Docket No. ER14–79, Entergy New Federal Energy Regulatory Docket No. ER09–1224, Entergy Orleans, Inc. Commission Services, Inc. Docket No. ER14–80, Entergy Texas, Inc. Docket No. ER14–89, Entergy Arkansas, Notice of FERC Staff Attendance at the Docket No. ER10–794 Entergy Services, Inc. Entergy Regional State Committee Inc. Docket No. ER14–108, Entergy Services, Meeting Docket No. ER10–1350, Entergy Services, Inc. Inc. The Federal Energy Regulatory Docket No. ER10–2001, Entergy Docket No. ER14–128, Entergy Texas, Commission (Commission) hereby gives Arkansas, Inc. Inc. notice that members of its staff may Docket No. ER10–3357, Entergy Docket No. ER14–148, Midcontinent attend the meeting noted below. Their Arkansas, Inc. Independent System Operator attendance is part of the Commission’s Docket No. ER11–2161, Entergy Texas, Docket No. ER14–673, Entergy ongoing outreach efforts. Inc. Arkansas, Inc. Docket No. ER11–3658, Entergy Docket No. ER14–693, Entergy Services, Entergy Regional State Committee Services, Inc. Inc. December 2, 2014 (9:30 a.m.–12:30 p.m. Docket No. ER12–1384, Entergy Docket No. ER14–694, Entergy Services, Central) Arkansas, Inc. Inc. Docket No. ER12–1385, Entergy Gulf Docket No. ER14–696, Entergy Services, This meeting will be held at the States Louisiana, L.L.C. Inc. Hilton Austin, 500 East 4th St., Austin, Docket No. ER12–1386, Entergy Docket No. ER14–697, Entergy Services, TX 78701. Louisiana, LLC Inc. The discussions may address matters Docket No. ER12–1387, Entergy Docket No. ER14–700, Entergy Services, at issue in the following proceedings: Mississippi, Inc. Inc. Docket No. EL01–88, Louisiana Public Docket No. ER12–1388, Entergy New Docket No. ER14–702, Entergy Services, Service Commission v. Entergy Orleans, Inc. Inc. Services, Inc. Docket No. ER12–1390, Entergy Texas, Docket No. ER14–703, Entergy Services, Docket No. EL09–50, Louisiana Public Inc. Inc. Service Commission v. Entergy Docket No. ER12–1920, Entergy Docket No. ER14–704, Entergy Services, Services, Inc. Services, Inc. Inc. Docket No. EL09–61, Louisiana Public Docket No. ER13–432, Entergy Services, Docket No. ER14–1174, Southwest Service Commission v. Entergy Inc. Power Pool, Inc. Services, Inc. Docket No. ER13–769, Entergy Docket No. ER14–1263, Entergy Gulf Docket No. EL10–55, Louisiana Public Arkansas, Inc. and Entergy States Louisiana, L.L.C. Service Commission v. Entergy Mississippi, Inc. Docket No. ER14–1264, Entergy Services, Inc. Docket No. ER13–770, Entergy Louisiana, LLC Docket No. EL10–65, Louisiana Public Arkansas, Inc. and Entergy Docket No. ER14–1265, Entergy Service Commission v. Entergy Louisiana, LLC. Mississippi, Inc. Services, Inc. Docket No. ER13–948, Entergy Services, Docket No. ER14–1266, Entergy New Docket No. EL11–30, Midcontinent Inc. Orleans, Inc. Independent System Operator, Inc. Docket No. ER13–1195, Entergy Docket No. ER14–1267, Entergy Texas, v. Southwest Power Pool, Inc. Services, Inc. Inc.
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Docket No. ER14–1268, Entergy The FCC may not conduct or sponsor reporting requirements, recordkeeping Arkansas, Inc. a collection of information unless it requirement, third-party disclosure Docket No. ER14–1328, Entergy displays a currently valid OMB control requirements, and every ten years Louisiana, LLC number. No person shall be subject to reporting requirements. Docket No. ER14–1329, Entergy Gulf any penalty for failing to comply with Obligation To Respond: Required to States Louisiana, L.L.C. a collection of information subject to the obtain or retain benefits. The statutory Docket No. ER14–2085, Entergy PRA that does not display a valid OMB authority for this collection is contained Services, Inc. control number. in sections 1, 2, 4(i), 201, 301, 302, 303, Docket No. ER14–2850, Southwest DATES: Written comments should be 307, 308, 309, 310, 316, 319, 324, 332, Power Pool, Inc. submitted on or before January 5, 2015. and 333 of the Communications Act of Docket No. ER14–2851, Southwest If you anticipate that you will be 1934, as amended, and sections 6003, Power Pool, Inc. submitting comments, but find it 6004, and 6401 of the Middle Class Tax These meetings are open to the difficult to do so within the period of Relief Act of 2012, Public Law 112–96, public. time allowed by this notice, you should 126 Stat. 156, 47 U.S.C. 151, 152, 154(i), For more information, contact Patrick advise the contacts below as soon as 201, 301, 302(a), 303, 307, 308, 309, 310, Clarey, Office of Energy Market possible. 316, 319, 324, 332, 333, 1403, 1404, and Regulation, Federal Energy Regulatory 1451. ADDRESSES: Direct all PRA comments to Total Annual Burden: 24,417 hours. Commission at (317) 249–5937 or Nicholas A. Fraser, OMB, via email Total Annual Cost: $508,120. [email protected]. [email protected]; and Privacy Impact Assessment: No Dated: November 25, 2014. to Cathy Williams, FCC, via email PRA@ impact(s). Kimberly D. Bose, fcc.gov and to [email protected]. Nature and Extent of Confidentiality: Secretary. Include in the comments the OMB There is no need for confidentiality with [FR Doc. 2014–28491 Filed 12–3–14; 8:45 am] control number as shown in the this collection of information. Needs and Uses: The Commission BILLING CODE 6717–01–P SUPPLEMENTARY INFORMATION section below. seeks the Office of Management and Budget (‘‘OMB’’) approval for a revision FOR FURTHER INFORMATION CONTACT: For to obtain the full three-year clearance FEDERAL COMMUNICATIONS additional information or copies of the for the requirements described below. COMMISSION information collection, contact Cathy We are revising the estimates of the Williams at (202) 418–2918. To view a currently approved information [OMB 3060–1030] copy of this information collection collections primarily to reflect the request (ICR) submitted to OMB: (1) Go Information Collection Being issuance of the AWS–3 Report and to the Web page http://www.reginfo.gov/ Order, FCC 14–31, whose information Submitted for Review and Approval to public/do/PRAMain, (2) look for the the Office of Management and Budget collection requirements for new section of the Web page called spectrum bands would increase the AGENCY: Federal Communications ‘‘Currently Under Review,’’ (3) click on number of respondents, responses, Commission. the downward-pointing arrow in the hourly burden, and annual costs ‘‘Select Agency’’ box below the ACTION: Notice and request for associated with these bands. We are also ‘‘Currently Under Review’’ heading, (4) comments. updating prior estimates for other select ‘‘Federal Communications related spectrum bands. The following SUMMARY: As part of its continuing effort Commission’’ from the list of agencies information collection requirements by to reduce paperwork burdens, and as presented in the ‘‘Select Agency’’ box, AWS–3 applicants are not effective until required by the Paperwork Reduction (5) click the ‘‘Submit’’ button to the approved by the Office of Management Act (PRA) of 1995 (44 U.S.C. 3501– right of the ‘‘Select Agency’’ box, (6) and Budget and apply to the following 3520), the Federal Communications when the list of FCC ICRs currently rule sections: Commission (FCC or Commission) under review appears, look for the OMB Section 27.14(k) and (s)—set forth invites the general public and other control number of this ICR and then performance requirements for AWS–3 Federal agencies to take this click on the ICR Reference Number. A licensees. Section 27.14(s) requires opportunity to comment on the copy of the FCC submission to OMB AWS–3 licensees to offer service to 40 following information collections. will be displayed. percent of the population of their Comments are requested concerning: SUPPLEMENTARY INFORMATION: license areas within six years of Whether the proposed collection of OMB Control Number: 3060–1030. licensing, and to 75 percent of the information is necessary for the proper Title: Service Rules for Advanced population within 12 years (accelerated performance of the functions of the Wireless Services (AWS) in the 1.7 GHz to 10 years if the interim performance Commission, including whether the and 2.1 GHz Bands. requirement is not met). These information shall have practical utility; Form Number: N/A. performance timeframes are different the accuracy of the Commission’s Type of Review: Revision of a from those for AWS–4 due to the longer burden estimate; ways to enhance the currently approved collection. initial AWS–3 license terms (12 years quality, utility, and clarity of the Respondents: Business or other for- versus 10 years for AWS–4). Section information collected; ways to minimize profit entities; state, local, or tribal 27.14(k) requires AWS–3 licensees to the burden of the collection of government; Federal Government and demonstrate compliance with the information on the respondents, not for profit institutions. performance requirements by filing including the use of automated Number of Respondents: 393 construction notifications with the collection techniques or other forms of respondents; 83,505 responses. Commission within 15 days of the information technology; and ways to Estimated Time per Response: 0.25 to expiration of the applicable benchmark, further reduce the information 5 hours. certifying whether they meet the collection burden on small business Frequency of Response: Annual, semi- applicable performance requirements, concerns with fewer than 25 employees. annual, one time, and on occasion and including a description and
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certification of the areas for which they coordination does not resolve potential FEDERAL COMMUNICATIONS are providing service. Construction conflicts, an AWS licensee may COMMISSION notifications must include electronic undertake to relocate the FS stations coverage maps, supporting technical under Part 101, Subpart B of the [OMB 3060–xxxx] documentation, and any other Commission’s rules. Although AWS–1 information as the Wireless licensees have relocated many FS legacy Information Collection Being Reviewed Telecommunications Bureau may operations, AWS–3 licensees will likely by the Federal Communications prescribe by public notice. have to relocate some remaining Commission Section 27.14(s)—requires AWS–3 incumbents, resulting in disclosures licensees to make a ‘‘renewal showing’’ AGENCY: Federal Communications described below. Under section 101.79 at the time of license renewal— Commission. independent of the performance of the Commission’s rules, these requirements will sunset ten years after ACTION: Notice and request for requirements—as a condition of comments. renewal. The showing must include a the first AWS license is issued in the band. detailed description of the applicant’s SUMMARY: As part of its continuing effort provision of service during the entire Section 27.1132—requires AWS–3 to reduce paperwork burdens, and as license period and address: (1) The level licensees in the 2155–2160/62 MHz required by the Paperwork Reduction and quality of service provided by the band to protect BRS stations from Act (PRA) of 1995 (44 U.S.C. 3501– applicant (e.g., the population served, interference or to relocate them prior to 3520), the Federal Communications the area served, the number of initiating operations. Under section Commission (FCC or Commission) subscribers, the services offered); (2) the 27.1253 of the Commission’s rules, invites the general public and other date service commenced, whether these requirements will sunset fifteen Federal agencies to take this service was ever interrupted, and the years after the first AWS license is opportunity to comment on the duration of any interruption or outage; issued in the band. following information collections. (3) the extent to which service is Comments are requested concerning: Section 27.1134(c)—requires AWS–3 provided to rural areas; (4) the extent to Whether the proposed collection of which service is provided to qualifying licensees to coordinate with Federal information is necessary for the proper tribal land as defined in § 1.2110(f)(3)(i); Government incumbents before performance of the functions of the and (5) any other factors associated with commencing operations in the 1695– Commission, including whether the the level of service to the public. 1710 MHz band. For transmitters information shall have practical utility; Section 27.17(c)—requires that an operating with a maximum EIRP of 20 the accuracy of the Commission’s AWS–3 licensee that permanently dBm, coordination is required inside 27 burden estimate; ways to enhance the discontinues service must notify the specific Protection Zones detailed in quality, utility, and clarity of the Commission of the discontinuance U.S. note 88 to section 2.106 of the information collected; ways to minimize within 10 days by filing FCC Form 601 Commission’s rules and in the 2014 the burden of the collection of or 605 requesting license cancellation. It Joint PN. For higher-powered information on the respondents, also provides that an authorization will operations, § 27.1134(c) and U.S. note including the use of automated automatically terminate, without 88 to § 2.106 both require coordination collection techniques or other forms of specific Commission action, if service is nationwide unless otherwise specified information technology; and ways to permanently discontinued, even if a further reduce the information licensee fails to file the required form by FCC rule, order, or notice. The 2014 collection burden on small business requesting license cancellation. Sections Joint PN (see below) refined the concerns with fewer than 25 employees. 27.17(a) and (b) define permanent nationwide default zone for higher- The FCC may not conduct or sponsor a discontinuation of service as 180 days power operations by adding 27 collection of information unless it during which a licensee does not Protection Zones (larger than the zones displays a currently valid OMB control provide service to at least one for operations up to 20 dBm, to account number. No person shall be subject to unaffiliated subscriber. for the higher power). Section 27.50(d)(3)—requires that a any penalty for failing to comply with Section 27.1134(f)—requires AWS–3 a collection of information subject to the licensee operating an AWS–3 base or licensees to coordinate with Federal fixed station utilizing a power greater PRA that does not display a valid OMB Government incumbents before control number. than 1640 watts EIRP or 1640 watts/ commencing operations in the 1755– MHz EIRP must be coordinated in DATES: Written PRA comments should 1780 MHz band. While the default advance with the following licensees be submitted on or before February 2, coordination requirement for this band authorized to operate within 120 2015. If you anticipate that you will be kilometers (75 miles) of the base or fixed is nationwide, the 2014 Joint PN (see submitting comments, but find it station: All Broadband Radio Service below) effectively reduced the scope of difficult to do so within the period of (BRS) licensees authorized in the 2155– coordination to specific Protection time allowed by this notice, you should 2160 MHz band, and all AWS licensees Zones for many AWS–3 licensees that advise the contact listed below as soon authorized to operate on adjacent limit transmitter power to 20 dBm EIRP. as possible. frequency blocks in the 2110–2180 MHz Federal Communications Commission. ADDRESSES: Direct all PRA comments to band. Marlene H. Dortch, Cathy Williams, FCC, via email PRA@ Section 27.1131—requires AWS–3 fcc.gov and to [email protected]. licensees, prior to initiating operations Secretary, Office of the Secretary, Office of the Managing Director. from any base or fixed station, to FOR FURTHER INFORMATION CONTACT: For coordinate their frequency usage with [FR Doc. 2014–28496 Filed 12–3–14; 8:45 am] additional information about the incumbent co-channel and adjacent- BILLING CODE 6712–01–P information collection, contact Cathy channel fixed point-to-point microwave Williams at (202) 418–2918. licensees operating in the 2110–2150 SUPPLEMENTARY INFORMATION: MHz and 2160–2200 MHz bands. If OMB Control No.: 3060–xxxx.
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Title: Certification of TV Broadcast the completion of the incentive auction. If you plan to attend the open meeting Licensee Technical Information in Licensees will submit FCC Form 2100, in person, we ask that you notify us in Advance of Incentive Auction. Schedule 381 one time, at a deadline to advance and provide your name, date of Form No.: Form 2100, Schedule 381, be announced by the Media Bureau in birth, and social security number (SSN) Pre-Auction Technical Certification advance of the incentive auction. or passport number. You may provide Form. Federal Communications Commission. this information by calling 202–452– Type of Review: New information Marlene H. Dortch, 2474 or you may register online. You collection. may pre-register until close of business Respondents: Business or other for Secretary, Office of the Secretary, Office of the Managing Director. on December 8, 2014. You also will be profit entities; not for profit institutions. asked to provide identifying Number of Respondents and [FR Doc. 2014–28497 Filed 12–3–14; 8:45 am] information, including a photo ID, Responses: 2,170 respondents and 2,170 BILLING CODE 6712–01–P before being admitted to the Board responses. meeting. The Public Affairs Office must Estimated Time per Response: 2 approve the use of cameras; please call hours. FEDERAL ELECTION COMMISSION 202–452–2955 for further information. If Frequency of Response: One-time you need an accommodation for a reporting requirement. Sunshine Act Meeting disability, please contact Penelope Obligation to Respond: Required to Beattie on 202–452–3982. For the obtain or retain benefits. The statutory AGENCY: Federal Election Commission. hearing impaired only, please use the authority for this collection is contained DATE AND TIME: Tuesday December 9, Telecommunication Device for the Deaf in Public Law 112–96, §§ 6402 (codified 2014 at 10:00 a.m. (TDD) on 202–263–4869. at 47 U.S.C. 309(j)(8)(G)), 6403 (codified PLACE: 999 E Street NW., Washington, PRIVACY ACT NOTICE: The information at 47 U.S.C. 1452), 126 Stat. 156 (2012) DC. (Spectrum Act). you provide will be used to assist us in STATUS: This meeting will be closed to prescreening you to ensure the security Total Annual Burden: 2,170 hours. the public. Annual Cost Burden: $542,500. of the Board’s premises and personnel. Privacy Act Impact Assessment: No ITEMS TO BE DISCUSSED: In order to do this, we may disclose impact(s). Compliance matters pursuant to 2 your information consistent with the Nature and Extent of Confidentiality: U.S.C. § 437g. routine uses listed in the Privacy Act Some assurances of confidentiality are Matters concerning participation in Notice for BGFRS–32, including to being provided to the respondents. civil actions or proceedings or appropriate federal, state, local, or Parties filing Form 2100, Schedule 381 arbitration. foreign agencies where disclosure is may seek confidential treatment of * * * * * reasonably necessary to determine information they provide pursuant to PERSON TO CONTACT FOR INFORMATION: whether you pose a security risk or the Commission’s existing Judith Ingram, Press Officer, Telephone: where the security or confidentiality of confidentiality rules (See 47 CFR 0.459). (202) 694–1220. your information has been Needs and Uses: The information compromised. We are authorized to gathered in this collection will be used Shelley E. Garr, collect your information by 12 U.S.C. to support the Federal Communications Deputy Secretary of the Commission. §§ 243 and 248, and Executive Order Commission’s efforts to hold an [FR Doc. 2014–28590 Filed 12–2–14; 4:15 pm] 9397. In accordance with Executive incentive auction, as required by the BILLING CODE 6715–01–P Order 9397, we collect your SSN so that Middle Class Tax Relief and Job we can keep accurate records, because Creation Act of 2012 (Spectrum Act) other people may have the same name (Pub. L. 112–96, §§ 6402 (codified at 47 FEDERAL RESERVE SYSTEM and birth date. In addition, we use your U.S.C. 309(j)(8)(G)), 6403 (codified at 47 SSN when we make requests for U.S.C. 1452), 126 Stat. 156 (2012)). In Sunshine Act Meeting information about you from law the Incentive Auction Order, the enforcement and other regulatory Commission directed the Media Bureau Board of Governors of the Federal agency databases. Furnishing the to develop a form to be submitted prior Reserve System Meeting Notice information requested is voluntary; to the incentive auction by each full however, your failure to provide any of power and Class A broadcast licensee to TIME AND DATE: 3:00 p.m. on Tuesday, the information requested may result in certify that it has reviewed the technical December 9, 2014. disapproval of your request for access to data on file with the Commission PLACE: Marriner S. Eccles Federal the Board’s premises. You may be related to its current license Reserve Board Building, 20th Street subject to a fine or imprisonment under authorization and confirm that the entrance between Constitution Avenue 18 U.S.C. § 1001 for any false statements technical data is correct with respect to and C Streets NW., Washington, DC you make in your request to enter the actual operations FCC Form 2100, 20551. Board’s premises. Schedule 381, Pre-Auction Technical STATUS: Open. Matters To Be Considered Certification Form. See Expanding the On the day of the meeting, you will Economic and Innovation Opportunities be able to view the meeting via webcast Discussion Agenda of Spectrum Through Incentive from a link available on the Board’s 1. Proposal to Establish Risk-Based Auctions, Report and Order, GN Docket public Web site. You do not need to Capital Surcharges for Systemically 12–268, Report and Order, 29 FCC Rcd register to view the webcast of the Important Bank Holding Companies. 6567, 6820 (2014) (‘‘Incentive Auction meeting. A link to the meeting Notes: 1. The staff memo to the Board will Order’’). This data collection will also documentation will also be available be made available to the public on the day collect from licensees basic data approximately 20 minutes before the of the meeting in paper and the background regarding equipment currently in use at start of the meeting. Both links may be material will be made available on a compact each licensed facility to facilitate the accessed from the Board’s public Web disc (CD). If you require a paper copy of the channel reassignment process following site at www.federalreserve.gov. entire document, please call Penelope Beattie
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on 202–452–3982. The documentation will FOR FURTHER INFORMATION CONTACT: Division of Program Evaluation and not be available until about 20 minutes Lillian Sparks-Robinson, Commissioner, Planning (KED) before the start of the meeting. Administration for Native Americans, Division of Policy (KEE) 2. This meeting will be recorded for 901 D Street SW., Washington, DC KE.20 Functions the benefit of those unable to attend. 20447, 202–401–5590. The webcast recording and a transcript This notice amends Part K of the A. The Office of the Commissioner of the meeting will be available after the Statement of Organization, Functions, provides executive leadership, meeting on the Board’s public Web site and Delegations of Authority of the management strategies, and day-to-day http://www.federalreserve.gov/about Department of Health and Human operational leadership for all thefed/boardmeetings/ or if you prefer, Services (HHS), Administration for components of ANA. The Commissioner a CD recording of the meeting will be Children and Families (ACF), as serves as an effective and visible advocate on behalf of Native Americans available for listening in the Board’s follows: Chapter KE, Administration for within the Department, and with other Freedom of Information Office, and Native Americans (ANA), as last departments and agencies of the Federal copies can be ordered for $4 per disc by amended in 74 FR 3053–54, Jan. 16, Government regarding all federal calling 202–452–3684 or by writing to: 2009. policies affecting Native Americans. The Freedom of Information Office, Board of SUPPLEMENTARY INFORMATION: Commissioner provides policy direction Governors of the Federal Reserve I. Under Chapter KE, Administration and guidance to ACF Regional Offices System, Washington, DC 20551. for Native Americans, delete KE in its with respect to programs for reservation- FOR MORE INFORMATION PLEASE CONTACT: entirety and replace with the following: based Indians, urban Indians, off- Michelle Smith, Director, Office of KE.00 MISSION. The mission of the Reservation Indians, and other Native Board Members at 202–452–2955. Administration for Native Americans American projects in Hawaii and the SUPPLEMENTARY INFORMATION: You may (ANA) is to promote the goal of self- Pacific Islands. The Commissioner access the Board’s public Web site at sufficiency and cultural preservation for oversees the Native Hawaiian Revolving www.federalreserve.gov for an electronic Native Americans by providing social Loan Fund administered by the Office of announcement. (The Web site also and economic development Hawaiian Affairs. The Commissioner includes procedural and other opportunities through financial also ensures training and technical information about the open meeting.) assistance, training, and technical assistance and other resources are Dated: December 2, 2014. assistance to eligible Tribes and Native allocated and deployed to support and promote ANA’s mission. Margaret M. Shanks, American communities, including American Indians, Alaska Natives, The Commissioner is the Chair of the Deputy Secretary of the Board. Intra-Departmental Council on Native [FR Doc. 2014–28559 Filed 12–2–14; 11:15 am] Native Hawaiians, and other Native Pacific Islander organizations. ANA American Affairs (ICNAA) and advises BILLING CODE 6210–01–P provides funding for community-based the Secretary on Native American projects that are designed to improve issues. ICNAA staff members provide the lives of Native children and families support to the Commissioner. ICNAA and reduce long-term dependency on develops and promotes HHS policy to DEPARTMENT OF HEALTH AND provide greater access and quality HUMAN SERVICES public assistance. Competitive funding authorized under the Native American services for American Indians, Alaska Natives, and Native Americans (AI/AN/ Administration for Children and Programs Act of 1974 (NAPA), as NAs) throughout the Department and Families amended, for community-based projects is provided through three competitive where possible, the Federal Administration for Native Americans; discretionary grant programs to eligible Government; promotes implementation Statement of Organization, Functions, Tribes and non-profit Native American of HHS policy and agency plans on and Delegations of Authority organizations: Social and economic consultation with AI/AN/NAs and development, language preservation, Tribal Governments; identifies and AGENCY: Administration for Children and environmental regulatory develops legislative, administrative, and and Families, HHS. enhancement. In carrying out the regulatory proposals that promotes an ACTION: Notice. provisions of NAPA, the Commissioner effective, meaningful AI/AN/NA policy advises the Secretary, through the to improve health and human services SUMMARY: The Administration for Assistant Secretary for Children and for AI/AN/NAs; identifies and develops Children and Families (ACF) has Families, on federal policies affecting comprehensive Departmental strategy reorganized the Administration for Native Americans and matters proposal to promote self-sufficiency and Native Americans (ANA). This pertaining to Native Americans within self-determination for all AI/AN/NA reorganization creates the Division of the Department of Health and Human people; and promotes the Tribal/Federal Policy and makes other technical Services and with other Departments government-to-government relationship changes to reflect the current functions and agencies of the Federal on a Department-wide basis in within ANA. The realignment of Government. accordance with Presidential Executive functions better reflects the current Order. work environment and priorities within KE.10 ORGANIZATION. ANA is The Deputy Commissioner reports to ANA, manifests ANA’s commitment to headed by a Commissioner who is the Commissioner, assists the Federal/Tribal government-to- confirmed by the Senate and reports Commissioner in carrying out the government relationships, and promotes directly to the Assistant Secretary for responsibilities of ANA, and performs self-determination for all Native Children and Families. ANA is the duties of the Commissioner when Americans. The statement of mission, organized as follows: absent. The Deputy Commissioner organization, functions, and delegations Office of the Commissioner (KEA) supervises all three Division Directors. of authority conforms to and carries out Intra-Departmental Council on Native In addition, the Deputy Commissioner the statutory requirements of the Native American Affairs (KEB) provides day-to-day supervision and American Programs Act (NAPA). Division of Program Operations (KEC) oversight to the Management Operations
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Staff (MOS), coordinates the activities of D. The Division of Policy is the Paperwork Reduction Act of 1995, the ACF Native American Affairs responsible for providing support and for opportunity for public comment on Liaison Workgroup, serves as the ANA guidance to define, establish, and proposed data collection projects, the liaison to the Inter-Departmental disseminate policy affecting Native National Cancer Institute (NCI), Council on Native American Affairs, American communities at large. These National Institutes of Health (NIH), will provides coordination of ANA’s data responsibilities include: (1) publish periodic summaries of proposed driven strategic plan, and advises the Management of a unified and effective projects to be submitted to the Office of Commissioner on strategic and policy formulation process, including Management and Budget (OMB) for operational activities of ANA. coordination of ANA regulations and review and approval. The MOS provides administrative and other policy issuances affecting grantees Written comments and/or suggestions budget support to ANA. These and Native American communities; (2) from the public and affected agencies responsibilities include: (1) Serving as formulation of advice on tribal and state are invited on one or more of the the Executive Secretariat for ANA, legislative, and other activities affecting following points: (1) Whether the including managing correspondence, Native Americans; (3) development of proposed collection of information is correspondence systems, and public long- and short-term strategies to necessary for the proper performance of requests including, but not limited to address issues raised in consultations the function of the agency, including Freedom of Information Act (FOIA) and collaborations with Native whether the information will have requests; (2) coordinating human Americans; (4) support of the activities practical utility; (2) The accuracy of the resources activities; (3) developing and of the ACF Tribal Advisory Committee agency’s estimate of the burden of the executing the budget; (4) providing on- and other committees, councils, and proposed collection of information, going administrative technical support workgroups affecting Native Americans; including the validity of the of ANA contracts; and (5) as and (5) liaison with the Office of the methodology and assumptions used; (3) appropriate, developing internal General Counsel and others in the Ways to enhance the quality, utility, and policies and procedures relating to these Department on matters involving or clarity of the information to be activities. affecting Native Americans. collected; and (4) Ways to minimize the B. The Division of Program II. Continuation of Policy. Except as burden of the collection of information Operations is primarily responsible for inconsistent with this reorganization, all on those who are to respond, including the pre-award and post-award statements of policy and interpretations the use of appropriate automated, administration of discretionary grant with respect to organizational electronic, mechanical, or other programs to eligible Tribes and non- components affected by this notice technological collection techniques or profit Native American organizations. within ACF, heretofore issued and in other forms of information technology. These responsibilities include: (1) effect on this date of this reorganization To Submit Comments and For Further Developing ANA’s Funding are continued in full force and effect. Information: To obtain a copy of the Opportunity Announcements; (2) III. Delegation of Authority. All data collection plans and instruments, managing annual grant competitions, delegations and redelegations of submit comments in writing, or request including coordination of the panel authority made to officials and more information on the proposed review process and internal application employees of affected organizational project contact: Bradford W. Hesse, review; (3) on-going grantee monitoring components will continue in them or Ph.D., Health Communication and and support; (4) administering grant their successors pending further Informatics Research Branch, 9609 award portfolio, including close-out; redelegations, provided they are Medical Center Drive, MSC 9761, Room and (5) providing liaison to the Office of consistent with this reorganization. 3E610, Rockville, MD 20850 or call non- Administration, Divisions of Grants IV. Funds, Personnel, and Equipment. toll free number 240–276–6721 or Email Management and Division of Grants Transfer of organizations and functions your request, including your address, to Policy. affected by this reorganization shall be [email protected]. Formal requests C. The Division of Program Evaluation accompanied in each instance by direct for additional plans and instruments and Planning is responsible for and support funds, positions, personnel, must be requested in writing. evaluations of grantee effectiveness and records, equipment, supplies, and other Comment Due Date: Comments impact as well as ANA performance resources. regarding this information collection are including, but not limited to This reorganization will be effective best assured of having their full effect if Government Performance and Results upon date of signature. received within 60 days of the date of Act measures. These responsibilities this publication. include: (1) Oversight of planning and Dated: November 24, 2014. Proposed Collection: Health implementation activities related to Mark H. Greenberg, Information National Trends Survey ANA program evaluation, including Acting Assistant Secretary for Children and (HINTS) 0925–0538, Reinstatement with development of annual reports, which Families. Change, National Cancer Institute (NCI), includes the annual Report to Congress [FR Doc. 2014–28486 Filed 12–3–14; 8:45 am] National Institutes of Health (NIH). on Impact and Effectiveness; (2) data BILLING CODE 4184–01–P Need and Use of Information analyses and special organizational Collection: This partnership between studies to guide programmatic NCI and FDA will include assessing the enhancements and inform training and DEPARTMENT OF HEALTH AND public’s knowledge of medical devices, technical assistance efforts; (3) HUMAN SERVICES communications related to product coordination of pre-award and post- recalls, nutritional supplement labeling, award training and technical assistance National Institutes of Health and topics to inform FDA’s regulatory activities in Alaska, the Pacific Basin, Proposed Collection; 60-Day Comment authority over tobacco, such as risk and the lower forty-eight states; (4) Request; Health Information National perceptions about new tobacco coordination of ANA’s data and social Trends Survey (HINTS) products, product pack color gradations, media tools; and (5) liaison with the perceptions of product harm, and Office of Planning, Research and Summary: In compliance with the tobacco product claims and labels. This Evaluation. requirement of Section 3506(c)(2)(A) of HINTS survey will couple knowledge-
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related questions with inquiries into the which have been to provide a prevention, early detection, diagnosis, communication channels through which comprehensive assessment of the treatment, and survivorship. understanding is being obtained, and American public’s current access to, and OMB approval is requested for 1 year. assessment of FDA-regulated material. use of, information about cancer across There are no costs to respondents other This survey will extend the information the cancer care continuum from cancer than their time. The total estimated collected and priorities from HINTS annualized burden hours are 2,159.
ESTIMATED ANNUALIZED BURDEN HOURS
Average Number of Number of burden per Total annual Type of respondents respondents responses per response burden hour respondent (in hours)
Individuals ...... 4,318 1 30/60 2,159
Dated: November 24, 2014. the use of appropriate automated, National Institutes of Health (NIH), and Karla Bailey, electronic, mechanical, or other perhaps other federal agencies, NCI Project Clearance Liaison, National technological collection techniques or considering the costs and benefits of Institutes of Health. other forms of information technology. directing resources towards supporting [FR Doc. 2014–28513 Filed 12–3–14; 8:45 am] To Submit Comments and For Further technology development. An award BILLING CODE 4140–01–P Information: To obtain a copy of the through the NIH Evaluation Set-Aside data collection plans and instruments, program to support this evaluation, for submit comments in writing, or request which NIH-wide relevance is a principle DEPARTMENT OF HEALTH AND more information on the proposed element of determining merit for HUMAN SERVICES project, contact: Anthony Dickherber, support, is testament to this. The NCI Center for Strategic Scientific evaluation serves as an opportunity to National Institutes of Health Initiatives, 31 Center Drive, Rm10A33, gauge the impact of investments in Bethesda, MD 20892 or call non-toll-free technology development and also to Proposed Collection; 60-Day Comment number 301–547–9980 or Email your assess the strengths and weaknesses of Request; Surveys and Interviews To request, including your address to: phased innovation award mechanisms. Support an Evaluation of the [email protected]. Formal Like all institutes and centers (ICs) of Innovative Molecular Analysis requests for additional plans and the NIH, NCI seeks opportunities for Technologies (IMAT) Program (NCI) instruments must be requested in improving their programs’ utility for the SUMMARY: In compliance with the writing. broad continuum of researchers, requirement of Section 3506(c)(2)(A) of Comment Due Date: Comments clinicians and ultimately patients. NCI the Paperwork Reduction Act of 1995, regarding this information collection are Director Harold Varmus and other for opportunity for public comment on best assured of having their full effect if leadership across NCI, as well as the proposed data collection projects, the received within 60 days of the date of NCI Board of Scientific Advisors, will National Cancer Institute (NCI), this publication. be the primary users of the evaluation National Institutes of Health (NIH), will Proposed Collection: Surveys and results. Findings are primarily intended publish periodic summaries of proposed Interviews to Support an Evaluation of for considering the long-term strategy to projects to be submitted to the Office of the Innovative Molecular Analysis support innovative technology Management and Budget (OMB) for Technologies (IMAT) Program (NCI), development and how to more review and approval. 0925–NEW, National Cancer Institute efficiently translate emerging Written comments and/or suggestions (NCI), National Institutes of Health capabilities through such technologies from the public and affected agencies (NIH). into the promised benefits for cancer are invited on one or more of the Need and Use of Information research and clinical care. Interviews following points: (1) Whether the Collection: The purpose of the proposed with grantees, program officers, review proposed collection of information is evaluation is to pursue a comprehensive officers, and other NIH awardees make necessary for the proper performance of process and outcome assessment of the up a crucial component of the the function of the agency, including 15-year old Innovative Molecular evaluation plan and will largely follow whether the information will have Analysis Technologies (IMAT) program. set survey protocols. Specific near-term practical utility; (2) The accuracy of the While the program consistently offers aims include the use of this information agency’s estimate of the burden of the promising indicators of success, the full to consider the utility of continued proposed collection of information, program has not been evaluated since investment through existing including the validity of the 2008, and never in as comprehensive a solicitations and in strategic planning methodology and assumptions used; (3) manner as has been formulated in the generally for institute support for Ways to enhance the quality, utility, and current evaluation plan. An outcome innovative technology development. clarity of the information to be evaluation of the long-standing National OMB approval is requested for 1 year. collected; and (4) Ways to minimize the Cancer Institute’s (NCI) IMAT program There are no costs to respondents other burden of the collection of information presents a rich and unique opportunity than their time. The total estimated on those who are to respond, including likely to serve institutes across the annualized burden hours are 575.
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ESTIMATED ANNUALIZED BURDEN HOURS
Average Number of Number of burden per Total annual Form name Type of respondents respondents responses per response burden hours respondent (in hours)
IMAT Awardee Interview ...... IMAT Awardees ...... 100 1 1 100 Evaluation Web-based Survey...... IMAT Awardees, and other NIH 900 1 30/60 450 Awardees (Comparison group). Tech End Users Interview ...... Technology End-Users ...... 50 1 30/60 25
Dated: November 24, 2014. at the end and will be omitted from the HHS-Certified Laboratories Karla Bailey, monthly listing thereafter. ACM Medical Laboratory, Inc., 160 NCI Project Clearance Liaison, National This notice is also available on the Elmgrove Park, Rochester, NY 14624, Institutes of Health. Internet at http://beta.samhsa.gov/ 585–429–2264 [FR Doc. 2014–28498 Filed 12–3–14; 8:45 am] workplace. Aegis Analytical Laboratories, Inc., 345 BILLING CODE 4140–01–P Hill Ave., Nashville, TN 37210, 615– FOR FURTHER INFORMATION CONTACT: 255–2400, (Formerly: Aegis Sciences Giselle Hersh, Division of Workplace Corporation, Aegis Analytical DEPARTMENT OF HEALTH AND Programs, SAMHSA/CSAP, Room 7– Laboratories, Inc., Aegis Analytical HUMAN SERVICES 1051, One Choke Cherry Road, Laboratories) Rockville, Maryland 20857; 240–276– Alere Toxicology Services, 1111 Newton Substance Abuse and Mental Health 2600 (voice), 240–276–2610 (fax). St., Gretna, LA 70053, 504–361–8989/ Services Administration SUPPLEMENTARY INFORMATION: The 800–433–3823, (Formerly: Kroll Current List of HHS-Certified Mandatory Guidelines were initially Laboratory Specialists, Inc., Laboratories and Instrumented Initial developed in accordance with Executive Laboratory Specialists, Inc.) Testing Facilities Which Meet Minimum Order 12564 and section 503 of Public Alere Toxicology Services, 450 Standards To Engage in Urine Drug Law 100–71. The ‘‘Mandatory Southlake Blvd., Richmond, VA Testing for Federal Agencies Guidelines for Federal Workplace Drug 23236, 804–378–9130, (Formerly: Testing Programs,’’ as amended in the Kroll Laboratory Specialists, Inc., AGENCY: Substance Abuse and Mental revisions listed above, requires strict Scientific Testing Laboratories, Inc.; Health Services Administration, HHS. standards that laboratories and IITFs Kroll Scientific Testing Laboratories, Inc.) ACTION: must meet in order to conduct drug and Notice. Baptist Medical Center-Toxicology specimen validity tests on urine Laboratory, 11401 I–30, Little Rock, SUMMARY: The Department of Health and specimens for federal agencies. AR 72209–7056, 501–202–2783, Human Services (HHS) notifies federal To become certified, an applicant (Formerly: Forensic Toxicology agencies of the laboratories and laboratory or IITF must undergo three Laboratory Baptist Medical Center) Instrumented Initial Testing Facilities rounds of performance testing plus an Clinical Reference Lab, 8433 Quivira (IITF) currently certified to meet the on-site inspection. To maintain that Road, Lenexa, KS 66215–2802, 800– standards of the Mandatory Guidelines certification, a laboratory or IITF must 445–6917 for Federal Workplace Drug Testing participate in a quarterly performance DrugScan, Inc., 200 Precision Road, Programs (Mandatory Guidelines). The testing program plus undergo periodic, Suite 200, Horsham, PA 19044, 800– Mandatory Guidelines were first on-site inspections. 235–4890 published in the Federal Register on ElSohly Laboratories, Inc., 5 Industrial April 11, 1988 (53 FR 11970), and Laboratories and IITFs in the Park Drive, Oxford, MS 38655, 662– subsequently revised in the Federal applicant stage of certification are not to be considered as meeting the minimum 236–2609 Register on June 9, 1994 (59 FR 29908); Fortes Laboratories, Inc., 25749 SW., September 30, 1997 (62 FR 51118); requirements described in the HHS Mandatory Guidelines. A HHS-certified Canyon Creek Road, Suite 600, April 13, 2004 (69 FR 19644); November Wilsonville, OR 97070, 503–486–1023 25, 2008 (73 FR 71858); December 10, laboratory or IITF must have its letter of certification from HHS/SAMHSA Gamma-Dynacare Medical 2008 (73 FR 75122); and on April 30, Laboratories *, A Division of the 2010 (75 FR 22809). (formerly: HHS/NIDA), which attests that it has met minimum standards. Gamma-Dynacare Laboratory A notice listing all currently HHS- Partnership, 245 Pall Mall Street, certified laboratories and IITFs is In accordance with the Mandatory London, ONT, Canada N6A 1P4, 519– published in the Federal Register Guidelines dated November 25, 2008 679–1630 during the first week of each month. If (73 FR 71858), the following HHS- Laboratory Corporation of America any laboratory or IITF certification is certified laboratories and IITFs meet the Holdings, 7207 N. Gessner Road, suspended or revoked, the laboratory or minimum standards to conduct drug Houston, TX 77040, 713–856–8288/ IITF will be omitted from subsequent and specimen validity tests on urine 800–800–2387 lists until such time as it is restored to specimens: Laboratory Corporation of America full certification under the Mandatory HHS-Certified Instrumented Initial Holdings, 69 First Ave., Raritan, NJ Guidelines. Testing Facilities 08869, 908–526–2400/800–437–4986, If any laboratory or IITF has (Formerly: Roche Biomedical withdrawn from the HHS National Gamma-Dynacare Medical Laboratories, Laboratories, Inc.) Laboratory Certification Program (NLCP) 6628 50th Street NW., Edmonton, AB Laboratory Corporation of America during the past month, it will be listed Canada T6B 2N7, 780–784–1190 Holdings, 1904 Alexander Drive,
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Research Triangle Park, NC 27709, 800–729–6432, (Formerly: SmithKline participate in the NLCP certification 919–572–6900/800–833–3984, Beecham Clinical Laboratories; maintenance program. (Formerly: LabCorp Occupational SmithKline Bio-Science Laboratories) Janine Denis Cook, Testing Services, Inc., CompuChem Quest Diagnostics Incorporated, 400 Chemist, Division of Workplace Programs, Laboratories, Inc.; CompuChem Egypt Road, Norristown, PA 19403, Center for Substance Abuse Prevention, Laboratories, Inc., A Subsidiary of 610–631–4600/877–642–2216, SAMHSA. Roche Biomedical Laboratory; Roche (Formerly: SmithKline Beecham [FR Doc. 2014–28493 Filed 12–3–14; 8:45 am] CompuChem Laboratories, Inc., A Clinical Laboratories; SmithKline Bio- BILLING CODE 4162–20–P Member of the Roche Group) Science Laboratories) Laboratory Corporation of America Quest Diagnostics Incorporated, 8401 Holdings, 1120 Main Street, Fallbrook Ave., West Hills, CA 91304, Southaven, MS 38671, 866–827–8042/ DEPARTMENT OF THE INTERIOR 818–737–6370, (Formerly: SmithKline 800–233–6339, (Formerly: LabCorp Beecham Clinical Laboratories) Fish and Wildlife Service Occupational Testing Services, Inc.; MedExpress/National Laboratory Redwood Toxicology Laboratory, [FWS–HQ–IA–2014–N248; Center) 3700650 Westwind Blvd., Santa Rosa, FXIA16710900000–156–FF09A30000] LabOne, Inc. d/b/a Quest Diagnostics, CA 95403, 800–255–2159 10101 Renner Blvd., Lenexa, KS Southwest Laboratories, 4625 E. Cotton Endangered Species; Marine 66219, 913–888–3927/800–873–8845, Center Boulevard, Suite 177, Phoenix, Mammals; Issuance of Permits (Formerly: Quest Diagnostics AZ 85040, 602–438–8507/800–279– AGENCY: Fish and Wildlife Service, Incorporated; LabOne, Inc.; Center for 0027 Interior. Laboratory Services, a Division of STERLING Reference Laboratories, 2617 ACTION: Notice of issuance of permits. LabOne, Inc.) East L Street, Tacoma, Washington MedTox Laboratories, Inc., 402 W. 98421, 800–442–0438 SUMMARY: We, the U.S. Fish and County Road D, St. Paul, MN 55112, Wildlife Service (Service), have issued 651–636–7466/800–832–3244 U.S. Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., the following permits to conduct certain MetroLab-Legacy Laboratory Services, activities with endangered species, 1225 NE 2nd Ave., Portland, OR Fort George G. Meade, MD 20755– 5235, 301–677–7085 marine mammals, or both. We issue 97232, 503–413–5295/800–950–5295 these permits under the Endangered Minneapolis Veterans Affairs Medical * The Standards Council of Canada (SCC) Species Act (ESA) and Marine Mammal voted to end its Laboratory Accreditation Center, Forensic Toxicology Protection Act (MMPA). Laboratory, 1 Veterans Drive, Program for Substance Abuse (LAPSA) ADDRESSES: Brenda Tapia, U.S. Fish and Minneapolis, MN 55417, 612–725– effective May 12, 1998. Laboratories certified through that program were accredited to Wildlife Service, Division of 2088 conduct forensic urine drug testing as National Toxicology Laboratories, Inc., Management Authority, Branch of required by U.S. Department of Permits, MS: IA, 5275 Leesburg Pike, 1100 California Ave., Bakersfield, CA Transportation (DOT) regulations. As of that 93304, 661–322–4250/800–350–3515 Falls Church, VA 22041; fax (703) 358– date, the certification of those accredited 2281; or email [email protected]. One Source Toxicology Laboratory, Inc., Canadian laboratories will continue under 1213 Genoa-Red Bluff, Pasadena, TX DOT authority. The responsibility for FOR FURTHER INFORMATION CONTACT: 77504, 888–747–3774, (Formerly: conducting quarterly performance testing Brenda Tapia, (703) 358–2104 University of Texas Medical Branch, plus periodic on-site inspections of those (telephone); (703) 358–2281 (fax); Clinical Chemistry Division; UTMB LAPSA-accredited laboratories was [email protected] (email). transferred to the U.S. HHS, with the HHS’ Pathology-Toxicology Laboratory) SUPPLEMENTARY INFORMATION: On the NLCP contractor continuing to have an active Pacific Toxicology Laboratories, 9348 role in the performance testing and dates below, as authorized by the DeSoto Ave., Chatsworth, CA 91311, laboratory inspection processes. Other provisions of the ESA (16 U.S.C. 1531 800–328–6942, (Formerly: Centinela Canadian laboratories wishing to be et seq.), as amended, and/or the MMPA, Hospital Airport Toxicology considered for the NLCP may apply directly as amended (16 U.S.C. 1361 et seq.), we Laboratory) to the NLCP contractor just as U.S. issued requested permits subject to Pathology Associates Medical laboratories do. certain conditions set forth therein. For Laboratories, 110 West Cliff Dr., Upon finding a Canadian laboratory to be each permit for an endangered species, Spokane, WA 99204, 509–755–8991/ qualified, HHS will recommend that DOT we found that (1) The application was 800–541–7891x7 certify the laboratory (Federal Register, July filed in good faith, (2) The granted 16, 1996) as meeting the minimum standards Phamatech, Inc., 10151 Barnes Canyon of the Mandatory Guidelines published in the permit would not operate to the Road, San Diego, CA 92121, 858–643– Federal Register on April 30, 2010 (75 FR disadvantage of the endangered species, 5555 22809). After receiving DOT certification, the and (3) The granted permit would be Quest Diagnostics Incorporated, 1777 laboratory will be included in the monthly consistent with the purposes and policy Montreal Circle, Tucker, GA 30084, list of HHS-certified laboratories and set forth in section 2 of the ESA.
Permit No. Applicant Receipt of application Federal Register notice Permit issuance date
Endangered Species
37543B ...... Byron Wates ...... 79 FR 39409; July 10, 2014 ...... September 16, 2014. 40316B ...... Ramon Gonzalez ...... 79 FR 52038; September 2, 2014 ...... September 2, 2014. 39418B ...... Exotic Feline Breeding Com- 79 FR 52038; September 2, 2014 ...... November 25, 2014. pound Inc. 43610B ...... Exotic Feline Breeding Com- 79 FR 52038; September 2, 2014 ...... November 25, 2014. pound Inc.
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Permit No. Applicant Receipt of application Federal Register notice Permit issuance date
43611B ...... Exotic Feline Breeding Com- 79 FR 52038; September 2, 2014 ...... November 25, 2014. pound Inc. 42019B ...... Byron Christie ...... 79 FR 52038; September 2, 2014 ...... November 25, 2014. 27473B ...... Ryan Blakley ...... 79 FR 57968; September 26, 2014 ...... November 17, 2014. 43444B ...... William Farrar ...... 79 FR 57968; September 26, 2014 ...... November 25, 2014. 43445B ...... Robert Brocchini ...... 79 FR 57968; September 26, 2014 ...... November 25, 2014. 43448B ...... Richard Lane ...... 79 FR 57968; September 26, 2014 ...... November 25, 2014. 187330 ...... University of Illinois–Zoological 79 FR 60182; October 6, 2014 ...... November 10, 2014. Pathology Program. 42307B ...... Lions, Tigers & Bears ...... 79 FR 62662; October 20, 2014 ...... November 20, 2014.
Marine Mammals
067116 ...... University of Florida, Aquatic 79 FR 48244; August 15, 2014 ...... November 10, 2014. Animal Health Program.
Availability of Documents requests for marine mammal permit We will not consider or include in our Documents and other information public hearings, in writing, at the administrative record comments we submitted with these applications are address shown in the ADDRESSES section receive after the close of the comment available for review, subject to the by January 5, 2015. period (see DATES) or comments requirements of the Privacy Act and ADDRESSES: Brenda Tapia, U.S. Fish and delivered to an address other than those Freedom of Information Act, by any Wildlife Service, Division of listed above (see ADDRESSES). party who submits a written request for Management Authority, Branch of B. May I review comments submitted by a copy of such documents to: U.S. Fish Permits, MS: IA, 5275 Leesburg Pike, others? and Wildlife Service, Division of Falls Church, VA 22041; fax (703) 358– 2281; or email [email protected]. Comments, including names and Management Authority, Branch of street addresses of respondents, will be FOR FURTHER INFORMATION CONTACT: Permits, MS: IA, 5275 Leesburg Pike, available for public review at the street Brenda Tapia, (703) 358–2104 Falls Church, VA 22041; fax (703) 358– address listed under ADDRESSES. The (telephone); (703) 358–2281 (fax); 2281. public may review documents and other [email protected] (email). Brenda Tapia, information applicants have sent in SUPPLEMENTARY INFORMATION: Program Analyst/Data Administrator, Branch support of the application unless our of Permits, Division of Management I. Public Comment Procedures allowing viewing would violate the Authority. Privacy Act or Freedom of Information A. How do I request copies of Act. Before including your address, [FR Doc. 2014–28480 Filed 12–3–14; 8:45 am] applications or comment on submitted BILLING CODE 4310–55–P phone number, email address, or other applications? personal identifying information in your Send your request for copies of comment, you should be aware that DEPARTMENT OF THE INTERIOR applications or comments and materials your entire comment—including your concerning any of the applications to personal identifying information—may Fish and Wildlife Service the contact listed under ADDRESSES. be made publicly available at any time. [FWS–HQ–IA–2014–N249; Please include the Federal Register While you can ask us in your comment FXIA16710900000–156–FF09A30000] notice publication date, the PRT- to withhold your personal identifying number, and the name of the applicant information from public review, we Endangered Species; Marine in your request or submission. We will cannot guarantee that we will be able to Mammals; Receipt of Applications for not consider requests or comments sent do so. to an email or address not listed under Permit II. Background ADDRESSES. If you provide an email AGENCY: Fish and Wildlife Service, address in your request for copies of To help us carry out our conservation Interior. applications, we will attempt to respond responsibilities for affected species, and ACTION: Notice of receipt of applications to your request electronically. in consideration of section 10(a)(1)(A) of for permit. Please make your requests or the Endangered Species Act of 1973, as comments as specific as possible. Please amended (16 U.S.C. 1531 et seq.), and SUMMARY: We, the U.S. Fish and confine your comments to issues for the Marine Mammal Protection Act of Wildlife Service, invite the public to which we seek comments in this notice, 1972, as amended (16 U.S.C. 1361 et comment on the following applications and explain the basis for your seq.), along with Executive Order 13576, to conduct certain activities with comments. Include sufficient ‘‘Delivering an Efficient, Effective, and endangered species, marine mammals, information with your comments to Accountable Government,’’ and the or both. With some exceptions, the allow us to authenticate any scientific or President’s Memorandum for the Heads Endangered Species Act (ESA) and commercial data you include. of Executive Departments and Agencies Marine Mammal Protection Act The comments and recommendations of January 21, 2009—Transparency and (MMPA) prohibit activities with listed that will be most useful and likely to Open Government (74 FR 4685; January species unless Federal authorization is influence agency decisions are: (1) 26, 2009), which call on all Federal acquired that allows such activities. Those supported by quantitative agencies to promote openness and DATES: We must receive comments or information or studies; and (2) Those transparency in Government by requests for documents on or before that include citations to, and analyses disclosing information to the public, we January 5, 2015. We must receive of, the applicable laws and regulations. invite public comment on these permit
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applications before final action is taken. Gekkonidae Applicant: Black Eagle Ranch, Under the MMPA, you may request a Iguanidae Fredericksburg, TX; PRT–52197B hearing on any MMPA application Sphenodontidae received. If you request a hearing, give Testudinidae The applicant requests authorization specific reasons why a hearing would be Varanidae to take up to five Arabian oryx (Oryx appropriate. The holding of such a Viperidae leucoryx), up to five red lechwe (Kobus hearing is at the discretion of the Species: lechwe), and up to five Barasingha deer Service Director. Koala (Phascolarctos cinereus) (Cervus duvaucelii) per year, under their captive-bred wildlife registration 50 III. Permit Applications Jackass penguin (Spheniscus demersus) CFR 17.21(g). This notification covers A. Endangered Species activities to be conducted by the Applicant: Washington Park Zoo, applicant over a 5-year period. Applicant: Space Wild Animal Farm Michigan City, IN; PRT–694606 Inc. Sussex, NJ; PRT–047058 Applicant: Larry Johnson, Boerne, TX; The applicant requests renewal of The applicant requests renewal of PRT–49080B their captive-bred wildlife registration their captive-bred wildlife registration under 50 CFR 17.21(g) for the family under 50 CFR 17.21(g) for leopards The applicant requests a permit to Lemuridae or the species white-collared (Panthera pardus) and ring-tailed export 51 captive-bred Scimitar-horned mangabey (Cercocebus torquatus) to lemurs (Lemur catta) to enhance the oryx (Oryx dammah) for the purpose of enhance the species’ propagation or species’ propagation or survival. This enhancement of the survival of the survival. This notification covers notification covers activities to be species. This notification covers activities to be conducted by the conducted by the applicant over a 5- activities to be conducted by the applicant over a 5-year period. year period. applicant over a 5-year period. Applicant: Mac Embury, Grants Pass, Applicant: GTWT, LLC, Okeechobee, Applicant: Honolulu Zoo, Honolulu, HI; OR; PRT–37451A FL; PRT–48054A PRT–48586B The applicant requests a captive-bred The applicant requests renewal of The applicant requests a permit to their captive-bred wildlife registration wildlife registration under 50 CFR 17.21(g) for the following species, to import one male and two female under 50 CFR 17.21(g) for barasingha captive-born Japanese giant salamanders (Rucerus duvaucelii) to enhance the enhance the species’ propagation or survival. This notification covers (Andrias japonicus) from Asa Zoo, species’ propagation or survival. This Hiroshima, Japan, for the purpose of notification covers activities to be activities to be conducted by the enhancement of the survival of the conducted by the applicant over a 5- applicant over a 5-year period. species. year period. Species: Golden parakeet (Guarouba guarouba) Applicant: Toledo Zoo, Toledo, OH; Applicant: Louisiana State University, Cuban parrot (Amazona Baton Rouge, LA; PRT–003005 PRT–677660 leucocephala) The applicant requests a renewal of Vinaceous parrot (Amazona vinacea) The applicant requests a permit to their captive-bred wildlife registration Blyth’s tragopan (Tragopan blythii) export and reimport nonliving museum under 50 CFR 17.21(g) for the following Cabot’s tragopan (Tragopan caboti) specimens of endangered and families and species, to enhance the Red-crowned crane (Grus japonensis) threatened species previously species’ propagation or survival. This Black-necked crane (Grus nigricollis) accessioned into the applicant’s notification covers activities to be White-naped crane (Grus vipio) collection for scientific research. This conducted by the applicant over a 5- Hooded crane (Grus monacha) notification covers activities to be year period. Galapagos tortoise (Chelonoidis nigra) conducted by the applicant over a 5- Families: Radiated tortoise (Astrochelys radiata) year period. Bovidae Canidae Applicant: St. Augustine Alligator Farm, Multiple Applicants Cebidae St. Augustine, FL; PRT–749207 The following applicants each request Cercopithecidae The applicant requests renewal of Felidae (does not include jaguar, a permit to import the sport-hunted their captive-bred wildlife registration trophy of one male bontebok margay or ocelot) under 50 CFR 17.21(g) for the following (Damaliscus pygargus pygargus) culled Hominidae families and species to enhance their from a captive herd maintained under Hylobatidae propagation or survival. This Lemuridae notification covers activities to be the management program of the Rhinocerotidae conducted by the applicant over a 5- Republic of South Africa, for the Columbidae year period. purpose of enhancement of the survival Psittacidae (does not include thick- of the species. billed parrot) Families: Rallidae Alligatoridae (does not include the Sturnidae (does not include Aplonis American alligator) pelzelni) Crocodylidae (does not include the Alligatoridae American crocodile) Boidae (does not include Mona or Species: Puerto Rican boa) Cotton-top tamarin (Saguinus Chelidae oedipus) Crocodylidae (does not include Golden parakeet (Aratinga guarouba) American crocodile) Blue-throated macaw (Ara Emydidae glaucogularis)
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Applicant: Richard Boyer, Morrison, SUPPLEMENTARY INFORMATION: The Phone: (907) 825–4073; Fax: (907) CO; PRT–46005B regulations implementing ICWA, 25 825–4029 and Cheryl Offt, ICWA Applicant: Frank Giacalone, Magnolia, U.S.C. 1901 et seq., provide that Indian Director, Association of Village TX; PRT–46530B tribes may designate an agent other than Council Presidents, P.O. Box 219, the tribal chairman for service of notice Bethel, AK 99559; Phone: (907) 543– Applicant: Lee Friend, Loganville, GA; of proceedings under the Act. See 25 7400; Fax: (907) 543–5759; Email: PRT–48426B CFR 23.12. The Secretary of the Interior [email protected] Applicant: David L. Bahl, Waukesha, is required to publish as necessary in Akiak Native Community, Sheila WI; PRT–49174B the Federal Register the names and Williams, Tribal Administrator P.O. addresses of the designated tribal Box 52127, Akiak, AK 99552 Phone: Applicant: Robert M. Pirnie, Pike Road, agents. This notice is published in (907) 765–7117; Fax: (907) 765–7512 AK; PRT–49743B exercise of authority delegated by the Akutan, Native Village of, Tara B. Endangered Marine Mammals and Secretary of the Interior to the Principal Bourdukofsky, M.S., Human Services Marine Mammals Deputy Assistant Secretary—Indian Director, Aleutian/Pribilof Islands Affairs by 209 DM 8. In addition to this Association, 1131 East International Applicant: Terrie Williams, University notice, the updated list of designated Airport Road, Anchorage, AK 99518– of California, Santa Cruz, CA; PRT– tribal agents by Bureau of Indian Affairs 1408; Phone: (907) 276–2700; Fax: 45505B (BIA) Region can also be found on the (907) 279–4351, Email: taralb@ The applicant requests a permit to BIA Web site at: http://www.bia.gov/ apiai.org take southern sea otters (Enhydra lutris WhoWeAre/BIA/OIS/HumanServices/ Alakanuk, Village of, Charlene Striling, nereis) for the purpose of scientific IndianChildWelfareAct/index.htm. ICWA Worker, Box 149, Alakanuk, research on the physiology of and AK 99554; Phone: (907) 238–3704; A. List of Regions metabolic demands on female southern Fax: (907) 238–3705; and Cheryl Offt, sea otters. This notification covers 1. Alaska Region ICWA Director, Association of Village activities to be conducted by the 2. Eastern Region Council Presidents, P.O. Box 219, applicant over a 5-year period. 3. Eastern Oklahoma Region Bethel, AK 99559; Phone: (907) 543– Concurrent with publishing this 4. Great Plains Region 7400; Fax: (907) 543–5759; Email: notice in the Federal Register, we are 5. Midwest Region [email protected]; [email protected] Alatna Village, Catherine Henzie, Tribal forwarding copies of the above 6. Navajo Region Family Youth Specialist, P.O. Box 70 applications to the Marine Mammal 7. Northwest Region Allakaket, AK 99720; Phone: (907) Commission and the Committee of 8. Pacific Region 968–2261; Fax: (907) 968–2305; and Scientific Advisors for their review. 9. Rocky Mountain Region 10. Southern Plains Region Tanana Chiefs Conference, Legal Brenda Tapia, 11. Southwest Region Department, 122 First Avenue, Suite Program Analyst/Data Administrator, Branch 12. Western Region 600 Fairbanks, AK 99701; Phone: of Permits, Division of Management (907) 452–8251 Ext. 3178; Fax: (907) Authority. B. List of Designated Tribal Agents by 459–3953 [FR Doc. 2014–28479 Filed 12–3–14; 8:45 am] Region Aleknagik, Native Village of, Jane Gottschalk, Caseworker II, P.O. Box BILLING CODE 4310–55–P 1. Alaska Region 115, Aleknagik, AK 99555; Phone: Alaska Region, Human Services (907) 842–4577; Fax: (907) 842–2229 DEPARTMENT OF THE INTERIOR Director, 3601 C Street, Suite 1100 and Bristol Bay Native Association, Anchorage, AK 99503 Phone: (907) 271– Children’s Services Program Manager, Bureau of Indian Affairs 4111. P.O. Box 310, 1500 Kanakanak Road, [AAK3000000/156A2100DD/ A Dillingham, AK 99576; Phone: (907) A0H501010.999900] 842–4139; Fax: (907) 842–4106; Afognak, Native Village of, Denise Email: [email protected] Indian Child Welfare Act; Designated Malutin, ICWA Worker, 323 Carolyn Algaaciq Native Village, Theresa Kelly, Tribal Agents for Service of Notice Street Kodiak, AK 99615; Phone: (907) Box 48, St. Mary’s, AK 99658; Phone: 486–6357; Fax: (907) 486–6529 Email: (907) 438–2335; Fax: (907) 438–2227 AGENCY: Bureau of Indian Affairs, [email protected]; taletha@ and Cheryl Offt, ICWA Director, Interior. afognak.org;[email protected] Association of Village Council ACTION: Notice. Agdaagux Tribe of King Cove, Tara Presidents, P.O. Box 219, Bethel, AK Bourdukofsky, M.S., Human Services 99559; Phone: (907) 543–7400; Fax: SUMMARY: The regulations implementing Director, Aleutian/Pribilof Islands (907) 543–5759; Email: tkelly@ the Indian Child Welfare Act (ICWA) Association, 1131 East International avcp.org; [email protected] provide that Indian tribes may designate Airport Road, Anchorage, AK 99518– Allakaket Village, Melanie an agent other than the tribal chairman 1408; Phone: (907) 276–2700; Fax: Wholecheese, Tribal Family Youth for service of notice of proceedings (907) 279–4351; Email: taralb@ Specialist, P.O. Box 50, Allakaket, AK under ICWA. This notice includes the apiai.org 99720; Phone: (907) 968–2337; Fax: current list of designated tribal agents Akhiok, Native Village of, Cassie (907) 968–2233; and Tanana Chiefs for service of notice. Hickey, ICWA Coordinator, 3449 Conference, Legal Department, 122 FOR FURTHER INFORMATION CONTACT: Ms. Rezanof Drive East, Kodiak, AK First Avenue, Suite 600 Fairbanks, AK Debra Burton, Bureau of Indian Affairs 99615; Phone: (907) 486–9882; Fax: 99701; Phone: (907) 452–8251 Ext. Division of Human Services, 1849 C (907) 486–1410 Email: cassie.hickey@ 3178; Fax: (907) 459–3953 Street NW., Mail Stop 4513–MIB, kanaweb.org Ambler, Native Village, Lois Sheldon, Washington, DC 20240; Telephone: Akiachak Native Community, ICWA Coordinator; or Effie Esenituk, (202) 513–7610, Email: debra.burton@ Georgianna Wassilie, ICWA Worker Alternate, P.O. Box 86047 Ambler, AK bia.gov. P.O. Box 51070 Akiachak, AK 99551; 99786; Phone: (907) 445–2189/445–
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2196/444–3852; Fax: (907) 445–2257; 852–4413 Email: marjorie.solomon@ Chalkyitsik Village, Amanda Wright, Email: [email protected] nvbarrow.net Tribal Administrator, P.O. Box 57, Anaktuvuk, Village of, Social Services Beaver Village, Arlene Pitka, Tribal Chalkyitsik, AK 99788; Phone: (907) Director, Inupiat Community of the Family Youth Specialist, P.O. Box 848–8117; Fax: (907) 848–8986; and Arctic Slope, P.O. Box 934, Barrow, 24029, Beaver, AK 99724; Phone: Tanana Chiefs Conference, Legal AK 99723, Phone: (907) 852–5923; (907) 628–6126; Fax: (907) 628–6185; Department, 122 First Avenue, Suite Fax: (907) 852–5924; Email: social@ and Tanana Chiefs Conference, Legal 600 Fairbanks, AK 99701; Phone: inupiatgov.com Department, 122 First Avenue, Suite (907) 452–8251 Ext. 3178; Fax: (907) Andreafski (see Yupiit of Andreafski) 600, Fairbanks, AK 99701; Phone: 459–3953 Angoon Community Association, (907) 452–8251 Ext. 3178; Fax: (907) Chanega (aka Chenega), Native Village Marcie Kookesh, ICWA Worker, P.O. 459–3953 of, Norma J. Selanoff, ICWA Box 328, Angoon, AK, 99820 Phone: Belkofski, Native Village of, Tara Representative, P.O. Box 8079, (907) 788–3411; Fax: (907) 788–3412 Bourdukofsky, M.S., Human Services Chenega Bay, AK 99574–8079; Phone: Aniak, Village of, Muriel Morgan, ICWA Director, Aleutian/Pribilof Islands (907) 573–5386; Fax: (907) 573–5387 Worker, P.O. Box 349, Aniak, AK Association, 1131 East International Cheesh-Na- Tribe, Ms. Cecil Sanford, 99557; Phone: (907) 675–4349; Fax: Airport Road, Anchorage, AK 99518– Social Services Coordinator, P.O. Box (907) 675–4513 1408; Phone: (907) 276–2700 Fax: 241 Gakona, AK 99586; Phone: (907) Anvik Village, Tami Jerue, Tribal (907) 279–4351, Email: taralb@ 822–3503; Fax: (907) 822–5179; Family Youth Specialist, P.O. Box 22 apiai.org Email: [email protected] Anvik, AK 99558; Phone: (907) 663– Bettles Field (see Evansville Village) Chefornak, Native Village of, Edward 6378; Fax: (907) 663–6357; and Bill Moore’s Slough Village, Nancy C. Kelly, Community Family Services Tanana Chiefs Conference, Legal Andrews, ICWA Worker & Rose Specialist, P.O. Box 110 Chefornak, Department, 122 First Avenue, Suite Cheemuk, Tribal Administrator, P.O. AK. 99651; Phone: (907) 867–8808; 600 Fairbanks, AK 99701; Phone: Box 20288, Kotlik, AK 99620; Main Fax: (907) 867–8711 and Cheryl Offt, (907) 452–8251 Ext. 3178; Fax: (907) Office Phone: (907) 899–4232; Main ICWA Director, Association of Village 459–3953 Office Fax: (907) 899–4461; ICWA Council Presidents, P.O. Box 219, Arctic Village, Lisa Frank, Tribal Family Office Phone: (907) 899–4236; ICWA Bethel, AK 99559; Phone: (907) 543– Youth Specialist, P.O. Box 22069, Office Fax: (907) 899–4002 7400; Fax: (907) 543–5759; Email: Arctic Village, AK 99722; Phone: Birch Creek Tribe, Jackie Balaam, Tribal [email protected]; [email protected] or (907) 587–5523; Fax: (907) 587–5128; Family Youth Specialist, P.O. Box [email protected] and Tanana Chiefs Conference, Legal KBC Fairbanks, AK 99707; Phone: Chevak, Native Village of, Esther Friday, Department, 122 First Avenue, Suite (907) 378–1573; Fax (907) 452–5063; ICWA Worker, Box 140, Chevak, AK 600 Fairbanks, AK 99701; Phone: and Tanana Chiefs Conference, Legal 99563; Phone: (907) 858–7918; Fax: (907) 452–8251 Ext. 3178; Fax: (907) Department, 122 First Avenue, Suite (907) 858–7919 and Cheryl Offt, 459–3953 600 Fairbanks, AK 99701; Phone: ICWA Director, Association of Village Asa’carsarmiut Tribe (formerly Native (907) 452–8251 Ext. 3178; Fax: (907) Council Presidents, P.O. Box 219, Village of Mountain Village), Darlene 459–3953 Peterson, Director of Social Services, Brevig Mission, Native Village of, Linda Bethel, AK 99559; Phone: (907) 543– and Daphne Joe, Social Services, P.O. M. Divers, Tribal Family Coordinator, 7400; Fax: (907) 543–5759; Email: Box 32107; Mountain Village, AK P.O. Box 85039, Brevig Mission, AK [email protected]; [email protected]; 99632; Phone: (907) 591–2428; Fax: 99785; Phone: (907) 642–3012; Fax: [email protected] (907) 591–2934; Email: atcicwa@ (907) 642–3042 Email: linda@ Chickaloon Native Village, Penny gci.net kawerak.org and Ms. Traci McGarry, Westing, ICWA Case Manager, P.O. Atka, Native Village of, Tara Program Director, Kawerak, Inc. Box 1105, Chickaloon, AK 99674; Bourdukofsky, M.S., Human Services Children & Family Services, P.O. Box Phone: (907) 745–0794; Fax: (907) Director, Aleutian/Pribilof Islands 948 Nome, AK 99762 Phone: (907) 745–0709; Email: penny@ Association, 1131 East International 443–4376/4261 Fax: (907) 443–4464/ chickaloon.org Airport Road, Anchorage, AK 99518– 4457; Email: [email protected] Chignik Bay Tribal Council, Debbie 1408; Phone: (907) 276–2700; Fax: Buckland, Native Village of, Tracey Carlson, Administrator, Box 50, (907) 279–4351, Email: taralb@ Hadley, ICWA Coordinator, P.O. Box Chignik, AK 99564; Phone: (907) 749– apiai.org 67 Buckland, AK 99727; Phone: (907) 2445; Fax: (907) 749–2423; Email: Atmautluak, Village of, Alexie Earl 494–2169; Fax: (907) 494–2168 Email: [email protected]; and Bristol Bay Brown, ICWA Worker & Daniel [email protected] Native Association, Children’s Waska, Tribal Administrator, P.O. Box Services Program Manager, P.O. Box C 6568, Atmautluak, AK 99559 Phone: 310, 1500 Kanakanak Road, (907) 553–5610; Fax: (907) 553–5612 Cantwell, Native Village of, Dorothy Dillingham, AK 99576; Phone: (907) Atqasuk Village, Maude Hopson, ICWA Slater, ICWA Program, Copper Center 842–4139; Fax: (907) 842–4106; Coordinator, Social Services Native Association, P.O. Box 206, Email: [email protected] Department, Arctic Slope Native Copper Center, AK 99573; Phone: Native Village of Chignik Lagoon, Nancy Association, Ltd., P.O. Box 1232, (907) 822–5241; Fax: (907) 822–8800 Anderson, ICWA, P.O. Box 09, Barrow, AK 99723; Phone: (907) 852– Email: [email protected] Chignik Lagoon, AK 99565; Phone: 9374; Fax: (907) 852–9152 Email: Central Council of the Tlingit and Haida (907) 840–2281; Fax: (907) 840–2217; [email protected] Indian Tribes of Alaska, Amalia Email: [email protected] and Bristol Monreal, ICWA Coordinator; 320 W. Bay Native Association, Children’s B Willoughby Ave., Suite 300, Juneau, Services Program Manager, P.O. Box Barrow, Native Village of, Marjorie AK 99801; Phone: (907) 463–7169; 310, 1500 Kanakanak Road, Solomon, Social Services Director, Fax: (907) 463–7343; Dillingham, AK 99576; Phone: (907) P.O. Box 1130 Barrow, AK 99723; Email:[email protected] 842–4139; Fax: (907) 842–4106; Phone: (907) 852–4411 Fax: (907) [email protected] Email: [email protected]
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Chignik Lake Village, ICWA Worker, Services Program Manager, P.O. Box E P.O. Box 33, Chignik Lake, AK 99548; 310, 1500 Kanakanak Road, Eagle, Native Village, Claire Ashley, Phone (907) 845–2358; Fax: (907) Dillingham, AK 99576; Phone: (907) Tribal Family Youth Specialist, P.O. 845–2246 and Bristol Bay Native 842–4139; Fax: (907) 842–4106; Box 19, Eagle, AK 99738; Phone: (907) Association, Children’s Services Email: [email protected] 547–2271; Fax: (907) 547–2318; Program Manager, P.O. Box 310, 1500 Copper Center (see Native Village of Email: Claire.ashley@ Kanakanak Road, Dillingham, AK Kluti-Kaah) tananachiefs.org; and Tanana Chiefs 99576; Phone: (907) 842–4139; Fax: Cordova (see Eyak) Conference, Legal Department, 122 (907) 842–4106; Email: cnixon@ Council, Native Village of, Rhonda First Avenue, Suite 600 Fairbanks, AK bbna.com Hanebuth, ICWA Coordinator, P.O. 99701; Phone: (907) 452–8251 Ext. Chilkat Indian Village, Carrie Durr, Box 986, Nome, AK 99762; Phone: 3178; Fax: (907) 459–3953 ICWA Caseworker, HC 60 Box 2207 (907) 443–7649; Fax: (907) 443–5965. Edzeno (see Nikolai Native Council) Haines, AK 99827; Phone: (907) 767– Eek, Native Village, Lillian Cleveland, 5505; Fax: (907) 767–5408; Email: Craig Community Association, Roberta Patten, Family Casework I, P.O. Box ICWA Worker, Box 89, Eek, AK [email protected] 99578; Phone: (907) 536–5572; Fax: Chilkoot Indian Association, Stella 746 Craig, AK 99921 Phone: 907 826– 3948 Fax: (907) 826–5526 and Central (907) 536–5582; and Cheryl Offt, Howard, Family Caseworker/CCTH ICWA Director, Association of Village Council Tlingit and Haida Tribes of Field Supervisor, P.O. Box 624, Council Presidents, P.O. Box 219, Alaska; Email: [email protected] Haines, AK 99827; Phone: (907) 766– Bethel, AK 99559; Phone: (907) 543– 2810; Fax: (907) 766–2845; Email: Crooked Creek, Village of, Helen Macar, 7400; Fax: (907) 543–5759; Email: [email protected] ICWA Worker & Evelyn Thomas, [email protected]; [email protected] Chinik Eskimo Community (aka President, P.O. Box 69, Crooked Egegik Village, Marcia Abalama, Case Golovin), Kirstie Ione,Tribal Family Creek, AK 99575; Phone: (907) 432– Worker III–ICWA Team Leader, P.O. Coordinator, P.O. Box 62020, Golovin, 2200 Fax: (907) 432–2201 Email: Box 154, Egegik, AK 99579; Phone: AK 99762;Phone: (907) 779–3489; [email protected] (907) 233–2207; Fax: (907) 233–2212; Fax: (907) 779–2000; Email: tfc.glv@ Curyung Tribal Council (formerly the and Bristol Bay Native Association, kawerak.org and Ms. Traci McGarry, Native Village of Dillingham), ICWA Children’s Services Program Manager, Program Director, Kawerak, Inc. Case Worker II, P.O. Box 216, P.O. Box 310, 1500 Kanakanak Road, Children & Family Services, P.O. Box Dillingham, AK 99576; Phone: (907) Dillingham, AK 99576; Phone: (907) 948 Nome, AK 99762 Phone: (907) 842–4508; Fax: (907) 842–4508; and 842–4139; Fax: (907) 842–4106; 443–4376/4261; Fax: (907) 443–4464/ Bristol Bay Native Association, Email: [email protected] 4457; Email: [email protected] Children’s Services Program Manager, Eklutna, Native Village of, Ms. Jamison Chistochina (see Cheesh-na Tribe) P.O. Box 310, 1500 Kanakanak Road, M. Cole, LCSW, ICWA Worker, Social Chitina, Native Village of, Tribal Dillingham, AK 99576; Phone: (907) Services Director, P.O. Box 670666 President and Tribal Administrator, 842–4139; Fax: (907) 842–4106; Chugiak, AK 99567; Phone: (907) P.O. Box 31, Chitina, AK. 99566; Email: [email protected] 688–1808 Office (907) 242–6980 cell; Phone: (907) 823–2215; FAX: (907) Fax: (907) 688–6032; Email: D 823–2233. [email protected]; Chuathbaluk, Native Village of, Tracy Deering, Native Village of, ICWA [email protected] Simeon, ICWA Worker, Box CHU, Coordinator and Tribal Administrator, Ekuk, Native Village of, Helen Foster, Chuathbaluk, AK 99557 Phone: (907) P.O. Box 360, Deering, AK 99736; Tribal Administrator and Maria 467–4313; Fax: (907) 467–4113; and Phone: (907) 363–2229; Fax: (907) Binkowski, Receptionist/File Clerk, Cheryl Offt, ICWA Director, 363–2195 and Maniilaq Association, 300 Main St., P.O. Box 530 Association of Village Council Family Services, P.O. Box 256, Dillingham, AK 99576; Phone: (907) Presidents, P.O. Box 219, Bethel, AK Kotzebue, AK 99752; Phone: (907) 842–4139; Fax: (907) 842–3843 and 99559; Phone: (907) 543–7400; Fax: 442–7870 Bristol Bay Native Association, (907) 543–5759; Email: cofft@ Dillingham (see Curyung Tribal Children’s Services Program Manager, avcp.org; [email protected]; Council) P.O. Box 310, 1500 Kanakanak Road, [email protected] Dillingham, AK 99576; Phone: (907) Diomede (aka Inalik) Native Village of, Chuloonawick, Native Village of, Bambi 842–4139; Fax: (907) 842–4106; Etta Ahkinga, Tribal Family Akers, Tribal Administrator, P.O. Box Email: [email protected] 245, Emmonak, AK 99581; Phone: Coordinator, P.O. Box 948 Nome, AK Ekwok Village, Sandra Stermer, ICWA (907) 949–1345; Fax: (907) 949–1346; 99762; Phone: (907) 443–4261; Fax: Case Worker II, P.O. Box 70, Ekwok, Email: [email protected] (907) 443–4464; Email: tfc.dio@ AK 99580; Phone: (907) 464–3349; Circle Native Community, Jessica Boyle, kawerak.org Fax: (907) 464–3350; Email: Tribal Family Youth Specialist, P.O. Dot Lake, Village of, Clara Perdue, [email protected] and Bristol Box 89, Circle, AK 99733; Phone: ICWA Worker, P.O. Box 2279 Dot Bay Native Association, Children’s (907) 773–2822; Fax: (907) 773–2823; Lake, AK 99737; Phone: (907) 882– Services Program Manager, P.O. Box Email: Jessica.boyle@ 2695; Fax: (907) 882–5558; and 310, 1500 Kanakanak Road, tananachiefs.org; and Tanana Chiefs Tanana Chiefs Conference, Legal Dillingham, AK 99576; Phone: (907) Conference, Legal Department, 122 Department, 122 First Avenue, Suite 842–4139; Fax: (907) 842–4106; First Avenue, Suite 600 Fairbanks, AK 600 Fairbanks, AK 99701; Phone: Email: [email protected] 99701; Phone: (907) 452–8251 Ext. (907) 452–8251 Ext. 3178; Fax: (907) Elim, Native Village of, Joseph H. 3178; Fax: (907) 459–3953 459–3953 Murray, Tribal Family Coordinator, Clarks Point, Village of, Harry Wassily Douglas Indian Association, Loretta P.O. Box 70, Elim, AK 99739 Phone: Sr., President, P.O. 9, Clarks Point, Marvin, ICWA Worker, 811 West 12th (907) 890–2457; Fax: (907) 890–2458 AK 99569 Phone: (907) 236–1427; Street, Suite 200, Juneau, AK 99801; Email: [email protected] and Fax: (907) 236–1428 and Bristol Bay Phone: (907) 364–2983; Fax: (907) Ms. Traci McGarry, Program Director, Native Association, Children’s 364–2917; Email: [email protected] Kawerak, Inc. Children & Family
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Services, P.O. Box 948 Nome, AK Arctic Blvd., Suite 104, Anchorage, Hooper Bay, Native Village, Pearl 99762 Phone: (907) 443–4376/4261; AK 99518; Phone: (907) 274–2195; Semaken, ICWA Program, Box 62, Fax: (907) 443–4464/4457; Email: Fax: (907) 274–2196; Email: gtc@ Hooper Bay, AK 99604; Phone: (907) [email protected] gci.net 758–4006; Fax: 758–4606 and Cheryl Emmonak, Native Village, Priscilla S. Golovin (see Chinik Eskimo Offt, ICWA Director, Association of Kameroff, ICWA Coordinator and Community) Village Council Presidents, P.O. Box Tribal Administrator, P.O. Box 126, Goodnews Bay, Native Village, Pauline 219, Bethel, AK 99559; Phone: (907) Emmonak, AK 99581; Phone: (907) Echuk, ICWA Worker, Box 48, 543–7400; Fax: (907) 543–5759; 949–1720/1820; Fax: (907) 949–1384; Goodnews Bay, AK 99589 Phone: Email: [email protected]; psemaken@ Email: [email protected] (907) 967–8929; Fax: (907) 967–8330 avcp.org English Bay (see Native Village of and Cheryl Offt, ICWA Director, Hughes Village, Janet Bifelt, Tribal Nanwalek) Association of Village Council Administrator or Tribal Family Youth Evansville Village (aka Bettles Field), Presidents, P.O. Box 219, Bethel, AK Specialist, P.O. Box 45029 Hughes, Naomi Costello, Tribal Family Youth 99559; Phone: (907) 543–7400; Fax: AK 99745; Phone: (907) 889–2249; Specialist, P.O. Box 26087, (907) 543–5759; Email: cofft@ Fax: (907) 889–2252 Evansville, AK 99726; Phone: (907) avcp.org; [email protected]; Huslia Village, Cesa Sam, Tribal Family 692–5005; Fax: (907) 692–5006; and [email protected] Youth Specialist, P.O. Box 70, Huslia, Tanana Chiefs Conference, Legal Organized Village of Grayling, Johanna AK 99746; Phone: (907) 829–2202; Department, 122 First Avenue, Suite Hamilton, Tribal Family Youth Fax: (907) 829–2214; and Tanana 600 Fairbanks, AK 99701; Phone: Specialist, P. O. Box 49, Grayling, AK Chiefs Conference, Legal Department, (907) 452–8251 Ext. 3178; Fax: (907) 99590; Phone: (907) 453–5142; Fax: 122 First Avenue, Suite 600 459–3953 (907) 453–5146; and Tanana Chiefs Fairbanks, AK 99701; Phone: (907) Eyak, Native Village, Erin Kurz, Tribal Conference, Legal Department, 122 452–8251 Ext. 3178; Fax: (907) 459– Family Services Coordinator, P.O. Box First Avenue, Suite 600 Fairbanks, AK 3953 1388, Cordova, AK 99574; Phone: 99701; Phone: (907) 452–8251 Ext. Hydaburg Cooperative Association, (907) 424–7738; Fax: (907)424–7809; 3178; Fax: (907) 459–3953 Colleen Kashevarof, Human Services Email: [email protected] Gulkana Village Council, Jan Miller, Director, P.O. Box 349, Hydaburg, AK Family Services Specialist, P.O. Box F 99922; Phone: (907) 285–3662; Fax: 254 Gakona, AK 99586 Phone: (907) (907) 285–3541 False Pass, Native Village, Tara 822–5363; Fax: (907) 822–3976 Email: Bourdukofsky, M.S., Human Services [email protected] I Director, Aleutian/Pribilof Islands Gwichyaa Zhee Gwich’in Tribal Igiugig Village, Tanya Salmon, ICWA Association, 1131 East International Government (aka Fort Yukon) Worker, P.O. Box 4008, Igiugig, AK Airport Road, Anchorage, AK 99518– H 99613; Phone: (907) 533–3211; Fax: 1408; Phone: (907) 276–2700; Fax: (907) 533–3217 (907) 279–4351; Email: taralb@ Haines (see Chilkoot Indian Iliamna Village Council, Thomas apiai.org Association) Hedlund, Tribal President, P.O. Box Fort Yukon, Native Village (see Hamilton, Native Village of, Tribal 286 Iliamna, AK 99606; Phone: (907) Gwichyaa Zhee Gwich’in Tribal Administrator, P.O. Box 20248 571–1246; Fax: 571–3539; Email: ivc@ Government), Kimberly Ansaknok, Hamilton, AK 99620; Phone: (907) iliamnavc.org Tribal Family Youth Specialist, P.O. 899–4252; Fax: (907) 899–4202; and Box 10 Fort Yukon, AK 99740; Phone: Cheryl Offt, ICWA Director, Inupiat Community of the Arctic Slope, (907) 662–3625; Fax: (907) 662–3118; Association of Village Council Dora Neakok, Social Services Director and Tanana Chiefs Conference, Legal Presidents, P.O. Box 219, Bethel, AK P.O. Box 934, Barrow, AK 99723; Department, 122 First Avenue, Suite 99559; Phone: (907) 543–7400; Fax: Phone: (907) 852–4227, ext. 234; Fax: 600 Fairbanks, AK 99701; Phone: (907) 543–5759; Email: cofft@ (907) 852–4246; Email: social@ (907) 452–8251 Ext. 3178; Fax: (907) avcp.org; [email protected]; inupiatgov.com 459–3953 [email protected] Iqurmuit Traditional Council (aka Fortuna Ledge (see Native Village of Healy Lake Village, (No tribal contact Russian Mission), Katie Nick, Marshall) information at this time. Contact the Community Family Services BIA Human Services, Alaska Region) Specialist, P.O. Box 38 Russian G Holikachuk (see Grayling) Mission, AK 99657; Phone: (907) 584– Gakona, Native Village of, Charlene Holy Cross Village, Rebecca 5594; Fax: (907) 584–5596; and Cheryl Nollner, Tribal Administrator, P.O. Demientieff, Tribal Family Youth Offt, ICWA Director, Association of Box 102, Gakona, AK 99586; Phone: Specialist, P.O. Box 191, Holy Cross, Village Council Presidents, P.O. Box (907) 822–5997; Fax: (907) 822–5997; AK 99602; Phone: (907) 476–7249; 219, Bethel, AK 99559; Phone: (907) Email: [email protected] Fax: (907) 476–7132; Email: rebecca. 543–7400; Fax: (907) 543–5759; Galena Village (aka Louden Village), [email protected] and Email: [email protected]; knick@ March Runner, Tribal Administrator/ Tanana Chiefs Conference, Legal avcp.org Tribal Family Youth Specialist P.O. Department, 122 First Avenue, Suite Ivanoff Bay Village, Edgar Shangin, Box 244 Galena, AK 99741; Phone: 600 Fairbanks, AK 99701; Phone: Tribal President, 7926 Old Seward (907) 656–1711; Fax: (907) 656–2491; (907) 452–8251 Ext. 3178; Fax: (907) Hwy, Suite B–5, Anchorage, AK Email: [email protected] 459–3953 99518; Phone (907) 522–2263; Fax: Gambell, Native Village of, Tyler Hoonah Indian Association, Candy (907) 522–2363; Email: nicole@ Campbell, Sr., ICWA, P.O. Box 90, Keown, Human Services Director, ivanofbaytribe.org; and Bristol Bay Gambell, AK 99742; Phone: (907) P.O. Box 602 Hoonah, AK 99829 Native Association, Children’s 985–5346 Ext. 4; Fax: (907) 985–5014 Phone: (907) 945–3545; Fax: (907) Services Program Manager, P.O. Box Georgetown, Native Village of, Will 945–3530; Email: ckeown@ 310, 1500 Kanakanak Road, Hartman, Tribal Administrator, 5313 hiatribe.org Dillingham, AK 99576; Phone: (907)
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842–4139; Fax: (907) 842–4106; Kenaitze Indian Tribe, Donna Knik Tribe, Geraldine Nicoli, ICWA Email: [email protected] Huntington or Kalyn Simpson, Family Worker, P.O. Box 871565, Wasilla, AK Case Managers, P.O. Box 988, Kenai, 99687; Phone: (907) 373–7938; Fax: K AK 99611; Phone: (907) 335–7243 or (907) 373–2153; Email: gnicoli@ Kaguyak Village, Phyllis Amodo, Tribal (907) 335–7217; Fax: (907) 335–7236; kniktribe.org President, P.O. Box 5078, Akhiok, AK Email: [email protected] Kobuk, Native Village of, Tribal 99615; Phone: (907) 836–2231; Fax: [email protected] Administrator, P.O. Box 51039, (907) 836–2345 Ketchikan Indian Community, Pauline Kobuk, AK 99751; Phone: (907) 948– Organized Village of Kake, Ann Jackson, Sena-Edenshaw, ICWA Specialist, 2007; Fax: (907) 948–2123 Social Services Director, P. O. Box 2960 Tongass Ave., Ketchikan, AK Kodiak Tribal Council (see Sun’aq) 316, Kake, AK 99830; Phone: (907) 99901 Phone: (907) 228–9404; Fax: Kokhanok Village, Mary Andrew, 785–6471; Fax: (907)785–4902 800–865–6310 Email: psedenshaw@ Caseworker II, P.O. Box 1007 Kaktovik Village (aka Barter Island), kictribe.org Kokhanok, AK 99606; Phone: (907) Maude Hopson, ICWA Coordinator, Kiana, Native Village, Naomi Chappel, 282–2224; Fax: (907) 282–2221 and Social Services Department, Arctic ICWA Coordinator, P.O. Box 69 Bristol Bay Native Association, Slope Native Association, Ltd., P.O. Kiana, AK 99749 Phone: (907) 475– Children’s Services Program Manager, Box 1232, Barrow, AK 99723; Phone: 2226; Fax: (907) 475–2266; Email: P.O. Box 310, 1500 Kanakanak Road, (907) 852–9374; Fax: (907) 852–9152; [email protected] Dillingham, AK 99576; Phone: (907) Email: [email protected] King Cove (see Agdaagux) 842–4139; Fax: (907) 842–4106; Kalskag, Village of, (aka Upper Kalskag) King Island Native Community, Email: [email protected] Bonnie Persson, Tribal Administrator, Koliganek Village (see New Kolignanek) Benjamin Payenna, Tribal Family Kongiganak, Native Village of, Janet P.O. Box 50 Kalskag, AK 99607; Coordinator, P.O. Box 682 Nome, AK Otto, Community Family Services Phone: (907) 471–2296; Fax: (907) 99762; Phone: (907) 443–2209; Fax: Specialist, P.O. Box 5092, 471–2399; and Cheryl Offt, ICWA (907) 443–8049; Email: tfc.ki@ Kongiganak, AK 99545; Phone: (907) Director, Association of Village kawerak.org and Ms. Traci McGarry, 557–5311; Fax: (907) 557–5348; and Council Presidents, P.O. Box 219, Program Director, Kawerak, Inc. Cheryl Offt, ICWA Director, Bethel, AK 99559; Phone: (907) 543– Children & Family Services, P.O. Box Association of Village Council 7400; Fax: (907) 543–5759; Email: 948, Nome, AK 99762 Phone: (907) Presidents, P.O. Box 219, Bethel, AK [email protected]; [email protected]; 443–4376/4261; Fax: (907) 443–4464/ 99559; Phone: (907) 543–7400; Fax: [email protected] 4457; Email: [email protected] (907) 543–5759; Email: cofft@ Lower Kalskag (See Lower Kalskag) King Salmon Tribe, Ralph Angasan, Jr., avcp.org; [email protected] Kaltag, Village of, Donna Esmailka, Tribal Administrator and Joni Kotlik, Native Village of, Ursula Akaran, Tribal Administrator, P.O. Box 129 O’Domin, Tribal Enrollment Manager, Community Family ServicesWorker, Kaltag, AK 99748 Phone: (907) 534– P.O. Box 68 King Salmon, AK 99613 P.O. Box 20210, Kotlik, AK 99620 2243; Fax: (907) 534–2264; and Phone: (907) 246–3553 (907) 246– Phone: (907) 899–4459 Fax: (907) Tanana Chiefs Conference, Legal 3447; Fax: (907) 246–3449; Email: 899–4202 and Cheryl Offt, ICWA Department, 122 First Avenue, Suite [email protected] joni@ Director, Association of Village 600 Fairbanks, AK 99701; Phone: kstribe.com Council Presidents, P.O. Box 219, (907) 452–8251 Ext. 3178; Fax: (907) Kipnuk, Native Village of Helen Paul, Bethel, AK 99559; Phone: (907) 543– 459–3953 Community Family Services 7400; Fax: (907) 543–5759; Email: Kanatak, Native Tribe of, Shawn Specialist, P.O. Box 57, Kipnuk, AK [email protected]; [email protected]; Shanigan, Tribal Administrator, P.O. 99614; Phone: (907) 896–5430; Fax: [email protected] Box 876822 Wasilla, AK 99687; (907) 896–5704; and Cheryl Offt, Kotzebue, Native Village of, Clarissa Phone: (907) 357–5991; Fax: (907) ICWA Director, Association of Village Ballot, Tribal Family Resource 357–5992 and Bristol Bay Native Council Presidents, P.O. Box 219, Director, P.O. Box 296, Kotzebue, AK Association, Children’s Services Bethel, AK 99559; Phone: (907) 543– 99752; Phone: (907) 442–3467 Ext. Program Manager, P.O. Box 310, 1500 7400; Fax: (907) 543–5759; Email: 205; Fax: (907) 442–2162; Email: Kanakanak Road, Dillingham, AK [email protected]; [email protected] [email protected] 99576; Phone: (907) 842–4139; Fax: Kivalina, Native Village of, Stanley Koyuk, Native Village of, Leo M. Charles (907) 842–4106; Email: cnixon@ Hawley, Tribal Administrator, P.O. Sr. Supervisor, P.O. Box 53030, bbna.com Box 50051, Kivalina, AK 99750; Koyuk, AK 99753; Phone: (907)963– Karluk, Native Village of, Kristeen Reft, Phone: (907) 645–2201; Fax: (907) 2215; Fax: (907)963–2300; Email: ICWA Worker, P.O. Box 22, Karluk, 645–2193; Email: tribeadmin@ [email protected] and Ms. Traci AK 99608 Phone: (907) 241–2218; kivaliniq.org and Maniilaq McGarry, Program Director, Kawerak, Fax: (907) 241–2208; Email: Association, Family Services, P.O. Inc. Children & Family Services, P.O. [email protected] Box 256, Kotzebue, AK 99752; Phone: Box 948 Nome, AK 99762 Phone: Organized Village of Kasaan, Paula (907) 442–7870 (907) 443–4376/4261; Fax: (907) 443– Peterson, Tribal Administrator, P.O. Klawock Cooperative Association, 4464/4457; Email: [email protected] Box 26–KXA, Ketchikan, AK 99950; Family Caseworker, P.O. Box 173, Koyukuk, Native Village of, Sharon Phone: (907) 542–2230; Fax: Klawock, AK 99925; Phone: (907) Pilot, Tribal Family Youth Specialist, (907)542–3006; Email: paula@ 755–2325; Fax: (907) 755–2647 P.O. Box 109, Koyukuk, AK 99754; kasaan.org Klukwan (see Chilkat Indian Village) Phone: (907) 927–2208; Fax: (907) Kashnumiut Tribe (see Chevak) Kluti- Kaah, Native Village of, Dorothy 927–2220; Email: sharon.pilot@ Kasigluk Traditional Council, Lucy Slater, Copper Center Native tananachiefs.org; and Tanana Chiefs Kassel, Tribal President, Lena Keene, Association, P.O. Box 206, Copper Conference, Legal Department, 122 ICWA Worker, P.O. Box 19, Kasigluk, Center, AK 99573 Phone: (907) 822– First Avenue, Suite 600 Fairbanks, AK AK 99609 Phone: (907) 477–6405/ 5241; Fax: (907) 822–8800; Email: 99701; Phone: (907) 452–8251 Ext. 6418; Fax: (907) 477–6416 [email protected] 3178; Fax: (907) 459–3953
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Kwethluk (see Organized Village of Bristol Bay Native Association, AK 99633; Phone: (907) 246–4210; Kwethluk) Children’s Services Program Manager, Fax: (907) 246–3563; Email: Kwigillingok, Native Village of, Andrew P.O. Box 310, 1500 Kanakanak Road, [email protected] Beaver, Tribal Administrator, P.O. Dillingham, AK 99576; Phone: (907) Nanwalek, Native Village of, Alma Box 90, Kwigillingok, AK 99622; 842–4139; Fax: (907) 842–4106; Moonin, ICWA Advocate, P.O. Box Phone: 588–8117; Fax: (907) 588– Email: [email protected] 8028, Nanwalek, AK 99603; Phone: 8429 Marshall, Native Village of, ICWA (907) 281–2307; Fax: (907)281–2252. Kwinhagak (aka Quinhagak), Native Worker and Tribal Administrator, Napaimute, Native Village of, Sarah Village of, Grace Friendly, ICWA, P.O. P.O. Box 110 Marshall, AK 99585; Jenkins, and Cheryl Offt, ICWA Box 149, Quinhagak, AK 99655; Phone: (907) 679–6302; Fax: (907) Director, Association of Village Phone: (907) 556–8165; Fax (907) 676–6187 2227 and Cheryl Offt, ICWA Council Presidents, P.O. Box 219, 556–8340 Director, Association of Village Bethel, AK 99559; Phone: (907) 543– Council Presidents, P.O. Box 219, L 7400; Fax: (907) 543–5759; Email: Bethel, AK 99559; Phone: (907) 543– [email protected]; mfredricks@ Larsen Bay, Native Village of, Cassie 7400; Fax: (907) 543–5759; Email: avcp.org; [email protected] Hickey, ICWA Coordinator, Kodiak [email protected] Napakiak, Native Village of, Julia Area Native Association, 3449 Mary’s Igloo, Native Village of, Dolly Andrew, Tribal Administrator, P. O. Rezanof Drive East Kodiak, AK 99615 Kugzruk, Tribal Family Coordinator; Box 34114 Napakiak, AK 99634; Phone: (907) 486–9882; Fax: (907) P.O. Box 546, Teller, AK 99778; Phone: (907) 589–2815; Fax: (907) 486–1410; Email: cassie.hickey@ Phone: (907) 642–2185; Fax: (907) 589–2814; Email: [email protected] kanaweb.org 642–2189; Email: dkugzruk@ and Cheryl Offt, ICWA Director, Lesnoi Village (aka Woody Island), kawerak.org; and Ms. Traci McGarry, Association of Village Council Robert Stauffer, 194 Alimaq Dr., Program Director, Kawerak, Inc. Presidents, P.O. Box 219, Bethel, AK Kodiak, AK 99615 Phone: (907) 486– Children & Family Services, P.O. Box 99559; Phone: (907) 543–7400; Fax: 9806. 948 Nome, AK 99762 Phone: (907) (907) 543–5759; Email: [email protected] Levelock Village, Ida Apokedak, 443–4376; Fax: (907) 443–4464; Napaskiak, Native Village of, Elizabeth President, Box 70, Levelock, AK Email: [email protected] Steven, ICWA Worker, P.O. Box 6009 99625; Phone: (907) 287–3030; Fax: McGrath Native Village, Helen Napaskiak, AK 99559; Phone: (907) (907) 287–3032; Email: levelock@ Vanderpool, Tribal Family Youth 737–7364; Fax: (907) 737–7039 Email: gci.net; and Bristol Bay Native Specialist, P.O. Box 134 McGrath, AK [email protected]; mfredricks@ Association, Children’s Services 99672; Phone: (907) 524–3023; Fax: avcp.org and Cheryl Offt, ICWA Program Manager, P.O. Box 310, 1500 (907) 524–3899; Email: helenvhf@ Director, Association of Village Kanakanak Road, Dillingham, AK mcgrath.net; and Tanana Chiefs Council Presidents, P.O. Box 219, 99576; Phone: (907) 842–4139; Fax: Conference, Legal Department, 122 Bethel, AK 99559; Phone: (907) 543– (907) 842–4106; Email: cnixon@ First Avenue, Suite 600 Fairbanks, AK 7400; Fax: (907) 543–5759; Email: bbna.com 99701; Phone: (907) 452–8251 Ext. Lime Village Traditional Council, [email protected] 3178; Fax: (907) 459–3953 Nelson Lagoon, Native Village of, Tara Jennifer John, Tribal President, P.O. Mekoryuk, Native Village of, Melanie Bourdukofsky, M.S., Human Services Box LVD- Lime Village VIA McGrath, Shavings, ICWA Coordinator & Jobe Director, Aleutian/Pribilof Islands AK 99627; Phone: (907) 526–5236; Weston, Executive Director, P.O. Box Association, 1131 East International Fax: (907) 526–5235 66 Mekoryuk, AK 99630; Main Phone: Airport Road, Anchorage, AK 99518– Louden (see Galena) (907) 827–8828; ICWA Dept. Phone: 1408; Phone: (907) 276–2700 Fax: Lower Kalskag, Village of, Nastasia (907) 827–8827; Fax: (907) 827–8133; (907) 279–4351, Email: taralb@ Evan, ICWA Worker, P.O. Box 27 Email: [email protected] apiai.org Lower Kalskag, AK 99626 Phone: Mentasta Traditional Council, Andrea (907) 471–2412 Fax: (907) 471–2378 David, ICWA Worker, P.O. Box 6019, Nenana Native Association, Jo Noble, and Cheryl Offt, ICWA Director, Mentasta, AK 99780; Phone: (907) Tribal Administrator, P.O. Box 369, Association of Village Council 291–2319; Fax: (907) 291–2305 Nenana, AK 99760; Phone: (907) 832– Presidents, P.O. Box 219, Bethel, AK Metlakatla Indian Community, Craig 5461; Fax: (907) 832–5447; and 99559; Phone: (907) 543–7400; Fax: White, Social Services Director, P.O. Tanana Chiefs Conference, Legal (907) 543–5759; Email: cofft@ Box 8, Metlakatla, AK 99926; Phone: Department, 122 First Avenue, Suite avcp.org; [email protected]; (907) 886–6914/6916; Fax: (907) 886– 600 Fairbanks, AK 99701; Phone: [email protected]; [email protected] 6913; Email: [email protected] (907) 452–8251 Ext. 3178; Fax: (907) Minto, Native Village of, Lou Ann 459–3953 M Williams, Tribal Family Youth New Koliganek Village Council, Herman Manley Hot Springs Village, Elizabeth Specialist, P.O. Box 26087 Minto, AK Nelson, President, P.O. Box 5057, Woods, Tribal Family Youth 99758; Phone: (907) 798–7007; Fax: Koliganek, AK 99576; Phone: (907) Specialist, P.O. Box 105 Manley Hot (907) 798–7008; Email: lou.williams@ 596–3434; Fax: (907) 596–3462 and Springs, AK 99756; Phone: (907) 672– tananachiefs.org; and Tanana Chiefs Bristol Bay Native Association, 3177; Fax: (907) 672–3200; and Conference, Legal Department, 122 Children’s Services Program Manager, Tanana Chiefs Conference, Legal First Avenue, Suite 600 Fairbanks, AK P.O. Box 310, 1500 Kanakanak Road, Department, 122 First Avenue, Suite 99701; Phone: (907) 452–8251 Ext. Dillingham, AK 99576; Phone: (907) 600 Fairbanks, AK 99701; Phone: 3178; Fax: (907) 459–3953 842–4139; Fax: (907) 842–4106; (907) 452–8251 Ext. 3178; Fax: (907) Mountain Village (see Asa’carsarmiut) Email: [email protected] 459–3953 New Stuyahok Village, Bristol Bay Manokotak Village, Diana Gamechuk, N Native Association, Cynthia Nixon, Caseworker I, P.O. Box 169, Naknek Native Village, Donna Mae Children’s Services Program Manager, Manokotak, AK 99628; Phone: (907) Williams, ICWA Worker & Tribal P.O. Box 310, 1500 Kanakanak Road, 289–2074; Fax: (907) 289–1235 and Administrator, P.O. Box 210, Naknek, Dillingham, AK 99576; Phone:
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(907)842–4139; Fax: (907)842–4106; Nuiqsut, Native Village of, Maude 99559; Phone: (907) 543–7400; Fax: Email: [email protected]. Hopson, ICWA Coordinator, Social (907) 543–5759; Email: [email protected] Newhalen Village, Maxine Wassillie, Services Department, Arctic Slope Ouzinkie, Native Village of, Robert ICWA Worker; P.O. Box 207, Native Association, Ltd., P.O. Box Katelnikoff, Tribal Administrator, Newhalen, AK 99606; Phone: (907) 1232, Barrow, AK 99723; Phone: (907) P.O. Box 130, Ouzinkie, AK 99644; 571–1410; Fax: (907) 571–1537. 852–9374; Fax: (907) 852–9152; Phone (907) 680–2259; Fax: (907) Newtok Village, Walter Kassaiuli, Vice- Email: [email protected] 680–2359; and Cassie Hickey, ICWA President, P.O. Box 5545 Newtok, AK Nulato Village, Brittany Smith, Director Coordinator, Kodiak Area Native 99559; Phone: (907) 237–2314; Fax: of Human Services, P.O. Box 65049, Association, 3449 Rezanof Drive East (907) 237–2428; Email: newtoktc@ Nulato, AK 99765 Phone: (907) 898– Kodiak, AK 99615 Phone: (907) 486– gci.net. 2329; Fax: (907) 898–2296; Email: 9882; Fax: (907) 486–1410; Email: Nightmute, Native Village of, Sarah [email protected] [email protected] Nunakauyarmiut Tribe (formerly Jenkins, and Cheryl Offt, ICWA P Director, Association of Village Toksook Bay Native Village), Tribal Council Presidents, P.O. Box 219, Administrator and Marcella White, Paimiut, Native Village of, Tribal Bethel, AK 99559; Phone: (907) 543– ICWA Worker, P.O. Box 37048, President or Tribal Administrator, 7400; Fax: (907) 543–5759; Email: Toksook Bay, AK 99637; Phone: (907) P.O. Box 230, Hooper Bay, AK 99604; [email protected]; mfredricks@ 427–7114/7615; Fax: (907) 427–7714 Phone: (907) 758–4002; Fax: (907) avcp.org; [email protected] Nunam Iqua (formerly Sheldon’s Point), 758–4024 Pauloff Harbor Village, Tara Nikolai Village (Edzeno’), Balassa Sarah Jenkins and Cheryl Offt, ICWA Bourdukofsky, M.S., Human Services Alexie, Tribal Administrator, P.O. Box Director, Association of Village Director, Aleutian/Pribilof Islands 9107 Nikolai, AK 99691; Phone: (907) Council Presidents, P.O. Box 219, Association, 1131 East International 293–2210; Fax: (907) 293–2216; and Bethel, AK 99559; Phone: (907) 543– Airport Road, Anchorage, AK 99518– Tanana Chiefs Conference, Legal 7400; Fax: (907) 543–5759; Email: 1408; Phone: (907) 276–2700; Fax: Department, 122 First Avenue, Suite [email protected]; mfredricks@ (907) 279–4351, Email: taralb@ 600 Fairbanks, AK 99701; Phone: avcp.org; [email protected] apiai.org (907) 452–8251 Ext. 3178; Fax: (907) Nunapitchuk, Native Village of, Aldine Simon, Community Family Service Pedro Bay Village, Verna Kolyaha, 459–3953 Program Specialist, P.O. Box 47020, Nikolski, Native Village, Tara Specialist, P.O. Box 104 Nunapitchuk, AK 99641; Phone: (907) 527–5731; Pedro Bay, AK 99647 Phone: (907) Bourdukofsky, M.S., Human Services 850–2341; Fax: (907) 850–2221 Director, Aleutian/Pribilof Islands Fax: (907) 527–5740; Email: icwa@ yupik.org Perryville, Native Village of, Bernice Association, 1131 East International O’Domin, Case Manager II (ICWA), Airport Road, Anchorage, AK 99518– O P.O. Box 97, Perryville, AK 99648; 1408; Phone: (907) 276–2700; Fax: Ohagamiut, Village of, Gabriel Evan, Phone: (907) 853–2242; Fax: (907) (907) 279–4351, Email: taralb@ Tribal Administration, P.O. Box 49, 853–2229; and Bristol Bay Native apiai.org Marshall, AK 99585; Phone: (907) Association, Children’s Services Ninilchik Village, Bettyann Steciw, 679–6517/6598; Fax: (907) 679–6516; Program Manager, P.O. Box 310, 1500 ICWA Specialist, P.O. Box 39444, Email: [email protected] Kanakanak Road, Dillingham, AK Ninilchik, AK 99639; Phone: (907) Old Harbor Tribal Council, Bobbi Anne 99576; Phone: (907) 842–4139; Fax: 567–3313; Fax: (907) 567–3354; Barnowsky, Tribal Administrator; Jim (907) 842–4106; Email: cnixon@ Email: bettyann@ninilchiktribe- Cedeno, ICWA Worker, P.O. Box 62, bbna.com nsn.gov Old Harbor, AK 99643 Phone: (907) Petersburg Indian Association, Jeanette Noatak, Native Village of, Audrey Arey, 286–2215; Fax: (907) 286–2350; Ness, Caseworker, P.O. Box 1410 ICWA Coordinator, P.O. Box 89 Email: [email protected]; Petersburg, AK 99833 Phone: (907) Noatak, AK 99761; Phone: (907) 485– [email protected] 772–3637; Fax: (907) 772–3686 Email: 2173; Fax: (907) 485–2137; Email: Organized Village of Kwethluk, [email protected] [email protected] Chariton Epchook, ICWA Coordinator, Pilot Point, Native Village of, Suzanne Nome Eskimo Community, Lola P.O. Box 130 Kwethluk, AK 99621– Evanoff, Village Administrator, P.O. Stepetin, Family Services Director, 0130; Phone: (907) 757–6714/6715; Box 449, Pilot Point, AK 99649; 3600 San Jeronimo, Suite 138, Fax: (907) 757–6328 Phone: (907) 797–2208; Fax: (907) Anchorage, AK 99508; Phone: (907) Organized Village of Saxman, Family 797–2258 and Bristol Bay Native 793–3145; Fax: (907) 793–3127; Caseworker or Tribal Administrator, Association, Children’s Services Email: [email protected] Route 2, Box 2, Ketchikan, AK 99901; Program Manager, P.O. Box 310, 1500 Nondalton Village, Susan Bobby, Social Phone: (907) 247–2502; Fax: (907) Kanakanak Road, Dillingham, AK Service/ICWA Worker P.O. Box 49 247–2504 99576; Phone: (907) 842–4139; Fax: Nondalton, AK 99640; Phone: (907) Orutsararmuit Native Village, Marilyn (907) 842–4106; Email: cnixon@ 294–2257; Fax: (907) 294–2271. Johnston, ICWA Program, P.O. Box bbna.com Noorvik Native Community, ICWA 971, Bethel, AK 99559 Phone: (907) Pilot Station Traditional Village, Olga Coordinator, P.O. Box 209 Noorvik, 543–2608; Fax: (907) 543–2639; Xavier, Community Family Services AK 99763 Phone: (907) 636–2144; Email: [email protected] Specialist, P.O. Box 5119, Pilot Fax: (907) 636–2284; and Maniilaq Oscarville Traditional Village, Andrew Station, AK 99650; Phone: (907) 549– Association, Family Services, P.O. J. Larson Jr., Community Family 3550; Fax: (907) 549–3551; and Cheryl Box 256, Kotzebue, AK 99752; Phone: Services Specialist, P.O. Box 6129, Offt, ICWA Director, Association of (907) 442–7870 Oscarville, AK 99559; Phone: (907) Village Council Presidents, P.O. Box Northway Village, Tasha Demit, ICWA 737–7100; Fax: (907) 737–7101; and 219, Bethel, AK 99559; Phone: (907) Worker, P.O. Box 516, Northway, AK Cheryl Offt, ICWA Director, 543–7400; Fax: (907) 543–5759; 99764; Phone: (907)778–2311; Fax: Association of Village Council Email: [email protected]; oxavier@ (907) 778–2220. Presidents, P.O. Box 219, Bethel, AK avcp.org
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Pitka’s Point, Native Village of, Tribal 478–2742; Fax: (907) 279–4351, Box 948 Nome, AK 99762; Phone: Administrator, P.O. Box 8 Platinum, Email: [email protected] (907) 443–4376/4261; Fax: (907) 443– AK 99651 and Cheryl Offt, ICWA Qawalangin Tribe of Unalaska, Tara 4464/4457; Email: cfsdir@ Director, Association of Village Bourdukofsky, M.S., Human Services kawerak.org; [email protected] Council Presidents, P.O. Box 219, Director, Aleutian/Pribilof Islands Saxman (see Organized Village of Bethel, AK 99559; Phone: (907) 543– Association, 1131 East International Saxman) 7400; Fax: (907) 543–5759; Email: Airport Road, Anchorage, AK 99518– Scammon Bay, Native Village of, [email protected]; mfredricks@ 1408; Phone: (907) 276–2700; Fax: Michelle Akerealrea, Community avcp.org; [email protected] (907) 279–4351, Email: taralb@ Family Services Specialist, P.O. Box Platinum Traditional Village, Tribal apiai.org 110, Scammon Bay, AK 99662; Phone: Administrator, P.O. Box 8 Platinum, Quinhagak (see Kwinhagak) (907) 558–5078; Fax: (907) 558–5079; AK 99651; Phone: (907) 979–8220; Qissunaimut Tribe (see Chevak) and Cheryl Offt, ICWA Director, Association of Village Council Fax: (907) 979–8178 and Cheryl Offt, R ICWA Director, Association of Village Presidents, P.O. Box 219, Bethel, AK Council Presidents, P.O. Box 219, Rampart Village, Tribal Administrator, 99559; Phone: (907) 543–7400; Fax: Bethel, AK 99559; Phone: (907) 543– P.O. Box 29 Rampart, AK 99767; (907) 543–5759; Email: cofft@ 7400; Fax: (907) 543–5759; Email: Phone: (907) 358–3312; Fax: (907) avcp.org; [email protected] [email protected]; [email protected]; 358–3115; and Tanana Chiefs Selawik, Native Village of, Jessie [email protected] Conference, Legal Department, 122 Hingsbergen, ICWA Coordinator, P.O. Point Hope, Native Village, Martha First Avenue, Suite 600 Fairbanks, AK Box 59, Selawik, AK 99770; Phone: Douglas, Family Caseworker, P.O. Box 99701; Phone: (907) 452–8251 Ext. (907) 484–2165 Ext. 12; Fax: (907) 109 Point Hope, AK 99766; Phone: 3178; Fax: (907) 459–3953 424–2001; Email: [email protected] (907) 368–3122; Fax: (907) 368–2332; Red Devil Village, Tribal Administrator, and Maniilaq Association, Family Email: [email protected] P.O. Box 8 Platinum, AK 99651; and Services, P.O. Box 256, Kotzebue, AK Cheryl Offt, ICWA Director, Point Lay, Native Village, Social 99752; Phone: (907) 442–7870 Association of Village Council Seldovia Village Tribe Laurel Hilts, Services Director, Inupiat Community Presidents, P.O. Box 219, Bethel, AK ICWA Representative, P.O. Drawer L, of the Arctic Slope, P.O. Box 934, 99559; Phone: (907) 543–7400; Fax: Seldovia, AK 99663 Phone: (907) 234– Barrow, AK 99723, Phone: (907) 852– (907) 543–5759; Email: sjenkins@ 7898 or (907) 435–3252; Fax: (907) 5923; Fax: (907) 852–5924; Email: avcp.org; [email protected]; cofft@ 234–7865; Email: [email protected] or [email protected] avcp.org [email protected] Port Graham, Native Village, Patrick Ruby, Native Village of, Elaine Wright, Shageluk Native Village, Sheila Norman, Chief, and James Miller, Tribal Family Youth Specialist, P.O. Workman, Tribal Family Youth ICWA Representative, P.O. Box 5510 Box 68117 Ruby, AK 99768; Phone: Specialist, P.O. Box 69, Shageluk, AK Port Graham, AK 99603; Phone: (907) (907) 468–4400; Fax: (907) 468–4500; 99665; Phone: (907) 473–8229; Fax: 284–2227; Fax: (907) 284–2222 and Tanana Chiefs Conference, Legal (907) 473–8275; and Tanana Chiefs Port Heiden, Native Village, (Native Department, 122 First Avenue, Suite Conference, Legal Department, 122 Council of Port Heiden), Larissa 600 Fairbanks, AK 99701; Phone: First Avenue, Suite 600 Fairbanks, AK Orloff, Tribal Children Service (907) 452–8251 Ext. 3178; Fax: (907) 99701; Phone: (907) 452–8251 Ext. Worker, P.O. Box 49007, Port Heiden, 459–3953 3178; Fax: (907) 459–3953 AK 99549; Phone: (907) 837–2291/ Russian Mission (see Iqurmuit Shaktoolik, Native Village, Gail L. Evan, 2296; Fax: (907) 837–2297; Email: Traditional Council) Tribal Family Coordinator, P.O. Box [email protected] 100, Shaktoolik, AK 99771; Phone: Port Lions, Native Village, Susan S (907) 955–2444; Fax: (907) 955–2443; Boskofsky, Tribal Administrator and Saint George Island, Native Village of, and Ms. Traci McGarry, Program Yvonne Mullan, Tribal Services Tara Bourdukofsky, M.S., Human Director, Kawerak, Inc. Children & Coordinator, P.O. Box 69, Port Lions, Services Director, Aleutian/Pribilof Family Services, P.O. Box 948 Nome, AK 99550; Phone: (907) 454–2234; Islands Association, 1131 East AK 99762; Phone: (907) 443–4376/ Fax: (907) 454–2434; International Airport Road, 4261; Fax: (907) 443–4464/4457; Portage Creek Village (aka Ohgensakale), Anchorage, AK 99518–1408; Phone: Email: [email protected]; tfc.skk@ Eva Kapotak, Caseworker, 1327 E. (907) 276–2700; Fax: (907) 279–4351, kawerak.org 72nd Ave., Unit B, Anchorage, AK Email: [email protected] Sheldon’s Point (see Nunam Iqua) 99518; Phone: (907) 277–1105; Fax: Saint Michael (see St. Michael) Shishmaref, Native Village of, Karla (907) 277–1104 and Bristol Bay Native Salamatoff, Village of, Jeannine Vasillie Nayokpuk, Tribal Family Coordinator, Association, Children’s Services or Donna Huntington, ICWA Workers, P.O. Box 72110, Shishmaref, AK Program Manager, P.O. Box 310, 1500 Kenaitze Indian Tribe, P.O. Box 988, 99772; Phone: (907) 649–3078; Fax: Kanakanak Road, Dillingham, AK Kenai, AK 99611; Phone: (907) 335– (907) 649–2278; and Ms. Traci 99576; Phone: (907) 842–4139; Fax: 7200; Fax: (907) 335–7236; Email: McGarry, Program Director, Kawerak, (907) 842–4106; Email: cnixon@ [email protected]; dhuntington@ Inc. Children & Family Services, P.O. bbna.com kenaitze.org Box 948 Nome, AK 99762; Phone: Sand Point (see Qagan Tayaguyngin (907) 443–4376/4261; Fax: (907) 443– Q Tribe of Sand Point Village) 4464/4457; Email: cfsdir@ Qagan Tayaguyngin Tribe of Sand Point Savoonga, Native Village of, Ruthie kawerak.org; [email protected] Village, Tara Bourdukofsky, M.S., Okoomealingok, Tribal Family Shungnak, Native Village of, Sally Human Services Director, Aleutian/ Coordinator, P.O. Box 34 Savoonga, Custer, ICWA Worker, P.O. Box 64 Pribilof Islands Association, 1131 East AK 99769; Phone: (907) 984–6758; Shungnak, AK 99773 Phone: (907) International Airport Road, Fax: (907) 984–6759 and Ms. Traci 432–2138; Fax: (907) 437–2183; Anchorage, AK 99518–1408; Phone: McGarry, Program Director, Kawerak, Email: [email protected] and (907) 276–2700; Toll-Free: 1–800– Inc. Children & Family Services, P.O. Maniilaq Association, Family
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Services, P.O. Box 256, Kotzebue, AK (907) 443–4376/4261; Fax: (907) 443– 452–8251 Ext. 3178; Fax: (907) 459– 99752; Phone: (907) 442–7870 4464/4457; Email: [email protected] 3953 Sitka Tribe of Alaska, Glade Morales, Stevens, Native Village of, Harold Teller, Native Village of, Dolly Kugzruk, Social Services Director Mindy Simon, 1st Chief, P.O. Box 74016, Tribal Family Coordinator; P.O. Box Lowrance, ICWA Caseworker,, 456 Stevens Village, AK 99774; Phone: 546, Teller, AK 99778; Phone: (907) Katlian Street, Sitka, AK 99835; (907) 478–7228; Fax: (907) 478–7229. 642–2185; Fax: (907) 642–2189; and Phone: (907) 747–7293 & (907) 747– Cheryl Mayo-Kriska, Indian Child Ms. Traci McGarry, Program Director, 3207; Fax: (907) 747–7643; Email: Welfare Case Manager. Kawerak, Inc. Children & Family [email protected]; Stony River, Village of, Tribal Services, P.O. Box 948, Nome, AK [email protected] Administrator, P.O Box SRV, Stony 99762 Phone: (907) 443–4376; Fax: Skagway Village, Delia Commander, River, AK 99557 and ICWA Director, (907) 443–4464; Email: cfsdir@ Tribal President/Administrator, P.O. Association of Village Council kawerak.org; [email protected] Box 1157, Skagway, AK 99840–1157; Presidents, P.O. Box 219, Bethel, AK Tetlin, Native Village of, Nettie Phone: (907) 983–4068; Fax: (907) 99559; Phone: (907) 543–7400; Fax: Warbelow, Tribal Family Youth 983–3068 Email: dcommander@ (907) 543–5759; Email: sjenkins@ Specialist, 2763 Mack Blvd. Apt. 2, skagwaytraditonal.org avcp.org; [email protected] Fairbanks, AK 99709; Phone: (907) Sleetmute, Village of, Cheryl Mellick, Sun’aq Tribe of Kodiak, Linda Resoff, 378–3608; Fax: N/A; and Tanana ICWA Worker, P.O. Box 109, Social Services Director, 312 West Chiefs Conference, Legal Department, Sleetmute, AK 99668 Phone: (907) Marine Way, Kodiak, AK 99615 122 First Avenue, Suite 600, 449–4263; Fax: (907) 449–4265 Phone: (907) 486–4449; Fax: (907) Fairbanks, AK 99701; Phone: (907) Solomon, Native Village of, Elizabeth 486–3361; Email: socialservices@ 452–8251 Ext. 3178; Fax: (907) 459– Johnson, Tribal Coordinator, P.O. Box sunaq.org 3953 Tlingit & Haida Indian Tribes of Alaska 2053, Nome, AK 99762; Phone: (907) T (see Central Council Tlingit and Haida 443–4985; Fax: (907) 443–5189; Tribes) Takotna Village, Janice Newton, P.O. Email: [email protected] Togiak, Traditional Council of, Tribal Box 7529, Takotna, AK 99675; Phone: South Naknek Village, Lorianne Administrator and Emma Wasillie, (907) 298–2212; Fax: (907) 298–2314; Rawson, Tribal Administrator, 1830 E. ICWA Worker, P.O. Box 310, Togiak, and Tanana Chiefs Conference, Legal Parks Highway, Ste. A113, PMB 388, AK 99678; Phone: (907) 493–5003; Department, 122 First Avenue, Suite Wasilla, AK 99654; Phone: (907) 631– Fax: (907) 493–5005; Email: 600, Fairbanks, AK 99701; Phone: 3648; Fax: (907) 631–0949 and Bristol [email protected]; and Bristol (907) 452–8251 Ext. 3178; Fax: (907) Bay Native Association, Children’s Bay Native Association, Children’s 459–3953 Services Program Manager, P.O. Box Services Program Manager, P.O. Box 310, 1500 Kanakanak Road, Tanacross, Native Village of, Colleen 310, 1500 Kanakanak Road, Dillingham, AK 99576; Phone: (907) Denny, Tribal Family Youth Dillingham, AK 99576; Phone: (907) 842–4139; Fax: (907) 842–4106; Specialist, P.O. Box 76009, Tanacross, 842–4139; Fax: (907) 842–4106; Email: [email protected] AK 99776; Phone: (907) 883–5024; Email: [email protected] St. Mary’s (see Algaaciq) Fax: (907) 883–4497; and Tanana Toksook Bay (see Nunakauyarmiut St. Mary’s Igloo (see Teller) Chiefs Conference, Legal Department, Tribe) St. George (see Saint George) 122 First Avenue, Suite 600, Tuluksak Native Community, Agatha St. Michael, Native Village of, Shirley Fairbanks, AK 99701; Phone: (907) Fly, Community Family Services Martin, Tribal Family Coordinator, 452–8251; Ext. 3178; Fax: (907) 459– Specialist, P.O. Box 93, Tuluksak, AK P.O. Box 59050, St. Michael, AK 3953 99679; Phone: (907) 695–6902; Fax: 99659; Phone: (907) 923–2546; Fax: Tanana, Native Village of, Donna May (907) 695–6903; Email: sjenkins@ (907) 923–2474; and Ms. Traci Folger, ICWA Worker, Box 130, avcp.org; [email protected] and McGarry, Program Director, Kawerak, Tanana, AK 99777; Phone: (907) 366– Cheryl Offt, ICWA Director, Inc. Children & Family Services, P.O. 7170; Fax: (907) 366–7246; and Association of Village Council Box 948 Nome, AK 99762 Phone: Tanana Chiefs Conference, Legal Presidents, P.O. Box 219, Bethel, AK (907) 443–4376/4261; Fax: (907) 443– Department, 122 First Avenue, Suite 99559; Phone: (907) 543–7400; Fax: 4464/4457; Email: cfsdir@ 600, Fairbanks, AK 99701; Phone: (907) 543–5759; Email: [email protected] kawerak.org; [email protected] (907) 452–8251, Ext. 3178; Fax: (907) Tuntutuliak, Native Village of, St. Paul, Charlene Naulty, MS, 459–3953 Samantha White, Community Family Department of Health and Human Tatitlek, Native Village of, Victoria Services Specialist, P.O. Box 8086, Services, 1500 W. 33rd Street, Suite Vlasoff, Administrator, P.O. Box 171, Tuntutuliak, AK 99680; Phone: (907) 100 Anchorage, AK 99503; and P.O. Tatitlek, AK 99677; Phone: (907) 325– 256–2311; Fax: (907) 256–2080; and Box 86 St. Paul Island, AK 99660; 2311; Fax: (907) 325–2298 Cheryl Offt, ICWA Director, Phone: (907) 762–8426; Fax: (907) Tazlina, Native Village of, Marce Association of Village Council 770–0540 & (907) 546–3254; Email: Simeon, ICWA Coordinator, P.O. Box Presidents, P.O. Box 219, Bethel, AK [email protected] 87, Glennallen, AK 99588; Phone: 99559; Phone: (907) 543–7400; Fax: Stebbins Community Association, Anna (907) 822–4375; Fax: (907) 822–5865; (907) 543–5759; Email: [email protected] Nashoanak, Tribal Family Email: [email protected] [email protected]; Coordinator, P.O. Box 71002, Telida Village, Josephine Royal, Tribal Tununak, Native Village of, Richard Stebbins, AK 99671, Phone: (907) Administrator/Tribal Family Youth Lincoln III, Community Family 934–2334; Fax: (907) 934–2675; Specialist, P.O. Box 84771, Fairbanks, Services Specialist, P.O. Box 77, Email: [email protected]; AK 99708; Phone: (907) 864–0629; Tununak, AK 99681; Phone: (907) [email protected] and Ms. Traci Fax: (907) 376–3540; and Tanana 652–6220; Fax: (907) 652–6011; and McGarry, Program Director, Kawerak, Chiefs Conference, Legal Department, Cheryl Offt, ICWA Director, Inc. Children & Family Services, P.O. 122 First Avenue, Suite 600, Association of Village Council Box 948, Nome, AK 99762; Phone: Fairbanks, AK 99701; Phone: (907) Presidents, P.O. Box 219, Bethel, AK
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99559; Phone: 907 543–7400; Fax: W Chitimacha Tribe of Louisiana, Karen (907) 543–5759; Email: cofft@ Village of Wainwright, Maude Hopson, Matthews, MSW, LMSW, Director of avcp.org; [email protected] ICWA Coordinator, Social Services Health & Human Services, P.O. Box Twin Hills Village, John W. Sharp, Department, Arctic Slope Native 520, Charenton, LA 70523; President, P.O. Box TWA, Twin Hills, Association, Ltd., P.O. Box 1232, Telephone: (337) 923–7000; (337) AK 99576; Phone: (907) 525–4821; Barrow, AK 99723; Phone: (907) 852– 923–9955 (Health Clinic), Fax: (337) Fax: (907) 525–4822; and Bristol Bay 9374; Fax: (907) 852–9152; Email: 923–2475 Native Association, Children’s [email protected] Coushatta Tribe of Louisiana, Milton Services Program Manager, P.O. Box Wales, Native Village of, Linda Divers, Hebert, MSW, CADC, CGAC, Social 310, 1500 Kanakanak Road, Tribal Family Coordinator, P.O. Box Service Director, 2003 CC Bel Road, Dillingham, AK 99576; Phone: (907) 85039, Brevig Mission, AK 99785; Elton, LA 70532; Telephone: (337) 842–4139; Fax: (907) 842–4106; Phone: (907) 642–3012 Fax: (907) 584–1439; Fax: (337) 584–1473; Email: [email protected]; william15@ 642–3042; Email: [email protected] Email: [email protected] starband.net White Mountain, Native Village of, E Tyonek, Native Village of, Frank Carol Smith, Tribal Family Eastern Band of Cherokee Indians, Standifer, III, Tribal President and Coordinator, P.O. Box 549, White Barbara Jones, Program Manager, 134 Arthur Standifer, ICWA Worker, P.O. Mountain, AK 99784; Phone: (907) Boys Club Loop, P.O. Box 666, Box 82009, Tyonek, AK 99682–0009; 638–2008; Fax: (907) 638–2009; Cherokee, NC 28719; Telephone: (828) Phone: 907 227–3574; Fax: (907) 583– Email: [email protected] Woody Island (see Lesnoi Village) 497–6092; Fax: (828) 497–3322; 2442; Email: [email protected] Wrangell Cooperative Association, Email: [email protected] U Elizabeth Newman, Family H Caseworker II, P.O. Box 1198, Ugashik Village, Irma Joyce Rhodes Wrangell, AK 99929; Phone: (907) Houlton Band of Maliseet Indians, King, ICWA Worker, 2525 Blueberry 874–3482; Fax: (907) 874–2982 Email: Tiffany Randall, ICWA Director, 13–2 Road, Suite 205, Anchorage, AK [email protected] Clover Court, Houlton, ME 04730; 99503; Phone: (907) 338–7611; Fax: Telephone: (207) 694–0213; Fax: (207) Y (907) 338–7659; Email: icwa@ 532–7287; Email: icwa.director@ ugashikvillage.com Yakutat Tlingit Tribe, Gloria A. Benson, maliseets.com Umkumiut Native Village, Joseph Tony, ICWA Director, P.O. Box 387, Yakutat, J Council President, P.O. Box 90062, AK 99689; Phone: (907) 784–3368; Nightmute, AK; Phone: (907) 647– Fax: (907) 784–3664; Email: gbenson@ Jena Band of Choctaw Indians, Mona 6145; Fax: (907) 647–6146 ytttribe.org Maxwell, Social Services Director, Yupiit of Andreafski, Geraldine Beans, Unalakleet, Native Village of, Marie P.O. Box 14, Jena, LA 71342; ICWA Director, P.O. Box 88, St. Ivanoff, Tribal Family Coordinator, Telephone: (318) 992–0136; Cell: Mary’s, AK 99658; Phone: (907) 438– P.O. Box 270, Unalakleet, AK 99684; (318) 419–8432; Fax: (318) 992–4162 2572; Fax: (907) 438–2573 Phone: (907) 624–3526; Fax: (907) M 624–5104; and Ms. Traci McGarry, 2. Eastern Region Program Director, Kawerak, Inc. Mashantucket Pequot Tribal Nation, Eastern Region Director, 545 Marriott Valerie Burgess, Director Child Children & Family Services, P.O. Box Drive, Suite 700, Nashville, TN 37214; 948, Nome, AK 99762; Phone: (907) Protective Services, 102 Muhshee Telephone: (615) 564–6500; Fax: (615) Mahchaq, P.O. Box 3313, 443–4376/4261; Fax: (907) 443–4464/ 564–5701 4457; Email: [email protected]; Mashantucket, CT 06338; Telephone: [email protected]; A (860) 396–2007; Fax: (860) 396–2144; Email: [email protected] Unalaska (see Qawalangin Tribe of Aroostook Band of Micmac Indians, Mashpee Wampanoag Tribe, Catherine Unalaska) Tania M. Morey Paul, Child Welfare Hendricks, Director, ICWA & Human Unga, Native Village of, Tara Director, 7 Northern Road, Presque Isle, Maine 04769; Telephone: (207) and Social Services, 483 Great Neck Bourdukofsky, M.S., Human Services Road, South Mashpee, MA 02649; Director, Aleutian/Pribilof Islands 764–1972; Fax: (207) 764–7667; Email: [email protected] Phone: (508) 419–6017 Ext: 604; Cell: Association, 1131 East International (774) 255–0119–604; Fax: (508) 477– Airport Road, Anchorage, AK 99518– C 1652; Email: catherinehendricks@ 1408; Phone: (907) 276–2700; Fax: Catawba Indian Nation, Carla Hudson, mwtribe.com (907) 279–4351, Email: taralb@ ICWA Representative and Linda Love, Miccosukee Tribe of Indians of Florida, apiai.org MSW, LMSW, Social Services Colley Billie, Tribal Chairman, P.O. Upper Kalskag Native Village (see Director, Catawba Indian Nation, 996 Box 440021, Miami, FL 33144; Kalskag), Avenue of Nations, Rock Hill, South Telephone: (305) 223–8380 Ext. 2377/ V Carolina 29730; Telephone: (803) 2386; Fax: (305) 223–1011; Email: 366–4792 Ext: 245; Fax: (803) 325– [email protected] or Village of Venetie, Larry Williams, 1242; Email: carla.hudson@ [email protected] Tribal Family Youth Specialist, P.O. catwbaindian.net and linda.love@ Mississippi Band of Choctaw Indians, Box 119, Venetie, AK 99781; Phone: catawbaindian.net Kirsten L. Clegg, Child Welfare (907) 849–8212; Fax: (907) 849–8149/ Cayuga Nation of New York, Sharon Supervisor, Department of Family & 8216; and Tanana Chiefs Conference, Leroy, Assistant Administration, P.O. Community Services, Children & Legal Department, 122 First Avenue, Box 803, Seneca Falls, NY 13148, Family Services Program; P.O. Box Suite 600, Fairbanks, AK 99701; Phone: (315) 568–0750, Fax: (315) 6050, Choctaw, MS 39350; Telephone: Phone: (907) 452–8251 Ext. 3178; Fax: 568–0752, Email: sharon.leroy@ (601) 650–1741; Fax: (601) 656–8817; (907) 459–3953 nsncayuganation-nsn.gov Email: [email protected]
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Mohegan Indian Tribe, Irene Miller, Coordinator, 987 RC Hoag Drive or 1210, Durant, OK 74702; Telephone: APRN, Director, Family Services, 5 P.O. Box 500, Salamanca, NY 14779; (580) 924–8280; Fax: (580) 920–3197; Crow Hill Road, Uncasville, CT Telephone: (716) 945–5894; Fax: (716) Email: [email protected] 06382; Telephone: (860) 862–6236; 945–7881; Email: tracy.pacini@ D Fax: (860) 862–6324 senecahealth.org Shinnecock Indian Nation, Paula Delaware Tribe of Indians, Allan Barnes, N Collins, Shinnecock Health Services, ICW Coordinator, 170 NE Barbara, Narragansett Indian Tribe, Wenonah P.O. Box 1268, Southhampton, NY Bartlesville, OK 74006; Telephone: Harris, Director, Tribal Child and 11969 Attn: CHWP; Telephone: (631) (918) 336–6590; Fax: (918) 337–6591, Family Services, 4375B South County 287–6476; Email: ndnpc@ Email: [email protected] Trail or P.O. Box 268, Charlestown, RI hotmail.com E 02813; Telephone: (401) 364–1100 Ext: 233; Cell: (401) 862–8863; Fax: T Eastern Shawnee Tribe of Oklahoma, (401) 364–1104: Email: Wenonah@ Tonawanda Band of Seneca, Darwin Faye Woods, ICW Coordinator, 10100 nithpo.com Hill, Chief, Council of Chiefs, 7027 S. Bluejacket Rd. #3, Wyandotte, OK Meadville Road, Basom, NY 14013; 74370; Telephone: (918) 666–7710 O Telephone: (716) 542–4244; Fax: (716) ext. 1123; Fax: (918) 666–7717; Email: Oneida Indian Nation, Kim Jacobs, 542–4008 Email: [email protected] [email protected] Nation Clerk, Box 1 Vernon, NY Tunica Biloxi Indian Tribe of Louisiana, K 13476; Telephone: (315) 829–8337; Betty Pierite Logan, Registered Social Fax: (315) 829–8392; Email: kjacobs@ Worker, P.O. Box 493, Marksville, LA Kialegee Tribal Town, Angie Beaver, oneida.nation.org 71351 Telephone: (318) 240–6442; ICW Coordinator, P.O. Box 332, Onondaga Nation of New York, Mr. Fax: (318) 253–9791; Email: blogan@ Wetumka, OK 74883; Telephone: Laverne Lyons, 104 W. Conklin Ave, tunica.org (405) 452–5388; Fax: (405) 452–3413; Nedrow, NY 13120; Phone: (315) 469– Tuscarora Nation of New York, Chief Email: [email protected] 9196; Fax: (315) 469–3250; Email: Leo Henry, Clerk, 206 Mount Hope M [email protected] Road, Lewistown, NY 14092; Miami Tribe of Oklahoma, Callie P Telephone: (716) 297–1148; Fax: (716)297–7355 Lankford, Social Services Director, Passamaquoddy Indian Township, Dolly P.O. Box 1326, Miami, OK 74355; Barnes, LCSW, Director Child and W Telephone: (918) 541–1445; Fax: (918) Family Services, P.O. Box 301, Wampanoag Tribe of Gay Head 540–2814; Email: clankford@ Princeton, ME 04668; Telephone: (Aquinnah), Bonnie Chalifoux, miamination.com (207) 796–6134; Fax: (207) 796–5606 Director Human Services, 20 Black Modoc Tribe of Oklahoma, Regina Passamaquoddy Tribe-Pleasant Point, Brook Road, Aquinnah, MA 02535; Shelton, Child Protection, 625 6th Molly Newell, Sipayik, Human Telephone: (508) 645–9265 Ext. 133; SE., Miami, OK 74354; Telephone: Services Director, P.O. Box 343 Perry, Fax: (508) 645–2755; Email: bonnie@ (918) 542–7890; Fax: (918) 542–7878; ME 04667, Telephone: (207) 853–2600 wampanoagtribe.net Email: [email protected] Ext: 258; Fax: (207) 853–9618; Email: Muscogee (Creek) Nation, Carmin [email protected] 3. Eastern Oklahoma Region Tecumseh-Williams, Director of Child Penobscot Indian Nation of Maine, Eastern Oklahoma Region Director, P.O. & Family Services, P.O. Box 580, Sonya LaCoute-Dana, Director of Box 8002, Muskogee, OK 74402–8002; Okmulgee, OK 74447; Telephone: Social Services, P.O. Box 446, Old Telephone: (918) 781–4600; Fax (918) (918) 732–7859 and 1–800–482–1979; Town, ME 04468; Telephone: (207) 781–4604 Fax: (918) 732–7855 817–3164; Fax: (207) 817–3166; Email: Sonya.lacoute-dana@ A O penobscotnation.org Alabama-Quassarte Tribal Town, Annie Osage Nation, Ann Davis, Social Work Poarch Band of Creek Indians, Martha Merritt, ICWA Director, P.O. Box 187, Supervisor, 255 Senior Drive, Gookin, Family Services Director, Wetumka, OK 74883; Telephone: Pawhuska, OK 74056; Telephone: 5811 Jack Springs Rd., Atmore, AL (405) 452–3881; Fax: (405) 452–3889; (918) 287–5218; Fax: (918) 287–5231; 36502; Telephone: (251) 368–9136 Email: amerritt@alabama- Email: [email protected] Ext. 2600; Fax: (251) 368–0828; Email: quassarte.org Ottawa Tribe of Oklahoma, Roy A. Ross, [email protected] Social Services/CPS Director, P.O. C Box 110, Miami, OK 74355; S Cherokee Nation, Nikki Baker-Limore, Telephone: (918) 540–1536; Fax: (918) Saint Regis Mohawk Tribe, Haley Cree, Director Division of Children Youth 542–3214; Email: rross.oto@ ICWA program Coordinator, 412 and Family Services, P.O. Box 948, gmail.com State, Route 37, Akwesasne, NY Tahlequah, OK 74465, Telephone: 13655; Telephone: (518) 358–2728; (918) 458–6939, Fax: (918) 458–6146, P Fax: (518) 358–9258; Email: Email: Nikki-baker-limore@ Peoria Tribe of Indians of Oklahoma, [email protected] Cherokee.org Doug Journeycake, Indian Child Seminole Tribe of Florida, Kristi Hill, The Chickasaw Nation, Angela Connor, Welfare Director, P.O. Box 1527, Family Preservation Administrator, Division of Family Support, 231 Miami, OK 74355; Telephone: (918) 3006 Josie Billie Avenue, Hollywood, Seabrook Road, Ada, OK 74820; 540–2535; Fax: (918) 540–4370; FL 33024; Telephone: (954) 965–1314; Telephone: (580) 272–5580, Fax: (580) Email: [email protected] Fax: (954) 965–1304; Email: 272–5590; Email: Angela.Connor@ [email protected] chickasaw.net Q Seneca Nation of Indians, Tracy Pacini, Choctaw Nation of Oklahoma, Alison Quapaw Tribe of Oklahoma, Dee Child and Family Services Program Wolfe, ICW Supervisor, P.O. Box Killion, ICW Director, P.O. Box 765,
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Quapaw, OK 74363; Telephone: (918) L 477–5688; Fax: (701) 477–5797; 674–2522; Fax: (918) 674–2581; Lower Brule Sioux Tribe, L. Greg Miller, Email: [email protected] Email: [email protected] LBST Counseling Service Director, W 187 Oyate Circle, Lower Brule, SD S Winnebago Tribe of Nebraska, Barbara 57528; Telephone: (605) 473–5584; Eagle, ICWA Specialist, #1 Mission Seminole Nation of Oklahoma, Tracy Fax: (605) 473–8051; Email: Drive Box 723, Winnebago, NE 68071; Haney, Director of Indian Child [email protected] Welfare, P.O. Box 1498, Wewoka, OK Telephone: (402) 878–2378; Fax: (402) 74884; Telephone: (405) 257–9038; O 878–2228; Email: baeagleW@ Fax: (405) 257–9036; Email: haney.t@ Oglala Sioux Tribe, Juanita Sherick, winnebagotribe.com sno-nsn.gov Director ONTRAC, P.O. Box 2080 Y Seneca-Cayuga Tribe of Oklahoma, Janet Pine Ridge, SD 57752; Telephone: Grant, ICWA Director, 23701 S 655 (605) 867–5805; Fax: (605) 867–1893; Yankton Sioux Tribe, Raymond Road, Grove, OK 74344; Telephone: Email: [email protected] Cournoyer, ICWA Director, P.O. Box (918) 786–3508; Fax: (918) 516–0248; Omaha Tribe of Nebraska, Deanna 1153, 108 East Avenue South East, Email: [email protected] Parker, ICWA Specialist, P.O. Box Wagner, SD 57380; Telephone: (605) Shawnee Tribe, Jodi Hayes, Tribal 368, Macy, NE 68039; Telephone: 384–5712; Fax: (605) 384–5014; Email Administrator, P.O. Box 189 Miami, (402) 837–5331; Fax: (402) 837–5362 [email protected] Oklahoma 74354; Telephone: (918) 5. Midwest Region 542–2441; Fax: (918) 542–2922; P Email: shawneetribe@ Ponca Tribe of Nebraska, Jill Holt, ICWA Midwest Regional Director, 5600 West shawneetribe.com Specialist, 2602 J Street, Omaha, NE American Blvd., Suite 500, Norman Pointe II Building, Bloomington, MN T 68107; Telephone: (402) 734–5275; Fax: (402) 734–5708 55437; Telephone: (612) 713–4400; Thlopthlocco Tribal Town, Stephanie Fax: (612) 713–4453 R Rogers, Program Manager, P.O. Box B 188, Okemah, OK 74859; Telephone: Rosebud Sioux Tribe, Shirley J. Bad (918) 560–6198; Fax: (918) 623–3023; Wound, ICWA Specialist, Rosebud Bad River Band of Lake Superior Email: [email protected] Sioux Tribe ICWA Program, P.O. Box Chippewa, Esie Leoso-Corbine, 609 Mission, SD 57555; Telephone: Director, Family and Social Services, U (605) 856–5270; Fax: (605) 856–5268 P.O. Box 55, Odanah, WI 54861; United Keetoowah Band of Cherokee Telephone: (715) 682–7135 Ext: 3; Indians in Oklahoma, Joyce Hawk, S Fax: (715) 682–7883; Email: bricw2@ Tribal Secretary, P.O. Box 746, Santee Sioux Nation, Clarissa LaPlante, badriver-nsn.gov Tahlequah, OK 74464; Telephone: ICWA Specialist, Dakota Tiwahe Bay Mills Indian Community, Phyllis (918) 453–9375; Fax: (918) 453–9345; Service Unit, Route 2, Box 5191, Kinney, Tribal Court Administrator, [email protected] Niobrara, NE 68760; Telephone: (402) 12140 W. Lakeshore Dr., Brimley, MI Wyandotte Nation, Kate Randall, 857–2342; Fax: (402) 857–2361; 49715; Phone: (906) 248–3241, (906) Director of Family Services, 64700 E. Email: [email protected] 8811; Fax: (906) 248–5817; Email: Hwy 60, Wyandotte, OK 74370; Sisseton-Wahpeton Oyate, Evelyn [email protected] Telephone: (918) 678–2297; Fax: (918) Pilcher, ICWA Specialist, P.O. Box Bois Forte Reservation Business 678–3087; Email: krandall@ 509 Agency Village, SD 57262; Committee, Angela Wright, Indian wyandotte-nation.org Telephone: (605) 698–3992; Fax: (605) Child Welfare Supervisor, 13071 Nett 698–3999; Email: evelynp@swo- Lake Road Suite A, Nett Lake, MN 4. Great Plains Region [email protected] 55771; Telephone: (218) 757–3295 or Great Plains Region Director, 115 4th Spirit Lake Tribe, ICWA Director, P.O. (218) 757–3916; Fax: (218) 757–3335; Avenue SE, Aberdeen, SD 57401; Box 356, Fort Totten, ND 58335; Email: [email protected] Telephone: (605) 226–7343; Fax: (605) Telephone: (701) 766–4855; Fax: (701) F 226–7443 766–4273; Email: icwadirector@ spiritlakenation.com Fond du Lac Reservation Business C Standing Rock Sioux Tribe, Terrance Committee, Karen Diver, Cheyenne River Sioux Tribe, Ms. Diane Yellow Fat, Director, Indian Child Chairwoman, 1720 Big Lake Road, Garreau, Indian Child Welfare Act Welfare Program, P.O. Box 770, Fort Cloquet, MN 55720; Telephone: (218) Program Director, P.O. Box 590, Eagle Yates, ND 58538; Telephone: (701) 879–4593; Fax: (218) 878–2189; Butte, SD 57625; Telephone: (605) 854–3095; Fax: (701) 854–5575; Email: [email protected] 964–6460; Fax: (605) 964–6463 Email: [email protected] Forest County Potawatomi Community Crow Creek Sioux Tribe, Crow Creek of Wisconsin, Abbey Lukowski, Sioux Tribal Court, P.O. Box 247, Fort T Family Services Division Director, Thompson, SD 57339; Telephone: Three Affiliated Tribes (Mandan, 5415 Everybody’s Road, Crandon, WI (605) 245–2325/2326; Fax: (605) 245– Arikara & Hidatsa), Katherine Felix, 54520; Telephone: (715) 478–4812; 2401 ICWA Specialist, 404 Frontage Road, Fax: (715) 478–7442; Email: New Town, ND 58763; Telephone: Abbey.lukowski@fcpotawatomi- F (701) 627–4781; Fax: (701) 627–5550; nsn.gov Flandreau Santee Sioux Tribe-Dakota, Email: [email protected] Celeste Honomichl, ICWA Turtle Mountain Band of Chippewa G Administrator, Flandreau Santee Indians, Marilyn Poitra, Indian Child Grand Portage Reservation Business Sioux Tribal Social Services, P.O. Box Welfare Specialist, Child Welfare and Committee, Patti Foley, Social 283, Flandreau, SD 57028; Telephone: Family Services, P.O. Box 900, Worker, P.O. Box 428, Grand Portage, (605) 997–5055; Fax: (605) 997–3694 Belcourt, ND 58316; Telephone: (701) MN 55605; Telephone: (218) 475–
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2169; Fax: (218) 475–2455; Email: Fax: (231) 398–3404; Email: 88385 Pike Road, Highway 13, [email protected] [email protected] Bayfield, WI 54814; Telephone: (715) Grand Traverse Band of Ottawa and Little Traverse Bay Bands, Denneen 779–3785; Fax: (715) 779–3783; Chippewa Indians, Helen Cook, Smith, Human Services Director, 7500 Email: [email protected] Anishinaabek Family Services Odawa Circle, Harbor Springs, MI Red Lake Band of Chippewa Indians, Supervisor, 2605 N. West Bayshore 49740; Telephone: (231) 242–1620; Paula Woods, Executive Director— Drive, Peshawbestown, MI 49682– Fax: (213) 242–1635; Email: Family & Children Services, P.O. Box 9275; Telephone: (231) 534–7681; [email protected] 427 Red Lake, MN 56671; Telephone: Fax: (231) 534–7706; Email: Lower Sioux, Reanna Jacobs, ICWA (218) 679–2122; Fax: (218) 679–2929; [email protected] Advocate, Darin Prescott, Director, Email: pwoods@redlak enation.org 39568 Reservation Highway 1, S H Morton, MN 56270; Telephone: (507) Hannahville Indian Community of 697–9108; Fax: (507) 697–9111; Sac & Fox Tribe of the Mississippi in Michigan, Jessica Brock, ICWA Email: [email protected] Iowa—Meskwaki, Mylene Wanatee, Meskwaki Family Services Director, Worker, N15019 Hannahville B1 M Road, Wilson, MI 49896; Telephone: P.O. Box 245, 349 Meskwaki Road, (906) 723–2514; Fax: (906) 466–7397; Match-E-Be-Nash-She-Wish Band of Tama, IA 52339; Telephone: (641) Email: [email protected] Potawatomi Indians of Michigan (Gun 484–4444 Fax: (641) 484–2103; Email: The Ho-Chunk Nation, Stephanie Lake Tribe), Leslie Pigeon, Behavior [email protected] Lozano, ICWA Supervisor, P.O. Box Health/Human Services Coordinator, Saginaw Chippewa Indians of MI, Attn: 40, Black River Falls, WI 54615; P.O. Box 306, Dorr, MI 49323; ICWA Director, 7070 East Broadway, Telephone: (715) 284–2622; Fax: (715) Telephone: (616) 681–0360 Ext: 316; Mt. Pleasant, MI 48858; Telephone: 284–0097; Email: stephanie.Lozano@ Fax: (616) 681–0380 (989) 775–4909; Fax: (989) 775–4912 ho-chunk.com Menominee Indian Tribe of Wisconsin, Sault Ste. Marie Tribe of Chippewa Nottawaseppi Huron Band of the Mary Husby, Director of Social Indians, Juanita Bye, ACFS Division Potawatomi, Meg Fairchild, LMSW, Services, P.O. Box 910 Keshena, WI Director, 2218 Shunk Rd, Sault Ste. CAAC, Clinical Social Worker, 1474 54135; Telephone: (715) 799–5161; Marie, MI 49783; Telephone: (906) Mno Bmadzewen Way, Fulton, MI Fax: (715) 799–6061; Email: mhusby@ 632–5250; Fax: (906) 632–5266; 49052; Telephone: (269) 729–4422; mitw.org Email: [email protected] Shakopee Mdewakanton Sioux Fax: (269) 729–4460; Email: Mille Lacs Band of Ojibwe, Ted Community, Karen Ross—ICWA [email protected] Waukey, Director of Family Services, Mille Lacs Band Government Center, Representative, 2330 Sioux Trail NW., K 43408 Oodena Drive, Onamia, MN Prior Lake, MN 55372; Telephone: Keweenaw Bay Indian Community, Judy 56359; Telephone: (320) 532–7778; (952) 445–8900 or (952) 496–6112; Heath, Director Social Service, 16429 Fax: (320) 532–7583; Email: Fax: (952) 445–8906 Sokaogon Chippewa Community of Beartown Road, Baraga, MI 49908; [email protected] Wisconsin, Angela Vanzile, Director, Telephone: (906) 353–4201; Fax: (906) Minnesota Chippewa Tribe, Linda Family Services, 10808 Sokaogon 353–8171; Email: [email protected] Johnston, Human Services Director, P.O. Box 217, Cass Lake, MN 56633; Drive, Crandon, WI 54520; Telephone: L Telephone: (218) 335–8585; Fax: (218) (715) 478–3265; Fax: (715) 478–7618; Lac Courte Oreilles, LuAnn Kolumbus, 335–8080; Email: ljohnston@ Email: [email protected] St. Croix Chippewa Indians of Tribal Social Services Director, 13394 mnchippewatribe.org Wisconsin, Erin Fowler, Indian Child W. Trepania Road, Hayward, WI O Welfare Director, 24670 State Road 54843; Telephone: (715) 634–8934 Oneida Tribe of Indians of Wisconsin, 35/70, Suite 800, Siren, WI 54872; ext. 7435; Fax: (715) 634–2981 Email: Attn: Children and Family Services, Telephone: (715) 349–2195; Fax: (715) [email protected] P.O. Box 365, Oneida, WI 54155; 349–8665; Email: erinf@ Lac du Flambeau, Kristin Allen, ICW Telephone: (920) 490–3724; Fax: (920) stcroixtribalcenter.com Director, P.O. Box 216, Lac du 490–3820; Email: icw@ Stockbridge Munsee Community, Flambeau, WI 54538; Telephone: oneidanation.org Stephanie Bowman, ICWA Manager, (715) 588–4275; Fax: (715) 588–3855; Stockbridge Munsee Health and P Email: [email protected] Wellness Center, W12802 County A, Lac Vieux Desert, Dee Dee McGeshick, Pokagon Band of Potawatomi Indians, Bowler, WI 54416; Telephone: (715) Social Services Director, P.O. Box Mark Pompey, Social Services 793–4580; Fax: (715) 793–1312; 249, Watersmeet, MI 49969; Director, 58620 Sink Road, Dowagiac, Email: Stephanie.bowman@ Telephone: (906) 358–4940; Fax: (906) MI 49047; Telephone: (269) 782–8998; mohican.com 358–4900; Email: dee.mcgeshick@ Fax: (269) 782–4295; Email: lvdtribal.com [email protected] U Leech Lake Band of Ojibwe, Victoria Prairie Island Indian Community, Nancy Upper Sioux Community of Minnesota, White, Child Welfare Director, 115 Anderson, Family Service Manager, Linette Tellinghuisen, ICWA Sixth Street NW., Suite E, Cass Lake, 5636 Sturgeon Lake Road, Welch, MN Manager, P.O. Box 147, 5744 Hwy. 67, MN 56633; P.O. Box 967, Cass Lake, 55089; Telephone: (651) 385–4185; Granite Falls, MN 56241; Telephone: MN 56633; Telephone: (218) 335– Fax: (651) 385–4183; Email: (320) 564–6315; Fax: (320) 564–2550; 8270; Fax: (218) 335–3768; Email: [email protected] Email: linettet@ [email protected] uppersiouxcommunity-nsn.gov Little River Band of Ottawa Indians, R William Gregory, Tribal Prosecutor, Red Cliff Band of Lake Superior W 3031 Domres Road, Manistee, MI Chippewa, Lorna Gamble, Indian White Earth Indian Child Welfare, Jeri 49660; Telephone: (213) 398–2242; Child Welfare Department Director, Jasken, Program Director, P.O. Box
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358, White Earth, MN 56591; Confederated Tribes of the Umatilla Lummi Nation, Amy Finkbonner, Telephone: (218) 983–4647; Fax: (218) Indian Reservation, M. Brent Lummi Children’s Services Manager, 983–3712; Email: jeri.jasken@ Leonhard, Deputy Attorney General, P.O. Box 1024 Ferndale, WA 98248; whiteearth.com 46411 Timine Way, Pendleton, OR Telephone: (360) 384–2324; Fax: (360) 97801; Telephone/Fax: (541) 429– 380–2157; Email: amyf@lummi- 6. Navajo Region 7406; Email: [email protected] nsn.gov Navajo Region Director, Navajo Regional Coquille Indian Tribe, Bridgett Wheeler, M Office, P.O. Box 1060, Gallup, NM ICWA Worker, 3050 Tremont St., 87301; Telephone: (505) 863–8314; North Bend, OR 97459; Telephone: Makah Indian Tribal Council, Robin Fax: (505) 863–8324 (541) 888–9494; Fax: (541) 888–6701; Denney, Social Service Manager, P.O. Box 115, Neah Bay, WA 98357; N Email: [email protected] Cow Creek Band of Umpqua Tribe of Telephone: (360) 645–3251/3257; Fax: Navajo Nation, Regina Yazzie, MSW, Indians, Andrea Davis, Human (360) 645–2806 Director, Navajo Children and Family Services Director, 2371 NE Stephens Metlakatla Indian Community, Services (ICWA), P.O. Box 1930, Street, Roseburg, OR 97470; Metlakatla Indian Community Window Rock, AZ 86515; Telephone: Telephone: (541) 677–5575 Ext: 5513; (Northwest Region), Marge Edais- (928) 871–6806; Fax: (928) 871–7667; Fax: (541) 677–5574 Yeltatzie, Director, Social Services Email: [email protected] Cowlitz Indian Tribe, Jim Sherrill, Children’s Mental Health & ICW, P.O. 7. Northwest Region Health and Human Services, P.O. Box Box 85, Metlakatla, AK 99926; 2429, Longview, WA 98632–8594; Telephone: (907) 886–6911; Fax: (907) Northwest Regional Director, 911 NE Telephone: (360) 577–3307; Fax: (360) 886–6913; Email: [email protected] 11th Avenue, Portland, OR 97232; 577–1948 Muckleshoot Indian Tribe, Human Telephone: (503) 231–6702; Fax (503) Services Division Director, 39015 231–2201 H 172nd Avenue SE., Auburn, WA B Hoh Indian Tribe, Annette Penn, ICW, 98092; Telephone: (253) 939–3311; P.O. Box 2196, Forks, WA 98331; Fax: (253) 876–2855 Burns Paiute Tribe, Michelle Bradach, Telephone: (360) 374–5022; Fax: (360) Social Service Director, 100 Pasigo 374–5039; Email: milab@hohtribe- N Street, Burns, OR 97720; Telephone: nsn.org Nez Perce Tribe, Jeanette Pinkham, (541) 573–7312 Ext. 230; Fax: (541) ICWA Supervisor, P.O. Box 365, 573–4217; Email: bradachma@ J Lapwai, ID 83540; Telephone: (208) burnspaiute-nsn.gov Jamestown Skallam Tribal Council, 843–7302; Fax: (208) 843–9401; C ICWA Specialist, 1033 Old Blyn Hwy, Email: [email protected] Sequim, WA 98382; Telephone: (360) Nisqually Indian Community, Cynthia Confederated Tribes of the Chehalis 681–4639; Fax: (360) 681–3402 Orie, ICWA Contact, 4820 She- Nah- Reservation, Nancy Dufraine, Director Num Drive SE., Olympia, WA 98513; K of Social Services, P.O. Box 536, Telephone: (360) 456–5221; Fax: (360) Oakville, WA 98568; Telephone: (360) Kalispel Tribe of Indians, Wendy L. 486–9555 709–1768; Fax: (360) 273–5207; Thomas, MSW, Support Services Nooksack Indian Tribe of Washington, Email: [email protected] Director, 934 S Gargeld Road, Airway ICW Program Manager, P.O. Box 157, Confederated Tribe of the Coville Heights, WA 99001; Telephone: (509) Deming, WA 98244; Telephone: (360) Reservation, Michael Humiston, 789–7634/Cell (509) 671–6972; Fax: 306–5090; Fax: (360) 592–0167 Office of the Reservation Attorney, (509) 789–7659; Email: wthomas@ Northwestern Band of Shoshoni Nation, P.O. Box 150, Nespelem, WA 99155– camashealth.com Jason S. Walker, Chairman, 505 011; Telephone: (509) 634–2382; Fax: The Klamath Tribes, Misty Barney, Pershing Ave. Suite 200, Pocatello, ID (509) 634–2387 Child Welfare Program Manager; 83201; Telephone: (208) 478–5712; Coeur d’Alene Tribal Council Social Candi Crume, Child Protective Fax: (208) 478–5713 Worker Lead, P.O. Box 408, Plummer, Specialist; Jim Collins, ICW ID 83851; Telephone: (208) 686–8106; Specialist; Lisa Ruiz, Child Welfare P Fax: (208) 686–4410 Caseworker; P.O. Box 436, Chiloquin, Port Gamble S’Klallam, David Confederated Salish & Kootenai Tribes OR 97624; Telephone: (541) 783– Delmendo, ICWA Program Manager, of the Flathead Reservation, Charlene 2219; Fax: (541) 783–7783; Email: 31912 Little Boston Road NE., Petet, Contract Specialist, P.O. Box [email protected]; Kingston, WA 98346; Telephone: 278, Pablo, MT 59855; Telephone: [email protected]; (360) 297–9672; Fax: (360) 297–9666; (406) 675–2700 Ext. 1120, Fax: (406) [email protected]; Email: [email protected] 275–2898; Email: [email protected] [email protected]. Puyallup Tribe, Sandra Cooper, ICWA Confederated Tribes of Coos, Lower Kootenai Tribe of Idaho, Jennifer Porter, Liaison, 3009 E. Portland Avenue, Umpqua, & Siuslaw Indians, Dottie Vice-Chairwoman, P.O. Box 1269, Tacoma, WA 98404; Telephone: (253) Garcia, Family Service Coordinator, Bonners Ferry, ID 83805–1269; 405–7544; Fax: (253) 680–5998 P.O. Box 3279, Coos Bay, OR 97420; Telephone: (208) 267–3519; Fax: 208– Q Telephone: (541) 888–3012; Cell: 267–2960 (541) 297–0370; Fax: (541) 888–1027; Quileute Tribal Council, Jessica Smith, Email: [email protected] L ICWA Program Manager, P.O. Box Confederated Tribes of the Grande Lower Elwha Tribal Community 279, LaPush, WA 98331; Telephone: Ronde Community of Oregon, Dana Council, Becca Weed, ICWA Contact, (360) 374–4340; Fax: (360) 374–7796; Ainam, ICWA Contact, 9615 Grand 3080 Lower Elwha Road, Port Email: jessica.smith@ Ronde Road, Grand Ronde, OR Angeles, WA 98363–9518; Telephone: quileutenation.org 97347–0038; Telephone: (503) 879– (360) 565–7257, ext. 7456; Fax: (360) Quinault Indian Nation Business 2034; Fax: (503) 879–2142 457–8429 Committee, William (Bill) Lay,
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Quinault Family Services Supervisor, Reservation Rd, LaConner, WA 98257; Berry Creek Rancheria (See Tyme Maidu P.O. Box 189, Taholah, WA 98587; Telephone: (360) 466–7222; Email: Tribe) Big Lagoon Rancheria, Telephone: (360) 276–8215 Ext. 355; [email protected] Chairperson, P.O. Box 3060, Trinidad, Fax: (360) 267–4152; Email: wlay@ CA 95570; Telephone: (707) 826– T quinault.org 2079; Fax: (707) 826–0495 Tulalip Tribe, beda?chelh Manager, Big Pine Paiute Tribe, Rita Mendoza, S 2828 Mission Hill Road, Tulalip, WA Tribal Court Clerk/ICWA Samish Indian Nation, Michelle 98271; Telephone: (360) 716–3284 Representative, P.O. Box 700 or 825 S. Johnson, Family Services Specialist, Main Street, Big Pine, CA 93513; U P.O. Box 217, Anacortes, WA 98221; Telephone: (760) 938–2003; Fax: (760) Telephone: (360) 899–5282; Fax: (360) Upper Skagit Indian Tribe, Felice 938–2942; Email: r.mendoza@ 299–4357; Email: mjohnson@ Keegahn, Indian Child Welfare bigpinepaiute.org samishtribe.nsn.us Coordinator, 25959 Community Plaza Big Sandy Rancheria Band of Western Sauk-Suiattle Indian Tribe, Raju A.T. Way, Sedro Woolley, WA 98284; Mono Indians, Dorothy Barton, MSW, Dahlstrom, MSW, Program Telephone: (360) 854–7077; Fax: (360) ICWA/Social Services Coordinator, Administrator Indian Child Welfare, 854–7125; Email: felicek@ P.O. Box 337, Auberry, CA 93602; 5318 Chief Brown Lane, Darrington, upperskagit.com. Telephone: (559) 374–0049; Fax: (559) WA 98241; Telephone: (425) 760– W 855–4129; Email: dbarton@ 0306; Fax: (360) 436–0242; Email: bsrnation.com [email protected]. Warm Springs Tribal Court, Big Valley Rancheria, ICWA, 2726 Shoalwater Bay Tribal Council, Confederated Tribes of Warm Springs Mission Rancheria Road, Lakeport, Katherine Horne, ICWA Contact, P.O. Reservation, Chief Judge Lola CA 95453; Telephone: (707) 263– Box 130, Tokeland, WA 98590; Sohappy, ICWA Contact, P.O. Box 3924; Fax: (707) 263–3977; Email: Telephone: (360) 267–6766 Ext. 3100; 850, Warm Springs, OR 97761; [email protected] Fax: (360) 267–0247 Telephone: (541) 553–3454; Fax: (541) Bishop Paiute Tribe, Margaret L. Shoshone Bannock Tribe, Brandelle 553–3281 Romero, ICWA Specialist; 50 TuSu Whitworth, Tribal Attorney, P.O. Box Lane, Bishop, CA 93514; Telephone: Y 306, Ft. Hall, ID 83203; Telephone: (760) 873–4414; Fax: (760) 873–4143; (208) 478–3923; Fax: (208) 237–9736; Confederated Tribes and Bands of the Email: margaret.romero@ Email: [email protected] Yakama Nation, David Lees, Esq, bishoppaiute.org Confederated Tribes of Siletz Indians, Chief Prosecutor, P.O. Box 1119, Blue Lake Rancheria, Bonnie Mobbs, Cathern Tufts, Staff Attorney, P.O. Toppenish, WA 98948; Telephone: Exec Assistant, P.O. Box 428, Blue Box 549, Siletz, OR 97380; Telephone: (509) 865–5121 Ext: 4558; Fax: (509) Lake, CA 95525; Telephone: (707) (541) 444–8211; Fax: (541) 444–2307; 865–7078; Email: [email protected]. 668–5101; Fax: (707) 668–4272; Email: [email protected] 8. Pacific Region Email: bmobbs@bluelakerancheria- Skokomish Tribal Council, Laura Munn nsn.gov or Ralph Pulsiser, ICWA Contact, N. Pacific Region Director, BIA, Federal Bridgeport Indian Colony, Michael 80 Tribal Center Road, Shelton, WA Building, 2800 Cottage Way, Lumsden, Tribal Administrator, P.O. 98584–9748; Telephone: (360) 426– Sacramento, CA 95825; Telephone: Box 37 or 355 Sage Brush Drive, 7788; Fax: (360) 877–2151 (916) 978–6000; Fax: (916) 978–6099 Bridgeport, CA 93517; Telephone: Snoqualmie Tribe, Marie Ramirez, A (760) 932–7083; Fax: (760) 932–7846; MSW, ICWA Contact, P.O. Box 280, Email: admin@ Carnation, WA 98014; Telephone: Agua Caliente Band of Cahuilla Indians, bridgeportindiancolony.com (425) 333–5425; Fax: (425) 333–5428 Attn: Tribal Legal Department, 5401 Buena Vista Rancheria of Me-Wuk Spokane Tribe of Indians, Tawhnee Dinah Shore Drive, Palm Springs, CA Indians, Penny Arciniaga, Tribal Colvin, Program Manager/Case 92264; Telephone: (760) 699–6952; Member Services, 1418 20th Street, Manager, P.O. Box 540, Wellpinit, Fax: (760) 699–6865 Suite 200, Sacramento, CA 95811; WA 99040; Telephone: (509) 258– Alturas Rancheria, Chairman, P.O. Box Telephone: (916) 491–0011; Fax: (916) 7502; Fax: (509) 258–7029; Email: 340, Alturas, CA 96101; Telephone: 491–0012; Email: penny@ [email protected]. (530) 233–5571; Fax: 223–4165 buenavistatribe.com Squaxin Island Tribe, Donald Whitener, Augustine Band of Cahuilla Indians, Tribal Administrator, 10 SE Squaxin Mary Ann Green, Chairperson, P.O. C Lane, Shelton, WA 98584–9200; Box 846, Coachella, CA 92236; Cabazon Band of Mission Indians, Telephone: (360) 432–3900; Fax: (360) Telephone: (760) 398–4722 Chairman, 84–245 Indio Springs 426–6577; Email: dwhitener@ B Drive, Indio, CA 92201; Telephone: squaxin.us. (760) 342–2593; Fax: (760) 347–7880 Stillaguamish Tribe of Indians, Gloria Barona Band of Mission Indians, Charity California Valley Miwok Tribe, Rashel Green, ICW Director, P.O. Box 3782 or White-Voth, Kumeyaay Family Reznor, ICWA Coordinator, 10601 N. 17014 59th Ave NE., Arlington, WA Services Director, Southern Indian Escondido Pl., Stockton, Calif. 95212; 98223; Telephone: (360) 435–3985 Health Council, Inc., 4058 Willow Telephone: (209) 931–4567; Fax: (209) Ext. 21; Fax: (360) 435–2867 Rd., Alpine, CA 91903; Telephone: 931–4333; Email: icwa@ Suquamish Indian Tribe of the Port (619) 445–1188; Fax: (619) 445–0765 californiavalleymiwoktribe-nsn.gov Madison Reservation, Dennis Deaton, Bear River Band of Rohnerville Cahuilla Band of Indians, Executive ICWA Contact, P.O. Box 498, Rancheria, Vevila Hussey, Social Director, 52701 Hwy 371, Anza, CA Suquamish, WA 98392; Telephone: Services Director, 27 Bear River Drive, 92539; Telephone: (951) 763–5549; (360) 394–8478; Fax: (360) 697–6774 Loleta, CA 95551; Telephone: (707) Fax: (951) 763–2808; Email: Swinomish Indian Tribal Community, 773–1900 Ext: 290; Fax: (888) 733– [email protected] Tracey Parker, Swinomish Family 1900; Email: vevilahussey.brb@ Campo Band of Mission Indians, Charity Services Coordinator, 17337 nsn.gov White-Voth, Kumeyaay, Family
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Services Director, Southern Indian (707) 994–3400; Fax: (707) 994–3408; 95546; Telephone: (530) 625–4211; Health Council, Inc., 4058 Willow Email: [email protected] Fax: (530) 625–4594 Rd., Alpine, CA 91903; Telephone: Elk Valley Rancheria, LaWanda Hopland Band of Pomo Indians, Tania (619) 445–1188; Fax: (619) 445–0765 Quinnell, Council Secretary, 2332 Mota, ICWA Social Case Management Cedarville Rancheria, Melissa Davis, Howland Hill Rd, Crescent City, CA Worker, 3000 Shanel Rd., Hopland, Administrative Assistant, 300 West 95531; Telephone: (707) 464–4680; CA 95449; Telephone: (707) 472–2100 First Street, Alturas, CA 96101; Fax: (707) 464–4519; Email: Ext: 1114; Fax: (707) 472–2109; Email: Telephone: (530) 233–3969; Fax: (530) [email protected] [email protected] 233–4776; Email: phyrra@ Enterprise Rancheria Estom Yumeka I rocketmail.com Maidu Tribe, Shari Ghalayini, ICWA Cher-Ae Heights Indian Community of Director, 2133 Monte Vista Ave, Inaja & Cosmit Band of Mission Indians, the Trinidad Rancheria, Amy Atkins, Oroville, CA 95966; Telephone: (530) Tribal Family Services, Manager Executive Manager, P.O. Box 630, 532–9214; Fax: (530) 532–1768; Indian Health Council, Inc., P.O. Box 406, Pauma Valley, CA 92061; Trinidad, CA 95570; Telephone: (707) Email: [email protected] Telephone: (760) 749–1410; Fax: (760) 677–0211; Fax: (707) 677–3921; Ewiiaapaayp Band of Kumeyaay 749–5518 Email: aatkins@ Indians, Will Micklin, CEO, 4050 Willow Road. Alpine, CA 91901; Ione Band of Miwok Indians, Pamela trinidadrancheria.com Baumgartner, Tribal Administrator, Chicken Ranch Rancheria, Jan Costa, Telephone: (619) 445–6315; Fax: (619) 445–9126 P.O. Box 699, Plymouth, CA 95669; Tribal Administrator, P.O. Box 1159, Telephone: (209) 245–5800 Ext: 5801; Jamestown, CA 95327; Telephone: F Email: [email protected] (209) 984–4806; Fax: (209) 984–5606; Email: [email protected] Federated Indians of Graton Rancheria, J Lara Walker, Wellness and Justice Cloverdale Rancheria of Pomo Indians, Director, 6400 Redwood Drive, Suite Jackson Rancheria Band of Miwuk Christina Hermosillo, ICWA 300, Rohnert Park, CA 94928; Indians, Marshawn Morla, Tribal Advocate, 555 S. Cloverdale Blvd., Telephone: (707) 586–6110; Fax: (707) Secretary, P.O. Box 1090, Jackson, CA Cloverdale, CA 95425; Telephone: 566–2291; Email: lwalker@ 95642; Telephone: (209) 223–1935; (707) 894–5775; Fax: (707) 894–5727 Fax: (209) 223–5366; Email: mmorla@ gratonrancheria.com Cold Springs Rancheria, Terri Works, Fort Bidwell Reservation, Bernold jacksoncasino.com Jamul Indian Village, Charity White- ICWA Director, P.O. Box 209, Pollard, Chairperson, P.O. Box 129, Voth, Kumeyaay Family Services Tollhouse, CA 93667; Telephone: Fort Bidwell, CA 96112; Telephone: Director, Southern Indian Health (559) 855–5043/(559) 855–8360; Fax: (530) 279–6310; Fax: (530) 279–2233 Council, Inc., 4058 Willow Rd., (559) 855–4445; Email: Fort Independence Indian Reservation, Alpine, CA 91903; Telephone: (619) [email protected] Israel Naylor, Tribal Chairman, P.O. 445–1188; Fax: (619) 445–0765 Colusa Indian Community Council, Box 67 or 131 North Hwy 395, Daniel Gomez Sr., Chairman, 3730 Independence, CA 93526; Telephone: K Highway 45, Colusa, CA 95932; (760) 878–5160: Fax: (760) 878–2311; Karuk Tribe of California, April Telephone: (530) 458–8231; Fax: (530) Email: [email protected] 458–4186; Email: dgomez@ Attebury, Administrator, Child colusansn.gov G Welfare Services Program/ICWA Unit, 1519 S. Oregon Street, Yreka, CA Cortina Band of Wintun Indians Greenville Rancheria, Dr. Gonzalo (Cortina Indian Rancheria), Charlie 96097; Telephone: (530) 841–3141; Gonzalez, ICWA Representative, P.O. Fax: (530) 842–6283 Wright, Tribal Chairman, P.O. Box Box 279, Greenville, CA 95947; 1630, Williams, CA 95987; Telephone: (530) 284–7990; Fax: (530) L Telephone: (530) 473–3274, Fax: (530) 284–6612 ; Email: ggonzalez@ La Jolla Band of Luiseno Indians, Tribal 473–3301 greenvillerancheria.com Family Services, Manager, Indian Coyote Valley Band of Pomo Indians, Grindstone Indian Rancheria, Aaston Health Council, Inc., P.O. Box 406, c/o Lorraine Laiwa, Indian Child And Bill, ICWA, P.O. Box 63, Elk Creek, Pauma Valley, CA 92061; Telephone: Family Preservation Program, 684 CA 95939; Telephone: (530) 968– (760) 749–1410; Fax: (760) 749–5518 South Orchard Avenue, Ukiah, CA 5365; Fax: (530) 968–5366 La Posta Band of Mission Indians, 95482; Telephone: (707) 463–2644; Guidiville Band of Pomo Indians, Charity White-Voth, Kumeyaay Fax: (707) 463–8956; Email: Merlene Sanchez, Tribal Chairperson, Family Services Director, Southern [email protected] P.O. Box 339, Talmage, CA 95481; Indian Health Council, Inc., 4058 Cuyapaipe Ewiiaapaayp Band of Telephone: (707) 462–3682; Fax: (707) Willow Rd., Alpine, CA 91903; Kumeyaay Indians (See Ewiiaapaayp 462–9183; Email: admin@ Telephone: (619) 445–1188; Fax: (619) Band of Kumeyaay Indians guidiville.net 445–0765 Laytonville Rancheria, Cherie Smith- D H Gibson, Tribal Administrator, P.O. Dry Creek Rancheria Band of Pomo Habematolel Pomo of Upper Lake, Box 1239, Laytonville, CA 95454; Indians, Percy Tejada, ICWA Angelina Arroyo, ICWA Advocate, Telephone: (707) 984–6197 Ext: 104; Advocate, P.O. Box 607 Geyserville, 375 E. Hwy 20, Suite ‘‘I’’, Upper Lake, Fax: (707) 984–6201; Email: ta@ CA 95441; Telephone: (707) 522– CA 95485–0516; Telephone: (707) cahto.org 4248; Fax: (707) 522–4291; Email: 275–0737; Cell: (707) 275–2947; Fax: Lone Pine Reservation, Kathy Brancroft, [email protected] (707) 275–0757; Email: tribaladmin@ Enrollment Committee Chairperson, upperlepomo.com or P.O. Box 747, Lone Pine, CA 93545; E executive.secretary@ Telephone: (760) 876–1034; Fax: (760) Elem Indian Colony Pomo Tribe, Nathan upperlakepomo.com 876–8302 M. Brown II, Chairman, P.O. Box 757 Hoopa Valley Tribe, Director, Human Los Coyotes Band of Cahuilla & Cupeno Lower Lake, CA 95457; Telephone: Services, P.O. Box 1348, Hoopa, CA Indians, Tribal Family Services
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Manager, Indian Health Council, Inc., Social Services, 35008 Pala-Temecula Resighini Rancheria, Keshan Dowd, P.O. Box 406, Pauma Valley, Road, PMB 50, Pala, CA 92059. Social Services Director, P.O. Box California 92061; Telephone: (760) Telephone: (760) 891–3542; Fax: (760) 529, Klamath, CA 95548; Telephone: 749–1410; Fax: (760) 749–5518 742–1293 (707) 482–2431; Fax: (707) 482–3425 Koi Nation of Northern California, Paskenta Band of Nomlaki Indians, Ines Rincon Band of Mission Indians, Tribal Chairperson, P.O. Box 3162, Santa Crosby, Tribal Administrator, 1012 Family Services, Manager, Indian Rosa, CA 95402; Telephone: (707) South Street, Orland, CA 95963; Health Council, P.O. Box 406, Pauma 575–5586; Fax: (707) 575–5506 Telephone: (530) 865–2010; Fax: (530) Valley, CA 92061; Telephone: (760) Lytton Rancheria c/o Indian Child and 865–1870; Email: [email protected] 749–1410; Fax: (760) 749–8901 Family Preservation Program, Liz Pauma & Yuima Band of Mission Robinson Rancheria, ICWA Coordinator, DeRouen, 2525 Cleveland Ave, Suite Indians, Tribal Family Services, P.O. Box 4015, Nice, CA 95464; H, Santa Rosa, CA 95403; Telephone: Manager, Indian Health Council, Inc., Telephone: (707) 275–0527; Fax: (707) (707) 544–8509; Fax: (707) 544–8729; P.O. Box 406, Pauma Valley, CA 275–0235; Email: mvasquez@ email: [email protected] 92061; Telephone: (760) 749–1410; robinsonrancheria.com Fax: (760) 749–5518 Round Valley Indian Tribes, Lois M Pechanga Band of Mission Indians, Whipple, Tribal President, 77826 Manchester-Point Arena Band of Pomo Mark Macarro, Spokesman, P.O. Box Covelo Road, Covelo, CA 95428; Indians, Lorraine Laiwa, Executive 1477, Temecula, CA 92593; Telephone: (707) 983–6126; Fax: (707) Director, Indian Child and Family Telephone: (951) 676–2768; Fax: (951) 983–6128; Email: administrator@ Preservation Program, 684 South 695–1778 rvit.org Orchard Avenue, Ukiah, CA 95482; Picayune Rancheria of the Chukchansi Yocha Dehe Wintun Nation, James Telephone: (707) 463–2644; Fax: (707) Indians, Orianna C. Walker, ICWA Kinter, Tribal Council Secretary, P.O. 463–8956; Email: lorrainel_1@ Coordinator, 46575 Road 417, Box 18, Brooks, CA 95606; Telephone: comcast.net Coarsegold, CA 93614; Telephone: (530) 796–3400; Fax: (530) 796–2143; Manzanita Band of Mission Indians, (559) 683–6633 Ext: 212; Fax: (559) Email: [email protected] Chairperson, P.O. Box 1302, 692–8792; Email: owalker@ S Boulevard, CA 91905; Telephone: picayunerancheria-nsn.gov (619) 766–4930; Fax: (619) 766–4957 Pinoleville Pomo Nation, Lenora Steele, San Manuel Band of Mission Indians, Mechoopda Indian Tribe of Chico Self-Governance Director, 500 B Tribal Secretary, 26569 Community Rancheria, Arlene Ward, Office Pinoleville Drive, Ukiah, CA 95482; Center Drive, Highland, CA 92346; Manager, 125 Mission Ranch Telephone: (707) 463–1454; Fax: (707) Telephone: (909) 864–8933; Fax: (909) Boulevard, Chico, CA 95926; 463–6601; Email: lenora@ 864–3370 Telephone: (530) 899–8922; Fax: (530) pinolevillensn.us San Pasqual Band of Diegueno Indians, 899–8517; Email: baward@ Pit River Tribe, Veronon Ward, Jr., Tribal Family Services, Manager, mechoopda-nsn.gov Coordinator, Social Services, 36970 Indian Health Council, Inc., P.O. Box Mesa Grande Band of Mission Indians, Park Avenue, Burney, CA 96013; 406, Pauma Valley, CA 92061; Tribal Family Services, Manager, Telephone: (530) 335–5530; Fax: (530) Telephone: (760) 749–1410; Fax: (760) Indian Health Council, Inc., P.O. Box 335–3140 749–5518 406, Pauma Valley, CA 92061; Potter Valley Tribe, Salvador Rosales, Santa Rosa Band of Cahuilla Indians, Telephone: (760) 749–1410; Fax: (760) Tribal Chairman, 2251 South State John Marcus, Chairman, P.O. Box 749–5518 Street, Ukiah, CA 95482; Telephone: 391820, Anza, CA 92539; Telephone: Middletown Rancheria, ICWA Director, (707) 462–1213; Fax: (707) 462–1240; (951) 659–2700; Fax: (951) 689–2228. Mary Comito, P.O. Box 1829; Email: pottervalleytribe@ Santa Rosa Rancheria Tachi-Yokut Middletown, CA 95461; Telephone: pottervalleytribe.com Tribe, Janice Cuara, Tribal (707) 987–8288; Fax: (707) 987–8205; Administrator, 16835 Alkali Drive; Q Cell: (707) 326–6876; Email: P.O. Box 8, Lemoore, CA 93245; [email protected] Quartz Valley Indian Reservation, Telephone: (559) 924–1278 Ext: 4051; Mooretown Rancheria, Francine Frieda Bennett, Education Director/ Cell: (559) 381–4928; Fax: (559) 925– McKinley, ICWA Director, 1 Alverda Social Services, 13601 Quartz Valley 2931; Email: [email protected] Drive, Oroville, CA 95966; Telephone: Rd., Fort Jones, CA 96032; Telephone: Santa Ynez Band of Chumash Indians, (530) 533–3625; Fax: (530) 533–0664; (530) 468–5907; Fax: (530) 468–5908 Caren Romero, ICWA Representative, P.O. Box 539, Santa Ynez, CA 93460; Email: [email protected]; R Morongo Band of Cahuilla Mission Telephone: (805) 694–2671; Fax: (805) Indians, Paula Tobler, Social Worker, Ramona Band or Village of Cahuilla, 686–2060; Email: [email protected] 11581 Potrero Road, Banning, CA Susan Reckker, Tribal Administrator, Santa Ysabel Band of Mission Indians- 92220; Telephone: (951) 849–4697; P.O. Box 391670 Anza, CA 92539; Iipay Nation, Linda Ruis, Director, Fax: (951) 922–0338 Phone: (951)763–4105; Fax: (951) Santa Ysabel Social Services Dept., 763–4325; Email: sreckker@ P.O. Box 701, Santa Ysabel, CA N ramonatribe.com 92070; Telephone: (760) 765–1106; North Fork Rancheria of Mono Indians, Redding Rancheria, Director, Social Fax: (760) 765–0312 Elaine Fink, Tribal Chairwoman, P.O. Services, 2000 Rancheria Road, Scotts Valley Band of Pomo Indians, Box 929, North Fork, CA 93643; Redding, CA 96001–5528; Telephone: Tribal ICWA Worker, 1005 Parallel Telephone: (559) 877–2484; Fax: (559) (530) 225–8979 Drive, Lakeport, CA 95453; 877–2467; Email: efink@ Redwood Valley Rancheria-Band of Telephone: (707) 263–4220; Fax: (707) northforkrancheria-nsn.gov Pomo, Janie Navarez, ICWA 263–4345; Email: [email protected] Coordinator, 3250 Road I, ‘‘A’’ Sherwood Valley Band of Pomo Indians, P Building, Redwood Valley, CA 95470; Stefan Hood, ICWA Advocate, 190 Pala Band of Mission Indians, Season Telephone: (707) 485–0361; Fax: (707) Sherwood Hill Drive, Willits, CA Lattin, ICWA Manager, Department of 485–5726 95490; Telephone: (707) 459–9690;
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Fax: (707) 459–6936; Email: svrchair@ 791–2122; Email: icwadir@ H. Peterson, ICWA Inquiry gmail.com tulerivertribe-nsn.gov Technician, P.O. Box 588 Browning, Shingle Springs Band of Miwok Indians Tuolumne Band of Me-Wuk Indians, MT 59417; Telephone: (406) 338– (Shingle Springs Rancheria), Malissa Kevin Day, Tribal Chair, P.O. Box 699, 7806; Fax: (406) 338–7726; Email: Tayaba, Social Services Director, P.O. Tuolumne, CA 95379; Telephone: [email protected] Box 1340; Shingle Springs, CA 95682; (209) 928–5300; Fax: (209) 928–1677; Telephone: (530) 698–1436 or (530) Email: [email protected] C 698–1400; Fax: (530) 387–8041; Twenty-Nine Palms Band of Mission Chippewa-Cree Tribe, Rocky Boy’s Email: [email protected] Indians, Executive Director, Indian Agency, Montana, Christina Trottier, Smith River Rancheria, Dorothy Perry, Child & Family Services, P.O. Box ICWA Case Manager, 31 Agency Director, 140 Rowdy Creek Road, 2269, Temecula, CA 92590; Square, Box Elder, MT 59521; Smith River, CA 95567–9446; Telephone: (951) 676–8832; Fax: (951) Telephone: (406) 395–4735; Fax: (406) Telephone: (707) 487–9255; Fax: (707) 676–3950 395–5184; Email: christina.trottier@ 487–0930 Tyme Maidu Tribe (Berry Creek yahoo.com Soboba Band of Luiseno Indians, Nancy Rancheria), Terilynn Steel, ICWA Crow Tribe of the Crow Reservation of Currie, Tribal Social Worker, Soboba Supervisor, 5 Tyme Way, Oroville, CA Montana, Melveen Paula Fisher, Tribal Family Services Department; 95966; Telephone: (530) 534–3859, ICWA Coordinator, P.O. Box 340, P.O. Box 487, San Jacinto, CA 92581; Fax: (530) 534–1151; Email: Crow Agency, MT 59022; Telephone: Telephone: (951) 487–0283; Fax: (951) [email protected] (406) 638–7429; Fax: (406) 638–7413; 487–1738 U Email: MelveenPaula.Fisher@crow- Kashia Band of Pomo Indians of the nsn-gov Stewarts Point Rancheria, Reno K. United Auburn Indian Community, Franklin, Tribal Chairman, 1420 Melanie Connors, MSW, ICWA Case E Guerneville Rd, Suite 1, Santa Rosa, Manager, 945 Indian Rancheria Rd., Eastern Shoshone Tribe of the Wind CA 95403; Telephone: (707) 591– Auburn, CA 95603; Telephone: (530) River Reservation, Arnella Oldman, 0580; Fax: (707) 591–0583; Email: 251–1510; Fax: (530) 878–5470, ICWA Coordinator, P.O. Box 1796, [email protected] Email: MConnors@ Fort Washakie, WY 82514; Telephone: Susanville Indian Rancheria, Deborah auburnrancheria.com (307) 332–2669; Fax: (307) 332–6593 A. Olstad, Tribal Office Manager, 745 Utu Utu Gwaitu Paiute Tribe, Billie F Joaquin St., Susanville, CA 96130; Saulque, Chairman, 25669 Hwy 6, Telephone: (530)251–5153; Fax: (530) PMB I, Benton, CA 93512; Telephone: Fort Belknap Indian Community, Myron 257–7986; Email: [email protected] (760) 933–2321; Fax: (760) 933–2412; L. Trottier, ICWA Case Manager, Fort Sycuan Band of Mission Indians, Email: [email protected] Belknap Social Services, 656 Agency Charity White-Voth, Kumeyaay V Main Street, Harlem, MT 59526; Family Services Director, Southern Telephone: (406) 353–8328; Fax: (406) Viejas (Baron Long) Band of Mission Indian Health Council, Inc., 4058 353–4634; Email: mtrottier@ Indians, Charity White-Voth, Willow Rd., Alpine, CA 91903; ftbelknap.org Kumeyaay Family Services Director, Telephone: (619) 445–1188; Fax: (619) Fort Peck Assiniboine and Sioux Tribes, Southern Indian Health Council, Inc., 445–0765 Ms. Lois Weeks, ICWA Case Manager, 4058 Willow Rd., Alpine, CA 91903; P.O. Box 1027, Poplar, MT 59255; T Telephone: (619) 445–1188; Fax: (619) Telephone: (406) 768–2402; Fax: (406) 445–0765 Table Mountain Rancheria, Frank 768–3710; Email: [email protected] Marquez Jr., Tribal Chief of Police, W N 23736 Sky Harbour Rd., Friant, CA Wilton Rancheria, Anastasia Tran, 93626; Telephone: (559) 822–6336; ICWA Advocate, 9300 West Stockton Northern Arapaho Tribe of the Wind Fax: (559) 822–6340; Email: Blvd., Ste. 200 Elk Grove, CA 95758; River Reservation, ICWA Coordinator, [email protected] Telephone: (916) 683–6000; Fax: (916) P.O. Box 396, Fort Washakie, WY Tejon Indian Tribe, Kathryn Montes 683–6015 82514; Telephone: (307) 332–6120 Morgan, Tribal Chair, 1731 Hasti- Wiyot Tribe, Sarah Vevoda, Director of ext. 130; Fax: (307) 332–7543 Acres Drive #108, Bakersfield, CA Social Services, 1000 Wiyot Drive, Northern Cheyenne, Michelle Little 93309; Telephone: (661) 834–8566; Loleta, CA 95551; Telephone: (707) Wolf Sandcrane, ICWA Coordinator, Email: [email protected] 733–5055; Fax: (707) 482–1377 P.O. Box 128, Lame Deer, Montana Timbi-sha Shoshone Tribe, Attention: 59043; Telephone: (406) 477–4830; Wally Eddy, 621 West Line Street, Y Fax: (406) 477–8333; Email: Suite 109, Bishop, CA 93514; Yurok Tribe, Stephanie Weldon, michelle.littlewolf@ Telephone: (760) 872–3614; Fax: (760) Director Social Services, P.O. Box cheyennenation.com 872–3670; Email: [email protected] 1027, Klamath, CA 95548; Telephone: 10. Southern Plains Region Torres Martinez Desert Cahuilla Indians, (707) 482–1350; Fax: (707) 482–1377; Annette Chihuahua, ICWA Case Email: [email protected] Southern Region Director, 1 Mile North, Assistant/Tribal Delegate TMDCI, 66– Hwy 281, Anadarko, OK 73005; 725 Martinez Rd., Thermal, CA 92274; 9. Rocky Mountain Region Telephone: (405) 247–6673; Fax: (405) Telephone: (760) 578–8334 or (760) Rocky Mountain Regional Director, 2021 247–5611 397–0455 Ext: 1101; Fax: (760) 397– 4th Avenue North, Billings, MT A 3925; Email: [email protected] 59101; Telephone: (406) 247–7943; Tule River Reservation, Lolita Garfield, Fax: (406) 247–7976 Absentee-Shawnee Tribe of Oklahoma MSW, Director Family Social Indians, Ronelle Baker, ICWA Services, 340 North Reservation Road, B Director, 2025 S. Gordon Cooper Porterville, CA 93258; Telephone: Blackfeet Tribe of Montana, Kathy Calf Drive, Shawnee, OK 74801; (559) 781–4271 ext: 1013; Fax: (559) Boss Ribs, ICWA Coordinator; Darlene Telephone: (405) 874–4702 Ext. 133;
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Fax: (405) 878–4540; Email: rbaker@ Falcon Blvd., Eagle Pass, TX 78852; 73005; Telephone: (405) 247–8627; astribe.com Telephone: (830) 766–5601; Work Fax: (405) 247–8873; Email: Alabama-Coushatta Tribe of Texas, Cell: (830) 513–2937; Fax: (830) 776– [email protected] Samantha Battiest (936) 563–1252; 5605 11. Southwest Region Fax: (936) 563–1254; Email: Kickapoo Tribe of Indians of The [email protected] Kickapoo Reservation in Kansas, Southwest Region Director, 1001 Indian Apache Tribe of Oklahoma, Anadarko Chairperson, P.O. Box 271, Horton, School Road, NW., Albuquerque, NM Agency, Community Services, P.O. KS 66439; Telephone: (785) 486–2131 87104; Phone: (505) 563–3103; Fax: Box 309, Anadarko Oklahoma, 73005, Kickapoo Tribe of Oklahoma, Jodi (505) 563–3101 Sallie Allen, Supervisory Social Owings, ICW and Family Violence A Worker, (405) 247–8515, Fax (405) Director, P.O. Box 46, McLoud, OK 247–2252; Email: [email protected] 74851; Telephone: (405) 964–5426; Pueblo of Acoma, Marsha Vallo, Child Caddo Nation of Oklahoma, Mary Fax: (405) 964–5431; Email: jwarrior@ Welfare Coordinator, P.O. Box 354, Prentiss, ICW Caseworker, P.O. Box kickapootribeofoklahoma.com Acoma, NM 87034; Phone: (505) 552– 309, Binger, OK 73009; Telephone: Kiowa Tribe of Oklahoma, Shannon 5162; Fax: (505) 552–0903; Email: (405) 656–9231; Fax: (405) 656–9237; Ahtone, ICWA Director, P.O. Box 9, [email protected] Email: [email protected] Carnegie, Oklahoma 73015; C Cheyenne and Arapaho Tribes of Telephone: (580) 654–2300; Fax: (580) Pueblo de Cochiti, Richard Pecos, Tribal Oklahoma, Yolanda Woods, ICW 654–2363 Coordinator, P.O. Box 27, Concho, OK Administrator, 255 Cochiti Street, 73022; Telephone: (405) 422–7471; O P.O. Box 70, Cochiti Pueblo, NM 87072; Phone: (505) 465–3104; Fax: Fax: (405) 422–8249; Email: ywoods@ Otoe-Missouria Indian Tribe of (505) 465–1135; Email: richard_ c-a-tribes.org Oklahoma, Ada Mehojah, Social [email protected] Citizen Potawatomi Nation, Janet Services Director, 8151 Highway 177 Draper, ICW Director, 1601 S. Gordon Red Rock, OK 74651; Telephone: I Cooper Drive, Shawnee, OK 74801; (580) 723–4466 Ext: 256; Cell Phone: Telephone: (405) 878–4831; Fax: (405) Pueblo of Isleta, New Mexico, (580) 307–7303; Fax: (580) 723–1016; Jacqueline Yalch, ICWA Coordinator, 878–4659; Email: jdraper@ Email: [email protected] potawatomi.org P.O. Box 1270, Isleta, NM 87022; Comanche Nation-Oklahoma, Carol P Phone: (505) 869–2772; Fax (505) Gooday-Mithlo, ICW Director, P.O. 869–7575; Email: Poi05009@ Pawnee Nation of Oklahoma, Joanna isletapueblo.com Box 908, Lawton, OK 73502; (Jodi) Flanders, BSW, MSW, ICW Telephone: (580) 492–3352; Fax: (580) Coordinator, P.O. Box 470, Pawnee, J 354–0808; Email: carolm@ OK 74058; Telephone: (918) 762– comanchenation.com Pueblo of Jemez, Annette Chinana, 4045; Fax: (918) 762–6449; Email: Jemez Social Service Program-Child D [email protected] Advocate, P.O. Box 340, Jemez The Delaware Nation, Carlos Juan Ponca Tribe of Oklahoma, Amy Pueblo, NM 87024; Phone: (575) 834– Feliciano, ICW Director, P.O. Box 825, Oldfield, ICW Director, 20 White 7117; Fax: (575) 834–7103; Email: Anadarko, OK 73005; Telephone: Eagle Drive, Ponca City, OK 74601; [email protected] (405) 247–2448 Ext: 1152; Fax (405) Telephone: (580) 763–0133; Fax: (580) Jicarilla Apache Nation, Olivia Nelson- 247–5942; Email: jfeliciano@ 763–0134; Email: amyo.ponka@ Lucero, Acting Program Manager, delawarenation.com gmail.com Jicarilla Behavioral Health, P.O. Box Prairie Band of Potawatomi Nation, 546, Dulce, NM 87528; Phone: (575) F Chairperson, 16281 Q. Road, Mayetta, 759–1712; Fax: (575) 759–3757; Fort Sill Apache Tribe of Oklahoma, KS 66509; Telephone: (785) 966–2255 Email: [email protected] Ramona Austin, ICWA Director, S L 43187 US Highway 281, Apache, OK 73006; Telephone: (580) 588–2298; Sac and Fox Nation in Kansas and Pueblo of Laguna, Marie A. Alarid, Fax: (580) 588–2106; Email: Nebraska, Michael Dougherty, Tribal Program Manager and Rebecca Quam, [email protected] Chairperson, 305 N. Main Street, Social Services Specialist II (back-up), Reserve, KS 66434; Telephone: (785) P.O. Box 194, Laguna, NM 87026; I 742–0053 Ext: 23; Fax: (785) 742– Phone: (505) 552–9712 Fax: (505) Iowa Tribe of Kansas, Chairperson, 3345 7146 552–6484; Email: malarid@ B. Thrasher Rd., White Cloud, KS Sac and Fox Nation, Principal Chief, lagunapueblo-nsn.gov; or rquam@ 66094; Telephone: (785) 595–3258 Route 2, Box 246, Stroud, OK 74079; lagunapueblo-nsn.gov Iowa Tribe of Oklahoma, Mary Telephone: (918) 968–3526 Davenport, ICW Director, 335588 E. M T 750 Road, Perkins, OK 74059; Mescalero Apache Tribe, Crystal Lester, Telephone: (405) 547–4234; Fax: (405) Tonkawa Tribe of Oklahoma, Christi Tribal Census Clerk, P.O. Box 227, 547–1060; Email: mdavenport@ Gonzalez, ICWA Director, P.O. Box Mescalero, NM 88340; Phone (575) iowanation.org 70, 1 Rush Buffalo Road, Tonkawa, 464–4494; Fax: (575) 464–9191; OK 74653; Telephone: (580) 628– Email: [email protected] K 7025; Fax: (580) 628–3336; Email: Kaw Nation, Roger Sober, ICW Director, [email protected] N P.O. Box 5, Kaw City, Oklahoma Pueblo of Nambe, Venus Montoya- W 74641;Telephone: (580) 269–2003; Felter, Coordinator, 15A NP102 West, Email: [email protected] Wichita & Affiliated Tribes, Joan Santa Fe, NM 87506; Phone (505) Kickapoo Traditional Tribe of Texas, Williams, Family & Children Services 455–4412; Fax (505) 455–4455; Email: Director Indian Child Welfare, 286 Director, P.O. Box 729, Anadarko, OK [email protected]
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O 0334; Email: jsindelar@ C Ohkay Owingeh, Rochelle Thompson, southernute.nsn.us Chemehuevi Indian Tribe, Ronald ICWA Director, P.O. Box 1187, Ohkay T Escobar, Secretary/Treasurer, P.O. Owingeh, NM 87566; Phone (575) Box 1976, Havasu Lake, CA 92363; 770–0033; Fax: (505) 852–1372; Pueblo of Taos, Ezra Bayles, Taos Telephone: (760) 858–4219; Fax: (760) Email: Rochelle.thompson@ Pueblo Health and Community 858–5400 ohkayowingehnsn.gov Services, P.O. Box 1846, Taos, NM Cocopah Indian Tribe, Tomas Romero, 87571; Phone: (575) 758–7824; Fax: CTS–ICWA Specialist, 14515 South P (575) 758–3346; Email: EBayles@ Veterans Drive, Somerton, AZ 85350; Pueblo of Picuris, Jose Albert Valdez, taospueblo.com Telephone: (928) 627–3729; Fax: (928) P.O. Box 127, Penasco, NM 87553; Pueblo of Tesuque, Jeanette Jagles, 627–3316; Email: cocopahicwa@ Phone (575) 587–1003; Cell: (575) Director Social Services, Route 42, cocopah.com 779–2146; Fax (575) 587–1003; Email: Box 360–T, Santa Fe, NM 87506; Colorado River Indian Tribes, Ray [email protected] Phone: (505) 955–7713; Fax: (505) Barnett Social Services Manager, Pueblo of Pojoaque, Elizabeth Duran 982–2331; Email: jjagles@ 12302 Kennedy Drive, Parker, AZ MSW, MPH, Social Services Director, pueblooftesuque.org 85344; Telephone: (928) 669–8187; 58 Cities of Gold Road, Suite 4, Santa U Fax: (928) 669–8881; Email: Fe, NM 87506; Phone: (505) 455– ray.barnett@CRIT–DHS.org 0238; Fax: (505) 455–2363; Email: Ute Mountain Ute Tribe, Constance Confederated Tribes of the Goshute [email protected] Lehi, Director, P.O. Box 300, Towaoc, Reservation, Stefany Sellick, ICWA, CO 81334; Phone: (970) 564–5302; P.O. Box HC61 Box 6104,, Ibapah, UT R Fax: (970) 564–5300; Email: Clehi@ 84034; Telephone: (435) 234–1178; Ramah Navajo School Board, Inc., utemoutain.org Fax: (435) 234–1219; Email: Marlene Martinez, Administrative Y [email protected] Services Director, P.O. Box 10, Pine Hill, NM 87357; Phone (505) 775– Ysleta del Sur Pueblo, Jesus Donacio, D 3256; Fax: (505) 775–3240; Email: ICW Specialist, 9314 Juanchido Ln., Duckwater Shoshone Tribe, Iskandar [email protected] El Paso, TX 79907; Phone: (915) 860– Alexandar, MSW, Social Worker ; 6119, Ext. 6174; Fax: (915) 858–2367; P.O. Box 140087, Duckwater, NV S Email: [email protected] 89314; Telephone: (775) 863–0222; Pueblo of San Felipe, Darlene Valencia, Z Fax: (775) 863–0142 MSW, Family Services Department Director, P.O. Box 4339, San Felipe Pueblo of Zia, Victoria Herrera, ICWA E Pueblo, NM 87004; Phone (505) 771– Coordinator, 135 Capital Square Elko Band Council of Te- Moak Tribe, 9900; Fax: (505) 867–6166; Email: Drive, Zia Pueblo, NM 87053; Phone: Chesarae Christean, Social Worker [email protected] (505) 867–3304; Fax: (505) 867–3308; 1745 Silver Eagle Drive, Elko, NV Pueblo of San Ildelfonso, Julie Sanchez, Email: [email protected] 89801; Telephone: (775) 738–8889; ICWA Manager/Family Advocate, 02 Pueblo of Zuni, Betty Nez, Program Fax: (775) 778–3397; Email: Tunyo Po, Santa Fe, NM 87506; Manager, P.O. Box 339, Zuni, NM [email protected] Phone (505) 455–4164; Fax: (505) 87327; Phone: (505) 782–7166; Fax: Ely Shoshone Tribe, RaeJean Morrill, 455–7942; Email: jjsanchez@ (505) 782–7221; Email: betnez@ Social Worker II, 16 Shoshone Circle, sanipueblo.org ashiwi.org Ely, NV 89301; Telephone: (775) 289– Pueblo of Sandia, Randall Berner, 12. Western Region 4133; Fax: (775) 289–3237 Behavioral Health Manager, 481 Sandia Loop, Bernalillo, NM 87004; Western Region Director, 2600 North F Phone: (505) 867–5131; Fax: (505) Central Avenue, Phoenix, AZ 85004; Fallon Paiute-Shoshone Tribe, ICWA 867–7099; Email: rberner@ Telephone: (602) 379–6600; Fax: (602) Representative, 1007 Rio Vista, sandiapueblo.nsn.us 379–4413; Marjorie Eagleman, MSW, Fallon, NV 89406; Telephone: (775) Pueblo of Santa Ana, George M. Regional Social Worker, 2600 North 423–1215; Fax: (775) 423–8960; Montoya, Governor, Santa Ana Central Avenue, Phoenix, AZ 85004; Email: [email protected] Pueblo, 02 Dove Road, Santa Ana Telephone: (602) 379–6785; Fax: (602) Fort McDermitt Paiute-Shoshone Tribe, Pueblo, NM 87004; Phone: (505) 771– 379–3010; Email: Marjorie.eagleman@ Dee Crutcher, ICWA Advocate, P.O. 6702; Fax:(505) 771–6575; Email: bia.gov Box 68, McDermitt, NV 89421; [email protected] Telephone: (775) 532–8263, Ext. 111; Pueblo of Santa Clara, Cheryl Tafoya, A Fax: (775) 532–8060; Email: ICWA Worker, P.O. Box 580, Ak-Chin Indian Community, Carole [email protected] Espanola, NM 87532; Phone: (505) Lopez, Enrollment Specialist, 42507 Fort McDowell Yavapai Nation, James 753–0419 or (505) 692–6250; Fax: West Peters & Nall Road, Maricopa, Esquirell, ICWA Coordinator/CPS (505) 753–0420; Email: ectafoya@ AZ 85138; Telephone: (520) 568– Worker, P.O. Box 17779, Fountain santaclarapueblo.org 1006; Fax: (520) 568–1001; Email: Hills, AZ 85269; Telephone: (480) Santo Domingo, Doris Bailon, Program [email protected] 789–7990; Fax: (480) 837–4809; Director, P.O. Box 129, Santo Email: [email protected] B Domingo, NM 87052; Phone: (505) Fort Mojave Indian Tribe, Melvin Lewis 465–0630; Fax: (505) 465–2554; Battle Mountain Band Council, Monica Sr., Director, Social Services, 500 Email: [email protected] Price, Social Worker III/ICWA Merriman Avenue, Needles, CA Southern Ute Indian Tribe, Jerri Coordinator, 37 Mountain View Drive, 92363; Telephone: (928) 346–1550 or Sindelar, ICWA Caseworker, MS 40, Battle Mountain, NV 89820; Toll Free Number: (866) 346–6010; P.O. Box 737, Ignacio, CO 81137; Telephone: (775) 635–2004; Fax: (775) Fax: (928) 346–1552; Email: ssdir@ Phone (970) 769–2920; Fax (970) 563– 635–8528 ftmojave.com
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G Email: tamara.walters@pascuayaqui- T Gila River Indian Community, nsn.gov Te-Moak Tribe of Western Shoshone Antoinette Enos, MSW, ICWA Case Pyramid Lake Paiute Tribe, Rose Mary Indians (See Elko Band Council) Manager, Tribal Social Services, P.O. Joe-Kinale, Social Services Director, Tohono O’odham Nation, Jonathan L. Box 427, Sacaton, AZ 85147; P.O. Box 256, Nixon, NV 89424; Jantzen, Attorney General, P.O. Box Telephone: (520) 562–3396; Fax: (520) Telephone: (775) 574–1047; Fax: (775) 830, Sells, AZ 85634; Telephone: 562–3633; Email: Antoinette.Enos@ 574–1052; Email: [email protected] (520) 383–3410; Fax: (520) 383–2689; gric.nsn.us Q Email: jonathan.jantzen@tonation- nsn.gov H Quechan Tribe, Ft. Yuma, Rod Nelson, Tonto Apache Tribe, Brian Echols, Havasupai Tribe, Tanya Watahomigie, Quechan Social Services, Director, Social Services Director, T.A.R. #30, ICWA Coordinator, P.O. Box 10, P.O. Box 1890, Yuma, AZ 85366– Payson, AZ 85541; Telephone: (928) Supai, AZ 86435; Telephone: (928) 1899; Telephone: (760) 572–0201; 474–5000, Ext. 8120, Fax: (928) 474– 448–2661; Fax: (928) 448–2662; Fax: (760) 572–2099; Email: 4159; Email: bechols@ [email protected] socialservicedirector@ TontoApache.org quechantribe.com The Hopi Tribe, Hopi Guidance Center, U ICWA Coordinator, P.O. Box 68, R Second Mesa, AZ 86043; Telephone: Ute Indian Tribe, Floyd M. Wyasket, (928) 737–1800; Fax: (928) 737–2697 Reno-Sparks Indian Colony, Cheryl Social Services Director, Box 190, Fort Hualapai Tribe, Vonda R. Beecher, Douglas, Human Services Manager, Duchesne, UT 84026; Telephone: ICWA Worker, P.O. Box 480, Peach 405 Golden Lane, Reno, NV 89502; (435) 725–4026 or (435) 823–0141; Springs, AZ 86434; Telephone: (928) Telephone: (775) 329–5071; Fax: (775) Fax: (435) 722–5030; Email: floydw@ 769–2269/2383/2384/2397; Fax: (928) 785–8758; Email: [email protected] utetribe.com 769–2659 S W Walker River Paiute Tribe, Elliott K Salt River Pima-Maricopa Indian Aguilar, ICWA Specialist, P.O. Box Community, Allison Miller, ICWA Kaibab Band of Paiute Indians, Ronica 146 or 1029 Hospital Road, Schurz, Coordinator, SRPMIC Social Services L. Spute, Tribal Administrator; HC 65 NV 89427; Telephone: (775) 773–2058 Division, 10005 East Osborn Road, Box 2, Fredonia, AZ 86022; Ext: 11; Fax: (775) 773–2096;Email: Scottsdale, AZ 85256; Telephone: Telephone: (928) 643–7245; Fax: (888) [email protected] 822–3734; Email: rspute@ (480) 362–5645, Direct: (480) 362– Washoe Tribe of Nevada and California, kaibabpaiute-nsn.gov 7533; Fax: (480) 362–5574; Email: Office of the Chairperson, 919 U.S. [email protected] L Highway. 395 South, Gardnerville, San Carlos Apache Tribe, Aaron Begay, NV 89410; Telephone: (775) 265– Las Vegas Paiute Tribe, Ruth Fitz- ICWA Coordinator, P.O. Box 0, San 8600; Fax: (775) 265–6240 Patrick, Social Services Caseworker, Carlos, AZ 85550; Telephone: (928) Wells Band Te-Moak Shoshone, Sarai 1257 Paiute Circle, Las Vegas, NV 475–2313; Fax: (928) 475–2342; Harney, Social Services/ICWA, P.O. 89106; Telephone: (702) 382–0784, Email: [email protected] Box 809, Wells, NV 89835; #410; Fax: (702) 384–5272; Email: San Juan Southern Paiute Tribe, Savania Telephone: (775) 345–3079; Fax: (775) [email protected] Tsosie, Social Worker, 180 North 200 752–2474 Lovelock Paiute Tribe, Fran Machado, East, Suite 111, St. George, UT 84770; White Mountain Apache Tribe, Cora Director Social Services Director, 201 Telephone: (435) 674–9720; Fax: (435) Hinton, ICWA Representative/CPS Bowean Street, Lovelock, NV 89419; 674–9714; Email: savania.tsosie@ Supervisor, P.O. Box 1870, Telephone: (775) 273–5081; Fax: (775) bia.gov Whiteriver, AZ 85941; Telephone: 273–5151; fmachado@ Shoshone-Paiute Tribes, Zannetta (928) 338–4164, Fax: (928) 338–1469; lovelockpaiutetribe.com Hanks, LSW, Social Worker, P.O. Box Email: [email protected] M 219, Owyhee, NV 89832; Telephone: Winnemucca Tribe, Chairman, P.O. Box (775) 757–2921, Ext. 26; Fax: (775) 1370, Winnemucca, NV 89446 Moapa Band of Paiutes, Dawn M. Bruce, 757–2253; Email: hanks.zannetta@ Social Services Director, P.O. Box Y shopai.org 308, Moapa, NV 89025; Telephone: Yavapai Apache Nation, Linda Fry, (702) 865–2708; Fax: (702) 864–0408; Skull Valley Band of Goshute Indians, Director, Department of Social Email: mbopsocialservices@ Lori Bear, Chairwoman, P.O. Box 448, Services, 2400 West Datsi Street, mvdsl.com Grantsville, UT 84029; Telephone: Camp Verde, AZ 86322; Telephone: (435) 882–4532; Fax: (435) 882–4889; P (928) 649–7106; Fax: (928) 567–6832; Email: [email protected] Email: [email protected] Paiute Indian Tribe of Utah, Tyler South Fork Band Council, Debbie Yavapai-Prescott Indian Tribe, Elsie Goddard, Behavioral Health Director, Honeyestewa, Social Services Watchman, Family Support 440 North Paiute Drive, Cedar City, Director, 21 Lee, B–13, Spring Creek, Supervisor, 530 East Merritt, Prescott, UT 84721; Telephone: (435) 586– NV 89815; Telephone: (775) 744– AZ 86301; Telephone: (928) 515– 1112; Fax: (435) 867–2659; Email: 4273; Fax: (775) 744–4523 7351; Fax: (928) 541–7945; Email: [email protected] Summit Lake Paiute Tribe, Elizabeth [email protected] Pascua Yaqui Tribe, Office of the Delaluz, Council Member ICWA Yerington Paiute Tribe, Vonnie Snooks, Attorney General, Attn: Tamara Liaison, 1708 H Street, Sparks, NV Human Services Assistant, 171 Walters, Assistant Attorney General, 89431; Telephone: (775) 827–9670; Campbell Lane, Yerington, NV 89447; 7777 S. Camino Huivisim, Bldg. C, Fax: (775) 827–9678; Email: Telephone: (775) 463–7705; Fax: (775) Tucson, AZ 85757; Telephone: (520) elizabeth.delaluz@ 463–5929; Email: vsnooks@ypt- 883–5108; Fax: (520) 883–5084; summitlaketribe.org nsn.gov
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Yomba Shoshone Tribe, Raylon M. docket number (OSHA–2011–0060) for reduce to the maximum extent feasible Dyer, Eligibility Worker, HC 61 Box the Information Collection Request unnecessary duplication of efforts in 6275, Austin, NV 89310; Telephone: (ICR). All comments, including any obtaining information (29 U.S.C. 657). (775) 964–2463, Ext. 107; Fax: (775) personal information you provide, are The Standard protects workers from 964–1352; Email: Socialservices@ placed in the public docket without the adverse health effects that may yombatribe.org change, and may be made available result from their exposure to methylene Dated: November 24, 2014. online at http://www.regulations.gov. chloride (MC). The requirements in the Kevin K. Washburn, For further information on submitting Standard include worker exposure comments see the ‘‘Public monitoring, notifying workers of their Assistant Secretary—Indian Affairs. Participation’’ heading in the section of MC exposures, administering medical [FR Doc. 2014–28510 Filed 12–3–14; 8:45 am] this notice titled SUPPLEMENTARY examinations to workers, providing BILLING CODE 4310–4J–P INFORMATION. examining physicians with specific Docket: To read or download program and worker information, comments or other material in the ensuring that workers receive a copy of DEPARTMENT OF LABOR docket, go to http://www.regulations.gov their medical examination results, or the OSHA Docket Office at the maintaining workers’ exposure Occupational Safety and Health address above. All documents in the monitoring and medical examination Administration docket (including this Federal Register records for specific periods, and [Docket No. OSHA–2011–0060] notice) are listed in the http:// providing access to these records by www.regulations.gov index; however, OSHA, the National Institute for Methylene Chloride Standard; some information (e.g., copyrighted Occupational Safety and Health, the Extension of the Office of Management material) is not publicly available to affected workers, and their authorized and Budget’s (OMB) Approval of read or download from the Web site. All representatives. Information Collection (Paperwork) submissions, including copyrighted Requirements material, are available for inspection II. Special Issues for Comment AGENCY: Occupational Safety and Health and copying at the OSHA Docket Office. OSHA has a particular interest in Administration (OSHA), Labor. You also may contact Theda Kenney at comments on the following issues: the address below to obtain a copy of • Whether the proposed information ACTION: Request for public comments. the ICR. collection requirements are necessary SUMMARY: OSHA solicits public FOR FURTHER INFORMATION CONTACT: for the proper performance of the comments concerning its proposal to Theda Kenney or Todd Owen, Agency’s functions, including whether extend the Office of Management and Directorate of Standards and Guidance, the information is useful; Budget’s (OMB) approval of the OSHA, U.S. Department of Labor, Room • The accuracy of OSHA’s estimate of information collection requirements N–3609, 200 Constitution Avenue NW., the burden (time and costs) of the specified in the Methylene Chloride Washington, DC 20210; telephone (202) information collection requirements, Standard (29 CFR 1910.1052). 693–2222. including the validity of the DATES: Comments must be submitted SUPPLEMENTARY INFORMATION: methodology and assumptions used; (postmarked, sent, or received) by • The quality, utility, and clarity of I. Background February 2, 2015. the information collected; and • ADDRESSES: The Department of Labor, as part of its Ways to minimize the burden on Electronically: You may submit continuing effort to reduce paperwork employers who must comply; for comments and attachments and respondent (i.e., employer) burden, example, by using automated or other electronically at http:// conducts a preclearance consultation technological information collection www.regulations.gov, which is the program to provide the public with an and transmission techniques. opportunity to comment on proposed Federal eRulemaking Portal. Follow the III. Proposed Actions instructions online for submitting and continuing information collection comments. requirements in accord with the The Agency is requesting an Facsimile: If your comments, Paperwork Reduction Act of 1995 adjustment decrease in the number of including attachments, are not longer (PRA–95) (44 U.S.C. 3506(c)(2)(A)). This burden hours from 63,560 to 54,481 than 10 pages you may fax them to the program ensures that information is in hours (a total decrease of 9,079 hours). OSHA Docket Office at (202) 693–1648. the desired format, reporting burden The reduction is a result the Agency’s Mail, hand delivery, express mail, (time and costs) is minimal, collection estimate, based on updated data, that messenger, or courier service: When instruments are clearly understood, and the number of establishments and using this method, you must submit OSHA’s estimate of the information workers affected by the Standard has your comments and attachments to the collection burden is accurate. The decreased. Also, part of the decrease in OSHA Docket Office, Docket No. Occupational Safety and Health Act of burden hours is related to the OSHA–2011–0060, Occupational Safety 1970 (the OSH Act) (29 U.S.C. 651 et determination that the training and Health Administration, U.S. seq.) authorizes information collection provision of the Standard, although still Department of Labor, Room N–2625, by employers as necessary or in effect, is not considered to be a 200 Constitution Avenue NW., appropriate for enforcement of the OSH collection of information. The estimated Washington, DC 20210. Deliveries Act or for developing information operation and maintenance cost (hand, express mail, messenger, and regarding the causes and prevention of increased from $19,214,570 to courier service) are accepted during the occupational injuries, illnesses, and $19,381,635 due to the increase in the Department of Labor’s and Docket accidents (29 U.S.C. 657). The OSH Act cost of medical exams and exposure Office’s normal business hours, 8:15 also requires that OSHA obtain such monitoring associated with the a.m. to 4:45 p.m., e.t. information with minimum burden Standard. Instructions: All submissions must upon employers, especially those Type of Review: Extension of a include the Agency name and OSHA operating small businesses, and to currently approved collection.
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Title: Methylene Chloride Standard www.regulations.gov Web site to submit to the OSHA Docket Office, Docket No. (29 CFR 1910.1052). comments and access the docket is OSHA–2011–0196, U.S. Department of OMB Control Number: 1218–0179. available at the Web site’s ‘‘User Tips’’ Labor, Occupational Safety and Health Affected Public: Business or other for- link. Contact the OSHA Docket Office Administration, Room N–2625, 200 profits. for information about materials not Constitution Avenue NW., Washington, Number of Respondents: 78,770. available from the Web site, and for DC 20210. Deliveries (hand, express Frequency of Response: Annually; assistance in using the Internet to locate mail, messenger, and courier service) semi-annually; quarterly; on occasion. docket submissions. are accepted during the Department of Total Responses: 214,575. Labor’s and Docket Office’s normal V. Authority and Signature Average Time per Response: Varies business hours, 8:15 a.m. to 4:45 p.m., from 1 hour for administering a medical David Michaels, Ph.D., MPH, e.t. examination to 5 minutes (.08 hour) to Assistant Secretary of Labor for Instructions: All submissions must maintain a worker’s medical or Occupational Safety and Health, include the Agency name and the OSHA exposure record. directed the preparation of this notice. docket number (OSHA–2011–0196) for Estimated Total Burden Hours: The authority for this notice is the the Information Collection Request 54,481. Paperwork Reduction Act of 1995 (44 (ICR). All comments, including any Estimated Cost (Operation and U.S.C. 3506 et seq.) and Secretary of personal information you provide, are Maintenance): $19,381,635. Labor’s Order No. 1–2012 (77 FR 3912). placed in the public docket without IV. Public Participation—Submission of Signed at Washington, DC, on December 1, change, and may be made available Comments on This Notice and Internet 2014. online at http://www.regulations.gov. Access to Comments and Submissions David Michaels, For further information on submitting You may submit comments in Assistant Secretary of Labor for Occupational comments see the ‘‘Public response to this document as follows: Safety and Health. Participation’’ heading in the section of SUPPLEMENTARY (1) Electronically at http:// [FR Doc. 2014–28499 Filed 12–3–14; 8:45 am] this notice titled INFORMATION. www.regulations.gov, which is the BILLING CODE 4510–26–P Federal eRulemaking Portal; (2) by Docket: To read or download facsimile; or (3) by hard copy. All comments or other material in the comments, attachments, and other DEPARTMENT OF LABOR docket, go to http://www.regulations.gov material must identify the Agency name or the OSHA Docket Office at the and the OSHA docket number (Docket Occupational Safety and Health address above. All documents in the No. OSHA–2011–0060) for this ICR. You Administration docket (including this Federal Register notice) are listed in the http:// may supplement electronic submissions [Docket No. OSHA–2011–0196] by uploading document files www.regulations.gov index; however, electronically. If you wish to mail The Vinyl Chloride Standard; some information (e.g., copyrighted additional materials in reference to an Extension of the Office of Management material) is not publicly available to electronic or facsimile submission, you and Budget’s (OMB) Approval of read or download from the Web site. All must submit them to the OSHA Docket Information Collection (Paperwork) submissions, including copyrighted Office (see the section of this notice Requirements material, are available for inspection titled ADDRESSES). The additional and copying at the OSHA Docket Office. AGENCY: materials must clearly identify your Occupational Safety and Health You may also contact Theda Kenney at electronic comments by your name, Administration (OSHA), Labor. the address below to obtain a copy of date, and docket number so the Agency ACTION: Request for public comments. the ICR. can attach them to your comments. FOR FURTHER INFORMATION CONTACT: SUMMARY: OSHA solicits public Because of security procedures, the Theda Kenney or Todd Owen, comments concerning its proposal to use of regular mail may cause a Directorate of Standards and Guidance, extend OMB approval of the significant delay in the receipt of OSHA, U.S. Department of Labor, Room information collection requirements comments. For information about N–3609, 200 Constitution Avenue NW., specified in the Vinyl Chloride Standard security procedures concerning the Washington, DC 20210; telephone (202) (29 CFR 1910.1017). delivery of materials by hand, express 693–2222. delivery, messenger, or courier service, DATES: Comments must be submitted SUPPLEMENTARY INFORMATION: please contact the OSHA Docket Office (postmarked, sent, or received) by at (202) 693–2350, (TTY (877) 889– February 2, 2015. I. Background 5627). ADDRESSES: The Department of Labor, as part of its Comments and submissions are Electronically: You may submit continuing effort to reduce paperwork posted without change at http:// comments and attachments and respondent (i.e., employer) burden, www.regulations.gov. Therefore, OSHA electronically at http:// conducts a preclearance consultation cautions commenters about submitting www.regulations.gov, which is the program to provide the public with an personal information such as social Federal eRulemaking Portal. Follow the opportunity to comment on proposed security numbers and date of birth. instructions online for submitting and continuing information collection Although all submissions are listed in comments. requirements in accord with the the http://www.regulations.gov index, Facsimile: If your comments, Paperwork Reduction Act of 1995 some information (e.g., copyrighted including attachments, are not longer (PRA–95) (44 U.S.C. 3506(c)(2)(A)). This material) is not publicly available to than 10 pages you may fax them to the program ensures that information is in read or download from this Web site. OSHA Docket Office at (202) 693–1648. the desired format, reporting burden All submissions, including copyrighted Mail, hand delivery, express mail, (time and costs) is minimal, collection material, are available for inspection messenger, or courier service: When instruments are clearly understood, and and copying at the OSHA Docket Office. using this method, you must submit a OSHA’s estimate of the information Information on using the http:// copy of your comments and attachments collection burden is accurate. The
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Occupational Safety and Health Act of (C) Respirator Program (G) Recordkeeping (§ 1910.1017(m)) 1970 (the OSH Act) (29 U.S.C. 651 et (§ 1910.1017(g)(2)) Employers must maintain worker seq.) authorizes information collection exposure and medical records. Medical by employers as necessary or When respirators are required, the employer must establish a respiratory and monitoring records are maintained appropriate for enforcement of the Act principally for worker access, but are or for developing information regarding protection program in accord with 1910.134, paragraphs (b) through (d) designed to provide valuable the causes and prevention of (except (d)(1)(iii) and (d)(3)(iii)(B)(1) information to both workers and occupational injuries, illnesses, and and (2)) and (f) through (m). Paragraph employers. The medical and monitoring accidents (29 U.S.C. 657). The OSH Act 1910.134(c) requires the employer to records required by this standard will also requires that OSHA obtain such develop and implement a written aid workers and their physicians in information with minimum burden respiratory protection program with determining whether or not treatment or upon employers, especially those worksite-specific procedures and other interventions are needed for VC operating small businesses, and to elements for required respirator use. exposure. The information also will reduce to the maximum extent feasible The purpose of these requirements is to enable employers to ensure that workers unnecessary duplication of efforts in ensure that employers establish a are not being overexposed; such obtaining information (29 U.S.C. 657). standardized procedure for selecting, information may alert the employer that The Standard specifies a number of using, and maintaining respirators for steps must be taken to reduce VC paperwork requirements. The following each workplace where respirators will exposures. is a brief description of the collection of be used. Developing written procedures Exposure records must be maintained information requirements contained in ensures that employers develop a for at least 30 years, and medical the Vinyl Chloride (VC) Standard. respirator program that meets the needs records must be kept for the duration of of their workers. employment plus 20 years, or for a total (A) Exposure Monitoring (§ 1910.1017(d) of 30 years, whichever is longer. and (§ 1910.1017(n)) (D) Emergency Plan (§ 1910.1017(i)) Records must be kept for extended periods because of the long latency Employers must develop a written Paragraph 1910.1017(d)(2) requires period associated with VC-related operational plan for dealing with employers to conduct exposure carcinogenesis (i.e., cancer). Cancer emergencies; the plan must address the monitoring at least quarterly if the often cannot be detected until 20 or storage, handling, and use of VC as a results show that worker exposures are more years after the first exposure to liquid or compressed gas. In the event above the permissible exposure limit VC. (PEL), while those exposed at or above of an emergency, appropriate elements the Action Level (AL) must be of the plan must be implemented. II. Special Issues for Comment monitored no less than semiannually. Emergency plans must maximize OSHA has a particular interest in Paragraph (d)(3) requires that employers workers’ personal protection and comments on the following issues: perform additional monitoring minimize the hazards of an emergency. • Whether the proposed information whenever there has been a change in VC (E) Medical Surveillance collection requirements are necessary production, process or control that may (§ 1910.1017(k)) for the proper performance of the result in an increase in the release of Agency’s functions, including whether VC. Paragraph (k) requires employers to the information is useful; develop a medical surveillance program • The accuracy of OSHA’s estimate of Paragraph 1910.1017(n) requires for workers exposed to VC in excess of employers to inform each worker of the burden (time and costs) of the the action level. Examinations must be information collection requirements, their exposure monitoring results within provided in accord with this paragraph 15 working days after receiving these including the validity of the at least annually. Employers must also methodology and assumptions used; results. Employers may notify workers obtain, and provide to each worker, a • either individually in writing or by The quality, utility, and clarity of copy of a physician’s statement the information collected; and posting the monitoring results in an regarding the worker’s suitability for • appropriate location that is accessible to Ways to minimize the burden on continued exposure to VC, including employers who must comply; for the workers. In addition, if the exposure use of protective equipment and example, by using automated or other monitoring results show that a worker’s respirators, if appropriate. technological information collection exposure exceeds the PEL, the employer and transmission techniques. must inform the exposed worker of the (F) Communication of VC Hazards corrective action the employer is taking (§ 1910.1017(l)) III. Proposed Actions to prevent such overexposure. Under paragraph 1910.1017(l)(2), the OSHA is requesting that OMB extend (B) Written Compliance Plan employer shall include vinyl chloride its approval of the information (§§ 1910.1017(f)(2) and (f)(3)) and polyvinyl chloride (PVC) in the collection requirements contained in the program established to comply with the Vinyl Chloride Standard. The Agency is Paragraph (f)(2) requires employers Hazard Communication Standard (HCS) requesting an adjustment decrease in whose engineering and work practice (§ 1910.1200). The employer shall burden hours from 549 to 535 hours, a controls cannot sufficiently reduce ensure that each employee has access to total decrease of 14 burden hours. The worker VC exposures to a level at or labels on containers of chemicals and reduction is a result of few VC and PVC below the PEL to develop and substances associated with vinyl and establishments identified for this ICR. implement a plan for doing so. polyvinyl chloride and to safety data The currently approved ICR estimates a Paragraph (f)(3) requires employers to sheets, and is trained in accord with the total of 26 establishments, and this develop this written plan and provide it provisions of HCS and paragraph (l) of proposed ICR estimates a total of 24 upon request to OSHA for examination this section. The employer shall ensure establishments. The adjustment of the and copying. These plans must be that at least the following hazard is burden hours are shown in detail by updated annually. addressed: Cancer. provision in the supporting statement.
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Type of Review: Extension of a inspection and copying at the OSHA at telephone number 301–837–1694, or currently approved collection. Docket Office. Information on using the fax number 301–713–7409. Title: Vinyl Chloride Standard (29 http://www.regulations.gov Web site to SUPPLEMENTARY INFORMATION: Pursuant CFR 1910.1017). submit comments and access the docket to the Paperwork Reduction Act of 1995 OMB Control Number: 1218–0010. is available at the Web site’s ‘‘User (Pub. L. 104–13), NARA invites the Affected Public: Business or other for- Tips’’ link. Contact the OSHA Docket general public and other Federal profits. Office for information about materials agencies to comment on proposed Number of Respondents: 24. not available from the Web site, and for information collections. The comments Frequency of Responses: On occasion; assistance in using the Internet to locate and suggestions should address one or annually. docket submissions. more of the following points: (a) Total Responses: 835. Whether the proposed information V. Authority and Signature Average Time per Response: Varies collection is necessary for the proper from five minutes (.08 hour) for David Michaels, Ph.D., MPH, performance of the functions of NARA; employers to maintain records to 12 Assistant Secretary of Labor for (b) the accuracy of NARA’s estimate of hours for employers to update their Occupational Safety and Health, the burden of the proposed information compliance plans. directed the preparation of this notice. collection; (c) ways to enhance the Estimated Total Burden Hours: 535. The authority for this notice is the quality, utility, and clarity of the Estimated Cost (Operation and Paperwork Reduction Act of 1995 (44 information to be collected; and (d) Maintenance): $43,320. U.S.C. 3506 et seq.) and Secretary of ways to minimize the burden of the IV. Public Participation—Submission of Labor’s Order No. 1–2012 (77 FR 3912). collection of information on Comments on This Notice and Internet Signed at Washington, DC, on December 1, respondents, including the use of Access to Comments and Submissions 2014. information technology; and (e) whether You may submit comments in David Michaels, small businesses are affected by this response to this document as follows: Assistant Secretary of Labor for Occupational collection. The comments that are (1) Electronically at http:// Safety and Health. submitted will be summarized and included in the NARA request for Office www.regulations.gov, which is the [FR Doc. 2014–28500 Filed 12–3–14; 8:45 am] of Management and Budget (OMB) Federal eRulemaking Portal; (2) by BILLING CODE 4510–26–P facsimile (fax); or (3) by hard copy. All approval. All comments will become a comments, attachments, and other matter of public record. In this notice, material must identify the Agency name NARA is soliciting comments NATIONAL ARCHIVES AND RECORDS concerning the following information and the OSHA docket number (Docket ADMINISTRATION No. OSHA–2011–0196) for the ICR. You collections: Title: National Historical Publications may supplement electronic submissions [NARA–2015–014] and Records Commission (NHPRC) by uploading document files Grant Program, Budget Form and electronically. If you wish to mail Agency Information Collection Instructions. additional materials in reference to an Activities: Proposed Collection; Comment Request OMB number: 3095–0013. electronic or facsimile submission, you Agency form number: NA Form must submit them to the OSHA Docket AGENCY: National Archives and Records 17001. Office (see the section of this notice Administration (NARA). Type of review: Reinstatement of a titled ADDRESSES). The additional ACTION: Notice. previously cleared information materials must clearly identify your collection. electronic comments by your name, SUMMARY: NARA is giving public notice Affected public: Nonprofit date, and the docket number so the that the agency proposes to reinstate the organizations and institutions, state and Agency can attach them to your information collection described in this local government agencies, Federally comments. notice, which is used in the National acknowledged or state-recognized Because of security procedures, the Historical Publications and Records Native American tribes or groups, and use of regular mail may cause a Commission (NHPRC) grant program. individuals who apply for NHPRC significant delay in the receipt of The public is invited to comment on the grants for support of historical comments. For information about proposed information collections documentary editions, archival security procedures concerning the pursuant to the Paperwork Reduction preservation and planning projects, and delivery of materials by hand, express Act of 1995. other records projects. delivery, messenger, or courier service, DATES: Written comments must be Estimated number of respondents: please contact the OSHA Docket Office received on or before February 2, 2015 144 per year submit applications; at (202) 693–2350, (TTY (877) 889– to be assured of consideration. approximately 100 grantees among the 5627). applicant respondents also submit ADDRESSES: Comments and submissions are Comments should be sent semiannual narrative performance posted without change at http:// to: Paperwork Reduction Act Comments reports. www.regulations.gov. Therefore, OSHA (ISSD), Room 4400, National Archives Estimated time per response: 10 hours cautions commenters about submitting and Records Administration, 8601 per application; 2 hours per narrative personal information such as social Adelphi Rd, College Park, MD 20740– report. security numbers and date of birth. 6001; or faxed to 301–713–7409; or Frequency of response: On occasion Although all submissions are listed in electronically mailed to for the application; semiannually for the the http://www.regulations.gov index, [email protected]. narrative report. Currently, the NHPRC some information (e.g., copyrighted FOR FURTHER INFORMATION CONTACT: considers grant applications 2 times per material) is not publicly available to Requests for additional information or year; respondents usually submit no read or download from this Web site. copies of the proposed information more than one application per year. All submissions, including collections and supporting statements Estimated total annual burden hours: copyrighted material, are available for should be directed to Tamee Fechhelm 1,440 hours.
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Abstract: The NHPRC posts grant RAILROAD RETIREMENT BOARD requires evidence of full-time school announcements to their Web site and to attendance. This evidence is acquired Grants.gov (www.grants.gov), where the Agency Forms Submitted for OMB through the RRB’s student monitoring information will be specific to the grant Review, Request for Comments program, which utilizes the following opportunity named. The basic Summary: In accordance with the forms. Form G–315, Student information collection remains the Paperwork Reduction Act of 1995 (44 Questionnaire, obtains certification of a same. The NA Form 17001 is used by U.S.C. Chapter 35), the Railroad student’s full-time school attendance as the NHPRC staff, reviewers, and the Retirement Board (RRB) is an well as information on the student’s Commission to determine if the forwarding Information Collection marital status, social security benefits, applicant and proposed project are Request (ICR) to the Office of and employment, which are needed to eligible for an NHPRC grant, and Information and Regulatory Affairs determine entitlement or continued whether the proposed project is (OIRA), Office of Management and entitlement to benefits under the RRA. methodologically sound and suitable for Budget (OMB). Our ICR describes the support. Form G–315A, Statement of School information we seek to collect from the Official, is used to obtain, from a school, Dated: November 25, 2014. public. Review and approval by OIRA verification of a student’s full-time Swarnali Haldar, ensures that we impose appropriate attendance when the student fails to Executive for Information Services/CIO. paperwork burdens. return a monitoring Form G–315. Form The RRB invites comments on the [FR Doc. 2014–28489 Filed 12–3–14; 8:45 am] G–315A.1, School Official’s Notice of BILLING CODE 7515–01–P proposed collections of information to determine (1) the practical utility of the Cessation of Full-Time School collections; (2) the accuracy of the Attendance, is used by a school to notify estimated burden of the collections; (3) the RRB that a student has ceased full- OVERSEAS PRIVATE INVESTMENT time school attendance. CORPORATION ways to enhance the quality, utility, and clarity of the information that is the Previous Requests for Comments: The Sunshine Act Meeting; Board of subject of collection; and (4) ways to RRB has already published the initial Directors Meeting Notice minimize the burden of collections on 60-day notice (79 FR 57988 on respondents, including the use of September 26, 2014) required by 44 TIME AND DATE: Thursday, December 11, automated collection techniques or U.S.C. 3506(c)(2). That request elicited 2014, 2 p.m. (OPEN Portion), 2:15 p.m. other forms of information technology. no comments. (CLOSED Portion) Comments to the RRB or OIRA must PLACE: Offices of the Corporation, contain the OMB control number of the Information Collection Request (ICR) Twelfth Floor Board Room, 1100 New ICR. For proper consideration of your York Avenue NW., Washington, DC comments, it is best if the RRB and Title: Student Beneficiary Monitoring. STATUS: Meeting OPEN to the Public OIRA receive them within 30 days of OMB Control Number: 3220–0123. from 2 p.m. to 2:15 p.m. Closed portion the publication date. Form(s) submitted: G–315, G–315A, will commence at 2:15 p.m. (approx.) 1. Title and purpose of information G–315A.1. collection: Student Beneficiary MATTERS TO BE CONSIDERED: Type of request: Revision of a 1. President’s Report Monitoring; OMB 3220–0123. currently approved collection of 2. Minutes of the Open Session of the Under provisions of the Railroad September 18, 2014 Board of Retirement Act (RRA), there are two information. Directors Meeting types of benefit payments that are based Affected public: Individuals or on the status of a child being in full- FURTHER MATTERS TO BE CONSIDERED Households. time elementary or secondary school (Closed to the Public 2:15 p.m.): Abstract: Under the Railroad 1. Finance Project—Kenya attendance at age 18–19: a survivor child’s annuity benefit under Section Retirement Act (RRA), a student benefit 2. Finance Project—India is not payable if the student ceases full- 3. Minutes of the Closed Session of the 2(d)(1)(iii) and an increase in the time school attendance, marries, works September 18, 2014 Board of employee retirement annuity under the Directors Meeting Special Guaranty computation as in the railroad industry, has excessive 4. Reports prescribed in section 3(f)(2) and 20 CFR earnings or attains the upper age limit 5. Pending Projects 229. under the RRA. The report obtains CONTACT PERSON FOR INFORMATION: The survivor student annuity is information to be used to determine if Information on the meeting may be usually paid by direct deposit to a benefits should cease or be reduced. obtained from Connie M. Downs at (202) financial institution either into the Changes proposed: The RRB proposes student’s checking or savings account or 336–8438. minor editorial and formatting changes into a joint bank account with a parent. Dated: December 1, 2014. The requirements for eligibility as a to Forms G–315, G–315A, and G– Connie M. Downs, student are prescribed in 20 CFR 216.74, 315A.1. Corporate Secretary, Overseas Private and include students in independent The burden estimate for the ICR is as Investment Corporation. study and home schooling. follows: [FR Doc. 2014–28561 Filed 12–2–14; 11:15 am] To help determine if a child is BILLING CODE 3210–01–P entitled to student benefits, the RRB
Annual Time Burden Form No. responses (minutes) (hours)
G–315 ...... 860 15 215 G–315a ...... 20 3 1 G–315a.1 ...... 20 2 1
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Annual Time Burden Form No. responses (minutes) (hours)
Total ...... 900 ...... 217
2. Title and purpose of information The railroad employer can elect to September 26, 2014) required by 44 collection: RUIA Claims Notification receive Form ID–4K by one of three U.S.C. 3506(c)(2). That request elicited and Verification System; OMB 3220– options: A computer-generated paper no comments. 0171. notice, by Electronic Data Interchange Information Collection Request (ICR) Section 5(b) of the Railroad (EDI), or online via the RRB’s Employer Title: RUIA Claims Notification and Unemployment Insurance Act (RUIA), Reporting System (ERS). The railroad employer can respond to the ID–4K Verification System. requires that effective January 1, 1990, notice by telephone, manually by OMB Control Number: 3220–0171. when a claim for benefits is filed with mailing a completed ID–4K back to the the Railroad Retirement Board (RRB), Form(s) submitted: ID–4K, ID–4K RRB, or electronically via EDI or ERS. (INTERNET), ID–4E, ID–4E the RRB shall provide notice of the Completion is voluntary. The RRB (INTERNET). claim to the claimant’s base year proposes no changes to any of the ID– employer(s) to provide them an Type of request: Extension without 4K options. change of a currently approved opportunity to submit information Once the RRB determines to pay a collection. relevant to the claim before making an claim post-payment Form Letter ID–4E, initial determination. If the RRB Affected public: Private Sector; Notice of RUIA Claim Determination, is Businesses or other for-profits. determines to pay benefits to the used to notify the base-year employer(s). claimant under the RUIA, the RRB shall Abstract: Section 5(b) of the RUIA This gives the employer a second notify the base-year employer(s). requires that effective January 1, 1990, opportunity to challenge the claim for when a claim for benefits is filed with The purpose of the RUIA Claims benefits. the Railroad Retirement Board (RRB), Notification and Verification System is The ID–4E mainframe-generated the RRB shall provide notice of such to provide two notices, pre-payment paper notice, EDI, and Internet versions claim to the claimant’s base-year Form ID–4K, Prepayment Notice of are transmitted on a daily basis, employer(s) and afford such employer(s) Employees’ Applications and Claims for generally on the same day that the an opportunity to submit information Benefits Under the Railroad claims are approved for payment. relevant to the claim before making an Unemployment Insurance Act, and post- Railroad employers who are mailed initial determination on the claim. payment Form ID–4E, Notice of RUIA Form ID–4E are instructed to write if When the RRB determines to pay Claim Determination. Prepayment Form they want a reconsideration of the RRB’s benefits to a claimant under the RUIA, ID–4K provides notice to a claimant’s determination to pay. Employers who the RRB shall provide notice of such base-year employer(s), of each receive the ID–4E electronically, may determination to the claimant’s base unemployment application and file a reconsideration request by year employer. unemployment and sickness claim filed completing the ID–4E by either EDI or Changes proposed: The RRB proposes for benefits under the RUIA and ERS. Completion is voluntary. no changes to the forms in the provides the employer an opportunity to Previous Requests for Comments: The collection. convey information relevant to the RRB has already published the initial The burden estimate for the ICR is as proper adjudication of the claim. 60-day notice (79 FR 57988 on follows:
Annual Time Burden Form No. responses (minutes) (hours)
ID–4K (Manual) ...... 1,250 2 42 ID–4K (EDI) ...... 17,500 (*) 210 ID–4K (Internet) ...... 57,000 2 1,900 ID–4E (Manual) ...... 50 2 2 ID–4E (Internet) ...... 120 2 4
Total ...... 75,920 ...... 2,158 * The burden for the 5 participating employers who transmit EDI responses is calculated at 10 minutes each per day, 251 workdays a year or 210 total hours of burden.
Additional Information or Comments: Charles Mierzwa, Railroad Retirement 202–395–6974, Email address: OIRA_ Copies of the forms and supporting Board, 844 North Rush Street, Chicago, [email protected]. documents can be obtained from Dana Illinois, 60611–2092 or Charles Mierzwa, Hickman at (312) 751–4981 or [email protected] and to the Chief of Information Resources Management. [email protected]. OMB Desk Officer for the RRB, Fax: Comments regarding the information [FR Doc. 2014–28467 Filed 12–3–14; 8:45 am] collection should be addressed to BILLING CODE 7905–01–P
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SECURITIES AND EXCHANGE The Exchange has prepared summaries, replicate electronically the current COMMISSION set forth in sections A, B, and C below, manual London Fix processes employed of the most significant parts of such by the LPPFCL as well as provide [Release No. 34–73701; File No. SR– statements. NYSEArca–2014–135] electronic market clearing processes for A. Self-Regulatory Organization’s platinum and palladium bullion Self-Regulatory Organizations; NYSE Statement of the Purpose of, and the transactions at the fixed prices Arca, Inc.; Notice of Filing and Statutory Basis for, the Proposed Rule established by the LME pricing Immediate Effectiveness of Proposed Change mechanism.5 The new electronic price Rule Change to Reflect a Change to fixing processes to be used by the LME 1. Purpose the Process for Determining the will continue to establish and publish Benchmark Values Used by the ETFS The Exchange proposes to reflect a fixed prices for troy ounces of platinum Platinum Trust, ETFS Palladium Trust, change in the administrative process for and palladium twice each London ETFS Precious Metals Trust and ETFS determining the benchmark values used trading day during fixing sessions White Metals Basket Trust by the ETFS Platinum Trust, the ETFS beginning at 9:45 a.m. London time (the Palladium Trust, the ETFS Precious ‘‘LME AM Fix’’) and 2:00 p.m. London November 28, 2014. Metals Trust and the ETFS White Metals 1 time (the ‘‘LME PM Fix’’). In addition to Pursuant to Section 19(b)(1) of the Basket Trust (each a ‘‘Trust’’ and, utilizing the same London Fix standards Securities Exchange Act of 1934 (the collectively, the ‘‘Trusts’’) with respect 2 3 and methods, the LME will also ‘‘Act’’) and Rule 19b–4 thereunder, to calculation of the net asset value notice is hereby given that, on (‘‘NAV’’) of shares (‘‘Shares’’) of each supervise the platinum and palladium November 25, 2014, NYSE Arca, Inc. such Trust. The Trusts are listed and electronic price fixing processes through (the ‘‘Exchange’’ or ‘‘NYSE Arca’’) filed traded pursuant to NYSE Arca Equities its market operations, compliance, with the Securities and Exchange Rules 8.201 for Commodity-Based Trust internal audit and third-party complaint Commission (the ‘‘Commission’’) the Shares. The sponsor for the Trusts is handling capabilities in order to support proposed rule change as described in ETFS Services USA LLC (‘‘Sponsor’’). the integrity of the LME AM and PM Items I and II below, which Items have The proposed administrative change Fixes. been prepared by the self-regulatory would replace as of the close of business The Sponsor anticipates that, organization. The Commission is November 30, 2014 references to the commencing December 1, 2014, the publishing this notice to solicit ‘‘London AM Fix’’ and ‘‘London PM Sponsor will determine that the LME comments on the proposed rule change Fix,’’ (collectively, the ‘‘London Fix’’), PM Fix will continue to be an from interested persons. the current platinum and palladium appropriate basis for valuing platinum I. Self-Regulatory Organization’s price mechanism that the London Platinum and Palladium Fixing and palladium, as applicable, received Statement of the Terms of Substance of upon purchase of a Trust’s Shares, the Proposed Rule Change Company Limited (the ‘‘LPPFCL’’) manually administers, with an delivered upon redemption of a Trust’s The Exchange proposes to change rule electronic platinum and palladium Shares and for determining the value of [sic] to reflect a change to the process bullion price fixing system (known as a Trust’s platinum and palladium for determining the benchmark values LMEbullion) administered by the bullion, as applicable each trading day. used by the ETFS Platinum Trust, the London Metal Exchange (‘‘LME’’),4 as The Sponsor also expects to determine ETFS Palladium Trust, the ETFS described below. that the LME PM Fix will fairly Precious Metals Trust and the ETFS represent the commercial value of Revised London Fix Procedures for White Metals Basket Trust, each of platinum and palladium bullion, as Platinum and Palladium which is currently listed on the applicable, held by each Trust. Exchange under NYSE Arca Equities On November 18, 2014, the Sponsor Rule 8.201, with respect to calculation issued a press release (‘‘Press Release’’) Exchange-Listed Platinum and of the net asset value of shares of each stating that the LPPFCL has announced Palladium-based Products such trust. The text of the proposed rule its intention to revise the London Fix change is available on the Exchange’s pricing benchmark processes for The Exchange lists and trades shares Web site at www.nyse.com, at the platinum and palladium after November of exchange traded products that principal office of the Exchange, and at 30, 2014. The afternoon session of the reference the London Fix for one or the Commission’s Public Reference London Fix has been the ‘‘Benchmark more purposes. Specifically, the Room. Price’’ for valuation of platinum and Exchange lists and trades shares of the palladium bullion held respectively by ETFS Platinum Trust 6, the ETFS II. Self-Regulatory Organization’s each of the Trusts. The LPPFCL has Statement of the Purpose of, and accepted a proposal by the LME to Statutory Basis for, the Proposed Rule 5 In a press release dated October 16, 2014, LME administer revised platinum and Change stated that LME’s electronic solution relating to the palladium price benchmark fix for platinum and palladium, LMEbullion, will In its filing with the Commission, the mechanisms on its behalf. Commencing provide a pricing methodology that fully meets the self-regulatory organization included December 1, 2014, the LME will operate administrative and regulatory needs of market statements concerning the purpose of, participants including the International platinum and palladium bullion price Organization of Securities Commissions (‘‘IOSCO’’) and basis for, the proposed rule change fixing systems (LMEbullion) that will Principles for Financial Benchmarks. and discussed any comments it received 6 See Securities Exchange Act Release Nos. 60970 on the proposed rule change. The text 4 The LME is regulated by the Financial Conduct (November 9, 2009), 74 FR 59319 (November 17, of those statements may be examined at Authority (FCA), an independent non-governmental 2009) (SR–NYSEArca–2009–95) (notice of filing of the places specified in Item IV below. body which exercises statutory regulatory power proposed rule change to list and trade shares of the under the Financial Services and Markets Act of ETFS Platinum Trust) (‘‘ETFS Platinum Notice’’); 2000 of the United Kingdom and which also 61220 (December 22, 2009), 74 FR 68886 (December 1 15 U.S.C. 78s(b)(1). regulates the major participating members of the 29, 2009) (SR–NYSEArca–2009–95) (order 2 15 U.S.C. 78a. London Bullion Market Association and the London approving proposed rule change to list and trade 3 17 CFR 240.19b–4. Platinum and Palladium Market (the ‘‘LPPM’’). shares of the ETFS Platinum Trust).
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Palladium Trust 7, the ETFS White registration statement under the LPPM fixing members). The LME’s Metals Basket Trust 8 and the ETFS Securities Act of 1933 Act (‘‘1933 Act’’) electronic price fixing processes also Precious Metals Basket Trust,9 each of relating to each such Trust.11 After will be fully auditable by third parties which is currently listed on the November 30, 2014, the Trusts will since an audit trail exists from the Exchange under NYSE Arca Equities utilize the benchmark price ascertained beginning of each fixing session. Rule 8.201. through the LME administered Moreover, the market operation, With respect to the Trusts, the NAV electronic fixing process for purposes of compliance, internal audit and third- of Shares of the respective Trusts is calculating the NAV of such Trust’s party complaint handling capabilities of based on the London PM Fix, as Shares. The Sponsor of the Trusts has the LME will support the integrity of the described in the applicable rule filings represented that, on December 1, 2014, LME AM and PM Fix.12 relating to listing and trading of Shares the Sponsor intends to use the LME PM The Exchange believes the new LME of each of the Trusts 10 and in the Fix for purposes of determining the net electronic price fixing processes will asset value of Shares of the Trusts. serve as an appropriate replacement to 7 See Securities Exchange Act Release Nos. 60971 Accordingly, the Exchange proposes to the London Fix for purposes of (November 9, 2009), 74 FR 59283 (November 17, change the benchmark price used by the 2009) (SR–NYSEArca–2009–94) (notice of filing of determining the NAV of Shares of the proposed rule change to list and trade shares of the Trusts for calculation of the NAV of Trusts because of the transparency of ETFS Palladium Trust) (‘‘ETFS Palladium Notice’’); Shares of each of such Trust to the LME the fixing process, the anticipated 61220 (December 22, 2009), 74 FR 68895 (December PM Fix. participation of an increased number of 29, 2009) (SR–NYSEArca–2009–94) (order Each LME AM and PM Fix is widely market participants compared to the approving proposed rule change to list and trade expected to be viewed as a full and fair shares of the ETFS Palladium Trust). London Fix, and the auditability of the representation of all market interest. 8 See Securities Exchange Act Release No. 62620 palladium and platinum pricing (July 30, 2010), 75 FR 47655 (August 6, 2010) (SR– The LME’s electronic price fixing mechanism. processes are similar to the non- NYSEArca–2010–71) (notice of filing of proposed In connection with this proposed rule rule change to list and trade shares of the ETFS electronic processes previously used to White Metals Basket Trust); 62875 (September 9, establish the applicable London Fix change, (1) the Sponsor of the Trusts 2010), 75 FR 56156 (September 15, 2010) (SR– where the London Fix process adjusted will issue a press release informing the NYSEArca–2010–71) (order approving proposed the platinum or palladium price up or public of the date a Trust will first use rule change to list and trade shares of the ETFS the LME PM Fix to value the palladium White Metals Basket Trust). down until all the buy and sell orders or platinum, as applicable, held by a 9 See Securities Exchange Act Release No. 62402 entered by LPPM fixing members are (June 29, 2010), 75 FR 39292 (July 8, 2010) (SR– matched, at which time the price was Trust; (2) the Sponsor will file the NYSEArca–2010–56) (notice of filing of proposed declared fixed. Nevertheless, the LME applicable press release with the rule change to list and trade shares of the ETFS AM and PM Fixes have several Commission by means of Form 8–K, Precious Metals Basket Trust); 62692 (August 11, which will be available on the 2010), 75 FR 50789 (August 17, 2010) (order advantages over the previous London approving proposed rule change to list and trade Fix. The LME’s electronic price fixing applicable Trust’s Web site; and (3) the shares of the ETFS Precious Metals Basket Trust). processes will be fully transparent in Sponsor will file an amendment to the 10 As described in the ETFS Platinum Notice and real time to the platinum and palladium applicable Registration Statement 13 the ETFS Palladium Notice, twice daily during market participants and, at the close of relating to the proposed change. London trading hours there is a fix which provides The Sponsor for the Trusts represents reference platinum and palladium prices for that each electronic fixing, to the general day’s trading. Many long-term contracts will be public. The LME AM and PM Fixes are that there is no change to the investment priced on the basis of either the morning (AM) or also to be established by more LBBM objective of the applicable Trust from afternoon (PM) London Fix, and market participants [sic] members (initially approximately that described in the applicable will usually refer to one or the other of these prices proposed rule change.14 The Trusts will when looking for a basis for valuations. The London ten) than was the London Fix (four Fix is the most widely used benchmark for daily be subject to all initial and continued platinum and palladium prices and is quoted by market participant may enter the fixing process at listing requirements under NYSE Arca various financial information sources. The LPPM any time, or adjust or withdraw his order. The Equities Rule 8.201. designated the LPPFCL to administer the London platinum or palladium price is adjusted up or down Except for the changes noted above, Fix. Formal participation in the London Fix is until all the buy and sell orders are matched, at traditionally limited to four firms, each of which is which time the price is declared fixed. All fixing all other facts presented and a bullion dealer and a member of the LPPM. The orders are transacted on the basis of this fixed price, representations made in the proposed chairmanship now rotates annually among the four which is instantly relayed to the market through rule changes referenced above remain LPPM fixing member firms. The morning session of various media. The London Fix is widely viewed unchanged. the fix starts at 9:45 a.m. London time and the as a full and fair representation of all market afternoon session starts at 2:00 p.m. London time. interest at the time of the fix. The four LPPM fixing members are currently: BASF 11 See the registration statement for the ETFS 12 The Prudential Regulation Authority (PRA) at SE., Goldman Sachs Group Inc., HSBC Holdings Palladium Trust on Form S–3, filed with the the Bank of England has overall responsibility for and Standard Bank PLC. Any other market Commission on April 17, 2014 (No. 333–195335); the prudential regulation of banks, building participant wishing to participate in platinum and the registration statement for the ETFS Platinum societies, credit unions, insurers and major palladium trading on the fix is required to do so Trust on Form S–3ASR, filed with the Commission investment firms, many of whom are active in the through one of the four LPPM fixing members. on June 3, 2013, and Post-Effective Amendment No. bullion market. The conduct of financial Orders are placed either with one of the four LPPM 1 thereto, filed with the Commission on June 5, institutions is overseen by the Financial Conduct fixing members or with another precious metals 2013 (File No. 333–189061); Post-Effective Authority (FCA), which was formed from the dealer who will then be in contact with a LPPM Amendment No. 1 to the registration statement for former Financial Services Authority and is separate fixing member during the fixing. The fixing the ETFS Precious Metals Trust on Form S–3, filed from the Bank of England. members net-off all orders when communicating with the Commission on August 13, 2014 (No. 333– 13 The Sponsor for the Trusts represents that it their net interest at the fixing. The fix begins with 195675); and Post-Effective Amendment No. 1 to manages the Trusts in the manner described in the the fixing chairman suggesting a ‘‘trying price,’’ the registration statement for the ETFS White applicable proposed rule change (see supra, notes reflecting the market price prevailing at the opening Metals Basket Trust on Form S–1, filed with the 6–9), and will not implement the changes described of the fix. This is relayed by the fixing members to Commission on August 13, 2014 (No. 333–195441) herein until the instant proposed rule change is their dealing rooms which have direct (each a ‘‘Registration Statement’’ and, collectively, operative. communication with all interested parties. Any the ‘‘Registration Statements’’). 14 See supra, notes 6–9.
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All terms referenced but not defined Shares of the Trusts because of the made in proposed rule changes herein are defined in the applicable transparency of the fixing process, the referenced above remain unchanged. proposed rule changes referenced participation of an increased number of The proposed rule change is designed above.15 market participants (initially, to perfect the mechanism of a free and 2. Statutory Basis approximately ten LPPM members) open market and, in general, to protect compared to the London Fix (four LPPM investors and the public interest in that The basis under the Act for this members), and the auditability of the the LME’s electronic price fixing proposed rule change is the requirement pricing mechanism. For each LME AM processes will be fully transparent in under Section 6(b)(5) 16 that an and PM Fix session, buying and selling real time to the platinum and palladium exchange have rules that are designed to order placements will be displayed market participants and, at the close of prevent fraudulent and manipulative electronically in real time for all each electronic fixing, to the general acts and practices, to promote just and platinum and palladium fixing public. The LME’s electronic price equitable principles of trade, to remove participants. The LME will observe all fixing processes also will be fully impediments to, and perfect the fixing session buying and selling order auditable by third parties since an audit mechanism of a free and open market placements, including the identity of trail exists from the beginning of each and, in general, to protect investors and those submitting orders. In addition, fixing session. Moreover, the market the public interest. each LME AM and PM Fix and all order operation, compliance, internal audit The Exchange believes that the placement information will become and third-party complaint handling proposed rule change is designed to publicly available electronically through capabilities of the LME will support the prevent fraudulent and manipulative the LME via financial news media integrity of the LME AM and PM Fix. acts and practices in that, according to services (such as, Bloomberg, Thomson The Trusts will continue to be listed the LME press release, the new Reuters, FactSet, Metal Radar and other and traded on the Exchange pursuant to LMEbullion fixing processes will services) instantly after the conclusion the initial and continued listing criteria provide a pricing methodology that fully in NYSE Arca Equities Rule 8.201. meets the administrative and regulatory of the fixing process, as described above. Except for the changes noted above, all needs of market participants, including other facts presented and the IOSCO Principles for Financial The proposed change will permit the representations made in proposed rule Benchmarks (the ‘‘IOSCO Trusts to continue to function as changes referenced above remain Principles’’).17 In order to meet the platinum- and palladium-based unchanged.18 IOSCO Principles, the LMEbullion exchange-traded products by utilizing a electronic process will be auditable and new price mechanism to replace the B. Self-Regulatory Organization’s transparent. Moreover, the LME AM and London Fix, which is not expected to be Statement on Burden on Competition PM Fix will be the clearing prices for available after November 30, 2014, and The Exchange does not believe that platinum and palladium bullion that will provide a sound and the proposed rule change will impose transactions that will clear through an reasonable basis for calculation of NAV. any burden on competition that is not electronic clearing process that the LME Such prices will be widely disseminated necessary or appropriate in furtherance is establishing simultaneously with the by one or more major market data of the purposes of the Act. The establishment of the LMEbullion vendors and/or exchanges. Prior to or proposed change will permit the Trusts process. The Exchange believes the new following the effectiveness of this to continue to function as platinum- or LME fixing processes will serve as an proposed rule change, (1) the Sponsor of palladium-based exchange-traded appropriate replacement to the London the Trusts will issue a press release products by utilizing an electronic Fix for platinum and palladium for informing the public of the date a Trust mechanism to replace the manual purposes of determining the NAV of will first use the LME Fix to value the London Fix, which is not expected to be platinum and palladium held by a available after November 30, 2014, and 15 See supra, notes 6–9. Trust; (2) the Sponsor of the Trusts will that will provide a sound and 16 15 U.S.C. 78f(b)(5). file the applicable press release with the 17 reasonable basis for calculation of NAV. The IOSCO Principles are designed to enhance Commission by means of Form 8–K, the integrity, the reliability and the oversight of which will be available on the C. Self-Regulatory Organization’s benchmarks by establishing guidelines for Statement on Comments on the benchmark administrators and other relevant bodies applicable Trust’s Web site; and (3) the in the following areas: Governance: To protect the Sponsor will file an amendment to the Proposed Rule Change Received From integrity of the benchmark determination process Members, Participants, or Others and to address conflicts of interest; Benchmark applicable Registration Statements quality: To promote the quality and integrity of under the 1933 Act relating to the No written comments were solicited benchmark determinations through the application proposed change. Such press releases or received with respect to the proposed of design factors; Quality of the methodology: To and Registration Statement amendments rule change. promote the quality and integrity of methodologies will protect investors and the public by setting out minimum information that should be III. Date of Effectiveness of the interest by providing notification to addressed within a methodology. These principles Proposed Rule Change and Timing for also call for credible transition policies in case a investors of the new LME price Commission Action benchmark may cease to exist due to market mechanism prior to the use of the LME structure change. Accountability mechanisms: To establish complaints processes, documentation PM Fix by the Trusts. The Sponsor Because the proposed rule change requirements and audit reviews. The IOSCO represents that there is no change to the does not (i) significantly affect the Principles provide a framework of standards that investment objective of the applicable protection of investors or the public might be met in different ways, depending on the Trust from that described in the interest; (ii) impose any significant specificities of each benchmark. In addition to a set of high level principles, the framework offers a applicable proposed rule change. The burden on competition; and (iii) become subset of more detailed principles for benchmarks Trusts will comply with all initial and operative for 30 days from the date on having specific risks arising from their reliance on continued listing requirements under which it was filed, or such shorter time submissions and/or their ownership structure. For NYSE Arca Equities Rule 8.201. Except as the Commission may designate, the further information concerning the IOSCO Principles, see http://www.iosco.org/library/ for the changes noted above, all other pubdocs/pdf/IOSCOPD415.pdf. facts presented and representations 18 See supra, notes 6–9.
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proposed rule change has become temporarily suspend such rule change if the Commission does not edit personal effective pursuant to Section 19(b)(3)(A) it appears to the Commission that such identifying information from of the Act 19 and Rule 19b–4(f)(6) action is necessary or appropriate in the submissions. You should submit only thereunder.20 public interest, for the protection of information that you wish to make The Exchange has asked the investors, or otherwise in furtherance of available publicly. All submissions Commission to waive the 30-day the purposes of the Act. If the should refer to File Number SR– operative delay so that the proposal may Commission takes such action, the NYSEArca–2014–135 and should be become operative immediately upon Commission shall institute proceedings submitted on or before December 26, filing. The Exchange states that the 22 under Section 19(b)(2)(B) of the Act to 2014. proposed change will provide determine whether the proposed rule additional transparency to platinum and change should be approved or For the Commission, by the Division of palladium pricing compared to the disapproved. Trading and Markets, pursuant to delegated previous London Fix for several reasons. authority.23 IV. Solicitation of Comments The Exchange represents that LME’s Brent J. Fields, electronic price fixing processes will be Interested persons are invited to Secretary. submit written data, views, and fully transparent in real time to the [FR Doc. 2014–28473 Filed 12–3–14; 8:45 am] platinum and palladium market arguments concerning the foregoing, participants and, at the close of each including whether the proposed rule BILLING CODE 8011–01–P electronic fixing, to the general public. change is consistent with the Act. Comments may be submitted by any of The Exchange represents that LME’s SECURITIES AND EXCHANGE electronic price fixing processes also the following methods: COMMISSION will be fully auditable by third parties Electronic Comments because an audit trail exists from the • beginning of each fixing session. Use the Commission’s Internet [Release No. 34–73703; File No. SR–NYSE– Moreover, the Exchange states that the comment form (http://www.sec.gov/ 2014–59] rules/sro.shtml); or market operation, compliance, internal • audit and third-party complaint Send an email to rule-comments@ Self-Regulatory Organizations; New handling capabilities of the LME will sec.gov. Please include File Number SR– York Stock Exchange LLC; Notice of support the integrity of the LME AM NYSEArca–2014–135 on the subject Filing of Proposed Rule Change and PM Fix. The Exchange represents line. Amending Rule 13 and Related Rules that the number of platinum and Paper Comments Governing Order Types and Modifiers palladium participants that initially are To Clarify the Nature of Order Types • Send paper comments in triplicate expected to participate in the to Brent J. Fields, Secretary, Securities LMEbullion fixing process November 28, 2014. and Exchange Commission, 100 F Street (approximately ten LPPM members) Pursuant to Section 19(b)(1) 1 of the NE., Washington, DC 20549–1090. exceeds the number of market Securities Exchange Act of 1934 All submissions should refer to File participants determining the London (‘‘Act’’) 2 and Rule 19b–4 thereunder,3 Number SR–NYSEArca–2014–135. This Fix prior to December 1, 2014 (currently notice is hereby given that, on file number should be included on the four LPPM fixing members), and will November 14, 2014, New York Stock contribute to the integrity and reliability subject line if email is used. To help the Commission process and review your Exchange LLC (‘‘NYSE’’ or the of the pricing process. ‘‘Exchange’’) filed with the Securities The Commission believes that waiver comments more efficiently, please use only one method. The Commission will and Exchange Commission of the operative delay is consistent with (‘‘Commission’’) the proposed rule the protection of investors and the post all comments on the Commission’s change as described in Items I and II public interest. Waiver of the operative Internet Web site (http://www.sec.gov/ below, which Items have been prepared delay will allow the Trusts, whose rules/sro.shtml). Copies of the Shares are actively traded, to use the submission, all subsequent by the self-regulatory organization. The LME Fix as the basis for calculating the amendments, all written statements Commission is publishing this notice to NAV by December 1, 2014, thereby with respect to the proposed rule solicit comments on the proposed rule facilitating the transition to the new change that are filed with the change from interested persons. Commission, and all written price mechanism without disruption in I. Self-Regulatory Organization’s trading. Therefore, the Commission communications relating to the proposed rule change between the Statement of the Terms of Substance of designates the proposed rule change to the Proposed Rule Change be operative upon filing.21 Commission and any person, other than At any time within 60 days of the those that may be withheld from the The Exchange proposes to amend filing of such proposed rule change, the public in accordance with the Rule 13 and related rules governing Commission summarily may provisions of 5 U.S.C. 552, will be order types and modifiers. The text of available for Web site viewing and the proposed rule change is available on 19 printing in the Commission’s Public 15 U.S.C. 78s(b)(3)(A). the Exchange’s Web site at 20 17 CFR 240.19b–4(f)(6). As required under Rule Reference Room, 100 F Street NE., 19b–4(f)(6)(iii), the Exchange provided the Washington, DC 20549, on official www.nyse.com, at the principal office of Commission with written notice of its intent to file business days between the hours of the Exchange, and at the Commission’s the proposed rule change, along with a brief Public Reference Room. description and the text of the proposed rule 10:00 a.m. and 3:00 p.m. Copies of such change, at least five business days prior to the date filing will also be available for of filing of the proposed rule change, or such inspection and copying at the principal shorter time as designated by the Commission. office of the Exchange. All comments 23 17 CFR 200.30–3(a)(12). 21 For purposes only of waiving the 30-day 1 15 U.S.C.78s(b)(1). operative delay, the Commission has considered the received will be posted without change; proposed rule’s impact on efficiency, competition, 2 15 U.S.C. 78a. and capital formation. See 15 U.S.C. 78c(f). 22 15 U.S.C. 78s(b)(2)(B). 3 17 CFR 240.19b–4.
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II. Self-Regulatory Organization’s when filing rule changes to adopt new • Limit Orders. Rule text governing Statement of the Purpose of, and functionality, the Exchange has used Limit Orders would be moved to new Statutory Basis for, the Proposed Rule those filings as an opportunity to Rule 13(a)(2). The Exchange proposes a Change streamline related existing rule text for non-substantive change to capitalize the In its filing with the Commission, the which functionality has not changed.7 term ‘‘Limit Order,’’ and to shorten the self-regulatory organization included The Exchange is filing this proposed definition in a manner that streamlines statements concerning the purpose of, rule change to continue with its efforts the rule text without changing the and basis for, the proposed rule change to review and clarify its rules governing meaning of the rule. The Exchange notes and discussed any comments it received order types, as appropriate. Specifically, that it proposes to capitalize the term on the proposed rule change. The text the Exchange notes that Rule 13 is ‘‘Limit Order’’ throughout new Rule 13. of those statements may be examined at currently structured alphabetically, and The Exchange notes that it proposes the places specified in Item IV below. does not include subsection numbering. to delete the definition of ‘‘Auto Ex The Exchange has prepared summaries, The Exchange proposes to provide Order’’ because all orders entered set forth in sections A, B, and C below, additional clarity to Rule 13 by re- electronically at the Exchange are of the most significant parts of such grouping and re-numbering current rule eligible for automatic execution in statements. text and making other non-substantive, accordance with Rules 1000–1004 and clarifying changes. The proposed rule therefore the Exchange does not believe A. Self-Regulatory Organization’s changes are not intended to reflect that it needs to separately define an Statement of the Purpose of, and the changes to functionality but rather to Auto Ex Order. Rather than maintain a Statutory Basis for, the Proposed Rule clarify Rule 13 to make it easier to separate definition, the Exchange Change navigate.8 In addition, the Exchange proposes to specify in proposed Rule 1. Purpose proposes to amend certain rules to 13(a) that all orders entered electronically at the Exchange are On June 5, 2014, in a speech entitled remove references to functionality that is no longer operative. eligible for automatic execution ‘‘Enhancing Our Market Equity consistent with the terms of the order Structure,’’ Mary Jo White, Chair of the Proposed Rule 13 Restructure and Rules 1000–1004. The Exchange Securities and Exchange Commission notes that Rule 13 currently provides for (‘‘SEC’’ or the ‘‘Commission’’) requested The Exchange proposes to re-structure Rule 13 to re-group existing order types specified instructions for orders that the equity exchanges to conduct a may not execute on arrival, even if comprehensive review of their order and modifiers together along functional lines. marketable, e.g., a Limit Order types and how they operate in practice, designated ALO, or may only be eligible and as part of this review, consider Proposed new subsection (a) of Rule 13 would set forth the Exchange’s order to participate in an auction, accordingly, appropriate rule changes to help clarify the terms of the order also control 4 types that are the foundation for all the nature of their order types. whether a marketable order would other order type instructions, i.e., the Subsequent to the Chair’s speech, the automatically execute upon arrival. The primary order types. The proposed SEC’s Division of Trading and Markets Exchange further proposes to specify primary order types would be: requested that the equity exchanges that interest represented manually by • Market Orders. Rule text governing complete their reviews and submit any Floor brokers, i.e., orally bid or offered proposed rule changes by November 1, Market Orders would be moved to new at the point of sale on the Trading Floor, 2014.5 Rule 13(a)(1). The Exchange proposes a is not eligible for automatic execution. The Exchange notes that it non-substantive change to replace the The Exchange notes that the order types continually assesses its rules governing reference to ‘‘Display Book’’ with a 9 currently specified in the definition for order types and undertook on its own reference to ‘‘Exchange systems.’’ The auto ex order are already separately initiative a review of its rules related to Exchange notes that it proposes to defined in Rule 13 or Rule 70(a)(ii) order functionality to assure that its capitalize the term ‘‘Market Order’’ (definition of G order). various order types, which have been throughout new Rule 13. Proposed new subsection (b) of Rule adopted and amended over the years, 13 would set forth the existing Time in accurately describe the functionality 7 See, e.g., Securities Exchange Act Release Nos. Force Modifiers that the Exchange associated with those order types, and 68302 (Nov. 27, 2012), 77 FR 71658 (Dec. 3, 2012) makes available for orders entered at the more specifically, how different order (SR–NYSE–2012–65) (amending rules governing pegging interest to, among other things, make non- Exchange. The Exchange proposes to: (i) types may interact. As a result of that substantive changes, including moving the rule text Move rule text governing Day Orders to review, the Exchange submitted a from Rule 70.26 to Rule 13, to make the rule text new Rule 13(b)(1), without any proposed rule change to delete rules more focused and streamlined) (‘‘2012 Pegging substantive changes to the rule text; (ii) Filing’’), and 71175 (Dec. 23, 2013), 78 FR 79534 relating to functionality that was not move rule text governing Good til 6 (Dec. 30, 2013) (SR–NYSE–2013–21) (approval available. In addition, over the years, order for rule proposal that, among other things, Cancelled Orders to new Rule 13(b)(2), amended Rule 70 governing Floor broker reserve e- without any substantive changes to the 4 See Mary Jo White, Chair, Securities and quotes that streamlined the rule text without rule text; and (iii) move rule text Exchange Commission, Speech at the Sandler, making substantive changes) (‘‘2013 Reserve e- O’Neill & Partners, L.P. Global Exchange and Quote Filing’’). governing Immediate or Cancel Orders Brokerage Conference (June 5, 2014) (available at 8 The Exchange notes that its affiliated exchange, to new Rule 13(b)(3) without any www.sec.gov/News/Speech/Detail/Speech/ NYSE MKT LLC has filed a proposed rule change changes to rule text. The Exchange notes 1370542004312#.U5HI-fmwJiw). with a similar restructuring of its respective order that these time-in-force conditions are 5 See Letter from James Burns, Deputy Director, type rules to group order types and modifiers. See not separate order types, but rather are Division of Trading and Markets, Securities and SR–NYSEMKT–2014–95. Exchange Commission, to Jeffrey C. Sprecher, Chief 9 The Exchange proposes to replace the term modifiers to orders. Accordingly, the Executive Officer, Intercontinental Exchange, Inc., ‘‘Display book’’ with the term ‘‘Exchange systems’’ Exchange proposes to re-classify them dated June 20, 2014. when use of the term refers to the Exchange systems as modifiers and remove the references 6 See Securities Exchange Act Release No. 71897 that receive and execute orders. The Exchange to the term ‘‘Order.’’ In addition, as (April 8, 2014), 79 FR 20953 (April 14, 2014) (SR– proposes to replace the term ‘‘Display Book’’ with NYSE–2014–16) (amending rules governing pegging the term ‘‘Exchange’s book’’ when use of the term noted above, the Exchange proposes to interest to conform to functionality that is available refers to the interest that has been entered and capitalize the term ‘‘Limit Order’’ in at the Exchange). ranked in Exchange systems. Rule 13(b).
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Proposed new subsection (c) of Rule an MPL Order to have an MTV that is price point has been executed, is 13 would specify the Exchange’s larger than the order, thereby bypassing applicable to all Reserve Orders, and is existing Auction-Only Orders. In contra-side interest that is larger than not limited to Non-Displayed Reserve moving the rule text, the Exchange the size of the MPL Order.11 Finally, the Orders.17 proposes the following non-substantive Exchange proposes to make a non- Proposed new subsection (e) of Rule changes: (i) Capitalize the terms ‘‘Limit substantive change to new Rule 13 would specify the Exchange’s Order,’’ ‘‘CO Order,’’ and ‘‘Market 13(d)(1)(E) to replace the term existing order types that, by definition, Order’’; (ii) move the rule text for CO ‘‘discretionary trade’’ with ‘‘d-Quote,’’ do not route. The order types proposed Orders to new Rule 13(c)(1); (iii) rename because d-Quotes are the only type of to be included in this new subsection a ‘‘Limit ‘At the Close’ Order’’ as a Exchange interest that is eligible to are: • ‘‘Limit-on-Close (LOC) Order’’ and move include discretionary pricing Add Liquidity Only (‘‘ALO’’) the rule text to new Rule 13(c)(2); (iv) instructions.12 Modifiers. Existing rule text governing rename a ‘‘Limit ‘On-the-Open’ Order’’ • Reserve Orders. Existing rule text ALO modifiers would be moved to new as a ‘‘Limit-on-Open (LOO) Order’’ and governing Reserve Orders would be Rule 13(e)(1) with non-substantive move the rule text to new Rule 13(c)(3); moved to new Rule 13(d)(2) with non- changes to capitalize the term ‘‘Limit (v) rename a ‘‘Market ‘At-the-Close’ substantive changes to capitalize the Order’’ and update cross-references. Order’’ as a ‘‘Market-on-Close (MOC) term ‘‘Limit Order’’ and hyphenate the Existing rule text that is being moved to Order’’ and move the rule text to new term ‘‘Non-Displayed.’’ The Exchange new Rule 13(e)(1)(A) currently provides Rule 13(c)(4); and (vi) rename a ‘‘Market proposes further non-substantive that Limit Orders designated ALO may ‘On-the-Open’ Order’’ as a ‘‘Market-on- changes to the rule text governing participate in opens and closes, but that Open (MOO) Order’’ and move the rule Minimum Display Reserve Orders, the ALO instructions would be ignored. text to new Rule 13(c)(5). which would be in new Rule Because Limit Orders designated ALO Proposed new subsection (d) of Rule 13(d)(2)(C), to clarify that a Minimum could also participate in re-openings, 13 would specify the Exchange’s Display Reserve Order would and the ALO instructions would existing orders that include instructions participate in both automatic and similarly be ignored, the Exchange not to display all or a portion of the manual executions. This is existing proposes to clarify new Rule 13(e)(1)(A) order. The order types proposed to be functionality relating to Minimum to provide that Limit Orders designated included in this new subsection are: Display Reserve Orders 13 and the ALO could participate in openings, re- • Mid-point Passive Liquidity proposed rule text aligns with Rule openings, and closings, but that the 70(f)(i) governing Floor broker ALO instructions would be ignored. (‘‘MPL’’) Orders. Existing rule text • governing MPL Orders would be moved Minimum Display Reserve e-Quotes.14 Do Not Ship (‘‘DNS’’) Orders. to new Rule 13(d)(1) with non- Similarly, the Exchange proposes non- Existing rule text governing DNS Orders substantive changes to capitalize the substantive changes to the rule text would be moved to new Rule 13(e)(2) term Limit Order, update cross governing Non-Displayed Reserve with non-substantive changes to references, and refer to ‘‘Add Liquidity Orders, which would be in new Rule capitalize the term ‘‘Limit Order’’ and Only’’ as ALO, since ALO is now a 13(d)(2)(D), to clarify that a Non- replace the reference to ‘‘Display Book’’ separately defined term in new Rule Displayed Reserve Order would not with a reference to ‘‘Exchange systems.’’ • Intermarket Sweep Order. Existing 13(e)(1). The Exchange also proposes to participate in manual executions. This rule text governing ISOs would be clarify the rule text by deleting the term is existing functionality relating to Non- 15 moved to new Rule 13(e)(3) with non- ‘‘including’’ from the phrase ‘‘[a]n MPL Displayed Reserve Orders and the substantive changes to capitalize the Order is not eligible for manual proposed rule text aligns with Rule term ‘‘Limit Order’’, update cross- executions, including openings, re- 70(f)(ii) governing Non-Display Reserve eQuotes excluded from the DMM.16 references, and replace the reference to openings, and closings,’’ because MPL ‘‘Display Book’’ with a reference to Orders would not participate in an Finally, in proposed new Rule 13(d)(2)(E), the Exchange proposes to ‘‘Exchange’s book.’’ opening, re-opening, or closing that is Proposed new subsection (f) of Rule 10 clarify that the treatment of reserve effectuated electronically. The 13 would specify the Exchange’s other Exchange further proposes to make a interest, which is available for execution only after all displayable interest at that existing order instructions and substantive amendment to the rule text modifiers, including: set forth in new Rule 13(d)(1)(C) to • 11 The Exchange notes that because of technology Do Not Reduce (‘‘DNR’’) Modifier. specify that Exchange systems would changes associated with rejecting MPL Orders that Existing rule text governing DNR Orders reject an MPL Order on entry if the have an MTV larger than the size of the order, the would be moved to new Rule 13(f)(1) Minimum Triggering Volume (‘‘MTV’’) Exchange will announce by Trader Update when with non-substantive changes to is larger than the size of the order and this element of the proposed rule change will be implemented. capitalize the terms ‘‘Limit Order’’ and would reject a request to partially cancel 12 See Rule 70.25 (Discretionary Instructions for ‘‘Stop Order.’’ In addition, the Exchange a resting MPL Order if it would result Bids and Offers Represented via Floor Broker believes that because DNR instructions in the MTV being larger than the size of Agency Interest Files (e-QuotesSM)). would be added to an order, DNR is 13 the order and make conforming changes See Securities Exchange Act Release No. 57688 more appropriately referred to as a to the existing rule text. The Exchange (April 18, 2008), 73 FR 22194 at 22197 (April 24, 2008) (SR–NYSE–2008–30) (order approving rule modifier rather than as an order type. would continue to enforce an MTV change that, among other things, adopted new • Do Not Increase (‘‘DNI’’) Modifiers. restriction if the unexecuted portion of Reserve Order for which the non-displayed portion Existing rule text governing DNI Orders an MPL Order with an MTV is less than of the order is eligible to participate in manual would be moved to new Rule 13(f)(2) the MTV. The Exchange believes that executions) (‘‘2008 Reserve Order Filing’’). 14 with non-substantive changes to this proposed rule change would See 2013 Reserve e-Quote Filing, supra n. 7. 15 See Securities Exchange Act Release No. 58845 capitalize the terms ‘‘Limit Order’’ and prevent an entering firm from causing (Oct. 24, 2008), 73 FR 64379 at 64384 (Oct. 29, 2008) (SR–NYSE–2008–46) (order approving the 17 See 2008 Reserve Order Filing supra n. 13 at 10 See Rule 123C.10 (‘‘Closings may be effectuated Exchange’s New Market Model, including adopting 22196 (displayable portion of Reserve Order manually or electronically’’) and Rule 123D(1) a Non-Displayed Reserve Order that would not be executed together with other displayable interest at (‘‘Openings may be effectuated manually or eligible to participate in manual executions). a price point before executing with reserve portion electronically’’). 16 See 2013 Reserve e-Quote Filing, supra n. 7. of the order).
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‘‘Stop Order.’’ In addition, the Exchange • Self-Trade Prevention (‘‘STP’’) definition of ‘‘not held’’ with guidance believes that because DNI instructions Modifier. Existing rule text governing from the Financial Industry Regulatory would be added to an order, DNI is STP Modifiers and related subsections Authority, Inc. (‘‘FINRA’’) and other more appropriately referred to as a would be moved to new Rule 13(f)(5) markets regarding not held modifier rather than as an order type. with non-substantive changes to instructions.20 The Exchange notes that • Pegging Interest. Existing rule text capitalize the terms ‘‘Limit Orders,’’ the existing Rule 13 text regarding how governing Pegging Interest and related ‘‘Market Orders,’’ and ‘‘Stop Orders’’ to mark a Not Held Order, e.g., ‘‘not subsections would be moved to new and hyphenate the term ‘‘Self-Trade held,’’ ‘‘disregard tape,’’ ‘‘take time,’’ Rule 13(f)(3) with one clarifying change Prevention.’’ etc., are outdated references regarding • Sell ‘‘Plus’’—Buy ‘‘Minus’’ to the existing rule text and one order marking between a customer and Instructions. Existing rule text proposed clarifying addition to the rule a member or member organization. All governing Sell ‘‘Plus’’—Buy ‘‘Minus’’ text. Because Pegging Interest is Exchange members and member Orders would be moved to new Rule currently available for e-Quotes and d- organizations that receive customer 13(f)(6) with non-substantive changes to Quotes only, the Exchange proposes to orders are subject to Order Audit Trail break the rule into subsections, replace the term ‘‘can’’ with the term System (‘‘OATS’’) obligations, capitalize the terms ‘‘Market Order,’’ ‘‘must’’ in new Rule 13(f)(3)(a)(i) to consistent with Rule 7400 Series and ‘‘Limit Order,’’ and ‘‘Stop Order,’’ and FINRA Rule 7400 Series, which require provide that Pegging Interest ‘‘must be replace the references to Display Book that order-handling instructions be an e-Quote or d-Quote.’’ In addition, the with references to Exchange systems. In documented in OATS. Among the Exchange proposes to add rule text to addition, the Exchange proposes to re- order-handling instructions that can be new Rule 13(f)(3)(A)(iv)(a) to clarify the classify this as an order instruction captured in OATS is whether an order definition of ‘‘next best-priced available rather than as a separate order. is not held.21 The Exchange believes interest’’[sic] in that Rule. Specifically, • Stop Orders. Existing rule text that these OATS-related obligations now the Exchange has recently adopted non- governing Stop Orders would be moved govern how a member or member displayed order types that are priced to new Rule 13(f)(7) with non- organization records order-handling based on the PBBO, including MPL substantive changes to break the rule instructions from a customer and Orders, discussed above, and Retail into subsections, capitalize the term therefore the terms currently set forth in Price Improvement Orders (‘‘RPI’’), ‘‘Market Order,’’ and replace references 18 Rule 13 relating to Not Held Orders are defined in Rule 107C(a)(4). Because to ‘‘Exchange’s automated order routing no longer necessary. Pegging Interest would not peg to either system’’ with references to ‘‘Exchange Finally, the Exchange proposes to MPL Orders or RPIs, the Exchange systems.’’ amend Rule 70.25 governing d-Quotes proposes to clarify that for purposes of As part of the proposed restructure of to clarify that certain functionality set new Rule 13(f)(3)(A)(iv)(a), the term Rule 13, the Exchange proposes to move forth in the Rule is no longer available. next available best-priced interest refers existing rule text in Rule 13 governing Specifically, Rule 70.25(c)(ii) currently to the highest-(lowest-) priced buy (sell) the definition of ‘‘Routing Broker’’ to provides that a Floor broker may interest within the specified price range Rule 17(c), without any change to the designate a maximum size of contra-side of pegging interest to buy (sell), rule text. The Exchange believes that volume with which it is willing to trade including displayable bids (offers), Non- Rule 17 is a more logical location for the using discretionary pricing instructions. Display Reserve Orders, Non-Display definition of Routing Broker because Because this functionality is not Reserve e-Quotes, odd-lot sized interest, Rule 17(c) governs the operations of available, the Exchange proposes to and protected bids (offers) on away Routing Brokers. delete references to the maximum markets, but does not include non- In addition, the Exchange proposes to discretionary size parameter from Rules displayed interest that is priced based delete existing rule text in Rule 13 70.25(c)(ii) and (c)(v). In addition, the on the PBBO. The Exchange notes that governing Not Held Orders and add rule Exchange proposes to amend Rule this would be applicable regardless of text relating to not held instructions to 70.25(c)(iv) to clarify that the whether an MPL Order or RPI is supplementary material .20 to Rule 13. circumstances of when the Exchange marketable.19 Supplementary material .20 to Rule 13 would consider interest displayed by • Retail Modifiers. Existing rule text reflects obligations that members have other market centers at the price at governing Retail Modifiers and related in handling customer orders. Because which a d-Quote may trade are not subsections would be moved to new not held instructions are instructions limited to determining when a d- Rule 13(f)(4) with non-substantive from a customer to a member or member Quote’s minimum or maximum size changes to update cross-references. organization regarding the handling of range is met. Accordingly, the Exchange an order, and do not relate to proposes to delete the clause ‘‘when instructions accepted by Exchange 18 See Securities Exchange Act Release Nos. determining if the d-Quote’s minimum 71330 (Jan. 16, 2014), 79 FR 3895 (Jan. 16, systems for execution, the Exchange 2014)[sic] (SR–NYSE–2013–71) (approval order for believes that references to not held 20 See FINRA Regulatory Notice 11–29, Answer 3 the Exchange’s adoption of the MPL Order); and instructions are better suited for this (June 2011) (‘‘Generally, a ‘not held’ order is an 67347 (July 3, 2012), 77 FR 40673 (July 10, 2012) existing supplementary material. unpriced, discretionary order voluntarily (SR–NYSE–2011–55) (approval order for the categorized as such by the customer and with Exchange’s Retail Liquidity Program, which Accordingly, the Exchange proposes respect to which the customer has granted the firm adopted the new RPI). to amend supplementary material .20 to price and time discretion.’’). See also Definition of 19 For example, assume the best protected bid Rule 13 to add that generally, an Market Not Held Order on Nasdaq.com Glossary of (‘‘PBB’’) is $10.00, the Exchange has pegging instruction that an order is ‘‘not held’’ Stock Market Terms, available at http:// interest to buy at $9.99, an MPL Order priced at www.nasdaq.com/investing/glossary/m/market-not- $9.98 and a Non-Displayed Reserve Order to buy refers to an unpriced, discretionary held-order. priced at $9.97. Because the PBB is outside the order voluntarily categorized as such by 21 See FINRA OATS Frequently Asked specified price range of the pegging interest to buy, the customer and with respect to which Questions—Technical, at T21 (‘‘An order submitted it would peg to the next available best-priced the customer has granted the member or by a customer who gives the broker discretion as interest, which in this scenario would be the Non- to the price and time of execution is denoted as a Displayed Reserve Order to buy priced at $9.97. The member organization price and time ‘‘Not Held’’ order.’’), available at http:// pegging interest to buy would not peg to the MPL discretion. The Exchange believes that www.finra.org/Industry/Compliance/ Order to buy priced at $9.98. this proposed amendment aligns the MarketTransparency/OATS/FAQ/P085542.
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and/or maximum size range is met.’’ an MTV larger than the size of the order change is consistent with the Act. The Exchange believes that the and instructions to partially cancel an Comments may be submitted by any of proposed changes to Rule 70.25(c) will MPL Order that would result in an MTV the following methods: provide clarity and transparency larger than the size of the order would regarding the existing functionality remove impediments to and perfect the Electronic Comments relating to d-Quotes at the Exchange. mechanism of a free and open market • Use the Commission’s Internet 2. Statutory Basis and national market system in general comment form (http://www.sec.gov/ because it could potentially reduce the rules/sro.shtml); or The proposed rule change is ability of a member organization from • consistent with Section 6(b) of the using MPL Orders to bypass contra-side Send an email to rule-comments@ Securities Exchange Act of 1934 (the interest that may be larger than the size sec.gov. Please include File Number SR– ‘‘Act’’),22 in general, and furthers the of the MPL Order. NYSE–2014–59 on the subject line. objectives of Section 6(b)(5),23 in Finally, the Exchange believes that Paper Comments particular, because it is designed to the proposed changes to Rule 70.25(c) prevent fraudulent and manipulative would remove impediments to and • Send paper comments in triplicate acts and practices, to promote just and perfect the mechanism of a free and to Brent J. Fields, Secretary, Securities equitable principles of trade, to foster open market and national market system and Exchange Commission, 100 F Street cooperation and coordination with in general because it assures that the NE., Washington, DC 20549–1090. persons engaged in facilitating Exchange’s rules align with the existing transactions in securities, to remove functionality available at the Exchange All submissions should refer to File impediments to, and perfect the for d-Quotes. Number SR–NYSE–2014–59. This file mechanism of, a free and open market number should be included on the and a national market system and, in B. Self-Regulatory Organization’s subject line if email is used. To help the general, to protect investors and the Statement on Burden on Competition Commission process and review your public interest. Specifically, the The Exchange does not believe that comments more efficiently, please use Exchange believes that the proposed the proposed rule change will impose only one method. The Commission will restructuring of Rule 13, to group any burden on competition that is not post all comments on the Commission’s existing order types to align by necessary or appropriate in furtherance Internet Web site (http://www.sec.gov/ functionality, would remove of the purposes of the Act. The rules/sro.shtml). Copies of the impediments to and perfect the proposed change is not designed to submission, all subsequent mechanism of a free and open market by address any competitive issue but rather amendments, all written statements ensuring that members, regulators, and would re-structure Rule 13 and remove with respect to the proposed rule the public can more easily navigate the rule text that relates to functionality that change that are filed with the Exchange’s rulebook and better is no longer operative, thereby reducing Commission, and all written understand the order types available for confusion and making the Exchange’s communications relating to the trading on the Exchange. In addition, rules easier to navigate. proposed rule change between the the Exchange believes that the proposed C. Self-Regulatory Organization’s Commission and any person, other than revisions to Rule 13 promote clarity those that may be withheld from the regarding existing functionality that has Statement on Comments on the Proposed Rule Change Received From public in accordance with the been approved in prior rule filings, but provisions of 5 U.S.C. 552, will be which may not have been codified in Members, Participants, or Others 24 available for Web site viewing and rule text. Moreover, the Exchange No written comments were solicited printing in the Commission’s Public believes that moving rule text defining or received with respect to the proposed Reference Room, 100 F Street NE., a Routing Broker to Rule 17 represents rule change. Washington, DC 20549, on official a more logical location for such business days between the hours of 10 definition, thereby making it easier for III. Date of Effectiveness of the a.m. and 3 p.m. Copies of such filing market participants to navigate Proposed Rule Change and Timing for also will be available for inspection and Exchange rules. Likewise, the Exchange Commission Action copying at the principal office of the believes the proposed changes to ‘‘Not Within 45 days of the date of Exchange. All comments received will Held Order,’’ to move it to publication of this notice in the Federal be posted without change; the supplementary material .20 to Rule 13 Register or within such longer period Commission does not edit personal and revise the rule text to conform with up to 90 days of such date (i) as the identifying information from guidance from FINRA and OATS Commission may designate if it finds submissions. You should submit only requirements, would remove such longer period to be appropriate information that you wish to make impediments to and perfect the and publishes its reasons for so finding available publicly. All submissions mechanism of a free and open market or (ii) as to which the self-regulatory and a national market system by organization consents, the Commission should refer to File Number SR–NYSE– applying a uniform definition of not will: 2014–59 and should be submitted on or held instructions across multiple (A) By order approve or disapprove before December 26, 2014. markets, thereby reducing the potential the proposed rule change, or For the Commission, by the Division of for confusion regarding the meaning of (B) institute proceedings to determine Trading and Markets, pursuant to delegated not held instructions. whether the proposed rule change authority.25 The Exchange further believes that the should be disapproved. Brent J. Fields, proposed amendment regarding MPL IV. Solicitation of Comments Secretary. Orders to reject both MPL Orders with Interested persons are invited to [FR Doc. 2014–28476 Filed 12–3–14; 8:45 am] 22 15 U.S.C. 78f(b). submit written data, views, and BILLING CODE 8011–01–P 23 15 U.S.C. 78f(b)(5). arguments concerning the foregoing, 24 See supra nn. 13–18. including whether the proposed rule 25 17 CFR 200.30–3(a)(12).
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SECURITIES AND EXCHANGE additional extension of time until Regular Trading Hours.10 Extended COMMISSION November 24, 2014. On November 21, Trading Hours will operate using 2014, CBOE filed Amendment No. 2 to separate Exchange servers 11 and [Release No. 34–73704; File No. SR–CBOE– 2014–062] the proposed rule change and also hardware from those used during granted the Commission a further Regular Trading Hours.12 Accordingly, Self-Regulatory Organizations; extension of time to consider its the electronic order book used during Chicago Board Options Exchange, proposal to December 3, 2014.5 The Regular Trading Hours will not be Incorporated; Notice of Filing of Commission received no substantive connected to the electronic order book Amendment Nos. 1 and 2 and Order comments on the proposal.6 The used during Extended Trading Hours, Granting Accelerated Approval of a Commission is publishing this notice to and orders and quotes will not interact Proposed Rule Change, as Modified by solicit comments on Amendment Nos. 1 between the two sessions.13 Rather, all Amendment Nos. 1 and 2, To Adopt and 2 from interested persons and is orders will be cancelled at the end of Extended Trading Hours for SPX and approving the proposed rule change, as each Extended Trading Hours session.14 VIX modified by Amendment Nos. 1 and 2, During Extended Trading Hours, all on an accelerated basis. Exchange rules will apply, except as set November 28, 2014. forth in proposed CBOE Rule 6.1A II. Description of the Proposed Rule I. Introduction (Extended Trading Hours), and except Change, as Modified by Amendment for CBOE rules that by their terms are On August 26, 2014, Chicago Board Nos. 1 and 2 7 inapplicable during Extended Trading Options Exchange, Incorporated (the Currently, transactions in index Hours.15 For example, since all trading ‘‘Exchange’’ or ‘‘CBOE’’) filed with the options may be effected on the during Extended Trading Hours will be Securities and Exchange Commission Exchange generally between 8:30 a.m. electronic on the Hybrid Trading (the ‘‘Commission’’) a proposed rule 16 and 3:15 p.m.,8 Monday through Friday System, all CBOE rules relating to change pursuant to Section 19(b)(1) of (‘‘Regular Trading Hours’’). CBOE has open outcry trading and the Hybrid 3.0 the Securities Exchange Act of 1934 (the proposed to adopt rules that will allow System will be inapplicable to Extended ‘‘Act’’),1 and Rule 19b–4 thereunder,2 to 17 it to conduct a separate, fully-electronic Trading Hours. However, CBOE rules establish a separate early morning trading session from 2:00 a.m. to 8:15 relating to business conduct, doing trading session specifically for options a.m. Monday through Friday (‘‘Extended business with the public, due diligence, on the S&P 500 Index (‘‘SPX’’) and Trading Hours’’) for SPX and VIX, two and best execution will apply during CBOE Volatility Index (‘‘VIX’’). The 18 index options that are exclusively-listed Extended Trading Hours. proposed rule change was published for on CBOE. According to the Exchange, it Access. As is true during Regular comment in the Federal Register on is proposing Extended Trading Hours to Trading Hours, only authorized Trading September 12, 2014.3 On October 24, meet demand from investors who want Permit Holders, their nominees, and 2014, CBOE filed Amendment No. 1 to their associated persons will be able to the proposed rule change and also to trade these two products outside of Regular Trading Hours.9 access CBOE’s electronic trading granted the Commission an extension of 19 Under the proposal, Extended Trading system. However, trading privileges time to consider its proposal to will be separate and distinct for November 3, 2014.4 On October 31, Hours will be a separate trading session from Regular Trading Hours and there 2014, CBOE granted the Commission an 10 will be no carryover from one trading See id. 11 Bandwidth packets will be sold separately for 1 15 U.S.C. 78s(b)(1). session to the other and no interaction Regular Trading Hours and Extended Trading 2 17 CFR 240.19b–4. between Extended Trading Hours and Hours. See id. at 54766. Also, while the same 3 See Securities Exchange Act Release No. 73017 telecommunications lines may be used for both Regular and Extended Trading Hours, those lines (September 8, 2014), 79 FR 54758 (September 12, 5 CBOE filed Amendment No. 2 to the proposed will be connected to a separate application server 2014) (‘‘Notice’’). rule change to delete proposed rule text in Exhibit at the Exchange to trade during Extended Trading 4 CBOE filed Amendment No. 1 to the proposed 5 and delete related parts in the purpose and Hours. See id. at note 45. rule change to (i) amend the requirements for statutory basis sections of its Form 19b–4 12 foreign Trading Permit Holders to ensure, in part, submission, as well as Exhibit 1 and Item 8 in the See id. at 54758. that foreign Trading Permit Holders will be able to Form 19b–4 (each as amended by Amendment No. 13 See id. at 54759. provide the Exchange with information, including 1), all of which related to the removal of proposed 14 See id. at 54763. their books and records; (ii) clarify why VIX index requirements that would have applied to foreign 15 See proposed CBOE Rule 6.1A(a). values will not be calculated and disseminated Trading Permit Holders. See Amendment No. 2 to 16 According to the Exchange, SPX currently during Extended Trading Hours; (iii) clarify that File No. SR–CBOE–2014–062, dated November 21, trades on the Hybrid 3.0 trading platform during CBOE will make available the number of Trading 2014 (‘‘Amendment No. 2’’). To promote Regular Trading Hours (except that the weekly SPX Permits during Extended Trading Hours to comply transparency of its proposed amendment, when series trade on the Hybrid trading platform during with Section 6(c)(4) of the Act; (iv) represent that CBOE filed Amendment No. 2 with the Regular Trading Hours). Pursuant to proposed Rule the Exchange will establish procedures to ensure Commission, it also submitted Amendment No. 2 as 6.1A(b), SPX will trade on the Hybrid trading that Trading Permit Holders only utilize clearing a comment letter to the file, which the Commission platform (and not the Hybrid 3.0 trading platform) brokers that are authorized by OCC for clearing posted on its Web site and placed in the public during Extended Trading Hours and thus will trade during Extended Trading Hours; (v) represent that comment file for SR–CBOE–2014–062. The pursuant to rules applicable to the Hybrid trading CBOE’s systems are designed to prohibit Exchange also posted a copy of its Amendment No. platform (rather than the Hybrid 3.0 trading unauthorized access; and (vi) correct an internal 2 on its Web site at http://www.cboe.com/publish/ platform) during Extended Trading Hours. See cross-reference in proposed CBOE Rule RuleFilingsSEC/SR-CBOE-2014-062.a2.pdf when it Notice, supra note 3 at note 18. 6.1A(e)(iii)(B). See Amendment No. 1 to File No. filed the amendment with the Commission. 17 SR–CBOE–2014–062, dated October 24, 2014 See id. at 54759. 6 See infra notes 4 and 5 (noting that when CBOE 18 (‘‘Amendment No. 1’’). To promote transparency of See id. at note 13. submitted each Amendment to its proposal, it also its proposed amendment, when CBOE filed 19 See id. at 54760. This requirement will apply submitted them as a comment letter to the file to Amendment No. 1 with the Commission, it also to any non-U.S. based person seeking access to the promote the broad dissemination of its submitted Amendment No. 1 as a comment letter Extended Trading Hours session. Persons that are Amendments). to the file, which the Commission posted on its not Trading Permit Holders, such as employees of 7 Web site and placed in the public comment file for A full description of the proposed rule change affiliates of Trading Permit Holders located outside SR–CBOE–2014–062. The Exchange also posted a can be found in the Notice. See Notice, supra note of the United States, will not have direct access to copy of its Amendment No. 1 on its Web site at 3. the Exchange, and thus their orders and quotes http://www.cboe.com/publish/RuleFilingsSEC/SR- 8 See CBOE Rule 24.6. All times in this order refer must be submitted to the Exchange through a CBOE-2014-062.a1.pdf when it filed the to Chicago time. Trading Permit Holder, subject to applicable laws, amendment with the Commission. 9 See Notice, supra note 3 at 54758. rules, and regulations. See id. at note 59.
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Extended Trading Hours. In other Extended Trading Hours. Although, a Trading. During Extended Trading words, a broker-dealer that is not Market Maker that elects to use QRM for Hours, the Exchange proposes to limit currently a CBOE member, as well as a both Regular Trading Hours and the available order types that may be current CBOE Trading Permit Holder Extended Trading Hours will need to entered into the system. Specifically, in (for Regular Trading Hours) will both establish parameters separately for each recognition of the expected reduced need to obtain a separate Extended trading session (even though a Market liquidity, higher volatility, and wider Trading Hours Trading Permit if they Maker may elect to use the same spreads during Extended Trading Hours, want to trade during CBOE’s new parameters for both trading sessions or the Exchange will not allow market Extended Trading Hours session.20 The use QRM for one trading session and not orders, market-on-close orders, stop separate nature of access for the two the other).26 orders, and good-til-cancelled orders.32 trading sessions means that Trading LMMs. The Exchange also may Otherwise, order processing during Permit Holders will need to use separate approve one or more Market Makers to Extended Trading Hours will operate in log-ins for Extended versus Regular act as Lead Market Makers (‘‘LMMs’’) in the same manner as it does for Regular Trading Hours.21 In this respect, CBOE’s each class during Extended Trading Trading Hours and there will be no systems will be designed to prevent Hours.27 Unlike Regular Trading Hours, change to ranking, display, or allocation unauthorized access by persons not however, LMMs will only be required to algorithms rules.33 Moreover, there will eligible to trade on CBOE during the comply with the continuous quoting be no change between Regular and Extended Trading Hours session.22 obligations and other obligations Extended Trading Hours in regards to Market Makers. CBOE’s proposal applicable to regular Market Makers in the processes for clearing, settlement, contemplates participation from Market their assigned classes.28 Consequently, exercise, and expiration.34 In addition, Makers in the Extended Trading Hours LMMs will not be entitled to receive a the Exchange will report the best bid session. To be eligible, Market Makers participation entitlement in the and offer and executed trades to the will need to obtain a separate Extended Extended Hours Session.29 However, if Options Price Reporting Authority Trading Hours Trading Permit and also an LMM meets specific performance (‘‘OPRA’’) during Extended Trading will need to request a separate criteria during a month, it will be Hours in the same manner that it reports appointment during Extended Trading eligible to receive a specified monetary that information to OPRA during Hours.23 During Extended Trading incentive from CBOE. Specifically, if an Regular Trading Hours.35 Hours, Market Makers will be required LMM: (1) Provides continuous The Exchange also may halt trading to maintain continuous electronic electronic quotes in at least the lesser of during Extended Trading Hours in the quotes in 60% of the non-adjusted 99% of the non-adjusted series or 100% interests of a fair and orderly market options series of the Market Maker’s of the non-adjusted series minus one largely in the same manner that it can appointed classes that expire in less call-put pair in an Extended Trading during Regular Trading Hours.36 For than nine months for 90% of the time Hours allocated class (excluding intra- when the Market Maker is quoting in a day add-on series on the day during 32 See Notice, supra note 3 at 54763. See also 24 class. In addition, the Exchange’s which such series are added for trading) proposed CBOE Rule 6.1A(f). proposal gives it the authority to during Extended Trading Hours in a 33 See Notice, supra note 3 at 54765. The determine to have no bid/ask given month and (2) ensures an opening Exchange also intends to activate the complex order auction and the automated improvement differential requirement in the Extended of the same percentage of series by 2:05 25 mechanism (‘‘AIM’’) auction during Extended Trading Hours session. Further, a.m. for at least 90% of the trading days Trading Hours. These auctions will operate in the Market Makers generally will be able to during Extended Trading Hours in a same manner as they do during Regular Trading use the same Exchange functionality given month, the LMM will be eligible Hours, except with respect to AIM, the requirement during Extended Trading Hours that is that three Market Makers must be quoting to initiate to receive a rebate for that month in an an AIM auction will not apply during Extended available to them during Regular amount set forth in the Exchange Fees Trading Hours. See id. at note 43. Trading Hours. For example, Market Schedule.30 For purposes of this 34 See Notice, supra note 3 at 54765. According Makers may elect to use a quote risk heightened continuous quoting to the Exchange, the Options Clearing Corporation monitor (‘‘QRM’’) mechanism during has stated that it will be able to clear and settle all standard, an LMM will be deemed to transactions and handle exercises of options during have provided continuous electronic Extended Trading Hours. See id. at note 48. In 20 See proposed CBOE Rule 6.1A(d). The quotes during Extended Trading Hours addition, the Exchange has represented that it will Exchange represents that it will make available a if the LMM provides electronic two- work with OCC to establish procedures in sufficient number of Trading Permits during connection with on-boarding Trading Permit Extended Trading Hours to comply with Section sided quotes for 90% of the time in Holders to ensure that Extended Trading Hours 6(c)(4) of the Act. See Amendment No. 1, supra Extended Trading Hours in a given Trading Permit Holders only utilize clearing brokers note 4. The Exchange intends to set the initial limit month.31 that are properly authorized by OCC for operating of Extended Trading Hours Trading Permits at 900 during Extended Trading Hours. See Amendment Market Maker Trading Permits and 150 Electronic No. 1, supra note 4. Access Trading Permits (the same total number as 26 See proposed CBOE Rule 8.18. 35 See Notice, supra note 3 at 54765. The operator available during Regular Trading Hours). See id. 27 See proposed CBOE Rule 6.1A(e)(iii)(A). of OPRA has informed CBOE that it intends to add 21 See Notice, supra note 3 at 54765. 28 See proposed CBOE Rule 6.1A(e)(iii)(B). a modifier to the disseminated information during 22 See Amendment No. 1, supra note 4. 29 See, e.g., CBOE Rules 6.45B and 8.15B Extended Trading Hours. See id. at note 57. The 23 See proposed CBOE Rule 6.1A(e). For Extended (concerning participation entitlements). Exchange also will disseminate Extended Trading Trading Hours, the appointment cost for VIX will 30 CBOE’s adoption of any such rebate will be Hours data through its proprietary data feed in the be 0.5 and for SPX it also will be 0.5. Each Extended subject to the rule filing process of Section 19 of same format and manner that it distributes data Trading Hours Trading Permit will have an the Act. CBOE is not proposing any rebate in this during Regular Trading Hours. See id. at 54765. appointment credit of 1.0 (the same as a Regular current proposal. Any fees to be charged by CBOE for the Extended Trading Hours Trading Permit), so at the launch of 31 See proposed CBOE Rule 6.1A(e)(iii)(C). Trading Hours proprietary data feed will be subject Extended Trading Hours, a Market Maker will only Because the heightened quoting standard for LMMs to a separate fee change filing. See id. at note 49. need to hold one Extended Trading Hours Trading in the Extended Hours Trading session is applicable 36 See proposed CBOE Rule 24.7(d). Further, Permit if it wants to quote in both SPX and VIX only to a fee rebate and not a participation clearly erroneous trade breaks during Extended during Extended Trading Hours. See Notice, supra entitlement, the monthly measuring period is Trading Hours will be processed in the same note 3 at 54760. See also proposed CBOE Rule separate and distinct from the heightened quoting manner as Regular Trading Hours, except that 6.1A(e)(i). standard in the Regular Trading Hours session, during Extended Trading Hours, only two Exchange 24 See proposed CBOE Rule 6.1A(e)(ii). which is measured on a daily basis. See Notice, Officials that are members of the Exchange’s staff 25 See id. supra note 3 at 54762. Continued
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example, if there was a marketwide prior to accepting an order from a in Europe, and therefore CBOE’s trading halt at the end of the prior customer for execution during Extended proposal may be of particular interest to trading day, CBOE could consider that Trading Hours.41 The Exchange also traders located in non-U.S. jurisdictions. as an ‘‘unusual condition’’ in will distribute a Regulatory Circular At the same time, CBOE has proposed determining whether to halt trading detailing, among other things, some of certain limitations and protections on during the following day’s Extended the risks of trading during Extended access and trading during Extended Trading Hours session.37 Separately, Trading Hours.42 Trading Hours that are designed to CBOE proposed to amend its trade halt promote just and equitable principles of III. Discussion and Commission rule to provide that it also may consider trade and foster cooperation and Findings whether trading in related futures has coordination with persons engaged in been halted as a factor in determining After careful consideration, the regulating, clearing, settling, processing whether to halt trading in an option.38 Commission finds that the proposed information with respect to, and Surveillance and Disclosures. The rule change, as modified by Amendment facilitating transactions in securities. Exchange has represented that it will Nos. 1 and 2, is consistent with the For example, as discussed above, only perform all necessary surveillance requirements of the Act and the rules authorized Trading Permit Holders, coverage and will have appropriately and regulations thereunder applicable to their nominees, and their associated trained and qualified regulatory and a national securities exchange.43 In persons will be able to access the CBOE operations staff in place during particular, the Commission finds that trading system during Extended Trading Extended Trading Hours to satisfy its the proposed rule change, as amended, Hours, and CBOE’s system is designed regulatory obligations and administer is consistent with Section 6(b)(5) of the to allow CBOE to restrict unauthorized the Extended Trading Hours session in Act,44 which requires, among other access to its systems in Extended real time.39 In addition, because of the things, that the rules of an exchange be Trading Hours.46 Specifically, CBOE is differences in the nature of the market designed to prevent fraudulent and requiring a new class of trading permits and trading between Regular and manipulative acts and practices, to for Extended Trading Hours with their Extended Trading Hours, CBOE will promote just and equitable principles of own unique log-in ID, and only persons require Trading Permit Holders to trade, to foster cooperation and in possession of those credentials will disclose to customers that trading coordination with persons engaged in have access to CBOE’s systems to trade during Extended Trading Hours may regulating, clearing, settling, processing during Extended Trading Hours. involve material risks, including, in information with respect to, and Moreover, consistent with fostering part, the possibility of lower liquidity, facilitating transactions in securities, to cooperation and coordination with higher volatility, and lack of an updated remove impediments to and perfect the persons engaged in clearing and settling underlying index or portfolio value,40 mechanism of a free and open market transactions in securities, CBOE has and a national market system, and, in represented that it will work with OCC will be necessary to make such a determination. See general, to protect investors and the to establish procedures in connection Notice, supra note 3 at 54765. public interest. While no other options with on-boarding Extended Trading 37 See Notice, supra note 3 at 54766; and exchange is currently open for trading proposed CBOE Rule 24.7(d). Also, under the Hours permit holders to ensure that proposed rule change, CBOE will not have to outside of Regular Trading Hours, the Trading Permit Holders only utilize consider during Extended Trading Hours existing Commission notes that it has previously clearing brokers that have been properly factors that are not applicable to the Extended approved extended trading hours in the authorized by OCC for operating during session, such as (i) the extent to which trading is 45 cash equities markets. Extended Trading Hours.47 This process not occurring in the stocks or options underlying The proposed rule change, as the index; (ii) the current calculation of the index is designed to help assure the orderly modified by Amendment Nos. 1 and 2, derived from the current market prices of the stocks functioning of the clearing process in is not available; (iii) the ‘‘current index level’’ for will allow investors additional trading Extended Trading Hours by avoiding a volatility index is not available or the cash (spot) opportunities to trade in two CBOE any risk associated with a CBOE permit value for a volatility index is not available; and (iv) exclusively-listed products outside of the extent to which the rotation has been completed holder trading through a clearing broker CBOE’s current Regular Trading Hours. or other factors regarding the status of the rotation, during Extended Trading Hours if such in determining whether to halt trading during The hours of CBOE’s proposed clearing broker does not, in OCC’s Extended Trading Hours. See Notice, supra note 3 Extended Trading Hours roughly opinion, meet OCC’s standards for at note 53; and proposed CBOE Rule 24.7(d). coincide with the regular trading hours 38 See proposed CBOE Rule 24.7, Interpretation clearing outside of regular trading and Policies .01. Currently, CBOE’s rule allows it expects CBOE to reevaluate this decision and hours. to consider the activation of price limits on futures In addition, as discussed above, all of exchanges when determining whether to halt consider disseminating a VIX index value if and trading in an index options. The proposed change when quoting activity becomes sufficient to allow CBOE’s rules, with certain exceptions, will allow CBOE to consider any halt in futures CBOE to calculate accurate and meaningful VIX will continue to apply during Extended trading, including halts called in situations other index values during the Extended Trading Hours Trading Hours. These rules, among session. than in response to the activation of a price limit. other things, prohibit Trading Permit See Notice, supra note 3 at 54765. 41 See proposed CBOE Rule 6.1A(j). 39 See Notice, supra note 3 at 54765 and 54767. 42 See Notice, supra note 3 at 54764. Holders from engaging in acts or 40 CBOE is the index calculator for the VIX. 43 In approving this proposed rule change, the practices inconsistent with just and According to CBOE, the accuracy of the calculation Commission has considered the proposed rule’s equitable principles of trade, making for VIX indicative (or spot) values depends upon impact on efficiency, competition, and capital any willful or material formation. See 15 U.S.C. 78c(f). the quality of bid and offer quotes for constituent misrepresentation or omission in any SPX option series. CBOE is unsure whether the SPX 44 15 U.S.C. 78f(b)(5). option quotes displayed during Extended Trading 45 See e.g., Securities Exchange Act Release Nos. Hours will be sufficient to calculate accurate and 29237 (May 24, 1991), 56 FR 24853 (May 31, 1991) 46 The Commission notes that in order to be a meaningful VIX indicative quote values during (SR–NYSE–90–52 and SR–NYSE–90–53) (approving Trading Permit Holder, an individual or Extended Hours. Accordingly, CBOE has an off-hours trading facility on a pilot basis); 42004 organization must be, in part, registered as a broker determined to not calculate VIX spot values during (October 13, 1999), 64 FR 56548 (October 20, 1999) or dealer pursuant to Section 15 of the Act or be Extended Trading Hours. See Amendment No. 1, (SR–CHX–99–16) (approving extended trading associated with a Trading Permit Holder supra note 4. However, as the Exchange and market hours on a pilot basis); and 56985 (December 18, organization that is registered as a broker or dealer participants gain experience with the Extended 2007), 72 FR 73388 (December 27, 2007) (SR– pursuant to Section 15 of the Act. See CBOE Rules Trading Hours session and if activity and market NASDAQ–2007–098) (approving the trading of 3.2 and 3.3. maker participation increases, the Commission certain securities outside of regular market hours). 47 See Amendment No. 1, supra note 4.
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application, report, or other and wider spreads during Extended volatility, and wider spreads during communication to the Exchange or the Trading Hours as compared to Regular Extended Trading Hours. OCC, and from effecting or inducing the Trading Hours.53 The Commission Furthermore, CBOE has proposed to purchase, sale, or exercise of any believes that such disclosures should provide for Market Makers during security for the purpose of manipulating help ensure that customers are Extended Trading Hours. Any Market the price or activity of the security,48 as reasonably informed about the specific Maker that elects to have an well as impose best execution risks associated with trading in the non- appointment during Extended Trading requirements and prohibit trading ahead core market before they decide to Hours will be subject to the same of customer orders.49 In addition, the submit their first order in the Extended general quoting obligations as are Exchange has represented that it will Trading Hours session. Further, these applicable during Regular Trading revise its surveillance procedures to requirements are designed to mitigate, Hours, though CBOE may determine not incorporate transactions that occur and to the extent possible, the likelihood of to impose bid/ask differential orders and quotations that are submitted investor confusion regarding the requirements during Extended Trading during Extended Trading Hours and significant differences between the Hours.56 perform all necessary surveillance character of the market typical of CBOE also has provided for Lead coverage during Extended Trading Regular and Extended Trading Hours Market Makers, though the Commission Hours.50 Importantly, CBOE has sessions. notes that LMMs will not be entitled to represented that it will have a sufficient The Commission further believes that a participation entitlement in Extended number of appropriately qualified staff CBOE’s proposal to use a fully Trading Hours. However, LMMs that on-site and otherwise available as electronic trading platform during satisfy a heightened quoting standard necessary during Extended Trading Extended Trading Hours that shares during a month will be eligible to Hours to provide support and handle most of the functionality of its Hybrid receive a rebate from CBOE for that 57 any operations and regulatory issues System is reasonable. As discussed month. The Commission believes that 51 that may arise. CBOE’s represented above, CBOE will use separate servers CBOE’s proposed LMM incentive commitment to adequately staff its and hardware for the Extended Trading program during Extended Trading operations during Extended Trading Hours session and the two sessions will Hours is designed to encourage two- Hours is important to assure the not be linked or otherwise interact with sided liquidity during Extended Trading integrity of CBOE’s operations during each other. Nevertheless, according to Hours and, to the extent it is successful, those early morning hours and the Exchange, orders will be processed may contribute to the maintenance of necessary to assure that CBOE is able to in the same manner during Extended fair and orderly markets during carry out and enforce its rules during Trading Hours as Regular Trading Hours Extended Trading Hours. To the extent this session, including rules relating to and there will be no changes to the that CBOE is successful in encouraging trading halts and obvious error trades, ranking, display, or allocation algorithm active participation of Market Makers as well as thoroughly monitor trading rules.54 CBOE also explained that there and LMMs during Extended Trading and the operations of its trading will be no changes to the processes for Hours, then CBOE may be able to help systems. Accordingly, the Commission clearing, settlement, exercise, and address some of the risks inherent in a believes that CBOE has designed its expiration.55 The Commission believes non-core hours trading session, Extended Trading Hours session to that maintaining separate infrastructure including the risks of reduced liquidity, promote just and equitable principles of for the two separate trading systems is higher volatility, and wider markets. trade and prevent fraudulent and designed to protect the resiliency of the Therefore, the proposal’s provision for manipulative acts and practices to the Regular Trading Hours session. Further, Market Makers and LMMs during the same extent that its Regular Trading Extended Trading Hours session is Hours session has been so designed. utilizing the existing trading and clearing process for the Extended consistent with the protection of The Commission also believes that investors and the public interest as well CBOE’s disclosure requirement that Trading Hours session that CBOE uses for its electronic trading during Regular as the promotion of fair and orderly obligates members to make certain markets. written disclosures to customers Trading Hours should facilitate the ability of CBOE members to trade in the The Commission also believes that regarding material trading risks that may CBOE’s proposed changes to its trading exist during Extended Trading Hours is new session on terms and with functionality that is familiar to them. halt rule are consistent with the Act and consistent with the protection of designed to promote fair and orderly 52 investors. Specifically, Trading Permit However, there will be some markets. The Commission notes that the Holders will be required to make certain differences during Extended Trading Exchange will consider halting trading disclosures to customers regarding the Hours, such as returning certain kicked- during Extended Trading Hours in the risk of lower liquidity, higher volatility, out orders to a Trading Permit Holder in interests of a fair and orderly market in lieu of routing such order to PAR, and the same manner that it could halt 48 See Chapter IV (Business Conduct) of CBOE’s limiting the types of orders available for trading during Regular Trading Hours. rules. electronic processing to avoid the use of 49 CBOE’s proposed amendment to the See CBOE Rules 53.2 (Prohibition Against market orders or any order that could Trading Ahead of Customer Orders) and 53.8 (Best trading halt rule to allow it to consider Execution and Interpositioning). The Commission convert into a market order. The a halt in trading in related futures notes that CBOE Rule 53.2, Interpretations and Commission believes these differences contracts is a reasonable additional Policies .07, specifically provides that Trading reflect that the character of trading Permit Holders may limit the life of a customer order to the period of normal market hours. during Extended Trading Hours will 56 As noted above, Market Makers will not have However, if the customer and Trading Permit likely differ from typical trading during to satisfy the open outcry quoting obligations since Holder agree to the processing of the customer’s Regular Trading Hours, including the all trading during Extended Trading Hours will be order outside normal market hours, the protections likelihood of reduced liquidity, higher electronic. See proposed CBOE Rule 6.1A(e)(ii). of the rule will apply to that customer’s order for 57 The Commission notes that the Exchange will the entirety of the agreed upon executable time. need to submit a proposed rule change pursuant to 50 See Notice, supra note 3 at 54765 and 54767. 53 See id. Section 19(b) of the Act if and when it seeks to add 51 See id. 54 See Notice, supra note 3 at 54758. such a rebate for LMMs to the Exchange’s fee 52 See proposed CBOE Rule 6.1A(j). 55 See id. at 54765. schedule.
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factor and consistent with the existing submission, all subsequent Extended Trading Hours.62 CBOE also factors under the rule that allows CBOE amendments, all written statements represented that it will comply with the to consider the activation of price limits with respect to the proposed rule provisions of Section 6(c)(4) of the Act in the futures markets.58 change that are filed with the in making Trading Permits available In addition, the Commission finds Commission, and all written during Extended Trading Hours by that the proposed rule change, as communications relating to the authorizing a total of 1,050 total permits amended, is consistent with Section proposed rule change between the for the Extended Trading Hours 11A(a)(1)(C) of the Act.59 Congress Commission and any person, other than session.63 Finally, CBOE provided found in those provisions that it is in those that may be withheld from the additional support to justify its decision the public interest and appropriate for public in accordance with the to not disseminate VIX values during the protection of investors and the provisions of 5 U.S.C. 552, will be Extended Trading Hours.64 As the index maintenance of fair and orderly markets available for Web site viewing and calculator for VIX, CBOE explained that to assure the availability to brokers, printing in the Commission’s Public it does not currently know whether SPX dealers, and investors of information Reference Room, 100 F Street NE., options quotes (on which the VIX index with respect to quotations for and Washington, DC 20549, on official is calculated) displayed in Extended transactions in securities, and to assure business days between the hours of Trading Hours will be sufficient to the practicability of brokers executing 10:00 a.m. and 3:00 p.m. Copies of such calculate an accurate and meaningful investors’ orders in the best market. The filing will also be available for VIX indicative value in the same proposed rule change is designed to inspection and copying at the principal manner as what typically occurs during accomplish these objectives by ensuring office of the Exchange. All comments Regular Trading Hours. CBOE further that the Exchange will report its best bid received will be posted without change; pledged to reconsider the issue in the and offer and executed trades to OPRA the Commission does not edit personal future and reassess whether trading in during Extended Trading Hours in the identifying information from the Extended Trading Hours session same manner that they are reported submissions. You should submit only rises to a sufficient level that is capable during Regular Trading Hours,60 thereby information that you wish to make of supporting the calculation of accurate providing public transparency of available publicly. All submissions and meaningful VIX indicative values. activity in the Extended Trading Hours should refer to File No. SR–CBOE– The Commission believes that these market. 2014–062 and should be submitted on proposed changes in Amendment No. 1 or before December 26, 2014. IV. Solicitation of Comments on are reasonable and clarify the Amendment Nos. 1 and 2 V. Accelerated Approval of Proposed application and operation of CBOE’s original proposal in a manner that is Interested persons are invited to Rule Change as Modified by Amendment Nos. 1 and 2 materially consistent with the scope of submit written data, views, and what CBOE originally proposed and The Commission finds good cause to arguments concerning the foregoing, what the Commission noticed for public approve the proposed rule change, as including whether Amendment Nos. 1 comment in the Federal Register. and 2 are consistent with the Act. modified by Amendment Nos. 1 and 2, In addition, in Amendment No. 1, prior to the thirtieth day after the date Comments may be submitted by any of CBOE revised its proposed rules of publication of notice of Amendment the following methods: regarding foreign Trading Permit Nos. 1 and 2 in the Federal Register. Holders and access from foreign Electronic Comments The Commission notes that, in addition jurisdictions. However, in Amendment • Use the Commission’s Internet to filing Amendment Nos. 1 and 2 with No. 2 CBOE withdrew those proposed comment form (http://www.sec.gov/ the Commission, CBOE also submitted rule changes. The Commission believes rules/sro.shtml); or Amendment No. 1 and 2 as comments that those proposed changes were • Send an email to rule-comments@ to the file, which the Commission incidental to the Exchange’s core sec.gov. Please include File No. SR– promptly posted on its Web site on proposal to adopt an Extended Trading CBOE–2014–062 on the subject line. October 27, 2014 and November 21, Hours session for SPX and VIX, and that Paper Comments 2014, respectively, in order to promote public availability and accessibility of their deletion from the proposal does • Send paper comments in triplicate the Amendments. The Commission not raise any concerns with the to Brent J. Fields, Secretary, Securities notes that it did not receive any remainder of the proposal. If, in the and Exchange Commission, 100 F Street comments on CBOE’s initial proposal or future, CBOE decides to revisit its rules NE., Washington, DC 20549–1090. on either Amendment Nos. 1 or 2 prior applicable to foreign Trading Permit All submissions should refer to File No. to the date of this order. Holders, it would need to submit a SR–CBOE–2014–062. This file number In Amendment No. 1, the Exchange proposed rule change filing pursuant to 65 should be included on the subject line made several discrete changes to its Section 19(b) of the Act. if email is used. To help the proposal to provide additional clarity Accordingly, the Commission finds Commission process and review your and further legal support for why its good cause, pursuant to Section 19(b)(2) comments more efficiently, please use proposal is consistent with the Act. In of the Act, to approve the proposed rule only one method. The Commission will particular, CBOE represented that it will change, as modified by Amendment post all comments on the Commission’s establish procedures with OCC to Nos. 1 and 2, on an accelerated basis. Internet Web site (http://www.sec.gov/ ensure that Trading Permit Holders only VI. Conclusion rules/sro.shtml). Copies of the utilize clearing brokers that have been It is therefore ordered, pursuant to authorized by OCC to clear during Section 19(b)(2) of the Act,66 that the 58 See proposed CBOE Rule 24.7, Interpretations Extended Trading Hours.61 Further, and Policies .01. CBOE clarified that it will be able to 62 59 15 U.S.C. 78k–1(a)(1)(C). See id. prohibit an unauthorized user from 63 60 See Notice, supra note 3 at 54765. See also See id. supra note 35 (noting that OPRA intends to add a accessing the trading system during 64 See id. modifier to Extended Trading Hours quotes and 65 15 U.S.C. 78s(b). trades). 61 See Amendment No. 1, supra note 4. 66 15 U.S.C. 78s(b)(2).
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proposed rule change, as modified by October 10, 2014, the Exchange by at least $0.001 per share. When RPI Amendment Nos. 1 and 2, (SR–CBOE– submitted a letter requesting that the interest priced at least $0.001 per share 2014–062), be, and it hereby is, staff of the Division of Trading and better than the Protected Bid or approved on an accelerated basis. Markets not recommend any Protected Offer for a particular security For the Commission, by the Division of enforcement action under Rule 602 of is available in the Exchange’s system Trading and Markets, pursuant to delegated Regulation NMS based on the (the ‘‘System’’), the Exchange would authority.67 Exchange’s and its Members’ disseminate an identifier, known as the 6 Brent J. Fields, participation in the Program. Retail Liquidity Identifier, indicating This order approves the proposed rule Secretary. that such interest exists. A Retail Order change and grants the exemption from would interact, to the extent possible, [FR Doc. 2014–28475 Filed 12–3–14; 8:45 am] the Sub-Penny Rule sought by the with available contra-side RPI Orders BILLING CODE 8011–01–P Exchange in relation to the proposed and other price improving liquidity.10 rule change. Types of Orders and Identifier SECURITIES AND EXCHANGE II. Description of the Proposal A Retail Order would be an agency or COMMISSION The Exchange is proposing a 12- riskless principal 11 order that originates [Release No. 34–73702; File No. SR–BX– month pilot program to attract from a natural person and is submitted 2014–048] additional retail order flow to the to the Exchange by an RMO, provided Exchange, while also providing the that no change is made to the terms of Self-Regulatory Organizations; potential for price improvement to retail the order with respect to price (except NASDAQ OMX BX, Inc.; Order Granting order flow. The Program would be in the case of a market order being Approval to Proposed Rule Change To limited to trades occurring at prices changed to a marketable limit order) or Establish the Retail Price Improvement equal to or greater than $1.00 per share.7 side of market and provided that the Program on a Pilot Basis Expiring All Regulation NMS securities traded on order does not originate from a trading Twelve Months From the Date of the Exchange would be eligible for algorithm or any other computerized Implementation inclusion in the Program. methodology. A Retail Order is an Under the Program, a new class of Immediate or Cancel Order. As November 28, 2014. market participants called Retail discussed in greater detail below, Retail I. Introduction Member Organizations (‘‘RMOs’’) 8 Orders may be designated as Type 1 or On October 17, 2014, The NASDAQ would be eligible to submit certain retail Type 2. Retail Orders, regardless of OMX BX Stock Market LLC (the order flow (‘‘Retail Orders’’) to the Type, may be entered in sizes that are ‘‘Exchange’’ or ‘‘BX’’) filed with the Exchange. All Exchange Members odd lots, rounds lots, or mixed lots. Securities and Exchange Commission would be permitted to provide potential An RPI Order would be non-displayed liquidity on the Exchange that is priced (‘‘Commission’’) pursuant to Section price improvement for Retail Orders in better than the Protected NBBO by at 19(b)(1) of the Securities Exchange Act the form of designated non-displayed of 1934 (‘‘Act’’) 1 and Rule 19b–4 interest, called a Retail Price exception under Regulation NMS Rule 611(b)(1) or thereunder,2 a proposed rule change to Improvement Order (‘‘RPI Order’’ or ‘‘RPI interest’’), that is priced more if such NBB or NBO is otherwise not available for establish a Retail Price Improvement an automatic execution. In such case, the Exchange (‘‘RPI’’) Program (the ‘‘Program’’) on a aggressively than the Protected National states that the Protected NBBO would be the best- 9 pilot basis for a period of 12 months Best Bid or Offer (‘‘Protected NBBO’’) priced protected bid or offer to which a market center must route interest pursuant to Rule 611 of from the date of implementation, if relating to the required form of a filing on Form Regulation NMS. approved. The proposed rule change 19b-4, it was rejected. 10 As explained further below, the Exchange has was published for comment in the 6 See Letter from Jeffrey Davis, Deputy General proposed two types of Retail Orders, one of which Federal Register on October 29, 2014.3 Counsel, NASDAQ OMX BX, Inc., to Stephen could execute against other contra-side interest if it Luparello, Director, Division of Trading and was not completely filled by contra-side RPI The Commission did not receive any Interest or other price-improving liquidity. All comments on the proposed rule change. Markets, Commission, dated October 10, 2014. This letter was submitted contemporaneously with the Retail Orders would first execute against available contra-side RPI Orders or other price-improving In connection with the proposal, the Exchange’s original filing for this proposed rule liquidity. Any remaining portion of the Retail Order Exchange requested exemptive relief change, which was filed on October 10, 2014. As would then either cancel, be executed as an 4 noted above, that filing was rejected because it did from Rule 612 of Regulation NMS, immediate-or-cancel order, or be routed to another not comply with the rules of the Commission which, among other things, prohibits a market for execution, depending on the type of relating to the required form of a filing on Form Retail Order. The Exchange notes that other price national securities exchange from 19b–4. improving liquidity may include, but is not limited accepting or ranking orders priced 7 The Exchange notes that certain orders to: Booked non-displayed orders with a limit price greater than $1.00 per share in an submitted to the Program designated as eligible to that is more aggressive than the then-current NBBO; increment smaller than $0.01.5 On interact with liquidity outside of the Program— midpoint-pegged orders (which are by definition Type 2 Retail Orders, discussed below—could non-displayed and priced more aggressively than execute at prices below $1.00 if they do in fact 67 17 CFR 200.30–3(a)(12). the NBBO); non-displayed orders pegged to the execute against liquidity outside of the Program. NBBO with an aggressive offset, as defined in 1 15 U.S.C. 78s(b)(1). 8 An RMO would be a Member (or a division Proposed BX Rule 4780(a)(4) as Other Price 2 17 CFR 240.19b–4. thereof) that has been approved by the Exchange to Improving Contra-Side Interest. Orders that do not 3 See Securities Exchange Act Release No. 73410 submit Retail Orders. See Proposed BX Rule 4780. constitute other price improving liquidity include, (October, 23, 2014), 79 FR 64447 (SR–BX–2014– A ‘‘Member’’ is any registered broker or dealer that but are not limited to: Orders with a time-in-force 048) (‘‘Notice’’). has been admitted to membership in the Exchange. instruction of IOC; displayed orders; limit orders 4 17 CFR 242.612 (‘‘Sub-Penny Rule’’). See BX Rule 0120(i). priced less aggressively than the NBBO. 5 See Letter from Jeffrey Davis, Deputy General 9 The terms Protected Bid and Protected Offer are 11 In order to qualify as a ‘‘Retail Order,’’ a Counsel, NASDAQ OMX BX, Inc., to Brent J. Fields, defined in Rule 600(b)(57) of Regulation NMS. 17 ‘‘riskless principal’’ order must satisfy the criteria Secretary, Commission, dated October 10, 2014 CFR 242.600(b)(57). The Exchange represents that, set forth in FINRA Rule 5320.03. RMOs that submit (‘‘Request for Sub-Penny Rule Exemption’’). The generally, the Protected Bid and Protected Offer, riskless principal orders as Retail Orders must Request for Sub-Penny Rule Exemption was and the national best bid (‘‘NBB’’) and national best maintain supervisory systems to reconstruct such submitted contemporaneously with the Exchange’s offer (‘‘NBO,’’ together with the NBB, the ‘‘NBBO’’), orders in a time-sequenced manner, and the RMOs original filing for this proposed rule change, which will be the same. However, it further represents that must submit reports contemporaneous with the was filed on October 10, 2014. Because that filing a market center is not required to route to the NBB execution of the facilitated orders that identify such did not comply with the rules of the Commission or NBO if that market center is subject to an trades as riskless principal.
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least $0.001 per share and that is better than the Exchange’s Protected Bid monitor whether its broker-dealer identified as such. RPI interest can be or Protected Offer by at least the customer’s Retail Order flow continues priced either as an explicitly priced minimum level of price improvement as to meet the applicable requirements.14 limit order or implicitly priced as required by the Program. Retail Order Designations relative to the NBBO with an offset of Retail Member Organizations at least $0.001. The price of an RPI Under Proposed BX Rule 4780(f), an Order with an offset would be In order to become an RMO, a RMO submitting a Retail Order could determined by a Member’s entry of the Member must conduct a retail business choose one of two designations dictating following into the Exchange: (1) RPI buy or handle retail orders on behalf of how the Retail Order would interact or sell interest; (2) an offset from the another broker-dealer. Any Member that with available contra-side interest. First, Protected NBBO, if any; and (3) a ceiling wishes to obtain RMO status would be a Retail Order could interact only with or floor price. RPI Orders submitted required to submit: (1) An application available contra-side RPI interest and with an offset would be similar to other form; (2) supporting documentation other price-improving liquidity. The peg orders available to Members in that sufficient to demonstrate the retail RMO would label this a Type 1 Retail the order is tied or ‘‘pegged’’ to a certain nature and characteristics of the Order, and such orders would not price, and would have its price applicant’s order flow; 13 and (3) an interact with available non-price- automatically set and adjusted upon attestation, in a form prescribed by the improving, contra-side interest in the changes in the Protected NBBO, both Exchange, that substantially all orders System or route to other markets. upon entry and any time thereafter. submitted by the Member as a Retail Portions of a Type 1 Retail Order that RPI Orders in their entirety (the buy Order would meet the qualifications for were not executed would be cancelled or sell interest, the offset, and the such orders under Proposed BX Rule immediately and automatically. ceiling or floor) will remain non- 4780(b). If the Exchange disapproves the Second, an RMO could label a Retail displayed. The Exchange will also allow application, it would provide a written Order as a Type 2-designated Retail Members to enter RPI Orders that notice to the Member. The disapproved Order. A Type 2-designated Retail Order establish the exact limit price, which is applicant could appeal the disapproval would interact first with available similar to a non-displayed limit order as provided below or re-apply 90 days contra-side RPI Orders and other price- currently accepted by the Exchange after the disapproval notice is issued by improving liquidity, and any remaining today, except that the Exchange will the Exchange. An RMO also could portion would be eligible to interact accept sub-penny limit prices on RPI voluntarily withdraw from RMO status with other interest in the System and, if Orders in increments of $0.001.12 The at any time by giving written notice to designated as eligible for routing, would Exchange will monitor whether RPI buy the Exchange. route to other markets in compliance or sell interest, adjusted by any offset The Exchange would require an RMO with Regulation NMS and pursuant to and subject to the ceiling or floor price, to have written policies and procedures BX Rule 4758. Any portion of the Retail is eligible to interact with incoming reasonably designed to assure that it Order that remained unexecuted would Retail Orders. will only designate orders as Retail then be cancelled. When RPI interest priced at least Orders if all the requirements of a Retail Priority and Allocation $0.001 better than the Exchange’s Order are met. Such written policies Under Proposed BX Rule 4780(g), the Protected Bid or Protected Offer for a and procedures would have to require Exchange would follow price-time particular security is available in the the Member to exercise due diligence priority, ranking RPI interest in the System, the Exchange would before entering a Retail Order to assure same security according to price and disseminate an identifier, known as the that entry as a Retail Order is in then time of entry into the System.15 Retail Liquidity Identifier, indicating compliance with the proposed rule and that such interest exists. The Exchange to monitor whether orders entered as Any remaining unexecuted RPI Orders would implement the Program in a Retail Orders meet the applicable would remain available to interact with manner that allowed the dissemination requirements. If the RMO represents other incoming Retail Orders if such of the identifier through consolidated Retail Orders from another broker-dealer interest is at an eligible price. Any data streams (i.e., pursuant to the customer, the RMO’s supervisory remaining unexecuted portion of a Consolidated Tape Association Plan/ procedures must be reasonably designed Retail Order would cancel or execute in Consolidated Quotation Plan (‘‘CTA/CQ accordance with Proposed BX Rule to assure that the orders received from 16 Plan’’) for Tape A and Tape B securities, the broker-dealer customer that are 4780(f). and the Nasdaq UTP Plan for Tape C designated as Retail Orders meet the Failure of RMO To Abide by Retail securities as well as through proprietary definition of a Retail Order. The RMO Order Requirements Exchange data feeds). The Retail must obtain, from each broker-dealer Proposed BX Rule 4780(c) addresses Liquidity Identifier would reflect the customer that sends it orders to be symbol and the side (buy or sell) of the an RMO’s failure to abide by Retail designated as Retail Orders, an annual Order requirements. If an RMO were to RPI Order, but it would not include the written representation, in a form price or size. In particular, the designate orders submitted to the acceptable to the Exchange, that entry of Exchange as Retail Orders and the consolidated quoting outputs would orders as Retail Orders will be in include a field for codes related to the compliance with the requirements of 14 The Exchange represents that it or another self- Retail Liquidity Identifier. The codes this proposed rule, and the RMO must regulatory organization on behalf of the Exchange will indicate RPI interest that is priced will review an RMO’s compliance with these 13 For example, a prospective RMO could be requirements through an exam-based review of the 12 As noted above, supra note 5 and required to provide sample marketing literature, RMO’s internal controls. See Notice, supra note 3, accompanying text, in connection with the Web site screenshots, other publicly disclosed 79 FR at 6449 n.8. Program, the Exchange requested exemptive relief materials describing the retail nature of their order 15 See also BX Rule 4757 (setting forth the from the Sub-Penny Rule of Regulation NMS, flow, and such other documentation and Exchange’s price-time priority methodology). which, among other things, prohibits a national information as the Exchange may require to obtain 16 The Exchange has provided three examples of securities exchange from accepting or ranking reasonable assurance that the applicant’s order flow how the priority and ranking of RPI Orders would orders priced greater than $1.00 per share in an would meet the requirements of the Retail Order operate. See Notice, supra note 3, 79 FR at 64449– increment smaller than $0.01. definition. 50.
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Exchange determined, in its sole system; and, in general, to protect price improvement provided by the discretion, that those orders failed to investors and the public interest and Program, and any effects on the broader meet any of the requirements of Retail that the rules of a national securities market structure.’’ 22 Orders, the Exchange could disqualify a exchange not be designed to permit The Program proposes to create Member from its status as an RMO. unfair discrimination between additional price improvement When disqualification determinations customers, issuers, brokers or dealers. opportunities for retail investors by are made, the Exchange would provide The Commission finds that the segmenting retail order flow on the a written disqualification notice to the Program, as it is proposed on a pilot Exchange and requiring liquidity Member. A disqualified RMO could basis, is consistent with the providers that want to interact with appeal the disqualification as provided requirements of the Act because the such retail order flow to do so at a price below or re-apply 90 days after the Program is reasonably designed to at least $0.001 per share better than the disqualification notice is issued by the benefit retail investors by providing Protected NBBO. The Commission finds Exchange. price improvement to retail order that, while the Program would treat flow.18 The Commission also believes retail order flow differently from order Appeal of Disapproval or that the Program could promote flow submitted by other market Disqualification competition for retail order flow among participants, such segmentation would Under Proposed BX Rule 4780(d), the execution venues and that this could not be inconsistent with Section 6(b)(5) Exchange would establish a Retail Price benefit retail investors by creating of the Act, which requires that the rules Improvement Program Panel (‘‘RPI additional price improvement of an exchange are not designed to Panel’’) to review disapproval or opportunities for their order flow. permit unfair discrimination. The disqualification decisions. If a Member Currently, most marketable retail order Commission previously has recognized disputes the Exchange’s decision to flow is executed in the over-the-counter that the markets generally distinguish disapprove or disqualify it as an RMO, (‘‘OTC’’) markets, pursuant to bilateral between individual retail investors, such Member could request, within five agreements, without ever reaching a whose orders are considered desirable business days after notice of the public exchange. The Commission has by liquidity providers because such decision is issued by the Exchange, that noted that ‘‘a very large percentage of retail investors are presumed on average the RPI Panel review the decision to marketable (immediately executable) to be less informed about short-term determine if it was correct. The RPI order flow of individual investors’’ is price movements, and professional Panel would consist of the Exchange’s executed, or ‘‘internalized,’’ by broker- traders, whose orders are presumed on Chief Regulatory Officer (or his or her dealers in the OTC markets.19 A average to be more informed.23 The designee) and two officers of the previous review of the order flow of Commission has further recognized that, Exchange designated by the Exchange’s eight retail broker-dealers revealed that because of this distinction, liquidity Chief Executive Officer, and it would nearly 100% of their customer market providers are generally more inclined to review the facts and render a decision orders were routed to OTC market offer price improvement to less within the timeframe prescribed by the makers.20 The same review found that informed retail orders than to more Exchange. The RPI Panel could overturn such routing is often done pursuant to informed professional orders.24 Absent or modify an action taken by the arrangements under which retail brokers opportunities for price improvement, Exchange under Proposed Rule 4780, route their order flow to certain OTC retail investors may encounter wider and all determinations by the RPI Panel market makers in exchange for payment spreads that are a consequence of would constitute final action by the for such order flow.21 To the extent that liquidity providers interacting with Exchange on the matter at issue. the Program may provide price informed order flow. By creating III. Discussion and Commission improvement to retail orders that equals 22 Findings what would be provided under such See Notice, supra note 3, 79 FR at 64450. OTC internalization arrangements, the 23 See NASDAQ RPI Approval Order, supra note After careful review of the proposal, Program could benefit retail investors. 18, BATS Y RPI Approval Order, supra note 18 and the Commission finds that the proposed NYSE RLP Approval Order, supra note 18. See also So that the Exchange and the Concept Release on Equity Market Structure, supra rule change is consistent with the Commission can better understand the note 19; Securities Exchange Act Release No. 64781 requirements of the Act and the rules Program’s potential impact, the (June 30, 2011), 76 FR 39953 (July 7, 2011) (SR– and regulations thereunder that are Exchange represents that it ‘‘will BATS–2011–009) (approving a program proposed applicable to a national securities by an options exchange that would provide price produce data throughout the pilot, improvement opportunities to retail orders based, exchange. In particular, the Commission which will include statistics about in part, on questions about execution quality of finds that the proposed rule change, participation, the frequency and level of retail orders under payment for order flow subject to its term as a pilot, is arrangements in the options markets). 24 See NASDAQ RPI Approval Order, supra note consistent with Section 6(b)(5) of the 18 The Commission has approved similar 17 18, BATS Y RPI Approval Order, supra note 18 and Act, which requires, among other programs for New York Stock Exchange LLC and NYSE RLP Approval Order, supra note 18. See also things, that the rules of a national NYSE MKT LLC, Securities Exchange Act Release Securities Exchange Act Release No. 64781 (June securities exchange be designed to No. 67347 (July 3, 2012), 77 FR 40673 (July 10, 30, 2011), 76 FR 39953, 39957 n.50 (July 7, 2011) 2012) (SR–NYSE–2011–55; SR–NYSEAmex–2011– prevent fraudulent and manipulative (SR–BATS–2011–009) (noting that ‘‘it is well 84) (‘‘NYSE RLP Approval Order’’), BATS Y- known in academic literature and industry practice acts and practices; to promote just and Exchange, Inc., Securities Exchange Act Release No. that prices tend to move against market makers after equitable principles of trade; to foster 68303 (November 27, 2012), 77 FR 71652 trades with informed traders, often resulting in cooperation and coordination with (December 3, 2012) (SR–BYX–2012–019) (‘‘BATS Y losses for market makers,’’ and that such losses are RPI Approval Order’’), and The NASDAQ Stock persons engaged in regulating, clearing, often borne by uninformed retail investors through Market LLC, Securities Exchange Act Release No. wider spreads (citing H.R. Stoll, ‘‘The supply of settling, processing information with 68937 (February 15, 2013), 78 FR 12397 (February dealer services in securities markets,’’ Journal of respect to, and facilitating transactions 22, 2013) (SR–NASDAQ–2012–129) (‘‘NASDAQ RPI Finance 33 (1978), at 1133–51; L. Glosten & P. in securities; to remove impediments to Approval Order’’). Milgrom, ‘‘Bid ask and transaction prices in a 19 and perfect the mechanism of a free and See Securities Exchange Act Release No. 61358 specialist market with heterogeneously informed (Jan. 14, 2010), 75 FR 3594, 3600 (Jan. 21, 2010) agents,’’ Journal of Financial Economics 14 (1985), open market and a national market (‘‘Concept Release on Equity Market Structure’’). at 71–100; and T. Copeland & D. Galai, 20 See id. ‘‘Information effects on the bid-ask spread,’’ Journal 17 15 U.S.C. 78f(b)(5). 21 See id. of Finance 38 (1983), at 1457–69)).
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additional competition for retail order with the terms of these provisions. The The Exchange asserts that the Program flow, the Program is reasonably Exchange has limited the definition of will operate in substantially the same designed to attract retail order flow to Retail Order to an agency or riskless manner as NASDAQ Rule 4780 28 and the exchange environment, while principal order that originates from a BATS Y-Exchange Rule 11.24,29 which helping to ensure that retail investors natural person and not from a trading set forth the NASDAQ and BATS Y- benefit from the better price that algorithm or any other computerized Exchanges’ Retail Price Improvement liquidity providers are willing to give methodology. Furthermore, a Retail Programs, respectively, and that it their orders. Order must be submitted by an RMO would be similar to, but with The Commission notes that the that is approved by the Exchange. In distinctions from, New York Stock Program might also create a desirable addition, RMOs would be required to Exchange LLC’s (‘‘NYSE’’) Rule 107C, opportunity for institutional investors to maintain written policies and which governs NYSE’s Retail Liquidity interact with retail order flow that they procedures to help ensure that they Program.30 Accordingly, the Exchange are not able to reach currently. Today, designate as Retail Orders only those believes that the Program should both institutional investors often do not have orders that qualify under the Program. If enhance competition among market the chance to interact with marketable a Member’s application to become an participants and encourage competition 31 retail orders that are executed pursuant RMO is denied by the Exchange, that among exchange venues. Specifically, to internalization arrangements. Thus, Member may appeal the determination the Exchange asserts that allowing all by submitting RPI Orders, institutional or re-apply. The Commission believes Members to enter RPI Orders on equal investors may be able to reduce their that these standards should help ensure terms, as opposed to adopting a special possible adverse selection costs by that only retail order flow is submitted category of retail liquidity providers, as interacting with retail order flow. into the Program and that these NYSE did with its Retail Liquidity When the Commission is engaged in standards thereby promote just and Program, could result in a higher level rulemaking or the review of a rule filed equitable principles of trade and protect of competition and maximize price improvement to incoming Retail by a self-regulatory organization, and is investors and the public interest, while Orders; 32 that the Program should required to consider or determine also providing an objective process provide the maximum price whether an action is necessary or through which Members may become improvement available to incoming appropriate in the public interest, the RMOs. Commission shall also consider, in Retail Orders because they will always addition to the protection of investors, In addition, the Commission finds interact with resting RPI Orders and whether the action will promote that the Program’s proposed other resting non-displayed liquidity; 33 efficiency, competition, and capital dissemination of a Retail Liquidity and that the Program will provide all of formation.25 As discussed above, the Identifier would increase the amount of the price improvement available to Commission believes this Program will pricing information available to the incoming Retail Orders by allowing promote competition for retail order marketplace and that is consistent with executions at multiple price levels, as flow by allowing Exchange Members to the requirement of the Act. The opposed to a single clearing price submit RPI Orders to interact with identifier would be disseminated level.34 The Commission finds that the Retail Orders. Such competition may through the consolidated public market Program is reasonably designed to promote efficiency by facilitating the data stream and proprietary Exchange enhance competition among market price discovery process. Moreover, the data feeds to advertise the presence of participants and encourage competition Commission does not believe that the a RPI Order with which Retail Orders among exchange venues. The Program will have a significant effect on could interact. The identifier would Commission also finds that the market structure, or will create any new reflect the symbol for a particular distinctions between the Exchange’s inefficiencies in current market security and the side of the RPI Order Program and the approved programs on structure. Finally, to the extent the interest, but it would not include the Program is successful in attracting retail price or size of such interest. The 28 See NASDAQ RPI Approval Order, supra note identifier would alert market 18. order flow, it may generate additional 29 See BATS Y RPI Approval Order, supra note investor interest in trading securities, participants to the existence of a RPI 18. thereby promoting capital formation. Order and should provide market 30 See NYSE RLP Approval Order, supra note 18. The Commission also believes that the participants with more information 31 See Notice, supra note 3, 79 FR at 64451. Program is sufficiently tailored to about the availability of price 32 See id. at 64450. The NYSE’s Retail Liquidity provide the benefits of potential price improvement opportunities for retail Program creates a category of members, Retail 27 Liquidity Providers, who are required to maintain improvement only to bona fide retail orders than is currently available. a NYSE Retail Price Improvement Order that betters order flow originating from natural the protected best bid or offer at least 5% of the persons.26 The Commission finds that 27 As the Commission noted when approving the trading day in each assigned security and who the Program provides an objective comparable NASDAQ, BATS Y-Exchange, and receive lower execution fees as a result. 33 process by which a Member NYSE programs, the Commission believes that the See Notice, supra note 3, 79 FR at 64450. In Program will not create any best execution contrast, pursuant to NYSE Rule 107C(k)(1), a NYSE organization could become an RMO and challenges for brokers that are not already present Type 1-designated Retail Order will interact only that the Program provides for in today’s markets. A broker’s best execution with available contra-side NYSE Retail Price appropriate oversight by the Exchange obligations are determined by a number of facts and Improvement Orders and NYSE Mid-Point Passive to monitor for continued compliance circumstances, including: (1) The character of the Liquidity Orders. Pursuant to NYSE Rule 13, a Mid- market for the security (e.g., price, volatility, Point Passive Liquidity Order ‘‘is an undisplayed relative liquidity, and pressure on available limit order that automatically executes at the mid- 25 See 15 U.S.C. 78c(f). communications); (2) the size and type of point of the protected best bid or offer.’’ 26 In addition, the Commission believes that the transaction; (3) the number of markets checked; (4) 34 See Notice, supra note 3, 79 FR at 64450–51. Program’s provisions concerning the approval and accessibility of the quotation; and (5) the terms and Under the NYSE’S Retail Liquidity Program, Retail potential disqualification of RMOs are not conditions of the order that results in the Orders execute at the single price at which the inconsistent with the Act. See, e.g., NASDAQ RPI transaction. See NASDAQ RPI Approval Order, order will be fully executed, unless there are Approval Order, supra note 18, 78 FR at 12400 supra note 18, 78 FR at 12400 n.33, BATS Y RPI separate MPL Orders with better pricing on the n.32, BATS Y RPI Approval Order, supra note 18, Approval Order, supra note 18, 77 FR at 71657, and other side of the Retail Order. See NYSE Rule 77 FR at 71656 n.41 and NYSE RLP Approval NYSE RLP Approval Order, supra note 18, 77 FR 107C(l) (providing examples of how orders execute Order, supra note 18, 77 FR at 40680 n.77. at 40680 n.75 (all citing FINRA Rule 5310). under the NYSE’s Retail Liquidity Program).
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other exchanges are reasonably designed When the Commission adopted the broker-dealer can offer sub-penny to enhance the Program’s price- Sub-Penny Rule in 2005, it identified a executions, provided that such improvement benefits to retail investors variety of problems caused by sub- executions do not result from and are, therefore, consistent with the pennies that the Sub-Penny Rule was impermissible sub-penny orders or Act. designed to address: quotations. Accordingly, OTC market The Commission notes that it is • If investors’ limit orders lose makers typically select a sub-penny approving the Program on a pilot basis. execution priority for a nominal price for a trade without quoting at that Approving the Program on a pilot basis amount, investors may over time exact amount or accepting orders from will allow the Exchange and market decline to use them, thus depriving the retail customers seeking that exact price. participants to gain valuable practical markets of liquidity. Exchanges—and exchange member • experience with the Program during the When market participants can gain firms that submit orders and quotations pilot period. This experience should execution priority for a nominal to exchanges—cannot compete for allow the Exchange and the Commission amount, important customer protection marketable retail order flow on the same to determine whether modifications to rules such as exchange priority rules basis, because it would be impractical the Program are necessary or and the Manning Rule could be for exchange electronic systems to appropriate prior to any Commission undermined. generate sub-penny executions without • decision to approve the Program on a Flickering quotations that can result exchange liquidity providers or retail permanent basis. The Exchange also has from widespread sub-penny pricing brokerage firms having first submitted agreed to provide the Commission with could make it more difficult for broker- sub-penny orders or quotations, which a significant amount of data that should dealers to satisfy their best execution the Sub-Penny Rule expressly prohibits. assist the Commission in its evaluation obligations and other regulatory The limited exemption granted today responsibilities. should promote competition between of the Program. Specifically, the • Exchange has represented that it ‘‘will Widespread sub-penny quoting exchanges and OTC market makers in a produce data throughout the pilot, could decrease market depth and lead to manner that is reasonably designed to which will include statistics about higher transaction costs. minimize the problems that the • Decreasing depth at the inside participation, the frequency and level of Commission identified when adopting could cause institutions to rely more on price improvement provided by the the Sub-Penny Rule. Under the Program, execution alternatives away from the Program, and any effects on the broader sub-penny prices will not be exchanges, potentially increasing disseminated through the consolidated market structure.’’ 35 The Commission fragmentation in the securities quotation data stream, which should expects that the Exchange will monitor markets.37 avoid quote flickering and reduced the scope and operation of the Program At the same time, the Commission depth at the inside quotation. and study the data produced during that ‘‘acknowledge[d] the possibility that the Furthermore, while the Commission time with respect to such issues and balance of costs and benefits could shift remains concerned about providing that the Exchange will propose any in a limited number of cases or as the enough incentives for market modifications to the Program that may markets continue to evolve.’’ 38 participants to display limit orders, the be necessary or appropriate. Therefore, the Commission also adopted Commission does not believe that The Commission also welcomes Rule 612(c), which provides that the granting this exemption (and approving comments, and empirical evidence, on Commission may grant exemptions from the accompanying proposed rule the Program during the pilot period to the Sub-Penny Rule, either change) will reduce such incentives. further assist the Commission in its unconditionally or on specified terms Market participants that display limit evaluation of the Program. The and conditions, if it determined that orders currently are not able to interact Commission notes that any permanent such an exemption is necessary or with marketable retail order flow approval of the Program would require appropriate in the public interest, and is because it is almost entirely routed to a proposed rule change by the consistent with the protection of internalizing OTC market makers that Exchange, and any such proposed rule investors. offer sub-penny executions. change would provide an opportunity The Commission believes that the Consequently, enabling the Exchanges for public comment prior to further Exchange’s proposal raises such a case. to compete for this retail order flow Commission action. As described above, under the current through the Program should not IV. Exemption From the Sub-Penny market structure, few marketable retail materially detract from the current Rule orders in equity securities are routed to incentives to display limit orders, while exchanges. The vast majority of potentially resulting in greater order Pursuant to its authority under Rule marketable retail orders are internalized interaction and price improvement for 36 612(c) of Regulation NMS, the by OTC market makers, who typically marketable retail orders. To the extent Commission hereby grants the Exchange pay retail brokers for their order flow. that the Program may raise Manning and a limited exemption from the Sub- Retail investors can benefit from such best-execution issues for broker-dealers, Penny Rule to operate the Program. For arrangements to the extent that OTC these issues are already presented by the the reasons discussed below, the market makers offer them price existing practices of OTC market Commission determines that such an improvement over the NBBO. Price makers. exemption is necessary or appropriate improvement is typically offered in sub- The exemption being granted today is in the public interest and is consistent penny amounts.39 An internalizing limited to a one-year pilot. The with the protection of investors. The Exchange has stated that ‘‘sub-penny exemption shall operate for a period of 37 See Securities Exchange Act Release No. 51808 trading and pricing could potentially 12 months, ending on the same date as (June 9, 2005), 70 FR 37496, 37551–52 (June 29, the 12-month pilot period of the 2005). customers, but declined to do so. The Commission Program. 38 Id. at 37553. stated that ‘‘trading in sub-penny increments does 39 When adopting the Sub-Penny Rule, the not raise the same concerns as sub-penny quoting’’ Commission considered certain comments that and that ‘‘sub-penny executions due to price 35 See supra note 22 and accompanying text. asked the Commission to prohibit broker-dealers improvement are generally beneficial to retail 36 17 CFR 242.612(c). from offering sub-penny price improvement to their investors.’’ Id. at 37556.
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result in undesirable market behavior’’ 81), as amended, that as of November information collection, including (a) and that, therefore, it will ‘‘monitor the 20, 2014, each of the following Whether the proposed collection of Program in an effort to identify and purchasers of oil from Iran has qualified information is necessary for FAA’s address any such behavior.’’ 40 for the 180-day exception outlined in performance; (b) the accuracy of the Furthermore, the Exchange has section 1245(d)(4)(D): Malaysia, estimated burden; (c) ways for FAA to represented that it ‘‘will produce data Singapore, and South Africa. The enhance the quality, utility and clarity throughout the pilot, which will include Secretary of State last made exception of the information collection; and (d) statistics about participation, the determinations under Section ways that the burden could be frequency and level of price 1245(d)(4)(D) of the NDAA regarding minimized without reducing the quality improvement provided by the Program, these purchasers on May 27, 2014. of the collected information. The agency and any effects on the broader market Dated: November 28, 2014. 41 will summarize and/or include your structure.’’ The Commission expects Robert F. Ichord, to review the data and observations of comments in the request for OMB’s Deputy Assistant Secretary, Bureau of Energy clearance of this information collection. the Exchange before determining Resources, U.S. Department of State. whether and, if so, how to extend the FOR FURTHER INFORMATION CONTACT [FR Doc. 2014–28520 Filed 12–3–14; 8:45 am] : exemption from the Sub-Penny Rule.42 BILLING CODE 4710–09–P Kathy DePaepe at (405) 954–9362, or by V. Conclusion email at: [email protected]. It is therefore ordered, pursuant to SUPPLEMENTARY INFORMATION: 43 DEPARTMENT OF TRANSPORTATION Section 19(b)(2) of the Act, that the OMB Control Number: 2120–0056. proposed rule change (SR–BX–2014– 048) be, and hereby is, approved on a Federal Aviation Administration Title: Report of Inspections Required by Airworthiness Directives. one-year pilot basis. Agency Information Collection It is also hereby ordered that, Activities: Requests for Comments; Form Numbers: There are no FAA pursuant to Rule 612(c) of Regulation Clearance of Renewed Approval of forms associated with this collection. NMS, the Exchange is given a limited Information Collection: Report of Type of Review: Renewal of an exemption from Rule 612 of Regulation Inspections Required by Airworthiness information collection; conversion to NMS allowing it to accept and rank Directives orders priced equal to or greater than generic information collection request. $1.00 per share in increments of $0.001, AGENCY: Federal Aviation Background: Title 14 CFR part 39, in the manner described in the proposed Administration (FAA), DOT. Airworthiness Directives (AD), rule change above, for a period of 12 ACTION: Notice and request for authorized by §§ 40113(a), 44701, and months, ending on the same date as the comments. 44702 of Title 49 United States Code, 12-month pilot period of the Program. prescribes how the FAA issues ADs. SUMMARY: In accordance with the For the Commission, by the Division of The FAA issues ADs when an unsafe Trading and Markets, pursuant to delegated Paperwork Reduction Act of 1995, FAA condition is discovered on a specific authority.44 invites public comments about our aircraft type. If the condition is serious intention to request the Office of Brent J. Fields, enough and more information is needed Management and Budget (OMB) Secretary. to develop corrective action, specific approval to renew an information [FR Doc. 2014–28474 Filed 12–3–14; 8:45 am] collection. Airworthiness Directives information may be required from BILLING CODE 8011–01–P (ADs) are regulations issued to require aircraft owners/operators. If it is correct corrective action to correct necessary for the aircraft manufacturer unsafe conditions in aircraft, engines, or airworthiness authority to evaluate DEPARTMENT OF STATE propellers, and appliances. Reports of the information, owners/operators will [Public Notice 8963] inspections are often needed when be instructed to send the information to emergency corrective action is taken to them. Determination by the Secretary of determine if the action was adequate to Respondents: Approximately 1,120 State Relating to Iran Sanctions correct the unsafe condition. The aircraft owners/operators. respondents are aircraft owners and SUMMARY: This notice is to inform the operators. Currently, FAA has blanket Frequency: Information is collected public that the Secretary of State Paperwork Reduction Act approval from on occasion. determined on November 20, 2014, OMB for all ADs with information Estimated Average Burden per pursuant to Section 1245(d)(4)(D) of the collection requirements. Per OMB’s Response: 5 minutes. National Defense Authorization Act for request, this collection is being Fiscal Year 2012 (NDAA) (Pub. L. 112– Estimated Total Annual Burden: converted to a generic information 3,080 hours. collection request, which will require 40 See Request for Sub-Penny Rule Exemption, FAA to submit individual ADs to OMB Issued in Washington, DC, on December 1, supra note 5, at 3, n.6. 2014. 41 See supra note 22 and accompanying text. for approval prior to their release. 42 In particular, the Commission expects the DATES: Written comments should be Albert R. Spence, Exchange to observe how maker/taker transaction submitted by February 2, 2015. FAA Assistant Information Collection charges, whether imposed by the Exchange or by Clearance Officer, IT Enterprises Business other markets, might impact the use of the Program. ADDRESSES: Send comments to the FAA Market distortions could arise where the size of a at the following address: Ms. Kathy Services Division, ASP–110. transaction rebate, whether for providing or taking DePaepe, Room 126B, Federal Aviation [FR Doc. 2014–28517 Filed 12–3–14; 8:45 am] liquidity, is greater than the size of the minimum Administration, AES–200, 6500 S. BILLING CODE 4910–13–P increment permitted by the Program ($0.001 per share). MacArthur Blvd., Oklahoma City, OK 43 15 U.S.C. 78s(b)(2). 73169. 44 17 CFR 200.30–3(a)(12); 17 CFR 200.30– Public Comments Invited: You are 3(a)(83). asked to comment on any aspect of this
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DEPARTMENT OF TRANSPORTATION Frequency: Information is collected FOR FURTHER INFORMATION CONTACT: on occasion. Kathy DePaepe at (405) 954–9362, or by Federal Aviation Administration Estimated Average Burden per email at: [email protected]. Response: 4 hours. SUPPLEMENTARY INFORMATION: Agency Information Collection Estimated Total Annual Burden: 616 OMB Control Number: 2120–0018. Activities: Requests for Comments; hours. Title: Certification Procedures for Clearance of Renewed Approval of Issued in Washington, DC, on December 1, Products and Parts. Information Collection: Aviation Form Numbers: FAA Forms 8110–12, Insurance 2014. Albert R. Spence, 8130–1, 8130–6, 8130–9, 8130–12. Type of Review: Renewal of an AGENCY: Federal Aviation FAA Assistant Information Collection Administration (FAA), DOT. Clearance Officer, IT Enterprises Business information collection. ACTION: Notice and request for Services Division, ASP–110. Background: 14 CFR part 21 prescribes certification standards for comments. [FR Doc. 2014–28522 Filed 12–3–14; 8:45 am] aircraft, aircraft engines, propellers BILLING CODE 4910–13–P SUMMARY: In accordance with the appliances and parts. The information Paperwork Reduction Act of 1995, FAA collected is used to determine invites public comments about our DEPARTMENT OF TRANSPORTATION compliance and applicant eligibility. intention to request the Office of FAA Airworthiness inspectors, Management and Budget (OMB) Federal Aviation Administration designated inspectors, engineers, and approval to renew an information designated engineers review the collection. The requested information is Agency Information Collection required data submittals to determine included in air carriers applications for Activities: Requests for Comments; that aviation products and articles and insurance when insurance is not Clearance of Renewed Approval of their manufacturing facilities comply available from private sources. Information Collection: Certification with the applicable requirements, and DATES: Written comments should be Procedures for Products and Parts that the products and articles have no submitted by February 2, 2015. unsafe features. AGENCY: Federal Aviation Respondents: Approximately 13,339 ADDRESSES: Send comments to the FAA Administration (FAA), DOT. at the following address: Ms. Kathy aircraft parts designers, manufacturers, ACTION: Notice and request for DePaepe, Room 126B, Federal Aviation and aircraft owners. comments. Administration, ASP–110, 6500 S. Frequency: Information is collected on occasion. MacArthur Blvd., Oklahoma City, OK SUMMARY: In accordance with the 73169. Estimated Average Burden per Paperwork Reduction Act of 1995, FAA Response: 30 minutes. Public Comments Invited: You are invites public comments about our asked to comment on any aspect of this Estimated Total Annual Burden: intention to request the Office of 19,487 hours. information collection, including (a) Management and Budget (OMB) Whether the proposed collection of approval to renew an information Issued in Washington, DC, on December 1, 2014. information is necessary for FAA’s collection. 14 CFR part 21 prescribes performance; (b) the accuracy of the certification standards for aircraft, Albert R. Spence, estimated burden; (c) ways for FAA to aircraft engines, propellers appliances FAA Assistant Information Collection enhance the quality, utility and clarity and parts. The information collected is Clearance Officer, IT Enterprises Business Services Division, ASP–110. of the information collection; and (d) used to determine compliance and ways that the burden could be applicant eligibility. The respondents [FR Doc. 2014–28519 Filed 12–3–14; 8:45 am] minimized without reducing the quality are aircraft parts designers, BILLING CODE 4910–13–P of the collected information. The agency manufacturers, and aircraft owners. will summarize and/or include your comments in the request for OMB’s DATES: Written comments should be DEPARTMENT OF TRANSPORTATION clearance of this information collection. submitted by February 2, 2015. Federal Aviation Administration FOR FURTHER INFORMATION CONTACT: ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy Kathy DePaepe at (405) 954–9362, or by Agency Information Collection DePaepe, Room 126B, Federal Aviation email at: [email protected]. Activities: Requests for Comments; Administration, ASP–110, 6500 S. SUPPLEMENTARY INFORMATION: Clearance of Renewed Approval of MacArthur Blvd., Oklahoma City, OK OMB Control Number: 2120–0514. Information Collection: Airport Noise 73169. Title: Aviation Insurance. Compatibility Planning Form Numbers: There are no FAA Public Comments Invited: You are forms associated with this collection. asked to comment on any aspect of this AGENCY: Federal Aviation Type of Review: Renewal of an information collection, including (a) Administration (FAA), DOT. information collection. Whether the proposed collection of ACTION: Notice and request for Background: The information information is necessary for FAA’s comments. submitted by applicants for insurance performance; (b) the accuracy of the under Chapter 443 of Title 49 U.S.C. is estimated burden; (c) ways for FAA to SUMMARY: In accordance with the used by the FAA to identify the enhance the quality, utility and clarity Paperwork Reduction Act of 1995, FAA eligibility of parties to be insured, the of the information collection; and (d) invites public comments about our amount of coverage required, and ways that the burden could be intention to request the Office of insurance premiums. Without collection minimized without reducing the quality Management and Budget (OMB) of this information, the FAA would not of the collected information. The agency approval to renew an information be able to issue required insurance. will summarize and/or include your collection. The respondents are those Respondents: Approximately 61 comments in the request for OMB’s airport operators voluntarily submitting applicants. clearance of this information collection. noise exposure maps and noise
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compatibility programs to the FAA for DEPARTMENT OF TRANSPORTATION K. Information is used to determine if review and approval. these entities are operating in DATES: Written comments should be Federal Aviation Administration accordance with the minimum safety submitted by February 2, 2015. standards of these regulations. The FAA Agency Information Collection ADDRESSES: Send comments to the FAA will use the information it reviews and Activities: Requests for Comments; collects to evaluate the effectiveness of at the following address: Ms. Kathy Clearance of Renewed Approval of DePaepe, Room 126B, Federal Aviation the program and make improvements as Information Collection: Fractional needed, and ensure compliance and Administration, ASP–110, 6500 S. Aircraft Ownership Programs MacArthur Blvd., Oklahoma City, OK adherence to regulations. 73169. AGENCY: Federal Aviation Respondents: 11 fractional aircraft Public Comments Invited: You are Administration (FAA), DOT. program managers/operators. Frequency: Information is collected asked to comment on any aspect of this ACTION: Notice and request for on occasion. information collection, including (a) comments. Whether the proposed collection of Estimated Average Burden per information is necessary for FAA’s SUMMARY: In accordance with the Response: 46 minutes. performance; (b) the accuracy of the Paperwork Reduction Act of 1995, FAA Estimated Total Annual Burden: estimated burden; (c) ways for FAA to invites public comments about our 19,609 hours. enhance the quality, utility and clarity intention to request the Office of Issued in Washington, DC, on December 1, of the information collection; and (d) Management and Budget (OMB) 2014. ways that the burden could be approval to renew an information Albert R. Spence, minimized without reducing the quality collection. Fractional Ownership is a FAA Assistant Information Collection of the collected information. The agency program that offers increased flexibility Clearance Officer, IT Enterprises Business will summarize and/or include your in aircraft ownership. Owners purchase Services Division, ASP–110. comments in the request for OMB’s shares of an aircraft and agree to share [FR Doc. 2014–28524 Filed 12–3–14; 8:45 am] clearance of this information collection. their aircraft with others having an BILLING CODE 4910–13–P FOR FURTHER INFORMATION CONTACT: ownership share in that same aircraft. Kathy DePaepe at (405) 954–9362, or by Owners agree to put their aircraft into a email at: [email protected]. ‘‘pool’’ of other shared aircraft and to DEPARTMENT OF TRANSPORTATION lease their aircraft to another owner in SUPPLEMENTARY INFORMATION: Federal Aviation Administration OMB Control Number: 2120–0517. that pool. Title: Airport Noise Compatibility DATES: Written comments should be Agency Information Collection Planning. submitted by February 2, 2015. Activities: Requests for Comments; Form Numbers: There are no FAA ADDRESSES: Send comments to the FAA Clearance of Renewed Approval of forms associated with this collection. at the following address: Ms. Kathy Information Collection(s): Criteria for Type of Review: Renewal of an DePaepe, Room 126B, Federal Aviation Internet Communications of Aviation information collection. Administration, ASP–110, 6500 S. Weather, NOTAM, and Aeronautical Background: The voluntarily MacArthur Blvd., Oklahoma City, OK Data submitted information from the current 73169. CFR part 150 collection, e.g., airport Public Comments Invited: You are AGENCY: Federal Aviation noise exposure maps and airport noise asked to comment on any aspect of this Administration (FAA), DOT. compatibility programs, or their information collection, including (a) ACTION: Notice and request for revisions, is used by the FAA to conduct Whether the proposed collection of comments. reviews of the submissions to determine information is necessary for FAA’s if an airport sponsor’s noise performance; (b) the accuracy of the SUMMARY: In accordance with the compatibility program is eligible for estimated burden; (c) ways for FAA to Paperwork Reduction Act of 1995, FAA Federal grant funds. If airport operators enhance the quality, utility and clarity invites public comments about our did not voluntarily submit noise of the information collection; and (d) intention to request the Office of exposure maps and noise compatibility ways that the burden could be Management and Budget (OMB) programs for FAA review and approval, minimized without reducing the quality approval to renew an information the airport operator would not be of the collected information. The agency collection. An Advisory Circular (AC) eligible for the set aside of discretionary will summarize and/or include your establishes criteria for Qualified Internet grant funds. comments in the request for OMB’s Communications Providers (ICP), who Respondents: Approximately 15 clearance of this information collection. provide access to aviation weather, airport operators. FOR FURTHER INFORMATION CONTACT: Notices to Airmen (NOTAM), and Frequency: Information is collected Kathy DePaepe at (405) 954–9362, or by aeronautical data via the Public Internet. on occasion. email at: [email protected]. The information collected is used to Estimated Average Burden per determine the provider’s eligibility. Response: 3882.6 hours. SUPPLEMENTARY INFORMATION: OMB Control Number: 2120–0684. DATES: Written comments should be Estimated Total Annual Burden: submitted by February 2, 2015. 56,160 hours. Title: Fractional Aircraft Ownership Programs. ADDRESSES: Send comments to the FAA Issued in Washington, DC, on December 1, Form Numbers: There are no FAA at the following address: Ms. Kathy 2014. forms associated with this collection. DePaepe, Room 126B, Federal Aviation Albert R. Spence, Type of Review: Renewal of an Administration, ASP–110, 6500 S. FAA Assistant Information Collection information collection. MacArthur Blvd., Oklahoma City, OK Clearance Officer, IT Enterprises Business Background: Each fractional 73169. Services Division, ASP–110. ownership program manager and each Public Comments Invited: You are [FR Doc. 2014–28523 Filed 12–3–14; 8:45 am] fractional owner must comply with the asked to comment on any aspect of this BILLING CODE 4910–13–P requirements of 14 CFR part 91, subpart information collection, including (a)
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Whether the proposed collection of SUMMARY: The FAA announces the DEPARTMENT OF TRANSPORTATION information is necessary for FAA’s charter renewal of the COMSTAC, a performance; (b) the accuracy of the Federal Advisory Committee that Federal Aviation Administration estimated burden; (c) ways for FAA to provides information, advice, and enhance the quality, utility and clarity recommendations to the Department of Notice of Passenger Facility Charge of the information collection; and (d) Transportation and the Administrator of (PFC) Approvals and Disapprovals ways that the burden could be the Federal Aviation Administration AGENCY: Federal Aviation minimized without reducing the quality (FAA) on the critical matters facing the Administration (FAA), DOT. of the collected information. The agency U.S. commercial space transportation ACTION: Monthly Notice of PFC will summarize and/or include your industry. Approvals and Disapprovals. In October comments in the request for OMB’s DATES: 2014, there were eight applications clearance of this information collection. Effective Date: December 4, 2014. The effective date of the charter renewal approved. This notice also includes FOR FURTHER INFORMATION CONTACT: is November 17, 2014, and will expire information on two applications, Kathy DePaepe at (405) 954–9362, or by after 2 years. approved in September 2014, email at: [email protected]. FOR FURTHER INFORMATION CONTACT: inadvertently left off the September SUPPLEMENTARY INFORMATION: 2014 notice. Additionally, 11 approved OMB Control Number: 2120–0672. Michael Beavin, COMSTAC Executive Director, telephone (202) 267–9051; amendments to previously approved Title: Criteria for Internet applications are listed. Communications of Aviation Weather, email [email protected], FAA NOTAM, and Aeronautical Data. Office of Commercial Space SUMMARY: The FAA publishes a monthly Form Numbers: There are no FAA Transportation (AST–3), 800 notice, as appropriate, of PFC approvals forms associated with this collection of Independence Avenue SW., Room 331, and disapprovals under the provisions information. Washington, DC 20591. of the Aviation Safety and Capacity Type of Review: Renewal of an SUPPLEMENTARY INFORMATION: Pursuant Expansion Act of 1990 (Title IX of the information collection. to Section 10(a)(2) of the Federal Omnibus Budget Reconciliation Act of Background: Any interested person or Advisory Committee Act (Pub. L. 92– 1990) (Pub. L. 101–508) and Part 158 of organization desiring to become a QICP 463), FAA is giving notice of the charter the Federal Aviation Regulations (14 shall provide the FAA Aviation Weather renewal for the COMSTAC. This charter CFR part 158). This notice is published Division, ANG–C6 with a written renewal took effect on November 17, pursuant to paragraph d of § 158.29. application documenting their 2014, and will expire after 2 years. PFC Applications Approved capability to meet the QICP criteria. The The primary goals of COMSTAC are purpose of the information is to ensure to: Evaluate economic, technological, Public Agency: Westmoreland County the reliability, accessibility and security and institutional developments relating Airport Authority, Latrobe, of aviation weather data, NOTAM and to the U.S. commercial space Pennsylvania. aeronautical data accessed via the transportation industry; provide a forum Application Number: 14–03–C–00– Internet as well as to encourage data for the discussion of problems involving LBE. providers to identify the approval status the relationship between industry Application Type: Impose and use a (e.g., experimental or operational) of activities and government requirements; PFC. aviation weather products. and make recommendations to the FAA PFC Level: $4.50. Respondents: Approximately 6 Administrator on issues and approaches Total PFC Revenue Approved in This applicants. for Federal policies and programs Decision: $382,641. Frequency: Information is collected regarding the industry. Earliest Charge Effective Date: March on occasion. COMSTAC membership consists of 1, 2016. Estimated Average Burden per senior executives from the commercial Estimated Charge Expiration Date: Response: 240 hours. space transportation industry; July 1, 2017. Estimated Total Annual Burden: representatives from the satellite Class of Air Carriers Not Required To 3,840 hours. industry, both manufacturers and users; Collect PFC’s: None. Issued in Washington, DC, on December 1, state and local government officials; Brief Description of Projects Approved 2014. representatives from firms providing for Collection and Use: Albert R. Spence, insurance, financial investment and Install runway 23 vertical/visual FAA Assistant Information Collection legal services for commercial space guidance system. Clearance Officer, IT Enterprises Business activities; and representatives from Master plan update. Services Division, ASP–110. academia, space advocacy Expand terminal parking. [FR Doc. 2014–28521 Filed 12–3–14; 8:45 am] organizations, and industry Rehabilitate parallel taxiway phase 1 BILLING CODE 4910–13–P associations. design. Complete information regarding Sustainable master plan. COMSTAC is available on the FAA Web Terminal improvements. DEPARTMENT OF TRANSPORTATION site at: http://www.faa.gov/about/office_ Terminal expansion design. _ _ Rehabilitate parallel taxiway phase 2 Federal Aviation Administration org/headquarters offices/ast/advisory committee/. construction. Rehabilitate main terminal apron. Notice of Charter Renewal of the Issued in Washington, DC, on November Commercial Space Transportation 24, 2014. Brief Description of Withdrawn Advisory Committee (COMSTAC) George C. Nield, Project: Acquire snow removal equipment. AGENCY: Federal Aviation Associate Administrator for Commercial Space Transportation. Administration (FAA), DOT. Date of Withdrawal: September 18, [FR Doc. 2014–28525 Filed 12–3–14; 8:45 am] 2014. ACTION: Notice. BILLING CODE 4910–13–P Decision Date: September 29, 2014.
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FOR FURTHER INFORMATION CONTACT: Lori Determination: Disapproved. The Class of Air Carriers Not Required To Ledebohm, Harrisburg Airports District FAA determined that the proposed Collect PFC’s: Air taxi/commercial Office, (717) 730–2835. upgrade was not addressing a deficiency operators filing FAA Form 1800–31 and Public Agency: Metropolitan Airports in the existing noise monitoring system. operating at Florence Regional Airport Commission, Minneapolis, Minnesota. Therefore, the project did not meet the (FLO). Application Number: 13–11–C–00– requirements of § 158.15(b). Determination: Approved. Based on Decision Date: September 30, 2014. MSP. information contained in the public Application Type: Impose and use a FOR FURTHER INFORMATION CONTACT: agency’s application, the FAA has PFC. Chris Hugunin, Minneapolis Airports determined that the approved class PFC Level: $4.50. District Office, (612) 253–4630. accounts for less than 1 percent of the Total PFC Revenue Approved In This Public Agency: Huntsville-Madison total annual enplanements at FLO. Decision: $52,827,265. County Airport Authority, Huntsville, Brief Description of Projects Approved Earliest Charge Effective Date: March Alabama. for Collection: 1, 2018. Application Number: 14–20–C–00– Install an animal control fence. Estimated Charge Expiration Date: HSV. General aviation terminal facility October 1, 2018. Application Type: Impose and use a (design and construction). Class of Air Carriers Not Required To PFC. Construct a new aircraft rescue and Collect PFC’s: Air taxi/commercial PFC Level: $4.50. firefighting facility (design and operators filing FAA Form 1800–31. Total PFC Revenue Approved in This construction). Determination: Approved. Based on Decision: $1,750,085. information contained in the public Earliest Charge Effective Date: Brief Description of Projects Approved agency’s application, the FAA has October 1, 2023. for Collection and use: Estimated Charge Expiration Date: determined that the approved class Removal of airspace obstructions. August 1, 2024. accounts for less than 1 percent of the Terminal renovations reimbursement— Classes of Air Carriers Not Required design and construction. total annual enplanements at To Collect PFC’S: Minneapolis-St. Paul International Terminal apron reimbursement—design (1) Air taxi/commercial operators and construction. Airport (MSP). filing FAA Form 1800–31, operating at Brief Description of Projects Approved Taxiways D, B, and E lighting and Huntsville International Airport (HSV), generator (phase II construction). for Collection and Use at MSP at a $3.00 and having fewer than 500 annual PFC Level: Upgrade airfield signage. passenger enplanements; (2) certified air Perform wildlife assessment study. Terminal 1—Lindbergh Concourse F carriers filing Department of Refurbish airfield storm water drainage pedestrian bridge rehabilitation. Transportation (DOT) Form T–100, systems (design and construction). Electronic video information display operating at HSV, and having fewer than Purchase airfield pavement sweeper. systems. 500 annual enplanements; (3) certified Master plan update. Runway 12R/30L service road tunnel route air carriers filing DOT Form T– Refurbish and upgrade the airport improvements. 100, operating at HSV, and having fewer beacon. Aircraft rescue and firefighting station than 500 annual passenger Refurbish the airfield electrical vault. 2/building roof replacements. enplanements; and (4) foreign air Install a new airport wind cone. Taxiway C extension. carriers filing DOT Form T–100(f), PFC application development. Orange parking ramp skyway link/ operating at HSV, and having fewer than PFC administration. terminal expansion. 500 annual passenger enplanements. Decision Date: October 20, 2014. Brief Description of Projects Approved Determination: Approved. Based on FOR FURTHER INFORMATION CONTACT: for Collection and Use at MSP at a $4.50 information contained in the public PFC Level: agency’s application, the FAA has Robert Rau, Atlanta Airports District Office, (404) 305–7162. Terminal 1—Lindbergh passenger determined that each approved class boarding bridges replacement. accounts for less than 1 percent of the Public Agency: Metropolitan Perimeter fence/gate security total annual enplanements at HSV. Nashville Airport Authority, Nashville, improvements. Brief Description of Project Approved Tennessee. Runway 30L engineered materials for Collection and Use: Group VI airfield Application Number: 14–20–C–00– arresting system replacement. improvements 18L/36R. BNA. Terminal 2—Humphrey security Decision Date: October 2, 2014. Application Type: Impose and use a PFC. checkpoint. FOR FURTHER INFORMATION CONTACT: PFC Level: $4.50. Terminal 2—Humphrey passenger Matthew Felton, Jackson Airports Total PFC Revenue Approved In This boarding bridges replacement. District Office, (601) 664–9894, ext. 194. Decision: $4,900,000. Brief Description Of Disapproved Public Agency: Pee Dee Regional Earliest Charge Effective Date: August Projects: Airport Authority, Florence South 1, 2016. Runway 30R maximum intensity Carolina. Estimated Charge Expiration Date: approach lighting system with Application Number: 14–02–C–00– November 1, 2016. sequence flashers. FLO. Class of Air Carriers Not Required To Application Type: Impose and Use a Determination: Disapproved. The Collect PFC’s: Air taxi/commercial PFC. FAA determined that the proposed PFC Level: $4.50. operators filing FAA Form 1800–31 and project did not improve the visibility Total PFC Revenue Approved in This operating at Nashville International minimums for runway 30R. Therefore, Decision: $827,258. Airport (BNA). the project did not meet the Earliest Charge Effective Date: Determination: Approved. Based on requirements of § 158.15(b). December 1, 2014. information contained in the public Airport noise and operations monitoring Estimated Charge Expiration Date: agency’s application, the FAA has system upgrades. February 1, 2018. determined that the approved class
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accounts for less than 1 percent of the Determination: Approved. Based on eligibility is limited to the new gate total annual enplanements at BNA. information contained in the public facilities and general aviation facilities Brief Description of Projects Approved agency’s application, the FAA has portion of the project. for Collection and Use at a $4.50 PFC determined that the approved class Decision Date: October 24, 2014. Level: accounts for less than 1 percent of the FOR FURTHER INFORMATION CONTACT: Reconstruct taxiway T3. total annual enplanements at Los Michael Brown, Chicago Airports Reconstruct taxiways L and J-east. Angeles International Airport. District Office, (847) 294–7195. Decision Date: October 22, 2014. Brief Description of Project Partially Public Agency: Border Coast Regional FOR FURTHER INFORMATION CONTACT: Approved for Collection and Use: Airport Authority, Crescent City, Cynthia Wills, Memphis Airports Inglewood Unified School District California. District Office, (901) 322–8190. soundproofing program. Application Number: 15–05–C–00– Public Agency: City of Long Beach, Determination: Partially approved. CEC. California. The FAA determined that two schools Application Type: Impose and use a Application Number: 14–07–C–00– (Inglewood High School and Hudnall PFC. LGB. Elementary School) proposed for PFC Level: $4.50. Application Type: Impose and use a inclusion in this project were not Total PFC Revenue Approved in This PFC. eligible for PFC funding. In addition, the Decision: $263,158. PFC Level: $4.50. FAA determined that two items of work Earliest Charge Effective Date: Total PFC Revenue Approved in This (annual audit reports and ARUP December 1, 2014. Decision: $10,697,988. consultants) were not eligible for PFC Estimated Charge Expiration Date: Earliest Charge Effective Date: June 1, funding. Therefore, the approved PFC February 1, 2021. 2032. amount was reduced from the amount Class of Air Carriers Not Required To Estimated Charge Expiration Date: requested. Collect PFC’s: Non-scheduled/on- April 1, 2034. Decision Date: October 24, 2014. demand air carriers filing FAA Form Class of Air Carriers Not Required To FOR FURTHER INFORMATION CONTACT: 1800–31. Collect PFC’s: Non-scheduled/on- Darlene Williams, Los Angeles Airports Determination: Approved. Based on demand air carriers filing FAA Form District Office, (310) 725–3625. information contained in the public 1800–31. Public Agency: Greater Peoria Airport agency’s application, the FAA has Determination: Approved. Based on Authority, Peoria, Illinois. determined that the approved class information contained in the public Application Number: 15–06–C–00– accounts for less than 1 percent of the agency’s application, the FAA has PIA. total annual enplanements at Jack determined that the approved class Application Type: Impose and use a McNamara Field Airport. accounts for less than 1 percent of the PFC. Brief Description of Projects Approved total annual enplanements at Long PFC Level: $4.50. for Collection and Use: Beach/Daugherty Field Airport. Total PFC Revenue Approved in This Runway safety area improvements— Brief Description of Projects Approved Decision: $11,708,250. design. for Collection and Use: Earliest Charge Effective Date: Terminal building design—phase I. Reconstruction of air carrier apron— February 1, 2015. Terminal building design—design phase phases II and III. Estimated Charge Expiration Date: II. Pavement management and September 1, 2023. Decision Date: October 28, 2014. maintenance program. Class of Air Carriers Not Required To FOR FURTHER INFORMATION CONTACT: Neil Airfield geometry study and strategic Collect PFC’S: Non-scheduled/on- Kumar, San Francisco Airports District planning. demand air carriers filing FAA Form Office, (650) 827–7627. Runway 30 safety area improvements. 1800–31 that are operating at General Public Agency: Grand Forks Regional Runway 07L/25R rehabilitation. Wayne A. Downing Peoria International Airport Authority, Grand Forks, North Perimeter security improvements. Airport (PIA). Terminal access road improvements. Dakota. PFC application and program Determination: Approved. Based on Application Number: 15–10–C–00– administration. information contained in the public GFK. agency’s application, the FAA has Application Type: Impose and use a Decision Date: October 24, 2014. determined that the approved class PFC. FOR FURTHER INFORMATION CONTACT: accounts for less than 1 percent of the PFC Level: $4.50. Darlene Williams, Los Angeles Airports total annual enplanements at PIA. Total PFC Revenue Approved in This District Office, (310) 725–3625. Brief Description of Projects Approved Decision: $1,867,720. Public Agency: Los Angeles World for Collection and Use: Earliest Charge Effective Date: January Airports, Los Angeles, California. Drainage improvements and slope 1, 2019. Application Number: 13–09–C–00– stabilization. Estimated Charge Expiration Date: LAX. Expand terminal parking lot. February 1, 2022. Application Type: Impose and use a Rehabilitate airport entrance road. Class of Air Carriers Not Required To PFC. Snow removal equipment building. Collect PFC’s: Air taxi/Commercial PFC Level: $3.00. Master plan and airport layout plan Total PFC Revenue Approved in This operators filing FAA Form 1800–31 that update. Decision: $44,378,659. are operating at Grand Forks PFC application costs. Earliest Charge Effective Date: June 1, International Airport (GFK). 2019. Brief Description of Project Partially Determination: Approved. Based on Estimated Charge Expiration Date: Approved for Collection and Use: information contained in the public October 1, 2019. Additional terminal gates/Federal agency’s application, the FAA has Class of Air Carriers Not Required To Inspection Services. determined that the approved class Collect PFC’s: Air taxi/Commercial Determination: Partially approved. accounts for less than 1 percent of the operators filing FAA Form 1800–31. The FAA determined that PFC total annual enplanements at GFK.
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Brief Description of Projects Approved Construct aircraft rescue and fire Decision Date: October 28, 2014. for Collection and Use: fighting building. FOR FURTHER INFORMATION CONTACT: Purchase snow removal equipment. Reconstruct taxiways A, B, and D Chris Hugunin, Minneapolis Airports Construct snow removal equipment intersection. District Office, (612) 253–4630. building.
AMENDMENTS TO PFC APPROVALS
Original Amended Amendment Original Amended estimated estimated Amendment No. city, state approved date approved net approved net charge exp. charge exp. PFC revenue PFC revenue date date
09–14–C–01–OAK, Oakland, CA ...... 09/26/14 $293,219,000 $396,564,898 04/01/21 01/01/28 08–14–C–03–BNA, Nashville, TN ...... 09/30/14 66,013,179 66,013,179 06/01/16 06/01/16 11–17–C–03–BNA, Nashville, TN ...... 09/30/14 2,797,105 2,722,105 06/01/17 04/01/17 13–19–C–01–BNA, Nashville, TN ...... 09/30/14 4,430,000 4,750,000 11/01/17 11/01/17 10–05–C–01–BIS, Bismarck, ND ...... 10/08/14 7,099,409 4,036,922 02/01/22 02/01/15 01–03–C–02–BFL, Bakersfield, CA ...... 10/10/14 9,086,000 10,526,514 12/01/17 01/01/21 10–05–C–01–CIC, Chico, CA ...... 10/10/14 590,000 7,569 12/01/16 12/01/14 12–10–C–01–LSE, La Crosse, WI ...... 10/14/14 2,665,657 4,175,370 01/01/23 05/01/28 08–14–C–04–BNA, Nashville, TN ...... 10/15/14 66,013,179 56,871,177 06/01/16 05/01/15 09–15–C–02–BNA, Nashville, TN ...... 10/15/14 6,196,434 4,314,382 09/01/16 09/01/16 10–03–C–02–DAL, Dallas, TX ...... 10/16/14 383,636,108 374,336,108 04/01/26 04/01/25
Issued in Washington, DC, on December 1, Expansion Act of 1990 (Title IX of the Construct snow removal building. 2014. Omnibus Budget Reconciliation Act of Decision Date: November 6, 2014. Joe Hebert, 1990) (Pub. L. 101–508) and Part 158 of FOR FURTHER INFORMATION CONTACT: Manager, Financial Analysis and Passenger the Federal Aviation Regulations (14 Facility Charge Branch. CFR part 158). This notice is published Jeffrey Breeden, Washington Airports District Office, (703) 661–1363. [FR Doc. 2014–28535 Filed 12–3–14; 8:45 am] pursuant to paragraph d of § 158.29. Public Agency: Williamsport Regional BILLING CODE 4910–13–P PFC Applications Approved Airport, Montoursville, Pennsylvania. Public Agency: Capital Region Airport Application Number: 14–04–I–00– DEPARTMENT OF TRANSPORTATION Commission, Richmond, Virginia. IPT. Application Number: 14–07–U–00– Application Type: Impose and use a Federal Aviation Administration RIC. PFC. Application Type: Use PFC revenue. PFC Level: $4.50. Notice of Passenger Facility Charge PFC Level: $4.50. Total PFC Revenue Approved in This (PFC) Approvals and Disapprovals Total PFC Revenue Approved for Use in This Decision: $9,559,375. Decision: $1,500,000. AGENCY: Federal Aviation Charge Effective Date: October 1, Earliest Charge Effective Date: June 1, Administration (FAA), DOT. 2019. 2015. ACTION: Monthly Notice of PFC Estimated Charge Expiration Date: Estimated Charge Expiration Date: Approvals and Disapprovals. In March 1, 2025. September 1, 2028. November 2014, there were two Class of Air Carriers Not Required To Class of Air Carriers Not Required To applications approved. Additionally, Collect PFC’s: No change from previous Collect PFC’s: None. four approved amendments to decision. Brief Description of Project Approved previously approved applications are Brief Description of Projects Approved for Collection: Construct new passenger listed. for Use: terminal building. Construct cargo apron improvements. SUMMARY: The FAA publishes a monthly Construct general aviation apron Decision Date: November 10, 2014. notice, as appropriate, of PFC approvals improvements. FOR FURTHER INFORMATION CONTACT: Lori and disapprovals under the provisions Reconstruction of taxiway E and a Ledebohm, Harrisburg Airports District of the Aviation Safety and Capacity portion of taxiway L. Office, (717) 730–2835.
AMENDMENT TO PFC APPROVALS
Original Amended Amendment Original Amended estimated estimated Amendment No., city, state approved date approved net approved net charge exp. charge exp. PFC revenue PFC revenue date date
12–08–C–01–SUN, Hailey, ID ...... 11/03/14 $527,500 $526,722 07/01/14 07/01/14 10–09–C–01–BTM, Butte, MT ...... 11/03/14 271,635 222,908 02/01/13 01/01/14 11–05–C–01–SFO, San Francisco, CA ...... 11/07/14 610,451,805 741,744,636 06/01/23 10/01/24 12–05–C–01–CHA, Chattanooga, TN ...... 11/12/14 6,896,122 7,969,956 06/01/17 10/01/15
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Issued in Washington, DC, on December 1, DEPARTMENT OF TRANSPORTATION therefore, if any parties object to these 2014. requests, they should file their Joe Hebert, Surface Transportation Board objections with the Director of the Board’s Office of Economics within 14 Manager, Financial Analysis and Passenger Release of Waybill Data Facility Charge Branch. calendar days of the date of this notice. [FR Doc. 2014–28526 Filed 12–3–14; 8:45 am] The Surface Transportation Board has The rules for release of waybill data are codified at 49 CFR 1244.9. BILLING CODE 4910–13–P received a request from BTGPactual (WB980–1—12/1/14) for permission to Contact: Alexander Dusenberry, (202) use certain data from the Board’s 2013 245–0319. Carload Waybill Sample. A copy of this request may be obtained from the Office Jeffrey Herzig, of Economics. Clearance Clerk. The waybill sample contains [FR Doc. 2014–28483 Filed 12–3–14; 8:45 am] confidential railroad and shipper data; BILLING CODE 4915–01–P
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Part II
Department of Health and Human Services
Food and Drug Administration 21 CFR Part 201 Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling; Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format; Draft Guidance for Industry; Availability; Final Rule and Notice
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DEPARTMENT OF HEALTH AND Drug Administration, 10903 New to the content and format requirements HUMAN SERVICES Hampshire Ave., Bldg. 51, Rm. 6246, for prescription drug and biological Silver Spring, MD 20993–0002, 301– product labeling are authorized by the Food and Drug Administration 796–3432; or Stephen Ripley, Center for Federal Food, Drug, and Cosmetic Act Biologics Evaluation and Research, (the FD&C Act) and by the Public Health 21 CFR Part 201 Food and Drug Administration, 10903 Service Act (PHS Act). [Docket No. FDA–2006–N–0515 (formerly New Hampshire Ave., Bldg. 71, Rm. Summary of the Major Provisions of the Docket No. 2006N–0467)] 7301, Silver Spring, MD 20993–0002, Regulatory Action in Question 240–402–7911. RIN 0910–AF11 SUPPLEMENTARY INFORMATION: The final rule requires that for the labeling of certain drug products (as Content and Format of Labeling for Table of Contents described in the ‘‘Implementation’’ Human Prescription Drug and section of this document), the Biological Products; Requirements for Executive Summary Purpose of the Regulatory Action subsections ‘‘Pregnancy,’’ ‘‘Nursing Pregnancy and Lactation Labeling Summary of the Major Provisions of the mothers,’’ and ‘‘Labor and delivery’’ be AGENCY: Food and Drug Administration, Regulatory Action in Question replaced by three subsections entitled HHS. Costs and Benefits ‘‘Pregnancy,’’ ‘‘Lactation,’’ and I. Background ‘‘Females and Males of Reproductive ACTION: Final rule. A. History of FDA-Approved Pregnancy Potential.’’ The final rule also requires and Lactation Labeling for Prescription SUMMARY: The Food and Drug the removal of the pregnancy categories Drugs A, B, C, D, and X from all drug product Administration (FDA) is amending its B. Development of the Proposed Rule regulations governing the content and C. The Proposed Rule labeling. format of the ‘‘Pregnancy,’’ ‘‘Labor and D. Mental Models Research ‘‘Pregnancy’’ delivery,’’ and ‘‘Nursing mothers’’ II. Overview of the Final Rule Including The final rule merges the current subsections of the ‘‘Use in Specific Significant Changes to the Proposed Rule ‘‘Pregnancy’’ and ‘‘Labor and delivery’’ Populations’’ section of the labeling for A. Overview subsections into a single ‘‘Pregnancy’’ human prescription drug and biological B. Significant Changes to the Proposed subsection of labeling. If there is a products. The final rule requires the Rule III. Comments on the Proposed Rule scientifically acceptable pregnancy removal of the pregnancy categories A, A. Proposed Rule as a Whole exposure registry for the drug, the B, C, D, and X from all human B. Specific Provisions of the Proposed Rule ‘‘Pregnancy’’ subsection must contain a prescription drug and biological product IV. Implementation specified statement about the existence labeling. For human prescription drug V. Legal Authority of the registry, followed by contact and biological products subject to the A. Statutory Authority B. First Amendment information needed to enroll or to Agency’s 2006 Physician Labeling Rule, obtain information about the registry. the final rule requires that the labeling VI. Environmental Impact VII. Summary of Final Regulatory Impact The Agency has concluded that include a summary of the risks of using including information about pregnancy a drug during pregnancy and lactation, Analysis A. Introduction exposure registries in prescription drug a discussion of the data supporting that B. Summary of Costs and Benefits labeling will encourage participation in summary, and relevant information to VIII. Paperwork Reduction Act of 1995 registries, thereby improving data help health care providers make IX. Federalism collection in pregnant women. Under prescribing decisions and counsel X. References ‘‘Pregnancy,’’ the final rule also requires women about the use of drugs during Executive Summary that the labeling include a summary of pregnancy and lactation. The final rule the risks of using a drug during eliminates the ‘‘Labor and delivery’’ Purpose of the Regulatory Action pregnancy. If data demonstrate that a subsection because information about FDA is amending its regulations drug is not absorbed systemically, the labor and delivery is included in the governing the content and format of the ‘‘Risk Summary’’ must contain only a ‘‘Pregnancy’’ subsection. The final rule ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ and specified statement regarding this fact. If requires that the labeling include ‘‘Nursing mothers’’ subsections of the data demonstrate that the drug is relevant information about pregnancy ‘‘Use in Specific Populations’’ section absorbed systemically, the ‘‘Risk testing, contraception, and infertility for (under § 201.57 (21 CFR 201.57)) and Summary’’ must include risk statements health care providers prescribing for the ‘‘Precautions’’ section (under based on data from all relevant sources females and males of reproductive § 201.80 (21 CFR 201.80)) of the labeling (human, animal, and/or pharmacologic), potential. The final rule creates a for human prescription drug and that describe, for the drug, the risk of consistent format for providing biological products (both referred to as adverse developmental outcomes. information about the risks and benefits ‘‘drugs’’ or ‘‘drug products’’ in this final The labeling must also contain of prescription drug and/or biological rule). In this rulemaking, the Agency is relevant information, if it is available, to product use during pregnancy and finalizing many of the provisions in the help health care providers make lactation and by females and males of proposed rule issued on May 29, 2008 prescribing decisions and counsel reproductive potential. These revisions (73 FR 30831). women about the use of the drug during will facilitate prescriber counseling for This rulemaking is part of a broad pregnancy; this could include these populations. effort by the Agency to improve the information on disease-associated DATES: This rule is effective June 30, content and format of prescription drug maternal and/or embryo/fetal risk, dose 2015. See section IV of this document labeling. The final rule creates a adjustments during pregnancy and the for the implementation dates of this consistent format for providing postpartum period, maternal adverse final rule. information about the risks and benefits reactions, fetal/neonatal adverse FOR FURTHER INFORMATION CONTACT: of drug use during pregnancy and reactions, and/or the effect of the drug Kathy Schreier, Center for Drug lactation and by females and males of on labor or delivery. FDA believes that Evaluation and Research, Food and reproductive potential. FDA’s revisions including such information supports
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health care providers’ understanding of presented elsewhere in the labeling. In and convey the potential risks of drug drug product risks and benefits and addition, the labeling must also include exposure based on animal or human facilitates informed prescribing pertinent information about the data data, or both. FDA has determined that decisions and patient counseling. The that are the basis for the risk summary retaining the pregnancy categories is labeling must also describe the data that and clinical information included in the inconsistent with the need to accurately are the basis for the risk statements and ‘‘Lactation’’ subsection of labeling. and consistently communicate clinical information included in the ‘‘Females and Males of Reproductive differences in degrees of fetal risk. ‘‘Pregnancy’’ subsection of labeling. Potential’’ Therefore, the final rule requires the removal of the pregnancy categories A, ‘‘Lactation’’ FDA determined that because there B, C, D, and X from all drug product The final rule requires that the was no consistent placement in the labeling. ‘‘Lactation’’ subsection of labeling labeling of information about pregnancy Costs and Benefits contain a summary of the risks of using testing, contraception, and infertility, it a drug during lactation. If data was difficult for health care providers to find this important information that can We estimate that over 10 years with demonstrate that the drug is not a 7 percent discount rate, the present absorbed systemically, this summary affect decisionmaking before or during pregnancy. Thus, the final rule requires value of one-time costs of the rule equal must contain only a specified statement $52.4 million and the present value of regarding this fact. If data demonstrate that the ‘‘Females and Males of Reproductive Potential’’ subsection the annual costs equal $14.4 million; that the drug is absorbed systemically with a 3 percent discount rate, the by the mother, this summary must include relevant information when pregnancy testing or contraception is present value of one-time costs equal include, to the extent it is available, required or recommended before, $60.1 million and the present value of relevant information on the presence of during, or after drug therapy or when the annual costs equal $18.2 million. the drug in human milk, effects of the there are human or animal data that The present value of the total costs drug on the breast-fed child, and effects suggest drug-associated fertility effects. equal $66.8 million with a 7 percent of the drug on milk production. For discount rate and $78.2 million with a drugs absorbed systemically, a risk and Removal of Pregnancy Categories 3 percent discount rate. The annualized benefit statement must appear at the end Through experience and stakeholder costs of the rule total $9.5 million with of the summary of risks, unless feedback, FDA learned that the a 7 percent discount rate and $9.2 breastfeeding is contraindicated during pregnancy categories were confusing million with a 3 percent discount rate. drug therapy. FDA has determined that and did not accurately and consistently The final rule will address issues raised the inclusion of a risk and benefit communicate differences in degrees of by experts and stakeholders and statement will provide a useful fetal risk. In addition, FDA learned that improve the quality of the affected framework for health care providers to the pregnancy categories were heavily sections of prescription drug labeling. use when making prescribing decisions relied upon by clinicians but were often Better quality prescribing information for a lactating patient. misinterpreted and misused in that will enhance the usefulness of the The ‘‘Lactation’’ subsection must also prescribing decisions were being made labeling. The public health benefits of include, to the extent information is based on the pregnancy category, rather the final rule would result from available, relevant information than an understanding of the underlying improved health outcomes. However, concerning ways to minimize drug information that informed the because we have no information about exposure in the breast-fed child in assignment of the pregnancy category. how improved labeling will affect certain situations and concerning FDA believes that a narrative structure prescriber behavior and patient available interventions for monitoring or for pregnancy labeling, rather than a outcomes, we are unable to quantify the mitigating the adverse reactions category system, is best able to capture benefits of the final rule.
SUMMARY OF BENEFITS AND COSTS OF THE FINAL RULE
Total Total annualized annualized Present value Present value costs over 10 costs over 10 of total costs of total costs years with 3 years with 7 Total benefits with 3 percent with 7 percent percent percent discount rate discount rate discount discount ($ mil) ($ mil) rate rate ($ mil) ($ mil)
Not estimated ...... 78.2 66.8 9.2 9.5
I. Background broad effort by the Agency to improve products (both referred to as ‘‘drugs’’ or the content and formatting of ‘‘drug products’’ in this final rule) are In the Federal Register of May 29, prescription drug labeling. accompanied by labeling (including 2008 (73 FR 30831), FDA issued a prescribing information) that proposed rule to amend the content and A. History of FDA-Approved Pregnancy summarizes scientific information format of the ‘‘Pregnancy,’’ ‘‘Labor and and Lactation Labeling for Prescription concerning their safe and effective use. delivery,’’ and ‘‘Nursing mothers’’ Drugs subsections of the ‘‘Use in Specific FDA regulations on labeling for use Populations’’ section of labeling for Under sections 502 and 505 of the during pregnancy, during labor and human prescription drug and biological FD&C Act (21 U.S.C. 352 and 355), FDA delivery, and by nursing mothers were products, which appear in § 201.57. The has responsibility for ensuring that originally issued in 1979 as part of a proposed rulemaking was part of a prescription drug and biological rule prescribing the content and format
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for labeling for human prescription include information on the effects of the regarding the 1979 regulations drugs (part 201 (21 CFR part 201)) (44 drug on, among other things, the mother governing labeling of drug products for FR 37434, June 26, 1979) (the 1979 and the fetus, the duration of labor and use during pregnancy, during labor and regulations).1 The requirements on delivery, and the effect of the drug on delivery, and while nursing (73 FR content and format of labeling for drug the later growth, development, and 30831 at 30832–30838). products were revised on January 24, functional maturation of the child. C. The Proposed Rule 2006, in the final rule on ‘‘Requirements With regard to labeling on lactation, on Content and Format of Labeling for the 1979 regulations required, at what FDA proposed to amend the content Human Prescription Drug and Biological was redesignated in 2006 as and format of the ‘‘Pregnancy,’’ ‘‘Labor Products’’ (71 FR 3922), commonly § 201.57(c)(9)(iii) and § 201.80(f)(8), that and delivery,’’ and ‘‘Nursing mothers’’ referred to as the ‘‘Physician Labeling a ‘‘Nursing mothers’’ subsection be subsections of the ‘‘Use in Specific Rule’’ (PLR).2 As part of the January included in the ‘‘Precautions’’ section of Populations’’ section of physician 2006 revision, the subsections of the the labeling. The ‘‘Nursing mothers’’ labeling for prescription drug products labeling on pregnancy, labor and subsection provided that if a drug was subject to § 201.57. The Agency’s delivery, and nursing mothers were absorbed systemically, the labeling must proposed changes were intended to moved from the ‘‘Precautions’’ section contain information about excretion of create a consistent format for providing under § 201.57 to the ‘‘Use in Specific the drug in human milk and effects on information about the effects of a drug Populations’’ section. The content of the nursing infant, as well as a on pregnancy and lactation that would these sections in part 201 was not description of any pertinent adverse be useful for decisionmaking by health revised, but the sections were effects observed in animal offspring. care providers and their patients. With redesignated as § 201.57(c)(9)(i) through The ‘‘Nursing mothers’’ subsection respect to the ‘‘Pregnancy,’’ ‘‘Labor and (c)(9)(iii). The previous labeling required the use of certain standard delivery,’’ and ‘‘Nursing mothers’’ regulation (adopted in 1979) was statements depending on whether the subsections of the ‘‘Precautions’’ section redesignated as § 201.80, and applies to drug was known to be excreted in of prescription drug labeling for drug products not affected by the January human milk and whether it was products subject to § 201.80, the Agency 2006, revisions. In redesignated associated with serious adverse proposed only to remove the pregnancy § 201.80, the subsections on pregnancy, reactions.4 category from the ‘‘Pregnancy’’ labor and delivery, and nursing mothers subsection. B. Development of the Proposed Rule are § 201.80(f)(6) through (f)(8). 1. Proposed Provisions for New and The 1979 regulations provided, at Over a number of years after the 1979 Recently Approved Drugs what was redesignated in 2006 as regulations were issued, FDA received § 201.57(c)(9)(i) and § 201.80(f)(6)(i), feedback on the issues and concerns FDA proposed the following format that unless a drug was not absorbed with the ‘‘Pregnancy,’’ ‘‘Labor and and content changes to the systemically and was not known to have delivery,’’ and ‘‘Nursing mothers’’ ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ and a potential for indirect harm to a fetus, subsections of prescription drug ‘‘Nursing mothers’’ subsections of a ‘‘Pregnancy’’ subsection must be labeling as defined by the 1979 prescription drug labeling for products subject to § 201.57. included within the ‘‘Precautions’’ regulations. In response to this • section of the labeling. The 1979 feedback, FDA held a part 15 public Merge the current ‘‘Pregnancy’’ and regulations required that the hearing, conducted focus groups, and ‘‘Labor and delivery’’ subsections into a ‘‘Pregnancy’’ subsection contain convened two advisory committees to single ‘‘Pregnancy’’ subsection information on the drug’s teratogenic provide expert input. During this designated 8.1 under the section ‘‘8 Use in Specific Populations.’’ effects and other effects on reproduction process, many stakeholders stated that • and pregnancy and, when available, a these subsections of prescription drug Rename the ‘‘Nursing mothers’’ description of human studies with the labeling lacked clarity, often failed to subsection as ‘‘Lactation’’ designated drug and data on its effects on later provide meaningful clinical information with the identifying number 8.2 under growth, development, and functional about drug exposure during pregnancy the section ‘‘8 Use in Specific maturation of the child. The 1979 and lactation, and did not address the Populations.’’ • Reserve the identifying number 8.3 regulations also required that each potential maternal and fetal for future use. product be classified under one of five consequences of discontinuing needed • Replace the format and content of pregnancy categories (A, B, C, D, or X) maternal drug therapy during the ‘‘Pregnancy’’ subsection in its on the basis of risk of reproductive and pregnancy. Experts and other entirety with the following: developmental adverse effects or, for stakeholders noted that the pregnancy Æ If there is a pregnancy exposure certain categories, on the basis of such categories, although highly relied upon registry for the drug, the telephone 3 risk weighed against potential benefit. by health care providers, were often number or other information needed to With regard to labor and delivery, the misinterpreted and misused. FDA also enroll in the registry or to obtain 1979 regulations stated, at what was sought input on the development of a information about the registry must be redesignated in 2006 as § 201.57(c)(9)(ii) model format for these subsections of included at the beginning of the and § 201.80(f)(7), that under certain labeling, and the resulting model served ‘‘Pregnancy’’ subsection of labeling. circumstances, the labeling must as the basis for the May 29, 2008, Æ Require the inclusion of a general proposed rule (73 FR 30831). The statement about background risk, 1 Thus, the labeling for drugs originally approved preamble to the proposed rule contains specifically ‘‘All pregnancies have a before 1979 may not contain the information a detailed discussion about the required by those regulations regarding pregnancy, background risk of birth defect, loss, or labor and delivery, and nursing mothers. background of the development of the other adverse outcome regardless of 2 FDA’s regulations governing the content and proposed rule and additional details drug exposure. The fetal risk summary format of labeling for human prescription drug and below describes (name of drug)’s biological products are contained in §§ 201.56, 4 For further discussion of the history of both the 201.57, and 201.80. ‘‘Pregnancy’’ and the ‘‘Nursing mothers’’ potential to increase the risk of 3 For further discussion of the pregnancy subsections of prescription drug labeling, see 73 FR developmental abnormalities above the categories, see 73 FR 30831 at 30832 through 30833. 30831 at 30833. background risk.’’
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Æ Under the subheading ‘‘Fetal Risk Æ Require the fetal risk summary to the content requirements of ‘‘Nursing Summary,’’ require the labeling to refer to the ‘‘Contraindications’’ and/or mothers’’ in its entirety with the contain a risk conclusion and a ‘‘Warnings and Precautions’’ sections of following: narrative description of the risk(s) (if the the labeling if there is any information Æ Require that the labeling of all risk conclusion is based on human in those sections on an increased risk to drugs contain a ‘‘Lactation’’ subsection. data). the fetus from exposure to the drug. Æ Under the subheading ‘‘Risk Æ Require the fetal risk summary to Æ Require under the subheading Summary,’’ if the data demonstrate that characterize the likelihood that the drug ‘‘Clinical Considerations’’ the inclusion the drug does not affect the quantity increases the risk of developmental of information about the known or and/or quality of human milk and there abnormalities and other risks in predicted risks to the fetus from is reasonable certainty either that the humans. inadvertent exposure to the drug, drug is not detectable in human milk or Æ Require that if data demonstrate including human or animal data on that the amount of drug consumed that a drug is not systemically absorbed, dose, timing, and duration of exposure. through breast milk will not adversely the fetal risk summary contain only the If there are no data to assess the risk affect the breast-fed child, the labeling following statement: (Name of drug) is from inadvertent exposure, require the must state: The use of (name of drug) is labeling to so state. compatible with breastfeeding. After not absorbed systemically from (part of Æ body) and cannot be detected in the Require under the subheading this statement (if applicable), the blood. Maternal use is not expected to ‘‘Clinical Considerations’’ the inclusion labeling must summarize the drug’s result in fetal exposure to the drug. of information related to prescribing effect on milk production, what is Æ When both human and animal data decisions for pregnant women, known about the presence of the drug in are available, require that risk including the risk, if known, to the human milk, and the effects on the conclusions based on human data be pregnant woman and the fetus from the breast-fed child. disease or condition the drug is Æ presented before risk conclusions based The source(s) of the data (e.g., indicated to treat and the potential on animal data. Require that a risk human, animal, in vitro) that are the influence of drug treatment on that risk; conclusion based on human data be basis for the ‘‘Risk Summary’’ must be information about dosing adjustments followed by a narrative description of stated. When there are insufficient data during pregnancy; if use of the drug is the risks. or no data to assess the drug’s effect on associated with any maternal adverse milk production, the presence of the Æ When human data are sufficient to reactions that are unique to pregnancy drug in human milk, and/or the effects reasonably determine the likelihood that or if known adverse reactions occur on the breast-fed child, the ‘‘Risk the drug increases the risk of fetal with increased frequency or severity in Summary’’ must so state. developmental abnormalities or specific pregnant women, a description of such Æ If the drug is not systemically developmental abnormalities, require adverse reactions; if it is known or absorbed, require that the subheading the labeling to contain one of two risk anticipated that treatment of the ‘‘Risk Summary’’ contain only the conclusions: Human data do not pregnant woman will cause a following statement: (Name of drug) is indicate that (name of drug) increases complication in the fetus or the neonate, not absorbed systemically from (part of the risk of (type of developmental a description of the complication, the body) and cannot be detected in the abnormality or specific developmental severity and reversibility of the mother’s blood. Therefore, detectable abnormality) or Human data indicate complication, and general types of amounts of (name of drug) will not be that (name of drug) increases the risk of interventions, if any, that may be present in breast milk. Breastfeeding is (type of developmental abnormality or needed. not expected to result in fetal exposure specific developmental abnormality). Æ If the drug has a recognized use Æ to the drug. When human data are available but during labor or delivery, whether or not Æ If the drug is absorbed systemically, not sufficient to reasonably determine that use is stated as an indication in the require the following under the the drug’s effects on fetal developmental labeling, or is expected to affect labor or subheading ‘‘Risk Summary’’: abnormalities, require the labeling to delivery, require the inclusion of D A description of the effects of the characterize the likelihood that the drug available information about the effect of drug’s impact on milk production, increases the risk of developmental the drug on the mother; the fetus/ including the effect of the drug on the abnormalities as low, moderate, or high. neonate; the duration of labor and quality and quantity of milk, including Æ Require that when the data on delivery; the possibility of milk composition, and the implications which the risk conclusion is based are complications, including interventions, of these changes to the breast-fed child. animal data, the fetal risk summary if any, that may be needed; and the later D A description of the presence of the characterize the likelihood that the drug growth, development, and functional drug in human milk in one of the increases the risk of developmental maturation of the child. following ways: (1) The drug is not abnormalities using one of the following Æ Require the inclusion of a ‘‘Data’’ detectable in human milk, (2) the drug risk conclusions: Not predicted to subheading that, for human data, has been detected in human milk, (3) increase the risk, low likelihood of describes positive and negative the drug is predicted to be present in increased risk, moderate likelihood of experiences during pregnancy, human milk, (4) the drug is not increased risk, high likelihood of including developmental abnormalities, predicted to be present in human milk, increased risk, or insufficient animal and, to the extent applicable, the or (5) the data are insufficient to know data on which to assess the likelihood number of subjects and duration of the or predict whether the drug is present of increased risk. study. For animal data, require under in human milk. Æ When human data are available, the subheading ‘‘Data’’ a description of D Require that if studies demonstrate require that in addition to the risk the relationship of the exposure and that the drug is not detectable in human conclusion(s), the fetal risk summary be mechanism of action in the animal milk, the ‘‘Risk Summary’’ state the followed by a brief narrative description species to the anticipated exposure and limits of the assay used. of the risks of developmental mechanism of action in humans. D Require that if the drug has been abnormalities as well as on other • Replace the ‘‘Nursing mothers’’ detected in human milk, the ‘‘Risk relevant risks associated with the drug. subsection with ‘‘Lactation’’ and replace Summary’’ give the concentration
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detected in milk in reference to a stated D. Mental Models Research described in the ‘‘Implementation’’ maternal dose (or, if the drug has been In a separate but related effort, FDA section of this document), the labeled for pediatric use, in reference to contracted with a third party research subsections ‘‘Pregnancy,’’ ‘‘Nursing the pediatric dose), an estimate of the firm to conduct a Mental Models mothers,’’ and ‘‘Labor and delivery’’ be amount of the drug consumed daily by Research study in 2009 to better replaced by three subsections entitled the infant based on an average daily understand the decisionmaking ‘‘Pregnancy,’’ ‘‘Lactation,’’ and milk consumption of 150 milliliters per processes of health care providers ‘‘Females and Males of Reproductive kilogram of infant weight per day, and prescribing drugs to pregnant and Potential.’’ Information previously an estimate of the percentage of the lactating women with chronic placed in ‘‘Labor and delivery’’ is maternal dose excreted in human milk. conditions (Ref. 1). Mental Models required to be included in the D Require the inclusion of Research is an established risk analysis ‘‘Pregnancy’’ subsection of labeling. The information about the likelihood and approach that evaluates, using a final rule requires ‘‘Risk Summary’’ seriousness of known or predicted structured interview, decisionmaking subheadings in the ‘‘Pregnancy’’ and effects on the breast-fed child from practices that require the synthesis of ‘‘Lactation’’ subsections of labeling. The exposure to the drug in human milk complex issues. The specific objectives ‘‘Pregnancy Exposure Registry’’ based on the pharmacologic and of this study, which involved interviews subheading under ‘‘Pregnancy’’ is only toxicologic profile of the drug, the with 54 health care providers, were to required if there is such a registry. The amount of drug detected or predicted to understand how health care providers ‘‘Clinical Considerations’’ and ‘‘Data’’ be found in human milk, and age- used FDA-approved prescribing subheadings are required under information (in the labeling format in related differences in absorption, ‘‘Pregnancy’’ and under ‘‘Lactation’’ place at the time of the study in 2009), distribution, metabolism, and only to the extent relevant information in order to determine the factors that elimination. is available. If data demonstrate that the influence their treatment decisions for Æ Under the subheading ‘‘Clinical pregnant and lactating women with drug is systemically absorbed, the ‘‘Risk Considerations,’’ require the labeling to chronic conditions, and to define Summary’’ in the ‘‘Pregnancy’’ provide the following information to the measures that could be used to quantify subsection requires a statement extent it is available: Information the value of prescribing information as regarding the background risk, in concerning ways to minimize the a tool for these decision makers. addition to certain other information, exposure of the breast-fed child to the The findings from the Mental Models and the ‘‘Risk Summary’’ in the drug, such as timing the dose relative to Research were consistent with the ‘‘Lactation’’ subsection of labeling breastfeeding or pumping and feedback the Agency received during its requires the inclusion of a risk and discarding milk for a specified period; work on the proposed and final rules. benefit statement, unless breastfeeding information about potential drug effects For example, the research showed that is contraindicated. The ‘‘Females and in the breast-fed child that could be the pregnancy categories were relied Males of Reproductive Potential’’ useful to caregivers, including upon by many health care providers subsection is not required if none of the recommendations for monitoring or almost to the exclusion of other subheadings are applicable. However, responding to these effects; information information found in the labeling. It also when pregnancy testing and/or about dosing adjustments during showed that providers often relied on contraception is required or lactation. secondary sources to find the pregnancy recommended before, during, or after Æ Require that the labeling include, category for a particular product rather drug therapy and/or when there are under the subheading ‘‘Data,’’ an than using the product’s labeling. human and/or animal data that suggest overview of the data that are the basis Interviewees made suggestions for drug-associated fertility effects, the for the ‘‘Risk Summary’’ and ‘‘Clinical improving prescribing information, ‘‘Females and Males of Reproductive Considerations.’’ including simplifying the information Potential’’ subsection requires the presented, centralizing the relevant 2. Pregnancy Categories and inclusion of such information under the information, and making the Implementation subheadings ‘‘Pregnancy Testing,’’ information included in labeling ‘‘Contraception,’’ and ‘‘Infertility,’’ FDA proposed to require the new clinically relevant. respectively. The final rule also requires content and format changes for II. Overview of the Final Rule, statements acknowledging when data on prescription drug labeling for all Including Significant Changes to the various labeling elements either are not applications (including new drug Proposed Rule available or do not establish the applications (NDAs), biologics license A. Overview presence or absence of drug-associated applications (BLAs), or efficacy risk In addition, the final rule requires supplements) required to comply with In this rulemaking, the Agency removal of pregnancy categories from all the PLR, i.e., for drug products for finalizes many of the provisions in the drug product labeling, including those which an application was approved on May 2008 proposed rule. In addition, products for which an application was or after June 30, 2001. FDA proposed the final rule reflects revisions the approved before June 30, 2001. that holders of applications approved Agency made in response to comments before June 30, 2001 (i.e., applications on the May 2008 proposed rule. FDA B. Significant Changes to the Proposed not subject to the PLR), would not be has also made editorial and Rule required to implement the new content organizational changes to clarify and format changes. Instead, if the provisions. For the purposes of this The final rule reflects revisions to the labeling for such applications contains a rulemaking, the term ‘‘drug’’ or ‘‘drug proposed rule in response to comments pregnancy category, the application product’’ is used to refer to human received on the proposed rule, as holders would be required to remove prescription drugs and biological discussed in detail in section III of this the pregnancy category designation by 3 products that are regulated as drugs. document. FDA made the following years after the effective date of the final The final rule requires that for the organizational and content-based rule. labeling of certain products (as changes to the proposed rule:
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1. Pregnancy requirement that, if the drug is and the effects of dose, duration of • The final rule revises the proposed systemically absorbed, the labeling state exposure, and gestational timing of rule to clarify that the ‘‘Risk Summary’’ the percentage range of live births in the exposure. The final rule also requires subheading is always required in the United States with a major birth defect that if the human data indicate that ‘‘Pregnancy’’ subsection of labeling. The and the percentage range of pregnancies there is an increased risk for a specific subheading ‘‘Pregnancy Exposure in the United States that end in adverse developmental outcome in Registry’’ is only required when such a miscarriage, regardless of drug infants born to women exposed to the registry exists; the ‘‘Clinical exposure. The final rule also requires drug during pregnancy, this risk must be Considerations’’ and ‘‘Data’’ that if such information is available for quantitatively compared to the risk for subheadings are required when relevant the population(s) for which the drug is the same outcome in infants born to information is available. If the ‘‘Clinical labeled, it must also be included. women who were not exposed to the Æ Replaces the term ‘‘developmental Considerations’’ subheading is required, drug but who have the disease or abnormalities’’ with the term ‘‘adverse the following headings under it are also condition for which the drug is developmental outcomes.’’ The final required to the extent relevant indicated to be used. When risk rule defines ‘‘adverse developmental information is available: ‘‘Disease- information is not available for women outcomes’’ as structural abnormalities, associated maternal and/or embryo/fetal with these condition(s), then the risk for embryo-fetal and/or infant mortality, risk,’’ ‘‘Dose adjustments during the specific outcome must be compared functional impairment, and alterations pregnancy and the postpartum period,’’ to the rate at which the outcome occurs to growth. ‘‘Maternal adverse reactions,’’ ‘‘Fetal/ in the general population. Æ Clarifies that, when applicable, risk Æ Neonatal adverse reactions,’’ and ‘‘Labor Requires that the ‘‘Risk Summary’’ statements must include a cross- or delivery.’’ Similarly, if the ‘‘Data’’ must state when there are no human reference to additional details located subheading is required, the headings data or when available human data do under the ‘‘Data’’ subheading of ‘‘Human Data’’ and ‘‘Animal Data’’ are not establish the presence or absence of ‘‘Pregnancy.’’ drug-associated risk. required under it to the extent relevant Æ Revises the statement required Æ Eliminates the term ‘‘other human information is available. when a drug is not systemically • The final rule revises the proposed data’’ and the requirement that when absorbed as follows: there are other human data, the ‘‘Pregnancy Exposure Registry’’ D Replaces the phrase ‘‘from (part of subheading as follows: likelihood that the drug increases the Æ the body)’’ with ‘‘following (route of risk of developmental abnormalities Requires that contact information administration)’’ to describe how the and a standard statement on the must be characterized as low, moderate, drug enters the body. or high. pregnancy exposure registry will be D Replaces the phrase ‘‘cannot be • The ‘‘Risk conclusions based on included under its own subheading detected in the blood’’ with ‘‘maternal animal data’’ in the ‘‘Risk Summary’’ is ‘‘Pregnancy Exposure Registry’’ if there use is not expected to result in fetal is a pregnancy registry that is revised as follows: exposure to the drug.’’ Æ scientifically acceptable. Æ Adds a requirement that when use Replaces the term ‘‘risk Æ Eliminates the phrase ‘‘must be conclusions’’ with ‘‘risk statement.’’ of the drug is contraindicated during Æ stated at the beginning of the pregnancy, this must be stated first in Eliminates the requirement that ‘Pregnancy’ subsection of the labeling.’’ the ‘‘Risk Summary.’’ animal data be characterized as ‘‘not Æ Revises the phrase ‘‘telephone Æ Requires that risk statements be predicted to increase the risk,’’ ‘‘low number or other information needed to presented in the following order: Based likelihood of increased risk,’’ ‘‘moderate enroll’’ to ‘‘contact information needed on human data, based on animal data, likelihood of increased risk,’’ or ‘‘high to enroll.’’ based on pharmacology. likelihood of increased risk.’’ Æ Æ Adds a requirement that the • The ‘‘Risk conclusions based on Requires that when animal data are following statement be included in human data’’ in the ‘‘Risk Summary’’ is available, the labeling must summarize labeling before the contact information revised as follows: the findings in animals and based on for the pregnancy exposure registry: Æ Replaces the term ‘‘risk these findings, describe, for the drug, There is a pregnancy exposure registry conclusions’’ with ‘‘risk statement.’’ the potential risk of any adverse that monitors pregnancy outcomes in Æ Eliminates the term ‘‘sufficient developmental outcome(s) in humans. women exposed to (name of drug) human data’’ and the proposed rule’s The final rule requires that the risk during pregnancy. requirement that the labeling contain statement include: The number and • The final rule revises the proposed one of the following standardized risk type(s) of species affected, the timing of ‘‘Fetal Risk Summary’’ as follows: conclusions about sufficient human exposure, animal doses expressed in Æ Changes the title of the subheading data: Human data do not indicate that terms of human exposure or dose ‘‘Fetal Risk Summary’’ to ‘‘Risk (name of drug) increases the risk of equivalents, and outcomes for pregnant Summary.’’ (type of developmental abnormality or animals and offspring. When animal Æ Eliminates the requirement that the specific abnormality) and Human data studies do not meet current standards following background risk statement be indicate that (name of drug) increases for nonclinical developmental toxicity included in the labeling before the fetal the risk of (type of developmental studies, the labeling must so state. The risk summary: All pregnancies have a abnormality or specific abnormality). final rule requires that when there are background risk of birth defect, loss, or Æ Replaces the standardized risk no animal data, the ‘‘Risk Summary’’ other adverse outcome regardless of conclusions based on human data with must so state. drug exposure. The fetal risk summary the requirement that when human data • Adds a ‘‘Risk statement based on below describes (name of drug)’s are available that establish the presence pharmacology’’ to the ‘‘Risk Summary,’’ potential to increase the risk of or absence of any adverse requiring that when the drug has a well- developmental abnormalities above the developmental outcome(s) associated understood mechanism of action that background risk. with maternal use of the drug, the Risk may result in drug-associated adverse Æ Replaces the proposed standardized Summary must summarize the specific developmental outcome(s), the ‘‘Risk background risk statement with the developmental outcome, its incidence, Summary’’ must explain the mechanism
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of action and the potential associated with ‘‘increases or may increase the risk applicable, the types of studies or risks. of an adverse reaction in the fetus or reports, number of subjects and duration • Eliminates the ‘‘Narrative neonate.’’ of each study, exposure information, description of human data’’ requirement Æ Under ‘‘Fetal/Neonatal adverse and limitations of the data. Requires from the ‘‘Risk Summary.’’ reactions,’’ replaces ‘‘the severity and that both positive and negative study • Removes the requirement that the reversibility of the complication’’ with findings be included. ‘‘Risk Summary’’ refer to the ‘‘the potential severity and reversibility Æ For animal data, retains the ‘‘Contraindications’’ or ‘‘Warnings and of the adverse reaction,’’ and replaces requirement that the labeling describe Precautions’’ sections of the labeling ‘‘general types of interventions, if any, the types of studies, animal species, when those sections contain that may be needed’’ with ‘‘available dose, duration and timing of exposure, information on an increased risk to the intervention(s) for monitoring or and adds the requirement that the fetus from exposure to the drug. mitigating the reaction.’’ labeling also describe study findings, • The final rule revises the ‘‘Clinical Æ Under ‘‘Fetal/Neonatal adverse presence or absence of maternal Considerations’’ component as follows: reactions,’’ adds a requirement that the toxicity, and limitations of the data. Æ Requires headings, to the extent labeling must describe, if known, the Adds the requirement that the relevant information is available, for effect of dose, timing, and duration of description of maternal and offspring ‘‘Disease-associated maternal and/or exposure on the risk. findings must include information on embryo/fetal risk,’’ ‘‘Dose adjustments Æ Revises the heading ‘‘Drug effects the dose-response and severity of during pregnancy and the postpartum during labor or delivery’’ to ‘‘Labor or adverse developmental outcomes. period,’’ ‘‘Maternal adverse reactions,’’ delivery.’’ Requires that animal doses or exposures ‘‘Fetal/Neonatal adverse reactions,’’ and Æ Under ‘‘Labor or delivery,’’ revises be described in terms of human dose or ‘‘Labor or delivery’’. ‘‘[i]f the drug has a recognized use exposure equivalents and that the basis Æ Eliminates the ‘‘Inadvertent during labor or delivery, whether or not for those calculations must be included. exposure during pregnancy’’ heading. the use is stated as an indication in the Æ Eliminates the ‘‘Prescribing labeling, or if the drug is expected to 2. Lactation decisions for pregnant women’’ heading. affect labor or delivery’’ to ‘‘[i]f the drug • The final rule revises the ‘‘Risk Æ Revises ‘‘risk, if known, to the is expected to affect labor or delivery.’’ Summary’’ as follows: pregnant woman and the fetus from the Æ Under ‘‘Labor or delivery,’’ revises Æ Requires that when relevant human disease or condition the drug is ‘‘the possibility of complications, or animal lactation data are available, indicated to treat’’ (which was the including interventions, if any, that may the ‘‘Risk Summary’’ must include a language used in the proposed rule be needed’’ to ‘‘the increased risk of cross-reference to ‘‘Data’’ in the under the ‘‘Prescribing decisions for adverse reactions, including their ‘‘Lactation’’ subsection. pregnant women’’ heading) to ‘‘serious potential severity and reversibility.’’ Æ Removes the proposed known or potential risk to the pregnant Æ Under ‘‘Labor or delivery,’’ adds a standardized statement ‘‘The use of woman and/or the embryo/fetus requirement that the labeling provide (name of drug) is compatible with associated with the disease or condition information about available breastfeeding.’’ for which the drug is indicated to be intervention(s) that can mitigate effects Æ Requires that when human data are used’’ and places this information under and/or adverse reactions. available, animal data must not be the new heading ‘‘Disease-associated Æ Under ‘‘Labor or delivery,’’ clarifies included unless the animal model is maternal and/or embryo/fetal risk.’’ that the information described under specifically known to be predictive for Æ Under ‘‘Dose adjustments during that heading is not required for drugs humans. pregnancy and the postpartum period,’’ approved only for use during labor and Æ Requires that when use of a drug is requires the inclusion of information delivery. contraindicated during breastfeeding, about dose adjustments during Æ Under ‘‘Labor or delivery,’’ this information must be stated first in pregnancy and the postpartum period if eliminates the requirement that the the ‘‘Risk Summary.’’ supported by pharmacokinetic data. labeling include information about the Æ Revises the standardized statement Æ Under ‘‘Dose adjustments during effect of the drug on the later growth, required when the drug is not absorbed pregnancy and the postpartum period,’’ development, and functional maturation systemically from (Name of drug) is not removes the requirement that, if there of the child. absorbed systemically from (part of are no data on dosing in pregnancy, the • The final rule revises the ‘‘Data’’ body) and cannot be detected in the labeling must so state. subheading of labeling as follows: mother’s blood. Therefore, detectable Æ Under ‘‘Maternal adverse Æ Replaces ‘‘provide an overview of amounts of (name of drug) will not be reactions,’’ replaces the proposed the data that were the basis for the fetal present in breast milk. Breastfeeding is requirement that the ‘‘labeling must risk summary’’ with ‘‘describe the data not expected to result in fetal exposure describe any interventions that may be that are the basis for the Risk Summary to the drug to (Name of drug) is not needed (e.g., monitoring blood glucose and Clinical Considerations.’’ absorbed systemically by the mother for a drug that causes hyperglycemia in Æ Requires the inclusion of the following (route of administration) and pregnancy)’’ with the requirement that subheading ‘‘Data,’’ and the headings breastfeeding is not expected to result in the labeling include a description of ‘‘Human Data’’ and ‘‘Animal Data,’’ to exposure of the child to (name of drug). available intervention(s) for monitoring the extent available information is relied Æ Revises the order of the types of or mitigating the reaction. on in the Risk Summary and Clinical information required if the drug is Æ Adds a requirement that the Considerations subheadings. systemically absorbed as follows: (1) labeling include relevant information Æ Separates the requirements for Presence of drug in human milk, (2) about fetal/neonatal adverse reactions human data from the requirements for effects of drug on the breast-fed child, under the heading ‘‘Fetal/Neonatal animal data. and (3) effects of drug on milk adverse reactions’’. Æ For human data, requires that the production. Æ Under ‘‘Fetal/Neonatal adverse labeling describe adverse developmental Æ Replaces proposed standardized reactions,’’ replaces the phrase ‘‘will outcomes, adverse reactions, and other statements regarding the presence of the cause a complication in the neonate’’ adverse effects and, to the extent drug in human milk with a requirement
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that the ‘‘Risk Summary’’ state whether ‘‘Risk Summary’’ must describe the recommended before, during, or after the drug and/or its active metabolites effects of the drug and/or its active drug therapy and/or when there are are present in human milk, and when metabolite(s) on milk production. human and/or animal data that suggest there are no data to assess this, the D Adds a requirement that when there drug-associated fertility effects, this ‘‘Risk Summary’’ must so state. are no data to assess the effects of the subsection of labeling must contain this Æ Under ‘‘Presence of drug in human drug and/or its active metabolite(s) on information under the subheadings milk,’’ requires that if studies milk production, the ‘‘Risk Summary’’ ‘‘Pregnancy Testing,’’ ‘‘Contraception,’’ demonstrate the presence of the drug must so state. and ‘‘Infertility,’’ in that order. and/or its active metabolites in human Æ The final rule adds the requirement milk, the ‘‘Risk Summary’’ must state that for drugs absorbed systemically, III. Comments on the Proposed Rule the concentration of the drug and/or its unless breastfeeding is contraindicated The Agency received 72 comments on active metabolites in human milk and during drug therapy, the following risk the proposed rule. Comments were the actual or estimated daily dose for an and benefit statement must appear at the received from prescription drug infant fed exclusively with human milk. end of the ‘‘Risk Summary’’: The manufacturers, trade organizations The estimated amount of drug and/or its developmental and health benefits of representing prescription drug active metabolites ingested by the infant breastfeeding should be considered manufacturers and other interested must be compared to the labeled infant along with the mother’s clinical need for parties, professional associations and or pediatric dose, if available, or to the (name of drug) and any potential organizations representing health care maternal dose. adverse effects on the breast-fed child providers, health care and consumer Æ Under ‘‘Presence of drug in human from the drug or from the underlying advocacy organizations, individual milk,’’ retains the requirement that if maternal condition. physicians, pharmacists, consumers, studies demonstrate that the drug and/ • Under ‘‘Clinical Considerations,’’ and others. or its active metabolite(s) are not the final rule: Most of the comments supported detectable in human milk, the Risk Æ Revises the provisions of the FDA’s goal of improving the format and Summary must state the limits of the proposed rule to require that the content of the ‘‘Pregnancy,’’ ‘‘Labor and assay used. labeling include information concerning delivery,’’ and ‘‘Nursing mothers’’ Æ Under ‘‘Presence of drug in human ways to minimize exposure to the drug subsections of prescription drug milk,’’ adds the requirement that if and/or its active metabolite(s) in the labeling, and several of these comments studies demonstrate the presence of the breast-fed child in situations where the stated that the proposed rule would drug and/or its active metabolite(s) in following conditions are present: The address shortcomings of the previous human milk but the drug and/or its drug and/or its active metabolite(s) are labeling regulations. Other comments active metabolite(s) are not expected to present in human milk in clinically noted that the proposed rule would be systemically bioavailable to the relevant concentrations; do not have an improve the accessibility of relevant breast-fed child, then the ‘‘Risk established safety profile in infants; and information, thereby enabling better Summary’’ must describe the are used either intermittently, in single informed medical decisions regarding disposition of the drug and/or its active doses, or for short courses of therapy. the risks and benefits of prescription Æ metabolites. Adds a requirement that, when drug use by pregnant and lactating Æ Adds a requirement that if only applicable, the labeling must describe women. Although a number of animal lactation data are available, the ways to minimize a breast-fed child’s comments supported all of FDA’s ‘‘Risk Summary’’ must state only oral intake of topical drugs applied to proposed revisions, many comments whether or not the drug and/or its active the breast or nipple skin. opposed particular aspects of the Æ metabolite(s) were detected in animal Under ‘‘Monitoring for adverse proposed rule. milk and specify the animal species. reactions,’’ replaces the proposed To make it easier to identify Æ Under ‘‘Effects of drug on the requirement that the labeling include comments and our responses, the word breast-fed child,’’ the final rule: information about potential drug effects ‘‘Comment’’ and a comment number D Adds a requirement that the ‘‘Risk in the breast-fed child that could be appear in parentheses before each Summary’’ include available useful to caregivers, including comment’s description, and the word information on the known or predicted recommendations for monitoring or ‘‘Response’’ in parentheses precedes effects on the child from exposure to the responding to those effects, with a each response. Similar comments are drug and/or its active metabolite(s) requirement that the labeling must grouped together under the same through human milk or from contact describe available intervention(s) for number. Specific issues raised by the with breast or nipple skin from a topical monitoring or mitigating the adverse comments and the Agency’s responses product. reaction(s) presented in the ‘‘Risk follow. D Requires the inclusion of Summary.’’ information about systemic and/or local Æ Eliminates the proposed A. Proposed Rule as a Whole adverse reactions. requirement that the labeling include 1. Plain Language and Intended D Requires that the ‘‘Risk Summary’’ information about dosing adjustments Audience state if there are no data to assess the during lactation. effects of the drug and/or its active • Under ‘‘Data,’’ the final rule (Comment 1) Several comments metabolite(s) on the breast-fed child. replaces the phrase ‘‘provide an suggested that the language used in the Æ Under ‘‘Effects of drug on milk overview of the data’’ with the phrase pregnancy and lactation subsections of production,’’ the final rule: ‘‘describe the data.’’ prescription drug labeling should be D Replaces the proposed requirement clear and accessible to a variety of that the ‘‘Risk Summary’’ describe the 3. Females and Males of Reproductive audiences. One comment stated that effect of the drug on the quality and Potential because the intended audience for quantity of milk, including milk • Adds ‘‘8.3 Females and Males of prescription pregnancy and lactation composition, and the implications of Reproductive Potential’’ subsection labeling is females of reproductive these changes to the milk on the breast- requiring that when pregnancy testing potential and their health care fed child, with the requirement that the and/or contraception are required or providers, this portion of prescription
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drug labeling should not include overly before June 30, 2001, although a in danger, and is often associated with technical information. Another separate comment agreed with the greater risk to the developing fetus than comment suggested that to make the proposal to limit the rule to drugs for the risk of exposure to a maternal drug. information more accessible to the which an application was approved on FDA also declines the suggestion that general public, FDA should include a or after June 30, 2001. One comment the content changes required by this plain language summary of the suggested that the rule be expanded to final rule also apply to drugs for which pregnancy and lactation subsections. include vaccine products (we discuss an application was approved before Two comments suggested that because this suggestion later in our response to June 30, 2001. In developing this rule, females of reproductive potential may Comment 8). Two other comments FDA considered the scientific, read the ‘‘Pregnancy’’ and ‘‘Lactation’’ suggested that the rule provide economic, and practical implications of subsections of labeling, FDA should incentives to industry to perform alternative approaches, including include a statement that encourages studies on the use of drugs and requiring implementation of the content patients to always consult a health care biological products during pregnancy and format requirements for the provider before discontinuing and lactation. One comment suggested ‘‘Pregnancy,’’ ‘‘Lactation,’’ and medication. Another comment that depression should not be treated ‘‘Females and Males of Reproductive questioned how patients would access pharmacologically during pregnancy, Potential’’ subsections of labeling for all the proposed information and asked whereas a separate comment suggested drugs, regardless of approval date. FDA whether it would be included in that FDA ban the use of all drugs and concluded that requiring the content patient-specific information that vaccines during pregnancy. Another and format changes only for drugs for patients receive at the pharmacy. comment suggested that the which an application was approved on Several other comments suggested that presentation of the information required or after June 30, 2001, (as described in the final rule should aim to create user- under the rule be standardized as much the ‘‘Implementation’’ section of this friendly labeling that contains a concise as possible with applicable coding document) best balanced the public and accurate presentation of schema for ease of implementation in health benefits and the economic and information that is of clinical relevance. databases or electronic health record other costs of these labeling changes. In (Response) FDA acknowledges that systems. addition, this approach provides some females of reproductive potential (Response) FDA has considered these conformity with the rest of prescription may use prescribing information in the comments and declines to expand the drug labeling and the scope is consistent ‘‘Pregnancy’’ and ‘‘Lactation’’ scope of the final rule in any of the with the scope of the PLR. FDA, subsections of prescription drug suggested ways. This final rule amends however, encourages voluntary labeling. The intended audience of our labeling regulations in §§ 201.57 compliance with these content and prescription drug labeling, however, is and 201.80, which apply only to format changes for drugs for which an health care providers, and it is the prescription drug and biological application was approved before June responsibility of the prescribing health products. It is therefore not within the 30, 2001. care provider to communicate pertinent scope of this rulemaking to address 3. Combining the ‘‘Pregnancy’’ and information regarding drug risks and pregnancy and lactation labeling for ‘‘Lactation’’ Subsections benefits and proper use to his or her nonprescription drug products. patient. For this reason, we have The primary purpose of this final rule, (Comment 3) One comment suggested determined that it is not appropriate to and prescription drug labeling in that the ‘‘Pregnancy’’ and ‘‘Lactation’’ require a summary of the ‘‘Pregnancy’’ general, is to facilitate informed subsections should be combined for and ‘‘Lactation’’ subsections of labeling prescribing and safe and effective certain drugs. The comment explained as a mechanism for all patients to product use. FDA recognizes the that combining these sections would be readily access full prescribing importance of use of labeling useful, for example, in helping health information, or a statement that information in electronic health records care providers counsel women who take encourages patients to always consult a and other databases and agrees that, if selective serotonin reuptake inhibitors health care provider before possible, the presentation of information (SSRIs) for the treatment of perinatal discontinuing medication. We note that in labeling should facilitate its depression because clinicians have to in addition to the professional labeling accessibility. However, this final rule is consider the effects of the medication that is the subject of this rulemaking, not designed to standardize the required during both pregnancy and the some drugs also have FDA-approved information with a coding schema for postpartum period. patient labeling specifically written for use in databases or electronic health (Response) FDA disagrees. The risk the consumer, such as Medication record systems. It is also beyond the and benefit considerations for drug Guides (see 21 CFR part 208). Whether scope of this rule to address incentives product use are different between the information required under the final for collecting data on the use of drugs pregnant and lactating patients, and we rule will be included in FDA-approved and biological products during have determined that the information is patient labeling for an individual drug pregnancy and lactation. best presented in separate but adjacent will be decided on a case-by-case basis FDA does not make recommendations subsections of labeling. FDA believes in accordance with the applicable FDA about whether particular diseases or that if the sections were combined it regulations and guidance. conditions should or should not be would be more difficult for a health care treated pharmacologically, though we provider who has either a pregnant or a 2. Scope of the Rule specifically decline the suggestion to lactating patient to locate the (Comment 2) Several comments ban the use of all drugs during information relevant to the prescribing suggested that FDA expand the scope of pregnancy. We note that many diseases decision. For anticipatory counseling, the rule in various ways. Two comments and conditions are associated with for which the health care provider is suggested that the rule be expanded to adverse pregnancy outcomes when not discussing the use of the drug with a include nonprescription products. Four appropriately managed during pregnant patient who in the future may comments suggested that the proposed pregnancy, and under-treating or not be lactating, we believe that having content changes also apply to drugs for treating a pregnant woman’s medical ‘‘Lactation’’ denoted in a separate, which an application was approved condition may put the woman’s health numbered, indexed, and searchable
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subsection of labeling will not make it (Response) The requirements for Office of New Drugs at the Center for harder for a prescriber to find this labeling updates described in Drug Evaluation and Research, includes information. § 201.56(a) apply to this final rule as staff with expertise in obstetrics, follows: The labeling must be lactation, pediatrics, clinical pharmacy, 4. Updates informative and accurate and neither and regulatory science. The DPMH is In the preamble to the proposed rule, promotional in tone nor false or available for consultation by all FDA FDA stated that under § 201.56(a) ‘‘the misleading in any particular. In drug product review divisions to whom labeling must be updated when new accordance with §§ 314.70 and 601.12 of the final rule applies for all issues information becomes available that the chapter, the labeling must be related to labeling content and for causes the labeling to become updated when new information review of data on the use of drugs inaccurate, false, or misleading’’ (73 FR becomes available that causes the during pregnancy and lactation. The 30831 at 30841). The Agency also labeling to become inaccurate, false, or DPMH, by working across review explained that ‘‘[w]hen new human data misleading (§ 201.56(a)(2)). With respect divisions, helps to ensure consistent concerning the use of a drug during to the comment about updating labeling application of FDA pregnancy and pregnancy becomes available, if that as human lactation data becomes lactation labeling regulations to information is clinically relevant, FDA available, although § 201.56(a)(3) states different drug products. The DPMH also believes that it is necessary for the safe that the labeling must be based provides consultation services to and and effective use of the drug and, whenever possible on data derived from works collaboratively with other Offices therefore, the pregnancy subsection of human experience, it also requires that and Centers at FDA. FDA intends to the labeling must be updated to include conclusions based on animal data but provide staff with education and that information. Failure to include necessary for safe and effective use of training on the changes in the labeling clinically relevant new information the drug in humans must be identified regulations. about the use of a drug during as such and included with human data pregnancy could cause the drug’s in the appropriate section of the 6. Process for Development of the labeling to become inaccurate, false, or labeling. Proposed Rule misleading’’ (73 FR 30831 at 30841). Because studies are not usually (Comment 6) One comment stated (Comment 4) Several comments conducted in pregnant women prior to that FDA should have included requested that FDA clarify its approval, most of the data regarding use pharmacists in the focus tests used expectations for the process and timing in pregnancy and lactation will be during development of the proposed of updating the ‘‘Pregnancy’’ and collected in the postmarketing setting. rule. ‘‘Lactation’’ subsections of labeling after Accordingly, in order that a drug (Response) FDA acknowledges the new data become available. Two of product does not become misbranded, critical role that pharmacists play in these comments stated that the data the labeling must be updated when new communicating drug information both should be updated regularly or information becomes available that to patients and health care providers. continually. Another comment stated causes the labeling to become However, during the development of the that the labeling should be updated inaccurate, false, or misleading. proposed rule, FDA’s priority was to annually. Several other comments Applicants are responsible for following understand the information health care requested that FDA define the quantity the medical literature and also for providers need to most effectively make and quality of data that necessitates that updating labeling as new published and prescribing decisions that consider both the labeling be updated. One of these unpublished data become available. the risk and benefit to the mother and comments suggested that FDA state in FDA declines the suggestion to include her fetus or child. Therefore, the focus the final rule that the labeling should be references to online resources regarding testing was limited to health care updated if the benefit-risk profile drug use during lactation because the providers who both care for and changes because of new information, information has not been reviewed by prescribe for pregnant and lactating and that labeling changes should be FDA. women. done according to ‘‘current labeling regulations.’’ Another comment 5. Responsibility for Drafting and 7. Guidance on Formulating Labeling Reviewing Labeling questioned whether health care (Comment 7) FDA received one providers will be informed of changes to (Comment 5) One comment requested comment requesting that the Agency the ‘‘Pregnancy’’ and ‘‘Lactation’’ that FDA clarify whether industry or provide clear guidance to manufacturers subsections of labeling. One comment FDA would be responsible for writing regarding how to formulate the suggested that sponsors electronically and reviewing the new labeling. The pregnancy and lactation labeling post supplemental information before comment also questioned whether FDA subsections. updated printed labeling is available, would provide staff with the training (Response) Concurrent with the and another suggested using and expertise to make necessary publication of this final rule, FDA is surveillance systems to facilitate judgments. Another comment expressed issuing a draft guidance for industry on obtaining updated safety information. concern about the potential for ‘‘Pregnancy, Lactation, and Two comments expressed specific inconsistent implementation of the new Reproductive Potential: Labeling for concern that the ‘‘Lactation’’ subsection rule by FDA’s review divisions. This Human Prescription Drug and Biological of drug labeling will not be updated comment suggested that to increase Products—Content and Format’’ (the frequently enough to be useful for labeling consistency, the Agency should draft guidance on pregnancy and clinicians. One of these comments establish a group of FDA specialists that lactation labeling).5 The draft guidance stated that it is critical to routinely review pregnancy and lactation labeling. is intended to assist applicants in update labeling as human lactation data (Response) As with all prescription drafting the ‘‘Pregnancy,’’ ‘‘Lactation,’’ becomes available. A separate comment drug labeling, both the manufacturer and ‘‘Females and Males of suggested including references in and FDA reviewers will play a shared Reproductive Potential’’ subsections of labeling to online resources regarding role in determining the new labeling lactation data to provide prescribers and content. The Division of Pediatrics and 5 This guidance, when finalized, will represent patients with updated information. Maternal Health (DPMH), within the FDA’s current thinking on this topic.
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labeling for prescription drug products. (Response) As discussed in further development. Labeling development is a It provides recommendations for detail in section III.B of this document, detailed and iterative process unique to applicants revising labeling of already in this final rule, FDA designates 8.3 as each prescription drug product, a approved products and for applicants ‘‘Females and Males of Reproductive process that is driven by the product’s drafting labeling for new products that Potential.’’ Accordingly, we are no characteristics and actions, the efficacy will be submitted as part of an NDA or longer reserving 8.3 for future use. and safety data submitted to the Agency, BLA. and the conditions and populations for 10. International Harmonization and in which the product is intended to 8. Blood Products and Vaccines (Comment 10) Two comments be used. Accordingly, FDA has (Comment 8) FDA received two suggested that prescription drug concluded that the development of comments regarding the applicability of labeling should be consistent at an fictitious product labeling would not be the proposed rule to certain biological international level to reduce confusion useful to drug developers or FDA products. One comment requested that among health care providers, patients, reviewers who will be responsible for the final rule be expanded to include and regulators interpreting the risks and developing, revising, and approving vaccine products. The other comment benefits associated with drug use during product labeling under this new final stated that blood products are not pregnancy and lactation. rule. affected by the rule and requested that (Response) FDA declines to adopt this this be noted when the final rule is suggestion because it is beyond the 12. Cross-Referencing published. scope of this rule to address the FDA proposed that when the risk (Response) This final rule applies to international harmonization of conclusion in the fetal risk summary is vaccine products. Vaccine products are prescription drug labeling. Although we based solely on animal data, it must prophylactic biological products that are acknowledge the importance of working include a cross-reference to the ‘‘Data’’ developed and labeled to prevent with our international regulatory component of the ‘‘Pregnancy’’ specific diseases in specific colleagues to harmonize drug subsection, and the effects found in populations. The types of information development and drug regulatory animals must be described in the ‘‘Data’’ that must be communicated about a science where appropriate and component (73 FR 30831 at 30842). vaccine, in general, parallel the types of beneficial, we also recognize that there (Comment 12) One comment information that must be communicated is great variation internationally in suggested that any cross-references to about a drug or therapeutic biologic health care systems, access to care and the ‘‘Data’’ or ‘‘Clinical Considerations’’ through labeling to facilitate safe and drugs, and the regulation and marketing components made anywhere in labeling effective use, although there are some of drugs. The final rule reflects our specify whether the cross- reference is unique considerations for vaccines judgment regarding the most useful to the component in the ‘‘Pregnancy’’ addressed in the draft guidance on pregnancy and lactation prescription subsection or the component in the pregnancy and lactation labeling, which drug labeling for prescribers in the ‘‘Lactation’’ subsection. Another is being published concurrently with United States, which may not be comment explained that the rule would this final rule. applicable to prescribers in all other benefit from extensive use of cross- We disagree that blood products are countries. referencing within the text of each not affected by the final rule. The final section to ensure that the bases for the rule applies to any biological products, 11. Examples in an Appendix risk conclusions are thoroughly including blood products, that are (Comment 11) The proposed rule understood, regardless of whether the subject to the PLR. included an appendix containing risk conclusions are based on human or examples, based on the proposed rule, 9. Numbering of ‘‘Pregnancy’’ and animal data, for both the ‘‘Pregnancy’’ of pregnancy and lactation labeling for ‘‘Lactation’’ Subsections and ‘‘Lactation’’ subsections. fictitious drugs. (Response) FDA agrees that any cross- (Comment 9) FDA proposed that the FDA received several comments references to components of ‘‘8.1 identifying numbers and titles for the suggesting that the examples be revised Pregnancy’’ or ‘‘8.2 Lactation’’ must new labeling content under the section or expanded. One comment requested specify whether the cross-reference is to ‘‘8 Use in Specific Populations’’ would that in the final rule, FDA provide the component in the ‘‘Pregnancy’’ be 8.1 for ‘‘Pregnancy’’ and 8.2 for additional examples of sample labeling, subsection or the component in the ‘‘Lactation.’’ FDA stated in the proposed including examples for which extensive ‘‘Lactation’’ subsection. Accordingly, in rule that the identifying number 8.3 data exists. Another comment suggested the final rule, when applicable, risk would be available for future use (73 FR that the information included in the statements in the ‘‘Pregnancy’’ 30831 at 30838). Two comments sample labeling for the fictitious drug subsection must include a cross- pointed out that under this proposal, the products did not reflect the amount of reference to additional details in the next subsections after ‘‘8.2 Lactation’’ data that is typically available. The relevant portion of the ‘‘Data’’ will be ‘‘8.4 Pediatric Use’’ and ‘‘8.5 comment explained that the examples subheading in the ‘‘Pregnancy’’ Geriatric Use.’’ These comments stated would be more useful if they presented subsection. Also in the final rule, when that the absence of subsection 8.3 may situations where there is extensive data. relevant human and/or animal lactation be confusing and suggested that FDA Several other comments pointed out data are available, the ‘‘Risk Summary’’ renumber the subsections. One that the terminology in the examples must include a cross-reference to the comment requested that FDA clarify was not consistent with the terminology relevant portion of ‘‘Data’’ in the whether the Agency has a specific use in the proposed rule. ‘‘Lactation’’ subsection. in mind for 8.3 and, if it does not, (Response) FDA has not included suggested that the Agency renumber the sample drug labeling with the final rule. 13. Need for Educational Campaign subheadings to ‘‘8.3 Pediatric Use’’ and The draft guidance on pregnancy and (Comment 13) FDA received one ‘‘8.4 Geriatric Use.’’ The comment lactation labeling, which is being comment suggesting that the Agency explained that if a future need for an published concurrently with this final develop educational campaigns for additional subsection arose, it could rule, provides information about how to patients and health care providers become 8.5. interpret and apply the rule to labeling regarding the changes to pregnancy and
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lactation drug labeling brought about by discussion of FDA’s recommendations October 5, 2011). Based on this analysis, this rulemaking. on the content of the ‘‘Highlights of to the extent that the discussion in the (Response) FDA is developing prescribing information’’ may be found proposed rule relied on the discussion educational materials for FDA staff, in FDA’s guidance for industry on about preemption in the preamble to the health care providers, and patients to ‘‘Labeling for Human Prescription Drug PLR, we conclude that the statements inform them about the changes in these and Biological Products—Implementing we made regarding preemption in the labeling regulations and how these the PLR Content and Format preamble to the proposed rule are also changes will have a positive impact on Requirements’’ (February 2013).6 not justified. labeling regarding the use of drugs and biologics during pregnancy and 16. Preemption of State Law B. Specific Provisions of the Proposed lactation. The draft guidance on In the preamble to the proposed rule, Rule pregnancy and lactation labeling is FDA included a discussion in the 1. 8.1 Pregnancy being published concurrently with this Federalism section that referred to a a. Comments related to the pregnancy final rule; however, additional materials more extensive discussion and analysis subsection as a whole. may be completed following this date. in the PLR regarding the preemption of product liability lawsuits. i. Order of subsections—FDA 14. Inventory (Comment 16) Comments expressed proposed that information appear in (Comment 14) FDA received one different views about this discussion. subsection ‘‘8.1 Pregnancy’’ in the comment requesting that the final rule One comment suggested that in the final following order: (1) Pregnancy exposure address how distributors should manage rule FDA revise the preamble to registry (if applicable), (2) general drug products in their inventory that eliminate any reference to the statement about background risk, (3) have outdated labeling. The comment preemption of product liability lawsuits. fetal risk summary, (4) clinical suggested that product inventory Another comment expressed its considerations, and (5) data (proposed without the revised labeling should appreciation of FDA’s view that the rule § 201.57(c)(9)(i)). In the proposed rule, remain in the supply chain until the would preempt state laws that conflict FDA sought comment on how these labeled product’s expiration date, with its requirements. This comment elements should be ordered to optimize regardless of whether the product bears also expressed its support for FDA’s the clinical usefulness of this labeling the new labeling. intention to consult with State and local subsection (73 FR 30831 at 30839). (Response) For previously approved officials in an effort to avoid conflict Specifically, FDA asked whether the products, the implementation plan gives between State law and federally ‘‘Fetal Risk Summary’’ should precede sponsors a minimum of 3 years after the protected interests. the pregnancy exposure registry effective date of this final rule to submit (Response) FDA’s statement regarding information and the statement about labeling with the new content and preemption in the proposed rule relied background risk. format. As we explained in the on statements made in the preamble to (Comment 17) Comments expressed preamble to the proposed rule, FDA the PLR (71 FR 3922). In the preamble different opinions about the proposed believes that this 3-year period will to the PLR, FDA discussed its views on order of information in the ‘‘Pregnancy’’ allow industry sufficient time to use up the preemptive effect of both that subsection of labeling. Three comments any existing labeling stock such that regulation’s codified provisions and the agreed with the proposed order. One of none will remain in the supply chain FD&C Act. Subsequent to the these comments explained that the after the product bears the new labeling publication of the May 2008 proposed proposed order will maximize a (73 FR 30831 at 30846). rule, the Supreme Court, in Wyeth v. physician’s ability to find and Levine (555 U.S. 555 (2009)), addressed understand important pregnancy-related 15. Highlights the preamble to the PLR and held that information about a given drug product. FDA’s regulations require that all a State tort claim that an NDA-approved Another comment explained that prescription drug labeling described in drug should have had a stronger placing the pregnancy exposure registry § 201.56(b)(1) contain ‘‘Highlights of warning was not preempted by the information first is preferable because if prescribing information’’ (§ 201.57(a)). FD&C Act or FDA’s labeling this information were placed after the (Comment 15) Two comments requirements. Following the Court’s ‘‘Risk Summary,’’ it may be interpreted requested that FDA clarify which decision in Wyeth, FDA concluded that to imply that the pregnancy exposure elements of the ‘‘Pregnancy’’ and the position on preemption we registry exists because of the data in the ‘‘Lactation’’ subsections are likely to be articulated in the preamble to the PLR fetal risk summary. One comment included in the ‘‘Highlights of cannot be justified under legal supported placing the pregnancy prescribing information.’’ One of the principles governing preemption exposure registry information first so comments expressed hope that adoption (Preemption Review, 76 FR 61565, that it will appear more visible in of the rule will promote standardization labeling. with respect to which elements are 6 U.S. Food and Drug Administration, ‘‘Guidance Many comments disagreed with the elevated to the ‘‘Highlights of for Industry, Labeling for Human Prescription Drug proposed order and suggested a variety prescribing information,’’ thereby and Biological Products—Implementing the PLR of alternatives. Six comments suggested Content and Format Requirements,’’ (February facilitating consistent interpretation and 2013), available at http://www.fda.gov/downloads/ that the ‘‘Fetal Risk Summary’’ implementation of the rule’s Drugs/GuidanceComplianceRegulatoryInformation/ subheading be placed first because it requirements among FDA reviewers and Guidances/UCM075082.pdf. Many guidances are contains the most important and useful review divisions. referenced throughout this document. The guidance information. One of these comments referred to in this footnote, as well as others (Response) The requirements for referenced throughout the remainder of the pointed out that past FDA advisory placement of information in the document, can be found on the FDA Drugs committees have suggested that ‘‘Highlights of prescribing information’’ guidance Web page at http://www.fda.gov/Drugs/ summary information should be placed are specified in § 201.57(a). This final GuidanceComplianceRegulatoryInformation/ first. Two comments suggested that the Guidances/default.htm. We update guidances rule does not revise or change the periodically. To make sure you have the most ‘‘Background Risk Statement’’ should be requirements for the ‘‘Highlights of recent version of a guidance, check the FDA Drugs first followed by the ‘‘Fetal Risk prescribing information.’’ Additional guidance Web page. Summary.’’ These comments explained
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that the most important information Categories were not used to characterize A separate comment supported FDA’s should be placed first, as recommended the risks and benefits associated with proposal to eliminate the pregnancy by FDA advisory committees. Three drug treatment by lactating women. categories but thought they should be comments suggested that the pregnancy FDA proposed to remove pregnancy retained until the implementation of the exposure registry information be placed categories from all prescription drug final rule is complete. last. Another comment suggested that labeling because we determined that the (Response) FDA has determined that the information be placed in the categories were confusing and did not retaining the pregnancy categories is following order: Pregnancy exposure accurately and consistently inconsistent with the need to accurately registry information, clinical communicate differences in degrees of and consistently communicate considerations, fetal risk summary, data, fetal risk (73 FR 30831 at 30846). differences in degrees of fetal risk. As and background risk statement. (Comment 18) Comments expressed discussed in the proposed rule, the (Response) FDA has determined that different opinions about whether the current pregnancy category system has placing the pregnancy exposure registry elimination of the pregnancy category long been criticized as being confusing information first under ‘‘8.1 Pregnancy’’ system, in full or in part, would and overly simplistic (73 FR 30831 at best balances the objectives of this improve or diminish the usefulness of 30833–30834). Through experience and rulemaking. Although we agree that the the Pregnancy subsection of stakeholder feedback, FDA learned that ‘‘Risk Summary’’ information is most prescription drug labeling. FDA the pregnancy categories were heavily important to prescribers and we received 11 comments from medical relied upon by clinicians but acknowledge that the advisory associations, women’s and reproductive misinterpreted, misunderstood, and committee expressed a preference for health advocacy organizations, erroneously used as a grading system placing the most important information toxicologists, individual health care where fetal risk increased from A to X. first, it is also clear that stakeholders practitioners, pharmacists, and drug The categories gave the incorrect desire greater quality and quantity of manufacturers specifically supporting impression that drugs in the same human data in pregnancy labeling. FDA our proposal to retire the pregnancy category carried the same risk or believes that the benefits of prominently category system. Several of these potential for human adverse placing information about pregnancy comments explained that the categories developmental outcomes. In addition, registry availability at the beginning of were confusing or misleading. One of the categories did not discriminate ‘‘8.1 Pregnancy’’ outweigh the the comments stated that although the among risk information obtained from downsides of a minor decreased use of pregnancy categories is easier for nonclinical animal studies and prominence of the ‘‘Risk Summary’’ some practitioners, it results in postmarketing human studies and did information, which appears miscommunication and errors in not discriminate among drugs immediately after the information under decisionmaking. Another comment associated with adverse outcomes of ‘‘Pregnancy Exposure Registry.’’ Many explained that reliance on the categories differing severity or incidence. health care providers are still learning may result in poorly informed clinical Stakeholders also pointed out that the about pregnancy exposure registries and decisionmaking. pregnancy categories focused on their purpose. We have concluded that FDA received 16 comments from structural abnormalities and thus did routinely placing this information first physicians, pharmacists, pharmacy not adequately address the full range of in pregnancy labeling may increase associations, nurses, manufacturers, potential developmental toxicities. pregnancy registry enrollment, the drug safety consultants, and individual As described in greater length in the quality of human data that emerge from consumers, requesting that FDA either preamble of the proposed rule, FDA these studies, and the quality of retain the pregnancy category system or carefully explored a multitude of pregnancy labeling (including the ‘‘Risk replace the pregnancy category system models to determine whether the former Summary’’) that follows. Because we with another standardized schema. pregnancy category system or a different agree that the information under ‘‘Risk Many of these comments suggested that pregnancy category system could Summary’’ is most important to FDA add the additional narrative accurately and consistently prescribers, we also decline the information as proposed, but also retain communicate differences in degrees of suggestion to place the ‘‘Risk Summary’’ the category system. Two of these fetal risk (73 FR 30831 at 30833–30837). after ‘‘Clinical Considerations.’’ The comments explained that the pregnancy FDA found that when it applied these ‘‘Pregnancy’’ subsection will include, in categories are simple and effective, and criteria to actual animal and human data this order, information under the new information may confuse findings for drugs with known risk ‘‘Pregnancy Exposure Registry,’’ as patients or prescribers. Another profiles, none of the models produced applicable, ‘‘Risk Summary,’’ ‘‘Clinical comment stated that without a clinically informative and reliable Considerations,’’ as applicable, and standardized schema, there will not be differentiations of risk (73 FR 30831 at ‘‘Data,’’ as applicable. a consistent and useful format for 30838). Prescribing and drug-use ii. Removal of the pregnancy decisionmaking. Other comments decisions during pregnancy require categories—FDA proposed to remove agreed that the pregnancy categories consideration of not only fetal risk the pregnancy categories from all need to be revised but suggested that information, but also of various clinical prescription drug labeling. As discussed FDA develop new standardized and individual factors, including in greater detail in section I of this statements or categories or revise the maternal drug effects, the severity of document, in 1979 FDA adopted a bases for the current categories. Two maternal disease, maternal tolerance of pregnancy category system that was comments urged FDA to maintain an the drug, coexisting maternal used to convey risk and benefit ‘‘X’’-like category for drugs where the conditions, the impact of maternal information related to potential or risks outweigh any benefit to a pregnant disease on the fetus, and available documented human teratogenic risk and or nursing patient, and one comment alternative therapies. FDA concluded potential maternal/fetal benefits urged FDA to maintain an ‘‘X’’-like that continuing to use a category system associated with drug treatment during category so that providers and patients to characterize the risks of drug use pregnancy. Under the 1979 regulations, could easily identify those drugs that during pregnancy would not be each drug product was identified with are contraindicated for the mother, appropriate because of the complexity a pregnancy category: A, B, C, D, or X. fetus, and/or a breastfeeding infant. of medical decisionmaking regarding
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drug use during pregnancy (73 FR 30831 regulation would not be consistent with scientifically acceptable when it is at 30838). the Agency’s goal to avoid consistent with applicable FDA FDA continues to believe that a overburdening both the Agency and guidance, including the guidance for narrative structure for pregnancy industry. industry on ‘‘Establishing Pregnancy labeling is best able to capture and b. Comments related to specific Exposure Registries’’ (August 2002). If convey the potential risks of drug provisions of 8.1 Pregnancy. there are changes to an existing exposure based on animal or human i. Pregnancy exposure registry—FDA pregnancy registry or a new pregnancy data, or both. This perspective is proposed that if there is a pregnancy registry is initiated after drug approval, consistent with FDA’s approach to other exposure registry for a product labeling will need to be updated to aspects of product labeling. For described in § 201.56(b)(1) (i.e., include this new information. example, numeric or letter or other prescription drug products for which an (Comment 20) Two comments sought categorical gradations of risk have never application was approved after June 30, clarification regarding the standards for been used for safety labeling because 2001), the telephone number or other including contact information for a safety and risk are complex constructs information necessary to enroll in the pregnancy exposure registry. One in clinical medicine. For similar registry or to obtain information about comment stated that contact information reasons, FDA does not apply symbol or the registry must be stated at the should only be included if the registry letter designations of risk to other beginning of the ‘‘Pregnancy’’ is scientifically acceptable to the potential toxicities or adverse effects subsection of prescription drug labeling sponsor and FDA. Another comment expected with drug product use. (proposed § 201.57(c)(9)(i)(A)). For drug asked whether contact information for For the reasons discussed previously, products that do not have a pregnancy non-U.S. registries must be included. FDA declines the suggestion to maintain exposure registry, the proposed rule did (Response) As stated previously, if pregnancy category X. We note, not require the ‘‘Pregnancy’’ subsection there is a scientifically acceptable however, that labeling must clearly of prescription drug labeling to contain pregnancy registry for a drug product, identify populations in which use of a any statement about pregnancy FDA is requiring a standard statement drug is contraindicated. The labeling exposure registries. concerning the registry as well as regulations in § 201.57 clearly describe (Comment 19) Comments disagreed contact information needed to enroll in the information that must be included about the mandatory inclusion of the registry or obtain additional in the ‘‘Contraindications’’ section and pregnancy exposure registry information about it. For registries that all contraindications from the full information. Many comments supported include U.S. populations, U.S. contact prescribing information are always the mandatory inclusion of pregnancy information should be included in the listed in the ‘‘Highlights of prescribing exposure registry information in the labeling, regardless of whether the information’’ (§ 201.57(c)(5)). Therefore, ‘‘Pregnancy’’ subsection of prescription registry is maintained within the United when use of a drug is contraindicated in drug labeling. These comments States or elsewhere. pregnancy, this information must be explained, for example, that including (Comment 21) Four comments stated in the ‘‘Contraindications’’ pregnancy exposure registry information suggested that the pregnancy exposure section and listed in the ‘‘Highlights of in labeling may ‘‘encourage patient registry information should have its prescribing information,’’ as well as, per involvement in registries’’ and ‘‘pave own component header. the previous discussion, stated first the way for improved registry use by (Response) FDA agrees with the under the ‘‘Risk Summary’’ subheading clinicians leading to better suggestion that the pregnancy exposure of the ‘‘Pregnancy’’ subsection of documentation of drug effects and use registry information should have its labeling. during pregnancy.’’ own component header. In the final To the extent that the comment One comment stated that including a rule, contact information for an existing suggests that the pregnancy categories reference to an existing pregnancy pregnancy exposure registry and a should be retained for applications registry should not be mandatory. standard statement on the registry will subject to § 201.80 until the (Response) FDA believes that fall under the subheading ‘‘Pregnancy implementation of the new content and appropriately conducted pregnancy Exposure Registry’’ in the ‘‘Pregnancy’’ format requirements is complete, we registries are an important mechanism subsection of prescription drug labeling. decline this suggestion; we believe it is for the collection of clinically relevant Because of this change, FDA eliminated more consistent with the Agency’s data concerning the effects of exposure the phrase ‘‘must be stated at the overall concerns with respect to to drugs during pregnancy. The Agency beginning of the ‘Pregnancy’ subsection removing the pregnancy categories to believes that including information of the labeling’’ from the final rule. implement that change within a shorter about pregnancy exposure registries in (Comment 22) Two comments stated timeframe that nevertheless provides prescription drug labeling will that it should be easier to enroll patients sufficient time for compliance. We encourage participation in registries, in pregnancy exposure registries. would like to clarify that for thereby improving their usefulness. (Response) The importance of subject applications required to implement the Thus, if there is a pregnancy registry recruitment into pregnancy exposure new content and format requirements, that FDA has reviewed and found registries and the need to build the pregnancy categories are required to scientifically acceptable, FDA is awareness of pregnancy exposure be removed at the time the labeling is requiring that the ‘‘Pregnancy’’ registries among health care providers revised regardless of whether this will subsection of prescription drug labeling are both factors in FDA’s decision to result in the labeling including a include under its own subheading, place information about existing pregnancy category for more than 3 ‘‘Pregnancy Exposure Registry,’’ a pregnancy exposure registries at the years after the effective date of the final standard statement concerning the beginning of § 201.57, ‘‘8.1 Pregnancy.’’ rule (as described in the existence of the registry, as well as the The actual process of enrolling patients, ‘‘Implementation’’ section of this contact information necessary to enroll however, is beyond the scope of this document in response to Comment 92). in the pregnancy exposure registry or to rule. Requiring that the labeling for some obtain information about the registry. (Comment 23) Comments expressed applications be revised twice solely as The Agency generally considers a disagreement about whether the part of the implementation of this pregnancy exposure registry ‘‘Pregnancy Exposure Registry’’
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subheading should be omitted from the (Response) FDA believes that applicants be given the option to ‘‘Pregnancy’’ subsection of prescription including information about pregnancy identify in the background risk drug labeling when there is no existing exposure registries in the ‘‘Patient statement the specific risks described in registry for the drug. One comment Counseling Information’’ section of the fetal risk summary. The comment suggested that the ‘‘Pregnancy Exposure labeling would be useful. If the drug proposed that the second sentence of Registry’’ subheading should not be product has a pregnancy exposure the background statement be modified omitted even if there is no existing registry, the availability of a pregnancy to state: ‘‘The fetal risk summary below registry for the drug, and that it should exposure registry should be noted in the describes the potential of (name of drug) include a statement that there is no ‘‘Patient Counseling Information’’ to contribute to risk of (‘adverse specific pregnancy exposure registry for section of labeling, and a cross-reference outcomes, including developmental the drug. Another comment requested should be included to ‘‘8.1 Pregnancy’’ abnormalities’ or identify specific risks) that FDA consider incorporating a for the contact information necessary to above background risk.’’ statement that the subheading may be enroll. The preamble to the PLR states Several comments requested omitted if there is no pregnancy that ‘‘Highlights’’ summarizes the clarification about whether the exposure registry. information from the ‘‘Full Prescribing background risk statement refers to the (Response) FDA concludes that the Information’’ that is most important for general population or the population ‘‘Pregnancy Exposure Registry’’ prescribing the drug safely and with the disease. Two other comments subheading should be omitted when effectively and organizes it into logical suggested that when the background there is no pregnancy exposure registry. groups to enhance accessibility, risk of adverse outcomes in the relevant We have determined that requiring the retention, and access to the more disease population is known to be ‘‘Pregnancy Exposure Registry’’ detailed information (71 FR 3922 at higher than in the general population, subheading in labeling when there is no 3931). Information about the availability this information should be included in pregnancy exposure registry for the drug of and contact information for a the background risk statement. One of product, and the inclusion of a pregnancy exposure registry are not these comments suggested that relevant statement indicating that no registry considered essential information for literature citations should also be exists, would not further the goal of prescribing and should not appear in included as appropriate. improving the collection of data in ‘‘Highlights’’ (see FDA’s guidance for One comment asked FDA to clarify pregnant women who are exposed to a industry on ‘‘Labeling for Human how it will determine the background drug. Prescription Drug and Biological rate of adverse pregnancy outcomes. (Comment 24) One comment Products—Implementing the PLR Another comment suggested that FDA suggested that the labeling should state Content and Format Requirements’’ and industry develop a standard the purpose of the pregnancy exposure (February 2013)). The question of definition of background risk that would registry and provide the contact whether FDA anticipates requesting provide a common explanation for all information necessary for enrollment. more pregnancy exposure registries as a labeling, both for the general population (Response) FDA agrees that including condition of marketing approval is and for any specific disease states or a statement in the labeling about the outside the scope of this rule. conditions. This comment explained purpose of the pregnancy exposure In the final rule, FDA revised the that different reviewers may look at registry would be useful. In the final phrase ‘‘telephone number or other different criteria for assessing rule, FDA requires that if there is a information needed to enroll’’ to background risk (i.e., what constitutes a scientifically acceptable pregnancy ‘‘contact information needed to enroll.’’ developmental abnormality or a exposure registry for the drug, the FDA determined that this change would congenital malformation), and a labeling must include a statement that allow for more flexibility in the type of standard definition would provide for there is a pregnancy exposure registry contact information included under this consistency. A separate comment stated that monitors pregnancy outcomes in portion of the labeling. that the background risks of pregnancy women exposed to the drug during ii. Background risk statement—FDA can vary by demographics, location, pregnancy, and include contact proposed that a general statement about ethnicity, and other variables. The information needed to enroll in the the background risk of adverse comment suggested that to maintain registry or to obtain information about pregnancy outcomes be included in uniform and standardized descriptions the registry. Because the purpose of all labeling. The proposed rule stated in of background risk, FDA should provide pregnancy registries is to collect § 201.57(c)(9)(i)(B) that the following industry with a guidance document clinically relevant human data that can statement was required to be included describing background risk. be used in a product’s labeling to in the labeling: All pregnancies have a One comment recommended against provide health care providers with background risk of birth defect, loss, or requiring data in the background risk useful information for treating or other adverse outcome regardless of statement. The comment explained that counseling patients who are pregnant or drug exposure. The fetal risk summary background statistics change over time anticipating pregnancy, we do not below describes (name of drug)’s as new evidence is made available and believe it is necessary to include a more potential to increase the risk of accepted by the medical community. specific statement in labeling about developmental abnormalities above the Several comments suggested that FDA their purpose. background risk. revise or omit the second sentence of (Comment 25) Two comments (Comment 26) Two comments the background risk statement. One of suggested that pregnancy exposure expressed support for the inclusion of a the comments explained that the registry information be included in background risk statement. One of these sentence implies that the drug ‘‘Highlights’’ and in the ‘‘Patient comments noted that the statement will necessarily has the potential to increase Counseling Information’’ section of be useful to clinicians when explaining the risk of developmental abnormalities labeling. One comment requested that the fetal risks associated with drug use above the background risk. FDA clarify in guidance whether the during pregnancy. (Response) In the final rule, FDA has Agency anticipates requesting more Several comments suggested eliminated the proposed standardized pregnancy registries as a condition of modifying the background risk background risk statement. In its place, marketing approval. statement. One comment suggested that the final rule requires that the labeling
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state the percentage range of live births (§ 201.57(c)(9)(i)(C)). FDA proposed that outcomes as well as fetal outcomes in in the general population of the United the section include a risk conclusion, the ‘‘Fetal Risk Summary.’’ States with a major birth defect and the contain a narrative description of the (Response) FDA agrees that percentage range of pregnancies in the risk(s) (if the risk conclusion is based on information on drug-associated maternal United States that end in miscarriage, human data), and refer to any risk is important, and in the final rule regardless of drug exposure. The final contraindications or warnings and has created a separate heading, rule also requires that if such precautions. ‘‘Maternal adverse reactions,’’ under information is available for the (Comment 27) One comment ‘‘Clinical Considerations,’’ which population(s) for which the drug is expressed support for the proposed requires relevant information, to the labeled, it must also be included. The ‘‘Fetal Risk Summary,’’ explaining that extent it is available, about drug- final rule requires that the background the proposed labeling requirements associated maternal adverse reactions risk information appear in labeling increase the utility of the ‘‘Pregnancy’’ that are unique to or more frequent or under the subheading ‘‘Risk Summary,’’ subsection by expanding the teratology severe during pregnancy. FDA disagrees rather than as a standalone statement section to include information about that information on neonatal outcomes under its own subheading (as in the specific developmental abnormalities as well as fetal outcomes should be proposed rule). such as incidence, seriousness, included in the ‘‘Risk Summary.’’ The Agency has determined that reversibility, potential for correction, Rather, if available, this information is rather than including a standardized and effect of dose, duration, and included under its own heading, ‘‘Fetal/ general statement about background gestational timing of exposure. Several Neonatal adverse reactions,’’ under risk, it is beneficial to include the other comments suggested that the ‘‘Clinical Considerations.’’ FDA believes approximate background rates of major proposed ‘‘Fetal Risk Summary’’ be that consistent placement of this birth defects and miscarriage. This will revised in various ways, discussed in information under a specified heading provide some context to the risk detail as follows. under ‘‘Clinical Considerations’’ will statement, and a basis for comparison Sources of data. FDA proposed that allow health care providers to easily with risk estimates from studies in all available data, including human, locate this information. FDA also animal, and pharmacologic data, that pregnant women. Including the believes that this approach ensures that are relevant to assessing the likelihood approximate background rates allows maternal, fetal, and neonatal risks will that a drug will increase the risk of the prescriber to inform patients of the be captured and clearly conveyed in developmental abnormalities and other risk of major birth defects and prescription drug labeling. miscarriage, regardless of drug relevant risks must be considered Terms used to describe adverse fetal exposure. Accordingly, the final rule (Proposed § 201.57(c)(9)(i)(C)(1)). outcomes. FDA proposed that the fetal requires that the labeling include the (Comment 28) One comment risk summary must characterize the approximate background rates of major recommended that rather than likelihood that the drug increases the birth defects and miscarriage, regardless considering ‘‘all available data,’’ the risk of developmental abnormalities in of drug exposure, in the United States. data sources for the ‘‘Fetal Risk FDA agrees, however, that it is possible Summary’’ be limited to ‘‘scientifically humans (i.e., structural anomalies, fetal that these numbers may change over rigorous, organized data collection and infant mortality, impaired time. Therefore, the Agency did not schemes such as clinical or preclinical physiologic function, alterations to include any specific numbers in the studies, and registries.’’ growth) and other relevant risks (e.g., final rule. Instead, the Agency has (Response) FDA declines this transplacental carcinogenesis) provided information, including suggestion. For example, depending on (proposed § 201.57(c)(9)(i)(C)(1)). relevant literature citations, about the safety signal, valuable information (Comment 30) Several comments current background rates of major birth may come from epidemiological studies suggested that the term ‘‘developmental defects and miscarriage in the draft that are not prospective pregnancy abnormalities’’ should be replaced with guidance on pregnancy and lactation exposure registries. On occasion, a broader and more accurate term. One labeling, which is being published adverse event reporting or case series comment suggested FDA replace the concurrently with this final rule. reporting may raise enough concern term ‘‘developmental abnormalities’’ Although the literature citations are about a potential increased risk for a with the term ‘‘adverse outcomes, included in the draft guidance, the specific structural malformation or including developmental Agency does not believe it is either pattern of malformations, or a serious abnormalities.’’ This comment necessary or appropriate to include adverse event, that the information explained that the phrase them in the labeling. should be included in labeling. ‘‘developmental abnormalities’’ does not FDA agrees that the second sentence (Comment 29) Maternal and neonatal include ‘‘other relevant risks (e.g., in the proposed background risk risk. One comment suggested that FDA transplacental carcinogenesis)’’ that are statement, which states that the fetal include information regarding maternal also required to be described in the risk summary describes the drug’s and neonatal risks in the ‘‘Pregnancy’’ ‘‘Fetal Risk Summary.’’ Several potential to increase the risk of subsection of labeling. The comment comments suggested replacing the term developmental abnormalities above the suggested that FDA add a ‘‘maternal risk ‘‘developmental abnormalities’’ with the background risk, could have been subsection,’’ preferably before the ‘‘Fetal term ‘‘developmental effects’’ or misinterpreted as meaning that the drug Risk Summary,’’ which would address ‘‘adverse developmental effects.’’ These is associated with an increased risk. As side effects and adverse reactions comments explained that in the field of discussed previously, the Agency has associated with the use of a drug, developmental toxicology, a removed the standardized background including those unique to pregnancy. developmental abnormality would risk statement, including the second The comment explained that placing imply, in general, a dysmorphogenic sentence, from the final rule. this information higher on the label and effect (malformation or variation), rather iii. Fetal risk summary—FDA making it a separate subsection would than the wider definition intended by proposed that under ‘‘Pregnancy,’’ underscore the importance of the health the proposed rule. Several comments prescription drug labeling include a of the mother. The comment also noted the importance of using subheading ‘‘Fetal Risk Summary’’ suggested that FDA include neonatal terminology consistently in labeling.
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(Response) FDA agrees that the terms Several comments stated that because conflicting characterizations of risk used to describe various developmental there will be frequent conflicts between magnitude. effects or outcomes should be accurate human and animal data, FDA should FDA disagrees with the suggestion and understandable, and that standard develop an overall approach to that animal data be presented first in nomenclature in the field of characterize risk based on both human cases where the human data are developmental toxicology should be and animal data. One of these comments insufficient. FDA also disagrees that the used to the extent that it exists. FDA suggested that FDA consider the most robust and clinically relevant also agrees that terminology should be European Medicines Agency’s (EMEA’s) data—whether human data or animal used consistently in labeling. FDA (now EMA’s) Integration Table for Risk data—should always be presented first. concludes that the term ‘‘developmental Assessment and Recommendation for We have determined that to promote abnormalities’’ is widely recognizable as Use as an example of how to integrate consistency and to meet readers’ referring to structural defects risk conclusions based on animal and expectations that information will (malformations or variations), rather human data. always be found in the same place, a than the full range of possible Two comments stated that the fixed order of presentation must be manifestations of developmental proposed rule gives primary emphasis maintained. Moreover, we have toxicity as FDA had intended. to human studies, if they exist, while determined that human data should Therefore, in the final rule, FDA has downgrading the emphasis on animal precede animal data because it is the included the following terms that data. One of these comments explained most clinically relevant. describe various developmental that the quality and statistical power of We note that the purpose of this toxicities, as explained in the following human data often fall well short of rulemaking is to facilitate informed list: desirable, and suggested that human prescribing and safe and effective drug • ‘‘Adverse developmental data be accompanied by clear product use; placing restrictions on or outcomes’’ has replaced ‘‘developmental acknowledgement of any deficiencies. encouraging any type of studies that abnormalities’’ as the general term to The other comment explained that may be used as the basis for drug encompass all manifestations or types of emphasizing minimal human data over labeling is beyond the scope of this rule. developmental toxicity. strong animal data can misrepresent the Not systemically absorbed. FDA • ‘‘Structural abnormalities’’ is used fetal risk of a drug. proposed that if the drug is not Two comments suggested that if to describe dysmorphology, which systemically absorbed, the fetal risk human data are ‘‘insufficient’’ (i.e., do includes malformations, variations, statement must contain only the not meet the standard for inclusion in deformations, and disruptions, rather following statement: (Name of drug) is proposed § 201.57(c)(9)(i)(C)(2)(i)), a risk than the proposed ‘‘structural not absorbed systemically from (part of statement based on human data should anomalies.’’ body) and cannot be detected in the • not precede a risk statement based on ‘‘Embryo-fetal and/or infant animal data. One of these comments blood. Maternal use is not expected to mortality’’ is used to describe explained that the most robust and result in fetal exposure to the drug developmental mortality, which clinically relevant data should always (proposed § 201.57(c)(9)(i)(C)(1)). includes miscarriage, stillbirth, and be presented first. (Comment 32) One comment infant death (including neonatal death), Several comments stated that if risk suggested that this statement should instead of the proposed ‘‘fetal and infant conclusions are based on sufficient focus on the route of administration mortality.’’ human data, sponsors should not be rather than the part of the body. • ‘‘Functional impairment’’ is used to required to include animal data, even if (Response) FDA agrees that ‘‘part of describe functional toxicity, which such data are available. One comment the body’’ could be misconstrued and includes such outcomes as deafness, also suggested that if sufficient human we have determined that the use of endocrinopathy, neurodevelopmental data become available after the labeling ‘‘route of administration’’ to describe effects, and impairment of reproduction, is approved, animal data should be how the drug enters the body is more rather than ‘‘impaired physiologic removed when the human data are consistent with labeling language that function.’’ added to the labeling. This comment addresses dosing and administration. In • ‘‘Alterations to growth’’ is used to explained that ‘‘a risk conclusion based the final rule, FDA has replaced ‘‘part of describe such outcomes as growth on animal data might not support, or the body’’ with ‘‘route of restriction, excessive growth, and could flatly contradict, a risk conclusion administration.’’ FDA has determined delayed and early maturations. based on sufficient human data.’’ that ‘‘cannot be detected in the blood’’ These terms and descriptions are One comment suggested that FDA ban is redundant and that the statement is consistent with FDA’s guidance for all animal studies because human clear without this phrase. In the final industry on ‘‘Reproductive and studies are more accurate. rule, FDA has eliminated that phrase. Developmental Toxicities—Integrating (Response) We continue to believe (Comment 33) Standard statement for Study Results to Assess Concerns’’ that the ‘‘Risk Summary’’ is certain drugs. FDA received one (September 2011). appropriately based on both human and comment suggesting that we develop a Relationship between animal and animal data. Because of the importance standard statement for drugs that are human data. FDA proposed that when of human data, we also have determined indicated for use only by males or by both human and animal data are that when human data provide an females who are not of reproductive available, risk conclusions based on incomplete assessment, this should be potential. human data must be presented before stated in the risk statement based on (Response) FDA disagrees. We have risk conclusions based on animal data human data. Specifically, the ‘‘Risk determined that a standard statement is (proposed § 201.57(c)(9)(i)(C)(2)). Summary’’ must state when there are no not needed. We believe it is appropriate (Comment 31) A number of comments human data or when available human that the ‘‘Risk Summary’’ will be suggested that FDA reexamine the data do not establish the presence or included in labeling for all drugs, emphasis that the ‘‘Fetal Risk absence of a drug-associated risk. FDA regardless of their indicated population. Summary’’ places on human data as believes that the use of narrative This will promote consistency in drug compared to animal data. summaries of the data will avoid labeling.
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Risk conclusions based on human consistent implementation across conclusions be used to characterize the data. In the proposed rule, under the review divisions, a dedicated group of likelihood of increased risk. As subheading ‘‘Fetal Risk Summary,’’ FDA FDA specialists should review the discussed previously, in the final rule, proposed that when human data are determination of whether the human FDA requires instead, under ‘‘Risk sufficient to reasonably determine the data are sufficient or insufficient for all statement based on human data,’’ that likelihood that the drug increases the labeling subject to the rule. This when human data are available that risk of fetal developmental comment also requested that FDA establish the presence or absence of any abnormalities or specific developmental provide examples of sufficient and adverse developmental outcome(s) abnormalities, the likelihood of insufficient data and that FDA caution associated with maternal use of the increased risk must be characterized prescribers that such classifications drug, the labeling must summarize the using one of the following risk should not be considered as scientific specific developmental outcome; its conclusions: Human data do not proof that a drug may or may not harm incidence; and the effects of dose, indicate that (name of drug) increases a particular patient. duration of exposure, and gestational the risk of (type of developmental (Response) FDA agrees that the term timing of exposure. The final rule also abnormality or specific developmental ‘‘sufficient human data’’ is ambiguous requires that if the data indicate that abnormality) or Human data indicate and has eliminated it from the final rule. there is an increased risk for a specific that (name of drug) increases the risk of FDA has also eliminated from the final adverse developmental outcome in (type of developmental abnormality or rule the distinction between ‘‘sufficient infants born to women exposed to the specific abnormality) (proposed human data’’ and ‘‘other human data.’’ drug during pregnancy, this risk must be § 201.57(c)(9)(i)(C)(2)(i)). The proposed In the final rule, FDA requires that quantitatively compared to the risk for rule defined the sources of ‘‘sufficient when human data are available that the same outcome in infants born to human data’’ as clinical trials, establish the presence or absence of any women who were not exposed to the pregnancy exposure registries or other adverse developmental outcome(s) drug but who have the disease or large scale epidemiologic studies, or associated with maternal use of the condition for which the drug is case series reporting a rare event drug, the labeling must summarize the indicated to be used. The final rule (proposed § 201.57(c)(9)(i)(C)(2)(i)). specific developmental outcome; its requires that if the data indicate that incidence; and the effects of dose, (Comment 34) Many comments there is an increased risk for a specific duration of exposure, and gestational requested that FDA more clearly define adverse developmental outcome in timing of exposure. As stated infants born to women exposed to the the criteria for ‘‘sufficient human data’’ previously, the final rule also requires and provide further guidance on the drug during pregnancy, but risk that the ‘‘Risk Summary’’ state when information is not available for women quantity and quality of evidence there are no human data or when considered to be ‘‘sufficient human who were not exposed to the drug but available human data do not establish who have the disease or condition for data’’ rather than ‘‘other human data.’’ the presence or absence of drug- One comment requested that FDA which the drug is indicated to be used, associated risk. then the risk for the specific outcome clarify the standards that constitute FDA has also determined that the must be compared to the rate at which ‘‘sufficient human data,’’ including how term ‘‘risk conclusion’’ is inappropriate the outcome appears in the general those standards were developed. because the available data may not population. Another comment stated that there is no always lead to a conclusion regarding agreement among experts as to how the drug’s risk to the fetus. Therefore, in (Comment 36) FDA also received much data are needed to reach a risk the final rule, FDA has replaced the comments about the proposed sources conclusion and requested that FDA term ‘‘risk conclusion’’ with the term of sufficient human data. One comment clarify what is considered sufficient ‘‘risk statement.’’ stated that sufficient data must be based human data to reasonably determine the (Comment 35) Several comments on large-scale epidemiologic studies or risk of developmental abnormalities. suggested that the Agency revise the clinical trials, and cannot be based on Several comments questioned whether proposed risk statements to make them pregnancy registries or case reports/ data from an individual study could more straightforward and appropriately series requiring further evaluation. This ever constitute ‘‘sufficient human data.’’ qualify the nature of the data and the comment explained that most These comments explained that inability to draw definitive conclusions pregnancy registries can only serve to although individual clinical trials, about an absence of risk based on them. rule out a major teratogen and to pregnancy exposure registries, large- Two of these comments suggested that generally determine the similarity in scale epidemiologic studies, and case the term ‘‘human data’’ be replaced with array of effects seen in large registries, series can provide signals for potential the term ‘‘available human data.’’ One and they cannot provide a quantitative adverse pregnancy outcomes, an comment suggested that the risk estimate of population rates of individual study is not statistically conclusion ‘‘Human data do not individual defects or abnormalities. powered to fully assess the incidence indicate that (name of drug) increases Another comment stated that a risk and form one of the proposed risk the risk of (type of developmental conclusion cannot always be reached conclusions. A separate comment stated abnormality or specific developmental based on the types of human data that even if human data has multiple abnormality)’’ be replaced with described in the proposed rule, and sources, there is often not enough ‘‘Available human data indicate no questioned whether there is a consistent human data to make a risk conclusion. additional risk of (type of approach to sufficient human data as it This comment questioned how often the developmental abnormality or specific relates to case series reporting of a rare risk statements based on sufficient developmental abnormality) with (name event. This comment explained that human data would be used. One of drug).’’ One comment suggested that spontaneous reports should not be part comment stated that the proposed rule the term ‘‘indicate’’ should be replaced of the basis for this subsection. One does not discuss who will determine with the term ‘‘suggest.’’ comment questioned how the labeling whether the data are sufficient or how (Response) In the final rule, FDA has will summarize seemingly contradictory such a determination will be made. The eliminated the requirement in the results of well-powered pregnancy comment suggested that to increase proposed rule that standardized risk exposure registries or studies from
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which a definitive clinical conclusion high, the risk should instead be detailed narrative discussion of cannot be reached. characterized by specific statements insufficient human data in the fetal risk (Response) FDA recognizes that describing the findings, or whether the summary. because retrospective voluntary adverse findings should be described at all if (Response) As discussed previously, event reporting may be biased and they are not readily interpretable. FDA agrees that the term ‘‘sufficient incomplete, spontaneous reports cannot Examples of specific statements would human data’’ is ambiguous and we have rule in or out a causal relationship be: ‘Limited data in humans show removed the term from the final rule, as between drug exposure and clinical (describe outcomes),’ or ‘Limited data in well as the distinction between outcome. However, multiple humans show conflicting results ‘‘sufficient human data’’ and ‘‘other spontaneous reports (or case series) of (describe study types, number of cases, human data.’’ FDA also agrees that the rare events can be useful in suggesting outcomes, and limitations)’’’ (73 FR terms ‘‘low,’’ ‘‘moderate,’’ and ‘‘high’’ possible associations between adverse 30831 at 30842). are subjective and should not be used to events and drug exposure during (Comment 38) FDA received 10 describe human data that cannot pregnancy that warrant further comments from a variety of sources support a statement about fetal risk. The investigation. Furthermore, FDA has expressing strong disagreement with the final rule requires instead that when determined that data from studies with proposal to use the terms ‘‘low,’’ human data are available that establish small numbers of pregnancy exposures ‘‘moderate,’’ and ‘‘high’’ to characterize the presence or absence of any adverse may provide valuable information about the likelihood of increased risk of developmental outcome(s) associated potential safety signals, especially when adverse outcomes due to drug exposure with maternal use of the drug, the corroborated by findings from other based on less than sufficient human labeling must summarize the specific studies. data. FDA received only one comment developmental outcome; its incidence; (Comment 37) One comment supporting the proposal. and the effects of dose, duration of suggested that FDA eliminate the Four comments stated that the exposure, and gestational timing of proposed rule’s requirement that proposal to classify risk as low, exposure. As discussed earlier, the final sponsors specify all possible types of moderate, or high based on insufficient rule also requires that if the human data developmental abnormalities or specific human data might produce the same indicate that there is an increased risk abnormalities for which human data do confusion as the current pregnancy for a specific adverse developmental not indicate that the drug increases the category system. These comments outcome in infants born to women risk. The comment explained that such explained that, as with the A, B, C, D, exposed to the drug during pregnancy, a list could be lengthy and of little X category system, the use of the this risk must be quantitatively clinical benefit to health care providers. categories low, moderate, and high to compared to the risk for the same (Response) FDA did not intend to characterize the likelihood of increased imply that every potential type of risk of adverse outcomes would outcome in infants born to women who developmental abnormality must be oversimplify the data and lump drugs were not exposed to the drug but who included in labeling when human data with various types and amounts of data have the disease or condition for which are negative. We note that it is difficult together without describing the basis for the drug is indicated to be used. When to be certain that a lack of findings the conclusions. Another comment risk information is not available for equates to a lack of risk because the suggested that these characterizations women with the disease or condition for failure of a study to detect an are subjective and would be confusing which the drug is indicated, then the association between a drug exposure to health care providers. risk for the specific outcome must be and an adverse outcome may be related One comment recommended that compared to the rate at which the to many factors, including a true lack of when the human data are insufficient, outcome occurs in the general an association between exposure and FDA require the inclusion of the population. The final rule also requires outcome, a study of the wrong following risk conclusion: ‘‘Insufficient that the ‘‘Risk Summary’’ state when population, failure to collect or analyze data—risk conclusion not established.’’ there are no human data or when the right data endpoints, and/or Another comment recommended that available human data do not establish inadequate power. The intent of this FDA consider adopting something the presence or absence of drug- final rule is to require accurate similar to the EMA’s system. One associated risk. descriptions of available data and comment suggested that the ‘‘Risk Narrative description of risk(s) based facilitate the determination of whether Summary’’ should include information on human data. FDA proposed that the data demonstrate potential about the findings, such as the when there are human data, the risk associations between drug exposure and gestational age of exposure, the target conclusion must be followed by a brief an increased risk for developmental organ or organ system, and the findings description of the risks of toxicities. should be characterized in terms of developmental abnormalities as well as FDA proposed that when there are structural, developmental, growth, or other relevant risks associated with the available human data that are not functional abnormality. Another drug. To the extent possible, this sufficient to use one of the risk comment recommended that when the description must include the specific conclusions for sufficient human data, human data are not sufficient, the developmental abnormality (e.g., neural the likelihood that the drug increases labeling contain statements specific to tube defects); the incidence, the risk of developmental abnormalities the findings rather than classifying the seriousness, reversibility, and must be characterized as low, moderate, risk as low, moderate, or high. One correctability of the abnormality; and or high (proposed comment suggested that when there are the effect on the risk of dose, duration § 201.57(c)(9)(i)(C)(2)(ii)). In the insufficient data, the labeling should of exposure, and gestational timing of preamble to the proposed rule, FDA include a statement explaining that it is exposure. When appropriate, the sought comment on this subsection. not possible to draw conclusions based description must include the risk above Specifically, FDA sought ‘‘comment on on insufficient human data. This the background risk attributed to drug whether, in situations with human data comment also expressed a preference for exposure and confidence limits and that are not sufficient, rather than referring to the data portion of the power calculations to establish the classifying the risk as low, moderate, or labeling rather than including a more statistical power of the study to identify
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or rule out a specified level of risk heading, ‘‘Fetal/Neonatal adverse (Response) As discussed previously, (proposed § 201.57(c)(9)(i)(C)(4)). reactions,’’ under ‘‘Clinical the ‘‘Narrative description of risk(s)’’ In the final rule, FDA has removed the Considerations.’’ This portion of the heading was removed from the final ‘‘Narrative description of risk(s)’’ final rule requires that if it is known or rule, and the phrase ‘‘risk attributed to heading from the ‘‘Pregnancy’’ anticipated that maternal drug therapy drug exposure’’ is not used elsewhere in subsection. FDA has determined that increases or may increase the risk of an the final rule. much of the information required under adverse reaction in the fetus or neonate, (Comment 43) Two comments stated that heading by the proposed rule was the labeling must describe the adverse that confidence intervals and power duplicative of information now required reaction, the potential severity and calculations should not be included in in the ‘‘Risk Summary.’’ As discussed reversibility of the adverse reaction, and labeling because they are too technical previously, when human data are available interventions for monitoring or and not useful for most prescribers. available that establish the presence or mitigating the reaction. (Response) FDA does not agree. Under absence of any adverse developmental In response to the comments ‘‘Data,’’ the final rule requires a outcome(s) associated with maternal use requesting clarification of the terms description of the limitations of any of the drug, the ‘‘Risk Summary’’ in the ‘‘reversibility’’ and ‘‘correctability,’’ data included in the labeling. ‘‘Pregnancy’’ subsection must FDA considers a condition to be Confidence intervals and power summarize the specific developmental reversible if it can self-correct with calculations are important for the outcome; its incidence; and the effects routine care and nurturing or through an review and interpretation of the data. As of dose, duration of exposure, and intervention such as discontinuing the noted in the draft guidance on gestational timing of exposure. Because drug. An example of a potentially pregnancy and lactation labeling, which this information is required to be reversible drug effect in the neonate is is being published concurrently with included in a narrative form in the provided in the draft guidance on the final rule, the confidence intervals ‘‘Risk Summary,’’ we determined that pregnancy and lactation labeling, which and power calculation, when available, including a separate ‘‘Narrative is being published concurrently with should be part of that description of description of risk(s)’’ heading in the the final rule. The term ‘‘correctable’’ limitations. labeling was unnecessary. In addition, has been removed from the final rule. (Comment 44) One comment (Comment 41) One comment as explained in the following comments suggested that the ‘‘Narrative suggested that FDA include in the and our responses, some of the description of risk(s)’’ include a ‘‘Narrative description of risk(s)’’ information that was required by the discussion about the uncertainties or information about precautionary proposed rule to appear under limitations of the ‘‘Fetal Risk Summary’’ measures that can be taken to prevent an ‘‘Narrative description of risk(s)’’ is when appropriate. required by the final rule to appear adverse outcome caused by the drug. (Response) As discussed previously, instead under ‘‘Clinical (Response) FDA agrees that FDA has removed the ‘‘Narrative Considerations.’’ information about precautionary (Comment 39) One comment measures to prevent an adverse drug description of risk(s)’’ heading from the suggested that FDA add a statement to effect should be included in labeling. In final rule. In the final rule, any the ‘‘Narrative description of risk(s)’’ the final rule, under ‘‘8.1 Pregnancy,’’ uncertainties or limitations of the data portion of the ‘‘Pregnancy’’ subsection ‘‘Clinical Considerations,’’ ‘‘Maternal are required to be stated in ‘‘Data.’’ of labeling that explains that adverse reactions,’’ FDA requires that if (Comment 45) One comment spontaneous abortions caused by a drug the use of the drug is associated with a suggested that the ‘‘Narrative could potentially mask the risk of maternal adverse reaction that is unique description of risk(s)’’ cross-reference developmental abnormalities. to pregnancy or if a known adverse ‘‘Data’’ to direct readers to the (Response) Although FDA reaction occurs with increased information upon which the narrative is acknowledges that embryo-fetal death frequency or severity in pregnant based. (i.e., spontaneous abortion) does women, the labeling must describe the (Response) As discussed previously, sometimes occur due to severe adverse reaction and available the ‘‘Narrative description of risk(s)’’ developmental abnormalities, the intervention(s) for monitoring or was removed from the final rule. Agency has determined that it is not mitigating it. Also, in the final rule, FDA Risk statement based on animal data. necessary to explicitly include such a requires that under ‘‘8.1 Pregnancy,’’ FDA proposed to require that when the statement in labeling. Any increase in ‘‘Clinical Considerations,’’ ‘‘Fetal/ data on which the risk conclusion is spontaneous abortions attributed to drug Neonatal adverse reactions,’’ if it is based are animal data, the ‘‘Fetal Risk exposure above the background risk is known or anticipated that maternal drug Summary’’ must characterize the required to be described in the ‘‘Risk therapy increases or may increase the likelihood that the drug increases the Summary.’’ risk of an adverse reaction in the fetus risk of developmental abnormalities (Comment 40) One comment stated or neonate, the labeling must describe using one of the following risk that the term ‘‘seriousness’’ is the adverse reaction, the potential conclusions: Not predicted to increase ambiguous and suggested replacing it severity and reversibility of the adverse the risk, low likelihood of increased with the phrase ‘‘impact on health.’’ reaction, and available intervention(s) risk, moderate likelihood of increased Two comments requested clarification for monitoring or mitigating the risk, high likelihood of increased risk, or of the terms ‘‘reversibility’’ and reaction. For further discussion of these insufficient data (proposed ‘‘correctability.’’ requirements, see Comment 61 and our § 201.57(c)(9)(i)(C)(3)(i)– (Response) FDA agrees that the term response. (c)(9)(i)(C)(3)(v)). In the preamble to the ‘‘seriousness’’ is not clear, and it is not (Comment 42) One comment proposed rule, the Agency sought used in the final rule; it has been suggested that FDA replace the phrase comment on whether these standardized replaced with a requirement that the ‘‘risk attributed to drug exposure’’ in the statements can adequately communicate labeling describe the potential severity ‘‘Narrative description of risk(s)’’ with different levels of risk based on animal of the adverse reaction. Information the phrase ‘‘a drug’s potential to data and their potential relevance to about the reversibility of adverse contribute to the risk of adverse human fetal effects or whether these reactions should be included under the outcomes.’’ statements are likely to generate
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confusion among prescribers (73 FR One comment suggested that rather (Comment 47) Two comments 30831 at 30843). than using the proposed risk statements, suggested that labeling should include (Comment 46) Comments expressed FDA should instead use the language explaining the limitations of different opinions about the proposal to standardized statements presented in using animal data to predict the use standardized statements to the draft reviewer guidance on likelihood that the drug increases the characterize animal data. FDA received ‘‘Integration of Study Results to Assess risk of developmental abnormalities. 11 comments, primarily from Concerns about Human Reproductive (Response) FDA declines the toxicologists, teratologists, and and Developmental Toxicities’’ (October suggestion to include language in organizations representing toxicologists 2001). labeling explaining the limitations of and teratologists, as well as a few Most of the comments that disagreed using animal data to predict the comments from drug manufacturers, with the proposed standardized risk likelihood that the drug increases the expressing strong disagreement with the statements suggested that the labeling risk of developmental abnormalities, proposal to use risk statements to instead contain narrative statements because this is beyond the scope of this characterize animal data. FDA received describing the animal data and its rule, and is discussed in guidance three comments that supported using potential relationship to human documents, such as FDA’s guidance for standardized statements to characterize pregnancy risk. One of these comments industry on ‘‘Reproductive and the likelihood, based on animal data, explained that ‘‘succinct narrative Developmental Toxicities—Integrating that a drug will increase the risk for a statements will promote a reasoned risk Study Results to Assess Concerns’’ known developmental abnormality. assessment, facilitate comparisons (September 2011). These comments explained, for among drugs, and enhance risk (Comment 48) FDA proposed that the example, that a standardized statement communication.’’ Several of these ‘‘Risk Summary’’ contain ‘‘risk conclusions’’ based on animal data. One indicating the possible correlation comments suggested that the labeling comment suggested that the term ‘‘risk between animal and human data would should describe animal data conclusion’’ be replaced with the term be helpful to clinicians. qualitatively, including the number of ‘‘risk statement’’ because it is difficult to Two comments stated that the species with positive findings, reach any conclusions about fetal risk proposed categories are confusing and consistency of findings, and the type of posed by drugs based solely on animal subject to variable interpretation. One of findings. data. these comments explained that it will be (Response) The Agency has (Response) FDA agrees. As with very difficult to categorize the results of determined that the terms ‘‘not human data, in the final rule, the multiple studies conducted for a single predicted to increase the risk,’’ ‘‘low Agency has replaced the term ‘‘risk drug into one of the proposed likelihood of increased risk,’’ ‘‘moderate conclusion’’ with the term ‘‘risk categories, and there could be likelihood of increased risk,’’ and ‘‘high statement’’ when discussing risks based disagreement about whether to likelihood of increased risk’’ are on animal data. characterize the risk based on the confusing and subject to different (Comment 49) Risk statement based animal data as ‘‘low,’’ ‘‘moderate,’’ or interpretations. The Agency believes on pharmacology. One comment ‘‘high.’’ that using standardized risk statements suggested that FDA consider whether a Several comments stated that the may give the false impression that separate approach is appropriate for a proposal to use category language to animal data can provide a semi- group of drugs, such as oncology describe animal data demonstrates a quantitative assessment of human risk. products, for which the pharmacological misunderstanding of the function and The Agency also agrees that the use of and toxicological mechanisms are meaning of experimental animal standardized risk statements to similar. The comment suggested that for studies. These comments explained that characterize the risk of developmental cytotoxic drugs, FDA could use the although animal data can identify the abnormalities based on animal data following standard risk statement: potential of a therapeutic agent to cause would potentially have the same ‘‘(Drug name) is indicated for (cancer developmental toxicity, it cannot give drawbacks as the current pregnancy type) and is generally used in terminally rise to an estimate of the probability of category system. Therefore, in the final ill patients. There are very limited data human harm. rule, FDA removed the requirement that on exposure in pregnant patients and, Two comments expressed concern a standardized risk statement be used to therefore, no assessment of fetal or that the use of standardized risk describe human risk based on animal maternal risk is available. The statements would amount to a category data. Instead, the ‘‘Risk Summary’’ mechanism of action of this drug is to system similar to the one that FDA requires that when animal data are kill growing cells and it can be currently uses and would have all of its available, the labeling must summarize anticipated that there is a risk to the associated problems. the findings in animals and, based on fetus at all stages of development.’’ Several comments expressed these findings, describe, for the drug, (Response) FDA agrees that the particular concern with the proposal to the potential risk of adverse ‘‘Pregnancy’’ subsection of labeling use these categories without an developmental outcomes in humans. should address situations in which a accompanying narrative description of The final rule requires that the drug may result in an increased risk of the animal studies. One comment statement include the number and adverse developmental outcomes based suggested that the sample labels type(s) of species affected, timing of on a well-understood mechanism of provided in the Appendix of the exposure, animal doses expressed in action. The final rule requires that when proposed rule illustrate the difficulty of terms of human exposure or dose the drug has a well-understood trying to characterize the risk to humans equivalents, and outcomes for pregnant mechanism of action that may result in based on animal data. Another comment animals and offspring. The final rule adverse developmental outcome(s), the stated that ‘‘the terms ‘risk,’ ‘medium,’ also requires that when animal studies ‘‘Risk Summary’’ must explain the and ‘high’ are highly charged terms’’ do not meet current standards for mechanism of action and the potential and expressed concern that the risk nonclinical developmental toxicity associated risks. statements will be over-interpreted by studies or when there are no animal Contraindications, warnings, and anxious consumers and their clinicians. data, the labeling must so state. precautions. FDA proposed that the
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‘‘Fetal Risk Summary’’ refer to rule. A description of each comment we dictating prescribing decisions. Rather, information that is included in the received and our responses follow. FDA views the ‘‘Clinical ‘‘Contraindications’’ or ‘‘Warnings and (Comment 51) General comments. Considerations’’ component of Precautions’’ section of labeling Comments expressed different opinions ‘‘Pregnancy’’ as providing information regarding an increased risk to the fetus about the utility and appropriateness of that supports health care providers’ from exposure to the drug (proposed the proposed ‘‘Clinical Considerations’’ understanding of drug product risks and § 201.57(c)(9)(i)(C)(5)). component. Many comments expressed benefits and facilitates informed (Comment 50) One comment general support for including this prescribing decisions and patient suggested that FDA specify that any information. One comment stated that counseling. contraindications or warnings or ‘‘Clinical Considerations’’ will help Inadvertent exposure. FDA proposed precautions that must be included in the clinicians and patients to consider all that under the subheading ‘‘Clinical ‘‘Fetal Risk Summary’’ are those that aspects of the patient’s care when Considerations,’’ the ‘‘Pregnancy’’ relate to risk to the fetus. deciding when and how to prescribe subsection of labeling include (Response) In the final rule, FDA drugs during pregnancy and in women information regarding known or removed the requirement that the ‘‘Risk of childbearing potential. Another predicted risks to the fetus from Summary’’ refer to information that is comment stated that the title ‘‘Clinical inadvertent exposure to the drug during included in the ‘‘Contraindications’’ or Considerations’’ encourages pregnancy (proposed ‘‘Warnings and Precautions’’ section of professionals to make their own medical § 201.57(c)(9)(i)(D)(1)). The proposed labeling regarding an increased risk to judgments. A separate comment noted rule would have required that: The the fetus from exposure to the drug. As that FDA refrained from interfering with labeling must discuss the known or described in FDA’s draft guidance for the physician’s discretion by framing predicted risks to the fetus from industry implementing the PLR, when a ‘‘Clinical Considerations’’ as a practical inadvertent exposure to the drug topic is discussed in more than one guide that assists the provider in (exposure in early pregnancy before a section of labeling, the section decisionmaking. woman knows she is pregnant), Some comments cautioned that containing the most important including human or animal data on ‘‘Clinical Considerations’’ was too information relevant to prescribing dose, timing, and duration of exposure. directive in its advice and requiring this should typically include a succinct If there are no human or animal data to information intruded on the practice of description and should cross-reference assess the risk from inadvertent medicine and could increase physician sections that contain additional detail exposure, the labeling must so state. liability for failure to adhere to labeling (FDA’s guidance for industry on (Comment 52) Comments expressed instructions. One comment stated that ‘‘Labeling for Human Prescription Drug different opinions about the necessity ‘‘Clinical Considerations’’ should not and Biological Products—Implementing dictate prescribing by a physician for and utility of including this the PLR Content and Format pregnant women. The comment information. Requirements’’ (February 2013)). requested that FDA revisit this Two comments supported including Consistent with that principle, cross- provision to see whether the content can information about inadvertent exposure. referencing of information required be made more useful without advising One of these comments explained that under the final rule will typically physicians how to practice medicine. In the proposed section improves a appear in the section where the topic is particular, the comment suggested that physician’s ability to manage such briefly summarized, e.g., ‘‘Warnings and information about known alternative cases. Precautions,’’ and will refer the reader therapies should be included. Two comments, however, suggested to the place in labeling where it will be Alternatively, the comment suggested that FDA consider removing this presented in greater detail, i.e., that FDA consider the use of a general requirement because it will be ‘‘Pregnancy.’’ We note that because a statement about clinical considerations duplicative of the information contained contraindication is important rather than an extensive, clinically in the ‘‘Fetal Risk Summary.’’ One of information that needs to be based discussion that may be unable to these comments explained that communicated to the health care incorporate risk and benefit assuming equal exposure to the drug, provider, the final rule requires that information. Another comment stated the known or predicted risks to the fetus when use of a drug is contraindicated that it is the health care provider’s would be the same regardless of during pregnancy, this information must responsibility to keep abreast of the whether the exposure was intentional or be stated first in the ‘‘Risk Summary.’’ latest information about the disease not. This comment explained that iv. Clinical considerations. state and its effect on pregnant women because fetal risks are already fully FDA proposed that the ‘‘Pregnancy’’ and to apply that knowledge to described in the ‘‘Fetal Risk Summary,’’ subsection of prescription drug labeling treatment of each individual patient, including the same information under include a ‘‘Clinical Considerations’’ and the professional labeling is not the ‘‘inadvertent exposure during component to provide guidance and appropriate place for this information. pregnancy’’ would be redundant. The information to health care providers (Response) FDA disagrees both that comment suggested that the about the use of the drug in three ‘‘Clinical Considerations’’ is too ‘‘inadvertent exposure during distinct clinical situations: (1) directive and that professional labeling pregnancy’’ component instead include Counseling women who were is not the appropriate place for this a cross-reference to the ‘‘Fetal Risk inadvertently exposed to the drug information. As a Public Health Agency Summary’’ and describe only during pregnancy, (2) making with expertise in drug regulation and information not already described in the prescribing decisions for pregnant safety, FDA has a responsibility to issue ‘‘Fetal Risk Summary,’’ in particular, women, and (3) making prescribing regulations that facilitate the any information about ways to manage decisions during labor and delivery development of drug labeling that or mitigate the effects of inadvertent (proposed § 201.57(c)(9)(i)(D)). communicates how to safely and drug exposure. The other comment We received many comments on this effectively prescribe drugs in the explained that the risk of drug exposure proposal. Based on those comments, clinical setting. The Agency does not to the fetus early in pregnancy should FDA has made some changes to the final regard ‘‘Clinical Considerations’’ as not be different between women who
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choose to become pregnant and those FDA proposed that the ‘‘Prescribing comment also requested that the whose pregnancies were unplanned. decisions for pregnant women’’ information be updated on a timely Another comment suggested that FDA component under ‘‘Clinical basis. either delete the statement ‘‘exposure in Considerations’’ include information (Response) FDA agrees that it is early pregnancy before a woman knows about the risk, if known, to the pregnant important that information provided in that she is pregnant’’ or retain it as an woman and the fetus from the disease labeling is consistent and up-to-date, example. This comment explained that or condition the drug is indicated to and we address this issue in our although inadvertent exposure is more treat (proposed § 201.57(c)(9)(i)(D)(2)(i)). response to Comment 4. FDA is not likely in early pregnancy, it may occur (Comment 53) Comments disagreed mandating that labeling contain at any time during pregnancy. about whether the ‘‘Pregnancy’’ consistent disease-specific text, as One comment asked for clarification subsection of labeling should include knowledge of disease-associated risk as to what is expected to be included in information about the effects of not may change over time as more data this section. Specifically, this comment treating the woman’s underlying disease become available. questioned how the risk conclusions or condition. (Comment 55) One comment from animal data in the ‘‘Fetal Risk Two comments supported requiring suggested that FDA add a statement Summary’’ will be used to counsel the inclusion of information about the under ‘‘Clinical Considerations’’ clinicians on the risk of inadvertent short- and long-term effects of not taking explicitly stating that untreated or exposure, and requested that FDA a necessary drug to treat a chronic inadequately treated health conditions provide examples of this section in an disease or condition for the duration of (such as infections; chronic diseases Appendix. a pregnancy, as well as information such as diabetes, hypertension, renal about the severity of the condition for and thyroid diseases; and psychiatric (Response) The Agency agrees that the which the drug might be prescribed. disorders such as depression) can proposed ‘‘inadvertent exposure during Two other comments, however, adversely affect the health of the woman pregnancy’’ component would have disagreed with including information in and the outcomes of the pregnancy, and required information about drug effects ‘‘Clinical Considerations’’ about the that decisions about medication usage on the fetus that is largely redundant of risks of not treating the mother’s must be balanced with the risks of the information that is required to be underlying disease or condition during untreated and/or poorly managed health included in the ‘‘Risk Summary’’ in the pregnancy. These comments stated that conditions. ‘‘Pregnancy’’ subsection of prescription prescription drug labeling is not the (Response) FDA disagrees with this drug labeling. FDA has removed the appropriate place for health care suggestion. We have determined that ‘‘inadvertent exposure during providers to learn about the risks of requiring a general standardized pregnancy’’ component from the final diseases that drugs are indicated to statement is less effective than rule. treat. providing drug-specific information Prescribing decisions for pregnant (Response) FDA has determined that about the risks of not treating the women. FDA proposed that the when relevant information is available condition or disease for which the drug ‘‘Clinical Considerations’’ portion of the about the serious effects of not treating is indicated to be used. ‘‘Pregnancy’’ subsection of prescription conditions or diseases during (Comment 56) One comment drug labeling contain information about pregnancy, it must be included in this suggested that ‘‘Clinical Considerations’’ prescribing decisions for pregnant section of labeling. In the final rule, this should provide information about how women, including the following: (1) The requirement appears first under to discontinue or switch medications risk, if known, to the pregnant woman ‘‘Clinical Considerations’’ under the during pregnancy when necessary. and the fetus from the disease or heading ‘‘Disease-associated maternal (Response) FDA agrees that when condition the drug is indicated to treat; and/or embryo/fetal risk.’’ The wording such information is available, it may be (2) information about dosing of this portion of the final rule was appropriate to include it in ‘‘Clinical adjustments during pregnancy; (3) revised to require that when there is a Considerations.’’ We note that this does information about maternal adverse serious known or potential risk to the not require a change to the final rule, reactions associated with use of the pregnant woman and/or the embryo/ because this is consistent with current drug; and (4) information about any fetus associated with the disease or labeling practices. known or anticipated complications in condition for which the drug is (Comment 57) One comment the neonate from treatment of the indicated to be used, the labeling must suggested that ‘‘Clinical Considerations’’ pregnant woman (proposed describe the risk. take into account the severity of the § 201.57(c)(9)(i)(D)(2)). (Comment 54) Other comments disease, disorder, or condition to the In the final rule, FDA removed the suggested that the ‘‘Clinical mother, and the availability and the heading ‘‘Prescribing decisions for Considerations’’ component of the benefits and risks of alternative pregnant women.’’ FDA determined that proposed rule be altered in various therapies for which greater or lesser because the ‘‘inadvertent exposure’’ ways. knowledge may be known about their component was removed from the final Two comments expressed concern use in pregnant women. rule, the ‘‘Clinical Considerations’’ that descriptions of risks to the pregnant (Response) FDA disagrees with the portion of the ‘‘Pregnancy’’ subsection patient or fetus posed by diseases or suggestion that the labeling address the was shortened such that having a conditions would vary among drugs that availability and the benefits and risks of separate heading for ‘‘Prescribing are indicated to treat the same disease alternative therapies during pregnancy. decisions for pregnant women’’ was or condition, thereby promoting Because the comparative risks and unnecessary. confusion. One of these comments benefits for different therapies may vary FDA received comments about the suggested that FDA develop disease- by patient, this determination must be information required in the proposed specific text for developmental risks of made by the prescribing health care rule under the heading ‘‘Prescribing major disease classes, such as asthma, provider. FDA acknowledges, however, decisions for pregnant women.’’ A hypertension, diabetes, and epilepsy, that under certain circumstances it may description of each comment and our which sponsors can use in their be appropriate to include a statement in responses follow. prescription drug labeling. This the labeling that pregnant women
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should consider alternative drug (§ 201.57(c)(3)) and FDA’s guidance for (Response) FDA agrees with the therapies, and the appropriateness of industry on ‘‘Dosage and suggestion to replace the phrase this would be evaluated on a case-by- Administration Section of Labeling for ‘‘interventions that may be needed’’ case basis during the labeling review Human Prescription Drug and Biological with the phrase ‘‘available process for a specific application. Products—Content and Format’’ (March interventions.’’ In the final rule, FDA Dosing adjustments during 2012), which require that the labeling requires that if use of the drug is pregnancy. FDA proposed that ‘‘Clinical provide details on how to adjust or associated with a maternal adverse Considerations’’ provide information modify the dosage in the ‘‘Dosage and reaction that is unique to pregnancy or about dosing adjustments during Administration’’ section of labeling, if a known adverse reaction occurs with pregnancy (proposed including for specific patient increased frequency or severity in § 201.57(c)(9)(i)(D)(2)(ii)). The proposed populations. pregnant women, the labeling must rule stated that this information must FDA agrees with the suggestion to describe the adverse reaction and also be included in the ‘‘Dosage and remove the phrase ‘‘no data’’ from the available intervention(s) for monitoring Administration’’ and ‘‘Clinical final rule. In the final rule, we have or mitigating the reaction. This change Pharmacology’’ sections of the labeling, removed the requirement to state if also allows for differences that may and that if there are no data on dosing there are no data available on dose exist in community standards of care during pregnancy, the labeling must so adjustments during pregnancy and the and available services across the United state. postpartum period. In addition, as noted States. We note that in the final rule we (Comment 58) One comment in the draft guidance on pregnancy and removed the following language from suggested that dosing information lactation labeling, which is being the codified: ‘‘e.g., monitoring blood should be restricted to the ‘‘Dosage and published concurrently with the final glucose for a drug that causes Administration’’ section of labeling and rule, headings under ‘‘Clinical hyperglycemia in pregnancy.’’ that ‘‘Clinical Considerations’’ should Considerations’’ (including ’’Dose Fetal/Neonatal adverse reactions. cross-reference the ‘‘Dosage and adjustments during pregnancy and the FDA proposed that ‘‘Clinical Administration’’ and ‘‘Clinical postpartum period’’) should be omitted Considerations’’ contain information Pharmacology’’ sections of the labeling if there are no data available or the about any known or anticipated rather than repeat dosing adjustment available data are not relevant. complications in the neonate, including information in the ‘‘Pregnancy’’ Maternal adverse reactions. FDA any interventions that might be needed subsection of labeling. The comment proposed that ‘‘Clinical Considerations’’ (proposed § 201.57(c)(9)(i)(D)(2)(iv)). also suggested replacing the phrase ‘‘no contain information about maternal (Comment 61) Two comments asked data’’ because it could become outdated adverse reactions that are unique to FDA to clarify the meaning of the term and because, in some instances, there pregnancy or adverse reactions that ‘‘complication.’’ One comment may be data but it might not be occur with increased frequency or suggested that if FDA intended the term sufficient to support recommendations severity in pregnant women. The ‘‘complication’’ to mean adverse for dosing adjustments. proposed rule required that the labeling reaction in the neonate, the Agency (Response) We disagree with the also describe any interventions that may should use the term ‘‘adverse reaction.’’ suggestion that all information about be needed, such as monitoring blood This comment also suggested that if an dosing should be restricted to the glucose for a drug that causes adverse reaction/complication has been ‘‘Dosage and Administration’’ section of hyperglycemia in pregnancy (proposed described in the ‘‘Fetal Risk Summary,’’ labeling. FDA has determined that it is § 201.57(c)(9)(i)(D)(2)(iii)). only a cross-reference to important that labeling information (Comment 59) One comment § 201.57(c)(9)(i)(C) should be required to relevant to the use of the drug during suggested that a cross-reference, ‘‘see appear in § 201.57(c)(9)(i)(D)(2)(iv). pregnancy be included in the Pregnancy,’’ be added to the ‘‘Adverse Another comment suggested that FDA ‘‘Pregnancy’’ subsection. These issues Reactions’’ section of labeling to ensure state that a ‘‘complication’’ could be an are discussed in the draft guidance on that health care providers refer to this ‘‘adverse drug reaction,’’ and suggested pregnancy and lactation labeling, which section. that FDA state that the term ‘‘adverse is being published concurrently with (Response) FDA disagrees with this drug reaction’’ may be used when the final rule. If there are comment. The conventions for cross- appropriate. pharmacokinetic data that support dose referencing are explained in FDA’s (Response) FDA agrees that ‘‘adverse adjustment(s) during pregnancy and the guidance for industry on ‘‘Labeling for reaction’’ is a more appropriate term postpartum period, this information Human Prescription Drug and Biological and that it is more consistent with the must be provided under the heading, Products—Implementing the PLR other portions of the final rule. In the ‘‘Dose adjustments during pregnancy Content and Format Requirements’’ final rule, the term ‘‘adverse reaction’’ and the postpartum period’’ in ‘‘Clinical (February 2013). The suggestion that (as defined in § 201.57(b)(7)) has Considerations,’’ and there should be a this rule require a cross-reference from replaced ‘‘complication.’’ Additionally, cross-reference to other sections of the ‘‘Adverse Reactions’’ section to the in the final rule FDA is requiring the labeling that include more details (e.g., ‘‘Pregnancy’’ subsection of labeling is inclusion of information regarding fetal ‘‘Dosage and Administration’’ or not consistent with the conventions set adverse reactions in this section of ‘‘Clinical Pharmacology’’). Although in forth in that guidance. In addition, not labeling. Although the proposed rule the proposed rule FDA had required a every drug product will have only addressed adverse reactions cross-reference to ‘‘Dosage and pregnancy-related adverse reactions; (referred to there as ‘‘complications’’) in Administration’’ and ‘‘Clinical thus, a required cross-reference is the neonate under what in the final rule Pharmacology,’’ we have removed that unnecessary. is required in § 201.57(c)(9)(i)(C), FDA requirement. We believe, however, that (Comment 60) One comment concludes that information intended to when appropriate, a cross-reference suggested that ‘‘Clinical Considerations’’ inform prescribing decisions for should be included. This approach is refer to ‘‘available’’ interventions rather pregnant women appropriately includes consistent with the regulations and than ‘‘needed’’ interventions to avoid information on fetal adverse reactions as guidance applicable to the ‘‘Dosage and interfering with the practice of well as neonatal adverse reactions. FDA Administration’’ section of labeling medicine. does not believe that there is a
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principled distinction between the long-standing position that off-label FDA received comments about the importance of such information with information is not to be included in information required under ‘‘Data’’ in respect to the fetus and with respect to labeling. the proposed rule and made some the neonate. The consistent location (Response) We note that, as stated in changes to the final rule. The following under ‘‘Clinical Considerations’’ of the proposed rule (73 FR 30831 at discussion addresses these comments, information about potential adverse 30844), the language proposed for this our responses, and the changes to the reactions in the fetus as well as in the heading contained only slight final rule. pregnant woman and the neonate, and modifications from that in existing (Comment 63) References. One about available interventions, will make § 201.57(c)(9)(ii). However, because comment suggested that under ‘‘Data,’’ the information in that subsection more important safety information, whether the labeling should include references useful, as well as easier to identify for for an approved or unapproved use, may for the cited data. The comment prescribers and other health care be required to be included in labeling explained that including references for providers. Accordingly, the final rule (see, e.g., § 201.57(c)(6)(i)), we the data would allow clinicians and requires that if it is known or concluded that it is not necessary to other health care workers to further anticipated that maternal drug therapy include specific language regarding this research pregnancy issues. increases the risk of an adverse reaction issue. Therefore, FDA has removed the (Response) We decline this in the fetus or the neonate, the labeling language regarding ‘‘drugs that have a suggestion. FDA has determined that must describe the adverse reaction, the recognized use during labor or delivery, prescription drug labeling is intended to potential severity and reversibility of whether or not the use is stated as an facilitate prescribing decisions and is the adverse reaction, and available indication in the labeling.’’ In the final not intended as a research tool. We also intervention(s) for monitoring or rule, FDA revised the heading ‘‘Drug note that this final rule is a part of mitigating the reaction. effects during labor or delivery’’ to labeling regulations, found at § 201.57, FDA disagrees with the suggestion ‘‘Labor or delivery,’’ which is consistent which address the inclusion of that if an adverse reaction/complication with the level of specificity used in the references in prescription drug labeling has been described in the ‘‘Fetal Risk other headings under ‘‘Clinical (see § 201.57(c)(16)). Summary,’’ only a cross-reference to Considerations.’’ (Comment 64) Postmarketing § 201.57(c)(9)(i)(C) should be required to v. Data. reporting of adverse reactions. One appear in § 201.57(c)(9)(i)(D)(2)(iv). As FDA proposed that the following comment stated that if specific numbers discussed in the draft guidance on information be included in the of adverse event reports are included in pregnancy and lactation labeling, which ‘‘Pregnancy’’ subsection of labeling drug labeling, the labeling will need to is being published concurrently with under the subheading ‘‘Data’’: be constantly updated. The comment the final rule, the ‘‘Clinical (1) Under the subheading ‘‘Data,’’ the suggested that the Agency instead Considerations’’ portion of the labeling ‘‘Pregnancy’’ subsection of the labeling consider using quantitative measures of is intended to describe fetal/neonatal must provide an overview of the data frequency to produce a more stable adverse reactions that are not adverse that were the basis for the fetal risk label. developmental outcomes. Therefore, summary. (Response) FDA acknowledges that because the two portions of the labeling (2) Human and animal data must be the inclusion in labeling of actual address different potential reactions/ presented separately, and human data numbers of postmarketing reports for outcomes, a cross-reference would not must be presented first. particular adverse reactions is often not be appropriate. (3) The labeling must describe the appropriate. We agree that the number Additionally, in the final rule, FDA studies, including study type(s) (e.g., of postmarketing reports of adverse added the requirement that the labeling controlled clinical or nonclinical, reactions changes over time and labeling must describe, if known, the effect of ongoing or completed pregnancy may become rapidly outdated. In dose, timing, and duration of exposure exposure registries, other addition, postmarketing reports of on the risk of an adverse reaction in the epidemiological or surveillance studies), adverse reactions generally do not fetus or neonate as FDA has concluded animal species used, exposure establish an incidence or prevalence of that this information is important for information (e.g., dose, duration, a particular outcome or definitively informing prescribing decisions. timing), if known, and the nature of any demonstrate an association between Drug effects during labor or delivery. identified fetal developmental prenatal exposure to the drug in FDA proposed that the ‘‘Clinical abnormalities or other adverse effect(s). question and the adverse developmental Considerations’’ portion of pregnancy Animal doses must be described in outcome. However, FDA also recognizes labeling contain information about drug terms of human dose equivalents and that there may be isolated situations in effects during labor or delivery for drugs the basis for those calculations must be which reporting of adverse reactions that have a recognized use during labor included. corroborates other human data and, in or delivery, whether or not the use is (4) For human data, positive and these situations, it may be appropriate stated as an indication in the labeling, negative experiences during pregnancy, to list a specific number of cases with or are expected to affect labor or including developmental abnormalities, the date when the reporting was delivery (proposed must be described. To the extent collected. FDA will consider whether § 201.57(c)(9)(i)(D)(3)). applicable, the description must include the labeling for a drug product should (Comment 62) One comment the number of subjects and the duration include specific numbers of reports of supported the proposal to merge of the study. adverse reactions on a case-by-case basis information about labor and delivery (5) For animal data, the relationship based on evaluating all available data into the ‘‘Pregnancy’’ subsection of of the exposure and mechanism of and principles of epidemiology and data labeling. action in the animal species to the interpretation. Another comment expressed concern anticipated exposure and mechanism of In the final rule, FDA replaced the that including information about drugs action in humans must be described. If phrase ‘‘provide an overview of the used during labor or delivery, including this relationship is not known, that data’’ with ‘‘describe the data.’’ FDA drugs that are used off-label during should be stated (proposed made this change to clarify our labor or delivery, conflicts with FDA’s § 201.57(c)(9)(i)(E)). intention that under the subheading
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‘‘Data,’’ the labeling must include a in the preamble to the proposed rule, §§ 201.56(d)(1) and 201.57(c)(9)(ii)). more detailed description of the data the importance of human data in FDA proposed that the ‘‘Lactation’’ than might be understood from use of labeling was stressed by physicians who subsection of prescription drug labeling the term ‘‘overview.’’ In the final rule, participated in focus group testing of the contain the following subheadings: FDA also added the requirement that model labeling format and also by the ‘‘Risk Summary,’’ ‘‘Clinical under ‘‘Data,’’ the labeling describe the FDA advisory committee that provided Considerations,’’ and ‘‘Data’’ (proposed data that are the basis for the ‘‘Clinical input on the proposed format (73 FR § 201.57(c)(9)(ii)). FDA received many Considerations.’’ The proposed rule 30831 at 30841). FDA has determined comments about the proposed stated that ‘‘Data’’ must describe the that human data should always be ‘‘Lactation’’ subsection and made data that were the basis for the fetal risk presented first because human data are changes to the final rule based on these summary, and did not address the data often the most relevant to prescribers, comments. The discussion that follows that were the basis for ‘‘Clinical and animal data may not always be addresses these comments, our Considerations.’’ FDA has determined applicable to humans. responses, and the changes FDA made that there is no principled reason to FDA also proposed that animal doses to the final rule. distinguish between the data under the must be described in terms of human a. General comments. fetal risk summary and that underlying dose equivalents and the basis for those i. Support for ‘‘Lactation’’ subsection ‘‘Clinical Considerations.’’ Accordingly, calculations must be included. (Comment 67) FDA received many the final rule requires that under the (Comment 66) Two comments comments expressing support for the subheading ‘‘Data,’’ the labeling suggested that the final rule remove the proposed ‘‘Lactation’’ subsection. One describe the data that are the basis for requirement to use ‘‘administered dose’’ of these comments explained that it is both the ‘‘Risk Summary’’ and ‘‘Clinical as a comparator between animal and essential for drug labeling ‘‘to carry ’best Considerations.’’ This subheading, human data and to replace it with science’ information that enables therefore, is only required to the extent comparisons based on systemic clinicians to efficiently and thoroughly that there are data that are the basis for exposure, if available. One of these review what is known about the drug these two subheadings and the headings comments explained that basing the and any reported health effects to the under them. comparison on systemic exposure will breast-fed infant.’’ The comment stated FDA has also determined that the provide greater consistency within the that the proposed rule would facilitate information in labeling would be clearer labeling and will also provide a way to more efficient consideration of the data. if human data and animal data appeared more easily make comparisons between (Response) We agree with these separately under applicable headings. In drugs. comments, and our final rule requires the final rule, FDA requires that human (Response) FDA declines this labeling to include a subsection on and animal data be presented separately suggestion to restrict the comparison to lactation with risk and benefit under the headings ‘‘Human Data’’ and only those based on systemic exposure. information related to breastfeeding and ‘‘Animal Data.’’ We agree that comparisons based on the breast-fed infant. In the final rule, FDA requires that for systemic exposure could provide ii. Drug alternatives human data, the labeling must describe consistency within labeling and (Comment 68) One comment adverse developmental outcomes, therefore the final rule requires that they suggested that a statement should be adverse reactions, and other adverse must be included when data are included that many drugs for which we effects. To the extent applicable, the available, but the data are not always may not have lactation data have a labeling must describe the types of available for such a comparison. FDA suitable alternative for which we do studies or reports, number of subjects believes that including the human dose have data. and the duration of each study, equivalent may be more meaningful (Response) We decline to adopt this exposure information, and limitations of information for health care providers, comment. We do not believe it would be the data. The final rule requires that particularly in the absence of data to appropriate to include this type of both positive and negative study make comparisons based on systemic statement in labeling. Because the findings be included. The proposed rule exposure, and as such, in the final rule, comparative risks and benefits will vary listed various types of studies. These a comparison of the animal to human among individual patients, a health care were removed from the final rule doses must be included using the data provider, in consultation with his or her because we determined that it is more available. patient, is in the best position to appropriate to discuss these elements in The proposed rule required that for determine whether there is a ‘‘suitable guidance. animal data under the ‘‘Data’’ alternative’’ for a particular drug. Animal data. FDA proposed that component the relationship of the iii. Validating data human and animal data must be exposure and mechanism of action in (Comment 69) One comment presented separately, and human data the animal species to the anticipated expressed concern about the potential must be presented first. exposure and mechanism of action in for bias or omissions with respect to (Comment 65) One comment humans be described. In the final rule, which data the sponsor includes and the suggested that FDA omit the we removed this requirement because risk statements the sponsor uses to requirement that human data must be often this relationship is not known. characterize such data. The comment presented first. The comment explained The final rule requires that animal doses encouraged FDA to employ all that the most robust data should be or exposures be described in terms of reasonable means to validate the presented first regardless of whether it human dose or exposure equivalents, sponsor’s collection, evaluation, and is animal or human data. and that the basis for those calculations subsequent conclusions regarding (Response) FDA declines this be included. lactation data. suggestion. We have determined that to (Response) FDA agrees. FDA will promote consistency and to meet 2. 8.2 Lactation review data available in literature and readers’ expectations that information FDA proposed that the ‘‘Nursing sponsor-submitted data used for will always be found in the same place, mothers’’ subsection of prescription developing the ‘‘Lactation’’ subsection a fixed order of presentation must be drug labeling be replaced with the of drug labeling. We note that this does maintained. Additionally, as discussed subsection ‘‘Lactation’’ (proposed not require a change to the final rule
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because FDA’s normal review process addition to offering potential FDA proposed that if data for prescription drug labeling includes therapeutic benefit(s), all drugs have demonstrate that a drug is not validating the applicant’s collection, potential side effects and risks involved systemically absorbed, the fetal risk evaluation, and subsequent conclusions with their use. The balance between summary must contain only the regarding data. those benefits and risks is taken into following statement: (Name of drug) is b. Risk summary account not just at the approval stage, not absorbed systemically from (part of i. ‘‘Active metabolites’’ but also helps direct diagnostic and body) and cannot be detected in the (Comment 70) Two comments treatment recommendations for a mother’s blood. Therefore, detectable suggested that FDA revise the ‘‘Risk particular patient in a particular clinical amounts of (name of drug) will not be Summary’’ so that it explicitly refers to scenario. Accordingly, in the final rule present in milk. Breastfeeding is not active metabolites of the drug, in FDA removed the statement ‘‘The use of expected to result in fetal exposure to addition to the drug itself. (name of drug) is compatible with the drug (proposed § 201.57(c)(9)(ii)(A)). (Response) FDA agrees with this breastfeeding.’’ (Comment 72) One comment comment. We also have determined that Breastfeeding offers significant health suggested that the statement be revised it is appropriate to include information benefits to both the child and mother. to focus on the route of administration about the effects of a drug and/or its Different drugs and/or their active rather than on the part of the body active metabolite(s) not only in the metabolites pass into breast milk in where the drug is administered. The ‘‘Risk Summary,’’ but under other different concentrations; they may or comment also suggested that the subheadings in the ‘‘Lactation’’ may not be orally bioavailable in the language ‘‘cannot be detected in blood’’ subsection of labeling. Therefore, the infant, and they may or may not result could be omitted because it is final rule has been revised to refer in significant adverse reactions in the redundant with ‘‘not systemically explicitly to drugs and/or their active short term or adverse outcomes in the absorbed.’’ metabolites. (Response) FDA agrees with this ii. ‘‘Compatible with breastfeeding’’ long term. Often, all of the potential risks related to drug treatment during comment and we removed the phrase FDA proposed that under the ‘‘cannot be detected in blood’’ from the subheading ‘‘Risk Summary,’’ if, as lactation are not known even though the benefits of breastfeeding are known and final rule. described under § 201.57(c)(9)(ii)(A)(1) We also agree with the suggestion to substantial. through (c)(9)(ii)(A)(3) of the section, focus on the route of administration. the data demonstrate that the drug does FDA declines the suggestion to FDA agrees that ‘‘part of the body’’ not affect the quantity and/or quality of include a standardized statement that could be misconstrued and we have human milk and there is reasonable ‘‘sufficient’’ human data exist to determined that the use of ‘‘route of certainty either that the drug is not indicate that the drug does or does not administration’’ to describe how the detectable in human milk or that the adversely affect the breast-fed child, drug enters the body is more consistent amount of drug consumed via breast followed by a supportive narrative. with labeling language that addresses milk will not adversely affect the breast- However, the final rule requires that if dosing and administration. In the final fed child, the labeling must state: The the drug is absorbed systemically, the rule, FDA has replaced ‘‘part of the use of (name of drug) is compatible with labeling must include, under ‘‘Risk body’’ with ‘‘route of administration.’’ breastfeeding. After this statement (if Summary,’’ available information, if (Comment 73) Another comment applicable), the risk summary must relevant, on the known or predicted suggested revising the language summarize the drug’s effect on milk effects on the breast-fed child from ‘‘systemically absorbed’’ to ‘‘has a production, what is known about the exposure to the drug and/or its active systemic effect’’ to include the action of presence of the drug in human milk, metabolite(s), including systemic and/or biological products (vaccines) that are and the effects on the breast-fed child local adverse reactions. If the available immune stimulants rather than (proposed § 201.57(c)(9)(ii)(A)). information is sufficient to determine chemicals that are absorbed. (Comment 71) Two comments that use of the drug is contraindicated (Response) FDA declines the suggested that FDA eliminate the during breastfeeding, this significant suggestion to change the language statement, ‘‘The use of (name of drug) information is required at the beginning ‘‘systemically absorbed’’ to ‘‘has a is compatible with breastfeeding’’ from of the ‘‘Risk Summary.’’ The ‘‘Risk systemic effect.’’ The terms the ‘‘Lactation’’ subsection of the final Summary’’ must state when there are no ‘‘systemically absorbed’’ and ‘‘absorbed rule. One of the comments explained data to assess the effects of the drug on systemically’’ refer to the absorption of that it will be difficult to determine the child. the drug or biological product from its whether a drug is compatible with FDA also revised the final rule to site of administration into serum and/or breastfeeding with such definitive require that if studies demonstrate the other body tissues where the drug or certainty, especially since the term presence of the drug and/or its active biological product, including a vaccine, ‘‘compatible’’ implies safety. Another metabolite(s) in human milk but the can reach its receptor or target cell and comment suggested that in the final rule drug and/or its active metabolite(s) are exert its pharmacological or FDA should replace the statement not expected to be systemically immunological effect. A drug or ‘‘compatible with breastfeeding’’ with a bioavailable to the breast-fed child, then biological product that is not standardized statement that ‘‘sufficient’’ the ‘‘Risk Summary’’ must describe the systemically absorbed will not be human data exist to indicate that the disposition of the drug and/or its active excreted into human milk and, drug does or does not adversely affect metabolite(s). FDA added this therefore, breastfeeding should not the breast-fed child, followed by a requirement to the final rule to identify result in the child’s exposure to the supportive narrative. situations in which a drug and/or its drug. In the final rule, FDA has deleted (Response) FDA agrees that the term active metabolite(s) are present in the sentence, ‘‘Therefore, detectable ‘‘compatible’’ is not clearly defined and human milk but the breast-fed child amounts of (name of drug) will not be implies that the use of a drug during does not have any systemic exposure present in breast milk.’’ The final rule lactation is ‘‘safe.’’ No drug is because of degradation in the also replaces the sentence, completely safe even in a person who is gastrointestinal tract. ‘‘Breastfeeding is not expected to result not pregnant or breastfeeding. In iii. Not systemically absorbed in fetal exposure to the drug’’ with
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‘‘breastfeeding is not expected to result not be used in the ‘‘Risk Summary,’’ and added that clinicians may have in exposure of the child to (name of that a description of available data, if difficulty interpreting the calculations. drug).’’ relevant, on the presence of the drug One comment stated that the (Comment 74) Two comments noted and/or its active metabolite(s) in human concentration of the drug detected in that the term ‘‘fetal’’ was used milk should be used instead. In milk should not be made in reference to improperly in this section of the addition, FDA has determined that, in the maternal dose or the labeled proposed rule. order to provide clarity in the ‘‘Risk pediatric dose. The comment explained (Response) FDA agrees and has Summary,’’ in situations where there are that the concentration of a drug in milk removed the term ‘‘fetal’’ from the no data to assess whether the drug and/ may vary widely depending upon ‘‘Lactation’’ subsection and replaced it or its active metabolite(s) are present in whether it reflects steady-state or a with the term ‘‘child.’’ human milk, the ‘‘Risk Summary’’ must single dose, and could vary based on the iv. Presence of drug in human milk so state. timing between the ingestion of the drug FDA proposed that under the heading (Comment 76) Limits of the assay and taking the sample. The comment ‘‘Presence of drug in human milk’’: used. Two comments suggested omitting suggested that an estimate of the amount (1) The risk summary must describe assay information if the presence of of the drug consumed daily by the the presence of the drug in human milk drug in milk is not detectable. The infant could be made in reference to the in one of the following ways: The drug comments stated that assay information maximum maternal daily dose or the is not detectable in human milk; the is overly technical and unfamiliar for maximum labeled pediatric dose and drug has been detected in human milk; many health care providers. In addition, that ‘‘an estimate of the [percentage] of the drug is predicted to be present in the comments explained that it would the maternal dose excreted in human human milk; the drug is not predicted be presumed that during its review of milk’’ could be omitted. to be present in human milk; or the data the data, the review division at FDA One comment suggested that FDA are insufficient to know or predict would consider the validity of studies, standardize the approach to presenting whether the drug is present in human including the assay’s reliability and drug concentrations in breast milk and milk; stated that this would ensure that sensitivity, before approving the (2) If studies demonstrate that the uniform data are presented by all inclusion in labeling of a statement that drug is not detectable in human milk, manufacturers, allowing for easy the drug is not detectable in human the risk summary must state the limits comparisons between prescription milk. of the assay used; and products. The comment also suggested (3) If the drug has been detected in (Response) FDA declines this that FDA provide a guidance document human milk, the risk summary must comment. We have determined that the highlighting the value of breast milk give the concentration detected in milk limit of the assay is critical to area under the curve (AUC) in reference to a stated maternal dose understanding the amount of the drug concentrations, explaining that (or, if the drug has been labeled for and/or its active metabolite(s) that may providing standardized ways of pediatric use, in reference to the labeled or may not be present in human milk. calculating weight-normalized drug pediatric dose), an estimate of the We also believe that most health care doses and average breast milk amount of the drug consumed daily by providers are capable of interpreting consumption could better guide the infant based on an average daily this data when presented in labeling manufacturers and help create a unified milk consumption of 150 milliliters per and that health care providers are approach to describing drug kilogram of infant weight per day, and familiar with the importance of assay concentrations in breast milk. an estimate of the [percentage] of the limits for all types of laboratory testing. (Response) FDA addresses these maternal dose excreted in human milk In the final rule, FDA has retained the issues in the draft guidance for industry (proposed § 201.57(c)(9)(ii)(A)(2)(i)– requirement from the proposed rule that on ‘‘Clinical Lactation Studies—Study (c)(9)(ii)(A)(2)(iii)). We received if studies demonstrate that the drug Design, Data Analysis, and comments about this portion of the and/or its active metabolite(s) are not Recommendations for Labeling’’ ‘‘Lactation’’ subsection of the proposed detectable in human milk, the ‘‘Risk (February 2005) (the draft guidance on rule. The discussion that follows Summary’’ must state the limits of the clinical lactation studies). addresses these comments, our assay used. FDA agrees that it would be helpful responses, and the changes FDA made (Comment 77) Concentration of the to clinicians to provide infant drug to this portion of the ‘‘Lactation’’ drug detected in human milk. Two exposure dosing in milligrams per subsection of the final rule. comments expressed support for FDA’s kilograms received per day so that a (Comment 75) Predicting whether proposal that the ‘‘Lactation’’ subsection clinician may compare it to a labeled drug is present in human milk. Several of prescription drug labeling provide the infant or pediatric dose if available. comments objected to the proposal that concentration of the drug detected in However, because of the technical the ‘‘Risk Summary’’ state that the drug human milk in reference to a stated considerations for calculating drug and/ is ‘‘predicted’’ or ‘‘not predicted’’ to be adult or labeled pediatric dose. One of or active metabolite levels in milk, FDA present in human milk. One of these these comments suggested that the is not requiring this in the final rule. comments stated that avoiding labeling should also include the FDA has determined that the actual or predictions and relying instead on milligrams per kilogram received per calculated infant daily dose must be clinical data would better assist day and the percentage of the weight- compared to the labeled infant or providers. Two comments suggested equivalent therapeutic dose pediatric dose, when available, and to that the statements about whether the administered to the mother. This the maternal dose when pediatric drug is predicted or not predicted to be comment requested that the doses be dosing is not available. When infant or present in human milk should be presented according to infant age ranges pediatric dosing is available for a drug omitted because the other proposed when possible. A separate comment and pediatric pharmacokinetic data are descriptions effectively cover the range suggested providing a calculation of the available for a drug and/or its active of potential options. estimated infant daily dose consumed as metabolite(s), these data provide an (Response) FDA agrees that the terms compared to available pediatric dosing effective way to estimate comparative ‘‘predicted’’ and ‘‘not predicted’’ should rather than to maternal dosing, but exposure (and potentially comparative
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safety) of a breast-fed child versus a milk production, and if there are no data patients. In the final rule, FDA requires child receiving a drug therapeutically. to assess the effects of the drug and/or that for drugs absorbed systemically, Although not required by the final its active metabolite(s) on milk unless breastfeeding is contraindicated rule, FDA agrees that data presented production, the ‘‘Risk Summary’’ must during drug therapy, a statement that according to infant age groups could be so state. the developmental and health benefits useful given the changes in infant With respect to milk quality and of breastfeeding should be considered hepatic and renal function during the composition, there are currently no along with the mother’s clinical need for first few months of life, and infants’ established standards or documented the drug and any potential adverse increasing ability with age to metabolize population variability for milk content. effects on the breast-fed child from the and clear drugs and/or their active It is also not known how much change drug or from the underlying maternal metabolites. These data may not always in various milk components would condition, must be included at the end be available, but when they are, their reduce the known benefits of of the ‘‘Risk Summary’’ in the presentation stratified by age would be breastfeeding relative to the risks of ‘‘Lactation’’ subsection of labeling. clinically relevant and should be exposure to a drug and/or its active included in labeling. metabolite(s) through breast milk c. Clinical Considerations (Comment 78) ‘‘No data.’’ One combined with any potential effects on FDA proposed that under the comment suggested removing the phrase milk composition and quality. subheading ‘‘Clinical Considerations,’’ ‘‘no data’’ from the ‘‘Risk Summary’’ in Accordingly, in the final rule, FDA has the labeling must provide the following the ‘‘Lactation’’ subsection, because removed the requirement that the ‘‘Risk information to the extent it is available: there are rarely no data for a drug. Summary’’ describe the effect of the (1) Information concerning ways to (Response) FDA disagrees with the drug on the quality and composition of minimize the exposure of the breast-fed suggestion to remove the phrase ‘‘no milk, and the implications of these child to the drug, such as timing the data’’ from the ‘‘Risk Summary.’’ Often, changes to the milk on the breast-fed dose relative to breastfeeding or there are no lactation data (either child. pumping and discarding milk for a human or animal) at the time of specified period; (2) information about approval of NDAs and BLAs. vi. Sufficient Data potential drug effects in the breast-fed v. Effects on milk production and (Comment 80) One comment noted child that could be useful to caregivers, quality that the proposed rule does not require including recommendations for FDA proposed that if the drug is sufficient data to reach conclusions in monitoring or responding to these absorbed systemically, the risk summary the ‘‘Risk Summary’’ in the ‘‘Lactation’’ effects; and (3) information about dosing must describe the effect of the drug on subsection, and suggested that FDA adjustments during lactation. This the quality and quantity of milk, discuss what constitutes sufficient data, information must also be included in including milk composition, and the as it does in the ‘‘Pregnancy’’ the ‘Dosage and Administration’ and implications of these changes to the subsection. ‘Clinical Pharmacology’ sections milk on the breast-fed child (proposed (Response) As discussed previously, (proposed § 201.57(c)(9)(ii)(B)(1)– § 201.57(c)(9)(ii)(A)(1)). many comments disagreed with FDA’s (c)(9)(ii)(B)(3)). FDA received comments (Comment 79) Several comments proposed use of the term ‘‘sufficient’’ in about the proposed ‘‘Clinical stated that it is seldom feasible to the ‘‘Pregnancy’’ subsection of labeling. Considerations’’ subheading. The adequately study the effects of a drug on The comments stated that the term was discussion that follows addresses these the quality and quantity of breast milk, not clearly defined in the proposed rule, comments, our responses, and FDA’s and this information should only be and suggested that it would be difficult changes to the final rule. provided when available. One comment to apply the term consistently across explained that to be scientifically valid, drug labeling. Based on FDA’s i. Other Therapies such evaluation requires a study before, consideration of these comments, the In the Proposed rule, FDA included during, and after drug exposure. This final rule does not refer to ‘‘sufficient’’ sample labeling for several fictitious comment explained that further data in either the ‘‘Pregnancy’’ or the drugs. In the ‘‘Clinical Considerations’’ complicating factors are substantial ‘‘Lactation’’ subsection. portion of the ‘‘Lactation’’ subsection, inter- and intra-individual variation and the ALPHAZINE sample stated that small study sample size. vii. Risk and Benefit Statement ‘‘Other medical therapies are available One comment requested that FDA (Comment 81) FDA received seven for treatment of maternal hypertension.’’ include information about the effects of comments noting that the proposed (Comment 82) Two comments the drug on the woman’s milk supply ‘‘Lactation’’ subsection did not require disagreed with the inclusion of this and other issues that affect the process the inclusion in labeling of any statement. The comments explained that of breastfeeding. The comment stated information about the benefits of the statement is confusing because that many women are advised against breastfeeding. Some of these comments although no comparator data are taking medications that affect milk recommended that FDA add such a presented, clinicians may infer that supply while lactating but are not statement to the final rule to prevent other drugs in the class are safe and informed that this is the reason they patients from unnecessarily foregoing or effective. should avoid these medications. discontinuing breastfeeding. (Response) We note that the language (Response) Although FDA agrees that (Response) FDA acknowledges that to which these comments refer was it is not always possible to determine the proposed rule did not require the included in sample labeling included the effects of a drug and/or its active inclusion of information about the with the proposed rule, and not in the metabolite(s) on milk production, we benefits of breastfeeding. The Agency proposed rule itself. FDA included have determined that when the relevant has determined that the inclusion in the sample labeling with the proposed rule data are available, this information must ‘‘Lactation’’ subsection of labeling of a to serve as examples of how to apply the be included in the labeling. In the final risk and benefit statement will provide requirements of the proposed rule in rule, FDA requires that the ‘‘Risk a useful framework for health care different scenarios. We note that the Summary’’ describe the effects of the providers to use when making final rule does not include sample drug and/or its active metabolite(s) on prescribing decisions for lactating labeling. FDA agrees, however, that
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statements such as, ‘‘Other medical of topical drugs applied to the breast or the breast-fed child that could be useful therapies are available for treatment of nipple skin. to caregivers.’’ maternal hypertension,’’ may be (Comment 84) Topical products. In (Response) FDA acknowledges that confusing, and should not be included the proposed rule, FDA did not provide this portion of the proposed rule in the ‘‘Pregnancy’’ or ‘‘Lactation’’ for inclusion of data regarding topical appeared to require information subsections of labeling. drugs that are not absorbed systemically duplicative of information in the ‘‘Risk by the mother but that may transfer to Summary.’’ We removed the language, ii. Minimizing Exposure to the Breast- ‘‘information about potential drug Fed Child infants during breastfeeding. One comment requested that FDA include a effects in the breast-fed child,’’ from the (Comment 83) General comments. standardized statement in the ‘‘Risk ‘‘Clinical Considerations’’ portion of the Four comments disagreed with the Summary’’ about such drug products. ‘‘Lactation’’ subsection of the final rule. proposal to include information (Response) Situations in which a In the final rule, when relevant regarding minimizing exposure of the topical pharmaceutical product can information is available about potential breast-fed child in the ‘‘Clinical result in infant exposure without adverse effects in an infant due to Considerations’’ portion of the systemic absorption of the product into exposure to the maternal drug and/or its ‘‘Lactation’’ subsection. These maternal serum are limited to topicals active metabolite(s) through human comments explained that inclusion of applied to the skin of the breast, milk, this information must be included this information could discourage especially that of the nipple and areola. in the ‘‘Risk Summary.’’ FDA also women from breastfeeding even when For prescription drug products, these concluded that it was not necessary to there is no reason for concern. One topicals would most likely include characterize information about the comment noted that this information corticosteroids and anti-infectives. FDA potential effects of a drug and/or its should only be included when there is acknowledges that the proposed rule active metabolite(s) on a breast-fed child information that breastfeeding should be as being useful to caregivers because, did not accommodate a situation in withheld during drug therapy and the although caregivers sometimes read which a drug product does not result in timing of pumping and discarding of prescription drug labeling, it is not maternal systemic exposure but could breast milk can be provided. directed at them, and individual health result in infant systemic exposure. In Alternatively, the comment suggested care providers are in the best position to response to this comment, FDA revised stating when information regarding the discuss with their patients information the ‘‘Minimizing exposure’’ portion of timing of pumping and discarding that may be useful for the patients to ‘‘Clinical Considerations’’ to breast milk cannot be provided. Another share with other caregivers. Therefore, accommodate the inclusion of comment noted that this information the reference to information that may be information about such products. In the should not be obligatory when data useful to caregivers also has been suggest that there is not sufficient final rule, FDA added a requirement removed. excretion of the drug in milk to cause that, when applicable, the labeling must FDA acknowledges the comment concern for the infant. The comment also describe ways to minimize a breast- concerning the use of the term explained that including this fed child’s oral intake of topical drugs ‘‘recommendations’’ in the second part information when the ‘‘Risk Summary’’ applied to the breast or nipple skin. of this provision, and in the final rule and ‘‘Data’’ components have already iii. Drug Effects in the Breast-Fed Child has removed the term stated that the drug is compatible with and Monitoring for Adverse Reactions ‘‘recommendations for monitoring’’ and breastfeeding could give the false replaced it with ‘‘available interventions impression that the drug is unsafe for FDA proposed that the ‘‘Clinical for monitoring or mitigating.’’ The final the child and may encourage women to Considerations’’ portion of the rule requires that under ‘‘Clinical discontinue breastfeeding. One ‘‘Lactation’’ subsection of prescription Considerations’’ the labeling describe comment noted that in cases when the drug labeling include information about information about available drug disappears from breast milk with a potential drug effects in the breast-fed interventions for monitoring or known half-life, it is possible to child that could be useful to caregivers, mitigating the adverse reactions minimize infant exposure by including recommendations for described in the ‘‘Risk Summary.’’ We recommending dosing occur at certain monitoring or responding to these note that this language is consistent times related to feeding. effects (proposed with the language in the ‘‘Pregnancy’’ (Response) FDA notes that § 201.57(c)(9)(ii)(B)(2)). subsection. information concerning minimizing (Comment 85) FDA received one exposure to the breast-fed child must be comment about this portion of the iv. Dose Adjustments provided only to the extent it is proposed ‘‘Clinical Considerations.’’ (Comment 86) One comment stated available and relevant. In addition, the The comment suggested that FDA omit that dose adjustment information final rule was revised to clarify that the first part of this provision— should not be included in the information concerning minimizing ’’information about potential drug ‘‘Lactation’’ subsection. The comment drug exposure in the breast-fed child effects in the breast-fed child’’—because suggested that dosing information must be included only if the drug and/ this information duplicates the generally should be restricted to the or its active metabolite(s) are present in information required to appear in the ‘‘Dosage and Administration’’ section of human milk in clinically relevant ‘‘Risk Summary’’ under proposed labeling. concentrations; the drug does not have § 201.57(c)(9)(ii)(A)(3), ‘‘Effects of drug (Response) FDA agrees with the an established safety profile in infants; on the breast-fed child.’’ The comment suggestion that we omit information and the drug is used either also stated that the term about dose adjustments from the intermittently, in single doses, or for ‘‘recommendations’’ in the second part ‘‘Lactation’’ subsection of prescription short courses of therapy. As discussed of this provision could interfere with drug labeling, although this decision is further in our response to Comment 84, the practice of medicine. The comment not based on a conclusion (as suggested the final rule also requires that, when suggested the following language: in the comment) that dosing information applicable, the labeling describe ways to ‘‘Information about ways to monitor for, generally should be restricted to the minimize a breast-fed child’s oral intake or respond to, potential drug effects in ‘‘Dosage and Administration’’ section of
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labeling. FDA has determined that other animal data in the ‘‘Lactation’’ infertility be relocated in labeling under than during the immediate postpartum subsection. subsection ‘‘8.3 Females and Males of period when a woman’s physiology is (Response) The preamble to the Reproductive Potential.’’ FDA is adding reverting from a pregnant to a proposed rule did not include a this requirement to the final rule based nonpregnant state, a lactating woman is discussion of animal lactation data, and on public comments regarding these unlikely to require dose adjustments for the inclusion of animal lactation data issues, and based on the Agency’s drugs. The physiological changes was not addressed in the codified conclusion that this information should associated with lactation are unlikely to section of the proposed rule. In the final be presented in labeling in a consistent result in pharmacokinetic changes rule, under ‘‘Risk Summary,’’ FDA location. Subsection ‘‘8.3 Females and significant enough to warrant maternal defines situations for which animal Males of Reproductive Potential’’ dose adjustments. Therefore, FDA has lactation data must and must not be includes three subheadings, ‘‘Pregnancy determined that all available and included in the ‘‘Lactation’’ subsection. Testing,’’ ‘‘Contraception,’’ and relevant information about dose Animal lactation data can be helpful in ‘‘Infertility.’’ Each subheading should adjustments during pregnancy and the predicting whether a drug and/or its only be included if it is applicable or if postpartum period must be included in active metabolite(s) will be present in relevant information is available, and the ‘‘Pregnancy’’ subsection of labeling. human milk; however, because of Section 8.3 should be omitted in its In the final rule, FDA has removed the species-specific differences in lactation entirety if none of the subheadings are requirement that information about physiology, animal lactation data applicable. The comments are discussed dosing adjustments during lactation be typically do not reliably predict drug in detail in our responses to Comments included in the ‘‘Lactation’’ subsection levels in human milk. FDA added a 88, 89, and 90. of labeling. requirement to the final rule that when Information concerning pregnancy relevant human lactation data are testing, contraception, and infertility is d. Data available, animal data must not be important for informing decisions made FDA proposed that under the included unless the animal model is by patients, in consultation with their subheading ‘Data,’ the ‘Lactation’ specifically known to be predictive for health care providers, regarding the use subsection of the labeling must provide humans. In addition, under ‘‘Risk of prescription drugs before or during an overview of the data that are the Summary,’’ ‘‘Presence of drug in human pregnancy. This information is in many basis for the risk summary and clinical milk,’’ FDA clarified that if only animal ways inherently linked to the scientific considerations (proposed lactation data are available, the ‘‘Risk and medical rationale underpinning the § 201.57(c)(9)(ii)(C)). FDA received Summary’’ must state only whether or Pregnancy subsection of prescription comments about this portion of the rule. not the drug and/or its active drug labeling. However, in the course of One comment expressed support for metabolite(s) were detected in animal developing this final rule, and in presenting lactation data under ‘‘Data’’ milk and specify the animal species. particular in evaluating comments 88, when available. The other comments Although animal data do not reliably 89, and 90, FDA concluded that because and changes we made in response to predict whether a drug and/or its active there was no consistent placement in those comments are explained in this metabolite(s) will be present in human the labeling of information about section of the document. milk, in the absence of human data, pregnancy testing, contraception, and FDA determined that the fact that a drug infertility, it was difficult for health care (Comment 87) FDA received and/or its active metabolite(s) were or providers to find this important comments requesting that the Agency were not detected in animal milk may information. For example, clinical clarify when animal lactation data nevertheless be useful in informing advice on infertility might be found should be included in labeling. Several prescribing decisions. with the discussion of animal data in comments questioned the usefulness of In the final rule, FDA revised the the ‘‘Nonclinical Toxicology’’ section, in animal lactation data in the absence of ‘‘Data’’ portion of the ‘‘Lactation’’ the ‘‘Adverse Reactions’’ section, or in clinical data. One comment stated that subsection to require that the labeling the ‘‘Warnings and Precautions’’ extrapolation of animal data to humans ‘‘describe the data that are the basis for section. Contraception and pregnancy may not be helpful without stating what the Risk Summary and Clinical testing recommendations for known or is known about the correlation to Considerations’’ and removed the suspected teratogens might be found in humans. requirement that the labeling ‘‘provide the ‘‘Pregnancy’’ subsection or in the Several comments stated that only an overview of the data.’’ FDA made ‘‘Warnings and Precautions’’ section. human data should be presented when this change to clarify that under ‘‘Data,’’ (Comment 88) FDA received one it is available. Two comments requested the labeling must include a more comment suggesting that the new that if, in cases where both human and detailed description of the data than labeling explicitly state that a woman animal data are available, FDA decides might be understood from use of the taking drugs with potential or known to retain the requirement that both kinds term ‘‘overview,’’ as well as to maintain adverse effects on pregnancy outcomes of data be presented, the ‘‘Lactation’’ consistency between the ‘‘Data’’ should (1) consider using reliable subsection be revised to state that portions of the ‘‘Lactation’’ and contraception if she does not intend to clinical data are to be presented before ‘‘Pregnancy’’ subsections. Furthermore, become pregnant or (2) if she does preclinical data. this subheading is only required to the intend to become pregnant, seek One comment requested additional extent that there are data that are the consultation with her health care clarification regarding the quantity and basis for the Risk Summary and Clinical provider to discuss medical quality of animal data that would Considerations subheadings, and the management of her health condition support inclusion of the data in headings under them. before becoming pregnant, if possible. labeling, and asked that FDA provide (Response) FDA agrees that when a sample labeling for a drug for which 3. 8.3 Females and Males of drug has a potential or known adverse only animal lactation data are available. Reproductive Potential effect on pregnancy outcomes (e.g., is a Another comment suggested that the In the final rule, FDA is adding a known or suspected human teratogen), labeling state when there is an absence requirement that information regarding information regarding recommendations of available or sufficient human and/or pregnancy testing, contraception, and or requirements regarding contraception
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use must be included in prescription developmental toxicity and the transfer subsection ‘‘8.3. Females and Males of drug labeling. In the final rule, FDA of semen is unknown. This comment Reproductive Potential.’’ In addition, requires that when contraception is suggested that statements addressing when there are contraception required or recommended before, this issue be added when the recommendations based on animal during, or after drug therapy, this information is required for the product. mutagenesis data, this information must information must be included under the One of the comments suggested that be included in subsection 8.3 under the subheading ‘‘Contraception’’ in FDA add a section to the final rule that Contraception subheading. Because the subsection ‘‘8.3 Females and Males of addresses prescribing information for same concerns about drug-associated Reproductive Potential.’’ In addition, it male patients with a partner of fertility effects apply to human data, may be appropriate to include in this reproductive potential or a pregnant FDA has determined that human data subsection information concerning partner. Another comment suggested that raise such concerns also must be counseling females of reproductive that the risk conclusion statement included in the ‘‘Infertility’’ subsection. potential about pregnancy planning. specify whether it is based on maternal With respect to the question about Furthermore, the concerns expressed or paternal exposure when that cross-referencing, subsection 8.3 should in the comment regarding the inclusion information is available. cross-reference the applicable animal of information about contraception use (Response) FDA agrees that when data included in subsection 13.1, when taking a drug with potential or relevant information is available, this consistent with FDA’s cross-referencing known adverse effects on pregnancy information should be included in regulations (e.g., § 201.57(c)(1), outcomes apply equally to information labeling. In the final rule, FDA requires (c)(6)(iv), and (c)(15)(ii)). The draft about pregnancy testing, particularly that information about recommended or guidance on pregnancy and lactation when a drug is a known or suspected required use of contraception by men be labeling, which is being published human teratogen. Therefore, FDA has included under the subheading concurrently with this final rule, determined that information regarding ‘‘Contraception’’ in subsection ‘‘8.3 addresses these issues. recommendations or requirements Females and Males of Reproductive IV. Implementation concerning pregnancy testing before, Potential.’’ during, or after drug therapy must also (Comment 90) FDA received one FDA proposed that holders of be included in prescription drug comment requesting that the Agency applications (including an NDA, BLA, labeling. In the final rule, FDA requires clarify how and when animal data or efficacy supplement) approved before that this information be included under described in subsection 13.1 of labeling June 30, 2001, would be required to the subheading ‘‘Pregnancy Testing’’ in (‘‘Carcinogenesis, Mutagenesis, remove the pregnancy category from subsection ‘‘8.3 Females and Males of Impairment of Fertility’’) that raises their labeling within 3 years after the Reproductive Potential.’’ concerns about mutagenesis, effective date of this rule. These (Comment 89) FDA received three impairment of fertility, or pre- applications are those that are not comments noting that the ‘‘Pregnancy’’ implantation loss should be included in subject to the requirements of the PLR. subsection of the proposed rule only subsection ‘‘8.1 Pregnancy.’’ The For drugs with applications (including addresses risks to the fetus when the comment also requested that FDA an NDA, BLA, or efficacy supplement) drug is administered to a pregnant clarify when it would be appropriate to approved on or after June 30, 2001, FDA woman, and it does not address the move information from subsection 13.1 proposed a phased-in implementation potential for manifestations of to subsection 8.1 or to cross-reference plan that would stagger the required developmental toxicity associated with subsection 13.1 in subsection 8.1. dates these products would be required fetal drug exposure from transfer of drug (Response) As stated previously, FDA to replace the content and formatting of through semen to the maternal and fetal concluded that it is important to include the pregnancy and lactation subsections circulations. One of the three comments information about drug-associated of their labeling with the new content noted that the proposed rule does not fertility effects in labeling in a and formatting required by this rule. address the potential for manifestations consistent location and manner. In the These applications are those that are of developmental toxicity associated final rule, animal data that raise subject to the requirements of the PLR. with exposure resulting from transfer concerns about drug-associated Table 1 contains the implementation through the semen or the need for male impairment of fertility and/or pre- plan that was included in the proposed contraception when a compound is implantation loss effects must be rule. In table 1, ‘‘Applications’’ includes determined to have a predicted risk of included under ‘‘Infertility’’ in NDAs, BLAs, and efficacy supplements.
TABLE 1—IMPLEMENTATION PLAN
Applications required to conform to new pregnancy/lactation Time by which labeling with new pregnancy/lactation content must be content requirements submitted to FDA for approval
New or Pending Applications
Applications submitted on or after the effective date of the pregnancy Time of submission. final rule. Applications pending on the effective date of the pregnancy final rule ... 4 years after the effective date of pregnancy final rule or at time of ap- proval, whichever is later.
Approved Applications Subject to the Physician Labeling Rule
Applications approved any time from June 30, 2001, up to and includ- 3 years after the effective date of pregnancy final rule. ing June 29, 2002, and from June 30, 2005, up to and including June 29, 2007. Applications approved any time from June 30, 2007, up to and includ- 4 years after the effective date of pregnancy final rule. ing the effective date of the pregnancy final rule.
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TABLE 1—IMPLEMENTATION PLAN—Continued
Applications required to conform to new pregnancy/lactation Time by which labeling with new pregnancy/lactation content must be content requirements submitted to FDA for approval
Applications approved from June 30, 2002, up to and including June 5 years after the effective date of pregnancy final rule. 29, 2005.
(Comment 91) Two comments stated pregnancy categories will be removed FD&C Act and by the PHS Act. Section that the proposed implementation plan from the labeling for some drugs before 502(a) of the FD&C Act deems a drug to was confusing. One of these comments the new content required by the rule be misbranded if its labeling is false or requested that FDA explain the rationale will be added to the labeling, and this misleading ‘‘in any particular.’’ Under supporting the implementation could cause confusion among doctors section 201(n) of the FD&C Act (21 schedule. Another comment stated the and patients. U.S.C. 321(n)), labeling is misleading if proposed phased-in approach for (Response) We would like to clarify it fails to reveal facts that are material previously approved drugs may generate that a holder of an application that is with respect to consequences that may confusion. The comment explained that not subject to the PLR, and thus, not result from the use of the drug under the if drug labeling information and drug subject to the new content and format conditions of use prescribed in the reference materials contain pregnancy requirements of this final rule, must labeling or under customary or usual information that is inconsistent between remove the pregnancy category from its conditions of use. Section 502(f) of the newly approved and previously labeling within 3 years after the FD&C Act deems a drug to be approved drugs through a 3- to 5-year effective date of this rule. A holder of misbranded if its labeling lacks period, confusion may limit the an application that is subject to the PLR adequate directions for use and understanding of the new labeling. and thus, subject to the new content and adequate warnings against use in those Comments disagreed about whether format requirements of this rule, is not pathological conditions where its use the length of the implementation required to remove the pregnancy may be dangerous to health, as well as schedule was reasonable. One comment category until such time that it is adequate warnings against unsafe stated that the long implementation required to submit revised labeling with dosage or methods or duration of timeline will delay the delivery of the new content and format, even if that administration or application, in such complete information. Another occurs more than 3 years after the manner and form, as are necessary for comment stated that FDA should effective date of the final rule. FDA did the protection of users. Section 502(j) of expedite the implementation schedule not intend to suggest that application the FD&C Act deems a drug to be for licensed drugs that are necessary to holders of previously approved misbranded if it is dangerous to health maintain the health status of the mother applications subject to the PLR might, in when used in the dosage or manner, or and could harm the fetus if the mother some circumstances, be required to with the frequency or duration, is left untreated. This comment also revise labeling twice as a part of prescribed, recommended, or suggested suggested that the Agency should make implementation. Therefore, if a holder in its labeling. supplemental information available in of an application is subject to the PLR, In addition, the premarket approval advance of the printed label. Another FDA does not anticipate that the provisions of the FD&C Act authorize comment, however, expressed support pregnancy category will be removed FDA to require that prescription drug for the proposal to give sponsors 3 years from the labeling prior to submitting the labeling provide the practitioner with after the effective date of the rule to revised labeling with the new content adequate information to permit safe and remove the pregnancy categories. and format for that product under the effective use of the drug product. Under (Response) The Agency has taken all PLLR implementation schedule. In section 505 of the FD&C Act, FDA will of these comments into consideration, conjunction with the publication of the approve an NDA only if the drug is and has decided to maintain the final rule, the Agency is planning to shown to be both safe and effective for implementation schedule that was launch an education campaign for all use under the conditions set forth in the published in the proposed rule. The stakeholders, including health care drug’s labeling. Section 701(a) of the implementation schedule follows the providers and professional FD&C Act (21 U.S.C. 371(a)) authorizes timetable used for implementation of organizations, to ensure that they are FDA to issue regulations for the efficient the PLR and works to balance the well informed about the changes. enforcement of the FD&C Act. anticipated workload for the review of Under 21 CFR 314.125, FDA will not labels. The purpose of having a V. Legal Authority approve an NDA unless, among other staggered approach is to avoid things, there is adequate safety and A. Statutory Authority overburdening both the Agency and effectiveness information for the labeled industry. The implementation plan for FDA is revising its regulations on the uses and the product labeling complies the final rule (also referred to as the format and content of the ‘‘Pregnancy,’’ with the requirements of part 201. Pregnancy and Lactation Labeling Rule ‘‘Labor and delivery,’’ and ‘‘Nursing Under § 201.100(d) of FDA’s (PLLR)) is modeled from the mothers’’ subsections of the ‘‘Use in regulations, a prescription drug product implementation plan for the PLR and Specific Populations’’ section (under must bear labeling that contains experience acquired from that plan. The § 201.57) and the ‘‘Precautions’’ section adequate information under which PLLR implementation timeline also (under § 201.80) of the labeling for licensed practitioners can use the drug depends on the PLR implementation human prescription drugs (in addition safely for their intended uses. This final and the extent to which applications are to the list of headings and subheadings rule amends the regulations specifying subject to the PLR. under § 201.56(d)(1)). the format and content for such labeling. (Comment 92) One comment FDA’s revisions to the content and Section 351 of the PHS Act (42 U.S.C. expressed concern that under the format requirements for prescription 262) provides legal authority for the proposed implementation schedule, the drug labeling are authorized by the Agency to regulate the labeling and
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shipment of biological products. options that would minimize any annualized costs equal about $9.2 Licenses for biological products are to significant impact of a rule on small million. be issued only upon a showing that they entities. Because our analysis suggests The final rule will require that meet standards ‘‘designed to insure the that some small prescription drug applicants comply with new labeling continued safety, purity, and potency of manufacturers and prescription drug content and format requirements for such products’’ prescribed in repackagers and relabelers will incur affected subsections for prescription regulations (section 351(d) of the PHS costs that total more than 1 percent of drug and biological product labeling Act). The ‘‘potency’’ of a biological their annual income in some years, the subject to the PLR under § 201.57(c)(9) product includes its effectiveness (21 Agency finds that the final rule will (PLR labeling) and will require that CFR 600.3(s)). Section 351(b) of the PHS have a significant economic impact on applicants remove the pregnancy Act prohibits false labeling of a a substantial number of small entities. category from all prescription drug and biological product. FDA’s regulations in Section 202(a) of the Unfunded biological product labeling subject to part 201 apply to all prescription drug Mandates Reform Act of 1995 requires § 201.80(f)(6)(i) (non-PLR labeling). The products, including biological products. that Agencies prepare a written ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ and statement, which includes an B. First Amendment ‘‘Nursing mothers’’ subsections of the assessment of anticipated costs and ‘‘Use in Specific Populations’’ section FDA’s requirements for the content benefits, before proposing ‘‘any rule that will be replaced by the ‘‘Pregnancy,’’ and format of the ‘‘Pregnancy’’ and includes any Federal mandate that may ‘‘Lactation,’’ and ‘‘Females and Males of ‘‘Lactation’’ subsections of labeling for result in the expenditure by State, local, Reproductive Potential’’ subsections. prescription drug products are and tribal governments, in the aggregate, New information will be required to constitutionally permissible because or by the private sector, of $100,000,000 summarize the key information needed they are reasonably related to the or more (adjusted annually for inflation) by health care providers treating females government’s interest in ensuring the in any one year.’’ The current threshold and males of reproductive potential. safe and effective use of prescription after adjustment for inflation is $141 The information in these subsections drug products and because they do not million, using the most current (2013) will be presented in a narrative, impose unjustified or unduly Implicit Price Deflator for the Gross following a standardized order and burdensome disclosure requirements. In Domestic Product. FDA does not expect format with clear subheadings. this final rule to result in any 1-year the PLR, FDA explained in greater depth The primary objectives of the final expenditure that would meet or exceed why that rule passes muster under the rule are to improve labeling by updating First Amendment (see 71 FR 3922 at this amount. The first regulations on the content the content and format of these 3964, January 24, 2006). That analysis is subsections of prescription drug product equally applicable to this final rule, and and format of prescription drug labeling were established in 1979, including the labeling, and to remove the pregnancy we hereby adopt that discussion by category system. The Agency concluded reference. requirement to assign drugs to one of five pregnancy categories. Over time, that following a standardized structure VI. Environmental Impact however, labeling became long, is essential for effective communication. repetitive, and difficult to use. With the The final rule is needed to ensure that The Agency has determined under 21 these subsections contain the most up- CFR 25.30(h) that this action is of a type PLR in 2006, the Agency began to apply modern principles of effective to-date information available and that does not individually or provide prescribers with clinically cumulatively have a significant effect on communication to improve the quality of prescription drug labeling. However, relevant data that they can use in their the human environment. Therefore, decisionmaking processes. Consistent neither an environmental assessment the PLR left the content of the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ and with the approach taken by the PLR, the nor an environmental impact statement Agency intends to provide applicants is required. ‘‘Nursing mothers’’ subsections of the ‘‘Use in Specific Populations’’ section with clear guidance about the required VII. Summary of Final Regulatory untouched. This decision gave the content and format. Concurrent with the Impact Analysis Agency sufficient time to meet with publication of this final rule, FDA is issuing a draft guidance for industry on A. Introduction experts and stakeholders to develop a regulatory framework that encourages ‘‘Pregnancy, Lactation, and FDA has examined the impacts of the applicants to prepare content that Reproductive Potential: Labeling for final rule under Executive Order 12866, clearly communicates available Human Prescription Drug and Biological Executive Order 13563, the Regulatory information about prescription drug use Products—Content and Format.’’ Flexibility Act (5 U.S.C. 601–612), and during pregnancy and lactation, and in The level of effort needed to comply the Unfunded Mandates Reform Act of females and males of reproductive with the requirements of the final rule 1995 (Public Law 104–4). Executive potential. With this final rule, the will depend on the type of labeling (PLR Orders 12866 and 13563 direct Agencies Agency specifically addresses the or non-PLR labeling) and the length of to assess all costs and benefits of content and format of these subsections. time the product has been marketed. available regulatory alternatives and, Applicants and persons responsible for when regulation is necessary, to select B. Summary of Costs and Benefits existing prescription drug and biological regulatory approaches that maximize The final regulatory impact analysis product labeling will incur one-time net benefits (including potential of the final rule (Ref. 2) is available at costs to revise existing labeling in years economic, environmental, public health http://www.fda.gov/AboutFDA/ 3, 4, and 5. Applicants submitting new and safety, and other advantages; ReportsManualsForms/Reports/ BLAs, NDAs, and certain efficacy distributive impacts; and equity). The EconomicAnalyses/default.htm. Table 2 supplements will incur one-time costs Agency believes that this final rule is presents a summary of the annualized to gather and organize new content not a significant regulatory action under costs and benefits of the final rule over required by the final rule at the time Executive Order 12866. 10 years. With a 7 percent discount rate, they prepare labeling for the application The Regulatory Flexibility Act annualized costs equal about $9.5 or supplement. In addition, we estimate requires Agencies to analyze regulatory million; with a 3 percent discount rate, the additional annual printing costs for
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longer PLR labeling that will include million. The present value of the total years, the annualized present value will new content. costs will equal $78.2 million with a 3 equal $9.2 million with a 3 percent We estimate that the total cost of the percent discount rate and $66.8 million discount rate and $9.5 million with a 7 rule over 10 years will equal about $88.7 with a 7 percent discount rate. Over 10 percent discount rate.
TABLE 2—ECONOMIC DATA: COSTS AND BENEFITS ACCOUNTING STATEMENT
Units Category Primary Low High Discount Period Notes estimate estimate estimate Year rate covered dollars (percent) (years)
Benefits: Annualized ...... 7 ...... Monetized $millions/year ...... 3 ...... Annualized ...... 7 ...... Quantified ...... 3 ......
Qualitative ...... Improved quality of prescription drug labeling for health care providers
Costs: Annualized ...... $9.5 ...... 2011 7 10 ...... Monetized $millions/year .... 9.2 ...... 2011 3 10 ...... Annualized ...... 7 ...... Quantified ...... 3 ...... Qualitative ...... Transfers: Federal Annualized ...... 7 ...... Monetized $millions/year ...... 3 ......
From/To: From: To:
Other Annualized ...... 7 ...... Monetized $millions/year ...... 3 ......
From/To: From: To:
Effects:
State, Local or Tribal Government: No effect
Small Business: The final rule will have significant impacts on some small pharmaceutical manufacturers and prescription drug repackagers and relabelers.
Wages: No effect
Growth: No effect
VIII. Paperwork Reduction Act of 1995 Title: Content and Format of Labeling and counsel women about the use of for Human Prescription Drug and drugs during pregnancy and lactation. This final rule contains information Biological Products; Requirements for The final rule eliminates the current collection requirements that are subject Pregnancy and Lactation Labeling pregnancy categories A, B, C, D, and X. to review by the Office of Management Description: The final rule amends In addition, the ‘‘Labor and delivery’’ and Budget (OMB) under the Paperwork FDA regulations concerning the content subsection has been eliminated because Reduction Act of 1995 (the PRA) (44 and format of the ‘‘Pregnancy,’’ ‘‘Labor information on labor and delivery is U.S.C. 3501–3520). The title, and delivery,’’ and ‘‘Nursing mothers’’ included in the ‘‘Pregnancy’’ subsection. description, and respondent description subsections of the ‘‘Use in Specific The final rule also requires that the of the information collection provisions Populations’’ section of the labeling for labeling include relevant information are shown in the following paragraphs human prescription drugs. The final with an estimate of the total reporting rule requires that labeling include, about pregnancy testing, contraception, and disclosure burdens. Included in the among other things, a summary of the and infertility for health care providers estimate is the time for reviewing risks of using a drug during pregnancy prescribing for females and males of instructions, searching existing data and lactation and a discussion of the reproductive potential. The final rule is sources, gathering and maintaining the data supporting that summary. The intended to create a consistent format data needed, and completing and labeling also includes relevant for providing information about the reviewing each collection of information to help health care risks and benefits of prescription drug information. providers make prescribing decisions and/or biological product use during
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pregnancy and lactation and by females • Supplements to applications in accordance with §§ 201.56, 201.57, and males of reproductive potential. approved from June 30, 2001, to the and 201.80 is approved by OMB under Under § 201.57(c)(9)(i) and (c)(9)(ii), effective date of the final rule control numbers 0910–0572 and 0910– holders of approved applications are (§§ 314.70(b), 601.12(f)(1)); 0001. required to provide new labeling • Annual reports for applications In addition, FDA estimates that content in a new format—that is, to approved before June 30, 2001, that approximately 10,150 supplements to rewrite the pregnancy and lactation contain a pregnancy category, to report applications approved from June 30, portions of each drug’s labeling. Under removal of the pregnancy category letter 2001, to the effective date of the final § 201.57(c)(9)(iii), these application in their labeling (§§ 314.70(d), rule, or pending on the effective date, holders are also required to include a 601.12(f)(3)). will be submitted to FDA during the new subsection 8.3, ‘‘Females and Males The information collection third, fourth, and fifth years after the of Reproductive Potential,’’ which requirements and burden estimates are effective date to update labeling in requires that when pregnancy testing or summarized in tables 3 and 4 of this accordance with this final rule. This contraception is required or document. The burden estimates are estimate includes approximately 1,080 recommended before, during, or after based on data and timeframes used for NDA, BLA, and efficacy supplements, drug therapy or when there are human section VII of this document (Summary approximately 1,320 ANDA or animal data that suggest drug- of Final Regulatory Impact Analysis) supplements, and labeling supplements associated fertility effects, this and for the final regulatory impact from repackagers and relabelers for subsection must contain this analysis of the final rule (available at approximately 7,750 drug products. information. These application holders http://www.fda.gov/AboutFDA/ FDA estimates that approximately 390 are required to submit supplements ReportsManualsForms/Reports/ application holders and repackagers and requiring prior approval by FDA before EconomicAnalyses/default.htm). FDA relabelers will submit these distribution of the new labeling, as estimates that approximately 4,000 supplements, and that it will take applications containing labeling required in § 314.70(b) or § 601.12(f)(1). approximately 120 hours to prepare and consistent with this rulemaking will be Under § 201.80(f)(6)(i), holders of submit each supplement. submitted to FDA during the 10-year approved applications are required to period on or after the effective date of FDA also estimates that remove the pregnancy category the final rule by approximately 390 approximately 5,500 annual reports will designation (e.g., ‘‘Pregnancy Category applicants and repackagers and be submitted to FDA during the third C’’) from the ‘‘Pregnancy’’ subsection of relabelers. The estimate of 4,000 year after the effective date for the ‘‘Precautions’’ section of the applications includes labeling for applications approved before June 30, labeling. These application holders approximately 800 applications 2001, that contain a pregnancy category must report the labeling change in their submitted under section 505(b) of the (5,500 includes annual reports for annual reports, as required in FD&C Act or section 351 of the PHS Act, approximately 1,340 NDAs and BLAs § 314.70(d) or § 601.12(f)(3). and 1,200 applications submitted under and approximately 4,160 ANDAs The new content and format section 505(j) of the FD&C Act, and containing labeling changes resulting requirements of the final rule apply to revised labeling from repackagers and from this rulemaking). FDA estimates all applications that are required to relabelers for approximately 2,000 drug that approximately 320 application comply with the PLR, including: (1) products. This estimate also includes holders will submit these annual Applications submitted on or after the labeling amendments submitted to FDA reports, and that it will take effective date of the final rule; (2) for applications pending on the effective approximately 40 hours for each applications pending on the effective date of the final rule. Based on data submission. date of the final rule; and (3) provided in section VII of this document As indicated in tables 3 and 4 of this applications approved from June 30, and in the final regulatory impact document, we estimate that the total 2001, to the effective date of the final analysis of the final rule, FDA estimates hours resulting from the information rule. that for future approvals it will take collection in this rulemaking will be The following submissions under the applicants approximately 40 hours to approximately 1,598,000 hours. The final rule are subject to the PRA: prepare and submit labeling consistent costs associated with this rulemaking, • Applications submitted on or after with this rulemaking. The estimate of 40 including labor costs, are discussed in the effective date of the final rule hours applies only to the requirements section VII of this document and in the (§§ 314.50, 314.70(b), 601.2, of this rulemaking and does not indicate final regulatory impact analysis of the 601.12(f)(1)); the total hours required to prepare and final rule. • Amendments to applications submit complete labeling for these Description of Respondents: Persons pending on the effective date of the final applications. The information collection and businesses, including small rule (§§ 314.60, 601.2, 601.12(f)(1)); burden to prepare and submit labeling businesses and manufacturers.
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average Type of submission Number of responses per Total annual burden per Total (21 CFR section) respondents respondent responses response hours
Supplements to applications approved 6/30/ 390 26 10,150 (Submitted 3rd, 4th, 120 1,218,000 01 to effective date (§§ 314.70(b), and 5th years after effec- 601.12(f)(1)). tive date). Annual report submission of revised labeling 320 17 5,500 (Submitted 3rd year 40 220,000 for applications approved before 6/30/01 after effective date). that contain a pregnancy category (§§ 314.70(d), 601.12(f)(3)).
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TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average Type of submission Number of responses per Total annual burden per Total (21 CFR section) respondents respondent responses response hours
Total ...... 1,438,000 1 There are no capital costs or operating and maintenance costs associated with this information collection.
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Type of submission Number of disclosures Total annual Average Total (21 CFR section) respondents per disclosures burden per ours respondent disclosure
New NDAs/ANDAs/BLAs/efficacy supplements 390 10 4,000 (Submitted during 40 160,000 submitted on or after effective date, including 10-year period after amendments to applications pending on effec- effective date). tive date (§§ 314.50, 314.60, 314.70(b), 601.2, 601.12(f)(1)). 1 There are no capital costs or operating and maintenance costs associated with this information collection.
The information collection provisions through Friday, and are available 7. U.S. Food and Drug Administration of this final rule have been submitted to electronically at http:// ‘‘Guidance for industry, Establishing OMB for review, as required by section www.regulations.gov. (FDA has verified Pregnancy Exposure Registries,’’ 2002. 3507(d) of the PRA. Prior to the effective all Web site addresses in this reference 8. U.S. Food and Drug Administration ‘‘Guidance for Industry, Reproductive date of this final rule, FDA will publish section, but we are not responsible for and Developmental Toxicities— a notice in the Federal Register any subsequent changes to the Web sites Integrating Study Results to Assess announcing OMB’s decision to approve, after this document publishes in the Concerns,’’ 2011. modify, or disapprove the information Federal Register.) 9. Rynn, L., J. Cragan, and A. Correa, ‘‘Update on Overall Prevalence of Major Birth collection provisions in this final rule. 1. Decision Partners, LLC, ‘‘Evaluation of Defects—Atlanta, Georgia, 1978–2005.’’ An Agency may not conduct or sponsor, How Best to Communicate to Healthcare and a person is not required to respond Centers for Disease Control and Providers about the Risks and Benefits of Prevention Morbidity and Mortality to, a collection of information unless it Prescription Drug Use for Pregnant and displays a currently valid OMB control Weekly Report. 57(01):1–5, January 11, Nursing Women: A Mental Models 2008. number. Research Report,’’ September 2009 10. American College of Obstetricians and (available at http://www.fda.gov/ IX. Federalism Gynecologists Frequently Asked AboutFDA/ReportsManualsForms/ Questions: Miscarriage and Molar FDA has analyzed this final rule in Reports/EconomicAnalyses/default.htm). Pregnancy, 2011 (available at http:// accordance with the principles set forth 2. Final Regulatory Impact Analysis for www.acog.org/∼/media/For%20Patients/ in Executive Order 13132. FDA has Docket No. FDA–2006–N–0515 (formerly faq090.pdf?dmc=1&ts=20140130T determined that this final rule does not Docket No. 2006N–0467) (available at 1655496642). contain policies that have substantial http://www.fda.gov/AboutFDA/Reports 11. U.S. Food and Drug Administration, direct effects on the States, on the ManualsForms/Reports/Economic ‘‘Reviewer Guidance, Evaluating the relationship between the National Analyses/default.htm and at http:// Risks of Drug Exposure in Human Pregnancies,’’ 2005. Government and the States, or on the www.regulations.gov). 3. U.S. Food and Drug Administration, 12. U.S. Food and Drug Administration, distribution of power and ‘‘Guidance for Industry, Warnings and ‘‘Guidance for industry, Considerations responsibilities among the various Precautions, Contraindications, and for Developmental Toxicity Studies for levels of government. Accordingly, the Boxed Warning Sections of Labeling for Preventive and Therapeutic Vaccines for Agency has concluded that the rule does Human Prescription Drug and Biological Infectious Disease Indications,’’ 2006. not contain policies that have Products—Content and Format,’’ 2011. 13. U.S. Food and Drug Administration, ‘‘Guidance for industry, M3 (R2) federalism implications as defined in 4. Kweder, S.L., ‘‘Drugs and Biologics in Nonclinical Safety Studies for the the Executive order and, consequently, Pregnancy and Breastfeeding: FDA in the Conduct of Human Clinical Trials and a federalism summary impact statement 21st Century.’’ Birth Defects Research Marketing Authorization for is not required. Part A: Clinical and Molecular Pharmaceuticals and the International Teratology. 82(9):605–609, September X. References Conference on Harmonisation S5 (R2) 2008. Guideline: Detection of Toxicity to In addition to the references placed 5. Adam, M.P., J.E. Polifka, and J.M. Reproduction for Medicinal Products on display in the Division of Dockets Friedman, ‘‘Evolving Knowledge of the and Toxicity to Male Fertility,’’ 2010. Management for the proposed rule Teratogenicity of Medications in Human 14. Tracy, T.S., et al. ‘‘Temporal Changes in under Docket No. FDA–2006–N–0515 Pregnancy.’’ American Journal of Drug Metabolism (CYP1A2, CYP2D6 and (formerly Docket No. 2006N–0467), the Medical Genetics Part C: Seminars in CYP3A Activity) During Pregnancy.’’ Medical Genetics. 157C(3):175–182, following references are on display in American Journal of Obstetrics and August 15, 2011. Gynecology. 192(2):633–639, February the Division of Dockets Management 6. Law, R., P. Bozzo, G. Koren, et al. ‘‘FDA 2005. under Docket No. FDA–2006–N–0515 Pregnancy Risk Categories and the CPS. 15. Anderson, G.D., ‘‘Pregnancy-Induced (formerly Docket No. 2006N–0467) and Do They Help or Are They a Changes in Pharmacokinetics.’’ Clinical may be seen by interested persons Hindrance?’’ Canadian Family Pharmacokinetics. 44(10):989–1008, between 9 a.m. and 4 p.m., Monday Physician. 56:239–241, March 2010. 2005.
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16. American Academy of Pediatrics Policy enroll in the registry or to obtain indicated to be used. When risk Statement. ‘‘Breastfeeding and the Use of information about the registry must be information is not available for women Human Milk.’’ Pediatrics. 129(3):e827– provided following the statement: with the disease or condition for which 841, 2012. ‘‘There is a pregnancy exposure registry the drug is indicated, the risk for the 17. Sachs, H.C. and Committee on Drugs. that monitors pregnancy outcomes in specific outcome must be compared to ‘‘The Transfer of Drugs and Therapeutics Into Human Breast Milk: An Update on women exposed to (name of drug) the rate at which the outcome occurs in Selected Topics.’’ Pediatrics. during pregnancy.’’ the general population. The Risk 132(3):e796–809, September 2013. (B) Risk summary. The Risk Summary Summary must state when there are no 18. U.S. Food and Drug Administration, must contain risk statement(s) based on human data or when available human ‘‘Draft Guidance for industry Clinical data from all relevant sources (human, data do not establish the presence or Lactation Studies—Study Design, Data animal, and/or pharmacologic) that absence of drug-associated risk. Analysis, and Recommendations for describe, for the drug, the risk of (2) Risk statement based on animal Labeling,’’ 2005. adverse developmental outcomes (i.e., data. When animal data are available, 19. Proposed Pregnancy and Lactation structural abnormalities, embryo-fetal the Risk Summary must summarize the Labeling Rule (available at http:// and/or infant mortality, functional findings in animals and based on these www.fda.gov/Drugs/Development ApprovalProcess/Development impairment, alterations to growth). findings, describe, for the drug, the Resources/Labeling/ucm093307.htm). When multiple data sources are potential risk of any adverse 20. Public Comments on Proposed Pregnancy available, the statements must be developmental outcome(s) in humans. and Lactation Labeling Rule (available at presented in the following order: This statement must include: The http://www.regulations.gov/#!docket Human, animal, pharmacologic. The number and type(s) of species affected, Detail;D=FDA-2006-N-0515). source(s) of the data must be stated. The timing of exposure, animal doses labeling must state the percentage range expressed in terms of human dose or List of Subjects in 21 CFR Part 201 of live births in the United States with exposure equivalents, and outcomes for Drugs, Labeling, Reporting and a major birth defect and the percentage pregnant animals and offspring. When recordkeeping requirements. range of pregnancies in the United animal studies do not meet current States that end in miscarriage, standards for nonclinical developmental Therefore, under the Federal Food, regardless of drug exposure. If such toxicity studies, the Risk Summary must Drug, and Cosmetic Act and under information is available for the so state. When there are no animal data, authority delegated to the Commissioner population(s) for which the drug is the Risk Summary must so state. of Food and Drugs, 21 CFR part 201 is labeled, it must also be included. When (3) Risk statement based on amended as follows: use of a drug is contraindicated during pharmacology. When the drug has a PART 201—LABELING pregnancy, this information must be well-understood mechanism of action stated first in the Risk Summary. When that may result in adverse ■ 1. The authority citation for 21 CFR applicable, risk statements as described developmental outcome(s), the Risk part 201 continues to read as follows: in paragraphs (c)(9)(i)(B)(1) and (2) of Summary must explain the mechanism this section must include a cross- of action and the potential associated Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg–360ss, 371, reference to additional details in the risks. 374, 379e; 42 U.S.C. 216, 241, 262, 264. relevant portion of the ‘‘Data’’ (C) Clinical considerations. Under the subheading in the ‘‘Pregnancy’’ subheading ‘‘Clinical Considerations,’’ § 201.56 [Amended] subsection of the labeling. If data the labeling must provide relevant ■ 2. Amend § 201.56 in paragraph (d)(1) demonstrate that a drug is not information, to the extent it is available, by removing from the list of headings systemically absorbed following a under the headings ‘‘Disease-associated and subheadings the subheadings ‘‘8.2 particular route of administration, the maternal and/or embryo/fetal risk,’’ Labor and delivery’’ and ‘‘8.3 Nursing Risk Summary must contain only the ‘‘Dose adjustments during pregnancy mothers’’ and adding in their places the following statement: ‘‘(Name of drug) is and the postpartum period,’’ ‘‘Maternal subheadings ‘‘8.2 Lactation’’ and ‘‘8.3 not absorbed systemically following adverse reactions,’’ ‘‘Fetal/Neonatal Females and Males of Reproductive (route of administration), and maternal adverse reactions,’’ and ‘‘Labor or Potential’’, respectively. use is not expected to result in fetal delivery’’: ■ 3. Amend § 201.57 by revising exposure to the drug.’’ (1) Disease-associated maternal and/ paragraphs (c)(9)(i), (ii), and (iii) to read (1) Risk statement based on human or embryo/fetal risk. If there is a serious as follows: data. When human data are available known or potential risk to the pregnant that establish the presence or absence of woman and/or the embryo/fetus § 201.57 Specific requirements on content any adverse developmental outcome(s) associated with the disease or condition and format of labeling for human associated with maternal use of the for which the drug is indicated to be prescription drug and biological products drug, the Risk Summary must used, the labeling must describe the described in § 201.56(b)(1). summarize the specific developmental risk. * * * * * outcome(s); their incidence; and the (2) Dose adjustments during (c) * * * effects of dose, duration of exposure, pregnancy and the postpartum period. If (9) * * * and gestational timing of exposure. If there are pharmacokinetic data that (i) 8.1 Pregnancy. This subsection of human data indicate that there is an support dose adjustment(s) during the labeling must contain the following increased risk for a specific adverse pregnancy and the postpartum period, a information in the following order developmental outcome in infants born summary of this information must be under the subheadings ‘‘Pregnancy to women exposed to the drug during provided. Exposure Registry,’’ ‘‘Risk Summary,’’ pregnancy, this risk must be (3) Maternal adverse reactions. If use ‘‘Clinical Considerations,’’ and ‘‘Data’’: quantitatively compared to the risk for of the drug is associated with a maternal (A) Pregnancy exposure registry. If the same outcome in infants born to adverse reaction that is unique to there is a scientifically acceptable women who were not exposed to the pregnancy or if a known adverse pregnancy exposure registry for the drug but who have the disease or reaction occurs with increased drug, contact information needed to condition for which the drug is frequency or severity in pregnant
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women, the labeling must describe the Animal doses or exposures must be data are available, the Risk Summary adverse reaction and available described in terms of human dose or must state only whether or not the drug intervention(s) for monitoring or exposure equivalents and the basis for and/or its active metabolite(s) were mitigating the reaction. The labeling those calculations must be included. detected in animal milk and specify the must describe, if known, the effect of (ii) 8.2 Lactation. This subsection of animal species. dose, timing, and duration of exposure the labeling must contain the following (ii) Effects of drug on the breast-fed on the risk to the pregnant woman of information in the following order child. The Risk Summary must include experiencing the adverse reaction. under the subheadings ‘‘Risk information, on the known or predicted (4) Fetal/Neonatal adverse reactions. Summary,’’ ‘‘Clinical Considerations,’’ effects on the child from exposure to the If it is known or anticipated that and ‘‘Data’’: drug and/or its active metabolite(s) treatment of the pregnant woman (A) Risk summary. When relevant through human milk or from contact increases or may increase the risk of an human and/or animal lactation data are with breast or nipple skin (for topical adverse reaction in the fetus or neonate, available, the Risk Summary must products). The Risk Summary also must the labeling must describe the adverse include a cross-reference to the ‘‘Data’’ include information on systemic and/or reaction, the potential severity and subheading in the ‘‘Lactation’’ local adverse reactions. If there are no reversibility of the adverse reaction, and subsection of the labeling. When human data to assess the effects of the drug available intervention(s) for monitoring data are available, animal data must not and/or its active metabolite(s) on the or mitigating the reaction. The labeling be included unless the animal model is breast-fed child, the Risk Summary must describe, if known, the effect of specifically known to be predictive for must so state. dose, timing, and duration of exposure humans. When use of a drug is (iii) Effects of drug on milk on the risk. contraindicated during breastfeeding, production. The Risk Summary must (5) Labor or delivery. If the drug is this information must be stated first in describe the effects of the drug and/or expected to affect labor or delivery, the the Risk Summary. its active metabolite(s) on milk labeling must provide information about (1) Drug not absorbed systemically. If production. If there are no data to assess the effect of the drug on the pregnant data demonstrate that the drug is not the effects of the drug and/or its active woman and the fetus or neonate; the systemically absorbed by the mother, metabolite(s) on milk production, the effect of the drug on the duration of the Risk Summary must contain only Risk Summary must so state. labor and delivery; any increased risk of the following statement: ‘‘(Name of (3) Risk and benefit statement. For adverse reactions, including their drug) is not absorbed systemically by drugs absorbed systemically, unless potential severity and reversibility; and the mother following (route of breastfeeding is contraindicated during must provide information about administration), and breastfeeding is not drug therapy, the following risk and available intervention(s) that can expected to result in exposure of the benefit statement must appear at the end mitigate these effects and/or adverse child to (name of drug).’’ of the Risk Summary: ‘‘The reactions. The information described (2) Drug absorbed systemically. If the developmental and health benefits of under this heading is not required for drug is absorbed systemically, the Risk breastfeeding should be considered drugs approved for use only during Summary must describe the following to along with the mother’s clinical need for labor and delivery. the extent relevant information is (name of drug) and any potential (D) Data—(1) ‘‘Data’’ subheading. available: adverse effects on the breast-fed child Under the subheading ‘‘Data,’’ the (i) Presence of drug in human milk. from (name of drug) or from the labeling must describe the data that are The Risk Summary must state whether underlying maternal condition.’’ the basis for the Risk Summary and the drug and/or its active metabolite(s) (B) Clinical considerations. Under Clinical Considerations. are present in human milk. If there are ‘‘Clinical Considerations,’’ the following (2) Human and animal data headings. no data to assess this, the Risk Summary information must be provided to the Human and animal data must be must so state. If studies demonstrate extent it is available and relevant: presented separately, beneath the that the drug and/or its active (1) Minimizing exposure. The labeling headings ‘‘Human Data’’ and ‘‘Animal metabolite(s) are not detectable in must describe ways to minimize Data,’’ and human data must be human milk, the Risk Summary must exposure in the breast-fed child if: The presented first. state the limits of the assay used. If drug and/or its active metabolite(s) are (3) Description of human data. For studies demonstrate the presence of the present in human milk in clinically human data, the labeling must describe drug and/or its active metabolite(s) in relevant concentrations; the drug does adverse developmental outcomes, human milk, the Risk Summary must not have an established safety profile in adverse reactions, and other adverse state the concentration of the drug and/ infants; and the drug is used either effects. To the extent applicable, the or its active metabolite(s) in human milk intermittently, in single doses, or for labeling must describe the types of and the actual or estimated daily dose short courses of therapy. When studies or reports, number of subjects for an infant fed exclusively with applicable, the labeling must also and the duration of each study, human milk. The actual or estimated describe ways to minimize a breast-fed exposure information, and limitations of amount of the drug and/or its active child’s oral intake of topical drugs the data. Both positive and negative metabolite(s) ingested by the infant applied to the breast or nipple skin. study findings must be included. must be compared to the labeled infant (2) Monitoring for adverse reactions. (4) Description of animal data. For or pediatric dose, if available, or to the The labeling must describe available animal data, the labeling must describe maternal dose. If studies demonstrate intervention(s) for monitoring or the following: Types of studies, animal the presence of the drug and/or its mitigating the adverse reaction(s) species, dose, duration and timing of active metabolite(s) in human milk but presented in the Risk Summary. exposure, study findings, presence or the drug and/or its active metabolite(s) (C) Data. Under the subheading absence of maternal toxicity, and are not expected to be systemically ‘‘Data,’’ the labeling must describe the limitations of the data. Description of bioavailable to the breast-fed child, the data that are the basis for the Risk maternal and offspring findings must Risk Summary must describe the Summary and Clinical Considerations. include dose-response and severity of disposition of the drug and/or its active (iii) 8.3 Females and males of adverse developmental outcomes. metabolite(s). If only animal lactation reproductive potential. When pregnancy
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testing and/or contraception are § 201.80 [Amended] ■ d. Remove the paragraph heading required or recommended before, ■ 4. Amend § 201.80 as follows: ‘‘Pregnancy category D.’’ and the words during, or after drug therapy and/or ■ a. Remove the paragraph heading ‘‘Pregnancy Category D.’’ from when there are human and/or animal ‘‘Pregnancy category A.’’ and the words paragraph (f)(6)(i)(d); and data that suggest drug-associated ‘‘Pregnancy Category A.’’ from ■ e. Remove the paragraph heading fertility effects, this subsection of paragraph (f)(6)(i)(a); ‘‘Pregnancy category X.’’ and the words labeling must contain this information ■ b. Remove the paragraph heading ‘‘Pregnancy Category X.’’ from under the subheadings ‘‘Pregnancy ‘‘Pregnancy category B.’’ and the words paragraph (f)(6)(i)(e). ‘‘Pregnancy Category B.’’ both times Testing,’’ ‘‘Contraception,’’ and Dated: November 25, 2014. ‘‘Infertility,’’ in that order. they appear from paragraph (f)(6)(i)(b); ■ c. Remove the paragraph heading Leslie Kux, * * * * * ‘‘Pregnancy category C.’’ and the words Associate Commissioner for Policy. ‘‘Pregnancy Category C.’’ both times [FR Doc. 2014–28241 Filed 12–3–14; 8:45 am] they appear from paragraph (f)(6)(i)(c); BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND Silver Spring, MD 20993. Send one self- (for biological products that are HUMAN SERVICES addressed adhesive label to assist that regulated as drugs), and efficacy office in processing your requests. See supplements to BLAs, as well as to Food and Drug Administration the SUPPLEMENTARY INFORMATION section applicants that have previously [Docket No. FDA–2014–D–1551] for electronic access to the guidance submitted such applications during the document. time periods specified in the Pregnancy, Lactation, and Submit electronic comments on the implementation plan set out in the Reproductive Potential: Labeling for draft guidance to http:// preamble to the PLLR. FDA may revise Human Prescription Drug and www.regulations.gov. Submit written other Agency guidances as needed and Biological Products—Content and comments to the Division of Dockets appropriate to reflect the PLLR content Format; Draft Guidance for Industry; Management (HFA–305), Food and Drug and format requirements and the Availability Administration, 5630 Fishers Lane, Rm. recommendations in this guidance, once 1061, Rockville, MD 20852. it has been finalized. AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: This draft guidance is one of a series HHS. Division of Pediatric and Maternal of guidances FDA is developing, or has ACTION: Notice. Health, Center for Drug Evaluation and developed, to assist applicants with the Research, Food and Drug SUMMARY: The Food and Drug content and format of the labeling for Administration (FDA) is announcing the Administration, 10903 New Hampshire human prescription drug and biological availability of a draft guidance for Ave., Bldg. 22, Rm. 6312, Silver Spring, products. In the Federal Register of industry entitled ‘‘Pregnancy, Lactation, MD 20993–0002, 301–796–2200; or January 24, 2006 (71 FR 3999), FDA and Reproductive Potential: Labeling for Stephen Ripley, Center for Biologics announced the availability of final Human Prescription Drug and Biological Evaluation and Research, Food and guidances on the content and format of Products—Content and Format.’’ This Drug Administration, 10903 New the ‘‘Adverse Reactions’’ (http:// draft guidance is intended to assist Hampshire Ave., Bldg. 71, Rm. 7301, www.fda.gov/downloads/Drugs/ applicants in complying with the new Silver Spring, MD 20993, 240–402– GuidanceComplianceRegulatory content and format requirements in the 7911. Information/Guidances/ucm075057.pdf) Pregnancy, Lactation, and Females and SUPPLEMENTARY INFORMATION: and ‘‘Clinical Studies’’ (http:// www.fda.gov/downloads/Drugs/ Males of Reproductive Potential I. Background subsections of labeling for human GuidanceComplianceRegulatory prescription drug and biological FDA is announcing the availability of Information/Guidances/ucm075059.pdf) products, as described in the final rule, a draft guidance for industry entitled sections of labeling. In the Federal Content and Format of Labeling for ‘‘Pregnancy, Lactation, and Register of October 19, 2009 (74 FR Human Prescription Drug and Reproductive Potential: Labeling for 53507), FDA announced the availability Biological Products; Requirements for Human Prescription Drug and Biological of final guidance on determining Pregnancy and Lactation Labeling. The Products—Content and Format.’’ The established pharmacologic class for use rule, which is being published draft guidance provides in the ‘‘Highlights of Prescribing concurrently with this draft guidance, is recommendations on how to develop Information’’ (http://www.fda.gov/ referred to as the ‘‘Pregnancy and and revise professional labeling that downloads/Drugs/GuidanceCompliance Lactation Labeling Rule’’ (PLLR). The meets the new content and format RegulatoryInformation/Guidances/ draft guidance will assist applicants in requirements of the Pregnancy, UCM186607.pdf). In the Federal developing labeling for new products, Lactation, and Females and Males of Register of March 23, 2010 (75 FR revising existing labeling, and Reproductive Potential subsections of 13766), FDA announced the availability implementing the content and format labeling for human prescription drug of final guidance on the content and requirements of the PLLR for human and biological products. Specifically, it format of the ‘‘Dosage and prescription drug and biological provides information to assist Administration’’ section of labeling products. applicants in preparing subsections 8.1 (http://www.fda.gov/downloads/Drugs/ Pregnancy, 8.2 Lactation, and 8.3 GuidanceComplianceRegulatory DATES: Although you can comment on Females and Males of Reproductive Information/Guidances/UCM075066. any guidance at any time (see 21 CFR Potential of the USE IN SPECIFIC pdf). In the Federal Register of October 10.115(g)(5)), to ensure that the Agency POPULATIONS section of the full 12, 2011 (76 FR 63303), FDA announced considers your comment on this draft prescribing information under 21 CFR the availability of final guidance on the guidance before it begins work on the 201.56(d)(1) and 201.57(c)(9)(i) through content and format of the ‘‘Warnings final version of the guidance, submit (iii), as described in the PLLR. and Precautions,’’ ‘‘Contraindications,’’ either electronic or written comments The PLLR provides a framework to and ‘‘Boxed Warning’’ sections of on the draft guidance by February 2, clearly communicate information on the labeling (http://www.fda.gov/ 2015. benefits and risks of drug use during downloads/Drugs/GuidanceCompliance ADDRESSES: Submit written requests for pregnancy and lactation to help RegulatoryInformation/Guidances/ single copies of this draft guidance to facilitate prescribing decisions. The UCM075096.pdf),and in the Federal the Division of Drug Information, Center PLLR also includes a subsection on Register of March 3, 2009 (74 FR 9250), for Drug Evaluation and Research, Food females and males of reproductive FDA announced the availability of draft and Drug Administration, 10001 New potential to address issues in these guidance on the content and format of Hampshire Ave., Hillandale Bldg., 4th populations that are linked to pregnancy the ‘‘Clinical Pharmacology’’ section of Floor, Silver Spring, MD 20993, or either directly or indirectly. The draft labeling (http://www.fda.gov/ Office of Communication, Outreach and guidance provides recommendations to downloads/Drugs/GuidanceCompliance Development, Center for Biologics applicants submitting new drug RegulatoryInformation/Guidances/ Evaluation and Research (CBER), Food applications (NDAs), efficacy UCM109739.pdf). In the Federal and Drug Administration, 10903 New supplements to approved NDAs, Register of February 25, 2013 (78 FR Hampshire Ave., Bldg. 71, Rm. G102, biologics license applications (BLAs) 12760), FDA announced the availability
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of final guidance implementing the An alternative approach may be used if and the collection of information in 21 ‘‘Physician Labeling Rule’’ (January 24, such approach satisfies the CFR 314.90 for submitting waiver 2006, 71 FR 3922) content and format requirements of the applicable statutes requests for an application have been requirements of labeling for human and regulations. approved under OMB control number prescription drug and biological II. Comments 0910–0001. The collection of products under §§ 201.56(d) and 201.57 information in 21 CFR 601.12 for (http://www.fda.gov/downloads/Drugs/ Interested persons may submit either submitting supplements to an approved GuidanceComplianceRegulatory electronic comments regarding this application has been approved under Information/Guidances/ document to http://www.regulations.gov OMB control number 0910–0338. In ucm075082.pdf). In the Federal Register or written comments to the Division of addition, the information collection of February 28, 2013 (78 FR 13686), Dockets Management (see ADDRESSES). It provisions of the PLLR have been FDA announced the availability of draft is only necessary to send one set of submitted to OMB for review, as guidance on the placement and content comments. Identify comments with the required by section 3507(d) of the of pediatric information in the labeling docket number found in brackets in the Paperwork Reduction Act. Prior to the for human prescription drug and heading of this document. Received effective date of the PLLR, FDA will biological products in accordance with comments may be seen in the Division publish a notice in the Federal Register of Dockets Management between 9 a.m. the Physician Labeling Rule (http:// announcing OMB’s decision to approve, and 4 p.m., Monday through Friday, and www.fda.gov/downloads/Drugs/ modify, or disapprove the information will be posted to the docket at http:// GuidanceComplianceRegulatory collection provisions in the final rule. Information/Guidances/UCM341394. www.regulations.gov. pdf). III. Paperwork Reduction Act of 1995 IV. Electronic Access The labeling requirements and these guidances are intended to make This guidance refers to previously Persons with access to the Internet information in prescription drug approved collections of information that may obtain the draft guidance at either labeling easier for health care are subject to review by the Office of http://www.fda.gov/Drugs/Guidance practitioners to access, read, and use. Management and Budget (OMB) under ComplianceRegulatoryInformation/ This draft guidance is being issued the Paperwork Reduction Act of 1995 Guidances/default.htm, http:// consistent with FDA’s good guidance (44 U.S.C. 3501–3520). The collection of www.fda.gov/BiologicsBloodVaccines/ practices regulation (21 CFR 10.115). information in 21 CFR 201.56 and GuidanceComplianceRegulatory The draft guidance, when finalized, will 201.57 has been approved under OMB Information/default.htm, or http:// represent the Agency’s current thinking control number 0910–0572. The www.regulations.gov. on implementing the PLLR content and collection of information in 21 CFR Dated: November 25, 2014. format requirements for labeling for 314.70 and 314.97 for submitting Leslie Kux, human prescription drug and biological supplements to an approved products. It does not create or confer application, the collection of Associate Commissioner for Policy. any rights for or on any person and does information in 21 CFR 314.50(e) for [FR Doc. 2014–28242 Filed 12–3–14; 8:45 am] not operate to bind FDA or the public. submitting labeling for an application, BILLING CODE 4164–01–P
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