Federal Register Vol. 81, No.30,

Federal Register Volume 81, Issue 30 (February 16, 2016)

Page Range7695-7963
FR Document

81_FR_30
Current View
Page and SubjectPDF
81 FR 7959 - Establishment of the Federal Privacy CouncilPDF
81 FR 7787 - Contractor Access to Information Claimed as Confidential Business Information Submitted Under Title II of the Clean Air Act and Related to the Renewable Fuel Standard ProgramPDF
81 FR 7715 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coral, Coral Reefs, and Live/Hard Bottom Habitats of the South Atlantic Region; Amendment 8; CorrectionPDF
81 FR 7744 - Sunshine Act MeetingPDF
81 FR 7884 - Culturally Significant Objects Imported for Exhibition Determinations: “Pharaoh: King of Ancient Egypt” ExhibitionPDF
81 FR 7832 - Sunshine Act MeetingPDF
81 FR 7847 - Sunshine Act Meeting; March 9, 2016 Public HearingPDF
81 FR 7767 - Sunshine Act MeetingPDF
81 FR 7786 - Agency Information Collection Activities OMB ResponsesPDF
81 FR 7792 - Sunshine Act MeetingPDF
81 FR 7833 - Sunshine Act Meeting; National Science BoardPDF
81 FR 7847 - Notice of Submission for Approval: Information Collection 3206-0266; Privacy Act Request for Completed Standard Form SF85/SF85P/SF86, INV 100APDF
81 FR 7784 - Draft Technical Support Document: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand ModelPDF
81 FR 7778 - Request for Information: Accounting Conventions for Non-Combustible Renewable Energy UsePDF
81 FR 7787 - National Environmental Justice Advisory Council: Notification of Public Meeting and Public CommentPDF
81 FR 7791 - Notice of Availability of Draft Guidelines for Human Exposure Assessment: Extension of Public Comment PeriodPDF
81 FR 7829 - Notice of Proposed Information Collection; Request for Comments for 1029-0089PDF
81 FR 7817 - Notice of CorrectionPDF
81 FR 7777 - Energy Savings Performance Contract Energy Sales AgreementPDF
81 FR 7788 - Inquiry To Learn Whether Businesses Assert Business Confidentiality Claims Regarding Waste Import and ExportPDF
81 FR 7784 - Local Government Advisory Committee (LGAC); Notice of Charter RenewalPDF
81 FR 7776 - Flint Hills Resources, LP; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement NationsPDF
81 FR 7718 - Safety Zone, Block Island Wind Farm; Rhode Island Sound, RIPDF
81 FR 7704 - Safety Zone; James River, Newport News, VAPDF
81 FR 7770 - Applications for New Awards; Training Program for Federal TRIO ProgramsPDF
81 FR 7792 - Public HearingPDF
81 FR 7742 - Notice of Request for Approval of a New Information CollectionPDF
81 FR 7755 - Certain Biaxial Integral Geogrid Products From the People's Republic of China: Initiation of Less-Than-Fair-Value InvestigationPDF
81 FR 7750 - Polyethylene Terephthalate Film, Sheet, and Strip From India: Final Results of Antidumping Duty Administrative Review; 2013-2014PDF
81 FR 7753 - Polyethylene Terephthalate Film, Sheet, and Strip From India: Final Results of Countervailing Duty Administrative Review; 2013PDF
81 FR 7751 - Potassium Permanganate From the People's Republic of China: Preliminary Results of the 2014 Antidumping Duty Administrative ReviewPDF
81 FR 7745 - Foreign-Trade Zone 116-Port Arthur, Texas; Expansion of Subzone 116C; Premcor Refining Group Inc.; Jefferson County, TexasPDF
81 FR 7745 - Certain Biaxial Integral Geogrid Products From the People's Republic of China: Initiation of Countervailing Duty InvestigationPDF
81 FR 7824 - Agency Information Collection Activities: ProtestPDF
81 FR 7823 - Agency Information Collection Activities: Delivery TicketPDF
81 FR 7832 - Notice of Lodging of Proposed Modification to Previously Entered Consent Decree Under the Clean Air ActPDF
81 FR 7762 - Order Authorizing the National Futures Association as a Commission Designee for Direct Electronic Access to Data in Swap Data RepositoriesPDF
81 FR 7832 - Meeting of National Council on the HumanitiesPDF
81 FR 7800 - Notice of Availability of the Final Environmental Assessment and a Finding of No Significant Impact for HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025, Lawrenceville, GeorgiaPDF
81 FR 7775 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Enterprise Complaint SystemPDF
81 FR 7829 - Notice of Proposed Information Collection; Request for Comments for 1029-0087PDF
81 FR 7834 - Rare Element Resources, Inc.; Establishment of Atomic Safety and Licensing BoardPDF
81 FR 7835 - Atomic Safety And Licensing Board; Before Administrative Judges: Paul S. Ryerson, Chairman, Dr. Gary S. Arnold, Dr. Craig M. White; In the Matter of PSEG Power, LLC and PSEG Nuclear, LLC (Early Site Permit Application); Notice of HearingPDF
81 FR 7831 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 7884 - Projects Approved for Consumptive Uses of WaterPDF
81 FR 7761 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public MeetingPDF
81 FR 7760 - Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public MeetingPDF
81 FR 7793 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 7743 - Mt. Hood National Forest; Oregon; Cooper Spur-Government Camp Land ExchangePDF
81 FR 7800 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 7798 - Information Collection; Extraordinary Contractual Action RequestsPDF
81 FR 7767 - Intent To Grant an Exclusive License for U.S. Army Owned Invention to Faraday TechnologyPDF
81 FR 7744 - Eastern Washington Cascades Provincial Advisory CommitteePDF
81 FR 7891 - Sanctions Actions Pursuant to Executive Order 13224PDF
81 FR 7891 - Driving Behavioral Change in Traffic SafetyPDF
81 FR 7721 - Defense Federal Acquisition Regulation Supplement: Enhancing the Effectiveness of Independent Research and Development (DFARS Case 2016-D002)PDF
81 FR 7825 - Endangered Species Recovery Permit ApplicationsPDF
81 FR 7793 - Granting of Request for Early Termination of the Waiting Period Under the Premerger Notification RulesPDF
81 FR 7796 - Granting of Request for Early Termination of the Waiting Period Under the Premerger Notification RulesPDF
81 FR 7799 - Patient Safety Organizations: Voluntary Relinquishment From Verge Patient Safety OrganizationPDF
81 FR 7712 - Suspension of Community EligibilityPDF
81 FR 7822 - Expansion of Global Entry Eligibility to All Citizens of the Federal Republic of GermanyPDF
81 FR 7833 - Agency Information Collection Activities: Comment RequestPDF
81 FR 7830 - Certain Surgical Stapler Devices and Components Thereof Institution of InvestigationPDF
81 FR 7761 - Endangered Species; File No.17364-01PDF
81 FR 7760 - Endangered Species; File No. 19255PDF
81 FR 7783 - Sabine Pipe Line, LLC; Notice of Informal Settlement ConferencePDF
81 FR 7781 - Records Governing Off-the-Record Communications; Public NoticePDF
81 FR 7783 - Enterprise Texas Pipeline LLC; Notice of Informal Settlement ConferencePDF
81 FR 7780 - The City of Woonsocket; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing ProcessPDF
81 FR 7783 - Brookfield White Pine Hydro LLC, Project No. 2322-060-Maine, Shawmut Hydroelectric Project; Notice of Proposed Restricted Service List for a Programmatic AgreementPDF
81 FR 7782 - South Carolina Electric & Gas Company; Notice of Revised Restricted Service List for a Programmatic AgreementPDF
81 FR 7783 - Colonial Pipeline Company; Notice of Technical ConferencePDF
81 FR 7781 - Notice Establishing Post-Technical Conference CommentsPDF
81 FR 7780 - Combined Notice of Filings #1PDF
81 FR 7784 - Implementation Issues Under the Public Utility Regulatory Policies Act of 1978; Notice of Technical ConferencePDF
81 FR 7819 - Advisory Commission on Childhood Vaccines; Notice of MeetingPDF
81 FR 7818 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment RequestPDF
81 FR 7765 - Request for Information Regarding Crib BumpersPDF
81 FR 7799 - Information Collection; Schedules for Construction ContractsPDF
81 FR 7813 - Oncologic Drugs Advisory Committee; Notice of MeetingPDF
81 FR 7803 - Request for Nominations for Individuals and Consumer Organizations for Advisory CommitteesPDF
81 FR 7888 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MISTY; Invitation for Public CommentsPDF
81 FR 7888 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LIMERICK; Invitation for Public CommentsPDF
81 FR 7887 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ABBEY ROAD; Invitation for Public CommentsPDF
81 FR 7884 - Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of InterestPDF
81 FR 7887 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel TIME MACHINE; Invitation for Public CommentsPDF
81 FR 7886 - Petition for Authorization To Exceed Mach 1; Summary of Petition Received; The Boeing CompanyPDF
81 FR 7889 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LONE STAR; Invitation for Public CommentsPDF
81 FR 7698 - Harmonization of Airworthiness Standards-Fire Extinguishers and Class B and F Cargo CompartmentsPDF
81 FR 7749 - Aluminum Extrusions From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court DecisionPDF
81 FR 7865 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a Proposed Rule Change To Amend the Derivatives and Other Off-Balance Sheet Items Schedule Pursuant to FINRA Rule 4524 (Supplemental FOCUS Information)PDF
81 FR 7877 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee Schedule To Implement a Professional Rebate ProgramPDF
81 FR 7879 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 7290 (Price Protection for Limit Orders) To Enhance the Protections Provided to Participants Executing Orders and Quotes on the ExchangePDF
81 FR 7853 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 7070 (Opening the Market) To Implement a New Price Protection Feature for the OpeningPDF
81 FR 7867 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule To Amend the Fees SchedulePDF
81 FR 7873 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Add Rule 7310 (Drill-Through Protection) To Implement a New Price Protection FeaturePDF
81 FR 7848 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 21.16, Risk Monitor Mechanism, Relating to the EDGX Equity Options Trading PlatformPDF
81 FR 7851 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 21.16, Risk Monitor Mechanism, Relating to the BATS Equity Options Trading PlatformPDF
81 FR 7871 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Order Approving and Declaring Effective a Proposed Plan for the Allocation of Regulatory Responsibilities Between the Financial Industry Regulatory Authority, Inc. and the National Stock Exchange, Inc.PDF
81 FR 7857 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To List and Trade the Shares of the Elkhorn Dow Jones RAFI Commodity ETF of Elkhorn ETF TrustPDF
81 FR 7882 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 990NY(8) To Correct a Typographical ErrorPDF
81 FR 7816 - Allergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; AvailabilityPDF
81 FR 7807 - Proposed Pilot Project(s) Under the Drug Supply Chain Security Act; Public Workshop; Request for CommentsPDF
81 FR 7811 - Nonallergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; AvailabilityPDF
81 FR 7810 - Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; AvailabilityPDF
81 FR 7820 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 7821 - Center for Scientific Review; Notice of Closed MeetingPDF
81 FR 7819 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 7821 - Government-Owned Inventions; Availability for LicensingPDF
81 FR 7820 - Government-Owned Inventions; Availability for LicensingPDF
81 FR 7815 - Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012; Guidance for Industry; AvailabilityPDF
81 FR 7889 - Notice of Receipt of Petition for Decision That Nonconforming Model Year 2014 Mercedes-Benz SLK Class Passenger Cars Are Eligible for ImportationPDF
81 FR 7809 - Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for CommentsPDF
81 FR 7806 - Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness; Public Workshop; Request for CommentsPDF
81 FR 7802 - Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public WorkshopPDF
81 FR 7813 - Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Draft Guidance for Industry; AvailabilityPDF
81 FR 7766 - Proposed Extension of Approval of Information Collection; Comment Request-Standards for Full-Size Baby Cribs and Non-Full Size Baby Cribs; Compliance FormPDF
81 FR 7706 - Approval and Promulgation of Air Quality Implementation Plans; 2008 Ozone NAAQS Interstate Transport for Colorado, Montana, North Dakota and South DakotaPDF
81 FR 7721 - Approval of Iowa's Air State Implementation Plan (SIP); Electronic Reporting Consistent With the Cross Media Electronic Reporting Rule (CROMERR)PDF
81 FR 7708 - Approval of Iowa's State Implementation Plan (SIP); Electronic Reporting Consistent With the Cross-Media Electronic Reporting Rule (CROMERR)PDF
81 FR 7710 - Approval of Regional Haze BART Alternative Measure: WashingtonPDF
81 FR 7720 - Procedures Related to Motions; CorrectionPDF
81 FR 7767 - Agency Information Collection Activities; Submission for OMB Review; Comment Request-Safety Standard for Automatic Residential Garage Door OperatorsPDF
81 FR 7768 - Proposed Collection; Comment RequestPDF
81 FR 7768 - Privacy Act of 1974; System of RecordsPDF
81 FR 7835 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
81 FR 7716 - Regulatory Review SchedulePDF
81 FR 7927 - Public Company Accounting Oversight Board; Notice of Filing of Proposed Rules on Improving the Transparency of Audits: Rules To Require Disclosure of Certain Audit Participants on a New PCAOB Form and Related Amendments to Auditing StandardsPDF
81 FR 7893 - Notice of FTA Transit Program Changes, Authorized Funding Levels and Implementation of Federal Public Transportation Law as Amended by the Fixing America's Surface Transportation (FAST) Act and FTA Fiscal Year 2016 Apportionments, Allocations, Program Information and Interim GuidancePDF
81 FR 7717 - Occupational Exposure to BerylliumPDF
81 FR 7723 - Endangered and Threatened Wildlife and Plants; Removing the San Miguel Island Fox, Santa Rosa Island Fox, and Santa Cruz Island Fox From the Federal List of Endangered and Threatened Wildlife, and Reclassifying the Santa Catalina Island Fox From Endangered to ThreatenedPDF
81 FR 7695 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal AwardsPDF

Issue

81 30 Tuesday, February 16, 2016 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Patient Safety Organizations: Voluntary Relinquishment from Verge Patient Safety Organization, 7799-7800 2016-03034 Agriculture Department, Office of the Chief Financial Officer Agriculture Department, Office of the Chief Financial Officer RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473 Agriculture Agriculture Department See

Agriculture Department, Office of the Chief Financial Officer

See

Commodity Credit Corporation

See

Farm Service Agency

See

Foreign Agricultural Service

See

Forest Service

See

National Institute of Food and Agriculture

See

Rural Business-Cooperative Service

See

Rural Housing Service

See

Rural Utilities Service

RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473
Army Army Department NOTICES Exclusive Licenses Proposed Approvals: Faraday Technology, 7767-7768 2016-03043 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7800-7802 2016-03046 Environmental Impact Statements; Availability, etc.: HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025, Lawrenceville, GA, 7800 2016-03059 Chemical Chemical Safety and Hazard Investigation Board NOTICES Meetings; Sunshine Act, 7744-7745 2016-03257 Coast Guard Coast Guard RULES Safety Zones: James River, Newport News, VA, 7704-7706 2016-03090 PROPOSED RULES Safety Zones: Block Island Wind Farm, Rhode Island Sound, RI, 7718-7720 2016-03091 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Credit Commodity Credit Corporation RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473 Commodity Futures Commodity Futures Trading Commission NOTICES Orders: Authorization of National Futures Association as a Commission Designee for Direct Electronic Access to Data in Swap Data Repositories, 7762-7765 2016-03064 Consumer Product Consumer Product Safety Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Crib Bumpers, 7765-7766 2016-03013 Safety Standard for Automatic Residential Garage Door Operators, 7767 2016-02948 Standards for Full-Size Baby Cribs and Non-Full Size Baby Cribs; Compliance Form, 7766 2016-02963 Corporation Corporation for National and Community Service NOTICES Meetings; Sunshine Act, 7767 2016-03160 Defense Acquisition Defense Acquisition Regulations System PROPOSED RULES Defense Federal Acquisition Regulation Supplement: Enhancing the Effectiveness of Independent Research and Development, 7721-7723 2016-03039 Defense Department Defense Department See

Army Department

See

Defense Acquisition Regulations System

See

Navy Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7768 2016-02947 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Extraordinary Contractual Action Requests, 7798 2016-03045 Schedules for Construction Contracts, 7799 2016-03012
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Enterprise Complaint System, 7775-7776 2016-03057 Applications for New Awards: Training Program for Federal TRIO Programs, 7770-7775 2016-03089 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

NOTICES Application for Long-Term, Multi-Contract Authorization to Export Liquefied Natural Gas to Non-Free Trade Agreement Nations: Flint Hills Resources, LP, 7776-7777 2016-03093
Energy Efficiency Energy Efficiency and Renewable Energy Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accounting Conventions for Non-combustible Renewable Energy Use, 7778-7779 2016-03118 Energy Savings Performance Contract Energy Sales Agreement, 7777-7778 2016-03103 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Colorado, Montana, North Dakota and South Dakota; 2008 Ozone NAAQS Interstate Transport, 7706-7708 2016-02959 Iowa; Electronic Reporting Consistent with the Cross-Media Electronic Reporting Rule, 7708-7710 2016-02957 Approval of Regional Haze BART Alternative Measure: Washington, 7710-7712 2016-02953 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Iowa; Electronic Reporting Consistent with the Cross-Media Electronic Reporting Rule, 7721 2016-02958 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7786-7787 2016-03149 Charter Renewals: Local Government Advisory Committee, 7784 2016-03101 Contractor Access to Information Claimed as Confidential Business Information Submitted under Title II of the Clean Air Act and Related to the Renewable Fuel Standard Program, 7787 C1--2016--02728 Draft Guidelines for Human Exposure Assessment, 7791-7792 2016-03110 Draft Technical Support Documents: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model, 7784-7786 2016-03119 Inquiry to Learn Whether Businesses Assert Business Confidentiality Claims Regarding Waste Import and Export, 7788-7791 2016-03102 Meetings: National Environmental Justice Advisory Council, 7787 2016-03115 Equal Equal Employment Opportunity Commission NOTICES Meetings: Equal Employment Opportunity Commission; Hearing, 7792 2016-03088 Farm Service Farm Service Agency RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473 Federal Aviation Federal Aviation Administration RULES Harmonization of Airworthiness Standards: Fire Extinguishers and Class B and F Cargo Compartments, 7698-7704 2016-03000 NOTICES Petition for Authorization; Summaries: The Boeing Company, 7886-7887 2016-03003 Federal Deposit Federal Deposit Insurance Corporation NOTICES Meetings; Sunshine Act, 7792-7793 2016-03142 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 7712-7715 2016-03032 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Woonsocket, RI, 7780 2016-03022 Combined Filings, 7780-7781 2016-03017 Meetings: Colonial Pipeline Co.; Technical Conference, 7783 2016-03019 Enterprise Texas Pipeline LLC; Informal Settlement Conference, 7783 2016-03023 Implementation Issues Under the Public Utility Regulatory Policies Act; Technical Conference, 7784 2016-03016 PJM Interconnection, LLC; et al.; Post-Technical Conference Comments, 7781 2016-03018 Sabine Pipe Line, LLC; Informal Settlement Conference, 7783 2016-03025 Records Governing Off-the-Record Communications, 7781-7782 2016-03024 Restricted Service Lists: Brookfield White Pine Hydro LLC, 7783-7784 2016-03021 South Carolina Electric and Gas Co., 7782 2016-03020 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 7793 2016-03048 Federal Trade Federal Trade Commission PROPOSED RULES Regulatory Review Schedule, 7716-7717 2016-02894 NOTICES Request for Early Termination of the Waiting Period under the Premerger Notification Rules, 7793-7798 2016-03035 2016-03036 Federal Transit Federal Transit Administration NOTICES Transit Program Changes, etc., 7894-7925 2016-02821 Fish Fish and Wildlife Service PROPOSED RULES Endangered and Threatened Wildlife and Plants: Removing the San Miguel Island Fox, Santa Rosa Island Fox, and Santa Cruz Island Fox from the Federal List of Endangered and Threatened Wildlife, and Reclassifying the Santa Catalina Island Fox from Endangered to Threatened, 7723-7741 2016-02669 NOTICES Endangered Species Recovery Permit Applications, 7825-7829 2016-03037 Food and Drug Food and Drug Administration NOTICES Guidance for Industry: Allergic Rhinitis -- Developing Drug Products for Treatment, 7816-7817 2016-02978 Anthrax -- Developing Drugs for Prophylaxis of Inhalational Anthrax, 7813-7815 2016-02964 Bioequivalence Recommendations for Cyclosporine, 7810-7811 2016-02975 Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files under the Generic Drug User Fee Amendments, 7815-7816 2016-02969 Nonallergic Rhinitis -- Developing Drug Products for Treatment, 7811-7813 2016-02976 Meetings: Building the National Evaluation System for Medical Devices -- Using Real-World Evidence to Improve Device Safety and Effectiveness; Public Workshop, 7806-7807 2016-02966 Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop, 7809-7810 2016-02967 Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop, 7802-7803 2016-02965 Oncologic Drugs Advisory Committee, 7813 2016-03011 Proposed Pilot Project(s) under the Drug Supply Chain Security Act; Public Workshop, 7807-7809 2016-02977 Requests for Nominations: Individuals and Consumer Organizations for Advisory Committees, 7803-7806 2016-03010 Foreign Agricultural Foreign Agricultural Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7742 2016-03087 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 7891-7892 2016-03041 Foreign Trade Foreign-Trade Zones Board NOTICES Subzone Expansions: Premcor Refining Group Inc., Subzone 116C, Foreign-Trade Zone 116, Port Arthur, TX, 7745 2016-03072 Forest Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Cooper Spur - Government Camp Land, Mt. Hood National Forest; OR, 7743-7744 2016-03047 Meetings: Eastern Washington Cascades Provinicial Advisory Committee, 7744 2016-03042 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Extraordinary Contractual Action Requests, 7798 2016-03045 Schedules for Construction Contracts, 7799 2016-03012 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Disease Control and Prevention

See

Food and Drug Administration

See

Health Resources and Services Administration

See

National Institutes of Health

Health Resources Health Resources and Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7818 2016-03014 Bridging the Word Gap Competition Challenge; Correction, 7817 2016-03106 Meetings: Advisory Commission on Childhood Vaccines, 7819 2016-03015 Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Customs and Border Protection

Interior Interior Department See

Fish and Wildlife Service

See

Surface Mining Reclamation and Enforcement Office

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Aluminum Extrusions from the People's Republic of China, 7749-7750 2016-02998 Certain Biaxial Integral Geogrid Products from the People's Republic of China, 7745-7749 2016-03071 Polyethylene Terephthalate Film, Sheet, and Strip from India, 7750-7751, 7753-7755 2016-03082 2016-03083 Potassium Permanganate from the People's Republic of China, 7751-7753 2016-03073 Initiation of Less-Than-Fair-Value Investigations: Certain Biaxial Integral Geogrid Products from the People's Republic of China, 7755-7760 2016-03086 International Trade Com International Trade Commission NOTICES Complaints: Certain Automated Teller Machines, ATM Modules, Components Thereof, and Products Containing the Same, 7831-7832 2016-03052 Investigations; Determinations, Modifications, and Rulings, etc.: Surgical Stapler Devices and Components Thereof, 7830-7831 2016-03028 Justice Department Justice Department NOTICES Proposed Consent Decrees under the Clean Air Act, 7832 2016-03065 Labor Department Labor Department See

Occupational Safety and Health Administration

Maritime Maritime Administration NOTICES Requests for Administrative Waivers of the Coastwise Trade Laws: Vessel ABBEY ROAD, 7887-7888 2016-03007 Vessel LIMERICK, 7888-7889 2016-03008 Vessel LONE STAR, 7889 2016-03002 Vessel MISTY, 7888 2016-03009 Vessel TIME MACHINE, 7887 2016-03004 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Extraordinary Contractual Action Requests, 7798 2016-03045 Schedules for Construction Contracts, 7799 2016-03012 National Credit National Credit Union Administration NOTICES Meetings; Sunshine Act, 7832 2016-03210 National Endowment for the Humanities National Endowment for the Humanities NOTICES Meetings: National Council on the Humanities, 7832-7833 2016-03063 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Humanities

National Highway National Highway Traffic Safety Administration NOTICES Importation Eligibility; Petitions: Nonconforming Model Year 2014 Mercedes-Benz SLK Class Passenger Cars, 7889-7891 2016-02968 Meetings: Driving Behavioral Change in Traffic Safety, 7891 2016-03040 National Institute Food National Institute of Food and Agriculture RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 7820-7821 2016-02970 2016-02971 Meetings: Center for Scientific Review, 7819-7822 2016-02972 2016-02973 2016-02974 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Coral, Coral Reefs, and Live/Hard Bottom Habitats of the South Atlantic Region; Amendment 8; Correction, 7715 C1--2015--25488 NOTICES Meetings: Fisheries of the South Atlantic; South Atlantic Fishery Management Council, 7761 2016-03050 Fisheries of the South Atlantic; Southeast Data, Assessment, and Review, 7760-7761 2016-03049 Permits: Endangered Species; File No. 19255, 7760 2016-03026 Endangered Species; File No.17364-01, 7761-7762 2016-03027 National Science National Science Foundation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7833-7834 2016-03029 Meetings; Sunshine Act, 7833 2016-03126 Navy Navy Department NOTICES Privacy Act; Systems of Records, 7768-7770 2016-02946 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 7835-7847 2016-02916 Establishment of Atomic Safety and Licensing Board: Rare Element Resources, Inc., 7834-7835 2016-03055 Meetings: Atomic Safety and Licensing Board; Hearing, 7835 2016-03054 Occupational Safety Health Adm Occupational Safety and Health Administration PROPOSED RULES Meetings: Occupational Exposure to Beryllium; Rescheduled, 7717-7718 2016-02782 Overseas Overseas Private Investment Corporation NOTICES Meetings; Sunshine Act, 7847 2016-03184 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Privacy Act Request for Completed Standard Forms, 7847-7848 2016-03125 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Procedures Related to Motions; Correction, 7720 2016-02950 Presidential Documents Presidential Documents EXECUTIVE ORDERS Committees; Establishment, Renewal, Termination, etc.: Privacy Council, Federal; Establishment (EO 13719); Republication, 7959-7963 R1--2016--03141 Rural Business Rural Business-Cooperative Service RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473 Rural Housing Service Rural Housing Service RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473 Rural Utilities Rural Utilities Service RULES Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 7695-7698 2016-02473 Securities Securities and Exchange Commission NOTICES Program for Allocation of Regulatory Responsibilities: Order Approving and Declaring Effective a Proposed Plan for the Allocation of Regulatory Responsibilities Between the Financial Industry Regulatory Authority, Inc. and the National Stock Exchange, Inc., 7871-7873 2016-02982 Self-Regulatory Organizations; Proposed Rule Changes: BATS Exchange, Inc., 7851-7853, 7857-7865 2016-02981 2016-02983 BOX Options Exchange, LLC, 7853-7856, 7873-7876, 7879-7882 2016-02985 2016-02987 2016-02988 Chicago Board Options Exchange, Inc., 7867-7871 2016-02986 EDGX Exchange, Inc., 7848-7851 2016-02984 Financial Industry Regulatory Authority, Inc., 7865-7867 2016-02990 Miami International Securities Exchange, LLC, 7877-7879 2016-02989 NYSE MKT, LLC, 7882-7884 2016-02980 Public Company Accounting Oversight Board, 7928-7957 2016-02875 Small Business Small Business Administration NOTICES Conflict of Interest Exemptions: PennantPark SBIC II, LP, 7884 2016-03005 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Pharaoh -- King of Ancient Egypt Exhibition, 7884 2016-03218 Surface Mining Surface Mining Reclamation and Enforcement Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 7829-7830 2016-03056 2016-03109 Susquehanna Susquehanna River Basin Commission NOTICES Projects Approved for Consumptive Uses of Water, 7884-7886 2016-03051 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Transit Administration

See

Maritime Administration

See

National Highway Traffic Safety Administration

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81 30 Tuesday, February 16, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE 2 CFR Parts 400, 415, 416, 418, and 422 Office of the Chief Financial Officer 7 CFR Parts 3015, 3016, 3018, 3019, 3022, and 3052 Farm Service Agency 7 CFR Parts 761 and 785 Commodity Credit Corporation 7 CFR Parts 1407 and 1485 National Institute of Food and Agriculture 7 CFR Parts 3400, 3401, 3402, 3403, 3405, 3406, 3407, 3415, 3430, and 3431 Rural Utilities Service 7 CFR Parts 1703, 1709, 1710, 1717, 1724, 1726, 1737, 1738, 1739, 1740, 1773, 1774, 1775, 1776, 1778, 1779, 1780, 1782, and 1783 Rural Business-Cooperative Service Rural Housing Service Rural Utilities Service Farm Service Agency 7 CFR Parts 1942, 1944, 1951, and 1980 Rural Housing Service 7 CFR Parts 3570 and 3575 Rural Business-Cooperative Service Rural Utilities Service 7 CFR Parts 4274, 4279, 4280, 4284, 4285 and 4290 RIN 0505-AA15 Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards AGENCY:

Office of the Chief Financial Officer, Farm Service Agency, Commodity Credit Corporation, National Institute of Food and Agriculture, Rural Utilities Service, Rural Business-Cooperative Service, Rural Housing Service, Department of Agriculture.

ACTION:

Final rule.

SUMMARY:

The Office of the Chief Financial Officer, Farm Service Agency, Commodity Credit Corporation, National Institute of Food and Agriculture, Rural Utilities Service, Rural Business-Cooperative Service and Rural Housing Service finalize their portion of the uniform federal assistance rule and amend specific regulations to reference the conforming changes published by the Office of Management and Budget (OMB) in the Federal Register on December 19, 2014.

DATES:

This rule is effective February 16, 2016.

FOR FURTHER INFORMATION CONTACT:

Tyson Whitney, Office of the Chief Financial Officer, Director, Transparency and Accountability Reporting Division, United States Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250-9011, 202-720-8978, [email protected]

SUPPLEMENTARY INFORMATION:

OMB is streamlining the Federal government's guidance on Administrative Requirements, Cost Principles, and Audit Requirements for Federal awards. In a final rule published in the Federal Register on December 26, 2013, (78 FR 78590) OMB adopted final guidance, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance), that supersedes and streamlines requirements from OMB Circulars A-21, A-87, A-110, and A-122 (which were located previously in title 2 of the Code of Federal Regulation (CFR)); Circulars A-89, A-102, and A-133; and the guidance in Circular A-50 on Single Audit Act follow-up. The final guidance is located in title 2 part 200.

On December 19, 2014, OMB published a joint interim final rule in the Federal Register, (79 FR 75871). OMB made technical corrections to the Uniform Guidance, and Federal awarding agencies, including the Department of Agriculture, Office of the Chief Financial Officer, Farm Service Agency, Commodity Credit Corporation, National Institute of Food and Agriculture, Rural Utilities Service, Rural Business-Cooperative Service and Rural Housing Service, implemented the guidance in their respective chapters and titles in the CFR.

OMB's joint interim final rule requested additional comments on the rule. USDA received 13 comments. Of the 13 comments, one comment was directly related to USDA, Rural Housing Service (RHS). RHS will address this comment below as part of the preamble to 7 CFR 1944.422 of this final rule. The remaining comments were applicable to OMB and other Federal agencies. Notification was sent to OMB for resolution.

As part of the December 2014 rulemaking, the Office of the Chief Financial Officer adopted 2 CFR part 200, along with an agency-specific addendum in a new 2 CFR part 400. The Department of Agriculture added 2 CFR parts 415, 416, 418 and 422. In addition, the Office of the Chief Financial Officer removed parts 3015, 3016, 3018, 3019, 3022 and 3052 from title 7 of the CFR, as they became obsolete with the publication of the interim final rule. See 79 FR 75981, December 19, 2014. Title 2 of the CFR parts 400, 415, 416, 418 and 422 as described in the interim final rule are adopted with no changes.

The Farm Service Agency 7 CFR parts 761 and 785, and Commodity Credit Corporation 7 CFR parts 1407 and 1485 as described in the interim final rule are adopted with no changes.

The National Institute of Food and Agriculture 7 CFR parts 3400, 3401, 3402, 3403, 3405, 3406, 3407, 3415, 3430, and 3431 as described in the interim final rule are adopted with no changes.

The Rural Utilities Service 7 CFR parts 1703, 1709, 1710, 1717, 1724, 1726, 1737, 1738, 1739, 1740, 1773, 1779, and 1782 as described in the interim final rule are adopted with no changes. The changes to 7 CFR parts 1774, 1775, 1776, 1778, 1780, and 1783 as described in the interim final rule are adopted with technical changes to address the following issues. First, there were specific new regulations (including 2 CFR parts 200, 400, or other 400 series regulations) that should have had been referenced in the conforming changes published in the December 19, 2014, rule, but which were inadvertently not included. An example is that the Emergency and Imminent Community Water Assistance Grants regulations (7 CFR part 1778) should have had a conforming change reference to 2 CFR parts 200 and 400. Second, there were some streamlining measures implemented by OMB that might be interpreted by some as not applicable to 7 CFR part 1780 without the technical corrections. Examples include the change from $100,000 to $150,000 for the Simplified Acquisition Threshold for small purchase procedures, an increase in the associated threshold for the use of construction surety bonds, the addition of micro-purchases, and changes to contract clauses. Current language at 7 CFR 1780.72(a) states that small purchase procedures are applicable to procurement under $100,000 rather than referencing the Simplified Acquisition Threshold. The technical corrections would enable the use of the OMB streamlining measures. A standard contract clause that had been in 7 CFR 3016.36 requiring compliance with state energy plans was removed by OMB and should also be removed from 7 CFR 1780.75.

The Rural Housing Service, Rural Business-Cooperatives Service, Rural Utilities Service and Farm Service Agency 7 CFR parts 1942, 1951, and 1980 as described in the interim final rule are adopted with no changes. The regulation in 7 CFR part 1944 as described in the interim final rule is adopted with a technical change to 7 CFR 1944.422 in response to the following comment:

Comment: It appears that the USDA Rural Development requirement for an audit to be submitted within 90 days of the end of the grantee's fiscal year (§ 1944.422) has not been brought in line with the overall deadline for audits contained in § 200.512(a)(1). It is almost impossible for USDA funded affordable housing NFE's to complete the audit process and have even a draft Single Audit report within 90 days of the end of their fiscal year. Many of these organizations have related LLC's for which they are general partners and they must wait for the completion of those related entities' audit before completing the overall organization's audit. Why was this unreasonable audit deadline not reviewed or revised with the publication of the interim rule?

Response: USDA Rural Development agrees the regulation must be clear and consistent. The omission of language in 7 CFR 1944.422 was an oversight. We amended 7 CFR 1944.422 to address the oversight.

The Rural Housing Service 7 CFR parts 3570 and 3575 as described in the interim final rule are adopted with no changes.

The Rural Business-Cooperative Service and Rural Utilities Service 7 CFR parts 4274, 4279, 4280, 4284, 4285, and 4290 as described in the interim final rule are adopted with no changes.

Because the changes identified in the preamble are merely technical, advance notice and public comment are unnecessary and we find good cause to make these necessary changes effective immediately upon publication.

Regulatory Analysis

For the regulatory analysis regarding this rulemaking, please refer to the analysis prepared by OMB in the interim final rule, which is incorporated herein. See 79 FR 75876, December 19, 2014.

Executive Order 12866 Determination

Pursuant to Executive Order 12866, OMB has determined this final rule to be not significant. OMB has not reviewed this rule.

List of Subjects in 2 CFR Parts 400, 415, 416, 418, and 422; 7 CFR Parts 761, 785, 1407, 1485, 1703, 1709, 1710, 1717, 1724, 1726, 1737, 1738, 1739, 1740, 1773, 1774, 1775, 1776, 1778, 1779, 1780, 1782, 1783, 1942, 1944, 1951, 1980, 3015, 3016, 3018, 3019, 3022, 3052, 3400, 3401, 3402, 3403, 3405, 3406, 3407, 3415, 3430, 3431, 3570, 3575, 4274, 4279, 4280, 4284, 4285, and 4290

Accounting, Administrative practice and procedure, Agriculture, Auditing, Business and industry, Colleges and universities, Community development, Cost principles, Economic development, Government Contracts, Grants administration, Grant programs, Grant programs housing and community development, Hospitals, Indians, Loan programs—agriculture, Nonprofit organizations, State and local governments, Reporting and recordkeeping requirements, Research misconduct, Rural areas.

For the reasons discussed above, the interim rule adding 2 CFR parts 400, 415, 416, 418, and 422, removing 7 CFR parts 3015, 3016, 3018, 3019, 3022, and 3052, and amending 7 CFR parts 761, 785, 1407, 1485, 1703, 1709, 1710, 1717, 1724, 1726, 1737, 1738, 1739, 1740, 1773, 1774, 1775, 1776, 1778, 1779, 1780, 1782, 1783, 1942, 1944, 1951, 1980, 3400, 3401, 3402, 3403, 3405, 3406, 3407, 3415, 3430, 3431, 3570, 3575, 4274, 4279, 4280, 4284, 4285, and 4290, which was published at 79 FR 75871 on December 19, 2014, is adopted as a final rule with the following changes:

Title 7—Agriculture PART 1774—SPECIAL EVALUATION ASSISTANCE FOR RURAL COMMUNITIES AND HOUSEHOLDS PROGRAM (SEARCH) 1. The authority citation for part 1774 continues to read as follows: Authority:

7 U.S.C. 1926(a)(2)(C).

Subpart A—General Provisions 2. Amend § 1774.8 by revising paragraphs (g) through (j) and adding paragraph (k) to read as follows:
§ 1774.8 Other Federal Statutes.

(g) 2 CFR part 415—General Program Administrative Requirements.

(h) 2 CFR part 180, as adopted by USDA through 2 CFR part 417, Nonprocurement Debarment and Suspension, implementation of Executive Order 12549 on debarment and suspension.

(i) 2 CFR part 418, New Restrictions on Lobbying, prohibiting the use of appropriated funds to influence Congress or a Federal agency in connection with the making of any Federal grant and other Federal contracting and financial transactions.

(j) 2 CFR part 421, Requirements for Drug-Free Workplace (Financial Assistance), implementing the Drug-Free Workplace Act of 1988 (41 U.S.C 8102).

(k) 7 CFR part 15b, USDA implementation of section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), as amended, prohibiting discrimination on the basis of physical or mental handicap in Federally assisted programs.

PART 1775—TECHNICAL ASSISTANCE GRANTS 3. The authority citation for part 1775 continues to read as follows: Authority:

5 U.S.C. 301; 7 U.S.C. 1989; 16 U.S.C. 1005.

Subpart A—General Provisions 4. Amend § 1775.8 by adding paragraphs (g) and (k) to read as follows:
§ 1775.8 Other Federal statutes.

(g) 2 CFR part 415—General Program Administrative Requirements.

(k) 2 CFR part 200, subpart F—Audit Requirements.

PART 1776—HOUSEHOLD WATER WELL SYSTEM GRANT PROGRAM 5. The authority citation for part 1776 continues to read as follows: Authority:

7 U.S.C. 1926e.

Subpart A—General 6. Revise § 1776.2 to read as follows:
§ 1776.2 Uniform Federal Assistance Provisions.

(a) This program is subject to the general provisions that apply to all grants made by USDA and that are set forth in 2 CFR part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, as adopted by USDA through 2 CFR part 400, as well as the following:

(1) 2 CFR part 415—General Program Administrative Requirements.

(2) 2 CFR part 180, as adopted by USDA through 2 CFR part 417, Nonprocurement Debarment and Suspension, implementing Executive Order 12549 on debarment and suspension.

(3) 2 CFR part 418, New Restrictions on Lobbying, prohibiting the use of appropriated funds to influence Congress or a Federal agency in connection with the making of any Federal grant and other Federal contracting and financial transactions.

(4) 2 CFR part 421, Requirements for Drug-Free Workplace (Financial Assistance), implementing the Drug-Free Workplace Act of 1988 (41 U.S.C 8102).

(b) [Reserved]

PART 1778—EMERGENCY AND IMMINENT COMMUNITY WATER ASSISTANCE GRANTS 7. The authority citation for part 1778 continues to read as follows: Authority:

5 U.S.C. 301; 7 U.S.C. 1989; 16 U.S.C. 1005.

8. Amend § 1778.14 by revising paragraph (e) and adding paragraphs (g) through (i) to read as follows:
§ 1778.14 Other considerations.

(e) Governmentwide debarment and suspension (nonprocurement). All projects must comply with the requirements of 2 CFR part 180, as adopted by USDA through 2 CFR part 417, Nonprocurement Debarment and Suspension, implementing Executive Order 12549 on debarment and suspension.

(g) Uniform administrative requirements. All projects funded under this part are subject to 2 CFR part 200, as adopted by USDA through 2 CFR part 400, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, and 2 CFR part 415, General Program Administrative Requirements.

(h) Restrictions on lobbying. All projects funded under this part are subject to 2 CFR part 418, New Restrictions on Lobbying.

(i) Requirements for drug-free workplace. This program is subject to 2 CFR part 421, Requirements for Drug-Free Workplace (Financial Assistance).

PART 1780—WATER AND WASTE LOANS AND GRANTS 9. The authority citation for part 1780 continues to read as follows: Authority:

5 U.S.C. 301; 7 U.S.C. 1989; 16 U.S.C. 1005.

Subpart A—General Policies and Requirements 10. Amend § 1780.1 as follows: a. Revise paragraph (l)(3); b. Remove paragraphs (l)(4) and (5); and c. Revise paragraph (m).

The revisions read as follows:

§ 1780.1 General.

(l) * * *

(3) 2 CFR part 421-Requirements for Drug-Free Workplace (Financial Assistance).

(m) Applicants for loan or grant assistance will be required to comply with the following requirements as applicable:

(1) 2 CFR part 200, subpart F, “Audit Requirements.”

(2) 2 CFR part 180, as adopted by USDA through 2 CFR part 417, Nonprocurement Debarment and Suspension, implementation of Executive Order 12549 and Executive Order 12689 on debarment and suspension.

(3) 2 CFR part 418, New Restrictions on Lobbying.

11. Amend § 1780.3 by adding, in alphabetical order, the definition for “Simplified acquisition threshold” to read as follows:
§ 1780.3 Definitions and grammatical rules of construction.

(a) * * *

Simplified acquisition threshold means the dollar amount below which an applicant or owner may purchase property or services using small purchase methods as defined further at 2 CFR 200.88.

Subpart C—Planning, Designing, Bidding, Contracting, Constructing and Inspections 12. Amend § 1780.72 by revising the introducty text to read as follows:
§ 1780.72 Procurement methods.

Procurement shall be made by one of the following methods and in accordance with requirements of 2 CFR 200.320: Micro-purchases, procurement by small purchase procedures, procurement by sealed bids (formal advertising), procurement by competitive proposals, or procurement by noncompetitive proposals. The sealed bid method is the preferred method for procuring construction.

13. Amend § 1780.75 as follows: a. In paragraph (a), remove “Contracts other than small purchases” and add “Contracts for more than the Simplified Acquisition Threshold” in its place; b. In paragraph (c), remove “exceeding $100,000,” and add “exceeding the Simplified Acquisition Threshold,” in its place; c. Remove and reserve paragraphs (f) and (g); d. Revise paragraph (k); and e. Add paragraphs (l) through (o).

The revision and additions reads as follows:

§ 1780.75 Contract provisions.

(k) Clean Air Act (42 U.S.C. 7401-7671q) and the Federal Water Pollution Control Act (33 U.S.C. 1251-1388). Contracts and subgrants of amounts in excess of $150,000 must contain a provision that requires the contractor to agree to comply with all applicable standards, orders or regulations issued pursuant to the Clean Air Act (42 U.S.C. 7401-7671q) and the Federal Water Pollution Control Act as amended (33 U.S.C. 1251-1387). Violations must be reported to the Federal awarding agency and the Regional Office of the Environmental Protection Agency (EPA).

(l) Contract Work Hours and Safety Standards Act (40 U.S.C. 3701-3708). Where applicable, all contracts awarded by the non-Federal entity in excess of $100,000 that involve the employment of mechanics or laborers must include a provision for compliance with 40 U.S.C. 3702 and 3704, as supplemented by Department of Labor regulations (29 CFR part 5). Under 40 U.S.C. 3702, each contractor must be required to compute the wages of every mechanic and laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is permissible provided that the worker is compensated at a rate of not less than one and a half times the basic rate of pay for all hours worked in excess of 40 hours in the work week. The requirements of 40 U.S.C. 3704 are applicable to construction work and provide that no laborer or mechanic must be required to work in surroundings or under working conditions which are unsanitary, hazardous or dangerous. These requirements do not apply to the purchases of supplies or materials or articles ordinarily available on the open market.

(m) Debarment and suspension. A contract award (see 2 CFR 180.220) must not be made to parties listed on the governmentwide exclusions in the System for Award Management (SAM), in accordance with the OMB guidelines at 2 CFR part 180, as supplemented by 2 CFR part 417, “Debarment and Suspension.” SAM exclusion records contain the names of parties debarred, suspended, or otherwise excluded by agencies, as well as parties declared ineligible under statutory or regulatory authority other than Executive Order 12549.

(n) Byrd anti-lobbying amendment (31 U.S.C. 1352). Contractors that apply or bid for an award exceeding $100,000 must file the required certification. Each tier certifies to the tier above that it will not and has not used Federal appropriated funds to pay any person or organization for influencing or attempting to influence an officer or employee of any agency, a member of Congress, officer or employee of Congress, or an employee of a member of Congress in connection with obtaining any Federal contract, grant or any other award covered by 31 U.S.C. 1352. Each tier must also disclose any lobbying with non-Federal funds that takes place in connection with obtaining any Federal award. Such disclosures are forwarded from tier to tier up to the non-Federal award.

(o) Procurement of recovered materials. A public body, such as a state government, state agency, municipality, county, district, authority, or other political subdivision of a state, territory or commonwealth, must ensure its contracts include provisions requiring compliance with section 6002 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act. The requirements of Section 6002 include procuring only items designated in guidelines of the Environmental Protection Agency (EPA) at 40 CFR part 247 that contain the highest percentage of recovered materials practicable, consistent with maintaining a satisfactory level of competition, where the purchase price of the item exceeds $10,000 or the value of the quantity acquired during the preceding fiscal year exceeded $10,000; procuring solid waste management services in a manner that maximizes energy and resource recovery; and establishing an affirmative procurement program for procurement of recovered materials identified in the EPA guidelines.

PART 1783—REVOLVING FUNDS FOR FUNDING WATER AND WASTEWATER PROJECTS (REVOLVING FUND PROGRAM) 14. The authority citation for part 1783 continues to read as follows: Authority:

7 U.S.C. 1926 (a)(2)(B).

Subpart A—General 15. Amend § 1783.2 by adding paragraphs (c), (d), and (e) to read as follows:
§ 1783.2 What Uniform Federal Assistance Provisions apply to the Revolving Fund Program?

(c) 2 CFR part 180, as adopted by USDA through 2 CFR part 417, Nonprocurement Debarment and Suspension, implementing Executive Order 12549 and Executive Order 12689 on debarment and suspension.

(d) This program is subject to 2 CFR part 418, New Restrictions on Lobbying, prohibiting the use of appropriated funds to influence Congress or a Federal agency in connection with the making of any Federal grant and other Federal contracting and financial transactions.

(e) This program is subject to 2 CFR part 421, Requirements for Drug-Free Workplace (Financial Assistance), implementing the Drug-Free Workplace Act of 1988 (41 U.S.C. 8102).

PART 1944—HOUSING 16. The authority for part 1944 continues to read as follows: Authority:

5 U.S.C. 301; 42 U.S.C. 1480.

Subpart I—Self-Help Technical Assistance Grants
§ 1944.422 [Amended]
17. Amend § 1944.422 in the introductory text by removing “within 90 days of the end of the grantee's fiscal year, grant period, or termination of the grant.” and adding “the earlier of 30 calendar days after receipt of the auditor's report or nine months after the end of the grantee's audit period.” in its place.
Jon M. Holladay, Chief Financial Officer.
[FR Doc. 2016-02473 Filed 2-12-16; 8:45 am] BILLING CODE 3410-KS-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No.: FAA-2014-0001; Amdt. No. 25-141] RIN 2120-AK29 Harmonization of Airworthiness Standards—Fire Extinguishers and Class B and F Cargo Compartments AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

The FAA is amending certain airworthiness regulations for transport category airplanes by upgrading fire safety standards for Class B cargo compartments; establishing fire safety standards for a new type of cargo compartment, Class F; and updating related standards for fire extinguishers. This amendment is based on recommendations from the Aviation Rulemaking Advisory Committee (ARAC) and the National Transportation Safety Board (NTSB), and the changes address designs for which airworthiness directives (ADs) have been issued by both the FAA and the French civil aviation authority, Direction Générale de l'Aviation Civile (DGAC).

This amendment eliminates certain regulatory differences between the airworthiness standards of the FAA and the European Aviation Safety Agency (EASA), without affecting current industry design practices. These changes ensure an acceptable level of safety for these types of cargo compartments by standardizing certain requirements and procedures.

DATES:

Effective April 18, 2016.

ADDRESSES:

For information on where to obtain copies of rulemaking documents and other information related to this final rule, see “How To Obtain Additional Information” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

For technical questions concerning this action, contact Stephen M. Happenny, Propulsion/Mechanical Systems Branch, ANM-112, Transport Airplane Directorate, Aircraft Certification Service, Federal Aviation Administration, 1601 Lind Ave. SW., Renton, WA 98055-4056; telephone (425) 227-2147; facsimile (425) 227 1232; email: [email protected]

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules on aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for the design and performance of aircraft that the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it prescribes new safety standards for the design and operation of transport category airplanes.

I. Overview of Final Rule

The FAA is amending Title 14, Code of Federal Regulations (14 CFR) part 25 as described below. This action harmonizes part 25 requirements for fire extinguishers and cargo compartments with the corresponding requirements in EASA Certification Specifications and Acceptable Means of Compliance for Large Aeroplanes (CS-25).

This amendment defines a new classification of cargo compartment, Class F, with certification standards similar to those for Class C compartments. Class F cargo compartments have no size limit, but must be located on the main deck of the airplane. They must have a liner that meets the fire resistance requirements for Class C compartments, unless the proposed design provides other means to contain a fire and protect critical systems and structure. If a Class F cargo compartment is accessible to crewmembers in flight, at least one readily accessible fire extinguisher must be available for the crew's use. If a proposed Class F cargo compartment incorporates a built-in fire extinguishing system, the applicant must conduct flight tests to demonstrate that there are means to extinguish or control a fire without requiring a crewmember to enter the compartment, and hazardous quantities of extinguishing agent are excluded from any compartment occupied by crew or passengers. The floor panels of Class F cargo compartments must also be self-extinguishing under certain flammability tests in appendix F to part 25, and ceiling and sidewall liner panels must meet the flame penetration resistance test requirements of part III of appendix F.

In addition, this amendment requires Class B cargo compartments to have a defined firefighting access point that will allow a crewmember to fight a fire without stepping into the compartment. This requirement will indirectly limit the size of those compartments.

Finally, this amendment clarifies what the FAA considers “adequate” capacity for built-in fire extinguishing systems.

Manufacturers and modifiers seeking FAA type certification already use the principles of these changes through equivalent level of safety findings and special conditions. Harmonizing FAA and EASA requirements will benefit these applicants by providing a single set of requirements, thereby reducing the cost and complexity of certification and codifying a consistent level of safety.

The changes apply to new airplane designs only, not to existing airplanes. Applicability to derivative airplanes or changed products will be determined according to 14 CFR 21.101, “Designation of applicable regulations.”

II. Background A. Statement of the Problem

This rulemaking addresses the problem of fire safety of cargo compartments on passenger airplanes, specifically the need to detect and extinguish cargo compartment fires in a manner that is prompt, reliable, and without hazard to crew or passengers. The EASA enacted standards addressing those issues, and this amendment harmonizes with those standards.

The revised standards stem from actions following a 1987 accident that were discussed in detail in the notice of proposed rulemaking (NPRM), published in the Federal Register July 7, 2014 (79 FR 38266). In summary, a fire occurred in the Class B cargo compartment of a Boeing Model 747-244B airplane operated by South African Airways. It was carrying both passengers and cargo on the main deck, a configuration known as a “combi” and classified under FAA regulations as a Class B cargo compartment. The airplane crashed in the Indian Ocean about 140 miles northeast of Mauritius. All people aboard the airplane perished.

The South African Board of Inquiry reported that (1) there was clear indication that a fire broke out on a right-hand front pallet (one of six) in the main deck cargo hold, and (2) the fire could not be controlled and consequently led to the crash.

An FAA Review Team evaluated the fire protection requirements in Class B cargo compartments at that time and issued the following findings and conclusions: 1

1 FAA Review Team report, “Evaluation of Transport Airplane Main Deck Cargo Compartment Fire Protection Certification Procedures,” June 1, 1988, available in the docket.

1. Existing rules, policies, and procedures for the certification of Class B cargo or baggage compartments for smoke and fire protection were inadequate.

2. The required quantity of fire extinguishing agent and the number of portable fire extinguishers were inadequate.

3. The use of pallets to carry cargo in Class B compartments was no longer acceptable.

4. While entry into the cargo compartment was available, not all cargo was accessible.

5. The reliance on crewmembers to fight a cargo fire had to be discontinued.

This accident led to further investigations and the formation of industry and FAA study groups, including the ARAC and associated working groups, the Cargo Standards Harmonization Working Group (CSHWG) and the Mechanical Systems Harmonization Working Group (MSHWG). The findings and recommendations from these groups underscored the need to limit the size of, and enhance fire detection and suppression in, Class B compartments. They also recommended creating a new classification of cargo compartments on the main deck (Class F cargo compartment) with enhanced fire detection and suppression, and standardization of guidance for testing of fire extinguishing agent concentration.

The ARAC, in a related tasking, recommended harmonization of FAA regulations with EASA standards for cargo compartments and associated fire extinguishers.

These findings and recommendations, and the FAA's support of the harmonization effort with EASA, formed the basis for this rulemaking.

B. Related Actions

In response to the South African Airways accident, the FAA and the DGAC issued airworthiness directives (ADs) that require operational and procedural changes, additional equipment, and enhanced fire detection and suppression systems on applicable large, main-deck combi airplanes. These ADs provide options to the operators of the affected airplanes for achieving an adequate level of safety. The enhanced fire detection and suppression system standards of the ADs require modification of the design of Class B cargo compartments to either comply with the requirements for a Class C cargo compartment or incorporate other specified safeguards.

This amendment and associated guidance material encompass the enhanced standards and options included in the ADs.

C. National Transportation Safety Board (NTSB) Recommendations

The NTSB investigated the South African 747-244B accident and issued the following safety recommendations:

1. A-88-61. Until fire detection and suppression methods for Class B cargo compartment fires were evaluated and revised, as necessary, the NTSB recommended that the FAA require all cargo carried in Class B cargo compartments of U.S.-registered transport category airplanes be carried in fire resistant containers.

The FAA addressed this recommendation with current AD 93-07-15. The revisions in this amendment to the cargo compartment fire protection requirements and to part 25, appendix F, part I for fire testing requirements also address this recommendation.

2. A-88-62. The NTSB recommended that the FAA research the fire detection and suppression methods needed to protect transport category airplanes from catastrophic fires in Class B compartments.

To address this recommendation, the FAA and Europe's Joint Aviation Authorities (JAA), the predecessor to EASA, researched whether Class B cargo compartments might be unsafe. Both authorities concluded that entering the compartment to combat a fire was ineffective for cargo compartments larger than 200 cubic feet in volume and that tests with actual fires should be conducted to more closely establish the maximum safe size. The conclusions of these and other tests, as detailed in the NPRM, were that, when standing at an access point, the person fighting the fire must be able to reach any part of the compartment with the contents of a hand fire extinguisher, and that access should be a function of how the compartment was configured rather than by volume. The revisions to § 25.857(b)(2) in this amendment address these conclusions.

3. A-88-63. The NTSB recommended that the FAA establish fire resistance requirements for the ceiling and sidewall liners in Class B cargo compartments of transport category airplanes that equal or exceed the requirements for Class C as set forth in 14 CFR part 25, appendix F, part III.

The current AD and the revisions to cargo compartment classifications in this amendment address this recommendation.

D. Summary of the NPRM

On June 26, 2014, the FAA issued an NPRM to amend §§ 25.851, 25.855, and 25.857. The Federal Register published NPRM Notice No. 14-06, Docket No. FAA-2014-0001, on July 7, 2014 (79 FR 38266). In the NPRM, the FAA proposed to:

1. Extend the hand fire extinguisher and built-in fire extinguisher requirements for Class A, B, C, or E cargo or baggage compartments to a new Class F accessible cargo or baggage compartment;

2. Revise the requirements for built-in fire extinguishing and suppression systems to clarify that the capacity of the system must be adequate to respond to a fire that could occur in any part of the cargo compartment where cargo or baggage is placed;

3. Extend the material standards and design considerations for cargo compartment interiors and the requirement for flight test to demonstrate compliance with § 25.857 regarding the dissipation of extinguishing agent to include the new Class F cargo compartments (with designs that incorporate a built-in fire extinguisher/suppression system); and

4. Indirectly limit the size of a Class B cargo compartment by requiring a defined firefighting access point that will allow a crewmember to fight a fire without stepping into the compartment.

The comment period closed on October 6, 2014.

E. General Overview of Comments

The FAA received eight (8) comments from five (5) commenters representing airplane manufacturers, material manufacturers, and pilots. All of the commenters generally supported the proposed changes; however, some commenters suggested changes, as discussed more fully in the discussion of the final rule below. The Air Line Pilots Association International and SABIC Innovative Plastics concurred with the proposal without comment.

III. Discussion of the Final Rule and Public Comments A. New Class F Cargo Compartments

This final rule establishes a new classification, Class F, for cargo or baggage compartments. The design requirements for Class F cargo compartments are set forth in new § 25.857(f). We are also amending §§ 25.851 and 25.855, and appendix F to part 25 to include the new Class F compartment in their applicability.

1. “Cargo Compartment Classification,” (§ 25.857)

With one modification from what the FAA proposed in the NPRM, § 25.857(f) requires Class F compartments to be located on the main deck; have a separate approved smoke or fire detection system that provides a warning on the flight deck; have a means to exclude smoke, flames, or extinguishing agent from crew or passenger compartments; and have a means to control or extinguish a fire without requiring a crewmember to enter the compartment. This new class of cargo compartments is added to harmonize with EASA and provide a flexible option for cargo compartment certification.2

2 For example, the requirement that a Class F compartment have a means to control or extinguish a fire without crewmember entry allows flexibility in design. A proposed design may rely on a crewmember to control or extinguish a fire using a hand fire extinguisher without entering the compartment, similar to Class B compartments, or it could employ another means of compliance such as a built-in fire extinguishing/suppression system similar to Class C compartments. The FAA anticipates analyzing a variety of proposed designs for Class F cargo compartments. Alternative processes for approval, such as special conditions and equivalent level of safety findings, will remain available.

While the FAA originally proposed in the NPRM that Class F cargo compartments be readily accessible in flight, it is not adopting that proposed requirement. One of the purposes of this rulemaking is to harmonize with EASA. As noted in a comment by Boeing Commercial Airplanes (Boeing), EASA's rule does not include that requirement. The FAA concluded that requiring Class F cargo compartments to be readily accessible in flight would go beyond EASA's rule (CS 25.855 and 25.857, equivalent to 14 CFR 25.855 and 25.857) and associated Acceptable Means of Compliance (AMC). It would also be unduly restrictive. For example, the FAA currently certifies certain compartments that are not accessible in flight by using the Class C compartment requirements. As explained in the NPRM, a Class F cargo compartment located on the main deck and using a built-in fire suppression system would meet the requirements of a Class C cargo compartment, without accessibility. Therefore, accessibility in flight is an option, but not a requirement, for Class F cargo compartments.

Boeing also commented that requiring Class F cargo compartments to be located on the main deck would not harmonize with EASA's rule. The FAA's requirement is consistent with EASA's certification policy. EASA's AMC states that, “It is not envisaged that lower deck cargo compartments be approved as Class F cargo compartments.” The FAA agrees with EASA's position; however, instead of stating this position in guidance material as EASA did, the FAA opted to include it in the regulation. Since this is a harmonization rule, the FAA confirmed with EASA 3 that the FAA rule has the same intent as the corresponding EASA rule and AMC. Therefore, § 25.857(f) requires that Class F cargo compartments be located on the main deck of the airplane.4

3 Details of the communication are in the docket.

4 An editorial change from “is located on the main deck” to “must be located on the main deck” is adopted in this rule.

2. “Fire Extinguishers” (§ 25.851)

As proposed in the NPRM, § 25.851(a)(3), “Hand fire extinguishers,” adds Class F cargo compartments that are accessible in flight to the types of cargo compartments that must have hand fire extinguishers. This requirement is consistent with the FAA's prior regulatory practice for accessible cargo compartments and is harmonized with EASA's corresponding regulation.

Embraer commented that the proposed § 25.851(a)(3) would require an applicant to have one hand fire extinguisher in Class F cargo compartments despite any other fire extinguishing means that may be present, such as a built-in fire extinguishing system or fire containment covers.

This comment overlooks one of the conditions for requiring a hand fire extinguisher. Only those Class F cargo compartments that are accessible in flight must meet this requirement, so that hand fire extinguishers would not be required for all Class F compartments. Even for compartments that are accessible in flight and have a built-in fire extinguishing system, the presence of a hand fire extinguisher should, in most circumstances, mitigate the additional risk presented by accessibility.5

5 An exception would be a proposed Class F cargo compartment for which the combination of accessibility and use of a hand fire extinguisher would create additional risk. For example, a proposed design that included a fire-resistant cargo container with a built-in fire suppression unit would likely be safer if the compartment and container were left unopened.

Section 25.851(b)(2), “Built-in fire extinguishers,” describes the required capacity of built-in fire extinguishing systems. The FAA revises paragraph (b)(2), as proposed in the NPRM, to clarify what the FAA will accept as “adequate” capacity of built-in fire extinguishing systems. The revised rule states that a built-in fire extinguishing system is adequate if there is sufficient quantity of agent to extinguish the fire or suppress the fire anywhere baggage or cargo is placed within the cargo compartment for the time required to land and evacuate the airplane. The FAA is taking this step to harmonize with EASA and because testing has shown that current methods of compliance are inadequate.

Boeing recommended against this requirement because it is not included in EASA CS 25.851(b)(2). The FAA is adopting this clarification to ensure its enforceability. The FAA coordinated this addition with EASA 6 and ensured that this rule has the same effect as the corresponding EASA rule and AMC.

6 Details of the communications are in the docket.

3. “Cargo and Baggage Compartments,” (§ 25.855)

Sections 25.855(b) and (c) now include the new Class F compartment in those compartments that are required to have a liner that meets the flame penetration standards required for Class C cargo compartments, unless the proposed design provides other means to contain a fire and protect critical systems and structure.

One material manufacturer, Du Pont Protection Technologies (Du Pont), recommended, in addition to requiring such liners, the enhancement of material standards and design considerations for Class B and F cargo compartment interiors. Specifically, Du Pont suggested requiring the use of fire resistant unit load devices and fire containment covers that meet part 25, appendix F, part III flame penetration resistance test requirements in all Class F cargo compartments in addition to, rather than as an alternative to, requiring cargo compartment liners that meet the same test criteria. While the FAA appreciates the commenter's intent of providing improved fire protection, the proposed additional requirements are unnecessarily burdensome and restrictive, and therefore not adopted.

Section 25.855(h)(3) is revised to extend the requirement for flight tests to those Class F cargo compartments that have built-in fire extinguishers in order to demonstrate compliance with § 25.857.

Also, as a minor correction from what was proposed in the NPRM, this rule changes “or” to “and” to clarify that the flight test requirement in § 25.855(h)(3) applies to both Class C compartments and applicable Class F compartments. The rule now states, “The dissipation of the extinguishing agent in all Class C compartments and, if applicable, in any Class F compartment.”

4. Flammability Requirements of Class F Compartment Floor Panels (Appendix F to Part 25)

The FAA is including Class F as a compartment that must meet the flammability standards for certain materials used in interior compartments of airplanes. Specifically, Class F floor panels must meet the standards in part I of appendix F to part 25, “Test Criteria and Procedures for Showing Compliance with § 25.853 or § 25.855,” paragraphs (a)(1)(ii) and (a)(2)(iii).

B. Class B Cargo or Baggage Compartments

As proposed in the NPRM, § 25.857(b)(1) now requires sufficient access in flight to enable a crewmember, standing at any one access point and without stepping into a Class B compartment, to extinguish a fire occurring in any part of the compartment using a hand fire extinguisher. As discussed in the NPRM, this requirement will have the effect of limiting the size of Class B compartments.

C. Differences Between the NPRM and the Final Rule

The rule text as proposed in the NPRM is adopted with one exception. As explained above, Class F cargo or baggage compartments are not required to be readily accessible in flight.

E. Advisory Material

On July 9, 2014, the FAA published and solicited public comments on two proposed advisory circulars (ACs) that describe acceptable means for showing compliance with the NPRM's proposed regulations. The comment period for the proposed ACs closed on October 6, 2014. The FAA received 7 comments from 2 commenters representing airplane and helicopter manufacturers on proposed AC 25.851-1; and 12 comments from 5 commenters representing airplane manufacturers, an airplane equipment manufacturer, and industry standards committees on proposed AC 25.857-1. All of the commenters generally supported the proposed ACs; however, some commenters suggested changes. The FAA added clarification to the guidance in the ACs but did not change the regulatory requirements as a result of the comments to the proposed ACs. Concurrent with this final rule, the FAA is issuing the following final ACs to provide guidance material for the new regulations adopted by this amendment:

• AC 25.851-1, “Built-in Fire Extinguishing/Suppression Systems in Class C and Class F Cargo Compartments.”

• AC 25.857-1, “Class B and F Cargo Compartments.”

IV. Regulatory Notices and Analyses A. Regulatory Evaluation

Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, the Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), as codified in 2 U.S.C. 1532, requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

Department of Transportation (DOT) Order DOT 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.

The FAA tasked the ARAC through the Cargo Standards Harmonization Working Group and the Mechanical Systems Harmonization Working Group to review existing part 25 cargo compartments and fire extinguisher regulations and to recommend changes that would eliminate differences between the U.S. and the European airworthiness standards, while maintaining or improving the level of safety in the current regulations. The FAA agrees with the ARAC recommendations to harmonize airworthiness standards for cargo compartments and associated fire extinguishers with the corresponding EASA regulations, which were incorporated into the CS-25 requirements in 2007 and 2009. The final rule eliminates differences between the U.S. and European airworthiness standards.

The final rule applies to new airplane designs only and revises §§ 25.851, “Fire extinguishers;” 25.855, “Cargo or baggage compartments;” 25.857, “Cargo compartment classification;” and part 25, appendix F, part I, “Test Criteria and Procedures for Showing Compliance with § 25.853, or § 25.855.” A review of U.S. manufacturers of transport category airplanes revealed that these manufacturers intend to fully comply with the EASA standards (or are already complying). In the NPRM, the FAA stated this rule imposes no more than minimal cost, and cost-savings could occur. The FAA asked for comment on the cost estimates and received none. The FAA has therefore determined that this final rule will impose at most minimal cost with possible cost-savings and does not warrant a full regulatory evaluation.

The FAA has also determined that this final rule is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866 and is not “significant” as defined in DOT's Regulatory Policies and Procedures.

B. Regulatory Flexibility Determination

The Regulatory Flexibility Act (RFA) of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify, and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

Small Business Administration size standards specify aircraft manufacturing firms having less than 1,500 employees as small. However, there are no U.S. manufacturers of part 25 airplanes with less than 1,500 employees. Moreover, the final rule has no cost. The FAA made a similar determination for the initial regulatory flexibility analysis, and we received no comments. Therefore, as provided in § 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this rule and has determined that the rule is in accord with the Trade Agreements Act as the rule uses European standards as the basis for U.S. standards.

D. Unfunded Mandates Assessment

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million. This rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this final rule.

F. International Compatibility and Cooperation

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these regulations.

Executive Order (EO) 13609, Promoting International Regulatory Cooperation, [77 FR 26413, May 4, 2012] promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policy and agency responsibilities of Executive Order 13609, Promoting International Regulatory Cooperation. The agency has determined that this action eliminates differences between U.S. aviation standards and those of other civil aviation authorities by creating a single set of certification requirements for transport category airplanes that is acceptable in both the United States and Europe.

G. Environmental Analysis

FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 312f of Order 1050.1E and involves no extraordinary circumstances.

V. Executive Order Determinations A. Executive Order 13132, Federalism

The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The agency determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use

The FAA analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it is not be a “significant energy action” under the executive order and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

VI. How To Obtain Additional Information A. Rulemaking Documents

An electronic copy of a rulemaking document may be obtained by using the Internet—

1. Search the Federal eRulemaking Portal (http://www.regulations.gov);

2. Visit the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies/ or

3. Access the Government Printing Office's Web page at http://www.thefederalregister.org/fdsys/.

Copies may also be obtained by sending a request (identified by notice, amendment, or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680.

B. Comments Submitted to the Docket

Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the docket number for this action. Anyone is able to search the electronic form of all comments received into any of the FAA's dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.).

C. Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document, may contact its local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The Amendment

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

PART 25—AIRWORTHINESS STANDARDS: TRANSPORT CATEGORY AIRPLANES 1. The authority citation for part 25 continues to read as follows: Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

2. Amend § 25.851 by revising paragraphs (a)(3) and (b)(2) to read as follows:
§ 25.851 Fire extinguishers.

(a) * * *

(3) At least one readily accessible hand fire extinguisher must be available for use in each Class A or Class B cargo or baggage compartment and in each Class E or Class F cargo or baggage compartment that is accessible to crewmembers in flight.

(b) * * *

(2) The capacity of each required built-in fire extinguishing system must be adequate for any fire likely to occur in the compartment where used, considering the volume of the compartment and the ventilation rate. The capacity of each system is adequate if there is sufficient quantity of agent to extinguish the fire or suppress the fire anywhere baggage or cargo is placed within the cargo compartment for the duration required to land and evacuate the airplane.

3. Amend § 25.855 by revising paragraphs (b), (c), and (h)(3) to read as follows:
§ 25.855 Cargo or baggage compartments.

(b) Each of the following cargo or baggage compartments, as defined in § 25.857, must have a liner that is separate from, but may be attached to, the airplane structure:

(1) Any Class B through Class E cargo or baggage compartment, and

(2) Any Class F cargo or baggage compartment, unless other means of containing a fire and protecting critical systems and structure are provided.

(c) Ceiling and sidewall liner panels of Class C cargo or baggage compartments, and ceiling and sidewall liner panels in Class F cargo or baggage compartments, if installed to meet the requirements of paragraph (b)(2) of this section, must meet the test requirements of part III of appendix F of this part or other approved equivalent methods.

(h) * * *

(3) The dissipation of the extinguishing agent in all Class C compartments and, if applicable, in any Class F compartments.

4. Amend § 25.857 by revising paragraph (b)(1) and adding paragraph (f) to read as follows:
§ 25.857 Cargo compartment classification.

(b) * * *

(1) There is sufficient access in flight to enable a crewmember, standing at any one access point and without stepping into the compartment, to extinguish a fire occurring in any part of the compartment using a hand fire extinguisher;

(f) Class F. A Class F cargo or baggage compartment must be located on the main deck and is one in which—

(1) There is a separate approved smoke detector or fire detector system to give warning at the pilot or flight engineer station;

(2) There are means to extinguish or control a fire without requiring a crewmember to enter the compartment; and

(3) There are means to exclude hazardous quantities of smoke, flames, or extinguishing agent from any compartment occupied by the crew or passengers.

5. Amend appendix F to part 25 by revising the heading for part I and paragraphs (a)(1)(ii) and (a)(2)(iii) under part 1 to read as follows: APPENDIX F TO PART 25 Part I—Test Criteria and Procedures for Showing Compliance With § 25.853 or § 25.855

(a) * * *

(1) * * *

(ii) Floor covering, textiles (including draperies and upholstery), seat cushions, padding, decorative and non-decorative coated fabrics, leather, trays and galley furnishings, electrical conduit, air ducting, joint and edge covering, liners of Class B and E cargo or baggage compartments, floor panels of Class B, C, E, or F cargo or baggage compartments, cargo covers and transparencies, molded and thermoformed parts, air ducting joints, and trim strips (decorative and chafing), that are constructed of materials not covered in paragraph (a)(1)(iv) below, must be self-extinguishing when tested vertically in accordance with the applicable portions of part I of this appendix or other approved equivalent means. The average burn length may not exceed 8 inches, and the average flame time after removal of the flame source may not exceed 15 seconds. Drippings from the test specimen may not continue to flame for more than an average of 5 seconds after falling.

(2) * * *

(iii) A cargo or baggage compartment defined in § 25.857 as Class B, C, E, or F must have floor panels constructed of materials which meet the requirements of paragraph (a)(1)(ii) of part I of this appendix and which are separated from the airplane structure (except for attachments). Such panels must be subjected to the 45 degree angle test. The flame may not penetrate (pass through) the material during application of the flame or subsequent to its removal. The average flame time after removal of the flame source may not exceed 15 seconds, and the average glow time may not exceed 10 seconds.

Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and 44702 in Washington, DC, on January 29, 2016. Michael P. Huerta, Administrator.
[FR Doc. 2016-03000 Filed 2-12-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0044] RIN 1625-AA00 Safety Zone; James River, Newport News, VA AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a safety zone on the navigable waters of the James River, in the vicinity of the James River Reserve Fleet, in support of United States Navy explosives training on the M/V SS DEL MONTE. This safety zone will restrict vessel movement in the specified area during the explosives training. This action is necessary to provide for the safety of life and property on the surrounding navigable waters during the United States Navy explosives training.

DATES:

This rule is effective from 8 a.m. on February 29, 2016 through 4 p.m. on March 4, 2016.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0044 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email LCDR Barbara Wilk, Waterways Management Division Chief, Sector Hampton Roads, U.S. Coast Guard; telephone 757-668-5580, email [email protected]

SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive order FR Federal Register NPRM Notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because information about the training starting on February 29, 2016 was not received by the Coast Guard with sufficient time to allow for an opportunity to comment on the proposed rule. This military training is necessary to train and qualify Navy personnel in the use of explosives. This training is imperative to ensure that Navy personnel located within the Fifth Coast Guard District are properly trained and qualified before conducting military and national security operations for use in securing ports and waterways. Navy policy requires that Navy personnel meet and maintain certain qualification standards before being allowed to carry out certain missions. Delaying the effective date of this safety zone would be contrary to the public interest as immediate action is needed to ensure the safety of the training participants, patrol vessels, and other vessels transiting the military exercise area. The Coast Guard will provide advance notifications to users of the affected waterway via marine information broadcasts and local notice to mariners.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Failure to conduct this required training at this time will result in a lapse in personnel qualification standards and, consequently, the inability of Navy personnel to carry out important national security functions. Due to the need for immediate action, the restriction on vessel traffic is necessary to protect life, property and the environment. Delaying the effective date would be contrary to the safety zone's intended objectives of protecting persons and vessels, and enhancing public and maritime safety.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Hampton Roads (COTP) has determined that potential hazards associated with the military training starting on February 29, 2016 will be a safety concern for anyone within a 1500-foot radius of the M/V SS DEL MONTE. This rule is needed to protect the participants, patrol vessels, and other vessels transiting the navigable waters of the James River, in the vicinity of the James River Reserve Fleet, from hazards associated with military explosives operations. The potential hazards to mariners within the safety zone include shock waves, flying shrapnel, and loud noises.

IV. Discussion of the Rule

The Captain of the Port of Hampton Roads is establishing a safety zone on James River, in the vicinity of the James River Reserve Fleet, in Newport News, VA. The safety zone will encompass all navigable waters within a 1500 foot radius of the M/V SS DEL MONTE location at position 37°06′11″ N., 076°38′40″ W. (NAD 1983). This safety zone still allows for navigation on the waterway. This safety zone will be established and enforced from 8 a.m. on February 29, 2016 through 4 p.m. on March 4, 2016. Access to the safety zone will be restricted during the effective period. Except for participants and vessels authorized by the Captain of the Port or his Representative, no person or vessel may enter or remain in the regulated area.

The Captain of the Port will give notice of the enforcement of the safety zone by all appropriate means to provide the widest dissemination of notice to the affected segments of the public. This includes publication in the Local Notice to Mariners and Marine Information Broadcasts.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

Although this safety zone restricts vessel traffic through the regulated area, the effect of this rule will not be significant because: (i) This rule will only be impact a small designated area during a time of year when vessel traffic is normally low; and (ii) the Coast Guard will make extensive notification to the maritime community via marine information broadcasts so mariners may adjust their plans accordingly.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting less than 4 days that will prohibit entry within 1500 feet of the M/V SS DEL MONTE along the James River. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T05-0701 to read as follows:
165.T05-0202 Safety Zone, James River; Newport News, VA.

(a) Definitions. For the purposes of this section, Captain of the Port means the Commander, Sector Hampton Roads. Representative means any Coast Guard commissioned, warrant or petty officer who has been authorized to act on the behalf of the Captain of the Port. Participants mean individuals and vessels involved in explosives training.

(b) Locations. The following area is a safety zone:

(1) All waters in the vicinity of the of the James River Reserve Fleet, in the James River, within a 1500 foot radius of the M/V SS DEL MONTE in approximate position 37°06′11″ N., 076°38′40″ W. (NAD 1983).

(c) Regulations. (1) All persons are required to comply with the general regulations governing safety zones in § 165.23 of this part.

(2) With the exception of participants, entry into or remaining in this safety zone is prohibited unless authorized by the Captain of the Port, Hampton Roads or his designated representatives.

(3) All vessels underway within this safety zone at the time it is implemented are to depart the zone immediately.

(4) The Captain of the Port, Hampton Roads or his representative can be contacted at telephone number (757) 668-5555.

(5) The Coast Guard and designated James River Reserve Fleet security vessels enforcing the safety zone can be contacted on VHF-FM marine band radio channel 13 (165.65Mhz) and channel 16 (156.8 Mhz).

(6) This section applies to all persons or vessels wishing to transit through the safety zone except participants and vessels that are engaged in the following operations:

(i) Enforcing laws;

(ii) Servicing aids to navigation; and

(iii) Emergency response vessels.

(7) The U.S. Coast Guard may be assisted in the patrol and enforcement of the safety zone by Federal, State, and local agencies.

(d) Enforcement period. This rule will be enforced from 8 a.m. on February 29, 2016 through 4 p.m. on March 4, 2016.

Dated: January 13, 2016. Christopher S. Keane, Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2016-03090 Filed 2-12-16; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2015-0670; FRL-9942-31-Region 8] Approval and Promulgation of Air Quality Implementation Plans; 2008 Ozone NAAQS Interstate Transport for Colorado, Montana, North Dakota and South Dakota AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is approving State Implementation Plan (SIP) submissions from the states of Colorado, Montana, North Dakota and South Dakota that are intended to demonstrate that the SIP for each respective state meets certain interstate transport requirements of the Clean Air Act (Act or CAA) for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These submissions address the requirement that each SIP contain adequate provisions prohibiting air emissions that will have certain adverse air quality effects in other states. The EPA is approving these SIPs for all four states as containing adequate provisions to ensure that air emissions in the states do not significantly contribute to nonattainment or interfere with maintenance of the 2008 8-hour ozone NAAQS in any other state.

DATES:

This final rule is effective on March 17, 2016.

ADDRESSES:

EPA has established a docket for this action under Docket Identification Number EPA-R08-OAR-2015-0670. All documents in the docket are listed on the http://www.regulations.gov index. Although listed in the index, some information may not be publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the Air Program, Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street, Denver, Colorado, 80202-1129. EPA requests that you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding federal holidays.

FOR FURTHER INFORMATION CONTACT:

Adam Clark, Air Program, U.S. Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129, (303) 312-7104, [email protected]

SUPPLEMENTARY INFORMATION: I. Background

On November 23, 2015, the EPA proposed to approve submittals from Colorado, Montana, North Dakota and South Dakota as meeting the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS (80 FR 72937). An explanation of the CAA requirements, a detailed analysis of the states' submittals, and the EPA's rationale for approval of each submittal were all provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on December 23, 2015. The EPA received no comments on the proposal.

II. Final Action

The EPA is approving the following submittals as meeting the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS: Colorado's December 31, 2012 submission; Montana's January 3, 2013 submission; North Dakota's March 8, 2013 submission; and South Dakota's May 30, 2013 submission. This action is being taken under section 110 of the CAA.

III. Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state actions, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law provisions as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP does not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 18, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Authority:

42 U.S.C. 7401 et seq.

Dated: January 25, 2016. Signed: Debra H. Thomas, Acting Regional Administrator, Region 8.

40 CFR part 52 is amended as follows:

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

Subpart G—Colorado
2. Section 52.352 is amended by adding paragraph (d) to read as follows:
§ 52.352 Interstate transport.

(d) Addition to the Colorado State Implementation Plan of the Colorado Interstate Transport SIP regarding 2008 Ozone Standards for both of the CAA section 110(a)(2)(D)(i)(I) requirements submitted to EPA on December 31, 2012.

Subpart BB—Montana 3. Section 52.1393 is amended by adding paragraph (c) to read as follows:
§ 52.1393 Interstate transport requirements.

(c) EPA is approving both elements of CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS, which was submitted to EPA on January 3, 2013.

Subpart JJ—North Dakota 4. Section 52.1833 is amended by adding paragraph (e) to read as follows:
§ 52.1833 Section 110(a)(2) infrastructure requirements.

(e) EPA is approving both elements of CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS, which was submitted to EPA on March 8, 2013.

Subpart QQ—South Dakota 5. Section 52.2170, paragraph (e), is amended by adding the entry “XIX. Section 110(a)(2)(D)(i)(I) Infrastructure Requirements for the 2008 8-hour Ozone NAAQS” to read as follows:
§ 52.2170 Identification of plan.

(e) * * *

Rule title State effective date EPA Effective date Final rule citation, date Comments *         *         *         *         *         *         * XIX. Section 110(a)(2)(D)(i)(I) Interstate Transport Requirements for the 2008 8-hour Ozone NAAQS 5/21/13 3/2/15 80 FR 4799, 1/29/15
[FR Doc. 2016-02959 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2015-0840; FRL-9942-39-Region 7] Approval of Iowa's State Implementation Plan (SIP); Electronic Reporting Consistent With the Cross-Media Electronic Reporting Rule (CROMERR) AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is approving a SIP revision submitted by the State of Iowa. The revision pertains to the approval of Iowa's CROMERR submission which was published in the Federal Register on December 9, 2015, and will revise the Iowa SIP to provide for electronic submittal of emission inventory data.

DATES:

This direct final rule will be effective April 18, 2016, without further notice, unless EPA receives adverse comment by March 17, 2016. If EPA receives adverse comment, we will publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the rule will not take effect.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0840, to http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at 913-551-7039, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

Throughout this document “we,” “us,” or “our” refer to EPA.

I. Background

On November 4, 2008, Iowa submitted several revisions to EPA for approval into the SIP. On December 30, 2009, EPA took direct final action to approve the revisions to the SIP. (74 FR 68692). However, EPA did not act on several state administrative regulations that provided for electronic submittal of emissions inventory information, construction permit applications, and Title V operating permit applications, as Iowa had not obtained approval of its electronic document receiving system as required by the Cross-Media Electronic Reporting Rule (CROMERR) found at 40 CFR part 3 (70 FR 59848). Therefore, EPA did not take action on the electronic emissions inventory submittal provisions of Iowa Administrative Code (IAC) 567-21.1(3).

On December 9, 2015, EPA approved Iowa's CROMERR application for electronic reporting of emissions information through its State and Local Emissions Inventory System (SLEIS). (80 FR 76474). Accordingly, EPA is approving IAC 567-21-1(3) in to the SIP to allow for electronic submittal of emissions inventory data.

II. EPA's Evaluation

Section 110(1) of the Federal Clean Air Act (CAA) states that each revision to an implementation plan submitted by a state under this chapter shall be adopted by such state after reasonable notice and public hearing. In the November 4, 2008, submittal for rule IAC 567-21.1(3), Iowa provided documentation that reasonable notice and a public hearing were provided. No comments were received.

The EPA's regulations require states to revise the SIP to satisfy the requirements of 40 CFR part 3 (Cross-Media Electronic Reporting) in order to provide electronic documents to EPA in lieu of a paper document. Iowa submitted the CROMERR application to EPA on January 13, 2010, and amended the application on September 22, 2015. The application requests revisions to the state's EPA-authorized air program to allow electronic reporting of emissions inventories under 40 CFR part 52. EPA evaluated the application and determined that it meets the applicable requirements of the EPA air quality regulations because it is consistent with EPA's requirements for electronic reporting. The notice of EPA's decision to approve Iowa's application was published in the Federal Register on December 9, 2015, (80 FR 76474). This direct final action approves IAC 567-21.1(3) Emissions Inventory in to the Federally-approved SIP.

III. Final Action

EPA is approving a revision to the Iowa SIP by approving IAC 567-21.1(3) that allows electronic reporting of emissions inventories. Iowa's CROMERR submission was approved by the EPA on December 9, 2015.

We are publishing this direct final rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of this Federal Register, we are publishing a separate document that will serve as the proposed rule to approve the SIP revision if relevant adverse comments are received on this direct final rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information about commenting on this rule, see the ADDRESSES section of this document. If EPA receives adverse comment, we will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. We will address all public comments in any subsequent final rule based on the proposed rule.

Incorporation by Reference

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Iowa's Chapter 21 rule 567-21.1 “Compliance Schedule” described in the direct final amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

Statutory and Executive Order Reviews

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 18, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Dated: February 1, 2016. Mark Hague, Regional Administrator, Region 7.

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as set forth below:

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

Subpart Q—Iowa 2. Amend § 52.820(c) by revising entry 567-21.1 to read as follows:
§ 52.820 Identification of plan.

(c) * * *

EPA-Approved Iowa Regulations Iowa citation Title State effective date EPA Approval date Explanation Iowa Department of Natural Resources Environmental Protection Commission [567] *         *         *         *         *         *         * Chapter 21—Compliance 567-21.1 Compliance Schedule 10/15/08 02/16/16 and [Insert Federal Register citation] *         *         *         *         *         *         *
[FR Doc. 2016-02957 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2015-0398; FRL-9942-15-Region 10] Approval of Regional Haze BART Alternative Measure: Washington AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is taking final action to approve the Best Available Retrofit Technology (BART) alternative measure for the BP Cherry Point Refinery located near Ferndale, Washington. The BART alternative measure increases the oxides of nitrogen (NOX) emission limit from the R-1 HC Reactor Heater (R-1 Heater), a BART-eligible source currently subject to BART emission limits on NOX. To offset the increase in NOX emissions from this emission unit, the NOX emission limits on the 1st Stage Hydrocracker Fractionator Reboiler (R-1 Reboiler), also a BART-eligible source subject to BART emission limits on NOX, will be reduced. The net effect of these changes is a decrease of 10.4 tons per year (tpy) of allowable NOX emissions from sources subject to BART at the BP Cherry Point Refinery.

DATES:

This final rule is effective March 17, 2016.

ADDRESSES:

The EPA has established a docket for this action under Docket ID No. EPA-EPA-R10-OAR-2015-0398. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information may not be publicly available, i.e., Confidential Business Information or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and is publicly available only in hard copy form. Publicly available docket materials are available at http://www.regulations.gov or at EPA Region 10, Office of Air, Waste and Toxics, 1200 Sixth Avenue, Seattle, Washington 98101. The EPA requests that you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT:

For information please contact John Chi at (206) 553-1185, or [email protected]

SUPPLEMENTARY INFORMATION: Table of Contents I. Background Information II. Final Action III. Incorporation by Reference IV. Statutory and Executive Orders Review I. Background Information

On May 14, 2015, Washington submitted the BART alternative measure and the EPA proposed to approve it on November 16, 2015 (80 FR 70718). An explanation of the CAA requirements, a detailed analysis of the submittal, and the EPA's reasons for approval were provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on December 16, 2015. The EPA received one comment in support of this action and no adverse comments.

II. Final Action

The EPA is approving the BART alternative measure for the BP Cherry Point Refinery located near Ferndale, Washington by incorporating by reference the conditions of Revision 2 identified below. The EPA is removing the BP Cherry Point Refinery, BART Compliance Order No. 7836 currently in the Federally approved SIP at 40 CFR 52.2470(d) and replacing it with provisions of the BP Cherry Point Refinery, BART Compliance Order No. 7836 Revision 2. The EPA is also approving new Condition 9 of the BART Compliance Order 7836 Revision 2 relating to decommissioned units. The conditions of the BP BART Compliance Order Revision 2 that are proposed for incorporation by reference are:

Condition 1: 1.1, 1.1.1, 1.2, 1.2.1, 1.2.2;

Condition 2: 2.1, 2.1.1, 2.1.2, 2.1.3, 2.1.4, 2.1.5, 2.2, 2.2.1, 2.2.2, 2.3, 2.3.1, 2.3.2, 2.4, 2.4.1, 2.4.2, 2.4.2.1, 2.5, 2.5.1, 2.5.1.1, 2.5.1.2, 2.5.2, 2.5.3, 2.5.4, 2.6, 2.6.1, 2.6.2, 2.6.3, 2.7, 2.7.1, 2.7.2, 2.7.3, 2.7.4, 2.8, 2.8.1, 2.8.2,2.8.3, 2.8.4, 2.8.5, 2.8.6;

Condition 3, 3.1, 3.1.1, 3.1.2, 3.2, 3.2.1, 3.2.2, 3.2.3, 3.2.4;

Condition 4, 4.1, 4.1.1, 4.1.1.1, 4.1.1.2, 4.1.1.3, 4.1.1.4;

Condition 5, 5.1, 5.2;

Condition 6, 6.1, 6.2, 6.3;

Condition 7; and

Condition 9.

III. Incorporation by Reference

In accordance with requirements of 1 CFR 51.5, the EPA is revising our incorporation by reference located in 40 CFR 52.2470(d)—“EPA-Approved State Source-Specific Requirements” to reflect the approval of the BART alternative measure for the BP Cherry Point Refinery and the provision relating to decommissioned units. Due to the fact that the conditions in the original BART Order were renumbered in Revision 1, which was not submitted as a SIP revision, the EPA is removing the original IBR entry for “BP Cherry Point Refinery” in its entirety and incorporating in its place the specified conditions of Revision 2 included in the docket for this action. The end result is that all of the conditions in the Original BART order remain in the SIP (but with different numbers) except as discussed in the notice of the proposed rulemaking with respect to the BART alternative measure and the addition of Condition 9. The EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

IV. Statutory and Executive Orders Review

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);

• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standards; and

• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

The SIP is not approved to apply on any Indian reservation land in Washington except as specifically noted below and is also not approved to apply in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 18, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Dated: January 27, 2016. Dennis J. McLerran, Regional Administrator, Region 10.

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

42 U.S.C. 7401 et seq.

Subpart WW—Washington
2. In § 52.2470: a. In paragraph (d), the table is amended by revising the entry for “BP Cherry Point Refinery.” b. In paragraph (e), table 2 is amended by adding an entry entitled “Regional Haze State Implementation Plan—BP Cherry Point Refinery BART Revision” to the end of the table.

The revisions read as follows:

§ 52.2470 Identification of plan.

(d) * * *

EPA-Approved State of Washington Source-Specific Requirements Name of source Order/Permit number State effective date EPA approval date Explanation *         *         *         *         *         *         * BP Cherry Point Refinery Administrative Order No. 7836, Revision 2 5/13/15 2/16/16 [Insert Federal Register citation] The following conditions: 1.1, 1.1.1, 1.2, 1.2.1, 1.2.2, 2.1, 2.1.1, 2.1.2, 2.1.3, 2.1.4, 2.1.5, 2.2, 2.2.1, 2.2.2, 2.3, 2.3.1, 2.3.2, 2.4, 2.4.1, 2.4.2, 2.4.2.1, 2.5, 2.5.1, 2.5.1.1, 2.5.1.2, 2.5.2, 2.5.3, 2.5.4, 2.6, 2.6.1, 2.6.2, 2.6.3, 2.7, 2.7.1, 2.7.2, 2.7.3, 2.7.4, 2.8, 2.8.1, 2.8.2,2.8.3, 2.8.4, 2.8.5, 2.8.6, 3, 3.1, 3.1.1, 3.1.2, 3.2, 3.2.1, 3.2.2, 3.2.3, 3.2.4, 4, 4.1, 4.1.1, 4.1.1.1, 4.1.1.2, 4.1.1.3, 4.1.1.4, 5, 5.1, 5.2, 6, 6.1, 6.2, 6.3, 7, 9 *         *         *         *         *         *         *

(e) * * *

Table 2—Attainment, Maintenance, and Other Plans Name of SIP provision Applicable geographic or nonattainment area State submittal date EPA approval date Comments *         *         *         *         *         *         * Regional Haze State Implementation Plan—BP Cherry Point Refinery BART Revision Statewide 5/14/15 2/16/16 [Insert Federal Register citation]
[FR Doc. 2016-02953 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA-2015-0001; Internal Agency Docket No. FEMA-8419] Suspension of Community Eligibility AGENCY:

Federal Emergency Management Agency, DHS.

ACTION:

Final rule.

SUMMARY:

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES:

The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.

FOR FURTHER INFORMATION CONTACT:

If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Patricia Suber, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4149.

SUPPLEMENTARY INFORMATION:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

List of Subjects in 44 CFR Part 64

Flood insurance, Floodplains.

Accordingly, 44 CFR part 64 is amended as follows:

PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority:

42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376.

§ 64.6 [Amended]
2. The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain Federal assistance no longer available in SFHAs Region III Pennsylvania: Abington, Township of, Montgomery County 420695 August 13, 1971, Emerg; September 30, 1977, Reg; March 2, 2016, Susp. March 2, 2016 March 2, 2016. Ambler, Borough of, Montgomery County 420947 December 6, 1973, Emerg; November 2, 1977, Reg; March 2, 2016, Susp. ......do*   Do. Bridgeport, Borough of, Montgomery County 420948 October 4, 1973, Emerg; January 3, 1979, Reg; March 2, 2016, Susp. ......do   Do. Bryn Athyn, Borough of, Montgomery County 421899 March 10, 1976, Emerg; February 17, 1982, Reg; March 2, 2016, Susp. ......do   Do. Cheltenham, Township of, Montgomery County 420696 October 1, 1971, Emerg; November 22, 1976, Reg; March 2, 2016, Susp. ......do   Do. Collegeville, Borough of, Montgomery County 421900 October 29, 1974, Emerg; February 15, 1980, Reg; March 2, 2016, Susp. ......do   Do. Conshohocken, Borough of, Montgomery County 420949 April 10, 1973, Emerg; December 15, 1977, Reg; March 2, 2016, Susp. ......do   Do. Douglass, Township of, Montgomery County 421911 July 25, 1974, Emerg; May 15, 1984, Reg; March 2, 2016, Susp. ......do   Do. East Greenville, Borough of, Montgomery County 421901 August 20, 1975, Emerg; June 25, 1976, Reg; March 2, 2016, Susp. ......do   Do. East Norriton, Township of, Montgomery County 420950 December 19, 1973, Emerg; September 30, 1977, Reg; March 2, 2016, Susp. ......do   Do. Franconia, Township of, Montgomery County 422494 October 24, 1974, Emerg; March 15, 1982, Reg; March 2, 2016, Susp. ......do   Do. Green Lane, Borough of, Montgomery County 421902 November 22, 1974, Emerg; September 2, 1981, Reg; March 2, 2016, Susp. ......do   Do. Hatboro, Borough of, Montgomery County 420697 February 16, 1973, Emerg; June 15, 1977, Reg; March 2, 2016, Susp. ......do   Do. Hatfield, Borough of, Montgomery County 420698 June 2, 1972, Emerg; August 15, 1978, Reg; March 2, 2016, Susp. ......do   Do. Hatfield, Township of, Montgomery County 420699 April 21, 1972, Emerg; November 15, 1979, Reg; March 2, 2016, Susp. ......do   Do. Horsham, Township of, Montgomery County 420700 May 9, 1973, Emerg; November 16, 1977, Reg; March 2, 2016, Susp. ......do   Do. Jenkintown, Borough of, Montgomery County 422717 N/A, Emerg; January 10, 1997, Reg; March 2, 2016, Susp. ......do   Do. Lansdale, Borough of, Montgomery County 420951 December 19, 1973, Emerg; May 1, 1978, Reg; March 2, 2016, Susp. ......do   Do. Limerick, Township of, Montgomery County 421912 November 7, 1974, Emerg; March 16, 1981, Reg; March 2, 2016, Susp. ......do   Do. Lower Frederick, Township of, Montgomery County 420952 January 28, 1974, Emerg; September 30, 1977, Reg; March 2, 2016, Susp. ......do   Do. Lower Gwynedd, Township of, Montgomery County 420953 September 26, 1973, Emerg; October 14, 1977, Reg; March 2, 2016, Susp. ......do   Do. Lower Merion, Township of, Montgomery County 420701 December 10, 1971, Emerg; February 1, 1978, Reg; March 2, 2016, Susp. ......do   Do. Lower Moreland, Township of, Montgomery County 420702 November 17, 1972, Emerg; March 1, 1978, Reg; March 2, 2016, Susp. ......do   Do. Lower Pottsgrove, Township of, Montgomery County 421908 August 1, 1974, Emerg; January 2, 1981, Reg; March 2, 2016, Susp. ......do   Do. Lower Providence, Township of, Montgomery County 420703 March 30, 1973, Emerg; July 2, 1979, Reg; March 2, 2016, Susp. ......do   Do. Lower Salford, Township of, Montgomery County 421170 April 30, 1974, Emerg; February 3, 1982, Reg; March 2, 2016, Susp. ......do   Do. Marlborough, Township of, Montgomery County 421913 August 14, 1974, Emerg; September 2, 1981, Reg; March 2, 2016, Susp. ......do   Do. Montgomery, Township of, Montgomery County 421226 August 30, 1973, Emerg; May 15, 1984, Reg; March 2, 2016, Susp. ......do   Do. Narberth, Borough of, Montgomery County 421903 August 30, 1974, Emerg; January 16, 1981, Reg; March 2, 2016, Susp. ......do   Do. New Hanover, Township of, Montgomery County 421914 August 1, 1974, Emerg; September 16, 1981, Reg; March 2, 2016, Susp. ......do   Do. Norristown, Borough of, Montgomery County 425386 July 9, 1971, Emerg; December 22, 1972, Reg; March 2, 2016, Susp. ......do   Do. North Wales, Borough of, Montgomery County 420704 February 19, 1974, Emerg; September 30, 1977, Reg; March 2, 2016, Susp. ......do   Do. Pennsburg, Borough of, Montgomery County 422496 February 28, 1977, Emerg; March 2, 1988, Reg; March 2, 2016, Susp. ......do   Do. Perkiomen, Township of, Montgomery County 421915 October 29, 1974, Emerg; February 3, 1982, Reg; March 2, 2016, Susp. ......do   Do. Plymouth, Township of, Montgomery County 420955 December 3, 1971, Emerg; February 15, 1978, Reg; March 2, 2016, Susp. ......do   Do. Pottstown, Borough of, Montgomery County 420705 June 6, 1973, Emerg; September 30, 1977, Reg; March 2, 2016, Susp. ......do   Do. Royersford, Borough of, Montgomery County 421904 August 7, 1974, Emerg; November 5, 1980, Reg; March 2, 2016, Susp. ......do   Do. Salford, Township of, Montgomery County 422497 August 29, 1975, Emerg; February 3, 1982, Reg; March 2, 2016, Susp. ......do   Do. Schwenksville, Borough of, Montgomery County 421905 July 11, 1975, Emerg; September 30, 1981, Reg; March 2, 2016, Susp. ......do   Do. Skippack, Township of, Montgomery County 421149 April 9, 1974, Emerg; March 1, 1982, Reg; March 2, 2016, Susp. ......do   Do. Souderton, Borough of, Montgomery County 421906 July 24, 1974, Emerg; May 25, 1978, Reg; March 2, 2016, Susp. ......do   Do. Springfield, Township of, Montgomery County 425388 March 26, 1971, Emerg; July 7, 1972, Reg; March 2, 2016, Susp. ......do   Do. Towamencin, Township of, Montgomery County 422236 June 21, 1974, Emerg; July 2, 1980, Reg; March 2, 2016, Susp. ......do   Do. Trappe, Borough of, Montgomery County 421907 January 20, 1975, Emerg; January 20, 1982, Reg; March 2, 2016, Susp. ......do   Do. Upper Dublin, Township of, Montgomery County 420708 August 18, 1972, Emerg; January 3, 1979, Reg; March 2, 2016, Susp. ......do   Do. Upper Frederick, Township of, Montgomery County 421916 November 15, 1974, Emerg; August 17, 1981, Reg; March 2, 2016, Susp. ......do   Do. Upper Gwynedd, Township of, Montgomery County 420956 December 27, 1973, Emerg; March 1, 1978, Reg; March 2, 2016, Susp. ......do   Do. Upper Hanover, Township of, Montgomery County 421917 February 13, 1975, Emerg; January 20, 1982, Reg; March 2, 2016, Susp. ......do   Do. Upper Merion, Township of, Montgomery County 420957 December 17, 1973, Emerg; November 16, 1977, Reg; March 2, 2016, Susp. ......do   Do. Upper Moreland, Township of, Montgomery County 421909 November 14, 1974, Emerg; September 2, 1982, Reg; March 2, 2016, Susp. ......do   Do. Upper Pottsgrove, Township of, Montgomery County 421910 October 10, 1974, Emerg; September 30, 1980, Reg; March 2, 2016, Susp. ......do   Do. Upper Providence, Township of, Montgomery County 420709 January 21, 1972, Emerg; July 3, 1978, Reg; March 2, 2016, Susp. ......do   Do. Upper Salford, Township of, Montgomery County 421918 May 24, 1976, Emerg; May 17, 1982, Reg; March 2, 2016, Susp. ......do   Do. West Conshohocken, Borough of, Montgomery County 420710 May 4, 1973, Emerg; November 2, 1977, Reg; March 2, 2016, Susp. ......do   Do. West Norriton, Township of, Montgomery County 420711 December 23, 1971, Emerg; September 30, 1977, Reg; March 2, 2016, Susp. ......do   Do. West Pottsgrove, Township of, Montgomery County 421133 March 8, 1974, Emerg; November 1, 1979, Reg; March 2, 2016, Susp. ......do   Do. Whitemarsh, Township of, Montgomery County 420712 November 12, 1971, Emerg; December 1, 1977, Reg; March 2, 2016, Susp. ......do   Do. Whitpain, Township of, Montgomery County 420713 April 14, 1972, Emerg; January 5, 1978, Reg; March 2, 2016, Susp. ......do   Do. Worcester, Township of, Montgomery County 421919 March 4, 1975, Emerg; March 16, 1981, Reg; March 2, 2016, Susp. ......do   Do. Region IX Arizona: Navajo County, Unincorporated Areas 040066 January 30, 1975, Emerg; June 1, 1982, Reg; March 2, 2016, Susp. ......do   Do. * -do- = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension.
Dated: January 12, 2016. Roy E. Wright, Deputy Associate Administrator, Federal Insurance and Mitigation Administration, Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2016-03032 Filed 2-12-16; 8:45 am] BILLING CODE 9110-12-P
DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 150626556-5886-02] RIN 0648-BD81 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coral, Coral Reefs, and Live/Hard Bottom Habitats of the South Atlantic Region; Amendment 8; Correction Correction

In rule document 2015-25488, appearing on pages 60565-60566 in the Issue of Wednesday, October 7, 2015, make the following corrections:

§ 622.224 [Corrected]

(1) On page 60566 in the second column, Amendatory instruction 2 should read as follows:

2. In § 622.224, the entries for the Origin, point 7, and 8 in the table in paragraph (b)(1) and paragraph (b)(1)(i)(C) are revised to read as follows:

(2) On the same page the table should read:

Point North lat. West long. Origin 29°43′29.82″ 80°14′48.06″ *    *    *    *    * 7 28°56′01.86″ 80°08′53.64″ 8 28°52′44.40″ 80°08′53.04″ *    *    *    *    *
[FR Doc. C1-2015-25488 Filed 2-12-16; 8:45 am] BILLING CODE 1505-01-D
81 30 Tuesday, February 16, 2016 Proposed Rules FEDERAL TRADE COMMISSION 16 CFR Chapter I Regulatory Review Schedule AGENCY:

Federal Trade Commission.

ACTION:

Notice of intent to request public comments.

SUMMARY:

As part of its ongoing, systematic review of all Federal Trade Commission rules and guides, the Commission announces a modified ten-year regulatory review schedule. No Commission determination on the need for, or the substance of, the rules and guides listed below should be inferred from this notice.

DATES:

February 16, 2016.

FOR FURTHER INFORMATION CONTACT:

Jock Chung, (202) 326-2984, Federal Trade Commission, Bureau of Consumer Protection, Division of Enforcement, 600 Pennsylvania Ave. NW., Washington, DC 20850. Further details about particular rules or guides may be obtained from the contact person listed below for the rule or guide.

SUPPLEMENTARY INFORMATION:

To ensure that its rules and industry guides remain relevant and are not unduly burdensome, the Commission reviews them on a ten-year schedule. Each year the Commission publishes its review schedule, with adjustments made in response to public input, changes in the marketplace, and resource demands.

When the Commission reviews a rule or guide, it publishes a notice in the Federal Register seeking public comment on the continuing need for the rule or guide, as well as the rule's or guide's costs and benefits to consumers and businesses. Based on this feedback, the Commission may modify or repeal the rule or guide to address public concerns or changed conditions, or to reduce undue regulatory burden.

The Commission posts information about its review schedule on its Web site 1 to facilitate comment. This Web site provides links in one location to Federal Register notices requesting comments and comments for rules and guides that are currently under review. The Web site also contains an updated review schedule, a list of rules and guides previously eliminated in the regulatory review process, and the Commission's regulatory review plan.

1http://www.ftc.gov/enforcement/rules/regulatory-review.

Modified Ten-Year Schedule for Review of FTC Rules and Guides

For 2016, the Commission intends to initiate reviews of, and solicit public comments on, the following rules:

(1) Standards for Safeguarding Customer Information, 16 CFR part 314. Agency Contact: David Lincicum, (202) 326-2773, Federal Trade Commission, Bureau of Consumer Protection, Division of Privacy and Identity Protection, 600 Pennsylvania Ave. NW., Washington, DC 20580.

(2) CAN-SPAM Rule, 16 CFR part 316. Agency Contact: Christopher Brown, (202) 326-2825, Federal Trade Commission, Bureau of Consumer Protection, Division of Marketing Practices, 600 Pennsylvania Ave. NW., Washington, DC 20580.

(3) Labeling and Advertising of Home Insulation, 16 CFR part 460. Agency Contact: Hampton Newsome, (202) 326-2889, Federal Trade Commission, Bureau of Consumer Protection, Division of Enforcement, 600 Pennsylvania Ave. NW., Washington, DC 20580.

(4) Disposal of Consumer Report Information and Records, 16 CFR part 682. Agency Contact: Tiffany George, (202) 326-3040, Federal Trade Commission, Bureau of Consumer Protection, Division of Privacy and Identity Protection, 600 Pennsylvania Ave. NW., Washington, DC 20580.

The Commission is currently reviewing 9 of the 65 rules and guides within its jurisdiction. During 2015, it completed reviews of 12 rules and guides.

A copy of the Commission's modified regulatory review schedule for 2016 through 2026 is appended. The Commission, in its discretion, may modify or reorder the schedule in the future to incorporate new rules, or to respond to external factors (such as changes in the law) or other considerations.

Authority:

15 U.S.C. 41-58.

By direction of the Commission.

Donald S. Clark, Secretary.
Appendix Regulatory Review Modified Ten-Year Schedule 16 CFR Part Topic Year to review 23 Guides for the Jewelry, Precious Metals, and Pewter Industries Currently Under Review. 259 Guide Concerning Fuel Economy Advertising for New Automobiles Currently Under Review. 304 Rules and Regulations under the Hobby Protection Act Currently Under Review. 308 Trade Regulation Rule Pursuant to the Telephone Disclosure and Dispute Resolution Act of 1992 [Pay Per Call Rule] Currently Under Review. 310 Telemarketing Sales Rule Currently Under Review. 315 Contact Lens Rule Currently Under Review. 423 Care Labeling of Textile Wearing Apparel and Certain Piece Goods Currently Under Review. 455 Used Motor Vehicle Trade Regulation Rule Currently Under Review. 456 Ophthalmic Practice Rules (Eyeglass Rule) Currently Under Review. 314 Standards for Safeguarding Customer Information 2016. 316 CAN-SPAM Rule 2016. 460 Labeling and Advertising of Home Insulation 2016. 682 Disposal of Consumer Report Information and Records 2016. 233 Guides Against Deceptive Pricing 2017. 238 Guides Against Bait Advertising 2017. 251 Guide Concerning Use of the Word “Free” and Similar Representations 2017. 410 Deceptive Advertising as to Sizes of Viewable Pictures Shown by Television Receiving Sets 2017. 18 Guides for the Nursery Industry 2018. 311 Test Procedures and Labeling Standards for Recycled Oil 2018. 436 Disclosure Requirements and Prohibitions Concerning Franchising 2018. 681 Identity Theft [Red Flag] Rules 2018. 24 Guides for Select Leather and Imitation Leather Products 2019. 453 Funeral Industry Practices 2019. 14 Administrative Interpretations, General Policy Statements, and Enforcement Policy Statements 2020. 255 Guides Concerning Use of Endorsements and Testimonials in Advertising 2020. 313 Privacy of Consumer Financial Information 2020. 317 Prohibition of Energy Market Manipulation Rule 2020. 318 Health Breach Notification Rule 2020. 432 Power Output Claims for Amplifiers Utilized in Home Entertainment Products 2020. 444 Credit Practices 2020. 640 Duties of Creditors Regarding Risk-Based Pricing 2020. 641 Duties of Users of Consumer Reports Regarding Address Discrepancies 2020. 642 Prescreen Opt-Out Notice 2020. 660 Duties of Furnishers of Information to Consumer Reporting Agencies 2020. 680 Affiliate Marketing 2020. 698 Model Forms and Disclosures 2020. 801 [Hart-Scott-Rodino Antitrust Improvements Act] Coverage Rules 2020. 802 [Hart-Scott-Rodino Antitrust Improvements Act] Exemption Rules 2020. 803 [Hart-Scott-Rodino Antitrust Improvements Act] Transmittal Rules 2020. 437 Business Opportunity Rule 2021. 260 Guides for the Use of Environmental Marketing Claims 2022. 312 Children's Online Privacy Protection Rule 2022. 254 Guides for Private Vocational and Distance Education Schools 2023. 309 Labeling Requirements for Alternative Fuels and Alternative Fueled Vehicles 2023. 429 Rule Concerning Cooling-Off Period for Sales Made at Homes or at Certain Other Locations 2023. 20 Guides for the Rebuilt, Reconditioned, and Other Used Automobile Parts Industry 2024. 240 Guides for Advertising Allowances and Other Merchandising Payments and Services [Fred Meyer Guides] 2024. 300 Rules and Regulations under the Wool Products Labeling Act of 1939 2024. 301 Rules and Regulations under Fur Products Labeling Act 2024. 303 Rules and Regulations under the Textile Fiber Products Identification Act 2024. 425 Use of Prenotification Negative Option Plans 2024. 435 Mail, Internet, or Telephone Order Merchandise 2024. 424 Retail Food Store Advertising and Marketing Practices [Unavailability Rule] 2024. 239 Guides for the Advertising of Warranties and Guarantees 2025. 306 Automotive Fuel Ratings, Certification and Posting 2025. 305 Energy Labeling Rule 2025. 433 Preservation of Consumers' Claims and Defenses [Holder in Due Course Rule] 2025. 500 Regulations under Section 4 of the Fair Packaging and Labeling Act 2025. 501 Exemptions from Requirements and Prohibitions under Part 500 2025. 502 Regulations under Section 5(c) of the Fair Packaging and Labeling Act 2025. 503 Statements of General Policy or Interpretation [under the Fair Packaging and Labeling Act] 2025. 700 Interpretations of Magnuson-Moss Warranty Act 2025. 701 Disclosure of Written Consumer Product Warranty Terms and Conditions 2025. 702 Pre-Sale Availability of Written Warranty Terms 2025. 703 Informal Dispute Settlement Procedures 2025
[FR Doc. 2016-02894 Filed 2-12-16; 8:45 am] BILLING CODE 6750-01-P
DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Parts 1910, 1915, and 1926 [Docket No. OSHA-H005C-2006-0870-0353] RIN 1218-AB76 Occupational Exposure to Beryllium AGENCY:

Occupational Safety and Health Administration (OSHA), Labor

ACTION:

Proposed rule; notice of informal public hearing; Date change.

SUMMARY:

OSHA is rescheduling the informal public hearing on its proposed rule “Occupational Exposure to Beryllium and Beryllium Compounds.” The public hearing will now begin on Monday March 21, 2016 at 2 p.m., local time. The public hearing notice was published in the Federal Register on December 30, 2015. The proposed rule was published in the Federal Register on August 7, 2015 and the 90-day public comment period ended on November 5, 2015. The December 30, 2015 Federal Register notice of informal public hearing describes the procedures that will govern this hearing http://www.regulations.gov/#!documentDetail;D=OSHA-H005C-2006-0870-1706. All other information from this Federal Register notice remains the same.

DATES:

Informal public hearing. The hearing will begin on March 21, 2016 at 2 p.m., local time. If necessary, the hearing will continue from 9:30 a.m. to 5 p.m., local time, on subsequent days, in Washington, DC. The original public hearing start date of February 29, 2016 is withdrawn.

ADDRESSES:

Informal public hearing. The Washington, DC hearing will be held in the Cesar Chavez Auditorium at the Frances Perkins Building, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210.

FOR FURTHER INFORMATION CONTACT:

Press inquiries: Kimberly Darby, Office of Communications, Room N-3647, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone 202-693-1892.

Technical information: Maureen Ruskin, OSHA, Office of Chemical Hazards-Metals, Room N-3718, U.S. Department of Labor, 200 Constitution Avenue NW., Washington DC 20210; telephone (202) 693-1955.

Hearing inquiries: Gretta Jameson, OSHA, Office of Communications, Room N-3647; 200 Constitution Avenue NW., Washington, DC 20210; telephone 202-693-2176, email [email protected]

SUPPLEMENTARY INFORMATION:

On August 7, 2015, OSHA published a proposed rule to amend its existing exposure limits for occupational exposure in general industry to beryllium and beryllium compounds (80 FR 47565). The proposed rule would promulgate a substance-specific standard for general industry, regulating occupational exposure to beryllium and beryllium compounds. OSHA accepted comments concerning the proposed rule during the comment period, which ended on November 5, 2015. Commenters shared information and suggestions on a variety of topics, and the Non-Ferrous Founders' Society also requested that OSHA schedule an informal public hearing on the proposed rule.

On December 30, 2015, OSHA published a notice of informal hearing and invited interested persons in the rulemaking to participate by providing oral testimony and documentary evidence at the informal hearing. The Agency requested those interested persons submit a notice of intent to appear and all documentary evidence by January, 29, 2016.

The original hearing date of February 29, 2016 has been rescheduled to March 21, 2016 at 2:00pm. If necessary, the hearing will continue from 9:30 a.m. to 5:00 p.m., local time, on subsequent days, in Washington, DC.

Authority and Signature

This document was prepared under the direction of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, pursuant to section 6(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)), Secretary of Labor's Order 1-2012 (77 FR 3912), and 29 CFR part 1911.

Signed at Washington, DC, on February 5, 2016. David Michaels, Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-02782 Filed 2-12-16; 8:45 am] BILLING CODE 4510-26-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2016-0026] RIN 1625-AA00 Safety Zone, Block Island Wind Farm; Rhode Island Sound, RI AGENCY:

Coast Guard, DHS.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Coast Guard proposes to establish a 500-yard safety zone around each of five locations where the Block Island Wind Farm (BIWF) wind turbine generator (WTG) towers, nacelles, blades and subsea cables will be installed in the navigable waters of the Rhode Island Sound, RI, from April 1 to October 31, 2016. These safety zones are intended to safeguard mariners from the hazards associated with construction of the BIWF. Vessels would be prohibited from entering into, transiting through, mooring, or anchoring within these safety zones while construction vessels and associated equipment are present at any of the BIWF WTG sites, unless authorized by the Captain of the Port (COTP), Southeastern New England or the COTP's designated representative. We invited your comments on this proposed rulemaking.

DATES:

Comments and related material must be received by the Coast Guard on or before March 17, 2016.

ADDRESSES:

You may submit comments identified by docket number USCG-2016-0026 using the Federal e-Rulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT:

If you have questions about this proposed rulemaking, contact Mr. Edward G. LeBlanc, Chief of the Waterways Management Division at Coast Guard Sector Southeastern New England, telephone 401-435-2351, email [email protected]

SUPPLEMENTARY INFORMATION:

I. Table of Acronyms BIWF Block Island Wind Farm CFR Code of Federal Regulations COTP Captain of The Port DHS Department of Homeland Security E.O.  Executive order FR Federal Register NPRM Notice of proposed rulemaking NTM Notice To Mariners Pub. L. Public Law § Section U.S.C. United States Code WTG Wind Turbine Generator II. Background, Purpose, and Legal Basis

On January 6, 2016, the Coast Guard was notified by Deepwater Wind Inc, developer of the Block Island Wind Farm, that the second phase of construction activities are planned from April 1 to October 31, 2016, to install turbines, nacelles, blades, and subsea cables at each of the five WTG sites. The Coast Guard published a safety zone regulation, similar to this proposed rule, which applied to the first phase (installation of foundations) of construction of the BIWF in 2015. The Coast Guard is now proposing a similar rule for the second phase of BIWF construction.

This rule is necessary to provide for the safety of life and navigation, for construction and support vessels, BIWF workers, mariners, and the boating public during construction activities in the vicinity of the BIWF in Rhode Island Sound, RI.

The legal basis for the proposed rule is 33 U.S.C., 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5 Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish safety zones.

III. Discussion of Proposed Rule

The Coast Guard proposes to establish a 500-yard safety zone around each of five locations where the BIWF WTG towers, nacelles, blades, and subsea cables will be installed in the navigable waters of the Rhode Island Sound, RI, from 1 April to 31 October 2016. Locations of these platforms are:

Platform Latitude Longitude WTG 1 41°7′32.74″ N. 71°30′27.04″ W. WTG 2 41°7′11.57″ N. 71°30′50.22″ W. WTG 3 41°6′52.96″ N. 71°31′16.18″ W. WTG 4 41°6′36.54″ N. 71°31′44.62″ W. WTG 5 41°6′22.79″ N. 71°32′15.50″ W.

These safety zones are intended to safeguard mariners from the hazards associated with construction of the BIWF, and are of similar dimensions and duration as safety zones established in 2015 for the same purpose, during the first phase of construction of the BIWF. Vessels will be prohibited from entering into, transiting through, mooring, or anchoring within these safety zones while construction vessels and associated equipment are present unless authorized by the COTP, Southeastern New England or the COTP's designated representative.

IV. Regulatory Analyses

We developed this proposed rule after considering numerous statutes and E.O.s related to rulemaking. Below we summarize our analyses based on a number of these statutes and E.O.s, and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on a number of factors. The safety zones are only 500 yards in diameter, centered on each of five WTG locations, and enforced only when construction vessels are on scene or when construction activities are taking place. Also, construction of the five WTG sites is sequential, not concurrent, so that construction vessels and activities (and hence, safety zones) are present at only one or two sites at any given time. The Coast Guard will publicize these safety zones well in advance via the Local Notice to Mariners, and Deepwater Wind will update its Web site daily to keep mariners informed of what safety zones, if any, may be enforced. Lastly, safety zones of the same size and duration were implemented for the first phase of the BIWF construction in 2015 with no significant impact to mariners or small entities.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit these safety zones may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

This proposed rule would not call for new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

Also, this proposed rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves safety zones that would prohibit entry within 500 yards of each WTG site of the BIWF while construction vessels and associated equipment are present at any of the BIWF WTG sites and maybe categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

V. Public Participation and Request for Comments

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.

For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for Part 165 reads as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T0026 to read as follows:
§ 165.T0026 Safety Zone, Block Island Wind Farm; Rhode Island Sound, RI.

(a) Location. Areas within a 500-yard radius of the following five positions are safety zones:

Platform Latitude Longitude WTG 1 41°7′32.74″ N. 71°30′27.04″ W. WTG 2 41°7′11.57″ N. 71°30′50.22″ W. WTG 3 41°6′52.96″ N. 71°31′16.18″ W. WTG 4 41°6′36.54″ N. 71°31′44.62″ W. WTG 5 41°6′22.79″ N. 71°32′15.50″ W.

(b) Enforcement period. From April 1 to October 31, 2016, vessels will be prohibited from entering into any of these safety zones, when enforced, during construction activity of five Block Island Wind Farm (BIWF) wind turbine generators (WTG) located in the positions listed in 2(a) above.

(c) Definitions. The following definitions apply to this section:

(1) Designated representative. A “designated representative” is any Coast Guard commissioned, warrant or petty officer of the U.S. Coast Guard who has been designated by the Captain of the Port, Sector Southeastern New England (COTP), to act on his or her behalf.

(d) Regulations. (1) The general regulations contained in 33 CFR 165.23 as well as the following regulations apply to the safety zones established in conjunction with the construction of the BIWF; Rhode Island Sound, RI. These regulations may be enforced for the duration of construction.

(2) Vessels must not enter into, transit through, moor, or anchor in these safety zones during periods of enforcement unless authorized by the COTP, Southeastern New England or the COTP's designated representative. Vessels permitted to transit must operate at a no-wake speed, in a manner which will not endanger construction vessels or associated equipment.

(3) Failure to comply with a lawful direction from the COTP, Southeastern New England or the COTP's designated representative may result in expulsion from the area, citation for failure to comply, or both.

Dated: January 22, 2016. J.T. Kondratowicz, Captain, U.S. Coast Guard, Captain of the Port Southeastern New England.
[FR Doc. 2016-03091 Filed 2-12-16; 8:45 am] BILLING CODE 9110-04-P
POSTAL REGULATORY COMMISSION 39 CFR Part 3001 [Docket No. RM2016-6; Order No. 3048] Procedures Related to Motions; Correction AGENCY:

Postal Regulatory Commission.

ACTION:

Proposed rule; correction.

SUMMARY:

This document corrects the DATES section to a proposed rule published in the Federal Register of February 1, 2016. The Commission did not intend to permit interested persons to file reply comments. The Commission is seeking initial comments only.

DATES:

Comments are due: March 2, 2016. There will be no reply comment period.

FOR FURTHER INFORMATION CONTACT:

David A. Trissell, General Counsel, at 202-789-6820.

Correction

In proposed rule FR Doc. 2016-01735, beginning on page 5085 in the issue of February 1, 2016, make the following correction to the Dates section. On page 5085 in the first column, revise the DATES to read as follows:

DATES:

Comments are due: March 2, 2016. There will be no reply comment period.

By the Commission.

Stacy L. Ruble, Secretary.
[FR Doc. 2016-02950 Filed 2-12-16; 8:45 am] BILLING CODE 7710-FW-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2015-0840; FRL-9942-38-Region 7] Approval of Iowa's Air State Implementation Plan (SIP); Electronic Reporting Consistent With the Cross Media Electronic Reporting Rule (CROMERR) AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

The Environmental Protection Agency (EPA) is proposing to approve a SIP revision submitted by the State of Iowa. The revision pertains to the approval of Iowa's CROMERR submission which was published in the Federal Register on December 9, 2015, and will revise the Iowa SIP to provide for electronic submittal of emission inventory data.

DATES:

Comments on this proposed action must be received in writing by March 17, 2016.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0840, to http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

Heather Hamilton, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at 913-551-7039, or by email at [email protected]

SUPPLEMENTARY INFORMATION:

In the final rules section of this Federal Register, EPA is approving the state's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial revision amendment and anticipates no relevant adverse comments to this action. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the rules section of this Federal Register.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Dated: February 1, 2016. Mark Hague, Regional Administrator, Region 7.
[FR Doc. 2016-02958 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
DEPARTMENT OF DEFENSE Defense Acquisition Regulations System 48 CFR Parts 231 [Docket DARS-2015-0070] RIN 0750-AI81 Defense Federal Acquisition Regulation Supplement: Enhancing the Effectiveness of Independent Research and Development (DFARS Case 2016-D002) AGENCY:

Defense Acquisition Regulations System, Department of Defense (DoD).

ACTION:

Proposed rule.

SUMMARY:

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to improve the effectiveness of independent research and development investments by the defense industrial base that are reimbursed as allowable costs.

DATES:

Comments on the proposed rule should be submitted in writing to the address shown below on or before April 18, 2016, to be considered in the formation of a final rule.

ADDRESSES:

Submit comments identified by DFARS Case 2016-D002, using any of the following methods:

Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by entering “DFARS Case 2016-D002” under the heading “Enter keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “DFARS Case 2016-D002.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “DFARS Case 2016-D002” on your attached document.

Email: [email protected] Include DFARS Case 2016-D002 in the subject line of the message.

Fax: 571-372-6094.

Mail: Defense Acquisition Regulations System, Attn: Mr. Mark Gomersall, OUSD(AT&L)DPAP/DARS, Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060.

Comments received generally will be posted without change to http://www.regulations.gov, including any personal information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

FOR FURTHER INFORMATION CONTACT:

Mr. Mark Gomersall, telephone 571-372-6099.

SUPPLEMENTARY INFORMATION:

I. Background

Better Buying Power (BBP) is the implementation of best practices to strengthen DoD's buying power, improve industry productivity, and provide an affordable, value-added military capability to the warfighter (see http://bbp.dau.mil/.) Launched in 2010, BBP encompasses a set of fundamental acquisition principles to achieve greater efficiencies through affordability, cost control, elimination of unproductive processes and bureaucracy, and promotion of competition. BBP initiatives also incentivize productivity and innovation in industry and Government, and improve tradecraft in the acquisition of services.

The Independent Research and Development (IR&D) initiative outlined in BBP 3.0 is intended to improve the effectiveness of IR&D investments by the defense industrial base that are reimbursed as allowable costs. As stated in the Under Secretary of Defense for Acquisition, Technology, and Logistics BBP 3.0 Implementation Memorandum, dated April 9, 2015 (see http://bbp.dau.mil/references.html), IR&D investments need to meet the complementary goals of providing defense companies an opportunity to exercise independent judgement on investments in promising technologies that will provide a competitive advantage, including the creation of intellectual property, while at the same time pursuing technologies that may improve the military capability of the United States. To achieve this goal, both DoD and the industrial base need to work together to ensure that DoD has visibility into the opportunity created by Government-reimbursed IR&D efforts performed by defense contractors.

In accordance with 10 U.S.C. 2372(f), contractor IR&D investments are not directed by the Government—they are identified by individual companies and are intended to advance a particular company's ability to develop and deliver superior and more competitive products to the warfighter. However, these efforts can have the best payoff, both for DoD and for individual performing companies, when the Government is well informed of the investments that companies are making, and when companies are well informed about related investments being made elsewhere in the Government's research and development portfolios and about Government plans for potential future acquisitions where this IR&D may be relevant.

II. Discussion and Analysis

DoD is proposing to revise DFARS 231.205-18, Independent Research and Development and Bid and Proposal Costs, to require that proposed new IR&D efforts be communicated to appropriate DoD personnel prior to the initiation of these investments, and that results from these investments should also be shared with appropriate DoD personnel. The intent of such engagement is not to reduce the independence of IR&D investment selection, nor to establish a bureaucratic requirement for Government approval prior to initiating an IR&D project. Instead, the objective of this engagement is to ensure that both IR&D performers and their potential DoD customers have sufficient awareness of each other's efforts and to provide industry with some feedback on the relevance of proposed and completed IR&D work.

III. Executive Orders 12866 and 13563

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

IV. Regulatory Flexibility Act

DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act 5 U.S.C. 601, et seq. However, an initial regulatory flexibility analysis has been prepared and is summarized as follows:

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to improve the effectiveness of independent research and development (IR&D) investments by the defense industrial base that are reimbursed as allowable costs in accordance with Federal Acquisition Regulation 31.205-18(c). The IR&D initiative outlined in Better Buying Power 3.0 is intended to improve the effectiveness of IR&D investments by the defense industrial base that are reimbursed as allowable costs. To achieve this goal, both DoD and the industrial base need to work together to ensure the Department has visibility into the opportunity created by Government-reimbursed IR&D efforts performed by defense contractors. The rule proposes to revise DFARS 231.205-18, Independent Research and Development and Bid and Proposal Costs, to require that proposed new IR&D efforts be communicated to appropriate DoD personnel prior to the initiation of these investments, and that results from these investments should also be shared with appropriate DoD personnel.

At this time DoD is unable to estimate the number of small entities to which this rule will apply. However, DoD does not expect the rule to have a significant economic impact on a substantial number of small entities, because DFARS 231.205-18(c)(iii) applies only to major contractors, which are defined as those whose covered segments allocated a total of more than $11,000,000 in independent research and development and bid and proposal costs to covered contracts during the preceding fiscal year.

There is no change to reporting and recordkeeping as a result of this rule. The recordkeeping is limited to that required to properly record and report IR&D projects to the Defense Technical Information Center (DTIC) using DTIC's online IR&D database.

The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known significant alternative approaches to the rule that would meet the requirements.

DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2016-D002), in correspondence.

V. Paperwork Reduction Act

The rule affects the information collection requirements at Defense Federal Acquisition Regulation Supplement (DFARS) 231.205-18, currently approved under the Office of Management and Budget (OMB) Control Number 0704-0483, entitled, “Independent Research and Development Technical Descriptions,” in accordance with the Paperwork Reduction Act (44 U.S.C. chapter 35); however, the impact of this rule is negligible. Currently, contractors are required to (1) report Independent Research and Development (IR&D) projects to the Defense Technical Information Center (DTIC) using the DTIC's on-line IR&D database and (2) update these inputs at least annually and when the project is completed. This rule merely changes the web address for submission of this report and requires major contractors to include in the report the name of the Government employee with which a technical interchange was held prior to initiation of the IR&D effort and the date of such interchange.

List of Subjects in 48 CFR Parts 231

Government procurement.

Jennifer L. Hawes, Editor, Defense Acquisition Regulations System.

Therefore, 48 CFR part 231 is proposed to be amended as follows:

PART 231—CONTRACT COST PRINCIPLES AND PROCEDURES 1. The authority citation for part 231 continues to read as follows: Authority:

41 U.S.C. 1303 and 48 CFR chapter 1.

2. In section 231.205-18, revise paragraph (c)(iii)(C) to read as follows:
231.205-18 Independent research and development and bid and proposal costs.

(c) * * *

(iii) * * *

(C) For annual IR&D costs to be allowable—

(1) The IR&D projects generating the costs must be reported to the Defense Technical Information Center (DTIC) using the DTIC's on-line input form and instructions at http://www.defenseinnovationmarketplace.mil/;

(2) The inputs must be updated with a summary of results at least annually and when the project is completed;

(3) Copies of the input and updates must be made available for review by the cognizant administrative contracting officer (ACO) and the cognizant Defense Contract Audit Agency auditor to support the allowability of the costs;

(4) Contractors that do not meet the threshold as a major contractor are encouraged to use the DTIC on-line input form to report IR&D projects to provide DoD with visibility into the technical content of the contractors' IR&D activities; and

(5) For IR&D projects initiated in the contractor's fiscal year 2017 and later, as a prerequisite for the subsequent determination of allowability, major contractors must—

(i) Engage in a technical interchange with a technical or operational DoD Government employee before IR&D costs are generated so that contractor plans and goals for IR&D projects benefit from the awareness of and feedback by a DoD employee who is informed of related ongoing and future potential interest opportunities; and

(ii) Use the online input form for IR&D projects reported to DTIC to document the technical interchange, which includes the name of the DoD Government employee and the date the technical interchange occurred.

[FR Doc. 2016-03039 Filed 2-12-16; 8:45 am] BILLING CODE 5001-06-P
DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R8-ES-2015-0170; FFXES11130000-156-FF08E00000] RIN 1018-BA71 Endangered and Threatened Wildlife and Plants; Removing the San Miguel Island Fox, Santa Rosa Island Fox, and Santa Cruz Island Fox From the Federal List of Endangered and Threatened Wildlife, and Reclassifying the Santa Catalina Island Fox From Endangered to Threatened AGENCY:

Fish and Wildlife Service, Interior.

ACTION:

Proposed rule; availability of draft post-delisting monitoring plan.

SUMMARY:

We, the U.S. Fish and Wildlife Service (USFWS), propose to remove the San Miguel Island fox (Urocyon littoralis littoralis), Santa Rosa Island fox (U. l. santarosae), and Santa Cruz Island fox (U. l. santacruzae) from the Federal List of Endangered and Threatened Wildlife and to reclassify the Santa Catalina Island fox (U. l. catalinae) from an endangered species to a threatened species. This determination is based on a thorough review of the best available scientific and commercial information, which indicates that the threats to the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox have been eliminated or reduced to the point that each of the subspecies no longer meets the definition of an endangered species or a threatened species under the Endangered Species Act of 1973, as amended (Act), and that the threats to the Santa Catalina Island fox have been reduced to the point that the subspecies can be reclassified as a threatened species. We are seeking information and comments from the public regarding this proposed rule and the draft post-delisting monitoring plan for the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox.

DATES:

We will accept comments received or postmarked on or before April 18, 2016. We must receive requests for public hearings, in writing, at the address shown in the FOR FURTHER INFORMATION CONTACT section by April 1, 2016.

ADDRESSES:

Comment submission: You may submit comments by one of the following methods:

(1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-R8-ES-2015-0170, which is the docket number for this rulemaking. Then click on the Search button. On the resulting page, in the Search panel on the left side of the screen, under the Document Type heading, click on the Proposed Rules link to locate this document. You may submit a comment by clicking on “Comment Now!”

(2) By hard copy: Submit by U.S. mail or hand-deliver to: Public Comments Processing, Attn: FWS-R8-ES-2015-0170; Division of Policy, Performance, and Management Programs; U.S. Fish and Wildlife Service, MS: BPHC; 5275 Leesburg Pike, Falls Church, VA 22041-3803.

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

Document availability: A copy of the Recovery Plan for Four Subspecies of Island Fox (Urocyon littoralis) referenced throughout this document can be viewed at http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A08I, at http://www.regulations.gov under Docket No. FWS-R8-ES-2015-0170, or at the Ventura Fish and Wildlife Office's Web site at http://www.fws.gov/Ventura/. The post-delisting monitoring plan for the northern Channel Island fox subspecies (San Miguel, Santa Rosa, and Santa Cruz Island foxes) consists of two documents: the epidemic response plan for northern Channel Island foxes (Hudgens et al. 2013, entire) and the golden eagle management strategy (NPS 2015a, entire). These documents will also be posted on http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A08I, at http://www.regulations.gov under Docket No. FWS-R8-ES-2015-0170, and the Ventura Fish and Wildlife Office's Web site at http://www.fws.gov/Ventura/.

FOR FURTHER INFORMATION CONTACT:

Stephen P. Henry, Field Supervisor, U.S. Fish and Wildlife Service, Ventura Fish and Wildlife Office, 2493 Portola Road, Suite B, Ventura, CA 93003; by telephone 805-644-1766; or by facsimile 805-644-3958. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.

SUPPLEMENTARY INFORMATION:

Information Requested

We intend any final action resulting from this proposal will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other governmental agencies, tribes, the scientific community, industry, or other interested parties concerning this proposed rule. We particularly seek comments concerning:

(1) Additional information on the distribution, population size, and population trends of the San Miguel Island fox, Santa Rosa Island fox, Santa Cruz Island fox, and Santa Catalina Island fox (collectively referred to as “island foxes” below).

(2) Relevant information concerning any current or likely future threats (or lack thereof) to the island foxes.

(3) Current or planned activities within the range of the island foxes and their possible impacts.

(4) Regional climate change models and whether they are reliable and credible to use in assessing the effects of climate change on the island foxes and their habitats.

(5) Our draft post-delisting monitoring plan.

Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include. Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, may not meet the standard of information required by section 4(b)(1)(A) of the Act (16 U.S.C. 1531 et seq.), which directs that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best scientific and commercial data available.”

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

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Ventura Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

Public Hearings

Section 4(b)(5) of the Act provides for one or more public hearings on this proposal, if requested. We must receive your request within 45 days after the date of this Federal Register publication. Send your request to the address shown in FOR FURTHER INFORMATION CONTACT. We will schedule public hearings on this proposal, if any are requested, and announce the dates, times, and places of those hearings, as well as how to obtain reasonable accommodation, in the Federal Register and local newspapers at least 15 days before the hearing.

Previous Federal Actions

On December 10, 2001, we published a proposal to list four subspecies of island foxes as endangered species (66 FR 63654). Please refer to this proposed rule for information on Federal actions prior to December 10, 2001. On March 5, 2004, we published a final rule listing the four subspecies of island foxes as endangered species (69 FR 10335). Please refer to the final Recovery Plan for Four Subspecies of Island Fox (Urocyon littoralis) (USFWS 2015, entire) for a detailed description of Federal actions concerning this species. We did not designate critical habitat for the four subspecies of island fox, as explained in our November 9, 2005, final critical habitat determination (70 FR 67924).

We published a notice announcing the initiation of a review of the status of the San Miguel Island fox, Santa Rosa Island fox, Santa Cruz Island fox, and Santa Catalina Island fox under section 4(c)(2) of the Act on March 9, 2015 (80 FR 12521), with the notice announcing the availability of the final recovery plan. This proposed rule to remove the San Miguel Island fox, Santa Rosa Island fox, and the Santa Cruz Island fox from the Federal List of Endangered and Threatened Wildlife, and to reclassify the Santa Catalina Island fox from an endangered species to a threatened species, also constitutes a status review for each subspecies.

Background

The Recovery Plan for Four Subspecies of Island Fox (Urocyon littoralis) (Recovery Plan) (USFWS 2015, entire) was prepared by USFWS working with a Recovery Team that included public agency representatives, landowners, conservancies, zoological institutions, non-profits, and academics. The Recovery Plan includes discussion of the following: Species description and taxonomy, habitat use, social organization, reproduction, distribution and abundance, threats to the subspecies, and recovery strategies. Detailed information from the Recovery Plan is summarized in the following sections of this proposed rule: Background, Recovery and Recovery Plan Implementation, and Summary of Factors Affecting the Species. See the Recovery Plan for more information on the species' ecology, species' biological needs, and analysis of the threats that may be impacting the subspecies.

The island fox (Urocyon littoralis), a diminutive relative of the gray fox (U. cinereoargenteus), is endemic to the California Channel Islands. Island foxes inhabit the six largest of the eight Channel Islands (San Miguel Island, Santa Rosa Island, Santa Cruz Island, Santa Catalina Island, San Nicolas Island, and San Clemente Island) and are recognized as distinct subspecies on each of the six islands (see Figure 1, below). Islands inhabited by island foxes are owned by four major landowners: The National Park Service (NPS), the U.S. Navy (Navy), The Nature Conservancy (TNC), and the Santa Catalina Island Conservancy (CIC), all of whom have management authority for wildlife on their lands (Figure 1). The NPS, TNC, and CIC manage the islands where the listed subspecies occur.

EP16FE16.000

Both morphologic and genetic distinctions support the classification of separate subspecies of island foxes for each island (Collins 1993, entire; Gilbert et al. 1990, entire; Goldstein et al. 1999, entire; Wayne et al. 1991a, entire). The island fox is a habitat generalist, occurring in all natural habitats on the Channel Islands, although it prefers areas of diverse topography and vegetation (von Bloeker 1967, pp. 257-258; Laughrin 1977, p. 33; Collins and Laughrin 1979, p. 12). The island fox is primarily nocturnal, but more diurnal than the mainland gray fox (Collins and Laughrin 1979, p. 12.46; Crooks and Van Vuren 1995, p. 305; Fausett 1993, p. 30), possibly a result of historical absence of predators and freedom from human harassment (Laughrin 1977, pp. 19-20).

Even in the absence of catastrophic events, island fox populations may have fluctuated markedly over time (Laughrin 1980, entire). Residents of Santa Cruz Island occasionally noted periods of island fox scarcity and abundance (Laughrin 1980, p. 745). Santa Catalina Island fox population levels were low in 1972, and again in 1977 (Laughrin 1980, p. 747); however, by 1994, the adult Santa Catalina Island fox population was estimated at over 1,300 individuals (Roemer et al. 1994, p. 393). Demographic analysis indicated that island fox survival was positively related to the previous year's winter rainfall in the drier southern islands and negatively related to current and previous year's winter rainfall in the wetter northern islands (San Miguel, Santa Rosa, and Santa Cruz Island) (Bakker et al. 2009, p. 87; USFWS 2015 Appendix 2). Thus, indirect evidence suggests effects of climate on island fox survival.

The four federally listed island fox subspecies (San Miguel, Santa Rosa, Santa Cruz, and Santa Catalina Island foxes) all experienced precipitous population declines in the latter half of the 1990s (Roemer 1999, pp. 124-125, 169-171; Timm et al. 2000, pp. 6-7, 16-17; Coonan et al. 2000, entire; 2005a, pp. 263-264; Roemer et al. 2001, entire). San Miguel Island foxes declined from 450 individuals in 1994, to 15 in 1999/2000; Santa Rosa Island foxes declined from 1,780 individuals in 1994, to 15 in 1999/2000; Santa Cruz Island foxes declined from 1,465 individuals in 1994, to 55 in 1999/2000; and Santa Catalina Island foxes declined from 1,342 individuals in 1994, to 103 in 1999/2000. Island fox populations on the northern Channel Islands (San Miguel, Santa Rosa, and Santa Cruz Islands) declined by 90 to 95 percent and, prior to removal of foxes from the wild for captive breeding, were estimated to have a 50 percent chance of extinction over 5 to 10 years (Roemer 1999, p. 147; Roemer et al. 2001, p. 312). Thus, by 1999, researchers considered island fox subspecies on the northern Channel Islands to be critically endangered (Roemer 1999, p. 180). The Santa Catalina Island subspecies was considered to be critically endangered by 2000 (Timm et al. 2000, entire).

The decline of island foxes in the northern Channel Islands (San Miguel, Santa Rosa, and Santa Cruz Islands) is considered a consequence of hyperpredation by nonnative golden eagles (Roemer et al. 2001, entire). The presence of nonnative prey species (feral pigs on Santa Cruz Island, and mule deer and elk on Santa Rosa Island) and an open ecological niche created by the extirpation of bald eagles (Haliaeetus leucocephalus) from the islands as a result of dichlorodiphenyltrichloroethane (DDT) poisoning (USFWS 2004, p. 10343) enabled golden eagles to colonize the islands successfully and prey heavily on island foxes, which evolved in the absence of predators. In contrast, the decline of island foxes on Santa Catalina Island is considered a consequence of canine distemper virus (CDV). Analysis of CDV isolated from a Santa Catalina Island fox during the late 1990s epidemic indicated it was most closely related to the strain found in mainland raccoons (Timm et al. 2009, p. 339), and a number of stowaway raccoons have been removed from Santa Catalina Island (King and Duncan 2014, p. 20). Therefore, the catastrophic population decline of Santa Catalina Island foxes was likely caused by CDV transmitted from a raccoon accidentally transported from the mainland (Timm et al. 2009, p. 341). Other sources of mortality of island foxes have been identified, particularly for foxes on Santa Catalina Island, such as motor vehicle strikes, interactions with feral cats and dogs, and drought, but were not considered to have contributed substantially to declines of the four subspecies of island foxes.

In response to the catastrophic declines of 1999/2000, captive breeding was implemented on all islands. All known remaining island foxes on San Miguel and Santa Rosa Islands were brought into captivity in 1999 and 2000, respectively. By 2004, captive populations from both islands exceeded the target captive population size of 40 animals and allowed initial releases back to the wild (Coonan and Schwemm 2009, p. 366; Coonan et al. 2005a, p. 168-169). On Santa Cruz Island, 18 representative adult island foxes were brought into captivity in 2001, and the population grew to 62 individuals by 2005; releases of captive-born foxes were subsequently concluded in July 2008 (Hudgens and Sanchez 2009, p. 16). On Santa Catalina Island, 27 foxes were brought into captivity from the isolated west end of the island in 2000. From 2001 to 2004, foxes were released from captivity, including 37 captive-born pups and 20 of the original wild-captured adults (Schmidt et al. 2005, p. 17). Additionally, 32 foxes were moved from the west end of Santa Catalina Island to the depleted east end, with subsequent high survival. The success of these programs allowed all the captive breeding facilities to close by 2008.

For more information about the biology and historical population status and observed declines of island fox populations, please see the Recovery Plan (USFWS 2015, pp. 5-19).

Recovery and Recovery Plan Implementation

Section 4(f) of the Act directs us to develop and implement recovery plans for the conservation and survival of endangered and threatened species unless we determine that such a plan will not promote the conservation of the species. Under section 4(f)(1)(B)(ii), recovery plans must, to the maximum extent practicable, include: “objective, measurable criteria which, when met, would result in a determination, in accordance with the provisions of [section 4 of the Act], that the species be removed from the list.” However, revisions to the list (adding, removing, or reclassifying a species) must reflect determinations made in accordance with sections 4(a)(1) and 4(b) of the Act. Section 4(a)(1) requires that the Secretary determine whether a species is an endangered species or a threatened species (or not) because of one or more of five threat factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or human-made factors affecting its continued existence. Section 4(b) of the Act requires that the determination be made “solely on the basis of the best scientific and commercial data available.” Recovery criteria should therefore indicate when a species is no longer an endangered species or threatened species because of any of the five statutory factors.

Thus, while recovery plans provide important guidance to the USFWS, States, and other partners on methods of minimizing threats to listed species and measurable objectives against which to measure progress towards recovery, they are not regulatory documents and cannot substitute for the determinations and promulgation of regulations required under section 4(a)(1) of the Act. A decision to revise the status of or remove a species from the Federal List of Endangered and Threatened Wildlife (50 CFR 17.11) is ultimately based on an analysis of the best scientific and commercial data then available to determine whether a species is no longer an endangered species or a threatened species, regardless of whether that information differs from the recovery plan.

The Recovery Plan (USFWS 2015, pp. 47-53) includes the recovery goals, recovery objectives, and recovery criteria that we outline below to reclassify the island fox subspecies from endangered to threatened and to remove island fox subspecies from the List of Endangered and Threatened Wildlife. We summarize these goals and then discuss progress toward meeting the recovery objectives.

Recovery Goal

The goal of the Recovery Plan is to recover the San Miguel Island fox, the Santa Rosa Island fox, the Santa Cruz Island fox, and the Santa Catalina Island fox so they can be delisted (removed from the Federal List of Endangered and Threatened Wildlife) when existing threats to each respective subspecies have been ameliorated such that their populations have been stabilized and have increased. The interim goal is to recover these subspecies to the point that they can be downlisted from endangered to threatened status. Each listed subspecies may be considered for downlisting or delisting independently of the other subspecies.

Recovery Objectives

Recovery objectives identify mechanisms for measuring progress toward and achieving the recovery goal for each subspecies.

Recovery Objective 1: Each federally listed subspecies of island fox exhibits demographic characteristics consistent with long-term viability.

Recovery Objective 2: Land managers are able to respond in a timely fashion to predation by nesting golden eagles or significant predation rates by transient golden eagles, to potential or incipient disease outbreaks, and to other identified threats using the best available technology.

In order for any one of the four listed subspecies of island fox to be considered for downlisting from endangered to threatened status, recovery objective 1 should be met for that subspecies. In order for any one of the four listed subspecies of island fox to be considered for delisting, recovery objective 1 and recovery objective 2 should be met for that subspecies.

Recovery Criteria

Island fox recovery criteria are measurable standards for determining whether a subspecies has achieved its recovery objectives and may be considered for downlisting or delisting. Criteria presented in the Recovery Plan (USFWS 2015, pp. 50-53) represent our best assessment of the conditions most likely to result in a determination that downlisting or delisting of the San Miguel Island fox, Santa Rosa Island fox, Santa Cruz Island fox, and the Santa Catalina Island fox is warranted. Achieving the prescribed recovery criteria is an indication that a subspecies is no longer an endangered species or a threatened species. Each recovery criterion applies to all four subspecies, except where noted otherwise.

As presented in the Recovery Plan (USFWS 2015, pp. 50-55), the discussion of criteria below is organized by factors under 4(a)(1) to demonstrate how criteria indicate threats under that factor have been ameliorated.

Factor A: The present destruction, modification or curtailment of its habitat or range.

There are no recovery criteria for this factor. Herbivory by nonnative species resulted in habitat degradation on the Channel Islands. While habitat degradation was not identified as a primary threat to island foxes, presence of nonnative herbivores responsible for habitat degradation provided a prey base for golden eagles to become established and predate island foxes on the northern Channel Islands. If threats under Factors C and E are ameliorated, the habitat improvements expected to occur with removal of herbivores responsible for habitat degradation may provide a long-term benefit to the island fox subspecies; however, these habitat improvements are not necessary for recovery.

Factor B: Overutilization for commercial, scientific or educational purposes.

Overutilization is not a currently known threat for these subspecies; therefore, there are no recovery criteria that address threats under this factor.

Factor C: Disease or predation.

Disease and predation were identified as primary threats to island foxes. To address recovery objective 2, the magnitude and imminence of disease and predation threats must be reduced. The Recovery Plan (USFWS 2015, p. 51) states that this is accomplished when the following have occurred:

C/1: Golden eagle predation (applies only to the northern Channel Islands):

a. To reduce the threat of extinction to the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox, the rate of golden eagle predation is reduced and maintained at a level no longer considered a threat to island fox recovery through development of a golden eagle management strategy. The strategy will be developed by the land manager(s) in consultation with the USFWS and including review by the appropriate Integrated Island Fox Recovery Team Technical Expertise Group or the equivalent. This strategy includes:

• Response tactics (including the use of helicopters and net-guns) to capture nesting golden eagles and any transient golden eagle responsible for significant island fox predation, per the golden eagle response strategy;

• Tactics to minimize the establishment of successful nesting golden eagles;

• An established island fox monitoring program that is able to detect an annual island fox predation rate caused by golden eagles of 2.5 percent or greater, averaged over 3 years (Bakker and Doak 2009, entire); and

• An established mortality rate or population size threshold that, if reached due to golden eagle predation, would require land manager(s) to bring island foxes into captivity.

b. The golden eagle prey base of deer and elk is removed from Santa Rosa Island.

C/2: Disease:

A disease management strategy is developed, approved, and implemented by the land manager(s) in consultation with the USFWS and includes review by the appropriate Integrated Island Fox Recovery Team Technical Expertise Group or the equivalent. This strategy includes:

• Identification of a portion of each population that will be vaccinated against diseases posing the greatest risk, for which vaccines are safe and effective. Vaccinations and fox numbers vaccinated will be developed in consultation with appropriate subject-matter experts;

• Identification of actual and potential pathogens of island foxes, and the means by which these can be prevented from decimating fox populations;

• Disease prevention;

• A monitoring program that provides for timely detection of a potential epidemic, and an associated emergency response strategy as recommended by the appropriate subject-matter experts; and

• A process for updating the disease strategy as new information arises.

Factor D: Inadequacy of existing regulatory mechanisms.

The inadequacy of existing regulatory mechanisms was not identified as a primary threat to island foxes, and, therefore, there are no recovery criteria that address threats under this factor.

Factor E: Other natural or manmade factors affecting its continued existence.

Small population size and vulnerability to stochastic or catastrophic events were identified as primary threats to the species under Factor E. To address recovery objective 1, that each federally listed subspecies of island fox exhibits demographic characteristics consistent with long-term viability, the subspecies must be protected from other natural or manmade factors known to affect their continued existence. This is accomplished when the following has occurred:

E/1: An island fox subspecies has no more than 5 percent risk of quasi-extinction over a 50-year period (addresses objective 1). This risk level is based on the following:

• Quasi-extinction is defined as a population size of fewer than or equal to 30 individuals.

• The risk of quasi-extinction is calculated based on the combined lower 80 percent confidence interval for a 3-year running average of population size estimates, and the upper 80 percent confidence interval for a 3-year running average of mortality rate estimates.

• This risk level is sustained for at least 5 years, during which time the population trend is not declining. A declining trend is defined as the 3-year risk-level being greater in year 5 than year 1.

Achievement of Recovery Criteria

Golden eagle predation is no longer a threat due to successful golden eagle removals, nonnative prey removal, and bald eagle recovery. Recovery criterion C/1 addresses golden eagle predation in the northern Channel Islands (it does not apply to the Santa Catalina Island fox). A final golden eagle management strategy has been approved (NPS 2015a, entire), which involves actions that have already been implemented by the NPS and TNC, including: Complete removal of all golden eagles; ongoing prevention of golden eagle nesting; and removal of all nonnative golden eagle prey, including the deer and elk from Santa Rosa Island. In addition, as bald eagles reestablish their populations on the northern Channel Islands, they reduce the probability that golden eagles will recolonize because bald eagles aggressively defend their territories from golden eagles (USFWS 2004, pp. 10343-10344). Due to ongoing management as prescribed in the final golden eagle management strategy, current eagle predation is minimal, and has had a negligible effect on fox population trends; therefore, the intent of recovery criteria C/1 has been met.

Monitoring associated with criteriaC/1 will be accomplished as part of the epidemic response plan for the northern Channel Island subspecies (Hudgens et al. 2013, entire). This monitoring will allow detection of mortality related to depredation of island fox by golden eagles (as well as early detection of mortality related to a disease epidemic). As described above, ongoing management has reduced eagle predation on island foxes in the northern Channel Islands to minimal levels. Consequently, we recognize golden eagle predation is no longer a threat to foxes on the northern Channel Islands, and the current monitoring strategy allows for a rapid response to any identified mortalities resulting from predation or disease. National Park Service and TNC have committed through signed conservation management agreements (CMAs) to carrying out monitoring and other management actions as recommended in the epidemic response plan (Hudgens et al. 2013, entire) for the next 5 years (USFWS and NPS 2015; USFWS and TNC 2015). Prior to the expiration of the CMAs, the parties will meet to review, modify, and re-enter into a CMA.

Recovery criterion C/2 addresses the threat of disease to all four island fox subspecies. The intent of recovery criterion C/2 is currently being met for the Santa Catalina Island fox; however, the Santa Catalina Island fox subspecies has the highest risk of disease introduction and low assurance of continued implementation of the epidemic response plan in the future, creating uncertainty that this criterion will continue to be met in the future. Santa Catalina Island has the highest risk of disease introduction because movement of potential vectors such as domestic dogs, cats, and stow-away raccoons between the mainland and the island is not controlled. The island has heavy visitation and many points of access, and there are no restrictions on visitors transporting domestic pets to the island, no restrictions or inspections required of vessels visiting from the mainland, and leash laws for dogs are difficult to enforce (King and Duncan 2011, p. 15; Anderson 2012, pers. obs.; King 2012a, p. 1; Vissman and Anderson 2013 and 2014, pers. obs.; King 2015, p. 1). The Catalina Island Conservancy (CIC) has approved and is currently implementing an epidemic response plan for Santa Catalina Island foxes (Hudgens et al. 2014, entire). The CIC annually vaccinates a portion of the subspecies' population against CDV and rabies when vaccines are available (King 2015, pers. comm.) and monitors for detection of potential epidemics as recommended in the epidemic response plan (Hudgens et al. 2014, entire), although currently there are no assurances to ensure monitoring will continue into the future on Santa Catalina Island. If there is a lapse in continued implementation of the epidemic response plan, a potential disease outbreak could occur without detection or appropriate response to mediate the threat to the subspecies.

A final disease management strategy has also been approved in the form of an epidemic response plan for the northern Channel Island fox subspecies (Hudgens et al. 2013, entire). This epidemic response plan is currently implemented by the NPS and TNC, and provides direction for monitoring, vaccination for canine distemper virus and rabies annually to a portion of each island fox population, and response if mortality is detected. While disease was not responsible for the decline of island foxes on the northern Channel Islands, these subspecies, like all island fox subspecies, will always be at some risk of a disease outbreak and population decline because of their small population sizes and isolation. However, the risk potential for disease outbreak has been and continues to be reduced through implementation of the epidemic response plan. Additionally, NPS and TNC have committed through signed CMAs to carrying out monitoring and other management actions for detecting and appropriately responding to a potential disease outbreak into the future as recommended in the epidemic response plan (Hudgens et al. 2013, entire; USFWS and NPS 2015; USFWS and TNC 2015).

Recovery criterion E/1, which is intended to indicate when population levels are sufficiently robust to withstand natural variation in demographic parameters and avoid potential extirpations from stochastic or catastrophic events, has been achieved for all four island fox subspecies. This recovery criterion is attained when the 3-year means of adult mortality rate versus population size and confidence intervals lie below 5 percent risk of subspecies-specific quasi-extinction for 5 consecutive years (see Supplementary Material “Results of graphing/analysis tool to assess island fox recovery criterion E/1” posted on http://www.regulations.gov for more details). Population monitoring has been implemented for each listed subspecies, and population viability analyses indicate all subspecies have an acceptably small risk of extinction. The extinction risk has been less than 5 percent since 2008 for San Miguel, Santa Cruz, and Santa Catalina Islands, and since 2011 for Santa Rosa Island. As of 2014, island fox populations had increased to greater than 500 on San Miguel Island (Coonan 2015, pp. 7, 13), greater than 800 on Santa Rosa Island, greater than 2,500 individuals on Santa Cruz Island (Bakker 2015, p. 4), and greater than 1,700 on Santa Catalina Island (King and Duncan 2014, p. 11). All populations with the exception of Santa Rosa Island are at or above their pre-decline population estimates (Coonan 2015a, pers. comm.; King and Duncan 2014, pp. 1, 10). On San Miguel Island, low reproductive effort coupled with declining survival suggests that the San Miguel Island subspecies has reached carrying capacity (Coonan 2015, p. 8). We conclude, based on population viability analyses, that the intent of recovery criterion E/1 has been achieved for all four island fox subspecies. The graphing/analysis tool used to assess attainment of recovery criterion E/1 and associated discussion is found in Appendix 2 of the Recovery Plan (USFWS 2015, pp. 131-136). Detailed results of the tool through 2014 can be found in the Supplementary Material “Results of graphing/analysis tool to assess island fox recovery criterion E/1” (derived from Coonan 2015, p. 12, 16; Boser 2015, p. 8; King and Duncan 2015, p. 12) on http://www.regulations.gov under Docket No. FWS-R8-ES-2015-0170.

Summary of Recovery Criteria

With the golden eagle management strategy in place, complete removal of golden eagles and their nonnative prey-base from the northern Channel Islands, development and implementation of an epidemic response plan, and population levels consistent with long-term viability, the intent of recovery objectives 1 and 2, and the associated recovery criteria have been met for the San Miguel, Santa Rosa, and Santa Cruz Island foxes (see Table 1, below). With population levels consistent with long-term viability, recovery objective 1 has been met for the Santa Catalina Island fox. However, objective 2 has not been met because currently there are no assurances to ensure monitoring and management actions will continue into the future on Santa Catalina Island and, because this island has a high risk of introduced pathogens from the mainland, a disease outbreak could occur without detection or appropriate response to mediate the threat to the subspecies (Table 1).

Table 1—Summary of Achievement of Recovery Criteria for the Four Island Fox Subspecies Subspecies Population Risk-based
  • Recovery Criterion
  • Threat-based
  • Recovery Criterion
  • Threat-based
  • Recovery Criterion
  • Threat-based
  • Recovery Criterion
  • An island fox subspecies has no more than 5 percent risk of quasi-extinction over a 50 year period. Golden Eagle Predation: A golden eagle management strategy is developed and approved. Golden Eagle Predation: The golden eagle prey base of deer and elk is removed from Santa Rosa Island. Disease: A disease prevention and management strategy is developed, approved, and implemented. San Miguel Island Fox 2014 numbers increased to ~500+; annual survival estimates ~ 80 percent; since 2008, extinction risk less than 5 percent over the next 50 years Eagle predation on northern Channel Island foxes has been negligible since 2006; golden eagle management strategy is in place N/A Epidemic response plan developed and implemented; foxes vaccinated against CDV and rabies continuing; CMA signed committing to continued monitoring. Santa Rosa Island Fox 2014 numbers increased to ~800; annual survival estimates greater than 90 percent; since 2011, extinction risk less than 5 over the next 50 years percent Eagle predation on northern Channel Island foxes has been negligible since 2006; golden eagle management strategy is in place As of 2015, all elk and all but a few deer have been removed from Santa Rosa Island Epidemic response plan developed and implemented; foxes vaccinated against CDV and rabies continuing; CMA signed committing to continued monitoring. Santa Cruz Island Fox 2014 numbers increased to ~2,500+; annual survival estimates greater than 90 percent; since 2008, extinction risk less than 5 percent over the next 50 years Eagle predation on northern Channel Island foxes has been negligible since 2006; golden eagle management strategy is in place N/A Epidemic response developed and implemented; foxes vaccinated against CDV and rabies continuing; CMA signed committing to continued monitoring. Santa
  •  Catalina
  •  Island Fox.
  • 2014 numbers increased to ~1,700; annual survival estimates greater than 80 percent since 2006; since 2008, extinction risk less than 5 percent over the next 50 years N/A N/A Epidemic response plan developed and implemented; foxes vaccinated against CDV and rabies continuing; ongoing relatively high potential for disease vector exposure; insufficient long-term monitoring and management assurance.
    Summary of Factors Affecting the Species

    Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species on, reclassifying species on, or removing species from the Lists of Endangered and Threatened Wildlife and Plants. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature (16 U.S.C. 1532(16)). A species may be determined to be an endangered species or threatened species because of any one or a combination of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or human-made factors affecting its continued existence. A species may be reclassified on the same basis.

    A recovered species is one that no longer meets the Act's definition of endangered species or threatened species. Determining whether a species is recovered requires consideration of whether the species is an endangered species or threatened species because of the five categories of threats specified in section 4(a)(1) of the Act. For species that are already listed as endangered species or threatened species, this analysis of threats is an evaluation of both the threats currently facing the species and the threats that are reasonably likely to affect the species in the foreseeable future following the delisting or downlisting and the removal or reduction of the Act's protections.

    A species is an “endangered species” for purposes of the Act if it is in danger of extinction throughout all or a significant portion of its range and is a “threatened species” if it is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act does not define the term “foreseeable future.” For the purposes of this rule, we define the “foreseeable future” to be 50 years because the population viability analyses to determine the risk of quasi-extinction for each subspecies are over a 50-year period (Bakker et al. 2009, entire). Therefore, we estimate 50 years to be the extent to which, given the amount and substance of available data, we can anticipate events or effects, or reliably extrapolate threat trends, such that reliable predictions can be made concerning the future as it relates to the status of the four subspecies of island fox (San Miguel, Santa Rosa, Santa Cruz, and Santa Catalina Island foxes).

    A thorough analysis and discussion of the current status of the San Miguel, Santa Rosa, Santa Cruz, and Santa Catalina Island foxes is detailed in the Recovery Plan (USFWS 2015, pp. 21-29). Primary threats to island foxes identified in the listing rule included predation by golden eagles, disease, and stochastic risks to small populations and lack of genetic variability. Since listing, impacts of feral cat aggression, poisoning, and entrapment on Santa Catalina Island, and fire, drought, and global climate change for all four islands have been identified as possible new threats. The following sections provide a summary of the past, current, and potential future threats impacting the San Miguel, Santa Rosa, Santa Cruz, and Santa Catalina Island foxes.

    Factor A: Present or Threatened Destruction, Modification, or Curtailment of Habitat or Range

    At the time of listing in 2004, habitat modification by nonnative grazing animals and nonnative plant invasion was identified as a threat under Factor A impacting island foxes (69 FR 10335; March 5, 2004). The listing rule identified habitat modification as causing some adverse effects to island foxes, particularly conversion to grasslands, but considered it unlikely to have directly caused the observed declines. Annual grasslands constitute less preferred habitat for island foxes (Laughrin 1977, p. 22; Roemer and Wayne 2003, pp. 1256-1257) and do not provide cover from predators such as golden eagles (Roemer 1999, p. 99, 190-191). It is difficult to quantify the effects of past habitat loss and/or alteration on the status of island foxes. However, habitat on all islands occupied by island foxes has been affected by a combination of livestock grazing, cultivation, and other disturbances, particularly nonnative animal and plant invasion and urbanization on Santa Catalina Island. Although it is possible that these habitat changes may have exacerbated the effects of other threats, island fox populations remained relatively stable prior to the commencement of golden eagle predation in the mid-1990s and disease in 1999.

    Eradication programs on all islands have greatly reduced the number of nonnative herbivores on the islands and therefore the magnitude of impacts to the habitat (Laughrin 1973, p. 14; Schoenherr et al. 1999, pp. 191-194; Parkes et al. 2010, p. 636). Currently, impacts to island fox habitats are primarily attributed to continued modification by nonnative plant species, resulting in lower vegetation diversity and habitat structure. The seeds of nonnative annual grasses can also cause occasional damage or blindness by becoming lodged in the eyes and ears of island foxes.

    National Park Service (NPS) guidance supports the continued management of island fox habitat to benefit northern Channel Islands subspecies of island foxes. Title 54 of the U.S. Code, section 100101, paragraph (a), states that the NPS “shall promote and regulate the use of the National Park System . . . to conserve the scenery, natural and historic objects, and wild life in the System units and to provide for the enjoyment of the scenery, natural and historic objects, and wild life in such manner and by such means as will leave them unimpaired for the enjoyment of future generations.” Specifically, in its management plan, Channel Islands National Park identified restoration and maintenance of natural ecosystems and processes as a priority; Park staff would continue to eradicate, where feasible, nonnative flora and fauna from the islands.

    The island fox, as the species Urocyon littoralis (incorporating all six subspecies), is listed as threatened under the California Endangered Species Act (CESA) (section 2081(b)), which does provide a level of protection from actual possession or intentional killing of individual animals and actual death of individual animals incidental to otherwise lawful activity, such as habitat conversion, on the privately owned TNC-managed lands on Santa Cruz Island and privately owned lands on Santa Catalina Island. Santa Catalina Island foxes are impacted by the potential for land use change on non-conserved lands, including development and recreational events such as off-road vehicle racing. CESA contributes to the conservation of the species by providing a mechanism to reduce or regulate some individual sources of mortality and to review and permit development projects that may impact island foxes and their habitat on private lands.

    While past and ongoing effects of habitat modification by nonnative grazing animals and nonnative plant invasion may have some negative effects on island foxes, nonnative animals and plants no longer impact the habitat to the extent that would cause population-level declines that we would consider a threat to any of the subspecies of island fox now or in the future.

    Factor B: Overutilization for Commercial, Recreational, Scientific, or Educational Purposes

    As stated in the listing rule (69 FR 10335; March 5, 2004), although island foxes were used in the past for their pelts by Native Americans (Collins 1991, p. 215), these activities are no longer occurring. Research scientists are currently engaged in recovery activities via USFWS-issued 10(a)(1)(A) recovery permits. Our analyses have determined these research activities do not pose a threat to any island fox populations. Therefore, overutilization is not a threat to any of the island fox subspecies at this time or in the future.

    Factor C: Disease or Predation

    A canine distemper virus (CDV) epidemic was considered the primary threat to Santa Catalina Island fox at the time of listing (69 FR 10335; March 5, 2004). The listing rule also expressed some concern regarding the potential impacts of canine adenovirus and canine parvovirus. At the time of listing, golden eagle predation was the primary cause for the decline of northern Channel Islands foxes (San Miguel, Santa Rosa, and Santa Cruz Island foxes) (69 FR 10335; March 5, 2004), but potential for disease was also a concern, particularly given the small population sizes at the time.

    Disease

    Infectious Pathogens: In the past, disease severely impacted the island fox population on Santa Catalina Island. The eastern subpopulation of the Santa Catalina Island fox was estimated to be 1,342 in 1990 (Roemer et al. 1994, p. 393). Subsequent surveys conducted in 1999 and 2000 indicated the eastern island fox subpopulation had declined by over 90 percent in 10 years due to CDV (Timm et al. 2000, p. 17), likely transmitted from a raccoon that arrived from the mainland (Timm et al. 2009, p. 339). After a captive rearing and augmentation program was initiated, the eastern and western subpopulations were estimated to have reached 219 and 141 foxes in 2004, respectively (Schmidt et al. 2005, p. 11; King and Duncan 2011, p. 19). Population estimates have since greatly increased on Santa Catalina Island, surpassing the estimate from 1990, reaching a total of 1,717 individuals island-wide in 2014 (King and Duncan 2015, p. 10).

    In 2014, a final epidemic response plan was approved and is being implemented to detect and facilitate appropriate response to a potential future disease outbreak for Santa Catalina Island foxes (Hudgens et al. 2014, entire). The Catalina Island Conservancy annually monitors sentinel foxes inhabiting many areas of the island to facilitate early detection of a potential epidemic (King and Duncan 2011, p. 15). Island foxes have been and continue to be vaccinated against CDV and rabies (King 2015, pers. comm.). At this time, however, there is no assurance of continued funding for long-term monitoring and management that could detect a novel outbreak and facilitate threat abatement, as recommended in the epidemic response plan.

    Transport of domestic and wild animals to and from Santa Catalina Island increases the risk to island foxes of another disease outbreak. Santa Catalina Island currently allows visitors and residents to own and transport pets, including domestic dogs and cats, to and from the island (King and Duncan 2011, p. 15), and dogs are frequently observed off-leash (Anderson 2012, pers. obs.; King 2012a, p. 1; Vissman and Anderson 2013 and 2014, pers. obs.; King 2015, p. 22). There is no quarantine period for transported pets, and proof of current vaccination is only required by the City of Avalon when licensing dogs (rabies only), and for CIC employees and lessees with pets living in company-owned housing (King and Duncan 2011, p. 15). The CIC manages the majority of fox habitat on the island (except the City of Avalon) and through their regulations requires all nonnative animals entering CIC property be licensed; they also require that all dogs and cats be vaccinated against distemper and rabies, and they should be leashed at all times (CIC 2015, http://www.catalinaconservancy.org). Enforcement of CIC regulations is labor-intensive and costly, because the island is large, there are many remote coves and beaches where private boats can anchor, and the CIC does not have the funding or staff to patrol these areas regularly. Reduction of disease introduction risk also occurs through CIC outreach and education of local authorities and the public; to date, four stowaway raccoons have been removed from the island, but a fifth observed in 2010 was not captured (King and Duncan 2011, p. 15). Therefore, current measures to control introduction of diseases by domestic animals and stowaway wildlife on Santa Catalina Island, while providing some protection, are limited.

    Disease does not appear to be a significant mortality factor on the northern Channel Islands, although Leptospirosis (infectious bacterium) was found to be a mortality source for two Santa Rosa Island foxes in 2010 (Coonan and Guglielmino 2012, p. 21). Unlike on Santa Catalina Island, dogs and other pets are not permitted on the northern Channel Islands to reduce this risk of introduction of disease; however, dogs are occasionally illegally brought onto the islands. Channel Islands National Park General Management Plan prohibits pets from all Park islands, except for guide dogs for visually impaired persons (NPS 2015b, pp. 468, 487).

    In 2013, a final epidemic response plan was approved and is being implemented to detect and facilitate appropriate response to a potential disease outbreak for the northern Channel Islands (Hudgens et al. 2013, entire). Sentinel foxes are monitored to facilitate early detection of a potential epidemic (Hudgens et al. 2013, pp. entire), and foxes have been and continue to be vaccinated against CDV and rabies when vaccines are available. Also, the Park identified island foxes as an ecosystem element for which they will conduct long-term annual population monitoring as part of the Park's long-term ecological monitoring program, regardless of their status under the Act. Both NPS and TNC have committed through signed CMAs (USFWS and NPS 2015; USFWS and TNC 2015) to carrying out monitoring and management actions into the future as recommended in the epidemic response plan for northern Channel Island foxes (Hudgens et al. 2013, entire).

    Ear Canal Cancer: There is concern about the rate of ear canal cancer in Santa Catalina Island foxes and how it might affect long-term population viability. The first cases of ear canal cancer were documented in 2000 and 2001, with increased detection through 2007 (Timm et al. 2002, p. 26; Kohlmann et al. 2003, p. 39; Schmidt et al. 2004, p. 15; Schmidt et al. 2005, p. 11; Munson et al. 2009, p. 5). This cancer can have an aggressive clinical course, with local invasion, tissue damage, and metastasis, leading to death (Munson et al. 2009, p. 1). Ear inflammation correlated with cancer incidence in Santa Catalina Island foxes is triggered by ear mite infestations (Munson et al. 2009, pp. 3-4), and the severity can be reduced through aracacide application (Vickers et al. 2011, pp. 9-10). Treatment with aracacide is now standard practice by CIC during trapping of Santa Catalina Island foxes (King and Duncan 2011, p. 3). Since 2008, over 1,000 treatments were applied, and the prevalence of mites has been reduced in the fox population from 87 percent to 28 percent. Tumor prevalence in the Santa Catalina Island fox population remains an actively managed source of mortality (Vickers et al. 2011, pp. 9-10). However, we do not have long-term assurances that CIC will continue to carry out monitoring and management actions into the future as recommended in the epidemic response plan (Hudgens et al. 2014, entire).

    Parasites: Parasites have not been confirmed as a direct mortality source of island foxes; however, concurrent infection with a pathogen, such as Spirocerca (nematode), can negatively impact host health and decrease immunity (Munson 2010, pp. 134-136). In a species-wide survey, Spirocerca was found in a high prevalence of necropsied island foxes, but in most cases appeared to have little effect on the population (Munson 2010, pp. 129, 134-136). Preliminary genetic analysis and the location of lesions suggest that the Spirocerca found in island foxes may be a different species than S. lupi, which occurs in domestic dogs and other North American carnivores on the mainland. Currently, Spirocerca is not a major health concern for most island foxes. However, if island foxes are ever brought to the mainland for research or captive breeding, efforts should be made to prevent transmission of Spirocerca from island foxes to mainland carnivores and vice versa.

    Infection by parasites other than Spirocerca has been suspected as the cause of mortality in several island foxes, but is not considered a significant mortality factor. Infection by hookworms (Uncinaria stenocephala) and a lungworm (Angiocaulus gubernaculatus) may have contributed to two mortalities in the San Miguel Island fox subspecies (Coonan et al. 2005b, p. 38). In 2013, the San Miguel Island fox annual survival rate declined from approximately 90 percent to about 80 percent; 5 of the 11 mortalities that occurred in radio-collared foxes had evidence of acanthocephalans (spiny-headed worms), a parasite never before recorded in island foxes (Coonan 2014, p. 6).

    In summary, the possibility exists for domestic or wild animals carrying a disease or parasite to migrate or be transported to all the Channel Islands, although vector movement via boat is frequent to Santa Catalina Island. On all islands, an epidemic response plan is approved and being implemented (Hudgens et al. 2013, 2014 entire), which includes that a subset of foxes are vaccinated when vaccines are available and monitored to detect and respond to a potential disease outbreak (Coonan 2010, pp. 24-29; see appendices 3 and 4 in Recovery Plan (USFWS 2015)). The NPS and TNC have committed (USFWS and NPS 2015; USFWS and TNC 2015) to carrying out monitoring and management actions into the future as recommended in the epidemic response plan for northern Channel Island foxes (Hudgens et al. 2013, entire); therefore, we consider the potential threat of disease adequately controlled for the San Miguel, Santa Rosa, and Santa Cruz Island foxes at this time and into the future. We do not at this time have the assurance of continued implementation of the epidemic response plan on Santa Catalina Island. Disease was the main threat to Santa Catalina Island foxes at the time of listing in 2004, and given the lack of assurance for continued implementation of the epidemic response plan to detect and mitigate for future disease outbreaks, we still consider potential disease outbreaks to be a threat to the Santa Catalina Island fox.

    Predation

    As identified in the listing rule, golden eagle predation was the primary cause for the decline of the northern Channel Islands fox subspecies and the primary reason for the listing under the Act (69 FR 10335; March 5, 2004). Before golden eagles started using the northern Channel Islands in the 1990s, the only known predator of island foxes was the red-tailed hawk (Buteo jamaicensis), which preyed only occasionally on young island foxes (Laughrin 1973, pp. 10-11; Moore and Collins 1995, p. 4). Because of the lack of predators, island foxes did not evolve vigilance and are easy targets for golden eagles (Roemer et al. 2001, p. 316). Colonization of the northern Channel Islands by golden eagles was likely a combination of two factors: (1) Introduction of nonnative mammals on the northern Channel Islands, resulting in a historically unprecedented prey base for golden eagles (USFWS 2004, p. 10338); and (2) an open ecological niche created by the extirpation of bald eagles from the islands as a result of DDT poisoning (USFWS 2004, p. 10343).

    In the 2004 listing rule, the Federal Bald and Golden Eagle Protection Act (BGEPA; 16 U.S.C. 668-668d) and the California Fish and Game Code, section 3511, were thought to have delayed or precluded the implementation of needed recovery actions for island foxes. The protections afforded to golden eagles by the BGEPA were thought to limit lethal management alternatives to protect island foxes. The California Fish and Game Code, section 3511, deemed golden eagles a fully protected species, which would not have allowed any take to be authorized. In 2003, California amended this law to allow authorization of the take of fully protected species for scientific research, including research on recovery for other imperiled species (Senate Bill 412).

    To address the unprecedented number of golden eagles and the effects they were having on island foxes, in August 1999, the NPS and TNC initiated a nonlethal golden eagle removal program to protect island foxes on the northern Channel Islands. Between November 1999 and July 2006, 44 golden eagles, including 22 adults or near adults, were removed from Santa Rosa and Santa Cruz Islands and released in northeastern California (Latta et al. 2005, p. 348; Coonan et al. 2010, pp. 59-61). Satellite telemetry affixed to the first 12 translocated golden eagles confirmed that none of the relocated eagles attempted to return to the islands for the 1.5-year life of the transmitter (USFWS 2015, p. 30). Ten nestlings were removed by hand from seven different nests (two from Santa Rosa Island and five from Santa Cruz Island) and fostered into mainland golden eagle nests or released. By mid-2005, seven golden eagles were estimated to remain on the northern Channel Islands, and removal efforts yielded diminishing returns. The last eagles captured and removed from the islands were a pair of nesting golden eagles and their chick on Santa Cruz Island in 2006 (Coonan et al. 2010, p. 62), and there has been no record of breeding golden eagles on the northern Channel Islands since that time.

    Genetic work supports the long-term success of eagle translocation efforts. Sonsthagen et al. (2012, pp. entire) investigated the genetics of mainland golden eagles and those translocated from the islands, finding that the island population was likely the result of one colonization event. The likelihood of another successful golden eagle colonization is low, given changes in nonnative prey availability and monitoring/mitigation by land management agencies.

    To ensure that golden eagles would be less likely to attempt to establish territories again on Santa Rosa and Santa Cruz Islands, TNC and the NPS initiated a program in 2005 and 2011, respectively, to remove nonnative animals from those islands (Macdonald and Walker 2007, p. 20). The last known pig was removed from Santa Cruz Island in January 2007 (Parkes et al. 2010, p. 636). Deer and elk were removed from Santa Rosa Island as part of an agreement with the former owners of the island. All elk and all but a few deer had been removed by 2015, resulting in an island that was essentially ungulate-free for the first time in over 150 years (Coonan 2015b, pers. comm.).

    The 2004 listing rule also identified the extirpation of bald eagles from the Channel Islands as a likely contributor to the colonization of the northern Channel Islands by golden eagles. Bald eagles aggressively defend their territories from golden eagles (USFWS 2004, pp. 10343-10344), and their presence on the islands likely would have discouraged dispersing golden eagles from establishing residence. Prior to listing, NPS, Institute for Wildlife Studies, and TNC were actively engaged in the Montrose Settlements Restoration Program to reintroduce bald eagles to the Channel Islands, including Santa Catalina Island. The success of bald eagle reintroduction on the Channel Islands continues, with approximately 50 total resident bald eagles on the islands (Montrose Settlements Restoration Program 2015, p. 1).

    In summary, although golden eagle predation of island foxes may occasionally occur (Coonan et al. 2014, p. 374), predation has been significantly reduced and is not considered a significant threat. This reduction in predation by golden eagles is in direct response to the extensive removal of golden eagles from the northern Channel Islands, golden eagle prey being removed successfully from Santa Rosa and Santa Cruz Islands, and the successful reintroduction of bald eagles.

    Summary of Factor C

    To reduce the threat of disease, a subset of each island fox subspecies is protected from CDV and rabies through preventative vaccinations when available and through monitoring as recommended in epidemic response plans to detect and facilitate appropriate responses in the event of an epidemic. Mortality due to disease was the primary reason for the decline and listing of Santa Catalina Island foxes. Currently, the potential for an epidemic remains on Santa Catalina Island because of heavy visitation, many points of access, and few controls for pets and stowaway wild animals that could carry disease. In addition, we do not have the assurance of continued implementation of the epidemic response plan into the future on Santa Catalina Island to detect and mitigate for future disease outbreaks. Therefore, we still consider potential disease outbreaks to be a threat to the Santa Catalina Island fox at this time.

    Mortality due to golden eagle predation was the primary reason for the decline and listing of northern Channel Islands foxes (San Miguel, Santa Rosa, and Santa Cruz Island foxes). This threat has been substantially reduced by measures including the complete removal of golden eagles, eradication of golden eagles' nonnative prey, and reintroduction of bald eagles, such that we no longer consider predation to be occurring at such a level that would cause population-level declines on the northern Channel Islands now or in the future.

    Factor D: The Inadequacy of Existing Regulatory Mechanisms

    Under this factor, we examine whether existing regulatory mechanisms are inadequate to address the threats to the four island fox subspecies discussed under other factors. Section 4(b)(1)(A) of the Act requires the USFWS to take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species. . . .” In relation to Factor D under the Act, we interpret this language to require the USFWS to consider relevant Federal, State, and Tribal laws, regulations, and other such mechanisms that may minimize any of the threats we describe in the threat analyses under the other four factors, or otherwise enhance conservation of the species. We give strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations; an example would be State governmental actions enforced under a State statute or constitution, or Federal action under statute.

    For currently listed species, we consider the adequacy of regulatory mechanisms to address threats to the species absent the protections of the Act. If this proposal is made final, the San Miguel, Santa Rosa, and Santa Cruz Island foxes would no longer be protected under the Act; Santa Catalina Island foxes would remain protected under the Act as a threatened species. Therefore, we examine whether other regulatory mechanisms will remain in place after delisting, and the extent to which those mechanisms will continue to help ensure that future threats will be reduced or minimized.

    Having evaluated the significance of the threat as mitigated by any such conservation efforts, we analyze under Factor D the extent to which existing regulatory mechanisms are inadequate to address the specific threats to the species. Regulatory mechanisms, if they exist, may reduce or eliminate the impacts from one or more identified threats.

    As discussed under Factor C, the primary threats of golden eagle predation and disease have been ameliorated though management, monitoring, and CMAs on the northern Channel Islands. Other threats affecting all currently listed island foxes, such as habitat modification by nonnative grazing animals and nonnative plant invasion (Factor A), have been and are being controlled through appropriate management and conservation ownership as described in Factor A, and we anticipate that these efforts will continue into the future. Other sources of mortality are assessed under Factor E and found to not exert a significant population-level effect on island foxes now or in the future. Consequently, we find that existing regulatory mechanisms are adequate to address these specific threats. The remaining threat is the potential for a disease epidemic on Santa Catalina Island because of heavy visitation, many points of access, and few controls for pets and stowaway wild animals that could carry disease. In addition, we do not have the assurance of continued implementation of the epidemic response plan into the future on Santa Catalina Island to detect and mitigate for future disease outbreaks. Therefore, under Factor C, we still consider potential disease outbreaks to be a threat to the Santa Catalina Island fox at this time. Consequently, our analysis here examines how existing regulatory mechanisms address this remaining identified threat.

    The CIC manages the majority of fox habitat on Santa Catalina Island (except the City of Avalon) and through its regulations requires all nonnative animals entering CIC property be licensed and that all dogs and cats be vaccinated against distemper and rabies (CIC 2015, http://www.catalinaconservancy.org). Reduction of the risk of disease introduction also occurs through CIC outreach and education of local authorities and the public. However, enforcement of CIC regulations is labor-intensive and costly because the island is large with many remote coves and beaches where private boats can anchor, and the CIC does not have the funding or staff to patrol these areas regularly. Therefore, current measures to control introduction of diseases by domestic animals and stowaway wildlife on Santa Catalina Island, while providing some protection, are limited and thus do not fully address the threat of disease to Santa Catalina Island fox (see Factor C discussion, above).

    Summary of Factor D

    In summary, we have discussed that the threats previously facing the northern Channel Islands subspecies of island fox have been removed; disease remains a threat to the Santa Catalina population of island fox. Consequently, our Factor D analysis examines how existing regulatory mechanisms address this identified threat. Enforcement of CIC regulations, which are meant to limit the risk of disease introduction, is labor-intensive and costly because the island is large with many remote coves and beaches where private boats can anchor, and the CIC does not have the funding or staff to patrol these areas regularly. Thus, current measures to control introduction of diseases by domestic animals and stowaway wildlife on Santa Catalina Island, while providing some protection, are limited in addressing the threat of disease to Santa Catalina Island fox. Therefore, we still consider potential disease outbreaks to be a threat to the Santa Catalina Island fox at this time under Factor C that is not addressed by existing regulatory mechanisms, but, in and of itself, the inadequacy of existing regulatory mechanisms is not a current threat to any of the subspecies, nor is it expected to become a threat in the future.

    Factor E: Other Natural or Manmade Factors Affecting Its Continued Existence

    The 2004 listing rule identified stochastic risks to small populations and lack of genetic variability as threats to all four island fox subspecies under Factor E (69 FR 10335; March 5, 2004). Road mortalities were also discussed under Factor E in the 2004 listing rule. Since the time of listing, the impacts of feral cat aggression, poisoning, and entrapment on Santa Catalina Island, and fire, drought, and global climate change for all four islands have been identified as possible new threats.

    Small Population Size

    Island endemics, such as island foxes, have a high extinction risk due to isolation (i.e., no other populations to “rescue” a declining or extirpated one) and small total population sizes relative to mainland subspecies (MacArthur and Wilson 1967, entire), both of which make them more vulnerable, especially to stochastic events such as drought and wildfire (Miller et al. 2001, entire; Kohlman et al. 2005, entire). Each island fox subspecies is a single breeding population, (with San Miguel Island being the smallest population), which makes their populations inherently small and thus they may become more vulnerable to extinction when the size of a breeding population declines. In addition to small population size and the associated increased probability of extinction, lower and reduced genetic variation may make an island species less adapted to existing pressures and less capable of adaptation to new threats. Thus, small population size and low genetic diversity can have synergistic effects with respect to population decline. During the period when the island fox populations were at their lowest, they were extremely vulnerable to extinction from stochastic events. The populations have now increased substantially, returning to historical population highs, and the threat of extinction from demographic stochasticity has accordingly been reduced.

    The island fox populations have reduced or low genetic diversity due to the population bottlenecks they experienced during past extreme population lows (Gray et al. 2001, p. 8; Gray 2002, pp. entire). This lack of variability could be attributed either to extensive inbreeding or to bottlenecking resulting from low population densities (George and Wayne 1991, entire). However, island foxes have apparently existed for thousands of years with low effective population sizes (the number of individuals that can contribute genes equally to the next generation; low is defined as 150 to 1,000) and low genetic variability (Wayne et al. 1991a, p. 1858; 1991b, p. entire). While additional genetic diversity was lost during the recent declines, island foxes are probably tolerant of low genetic variation, occasional bottlenecks, and higher inbreeding because there is little evidence of inbreeding depression in island foxes (Coonan et al. 2010, pp. 13-15). Therefore, we do not consider reduced genetic diversity to be causing population-level effects at this time or in the future.

    Motor Vehicles

    The fearlessness of island foxes, coupled with relatively high vehicle traffic on Santa Catalina Island, results in multiple fox collisions each year. On the northern Channel Islands, vehicle use very limited, restricted to only land management personnel and researchers. On Santa Catalina Island, vehicle collision was considered the “number one cause of fox mortality” on Santa Catalina Island (CIC 2009, http://www.catalinaconservancy.org), and it remains the most frequently reported cause of death. In 2014, at least 20 foxes died from vehicle-related trauma (King and Duncan 2015, pp. 18-19). In some cases, during the breeding season, mortality of parents (lactating females or foraging males) may result in additional loss of offspring (Wolstenholme 2011, pers. comm.; King 2012g, p. 1). The increase in annual average vehicle-strike deaths is likely due to an increased fox population size on the island, and the island-wide 25 mile per hour speed limit (CIC 2015, http://www.catalinaconservancy.org) likely minimizes the number of vehicle strike mortalities that would otherwise occur. Although mortality by motor vehicles is not considered a population-level threat at this time or in the future, vehicles strikes remain the primary human-caused source of individual mortality on Santa Catalina Island.

    Interactions With Feral Cats and Domestic Dogs

    Feral cats and domestic dogs occur on Santa Catalina Island. Feral cats weigh approximately twice as much as island foxes, and they may negatively affect foxes through interactions including direct aggression and competition for food and habitat resources (Laughrin 1978, pp. 5-6; Kovach and Dow 1981, p. 443). Although hawks and owls may occasionally kill cats, there are no significant predators of cats on Santa Catalina Island that can control their population (Guttilla 2007, p. 8).

    Direct aggression between Santa Catalina Island foxes and cats has been documented in the wild, primarily near public coves and campgrounds that provide food and shelter (Guttilla 2007, p. 9). Researchers have routinely captured foxes that have severe injuries consistent with cat encounters (Guttilla 2007, p. 9). Aggressive exclusion of foxes by feral cats has also been observed. When cats move into fox habitat, foxes are no longer observed; when cats are no longer resident, foxes move back in to occupy the area (King 2013c, pers. comm.; Anderson 2013, pers. obs.).

    In the 2004 listing rule (69 FR 10335; March 5, 2004), we noted that the Food and Agricultural Code 31752.5 prohibited lethal control of feral cats unless cats are held for a minimum of 6 days, which was thought to prevent CIC from taking steps to eradicate feral cats on Santa Catalina Island. In 2008, a Feral Animal Task Force was convened by the City of Avalon, with representatives of the CIC and other island stakeholders, to address feral and free-ranging cats in the city and on the rest of the island, and most importantly, to draft legislation for consideration by the City Council for approval and incorporation into City ordinance. This task force is not currently active, however, and progress has stalled in initiating new feral cat control measures and enacting new legislation (King 2011e, pers. comm.). Although competition and other negative interactions with feral cats can affect individual foxes, they do not pose a population-level threat at this time or in the future.

    Instances of fox mortality from dog attacks have been observed over the past decade: Two in 2005 (Gaffney 2011, p. 1; Munson and Gaffney 2011, p. 1), one in 2010 (King and Duncan 2011, pp. 12-13), two in 2011 (King and Duncan 2012, p. 14), two probable in 2012 (King 2012a, p. 1; 2012b, p. 1), and one in 2015 (King 2015, p. 1). Because the likelihood of finding foxes killed by domestic dogs and identifying dogs as the mortality source is relatively low, these mortalities are likely underreported (Wolstenholme 2011, pers. comm.). It is common for dogs to be observed off-leash in campgrounds and other areas of the island outside of the City of Avalon (King and Duncan 2011, p. 15; Anderson 2012, pers. obs.; King 2012a, p. 1; Vissman and Anderson 2013 and 2014, pers. obs.; King 2015, p. 1). While mortality due to domestic dog attacks has been reported, it is limited in effect to individual foxes, and does not have a significant impact to fox populations at this time or in the future.

    Poisoning and Entrapment

    Other impacts to Santa Catalina Island foxes resulting from human interaction include mortality from poisoning and entrapment. A Santa Catalina Island fox died in 2012 from rodenticide poisoning (Duncan and King 2012, p. 4), another was euthanized because of poisoning in 2014 (King and Duncan 2015, p. 18), and a third was sickened in 2014 by insecticide poisoning (King and Duncan 2015, p. 20). Entrapment of foxes may occur in areas where development projects are ongoing. Examples include: Two foxes falling into a power line pole construction pit (CIC 2009, http://www.catalinaconservancy.org); one fox drowning due to entanglement in a food container (Vickers 2012a p. 2); one death from being trapped in a recycling barrel (Vickers 2012b, p. 1); and two deaths in 2014 from drowning in water or sediment containers (King and Duncan 2015, p. 18). Types of human-caused harm other than vehicle strikes and domestic dog attacks in urbanized areas are varied, but they do not have a population-level impact at this time or in the future.

    Fire

    On the northern Channel Islands, the frequency and intensity of wildland fire is less than on the adjacent mainland, because there are fewer ignition sources on the islands, and the typical maritime fog moisture inhibits fire spread. Natural lightning-strike fires are extremely rare; only three fires between 1836-1986 on the Channel Islands were started by lightning (Carroll et al. 1993, p. 77). On the northern Channel Islands, there are far fewer human-started fires than on the mainland or on Santa Catalina Island, as there are no permanent human occupants on the northern Channel Islands.

    Sediment cores indicate that fire on Santa Rosa and Santa Cruz Islands increased in frequency during the past 5,000 years and peaked during the historic period (200 years ago), though frequency and intensity are still far less than on the adjacent mainland (Anderson et al. 2010, p. 792). Because of this, island foxes on the northern Channel Islands have experienced very few large wildland fire events. The recent removal of grazers may increase fuel loads and thus the likelihood of larger fires, though cool and foggy conditions will continue to limit wildland fire spread. Additionally, the NPS adheres to a policy of total suppression on the Channel Islands, due to resource concerns (Kirkpatrick 2006, entire), reducing the chance that wildland fires will become large.

    Though not identified as a threat at the time of listing, Santa Catalina Island regularly experiences wildfires (CIC 2011) that could reduce food availability, alter the habitat, or directly result in the loss of individual foxes (USFWS 2004, p. 10347). The most devastating wildfire on record was the Island Fire ignited on May 10, 2007, which burned 4,760 ac (1,926 ha) (CIC 2011). The second largest fire in recent history (1999-2011) was the Empire Fire, which was started by lightning on July 22, 2006, and burned 1,063 ac (430 ha). Duncan and King's (2009, p. 384) findings indicate fire seasonality has an influence on fox survival; fires that occur when pups are young and most dependent on adults for mobility are most damaging, but in general, neither the Island Fire nor the Empire Fire seemed to have significant effects at the population level (Duncan and King 2009, p. 384).

    In summary, wildfires are infrequent on the northern Channel Islands and more frequent on Santa Catalina Island. On all islands, while wildfire can result in mortality of individuals, especially juveniles, depending on when the fires occur, wildfire does not pose a significant population-level impact to the island fox at this time nor do we anticipate it posing a significant population-level impact in the future.

    Drought

    The Channel Islands, as well as the rest of the State of California, are currently in the midst of a drought that began in 2012 and, as of mid-January 2016, has not abated (State of California 2016, http://ca.gov/drought/ accessed January 19, 2016). Island foxes have endured many droughts during their 10,000-year persistence on the islands (California Department of Water Resources 2015, http://www.water.ca.gov/waterconditions/droughtinfo.cfm). Deep multi-year droughts have occurred on the Channel Islands about once every 2 decades since 1900 (T. Coonan, NPS, unpubl. data). General drought conditions in the late 1920s and early 1930s combined with overgrazing denuded most vegetation, particularly on San Miguel Island, creating massive sand barrens, remnants of which are still evident today (Johnson 1980, entire). Even so, island foxes survived this period of soil erosion and episodic landscape stripping.

    The current period of intensive island fox monitoring and research began in 1993, after a 6-year drought concluded. The current drought is the first opportunity to study the effect of drought on island foxes, where foxes have recovered to historic numbers. On San Miguel Island, average adult weights declined in 2013 and 2014, to the lowest ever recorded, and fox reproduction was negligible in 2013 and 2014 (Coonan et al. 2014, p. 28; T. Coonan, NPS, unpubl. data). During this time, mortality also increased, and many fox carcasses were emaciated (Coonan et al. 2014, pp. 6-7). On Santa Catalina Island, it appears that decreasing precipitation may result in a reproductive decline; however adults' weights were not similarly affected during this time (King and Duncan 2015, pp. 21-22). These effects were not seen on neighboring Santa Rosa Island, where foxes are not yet at carrying capacity or pre-decline levels. Fox weights increased on Santa Rosa Island in the drought years, reproduction was higher, and foxes had higher body condition scores than on San Miguel Island. It is apparent that one response of island foxes to drought is to curtail reproduction, especially if the population is at carrying capacity (Coonan 2015, pp. 6, 8, 13; Coonan et al. 2010, p. 28). Given the past demonstrated ability of island foxes to survive pervasive drought, current healthy population numbers and apparent ability to respond to drought by shifting resource allocation, we do not consider drought to be a threat to island foxes at this time or in the future.

    Global Climate Change

    Our analyses under the Act include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). The term “climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements (IPCC 2013a, p. 1450). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate (for example, temperature or precipitation) that persists for an extended period, whether the change is due to natural variability or human activity (IPCC 2013a, p. 1450).

    Scientific measurements spanning several decades demonstrate that changes in climate are occurring, and that the rate of change has increased since the 1950s. Examples include warming of the global climate system, and substantial increases in precipitation in some regions of the world and decreases in other regions (for these and other examples, see Solomon et al. 2007, pp. 35-54, 82-85; IPCC 2013b, pp. 3-29; IPCC 2014, pp. 1-32). Results of scientific analyses presented by the IPCC show that most of the observed increase in global average temperature since the mid-20th century cannot be explained by natural variability in climate and is “very likely” (defined by the IPCC as 90 percent or higher probability) due to the observed increase in greenhouse gas (GHG) concentrations in the atmosphere as a result of human activities, particularly carbon dioxide emissions from use of fossil fuels (Solomon et al. 2007, pp. 21-35; IPCC 2013b, pp. 11-12 and figures SPM.4 and SPM.5). Further confirmation of the role of GHGs comes from analyses by Huber and Knutti (2011, p. 4), who concluded it is extremely likely that approximately 75 percent of global warming since 1950 has been caused by human activities.

    Scientists use a variety of climate models, which include consideration of natural processes and variability, as well as various scenarios of potential levels and timing of GHG emissions, to evaluate the causes of changes already observed and to project future changes in temperature and other climate conditions (Meehl et al. 2007, entire; Ganguly et al. 2009, pp. 11555, 15558; Prinn et al. 2011, pp. 527, 529). All combinations of models and emissions scenarios yield very similar projections of increases in the most common measure of climate change, average global surface temperature (commonly known as global warming), until about 2030. Although projections of the magnitude and rate of warming differ after about 2030, the overall trajectory of all the projections is one of increasing global warming through the end of this century, even for the projections based on scenarios that assume that GHG emissions will stabilize or decline. Thus, there is strong scientific support for projections that warming will continue through the 21st century, and that the magnitude and rate of change will be influenced substantially by the extent of GHG emissions (Meehl et al. 2007, pp. 760-764, 797-811; Ganguly et al. 2009, pp. 15555-15558; Prinn et al. 2011, pp. 527, 529; IPCC 2013b, pp. 19-23). See IPCC 2013b (entire), for a summary of other global projections of climate-related changes, such as frequency of heat waves and changes in precipitation.

    Various changes in climate may have direct or indirect effects on species. These effects may be positive, neutral, or negative, and they may change over time, depending on the species and other relevant considerations, such as threats in combination and interactions of climate with other variables (for example, habitat fragmentation) (IPCC 2014, pp. 4-11). Identifying likely effects often involves aspects of climate change vulnerability analysis. Vulnerability refers to the degree to which a species (or system) is susceptible to, and unable to cope with, adverse effects of climate change, including climate variability and extremes. Vulnerability is a function of the type, magnitude, and rate of climate change and variation to which a species is exposed, its sensitivity, and its adaptive capacity (Glick et al. 2011, pp. 19-22; IPCC 2014, p. 5). There is no single method for conducting such analyses that applies to all situations (Glick et al. 2011, p. 3). We use our expert judgment and appropriate analytical approaches to weigh relevant information, including uncertainty, in our consideration of the best scientific information available regarding various aspects of climate change.

    Probably the most potentially vulnerable aspect of island fox biology to climate change is indirect effects from affected invertebrates that are parasites and disease vectors. Invertebrates, because they are exothermic (cold-blooded), are particularly responsive to the effects of a warming climate that typically speeds development and enhances survival. For disease vectors such as mosquitos, survival may occur where it was previously too cold during the coolest nights of the year for overwintering. Invertebrates are also particularly well-suited to adapt to a changing climate because they have short generation times and a high reproductive output (Parmesan 2006, pp. 654-656). The warming climate typically has resulted in increased abundance and expanded ranges of parasites such as nematodes and ticks, as well as diseases they transmit (Parmesan 2006, pp. 650-651; Studer et al. 2010, p. 11). Climate change also produces ecological perturbations that result in altered parasite transmission dynamics, increasing the potential for host switching (Brooks and Hoberg 2007, p. 571). Moller's (2010, p. 1158) analysis of parasites on avian hosts over a 37-year period suggests climate change predictions for parasite effects should be made with caution, but that climate can alter the composition of the parasite community and may cause changes in the virulence of parasites (Moller 2010, p. 1158). Therefore, climate change may change and could potentially increase the parasites and disease vectors to which island foxes are exposed.

    Considering that island foxes are opportunistic feeders, and climate warming could increase the subspecies' insect prey base abundance, it is possible climate change could positively affect food quantity and quality. Increased consumption of insect species by mice associated with a warmer, drier climate on South African islands has been documented (Chown and Smith 1993, pp. 508-509). Because island foxes have shown relative plasticity with regard to utilizing nonnative species (Cypher et al. 2011, p. 13), most invasions of nonnative potential prey species are not likely to negatively affect island fox food resources. The only potential negative effect of climate change on the insect prey base of island foxes would be if increased storm intensity and frequency reduced prey abundance, as Roemer (1999, p. 187) hypothesized occurred on Santa Cruz Island in the mid-1990s.

    Global climate change has the potential to negatively and positively affect island fox populations. There is still uncertainty associated with predictions relative to the timing, location, and magnitude of future climate changes. Probably the most vulnerable aspect of island fox biology to climate change is indirect effects to the fox from affected invertebrates. Though difficult to quantify, change in global climate could impact island fox populations on each island and may pose a threat to this species that is not yet reflected in studied population dynamics. As with most endangered species, predicting likely future climate scenarios and understanding the complex effects of climate change are high priorities for island fox conservation planning. While we cannot accurately predict the effects of climate change on island fox subspecies because the foxes are generalists and exhibit plasticity with regards to prey and habitat use, we do not expect negative effects of such magnitude that would cause major declines. However, we anticipate ongoing monitoring and management will detect any significant changes in population health and allow for management responses, including possible relisting.

    Summary of Factor E

    In summary, during the period when the population was at its lowest, the four subspecies of Channel Island foxes were extremely vulnerable to extinction from stochastic events. The populations have now increased substantially and the likelihood of extinction has accordingly been reduced. The combined effects of interactions with feral cats and domestic dogs, motor vehicle collisions, mortality due to wildfire, and other human-caused mortalities result in the deaths of multiple individuals throughout Santa Catalina Island on an annual basis, but they do not constitute a combined threat to the relatively large population at this time nor do we anticipate that they will in the future. While we cannot accurately predict the effects of climate change on island fox subspecies because the foxes are generalists and exhibit plasticity with regards to prey and habitat use, we do not consider climate change to be a threat to island foxes now nor in the foreseeable future.

    Overall Summary of Factors Affecting Island Foxes

    At time of listing in 2004 (69 FR 10335; March 5, 2004), predation by golden eagles was the primary threat to San Miguel, Santa Rosa, and Santa Cruz Island foxes, and disease was the primary threat to the Santa Catalina Island fox. The threat of predation by golden eagles on the northern Channel Islands has been significantly reduced since the time of listing. This reduction in predation by golden eagles is in direct response to the extensive removal of golden eagles from the northern Channel Islands, golden eagle prey being removed successfully from Santa Rosa and Santa Cruz Islands, and the successful reintroduction of bald eagles.

    Potential disease outbreaks continue to pose a threat to Santa Catalina Island foxes due to relatively uncontrolled movement of vectors from the mainland that carry diseases the population may not be vaccinated against. The primary measures in place on all islands to reduce these threats are vaccination of a subset of the fox population for CDV and rabies, and monitoring of population sentinels to detect the start of another epidemic and respond appropriately to mitigate the outbreak. While disease is currently controlled on Santa Catalina Island, we do not have assurance that monitoring and management of Santa Catalina Island foxes necessary to detect and mitigate an epidemic in Santa Catalina Island foxes will continue into the future.

    During the period when the island fox populations were at their lowest, they were extremely vulnerable to extinction from stochastic events. Although there will always be some inherent risk of extinction due to stochastic events because each island fox subspecies is a single breeding population, the populations have now increased substantially, returning to historical population highs, and the threat of extinction from demographic stochasticity has accordingly been reduced.

    Mortality due to motor vehicle strikes, habitat loss, ear mite infection, ear canal cancer, feral cats, and domestic dogs results in loss of individuals, but these mortality factors are not considered independent threats to fox populations at this time because populations are relatively large. The impacts of climate change are hard to predict. Some effects to island fox populations could be negative while others could be positive. Predicting likely future climate scenarios and understanding the complex effects of climate change are high priorities for island fox conservation planning, but climate change is not considered to be a threat at this time.

    When mortality mechanisms or other stressors occur together, one may exacerbate the effects of another, causing effects not accounted for when stressors are analyzed individually. Synergistic or cumulative effects may be observed in a short amount of time or may not be noticeable for years into the future, and could affect the long-term viability of island fox population. For example, if a stressor hinders island fox survival and reproduction or affects the availability of habitat that supports island foxes, then the number of individuals the following year(s) will be reduced, increasing vulnerability to stochastic events like a disease epidemic or wildfire. While synergistic or cumulative effects may occur when mortality mechanisms or other stressors occur together, given the robust populations and ongoing management and monitoring, these effects do not pose a significant population-level impact to island foxes at this time nor do we anticipate that they will in the future.

    Finding

    We have assessed the best scientific and commercial information available regarding the past, present, and future threats faced by the San Miguel, Santa Rosa, Santa Cruz, and Santa Catalina Island foxes in this proposed rule. At the time of listing in 2004 (69 FR 10335; March 5, 2004), the Santa Catalina Island fox experienced a devastating CDV epidemic that resulted in an almost complete loss of the eastern subpopulation, which made up the majority of the island population. The precipitous decline of the northern Channel Island foxes (San Miguel, Santa Rosa, and Santa Cruz Island foxes) that led to their listing as endangered species was the result of depredation by golden eagles, facilitated by the presence of a nonnative, mammalian prey-base on the northern Channel Islands.

    The threat of disease to the Santa Catalina Island fox has been ameliorated through implementation of programs to provide vaccinations, ear mite treatments, and a sentinel monitoring program to aid in detection of and facilitate a response to an epidemic. However, we do not have assurances that this monitoring and management as prescribed in the epidemic response plan will continue into the future.

    As a result of concerted management efforts, golden eagle predation has been reduced to such a degree that it is no longer considered a threat to the northern island subspecies. Additional management efforts, including captive breeding and ongoing vaccinations for disease, have contributed to the substantial increase of all island fox populations. Although golden eagles will most likely continue to occasionally occur on the islands as transients, the removal of the nonnative prey-base and the constant presence of bald eagles are permanent, long-term deterrents to golden eagles establishing breeding territories and remaining on the northern Channel Islands. Ongoing management and monitoring are designed to detect any reemergence of threats and to take corrective actions should any threats be detected.

    Based on the information presented in this status review, the recovery criteria in the Recovery Plan have been achieved and the recovery objectives identified in the Recovery Plan have been met for the three northern Channel Island subspecies of island fox. San Miguel, Santa Rosa, and Santa Cruz Island fox abundance has increased steadily to the point where the number of individuals is again within the range of historical population estimates. Population viability analyses strongly indicate that the northern Channel Island foxes have an acceptably small risk of extinction and current population levels are consistent with long-term viability. Additionally, the primary threat (golden eagles) to northern Channel Island foxes has been controlled, and ongoing management and monitoring are in place to ensure that threats continue to be managed in the future. This information indicates that these three subspecies are no longer at immediate risk of extinction, nor are they likely to experience reemergence of threats and associated population declines in the future. We, therefore, conclude that the San Miguel, Santa Rosa, and Santa Cruz Island foxes are no longer in danger of extinction throughout all of their ranges, nor are they likely to become so in the foreseeable future.

    The Santa Catalina Island fox exhibits demographic characteristics consistent with long-term viability. The population has continued to increase over the past 11 years, reaching an estimated high of 1,852 individuals in 2013 (King and Duncan 2015, p. 11), then dropping slightly to 1,717 in 2014 (King and Duncan 2014, p. 11). Population viability analysis indicates the Santa Catalina Island fox population has an acceptably small risk of extinction—less than 5 percent since 2008. With population levels consistent with long-term viability, the intent of recovery objective 1 has been met for the Santa Catalina Island fox. However, objective 2 has not been met because we do not have assurance that the monitoring and management as prescribed in the epidemic response plan for Santa Catalina Island foxes will be funded and implemented in the future to ensure that the threat of disease continues to be managed. While population levels are currently consistent with long-term viability (indicating that the subspecies is no longer in danger of extinction in the immediate future), lack of adequate control of potential vectors along with lack of assured long-term monitoring could allow for lapses in management and monitoring and reemergence of disease that may cause epidemics and population declines before they can be detected and acted upon. We have coordinated with CIC to determine their ability to enter into an agreement to provide assurances of long-term implementation of the epidemic response plan. CIC indicated that they could not ensure availability of long-term funding at this time that would allow them to commit to long-term implementation of the epidemic response plan. Overall, we recognize that CIC's efforts have significantly contributed to a reduction of impacts to the Santa Catalina fox and its habitat on the island. As a result, we have determined that the Santa Catalina Island fox is no longer in danger of extinction throughout all of its range, but instead is threatened with becoming endangered in the foreseeable future throughout all of its range. We, therefore, propose a change in status for the Santa Catalina Island fox from an endangered species to a threatened species at this time. Because we have determined the Santa Catalina Island fox is likely to become an endangered species in the foreseeable future throughout all of its range, no portion of its range can be significant for purposes of the definitions of endangered species or threatened species (see 79 FR 37578; July 1, 2014) (also see Significant Portion of the Range Analysis, below).

    Significant Portion of the Range Analysis

    Having determined that the San Miguel, Santa Rosa, and Santa Cruz Island foxes are not in danger of extinction, or likely to become so, throughout all of their ranges, we next consider whether there are any significant portions of their ranges in which the island foxes are in danger of extinction or likely to become so. Under the Act and our implementing regulations, a species may warrant listing if it is an endangered species or a threatened species. The Act defines “endangered species” as any species which is “in danger of extinction throughout all or a significant portion of its range,” and “threatened species” as any species which is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The term “species” includes “any subspecies of fish or wildlife or plants, and any distinct population segment [DPS] of any species of vertebrate fish or wildlife which interbreeds when mature.” On July 1, 2014, we published a final policy interpreting the phrase “significant portion of its range” (SPR) (79 FR 37578). The final policy states that (1) if a species is found to be endangered or threatened throughout a significant portion of its range, the entire species is listed as an endangered species or a threatened species, respectively, and the Act's protections apply to all individuals of the species wherever found; (2) a portion of the range of a species is “significant” if the species is not currently endangered or threatened throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range; (3) the range of a species is considered to be the general geographical area within which that species can be found at the time USFWS or the National Marine Fisheries Service makes any particular status determination; and (4) if a vertebrate species is endangered or threatened throughout an SPR, and the population in that significant portion is a valid DPS, we will list the DPS rather than the entire taxonomic species or subspecies.

    The SPR policy is applied to all status determinations, including analyses for the purposes of making listing, delisting, and reclassification determinations. The procedure for analyzing whether any portion is an SPR is similar, regardless of the type of status determination we are making. The first step in our analysis of the status of a species is to determine its status throughout all of its range. If we determine that the species is in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range, we list the species as an endangered (or threatened) species and no SPR analysis will be required. Because we are proposing to list the Santa Catalina Island fox as a threatened species under the Act, we are not conducting an SPR analysis for this subspecies. If the species is neither endangered nor threatened throughout all of its range, we determine whether the species is endangered or threatened throughout a significant portion of its range. If it is, we list the species as an endangered species or a threatened species, respectively; if it is not, we conclude that the species is neither an endangered species nor a threatened species.

    When we conduct an SPR analysis, we first identify any portions of the species' range that warrant further consideration. The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose to analyzing portions of the range that are not reasonably likely to be significant and either endangered or threatened. To identify only those portions that warrant further consideration, we determine whether there is substantial information indicating that (1) the portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. We emphasize that answering these questions in the affirmative is not a determination that the species is endangered or threatened throughout a significant portion of its range—rather, it is a step in determining whether a more detailed analysis of the issue is required. In practice, a key part of this analysis is whether the threats are geographically concentrated in some way. If the threats to the species are affecting it uniformly throughout its range, no portion is likely to warrant further consideration. Moreover, if any concentration of threats apply only to portions of the range that clearly do not meet the biologically based definition of “significant” (i.e., the loss of that portion clearly would not be expected to increase the vulnerability to extinction of the entire species), those portions will not warrant further consideration.

    If we identify any portions that may be both (1) significant and (2) endangered or threatened, we engage in a more detailed analysis. As discussed above, to determine whether a portion of the range of a species is significant, we consider whether, under a hypothetical scenario, the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction or likely to become so in the foreseeable future throughout all of its range. This analysis considers the contribution of that portion to the viability of the species based on the conservation biology principles of redundancy, resiliency, and representation. (These concepts can similarly be expressed in terms of abundance, spatial distribution, productivity, and diversity.) The identification of an SPR does not create a presumption, prejudgment, or other determination as to whether the species in that identified SPR is in danger of extinction or likely to become so. We must go through a separate analysis to determine whether the species is in danger of extinction or likely to become so in the SPR. To determine whether a species is endangered or threatened throughout an SPR, we will use the same standards and methodology that we use to determine if a species is endangered or threatened throughout its range.

    Depending on the biology of the species, its range, and the threats it faces, it may be more efficient to address either the significance question first, or the status question first. Thus, if we determine that a portion of the range is not “significant,” we do not need to determine whether the species is endangered or threatened there; if we determine that the species is not endangered or threatened in a portion of its range, we do not need to determine if that portion is “significant.”

    Applying the process described above, we evaluated the respective ranges of the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox to determine if any area could be considered a significant portion of any one of the subspecies' range. As mentioned above, one way to identify portions for further analyses is to identify any natural divisions within the range that might be of individual biological or conservation importance to the species. We conducted our review based on examination of the Recovery Plan (USFWS 2015; entire) and other relevant and more recent information on the biology and life history of the northern Channel Island foxes. Because each of the three northern Channel Island fox subspecies is a narrow endemic where the foxes on each island constitute a single population, we determined that there are no natural divisions or separate areas of the range of each subspecies that contribute separately to the conservation of that particular subspecies. In other words, for each subspecies of island fox, there is only one biologically defined portion, and there are no separate portions that contribute incrementally to the conservation (i.e., to the redundancy, resiliency, and representation of the species). We also examined whether any portions might be endangered or threatened by examining whether threats might be geographically concentrated in some way. Although some of the factors we evaluated in the Summary of Factors Affecting the Species section, above, may continue to affect each of the subspecies, the factors affecting island foxes generally occur at similarly low levels throughout their ranges. The entire population of each subspecies is equally affected by threats and by the amelioration of such threats throughout their ranges. Based on our evaluation of the biology of the subspecies and current and potential threats to the island foxes, we conclude that no portion of the ranges of the three subspecies of the northern Channel Islands foxes warrants further consideration to determine if it is significant. In other words, threats have been sufficiently ameliorated, and all individuals and all portions of the range of each subspecies interact to such an extent that it is not reasonable to conclude that any portion of the range can have a different status than any other portion.

    In conclusion, we find that the San Miguel Island fox, Santa Rosa Island fox, and Santa Cruz Island fox are no longer in danger of extinction throughout all or a significant portion of their range, nor are they likely to become so in the foreseeable future. Therefore, at this time, the San Miguel, Santa Rosa, and Santa Cruz Island fox no longer meet the definitions of an endangered species or a threatened species under the Act, and we propose to remove these species from the List of Endangered and Threatened Wildlife under the Act.

    Effects of This Rulemaking

    If this proposed rule is made final, it would revise 50 CFR 17.11(h) to remove the San Miguel, Santa Rosa, and Santa Cruz Island foxes from the List of Endangered and Threatened Wildlife and would reclassify the Santa Catalina Island fox from an endangered species to a threatened species. The prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, would no longer apply to the San Miguel, Santa Rosa, or Santa Cruz Island foxes. Federal agencies would no longer be required to consult with the USFWS under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect the San Miguel Island fox, Santa Rosa Island fox, or Santa Cruz Island fox. As a result of their removal from the List of Endangered and Threatened Wildlife at 50 CFR 17.11(h), we would also remove the entries at 50 CFR 17.95(a) (Critical habitat—fish and wildlife) for the San Miguel, Santa Rosa, and Santa Cruz Island foxes; currently, each entry specifies that no areas meet the definition of critical habitat under section 3(5)(A) of the Act for the applicable subspecies. We would retain the entry at 50 CFR 17.95(a) for the Santa Catalina Island fox.

    Peer Review

    In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (50 FR 34270), we will seek the expert opinions of at least three appropriate and independent specialists regarding this proposed rule. The purpose of peer review is to ensure that decisions are based on scientifically sound data, assumptions, and analyses. A peer review panel will conduct an assessment of the proposed rule, and the specific assumptions and conclusions regarding the proposed delisting. This assessment will be completed during the public comment period.

    We will consider all comments and information we receive during the comment period on this proposed rule as we prepare the final determination. Accordingly, the final decision may differ from this proposal.

    Post-Delisting Monitoring

    Section 4(g)(1) of the Act requires us, in cooperation with the States, to implement a system to monitor effectively, for not less than 5 years, all species that have been recovered and delisted (50 CFR 17.11, 17.12). The purpose of this post-delisting monitoring is to verify that a species remains secure from risk of extinction after it has been removed from the protections of the Act. The monitoring is designed to detect the failure of any delisted species to sustain itself without the protective measures provided by the Act. If, at any time during the monitoring period, data indicate that protective status under the Act should be reinstated, we can initiate listing procedures, including, if appropriate, emergency listing under section 4(b)(7) of the Act. Section 4(g) of the Act explicitly requires us to cooperate with the States in development and implementation of post-delisting monitoring programs, but we remain responsible for compliance with section 4(g) and, therefore, must remain actively engaged in all phases of post-delisting monitoring. We also seek active participation of other entities that are expected to assume responsibilities for the species' conservation post-delisting.

    Post-Delisting Monitoring Overview

    If we make this proposed rule final, the post-delisting monitoring is designed to verify that northern Channel Island foxes (San Miguel, Santa Rosa, and Santa Cruz Island foxes) remain secure from risk of extinction after their removal from the Federal List of Endangered and Threatened Wildlife by detecting changes in population trend and mortality/survival. Post-delisting monitoring for the northern Channel Island fox subspecies would be conducted as recommended in the epidemic response plan for northern Channel Island foxes (Hudgens et al. 2013, entire) and golden eagle management strategy (NPS 2015a, entire). These documents are posted on http://ecos.fws.gov/speciesProfile/profile/speciesProfile.action?spcode=A08I, at http://www.regulations.gov under Docket No. FWS-R8-ES-2015-0170, and the Ventura Fish and Wildlife Office's Web site at http://www.fws.gov/Ventura/.

    Although the Act has a minimum post-delisting monitoring requirement of 5 years, the draft post-delisting monitoring plan for northern Channel Island foxes includes a 10-year monitoring period to account for environmental variability (for example, extended drought) that may affect fox populations and to document the range of population fluctuation as fox populations reach carrying capacity. If a decline in abundance is observed or a substantial new threat arises, post-delisting monitoring may be extended or modified as described below.

    Island foxes would be monitored for both population size and trend, and for annual survival and cause-specific mortality, as specified by the epidemic response plan for northern Channel island foxes (Hudgens et al. 2013, entire) and the golden eagle management strategy (NPS 2015a, entire). Monitoring as recommended in these plans is currently being implemented. Population size and trend are estimated using capture-mark-recapture data from trapping foxes on grids (Rubin et al. 2007, p. 2-1; Coonan et al. 2014, p. 2). Such monitoring has been implemented for island foxes since the late 1980s. The monitoring provides a continuous record of population fluctuation, including decline and recovery, upon which population viability analysis was used to develop island fox demographic recovery objectives (Bakker and Doak 2009, entire; Bakker et al. 2009, entire).

    Annual survival and cause-specific mortality of island foxes would be monitored, as it is now, via tracking of radio-collared foxes. Mortality checks would be conducted weekly on radio-collared foxes, and necropsies would be conducted on fox carcasses to determine the cause of mortality. A sample of at least 40 radio-collared foxes is maintained on each island, as that is the number of monitored foxes determined to be necessary to detect an annual predation rate of 2.5 percent (Rubin et al. 2007, p. 2-20). This level of radio-telemetry monitoring is part of the epidemic response plan and the golden eagle management strategy for island foxes on the northern Channel Islands (Hudgens et al. 2013, pp. 7-11).

    The USFWS, NPS, and TNC would annually review the results of monitoring, which would include annual estimated adult population size, annual adult survival, and identified causes of mortality. If there are apparent sharp declines in population size and/or survival or the appearance of significant mortality causes, the data would be reviewed by the Island Fox Conservation Working Group for evaluation and assessment of threat level. Monitoring results may also reach thresholds which precipitate increased monitoring or implementation of management actions, as specified in the epidemic response plan and golden eagle management strategy. At the end of the 10-year post-delisting monitoring period, USFWS, NPS, and TNC would determine whether monitoring should continue beyond the 10-year monitoring period.

    Required Determinations Clarity of the Proposed Rule

    We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

    (a) Be logically organized;

    (b) Use the active voice to address readers directly;

    (c) Use clear language rather than jargon;

    (d) Be divided into short sections and sentences; and

    (e) Use lists and tables wherever possible.

    If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the names of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

    National Environmental Policy Act

    We determined that we do not need to prepare an environmental assessment or an environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), in connection with regulations adopted pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    References Cited

    A complete list of all references cited in this proposed rule is available on the Internet at http://www.regulations.gov under Docket No. FWS-R8-ES-2015-0170, or upon request from the Field Supervisor, Ventura Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

    Author

    The primary author of this proposed rule is the Ventura Fish and Wildlife Office in Ventura, California, in coordination with the Pacific Southwest Regional Office in Sacramento California, and the Carlsbad Fish and Wildlife Office in Carlsbad, California.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Proposed Regulation Promulgation

    Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

    PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 1531-1544; 4201-4245, unless otherwise noted.

    2. Amend § 17.11(h), the List of Endangered and Threatened Wildlife, under MAMMALS, by: a. Removing the entries for “Fox, San Miguel Island”, “Fox, Santa Cruz Island”, and “Fox, Santa Rosa Island”; and b. Revising the entry for “Fox, Santa Catalina Island” to read as set forth below.
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Species Common name Scientific name Historic range Vertebrate
  • population where
  • endangered
  • or threatened
  • Status When listed Critical
  • habitat
  • Special rules
    Mammals *         *         *         *         *         *         * Fox, Santa Catalina Island Urocyon littoralis catalinae U.S.A. (CA) Entire T 742 17.95(a) NA *         *         *         *         *         *         *
    § 17.95 [Amended]
    3. Amend § 17.95(a) by removing the entries for “San Miguel Island Fox (Urocyon littoralis littoralis)”, “Santa Cruz Island Fox (Urocyon littoralis santacruzae)”, and “Santa Rosa Island Fox (Urocyon littoralis santarosae)”. Dated: January 29, 2016. Stephen Guertin, Acting Director, Fish and Wildlife Service.
    [FR Doc. 2016-02669 Filed 2-12-16; 8:45 am] BILLING CODE 4333-15-P
    81 30 Tuesday, February 16, 2016 Notices DEPARTMENT OF AGRICULTURE Foreign Agricultural Service Notice of Request for Approval of a New Information Collection AGENCY:

    Foreign Agricultural Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Foreign Agricultural Service to request approval for a new information collection for the USDA's Local and Regional Food Aid Procurement Program.

    DATES:

    Comments on this notice must be received by April 18, 2016.

    ADDRESSES:

    FAS invites interested persons to submit comments on this notice. Comments may be submitted by one of the following methods:

    Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment filed or attach a file for lengthier comments. Go to http://www/regulations.gov. Follow the on-line instructions at the site for submitting comments.

    Mail, including CD-ROMs, etc.: Send to Benjamin Muskovitz, U.S. Department of Agriculture, Foreign Agricultural Service, 1400 Independence Avenue SW., Room 4159, Mailstop 1034, Washington, DC 20250.

    Hand or courier delivered submittals: Deliver to Benjamin Muskovitz, U.S. Department of Agriculture, Foreign Agricultural Service, 1400 Independence Avenue SW., Room 4159, Mailstop 1034, Washington, DC 20250.

    Instructions: All items submitted by mail or electronic mail must include the agency name. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Benjamin Muskovitz, Director, Food Assistance Division, Foreign Agricultural Service, U.S. Department of Agriculture, Room 4159, Mailstop 1034, Washington, DC 20250-1034, telephone: (202) 720-4221, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: USDA Local and Regional Food Aid Procurement Program.

    OMB Number: 0551—New.

    Expiration Date of Approval: Three years from approval date.

    Type of Request: New information collection.

    Abstract: Under the USDA Local and Regional Food Aid Procurement Program, information will be gathered from applicants desiring to receive grants or enter into cooperative agreements under the program to determine the viability of requests for resources to implement activities in foreign countries. Recipients of grants or cooperative agreements under the program must submit performance and financial reports until funds provided by FAS and commodities purchased with such funds are utilized. Documents are used to develop effective grant or cooperative agreements and assure that statutory requirements and program objectives are met.

    Estimate of Burden: The public reporting burden for each respondent resulting from information collection under the USDA Local and Regional Food Aid Procurement Program varies in direct relation to the number and type of agreements entered into by such respondent. The estimated average reporting burden for USDA Local and Regional Food Aid Procurement Program is 78 hours per response.

    Type of Respondents: Private voluntary organizations, cooperatives, and intergovernmental organizations.

    Estimated Number of Respondents: 22 per annum.

    Estimated Number of Responses per Respondent: 17 per annum.

    Estimated Total Annual Burden of Respondents: 29,172 hours.

    Copies of this information collection can be obtained from Connie Ehrhart, the Agency Information Collection Coordinator, at (202) 690-1578 or email at [email protected]

    Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to the Director, Food Assistance Division, FAS, USDA, Room 4159, Mailstop 1034, Washington, DC 20250, or to [email protected] Comments may also be sent to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Washington, DC 20503.

    All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission for Office of Management and Budget approval.

    E-Government Act Compliance

    FAS is committed to complying with the E-Government Act of 2002, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

    Persons with disabilities who require an alternative means for communication of information (e.g., Braille, large print, audiotape, etc.) should contact USDA's Target Center at (202) 720-2600 (voice and TDD).

    Signed at Washington, DC, on February 9, 2016. Philip C. Karsting, Administrator, Foreign Agricultural Service.
    [FR Doc. 2016-03087 Filed 2-12-16; 8:45 am] BILLING CODE 3410-10-P
    DEPARTMENT OF AGRICULTURE Forest Service Mt. Hood National Forest; Oregon; Cooper Spur—Government Camp Land Exchange AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of intent to prepare an environmental impact statement.

    SUMMARY:

    The Mt. Hood National Forest will prepare an environmental impact statement to document and disclose the projected effects of a congressionally directed and conditioned land exchange. This land exchange includes the conveyance of approximately 110 acres of National Forest System lands adjacent to Government Camp in Clackamas County, Oregon, in exchange for the acquisition of approximately 765 acres of land owned by Mt. Hood Meadows Oreg., LLC, in Hood River County, Oregon.

    DATES:

    Comments concerning the scope of the analysis must be received by March 17, 2016. The draft environmental impact statement is expected November 2016 and the final environmental impact statement is expected January 2018.

    ADDRESSES:

    Send written comments to the Mt. Hood National Forest, 16400 Champion Way, Sandy, OR 97055. Comments may also be sent via email to [email protected], or via facsimile to (503) 668-1423.

    FOR FURTHER INFORMATION CONTACT:

    Michelle Lombardo, Forest Environmental Coordinator, Mt. Hood National Forest, at (503) 668-1796 or by email at [email protected]. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION: Purpose and Need for Action

    The purpose of the congressionally directed and conditioned land exchange between the Mt. Hood National Forest and the Mt. Hood Meadows Oregon, LLC, is to comply with and carry out the Omnibus Public Land Management Act of March 30, 2009 (123 Stat. 991, Pub. L. 111-11), which provides direction for this land exchange.

    Proposed Action

    The proposed action includes the conveyance of two parcels of National Forest System lands, totaling approximately 110 acres, in exchange for the acquisition of approximately 765 acres of land owned by Mt. Hood Meadows. The Federal land proposed for conveyance is located to the north of the Government Camp Loop Road in Government Camp, Oregon, in T3S, R8E, sections 13 & 24, and T3S, R8.5E, section 14 in Clackamas County. The land owned by Mt. Hood Meadows that is proposed for acquisition is located about one-half mile to the west of Highway 35 in the vicinity of the Cooper Spur Ski Area in T2S, R10E, sections 6 & 7, T1S, R10E, Sections 30 & 31, and T1S, R9E, Section 36 in Hood River County.

    The Omnibus Act (Section 1206(a)(2)(G)) prescribes as a condition to the land exchange that the Forest Service reserve wetland and trail easements on the Federal parcels to be exchanged. More specifically, the Omnibus Act requires the U.S. to reserve a conservation easement on the Federal land to protect existing wetland, as identified by the Oregon Department of State Lands, that allows equivalent wetland mitigation measures to compensate for minor wetland encroachments necessary for the orderly development of that land following the exchange. The Omnibus Act also requires the U.S. to reserve a trail easement on the Federal land that allows non-motorized use by the public of existing trails; roads, utilities, and infrastructure facilities to cross the trails; and improvement or relocation of the trails to accommodate development of the Federal land. The Omnibus Act also provides that, on completion of the land exchange, additional lands would be considered part of the Mt. Hood Wilderness and that the Crystal Springs Watershed Special Resource Management Unit would be created.

    The environmental impact statement to be prepared will also consider a proposed amendment to the the Mt. Hood National Forest Land and Resources Management Plan (1990), as amended by the Northwest Forest Plan (1994), that will be necessary to assign land use allocations to the acquired lands, change the land use allocations for the new Tilly Jane Wilderness Addition and the Crystal Springs Watershed Special Resource Management Unit, and add standards and guidelines for the Crystal Springs Watershed Special Resource Management Unit upon its creation.

    Possible Alternatives

    A bill, referred to as the “Mount Hood Cooper Spur Land Exchange Clarification Act,” has been introduced in the U.S. Congress that would amend the Omnibus Act to modify certain conditions of the land exchange as described in the proposed action. The proposed modifications set forth in the bill will be analyzed in the environmental impact statement as appropriate, depending upon future congressional developments regarding its status.

    Responsible Official

    The Responsible Official for this project is the Mt. Hood Forest Supervisor.

    Nature of Decision To Be Made

    The Responsible Official will decide whether to adopt and implement the proposed action, an alternative to the proposed action, or take no action. It should be noted that, in this context, this decision is necessarily informed and constrained by the Omnibus Act, which provides direction for the proposed action, and therefore, if the Responsible Official finds the congressionally-mandated conditions are satisfied, the Forest Service will execute the land exchange.

    Preliminary Issues

    A preliminary analysis of potential effects revealed the following preliminary issues:

    (1) Camp Creek and an intermittent tributary of Camp Creek run through the Federal parcels. Neither reach of the stream is fish-bearing. Camp Creek is not 303(d)-listed under the Clean Water Act, but it does have water quality issues associated with Government Camp (such as sewage and runoff from the roads). Depending on the type and quality of development that might occur on the parcels after the exchange, the water quality could further decrease. However, the impacts of development should be lessened by the congressionally-mandated conservation easement on the wetland, through which the streams flow. Detailed information is not available regarding fisheries or water quality on the non-Federal parcel.

    (2) Surveys for wetlands and floodplains on both parcels have been completed. Wetlands are present on the Federal parcels, and narrow, stream-associated wetlands exist on the non-Federal parcel. It appears that the Forest Service will be conveying more wetlands than would be acquired. In the Omnibus Act (Section 1206(a)(G)(i)), however, Congress mandated that a conservation easement be placed upon the wetlands at Government Camp. The Act directs that the easement protect the wetland and allow for equivalent wetland mitigation measures necessary for the orderly development of the conveyed land. The acquisition of the wetlands at Cooper Spur and the easement on the wetlands at Government Camp may therefore result in no net loss of wetlands.

    (3) A cultural and heritage resource survey was conducted on the Federal parcel. The survey revealed the potential for an adverse effect to a site of archaeological/cultural interest. Mitigation measures will be developed with Tribal and State Historic Preservation Officer (SHPO) consultation.

    (4) Trails 755, 755A, and 755B cross the Federal parcels. A trail easement has been congressionally mandated so that non-motorized users would continue to be able to use the trails to get to Federal land, so that roads, utilities, and infrastructure facilities could be built across the trails, and to allow for improvement or relocation of the trails so that development of the conveyed parcels could occur. While the trails (or relocated trails) would still exist, the recreation experience could be negatively impacted by new development (such as buildings and parking lots) or the presence of new infrastructure.

    Scoping Process

    This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly articulate the reviewer's concerns and contentions. Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered, however.

    Dated: February 9, 2016. Lisa A. Northrop, Mt. Hood Forest Supervisor.
    [FR Doc. 2016-03047 Filed 2-12-16; 8:45 am] BILLING CODE 3410-11-P
    DEPARTMENT OF AGRICULTURE Forest Service Eastern Washington Cascades Provincial Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Eastern Washington Cascades Provincial Advisory Committee (PAC) will meet in Wenatchee, Washington. The committee is authorized pursuant to the implementation of E-19 of the Record of Decision and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to provide advice and make recommendations to promote a better integration of forest management activities between Federal and non-Federal entities to ensure that such activities are complementary. PAC information can be found at the following Web site: http://www.fs.usda.gov/main/okawen/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held from 8:30 a.m. to 3:30 p.m. on Tuesday, March 22.

    All PAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Okanogan-Wenatchee National Forest headquarters office located at 215 Melody Lane, Wenatchee, Washington.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at 215 Melody Lane, Wenatchee, Washington. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Public Affairs Specialist Robin DeMario by phone at 509-664-9292 or via email at [email protected].

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is:

    1. To provide updates to advisory committee members on Forest Plan Revision, Travel Management Planning, Forest Restoration Strategy, review of the fires that occurred in 2015 on the Okanogan-Wenatchee National Forest, and Burned Area Emergency Response efforts.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by March 14, 2016 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Pubic Affairs Specialist Robin DeMario, 216 Melody Lane, Wenatchee, Washington, 98801; by email to [email protected], or via facsimile to 509-664-9286.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: February 9, 2016. Jason Kuiken, Deputy Forest Supervisor, Okanogan-Wenatchee National Forest.
    [FR Doc. 2016-03042 Filed 2-12-16; 8:45 am] BILLING CODE 3411-15-P
    CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Sunshine Act Meeting TIME AND DATE:

    February 23, 2016, 1:00 p.m. EST

    PLACE:

    U.S. Chemical Safety Board, 1750 Pennsylvania Ave. NW., Suite 910, Washington, DC 20006.

    STATUS:

    Open to the public.

    Matters To Be Considered

    The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on February 23, 2016, starting at 1:00 p.m. EST in Washington, DC at the CSB offices located at 1750 Pennsylvania Avenue NW., Suite 910. The Board will discuss the status of open investigations, advocacy related to the State of California's Process Safety Management (PSM) reforms, on the status of audits from the Office of the Inspector General, financial and organizational updates, and a review of the agency's action plan. An opportunity for public comment will be provided.

    Additional Information

    The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the “Contact Person for Further Information,” at least three business days prior to the meeting.

    A conference call line will be provided for those who cannot attend in person. Please use the following dial-in number to join the conference: 1-(888) 466-9863, passcode 6069134#.

    The CSB is an independent federal agency charged with investigating accidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.

    Public Comment

    The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their presentations will be limited to three minutes or less, but commenters may submit written statements for the record.

    Contact Person for Further Information

    Hillary Cohen, Communications Manager, at [email protected] or (202) 446-8094. Further information about this public meeting can be found on the CSB Web site at: www.csb.gov.

    Dated: February 11, 2016. Kara Wenzel, Acting General Counsel, Chemical Safety and Hazard Investigation Board.
    [FR Doc. 2016-03257 Filed 2-11-16; 4:15 pm] BILLING CODE 6350-01-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-6-2016] Foreign-Trade Zone 116—Port Arthur, Texas; Expansion of Subzone 116C; Premcor Refining Group Inc.; Jefferson County, Texas

    An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Foreign-Trade Zone of Southeast Texas, Inc., grantee of FTZ 116, requesting an expansion of Subzone 116C on behalf of Premcor Refining Group Inc. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on February 9, 2016.

    Subzone 116C was approved on October 7, 1996 (Board Order 848, 61 FR 54153-54154, October 17, 1996). The subzone (4,016 acres) currently consists of four sites located in Jefferson County: Site 1 (3,581 acres)—main refinery complex located at 1801 S. Gulfway Drive, 3 miles southwest of Port Arthur; Site 2 (101 acres)—Lucas/Beaumont Terminal Storage facility located at 9405 West Port Arthur Road, 15 miles northwest of the refinery; Site 3 (243 acres)—Fannett LPG storage terminal located at 16151 Craigen Road, near Fannett, some 2 miles west of the refinery; and, Site 4 (91 acres)—Port Arthur Products storage facility located at 1825 H.O. Mills Road, 4 miles northwest of the refinery.

    The applicant is requesting authority to expand the subzone to include an additional site: Proposed Site 5 (108.2 acres)—2500 Martin Luther King Jr. Drive (Highway 82), Port Arthur. The proposed site would include a 2.7 mile pipeline that links the dock to the main refinery complex (Site 1). No additional authorization for production activity has been requested at this time.

    In accordance with the FTZ Board's regulations, Camille Evans of the FTZ Staff is designated examiner to review the application and make recommendations to the FTZ Board.

    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is March 28, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to April 11, 2016.

    A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Camille Evans at [email protected] or (202) 482-2350.

    Dated: February 10, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-03072 Filed 2-12-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-037] Certain Biaxial Integral Geogrid Products From the People's Republic of China: Initiation of Countervailing Duty Investigation AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Effective date: February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Kabir Archuletta, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202.482.2593.

    SUPPLEMENTARY INFORMATION: The Petition

    On January 13, 2016, the Department of Commerce (the “Department”) received a countervailing duty (“CVD”) petition concerning imports of certain biaxial integral geogrid products (“geogrids”) from the People's Republic of China (“PRC”), filed in proper form by Tensar Corporation (“Petitioner”), a domestic producer of geogrids. The CVD petition was accompanied by an antidumping duty (“AD”) petition concerning imports of geogrids from the PRC.1 On January 15, and January 21, 2016, the Department issued additional requests for information and clarification of certain areas of the Petition. Based on the Department's requests, Petitioner timely filed additional information pertaining to the Petition on January 20, and 27, 2016.2

    1See the Petitions for the Imposition of Antidumping Duties and Countervailing Duties: Certain Biaxial Integral Geogrid Products from the People's Republic of China, dated January 13, 2016 (“the Petition”).

    2See Petitioner's January 20 and 27, 2016, responses.

    In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the “Act”), Petitioner alleges that producers/exporters of geogrids in the PRC received countervailable subsidies within the meaning of sections 701 and 771(5) of the Act, and that imports from these producers/exporters materially injure, or threaten material injury to, an industry in the United States.

    The Department finds that Petitioner filed this Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act, and Petitioner has demonstrated sufficient industry support with respect to the CVD investigation that it is requesting the Department to initiate.3

    3See “Determination of Industry Support for the Petition” below.

    Furthermore, the Department has exercised its discretion to toll deadlines as a result of the closure of the Federal Government during Snowstorm “Jonas.” 4 Therefore, the initiation date for this investigation has been tolled by 4 business days.

    4See Memorandum for the Record from Ron Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, “Tolling of Administrative Deadlines as a Result of the Government Closure during Snowstorm `Jonas,' ” (January 27, 2016).

    Period of Investigation

    The period of investigation (“POI”) is calendar year 2015, in accordance with 19 CFR 351.204(b)(2).

    Scope of the Investigation

    The product covered by this investigation is geogrids from the PRC. For a full description of the scope of the investigation, see the “Scope of the Investigation” at the Appendix of this notice.

    Comments on the Scope of the Investigation

    During our review of the Petition, we solicited information from Petitioner to ensure that the proposed scope language is an accurate reflection of the products for which the domestic industry is seeking relief. Moreover, as discussed in the preamble to the Department's regulations,5 we are setting aside a period for interested parties to raise issues regarding product coverage. If scope comments include factual information,6 all such factual information should be limited to public information. The Department encourages all interested parties to submit such comments by 5:00 p.m. Eastern Time (“ET”) on February 29, 2016, which is 20 calendar days from the signature date of this notice.7 Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on March 10, 2016, which is 10 calendar days after the initial comments.

    5See Antidumping Duties; Countervailing Duties; Final Rule, 62 FR 27296, 27323 (May 19, 1997).

    6See 19 CFR 351.102(b)(21).

    7 The 20th day falls on February 28, 2016. As this is a Sunday, we are applying our Next Business Day Rule. See Notice of Clarification: Application of “Next Business Day” Rule for Administrative Determination Deadlines Pursuant to the Tariff Act of 1930, As Amended, 70 FR24533 (May 10, 2005).

    The Department requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments must be filed on the record of the concurrent AD investigation.

    Filing Requirements

    All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by the time and date set by the Department. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, and stamped with the date and time of receipt by the deadline established by the Department.

    Consultations

    Pursuant to section 702(b)(4)(A)(i) of the Act, the Department notified representatives of the Government of China (GOC) of the receipt of the Petition. Also, in accordance with section 702(b)(4)(A)(ii) of the Act, the Department provided representatives of the GOC the opportunity for consultations with respect to the CVD petition. The GOC did not accept our invitation to hold consultations before the initiation.8

    8See Letter to Liu Fang, First Secretary, Embassy of the People's Republic of China, re: “Countervailing Duty Petition on Certain Biaxial Integral Geogrid Products from the People's Republic of China: Invitation for Consultations to Discuss the Countervailing Duty Petition,” dated January 14, 2016.

    Determination of Industry Support for the Petition

    Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

    Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (“ITC”), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,9 they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.10

    9See section 771(10) of the Act.

    10See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. v. United States, 688 F. Supp. 639, 644 (CIT 1988), aff'd 865 F.2d 240 (Fed. Cir. 1989)).

    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petition).

    With regard to the domestic like product, Petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that geogrids, as defined in the scope, constitute a single domestic like product and we have analyzed industry support in terms of that domestic like product.11

    11 For a discussion of the domestic like product analysis in this case, see Countervailing Duty Investigation Initiation Checklist: Certain Biaxial Integral Geogrid Products from the People's Republic of China (“PRC CVD Initiation Checklist”), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Certain Biaxial Integral Geogrid Products from the People's Republic of China (“Attachment II”). This checklist is dated concurrently with this notice and on file electronically via ACCESS. Access to documents filed via ACCESS is also available in the Central Records Unit, Room B8024 of the main Department of Commerce building.

    In determining whether Petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in Appendix I of this notice. To establish industry support, Petitioner provided its own production of the domestic like product in 2015.12 On February 1, 2016, we received a letter from the only other known U.S. producer of geogrids, Tenax Corporation (“Tenax”), stating that the company supports the Petition.13 Tenax also provided its own production of the domestic like product in 2015.14 Petitioner states that, based on reasonably available information regarding the U.S. geogrids industry, there are no other known producers of geogrids in the United States; therefore, the Petition is supported by 100 percent of the U.S. industry.15

    12See General Issues Supplement, at 13.

    13See Letter from Tenax Corporation, dated January 28, 2016. We note that, although this letter is dated January 28, 2016, it was filed after 5:00 p.m. on January 29, 2016 (via ACCESS); therefore, we consider it received on the next business day (February 1, 2016).

    14See Letter from Tenax Corporation, dated January 28, 2016.

    15See Volume I of the Petition, at 2-15 and Exhibits I-1 through I-4, I-6 through I-34, I-44, and I-52 through I-58; see also Letter from Tenax Corporation, dated February 1, 2016, at 1.

    Our review of the data provided in the Petition, General Issues Supplement, letters from Tenax, and other information readily available to the Department indicates that Petitioner has established industry support.16 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, the Department is not required to take further action in order to evaluate industry support (e.g., polling).17 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.18 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.19 Accordingly, the Department determines that the Petition was filed on behalf of the domestic industry within the meaning of section 702(b)(1) of the Act.

    16See PRC CVD Initiation Checklist, at Attachment II.

    17See section 702(c)(4)(D) of the Act; see also PRC CVD Initiation Checklist, at Attachment II.

    18See PRC CVD Initiation Checklist, at Attachment II.

    19Id.

    The Department finds that Petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the CVD investigation that it is requesting the Department initiate.20

    20Id.

    Injury Test

    Because the PRC is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from the PRC materially injure, or threaten material injury to, a U.S. industry.

    Allegations and Evidence of Material Injury and Causation

    Petitioner alleges that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, Petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.21

    21See Volume I of the Petition, at 34 and Exhibit I-4; see also General Issues Supplement, at 19.

    Petitioner contends that the industry's injured condition is illustrated by reduced market share; underselling and price suppression or depression; negative impact on the domestic industry's performance, including capacity utilization, shipments, and operating income; and lost sales and revenues.22 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, and causation, and we have determined that these allegations are properly supported by adequate evidence and meet the statutory requirements for initiation.23

    22See Volume I of the Petition, at 24-28, 32-45 and Exhibits I-4, I-35, I-39 through I-43, I-47, I-50, and I-51; see also General Issues Supplement, at 13-24 and Exhibits Supp. I-1 through I-5, I-10 through I-12, and I-43.

    23See PRC CVD Initiation Checklist, at Attachment III, Analysis of Allegations and Evidence of Material Injury and Causation for the Antidumping and Countervailing Duty Petitions Covering Certain Biaxial Integral Geogrid Products from the People's Republic of China.

    Initiation of Countervailing Duty Investigation

    Section 702(b)(1) of the Act requires the Department to initiate a CVD proceeding whenever an interested party files a CVD petition on behalf of an industry that: (1) Alleges the elements necessary for an imposition of a duty under section 701(a) of the Act; and (2) is accompanied by information reasonably available to the Petitioner supporting the allegations.

    The Department has examined the Petition on geogrids from the PRC and finds that it complies with the requirements of section 702(b)(1) of the Act. Therefore, in accordance with section 702(b)(1) of the Act, we are initiating a CVD investigation to determine whether producers/exporters of geogrids in the PRC receive countervailable subsidies. For a discussion of evidence supporting our initiation determination, see the CVD Initiation Checklist which accompanies this notice.

    Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation of 32 of the alleged programs, and part of two additional alleged programs. For six of the programs alleged by Petitioner, we have determined that the requirements for initiation have not been met. For a full discussion of the basis for our decision to initiate or not initiate on each program, see the CVD Initiation Checklist.

    Respondent Selection

    The Department normally selects respondents in a CVD investigation using CBP entry data. However, for this investigation, the HTSUS numbers the subject merchandise would enter under, 3926.90.9995, 3920.20.0050, and 3925.90.0000, are basket categories containing many products unrelated to geogrids, and much of the reported entry data do not contain quantity information. Therefore, we cannot rely on CBP entry data in selecting respondents. Instead, we intend to issue quantity and value (“Q&V”) questionnaires to each potential respondent, for which the Petitioner has provided a complete address,24 and base respondent selection on the responses received. In addition, the Department will post the Q&V questionnaire along with the filing instructions on the Enforcement and Compliance Web site (http://trade.gov/enforcement/news.asp). Exporters and producers that do not receive Q&V questionnaires via mail may still submit a Q&V response, and can obtain a copy from the Enforcement and Compliance Web site. The Q&V questionnaire must be submitted by all PRC exporters/producers no later than February 22, 2016.

    24See Volume I of the Petition at Exhibit I-37.

    All Q&V responses must be filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS, by 5 p.m. ET by the date noted above. We intend to make our decision regarding respondent selection within 20 days of publication of this Federal Register notice. Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on the Department's Web site at http://enforcement.trade.gov/apo.

    Distribution of Copies of the CVD Petition

    In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), we have provided a copy of the public version of the Petition to the representatives of the GOC. Because of the particularly large number of producers/exporters identified in the Petition, the Department considers the service of the public version of the petition to the foreign producers/exporters satisfied by the delivery of the public version to the GOC, consistent with 19 CFR 351.203(c)(2).

    ITC Notification

    We have notified the ITC of our initiation, as required by section 702(d) of the Act.

    Preliminary Determination by the ITC

    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of geogrids from the PRC materially injure, or threaten material injury to, a U.S. industry.25 A negative ITC determination will result in the investigation being terminated.26 Otherwise, the investigation will proceed according to statutory and regulatory time limits.

    25See section 703(a)(2) of the Act.

    26See section 703(a)(1) of the Act.

    Submission of Factual Information

    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)-(iv). The regulation requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Parties should review the regulations prior to submitting factual information in this investigation.

    Extension of Time Limits

    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301 expires. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Review Extension of Time Limits; Final Rule, 78 FR 57790 (September 20, 2013), available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in this investigation.

    Certification Requirements

    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.27 Parties are hereby reminded that the Department issued a final rule with respect to certification requirements, effective August 16, 2013, and that the revised certification requirements are in effect for company/government officials as well as their representatives. All segments of any AD or CVD proceedings initiated on or after August 16, 2013, including this investigation, should use the formats for the revised certifications provided at the end of the Certifications Final Rule. 28 The Department intends to reject factual submissions if the submitting party does not comply with the applicable revised certification requirements.

    27See section 782(b) of the Act.

    28See Certification of Factual Information To Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (“Certifications Final Rule”); see also the frequently asked questions regarding the Certifications Final Rule, available at the following: http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Notification to Interested Parties

    Interested parties must submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on the Department's Web site at http://enforcement.trade.gov/apo/index.html.

    This notice is issued and published pursuant to section 777(i) of the Act and 19 CFR 351.203(c).

    Dated: February 8, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix Scope of the Investigation

    The merchandise covered by the investigation is certain biaxial integral geogrid products. Biaxial integral geogrid products are a polymer grid or mesh material (whether or not finished, slit, cut-to-length, attached to woven or non-woven fabric or sheet material, or packaged) in which four-sided openings in the form of squares, rectangles, rhomboids, diamonds, or other four-sided figures predominate. The products covered have integral strands that have been stretched to induce molecular orientation into the material (as evidenced by the strands being thinner toward the middle between the junctions than at the junctions themselves) constituting the sides of the openings and integral junctions where the strands intersect. The scope includes products in which four-sided figures predominate whether or not they also contain additional strands intersecting the four-sided figures and whether or not the inside corners of the four-sided figures are rounded off or not sharp angles. As used herein, the term “integral” refers to strands and junctions that are homogenous with each other. The products covered have a tensile strength of greater than 5 kilonewtons per meter (“kN/m”) according to American Society for Testing and Materials (“ASTM”) Standard Test Method D6637/D6637M in any direction and average overall flexural stiffness of more than 100,000 milligram-centimeter according to the ASTM D7748/D7748M Standard Test Method for Flexural Rigidity of Geogrids, Geotextiles and Related Products, or other equivalent test method standards.

    Subject merchandise includes material matching the above description that has been finished, packaged, or otherwise further processed in a third country, including by trimming, slitting, coating, cutting, punching holes, stretching, attaching to woven or non-woven fabric or sheet material, or any other finishing, packaging, or other further processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the biaxial integral geogrid.

    The products subject to the scope are currently classified in the Harmonized Tariff Schedule of the United States (“HTSUS”) under the following subheading: 3926.90.9995. Subject merchandise may also enter under subheadings 3920.20.0050 and 3925.90.0000. The HTSUS subheadings set forth above are provided for convenience and U.S. Customs purposes only. The written description of the scope is dispositive.

    [FR Doc. 2016-03071 Filed 2-12-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-967; C-570-968] Aluminum Extrusions From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court Decision AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    On January 20, 2016, the United States Court of International Trade (CIT or Court) sustained the Department of Commerce's (Department) third and final results of redetermination,1 in which the Department determined, under protest, that certain refrigerator/freezer trim kits meet the description of excluded finished goods kits and are therefore not covered by the scope of the Orders, 2 pursuant to the CIT's remand order in Meridian LLC v. United States, Court No. 13-00018, Slip Op. 15-67 (CIT June 23, 2015) (Meridian IV).

    1See Meridian LLC v. United States, Court No. 13-00018, Slip Op. 16-5 (CIT January 20, 2016) (Meridian V), which sustained the Final Results of Redetermination Pursuant to Court Remand, Meridian Products, LLC v. United States, Court No. 13-00018, Slip. Op. 15-67 (Oct. 29, 2015) (Third Remand).

    2See Aluminum Extrusions from the People's Republic of China: Antidumping Duty Order, 76 FR 30650 (May 26, 2011) and Aluminum Extrusions from the People's Republic of China: Countervailing Duty Order, 76 FR 30653 (May 26, 2011) (Orders).

    Consistent with the decision of the United States Court of Appeals for the Federal Circuit (CAFC) in Timken, 3 as clarified by Diamond Sawblades, 4 the Department is notifying the public that the Court's final judgment in this case is not in harmony with the Department's Final Scope Ruling on Refrigerator Trim Kits and is therefore amending its final scope ruling.5

    3See Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (Timken).

    4See Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (Diamond Sawblades).

    5See Memorandum to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, “Final Scope Ruling on Certain Refrigerator/Freezer Trim Kits,” (December 17, 2012) (Final Scope Ruling on Refrigerator Trim Kits).

    DATES:

    Effective date: January 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    James Terpstra, AD/CVD Operations, Office III, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-3965.

    SUPPLEMENTARY INFORMATION:

    On December 17, 2012, the Department issued its Final Scope Ruling on Refrigerator Trim Kits in which it determined that the refrigerator/freezer trim kits imported by Meridian LLC (Meridian) did not meet the scope exclusions for “finished merchandise” and “finished goods kits.” 6 In particular, the Department held that because the trim kits at issue consisted of pieces of aluminum extrusions plus fasteners and extraneous materials, they did not meet either scope exclusion. Therefore, the Department found the products at issue to be within the scope of the Orders. 7

    6 The finished goods kit exclusion states: “A finished goods kits is understood to mean a packaged combination of parts that contains, at the time of importation, all of the necessary parts to fully assemble a final finished good and requires no further finishing or fabrication, such as cutting or punching, and is assembled `as is' into a finished product.” The scope further states that, “{a}n imported product will not be considered a `finished goods kit” and therefore excluded from the scope of the investigation merely by including fasteners such as screws, bolts, etc. in the packaging with an aluminum extrusion product.”

    7See Final Scope Ruling on Refrigerator Trim Kits at 11.

    As discussed in further detail in the Third Remand, the Court remanded the Final Scope Ruling on Refrigerator Trim Kits three times.8 Most recently, in Meridian IV, the Court held that the Department's long-standing recognition of a “fasteners” exception to the “finished goods kit” exclusion is unreasonable, finding that “the inclusion of `fasteners' or `extraneous materials' is not determinative when qualifying a kit consistent of multiple parts which otherwise meets the exclusionary requirements, as a `finished goods kit.' ” 9 Additionally, the Court explained that there is nothing in the scope language that indicates that the parts of a finished goods kit cannot consist entirely of aluminum extrusions.10 The Court explained that “to qualify as a `finished goods kit', a kit must contain every part required to assemble the final finished good, and it logically follows that if a kit is imported with all of the parts necessary to fully assemble the kit into its final finished form, then obviously (and necessarily) some of those `parts' may be fasteners.” 11

    8See Third Remand at 6-10.

    9See Meridian IV, Slip Op. 15-67 at 12-13.

    10Id.

    11Id. at 14 (emphasis omitted).

    In the Third Remand, the Department found, in accordance with the Court's instructions in Meridian IV, under respectful protest, that Meridian's trim kits are excluded from the scope of the Orders as finished goods kits because at the time of importation, the kits contained all the parts necessary to assemble a final finished good—a complete trim kit.12 In Meridian V, the Court sustained the Third Remand in its entirety.13

    12See Third Remand at 14.

    13See Meridian V, Slip Op. 16-5 at 4.

    Timken Notice

    In its decision in Timken14 as clarified by Diamond Sawblades, the CAFC has held that, pursuant to sections 516A(c) and (e) of the Tariff Act of 1930, as amended (the Act), the Department must publish a notice of a court decision that is not “in harmony” with a Department determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's January 20, 2016, judgment in Meridian V sustaining the Department's decision in the Third Remand to find that Meridian's trim kits are excluded from the scope of the Orders constitutes a final decision of that court that is not in harmony with the Department's Final Scope Ruling on Refrigerator Trim Kits. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, the Department will continue the suspension of liquidation of the trim kits at issue pending expiration of the period of appeal or, if appealed, pending a final and conclusive court decision.

    14See Timken, 893 F.2d at 341.

    In accordance with the Courts instructions in Meridian IV, we determine that Meridian's trim kits are excluded from the scope of the Orders as finished goods kits.

    Amended Final Determination

    Because there is now a final court decision with respect to the Final Scope Ruling on Refrigerator Trim Kits, the Department amends its final scope ruling. The Department finds that the scope of the Orders does not cover the products addressed in the Final Scope Ruling on Refrigerator Trim Kits. The Department will instruct U.S. Customs and Border Protection (CBP) that the cash deposit rate will be zero percent for the refrigerator/freezer trim kits imported by Meridian. In the event that the CIT's ruling is not appealed, or if appealed, upheld by the CAFC, the Department will instruct CBP to liquidate entries of Meridian's Refrigerator Trim Kits without regard to antidumping and/or countervailing duties, and to lift suspension of liquidation of such entries.

    This notice is issued and published in accordance with section 516A(c)(1) of the Act.

    Dated: February 8, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-02998 Filed 2-12-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-533-824] Polyethylene Terephthalate Film, Sheet, and Strip From India: Final Results of Antidumping Duty Administrative Review; 2013-2014 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    For the final results of the administrative review of the antidumping duty (AD) order on polyethylene terephthalate film, sheet, and strip (PET Film) from India, we find that Jindal Poly Films Limited (Jindal) and the four-non selected respondents made sales of subject merchandise at less than normal value; we also find that SRF Limited (SRF) did not make sales of subject merchandise at less than normal value. The period of review is July 1, 2013, through June 30, 2014.

    DATES:

    Effective date: February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Myrna Lobo or Alexander Cipolla, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2371 and (202) 482-4956, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On August 6, 2015, the Department of Commerce (the Department) published the Preliminary Results. 1 For a history of events that have occurred since the Preliminary Results, see the Issues and Decision Memorandum.2 The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Internet at http://trade.gov/login.aspx. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

    1See Polyethylene Terephthalate Film, Sheet, and Strip From India: Preliminary Results and Partial Rescission of Antidumping Duty Administrative Review; 2013-2014, 80 FR 46957 (August 6, 2015) (Preliminary Results).

    2See Department Memorandum, “Issues and Decision Memorandum for the Final Results of Antidumping Duty Administrative Review: Polyethylene Terephthalate Film From India; 2013-2014 Administrative Review” (Issues and Decision Memorandum), dated concurrently with, and hereby adopted by, this notice.

    As explained in the memorandum from the Acting Assistant Secretary for Enforcement & Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the final results of this review is now February 8, 2016.3

    3See Memorandum to the Record from Ron Lorentzen, Acting A/S for Enforcement & Compliance, regarding “Tolling of Administrative Deadlines as a Result of the Government Closure During Snowstorm Jonas,” dated January 27, 2016.

    Scope of the Order

    The products covered by the AD order are all gauges of raw, pretreated, or primed PET Film, whether extruded or coextruded. Excluded are metallized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer of more than 0.00001 inches thick. Imports of PET Film are currently classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under item number 3920.62.00.90. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the AD order is dispositive.

    Analysis of Comments Received

    All issues raised in the case briefs are addressed in the Issues and Decision Memorandum. A list of issues raised and to which we respond in the Issues and Decision Memorandum is attached to this notice as an Appendix.

    Changes Since the Preliminary Results

    Based on a review of the record and comments received from interested parties regarding our Preliminary Results, we have made changes to SRF's and Jindal's calculations.4 In addition, we have adjusted Jindal's reported U.S. prices to account for changes in its export subsidies in the final results of the companion countervailing duty administrative review.5

    4See Memoranda to Thomas Gilgunn, Program Manager “Analysis Memorandum for the Final Results of the Antidumping Duty Administrative Review of Polyethylene Terephthalate Film, Sheet, and Strip from India: Jindal Poly Films Limited, and “Analysis Memorandum for the Final Results of the Antidumping Duty Administrative Review of Polyethylene Terephthalate Film, Sheet, and Strip from India: SRF Limited,” both dated concurrently with these final results.

    5See Polyethylene Terephthalate Film, Sheet, and Strip From India: Preliminary Results and Partial Rescission of Countervailing Duty Administrative Review; 2013, 80 FR 46956 (August 3, 2015). See also Polyethylene Terephthalate Film, Sheet, and Strip from India: Final Results of Countervailing Duty Administrative Review; 2013 (signed February 2, 2016).

    Additionally, for companies not selected for individual review, we have assigned the rate calculated for Jindal in the final results of this review, in accordance with section 735(c)(5) of the Act.

    Final Results of Review

    As a result of our review, we determine the following weighted-average dumping margins exist for the period July 1, 2013, through June 30, 2014.

    6 The Initiation Notice lists the company as Jindal Poly Films Limited of India.

    Producer or exporter Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Jindal Poly Films Limited 6 0.59 SRF Limited 0.00 Ester Industries Limited 0.59 Garware Polyester Ltd 0.59 Polyplex Corporation Limited 0.59 Vacmet 0.59
    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1), the Department determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise, in accordance with the final results of this review. The Department will issue assessment instructions to CBP 15 days after the date of publication of the final results of review. We will instruct CBP to liquidate entries of merchandise produced and/or exported by the aforementioned companies. The Department will calculate importer-specific assessment rates for Jindal. Where the respondent reported the entered value for its sales, the Department calculates importer-specific ad valorem assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of those same sales.7 However, where the respondent did not report the entered value for its sales, the Department calculates importer-specific per-unit duty assessment rates. We will instruct CBP to apply an ad valorem assessment rate as indicated above to all entries of subject merchandise during the POR which were produced and/or exported by the four non-selected companies Ester Industries Limited, Garware Polyester Ltd, Polyplex Corporation Limited, and Vacmet. Pursuant to 19 CFR 351.106(c)(2), we will instruct CBP to liquidate without regard to antidumping duties any entries produced and/or exported by SRF during the POR.8

    7See 19 CFR 351.212(b).

    8See 19 CFR 351.106(c)(1).

    Cash Deposit Requirements

    The following deposit requirements will be effective for all shipments of PET Film from India entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided for by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the company under review will be equal to the weighted-average dumping margin established in the final results of this review (except, if the rate is de minimis, i.e., less than 0.5 percent, then the cash deposit rate will be zero); (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published in the completed segment for the most recent period for that company; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the manufacturer is, the cash deposit rate will be the rate established in the completed segment for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any other completed segment of this proceeding, then the cash deposit rate will be the all others rate for this proceeding, 5.71 percent. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    Notifications to Interested Parties

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

    The Department is issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: February 8, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I. Summary II. Background Scope of the Order III. Discussion of the Issues Comment 1: Whether To Exclude Certain Sales From the Margin Calculation Comment 2: Whether To Grant a Quantity Discount Adjustment to Jindal Comment 3: G&A Expense and Interest Expense Ratio Comment 4: Differential Pricing
    [FR Doc. 2016-03083 Filed 2-12-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-001] Potassium Permanganate From the People's Republic of China: Preliminary Results of the 2014 Antidumping Duty Administrative Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    In response to a request by Pacific Accelerator Limited (“PAL”), the Department of Commerce (the “Department”) is conducting an administrative review of the antidumping duty (“AD”) order on potassium permanganate from the People's Republic of China (the “PRC”) for the period of review (“POR”) January 1, 2014, through December 31, 2014.1 The Department preliminarily determines that PAL sold subject merchandise in the United States at prices below normal value (“NV”) during the POR. If these preliminary results are adopted in the final results, the Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries of subject merchandise during the POR. Interested parties are invited to comment on these preliminary results.

    1See Antidumping Duty Order: Potassium Permanganate from the People's Republic of China, 49 FR 3897 (January 31, 1984).

    DATES:

    Effective February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Paul Walker or Javier Barrientos, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone 202-482-0413 or 202-482-2243, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On March 2, 2015, the Department initiated an administrative review of the antidumping order on potassium permanganate from the PRC.2 Between April and September 2015, the Department sent AD questionnaires and supplemental questionnaires to PAL, to which it responded in a timely manner. On October 5, 2015, the Department partially extended the deadline for issuing the preliminary results until November 2, 2015.3 On October 27, 2015, the Department fully extended the deadline for issuing the preliminary results until February 1, 2016.4 As explained in the memorandum from the Acting Assistant Secretary for Enforcement and Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the preliminary results of this administrative review is now February 5, 2016.5

    2See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 11166 (March 2, 2015) (“Initiation Notice”).

    3See Memorandum to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, “Potassium Permanganate from the People's Republic of China: Extension of Deadline for Preliminary Results of 2014 Antidumping Duty Administrative Review,” dated October 5, 2015.

    4See Memorandum to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, “Potassium Permanganate from the People's Republic of China: Extension of Deadline for Preliminary Results of 2014 Antidumping Duty Administrative Review,” dated October 27, 2015.

    5See Memorandum to the Record from Ron Lorentzen, Acting A/S for Enforcement & Compliance, regarding “Tolling of Administrative Deadlines As a Result of the Government Closure During Snowstorm Jonas,” dated January 27, 2016.

    Scope of the Order

    Imports covered by the order are shipments of potassium permanganate, an inorganic chemical produced in free-flowing, technical, and pharmaceutical grades. Potassium permanganate is currently classifiable under item 2841.61.00 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS item number is provided for convenience and customs purposes, the written description of the merchandise remains dispositive.

    Methodology

    The Department conducted this review in accordance with sections 751(a)(1)(B) and 751(a)(2)(A) of the Tariff Act of 1930, as amended (the “Act”). Export prices have been calculated in accordance with section 772 of the Act. Because the PRC is a non-market economy (“NME”) within the meaning of section 771(18) of the Act, NV has been calculated in accordance with section 773(c) of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement aCnd Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    PRC-Wide Entity

    The Department's change in policy regarding conditional review of the PRC-wide entity applies to this administrative review.6 Under this policy, the PRC-wide entity will not be under review unless a party specifically requests, or the Department self-initiates, a review of the entity. Because no party requested a review of the PRC-wide entity in this review, the entity is not under review and the entity's rate (i.e., 128.94 percent) is not subject to change.

    6See Antidumping Proceedings: Announcement of Change in Department Practice for Respondent Selection in Antidumping Duty Proceedings and Conditional Review of the Nonmarket Economy Entity in NME Antidumping Duty Proceedings, 78 FR 65963 (November 4, 2013).

    Preliminary Results of Review

    The Department preliminarily determines that the following weighted-average dumping margins exist for the period January 1, 2014, through December 31, 2014:

    Exporter Weighted-
  • average
  • margin
  • (USD/
  • kilogram)
  • Pacific Accelerator Limited 2.20
    Disclosure, Public Comment and Opportunity To Request a Hearing

    The Department will disclose the calculations used in our analysis to parties in this review within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).

    Interested parties may submit case briefs within 30 days after the date of publication of these preliminary results of review in the Federal Register.7 Rebuttals to case briefs, which must be limited to issues raised in the case briefs, must be filed within five days after the time limit for filing case briefs.8 Parties who submit arguments are requested to submit with the argument (a) a statement of the issue, (b) a brief summary of the argument, and (c) a table of authorities.9 Parties submitting briefs should do so pursuant to the Department's electronic filing system, ACCESS.

    7See 19 CFR 351.309(c)(1)(ii).

    8See 19 CFR 351.309(d)(1)-(2).

    9See 19 CFR 351.309(c)(2), (d)(2).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a date and time to be determined. See 19 CFR 351.310(d). Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.

    The Department intends to issue the final results of this administrative review, which will include the results of our analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results in the Federal Register, pursuant to section 751(a)(3)(A) of the Act.

    Assessment Rates

    Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.10 The Department intends to issue assessment instructions to CBP 15 days after the publication date of the final results of this review.

    10See 19 CFR 351.212(b).

    For any individually examined respondent whose weighted average dumping margin is above de minimis (i.e., 0.50 percent) in the final results of this review, the Department will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of sales, in accordance with 19 CFR 351.212(b)(1). Where an importer- (or customer-) specific ad valorem rate is greater than de minimis, the Department will instruct CBP to collect the appropriate duties at the time of liquidation.11 Where either a respondent's weighted average dumping margin is zero or de minimis, or an importer- (or customer-) specific ad valorem is zero or de minimis, the Department will instruct CBP to liquidate appropriate entries without regard to antidumping duties.12

    11See 19 CFR 351.212(b)(1).

    12See 19 CFR 351.106(c)(2).

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by sections 751(a)(2)(C) of the Act: (1) For the companies listed above that have a separate rate, the cash deposit rate will be that established in the final results of this review (except, if the rate is zero or de minimis, then zero cash deposit will be required); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific rate; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be that for the PRC-wide entity; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during the POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    These preliminary results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: February 8, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum 1. Summary 2. Case History 3. Scope of the Order 4. Discussion of the Methodology a. Non-Market Economy Country Status b. Separate Rates c. Surrogate Country d. PRC-Wide Entity e. Determination of Comparison Method f. Results of Differential Pricing Analysis g. Comparisons to Normal Value h. Date of Sale i. Export Price j. Value Added Tax k. Normal Value l. Factor Valuations m. Currency Conversion 5. Recommendation
    [FR Doc. 2016-03073 Filed 2-12-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-533-825] Polyethylene Terephthalate Film, Sheet, and Strip From India: Final Results of Countervailing Duty Administrative Review; 2013 AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    On August 6, 2015, the Department published the preliminary results of the administrative review of the countervailing duty order on polyethylene terephthalate film, sheet, and strip (PET film) from India.1 The period of review (POR) is January 1, 2013, through December 31, 2013.2 Based on an analysis of the comments received, the Department has made changes to the subsidy rate determined for Jindal Poly Films Limited (Jindal). The final subsidy rates are listed in the “Final Results of Administrative Review” section below.

    1See Polyethylene Terephthalate Film, Sheet and Strip From India: Preliminary Results And Partial Rescission of Countervailing Duty Administrative Review; 2013, 80 FR 46956 (August 6, 2015) (Preliminary Results 2013).

    2 As explained in the memorandum from the Acting Assistant Secretary for Enforcement & Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the final results of this review is now February 8, 2016. See Memorandum to the Record from Ron Lorentzen, Acting A/S for Enforcement & Compliance, regarding “Tolling of Adminstrative Deadlines as a Result of the Government Closure During Snowstorm Jonas,” dated January 27, 2016.

    DATES:

    Effective date: February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Elfi Blum, AD/CVD Operations, Office VII, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0197.

    Scope of the Order

    For the purposes of the order, the products covered are all gauges of raw, pretreated, or primed polyethylene terephthalate film, sheet and strip, whether extruded or coextruded. Excluded are metallized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer of more than 0.00001 inches thick. Imports of PET film are classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) under item number 3920.62.00.90. HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of the order is dispositive.

    Analysis of Comments Received

    The issues raised by Petitioners 3 and Jindal in their case briefs, and Petitioners' rebuttal brief, are addressed in the Issues and Decision Memorandum.4 The issues are identified in the Appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Internet at http://trade.gov/enforcement/frn/index.html. The signed Issues and Decision Memorandum and electronic versions of the Issues and Decision Memorandum are identical in content.

    3 DuPont Teijin Films, Inc., Mitsubishi Polyester Film, Inc. and SKC, Inc. (collectively, “Petitioners”).

    4See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, “Issues and Decision Memorandum for the Final Results of Countervailing Duty Administrative Review: Polyethylene Terephthalate Film, Sheet, and Strip from India; 2013,” dated concurrently with this notice and herein incorporated by reference (Issues and Decision Memorandum).

    Changes Since the Preliminary Results

    Based on the comments received from Petitioners and Jindal, we adjusted the numerators used in Jindal's subsidy rate calculations for the Export Promotion Capital Goods Scheme (EPCGS) and the Duty Drawback (DDB) programs. For a discussion of these issues, see the Issues and Decision Memorandum and Memorandum to the File from Elfi Page, International Trade Compliance Analyst, titled “Final Results of 2013 Countervailing Duty Administrative Review: Polyethylene Terephthalate Film, Sheet, and Strip from India-Jindal Polyfilms Limited,” each dated concurrently with these final results.

    Methodology

    The Department conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we find that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific.5 For a description of the methodology underlying all of the Department's conclusions, see the Issues and Decision Memorandum.

    5See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and, section 771(5A) of the Act regarding specificity.

    Companies Not Selected for Individual Review

    For the companies not selected for individual review (Ester, Garware, Polyplex, Vacmet, and Vacmet India Limited), because the rates calculated for Jindal and SRF were above de minimis and not based entirely on facts available, we applied a subsidy rate based on a weighted average of the subsidy rates calculated for Jindal and SRF using publicly ranged sales data submitted by respondents.6

    6 The statute and the Department's regulations do not directly address the establishment of rates to be applied to companies not selected for individual examination where the Department limited its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, the Department normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides instructions for calculating the all others rate in an investigation. Section 705(c)(5)(A) of the Act instructs the Department to calculate an all others rate using the weighted average of the subsidy rates established for the producers/exporters individually examined, excluding any zero, de minimis, or facts available rates. In this review, calculating the non-selected rate by weight averaging Jindal's and SRF's rates risks disclosure of proprietary information. Therefore, we calculated the rate for the non-selected companies by weight averaging the rates of Jindal and SRF using publicly-ranged sales data.

    Final Results of Administrative Review

    In accordance with section 777A(e)(1) of the Act and 19 CFR 351.221(b)(5), we determine the total estimated net countervailable subsidy rates for the period January 1, 2013, through December 31, 2013 to be:

    Manufacturer/exporter Subsidy rate (percent ad valorem) Jindal Poly Films of India Limited 8.90 SRF Limited 2.11 Ester Industries Limited 6.09 Garware Polyester Ltd. 6.09 Polyplex Corporation Ltd. 6.09 Vacmet 6.09 Vacmet India Limited 6.09 Assessment and Cash Deposit Requirements

    In accordance with 19 CFR 351.212(b)(2), the Department intends to issue appropriate instructions to U.S. Customs and Border Protection (CBP) 15 days after publication of the final results of this review. The Department will instruct CBP to liquidate shipments of subject merchandise produced and/or exported by the companies listed above, entered or withdrawn from warehouse, for consumption from January 1, 2013, through December 31, 2013, at the percent rates, as listed above for each of the respective companies, of the entered value.

    The Department intends also to instruct CBP to collect cash deposits of estimated countervailing duties, in the amounts shown above for each of the respective companies shown above, on shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this review. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits at the most-recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Administrative Protective Order

    This notice also serves as a final reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    These final results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: February 8, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I—Issues and Decision Memorandum I. Summary II. Background Scope of the Order III. Subsidies Valuation Information A. Allocation Period B. Benchmarks Interest Rates C. Denominator IV. Analysis of Programs A. Programs Determined To Be Countervailable B. Programs Determined To Be Not Used or To Provide No Benefit During the POR V. Analysis of Comments Comment 1: Whether the Department Wrongly Countervailed Export Promotion Capital Goods Scheme (EPCGS) Benefits That Apply to Non-Subject Merchandise. Comment 2: Whether the Department Used the Wrong Numerator To Calculate the POR Benefit For the Status Holder Incentive Scheme (SHIS). Comment 3: Whether the Value Added Tax (VAT) and Central Sales Tax (CST) Refunds Under the Industrial Promotion Subsidy (IPS) of the State Government of Maharashtra's (SGOM) Package Scheme of Incentives (PSI) Is Countervailable. Comment 4: Whether the Department Double Counted One of the EPCGS Licences Reported by Jindal and Failed To Include the Benefit of Another License in Its Rate Calculations for Jindal Comment 5: Whether the Department Used the Wrong Figure To Calculate the Duty Drawback Subsidy for Jindal
    [FR Doc. 2016-03082 Filed 2-12-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-036] Certain Biaxial Integral Geogrid Products From the People's Republic of China: Initiation of Less-Than-Fair-Value Investigation AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    DATES:

    Effective date: February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Julia Hancock at (202) 482-1394 and Susan Pulongbarit (202) 482-4031, AD/CVD Operations, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: The Petition

    On January 13, 2016, the Department of Commerce (“the Department”) received an antidumping duty (“AD”) petition concerning imports of certain biaxial integral geogrid products (“geogrids”) from the People's Republic of China (“PRC”), filed in proper form on behalf of Tensar Corporation (“Petitioner”).1 The AD petition was accompanied by a countervailing duty (“CVD”) petition for the PRC.2 Petitioner is a domestic producer of geogrids.3

    1See the Petitions for the Imposition of Antidumping Duties and Countervailing Duties: Certain Biaxial Integral Geogrid Products from the People's Republic of China, dated January 13, 2016 (“the Petition”).

    2Id.

    3See Volume I of the Petition at 2.

    On January 15, 2016, the Department requested additional information and clarification of certain areas of the Petition,4 and Petitioner timely filed responses to these requests on January 20, 2016.5 On January 26, 2016, the Department requested additional information and clarification on the calculation of AD margins,6 and Petitioner timely filed a response to this request on January 28, 2016.7 On January 27, 2016, the Department determined to toll all deadlines four business days as a result of the Federal Government closure during snowstorm Jonas, which is applicable to this initiation.

    4See Letters from the Department to Petitioner entitled “Petitions for the Imposition of Antidumping and Countervailing Duties on Imports of Certain Biaxial Integral Geogrid Products from the People's Republic of China: Supplemental Questions,” January 15, 2016 (“General Issues Supplemental Questionnaire”); and “Petition for the Imposition of Antidumping Duties on Certain Biaxial Integral Geogrid Products from the People's Republic of China,” dated January 15, 2016 (“AD Supplemental Questionnaire”).

    5See Petitioner's Response to the AD Supplemental Questionnaire, dated January 20, 2016 (“AD Petition Supplement”) and Petitioner's Response to the General Issues Supplemental Questionnaire, dated January 20, 2016 (“General Issues Supplement”).

    6See Letter from the Department to Petitioner entitled “Petition for the Imposition of Antidumping Duties on Imports of Certain Biaxial Integral Geogrid Products from the People's Republic of China: Supplemental Questions,” January 26, 2016 (“Second AD Supplemental Questionnaire”).

    7See Petitioner's January 28, 2016 submission (“Second AD Petition Supplement”).

    As explained in the memorandum from the Acting Assistant Secretary for Enforcement and Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the initiation of this investigation is now February 8, 2016.8

    8See Memorandum to the Record from Ron Lorentzen, Acting A/S for Enforcement & Compliance, regarding “Tolling of Administrative Deadlines As a Result of the Government Closure During Snowstorm Jonas,”' dated January 27, 2016.

    In accordance with section 732(b) of the Tariff Act of 1930, as amended (the “Act”), Petitioner alleges that imports of geogrids from the PRC are being, or are likely to be, sold in the United States at less-than-fair value within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 732(b)(1) of the Act, the Petition is accompanied by information reasonably available to Petitioner supporting its allegations.

    The Department finds that Petitioner filed these Petitions on behalf of the domestic industry because Petitioner is an interested party as defined in section 771(9)(C) of the Act. The Department also finds that Petitioner demonstrated sufficient industry support with respect to the initiation of the AD investigation that Petitioner is requesting.9

    9See the “Determination of Industry Support for the Petition” section below.

    Period of Investigation

    Because the AD Petition was filed on January 13, 2015, the period of investigation (“POI”) is, pursuant to 19 CFR 351.204(b)(1), July 1, 2015, through December 31, 2015.

    Scope of the Investigation

    The products covered by this investigation are geogrids from the PRC. For a full description of the scope of this investigation, see the “Scope of the Investigation,” in Appendix I of this notice.

    Comments on Scope of the Investigation

    During our review of the AD and CVD Petitions, the Department issued questions to, and received responses from, Petitioner pertaining to the proposed scope to ensure that the scope language in the Petition would be an accurate reflection of the products for which the domestic industry is seeking relief.10

    10See General Issues Supplemental Questionnaire and General Issues Supplement.

    As discussed in the preamble to the Department's regulations,11 we are setting aside a period for interested parties to raise issues regarding product coverage (i.e., the scope). The Department will consider all comments received from parties and, if necessary, will consult with parties prior to the issuance of the preliminary determination. If scope comments include factual information (see 19 CFR 351.102(b)(21)), all such factual information should be limited to public information. In order to facilitate preparation of its questionnaires, the Department requests all interested parties to submit such comments by 5:00 p.m. Eastern Time (“ET”) on February 29, 2016, which is 20 calendar days from the signature date of this notice. Any rebuttal comments, which may include factual information, must be filed by 5:00 p.m. ET on March 10, 2016, which is 10 calendar days after the initial comments deadline.

    11See Antidumping Duties; Countervailing Duties, 62 FR 27296, 27323 (May 19, 1997).

    The Department requests that any factual information the parties consider relevant to the scope of the investigations be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments must be filed on the records of each of the concurrent AD and CVD investigations.

    Filing Requirements

    All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”).12 An electronically filed document must be received successfully in its entirety by the time and date when it is due. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

    12See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011); see also Enforcement and Compliance; Change of Electronic Filing System Name, 79 FR 69046 (November 20, 2014) for details of the Department's electronic filing requirements, which went into effect on August 5, 2011. Information on help using ACCESS can be found at https://access.trade.gov/help.aspx and a handbook can be found at https://access.trade.gov/help/Handbook%20on%20Electronic%20Filling%20Procedures.pdf.

    Comments on Product Characteristics for AD Questionnaires

    The Department requests comments from interested parties regarding the appropriate physical characteristics of geogrids to be reported in response to the Department's AD questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant factors and costs of production as accurately as well as to develop appropriate product-comparison criteria.

    Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe geogrids, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.

    In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all comments must be filed by 5:00 p.m. ET on February 29, 2016, which is twenty calendar days from the signature date of this notice. Any rebuttal comments must be filed by 5:00 p.m. ET on March 4, 2016. All comments and submissions to the Department must be filed electronically using ACCESS.

    Determination of Industry Support for the Petition

    Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

    Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (“ITC”), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,13 they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.14

    13See section 771(10) of the Act.

    14See USEC, Inc. v. United States, 132 F. Supp. 2d 1, 8 (CIT 2001) (citing Algoma Steel Corp., Ltd. v. United States, 688 F. Supp. 639, 644 (CIT 1988), aff'd 865 F.2d 240 (Fed. Cir. 1989)).

    Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petition).

    With regard to the domestic like product, Petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that geogrids, as defined in the scope, constitute a single domestic like product and we have analyzed industry support in terms of that domestic like product.15

    15 For a discussion of the domestic like product analysis in this case, see Antidumping Duty Investigation Initiation Checklist: Certain Biaxial Integral Geogrid Products from the People's Republic of China (“PRC AD Initiation Checklist”), at Attachment II, Analysis of Industry Support for the Antidumping and Countervailing Duty Petitions Covering Certain Biaxial Integral Geogrid Products from the People's Republic of China (“Attachment II”). This checklist is dated concurrently with this notice and on file electronically via ACCESS. Access to documents filed via ACCESS is also available in the Central Records Unit, Room B8024 of the main Department of Commerce building.

    In determining whether Petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in Appendix I of this notice. To establish industry support, Petitioner provided its own production of the domestic like product in 2015.16 On February 1, 2016, we received a letter from the only other known U.S. producer of geogrids, Tenax Corporation (“Tenax”), stating that the company supports the Petition.17 Tenax also provided its own production of the domestic like product in 2015.18 Petitioner states that, based on reasonably available information regarding the U.S. geogrids industry, there are no other known producers of geogrids in the United States; therefore, the Petition is supported by 100 percent of the U.S. industry.19

    16See General Issues Supplement, at 13.

    17See Letter from Tenax Corporation, dated January 28, 2016. We note that, although this letter is dated January 28, 2016, it was filed after 5:00 p.m. on January 29, 2016 (via ACCESS); therefore, we consider it received on the next business day (February 1, 2016).

    18See Letter from Tenax Corporation, dated February 1, 2016.

    19See Volume I of the Petition, at 2-15 and Exhibits I-1 through I-4, I-6 through I-34, I-44, and I-52 through I-58; see also Letter from Tenax Corporation, dated February 1, 2016, at 1.

    Our review of the data provided in the Petition, General Issues Supplement, letters from Tenax, and other information readily available to the Department indicates that Petitioner has established industry support.20 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, the Department is not required to take further action in order to evaluate industry support (e.g., polling).21 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product.22 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition.23 Accordingly, the Department determines that the Petition was filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.

    20See PRC AD Initiation Checklist, at Attachment II.

    21See section 732(c)(4)(D) of the Act; see also PRC AD Initiation Checklist, at Attachment II.

    22See PRC AD Initiation Checklist, at Attachment II.

    23Id.

    The Department finds that Petitioner filed the Petition on behalf of the domestic industry because it is an interested party as defined in section 771(9)(C) of the Act and it has demonstrated sufficient industry support with respect to the AD investigation that it is requesting the Department initiate.24

    24Id.

    Allegations and Evidence of Material Injury and Causation

    Petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (“NV”). In addition, Petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.25

    25See Volume I of the Petition, at 34 and Exhibit I-4; see also General Issues Supplement, at 19.

    Petitioner contends that the industry's injured condition is illustrated by reduced market share; underselling and price suppression or depression; negative impact on the domestic industry's performance, including capacity utilization, shipments, and operating income; and lost sales and revenues.26 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, and causation, and we have determined that these allegations are properly supported by adequate evidence and meet the statutory requirements for initiation.27

    26See Volume I of the Petition, at 24-28, 32-45 and Exhibits I-4, I-35, I-39 through I-43, I-47, I-50, and I-51; see also General Issues Supplement, at 13-24 and Exhibits Supp. I-1 through I-5, I-10 through I-12, and I-43.

    27See PRC AD Initiation Checklist, at Attachment III, Analysis of Allegations and Evidence of Material Injury and Causation for the Antidumping and Countervailing Duty Petitions Covering Certain Biaxial Integral Geogrid Products from the People's Republic of China.

    Allegation of Sales at Less-Than-Fair Value

    The following is a description of the allegation of sales at less-than-fair value upon which the Department based its decision to initiate the investigation of geogrids from the PRC. The sources of data for the deductions and adjustments relating to U.S. price and NV are discussed in greater detail in the initiation checklist.

    Export Price

    Petitioner based U.S. prices on geogrids produced in and exported from the PRC by one producer, Feicheng Lianyi Engineering Plastics Co., Ltd. (“Feicheng”), and offered for sale to customers in the United States.28 Petitioner made deductions from U.S. price for movement expenses consistent with the delivery terms.

    28See Volume II of the Petition at 7.

    Normal Value

    Petitioner stated that the Department has found the PRC to be a non-market economy (“NME”) country in every administrative proceeding in which the PRC has been involved.29 In accordance with section 771(18)(C)(i) of the Act, the presumption of NME status remains in effect until revoked by the Department. The presumption of NME status for the PRC has not been revoked by the Department and, therefore, remains in effect for purposes of the initiation of this investigation. Accordingly, the NV of the product is appropriately based on factors of production (“FOP”) valued in a surrogate market economy country, in accordance with section 773(c) of the Act. In the course of this investigation, all parties, and the public, will have the opportunity to provide relevant information related to the issues of the PRC's NME status and the granting of separate rates to individual exporters.

    29Id. at 2.

    Petitioner claims that South Africa is an appropriate surrogate country because it is a market economy that is at a level of economic development comparable to that of the PRC and it is a significant producer of the merchandise under consideration.30

    30Id. at 4.

    Based on the information provided by Petitioner, we believe it is appropriate to use South Africa as a surrogate country for initiation purposes. Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs within 30 days before the scheduled date of the preliminary determination.

    Factors of Production

    Petitioner based the FOPs for materials, labor, and energy on its own consumption rates for producing geogrids.31 Petitioner notes that Tensar, like Feicheng, is a large producer of geogrids using the same production process as Tensar.32 Petitioner valued the estimated factors of production using surrogate values from South Africa.33

    31See Volume II of the Petition at Exhibit II-18; see also AD Petition Supplement, at 4-5 and Exhibit Supp. II-18.

    32See Volume II of the Petition at Exhibit II-18.

    33Id.

    Valuation of Raw Materials

    Petitioner valued the FOPs for raw materials (e.g., polypropylene, black masterbatch) using public import data for South Africa from the Global Trade Atlas (“GTA”) from June 2015 through November 2015, the most recent POI-contemporaneous data available at the time the Petition was filed.34 Petitioner excluded all import values from countries previously determined by the Department to maintain broadly available, non-industry-specific export subsidies and from countries previously determined by the Department to be NME countries. In addition, in accordance with the Department's practice, the average import value excludes imports that were labeled as originating from an unidentified country. The Department determines that the surrogate values used by Petitioner are reasonably available, and thus, are acceptable for purposes of initiation.

    34See AD Petition Supplement at Exhibits Supp II-18 Attachments E-G.

    Valuation of Labor

    Petitioner valued labor using 2012 data for South Africa from the International Labor Organization for “Manufacturing.” 35 Specifically, Petitioner relied on data pertaining to wages earned by South African workers engaged in the manufacturing sector of the economy.36 Petitioner inflated the wage rate using data for the South African Consumer Price Index (“CPI”) published for the POI.37 Next, Petitioner converted the wage rates to hourly and converted South African Rands (“ZAR”) to U.S. Dollars (“USD”) using the average exchange rate for the POI.38

    35See Volume II of the Petition at Exhibit II-18.

    36Id.

    37Id.

    38Id.; see also AD Petition Supplement at 5 and Exhibit Supp. II-18 Attachment H(1).

    Valuation of Packing Materials

    Petitioner valued the packing materials used by PRC producers based on South African import data obtained from GTA.39

    39See AD Petition Supplement at Exhibits Supp. II-18 Attachments M and N.

    Valuation of Energy

    Petitioner valued electricity using data published by the South African electricity producer Eksom.40 The Eksom price information was reported in South African ZAR/kilowatt hour. Petitioner converted the price to USD using the average exchange rate during the POI.41 Petitioner valued natural gas using data from the National Energy Regulator of South Africa for natural gas provider ROMPCO.42 Petitioner converted ZAR/Gigajoule (“GJ”) to USD/therm.43

    40See Volume II of the Petition at Exhibit II-18.

    41Id.

    42Id.

    43Id.

    Valuation of Factory Overhead, Selling, General and Administrative (SG&A) Expenses, and Profit

    Petitioner relied on surrogate financial ratios (i.e., factory overhead, SG&A expenses, and profit) it calculated using the 2015 audited financial statement of Bowler Metcalf, a South African producer of comparable merchandise (i.e., rigid plastic packaging for consumer products).44

    44See AD Petition Supplement at Exhibit II-18 Attachment K(3) and K(5); see also Second AD Supplemental Questionnaire; Second AD Petition Supplement at 1 and Exhibit Second Supp. II-18; and PRC AD Initiation Checklist.

    Fair Value Comparisons

    Based on the data provided by Petitioner, there is reason to believe that imports of geogrids from the PRC are being, or are likely to be, sold in the United States at less-than-fair value. Based on comparisons of EP to NV, in accordance with section 773(c) of the Act, the estimated dumping margin for geogrids from the PRC range from 289.23 to 372.81 percent.45

    45See PRC AD Initiation Checklist.

    Initiation of Less-Than-Fair-Value Investigation

    Based upon the examination of the AD Petition on geogrids from the PRC, we find that the Petition meets the requirements of section 732 of the Act. Therefore, we are initiating an AD investigation to determine whether imports of geogrids from the PRC are being, or are likely to be, sold in the United States at less-than-fair value. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 140 days after the date of this initiation.

    On June 29, 2015, the President of the United States signed into law the Trade Preferences Extension Act of 2015, which made numerous amendments to the AD and CVD law.46 The 2015 law does not specify dates of application for those amendments. On August 6, 2015, the Department published an interpretative rule, in which it announced the applicability dates for each amendment to the Act, except for amendments contained in section 771(7) of the Act, which relate to determinations of material injury by the ITC.47 The amendments to sections 771(15), 773, 776, and 782 of the Act are applicable to all determinations made on or after August 6, 2015, and, therefore, apply to this AD investigation.48

    46See Trade Preferences Extension Act of 2015, Public Law 114-27, 129 Stat. 362 (2015).

    47See Dates of Application of Amendments to the Antidumping and Countervailing Duty Laws Made by the Trade Preferences Extension Act of 2015, 80 FR 46793 (August 6, 2015) (“Applicability Notice”).

    48Id. at 46794-95. The 2015 amendments may be found at https://www.congress.gov/bill/114th-congress/house-bill/1295/text/pl.

    Respondent Selection

    Petitioner named 78 companies from the PRC as producers/exporters of geogrids.49 Following standard practice for respondent selection in cases involving NME countries, we intend to issue quantity and value (“Q&V”) questionnaires to each potential respondent, for which the Petitioner has provided a complete address, and base respondent selection on the responses received. In addition, the Department will post the Q&V questionnaire along with filing instructions on the Enforcement and Compliance Web site at http://www.trade.gov/enforcement/news.asp.

    49See Volume I of Petition at Exhibit I-37; see also AD Petition Supplement at 1 and Exhibit Supp. I-37.

    Exporters/producers of geogrids from the PRC that do not receive Q&V questionnaires by mail may still submit a response to the Q&V questionnaire and can obtain a copy from the Enforcement and Compliance Web site. The Q&V response must be submitted by all PRC exporters/producers no later than February 22, 2016, which is two weeks from the signature date of this notice. All Q&V responses must be filed electronically via ACCESS.

    Separate Rates

    In order to obtain separate-rate status in an NME investigation, exporters and producers must submit a separate-rate application.50 The specific requirements for submitting a separate-rate application are outlined in detail in the application itself, which is available on the Department's Web site at http://enforcement.trade.gov/nme/nme-sep-rate.html. The separate-rate application will be due 30 days after publication of this initiation notice.51 Exporters and producers who submit a separate-rate application and have been selected as mandatory respondents will be eligible for consideration for separate-rate status only if they respond to all parts of the Department's AD questionnaire as mandatory respondents. The Department requires that respondents submit a response to both the Q&V questionnaire and the separate-rate application by their respective deadlines in order to receive consideration for separate-rate status.

    50See Policy Bulletin 05.1: Separate-Rates Practice and Application of Combination Rates in Antidumping Investigation Involving Non-Market Economy Countries (April 5, 2005), available at http://enforcement.trade.gov/policy/bull05-1.pdf (Policy Bulletin 05.1).

    51 Although in past investigations this deadline was 60 days, consistent with 19 CFR 351.301(a), which states that “the Secretary may request any person to submit factual information at any time during a proceeding,” this deadline is now 30 days.

    Use of Combination Rates

    The Department will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:

    {w}hile continuing the practice of assigning separate rates only to exporters, all separate rates that the Department will now assign in its NME Investigation will be specific to those producers that supplied the exporter during the period of investigation. Note, however, that one rate is calculated for the exporter and all of the producers which supplied subject merchandise to it during the period of investigation. This practice applies both to mandatory respondents receiving an individually calculated separate rate as well as the pool of non-investigated firms receiving the weighted-average of the individually calculated rates. This practice is referred to as the application of “combination rates” because such rates apply to specific combinations of exporters and one or more producers. The cash-deposit rate assigned to an exporter will apply only to merchandise both exported by the firm in question and produced by a firm that supplied the exporter during the period of investigation.52

    52See Policy Bulletin 05.1 at 6 (emphasis added).

    Distribution of Copies of the Petition

    In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the government of the PRC via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).

    ITC Notification

    We will notify the ITC of our initiation, as required by section 732(d) of the Act.

    Preliminary Determination by the ITC

    The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of geogrids from the PRC are materially injuring or threatening material injury to a U.S. industry.53 A negative ITC determination will result in the investigation being terminated; 54 otherwise, this investigation will proceed according to statutory and regulatory time limits.

    53See section 733(a) of the Act.

    54Id.

    Submission of Factual Information

    Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)-(iv). Any party, when submitting factual information, must specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted 55 and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct.56 Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Please review the regulations prior to submitting factual information in this investigation.

    55See 19 CFR 351.301(b).

    56See 19 CFR 351.301(b)(2).

    Extensions of Time Limits

    Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351 expires. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Please review Extension of Time Limits; Final Rule, 78 FR 57790 (September 20, 2013), available athttp://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.html, prior to submitting factual information in this investigation.

    Certification Requirements

    Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.57 Parties are hereby reminded that revised certification requirements are in effect for company/government officials, as well as their representatives. Investigations initiated on the basis of petitions filed on or after August 16, 2013, and other segments of any AD or CVD proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided at the end of the Final Rule.58 The Department intends to reject factual submissions if the submitting party does not comply with applicable revised certification requirements.

    57See section 782(b) of the Act.

    58See Certification of Factual Information to Import Administration during Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (Final Rule); see also frequently asked questions regarding the Final Rule, available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Notification to Interested Parties

    Interested parties must submit applications for disclosure under administrative protective order (“APO”) in accordance with 19 CFR 351.305. On January 22, 2008, the Department published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Parties wishing to participate in this investigation should ensure that they meet the requirements of these procedures (e.g., the filing of letters of appearance as discussed in 19 CFR 351.103(d)).

    This notice is issued and published pursuant to section 777(i) of the Act.

    Dated: February 8, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I—Scope of the Investigation

    The merchandise covered by the investigation is certain biaxial integral geogrid products. Biaxial integral geogrid products are a polymer grid or mesh material (whether or not finished, slit, cut-to-length, attached to woven or non-woven fabric or sheet material, or packaged) in which four-sided openings in the form of squares, rectangles, rhomboids, diamonds, or other four-sided figures predominate. The products covered have integral strands that have been stretched to induce molecular orientation into the material (as evidenced by the strands being thinner toward the middle between the junctions than at the junctions themselves) constituting the sides of the openings and integral junctions where the strands intersect. The scope includes products in which four-sided figures predominate whether or not they also contain additional strands intersecting the four-sided figures and whether or not the inside corners of the four-sided figures are rounded off or not sharp angles. As used herein, the term “integral” refers to strands and junctions that are homogenous with each other. The products covered have a tensile strength of greater than 5 kilonewtons per meter (“kN/m”) according to American Society for Testing and Materials (“ASTM”) Standard Test Method D6637/D6637M in any direction and average overall flexural stiffness of more than 100,000 milligram-centimeter according to the ASTM D7748/D7748M Standard Test Method for Flexural Rigidity of Geogrids, Geotextiles and Related Products, or other equivalent test method standards.

    Subject merchandise includes material matching the above description that has been finished, packaged, or otherwise further processed in a third country, including by trimming, slitting, coating, cutting, punching holes, stretching, attaching to woven or non-woven fabric or sheet material, or any other finishing, packaging, or other further processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the biaxial integral geogrid.

    The products subject to the scope are currently classified in the Harmonized Tariff Schedule of the United States (“HTSUS”) under the following subheading: 3926.90.9995. Subject merchandise may also enter under subheadings 3920.20.0050 and 3925.90.0000. The HTSUS subheadings set forth above are provided for convenience and U.S. Customs purposes only. The written description of the scope is dispositive.

    [FR Doc. 2016-03086 Filed 2-12-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD608 Endangered Species; File No. 19255 AGENCY:

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

    ACTION:

    Notice; issuance of a permit, and termination of a permit.

    SUMMARY:

    Notice is hereby given that the Delaware Department of Natural Resources and Environmental Control (DNREC) [Responsible Party: Michael Stangl], 3002 Bayside Dr., Dover, Delaware 19977, has been issued a permit to take shortnose (Acipenser brevirostrum) and Atlantic (Acipenser oxyrinchus oxyrinchus) sturgeon in the Delaware River for purposes of scientific research. Additionally, Permit No. 16431, issued to the same Permit Holder for study of Atlantic sturgeon, is hereby terminated.

    ADDRESSES:

    The permit and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Malcolm Mohead or Rosa L. González, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On November 17, 2014, notice was published in the Federal Register (79 FR 68413) of a request for a permit to conduct research on shortnose sturgeon had been submitted by the above-named applicant. On June 26, 2015, notice was published in the Federal Register (80 FR 36770) that the application was amended to include a request to conduct research on Atlantic sturgeon. The requested permit has been issued under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    Permit No. 19255 authorizes annual takes of endangered shortnose and Atlantic sturgeon to document nursery areas, individual movement patterns, seasonal movements, home ranges, and habitat usage(s) in the Delaware River. The authorized activities include capture of shortnose and Atlantic shortnose with gillnets. It also authorizes individuals to be weighed, measured, marked with Passive Integrated Transponder (PIT), T-bar tagged, anesthetized, acoustic tagged, genetic tissue sampled, gastric lavaged, and photographed. It also authorized one unintentional mortality per species during the life of the permit. Specific activities and number of animals authorized per species are found on the permit. The shortnose sturgeon research activities are a continuation of the ones authorized under the DNREC expired Permit No. 14396 (75 FR 4043). The Atlantic sturgeon research activities were incorporated from the ones authorized under the DNREC Permit No. 16431 (76 FR 58469), which was set to expire April 5, 2017. Permit No. 16431 was terminated with issuance of Permit No. 19225, valid until February 5, 2021.

    Issuance of this permit, as required by the ESA, was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of such endangered or threatened species, and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

    Dated: February 9, 2016. Perry F. Gayaldo, Deputy Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-03026 Filed 2-12-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE437 Fisheries of the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting AGENCY:

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

    ACTION:

    Notice of SEDAR 41 Review Workshop for South Atlantic red snapper and gray triggerfish.

    SUMMARY:

    The SEDAR 41 assessments of the South Atlantic stocks of red snapper (Lutjanus campechanus) and gray triggerfish (Balistes capriscus) will consist of a series of workshops and webinars: Data Workshops; an Assessment Workshop and webinars; and a Review Workshop. See SUPPLEMENTARY INFORMATION.

    DATES:

    The SEDAR 41 Review Workshop will be held on March 15-17, 2016, from 8:30 a.m. until 6 p.m. and March 18, 2016, from 8 a.m. until 1 p.m. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the assessment process. Such adjustments may result in the meeting being extended from, or completed prior to the time established by this notice.

    ADDRESSES:

    Meeting address: The SEDAR 41 Assessment Workshop will be held at the Crowne Plaza Hotel, 4831 Tanger Outlet Boulevard, North Charleston, SC 29418; phone: (843) 744-4422.

    SEDAR address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405; www.sedarweb.org.

    FOR FURTHER INFORMATION CONTACT:

    Julia Byrd, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing a workshop and webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.

    The items of discussion in the Review Workshop are as follows:

    Independent peer review of the assessment developed during the Data Workshop and Assessment Process. Panelists will review the assessment and document their comments and recommendations in a Summary Report.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

    Special Accommodations

    These meetings are accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see ADDRESSES) at least 10 business days prior to the meeting.

    Note:

    The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 10, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-03049 Filed 2-12-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE438 Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The South Atlantic Fishery Management Council (Council) will hold a meeting of its Scientific and Statistical Committee (SSC) to review methods for determining the recreational annual catch limit (ACL) in numbers for the Florida Keys/East Florida (FLK/EFL) Hogfish stock.

    DATES:

    The SSC meeting will be held via webinar on Friday, March 4, 2016, from 9 a.m. to 12 p.m.

    ADDRESSES:

    The meeting will be held via webinar. The webinar is open to members of the public. Those interested in participating should contact John Carmichael at the Council (see FOR FURTHER INFORMATION CONTACT) to request an invitation providing webinar access information. Please request webinar invitations at least 24 hours in advance of the webinar.

    Council address: South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405.

    FOR FURTHER INFORMATION CONTACT:

    John Carmichael; 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366 or toll free (866) SAFMC-10; fax: (843) 769-4520; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is held to review proposed methods for calculating the recreational ACL of FLK/EFL Hogfish in numbers of fish. The Council stated at their September 2015 meeting in Hilton Head, SC that they would like the recreational ACL for the FLK/EFL stock of Hogfish to be set in numbers rather than in pounds. Items to be addressed during this meeting:

    Review and comment on the risks and uncertainties associated with proposed methods for calculating the recreational ACL of the FLK/EFL Hogfish stock in numbers. The SSC will provide recommendations for Council consideration as appropriate.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES) at least 10 business days prior to the meeting.

    Note:

    The times and sequence specified in this agenda are subject to change.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 10, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-03050 Filed 2-12-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XC348 Endangered Species; File No.17364-01 AGENCY:

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

    ACTION:

    Notice; issuance of permit modification.

    SUMMARY:

    Notice is hereby given that the U.S. Fish and Wildlife Service (USFWS), Northeast Fishery Center, PO Box 75, Lamar, PA 16848 [Michael Millard: Responsible Party], has been issued a modification to scientific research Permit No. 17364 to take captive Atlantic sturgeon.

    ADDRESSES:

    The modification and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    FOR FURTHER INFORMATION CONTACT:

    Malcolm Mohead or Rosa L. González, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On August 13, 2014, notice was published in the Federal Register (79 FR 47440) that a modification of Permit No. 17364, issued March 14, 2013 (78 FR 17640), had been requested by the above-named organization. The requested modification has been granted under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226).

    The Permit Holder's original objectives were to refine propagation and culture techniques of captive Atlantic sturgeon held in refugia at the USFWS's Northeast Fisheries Center, providing a source of research animals for studies related to tagging, tracking, behavior, physiology, genetics, health, cryopreservation, and other methods to advance population conservation, recovery, or enhancement of the species in the wild.

    The Permit Holder is now authorized to conduct similar scientific research on captive Atlantic sturgeon at five captive holding facilities of Atlantic sturgeon located in the state of Maryland. Study objectives would include nutrition, physiology, propagation, contaminants, genetics, fish health, cryopreservation, aging, tagging techniques, and refugia. Additionally, studies would examine abiotic factors (e.g., pH, temperature, salinity dissolved oxygen, etc) influencing the distribution and abundance of Atlantic sturgeon in the wild. The modification would be valid until expiration of the permit on March 13, 2018.

    Issuance of this modification, as required by the ESA was based on a finding that such permit (1) was applied for in good faith, (2) will not operate to the disadvantage of such endangered or threatened species, and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

    Dated: February 9, 2016. Perry F. Gayaldo, Deputy Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-03027 Filed 2-12-16; 8:45 am] BILLING CODE 3510-22-P
    COMMODITY FUTURES TRADING COMMISSION Order Authorizing the National Futures Association as a Commission Designee for Direct Electronic Access to Data in Swap Data Repositories AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice and order.

    SUMMARY:

    The Commodity Futures Trading Commission (“Commission”) is issuing an order (“Order”) authorizing the National Futures Association (“NFA”) as a Commission designee to receive direct electronic access to data maintained in swap data repositories (“SDRs”) registered with the Commission. The Commission is authorized to designate persons to receive direct electronic access to SDR data pursuant to Section 21(c)(4)(A) of the Commodity Exchange Act (“CEA”). NFA is registered with the Commission as a registered futures association (“RFA”) pursuant to Section 17 of the CEA. Direct access to SDR data will facilitate NFA's performance of functions delegated to NFA by the Commission, as well as the performance of other duties authorized by the CEA and the Commission. As a condition to authorizing NFA as a Commission designee, NFA is required to keep all non-public information received through direct electronic access to SDR data confidential and to refer any request for such data to the Commission for handling.

    DATES:

    Effective date: February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Eileen T. Flaherty, Director, 202-418-5326, [email protected], or Frank Fisanich, Chief Counsel, 202-418-5949, [email protected], Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581.

    SUPPLEMENTARY INFORMATION: I. Authority and Background

    Title VII of the Dodd-Frank Wall Street Reform and Consumer Protection Act 1 amended the CEA 2 to establish a comprehensive new regulatory framework for swaps. Amendments to the CEA included the addition of provisions requiring the retention, and the reporting to Commission-registered SDRs, of data regarding swap transactions in order to enhance transparency, promote standardization, and reduce systemic risk. Such amendments also included certain core principles governing the operations of SDRs. Pursuant to these newly added provisions, the Commission adopted certain SDR registration requirements and provisions implementing core principles in part 49 of its regulations,3 and adopted rules for the reporting of swap transaction data to registered SDRs in parts 45 and 46 of its regulations.4

    1 Public Law 111-203, 124 Stat. 1376 (2010).

    2 7 U.S.C. 1 et seq.

    3See Swap Data Repositories: Registration Standards, Duties and Core Principles, 76 FR 54538 (Sept. 1, 2011).

    4 Swap Data Recordkeeping and Reporting Requirements, 77 FR 2136 (Jan. 13, 2012).

    Section 21(c) of the CEA sets forth the duties of a registered SDR. Among them is the duty to provide direct electronic access to the Commission (or any designee of the Commission).5 “Direct electronic access” is defined in Commission regulation 49.17(b)(3) as “an electronic system, platform or framework that provides internet or web-based access to real-time swap transaction data and also provides scheduled data transfers to the Commission's electronic systems.” 6 As used herein, “direct electronic access to SDR data” means “an electronic system, platform, or framework that provides internet or web-based access to real-time swap transaction data and/or swap transaction data transfers.”

    5See Section 21(c)(4)(A) of the CEA, 7 U.S.C. 24a(c)(4)(A).

    6 17 CFR 49.17(b)(3).

    As the Commission stated in adopting the SDR registration requirements, direct electronic access by the Commission is a critical function and responsibility of an SDR because real-time access to swap data is necessary for adequate oversight and surveillance of the swaps market.7 The Commission implemented the access requirements for Commission designees under Section 21(c)(4)(A) of the CEA by adopting Commission regulation 49.17(c)(1).

    7See Swap Data Repositories: Registration Standards, Duties and Core Principles, 76 FR 54538, 54551-52 (Sept. 1, 2011).

    Pursuant to Commission regulation 170.1, a basic purpose of an RFA is to regulate the practices of its members.8 In order to help NFA achieve this purpose and strengthen its regulatory oversight of its members, including registered swap dealers (“SDs”) and major swap participants (“MSPs”), NFA has requested direct electronic access to all SDRs.

    8 17 CFR 170.1.

    II. Use of SDR Data

    NFA is the only futures association registered with the Commission pursuant to Section 17 of the CEA and the Commission, as detailed below, has over decades delegated many Commission functions to NFA.9 Pursuant to Section 8a(10) of the CEA,10 the Commission may authorize any person—including an RFA—to perform any of the registration functions under the CEA. Further, pursuant to Section 17(o) of the CEA,11 the Commission may require an RFA to perform registration functions under the CEA with respect to its members. The Commission has previously authorized NFA to perform the full range of registration functions with regard to applicants for Commission registration and Commission registrants, including registration of SDs and MSPs.12 Additionally, pursuant to Sections 4p, 8a, and 17 of the CEA, the Commission issued Commission regulation 170.16 requiring each registered SD and MSP to become and remain a member of an RFA. As the only RFA, all registered SDs and MSPs are members of NFA.

    9 7 U.S.C. 21.

    10 7 U.S.C. 12a(10).

    11 7 U.S.C. 21(o).

    12See e.g., Performance of Registration Functions by National Futures Association, 49 FR 39593 (Oct. 9, 1984); 50 FR 34885 (Aug. 28, 1985); 51 FR 34490 (Sept. 29, 1986); Performance of Registration Processing Functions by National Futures Association With Respect to Floor Traders and Floor Brokers, 58 FR 19657 (Apr. 15, 1993); Performance of Certain Functions by National Futures Association With Respect to Non-U.S. Firms and Non-U.S. Markets, 62 FR 47792 (Sept. 11, 1997); Performance of Certain Functions by National Futures Association with Respect to Commodity Pool Operators and Commodity Trading Advisors, 62 FR 52088 (Oct. 6, 1997); Performance of Registration Functions by National Futures Association With Respect to Swap Dealers and Major Swap Participants 77 FR 2708 (Jan. 19, 2012).

    Other Commission functions delegated to NFA include: Reviewing disclosure documents and providing the Commission with related summaries and periodic reports; 13 and acting as the Commission's official custodian of records.14 The Commission has found that NFA exercises its delegated authority with proficiency.15

    13See 62 FR 52088 (Oct. 6, 1997); 64 FR 29273 (June 1, 1999).

    14See, e.g., 49 FR 39593 (Oct. 9, 1984) (regarding the registration records of future commission merchants, commodity pool operators, and commodity trading advisors); 66 FR 43227 (Aug. 17, 2001) (regarding notice registration filings as futures commission merchants or introducing brokers); 67 FR 77470 (Dec. 18, 2002) (regarding commodity pool operator annual financial reports required by regulation 4.22 and 4.7(b)(3)); 75 FR 55310 (Sep. 10, 2010) (regarding the registration records of retail foreign exchange dealers); and 77 FR 2708 (Jan. 19, 2012) (regarding registration records of swap dealers and major swap participants).

    15See, e.g., 67 FR 77470 (Dec. 18, 2002).

    In addition to performing functions delegated by the Commission, Section 17(p)(2) of the CEA requires an RFA to establish minimum capital, segregation, and other financial requirements applicable to its members for which such requirements are imposed by the Commission and implement a program to audit and enforce compliance with such requirements, except that such requirements may not be less stringent than those imposed on such firms by the CEA or by Commission regulation.16

    16 7 U.S.C. 21(p)(2).

    Pursuant to such requirement, where the Commission has imposed minimum financial requirements for its registrants, NFA has established minimum financial requirements for such registrants that are members of NFA that are no less stringent than those imposed by Commission regulations.17 All NFA rules and rule amendments are submitted to the Commission for review and approval, as required by Section 17(j) of the CEA.

    17 NFA's financial requirements for its members are contained in the NFA Manual, available on its Web site: http://www.nfa.futures.org/nfamanual/NFAManualTOC.aspx?Section=7. With respect to minimum financial requirements for SDs and MSPs, the Commission has proposed capital rules. See Capital Requirements of Swap Dealers and Major Swap Participants, 76 FR 27802 (May 12, 2011). In addition, the Commission has recently promulgated margin requirements for SDs and MSPs. See Margin Requirements for Uncleared Swaps for Swap Dealers and Major Swap Participants, 81 FR 636 (Jan. 6, 2016). NFA will in due course establish minimum financial requirements for its SD and MSP members that are no less stringent than the capital and margin requirements for SDs and MSPs imposed by the Commission.

    In order for NFA to adequately implement a program to audit and enforce compliance as required under Section 17(p)(2) of the CEA, to regulate the practices of its members pursuant to Commission regulation 170.1, and to carry out the functions delegated to it by the Commission, the Commission has determined that it is necessary for NFA to obtain SDR data. This information, together with adequate financial reporting by its members, will better enable NFA to monitor compliance with its minimum financial and other requirements.

    In requesting access to SDR data, NFA has stated that, as a front-line regulator of SDs and MSPs, it may be necessary in certain situations (e.g., investigations) for NFA to obtain data directly from an independent source, such as an SDR, as opposed to relying solely on data submitted by member firms. Furthermore, NFA has stated that if it had access to firm level transaction data on a regular (e.g., monthly or quarterly) basis, then this information would be a significant addition to NFA's SD/MSP risk profiling system. The Commission concurs with NFA's conclusion that it is far more efficient and timely for NFA to collect swap transaction data from a few consolidated sources, i.e., the SDRs, than for NFA to make constant requests either through the Commission or separately to over 100 SDs and MSPs.

    Finally, at the request of the Commission, NFA has represented its willingness to develop, at the direction of the Commission, reports generated from analyses of the SDR data NFA receives pursuant to this Order that the Commission or its staff may find necessary or desirable from time to time in order to carry out its legal and statutory responsibilities under the CEA and Commission regulations.

    The Commission believes that NFA's direct electronic access to SDR data will permit the Commission to carry out its legal and statutory responsibilities under the CEA, retaining its ultimate decision-making authority, while also freeing up Commission resources to be directed to other parts of its regulatory mandate. NFA may not use the SDR data obtained under the authority provided in this Order for any purpose other than to facilitate NFA's performance of functions delegated to NFA by the Commission and the performance of NFA's functions as an RFA.

    III. Confidentiality of SDR Data

    As a condition to receiving direct electronic access to SDR data as a Commission designee, NFA must keep all non-public information received through such access confidential.

    The SDR data contains information that is protected from disclosure by the Commission by Section 8 of the CEA.18 Pursuant to Section 8 of the CEA, the Commission is prohibited, except as specifically authorized by the CEA, from publishing data and information that would separately disclose the business transactions or market positions of any person and trade secrets or names of customers, subject to certain exceptions that permit disclosure to: (i) Either House of Congress, acting within the scope of its jurisdiction; (ii) a department, central bank and ministries, or agency of the Government of the United States, acting within the scope of its jurisdiction; (iii) a department, central bank and ministries, or agency of any State or any political subdivision thereof, acting within the scope of its jurisdiction; and (iv) any foreign futures authority, or any department, central bank and ministries, or agency of any foreign government or any political subdivision thereof, acting within the scope of its jurisdiction.19

    18 7 U.S.C. 12.

    19See Section 8(e) of the CEA; 7 U.S.C. 12(e).

    With respect to NFA's obligations regarding public disclosure of information it maintains as an official records custodian of the Commission,20 the Commission notes that NFA Compliance Rule 4-1 defines such information as “CFTC records” and subsection (c) of such rule states that:

    20See supra note 14 for orders by which the Commission determined to authorize NFA to maintain and serve as the official custodian of the Commission's registration records with respect to various Commission registrants.

    Requests for access to CFTC records, or portions thereof, not subject to disclosure as public or publicly available under paragraph (b)(1) of this Rule 21 shall be referred or transmitted to the Commission for response; except that, NFA will disclose such records or portion thereof:

    21 NFA Compliance Rule 4-1(b)(1) states: “If any member of the public requests access to CFTC records, or portions thereof, and the requested record, or portion, is “public” or “publicly available” under CFTC Regulations 1.10(g) or 145.0, then NFA will release that record or portion to the requester.”

    (1) otherwise with the authorization of the Assistant Secretary of the Commission for FOI, Privacy, and Sunshine Act Compliance or his or her designee, or the General Counsel of the Commission or his or her designee, in accordance with CFTC Regulations 145.7(b), (h) and (i); the Freedom of Information Act, 5 U.S.C. 552; and the Privacy Act, 5 U.S.C. 552a; and

    (2) to any individual or firm, or person acting on behalf of the individual or firm, who seeks access to his, her or its CFTC records: Provided, however, that NFA receives proper verification of the identity and authority of the party requesting the records.

    In order to ensure compliance with the Commission's obligations under Section 8 of the CEA, NFA has represented and confirmed to the Commission that all SDR data obtained by NFA through the direct electronic access authorized by this Order will be subject to more stringent obligations regarding public disclosure than are “CFTC records” under NFA Compliance Rule 4-1. Thus, the Commission is conditioning this Order on NFA's representation that it will not publicly disclose any information obtained by NFA through the direct electronic access to SDR data authorized by this Order. This Order is further conditioned on NFA's undertaking that any request for such SDR data received by NFA will be referred to the Commission for response directly by the Commission. Notwithstanding the foregoing, this Order provides that NFA may disclose the SDR data of a firm to such firm upon request, subject to NFA receiving proper verification of the identity and authority of the person making the request on behalf of such firm.

    With respect to disclosing to a firm such firm's own SDR data, the Commission notes that Commission regulation 49.17(f)(2) prohibits an SDR from disclosing to one counterparty the identity or the legal entity identifier (as such term is used in part 45 of the Commission's regulations) of the other counterparty to a swap, or the other counterparty's clearing member for the swap, if the swap is executed anonymously on a swap execution facility or a designated contract market and cleared in accordance with Commission regulations in 1.74, 23.610, and 37.12(b)(7). NFA has represented and confirmed that in disclosing to a firm such firm's own SDR data, such data will not include any information that an SDR would be prohibited from disclosing pursuant to Commission regulation 49.17(f)(2).

    IV. Conclusion and Order

    For the reasons discussed above, and pursuant to its authority under Section 21(c)(4)(A) of the CEA, the Commission has determined that NFA's access to SDR data will assist the Commission to carry out its legal and statutory responsibilities under the CEA and its regulations. Thus, the Commission has determined to, and hereby does, authorize NFA as a designee of the Commission for purposes of receiving direct electronic access to SDR data, subject to the terms and conditions specified below. Accordingly, subject to such terms and conditions, SDRs registered with the Commission must provide NFA with direct electronic access to such data as the Commission's designee in accordance with Commission regulation 49.17(c)(1).

    These determinations are based on NFA's representations and demonstration of its willingness and ability to accept the SDR data authorized by this Order for auditing and enforcing compliance with NFA member requirements, and to safeguard from public disclosure any information contained in such SDR data.

    Accordingly, NFA's direct electronic access to SDR data is specifically conditioned on NFA (1) safeguarding from public disclosure any information contained in such SDR data (other than pursuant to the limited exception specified below); (2) referring any request for such data received by NFA to the Commission for response directly by the Commission; (3) in no event disclosing any information regarding the identity of a counterparty to a swap, or such counterparty's clearing member for such swap, that an SDR would be prohibited from disclosing pursuant to Commission regulation 49.17(f)(2); and (4) accessing and using the SDR data obtained pursuant to the authority provided by this Order solely to facilitate NFA's performance of functions delegated to NFA by the Commission and NFA's performance of its functions as an RFA.

    Notwithstanding such conditions, upon request of a firm, NFA may disclose SDR data of that firm to such firm (other than information an SDR would be prohibited from disclosing pursuant to Commission regulation 49.17(f)(2)), subject to NFA receiving proper verification of the identity and authority of the person making the request on behalf of such firm.

    Further, the Commission hereby delegates to the Director of the Division of Swap Dealer and Intermediary Oversight the authority to: (1) Limit or otherwise condition NFA's direct electronic access to certain SDR data that such Director may determine in writing is unnecessary to facilitate NFA's performance of functions delegated to NFA by the Commission and the performance of NFA's functions as an RFA; and (2) direct Commission staff to review, examine, or audit NFA's access and use of the SDR data as such Director may determine is necessary to ensure NFA's compliance with the conditions of this Order. Nothing herein shall be deemed to prohibit the Commission, at its election, from exercising the authority delegated in this paragraph.

    This Order does not authorize NFA to render “no-action” positions, exemptions, or interpretations with respect to applicable disclosure, reporting, recordkeeping, and registration requirements.

    The Commission retains the authority to condition further, modify, suspend, terminate, or otherwise restrict any of the terms of the Order provided herein, in its discretion, including the kind of SDR data accessible through direct electronic access. Nothing in this order shall prevent the Commission from exercising its authority to receive direct electronic access to SDR data or its authority to authorize any other person to be a designee of the Commission to receive such access. Nothing in this order, or in Section 8a(10) or 17(o) of the CEA, shall affect the Commission's authority to review the performance by NFA of its oversight of its members, to adopt and enforce regulations applicable to SDs and MSPs as Commission registrants, and to conduct on-site examinations of the operations and activities of SDs and MSPs as Commission registrants.

    Issued in Washington, DC, on February 10, 2016, by the Commission. Christopher J. Kirkpatrick, Secretary of the Commission. Appendix to Order Authorizing the National Futures Association as a Commission Designee for Direct Electronic Access to Data in Swap Data Repositories—Commission Voting Summary

    On this matter, Chairman Massad and Commissioners Bowen and Giancarlo voted in the affirmative. No Commissioner voted in the negative.

    [FR Doc. 2016-03064 Filed 2-12-16; 8:45 am] BILLING CODE 6351-01-P
    CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0034] Request for Information Regarding Crib Bumpers AGENCY:

    U.S. Consumer Product Safety Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Consumer Product Safety Commission (“CPSC” or “Commission”) is seeking information regarding the safety benefits of crib bumpers, whether safety hazards are associated with crib bumpers, existing safety standards that apply to crib bumpers, and potential performance requirements, testing, and other standards that may reduce the risk of injury, if any, associated with crib bumpers.

    DATES:

    Submit comments by April 18, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC-2012-0034, by any of the following methods:

    Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov.

    Written Submissions: Submit written comments by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East-West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

    Instructions: All submissions must include the agency name and docket number for this notice. CPSC may post all comments, without change, to http://www.regulations.gov, including any personal identifiers, contact information, or other personal information. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, submit such information by mail/hand delivery/courier.

    Docket: For access to the docket to read background documents or comments, go to: http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Timothy P. Smith, Project Manager, Directorate for Engineering Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-987-2557; email: [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    The Consumer Product Safety Commission (“CPSC” or “Commission”) has granted a petition to initiate rulemaking regarding crib bumpers.1 To determine the need for and appropriate scope of such a rulemaking, the Commission is investigating whether crib bumpers pose a safety hazard to infants and, if so, what performance standards or requirements could mitigate that risk. As part of this effort, CPSC staff has reviewed incident data to identify what features or characteristics of crib bumpers create a safety hazard, if any; is evaluating existing safety standards that apply to crib bumpers and similar products; and is testing various types of crib bumpers. In this Request for Information (“RFI”), CPSC seeks input from interested parties to supplement the information, standards, and data currently available to the Commission. CPSC would find specific data regarding the safety risks and benefits associated with various types of crib bumpers and the empirical basis for, and effectiveness of, existing safety standards particularly helpful.

    1 On May 9, 2012, the Juvenile Products Manufacturers Association, Inc. (“JPMA”) filed a petition requesting CPSC initiate rulemaking under sections 7 and 9 of the Consumer Product Safety Act (“CPSA”; 15 U.S.C. 2051-2089) to create a performance standard for crib bumpers to distinguish “hazardous `soft' pillow-like” crib bumpers from “traditional” crib bumpers. See 77 FR 37836. On May 24, 2013, the Commission granted the petition, but adopted a broader framework than JPMA requested, directing staff to examine the safety benefits and risks associated with crib bumpers, evaluate existing standards, identify test methods and performance requirements that reduce any identified safety risks, and consider all regulatory options for addressing the risk of injury associated with crib bumpers.

    II. Information Requested

    To supplement the information currently available to CPSC, we request input relevant to the following questions:

    • What test data or other information is available to identify the specific features or characteristics of a crib bumper that might contribute to a risk of suffocation?

    • What objective, repeatable test methods, procedures or measures exist to assess the firmness of bedding, mattresses, and other possible sleep surfaces? To what extent, if any, can such tests, procedures or measures be used to assess whether these materials present a risk of suffocation by smothering?

    • To what extent does the test device specified in Australian/New Zealand Standard AS/NZS 8811.1:2013, Methods of Testing Infant Products, Method 1: Sleep Surfaces—Test for Firmness, 2 accurately and reliably assess the potential risk of suffocation associated with a sleep surface?

    2 The standard is available from Standards Australia Limited, GPO Box 476, Sydney, NSW 2011 and Standards New Zealand, Private Bag 2439, Wellington 6140, www.standards.co.nz.

    • To what extent would a test to accurately and reliably identify hazardous soft bedding or sleep surfaces be relevant to vertically-mounted surfaces, such as crib bumpers?

    • What safety benefits do crib bumpers offer to consumers? What data are available to demonstrate such benefits?

    • What, if any, evidence is there to indicate that “rebreathing” of carbon dioxide occurs with crib bumpers and presents a risk of suffocation?

    • The current U.S. voluntary standard covering crib bumpers is ASTM F1917-12, Standard Consumer Safety Performance Specification for Infant Bedding and Related Accessories (“ASTM F1917-12”).3 Are there other standards, aside from state or regional bans, that include performance requirements for crib bumpers?

    3 The standard is available from ASTM International at 100 Bar Harbor Drive, P.O. Box 0700, West Conshohocken, PA 19428, http://www.astm.org/cpsc.htm.

    • ASTM F1917-12 includes a requirement that essentially limits the compressed thickness of crib bumpers to 2 inches. What evidence exists to support this requirement, and what, if any, association exists between this ASTM requirement and the risk of infant suffocation?

    • What alternative or additional requirements beyond those specified in ASTM F1917-12 might address the risk of infant suffocation?

    • To what extent could a mesh-like or other “breathable” material present a risk of suffocation to an infant if the infant's face were pressed into the material? What specific characteristics would make a bumper “breathable,” and to what extent, if any, would such a bumper address the risk of suffocation? What data or research support these conclusions?

    • Are incident data or other objective safety information or research available that describe potential hazards associated with mesh-like bumpers or liners? Are similar data or information available on so-called “vertical bumpers,” which essentially are a series of small bumpers that individually cover each crib slat, and other bumper alternatives?

    Dated: February 10, 2016. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2016-03013 Filed 2-12-16; 8:45 am] BILLING CODE 6355-01-P
    CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0019] Proposed Extension of Approval of Information Collection; Comment Request—Standards for Full-Size Baby Cribs and Non-Full Size Baby Cribs; Compliance Form AGENCY:

    Consumer Product Safety Commission.

    ACTION:

    Notice.

    SUMMARY:

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (“CPSC” or “Commission”) requests comments on a proposed extension of approval of information collection requirements regarding a form that will be used to measure child care centers' compliance with the CPSC safety standards for full-size and non-full-size cribs (16 CFR parts 1219 and 1220). The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from the Office of Management and Budget (“OMB”).

    DATES:

    The Office of the Secretary must receive comments not later than April 18, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC-2012-0019, by any of the following methods:

    Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

    Written Submissions: Submit written submissions by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

    Instructions: All submissions received must include the agency name and docket number for this notice. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to:http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing.

    Docket: For access to the docket to read background documents or comments received, go to: http://www.regulations.gov, and insert the docket number CPSC-2012-0019, into the “Search” box, and follow the prompts.

    FOR FURTHER INFORMATION CONTACT:

    Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to: [email protected]

    SUPPLEMENTARY INFORMATION:

    CPSC seeks to renew the following currently approved collection of information:

    Title: Safety Standards for Full-Size Baby Cribs and Non-Full Size Baby Cribs-Verification of Compliance Form.

    OMB Number: 3041-0161.

    Type of Review: Renewal of collection.

    Frequency of Response: On occasion.

    Affected Public: Child care centers.

    Estimated Number of Respondents: 74 child care centers.

    Estimated Time per Response: .25 hour for each child care center to provide the information on the form.

    Total Estimated Annual Burden: 18.5 hours (.25 hour × 74 child care centers).

    General Description of Collection: CPSC staff intends to visit child care centers to measure compliance with the crib safety standards. Information from those visits would be recorded on a “Verification of Compliance Form.” CPSC investigators or designated state or local officials will use the form, which will be filled out entirely at the site during the normal course of the visit. The Commission will use the information to measure compliance with the crib safety standards and to develop an enforcement strategy. A pilot program was conducted in 2012, which included visits to approximately 50 child care centers in six states. Results of the pilot program were used to expand the program in 2013, to seven states and 112 inspections. CPSC conducted the program in 2015, in three states, which included 47 inspections. CPSC projects that four states will participate in the program in 2016 and approximately 74 inspections will be conducted.

    Request for Comments

    The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:

    —Whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility; —Whether the estimated burden of the proposed collection of information is accurate; —Whether the quality, utility, and clarity of the information to be collected could be enhanced; and —Whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology. Dated: February 9, 2016. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2016-02963 Filed 2-12-16; 8:45 am] BILLING CODE 6355-01-P
    CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC-2012-0054] Agency Information Collection Activities; Submission for OMB Review; Comment Request—Safety Standard for Automatic Residential Garage Door Operators AGENCY:

    Consumer Product Safety Commission.

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995 (44 U.S.C. chapter 35), the Consumer Product Safety Commission (“Commission” or “CPSC”) announces that the Commission has submitted to the Office of Management and Budget (“OMB”) a request for extension of approval of a collection of information associated with the CPSC's Safety Standard for Automatic Residential Garage Door Operators (OMB No. 3041-0125). In the Federal Register of December 3, 2015 (80 FR 75664), the CPSC published a notice to announce the agency's intention to seek extension of approval of the collection of information. The Commission received no comments. Therefore, by publication of this notice, the Commission announces that CPSC has submitted to the OMB a request for extension of approval of that collection of information, without change.

    DATES:

    Written comments on this request for extension of approval of information collection requirements should be submitted by March 17, 2016.

    ADDRESSES:

    Submit comments about this request by email: [email protected] or fax: 202-395-6881. Comments by mail should be sent to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the CPSC, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503. In addition, written comments that are sent to OMB also should be submitted electronically at http://www.regulations.gov, under Docket No. CPSC-2012-0054.

    FOR FURTHER INFORMATION CONTACT:

    For further information contact: Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to: [email protected]

    SUPPLEMENTARY INFORMATION:

    CPSC has submitted the following currently approved collection of information to OMB for extension:

    Title: Safety Standard for Automatic Residential Garage Door Operators.

    OMB Number: 3041-0125.

    Type of Review: Renewal of collection.

    Frequency of Response: On occasion.

    Affected Public: Manufacturers and importers of automatic residential garage door operators.

    Estimated Number of Respondents: An estimated 19 firms that conduct performance tests and maintain records based on the test results to maintain UL certification and verify compliance with the rule.

    Estimated Time per Response: Based on staff's review of industry sources, each respondent will spend an estimated 40 hours annually on the collection of information related to the rule.

    Total Estimated Annual Burden: 760 hours (19 firms × 40 hours).

    General Description of Collection: On December 22, 1992, the Commission issued rules prescribing requirements for a reasonable testing program to support certificates of compliance with the Safety Standard for Automatic Residential Garage Door Operators (57 FR 60449). These regulations also require manufacturers, importers, and private labelers of residential garage door operators to establish and maintain records to demonstrate compliance with the requirements for testing to support certification of compliance. 16 CFR part 1211, subparts B and C.

    Dated: February 9, 2016. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2016-02948 Filed 2-12-16; 8:45 am] BILLING CODE 6355-01-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Sunshine Act Meeting

    The National Civilian Community Corps Advisory Board gives notice of the following meeting:

    DATE AND TIME:

    Wednesday, March 16, 2016, 1:30 p.m.-2:30 p.m. (ET).

    PLACE:

    Corporation for National and Community Service, CALL-IN INFORMATION: This meeting is available to the public through the following toll-free call-in number: 888-469-1543 conference call access code number 9701432. Pete McRoberts will be the lead on the call. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Corporation will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Replays are generally available one hour after a call ends. The toll-free phone number for the replay is 866-443-1193, replay passcode 6222. The end replay date: April 16, 2016, 10:59 p.m. (CT).

    STATUS:

    Open.

    MATTERS TO BE CONSIDERED:

    I. Meeting Convenes • Call to Order, Welcome, and Preview of Today's Meeting Agenda • Introduction & Acknowledgements II. Director's Report III. Program Updates IV. Public Comment ACCOMMODATIONS:

    Anyone who needs an interpreter or other accommodations should notify the Corporation's contact person by 5:00 p.m. Friday, March 9, 2016.

    CONTACT PERSON FOR MORE INFORMATION:

    Erma Hodge, NCCC, Corporation for National and Community Service, 3rd Floor, Room 3244D, 250 E St. SW., Washington, DC 20525. Phone 202-606-6696. Fax 202-606-3465. TTY: 800-833-3722. Email address: [email protected]

    Dated: February 10, 2016. Jeremy Joseph, General Counsel.
    [FR Doc. 2016-03160 Filed 2-11-16; 11:15 am] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Department of the Army Intent To Grant an Exclusive License for U.S. Army Owned Invention to Faraday Technology AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Army announces that, unless there is an objection, after 15 days it contemplates granting an exclusive license to Faraday Technology Inc., 315 Huls Dr., Clayton, Ohio 45315, for co-developed invention(s) covering an apparatus and method for recovery of material generated during electrochemical material removal in acidic electrolytes, under SBIR Contract No W15QKN-12-C-0116, and referencing U.S. patent applications 62/114,278 filed February 10, 2015, 62/120,621 filed February 25, 2015, and 14/845,759 filed September 4, 2015. Any license granted shall comply with 35 U.S.C. 209 and 37 CFR part 404.

    DATES:

    Objections must be received within 15 days of this notice.

    ADDRESSES:

    Send written objections to Timothy Ryan, U.S. Army ARDEC, ATTN: RDAR-EIB (Bldg 93), Picatinny Arsenal, NJ 07806-5000.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Timothy Ryan, email: [email protected]; (973) 724-7953.

    SUPPLEMENTARY INFORMATION:

    None.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2016-03043 Filed 2-12-16; 8:45 am] BILLING CODE 5001-03-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID DoD-2016-OS-0011] Proposed Collection; Comment Request AGENCY:

    Office of the Secretary of Defense, DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Office of the Secretary of Defense announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by April 18, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to The United States of America Vietnam War Commemoration, ATTN: Yvonne Schilz, 1101 Wilson Blvd., Suite 810, Arlington, VA 22209-2203 or call 1-877-387-9951.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Vietnam War Commemoration Program Partner Events; DD Form 2956, DD Form 2957, Vietnam War 50th Commemoration Certificate of Honor (1) “In Memory Of” (DD Form x711), (2) “Former Vietnam POW” (DD Form x712), and (3) “Unaccounted For” (DD Form x713); OMB Control Number 0704-0500.

    Needs and Uses: The information collection requirement is necessary to notify the United States of America Vietnam War Commemoration Program of Commemorative Partner's planned events. Information is submitted for inclusion on the Program's events calendar and to request event support in the form of materials and/or speakers from the program. The information collection is necessary to obtain, vet, record, process and provide Certificates of Honor to be presented on behalf of a grateful nation by partner organizations. Additionally, this collection is necessary for the partner organizations to communicate to the Commemoration program the results of their events and lessons learned.

    Affected Public: Businesses or other for-profits; Not-for-profit institutions; Federal Government; State, local or tribal government, or, by exception, eligible individuals or households.

    Annual Burden Hours: 5,500.

    Number of Respondents: 11,000.

    Responses per Respondent: Two (2), on an average annual basis.

    Annual Responses: 22,000.

    Average Burden per Response: 15 minutes.

    Frequency: On occasion.

    Respondents are representatives of commemorative partner organizations or immediate family members of veterans listed on the Vietnam Veterans Memorial in Washington, DC or, by exception, individuals, acting on behalf of eligible family members of American military personnel who are listed as missing and unaccounted for from the Vietnam War by the Department of Defense. Burden is reported as an annual average, and not every respondent will complete all five (5) forms.

    Dated: February 9, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-02947 Filed 2-12-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID USN-2016-HQ-0002] Privacy Act of 1974; System of Records AGENCY:

    Department of the Navy, DoD.

    ACTION:

    Notice to alter a system of records.

    SUMMARY:

    The Department of the Navy proposes to alter a system of records notice N05350-1, entitled “Navy Drug and Alcohol Program System.” This system is used to train, educate, identify, screen, counsel, rehabilitate, and monitor the progress of individuals in drug and alcohol abuse programs. Information is used to screen and evaluate the certified counselors, counselor interns, and counselor applicants throughout the course of their duties.

    DATES:

    Comments will be accepted on or before March 17, 2016. This proposed action will be effective on the date following the end of the comment period unless comments are received which result in a contrary determination.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Robin Patterson, Head, PA/FOIA Office (DNS-36), Department of the Navy, 2000 Navy Pentagon, Washington, DC 20350-2000, or by phone at (202) 685-6545.

    SUPPLEMENTARY INFORMATION:

    The Department of the Navy's notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in the FOR FURTHER INFORMATION CONTACT or from the Defense Privacy and Civil Liberties Division Web site at http://dpcld.defense.gov/.

    The proposed systems reports, as required by 5 U.S.C. 552a(r) of the Privacy Act, as amended, were submitted on February 8, 2016, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

    Dated: February 9, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. N05350-1 System name:

    Navy Drug and Alcohol Program System (December 14, 2010, 75 FR 77855).

    Changes: SORN ID:

    Delete entry and replace with “NM05353-1”.

    System location:

    Delete entry and replace with “Primary location 21st Century Sailor Office (OPNAV N17), 5720 Integrity Drive, Millington, TN 38055-6000.

    Decentralized locations:

    Navy Alcohol Rehabilitation Centers, Navy Alcohol Rehabilitation Departments in Naval Hospitals, Counseling and Assistance Centers, Personal Responsibility and Values Education and Training Program (Prevent) Offices, Navy Drug Screening Laboratories, and local activities to which an individual is assigned. Addresses are contained in a directory which is available from the Director, Navy Alcohol and Drug Prevention (OPNAV N170A), 5720 Integrity Drive, Millington, TN 38055-6000.”

    Categories of individuals covered by the system:

    Delete entry and replace with “Navy and Marine personnel (officers and enlisted) and reserve personnel, who have been identified as drug or alcohol abusers and who are subsequently screened or referred for remedial education, outpatient counseling, or residential rehabilitation; counselors, counselor interns, and counselor applicants; Navy personnel who attend the drug and alcohol preventive education and training; Marine personnel who attend Prime for Life Program for preventive education and training; officer and enlisted members of facilities providing drug and alcohol education, screening, counseling, rehabilitation, and drug testing.”

    Categories of records in the system:

    Delete entry and replace with “Documentation containing full name, Social Security Number (SSN) or DoD ID Number, rate/rank, military status, demographic data, screening and assessment information, medical and laboratory data, results of active and reserve members' urinalysis and hair testing, narrative summaries of treatment, aftercare plans, and other information pertaining to a member's participation in substance abuse education and training, counseling, and rehabilitation programs.”

    Authority for maintenance of the system:

    Delete entry and replace with “10 U.S.C. 1090, Identifying and treating drug and alcohol dependence; 10 U.S.C. 5013, Secretary of the Navy; 10 U.S.C. 5041, Headquarters, Marine Corps; 42 U.S.C. 290dd-2, Confidentiality of records; DoD 6025.18-R, DoD Health Information Privacy Regulation; and E.O. 9397 (SSN), as amended.”

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    Delete entry and replace with “In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974, as amended, the records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    In order to comply with the provisions of 42 U.S.C. 290dd-2, the Department of Defense (DoD) blanket routine uses do not apply to this system of records.

    Specifically, records of the identity, diagnosis, prognosis, or treatment of any client/patient, irrespective of whether or when he/she ceases to be client/patient, maintained in connection with the performance of any alcohol or drug abuse, education, training, treatment, rehabilitation, or research which is conducted, regulated, or directly or indirectly assisted by any department or agency of the United States, shall, except as provided therein, be confidential and be disclosed only for the purposes and under the circumstances expressly authorized in 42 U.S.C. 290dd-2. This statute takes precedence over the Privacy Act of 1974, as amended, in regard to accessibility of such records, except to the individual to whom the record pertains.

    The content of any record may be disclosed in accordance with prior written consent of the patient with respect to whom such record is maintained, but only to such extent, under such circumstances, and for purposes as may be allowed under such prescribed regulations.

    Information from records may be released without the member's consent in the following situations:

    To medical personnel to the extent necessary to meet a bona fide medical emergency.

    To qualified personnel for the purpose of conducting scientific research, management audits, or program evaluation, but such personnel may not identify, directly or indirectly, any individual patient in any report of such research, audit or evaluation, or otherwise disclose patient identities in any manner.

    If authorized by an appropriate order of a court of competent jurisdiction granted after application showing good case therefore. In accessing good cause, the court shall weigh the public interest and the need for disclosure against the injury to the patient, to the physician patient relationship, and to the treatment services. Upon the granting of such order, the court, in determining the extent to which any disclosure of all or any part of any record is necessary, shall impose appropriate safeguards against unauthorized disclosures.

    The above prohibitions do not apply to any interchange of records within the Armed Forces or within those components of the Department of Veterans Affairs furnishing health care to veterans or between such components and the Armed Forces.

    Note:

    This system of records contains Individually Identifiable Health Information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) issued pursuant to the Health Insurance Portability and Accountability Act of 1996, applies to most such health information. DoD 6025-18-R may place additional procedural requirements on the uses and disclosures of such information beyond those found in the Privacy Act of 1974 or mentioned in this system of records notice.”

    Storage:

    Delete entry and replace with “Electronic storage media.”

    Retrievability:

    Delete entry and replace with “Name and SSN or DoD ID Number.”

    Safeguards:

    Delete entry and replace with “Computer facilities are located in restricted areas accessible only to authorized persons that are properly screened, cleared, and trained. Access to Computerized data is restricted by Common Access Card (CAC).”

    Retention and disposal:

    Delete entry and replace with “All electronic records are permanent and are archived within the Alcohol and Drug Management Information System.”

    System manager(s) and address:

    Delete entry and replace with “Director, Navy Alcohol and Drug Prevention Office (OPNAV N170A), 5720 Integrity Drive, Millington, TN 38055-6000.”

    Notification procedure:

    Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Director, Navy Alcohol and Drug Prevention Office (OPNAV N170A), 5720 Integrity Drive, Millington, TN 38055-6000 or to the naval activity providing treatment.

    Addresses are contained in a directory which is available from the Director, Navy Alcohol and Drug Prevention Office (OPNAV N170A), 5720 Integrity Drive, Millington, TN 38055-6000.

    Requests should contain full name, SSN or DoD ID Number, rank/rate, military status, and signature of the requester. The system manager may require an original signature or a notarized signature as a means of proving the identity of the individual.”

    Record access procedures:

    Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written inquiries to the Director, Navy Alcohol and Drug Prevention Office (OPNAV N170A), 5720 Integrity Drive, Millington, TN 38055-6000 or to the naval activity providing treatment.

    Addresses are contained in a directory which is available from the Director, Navy Alcohol and Drug Prevention Office (OPNAV N170A), 5720 Integrity Drive, Millington, TN 38055-6000.

    The letter should contain full name, SSN or DoD ID Number, rank/rate, military status, and signature of the requester. The system manager may require an original signature or a notarized signature as a means of proving the identity of the individual requesting access to the records.”

    [FR Doc. 2016-02946 Filed 2-12-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Training Program for Federal TRIO Programs AGENCY:

    Office of Postsecondary Education, Department of Education.

    ACTION:

    Notice.

    Overview Information:

    Training Program for Federal TRIO Programs (Training Program)

    Notice inviting applications for new awards for fiscal year (FY) 2016.

    Catalog of Federal Domestic Assistance (CFDA) Number: 84.103A. Dates:

    Applications Available: February 16, 2016.

    Deadline for Transmittal of Applications: April 15, 2016.

    Deadline for Intergovernmental Review: July 1, 2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Program: The Training Program provides grants to train the staff and leadership personnel employed in, participating in, or preparing for employment in, projects funded under the Federal TRIO Programs to improve the operation of these projects.

    Priorities: This notice contains six absolute priorities. In accordance with 34 CFR 75.105(b)(2)(iv) and 34 CFR 75.105(b)(2)(ii), the absolute priorities are from section 402G(b) of the Higher Education Act of 1965, as amended (HEA), and the regulations for this program (34 CFR 642.24).

    Absolute Priorities: For FY 2016 and any subsequent year in which we make awards from the list of unfunded applications from this competition, these priorities are absolute priorities. Under 34 CFR 75.105(c)(3), we consider only applications that meet these priorities.

    In accordance with 34 CFR 642.7, each application must clearly identify the specific absolute priority for which a grant is requested. An applicant must submit a separate application for each absolute priority it proposes to address. If an applicant submits more than one application for the same absolute priority, we will accept only the application with the latest “date/time received” validation and we will reject all other applications the applicant submits for that priority.

    These priorities are:

    Absolute Priority 1. Training to improve: Reporting student and project performance and the evaluation of project performance in order to design and operate a model project funded under the Federal TRIO Programs.

    Number of expected awards: 2.

    Maximum award amount: $257,500.

    Absolute Priority 2. Training on: Budget management and the statutory and regulatory requirements for operation of projects funded under the Federal TRIO Programs.

    Number of expected awards: 2.

    Maximum award amount: $257,500.

    Absolute Priority 3. Training on: Assessment of student needs; retention and graduation strategies, including both secondary and postsecondary retention and graduation strategies; and the use of appropriate educational technology in the operation of projects funded under the Federal TRIO programs.

    Number of expected awards: 1.

    Maximum award amount: $334,750.

    Absolute Priority 4. Training on: Assisting students in receiving adequate financial aid from programs assisted under title IV of the HEA and from other programs; college and university admissions policies and procedures; and proven strategies to improve the financial literacy and economic literacy of students, including topics such as basic personal finance information, household money management and financial planning skills, and basic economic decision making skills.

    Number of expected awards: 2.

    Maximum award amount: $257,500.

    Absolute Priority 5. Training on: Strategies for recruiting and serving hard to reach populations, including students who are limited English proficient, students from groups that are traditionally underrepresented in postsecondary education, students with disabilities, students who are homeless children and youths (as this term is defined in Section 725 of the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11434a)), students who are in foster care or are aging out of the foster care system, or other disconnected students.

    Number of expected awards: 1.

    Maximum award amount: $334,750.

    Absolute Priority 6. Training on general project management for new project directors who have been in their position less than two years, including training on the content of absolute priorities one through five. The training should provide new directors with the basic tools required to be a successful TRIO project director.

    Number of expected awards: 1.

    Maximum award amount: $285,500.

    Program Authority: 20 U.S.C. 1070a-11 and 1070a-17.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 82, 84, 86, 97, 98, and 99. (b) The OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The regulations for this program in 34 CFR part 642.

    Note: The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.

    Note: The regulations in 34 CFR part 86 apply to institutions of higher education (IHEs) only.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: $2,500,000.

    Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2017 from the list of unfunded applications from this competition.

    Estimated Range of Awards: $257,500-$334,750.

    Estimated Average Size of Awards: $277,778.

    Maximum Award: The maximum award amount is $257,500 under Absolute Priorities 1, 2, and 4 for a project that will serve a minimum of 224 participants at an approximate cost of $1,150 per participant. The maximum award amount is $334,750 under Absolute Priorities 3 and 5 for a project that will serve a minimum of 291 participants at an approximate cost of $1,150 per participant. The maximum award amount is $285,500 under Absolute Priority 6 for a project that will serve a minimum of 248 participants at an approximate cost of $1,150 per participant. We will reject any application that proposes a budget exceeding the applicable maximum award amount for a single budget period of 12 months. We will also reject an application that proposes to serve less than the minimum number of participants outlined in this paragraph.

    Estimated Number of Awards: 9.

    Note: The Department is not bound by any estimates in this notice.

    Project Period: Up to 24 months.

    III. Eligibility Information

    1. Eligible Applicants: IHEs and other public and private nonprofit institutions and organizations.

    2. Cost Sharing or Matching: This program does not require cost sharing or matching.

    IV. Application and Submission Information

    1. Address to Request Application Package: Suzanne Ulmer, Office of Postsecondary Education (OPE), U.S. Department of Education, 400 Maryland Avenue SW., Room 7E311, Washington, DC 20202. Telephone: (202) 502-7600 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., Braille, large print, audiotape, or compact disc) by contacting the program contact person listed in this section.

    2. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this program.

    Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the application narrative (Part III) to no more than 50 pages. For the purpose of determining compliance with the page limit, each page on which there are words will be counted as one full page. Applicants must use the following standards:

    • A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides. Page numbers and an identifier may be within the 1″ margin.

    • Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in figures and graphs. Text in charts and tables may be single-spaced. You should also include a table of contents in the application narrative, which will not be counted against the page limit.

    • Use a font that is either 12 point or larger, or no smaller than 10 pitch (characters per inch).

    • Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman and Arial Narrow) will not be accepted.

    The page limit does not apply to Part I, the Application for Federal Assistance face sheet (SF 424); Part II, the Budget Information Summary form (ED Form 524); Part III-A, the Program Profile form; Part III-B, the one-page Project Abstract form; and Part IV, the Assurances and Certifications. If you include any attachments or appendices, these items will be counted as part of the application narrative for the purpose of the page-limit requirement. You must include your complete response to the selection criteria and absolute priorities in the application narrative.

    We will reject your application if you exceed the page limit.

    3. Submission Dates and Times:

    Applications Available: February 16, 2016.

    Deadline for Transmittal of Applications: April 15, 2016.

    Applications for grants under this program must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Other Submission Requirements in section IV of this notice.

    We do not consider an application that does not comply with the deadline requirements.

    Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

    Deadline for Intergovernmental Review: July 1, 2016.

    4. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this program.

    5. Funding Restrictions: We specify unallowable costs in 34 CFR 642.31. We reference additional regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    6. Data Universal Numbering System Number, Taxpayer Identification Number, and System for Award Management: To do business with the Department of Education, you must—

    a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

    b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;

    c. Provide your DUNS number and TIN on your application; and

    d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

    You can obtain a DUNS number from Dun and Bradstreet at the following Web site: http://fedgov.dnb.com/webform. A DUNS number can be created within one to two business days.

    If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.

    The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.

    Note: Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.

    If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.

    Information about SAM is available at www.SAM.gov. To further assist you with obtaining and registering your DUNS number and TIN in SAM or updating your existing SAM account, we have prepared a SAM.gov Tip Sheet, which you can find at: http://www2.ed.gov/fund/grant/apply/sam-faqs.html.

    In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page: www.grants.gov/web/grants/register.html.

    7. Other Submission Requirements: Applications for grants under this program must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

    a. Electronic Submission of Applications.

    Applications for grants under the Training Program, CFDA number 84.103A, must be submitted electronically using the Governmentwide Grants.gov Apply site at www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

    We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement.

    You may access the electronic grant application for the Training Program at www.Grants.gov. You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.103, not 84.103A).

    Please note the following:

    • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

    • Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

    • The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

    • You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this program to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at www.G5.gov. In addition, for specific guidance and procedures for submitting an application through Grants.gov, please refer to the Grants.gov Web site at: www.grants.gov/web/grants/applicants/apply-for-grants.html.

    • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

    • You must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

    • You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (e.g., Word, Excel, WordPerfect, etc.) or submit a password-protected file, we will not review that material. Please note that this could result in your application not being considered for funding because the material in question—for example, the project narrative—is critical to a meaningful review of your proposal. For that reason it is important to allow yourself adequate time to upload all material as PDF files. The Department will not convert material from other formats to PDF.

    • Your electronic application must comply with any page-limit requirements described in this notice.

    • After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.

    Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.

    These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.

    • We may request that you provide us original signatures on forms at a later date.

    Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

    If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

    If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the persons listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that the problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. We will contact you after we determine whether your application will be accepted.

    Note: The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

    Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because—

    • You do not have access to the Internet; or

    • You do not have the capacity to upload large documents to the Grants.gov system; and

    • No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.

    If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Address and mail or fax your statement to: Dr. Katie Blanding and Suzanne Ulmer, OPE, U.S. Department of Education, 400 Maryland Avenue SW., Room 7E311, Washington, DC 20202. FAX: (202) 205-0063.

    Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.

    b. Submission of Paper Applications by Mail.

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.103A), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    We will not consider applications postmarked after the application deadline date.

    c. Submission of Paper Applications by Hand Delivery.

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.103A), 550 12th Street SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260. The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Note for Mail or Hand Delivery of Paper Applications: If you mail or hand deliver your application to the Department—

    (1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

    (2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

    Note: Applicants must indicate the absolute priority addressed in the application on the one-page abstract submitted with the application and on the Training Program Profile Sheet.

    V. Application Review Information

    1. Selection Criteria: The selection criteria for this program are in 34 CFR 642.21 and are listed in the application package.

    2. Review and Selection Process: We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    For this competition, a panel of non-Federal reviewers will review each application in accordance with the selection criteria in 34 CFR 642.21. The individual scores of the reviewers will be added and the sum divided by the number of reviewers to determine the peer review score received in the review process. Additionally, in accordance with 34 CFR 642.22, the Secretary will award prior experience points to eligible applicants by evaluating the applicant's current performance under its expiring Training Program grant. Pursuant to 34 CFR 642.22(b)(1), prior experience points, if any, will be added to the application's averaged peer review score to determine the total score for each application.

    Under section 402A(c)(3) of the HEA, the Secretary is not required to make awards under the Training Program in the order of the scores received.

    In the event a tie score exists, the Secretary will select for funding the applicant that has the greatest capacity to provide training to eligible participants in all regions of the Nation in order to assure accessibility to the greatest number of prospective training participants, consistent with 34 CFR 642.20(e).

    3. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this program the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to http://www.ed.gov/fund/grant/apply/appforms/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    4. Performance Measures: The success of the Training Program is measured by its cost-effectiveness based on the number of TRIO project personnel receiving training each year; the percentage of Training Program participants that, each year, evaluate the training as benefiting them in increasing their qualifications and skills in meeting the needs of disadvantaged students; and the percentage of Training Program participants that, each year, evaluate the training as benefiting them in increasing their knowledge and understanding of the Federal TRIO Programs. All grantees will be required to submit an annual performance report documenting their success in training personnel working on TRIO-funded projects, including the average cost per trainee and the trainees' evaluations of the effectiveness of the training provided. The success of the Training Program also is assessed on the quantitative and qualitative outcomes of the training projects based on project evaluation results.

    5. Continuation Awards: In making a continuation award under 34 CFR 75.253, the Secretary considers, among other things: whether a grantee has made substantial progress in achieving the goals and objectives of the project; whether the grantee has expended funds in a manner that is consistent with its approved application and budget; and, if the Secretary has established performance measurement requirements, the performance targets in the grantee's approved application.

    In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    VII. Agency Contacts FOR FURTHER INFORMATION CONTACT:

    Suzanne Ulmer or, if unavailable, Dr. Katie Blanding, OPE, U.S. Department of Education, 400 Maryland Avenue SW., Room 7E311, Washington, DC 20202. Telephone: (202) 502-7600 or by email: [email protected].

    If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

    VIII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to one of the program contact persons listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or PDF. To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Dated: February 10, 2016. Lynn Mahaffie, Deputy Assistant Secretary for Policy, Planning and Innovation Delegated the Duties of Assistant Secretary for Postsecondary Education.
    [FR Doc. 2016-03089 Filed 2-12-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2015-ICCD-0138] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Enterprise Complaint System AGENCY:

    Federal Student Aid (FSA), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 17, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2015-ICCD-0138. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-103, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Enterprise Complaint System.

    OMB Control Number: 1845—NEW.

    Type of Review: A new information collection.

    Respondents/Affected Public: Individuals and Households.

    Total Estimated Number of Annual Responses: 43,200.

    Total Estimated Number of Annual Burden Hours: 7,344.

    Abstract: This is a request for a new information collection. On March 10, 2015, the White House issued a Student Aid Bill of Rights. Among the objectives identified was the creation of a centralized complaint system. The purpose of the Enterprise Complaint System is to meet the objective: “Create a Responsive Student Feedback System: The Secretary of Education will create a new Web site by July 1, 2016, to give students and borrowers a simple and straightforward way to file complaints and provide feedback about federal student loan lenders, servicers, collections agencies, and institutions of higher education. Students and borrowers will be able to ensure that their complaints will be directed to the right party for timely resolution, and the Department of Education will be able to more quickly respond to issues and strengthen its efforts to protect the integrity of the student financial aid programs.” The Department of Education has charged Federal Student Aid with the development and oversight of this new collection.

    Dated: February 10, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-03057 Filed 2-12-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY [FE Docket No. 15-168-LNG] Flint Hills Resources, LP; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations AGENCY:

    Office of Fossil Energy, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on November 5, 2015, by Flint Hills Resources, LP (Flint Hills), requesting long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) primarily by use of approved ISO IMO7-TVAC-ASME LNG (ISO) containers transported on ocean-going carriers to any country with which the United States does not have a free trade agreement (FTA) requiring national treatment for trade in natural gas, and with which trade is not prohibited by U.S. law or policy (non-FTA countries).1 Flint Hills seeks authorization to export the LNG in a volume equivalent to approximately 3.62 billion cubic feet of natural gas per year (Bcf/yr) (0.01 Bcf per day), which it states is approximately 120,000 gallons of LNG per day. Flint Hills seeks to purchase the LNG for export from a LNG liquefaction facility owned by Stabilis LNG Eagle Ford, LLC (Stabilis Facility), located in George West, Texas.2 According to Flint Hills, the Stabilis Facility has the capacity to produce 120,000 gallons of LNG per day and to store approximately 270,000 gallons of LNG. Flint Hills states that the Stabilis Facility is currently operational and can accommodate both ISO container loadings and tanker truck loadings.3 Flint Hill therefore asserts that no additional plant infrastructure will be required as a result of the proposed exports. Flint Hills requests the authorization for a 20-year term to commence on the earlier of the date of first commercial export or a date three months from the issuance of a final order granting the requested authorization. Flint Hills seeks to export this LNG on its own behalf and as agent for other entities who hold title to the LNG at the time of export. The Application was filed under section 3 of the Natural Gas Act (NGA). Additional details can be found in Flint Hills's Application, posted on the DOE/FE Web site at: http://energy.gov/sites/prod/files/2015/11/f27/15_168_lng%20fta_nfta.pdf. Protests, motions to intervene, notices of intervention, and written comments are invited.

    1 In the Application, Flint Hills also requests authorization to export LNG to any nation that currently has, or in the future may enter into, a FTA requiring national treatment for trade in natural gas, and with which trade is not prohibited by U.S. law or policy (FTA countries). DOE/FE will review that request for a FTA export authorization separately pursuant to NGA section 3(c), 15 U.S.C. 717b(c).

    2 Flint Hills states that Stabilis LNG is owned in part (49%) by Flint Hills's affiliate, FHR LNG, LLC. App. at 3 n.4.

    3 Flint Hills states that it generally intends to use ISO containers to export LNG. Under this scenario, the ISO containers will be trucked to a port or dock located along the Gulf Coast, where the containers will be loaded onto a barge or ship for delivery to non-FTA countries. If Flint Hills uses tanker trucks, it will truck LNG from the Stabilis Facility directly to a bulk transport barge, ship, or floating storage container for distribution to customers in both FTA and non-FTA countries. App. at 4-5. Appendix A of the Application contains a list of ports from which Flint Hills may export LNG.

    DATES:

    Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, April 18, 2016.

    ADDRESSES:

    Electronic Filing by email: [email protected].

    Regular Mail U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, P.O. Box 44375, Washington, DC 20026-4375. Hand Delivery or Private Delivery Services (e.g., FedEx, UPS, etc.) U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. FOR FURTHER INFORMATION CONTACT:

    Larine Moore or Benjamin Nussdorf, U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478; (202) 586-7893. Cassandra Bernstein, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9793. SUPPLEMENTARY INFORMATION: DOE/FE Evaluation

    The Application will be reviewed pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. To the extent determined to be relevant, these issues will include the domestic need for the natural gas proposed to be exported, the adequacy of domestic natural gas supply, U.S. energy security, and the cumulative impact of the requested authorization and any other LNG export application(s) previously approved on domestic natural gas supply and demand fundamentals. DOE may also consider other factors bearing on the public interest, including the impact of the proposed exports on the U.S. economy (including GDP, consumers, and industry), job creation, the U.S. balance of trade, and international considerations; and whether the authorization is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of LNG:

    Effect of Increased Levels of Liquefied Natural Gas on U.S. Energy Markets, conducted by the U.S. Energy Information Administration upon DOE's request (2014 EIA LNG Export Study); 4 and

    4 The 2014 EIA LNG Export Study, published on Oct. 29, 2014, is available at: https://www.eia.gov/analysis/requests/fe/.

    The Macroeconomic Impact of Increasing U.S. LNG Exports, conducted jointly by the Center for Energy Studies at Rice University's Baker Institute for Public Policy and Oxford Economics, on behalf of DOE (2015 LNG Export Study).5

    5 The 2015 LNG Export Study, dated Oct. 29, 2015, is available at: http://energy.gov/sites/prod/files/2015/12/f27/20151113_macro_impact_of_lng_exports_0.pdf.

    Additionally, DOE will consider the following environmental document: Addendum to Environmental Review Documents Concerning Exports of Natural Gas From the United States, 79 FR 48132 (Aug. 15, 2014).6 Parties that may oppose this Application should address these issues in their comments and/or protests, as well as other issues deemed relevant to the Application.

    6 The Addendum and related documents are available at: http://energy.gov/fe/draft-addendum-environmental-review-documents-concerning-exports-natural-gas-united-states.

    The National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., requires DOE to give appropriate consideration to the environmental effects of its proposed decisions. No final decision will be issued in this proceeding until DOE has met its environmental responsibilities.

    Public Comment Procedures

    In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Due to the complexity of the issues raised by the Applicant, interested parties will be provided 60 days from the date of publication of this Notice in which to submit their comments, protests, motions to intervene, or notices of intervention.

    Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.

    Filings may be submitted using one of the following methods: (1) Emailing the filing to [email protected], with FE Docket No. 15-168-LNG in the title line; (2) mailing an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES; or (3) hand delivering an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES. All filings must include a reference to FE Docket No. 15-168-LNG. PLEASE Note: If submitting a filing via email, please include all related documents and attachments (e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner. Any hardcopy filing submitted greater in length than 50 pages must also include, at the time of the filing, a digital copy on disk of the entire submission.

    A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.

    The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

    The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address: http://www.fe.doe.gov/programs/gasregulation/index.html.

    Issued in Washington, DC, on February 9, 2016. John A. Anderson, Director, Office of Regulation and International Engagement, Office of Oil and Natural Gas. [FR Doc. 2016-03093 Filed 2-12-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Energy Savings Performance Contract Energy Sales Agreement AGENCY:

    Federal Energy Management Program (FEMP), Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy (DOE).

    ACTION:

    Notice of availability and request for comments.

    SUMMARY:

    The Federal Energy Management Program Office (FEMP), within the U.S. Department of Energy (DOE), published a notice, “Request for Comments on Including Onsite Renewable Energy Generation under Energy Savings Performance Contracts,” on its Web site to obtain information on potential obstacles associated with the implementation of privately-owned onsite renewable energy generation projects under the federal energy savings performance contract (ESPC) authority, including potential issues with regard to project eligibility for the federal solar investment tax credit (ITC) and the use of the ESPC ENABLE Program for such projects.

    DATES:

    Written comments and information are requested on or before March 2, 2016.

    ADDRESSES:

    Interested parties are to submit comments electronically to: [email protected]

    Instructions: All submissions received must include “Feb 2016 ESPC Request for Comments” in the subject of the message. The notice is available athttp://energy.gov/eere/femp/downloads/request-comments-including-onsite-renewable-energy-generation-under-energy.

    FOR FURTHER INFORMATION CONTACT:

    Tracy Logan, U.S. Department of Energy, Federal Energy Management Program (EE-2L), 1000 Independence Avenue SW., Washington, DC 20585; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    FEMP published a notice, “Request for Comments on Including Onsite Renewable Energy Generation under Energy Savings Performance Contracts,” to obtain information on potential obstacles associated with the implementation of privately-owned onsite renewable energy generation projects under the federal energy savings performance contract (ESPC) authority, including potential issues with regard to project eligibility for the federal solar investment tax credit (ITC) and the use of the ESPC ENABLE Program for such projects. The notice is available at http://energy.gov/eere/femp/downloads/request-comments-including-onsite-renewable-energy-generation-under-energy.

    FEMP invites all interested parties to submit in writing by March 2, 2016, comments and information on matters addressed in the notice.

    Issued in Washington, DC, on February 3, 2016. Hayes Jones, Operations Supervisor, Federal Energy Management Program.
    [FR Doc. 2016-03103 Filed 2-12-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy Request for Information: Accounting Conventions for Non-Combustible Renewable Energy Use AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy (DOE).

    ACTION:

    Notice of Request for Information (RFI).

    SUMMARY:

    The Department of Energy (DOE) gives notice of a Request for Information: “Accounting Conventions for Non-Combustible Renewable Energy Use” regarding using an alternative methodology for calculating source energy from non-combustible renewable resources in analysis that informs DOE, Office of Energy Efficiency and Renewable Energy (EERE) products, reports, and standards—such as the Home Energy Score. The current approach uses the equivalent average heat rate of fossil fuels to convert renewable electricity to source energy (approximately 9,500 BTU/kWh), while the proposed approach would use the heat content of electricity (3,412 BTU/kWh). This proposed change would better represent the lack of fuels used in generating renewable electricity, and would result in a slightly lower site-to-source ratio than the current approach.

    DATES:

    Written comments and information are requested on or before March 14, 2016, no later than 5:00 p.m. (ET).

    ADDRESSES:

    Interested persons are encouraged to submit comments, which must be submitted electronically to [email protected] Please visit https://eere-exchange.energy.gov/ for the full RFI and to ask and view responses to questions regarding this RFI.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information may be sent to Steve Capanna, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: 202-586-7367. Email: [email protected].

    SUPPLEMENTARY INFORMATION: Background

    EERE publishes reports, tools, and standards that include analyses that examine the impact of energy efficiency measures on total energy savings, and that compare energy savings between different types of technologies. A commonly used methodology for this is to convert the “site energy” into source energy (or “primary energy”) using a site-to-source ratio. For electricity, this essentially converts the energy used in a building (in kilowatt-hours, kWh) into the equivalent amount of fuel required to generate that electricity (typically in British Thermal Units, BTU).

    The site-to-source ratio accounts for the useful energy lost in converting, transmitting, and distributing energy carriers. As a result, the source energy can be three times the size of the equivalent site energy, depending on location and electricity generation technology used. The benefit of using source energy as a metric for determining the impact of energy efficiency measures and technologies is that it is a more equitable “apples-to-apples” comparison of energy use than looking at site energy alone.

    Typically, analyses use electricity energy data provided by the Energy Information Administration (EIA) in their Monthly Energy Review to calculate a site-to-source ratio. Using this EIA document, the total energy content of fuels used to generate electricity is divided by the total amount of electricity consumed by end users to calculate the site-to-source ratio.

    Accounting for the total source energy of electricity produced from combustible fuels (e.g., coal, natural gas, oil) is relatively straightforward as the energy content of these fuels is known. However, for non-combustible renewable resources (i.e., wind, solar, hydro, and geothermal) because there is no “fuel” used, a choice must be made to determine how to account for the primary energy of electricity generated from these sources.

    The current “fossil fuel equivalency” accounting convention used by the EIA to calculate the reported source energy number, assumes that non-combustible renewable electricity (RE) generation has the same source energy per kWh as the average of fossil fuel electricity. This factor, equivalent to a heat rate, represents the average amount of fossil fuel energy required to produce a kWh of electricity. Alternatively, the factor can be thought of as the amount of fossil energy displaced by a kWh of RE. The most recent value reported by EIA in Table A6 of the Monthly Energy Review is 9,541 BTU/kWh, which is equivalent to a generation efficiency of roughly 36%.

    The “captured energy” alternative convention accounts only for the energy output from a non-combustible generator. This assumes that the conversion from energy resource (e.g. sunlight, wind, water, etc.) into electricity is 100% efficient. The energy content of electricity generated from a non-combustible source using this accounting convention is 3,412 BTU/kWh, which is a unit conversion.

    An example comparison of the two methods of calculating source energy and site-to-source ratios using 2014 data is presented in the table below. Using the captured energy approach decreases the site-to-source ratio from 2.98 to 2.77 as compared to the fossil fuel equivalency approach.

    Comparison of Different Methodologies of Non-Combustible Renewable Energy Accounting on Site-to-Source Ratios, Using 2014 Data  a Method RE gen. (TWh) b Conversion
  • factor
  • (BTU/kWh)
  • RE source
  • energy
  • (quad)
  • Non-RE source
  • energy
  • (quad) c
  • Total source energy
  • (quad)
  • End use
  • (quad) d
  • Site-to-source ratio e
    Fossil Fuel Equivalency 475 f 9,541 4.53 35.21 39.74 13.32 2.98 Captured Energy 475 g 3,412 1.62 35.21 36.83 13.32 2.77 a 2014 data from December 2015 edition of EIA's Monthly Energy Review (http://www.eia.gov/totalenergy/data/monthly) Tables 7.1, 7.2a, 7.3a, and A6. 1 Quad = 1015 BTU. b Includes wind, solar photovoltaic, solar thermal, geothermal, and hydro generation c Coal, petroleum, natural gas, and nuclear generation from Table 7.2a is converted to Quads using the heat contents from Table A6. Wood, waste, other gases, and other generation source energy used as reported in Table 7.3a. d End use energy is calculated as net generation of electricity (13.97 Quads) plus imports (0.16 Quads) minus transmission & distribution losses (0.82 Quads), as reported in Table 7.1 and converted to Quads using 3,412 BTU/kWh. e Note that ratios reported here were calculated without independent rounding. f As reported in Table A6. g A constant unit conversion, Table A6.

    The fossil fuel equivalency approach to calculating RE source energy may be sufficient when the level of RE generation is small. However, with generation from RE resources increasing due to the continued trend of de-carbonizing the grid, the importance of the RE source energy accounting methodology also increases. EERE believes that using the “captured energy” approach most accurately reflects how RE generation differs from other types of conventional generation, and is therefore the best way to include it when accounting for the benefits of energy efficiency measures and standards.

    Purpose

    The purpose of this RFI is to solicit feedback from industry, academia, research laboratories, government agencies, and other stakeholders on issues related to the proposed modification to the accounting of RE source energy. EERE proposes to replace the fossil-fuel equivalency approach with the alternative captured energy approach presented above. This would impact the site-to-source ratios used in analyses that inform EERE reports, standards, and evaluations. This methodological choice is important as renewable generation continues to grow and accounts for more significant portions of the nation's electricity production. This is not announcing a proposed rule or policy change at this time, and is solely an effort to gather information from stakeholders to help inform EERE on whether a change to the source energy calculation should be proposed.

    Request for Information Categories and Questions

    1. Describe your organization and its relationship to any EERE products, analyses, or standards.

    2. Please provide comment on the proposed change in methodology from the current “fossil fuel equivalency” (e.g. 9,541 BTU/kWh) to the “captured energy” approach (e.g. 3,412 BTW/kWh) discussed in the background section. What are the advantages and disadvantages of each? How might it affect you/your organization?

    3. Please describe any alternative methodology not discussed in the background section that you think merits consideration, along with the advantages and disadvantages.

    4. Please describe any other important aspects of primary energy and site-to-source ratio methodologies for EERE to consider. What are these aspects and why are they important?

    Request for Information Response Guidelines

    Responses to this RFI must be submitted electronically to [email protected] no later than 5:00 p.m. (ET) on March 14, 2016. Responses must be provided as attachments to an email. It is recommended that attachments with file sizes exceeding 25MB be compressed (i.e., zipped) to ensure message delivery. Responses must be provided as a Microsoft Word (.docx) attachment to the email, and no more than 20 pages in length, 12 point font, 1 inch margins. Only electronic responses will be accepted.

    Please identify your answers by responding to a specific question or topic if applicable. Respondents may answer as many or as few questions as they wish. EERE will not respond to individual submissions or publish publicly a compendium of responses. A response to this RFI will not be viewed as a binding commitment to develop or pursue the project or ideas discussed.

    Respondents are requested to provide the following information at the start of their response to this RFI:

    • Company/institution name;

    • Company/institution contact;

    • Contact's address, phone number, and email address.

    Confidential Business Information

    Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email two well marked copies: One copy of the document marked “confidential” including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

    Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person that would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.

    Issued in Washington, DC, on February 9, 2016. Kathleen Hogan, Deputy Assistant Secretary.
    [FR Doc. 2016-03118 Filed 2-12-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2972-024] The City of Woonsocket; Notice of Intent To File License Application, Filing of Pre-Application Document, and Approving Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and Request to Use the Traditional Licensing Process.

    b. Project No.: 2972-024.

    c. Date Filed: October 19, 2015.

    d. Submitted By: The City of Woonsocket.

    e. Name of Project: Woonsocket Falls Project.

    f. Location: On the Blackstone River, in Providence County, Rhode Island. No federal lands are occupied by the project works or located within the project boundary.

    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.

    h. Potential Applicant Contact: Charles Rosenfield, Thundermist Hydropower, 87 Senexet Road, Woodstock, CT 06281; (860) 928-7100; or by email—[email protected]

    i. FERC Contact: Patrick Crile at (202) 502-8042; or email at [email protected]

    j. The City of Woonsocket filed its request to use the Traditional Licensing Process on October 19, 2015. The City of Woonsocket provided public notice of its request on December 21, 2015. In a letter dated February 9, 2016, the Director of the Division of Hydropower Licensing approved the City of Woonsocket's request to use the Traditional Licensing Process.

    k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR, Part 402. We are also initiating consultation with the Rhode Island Historical Preservation and Heritage Commission, the State Historic Preservation Office (SHPO), as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.

    l. With this notice, we are designating the City of Woonsocket as the Commission's non-federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act and consultation pursuant to section 106 of the National Historic Preservation Act.

    m. The City of Woonsocket filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.

    n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site (http://www.ferc.gov), using the “eLibrary” link. Enter the docket number, excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). A copy is also available for inspection and reproduction at the address in paragraph h.

    o. The licensee states its unequivocal intent to submit an application for a new license for Project No. 2972-024. Pursuant to 18 CFR 16.8, 16.9, and 16.10 each application for a new license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by October 31, 2018.

    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03022 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER12-162-016; ER11-3876-019; ER16-438-002; ER11-2044-019; ER15-2211-007; ER10-2611-017.

    Applicants: Bishop Hill Energy II LLC, Cordova Energy Company LLC, Marshall Wind Energy LLC, MidAmerican Energy Company, MidAmerican Energy Services, LLC, Saranac Power Partners, L.P.

    Description: Notification of Change in Status of the BHE MBR Sellers.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5181.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER15-13-004.

    Applicants: Transource Wisconsin, LLC.

    Description: Compliance filing: Transource Wisconsin Compliance Filing to be effective 12/1/2014.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5171.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER15-1196-006.

    Applicants: Nevada Power Company.

    Description: Compliance filing: OATT Errata to Attachment P NPC to be effective 2/16/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5056.

    Comments Due: 5 p.m. ET 3/1/16.

    Docket Numbers: ER15-1627-001.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Correction Filing to Beech Ridge II ISA No. 3087, Queue No. M24 to be effective 3/31/2015.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5089.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER15-958-004.

    Applicants: Transource Kansas, LLC.

    Description: Compliance filing: Transource Kansas Compliance Filing to be effective 4/3/2015.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5161.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-909-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Original Service Agreement No. 4400; Queue Position Z2-046/AA1-066 to be effective 1/8/2016.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5086.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-910-000.

    Applicants: EPP New Jersey Solar, LLC.

    Description: Tariff Cancellation: Cancellation of market-based rate tariff. to be effective 2/8/2016.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5147.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-911-000.

    Applicants: EPP New Jersey Biogas, LLC.

    Description: Tariff Cancellation: Cancellation of market-based rate tariff. to be effective 2/8/2016.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5148.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-912-000.

    Applicants: Arizona Public Service Company.

    Description: § 205(d) Rate Filing: Rate Schedule No. 274—Planning Participation Agreement to be effective 4/9/2016.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5160.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-913-000.

    Applicants: NextEra Energy Transmission West, LLC.

    Description: Compliance filing: NextEra Energy Transmission West, LLC Compliance Filing-2 to be effective10/20/2015.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5170.

    Comments Due: 5 p.m. ET 2/29/16.

    Docket Numbers: ER16-914-000.

    Applicants: Axpo U.S. LLC.

    Description: Baseline eTariff Filing: Axpo U.S. LLC Application for Market-Based Rate Authorization to be effective 4/5/2016.

    Filed Date: 2/4/16.

    Accession Number: 20160204-5238.

    Comments Due: 5 p.m. ET 2/25/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03017 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice Establishing Post-Technical Conference Comments Docket Nos. PJM Interconnection, L.L.C ER15-2562-000
  • ER15-2563-000.
  • Consolidated Edison Company of New York, Inc. v. PJM Interconnection, L.L.C EL15-18-001. Linden VFT, LLC v. PJM Interconnection, L.L.C EL15-67-000. Delaware Public Service Commission and Maryland Public Service Commission v. PJM Interconnection, L.L.C EL15-95-000. PJM Interconnection, L.L.C ER14-972-003. PJM Interconnection, L.L.C ER14-1485-005
  • Not Consolidated.
  • In an order dated November 24, 2015,1 the Commission found that the assignment of cost allocation for the projects in the filings and complaints listed in the caption using PJM's solution-based distribution factor (DFAX) cost allocation method had not been shown to be just and reasonable and may be unjust, unreasonable, or unduly discriminatory or preferential. The Commission directed its staff to establish a technical conference to explore both whether there is a definable category of reliability projects within PJM for which the solution-based DFAX cost allocation method may not be just and reasonable, such as projects addressing reliability violations that are not related to flow on the planned transmission facility, and whether an alternative just and reasonable ex ante cost allocation method could be established for any such category of projects.

    1PJM Interconnection, L.L.C., et al., 153 FERC ¶ 61,245 (2015) (November 2015 Order).

    The technical conference was held on January 12, 2016. At the technical conference, staff indicated that it would establish a schedule for post-technical conference comments after reviewing the technical conference transcript. A revised technical conference transcript was placed in the above-referenced dockets on February 9, 2016.

    Post-technical conference comments, not to exceed 20 pages, are due on or before March 1, 2016.

    For more information about this technical conference, please contact [email protected]; or Sarah McKinley, 202-502-8368, [email protected], regarding logistical issues.

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03018 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98-1-000] Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.

    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.

    Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.

    Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).

    The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659.

    Docket No. File date Presenter or requester Prohibited: 1. CP16-96-000 1-27-2016 Paul M. Blanch. 2. CP15-554-000 1-27-2016 Peggy Quarles. 3. CP15-500-000 1-27-2016 Brent Ducker. 4. CP15-500-000 1-29-2016 Joe Moore. 5. CP15-89-000 2-1-2016 FERC Staff.1 6. CP15-500-000 2-2-2016 Grouped Letters.2 7. CP15-500-000 2-2-2016 Grouped Letters.3 8. CP15-500-000 2-2-2016 James Glendinning. 9. CP15-500-000 2-2-2016 Barbel Helmert. 10. CP15-500-000 2-2-2016 Case Southerland. 11. CP15-500-000 2-2-2016 Linda Kay Wilde. 12. CP15-500-000 2-3-2016 Williams McGhee. 13. CP15-500-000 2-4-2016 Grouped Letters.4 14. CP16-21-000 2-5-2016 North Central Massachusetts Chamber of Commerce. Exempt: 1. CP15-91-000 1-12-2016 FERC Staff.5 2. CP14-347-000 1-27-2016 U.S. Senator David Vitter. 3. CP15-91-000 1-28-2016 FERC Staff.6 4. CP16-10-000, CP15-554-000 1-29-2016 State of Virginia Delegate Tony Wilt. 5. CP15-554-000 1-29-2016 State of North Carolina General Assembly Senator Philip E. Berger. 6. CP15-89-000 2-2-2016 State of New Jersey Legislature.7 7. CP15-554-000 2-4-2016 FERC Staff.8 8. CP09-6-001 2-8-2016 FERC Staff.9 1 Phone Memorandum dated February 1, 2016 with Keith Sturn (New Jersey Natural Gas) regarding Garden State Expansion Project. 2 Mass Mailing: 82 letters have been sent to FERC Commissioners and staff under this docket number. 3 Mass Mailing: 82 letters have been sent to FERC Commissioners and staff under this docket number. 4 Mass Mailing: 33 letters have been sent to FERC Commissioners and staff under this docket number. 5 Email dated January 12, 2016 between Lisa Connolly of Spectra Energy Transmissions and FERC Staff. 6 Memo to the File regarding two meetings (January 7 and 13, 2016) between FERC, Spectra/East Tennessee staff, and Spectra/East Tennessee contractors. 7 Senator Samuel D. Thompson, Assemblyman Ronald S. Dancer, and Assemblyman Robert D. Clifton. 8 Record of Project Meeting on January 14, 2016 with participants from FERC, U.S. Forest Service, and Dominion Transmission Inc. 9 LNG Engineering Phone Correspondence from November 23, 2015 and November 24, 2015 phone conferences between FERC and Oregon LNG Representatives. Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03024 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 1894-207—South Carolina Parr Hydroelectric Project] South Carolina Electric & Gas Company; Notice of Revised Restricted Service List for a Programmatic Agreement

    Rule 2010 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.2010, provides that, to eliminate unnecessary expense or improve administrative efficiency, the Secretary may establish a restricted service list for a particular phase or issue in a proceeding concerning non-public information. The restricted service list should contain the names of persons on the service list who, in the judgment of the decisional authority establishing the list, are active participants with respect to the phase or issue in the proceeding for which the list is established.

    The Commission staff is consulting with the South Carolina Department of Archives & History (South Carolina SHPO) and the Advisory Council on Historic Preservation (Advisory Council) pursuant to the Advisory Council's regulations, 36 CFR part 800, implementing section 106 of the National Historic Preservation Act, as amended, (54 U.S.C. 306108), to prepare a Programmatic Agreement for managing properties included in, or eligible for inclusion in, the National Register of Historic Places that could be affected by issuance of a new license for the Parr Hydroelectric Project No. 1894-207.

    On November 18, 2014, Commission staff established a restricted service list for the Parr Hydroelectric Project. Since that time, the United Keetoowah Band of Cherokee Indians in Oklahoma requested a change in the restricted service list and therefore, the restricted service list is revised as follows:

    Replace “Lisa C. Baker, Acting THPO, United Keetoowah Band of Cherokee Indians in Oklahoma” with “Assistant Chief Joe Bunch, or Representative, United Keetoowah Band of Cherokee Indians in Oklahoma.”

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03020 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR15-26-000] Enterprise Texas Pipeline LLC; Notice of Informal Settlement Conference

    Take notice that an informal settlement conference will be convened in the above-captioned proceeding on February 24, 2016, at 10:00 a.m. (EDT), in a room to be designated at the offices of the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, for the purpose of exploring the possible settlement of the above-referenced docket.

    At the conference, Enterprise Texas Pipeline LLC should be prepared to provide, as necessary, additional support for its position.

    FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to [email protected] or call toll free (866) 208-3372 (voice) or 202-502-8659 (TTY), or send a fax to 202-208-2106 with the required accommodations.

    All interested parties and staff are permitted to attend. For further information please contact David Tishman at (202) 502-8515 or email at [email protected] or Seong-Kook Berry at (202) 502-6544 or email at [email protected]

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03023 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. IS16-61-000] Colonial Pipeline Company; Notice of Technical Conference

    Take notice that a technical conference will be held on Wednesday, March 9, 2016, at 9:00 a.m. (Eastern Standard Time), in Hearing Room 1 at the offices of the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    At the technical conference, the Commission Staff and the parties to the proceeding should be prepared to discuss all issues set for technical conference as established in the December 3, 2015 Order (Colonial Pipeline Company, 153 FERC ¶ 61,270 (2015)).

    All interested persons are permitted to attend. Advanced registration is required for all attendees. Attendees may register in advance at the following Web page: https://www.ferc.gov/whats-new/registration/03-09-16-form.asp. Information on this event will be posted on the Calendar of Events on the Commission's Web site, www.ferc.gov, prior to the event.

    Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to [email protected] or call toll free 1-866-208-3372 (voice) or 202-502-8659 (TTY); or send a fax to 202-208-2106 with the required accommodations.

    For more information about this technical conference, please contact Adrianne Cook, 202-502-8849, [email protected] or David Faerberg, 202-502-8275, [email protected]

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03019 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP15-1322-000] Sabine Pipe Line, LLC; Notice of Informal Settlement Conference

    Take notice that an informal settlement conference will be convened in this proceeding commencing at 1:00 p.m. on February 17, 2016, at the offices of the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, for the purpose of exploring the possible settlement of the above-referenced dockets.

    Any party, as defined by 18 CFR 385.102(c), or any participant as defined by 18 CFR 385.102(b), is invited to attend. Persons wishing to become a party must move to intervene and receive intervenor status pursuant to the Commission's regulations (18 CFR 385.214).

    FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to the undersigned Trial Staff contacts with the required accommodations.

    For additional information, please contact Lorna Hadlock at 202-502-8737, [email protected]

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03025 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Brookfield White Pine Hydro LLC, Project No. 2322-060—Maine, Shawmut Hydroelectric Project; Notice of Proposed Restricted Service List for a Programmatic Agreement

    Rule 2010 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.2010, provides that, to eliminate unnecessary expense or improve administrative efficiency, the Secretary may establish a restricted service list for a particular phase or issue in a proceeding concerning non-public information. The restricted service list should contain the names of persons on the service list who, in the judgment of the decisional authority establishing the list, are active participants with respect to the phase or issue in the proceeding for which the list is established.

    The Commission staff is consulting with the Maine Historic Preservation Commission (Maine SHPO) and the Advisory Council on Historic Preservation (Advisory Council) pursuant to the Advisory Council's regulations, 36 CFR part 800, implementing section 106 of the National Historic Preservation Act, as amended, (54 U.S.C. 306108), to prepare a Programmatic Agreement for managing properties included in, or eligible for inclusion in, the National Register of Historic Places that could be affected by issuance of a new license for the Shawmut Hydroelectric Project No. 2322-060.

    The Programmatic Agreement, when executed by the Commission and the Maine SHPO, would satisfy the Commission's section 106 responsibilities for all individual undertakings carried out in accordance with the license until the license expires or is terminated (36 CFR 800.13[e]). The Commission staff proposes to draft the Programmatic Agreement in consultation with certain parties listed below.

    Brookfield White Pine Hydro LLC, as licensee for the Shawmut Hydroelectric Project, is invited to participate in consultations to develop the Programmatic Agreement and to sign as a concurring party to the Programmatic Agreement. For purposes of commenting on the Programmatic Agreement, we propose to restrict the service list for Project No. 2322-060 as follows:

    Dr. John Eddins, Advisory Council on Historic Preservation, 401 F Street NW., Suite 308, Washington, DC 20001-2637 Kirk F. Mohney, SHPO, Maine Historic Preservation Commission, 55 Capitol Street, 65 State House Station, Augusta, ME 04333-0065 Robin K. Reed or Representative, Maine Historic Preservation Commission, 55 Capitol Street, 65 State House Station, Augusta, ME 04333-0065 Frank Dunlap and Representative, Brookfield Renewable Energy Group, 26 Katherine Drive, Hallowell, ME 04347 Jennifer Pictou, THPO, or Representative, Aroostook Band of Micmac, 7 Northern Road, Presque Isle, ME 04769 Chris Sockalexis, THPO, or Representative, Penobscot Indian Nation, 12 Wabanaki Way, Indian Island, ME 04468 Donald Soctomah, THPO, Passamaquoddy Tribe—Pleasant Point, or Representative, P.O. Box 159, Princeton, ME 04668 Chief William Nicolas, Sr. or Representative, Passamaquoddy Tribe—Indian Township, P.O. Box 301, Princeton, ME 04668 Chief Brenda Commander or Representative, Houlton Band of Maliseet, 88 Bell Road, Littleton, ME 04730 David Saunders, Bureau of Indian Affairs, Eastern Region, 545 Marriott Drive, Suite 700, Nashville, TN 37214 Harold Peterson, Bureau of Indian Affairs, Eastern Region, 545 Marriott Drive, Suite 700, Nashville, TN 37214

    Any person on the official service list for the above-captioned proceedings may request inclusion on the restricted service list, or may request that a restricted service list not be established, by filing a motion to that effect within 15 days of this notice date. A copy of any such motion must be filed with the Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426 and must be served on each person whose name appears on the official service list. If no such motions are filed, the restricted service list will be effective at the end of the 15 day period. Otherwise, a further notice will be issued ruling on the motion.

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03021 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD16-16-000] Implementation Issues Under the Public Utility Regulatory Policies Act of 1978; Notice of Technical Conference

    Take notice that the Federal Energy Regulatory Commission plans to hold a technical conference in the above-captioned docket on implementation issues under the Public Utility Regulatory Policies Act of 1978, 16 U.S.C. 796(17)-(18), 824a-3 (2012) (PURPA). The technical conference will take place on June 29, 2016. The conference will be held at the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The technical conference will bewebcast and transcribed.

    Further information concerning topics and speakers, as well as matters relevant to the organization of the technical conference, will be provided at a later date in supplemental notices.

    Dated: February 9, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03016 Filed 2-12-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL 9942-42-OA] Local Government Advisory Committee (LGAC); Notice of Charter Renewal AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    Notice is hereby given that the Environmental Protection Agency (EPA) has determined that, in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, the Local Government Advisory Committee (LGAC) is a necessary committee which is in the public interest. Accordingly, LGAC will be renewed for an additional two-year period. The purpose of LGAC is to provide advice and recommendations to EPA's Administrator on ways to improve its partnership with Local Governments and provide more efficient and effective environmental protection.

    Inquiries may be directed to Frances Eargle, Designated Federal Officer, LGAC, U.S. EPA, (Mail Code 1301A), 1200 Pennsylvania Avenue NW., Washington, DC 20460, or [email protected]

    Dated: February 4, 2016. Nichole Distefano, Associate Administrator, Office of Congressional and Intergovernmental Relations.
    [FR Doc. 2016-03101 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2015-0469; FRL-9942-26-OW] Draft Technical Support Document: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of availability.

    SUMMARY:

    The Environmental Protection Agency (EPA) is announcing availability of the draft technical support document: Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model for public comment. In 2007, EPA published updated criteria for freshwater copper using the Biotic Ligand Model (BLM), a bioavailability model that relies on ten water quality input parameters to estimate copper criteria protective of aquatic life in freshwater. This draft technical support document summarizes data analysis approaches EPA used to develop recommendations for default values for water quality parameters used in the Freshwater Copper BLM when data are lacking. These default values may also be used to fill in missing water quality input parameters in the application of other metal BLM models as well, when data are lacking. Following closure of this 30 day public comment period, EPA will consider the comments, revise the document, as appropriate, and then publish a final technical support document that will serve as a source of information for states, tribes, territories, and other stakeholders.

    DATES:

    Comments must be received on or before March 17, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2015-0469, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Kathryn Gallagher, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: (202) 564-1398; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. General Information A. How can I get copies of this document and other related information?

    1. Docket: All documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426. For additional information about EPA's public docket, visit EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

    II. What is the relationship between state or tribal water quality standards and the draft technical support document? Recommended estimates for missing water quality parameters for application in EPA's biotic ligand model?

    As part of the water quality standards triennial review process defined in section 303(c)(1) of the CWA, the states and authorized tribes are responsible for maintaining and revising water quality standards. Water quality standards consist of designated uses, water quality criteria to protect those uses, a policy for antidegradation, and may include general policies for application and implementation. States and authorized tribes must adopt water quality criteria that protect designated uses. Protective criteria are based on a sound scientific rationale and contain sufficient parameters or constituents to protect the designated uses. States and authorized tribes have four options when adopting water quality criteria for which EPA has published section 304(a) criteria. They can:

    (1) Establish numerical values based on recommended section 304(a) criteria;

    (2) Adopt section 304(a) criteria modified to reflect site-specific conditions;

    (3) Adopt criteria derived using other scientifically defensible methods; or

    (4) Establish narrative criteria where numeric criteria cannot be established or to supplement numerical criteria (40 CFR 131.11(b)).

    The current 304(a) criteria recommendation for freshwater copper relies on implementation of the BLM model. The model requires 10 inputs to determine the criteria. This technical support document provides default values for 8 of the 10 parameters, where site-specific data are not available, and thereby facilitates the use of the BLM model. The document describes the methods used to estimate missing parameters.

    III. Information on the Draft Technical Support Document Recommended Estimates for Missing Water Quality Parameters for Application in EPA's Biotic Ligand Model

    The Biotic Ligand Model (BLM) is used to derive Aquatic Life Ambient water quality criteria for copper in freshwater. The BLM requires 10 input parameters: Temperature, pH, dissolved organic carbon, alkalinity, calcium, magnesium, sodium, potassium, sulfate, and chloride to derive water quality criteria. In 2007, EPA published updated criteria for freshwater copper using the biotic ligand model. An ongoing implementation challenge for state water quality standards is completing a parameter database for BLM use when a site has missing model input parameters. EPA developed approaches to estimate missing water quality parameters including geochemical ions (calcium, magnesium, sodium, potassium, sulfate, chloride, and alkalinity) and dissolved organic carbon (DOC). For geochemical ions (GI) parameter estimates, specific conductivity was combined with geostatistical techniques (Kriging) to generate protective estimates for use in the BLM when data are not available. DOC estimates were derived using several water quality databases including the National Organic Carbon Database, Storage and Retrieval Data System, National Waters Information System, Wadeable Stream Assessment, and National River and Stream Assessment (NRSA) database.

    This draft support document provides default recommended values that could be used to fill in missing water quality input parameters when data are lacking for 8 of 10 BLM parameters. Default recommended values for GI parameters are 10th percentile ecoregional, stream-order specific values. Default recommended values for DOC are 10th percentile ecoregional values. These default values could also be used to fill in missing water quality input parameters in the application of other metal BLM models as well, when data are lacking. In addition, the document also recommends that the other two parameters, temperature and pH, be measured directly in the field. Site-specific data are always preferable for use in the BLM and should be used to develop copper criteria via the BLM when possible. Users of the BLM are encouraged to sample their water body of interest, and to analyze the samples for the constituent (parameter) concentrations as a basis for determining BLM inputs, when possible.

    This document underwent an internal EPA review and an independent contractor-led external peer review.

    IV. Solicitation of Scientific Views

    EPA is soliciting additional scientific views, data, and information regarding the science and technical approach used in the derivation of this draft technical document.

    Dated: February 4, 2016. Elizabeth Southerland, Director, Office of Science and Technology.
    [FR Doc. 2016-03119 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9942-45-OEI] Agency Information Collection Activities OMB Responses AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

    FOR FURTHER INFORMATION CONTACT:

    Courtney Kerwin (202) 566-1669, or email at [email protected] and please refer to the appropriate EPA Information Collection Request (ICR) Number.

    SUPPLEMENTARY INFORMATION:

    OMB Responses to Agency Clearance Requests OMB Approvals

    EPA ICR Number 2031.08; Protection of Stratospheric Ozone: Request for Applications from Critical Use Exemption for the Phase out of Methyl Bromide (Renewal); 40 CFR part 82; was approved with change on 8/4/2015; OMB Number 2060-0482; expires on 8/31/2018.

    EPA ICR Number 2207.06; Exchange Network Grants Progress Reports (Renewal); 2 CFR parts 200 and 1500; was approved without change on 8/4/2015; OMB Number 2025-0006; expires on 8/31/2018.

    EPA ICR Number 2183.06; Drug Testing for Contractor Employees (Renewal); 5 CFR parts 731, 732 and 736; was approved without change on 8/4/2015; OMB Number 2030-0044; expires on 8/31/2018.

    EPA ICR Number 2159.06; Background Checks for Contractor Employees (Renewal); 5 CFR parts 731, 732 and 736; was approved without change on 8/4/2015; OMB Number 2030-0043; expires on 8/31/2018.

    EPA ICR Number 2494.01; Survey of the Public and Commercial Building Industry (New); was approved without change on 8/5/2015; OMB Number 2070-0193; expires on 8/31/2018.

    EPA ICR Number 1250.10; Request for Contractor Access to TSCA Confidential Business Information (CBI); 15 CFR part 2613; was approved without change on 8/11/2015; OMB Number 2070-0075; expires on 8/31/2018.

    EPA ICR Number 1365.10; Asbestos-Containing Materials in Schools and Asbestos Model Accreditation Plans (Renewal); 40 CFR part 763 subpart E appendix C, 40 CFR part 763 subpart E; was approved without change on 8/17/2015; OMB Number 2070-0091; expires on 8/31/2018.

    EPA ICR Number 2403.03; EG for Sewage Sludge Incinerators (Renewal); 40 CFR part 60, subparts A and MMMM; was approved without change on 8/18/2015; OMB Number 2060-0661; expires on 8/31/2015.

    EPA ICR Number 2025.06; NESHAP for Friction Materials Manufacturing (Renewal); 40 CFR part 63, subpart QQQQQ and 40 CFR part 63, subpart A; was approved without change on 8/18/2015; OMB Number 2060-0481; expires on 8/31/2018.

    EPA ICR Number 1284.10; NSPS for Polymeric Coating of Supporting Substrates Facilities (Renewal); 40 CFR part 60, subparts VVV and A; was approved without change on 8/18/2015; OMB Number 2060-0181; expires on 8/31/2018.

    EPA ICR Number 1643.08; Application Requirements for the Approval and Delegation of Federal Air Toxics Programs to State, Territorial, Local, and Tribal Agencies (Renewal); 40 CFR part 63, subpart E; was approved without change on 8/18/2015; OMB Number 2060-0264; expires on 8/31/2018.

    EPA ICR Number 2303.04; NESHAP for Ferroalloys Production Area Sources (Renewal); 40 CFR part 63, subpart YYYYYY and subpart A; was approved with change on 8/18/2015; OMB Number 2060-0625; expires on 8/31/2018.

    EPA ICR Number 2014.06; Reporting and Recordkeeping Requirements of the HCFC Allowance System (Change); 40 CFR part 82, subpart A; was approved without change on 8/18/2015; OMB Number 2060-0498; expires on 4/30/2016.

    EPA ICR Number 2466.01; Revisions to the Total Coliform Rule (Final Rule) (Revision); 40 CFR parts 141 and 142; was approved without change on 8/18/2015; OMB Number 2040-0288; expires on 8/31/2018.

    EPA ICR Number 1789.09; NESHAP for Natural Gas Transmission and Storage (Renewal); 40 CFR part 63, subparts HHH and A; was approved without change on 8/19/2015; OMB Number 2060-0418; expires on 8/31/2018.

    EPA ICR Number 1684.18; Emissions Certification and Compliance Requirements for Nonroad Compression-Ignition Engines and On-Highway Heavy Duty Engines (Renewal); 40 CFR part 63, subpart YYYYYY; 40 CFR part 1042, subparts C, D, G and H; 40 CFR parts 85, 86, 89, 94, 1027, 1039, 1042, 1045, 1060, 1065, and 1068; was approved with change on 8/20/2015; OMB Number 2060-0287; expires on 8/31/2018.

    EPA ICR Number 1051.13; NSPS for Portland Cement Plants (Renewal); 40 CFR part 40, subparts A and F; was approved without change on 8/21/2015; OMB Number 2060-0025; expires on 8/31/2018.

    EPA ICR Number 0276.15; Experimental Use Permits (EUPs) for Pesticides (Renewal); 40 CFR part 172; was approved without change on 8/21/2015; OMB Number 2070-0040; expires on 8/31/2018.

    EPA ICR Number 2455.02; Revision to the Export Provisions of the Cathode Ray Tube (CRT) Rule (Final Rule); 40 CFR part 261; was approved without change on 8/21/2015; OMB Number 2050-0208; expires on 8/31/2018.

    EPA ICR Number 1630.12; Oil Pollution Act Facility Response Plans (Renewal); 40 CFR parts 112.20, 112.21, and 40 CFR part 112, subpart D; was approved without change on 8/21/2015; OMB Number 2050-0135; expires on 8/31/2018.

    EPA ICR Number 0664.11; NSPS for Bulk Gasoline Terminals (Renewal); 40 CFR part 60, subparts XX and A; was approved without change on 8/24/2015; OMB Number 2060-0006; expires on 8/31/2018.

    Comment Filed

    EPA ICR Number 2517.01; Proposed Rule Related Addendum to the Existing EPA ICR Entitled: Chemical-Specific Rules; Toxic Substances Control Act Section 8(a) (Proposed Rule); 40 CFR part 704; OMB filed comment on 8/21/2015.

    EPA ICR Number 2394.04; Greenhouse Gas Emissions and Fuel Efficiency Standards (Proposed Rule for Medium- and Heavy-Duty Engines and Vehicles—Phase 2); 40 CFR parts 1043, 1065, 1066, 1068, 22, 600, 85, 86, 1033, 1036, 1037, 1039, 1042, 523, 5234, 534 and 535; OMB filed comment on 8/21/2015.

    EPA ICR Number 2506.01; Carbon Pollution Standards for Modified and Reconstructed Stationary Sources: Electric Utility Generating Units; 40 CFR part 60, subpart TTTT; OMB filed comment on 8/24/2015.

    Courtney Kerwin, Acting Director, Collections Strategies Division.
    [FR Doc. 2016-03149 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2012-0546; FRL-9942-21-OAR] Contractor Access to Information Claimed as Confidential Business Information Submitted Under Title II of the Clean Air Act and Related to the Renewable Fuel Standard Program Correction

    In notice document 2016-02728, appearing on pages 7095-7096 in the issue of Wednesday, February 10, 2016, make the following correction:

    On page 7096, in the first column, in the DATES: section, “FEBRUARY 10, 2021” should read “February 16, 2016”.

    [FR Doc. C1-2016-02728 Filed 2-12-16; 8:45 am] BILLING CODE 1505-01-D
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9942-35-OECA] National Environmental Justice Advisory Council: Notification of Public Meeting and Public Comment AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notification of public meeting.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act (FACA), Public Law 92-463, the U.S. Environmental Protection Agency (EPA) hereby provides notice that the National Environmental Justice Advisory Council (NEJAC) will meet on the dates and times described below. All meetings are open to the public. Members of the public are encouraged to provide comments relevant to the specific issues being considered by the NEJAC. For additional information about registering to attend the meeting or to provide public comment, please see “Registration” under SUPPLEMENTARY INFORMATION. Due to a limited space, seating at the NEJAC meeting will be on a first-come, first served basis. Pre-registration is required.

    DATES:

    The NEJAC will convene Wednesday, March 16, 2016 and Thursday, March 17, 2016, from 8:00 a.m. until 5:00 p.m. Central Time each day. The discussion will focus on several topics including, but not limited to, an update on recovery efforts; resources and technical assistance available to communities with environmental justice concerns; and climate change concerns of coastal communities.

    One public comment period relevant to the specific issues being considered by the NEJAC (see SUPPLEMENTARY INFORMATION) is scheduled for Wednesday, March 16, 2016, starting at 6:00 p.m. Central Time. Members of the public who wish to participate during the public comment period are highly encouraged to pre-register by Midnight, Central Time, on Monday, March 7, 2016.

    ADDRESSES:

    The NEJAC meeting will be held at the Courtyard Gulfport Beachfront located at 1600 E Beach Blvd., Gulfport, MS 39501.

    FOR FURTHER INFORMATION CONTACT:

    Questions or correspondence concerning the teleconference meeting should be directed to Karen L. Martin, U.S. Environmental Protection Agency, by mail at 1200 Pennsylvania Avenue NW. (MC2201A), Washington, DC 20460; by telephone at 202-564-0203; via email at [email protected]; or by fax at 202-564-1624. Additional information about the NEJAC is available at: www.epa.gov/environmentaljustice/nejac.

    SUPPLEMENTARY INFORMATION:

    The Charter of the NEJAC states that the advisory committee “will provide independent advice and recommendations to the Administrator about broad, crosscutting issues related to environmental justice. The NEJAC's efforts will include evaluation of a broad range of strategic, scientific, technological, regulatory, community engagement and economic issues related to environmental justice.”

    Registration

    Registrations for the March 16-17, 2016, pubic meeting will be processed http://nejac-public-meeting-march-16th-17th-2016.eventbrite.com. Pre-registration is required. Registration for the March 16-17, 2016, teleconference meeting closes at Midnight, Central Time on Friday, March 11, 2016. The deadline to sign up to speak during the public comment period, or to submit written public comments, is Midnight, Central Time Monday, March 7, 2016. When registering, please provide your name, organization, city and state, email address, and telephone number for follow up. Please also state whether you would like to be put on the list to provide public comment, and whether you are submitting written comments before the Monday, March 7, 2016, Midnight deadline. Due to a limited number of telephone lines, attendance will be on a first-come, first served basis.

    A. Public Comment

    Individuals or groups making remarks during the public comment period will be limited to seven (7) minutes. To accommodate the number of people who want to address the NEJAC, only one representative of a particular community, organization, or group will be allowed to speak. Written comments can also be submitted for the record. The suggested format for individuals providing public comments is as follows: Name of speaker; name of organization/community; city and state; and email address; brief description of the concern, and what you want the NEJAC to advise EPA to do. Written comments received by registration deadline, will be included in the materials distributed to the NEJAC prior to the teleconference. Written comments received after that time will be provided to the NEJAC as time allows. All written comments should be sent to Karen L. Martin, EPA, via email at [email protected].

    B. Information About Services for Individuals With Disabilities or Requiring English Language Translation Assistance

    For information about access or services for individuals requiring assistance, please contact Karen L. Martin, at (202) 564-0203 or via email at [email protected]. To request special accommodations for a disability or other assistance, please submit your request at least four working days prior to the meeting, to give EPA sufficient time to process your request. All requests should be sent to the address, email, or phone/fax number listed in the FOR FURTHER INFORMATION CONTACT section.

    Dated: February 3, 2016. Matthew Tejada, Designated Federal Officer, National Environmental Justice Advisory Council.
    [FR Doc. 2016-03115 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2016-0015; FRL-9942-34-OECA] Inquiry To Learn Whether Businesses Assert Business Confidentiality Claims Regarding Waste Import and Export AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; request for comment.

    SUMMARY:

    The Environmental Protection Agency (EPA) receives from time to time Freedom of Information Act (FOIA) requests for documentation received or issued by EPA or data contained in EPA database systems pertaining to the export and import of Resource Conservation and Recovery Act (RCRA) hazardous waste from/to the United States, the export of cathode ray tubes (CRTs) and spent lead acid batteries (SLABs) from the United States, and the export and import of RCRA universal waste from/to the United States. These documents and data may identify or reference multiple parties, and describe transactions involving the movement of specified materials in which the parties propose to participate or have participated. The purpose of this notice is to inform “affected businesses” about the documents and/or data sought by these types of FOIA requests in order to provide the businesses with the opportunity to assert claims that any of the information sought that pertains to them is entitled to treatment as confidential business information (CBI), and to send comments to EPA supporting their claims for such treatment. Certain businesses, however, do not meet the definition of “affected business,” and are not covered by today's notice. They consist of any business that actually submitted to EPA any document at issue pursuant to applicable RCRA regulatory requirements and did not assert a CBI claim as to information that pertains to that business in connection with the document at the time of its submission; they have waived their right to do so at a later time. Nevertheless, other businesses identified or referenced in the documents that were submitted to EPA by the submitting business may have a right to assert a CBI claim concerning information that pertains to them and may do so in response to this notice.

    DATES:

    Comments must be received on or before March 17, 2016. The period for submission of comments may be extended if, before the comments are due, you make a request for an extension of the comment period and it is approved by the EPA legal office. Except in extraordinary circumstances, the EPA legal office will not approve such an extension without the consent of any person whose request for release of the information under the FOIA is pending.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OECA-2016-0015, by one of the following methods:

    http://www.regulations.gov: Follow the on-line instructions for submitting comments.

    Email: [email protected]

    Address: Eva Kreisler, International Compliance Assurance Division, Office of Federal Activities, Office of Enforcement and Compliance Assurance, Environmental Protection Agency, Mailcode: 2254A, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-OECA-2016-0015. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. Instructions about how to submit comments claimed as CBI are given later in this notice.

    The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through http://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment. Please include your name and other contact information with any disk or CD-ROM you submit by mail. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the HQ EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the docket for this notice is (202) 566-1752.

    FOR FURTHER INFORMATION CONTACT:

    Eva Kreisler, International Compliance Assurance Division, Office of Federal Activities, Office of Enforcement and Compliance Assurance, Environmental Protection Agency, Mailcode: 2254A, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-8186; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Today's notice relates to any documents or data in the following areas: (1) Export of Resource Conservation and Recovery Act (RCRA) hazardous waste, during calendar year 2015 or before, under 40 CFR part 262, subparts E and H; (2) import of RCRA hazardous waste, during calendar year 2015 or before, under 40 CFR part 262, subparts F and H; (3) transit of RCRA hazardous waste, during calendar year 2015 or before, under 40 CFR part 262, subpart H, through the United States and foreign countries; (4) export of cathode ray tubes, during calendar year 2015 or before, under 40 CFR part 261, subpart E; (5) exports of non-crushed, spent lead acid batteries with intact casings, during calendar year 2015 or before, under 40 CFR part 266 subpart G; (6) export and import of RCRA universal waste, during calendar year 2015 or before, under 40 CFR part 273, subparts B, C, D, and F;(7) submissions from transporters, during calendar year 2015 or before, under 40 CFR part 263, or from treatment, storage or disposal facilities under 40 CFR parts 264 and 265, related to exports or imports of hazardous waste which occurred during calendar year 2015 or before, including receiving facility notices under 40 CFR 264.12(a)(1) and 265.12(a)(1) and import consent documentation under 40 CFR 264.71(a)(3) and 265.71(a)(3).

    I. General Information

    EPA has previously published notices similar to this one in the Federal Register, the latest one being at 80 FR 19080, April 9, 2015, that address issues similar to those raised by today's notice. The Agency did not receive any comments on the previous notices. Since the publication of the April 9, 2015, Federal Register notice, the Agency has continued to receive FOIA requests for documents and data contained in EPA's database related to hazardous waste exports and imports.

    II. Issues Covered by This Notice

    Specifically, EPA receives FOIA requests from time to time for documentation or data related to hazardous waste exports and imports that may identify or reference multiple parties, and that describe transactions involving the movement of specified materials in which the parties propose to participate or have participated. This notice informs “affected businesses,” 1 which could include, among others, “transporters,” 2 and “consignees,” 3 of the requests for information in EPA database systems and/or contained in one or more of the following documents: (1) Documents related to the export of Resource Conservation and Recovery Act (RCRA) hazardous waste, during calendar year 2015 or before, under 40 CFR part 262, subparts E and H, including but not limited to the “notification of intent to export,” 4 “manifests,” 5 “annual reports,” 6 “EPA acknowledgements of consent,” 7 “any subsequent communication withdrawing a prior consent or objection,” 8 “responses that neither consent nor object,” “exception reports,” 9 “transit notifications,” 10 and “renotifications”; 11 (2) documents related to the import of hazardous waste, during calendar year 2015 or before, under 40 CFR part 262, subparts F and H, including but not limited to notifications of intent to import hazardous waste into the U.S. from foreign countries; (3) documents related to the transit of hazardous waste, during calendar year 2015 or before, under 40 CFR part 262, subpart H, including notifications from U.S. exporters of intent to transit through foreign countries, or notifications from foreign countries of intent to transit through the U.S.; (4) documents related to the export of cathode ray tubes (CRTs), during calendar year 2015 or before, under 40 CFR part 261, subpart E, including but not limited to notifications of intent to export CRTs; (5) documents related to the export of non-crushed spent lead acid batteries (SLABs) with intact casings, during calendar year 2015 or before, under 40 CFR part 266 subpart G, including but not limited to notifications of intent to export SLABs; (6) submissions from transporters under 40 CFR part 263, or from treatment, storage or disposal facilities under 40 CFR parts 264 and 265, related to exports or imports of hazardous waste which occurred during calendar year 2015 or before, including receiving facility notices under 40 CFR 264.12(a)(1) and 265.12(a)(1) and import consent documentation under 40 CFR 264.71(a)(3) and 265.71(a)(3); and (7) documents related to the export and import of RCRA “universal waste” 12 under 40 CFR part 273, subparts B, C, D, and F.

    1 The term “affected business” is defined at 40 CFR 2.201(d), and is set forth in this notice, below.

    2 The term “transporter” is defined at 40 CFR 260.10.

    3 The term “consignee” is defined, for different purposes, at 40 CFR 262.51 and 262.81(c).

    4 The term “notification of intent to export” is described at 40 CFR 262.53.

    5 The term “manifest” is defined at 40 CFR 260.10.

    6 The term “annual reports” is described at 40 CFR 262.56.

    7 The term “EPA acknowledgement of consent” is defined at 40 CFR 262.51.

    8 The requirement to forward to the exporter “any subsequent communication withdrawing a prior consent or objection” is found at 42 U.S.C. 6938(e).

    9 The term “exception reports” is described at 40 CFR 262.55.

    10 The term “transit notifications” is described at 40 CFR 262.53(e).

    11 The term “renotifications” is described at 40 CFR 262.53(c).

    12 The term “universal waste” is defined at 40 CFR 273.9.

    Certain businesses, however, do not meet the definition of “affected business,” and are not covered by today's notice. They consist of any business that actually submitted information responsive to a FOIA request, under the authority of 40 CFR parts 260 through 266 and 268, and did not assert a claim of business confidentiality covering any of that information at the time of submission. As set forth in the RCRA regulations at 40 CFR 260.2(b), “if no such [business confidentiality] claim accompanies the information when it is received by EPA, it may be made available to the public without further notice to the person submitting it.” Thus, for purposes of this notice and as a general matter under 40 CFR 260.2(b), a business that submitted to EPA the documents at issue, pursuant to applicable regulatory requirements, and that failed to assert a claim as to information that pertains to it at the time of submission, cannot later make a business confidentiality claim.13 Nevertheless, other businesses identified or referenced in the same documents that were submitted to EPA by the submitting business may have a right to assert a CBI claim concerning information that pertains to them and may do so in response to this notice.

    13 However, businesses having submitted information to EPA relating to the export and import of RCRA universal waste are not subject to 40 CFR 260.2(b) since they submitted information in accordance with 40 CFR part 273, and not parts 260 through 266 and 268, as set forth in 40 CFR 260.2(b). They are therefore affected businesses that could make a claim of CBI at the time of submission or in response to this notice.

    In addition, EPA may develop its own documents and organize into its database systems information that was originally contained in documents from submitting businesses relating to exports and imports of hazardous waste. If a submitting business fails to assert a CBI claim for the documents it submits to EPA at the time of submission, not only does it waive its right to claim CBI for those documents, but it also waives its right to claim CBI for information in EPA's documents or databases that is based on or derived from the documents that were originally submitted by that business.14

    14 With the exception, noted above, of the submission of information relating to the export and import of RCRA universal waste.

    In accordance with 40 CFR 2.204(c) and (e), this notice inquires whether any affected business asserts a claim that any of the requested information constitutes CBI, and affords such business an opportunity to comment to EPA on the issue. This notice also informs affected businesses that, if a claim is made, EPA would determine under 40 CFR part 2, subpart B, whether any of the requested information is entitled to business confidential treatment.

    1. Affected Businesses

    EPA's FOIA regulations at 40 CFR 2.204(c)(1) require an EPA office that is responsible for responding to a FOIA request for the release of business information (“EPA office”) to determine which businesses, if any, are affected businesses. “Affected business” is defined at 40 CFR 2.201(d) as: With reference to an item of business information, a business which has asserted (and not waived or withdrawn) a business confidentiality claim covering the information, or a business which could be expected to make such a claim if it were aware that disclosure of the information to the public was proposed.

    2. The Purposes of This Notice

    This notice encompasses two distinct steps in the process of communication with affected businesses prior to EPA's making a final determination concerning the business confidentiality of the information at issue: The preliminary inquiry and the notice of opportunity to comment.

    a. Inquiry To Learn Whether Affected Businesses (Other Than Those Businesses That Previously Asserted a CBI Claim) Assert Claims Covering Any of the Requested Information

    Section 2.204(c)(2)(i) provides, in relevant part: If the examination conducted under paragraph (c)(1) of § 2.204 discloses the existence of any business which, although it has not asserted a claim, might be expected to assert a claim if it knew EPA proposed to disclose the information, the EPA office shall contact a responsible official of each such business to learn whether the business asserts a claim covering the information.

    b. Notice of Opportunity To Submit Comments

    Sections 2.204(d)(1)(i) and 2.204(e)(1) of Title 40 of the Code of Federal Regulations require that written notice be provided to businesses that have made claims of business confidentiality for any of the information at issue, stating that EPA is determining under 40 CFR part 2, subpart B, whether the information is entitled to business confidential treatment, and affording each business an opportunity to comment as to the reasons why it believes that the information deserves business confidential treatment.

    3. The Use of Publication in the Federal Register

    Section 2.204(e)(1) of Title 40 of the Code of Federal Regulations requires that this type of notice be furnished by certified mail (return receipt requested), by personal delivery, or by other means which allows verification of the fact and date of receipt. EPA, however, has determined that in the present circumstances the use of a Federal Register notice is a practical and efficient way to contact affected businesses and to furnish the notice of opportunity to submit comments. The Agency's decision to follow this course was made in recognition of the administrative difficulty and impracticality of directly contacting potentially thousands of individual businesses.

    4. Submission of Your Response in the English Language

    All responses to this notice must be in the English language.

    5. The Effect of Failure To Respond to This Notice

    In accordance with 40 CFR 2.204(e)(1) and 2.205(d)(1), EPA will construe your failure to furnish timely comments in response to this notice as a waiver of your business's claim(s) of business confidentiality for any information in the types of documents identified in this notice.

    6. What To Include in Your Comments

    If you believe that any of the information contained in the types of documents which are described in this notice and which are currently, or may become, subject to FOIA requests, is entitled to business confidential treatment, please specify which portions of the information you consider business confidential. Information not specifically identified as subject to a business confidentiality claim may be disclosed to the requestor without further notice to you.

    For each item or class of information that you identify as being subject to your claim, please answer the following questions, giving as much detail as possible:

    1. For what period of time do you request that the information be maintained as business confidential, e.g., until a certain date, until the occurrence of a specified event, or permanently? If the occurrence of a specific event will eliminate the need for business confidentiality, please specify that event.

    2. Information submitted to EPA becomes stale over time. Why should the information you claim as business confidential be protected for the time period specified in your answer to question no. 1?

    3. What measures have you taken to protect the information claimed as business confidential? Have you disclosed the information to anyone other than a governmental body or someone who is bound by an agreement not to disclose the information further? If so, why should the information still be considered business confidential?

    4. Is the information contained in any publicly available material such as the Internet, publicly available data bases, promotional publications, annual reports, or articles. Is there any means by which a member of the public could obtain access to the information? Is the information of a kind that you would customarily not release to the public?

    5. Has any governmental body made a determination as to the business confidentiality of the information? If so, please attach a copy of the determination.

    6. For each category of information claimed as business confidential, explain with specificity why and how release of the information is likely to cause substantial harm to your competitive position. Explain the specific nature of those harmful effects, why they should be viewed as substantial, and the causal relationship between disclosure and such harmful effects. How could your competitors make use of this information to your detriment?

    7. Do you assert that the information is submitted on a voluntary or a mandatory basis? Please explain the reason for your assertion. If the business asserts that the information is voluntarily submitted information, please explain whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.

    8. Any other issue you deem relevant.

    Please note that you bear the burden of substantiating your business confidentiality claim. Conclusory allegations will be given little or no weight in the determination. If you wish to claim any of the information in your response as business confidential, you must mark the response “BUSINESS CONFIDENTIAL” or with a similar designation, and must bracket all text so claimed. Information so designated will be disclosed by EPA only to the extent allowed by, and by means of, the procedures set forth in, 40 CFR part 2, subpart B. If you fail to claim the information as business confidential, it may be made available to the requestor without further notice to you.

    III. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through http://www.regulations.gov or email. Please submit this information by mail to the address identified in the ADDRESSES section of today's notice for inclusion in the non-public CBI docket. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. Information so marked will not be disclosed except in accordance with the procedures set forth in 40 CFR part 2, subpart B. In addition to the submission of one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket.

    2. Tips for Preparing Your Comments. When submitting comments, remember to:

    • Identify the notice by docket number and other iden tifying information (subject heading, Federal Register date and page number).

    • Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

    • Describe any assumptions and provide any technical information and/or data that you used.

    • Provide specific examples to illustrate your concerns, and suggest alternatives.

    • Make sure to submit your comments by the comment period deadline identified.

    Dated: January 14, 2016. Shari Wilson, Acting Director, Office of Federal Activities.
    [FR Doc. 2016-03102 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2015-0684; FRL-9942-25-ORD] Notice of Availability of Draft Guidelines for Human Exposure Assessment: Extension of Public Comment Period AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Extension of public comment period.

    SUMMARY:

    On January 7, 2016 the U.S. Environmental Protection Agency (EPA) announced the release of the external review draft of “Guidelines for Human Exposure Assessment” for public review and comment (81 FR 774-775). With this notice EPA is announcing the extension of the comment period to March 22, 2016. EPA is seeking public comment prior to external peer review. The document will undergo review during an expert peer review meeting, which will be convened, organized, and conducted by an independent contractor. The date and location of the peer review meeting will be announced in a subsequent Federal Register notice. All comments received in the docket by the closing date March 22, 2016 will be shared with the peer review panel for their consideration. Comments received after the close of the comment period may be considered by EPA when it finalizes the document. Members of the public may obtain the draft guidance at http://www.regulations.gov; or www.epa.gov/osa/guidelines-human-exposure-assessment or from Dr. Michael Broder via the contact information below.

    DATES:

    All comments received in the docket by March 22, 2016 will be shared with the external peer review panel for their consideration. Comments received beyond that time may be considered by EPA when it finalizes the document.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2015-0684 by one of the following methods:

    Internet: http://www.regulations.gov: Follow the on-line instructions for submitting comments.

    Email: [email protected]

    Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

    Hand Delivery: EPA Docket Center (EPA/DC), Room 3334, EPA West Building, 1301 Constitution Avenue NW., Washington, DC 20460, Attention Docket ID No EPA-HQ-ORD-2015-0684. Deliveries are only accepted from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. Special arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2015-0684. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected by statute through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA, without going through http://www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the ORD Docket is (202) 566-1752.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Michael Broder, Office of the Science Advisor, Mail Code 8105R, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number (202) 564-3393; fax number (202) 564-2070; or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The current guidance document for human exposure assessment, Guidelines for Exposure Assessment, was published in 1992, reflecting the state-of-the-science in the 1970s and 1980s. Since its publication, the field of exposure science has undergone significant transformation in methods and approaches, which EPA has incorporated into its policies and practices to better align with the current state-of-the-science. The 1992 guidelines are being updated to reflect the updated methods and approaches.

    The draft guidelines benefit from over two decades of experience with EPA assessments conducted by Agency programs under their respective authorities and constraints, and from input from external panels, including the National Academies of Sciences and EPA's Science Advisory Board. This draft document builds on topics covered in the 1992 exposure guidelines including planning and scoping for an assessment, data acquisition and use, modeling, and considerations of uncertainty in exposure assessment. It also includes new material on planning and conducting an observational human exposure measurement study and considerations of lifestages and sensitive populations in exposure assessments. These draft guidelines present the most current science used in EPA exposure assessments and incorporates information about the Agency's current policies.

    Dated: February 4, 2016. Thomas Burke, EPA Science Advisor.
    [FR Doc. 2016-03110 Filed 2-12-16; 8:45 am] BILLING CODE 6560-50-P
    EQUAL EMPLOYMENT OPPORTUNITY COMMISSION Public Hearing AGENCY:

    Equal Employment Opportunity Commission.

    ACTION:

    Notice of public hearing.

    SUMMARY:

    Notice is hereby given that the Equal Employment Opportunity Commission has scheduled a public hearing to gather information and hear public comment on its proposed revision of the Employer Information Report (EEO-1) published for public comment at 81 FR 5113 (February 1, 2016).

    Time and Date: March 16, 2016; 9:30 a.m. EDST.

    Place: 131 M Street NE., Washington, DC 20507, Jacqueline A. Berrien Commission Meeting Room.

    FOR FURTHER INFORMATION CONTACT:

    Ronald Edwards, Director, Program Research and Surveys Division, Equal Employment Opportunity Commission, 131 M Street NE., Room 4SW30F, Washington, DC 20507; (202) 663-4949 (voice) or (202) 663-7063 (TTY). Requests for this notice in an alternative format should be made to the Office of Communications and Legislative Affairs at (202) 663-4191 (voice) or (202) 663-4494 (TTY).

    SUPPLEMENTARY INFORMATION:

    Under section 709(c) of Title VII of the Civil Rights Act of 1964, as amended (42 U.S.C. 2000e-8(c)), the Equal Employment Opportunity Commission (EEOC) on February 1, 2016, published proposed revisions to the EEO-1 Report form to include collection of pay and hours worked data. 81 FR 5113. The proposed revised EEO-1 Report form can be found at http://www.eeoc.gov/employers/eeo1survey/2016_new_survey.cfm. The February 1, 2016, notice requested comments on the proposed changes to the EEO-1 Report and stated that a hearing would be held. This notice sets the hearing for March 16, 2016.

    Persons wishing to speak at the hearing should notify the Commission of their desire to do so by February 22, 2016. EEOC requests that written requests to participate in the hearing include a brief summary of the planned statement. Written requests may be submitted in hard copy to Bernadette Wilson, Acting Executive Officer, Executive Secretariat, Equal Employment Opportunity Commission, 131 M Street NE., Washington, DC 20507. The Office of the Executive Secretariat also will accept written requests by fax. The telephone number of the fax receiver is (202) 663-4114. (This is not a toll-free number.) Receipt of fax transmittals will not be acknowledged, except that the sender may request confirmation of receipt by calling the Executive Secretariat staff at (202) 663-4070 (voice) or (202) 663-4074 (TTY). (These are not toll-free telephone numbers.) Because of time limitations, all interested persons may not be able to testify at the hearing, but the Commission will consider all written statements submitted. EEOC will request that the speakers selected to testify limit their testimony to the time period allotted.

    Members of the public have until April 1, 2016, to submit written comments in accordance with the procedures set out in the February 1, 2016, notice. These comments will be available for review at the Commission's library between the hours of 9 a.m. and 5 p.m. To schedule an appointment to inspect the comments at the EEOC's library, contact the library staff at (202) 663-4630 (voice) or (202) 663-4641 (TTY). (These are not toll-free numbers.) The comments submitted in response to the February 1, 2016, notice will automatically become part of the hearing record unless the submitter directs otherwise.

    Dated: February 10, 2016.

    For the Commission.

    Jenny R. Yang, Chair.
    [FR Doc. 2016-03088 Filed 2-12-16; 8:45 am] BILLING CODE P
    FEDERAL DEPOSIT INSURANCE CORPORATION Sunshine Act Meeting

    Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that the Federal Deposit Insurance Corporation's Board of Directors will meet in open session at 10:00 a.m. on Wednesday, February 17, 2016, to consider the following matters:

    SUMMARY AGENDA:

    No substantive discussion of the following items is anticipated. These matters will be resolved with a single vote unless a member of the Board of Directors requests that an item be moved to the discussion agenda.

    Disposition of minutes of previous Board of Directors' Meetings.

    Memorandum and resolution: Notice of Proposed Rulemaking Regarding the Orderly Liquidation of Covered Brokers or Dealers under the Provisions of Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act-12 CFR part 380.

    DISCUSSION AGENDA:

    Memorandum and resolution re: Notice of Proposed Rulemaking Regarding Recordkeeping for Timely Deposit Insurance Determination.

    The meeting will be held in the Board Room located on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.

    This Board meeting will be Webcast live via the Internet and subsequently made available on-demand approximately one week after the event. Visit https://fdic.primetime.mediaplatform.com/#!/channel/1232003497484/Board+Meetings to view the event. If you need any technical assistance, please visit our Video Help page at: http://www.fdic.gov/video.html.

    The FDIC will provide attendees with auxiliary aids (e.g., sign language interpretation) required for this meeting. Those attendees needing such assistance should call 703-562-2404 (Voice) or 703-649-4354 (Video Phone) to make necessary arrangements.

    Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Executive Secretary of the Corporation, at 202-898-7043.

    Dated: February 10, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-03142 Filed 2-11-16; 11:15 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 1, 2016.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Bruce J. Essex, Jr. individually and as Trustee of the Bruce J. Essex, Jr. 2016 Revocable Trust; and the Bruce J. Essex, Jr. 2016 Revocable Trust, both of Spring Lake, Michigan (which will become part of the Essex Family Control Group), and Bruce J. Essex, Sr., individually, Twin Lake, Michigan; to acquire voting shares of Community Shores Bank Corporation, and thereby indirectly acquire voting shares of Community Shores Bank both in Muskegon, Michigan.

    Board of Governors of the Federal Reserve System, February 10, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-03048 Filed 2-12-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL TRADE COMMISSION Granting of Request for Early Termination of the Waiting Period Under the Premerger Notification Rules

    Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by Title II of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans. Section 7A(b)(2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the Federal Register.

    The following transactions were granted early termination—on the dates indicated—of the waiting period provided by law and the premerger notification rules. The listing for each transaction includes the transaction number and the parties to the transaction. The grants were made by the Federal Trade Commission and the Assistant Attorney General for the Antitrust Division of the Department of Justice. Neither agency intends to take any action with respect to these proposed acquisitions during the applicable waiting period.

    Early Terminations Granted December 1, 2015 thru December 31, 2015 12/01/2015 20151413 G Waste Management Inc.; Southern Waste Systems Holdings, LP; Waste Management Inc. 20160186 G Green Equity Investors Side VI, L.P.; Ensemble Investors, L.P.; Green Equity Investors Side VI, L.P. 20160188 G Green Equity Investors VI, L.P.; Ensemble Investors, L.P.; Green Equity Investors VI, L.P. 20160194 G TPG VII Ensemble Co-Invest, L.P.; Ensemble Investors, L.P.; TPG VII Ensemble Co-Invest, L.P. 20160218 G Acuity Brands, Inc.; Schneider Electric SE; Acuity Brands, Inc. 20160270 G Liberty Interactive Corporation; Lending Tree, Inc.; Liberty Interactive Corporation. 20160271 G Metawater Co., Ltd.; John D. Brubaker; Metawater Co., Ltd. 20160299 G Brenntag AG; David J. Waltz; Brenntag AG. 20160300 G Hon Hai Precision Industry Company Limited; Avago Technologies Limited; Hon Hai Precision Industry Company Limited. 20160306 G Simonpietro Salini; Lane Industries Incorporated; Simonpietro Salini. 20160340 G Rizvi Opportunistic Equity Fund III, L.P.; RealD Inc.; Rizvi Opportunistic Equity Fund III, L.P. 12/02/2015 20160292 G Verizon Communications Inc.; AT&T Inc.; Verizon Communications Inc. 20160293 G AT&T; Verizon Communications Inc.; AT&T. 20160332 G Tailwind Capital Partners II, L.P.; Distinct Holdings, Inc.; Tailwind Capital Partners II, L.P. 20160333 G Shire plc; Dyax Corp.; Shire plc. 20160345 G CONMED Corporation; SurgiQuest, Inc.; CONMED Corporation. 20160351 G Callaway Golf Company; TopGolf International, Inc.; Callaway Golf Company. 20160362 G GTCR Fund XI/B LP; WV AIV II (PPT), LLC; GTCR Fund XI/B LP. 20160378 G Reliance Steel & Aluminum Co.; TSI Holding Company Voting Trust Agreement dated September; Reliance Steel & Aluminum Co. 12/03/2015 20151091 G ARRIS Group, Inc.; Pace plc; ARRIS Group, Inc. 20160189 G JANA Nirvana Offshore Fund, Ltd.; Mattel, Inc.; JANA Nirvana Offshore Fund, Ltd. 20160190 G JANA Offshore Partners, Ltd.; Mattel, Inc.; JANA Offshore Partners, Ltd. 20160198 G Tsinghua Holdings Co., Ltd.; Western Digital Corporation; Tsinghua Holdings Co., Ltd. 20160290 G Deutsche Telekom AG; AB Spectrum LLC; Deutsche Telekom AG. 20160307 G Bristol-Myers Squibb Company; Cardioxyl Pharmaceuticals, Inc.; Bristol-Myers Squibb Company. 20160319 G Thurman J. Rodgers; Cypress Semiconductor Corporation; Thurman J. Rodgers. 20160323 G JR Shaw; BVIP Fund VIII, L.P.; JR Shaw. 20160338 G Glanbia Co-operative Society Limited; TSG5 L.P.; Glanbia Co-operative Society Limited. 20160366 G Novant Health, Inc.; Novant Health UVA Health System; Novant Health, Inc. 12/04/2015 20160211 G Blackstone Tactical Opportunities Fund II; NCR Corporation; Blackstone Tactical Opportunities Fund II. 20160212 G Blackstone Capital Partners VI L.P.; NCR Corporation; Blackstone Capital Partners VI L.P. 20160305 G Roche Holding Ltd; Upsher-Smith Laboratories, Inc.; Roche Holding Ltd. 20160357 G Kinder Morgan, Inc.; Myria Holdings Inc.; Kinder Morgan, Inc. 12/07/2015 20160230 G Atlantic Street Capital II, L.P.; Mohammad Honarkar; Atlantic Street Capital II, L.P. 20160303 G Tenable Holdings, Inc.; Tenable Network Security, Inc.; Tenable Holdings, Inc. 20160326 G John Wood Group PLC; Infinity Construction Holding, LLC; John Wood Group PLC. 20160349 G AMN Healthcare Services, Inc.; John D. Smith; AMN Healthcare Services, Inc. 20160353 G Triton Container International Limited; TAL International Group, Inc.; Triton Container International Limited. 20160360 G Neighborhood Credit Union; Pegasus Community Credit Union; Neighborhood Credit Union. 20160364 G Brookfield Infrastructure Partners, L.P.; Myria Holdings Inc.; Brookfield Infrastructure Partners, L.P. 20160371 G GCA Holding Corp.; Blackstone RGIS Capital Partners V L.P.; GCA Holding Corp. 20160381 G Bain Capital Fund XI, L.P.; H.I.G. Capital Partners IV, L.P.; Bain Capital Fund XI, L.P. 20160384 G Revelstoke Capital Partners Fund I, L.P.; Charterhouse Equity Partners IV, L.P.; Revelstoke Capital Partners Fund I, L.P. 20160397 G RoundTable Healthcare Partners III, L.P.; W. Whitfield Gardner; RoundTable Healthcare Partners III, L.P. 20160406 G Hawkins, Inc.; ICV Partners II, L.P.; Hawkins, Inc. 20160411 G Paychex, Inc.; Joel E. Adelman; Paychex, Inc. 12/08/2015 20160261 G Sun Capital Partners VI, L.P.; General Electric Company; Sun Capital Partners VI, L.P. 20160294 G Letterone Investment Holdings S.A.; MedAssets, Inc.; Letterone Investment Holdings S.A. 20160315 G Activision Blizzard, Inc.; King Digital Entertainment plc; Activision Blizzard, Inc. 20160320 G Eminence Partners, L.P.; Autodesk, Inc.; Eminence Partners, L.P. 20160321 G Eminence Fund, Ltd.; Autodesk, Inc.; Eminence Fund, Ltd. 20160336 G LSF9 Atlantis, LP; Atlantic Street Capital II, L.P.; LSF9 Atlantis, LP. 20160363 G Howard W. Lutnick; Intercontinental Exchange, Inc.; Howard W. Lutnick. 20160367 G Ashford Inc.; Archie Bennett, Jr.; Ashford Inc. 20160368 G Ashford Inc.; Monty J. Bennett; Ashford Inc. 20160383 G Calumet Concession Partners LLC; Ferrovial Corporacion, S.A.; Calumet Concession Partners LLC. 20160388 G New Mountain Partners IV, L.P.; Great Point Partners I, L.P.; New Mountain Partners IV, L.P. 20160392 G New Mountain Partners IV, L.P.; ABRY Partners VI, L.P.; New Mountain Partners IV, L.P. 12/09/2015 20160245 G Berkshire Fund VIII, L.P.; Archive Systems Holding, Inc.; Berkshire Fund VIII, L.P. 20160373 G ACP Investment Fund II-A, L.P.; Michael McMenamin; ACP Investment Fund II-A, L.P. 20160379 G Quintana Energy Partners, L.P.; Archer Limited; Quintana Energy Partners, L.P. 20160405 G Tenex Capital Partners, L.P.; MVC Capital, Inc.; Tenex Capital Partners, L.P. 12/10/2015 20160313 G Elliott Associates, L.P.; CenterPoint Energy, Inc.; Elliott Associates, L.P. 20160316 G Berkshire Hathaway, Inc.; Robert and Margaret Petrone; Berkshire Hathaway, Inc. 20160317 G Berkshire Hathaway, Inc.; James and Dorothy Petrone; Berkshire Hathaway, Inc. 20160342 G Stifel Financial Corp.; Eaton Holdings, LLC; Stifel Financial Corp. 20160377 G Perrigo Company plc; AstraZeneca PLC; Perrigo Company plc. 20160389 G Interval Leisure Group, Inc.; Starwood Hotels & Resorts Worldwide, Inc.; Interval Leisure Group, Inc. 12/11/2015 20160358 G The Walt Disney Company; Steven Spielberg; The Walt Disney Company. 20160359 G The Walt Disney Company; Anil D. Ambani; The Walt Disney Company. 20160391 G Carl C. Icahn; Xerox Corporation; Carl C. Icahn. 20160414 G DCA Acquisition Holdings LLC; Sentinel Capital Partners IV, L.P.; DCA Acquisition Holdings LLC. 20160417 G Marubeni Corporation; XL Parts Partnership, Ltd.; Marubeni Corporation. 20160420 G Trust 463; SCB Holdings, LLC; Trust 463. 20160422 G JAZ Ventures, LP; NRG Energy, Inc.; JAZ Ventures, LP. 20160424 G WS Atkins plc; Energy Capital Partners II-A, LP; WS Atkins plc. 20160437 G C.R. Bard, Inc.; Liberator Medical Holdings, Inc.; C. R. Bard, Inc. 20160448 G Mikhail Prokhorov; Forest City Enterprises, Inc.; Mikhail Prokhorov. 12/14/2015 20160262 G Fairholme Funds, Inc.; The St. Joe Company; Fairholme Funds, Inc. 20160428 G CVC Scooby Jersey Limited; Petco Holdings, Inc.; CVC Scooby Jersey Limited. 20160432 G Dnata; Jeffrey M. Kinsella; Dnata. 20160454 G Energy Transfer Equity, L.P.; ConocoPhillips; Energy Transfer Equity, L.P. 12/15/2015 20160370 G OCP Trust; Primus Capital Fund VI, LP; OCP Trust. 20160386 G ATOS S.E.; Unify Holdings B.V.; ATOS S.E. 20160394 G CEOF II DE I AIV, L.P.; WestView Capital Partners II, L.P.; CEOF II DE I AIV, L.P. 20160410 G EMP Holdings, Ltd.; MEP Health, LLC; EMP Holdings, Ltd. 20160415 G James Mark Burnett and Roma Burnett; MGM Holdings, Inc.; James Mark Burnett and Roma Burnett. 20160425 G Ascension Health Alliance; Wheaton Franciscan Services, Inc.; Ascension Health Alliance. 12/16/2015 20160310 G Elliott Associates, L.P.; American Capital, Ltd.; Elliott Associates, L.P. 20160311 G Elliott International Limited; American Capital, Ltd.; Elliott International Limited. 20160339 G Wang Jianlin; SMH Theatres, Inc.; Wang Jianlin. 20160374 G The Kroger Co.; Roundy's, Inc.; The Kroger Co. 20160403 G Computer Programs and Systems, Inc.; Francisco Partners II, L.P.; Computer Programs and Systems, Inc. 20160404 G Francisco Partners II, L.P.; Computer Programs and Systems, Inc.; Francisco Partners II, L.P. 20160427 G BlackRock, Inc.; Bank of America Corporation; BlackRock, Inc. 20160429 G Dr. Patrick Soon-Shiong; 3BE Holdings, LLC; Dr. Patrick Soon-Shiong. 20160434 G Vroom, Inc.; Richard D. Williams; Vroom, Inc. 20160435 G Vroom, Inc.; Michael D. Welch; Vroom, Inc. 20160450 G Pinnacle Foods Inc.; Boulder Brands, Inc.; Pinnacle Foods Inc. 12/17/2015 20160382 G International Business Machines Corporation; BBN Holdings, Inc.; International Business Machines Corporation. 20160438 G Spalding Cooperative Elevator Company; All Points Cooperative; Spalding Cooperative Elevator Company. 12/18/2015 20160344 G WAFRA Real Assets & Infrastructure Fund I, L.P.; Ronald K. Henriksen; WAFRA Real Assets & Infrastructure Fund I, L.P. 20160421 G Wellspring Capital Partners V, L.P.; Mason Wells Buyout Fund II, LP; Wellspring Capital Partners V, L.P. 20160451 G Devon Energy Corporation; EnCap Flatrock Midstream Fund II, L.P.; Devon Energy Corporation. 20160453 G Comtech Telecommunications Corp.; TeleCommunication Systems, Inc.; Comtech Telecommunications Corp. 20160466 G CST Brands, Inc.; The Jones Company; CST Brands, Inc. 20160467 G CST Brands, Inc.; Patrick C. Jones; CST Brands, Inc. 20160468 G CST Brands, Inc.; James C. Jones III; CST Brands, Inc. 20160472 G Welsh Carson Anderson & Stowe XII, L.P.; Total Community Options, Inc.; Welsh Carson Anderson & Stowe XII, L.P. 20160482 G Station Holdco LLC; Frank J. Fertitta, III; Station Holdco LLC. 20160483 G Station Holdco LLC; Lorenzo J. Fertitta; Station Holdco LLC. 12/21/2015 20160426 G Duke Energy Corporation; Piedmont Natural Gas Company, Inc.; Duke Energy Corporation. 20160443 G Linde AG; Highland Crusader Offshore Partners; Linde AG. 20160456 G Golden Gate Capital Opportunity Fund, L.P.; Jonathan Hershberg; Golden Gate Capital Opportunity Fund, L.P. 20160471 G Stichting Administratiekantoor Lauerwecht; The Heritage Group; Stichting Administratiekantoor Lauerwecht. 20160492 G Tesoro Corporation; Great Northern Midstream Holdings LLC; Tesoro Corporation. 12/22/2015 20160493 G CACI International Inc.; L-3 Communications Holdings, Inc.; CACI International Inc. 20160494 G JLL Partners Fund VI, L.P.; Mr. and Mrs. Richard T. Williams; JLL Partners Fund VI, L.P. 12/23/2015 20160162 G Blackhawk Network Holdings, Inc.; Jason Wolfe; Blackhawk Network Holdings, Inc. 20160246 G Genstar Capital Partners VI, L.P.; Bankrate, Inc.; Genstar Capital Partners VI, L.P. 20160444 G Warburg Pincus Private Equity X, L.P.; Financial Engines, Inc.; Warburg Pincus Private Equity X, L.P. 20160445 G Financial Engines, Inc.; Warburg Pincus Private Equity X, L.P.; Financial Engines, Inc. 20160446 G Carl C. Icahn; The Pep Boys—Manny, Moe & Jack; Carl C. Icahn. 20160455 G William H. Gates III; Bunzl plc; William H. Gates III. 20160488 G IMS Health Holdings, Inc.; STG III, L.P.; IMS Health Holdings, Inc. 12/28/2015 20151120 Y ArcLight Energy Partners Fund VI, L.P.; Cumberland Farms, Inc.; ArcLight Energy Partners Fund VI, L.P. 20160485 G TowerBrook Investors IV (Onshore), L.P.; Accretive Health, Inc.; TowerBrook Investors IV (Onshore), L.P. 20160495 G Newco Holdings; Southern Glazer's Wine and Spirits, LLC; Newco Holdings. 20160498 G RPX Corporation; Clearlake Capital Partners III, L.P.; RPX Corporation. 20160499 G Supreme Union Limited; Mindray Medical International Limited; Supreme Union Limited. 20160500 G NV Bekaert SA; Blue Topco Ltd; NV Bekaert SA. 20160507 G James S. Mahan III; Live Oak Bancshares, Inc.; James S. Mahan III. 20160510 G CH Holding L.P.; Derek G. Hennecke; CH Holding L.P. 20160513 G John J. Siegel; Peabody Energy Corporation; John J. Siegel. 12/29/2015 20160470 G Nordex SE; Acciona S.A.; Nordex SE. 20160511 G Louisville Resources LLC; John J. Siegel; Louisville Resources LLC. 12/30/2015 20151680 G Rangers Renal Holdings LP; Dialysis Parent, LLC; Rangers Renal Holdings LP. 20160458 G Kevin M. Ulrich; Conn's, Inc.; Kevin M. Ulrich. 20160479 G BGM Holding, L.P.; BATS Global Markets, Inc.; BGM Holding, L.P. 20160480 G ESL Partners, L.P.; Lands End, Inc.; ESL Partners, L.P. 20160496 G Lilia Neumann de Sielecky; ACP III AIV, L.P.; Lilia Neumann de Sielecky. 12/31/2015 20160459 G Piper Jaffray Companies; Simmons & Company International; Piper Jaffray Companies. 20160489 G Owl Creek Overseas Master Fund, Ltd.; Yahoo! Inc.; Owl Creek Overseas Master Fund, Ltd. 20160490 G Owl Creek II, L.P.; Yahoo! Inc.; Owl Creek II, L.P. FOR FURTHER INFORMATION CONTACT:

    Theresa Kingsberry Program Support Specialist, Federal Trade Commission Premerger Notification Office Bureau of Competition, Room CC-5301, Washington, DC 20024, (202) 326-3100.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2016-03036 Filed 2-12-16; 8:45 am] BILLING CODE 6750-01-P
    FEDERAL TRADE COMMISSION Granting of Request for Early Termination of the Waiting Period Under the Premerger Notification Rules

    Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by Title II of the Hart-Scott- Rodino Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans. Section 7A(b)(2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the Federal Register.

    The following transactions were granted early termination—on the dates indicated—of the waiting period provided by law and the premerger notification rules. The listing for each transaction includes the transaction number and the parties to the transaction. The grants were made by the Federal Trade Commission and the Assistant Attorney General for the Antitrust Division of the Department of Justice. Neither agency intends to take any action with respect to these proposed acquisitions during the applicable waiting period.

    01/05/2016 20160481 G Altimeter Partners Fund, L.P.; United Continental Holdings, Inc.; Altimeter Partners Fund, L.P. 20160503 G Canyon Value Realization Fund, L.P.; Yahoo! Inc.; Canyon Value Realization Fund, L.P. 20160519 G Aurora Resurgence Fund II L.P.; Cardiac Science Corporation; Aurora Resurgence Fund II L.P. 20160526 G Blackstone Capital Partners (Cayman) VI L.P.; Ultima Global Holdings S.a.r.l.; Blackstone Capital Partners (Cayman) VI L.P. 20160530 G WestRock Company; Cenveo, Inc.; WestRock Company. 20160538 G John R. Fields; A. Dano Davis; John R. Fields. 20160541 G KKR European Fund IV L.P.; LGC Science Group Limited; KKR European Fund IV L.P. 20160542 G American Securities Partners VI, L.P.; Blount International, Inc.; American Securities Partners VI, L.P. 20160543 G Cerberus Institutional Partners VI, L.P.; Avon Products, Inc.; Cerberus Institutional Partners VI, L.P. 20160544 G SPC Partners V, L.P.; Leland A. Swanson; SPC Partners V, L.P. 20160547 G PTC Inc.; G. Corson Ellis, II; PTC Inc. 20160548 G DaVita Healthcare Partners, Inc.; The Everett Clinic, P.S.; DaVita Healthcare Partners, Inc. 20160558 G Baring Asia Private Equity Fund VI, L.P.2; Interplex Holdings Ltd.; Baring Asia Private Equity Fund VI, L.P.2. 01/06/2016 20160520 G Thomas H. Lee Parallel (Cayman) Fund VII, L.P.; New Century Hospice, Inc.; Thomas H. Lee Parallel (Cayman) Fund VII, L.P. 20160539 G Textron Inc.; Lee Benson; Textron Inc. 01/07/2016 20151730 G Gray Television, Inc.; Schurz Communications, Inc.; Gray Television, Inc. 20160540 G 40 North Latitude Fund LP; Mattress Firm Holding Corp.; 40 North Latitude Fund LP. 01/08/2016 20160487 G Checkers Control Partnership, L.P.; TalentWise, Inc.; Checkers Control Partnership, L.P. 20160518 G HEICO Corporation; ASP-Robertson LLC; HEICO Corporation. 20160560 G Blackstone Capital Partners VI, L.P.; SunEdison, Inc.; Blackstone Capital Partners VI, L.P. 20160568 G LCM Investments II, LLP; Jeffrey P. Cadwell; LCM Investments II, LLP. 20160582 G Algonquin Power & Utilities Corp.; CIP U.S. Direct GP, L.P.; Algonquin Power & Utilities Corp. 01/11/2016 20160517 G Gilead Sciences, Inc.; Galapagos NV; Gilead Sciences, Inc. 20160561 G Community Health System, Inc.; Indiana University Health, Inc.; Community Health System, Inc. 20160564 G salesforce.com, inc.; SteelBrick, Inc.; salesforce.com, inc. 20160572 G Hillenbrand, Inc.; Red Valve Company, Inc.; Hillenbrand, Inc. 20160508 G Beijing E-Town International Investment & Development Co.,; Mattson Technology, Inc.; Beijing E-Town International Investment & Development Co. 20160534 G Accor SA; Lodge Investment Company; Accor SA. 20160557 G AEA Investors Fund V LP; Thomas H. Lee Equity Fund VI, L.P.; AEA Investors Fund V LP. 01/13/2016 20160497 G Linsalata Capital Partners Fund VI, L.P.; Robert James Campbell, Jr.; Linsalata Capital Partners Fund VI, L.P. 01/14/2016 20160533 G General Motors Company; Lyft, Inc.; General Motors Company. 01/19/2016 20160535 G The Guardian Life Insurance Company of America; Avesis Incorporated; The Guardian Life Insurance Company of America. 20160536 G Tyco International plc; ShopperTrak RCT Corporation; Tyco International plc. 20160546 G AstraZeneca PLC; Acerta Pharma B.V.; AstraZeneca PLC. 20160581 G LCP VIII (AIV I), L.P.; AM Holdco, LLC; LCP VIII (AIV I), L.P. 20160583 G Blue2 Topco Limited; Herculean CC S.A.R.L.; Blue2 Topco Limited. 20160585 G Bain Capital Asia Fund II, L.P.; QuEST Global Services Pte. Ltd.; Bain Capital Asia Fund II, L.P. 20160590 G Oracle Corporation; AddThis, Inc.; Oracle Corporation. 20160593 G Roger S. Penske; Roger S. Penske; Roger S. Penske. 20160594 G NuVasive, Inc.; Ellipse Technologies, Inc.; NuVasive, Inc. 20160596 G Nomura Holdings, Inc.; American Century Companies, Inc.; Nomura Holdings, Inc. 20160598 G Leonard M. Tannenbaum; Fifth Street Finance Corp.; Leonard M. Tannenbaum. 20160603 G Bakk AL Holdings Limited; Bakkavor Group Limited; Bakk AL Holdings Limited. 01/20/2016 20160452 G Prestige Brands Holdings, Inc.; TSG5 L.P.; Prestige Brands Holdings, Inc. 20160527 G WellStar Health System, Inc.; Tenet Healthcare; WellStar Health System, Inc. 01/21/2016 20160587 G Aegion Corporation; Underground Solutions, Inc.; Aegion Corporation. 20160216 G BIF III Holtwood Holding (Delaware) LLC; Talen Energy Corporation; BIF III Holtwood Holding (Delaware) LLC. 20160565 G KKR North America Fund XI (Indigo) Blocker L.P.; Intuit Inc.; KKR North America Fund XI (Indigo) Blocker L.P. 20160584 G Cubic Corporation; Paul A. Gierow; Cubic Corporation. 20160595 G Hooker Furniture Corporation; HMI Acquisition, Inc.; Hooker Furniture Corporation. 20160605 G AP VIII Aegis Holdings, L.P.; James H. Engen; AP VIII Aegis Holdings, L.P. 20160611 G Mr. Godard Abel; salesforce.com, inc.; Mr. Godard Abel. 20160613 G Hawaiian Electric Industries, Inc.; ArcLight Energy Partners Fund IV, L.P.; Hawaiian Electric Industries, Inc. 20160617 G Brynwood Partners VII L.P.; Winter Street Opportunities Fund, L.P.; Brynwood Partners VII L.P. 20160621 G ISQ Global Infrastructure Fund, L.P.; WPX Energy, Inc.; ISQ Global Infrastructure Fund, L.P. 20160630 G Mr. Aloke Lohia and Mrs. Suchitra Lohia; BP plc; Mr. Aloke Lohia and Mrs. Suchitra Lohia. 20160642 G Graphic Packaging International, Inc.; Walter G. Anderson, Inc.; Graphic Packaging International, Inc. 01/29/2016 20160608 G KKR North America XI (Platinum) Blocker Parent L.P.; Voting Trust with regard to Mills Fleet Farm entities; KKR North America XI (Platinum) Blocker Parent L.P. 20160614 G Stingray Holdco LLC; VEPF IV AIV V, L.P.; Stingray Holdco LLC. 20160625 G Henry Ford Health System; Allegiance Health Services; Henry Ford Health System. 20160626 G William Goldring; Brown-Forman Corporation; William Goldring. 20160628 G Western Refining, Inc.; Northern Tier Energy LP; Western Refining, Inc. FOR FURTHER INFORMATION CONTACT:

    Theresa Kingsberry, Program Support Specialist, Federal Trade Commission, Premerger Notification Office Bureau of Competition, Room CC-5301, Washington, DC 20024 (202) 326-3100.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2016-03035 Filed 2-12-16; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0029; Docket 2016-0053; Sequence 10] Information Collection; Extraordinary Contractual Action Requests AGENCY:

    Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration NASA).

    ACTION:

    Notice of request for comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning extraordinary contractual action requests.

    DATES:

    Submit comments on or before April 18, 2016.

    ADDRESSES:

    Submit comments identified by Information Collection 9000-0029, Extraordinary Contractual Action Requests, by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0029, Extraordinary Contractual Action Requests”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0029, Extraordinary Contractual Action Requests” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0029, Extraordinary Contractual Action Requests.

    Instructions: Please submit comments only and cite Information Collection 9000-0029, Extraordinary Contractual Action Requests, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Cecelia L. Davis, Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA, at 202-219-0202 or email at [email protected]

    SUPPLEMENTARY INFORMATION: A. Purpose

    FAR subpart 50.1 prescribes policies and procedures that allow contracts to be entered into, amended, or modified in order to facilitate national defense under the extraordinary emergency authority granted under 50 U.S.C. 1431 et seq. and Executive Order (E.O.) 10789 dated November 14, 1958, et seq.

    This authority applies to the Government Printing Office; the Department of Homeland Security; the Tennessee Valley Authority; the National Aeronautics and Space Administration; the Department of Defense; the Department of the Army; the Department of the Navy; the Department of the Air Force; the Department of the Treasury; the Department of the Interior; the Department of Agriculture; the Department of Commerce; and the Department of Transportation. Also included is the Department of Energy for functions transferred to that Department from other authorized agencies and any other agency that may be authorized by the President.

    In order for a contractor to be granted relief under the FAR, specific evidence must be submitted which supports the firm's assertion that relief is appropriate and that the matter cannot be disposed of under the terms of the contract.

    FAR 50.103-3 specifies the minimum information that a contractor must include in a request for contract adjustment in accordance with FAR 50-103-1 and 50.103-2.

    FAR 50-103-4 sets forth additional information that the contracting officer or other agency official may request from the contractor to support any request made under FAR 50.103-3.

    FAR 50.104-3 sets forth the information that the contractor shall include in a request for the indemnification clause to cover unusually hazardous or nuclear risks.

    FAR 52.250-1, Indemnification under Public Law 850804, requires in paragraph (g) that the contractor shall promptly notify the contracting officer of any claim or action against, or loss by, the contractor or any subcontractors that may reasonably to involve indemnification under the clause.

    The information is used by the Government to determine if relief can be granted under FAR and to determine the appropriate type and amount of relief.

    B. Annual Reporting Burden

    Respondents: 28.

    Responses per Respondent: About 6.

    Total Responses: 164.

    Hours per Response: About 41.5.

    Total Burden Hours: 6,800.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requester may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0029, Extraordinary Contractual Action Requests, in all correspondence.

    Dated: February 10, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.
    [FR Doc. 2016-03045 Filed 2-12-16; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0058; Docket 2016-0053; Sequence 9] Information Collection; Schedules for Construction Contracts AGENCY:

    Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of request for an extension regarding an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning schedules for construction contracts.

    DATES:

    Submit comments on or before April 18, 2016.

    ADDRESSES:

    Submit comments identified by Information Collection 9000-0058, Schedules for Construction Contracts by any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0058, Schedules for Construction Contracts”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0058, Schedules for Construction Contracts” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0058, Schedules for Construction Contracts.

    Instructions: Please submit comments only and cite Information Collection 9000-0058, Schedules for Construction Contracts, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Curtis E. Glover, Sr., Procurement Analyst, Office of Acquisition Policy, 202-501-1448 or email [email protected].

    SUPPLEMENTARY INFORMATION: A. Purpose

    Federal construction contractors may be required to submit schedules, in the form of a progress chart, showing the order in which the Contractor proposes to perform the work. In accordance with FAR 52.236-15, Schedules for Construction Contracts, the Contractor shall, within five days after work commences on the contract or another period of time determined by the contracting officer, prepare and submit to the contracting officer for approval three copies of a practicable schedule showing the order in which the Contractor proposes to perform the work, and the dates on which the Contractor contemplates starting and completing the several salient features of the work (including acquiring materials, plants, and equipment). This information is used to monitor progress under a Federal construction contract when other management approaches for ensuring adequate progress are not used. If the Contractor fails to submit a schedule within the time prescribes, the Contracting Officer may withhold approval of progress payments until the Contractor submits the required schedule.

    B. Annual Reporting Burden

    Respondents: 3,804.

    Responses per Respondent: 2.

    Annual Responses: 7,608.

    Hours per Response: 4.

    Total Burden Hours: 30,432.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0058, Schedules for Construction Contracts, in all correspondence.

    Dated: February 8, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Govenrmentwide Policy.
    [FR Doc. 2016-03012 Filed 2-12-16; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From Verge Patient Safety Organization AGENCY:

    Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS).

    ACTION:

    Notice of delisting.

    SUMMARY:

    The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Verge Patient Safety Organization of its status as a PSO, and has delisted the PSO accordingly.

    DATES:

    The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12:00 Midnight ET (2400) on February 2, 2016.

    ADDRESSES:

    Both directories can be accessed electronically at the following HHS Web site: http://www.pso.AHRQ.gov/listed.

    FOR FURTHER INFORMATION CONTACT:

    Eileen Hogan, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 06N94B, Rockville, MD 20857; Telephone (toll free): (866) 403-3697; Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local): (301) 427-1130; Email: [email protected].

    SUPPLEMENTARY INFORMATION: Background

    The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery.

    HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when the PSO's listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs.

    AHRQ has accepted a notification from Verge Patient Safety Organization, a component entity of Verge Solutions, LLC, PSO number P0118, to voluntarily relinquish its status as a PSO. Accordingly, Verge Patient Safety Organization was delisted effective at 12:00 Midnight ET (2400) on February 2, 2016.

    Verge Patient Safety Organization has patient safety work product (PSWP) in its possession. The PSO will meet the requirements of section 3.108(c)(2)(i) of the Patient Safety Rule regarding notification to providers that have reported to the PSO. In addition, according to sections 3.108(c)(2)(ii) and 3.108(b)(3) of the Patient Safety Rule regarding disposition of PSWP, the PSO has 90 days from the effective date of delisting and revocation to complete the disposition of PSWP that is currently in the PSO's possession.

    More information on PSOs can be obtained through AHRQ's PSO Web site at http://www.pso.ahrq.gov/.

    Sharon B. Arnold, AHRQ Deputy Director.
    [FR Doc. 2016-03034 Filed 2-12-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2015-0049] Notice of Availability of the Final Environmental Assessment and a Finding of No Significant Impact for HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025, Lawrenceville, Georgia AGENCY:

    Centers for Disease Control and Prevention, Department of Health and Human Services (HHS).

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is issuing this notice to advise the public that HHS/CDC has prepared and signed on February 9, 2016 a Finding of No Significant Impact (FONSI) based on the Final Environmental Assessment (Final EA) for the HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025 on the HHS/CDC Lawrenceville Campus, Lawrenceville, Georgia. The Final EA has been prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.

    DATES:

    The FONSI and Final EA are available as February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Copies of the FONSI and/or the Final EA or additional information may be obtained by contacting Angela Wagner, Portfolio Manager, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-K96, Atlanta, GA 30329. Telephone: (770) 488-8170.

    SUPPLEMENTARY INFORMATION:

    The Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services (HHS), has prepared an Environmental Assessment (EA), to assess the potential impacts associated with the undertaking of proposed improvements on the HHS/CDC's Lawrenceville Campus located at 602 Webb Gin House Road in Lawrenceville, Georgia. The proposed improvements include: (1) Building demolition; (2) new building construction, including an approximately 12,000 gross square feet (gsf) Science Support Building, a new Transshipping and Receiving Area at approximately 2,500 gsf and two new small Office Support Buildings at 8,000 gsf and 6,000 gsf; (3) expansion and relocation of parking on campus; and (4) the creation of an additional point of access to the campus. The proposed improvements would be undertaken between the time period of 2015 and 2025 and are contingent on receipt of funding. The proposed improvements are needed to maintain an appropriate facilities quality level on the Lawrenceville Campus.

    On August 14, 2015, HHS/CDC published a notice in the Federal Register (80 FR 48863) announcing the availability of a Draft EA and requesting public comment. The comment period ended on September 28, 2015. No substantive comments were received that raised specific issues or concerns with the methodology, analysis, conclusion or accurateness of the EA.

    Based on the analysis of environmental impacts in the EA and in accordance with NEPA, HHS/CDC has determined that the proposed action will not significantly affect the human or natural environment and therefore does not require the preparation of an environmental impact statement.

    Dated: February 10, 2016. Sandra Cashman, Executive Secretary, Centers for Disease Control and Prevention.
    [FR Doc. 2016-03059 Filed 2-12-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-15-0573] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected]. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    National HIV Surveillance System (NHSS) (OMB Control No. 0920-0573, Expires 02/29/2016)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Data collected as part of the National HIV Surveillance System (NHSS) are the primary data used to monitor the impact of HIV infection in the United States. The NHSS provides critical data that are used to describe the incidence and prevalence of HIV disease and the characteristics of infected persons. HIV surveillance data are used widely at the local, state and national levels for planning, evaluation and allocation of funding for HIV prevention and care programs.

    The NHSS has been updated periodically as science, technology, and our understanding of HIV has evolved. CDC in collaboration with health departments in the 50 states, the District of Columbia, and U.S. dependent areas, conducts national surveillance for cases of HIV infection that includes critical data across the spectrum of HIV disease from HIV diagnosis, to stage 3 (AIDS), the end-stage disease caused by infection with HIV, and death. In addition, this national system provides essential data to estimate HIV incidence and monitor patterns in HIV drug resistance and genetic diversity, as well as provide information on perinatal exposures in the United States.

    The CDC surveillance case definition has been modified periodically to accurately monitor disease in adults, adolescents and children and reflect use of new testing technologies and changes in HIV treatment. Information is then updated in the case report forms and reporting software as needed.

    In 2014, following extensive consultation and peer review, CDC and the Council of State and Territorial Epidemiologists (CSTE) revised and combined the surveillance case definitions for human immunodeficiency virus (HIV) infection into a single case definition for persons of all ages. Laboratory criteria for defining a confirmed case now accommodate new multi-test algorithms, including criteria for differentiating between HIV-1 and HIV-2 infection and for recognizing early HIV infection. Clinical (non-laboratory) criteria for defining a case for surveillance purposes have been made more practical by eliminating the requirement for information about laboratory tests. The surveillance case definition is intended primarily for monitoring the HIV infection burden and planning for prevention and care on a population level, not as a basis for clinical decisions for individual patients. CDC and CSTE recommend that all states and territories conduct case surveillance of HIV infection using this revised surveillance case definition.

    Modifications to data elements to accommodate the 2014 HIV case surveillance definition were approved in the last renewal of OMB Control No. 0920-0573. The revisions requested in this extension include modifications to currently collected data elements and forms to accommodate new testing technologies as well as clinical practice guidelines. Specifically, the HIV Testing and Antiretroviral Use History section will be revised on the adult/adolescent and pediatric case report forms to include new laboratory tests, additional information on use of antiretrioviral (ARV) medications for pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), prevention of mother-to-child-transmission among HIV infected women during pregnancy, and hepatitis B virus (HBV) treatment. Other changes include addition of dates to the address and patient ID fields to better track residence information and minor formatting changes to the form used for Perinatal HIV Exposure Reporting (PHER).

    The revisions to this request also include the addition of burden hours for annual reporting by health departments for the Standards Evaluation Report (SER) and Annual Performance Report (APR). Findings from these reports are used to improve data quality and ensure the accuracy, timeliness, and completeness of the national HIV surveillance, as well as to monitor performance and progress in achieving both state and national HIV surveillance program objectives. Fifty-nine health departments funded for HIV surveillance will report a Standards Evaluation Report (SER) and APR annually.

    CDC provides funding for 59 health departments to conduct adult and pediatric HIV case surveillance and report information to CDC. Health department staff compile information from laboratories, physicians, hospitals, clinics and other health care providers to complete adult and adolescent and pediatric HIV confidential case reports. Updates to case reports are also entered into an electronic database by health departments, as additional information may be received from laboratories, vital statistics offices, or additional providers. Evaluations are also conducted by health departments on a subset of case reports (e.g., re-abstraction/validation activities and routine interstate de-duplication) in all jurisdictions.

    Supplemental surveillance data are collected in a subset of areas to provide additional information necessary to estimate HIV incidence, to better describe the extent of HIV viral resistance and quantify HIV subtypes among persons infected with HIV and to monitor and evaluate perinatal HIV prevention efforts. Health departments funded for these supplemental data collections obtain this information from laboratories, health care providers, and medical records. CDC estimates that 25 health departments will be reporting data elements containing HIV Incidence Surveillance (HIS) data, 53 health departments will report additional data elements on HIV nucleotide sequences as part of Molecular HIV Surveillance (MHS), and 35 areas will be reporting data as part of 35 health departments will be reporting data collected as part of Perinatal HIV Exposure Reporting (PHER) annually. The total estimated annual burden hours are 50,504.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Health Departments Adult HIV Case Report 59 1,061 20/60 Health Departments Pediatric HIV Case Report 59 5 20/60 Health Departments Case Report Evaluations 59 107 20/60 Health Departments Case Report Updates 59 1,576 2/60 Health Departments Laboratory Updates 59 6,303 1/60 Health Departments HIV Incidence Surveillance (HIS) 25 2,288 10/60 Health Departments Molecular HIV Surveillance (MHS) 53 829 5/60 Health Departments Perinatal HIV Exposure Reporting (PHER) 35 114 30/60 Health Departments Annual Reporting: Standards Evaluation Report (SER) 59 1 8 Health Departments Annual Reporting: Annual Performance Report (APR) 59 1 42
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-03046 Filed 2-12-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practices; Public Workshop AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Educational Conference Co-Sponsored With the Society of Clinical Research Associates (SOCRA).” The public workshop on FDA's clinical trial requirements is designed to aid the Clinical Research Professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA, clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, of IRBs, and of research sponsors.

    DATES:

    The public workshop will be held on March 9 and 10, 2016, from 8 a.m. to 5 p.m.

    ADDRESSES:

    The public workshop will be held at the Holiday Inn San Diego Bayside, 4875 North Harbor Dr., San Diego, CA 92106, 619-224-3621.

    FOR FURTHER INFORMATION CONTACT:

    Jane Kreis, Food and Drug Administration, 1301 Clay St., Suite 1180N, Oakland, CA 94612, 510-287-2708, FAX: 510-287-2739, or Society of Clinical Research Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 18914, telephone: 800-762-7292 or 215-822-8644, FAX: 215-822-8633, [email protected], Web site: www.socra.org. (FDA has verified the Web site addresses throughout this document, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

    SUPPLEMENTARY INFORMATION:

    I. Background

    The public workshop helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. The workshop will provide those engaged in FDA-regulated (human) clinical trials with information on a number of topics concerning FDA requirements related to informed consent, clinical investigation requirements, IRB inspections, electronic record requirements, and investigator initiated research.

    FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach activities by Government Agencies to small businesses.

    II. Topics for Discussion at the Public Workshop

    Topics for discussion include the following: (1) The Role of the FDA District Office Relative to the Bioresearch Monitoring Program (BIMO); (2) Modernizing FDA's Clinical Trials/BIMO; (3) What FDA Expects in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects of Clinical Research; (5) Adverse Event Reporting—Science, Regulation, Error, and Safety; (6) Working With FDA's Center for Biologics Evaluation and Research; (7) Ethical Issues in Subject Enrollment; (8) Keeping Informed and Working Together; (9) FDA Conduct of Clinical Investigator Inspections; (10) Investigator Initiated Research; (11) Meetings With FDA—Why, When, and How; (12) Part 11 Compliance—Electronic Signatures; (13) IRB Regulations and FDA Inspections; (14) Informed Consent Regulations; (15) The Inspection is Over—What Happens Next? Possible FDA Compliance Actions; and (16) Question and Answer Session/Panel Discussion.

    Registration: The registration fee will cover actual expenses including refreshments, lunch, materials, and speaker expenses. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. The cost of the registration is as follows: SOCRA member—$575, SOCRA nonmember (includes membership)—$650, Federal Government member—$450, Federal Government nonmember—$525, and FDA Employee—(free) Fee Waived.

    Attendees are responsible for their own accommodations. Please mention SOCRA to receive the hotel room rate of $142 plus applicable taxes (available until the SOCRA room block is filled).

    If you need special accommodations due to a disability, please contact SOCRA (see FOR FURTHER INFORMATION CONTACT) at least 21 days in advance.

    Extended periods of question and answer and discussion have been included in the program schedule. SOCRA designates this education activity for a maximum of 13.3 Continuing Education (CE) Credits for SOCRA CE and Nurse CNE; SOCRA designates this live activity for a maximum of 13.3 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation. CME for Physicians: SOCRA is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.

    Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, telephone, fax number, and email, along with a check or money order payable to “SOCRA.” Mail to: SOCRA (see FOR FURTHER INFORMATION CONTACT). To register via the Internet, go to http://www.socra.org/html/FDAConference.htm. Payment by major credit card is accepted (Visa/MasterCard/AMEX only). For more information on the meeting registration, or for questions on the workshop, contact SOCRA (see FOR FURTHER INFORMATION CONTACT).

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02965 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization.

    FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

    DATES:

    Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by March 17, 2016, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by March 17, 2016. Nominations will be accepted for current vacancies and for those that will or may occur through March 31, 2016.

    ADDRESSES:

    All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to [email protected], by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640.

    Consumer Representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

    FOR FURTHER INFORMATION CONTACT:

    For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32., Rm. 5117, Silver Spring, MD 20993-0002, 301-796-8224, email: [email protected]

    For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1 in the SUPPLEMENTARY INFORMATION section.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing (see table 1 for Contact Person).

    Table 1—Advisory Committee Contacts Contact person Committee/panel Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993-0002, Phone: 301-796-9016, Email: [email protected] Cellular, Tissue and Gene Therapies. Philip Bautista, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2410, Silver Spring, MD 20993-0002, Phone: 301-796-9006, Email: [email protected] Drug Safety and Risk Management Advisory Committee. Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1552, Silver Spring, MD 20993-0002, Phone: 301-796-5290, Email: [email protected] Immunology Devices Panel. Terri Crescenzi, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5152, Silver Spring, MD 20993-0002, Phone: 301-796-8646, Email: [email protected] Pediatrics Advisory Committee. Donna Mendrick, National Center for Toxicological Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 2208, Silver Spring, MD 20993-0002, Phone: 301-796-8892, Email: [email protected] Science Advisory Board to National Center for Toxicological Research (NCTR). Bryan Emery, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, Phone: 240-402-8054, Email: [email protected] Transmissible Spongiform Encephalopathies Advisory Committee. Sujata Vijh, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, Phone: 240-402-7107, Email: [email protected] Vaccines and Related Biological Products Advisory Committee.

    FDA is requesting nominations for voting and/or nonvoting consumer representatives for the vacancies listed in table 2.

    Table 2—Committee Descriptions, Type of Consumer Representative Vacancy and Approximate Date Needed Committee/panel/areas of expertise needed Type of vacancy Approximate date needed Cellular, Tissue and Gene Therapies Advisory Committee—Knowledgeable in the fields of cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation (biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics 1-Voting 3/31/2016. Drug Safety and Risk Management Advisory Committee—Knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse 1-Voting Immediately. Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine 1-Non-Voting 2/28/2016. Pediatrics Advisory Committee—Knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. The core of voting members shall also include one representative from a pediatric health organization and one representative from a relevant patient or patient-family organization and may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests 1-Voting Immediately. Science Advisory Board to the NCTR—Knowledgeable in the fields related to toxicological research 1-Voting Immediately. Transmissible Spongiform Encephalopathies Advisory Committee—Knowledgeable in the fields of clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, and other related professions 1-Voting Immediately. Vaccines and Related Biological Products Advisory Committee—Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry 1-Voting Immediately. II. Functions and General Description of the Committee Duties A. Cellular, Tissue, and Gene Therapies Advisory Committee

    Reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products.

    B. Drug Safety and Risk Management Advisory Committee

    Risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the FDA has regulatory responsibility. Scientific and medical evaluation of all information gathered by the Department of Health and Human Service (DHHS) and the Department of Justice with regard to safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by DHHS with regard to the marketing, investigation, and control of such drugs or other substances.

    C. Certain Panels of the Medical Devices Advisory Committee

    The committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The panels engage in a number of activities to fulfill the functions the Federal Food, Drug, and Cosmetic Act (the act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner of Food and Drugs (the Commissioner) regarding recommended classification or reclassification of devices into one of three regulatory categories, advises on any possible risks to health associated with the use of devices, advises on formulation of product development protocols, reviews premarket approval applications for medical devices, reviews guidelines and guidance documents, recommends exemption of certain devices from the application of portions of the act, advises on the necessity to ban a device, and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use.

    D. Pediatrics Advisory Committee

    The Committee advises and makes recommendations to the Commissioner of Food and Drugs regarding: (1) Pediatric research; (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions; (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric labeling changes; (6) adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur; (7) any other pediatric issue or pediatric labeling dispute involving FDA regulated products; (8) research involving children as subjects; and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by DHHS.

    E. Science Advisory Board to the National Center for Toxicological Research

    Reviews and advises the Agency on the establishment, implementation and evaluation of the research programs and regulatory responsibilities as it relates to NCTR. The Board will also provide an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent.

    F. Transmissible Spongiform Encephalopathies Advisory Committee

    Reviews and evaluates available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products.

    G. Vaccines and Related Biological Products Advisory Committee

    Reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products.

    III. Criteria for Members

    Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate ties to consumer and community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers.

    IV. Selection Procedures

    Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document.

    Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or resume. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel.

    V. Nomination Procedures

    Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency's advisory committees or panels. Self-nominations are also accepted. Nominations should include a cover letter and current curriculum vitae or résumé for each nominee, including a current business and/or home address, telephone number, and email address if available, and a list of consumer or community-based organizations for which the candidate can demonstrate active participation.

    Nominations should also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations should include confirmation that the nominee is aware of the nomination, unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years.

    FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process.

    This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: February 8, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-03010 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0382] Building the National Evaluation System for Medical Devices: Using Real-World Evidence To Improve Device Safety and Effectiveness; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop titled “Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness.” The objective of the workshop is to discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. A national evaluation system for medical devices, which leverages real-world evidence, can help FDA more efficiently strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period. The promise of using real-world evidence to promote the safety and effectiveness of medical devices can only be achieved through robust public-private partnerships and new approaches to informatics, epidemiology, biostatistics, and healthcare data systems integration.

    DATES:

    The public workshop will be held on March 24, 2016, from 8:30 a.m. to 4:30 p.m.

    ADDRESSES:

    The public workshop will be held at the University of Maryland, Pharmacy Hall, 20 North Pine St., Baltimore, MD 21201. For additional travel and hotel information, please refer to www.pharmacy.umaryland.edu/DeviceEval. (FDA has verified the Web site addresses throughout this notice, but FDA is not responsible for subsequent changes to the Web sites after this document publishes in the Federal Register).

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-0382 for “Building the National Evaluation System for Medical Devices: Using Real-World Evidence to Improve Device Safety and Effectiveness; Public Workshop; Request for Comments”. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Ann Anonsen, University of Maryland, Fischell Department of Bioengineering, 2207 Jeong H. Kim Bldg., College Park, MD 20742, 301-405-0285, FAX: 304-405-9953, [email protected]; or Audrey Thomas, Office of Regulatory Science and Innovation, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4220, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    The purpose of this public workshop is to discuss the scientific progress being made in harnessing evidence generated from the real-world use of medical devices to improve device safety and effectiveness. The role that unique device identification plays in improving device evaluation, to support more informed clinical and patient decision-making, and device innovation will also be discussed.

    The foundation (strategy and steps) for the development of a national evaluation system for medical devices has been developed by FDA's Center for Devices and Radiological Health (available at www.pharmacy.umaryland.edu/DeviceEval). In 2015, two multistakeholder groups issued reports that develop the science and provide recommendations that further the establishment of this system: “Building an Effective National Medical Device Surveillance System” and “Recommendations for a National Medical Device Evaluation System: Strategically Coordinated Registry Networks to Bridge the Clinical Care and Research” (available at www.pharmacy.umaryland.edu/DeviceEval).

    To successfully harness relevant information from the diverse set of real-world evidence, the United States must develop the necessary infrastructure which is not yet in place today. We continue to explore ways to improve the efficiency and cost-effectiveness of data generation in traditional medical device clinical trials while maintaining data quality. The goal is to streamline the process and restore the United States to the country of first choice to conduct clinical research for medical technology innovation and ultimately bring their products first to U.S. patients. Limitations of current postmarket surveillance tools, such as passive reporting, also constrain ability to rapidly address safety concerns. A national evaluation system for medical devices, which leverages real-world evidence, can help FDA more efficiently strike the right balance between premarket and postmarket data collection, facilitate access to medical devices, and more quickly and robustly identify safety signals that may arise in the postmarket period. The promise of using real-world evidence to promote the safety and effectiveness of medical devices can only be achieved through robust public-private partnerships and new approaches to informatics, epidemiology, biostatistics, and healthcare data systems integration.

    This workshop will provide clinicians, researchers, and others from the medical device industry, professional societies, health care delivery systems groups, patient advocacy groups, and FDA the opportunity to discuss this important topic.

    Agenda: The agenda is located at www.pharmacy.umaryland.edu/DeviceEval.

    Registration: There is a registration fee to attend this public workshop. The registration fee is charged to help defray the costs for facilities, materials, and food. Seats are limited and registration will be on a first-come, first-served basis.

    To register, please complete registration online at: www.pharmacy.umaryland.edu/DeviceEval. The costs of registration for the different categories of attendees are as follows:

    Category Cost Industry Representative $50 Charitable Nonprofit and Academic Other Than University of Maryland 50 University of Maryland, College Park and Baltimore 0 Government 0

    Accommodations: Attendees are responsible for their own hotel accommodations. If you need special accommodations due to a disability, please contact Ann Anonsen (see FOR FURTHER INFORMATION CONTACT).

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02966 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0407] Proposed Pilot Project(s) Under the Drug Supply Chain Security Act; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing a public workshop entitled “Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).” This public workshop will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. The information gathered from the workshop and the public comments submitted to the docket will further inform FDA's development of its pilot project program.

    DATES:

    The public workshop will be held on April 5, 2016, from 9 a.m. to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. The deadline for submitting either electronic or written comments on this workshop is April 21, 2016. See the SUPPLEMENTARY INFORMATION section for registration date and information.

    ADDRESSES:

    The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the confirmed public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-0407 for “Proposed Pilot Project(s) under the Drug Supply Chain Security Act; Public Workshop; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130, [email protected] (include “DSCSA pilot projects” in the subject line).

    SUPPLEMENTARY INFORMATION: I. Background

    On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed within the United States. Section 202 of the DSCSA added the new sections 581 and 582 to the Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee and 360eee-1). Under section 582(j), FDA is required to establish one or more pilot projects, in coordination with authorized manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

    FDA intends to establish a pilot project program to implement section 582(j) of the FD&C Act. The overarching goals of this program include assessing the ability of supply chain members to satisfy the requirements of section 582 and to identify, manage, and prevent the distribution of suspect and illegitimate drugs; identifying the system attributes needed to implement the requirements of section 582, particularly the requirement to utilize a product identifier for product tracing purposes; and demonstrating the electronic, interoperable exchange of product tracing information across the pharmaceutical distribution supply chain. FDA intends to coordinate its pilot project program efforts with stakeholders that reflect the diversity of the pharmaceutical distribution supply chain, including large and small entities from all industry sectors.

    II. Purpose of the Public Workshop

    This public workshop is intended to provide an opportunity for interested persons to provide comments on and discuss the proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the pharmaceutical distribution supply chain, and identifying the system attributes that are necessary to implement the requirements under section 582. FDA would also like to learn more about the practices, processes, and systems that supply chain stakeholders currently use or plan to use to meet the requirements under section 582, particularly the product tracing and verification requirements. These practices, processes, and systems may include those that supply chain stakeholders would consider using in pilot projects or those that supply chain stakeholders have already used in other previous pilot projects.

    By March 29, 2016, FDA will post the workshop agenda and other relevant materials under the DSCSA section of its Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Supply chain stakeholders that might be interested in attending the public workshop include manufacturers, repackagers, wholesale distributors, dispensers, State and Federal authorities, solution providers, and standards organizations. Participants at the workshop will not be asked to develop consensus opinions during the discussion, but rather to provide their individual perspectives.

    Regardless of attendance at the public workshop, interested stakeholders may submit comments to the public docket related to any of the public workshop materials, including the agenda and other posted materials on FDA's Web site, in addition to comments specific to the design of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. Stakeholders may comment on utilizing the product identifier for product tracing and the technical capabilities of the pharmaceutical distribution supply chain and the system attributes that are necessary to implement the requirements under section 582. The information gathered from the workshop participants and from the comments submitted to the docket for the public workshop will further inform FDA's development of its pilot project program under section 582(j) of the FD&C Act.

    III. Registration for the Public Workshop

    To request registration for the public workshop, provide your information including name, company or organization, address, telephone number, and email address to FDA at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Registration requests should be received by March 11, 2016. FDA is limiting workshop attendance due to limited space. FDA may limit the number of participants from each organization based on space limitations. FDA recommends that each organization determine who should register for the workshop to represent his/her organization. This will help ensure that the workshop will have broad and varied representation across the pharmaceutical distribution supply chain. Registrants will receive confirmation of participation for the workshop from FDA by March 18, 2016. There is no registration fee for the public workshop. There will be no onsite registration. If registration reaches maximum capacity, FDA will post a notice closing registration for the workshop on FDA's Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. If you need special accommodations due to a disability, please contact Daniel Bellingham (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the public workshop.

    IV. Webcasting of the Public Workshop

    Portions of this public workshop will be recorded and Webcasted on the day of the workshop. Information for how to access the Webcast will be available at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm by March 29, 2016. The Webcast will be conducted in listening-mode only.

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02977 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0437] Evaluation of the Safety of Drugs and Biological Products Used During Lactation; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing a public workshop entitled “Evaluation of the Safety of Drugs and Biological Products used during Lactation.” The purpose of this workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The workshop will review current approaches to the collection of data when drugs are used or expected to be used during lactation. The workshop will also discuss and consider novel approaches to improve the quality and quantity of data, to inform of the potential risks of medication use during lactation, and to raise awareness and engage stakeholders about communication of safety information related to maternal use of medications during lactation.

    DATES:

    The public workshop will be held on April 27, 2016, from 8 a.m. to 5 p.m.; and April 28, 2016, from 8 a.m. to 1 p.m. Registration closes on April 8, 2016. Submit electronic or written comments to the public docket by May 28, 2016.

    ADDRESSES:

    The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-0437 for “Evaluation of the Safety of Drugs and Biological Products used during Lactation; Public Workshop; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    For questions regarding the workshop, contact Denise Pica-Branco, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1732, FAX: 301-796-9858, [email protected]; or Denise Johnson-Lyles, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6169; FAX: 301-796-9858, [email protected]

    Registration: Participation can be either in person attendance or by Webcast. There is no fee to attend the public workshop, but attendees must register in advance. Space is limited, and registration will be on a first-come, first-served basis. Persons interested in attending this workshop must register online at [email protected] Please include: (1) First and last name, (2) contact phone or email address, (2) live attendance or via Webcast, (4) indicate if you plan to attend day 1, day 2, or both days. Registration closes on April 8, 2016. For those without Internet access, please contact Denise Pica-Branco or Denise Johnson-Lyles (see FOR FURTHER INFORMATION CONTACT) to register. Onsite registration will not be available.

    If you need special accommodations due to a disability, please contact Denise Pica-Branco or Denise Johnson-Lyles (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA has engaged with regulatory, academic, and industry experts to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation. The first day of the workshop will focus on review and discussion of current approaches for the collection of data, and review and discussion of gaps in our present knowledge. The second day of the workshop will focus on consideration of novel approaches to improve the quality and quantity of data available to assess the safety of medications used during lactation as well as a review and discussion of strategies to communicate safety information related to maternal use of medications during lactation.

    This workshop includes a public comment session. If you would like to present during this session, please identify the topic(s) you will address during the registration. FDA will do its best accommodate requests to speak. FDA urges individuals and organizations with common interests to coordinate and give a joint, consolidated presentation. Following the close of registration, FDA will allot time for each presentation and notify presenters by April 21, 2016. Do not present or distribute commercial or promotional material during the workshop. Registered presenters should check in before the workshop begins.

    II. Transcripts

    Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20857. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov.

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02967 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on cyclosporine ophthalmic emulsion entitled “Draft Guidance on Cyclosporine.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclosporine ophthalmic emulsion. This draft guidance is a revised version of a previously issued draft guidance on the same subject.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2007-P-0369 for “Draft Guidance on Cyclosporine.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, “Bioequivalence Recommendations for Specific Products,” which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of revised draft BE recommendations for cyclosporine ophthalmic emulsion.

    FDA initially approved new drug application 050790 for RESTASIS (cyclosporine ophthalmic emulsion), 0.05% in December 2002. There are no approved ANDAs for this product. In June 2013, we issued a draft guidance for industry on BE recommendations for generic cyclosporine ophthalmic emulsion.

    Allergan, Inc., manufacturer of the reference listed drug, RESTASIS, submitted a citizen petition in February 2014 challenging the Agency's initial BE recommendations for generic cyclosporine ophthalmic emulsion. We responded to that petition on November 20, 2014 (Docket No. FDA-2014-P-0304). The following month, Allergan submitted a second citizen petition challenging the Agency's initial BE recommendations. In April 2015, FDA received a third citizen petition on its initial BE recommendations from Physical Pharmaceutica LLC. FDA has reviewed the issues raised by Allergan and Physical Pharmaceutica and is responding to their petitions (Docket Nos. FDA-2015-P-0065 and FDA-2015-P-1404).

    In addition, we are now issuing a revised draft guidance for industry on BE recommendations for generic cyclosporine ophthalmic emulsion (“Draft Guidance on Cyclosporine”).

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies to support ANDAs for cyclosporine ophthalmic emulsion. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

    II. Electronic Access

    Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02975 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0236] Nonallergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this draft guidance is to assist applicants in the development of drug and biological products for the treatment of nonallergic rhinitis (NAR).

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-D-0236 for “Nonallergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability”. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sofia Chaudhry, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3317, Silver Spring, MD 20993-0002, 301-796-4157.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this draft guidance is to assist applicants in the development of drug and biological products for the treatment of NAR.

    The nomenclature and understanding of the pathophysiology of NAR continue to evolve. The recommendations in this guidance are based on the Agency's current understanding of the definition of NAR and an assessment of issues raised by the presumed heterogeneity of NAR. The guidance discusses issues regarding the definition of a clinical phenotype, trial design, efficacy, and safety for new products under development.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on developing drug products for the treatment of NAR. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02976 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

    Name of Committee: Oncologic Drugs Advisory Committee.

    General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

    Date and Time: The meeting will be held on April 12, 2016, from 8:30 a.m. to 1 p.m.

    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    Contact Person: Lauren D. Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    Agenda: The committee will discuss new drug application (NDA) 208542, rociletinib tablets, application submitted by Clovis Oncology, Inc. The proposed indication (use) for this product is for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before March 29, 2016. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 21, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 22, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require special accommodations due to a disability, please contact Lauren D. Tesh at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: February 8, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-03011 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0412] Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.” The purpose of this draft guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This draft guidance supersedes the draft guidance entitled “Inhalational Anthrax (Post-Exposure)—Developing Antimicrobial Drugs” issued in March 2002.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-D-0412 for “Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Draft Guidance for Industry; Availability.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-796-1300.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.” The purpose of this draft guidance is to assist sponsors in the development of new drugs to be administered to persons who have inhaled Bacillus anthracis spores, but who have not yet manifested clinical evidence of disease, to prevent the development of inhalational anthrax disease. We refer to this indication as “prophylaxis of inhalational anthrax.” This draft guidance describes approaches for the designs of the animal model efficacy studies and recognizes that drug development for the sole indication of prophylaxis of inhalational anthrax is possible.

    This draft guidance supersedes the draft guidance for industry entitled “Inhalational Anthrax (Post-Exposure)—Developing Antimicrobial Drugs” published in March 2002 (2002 draft guidance). The 2002 draft guidance stated that drugs for the prophylaxis of inhalational anthrax would be approved under the accelerated approval regulations (21 CFR part 314, subpart H, for drugs and 21 CFR part 601, subpart E, for biological products), unless the drug already carried an anthrax indication. Shortly after the 2002 draft guidance issued, FDA amended its regulations to provide a regulatory mechanism to approve drugs and biological products when human efficacy studies are not ethical or feasible (part 314, subpart I, for drugs and part 601, subpart H, for biological products). These regulations are commonly referred to as the “animal rule.” 1 This draft guidance states that drugs developed for prophylaxis of inhalational anthrax will be considered for approval under the animal rule regulations. Other changes from the 2002 draft guidance are incorporated into the appropriate sections of this guidance and are based on comments received to the docket for the 2002 draft guidance as well as recent developments in scientific information that pertain to drugs being developed for prophylaxis of inhalational anthrax.

    1 The animal rule regulations in this guidance specifically refer to part 314, subpart I, for drugs and part 601, subpart H, for biological products. In October 2015, FDA finalized the guidance for industry entitled “Product Development Under the Animal Rule” that contains general information and recommendations on the development and approval of products under the animal rule.

    Issuance of this draft guidance fulfills a portion of the requirements of Title VIII, section 804, of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), which requires FDA to review and, as appropriate, revise not fewer than three guidance documents per year for the conduct of clinical trials with respect to antibacterial and antifungal drugs.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02964 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Completeness Assessments for Type II API DMFs Under GDUFA”. It finalizes the draft guidance entitled “Initial Completeness Assessments for Type II API DMFs Under GDUFA”, which published on October 2, 2012. This guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS (generic drug submissions).

    DATES:

    Submit either electronic or written comments on Agency guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2012-D-1010 for “Completeness Assessments for Type II API DMFs Under GDUFA”. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Elizabeth Giaquinto Friedman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1669, Silver Spring, MD 20993-0002, 240-402-7930; or Huyi Zhang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 75, Rm. 6604, Silver Spring, MD 20993-0002, 240-402-8843; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a guidance for industry entitled “Completeness Assessments for Type II API DMFs Under GDUFA”. This guidance is intended for holders of Type II API DMFs that are or will be referenced in an ANDA, an amendment to an ANDA, a PAS to an ANDA, or an amendment to a PAS (generic drug submissions). The guidance makes recommendations about the information that should be included in the DMF to facilitate a Generic Drug User Fee Amendments of 2012 (GDUFA) Completeness Assessment (CA). The guidance does not apply to Type II API DMFs used to support new drug applications (NDAs), biologics license applications, other submissions that are not generic drug submissions, or any other types of DMFs.

    Under GDUFA, beginning October 1, 2012, the holder of a Type II API DMF must pay a one-time DMF fee when the DMF is first referenced in a generic drug submission submitted to FDA on the basis of a letter of authorization from the DMF holder. Also under GDUFA, holders of Type II API DMFs that were evaluated before October 1, 2012, must pay a one-time fee for the DMF when their DMF is first referenced in a new ANDA, an ANDA amendment, or an ANDA PAS on or after October 1, 2012. Only Type II API DMFs for use in generic drug submissions incur this one-time fee. Type II API DMFs intended for reference in a generic drug submission for which the fee is paid will undergo a CA. Although the requirement for a CA for Type II API DMFs is new, FDA has previously evaluated DMFs in accordance with the criteria set out in the GDUFA Completeness Assessment Checklist for Type II API DMFs (CA Checklist), attached to the guidance.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Completeness Assessments for Type II API DMFs Under GDUFA”. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Electronic Access

    Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02969 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0277] Allergic Rhinitis: Developing Drug Products for Treatment; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this draft guidance is to assist sponsors in the development of drug products for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This draft guidance revises the draft guidance for industry entitled “Allergic Rhinitis: Clinical Development Programs for Drug Products” issued April 2000.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2000-D-0277 for “Allergic Rhinitis: Developing Drug Products for Treatment.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Sofia Chaudhry, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3317, Silver Spring, MD 20993-0002, 301-796-4157.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” The purpose of this draft guidance is to assist sponsors in the development of drug and biologic products for the treatment of SAR and PAR. Information about the pathophysiology and treatment of allergic rhinitis and its subtypes, SAR and PAR, has grown markedly in the past decade. The recommendations in this draft guidance are based on an assessment of important issues raised in the review of both adult and pediatric allergic rhinitis clinical trials and the Agency's current understanding of the mechanism of the two related disorders of SAR and PAR. The pathophysiology of SAR and PAR are similar in terms of the chemical mediators produced and end-organ manifestations, with differences between the two entities primarily based on the causes and duration of disease. The trial design issues pertaining to SAR and PAR are also similar. Thus, these two categories are treated collectively in this draft guidance as allergic rhinitis, with differences in recommendations for the design of SAR and PAR trials indicated.

    This draft guidance revises the draft guidance for industry entitled “Allergic Rhinitis: Clinical Development Programs for Drug Products” issued April 2000. All of the public comments we received for the draft guidance have been considered and the draft guidance has been revised as appropriate.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the development of drug products for the treatment of allergic rhinitis. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-02978 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Correction AGENCY:

    Health Resources and Services Administration, HHS.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Health Resources and Services Administration published a notice in the Federal Register, 80 FR 55861 (September 17, 2015) announcing the Bridging the Word Gap Competition Challenge. This correction notice extends the deadline for Phase 1 submissions by approximately 4 weeks to allow for additional submissions. Accordingly, the remaining timelines for all subsequent phases and judging periods will also be extended by approximately 4 weeks.

    FOR FURTHER INFORMATION CONTACT:

    Jessie Buerlein, Public Health Analyst, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane Rockville, MD 20852, [email protected], 301-443-8931.

    Correction

    In the Federal Register 80 FR 55861 (September 17, 2015), please make the following corrections:

    In the Summary section, correct dates of each phase to read:

    Dates for each phase are as follows:

    Phase 1 Effective: November 6, 2015 Phase 1 Submission Deadline: January 29, 2016, 11:59 p.m. ET Phase 1 Judging Period: January 30-February 28, 2016 Phase 1 Winners Announced: March 8, 2016 Phase 2 Begins: March 11, 2016 Phase 2 Submission Deadline: August 11, 2016 Phase 2 Judging Period: August 12-September 16, 2016 Phase 2 Winners Announced: Week of September 19, 2016 Phase 3 Begins: September 26, 2016 Phase 3 Submission Deadline: March 26, 2017 Phase 3 Winner Announced: May 2017 Dated: January 29, 2016. James Macrae, Acting Administrator.
    [FR Doc. 2016-03106 Filed 2-12-16; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request AGENCY:

    Health Resources and Services Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

    DATES:

    Comments on this ICR should be received no later than March 17, 2016.

    ADDRESSES:

    Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to [email protected] or by fax to 202-395-5806.

    FOR FURTHER INFORMATION CONTACT:

    To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443-1984.

    SUPPLEMENTARY INFORMATION:

    Information Collection Request Title: Medicare Rural Hospital Flexibility Grant Program Performance.

    OMB No.: 0915-0363—Revision.

    Abstract: The Medicare Rural Hospital Flexibility Program (Flex) is authorized by Section 1820 of the Social Security Act (42 U.S.C. 1395i-4), as amended. Flex engages 45 state-designated entities in activities relating to planning and implementing rural health care plans and networks; designating facilities as Critical Access Hospitals (CAHs); providing support for CAHs for quality improvement, quality reporting, performance improvements, and benchmarking; and integrating rural emergency medical services (EMS). Given the shifting priorities in health care related to delivery system reform, Flex provides funding for states to also deliver technical assistance in activities supporting population health management and the integration of innovative care models. State-designated Flex programs act as a resource and focal point for these activities, promoting the stability and delivery of high quality health care services for residents in rural communities. Identifying areas for program improvement and enhanced technical assistance in a systematic approach is paramount. The revised measures identified in the Flex Program complement work plan data and take into consideration existing measures and priorities set forth by HHS, avoiding duplication of efforts and minimizing burden as indicated by public comments and programmatic feedback from partners.

    Need and Proposed Use of the Information: For this program, measures were revised to provide performance data useful to the Flex Program and provide aggregate program data required by Congress under the Government Performance and Results Act (GPRA) of 2010. These measures cover principal topic areas of interest to the Federal Office of Rural Health Policy (FORHP) including: (a) Quality reporting; (b) quality improvement interventions; (c) financial and operational improvement initiatives; (d) population health management and EMS integration; and (e) innovative care models. Several measures related to critical access hospitals (CAHs) making improvements will be used for this program and will inform FORHP's progress toward meeting the goals set in GPRA. Furthermore, obtaining this information is important for identifying and understanding improvement trends across Flex program areas, prioritizing areas of need with technical assistance and support for grantees, and guiding future iterations of the Flex Program.

    Likely Respondents: Respondents will be the Flex Program coordinator for each state participating in the Flex Program. There are currently 45 states participating in the Flex Program.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

    Total Estimated Annualized Burden—Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • responses
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden hours
    Medicare Rural Hospital Flexibility Grant Program Performance 45 1 45 70 3,150 Total 45 1 45 70 3,150
    Jackie Painter, Director, Division of the Executive Secretariat.
    [FR Doc. 2016-03014 Filed 2-12-16; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Notice of Meeting

    In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given of the following meeting:

    Name: Advisory Commission on Childhood Vaccines (ACCV).

    Date and Time: March 3, 2016, 10:00 a.m. to 3:15 p.m. EDT.

    Place: Audio Conference Call and Adobe Connect Pro.

    The ACCV will meet on Thursday, March 3, 2016, from 10:00 a.m. to 3:15 p.m. (EDT). The public can join the meeting by:

    1. (Audio Portion) Calling the conference phone number 1-800-779-3561 and providing the following information:

    Leaders Name: Dr. Narayan Nair.

    Password: 8164763.

    2. (Visual Portion) Connecting to the ACCV Adobe Connect Pro Meeting using the following URL: https://hrsa.connectsolutions.com/accv/ (copy and paste the link into your browser if it does not work directly and enter as a guest). Participants should call and connect 15 minutes prior to the meeting in order for logistics to be set up. If you have never attended an Adobe Connect meeting, please test your connection using the following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm and get a quick overview by following URL: http://www.adobe.com/go/connectpro_overview. Call (301) 443-6634 or send an email to [email protected] if you are having trouble connecting to the meeting site.

    Agenda: The agenda items for the March 2016 meeting will include, but are not limited to, updates from the Division of Injury Compensation Programs (DICP), Department of Justice (DOJ), National Vaccine Program Office (NVPO), Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health) and Center for Biologics, Evaluation and Research (Food and Drug Administration). A draft agenda and additional meeting materials will be posted on the ACCV Web site (http://www.hrsa.gov/vaccinecompensation/accv.htm) prior to the meeting. Agenda items are subject to change as priorities dictate.

    Public Comment: Persons interested in providing an oral presentation should submit a written request, along with a copy of their presentation to: Annie Herzog, DICP, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 8N146B, 5600 Fishers Lane, Rockville, Maryland 20857 or email: [email protected] Requests should contain the name, address, telephone number, email address, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative. The allocation of time may be adjusted to accommodate the level of expressed interest. DICP will notify each presenter by email, mail, or telephone of their assigned presentation time. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may announce it at the time of the public comment period. Public participation and ability to comment will be limited to space and time as it permits. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed below at least 10 days prior to the meeting.

    FOR FURTHER INFORMATION CONTACT:

    Anyone requiring information regarding the ACCV should contact Annie Herzog, DICP, HSB, HRSA, Room 8N146B, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443-6593, or email: [email protected]

    Jackie Painter, Director, Division of the Executive Secretariat.
    [FR Doc. 2016-03015 Filed 2-12-16; 8:45 am] BILLING CODE 4165-15-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Biological Chemistry and Macromolecular Biophysics.

    Date: March 1, 2016.

    Time: 3:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: David R Jollie, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4150, MSC 7806, Bethesda, MD 20892, (301)-435-1722, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Investigations on Primary Immunodeficiency Diseases.

    Date: March 3, 2016.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Jin Huang, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4095G, MSC 7812, Bethesda, MD 20892, 301-435-1230, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Review: Synthetic Psychoactive Drugs and Strategic Approaches to Counteract Their Deleterious Effects.

    Date: March 4, 2016.

    Time: 11:00 a.m. to 1:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Nicholas Gaiano, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5178, MSC 7844, Bethesda, MD 20892-7844, 301-435-1033, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: February 9, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-02972 Filed 2-12-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: AIDS and Related Research Integrated Review Group, AIDS Discovery and Development of Therapeutics Study Section.

    Date: March 8, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Shiv A Prasad, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5220, MSC 7852, Bethesda, MD 20892, 301-443-5779, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel, Infectious Diseases and Microbiology.

    Date: March 8, 2016.

    Time: 9:30 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Guangyong Ji, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3211, MSC 7808, Bethesda, MD 20892, 301-435-1146, [email protected].

    Name of Committee: Center for Scientific Review Special Emphasis Panel, AREA application in Infectious Diseases and Microbiology.

    Date: March 8, 2016.

    Time: 9:30 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: Liangbiao Zheng, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3202, MSC 7808, Bethesda, MD 20892, 301-996-5819, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: February 9, 2016. Sylvia Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-02974 Filed 2-12-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

    ADDRESSES:

    Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702.

    FOR FURTHER INFORMATION CONTACT:

    Information on licensing and co-development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.

    SUPPLEMENTARY INFORMATION:

    Technology description follows.

    Title of Invention

    AAV-based Vectors for the Therapeutic Management of Menkes Disease and Related Copper Transport Disorders

    Description of Technology

    The only currently available treatment for Menkes disease, subcutaneous copper histidinate injections, is successful only in patients with ATP7A gene mutations that do not completely corrupt ATP7A copper transport function (estimated 20-25% of affected patients) and when started at a very early age (first month of life). The combination of viral gene therapy with copper injections provides working copies of the ATP7A copper transporter into the brain, together with a source of the substrate (copper) needed for proper brain growth and clinical neurodevelopment.

    Codon-optimized nucleic acids encoding a reduced-size ATP7A protein and compositions of AAV vectors were discovered by NICHD researchers along with methods of administering this therapy. Human P-type ATPase copper-transporting ATPase 1 (ATP7A) transports copper from enterocytes (where it is taken up from dietary copper) into the blood. ATP7A also mediates passage of copper across the blood-cerebrospinal fluid (CSF) barrier and the blood-brain barrier. In Menkes disease and occipital horn syndrome (OHS), copper accumulates in intestinal cells and less copper is absorbed into the blood, resulting in restricted copper supply to other tissues, particularly the brain. Death in infancy or early childhood is a common consequence. Therapeutic delivery of the copper transport protein via an AAV vector, combined with subcutaneous copper histidinate treatment will relieve the copper deficiency to the brain and permit normal neurological development and function.

    Potential Commercial Applications

    • Treatment of Menkes Disease, Occipital Horn Syndrome, and of ATP7A-related distal motor neuropathy

    Value Proposition

    • Provides working copies of the ATP7A copper transporter into the brain, together with a source of the substrate (copper) needed for proper brain growth and clinical neurodevelopment.

    Development Stage

    Pre-clinical (in vivo validation)

    Inventor(s)

    Stephen G. Kaler, M.D. (NICHD)

    Intellectual Property

    HHS Reference No. E-062-2015/0

    U.S. Provisional Application No. 62/244,594 filed 21 October 2015

    Licensing Opportunity: Researchers at the NICHD seek licensing and/or co-development research collaborations for the therapeutic management of Menkes Disease and related copper transport disorders.

    Contact Information

    Requests for copies of the patent application or inquiries about licensing, research collaborations, and co-development opportunities should be sent to John D. Hewes, Ph.D., email: [email protected]

    Dated: February 8, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute.
    [FR Doc. 2016-02970 Filed 2-12-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.

    ADDRESSES:

    Information on licensing, co-development research collaborations, and/or copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD, 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.

    FOR FURTHER INFORMATION CONTACT:

    Requests for copies of the patent application or inquiries about licensing and/or co-development should be sent to John D. Hewes, Ph.D., email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Technology description follows.

    Title of invention: Modified griffithsin tandemers for enhanced activity and reduced viral aggregation.

    Description of Technology: Griffithsin (GRFT) is a lectin with potent antiviral properties that is capable of preventing and treating infections caused by a number of enveloped viruses (including HIV, SARS, HCV, HSV, and Japanese encephalitis) and is currently in clinical development as an anti-HIV microbicide. In addition to its broad antiviral activity, GRFT is stable at high temperature and at a broad pH range, displays low toxicity and immunogenicity, and is amenable to large-scale manufacturing. Native GRFT is a domain-swapped homodimer that binds to viral envelope glycoproteins and has displayed mid-picomolar activity in cell-based anti-HIV assays. This invention is directed to synthetic proteins that comprise two (or more) obligate monomers (“mGRFT”) joined by an amino acid linker to form tandemers (“mGRFT tandemers”). Each obligate monomer is generated by the addition of Gly-Ser residues in the hinge region of wild-type GRFT. Two or more obligate monomers are joined by an amino acid linker to form the mGRFT tandamers. The properties of the mGRFT tandemers can be modulated by the length of the amino acid linker and the number of obligate monomers co-joined. mGRFT tandemers exhibit gore potent anti-viral properties when compared against native GRFT and are equipotent against viruses that are both sensitive and resistant to naive GRFT. As such, potential uses of the invention tandemers include topical and intravenous therapy to treat HIV infection, particularly to treat HIV infections that are resistant to native GRFT.

    Potential Commercial Applications • Broad-spectrum antiviral agent similar to wild type GRFT • Potential activity against SARS CoV, MERS, Ebola, HCV and influenza Value Proposition • Broad antiviral activity • Stable at high temperature and at a broad pH range • Displays low toxicity and immunogenicity.

    Development Stage: In vivo/Lead Validation.

    Inventor(s): Barry R. O'Keefe (NCI), A. Wlodawer (NCI), T. Moulaei (NCI).

    Publication(s) —Moulaei T. et al., Griffithsin tandemers: flexible and potent lectin inhibitors of the human immunodeficiency virus. Retrovirology. 2015 Jan 23;12:6. —A. Chatterjee et al.,Griffithsin and Carrageenan Combination To Target Herpes Simplex Virus 2 and Human Papillomavirus, Antimicrob Agents Chemother. 2015 Dec; 59(12): 7290-7298. Intellectual Property

    HHS Reference No. E-034-2013/0-US-01.

    PCT Application No. PCT/US2014/040992 (HHS Reference No. E-034-2013/0- US-01) filed June 5, 2013 entitled “Modified griffithsin tandemers for enhanced activity and reduced viral aggregation”.

    Licensing and Collaborative/Co-Development Research Opportunity: Researchers at the NCI seek licensees and/or co-development partners for the commercialization of Griffithsin and Griffithsin tandemers, specifically, additional studies on stability, toxicity, immunogenicity, and large-scale production.

    Dated: February 1, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute.
    [FR Doc. 2016-02971 Filed 2-12-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Special Topic: Social Sciences and Population Studies.

    Date: February 23, 2016.

    Time: 12:00 p.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Suzanne Ryan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3139, MSC 7770, Bethesda, MD 20892, (301) 435-1712, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: February 9, 2016. Sylvia Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-02973 Filed 2-12-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [CBP Dec. No. 16-04] Expansion of Global Entry Eligibility to All Citizens of the Federal Republic of Germany AGENCY:

    U.S. Customs and Border Protection; Department of Homeland Security.

    ACTION:

    General notice.

    SUMMARY:

    U.S. Customs and Border Protection (CBP) has established the Global Entry international trusted traveler program at most major U.S. airports. Global Entry allows pre-approved participants dedicated CBP processing into the United States using Global Entry kiosks located at designated airports. In 2013, CBP announced a limited pilot program through which certain citizens of the Federal Republic of Germany (Germany) were eligible to apply for participation in the Global Entry program. This document announces that CBP is concluding the pilot and expanding eligibility in the Global Entry program to include all German citizens. Additionally, this document announces that certain U.S. citizens may apply for membership in EasyPASS, Germany's registered traveler program.

    DATES:

    Global Entry eligibility will be expanded to German citizens on February 16, 2016. Applications will be accepted beginning February 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Larry Panetta, Office of Field Operations, (202) 344-1253, [email protected]

    SUPPLEMENTARY INFORMATION: Background Global Entry Program

    Global Entry is a voluntary program that allows for dedicated CBP processing of pre-approved travelers arriving in the United States at Global Entry kiosks located at designated airports. On February 6, 2012, CBP issued the final rule that promulgated the regulation (8 CFR 235.12) to establish Global Entry as an ongoing voluntary regulatory program in the Federal Register (77 FR 5681). The final rule contains a detailed description of the program, the eligibility criteria, the application and selection process, and the initial airport locations. Travelers who wish to participate in Global Entry must apply via the Global On-Line Enrollment System (GOES) Web site, https://goes-app.cbp.dhs.gov, and pay the applicable fee. Applications for Global Entry must be completed and submitted electronically.

    Eligibility for participation in Global Entry is limited to U.S. citizens, U.S. nationals, U.S. lawful permanent residents, and certain nonimmigrant aliens from countries that have entered into arrangements with CBP regarding international trusted traveler programs. Specifically, the regulation provides that certain nonimmigrant aliens from countries that have entered into arrangements with CBP concerning international trusted traveler programs may be eligible to apply for participation in Global Entry after CBP announces the arrangement by publication of a notice in the Federal Register. The notice will include the country, the scope of eligibility of nonimmigrant aliens from that country (e.g., whether only citizens of the foreign country or citizens and non-citizens are eligible) and other conditions that may apply based on the terms of the arrangement. See 8 CFR 235.12(b)(1)(ii). In the preamble of the Gl