Federal Register Vol. 81, No.11,

Federal Register Volume 81, Issue 11 (January 19, 2016)

Page Range2725-2966
FR Document

81_FR_11
Current View
Page and SubjectPDF
81 FR 2924 - Notice of Submission for Approval: Information Collection 3206-0150; Fingerprint Chart Standard Form 87, SF 87PDF
81 FR 2923 - Notice of Submission for Approval: Information Collection 3206-0259; Freedom of Information/Privacy Act Record Request Form, INV 100PDF
81 FR 2915 - Sunshine Act MeetingPDF
81 FR 2774 - United States Standards for Sunflower SeedPDF
81 FR 2914 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 2844 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Notice of Court Decision Not in Harmony With the Final Results of Review and Amended Final Results of the Antidumping Duty Administrative ReviewPDF
81 FR 2845 - Steel Wire Garment Hangers From the People's Republic of China; 2014-2015; Partial Rescission of the Seventh Antidumping Duty Administrative ReviewPDF
81 FR 2852 - Privacy Act of 1974; System of Records-Impact Evaluation of Data-Driven Instruction Professional Development for TeachersPDF
81 FR 2843 - Correction Notice; Authorization of Production Activity; Foreign-Trade Zone 265; Bauer Manufacturing Inc.; (Stationary Oil/Gas Drilling Rigs); Conroe, TexasPDF
81 FR 2843 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Notice of Court Decision Not in Harmony With the Final Results of Review and Amended Final Results of the Antidumping Duty Administrative ReviewPDF
81 FR 2903 - Notice of Inventory Completion: Carnegie Museum of Natural History, Pittsburgh, Pennsylvania; CorrectionPDF
81 FR 2901 - Notice of Inventory Completion: Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA; CorrectionPDF
81 FR 2839 - Submission for OMB Review; Comment RequestPDF
81 FR 2923 - Senior Executive Service Performance Review Board MembershipPDF
81 FR 2840 - Submission for OMB Review; Comment RequestPDF
81 FR 2862 - World War One Centennial Commission; Notification of Upcoming Public Advisory MeetingPDF
81 FR 2788 - Prohibitions in Region 8, Southern RegionPDF
81 FR 2860 - Sunshine Act MeetingPDF
81 FR 2911 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection: National Institute of Justice Compliance Testing ProgramPDF
81 FR 2924 - New Postal ProductPDF
81 FR 2913 - Notice of Opportunity To File Amicus BriefsPDF
81 FR 2903 - Hydrofluorocarbon Blends and Components From China; DeterminationPDF
81 FR 2860 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 2743 - Simplification of Disclosure Requirements for Emerging Growth Companies and Forward Incorporation by Reference on Form S-1 for Smaller Reporting CompaniesPDF
81 FR 2883 - Proposed Flood Hazard DeterminationsPDF
81 FR 2895 - Changes in Flood Hazard DeterminationsPDF
81 FR 2867 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 2864 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 2891 - Changes in Flood Hazard DeterminationsPDF
81 FR 2749 - Safety Zone; RICHLAND, Apra Harbor/Philippine Sea, GUPDF
81 FR 2837 - National Organic Program: Notice of Final Guidance for Accredited Certifying Agents and Certified Operations on Natural Resources and Biodiversity ConservationPDF
81 FR 2884 - Changes in Flood Hazard DeterminationsPDF
81 FR 2848 - Marine Mammals; File No. 18727PDF
81 FR 2965 - Notice of Intent To Initiate Covered Agreement Negotiations With the European UnionPDF
81 FR 2938 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
81 FR 2760 - Department of the Treasury Acquisition Regulation; CorrectionPDF
81 FR 2901 - Filing of Plats of Survey: CaliforniaPDF
81 FR 2850 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 2775 - United States Standards for OatsPDF
81 FR 2838 - Request for Public Comment on Services Currently Offered or Needed To Facilitate the Marketing of Grain and Related ProductsPDF
81 FR 2965 - Advisory Committee on Disability Compensation, Notice of MeetingPDF
81 FR 2851 - Agency Information Collection Activities; Comment Request; Parent Information and School Choice EvaluationPDF
81 FR 2868 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 2775 - Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States; Change to the Quality and Handling RequirementsPDF
81 FR 2748 - Annual Update of Filing FeesPDF
81 FR 2860 - Agency Information Collection Activities; Proposed Collection; Comment RequestPDF
81 FR 2869 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 2847 - Mid-Atlantic Fishery Management Council (MAFMC); Public MeetingPDF
81 FR 2939 - International Trade Data System Visa Requirements Under the African Growth and Opportunity ActPDF
81 FR 2931 - Equity Market Structure Advisory CommitteePDF
81 FR 2871 - Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other ProductsPDF
81 FR 2787 - Claims for Compensation Under the Energy Employees Occupational Illness Compensation Program ActPDF
81 FR 2841 - Privacy Act of 1974, New System of RecordsPDF
81 FR 2840 - Privacy Act of 1974, Amended System of RecordsPDF
81 FR 2850 - SES Performance Review BoardPDF
81 FR 2851 - Charter Renewal of Department of Defense Federal Advisory CommitteesPDF
81 FR 2866 - Request for Information on NIOSH Center for Direct Reading and Sensor Technologies: Sensors for Emergency Response ActivitiesPDF
81 FR 2863 - Request for Information on Development of a Performance Test Protocol for Closed System Transfer Devices That Incorporate Air-Cleaning Technology To Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous DrugsPDF
81 FR 2900 - Announcement of Public Meeting Via Teleconference: North American Wetlands Conservation CouncilPDF
81 FR 2870 - Request for Nominations on the Technical Electronic Product Radiation Safety Standards CommitteePDF
81 FR 2870 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of MeetingPDF
81 FR 2873 - Arthritis Advisory Committee; Notice of MeetingPDF
81 FR 2874 - Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications; Draft Guidance for Industry; AvailabilityPDF
81 FR 2846 - Marine Mammals; File No. 18902PDF
81 FR 2853 - Aquenergy Systems, LLC; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final AmendmentsPDF
81 FR 2857 - PE Hydro Generation, LLC; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final AmendmentsPDF
81 FR 2854 - Notice of Staff Attendance at Southwest Power Pool Regional Entity Trustee, Regional State Committee, Members' and Board of Directors' MeetingsPDF
81 FR 2856 - Records Governing Off-the-Record Communications; Public NoticePDF
81 FR 2856 - Pio Pico Energy Center, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 2859 - RE Garland A LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 2855 - RE Garland LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 2858 - CPV Valley, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 2853 - CPV Towantic, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 2943 - Notice of Final Federal Agency Actions on United States Highway 181 (U.S. 181), Harbor Bridge Project in TexasPDF
81 FR 2852 - Kingbird Solar A, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 2858 - Combined Notice of FilingsPDF
81 FR 2855 - Combined Notice of Filings #1PDF
81 FR 2899 - Endangered Species; Receipt of Applications for PermitPDF
81 FR 2846 - Endangered Species; File No. 19637PDF
81 FR 2912 - Agency Information Collection Activities; Proposed eCollection eComments Requested; National Tracing Center Trace Request, ATF F 3312.1PDF
81 FR 2902 - Assessment of Eligible and Ineligible Lands for Consideration as Wilderness Areas, Congaree National Park, South CarolinaPDF
81 FR 2859 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; CEQ-EPA Presidential Innovation Award for Environmental Educators Application (New)PDF
81 FR 2880 - National Institute on Aging; Notice of Closed MeetingPDF
81 FR 2879 - National Institute of Nursing Research; Notice of Closed MeetingsPDF
81 FR 2881 - National Institute on Aging; Notice of Closed MeetingPDF
81 FR 2882 - National Center for Advancing Translational Sciences; Notice of Closed MeetingPDF
81 FR 2879 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed MeetingsPDF
81 FR 2881 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
81 FR 2875 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 2881 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
81 FR 2880 - National Institute of Environmental Health Sciences; Notice of Closed MeetingPDF
81 FR 2882 - National Institute of Environmental Health Sciences; Notice of MeetingPDF
81 FR 2902 - Minor Boundary Revision at Yosemite National ParkPDF
81 FR 2907 - Importer of Controlled Substances Registration: Lipomed, Inc.PDF
81 FR 2933 - Submission for OMB Review; Comment RequestPDF
81 FR 2935 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Section (a)(6) of Rule 1120, Continuing Education RequirementsPDF
81 FR 2925 - Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Section (a)(6) of Rule 1120 (Continuing Education Requirements)PDF
81 FR 2928 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Section (a)(4) of Rule 640, Continuing Education for Registered PersonsPDF
81 FR 2931 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees SchedulePDF
81 FR 2910 - Importer of Controlled Substances Application: Siegfried USA, LLCPDF
81 FR 2911 - Manufacturer of Controlled Substances Registration: Rhodes TechnologiesPDF
81 FR 2910 - Manufacturer of Controlled Substances Registration: American Radiolabeled Chemicals, Inc.PDF
81 FR 2910 - Manufacturer of Controlled Substances Registration: Apertus PharmaceuticalsPDF
81 FR 2876 - Announcement of Requirements and Registration for “Pill Image Recognition Challenge”PDF
81 FR 2962 - Proposed Collection; Comment Request for Form 8824PDF
81 FR 2963 - Proposed Collection; Comment Request for Notice 2006-52PDF
81 FR 2964 - Proposed Information Collection; Comment RequestPDF
81 FR 2897 - Proposed Flood Hazard DeterminationsPDF
81 FR 2888 - Proposed Flood Hazard DeterminationsPDF
81 FR 2904 - Generalized System of Preferences: Possible Modifications, 2015 ReviewPDF
81 FR 2761 - Pacific Island Fisheries; 2016 Northwestern Hawaiian Islands Lobster Harvest GuidelinePDF
81 FR 2892 - Changes in Flood Hazard DeterminationsPDF
81 FR 2943 - Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by Flooding, River Scour, and River Channel MigrationPDF
81 FR 2848 - Proposed Information Collection; Comment Request; State and Local Implementation Grant Program Reporting RequirementsPDF
81 FR 2945 - Privacy Act of 1974, as Amended; System of RecordsPDF
81 FR 2805 - Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety RequirementsPDF
81 FR 2847 - Submission for OMB Review; Comment RequestPDF
81 FR 2942 - Petition for Exemption; Summary of Petition Received; JP Morgan Chase & Co.PDF
81 FR 2941 - Petition for Exemption; Summary of Petition Received; The Boeing CompanyPDF
81 FR 2942 - Petition for Exemption; Summary of Petition Received; The Boeing CompanyPDF
81 FR 2941 - Petition for Exemption; Summary of Petition Received; Innova Flights Training and SystemsPDF
81 FR 2791 - Treatment of Indian Tribes in a Similar Manner as States for Purposes of Section 303(d) of the Clean Water ActPDF
81 FR 2915 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
81 FR 2762 - Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin RegulationsPDF
81 FR 2725 - Supplemental Nutrition Assistance Program: Review of Major Changes in Program Design and Management Evaluation SystemsPDF
81 FR 2831 - Fisheries Off West Coast States; Pacific Coast Groundfish Fishery Management Plan; Trawl Rationalization Program; Flow Scale RequirementsPDF
81 FR 2803 - Withdrawal of Pesticide Petitions for Establishment or Modification of Pesticide Chemical Tolerances or Tolerance ExemptionsPDF
81 FR 2783 - Airworthiness Directives; Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.)PDF
81 FR 2785 - Airworthiness Directives; Bombardier, Inc. AirplanesPDF
81 FR 2742 - Administrative Debt Collection ProceduresPDF
81 FR 2751 - Revitalization of the AM Radio ServicePDF
81 FR 2818 - Revitalization of the AM Radio ServicePDF

Issue

81 11 Tuesday, January 19, 2016 Contents Agricultural Marketing Agricultural Marketing Service PROPOSED RULES Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the U.S.; Change to the Quality and Handling Requirements, 2775-2782 2016-00843 NOTICES Final Guidance for Accredited Certifying Agents and Certified Operations on Natural Resources and Biodiversity Conservation: National Organic Program, 2837-2838 2016-00862 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Animal and Plant Health Inspection Service

See

Food and Nutrition Service

See

Forest Service

See

Grain Inspection, Packers and Stockyards Administration

See

National Agricultural Statistics Service

See

National Institute of Food and Agriculture

Animal Animal and Plant Health Inspection Service PROPOSED RULES Guidance: Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations, 2762-2774 2016-00681 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2850 2016-00850 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2864-2868 2016-00866 2016-00867 Agency Information Collection Activities; Proposals, Submissions, and Approvals: NIOSH Center for Direct Reading and Sensor Technologies; Sensors for Emergency Response Activities, 2866-2867 2016-00828 Performance Test Protocol for Closed System Transfer Devices that Incorporate Air-Cleaning Technology to Provide Worker Protection During Pharmacy Compounding and Administration of Hazardous Drugs, 2863-2864 2016-00827 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2868-2869 2016-00844 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Child Care and Development Fund Plan for Tribes for FFY 2017-2019, 2869 2016-00840 Coast Guard Coast Guard RULES Safety Zones: RICHLAND, Apra Harbor/Philippine Sea, GU, 2749-2751 2016-00863 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

National Telecommunications and Information Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2840 2016-00830 Privacy Act; Systems of Records, 2840-2843 2016-00833 2016-00834
Comptroller Comptroller of the Currency NOTICES Privacy Act; Systems of Records, 2945-2962 2016-00763 Court Court Services and Offender Supervision Agency for the District of Columbia NOTICES Senior Executive Service Performance Review Board, 2850-2851 2016-00832 Defense Department Defense Department NOTICES Charter Renewals: Department of Defense Federal Advisory Committees, 2851 2016-00829 Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Applications: Siegfried USA, LLC, 2910 2016-00783 Importers of Controlled Substances; Registrations: Lipomed, Inc., 2907-2910 2016-00789 Manufacturers of Controlled Substances; Registrations: American Radiolabeled Chemicals, Inc., 2910 2016-00779 Apertus Pharmaceuticals, 2910-2911 2016-00778 Rhodes Technologies, 2911 2016-00781 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Parent Information and School Choice Evaluation, 2851-2852 2016-00845 Privacy Act; Systems of Records, 2852 2016-00919 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency PROPOSED RULES Treatment of Indian Tribes in a Similar Manner as States for Purposes of the Clean Water Act, 2791-2803 2016-00736 Withdrawal of Pesticide Petitions for Establishment or Modification of Pesticide Chemical Tolerances or Tolerance Exemptions, 2803-2804 2016-00431 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: White House Council on Environmental Quality/Environmental Protection Agency Presidential Innovation Award for Environmental Educators Application, 2859-2860 2016-00803 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.), 2783-2785 2016-00377 Bombardier, Inc. Airplanes, 2785-2787 2016-00375 NOTICES Petitions for Exemptions; Summaries: Innova Flights Training and Systems, 2941-2942 2016-00753 JP Morgan Chase and Co, 2942-2943 2016-00756 The Boeing Company, 2941-2942 2016-00754 2016-00755 Federal Communications Federal Communications Commission RULES Revitalization of the AM Radio Service, 2751-2760 2015-31950 PROPOSED RULES Revitalization of the AM Radio Service, 2818-2831 2015-31949 Federal Emergency Federal Emergency Management Agency NOTICES Flood Hazard Determinations, 2892-2895, 2897-2898 2016-00769 2016-00773 Flood Hazard Determinations; Changes, 2884-2888, 2891-2892, 2895-2897 2016-00861 2016-00864 2016-00869 Flood Hazard Determinations; Proposed, 2883-2884, 2888-2890 2016-00772 2016-00870 Federal Energy Federal Energy Regulatory Commission RULES Annual Update of Filing Fees, 2748-2749 2016-00842 NOTICES Applications: Aquenergy Systems, LLC, 2853 2016-00820 PE Hydro Generation, LLC, 2857-2858 2016-00819 Combined Filings, 2855, 2858 2016-00808 2016-00809 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorization: CPV Towantic, LLC, 2853-2854 2016-00812 CPV Valley, LLC, 2858-2859 2016-00813 Kingbird Solar A, LLC, 2852-2853 2016-00810 Pio Pico Energy Center, LLC, 2856 2016-00816 RE Garland A, LLC, 2859 2016-00815 RE Garland, LLC, 2855-2856 2016-00814 Records Governing Off-the-Record Communications, 2856-2857 2016-00817 Staff Attendances, 2854 2016-00818 Federal Highway Federal Highway Administration NOTICES Final Federal Agency Actions: Highway 181 (U.S. 181) Harbor Bridge Project, TX, 2943 2016-00811 Federal Mine Federal Mine Safety and Health Review Commission NOTICES Meetings; Sunshine Act, 2860 2016-00881 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 2860 2016-00873 Federal Trade Federal Trade Commission RULES Administrative Debt Collection Procedures, 2742-2743 2016-00313 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2860-2862 2016-00841 Fish Fish and Wildlife Service NOTICES Endangered Species Permit Applications, 2899-2900 2016-00807 Meetings: North American Wetlands Conservation Council; Teleconference, 2900-2901 2016-00826 Food and Drug Food and Drug Administration NOTICES Guidance: Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications, 2874-2875 2016-00822 Meetings: Arthritis Advisory Committee, 2873 2016-00823 Circulatory System Devices Panel of the Medical Devices Advisory Committee, 2870-2871 2016-00824 Requests for Information: Psychosocial Predictors of Uptake of Tobacco and Other Products, 2871-2872 2016-00836 Requests for Nominations: Technical Electronic Product Radiation Safety Standards Committee, 2870 2016-00825 Food and Nutrition Food and Nutrition Service RULES Supplemental Nutrition Assistance Program: Review of Major Changes in Program Design and Management Evaluation Systems, 2725-2741 2016-00674 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Bauer Manufacturing Inc., Foreign-Trade Zone 265, Conroe, TX; Correction, 2843 2016-00918 Forest Forest Service PROPOSED RULES Prohibitions in Region 8, Southern Region, 2788-2791 2016-00888 General Services General Services Administration NOTICES Meetings: World War One Centennial Commission, 2862-2863 2016-00911 Grain Inspection Grain Inspection, Packers and Stockyards Administration PROPOSED RULES United States Standards for Oats, 2775 2016-00848 United States Standards for Sunflower Seed, 2774-2775 2016-00958 NOTICES Services Currently Offered or Needed to Facilitate the Marketing of Grain and Related Products, 2838-2839 2016-00847 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

PROPOSED RULES Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements, 2805-2818 2016-00758
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

National Park Service

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2962-2964 2016-00774 2016-00775 2016-00776 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Diamond Sawblades and Parts Thereof from the People's Republic of China, 2843-2845 2016-00917 2016-00923 Steel Wire Garment Hangers from the People's Republic of China; 2014-2015, 2845-2846 2016-00920 International Trade Com International Trade Commission NOTICES Generalized System of Preferences: Possible Modifications, 2015 Review, 2904-2907 2016-00771 Investigations; Determinations, Modifications, and Rulings, etc.: Hydrofluorocarbon Blends and Components from China, 2903-2904 2016-00874 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Institute of Justice Compliance Testing Program, 2911-2912 2016-00877 National Tracing Center Trace Request, 2912-2913 2016-00805
Labor Department Labor Department See

Workers Compensation Programs Office

Land Land Management Bureau NOTICES Plats of Surveys: California, 2901 2016-00851 Merit Merit Systems Protection Board NOTICES Opportunity to File Amicus Briefs, 2913-2914 2016-00875 National Agricultural National Agricultural Statistics Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2839 2016-00914 National Archives National Archives and Records Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2914-2915 2016-00925 National Credit National Credit Union Administration NOTICES Meetings; Sunshine Act, 2915 2016-00986 National Institute Food National Institute of Food and Agriculture NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2840 2016-00912 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 2875-2876 2016-00794 National Center for Advancing Translational Sciences, 2882 2016-00799 National Heart, Lung, and Blood Institute, 2881 2016-00797 National Institute of Allergy and Infectious Diseases, 2881-2882 2016-00793 National Institute of Diabetes and Digestive and Kidney Diseases, 2879-2880 2016-00798 National Institute of Environmental Health Sciences, 2880, 2882 2016-00791 2016-00792 National Institute of Nursing Research, 2879 2016-00801 National Institute on Aging, 2880-2881 2016-00795 2016-00796 2016-00800 2016-00802 Pill Image Recognition Challenge; Requirements and Registration, 2876-2879 2016-00777 National Oceanic National Oceanic and Atmospheric Administration RULES Pacific Island Fisheries: Northwestern Hawaiian Islands Lobster Harvest Guideline, 2761 2016-00770 PROPOSED RULES Fisheries off West Coast States: Pacific Coast Groundfish Fishery Management Plan; Trawl Rationalization Program; Flow Scale Requirements, 2831-2836 2016-00585 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2847-2848 2016-00757 Applications: Endangered Species; File No. 19637, 2846-2847 2016-00806 Meetings: Mid-Atlantic Fishery Management Council, 2847 2016-00839 Permits: Marine Mammals; File No. 18727, 2848 2016-00857 Marine Mammals; File No. 18902, 2846 2016-00821 National Park National Park Service NOTICES Assessment of Eligible and Ineligible Lands for Consideration as Wilderness Areas: Congaree National Park, South Carolina, 2902 2016-00804 Boundary Revisions: Yosemite National Park, 2902-2903 2016-00790 Inventory Completions: Carnegie Museum of Natural History, Pittsburgh, PA; Correction, 2903 2016-00916 Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA; Correction, 2901-2902 2016-00915 National Telecommunications National Telecommunications and Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: State and Local Implementation Grant Program Reporting Requirements, 2848-2849 2016-00764 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations, 2915-2923 2016-00686 Occupational Safety Health Rev Occupational Safety and Health Review Commission NOTICES Senior Executive Service Performance Review Board Membership, 2923 2016-00913 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Fingerprint Chart Standard Form 87, 2924 2016-00993 Freedom of Information/Privacy Act Record Request Form, INV 100, 2923-2924 2016-00990 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Pipeline Safety: Potential for Damage to Pipeline Facilities Caused by Flooding, River Scour, and River Channel Migration, 2943-2945 2016-00765 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 2924-2925 2016-00876 Securities Securities and Exchange Commission RULES Disclosure Requirements for Emerging Growth Companies and Forward Incorporation by Reference for Smaller Reporting Companies, 2743-2748 2016-00872 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2933-2935 2016-00788 Meetings: Equity Market Structure Advisory Committee, 2931 2016-00837 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 2931-2933 2016-00784 NASDAQ OMX BX, Inc., 2925-2928 2016-00786 NASDAQ OMX PHLX, LLC, 2928-2930 2016-00785 NASDAQ Stock Market, LLC, 2935-2937 2016-00787 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2938-2939 2016-00855 Trade Representative Trade Representative, Office of United States NOTICES Intent to Initiate Covered Agreement Negotiations with the European Union, 2965 2016-00856 International Trade Data System Visa Requirements under the African Growth and Opportunity Act, 2939-2941 2016-00838 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Pipeline and Hazardous Materials Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

RULES Acquisition Regulations; Correction, 2760-2761 2016-00853 NOTICES Intent to Initiate Covered Agreement Negotiations with the European Union, 2965 2016-00856
Veteran Affairs Veterans Affairs Department NOTICES Meetings: Advisory Committee on Disability Compensation, 2965-2966 2016-00846 Workers' Workers Compensation Programs Office PROPOSED RULES Claims for Compensation under the Energy Employees Occupational Illness Compensation Program Act, 2787-2788 2016-00835 Reader Aids

Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

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81 11 Tuesday, January 19, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Food and Nutrition Service 7 CFR Parts 271, 272 and 275 [FNS-2011-0035] RIN 0584-AD86 Supplemental Nutrition Assistance Program: Review of Major Changes in Program Design and Management Evaluation Systems AGENCY:

Food and Nutrition Service (FNS), USDA.

ACTION:

Final rule.

SUMMARY:

This rule finalizes provisions of the proposed rule entitled Review of Major Changes in Program Design and Management Evaluation Systems, which was published May 3, 2011. This final rule amends the Supplemental Nutrition Assistance Program (SNAP) (formerly the Food Stamp Program) regulations to implement section 4116 of the Food, Conservation and Energy Act of 2008 (FCEA). Section 4116 of the FCEA, Review of Major Changes in Program Design, requires the United States Department of Agriculture (the Department) to identify standards for major changes in operations of State agencies' administration of SNAP. The provision also requires State agencies to notify the Department if they implement a major change in operations and to collect and report data that can be used to identify and correct problems relating to integrity and access, particularly for certain vulnerable households.

This final rule establishes criteria for changes that would be considered “major changes” in program operations and identifies the data State agencies must report in order to identify problems relating to integrity and access. It also sets forth when and how State agencies must report on the implementation of a major change. This rule also amends Management Evaluation (ME) Review regulations by modifying the requirements for State reviews. The rule revises the definitions of large, medium and small project areas. Finally, it removes sections of the regulations pertaining to coupons and coupon storage since they are obsolete.

DATES:

Effective Date: January 19, 2016.

Implementation date: This rule shall be implemented as follows: § 272.15 shall be implemented on March 21, 2016. Implementation of any major change that begins after that day must be reported to FNS. The changes in definitions in Part 271 that impact the requirements for State ME reviews in Part 275, shall be implemented October 1, 2016.

FOR FURTHER INFORMATION CONTACT:

Mary Rose Conroy, Chief, Program Design Branch, Program Development Division, Food and Nutrition Service, USDA, 3101 Park Center Drive, Alexandria, Virginia 22302, (703) 305-2515; [email protected] Questions regarding this rulemaking should be sent in writing to 3101 Park Center Drive, Alexandria, Virginia 22302, or by telephone at (703) 305-2803, or via email to [email protected]

SUPPLEMENTARY INFORMATION:

This action is needed to implement section 4116 of the FCEA. Section 4116, Review of Major Changes in Program Design, amends section 11 of the Food and Nutrition Act of 2008 (the Act) (7 U.S.C. 2020). Section 4116 requires the Department to develop standards for identifying major changes in the operations of State agencies that administer SNAP; State agencies to notify the Department upon implementing a major change in operations; and State agencies to collect any information required by the Department to identify and correct any adverse effects on program integrity or access, particularly access by vulnerable households. The provision identifies four major changes in operations for which standards for identifying changes must be developed: (1) Large or substantially-increased numbers of low-income households that do not live in reasonable proximity to a SNAP office; (2) substantial increases in reliance on automated systems for the performance of responsibilities previously performed by merit system personnel; (3) changes that potentially increase the households' difficulty in reporting information to the State; and (4) changes that may disproportionately increase the burdens on specific vulnerable households. In addition, the provision gives the Department the discretion to identify other major changes that a State agency would be required to report, as well as to identify the types of data the State agencies would have to collect to identify and correct adverse effects on integrity and access. Finally, the Department is modifying requirements for State reviews to allow more efficient use of staff and resources.

I. Additional Information on Electronic Access Electronic Access

You may view and download an electronic version of this final rule at http://www.fns.usda.gov/snap/.

II. Procedural Matters Executive Order 12866 and 13563

Executive Orders 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). This final rule has been determined to be not significant under Executive Order 12866 and was not reviewed by the Office of Management and Budget.

Costs

The rule will have a minimal cost in fiscal year (FY) 2016 and over the 5 years FY 2016 through FY 2020. To estimate the cost impact, we multiplied the estimated total burden hours, as outlined in the Paperwork Reduction Act section of the preamble, by the hourly mean wage for functions performed by State agency and local education agency staff. The hourly mean wage is based upon the U.S. Department of Labor, Bureau of Labor Statistics, May 2014 National Occupational and Wage Statistics, Occupational Group (for education-related occupations), which is $25.10. FNS estimates a total of 8,460 burden hours to fulfill the reporting requirements. The annual cost is estimated at $212,364 or approximately $1,061,730 over the 5 years FY 2016 through FY 2020.

Benefits

This rule requires State agencies to report on the impacts of implementing major changes in State agency operations, and to identify and correct problems caused by implementing these changes. This rule will benefit State agencies by requiring them to fully evaluate changes and thereby reduce the potential for these changes to cause hardships for applicants, recipients or compromise the integrity of the program. This rule will benefit applicants, recipients or individuals otherwise eligible for SNAP by requiring State agencies to identify and correct adverse impacts. This rule modifies the requirements for State ME reviews of local office operations. It will benefit State agencies by allowing them more time to conduct higher quality reviews.

Executive Order 12372

SNAP is listed in the Catalog of Federal Domestic Assistance under No. 10.551. For the reasons set forth in the final rule in 7 CFR part 3015, subpart V and related Notice (48 FR 29115, June 24, 1983), this program is excluded from the scope of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

Regulatory Flexibility Act

This rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act (5 U.S.C. 601-612). It has been certified that this rule will not have a significant economic impact on a substantial number of small entities. State welfare agencies will be the most affected to the extent that they administer the SNAP.

Unfunded Mandates Reform Act

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local and Tribal governments and the private sector. Under section 202 of the UMRA, the Food and Nutrition Service (FNS) generally must prepare a written statement, including a cost-benefit analysis for proposed and final rules with “Federal mandates” that may result in expenditures to State, local or Tribal governments in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, section 205 of the UMRA generally requires FNS to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and Tribal governments or the private sector of $100 million or more in any one year. This rule is, therefore, not subject to the requirements of sections 202 and 205 of the UMRA.

Federalism Summary Impact Statement

Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulations describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of E.O. 13132. FNS has considered this rule's impact on State and local agencies and has determined that it does not have federalism implications under E.O. 13132.

Civil Rights Impact Analysis

FNS has reviewed this rule in accordance with the Department Regulation 4300-4, “Civil Rights Impact Analysis,” to identify and address any major civil rights impacts that the rule might have on minorities, women and persons with disabilities. After a careful review of the rule's intent and provisions, FNS has determined that this rule has no intended impact on any of the protected classes. FNS specifically prohibits State and local government agencies that administer SNAP from engaging in actions that discriminate against any applicant or participant in any aspect of program administration, including, but not limited to, the certification of households, the issuance of benefits, the conduct of fair hearings, or the conduct of any other program service for reasons of age, race, color, sex, handicap, religious creed, national origin or political beliefs (SNAP nondiscrimination policy can be found at 7 CFR 272.6). Discrimination in any aspect of program administration is prohibited by these regulations, the Food and Nutrition Act of 2008, the Age Discrimination Act of 1975 (Pub. L. 94-135), the Rehabilitation Act of 1973 (Pub. L. 93-112, section 504) and Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d). Enforcement action may be brought under any applicable Federal law. Title VI complaints shall be processed in accordance with 7 CFR part 15.

Executive Order 13175

This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects 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.

FNS has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under EO 13175. On February 18, 2015 the agency held a webinar for tribal participation and comments. During the comment period, FNS did not receive any comments on the proposed rule. If a Tribe requests consultation, FNS will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. Chap. 35; see 5 CFR part 1320), requires that OMB approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. The Notice of Proposed Rulemaking (NPRM) contained new requirements that are subject to review and approval by OMB. FNS sought public comments on the changes in the information collection burden that would result from adoption of the NPRM provisions.

Comments were 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 collection of information, including the validity of the methodology and assumptions used; (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 use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments on the information collection pursuant to the proposed rule were minimal, but changes to provisions of the final rule have affected the reporting burden estimated from the NPRM.

Title: Review of Major Changes in Program Design.

OMB Number: [0584-NEW].

Expiration Date: Not Yet Determined.

Type of Request: New Collection.

Abstract: As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), FNS is submitting a copy of this section to OMB for its review. Section 4116, Review of Major Changes in Program Design, amends section 11 of the Act (7 U.S.C. 2020). It requires the Department to develop standards for identifying major changes in the operations of State agencies that administer SNAP. Section 272.15, of this final rule requires State agencies to notify the Department when planning to implement a major change in operations and State agencies to collect any information required by the Department to identify and correct any adverse effects on program integrity or access, including access by vulnerable households. Since decisions to make major changes to program operations rest with each individual State agency, the frequency and timing of the changes can only be estimated. The final rule requires State agencies to provide descriptive information regarding the major change together with an analysis of its projected impacts on program operations. The final rule also includes “automatic” reporting requirements for any State reporting a major change and sets out requirements for the State to collect and report additional information. The reports will consist of monthly information, to be provided on a quarterly basis. Reporting would continue for at least a year after the change is completely implemented. It is not uncommon for a State to pilot a change prior to statewide implementation. FNS could require information from the pilot and information regarding the statewide impacts of the change after full implementation.

Respondents: The 53 State agencies that administer SNAP.

Estimated Number of Responses per Respondent: The rule identifies six categories of major changes; changes to the States automated system, changing the responsibilities of merit system personnel, office closings, reductions in State SNAP merit system personnel, changes that may make it more difficult for households to report and an undefined “other” category. Such changes in operations are made by States based upon a variety of interrelated factors. There is no evidence that the State's size (population) or regional location predict when or what type of changes States will make.

In examining the first of the above criterion in isolation, it would be reasonable to expect one or two States per year to replace automated systems and another four States to make modifications to their systems that would require a major change report. However, with so many States running older systems and the delays caused by budget difficulties, it is likely this will increase to three per year beginning in FY 2017, as States' budgets improve. It is also likely that we will see more States look into implementing call centers and developing online applications that will be used by a large proportion of SNAP applicants and participants. Since it appears that 45 States will have online applications in place and over 30 States will be using call centers in FY 2016, the number of additional States that might implement these systems in a year is most likely no more than four per year. Therefore we estimate a total of ten States per year would report major changes under this criterion.

With regard to the second criterion, one State exploring such a change every two years would be a reasonable estimate.

The third criterion, office closings, may become more common with the expanded use of call centers and online applications. We estimate three States per year would report major changes under this criterion.

The fourth criterion, staff reductions, tends to fluctuate with States' budgetary situations, caseloads and other changes States make to their program design. We estimate there would be three significant staff reductions per year.

The fifth criterion, changes that may make it more difficult for households to report, would occur in conjunction with or as a result of changes in the States administration of SNAP. This is the most difficult to predict, but as States continue to take advantage of new technology and streamlined processes, changes of this type may become more common. An estimate of five such changes per year would appear to be reasonable.

Since, by definition, the “other” category cannot be estimated, one such major change per year is estimated as a place holder.

Criterion Responses per year Replacement of automated system 10 Changing the responsibilities of merit system personnel .5 Office closings 3 Significant reductions in SNAP staff 3 Changes that may make it more difficult for households to report 5 Other 1 Total 22.5

Once a State has triggered one of the six criteria, the State will be required to report the “automatic” information as required in § 272.15(b)(2)-(4) and FNS must determine what, if any, additional data the State will be required to collect and report as provided for in § 272.15(b)(5). FNS believes that most often, the automatic reporting requirements and its ongoing data collection tools it employs will be sufficient to provide the needed information on a major change. Additional data will occasionally need to be generated from States' automated eligibility systems or gathered by conducting additional case review surveys.

Estimated Total Annual Burden on Respondents:

Section 272.15(a)(3), requires States provide both descriptive and analytic information regarding the major change. FNS believes States will have completed the majority of the analysis in the normal course of their own planning and decision making. The descriptive information should also be readily available and require minimal data gathering since it is the State's decision to make the major change. We estimate it will take 8 hours to describe the change and 32 hours to repackage and complete the required analysis for a total of 40 hours per response. Thus, with 22.5 States reporting one major change per year, the initial reporting and analysis aspect of the rulemaking would be 22.5 annual responses × 40 hours per State = an estimated 900 burden hours per year (22.5 States × 1 response per respondent = 22.5 annual responses × 40 hours per respondent to respond = 900 annual burden hours).

FNS believes that for about seventy percent of the major changes States report, no additional reporting will be necessary beyond the automatic reporting requirements. Additional data collection will only be required for the remaining 30 percent of the reported major changes. Therefore, for about 15.75 of the major changes expected each year there would be no additional reporting burden.

All 22.5 of the major changes expected each year will require some automated system reprogramming to generate the required automatic data reporting. At 48 hours per reprogramming effort, this would be 1080 hours per year (22.5 × 48). The reports themselves would be estimated to require 12 hours each.

Respondents Estimated
  • annual
  • responses
  • Responses per year Hours per
  • response
  • Total hours per year
    22.5 States quarterly 4 90 12 1080

    The total for the 22.5 States would be 900 + 1,080 hours = 1,980 total hours for reporting (divided by the 22.5 states = 88 hours per State per year).

    For the 6.75 States expected to require additional data collection, this requirement would be in addition to the 1,980 hours from above. Such data will generally be collected through a sample of case reviews. While the required sample sizes may vary based on the type of major change and the proportion of the State's SNAP caseload it may affect, 200 cases per quarter would likely be an upper limit on what FNS could ask of a State. At an estimated one hour to review and report on a case, this would require 800 hours per year per State. The 6.75 States times 800 hours yields 5,400 hours (6.75 State respondents × 1 response per respondent = 6.75 annual responses × 800 hours per respondent to respond = 5,400 annual burden hours). When the 1,980 hours are added for the automatic information, the total for these 6.75 States is 7,380 hours (1,093 hours per State per year).

    With all 22.5 States reporting quarterly, there would be 90 responses annually. Twenty-seven of the 90 reports would contain additional information from sample data.

    Section Requirement States
  • responding
  • per year
  • Responses per respondent Number of
  • responses
  • Hours per
  • response
  • Total burden hours
    272.15(a)(3) Initial analysis of Major Change 22.5 1 22.5 40 900 272.15(b)(2)-(4) Reports required without additional data collection 15.75 4 63 22 1,386 272.15(b)(5) Reports required with additional data collection 6.75 4 27 273.25 7,377.75 Totals 22.5 5 (average) 112.5 85.9 (average) 9,663.75
    E-Government Act Compliance

    FNS 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.

    Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies that conflict with its provisions or that would otherwise impede its full implementation. This rule is not intended to have retroactive effect unless so specified in the “Effective Date” paragraph of the final rule. Prior to any judicial challenge to the provisions of this rule or to the application of its provisions, all applicable administrative procedures must be exhausted. In SNAP the administrative procedures are as follows: (1) For Program benefit recipients—State administrative procedures issued pursuant to 7 U.S.C. 2020(e)(10) and § 273.15; (2) for State agencies—administrative procedures issued pursuant to 7 U.S.C. 2023 set out at § 276.7 or Part 283; (3) for retailers and wholesalers—administrative procedures issued pursuant to 7 U.S.C. 2023 set out at 7 CFR part 279.

    What acronyms or abbreviations are used in this supplementary discussion of the proposed provisions? In the discussion of the provisions in this rule, the following acronyms or other abbreviations are used to stand in for certain words or phrases:

    Phrase Acronym,
  • Abbreviation,
  • or Symbol
  • Code of Federal Regulations CFR Federal Register FR Federal Fiscal Year FY Food and Nutrition Act of 2008 the Act Food and Nutrition Service FNS Food, Conservation, and Energy Act of 2008 FCEA Management Evaluation ME Notice of Proposed Rulemaking NPRM Supplemental Nutrition Assistance Program SNAP U.S. Department of Agriculture the Department
    III. Background

    Section 4116 of the FCEA amended section 11 of the Act to require the Department to define “major changes” in SNAP operations, State agencies to notify the Department when they implement a major change in SNAP operations, and to collect data for use in identifying and correcting problems with SNAP integrity and access, particularly among vulnerable populations. Many State agencies have changed or are in the process of changing the way they operate SNAP. Some of these changes have been small and have predominately impacted internal State agency operations. However, some of the changes have also included major overhauls of State agency operations that affect how the State interacts with applicants and participants. While the goal of such changes is to improve the efficiency and the effectiveness of the States' operations, some of these changes have adversely impacted the States' payment accuracy rates, and, critically, have impeded access to SNAP benefits. In recent years, States have faced rising caseloads and cut backs which in part have led many States to make use of new technologies that could help streamline their SNAP operations. Section 4116 of the FCEA anticipates this and provides the Department the authority to better provide States with technical assistance and to monitor implementation of major changes in their operation of SNAP. The proposed rule published May 3, 2011, at 76 FR 24820, provided a 60-day comment period. This final rule defines what changes to States' operations will be considered “major,” establishes the requirements for States to notify FNS of such changes and establishes reporting requirements for major changes. States' ME requirements have also been updated to allow States time to conduct more effective reviews. The changes will allow States to streamline operations while maintaining the integrity of SNAP.

    Public Comments

    The Department received 120 comments on the NPRM from various entities including: 95 individuals (many of whom are union members); 4 unions; 10 advocate organizations; 10 States; and an organization representing States. Following are the issues raised by commenters, paraphrased excerpts from the most illustrative comments, and recommendations they made for changes to this final rule. (Note: The May 3, 2011 NPRM proposed to add the Major Change provisions to a new § 272.12. However, this section now deals with Computer Matching Requirements. The provisions of this final rule are added in a new § 272.15. References in this preamble to provisions of the proposed rule have been converted from § 272.12 to § 272.15 to reduce confusion between the proposed and final rules.) General comments on the NPRM include:

    General Comments

    • We commend FNS for including application processing timelines at recertification (proposed § 272.15(b)(1)(iii)) as one of the measures it will examine in the event of a major change.

    • SNAP is an entitlement program. Therefore, the processes related to SNAP eligibility determinations are inherently governmental functions and must be performed by public employees. The proposed rule also includes changes to the performance reporting system, including elimination of the Federal biennial review of the State ME system. The proposed changes weaken Federal oversight of SNAP, and we recommend that the current requirements be maintained.

    • The proposed language creates the impression that States may be able to secure waivers or approval for the use of non-merit system personnel. We urge FNS to re-affirm its conclusions that it strongly disfavors the use of non-merit system personnel and not to change its position. The experience of our office and many other advocates is that all too often non-merit system personnel lack the training, supervision, experience and exposure to agency culture necessary to ensure maximum program access.

    • The Preamble states that “FNS has determined that the use of non-merit system personnel in these functions can have a detrimental impact on the efficient and effective operation of the program,” but then proceeds to explain that FNS must approve the use of non-merit system personnel. It is contrary to good sense and effective public policy for the Department to authorize this model when the Department itself acknowledges that all available evidence to date documents costly failures.

    • Section 4116 of the FCEA gives FNS the authority to identify “major changes” and to collect information on those changes, but it does not allow FNS to prevent or impair States' ability to implement administrative changes that otherwise meet legal and regulatory requirements. With this proposed regulation, FNS appears to go beyond its mandate under the law. FNS should take a proactive approach to assist States to quickly implement successful reengineering changes and to use existing SNAP performance data to measure outcomes rather than impose additional burdensome reporting requirements.

    • If implemented as written, we believe this regulation could prevent, weaken or at the very least delay many administrative improvements that would otherwise quickly bring a new level of efficiency, integrity and customer service to SNAP.

    • By not imposing any on-going data collection obligations under this provision, the proposed rule denies the Department a baseline. If data collection begins only after a problem has arisen, the Department will be ill-equipped to assess the severity of the problem and may be misled into believing that the problem has abated when measures of State performance rise even as the State's performance remains far below what it had been. At the same time, the proposed rule's failure to require all States to gather and submit basic data on application processing, case closures, and the like—and its failure to establish common definitions and formats for the collection and submission of that data to facilitate inter-state comparison—prevents meaningful cross-sectional comparison.

    • We request that the Department reconsider the scope of the proposed regulation to more closely mirror the Federal law, and to minimize duplicative and unnecessary reporting requirements when existing performance measures can be used.

    • While many of the regulatory changes were proposed to address legitimate issues, we are concerned that some of the proposed changes would negatively impact the ability for States to administer SNAP and the recipients that they serve. Many of the regulatory changes also appear to exceed the language and intent of the FCEA, and appear to run counter to recent Federal efforts to reduce, simplify and streamline regulations.

    • The final regulation must be changed to ensure that nationally consistent and straightforward data collection from any state that makes a major change in their service delivery model is publically available.

    As these general concerns indicate, commenters were divided with several believing that the proposed rule went too far, even beyond the FCEA provisions, in terms of its requirements and others suggesting that the final rule should impose additional requirements on States. The Department understands and appreciates these differing viewpoints, and seeks to provide proper balance in this final rule by allowing for effective oversight of SNAP operations while recognizing States' resource constraints.

    States are charged with the administration of SNAP and have broad discretion in deciding how they operate the program. This rule does not restrict States' discretion at all; it simply requires States to inform FNS of significant changes and provide information on their impact. In FY 2014, SNAP issued over $69 billion in benefits to a monthly average of 46.5 million individuals in need. The Federal share of administrative costs for States to operate SNAP totaled another $4.13 billion in FY 2014. Given the importance of SNAP in helping struggling families and the level of Federal funding, the Department believes this provision of the Act is critical to FNS' meeting its oversight responsibilities.

    There have been several situations in recent years where States made major changes to staffing, automated systems or business processes that had unintentional, adverse impacts on the accessibility and integrity of the program. FNS worked with these States to correct the problems, but these efforts were costly to the States in terms of time, additional administrative costs, business process modifications, and, in some cases, payments to the Department for benefits issued in error. If FNS had been aware of these changes earlier and had more detailed data, it is likely that some of the difficulties could have been minimized or even avoided. Implementation of this final rule is intended to provide FNS with the information it needs to fulfill its responsibilities to act as a steward of taxpayer funds, protect access to SNAP benefits for eligible individuals, and to provide States with technical assistance as necessary.

    Many of the comments received from individuals, unions and advocacy organizations focused on what appears to be a misunderstanding of the intent of the provision of the proposed rule dealing with use of non-merit system personnel in the administration of SNAP. While this provision is discussed in more detail later in this preamble, it is important to note that the proposed rule included the use of non-merit system personnel as a major change to ensure that the Department is aware of States' plans in this area prior to implementation. There was no intent to identify the use of non-merit system personnel in the administration of SNAP as a State option that the Department would support. On the contrary, the Department opposes and has actively sought to limit use of such staff in the administration of SNAP due to the negative impacts this has had on SNAP households and State agencies. The Department also agrees with the comment that States' reports on the implementation of major changes should be made available to the public.

    Discussion of Comments Grouped by Provision and Issue

    Provision/Issues—§ 272.15(a)(1): State agencies shall notify FNS when they make major changes in their operation of SNAP. State agencies shall notify FNS when the plans for the change are approved by State leadership, but no less than 120 days prior to beginning implementation of the change.

    Public Comments and Recommendations—Ten commenters addressed this provision of the proposed rule and their comments included the following:

    • The lengthy timeframes by which FNS intends to manage change is unreasonable. A 120-day advance alert of a change and a 90-day response time for FNS chokes the State's ability to respond quickly and effectively to its customer's needs and changes in the political, financial and technological environments.

    • The regulation allows FNS 90 days to respond to reports of major changes. Added to 120 days, this is over 7 months before a State could implement a change. This is unrealistic; FNS response time should be no more than 30 days from the date the report was submitted. The regulation also doesn't state what should happen if the FNS response is not received within 90 days. The regulation should state that implementation could proceed if that occurs.

    • Because of the potential for additional significant reporting requirements (which State systems may not have been programmed to provide), and the apparent potential to disapprove of a “major change” or require a change in one or more aspects of implementation, States must have sufficient time to include such requirements in their implementation and be aware of FNS objections well before implementation. Otherwise, the proposed process can significantly delay or derail implementation.

    • Under standard accounting and budget practices, this 120-day requirement would effectively reduce the State and counties' ability to implement major changes in the second half of the State's fiscal year, and would cause delays beyond the initial 120 days. For example, an online application may support new applications initially, and then later add additional client reporting functions, which are modified due to lessons learned.

    • It appears that these proposed regulations greatly exceed what was originally specified in the bill. The regulations speak of notifying FNS 120 days before a major change, while the FCEA merely states that if a State implements a major change they must notify FNS and provide information as required. Having to submit information prior to implementation as opposed to at the point of implementation would be a major workload and barrier. There is a big distinction between notification and approval, and these regulations tread dangerously into having the Federal government require States to seek approval prior to making major changes.

    • The level of detail that must be included in the initial report will potentially add 120 days of lead time to initiatives. Although States do conduct much of the analysis in the normal course of any policy change, the specific nature and the depth of the analysis requirements of the proposed regulations is overly burdensome. We recommend that FNS re-evaluate the proposed 120-day timeframe and create an evaluation system that is more flexible.

    • The 120-day minimum notice requirement is a timeframe that the majority of States would be unable to meet. Twenty-six States enact new State legislation within 90 days of passage unless otherwise declared in the specific legislation. The proposed rule's assumption that, “any properly planned major change would be approved by State leadership well in advance of implementation” is inconsistent with the fast-paced, budget-driven environment that exists in today's economy. The advance notice requirement also presumes that FNS has authority to approve or deny a specific plan of operation beyond the limits of the act. The provision requires that States mitigate adverse impacts, but does not give FNS approval authority over State agency operations.

    • The notification requirement is not sufficient. The final regulations should require not only that States notify FNS 120 days prior to implementation but also at least 120 days prior to entering into legal obligations to implement any proposed major changes.

    • Both the requirement that States submit an initial report and the 120-day timeframe should be maintained in the final rule.

    • Allow States to submit an annual report on major changes that were not previously identified thru an Advance Planning Document (APD) (e.g., reductions in staffing levels or office closures). FNS will still be able to negotiate with States on the additional reporting requirements after they have received the annual report.

    • FNS response time should be no more than 30 days from the date the report was submitted. The longer the time to implement, the less chance the change will be implemented.

    Final Rule—To clarify, the provisions of this rule do not give FNS authority to approve or deny a reported major change. However, it is important to note that existing provisions of the SNAP regulations require FNS approval or waivers for a variety of operational and policy changes that may constitute or be related to a major change.

    Significant changes to States' automated systems require submission of an APD for development and procurement. For any major change that does not require waiver authority or approval outside of this rule, States need not wait for FNS approval of their major change notification or a response to their major change notification.

    In response to comments that States sometimes are not aware of a major change 120 days in advance of implementation, the Department has modified the language in the final rule to account for these situations. However, by definition, major changes are significant and the Department generally believes that to be well planned and thought through, such changes require at least 120 days lead time. Therefore, the final rule maintains the 120-day reporting timeframe, but allows for rare instances when States cannot report with this amount of lead time. In such instances, States will be required to explain the lack of lead time.

    Provision/Issues—§ 272.15(a)(2): Major changes shall include the following criteria (comments on individual criteria discussed below):

    Public Comments and Recommendations—While almost all commenters offered their thoughts and recommendations on some aspect of the major change criteria in this section (as discussed below), a few comments were more general. General comments on this section include the following:

    • The final rules should include a residual category for any other major changes in State administration that the Department or a State agency identifies as having the potential to adversely affect program integrity or access. Even the best program administrators would not likely have anticipated all of the challenges the program faces today had they attempted to compile a list like this one a decade or two ago.

    • FNS should categorize major changes as being significant, medium or small, and require different reporting based on the scope of the change that the State is planning to make. FNS would retain discretion to require more reports in unusual circumstances, but this change would make the reporting requirements more predictable for States and for FNS. For significant changes, we recommend that FNS require States to report statewide information that will allow FNS and the State to assess whether the State's process is adequately providing access to eligible households, with enough detail on sub-state areas and sub-populations within the State that problems can be identified and corrected.

    • FNS should offer States the option to report certain new measures on an ongoing, statewide basis as an alternative to reporting each separate major change with an initial report and the subsequent negotiated data reports. FNS should retain discretion to require additional reports if the need arises.

    Final rule—The Department has included in the final rule the ability for the Department to define additional criterion under which States must report major changes at § 272.15(a)(2)(vi), to cover as yet unknown developments in State SNAP operations. The addition of this “other” criteria is based upon advocates' concerns that as time passes States could make innovative changes that are not enumerated in the regulations, and thus would not be required to be reported. The Department has not adopted the suggestion that major changes be categorized by “size.” After careful consideration, the Department believes that this approach would unnecessarily complicate the final rule by requiring the development of additional definitions and explanation with minor impacts on its implementation.

    The Department has not adopted the recommendation that an option be provided that would allow States to begin reporting certain new measures on an ongoing, statewide basis as an alternative to reporting on each separate major change. Such an option would seem to offer States little incentive since they would incur the additional cost of ongoing data reporting that may not be needed. In addition, if a few States were to adopt this option, it is not clear what FNS would do on an ongoing basis with data reported by a limited number of States. On the other hand, States can always submit additional information to FNS even without a formal option to do so. Additional information might also be required, depending on the nature of the major change.

    Provision/Issues—§ 272.15(a)(2)(i): Closure of one or more local offices that perform major functions for 500 or more SNAP households, and there is not another office available to serve the affected households within 25 miles or that can be reached via public transportation.

    Public Comments and Recommendations—Twelve commenters addressed this provision of the proposed rule and their comments included the following:

    • We agree that office closings are major changes. However, even if there is another office within 25 miles or that can be reached by public transportation, the change is unquestionably major if the nearest office takes more than an hour to get to or costs more than $10 round trip to reach by public transportation. The final regulation should provide a limit on the travel time by public transportation of one-hour one-way.

    • The final rule should make clear that households are at risk of hardship if the nearest office is either at least twenty-five miles away or not accessible via public transit. Of course, offices in some rural areas inevitably will not be on public transit lines because none exist. This rule does not prohibit such situations; it merely calls for monitoring of their impacts. The final rule should make clear that the closure of any office that takes applications requires scrutiny; of course, if another nearby office remains available nearby, the closure would not be a major systems change.

    • The proposed triggers are unrealistic in many States, including a closure that would require clients to travel more than 25 miles; there are many areas where households already do not live within 25 miles of a local office.

    • We recommend that this section be rewritten to require States to report when an office is closed that serves five percent of their caseload.

    • The opportunity for face-to-face contact for all clients in a conveniently located physical setting might be desirable, but it is not realistic in today's highly constrained fiscal environment. Services for clients will not necessarily suffer if staff is reduced or offices are closed. Interactions through electronic and automated means allow clients to choose a contact time that is best for them and allows them to do so from their home or other location with computer access (as is the case with numerous community organizations). Accompanied by the appropriate alternative methods and technology, not only can office closures be done without negative effects, but they can be done while improving program access and integrity. The proposed standards of 25 miles and 500 households are ridiculously low, and do not even remotely reflect the realities of the way business currently is being done by the States.

    • This definition may inadvertently include certain part-time or temporary eligibility worker locations, such as mobile vans or out-stationed workers and a change in schedule or termination of these placements should not be included as a major change. These types of temporary office locations are developed as a result of caseload or administrative funding decisions that may vary from year to year, and should not be considered a major change.

    • The harsh financial realities that States are facing may leave no choice other than to consolidate their offices. However, given the opportunities that clients will have for telephonic contact with State agencies, we do not believe that such consolidations will result in negative effects, but will likely improve access and integrity. In our opinion, office consolidation should not be considered a major change.

    • Rural States have many areas with more than 25 miles between towns. The miles should be increased to 100 or more. Also the number of households served should be increased from 500 to 1000.

    • In general, the office closure standard should be retained in the final rule. The regulation's standard of office closures that affect 500 households or more is reasonable and allows States to consolidate very small offices where they can achieve administrative efficiencies, while still protecting households' ability to appear in person to apply and get assistance. The final regulation should be revised to clarify that an office closure would count toward the State meeting the criterion only if there is another office within 25 miles or that can be reached easily via public transportation.

    • The final regulation should provide that, to qualify as an office that “performs major functions”, the office must be a place where households can file an application and receive assistance in filling out the application from a State employee.

    Final Rule—It is important to clarify that the Department does not assume that local office closures are always negative, but they do reduce program access for some households. As some commenters point out, the actions States take to offset such closure may benefit many other households. While keeping office closures as a major change criterion is necessary to provide FNS with information regarding the impact of the closures and what a State is doing to offset the impact of the closure, the Department modified this criterion in the final rule in response to commenter's concerns. The Department has increased the number of SNAP households affected by a local office closure from 500 to 750 households and changed the distance to another office available to serve the affected households from 25 to 35 miles. To balance these changes, the Department has also modified the final rule by setting the threshold that an office closing that represent the lower of 750 households or at least 5 percent of a State's caseload will be considered a major change. Thus, for example, if a State had a caseload of 14,000 and an office with 701 households is being closed, this would require a report because it would be more than 5 percent of the State's caseload.

    The reference to public transportation has been eliminated to simplify the criteria and because the cost of public transportation beyond 35 miles is generally prohibitive for SNAP households. The Department has also specified that an “office performing major function” is an office where households can file an application for SNAP in person and receive assistance from merit system personnel. Closing a “temporary” office or changing the location of a mobile unit would not be considered a major change.

    Provision/Issues—§ 272.15(a)(2)(ii): Substantial increased reliance on automated systems for the performance of responsibilities previously performed by State merit personnel (as described in section 11(e)(6)(B) of the Act) or changes in the way that applicants and participants interact with the State's SNAP agency. Establishment of an online application process through the Internet or the use of call centers to accept applications would not be a major change unless one of these methods is expected to account for five percent or more of the State's SNAP application. Reporting a major change as required in this section does not relieve States of meeting the requirements for new system approvals in § 277.18.

    Public Comments and Recommendations—Twelve commenters addressed this provision of the proposed rule and their comments included the following:

    • State systems are regulated under § 277.18. This section requires States to obtain prior approval from FNS for automated data processing equipment used in the administration of SNAP. Requiring States to complete another detailed document to notify FNS of change is duplicative, inefficient and unnecessary. The information in the APD could be expanded to include the analysis that would have been required with the 120-day advance notice.

    • Business rules of eligibility determination and benefit calculation are already built into the systems that workers use. The business rules, design and function of these systems are tested and approved by merit system employees.

    • Discussion under this criterion again reveals an assumption that changes such as call centers will almost by definition jeopardize customer service and access. This contradicts the experience of many State systems that have dramatically improved client service and access by the use of call centers.

    • The final rule should make all new or expanded online application systems and call center arrangements subject to review as major systems changes.

    • Document imaging systems should be included as a major change. In our experience, the introduction of a document imaging system is in fact a major change in office operations which has the potential to greatly enhance or undermine program administration and client access to benefits.

    • The proposed rule identifies the “replacement” of the State's certification system as an example of a systems change. Recommend that the final rule be changed to include significant changes to automated systems that fall short of “replacement,” such as adding major new functions or a web-based tool that feeds into an older system.

    • The proposed regulation makes clear that the reporting requirements for major changes under the proposed rule do not remove the separate APD approval requirements under § 277.18. This is an important clarification and should be retained in the final rule.

    • Recommend the final regulation provide that online and telephone applications will be considered a major change unless a State can demonstrate to FNS' satisfaction that such applications will not account for more than five percent of applications once the new application is fully implemented.

    Final Rule—The Department has made several changes to clarify this provision based upon the above comments and recommendations. The Department has clarified that a State must report the replacement of an automated system, adding functionality to an existing automated system and changes that impact the way applicants and participants interact with SNAP unless the State documents that less than five percent of the caseload will be affected by the change. Examples of changes that increased reliance on automation that would likely affect five percent or more of a State's caseload include, linking a portal (a computer Web site that allows greater access and functionality) to the State's SNAP eligibility system, introducing online applications, call centers, and finger imaging. The Department recognizes that technologies are evolving and the major changes that will be reported under this criterion may evolve as States find new practices that will improve efficiency and customer service.

    Provision/Issues—§ 272.15(a)(2)(iii): Changes in operations that potentially increase the difficulty of households reporting required information. This includes implementation of a call center for change reporting, a major modification to any forms that households use to report changes, or the discontinuation of an existing avenue for reporting changes, (e.g., households can no longer call the local office to report a change). Modifying selected change reporting policy options or the implementation of policy waivers would not be major changes.

    Public Comments and Recommendations—Nine commenters addressed this provision of the proposed rule and their comments included the following:

    • To ensure that changes in reporting practices and technologies do not harm households, it is important that this criterion be retained in the final regulation. There are two places where the proposed regulation needs to be changed in light of the other proposed rule that was published in the Federal Register on the same day regarding change reporting rules. First, this proposed regulation at § 272.15(a)(2)(iii) uses the example that States might “[discontinue] an existing avenue for reporting changes, e.g., households [could] no longer call the local office to report a change.” This example should be removed or refined. In addition, FNS should remove the clause that suggests that policy waivers could be needed to implement a change reporting policy option.

    • The final rule should treat as a major systems change any change in the systems that households must use for reporting changes except a simple switch between the reporting options allowed under section 6(c) of the Act.

    • Discussion under this criterion appears to assume that changes such as call centers will almost by definition jeopardize customer service and access. This contradicts the experience of many State systems that have dramatically improved client service and access by the use of call centers.

    • This section should be rewritten so that States are required to report only when reducing reporting options or requiring one specific process. Likewise, changing a form does not rise to the level of change intended by the Act.

    • Considering a modification to, or even a complete redesign of, a form for reporting to be a “major” change represents an unwarranted and unnecessary level of intrusion into the States' administration of the program.

    • This seems to presuppose that portals built by States for change reporting will automatically derive a negative impact. Today, customers can contact the agency in a wide variety of ways, e.g., via the telephone at multiple locations, through Web sites and in person at community partners and service locations.

    Final Rule—Based upon comments, the Department has revised the final rule to: (1) Add as a major change the adoption of internet portals to report changes in household circumstances; (2) clarify the example from the proposed rule to focus attention on a change that would limit participants' reporting avenues; and (3) clarify that States selecting reporting options allowed under the rules or obtaining a waiver from FNS are separate actions, but that neither would be considered a major change.

    Provision/Issues—§ 272.15(a)(2)(iv): Use of non-merit pay staff to perform functions previously performed by merit personnel. While the interview and the eligibility decision functions must be performed by merit personnel (unless FNS approves a waiver request under Section 17 of the Act), other functions including obtaining verification of household circumstances, accepting reports of changes in household circumstances, accepting applications and screening households for expedited service may be performed by non-merit personnel (although FNS must approve a State's use of non-merit pay staff before matching funds will be provided for the performance of these functions). Functions such as data entry and document imaging do not involve interaction with households, and consequently, the use of non-merit pay staff in activities of this type would not constitute a major change.

    Public Comments and Recommendations—This proposed provision received attention from 105 commenters (10 advocacy/legal aid groups, the American Public Human Services Association (APHSA), 5 States, 4 unions, and 85 individuals, many, who appeared to be case workers/union members that submitted form letters). Except for APHSA and the States, the commenters overwhelmingly opposed inclusion of this criterion as a major change. The reason most often cited is that including use of non-merit system personnel in the definition of a major change gave the appearance that the Department accepted such a change as an allowable State choice. Many commenters acknowledged that the preamble to the proposed rule expressed the Department's opposition to using non-merit system personnel, outlined the limitations in the Act on the functions such staff may perform, and explained that, without approval, FNS may not match funding for non-merit system personnel working in SNAP operations. However, several commenters felt that any use of non-merit system personnel should be prohibited in the rule. There was also a recommendation that any significant increase in reliance on other agencies, including “community partners” and other non-profit or local government entities, should be considered a major systems change. The primary recommendation from commenters is to remove this criterion from the definition of a major change. Some commenters suggested that information on use of non-merit system personnel could be obtained by amending § 272.15(a)(2)(v) on decreases in staffing levels to accomplish the same goal. If that criterion were amended to say that cuts in merit systems staff triggered the report, then any State that tried to replace merit systems personnel with private employees would meet the trigger criterion. APHSA and the States that commented on this provision generally objected to the Department's position that use of non-merit system personnel will result in poor program administration. They felt that the Department's position reduces States' ability to be innovative in improving program operations and respond to reduced budgets and increased caseloads. They felt it is inappropriate to prejudge based upon the experience in a couple of States. Specific comments included the following:

    • The final rule should explicitly identify all functions that may require discretion or professional judgment as “eligibility decision functions” that may not be privatized.

    • Further clarification is requested on the issue of the specific functions that non-merit system personnel may perform. Any significant increase in reliance on other agencies, including “community partners” and other non-profit or local government entities, should be considered a major systems change.

    • While the statute names this criterion as one that FNS can examine, it does not allow the agency to prejudge the impact of using non-merit system personnel.

    • The final regulation must be changed to ensure privatization is not codified and legitimized in Federal regulations as an allowable option.

    • The preamble to the proposed rule acknowledges that privatization of work currently performed by public employees constitutes a major change and that States would be required to report this change to FNS. The Department acknowledges that non-merit system personnel interacting directly with households has the potential of increasing the burden on households applying for and participating in SNAP. It is contrary to good sense and effective public policy for the Department to authorize this model when the Department itself acknowledges that all available evidence to date documents costly failures.

    • We are very much opposed to the apparent legitimization of the use of non-merit system personnel to perform critical SNAP functions. In our experience, private entities do a poor job of executing traditional State functions. Even well-meaning nonprofit organizations are unable to maintain timeliness, statewide uniformity and accuracy when they take over activities that have traditionally been done by merit system personnel. For-profit entities have even greater incentive to cut corners, regardless of the consequences for households. We urge FNS to strike proposed § 272.15(a)(2)(iv).

    • Many States have instituted fundamental delivery system changes hastily, such as closing offices and opening call centers. Privatized call center operations in two States proved to be disastrous for SNAP beneficiaries and applicants.

    • There is no reason to codify a practice that the Administration opposes and would not allow in the future.

    • The proposed language creates the impression that States may be able to secure waivers or approval for the use of non-merit system personnel. If FNS's position remains that it is not likely to grant a waiver to use non-merit system personnel for interviews and certification, and that it has determined that Federal financial participation (FFP) is not appropriate for use of non-merit system personnel in other client contacts, we recommend that the final regulation specify this policy so as not to encourage States to go down this path.

    • We strongly oppose the provisions in the proposed regulation that would allow the privatization of the SNAP certification process and the waiver of the merit system requirements. The Department previously advised States that it did not support privatization of portions of the SNAP certification process. The preamble to the proposed regulation notes these same concerns.

    Final Rule—Many comments on this provision of the proposed rule reflected a lack of clarity regarding the Department's intent. It is important to clarify that it was never the Department's intent to condone the use of non-merit system personnel in SNAP. On the contrary, the intent was to require States to report to FNS if they planned to begin using such staff in the administration of the program. The preamble to the proposed rule stated that, “In addition, FNS has determined that use of non-merit system personnel in these functions can have a detrimental impact on the efficient and effective operation of the program and, as a consequence, must approve States' use of such staff before sharing in the costs of non-merit staff in the performance of the above functions.” The Department continues to believe that the use of non-merit system personnel can be detrimental to program performance and service to participants and in April 2013, reiterated its concerns and policy regarding outsourcing in a letter to all States' Governors. In response to the significant number of comments, the Department has modified this provision in the final rule. The final rule requires States to report on any reduction or change of the functions or responsibilities currently assigned to SNAP merit system personnel staff. This will include, but not be limited to, relieving or supplementing merit system personnel's duties performed in the SNAP certification process, handling reported changes, responding to inquiries, handling complaints, collecting claims, investigating program violations or conducting SNAP related reviews. With this change in the final rule, a State will be required to notify FNS if it intends to change the role of its merit system personnel in any way that could impact SNAP operations, including the increased reliance on automated systems.

    Provision/Issues—§ 272.15(a)(2)(v): Any decrease in staffing levels from one year to the next of more than five percent in the number of State or local staff involved in the certification of SNAP households. This would include decreases resulting from State budget cuts or hiring freezes, but not include loss of staff through resignation, retirement or release when the State is seeking to replace the staff.

    Public Comments and Recommendations—Fourteen commenters addressed this provision of the proposed rule and their comments included the following:

    • Delete the language requiring States to notify FNS of office closures or reductions in staffing levels as it goes beyond the authority of the statute.

    • We strongly support including large decreases in staffing levels as one of the types of State changes that would trigger a State to report to FNS. This criterion should be retained in the final regulation. Also recommend that FNS: Add a staff cut of more than ten percent over three years as another measure of a decrease in staffing levels that would need to be reported; clarify that a decrease in merit system personnel would need to be reported; provide that cuts in State staff would not count “losses of staff that occur through resignation, retirement or release when the State is seeking to replace the staff”; and strengthen the final rule to clarify that the State must be seeking to replace the staff within the year to not warrant a report.

    • We suggest that FNS identify an additional baseline for staffing that would also trigger the application of this regulation. For example, a measure of cases per certification worker might be appropriate, so that States that have relatively few workers for the size of their caseload would be subject to this regulation in the event of staffing reductions, even if the five percent threshold were not met.

    • Support the recognition that adequate staffing is critical if States are to provide adequate service. However, the proposed regulations should be modified to recognize that “staffing levels” are not a measure of the absolute number of full-time equivalents, but rather a measure of the ratio of staff to the number of cases. If the ratio of staff to SNAP cases decreases either because of staff reductions or because of an increase in the caseload, the staffing level has declined even if the number of staff is constant.

    • The final rule should make clear that it refers to full-time equivalent (FTE) staff working on SNAP. The final rule should require States to report, on a county or regional basis, the FTE staff administering the program each month.

    • This proposal ignores scenarios in which staff reductions could be accompanied by well-known efficiency measures such as adoption of broader categorical eligibility rules, the six-month reporting option, or the implementation of an efficient new method of using electronic tools for verification of income. The proposed rule could also have an unusually severe impact on locally administered offices; if the five percent trigger is applied to them as well, some are so small that they might have to report the elimination of a single employee or even reductions in one employee's hours.

    • A prescribed reduction reporting threshold of five percent would be difficult for States to track. This is true especially if States must include loss of staff to budget cuts and temporary hiring freezes. This requirement should be removed from the proposed rule.

    • As written, it is unclear how the proposed rule would be applied to those States that are State-supervised but locally-administered. We urge FNS to consider only requiring the States to report aggregate, statewide reductions in State and local staffing, not reductions at each local office.

    • Reductions in staffing levels or the imposition of hiring freezes are budget actions that may not be known to or determined by the State or local agencies until after a budget action has occurred, and it may be impossible to notify FNS 120 days in advance. This definition of a five percent decrease in staff is not explicitly identified in the FCEA, and imposition of this requirement goes beyond the intent of the legislation.

    • This will be difficult to administer. Staff reductions are controlled by the Governor and the Legislature, not State agencies. Also, five percent is unreasonable. The five percent should be increased to at least ten percent at a minimum. This rule should be changed to state that if staff reductions of greater than ten percent are mandated, FNS should be notified of the change and how the State is handling the change.

    • The final rule should require States to report, on a county/regional basis, the FTE staff administering the program by month.

    Final Rule

    The final rule retains the basic requirement that a decrease of more than five percent in the number of State or local merit system personnel involved in the certification process of SNAP households from one year to the next will be considered a major change. In addition, the Department agreed with commenters that cumulative decreases beyond a single year can have a significant impact. Consequently, the final provision has been modified to also make a decrease of more than eight percent in the number of State or local merit system personnel involved in the certification process of SNAP households over a two year period a major change.

    Also in response to commenters' suggestions, the language of this provision has been clarified and strengthened. A reference to decreases across the State was added since this criterion is intended to apply to the total number of merit personnel in States rather than in each individual local office or county within a State. Major changes include decreases resulting from State budget cuts or hiring freezes, but do not include loss of staff through resignation, retirement or release when the State is seeking to replace the staff within a 6-month timeframe. Evidence of the intent to replace staff includes advertising to fill positions and having sufficient funding in the personnel budget for the new hires.

    It is important to note that this criterion defines when States are to report to FNS. The notification and accompanying analysis will allow FNS to determine whether there is a need for additional information.

    Provision/Issues—§ 272.15(a)(3): When a State initially reports a major change to FNS, as required in § 272.15(a)(1), an analysis of the expected impact of the major change shall accompany the report. The initial report to FNS that the State is making one of the major changes identified in § 272.15(a)(2) shall include a description of the change and an analysis of its anticipated impacts on program performance.

    Public Comments and Recommendations—Seven commenters addressed this provision of the proposed rule and their comments included the following:

    • FNS is correct to require States in the initial report to describe the features and timing of the planned major change, what it is intended to accomplish, how it will be tested, piloted, and monitored and the expected effects on eligibility workers and recipients. All of these elements should be maintained in the final rule.

    • The word disproportionately should be deleted from proposed § 272.15(a)(3)(ii)(E). Also, the two “ands” in the paragraph should be changed to “ors”. Not all of these types of households need to be affected or features of the certification process need to be more difficult. If one is true, then the clause should apply.

    • FNS should add one additional item to the list of items in the initial report: A discussion of the budgetary effects of the change. This item should include the estimated cost of any systems change, as well as the expected overall budgetary impact of the change for State and Federal SNAP costs, including benefit costs and administrative costs.

    • The five general analysis requirements are well-rounded, pulled from existing data, and should be sufficient to meet the intentions of the Act.

    • The final rule should require States to explain any stages in implementation, either as the change is fully implemented in one area or as it rolls out across multiple areas (whether or not it eventually becomes statewide).

    • The final rule should require the State to disclose what testing it has undertaken prior to implementing the change.

    • Several of the factors listed in proposed § 272.15(a)(3)(ii) are not so much measures as they are aspects of program performance. It should also include: The State's participation rate; share of households leaving the program at the conclusion of their certification periods; and the percentage of applications (divided by expedited initial applications, non-expedited initial applications, and applications for recertification) that are approved, are denied for substantive ineligibility (or eligibility for zero benefits), and are denied for procedural reasons.

    • We support proposed § 272.15(a)(3), which details the type of information that States must provide to FNS in connection with a planned major change. However, we suggest the regulation require States to analyze the impact of the change on timely processing of recertifications. The final rule should also require States to have a meaningful process for consulting with stakeholders (including program beneficiaries, advocates, community organizations and anti-hunger groups).

    • The regulations should require States intending to implement major changes to submit to FNS copies of procedures and other documents demonstrating that the State has taken steps to minimize the potential negative impact of the proposed change on individuals with disabilities.

    • FNS has quite sensibly acknowledged that the data collection requirements mandated by section 4116 of FCEA, as far as possible, should use data and reports already provided or available to meet these requirements.

    • Much of the data in question will be a normal part of any APD request in any event. The potential requirement for county-level impact data will be particularly difficult to implement, and that caseload sizes in many counties are low enough that the validity of data will be highly questionable.

    • The data collection mandates in this regulation would largely duplicate existing information that FNS has, and create increasingly burdensome data collection and report preparation.

    • FNS does an excellent job summing up what the Act requires in the opening paragraph. The remaining information is overly detailed, rigid and so burdensome to States that it will stall innovations, and prevent access and program integrity improvements in the SNAP program.

    • States do not have the time or resources to address every issue required to be reported.

    Final Rule

    The final rule retains the basic requirement that States' reports of major changes include a description of the change to be implemented and an analysis of its expected impacts on SNAP. In addition, the Department agreed with commenters that additional data items are necessary. Consequently, the final provision has been modified to add the following:

    • The projected administrative cost of the major change in the year it is implemented and the subsequent year;

    • A description of any consultation with stakeholders/advocacy groups or public comment obtained regarding the planned changes; and

    • Procedures the State will put in place to minimize the burdens on people with disabilities and other populations relative to the change.

    Also, in response to commenters' suggestions, the language of § 272.15(a)(3)(ii)(E) as amended by the final rule has been clarified to replace the use of the word “and” in two places with the word “or”. While seemingly minor, this change is important in examining the potential effect of major changes in SNAP on vulnerable populations.

    Some suggestions made for additional data to be reported were not adopted because the Department could not determine how the data would be used in making its determination or what, if any, data would be needed from the State beyond the automatic reporting requirements discussed below.

    Provision/Issues—§ 272.15(b)(1)-(5): § 272.15(b)(1) FNS will evaluate the initial report provided by a State to determine if it agrees that the change is, in fact, major and, if so, will propose what information it will require from the State. While FNS reserves the right to require the information it needs to determine the impact of a major change on integrity and access in SNAP, FNS will work with States to determine what information is practicable, and require only the data that is necessary and not otherwise available from ongoing reporting mechanisms. Depending upon the nature of the major change, FNS will require more specific or timely information concerning the impact of the major change (Please see the NPRM for full text of the proposed provision).

    § 272.15(b)(2): Additional data that States could be required to provide, depending upon the type of major change being implemented. (The rule goes on to give specific examples of the types of data that may be required relative to different types of major changes. Please see the NPRM for full text of the proposed provision).

    § 272.15(b)(3): Depending on the type of major change, its implementation schedule and negotiations with FNS, States shall submit reports on their major changes either monthly or quarterly.

    § 272.15(b)(4): States shall submit reports for one year after the major change is fully in place. FNS may extend this timeframe as it deems necessary.

    § 272.15(b)(5): If FNS becomes aware that a State appeared to be implementing a major change that had not been formally reported, FNS would work with the State to determine if it is a major change, and if so proceed as required by this section.

    These provisions are closely related and commenters' thoughts and recommendations are best examined together.

    Public Comments and Recommendations—Fifteen commenters addressed these provisions of the proposed rule and their comments included the following:

    • Collecting detailed data with case reviews is particularly burdensome for State and local staff during transition periods, and could negatively impact customer service.

    • Support the proposed regulation's detailed discussion of the types of information that FNS will require from the State as to the impact of the change. We commend FNS for its careful identification of the types of information needed to assess the effects of major changes, especially as they pertain to the effects on beneficiaries.

    • The proposed regulation at § 272.15(b)(2)(iii)(B) through (b)(2)(iii)(D) on call centers requires information on “hold time,” “wait time” and “abandoned calls”. The final rule should be amended to also include instances when a caller cannot get through (e.g., busy signals or dropped calls).

    • Particularly troubling is the emphasis of the proposed rules on potentially requiring county level impact data for changes deemed to be “major”. Again, such a requirement does not reflect the reality of the way many States operate. Even in those States that have county project areas, caseload size and case activity volumes in a given county often can make the gathering of the representative samples necessary to evaluate the effect of a change on that county difficult, and the confidence level of short term evaluations questionable.

    • FNS should categorize major changes as being small, medium or significant and require different reporting based on the scope of the change that the State is planning to make. FNS would retain discretion to require more reports in unusual circumstances, but this change would make the reporting requirements more predictable for States and for FNS.

    • FNS should offer States the option to report certain new measures on an ongoing, statewide basis as an alternative to reporting each separate major change with an initial report and the subsequent negotiated data reports.

    • The final rule should sort major systems changes into categories based on their likely risk. More data should be required for riskier changes.

    • We recommend that the exact measures be made more explicit in the final regulation and that FNS' discretion to introduce new measures and enter into negotiations with States be narrowed. These measures include sub-state information or case reviews to gather more detailed information on measures FNS already has at the State level, such as payment accuracy, negative error rates and timeliness.

    • States should have an ongoing data collection system for monitoring their monthly performance in processing of applications and recertifications. FNS should require all States to have such a data collection system, regardless of whether the State is embarking on a major system change.

    • To the extent that the final rule continues to rely upon case-by-case negotiated data requests rather than a stronger baseline of data provided on an on-going basis by all States, it also should specify in greater detail the data that the Department is likely to desire and indicate that the Department will attempt to avoid seeking more data than those elements except for the riskier categories of changes.

    • FNS should use the extensive data already collected in SNAP except in the most unusual situations.

    • The level of detailed data reporting that is being proposed may not be appropriate for all major changes, unless the scope of major changes is significantly narrowed. While the proposed Federal regulations specify that FNS will negotiate with the States on the reporting requirements and that FNS will utilize available data (e.g., quality control data), the amount of information that is required would be administratively onerous and costly given the potentially high degree of frequency that such changes could occur, conflicts with the Paperwork Reduction Act, and neither the counties nor the States have the additional staff resources.

    • A State implementing a major change should submit data regarding individuals with disabilities including the numbers of individuals who requested and received accommodations in the application, interview, or recertification process for disabilities, and the types of accommodations requested and provided (some State benefit agencies already have policies requiring the agency to track this information).

    • The final rule should provide for careful evaluation of the sufficiency of the State agency's fallback plan, including the availability of the resources necessary to carry it out. The final rule should provide that returning to the prior method of administration should presumptively be one of the elements of the State agency's fallback plan unless the State agency presents compelling reasons why it should not be.

    • The break-out of negative errors is important, but needs to be augmented. It also should include break-outs of denials between substantive and procedural. Moreover, it should be broken-out to identify problems affecting specific types of households, such as elderly persons who may have less comfort with technology or limited English proficient households who may have difficulties with online systems not in their language.

    • The proposed regulations reflect a common sense approach to analyzing the effects of a major change. States with effective administration should already be collecting and analyzing the types of data specified in § 272.15(b)(3) regardless of Federal regulations.

    • Nowhere in the Act is FNS given the authority to approve or deny a change a State intends to make, and yet throughout the proposed rule this authority is not only implied, but is assumed.

    • One commenter recommended that States be required to submit the data for each month on a quarterly basis for two years after the change is implemented (unless States have adopted the recommended ongoing reporting option).

    Final Rule

    The final rule retains the requirement that States will be required to report on the impact of major changes. However, the most significant modification to this final rule is the adoption of the suggestion from commenters that key “automatic” reporting requirements be established for all major changes. This is in response to commenters' suggestions that the regulations prescribe basic data that FNS will require for all major changes, as certain data elements would be useful in examining the impact of any major change in a State's operation. While the final rule retains FNS' ability to require additional information on a case-by-case basis (§ 272.15(b)(5)), the final rule establishes minimum data reporting requirements for all major changes, which will also enable States to build these requirements into their plans and systems when making major changes.

    This change has required some reorganization of the provisions as they appeared in the proposed rule. § 272.15(b)(1), (2) and (3) identify the data elements that shall be reported for all major changes, as well as those that must be broken out specifically for households with elderly and disabled members and those that are to be reported at the sub-State level (e.g., counties or local offices). Reporting this information for the most vulnerable SNAP households is consistent with the Act and the need to identify and address adverse impacts on program access for households that may struggle with change more than others. The Department agrees with the comments regarding local level reporting that sub-state information is generally necessary for States and FNS to understand, monitor, and address adverse impacts of a major change. The impacts can be uneven across urban and rural areas, for example, and can vary based upon the how and when a major change is rolled out in different jurisdictions. This is particularly true in county administered/state supervised situations. Since States generally collect sub-state information for their own management purposes, the Department expects the required inclusion of this information in reports to FNS should require minimal additional effort for most States. Therefore, § 272.15(b)(3) as amended by this final rule requires the majority of the key “automatic” reporting requirements be disaggregated to provide sub-state information. Because States utilize different units of analysis for management and other purposes, the regulation allows sub-state data to be provided by individual districts, counties, project areas, or local offices, subject to consultation with and approval by FNS. Section 272.15(b)(4) as amended by this final rule retains the provisions from the proposed rule that FNS will evaluate the major change to determine what reporting requirements will be necessary. In light of the “automatic” requirements for all major changes discussed above, this determination will focus on what, if any, additional reporting requirements will be necessary.

    The recommendation that reporting requirements be applied to all certification activities that are carried out using other telephonic methods has not been adopted since States have been using telephones in their operation of SNAP for decades. However, using telephonic technology to accept applications or relying upon an interactive voice response system to provide case status information to participants would be a major change under § 275.15(a)(2)(ii) as amended by this final rule.

    Some comments reflected misunderstandings of the proposed rule. As noted earlier, this final rule does not provide FNS with approval authority over States' plans to make a major change. Nor does the Act give the Department the authority to require additional ongoing reporting on State performance and operations beyond the context of major changes.

    Some comments suggested that requiring additional reporting indicates an assumption that major changes are detrimental to SNAP participants. On the contrary, FNS has long supported States' efforts to modernize and agrees that many State innovations have improved operations. Nevertheless, there have been times when well-intentioned changes have had adverse impacts on program access or integrity and FNS, not fully informed of States' plans, was unable to work with the State and help mitigate these impacts. Furthermore, certain changes have a greater inherent potential to adversely affect SNAP operations if they are not compensated for appropriately, e.g., office closings or staff reductions.

    With regard to the suggestion that the final rule categorize major changes as being small, medium or significant, and require different reporting based on the scope, the Department has not adopted this suggestion because it would complicate the rule and limit FNS' discretion without significantly streamlining the process for States or FNS. This rule is intended to provide FNS with the ability to examine major changes individually and require additional information beyond the automatic reporting requirements. For all major changes, FNS will also look to the data it already collects on an ongoing basis, i.e., quality control data. While FNS is interested in knowing what contingency plans a State may have, the suggestion that FNS should require States to have specific fall back plans is beyond the scope of the Act.

    The recommendation that the provisions of the final rule be applied to major changes made prior to its effective date has not been adopted for several reasons. First, States would have to obtain historical data on the impact of the change and such data is typically more difficult to obtain. Secondly, States' reports received on the impact of these older changes would be out of date and therefore less useful to FNS in monitoring their impact. Finally, the Department only requires retroactive implementation of final rules when it is both practical and there is a compelling need; neither of which apply to this rule. The recommendation for two years of monthly reports would exceed the Departments needs and place an unnecessary burden upon States. The suggestion that States be required to submit the monthly data on a quarterly basis has been adopted in the restructured final rule in § 272.15(b)(5). While the one year requirement is retained from the NPRM in this final rule at § 272.15(b)(6), FNS may extend this timeframe if necessary. The provision from § 272.15(b)(5) in the NPRM is retained in this final rule at § 272.15(b)(7).

    Provision/Issues—§ 272.15(b)(6): If the data a State submits regarding its major change or other information FNS obtains indicates an adverse impact on SNAP access or integrity, FNS would work with the State to correct the cause of the problem and provide whatever technical assistance it can. Depending upon the severity of the problem, FNS may require a formal corrective action plan as identified in § 275.16 and § 275.17.

    Public Comments and Recommendations—Three commenters addressed these provisions of the proposed rule and their comments included the following:

    • Strongly recommend that the final regulation be strengthened to identify the full range of action that FNS is authorized to initiate in response to information from the State about planned major systems changes.

    • Although requiring correction of problems that have arisen is sensible and appropriate, it puts the Department and the State agency in the all-too-familiar position of playing catch-up after a problem has occurred. The final rule should restructure this paragraph to focus on the implementation of the State agency's fallback plan or plans.

    • “Adverse impact” is not defined, which could lead to subjective and inconsistent results among regions regarding when a corrective action plan is imposed. Existing performance measures already have standards that States must meet, and corrective action plans can be required for failure to meet those standards. At best, the new process is duplicative; at worst, it opens up an avenue for corrective action plans for anything that FNS may decide has an “adverse impact.”

    Final Rule

    As explained earlier, the Department has neither the authority to approve or deny (unless a State's plans violate a provision of the Act or SNAP regulations) a State's plans, nor can it require that States develop fallback plans. With regard to when a State would be required to submit a corrective action plan due to an adverse impact, the Department agrees that the provisions of this rule could open another avenue for identification and correction of deficiencies in a State's operation; this is the intent of the Act. Therefore, the provision (now at § 272.15(b)(8)) as amended by this final rule remains unchanged from the NPRM.

    Provision/Issues—§ 275.3(a): FNS shall conduct management evaluation reviews of certain functions performed at the State agency level in the administration/operation of the program. FNS will designate specific areas required to be reviewed each fiscal year.

    Public Comments and Recommendations—Thirteen commenters addressed these provisions of the proposed rule and their comments included the following:

    • FNS and States should be engaging in additional monitoring activities of local service delivery, not fewer. The changes FNS proposes to ME reviews have no basis in statute -the 2008 FCEA made no changes to reduce FNS's oversight role. ME reviews are also the primary way that FNS monitors civil rights compliance. The final rule must not back away from FNS's commitment in these areas.

    • Caseloads have increased dramatically in recent years while, at the same time, the number of staff to process cases has not kept pace. This development points to the need for more, not less frequent, reviews because of the risk of access barriers. We recommend that the final rule reject these changes to the ME regulations and keep the current requirements.

    • The proposed regulation will weaken the longstanding requirement for ME reviews of State certification operations, and fails to require straightforward, publically available and nationally consistent data collection from States making major changes in their service delivery model. The proposal eviscerates a decades-old requirement that States and FNS conduct ME reviews of State certification operations. Such ME reviews are the cornerstone of FNS oversight of client access and program integrity.

    • The solution to staffing shortages is to prioritize. Reducing oversight of the largest program in the Department is not a sensible means of prioritizing. If the problem is an insufficient Federal Program Administration appropriation, the Department should realign staffing of the various food assistance programs to be more proportional to the taxpayers' dollars at stake in each.

    • Oppose the proposed changes that eliminate the requirement for an annual review of certain functions performed at the State agency level and the elimination of the requirement for a biennial review of the State's ME system. The proposed regulation, which lacks any specified frequency for reviews, could lead to FNS's abdication of these reviews for all practical purposes, now or in the future. The requirement that FNS designate specific areas for review each year does not necessarily mean that FNS must in fact conduct such reviews.

    • FNS should define what qualifies as “at-risk” to provide for consistency in the different regions. Providing the data for these “off-site” activities is more time-consuming for the States unless Federal reviewers are given total access to State systems.

    • We agree with the increased flexibility given to FNS in the conduct of MEs under the proposed rule and encourage that similar flexibility and ability to target reviews be given to the States in the conduct of their annual MEs.

    • We appreciate FNS' targeted approach and suggest that the reviews be less targeted by frequency and size, but more by performance and need.

    • We disagree with FNS removing its own burdens in the ME process while keeping the States' current requirements basically unchanged.

    • The term “at-risk” is vague. Recommend keeping the current requirement of a biennial review of the State's ME system. Having scheduled Federal reviews on a biennial basis would allow States to plan accordingly.

    • State and Federal ME requirements should not be changed. Proposals to weaken them should not be included in the final rule.

    Final Rule

    Based upon comments received, the Department is withdrawing the changes to this provision from the final rule. The Department agrees that monitoring SNAP is a high priority responsibility for FNS and supports the goal of maintaining sufficient resources to enable proper oversight of SNAP operations.

    Provision/Issues—§ 271.2: Amend the definitions of Large, Medium, and Small project areas for ME review purposes.

    Public Comments and Recommendations—Five commenters addressed these provisions of the proposed rule and their comments included the following:

    • These changes in the definitions of project areas are likely to have significant negative impacts on civil rights compliance within SNAP. Reducing the frequency or intensity of ME reviews will have the effect of reducing efforts to identify and correct civil rights violations.

    • We recommend that the final rule reject these changes to the ME regulations and keep the current requirements.

    • We agree with the need for a modification to the definitions of large and medium project areas but contend that the revised definitions do not reflect the reality of the larger States. We recommend further review of these proposed standards and even higher caseload thresholds in order to reflect the project areas of the large States.

    • These were the definitions that were in effect for California until FY 2011. Given the limitation of staff and resources, this new definition would create a workload issue in California. We recommend redefine project areas as follows:

    ○ Large—those with an average monthly caseload of more than 50,000 cases.

    ○ Medium—those with an average monthly caseload of between 25,000 and 50,000 cases.

    ○ Small—those with an average monthly caseload up to 24,999 cases.

    Final Rule

    Comments on this provision of the rule were mixed with some commenters believing that the provision of the proposed rule did not go far enough in reducing the frequency with which States are required to review their project areas. The Department acknowledges that while more monitoring of SNAP is generally more desirable than less monitoring, the quality of the monitoring must also be a factor. Reductions in States' budgets have put pressure on staffing for SNAP and this provision allows States to do a better job in the ME reviews that are conducted. Furthermore, the project area sizes in the current rules were set when the program was less than half its current size in terms of participation. Therefore, this provision of the final rule remains unchanged from the proposed rule.

    List of Subjects 7 CFR Part 271

    Food stamps, Grant programs-social program, Reporting and recordkeeping.

    7 CFR Part 272

    Alaska, Civil rights, SNAP, Grant programs-social programs, Penalties, Reporting and recordkeeping requirements, Unemployment compensation, Wages.

    7 CFR Part 275

    Administrative practice and procedure, SNAP, Reporting, and recordkeeping requirements.

    Accordingly, 7 CFR parts 271, 272 and 275 are amended as follows:

    PART 271—GENERAL INFORMATION AND DEFINITIONS 1. The authority citation for Part 271 continues to read as follows: Authority:

    7 U.S.C. 2011-2036.

    § 271.2 [Amended]
    2. In § 271.2: a. Amend the definition of Large project area by removing the number “15,000” and adding in its place the number “25,000”. b. Amend the definition of Medium project area by removing the numbers “2,001 to 15,000” and adding in their place the numbers “5,000 to 25,000”. c. Amend the definition of Small project area by removing the number “2,000” and adding in its place the number “4,999”.
    PART 272—REQUIREMENTS FOR PARTICIPATING STATE AGENCIES 3. The authority citation for Part 272 continues to read as follows: Authority:

    7 U.S.C. 2011-2036.

    4. Add § 272.15 to read as follows:
    § 272.15 Major changes in program design.

    (a) States' reporting of major changes. (1) State agencies shall notify FNS when they make major changes in their operation of SNAP. State agencies shall notify FNS when the plans for the change are approved by State leadership, but no less than 120 days prior to beginning implementation of the change or entering into contractual obligations to implement any proposed major changes. If it is not possible for a State to provide notification 120 days in advance, the State shall provide notification as soon as it is aware of the major change and explain why it could not meet the 120-day requirement. No approval from FNS is necessary for a State to proceed with implementation of the major change.

    (2) Major changes shall include the following:

    (i) Closure of any local office that performs major functions for 750 or more SNAP households or 5 percent of the State's total SNAP monthly caseload, whichever is less, and there is not another office available to serve the affected households within 35 miles. An office performing major functions is an office where households can file an application for SNAP in person and receive assistance from merit system personnel staff.

    (ii) Substantial increased reliance on automated systems for the performance of responsibilities previously performed by State merit system personnel (as described in section 11(e)(6)(B) of the Act) or changes in the way that applicants and participants interact with the State's SNAP agency. This includes the replacement of the State's automated systems used in the certification process, adding functionality to the existing automated systems used in the certification process, or changes in the way applicants and participants interact with SNAP. For example, adding an overlay on an existing legacy automated system used by eligibility workers, adding online portals to an existing automated system for use by SNAP applicants, participants or community partners, establishment of an online application, use of telephonic technology to accept applications, relying upon an interactive voice response system to provide case status information to participants or implementation of finger imaging shall be considered major changes. Under this criterion, if the State documents that the change is expected to impact less than five percent of the State's SNAP applicants or participants, it will not be considered a major change. Reporting a major change as required in this section does not relieve States of meeting the requirements for new system approvals in § 277.18 of this chapter.

    (iii) Changes in operations that potentially increase the difficulty of households reporting required information. This could include implementation of a call center or internet web portal for change reporting, a major modification to forms that households use to report changes or the discontinuation of an existing avenue for reporting changes (e.g., households can no longer contact the local office because all changes must be reported to a unit that handles change reports). Selecting a different change reporting policy option as allowed in § 273.12 of this chapter, or the implementation of a policy waiver related to change reporting would not be a major change.

    (iv) Any reduction or change of the functions or responsibilities currently assigned to SNAP merit system personnel.

    (v) A decrease of more than 5 percent in the total number of merit system personnel involved in the SNAP certification process in the State from one year to the next. In addition, a decrease of more than eight percent in the total number of merit system personnel involved in the SNAP certification process in the State over a two year period would be a major change. These decreases would include those resulting from State budget cuts or hiring freezes, but not include loss of personnel through resignation, retirement or release when the State is seeking to replace the personnel within 6 months. Evidence of the intent to replace personnel shall include advertising to fill positions and having sufficient funding in the personnel budget for the new hires.

    (vi) Other major changes identified by FNS.

    (3) When a State initially reports a major change to FNS as required in paragraph (a)(1) of this section, an analysis of the expected impact of the major change shall accompany the report. The initial report to FNS that the State is making one of the major changes identified in paragraph (a)(2) of this section, shall include a description of the change and an analysis of its anticipated impacts on program performance.

    (i) The description of the change shall include the following:

    (A) Identification of the major change the State is implementing;

    (B) An explanation of what the change is intended to accomplish;

    (C) The schedule for implementation;

    (D) How the change will be tested and whether it will be piloted;

    (E) Whether the change is statewide or identification of the jurisdictions it will encompass;

    (F) How the major change is expected to affect applicants and/or participants and how they will be informed;

    (G) How the change will affect caseworkers and, as applicable, how they will be trained;

    (H) The projected administrative cost of the major change in the year it is implemented and the subsequent year;

    (I) How the impact of the major change will be monitored;

    (J) How the major change will affect operation of the State automated system;

    (K) The State's backup plans if the major change creates significant problems in one or more of the program measures in paragraph (a)(3)(ii) of this section;

    (L) A description of any consultation with stakeholders/advocacy groups or public comment obtained regarding the planned changes; and

    (M) Procedures the State will put in place to minimize the burdens on people with disabilities and other populations (as identified in paragraph (a)(3)(ii)(E) of this section) relative to the change.

    (ii) The analysis portion of the State's initial report shall include the projected impact of the major change on:

    (A) The State's payment error rate;

    (B) Program access, including the impact on applicants filing initial applications and recertification applications;

    (C) The State's negative error rate;

    (D) Application processing timeliness including both the households entitled to 7-day expedited service and those subject to the 30-day processing standards;

    (E) Whether the major change will increase the difficulty elderly households, households living in rural areas, households containing a disabled member, homeless households, non-English speaking households, or households living on a reservation will have obtaining SNAP information, filing an initial application, providing verification, being interviewed, reporting changes or reapplying for benefits;

    (F) Customer service including the time it takes for a household to contact the State, be interviewed, report changes and any other parameter defined by the State agency; and

    (G) Timeliness of recertification actions.

    (b) FNS and State action on reports. (1) FNS will evaluate the initial report provided by a State to determine if the change is, in fact, a major change as described in paragraph (a)(2) of this section and notify the State of its determination. States implementing a major change shall report the following monthly State-level information to FNS on a quarterly basis beginning with the quarter prior to implementation of the major change:

    (i) The number of initial applications received;

    (ii) Of the number of initial applications received in paragraph (b)(1)(i) of this section, the number subject to expedited service;

    (iii) Of the number of initial applications received in paragraph (b)(1)(i) of this section, the number broken out by method of application (i.e., in-person, online, telephone, mail, fax);

    (iv) The number of initial applications that are approved timely;

    (v) Of the number of initial applications approved timely in paragraph (b)(1)(iv) of this section, the number subject to expedited service processed within the 7-day processing requirement;

    (vi) The number of initial applications that are approved untimely;

    (vii) Of the number of initial applications approved untimely in paragraph (b)(1)(vi) of this section, the number subject to expedited service processed outside the 7-day processing requirement;

    (viii) The number of initial applications that are denied;

    (ix) Of the number of initial applications that were denied in paragraph (b)(1)(viii) of this section, the number broken out by those denied due to ineligibility and those denied because the State agency was unable to determine eligibility;

    (x) The total number of households due for recertification;

    (xi) The number of recertification applications received;

    (xii) Of the number of recertification applications received in paragraph (b)(1)(xi) of this section, the number broken out by method of application (i.e., in-person, online, telephone, mail, fax);

    (xiii) The number of households that were recertified without a delay or break in benefits;

    (xiv) The number of households that the State recertifies with a delay or break in benefits of less than one month;

    (xv) Of the total number of households due for recertification in paragraph (b)(1)(x) of this section, the number of households that fail to reapply for recertification by the required deadline;

    (xvi) The number of recertification applications that are denied; and

    (xvii) Of the number of recertification applications that were denied in paragraph (b)(1)(xvi) of this section, the number broken out by those denied due to ineligibility and those denied because the State agency was unable to determine eligibility.

    (2) The information required by paragraph (b)(1)(1) of this section shall be reported separately for households with elderly members and households with members that have a disability.

    (3) At a minimum, the information required by paragraphs (b)(1)(i), (iv), (vi), (viii), (x), (xi), (xiii), (xiv), (xv), and (xvi) of this section shall be disaggregated to provide sub-state information. FNS will require the State to disaggregate all the information in paragraph (b)(2) if FNS determines that such data are necessary to evaluate the impact of the change. FNS will consult with States on a case-by-case basis to determine if this information shall be reported by: Local offices, call centers, county, project areas, or by other administrative structures within the State. FNS' determination will be based upon the type of major change and the State's SNAP organization.

    (4) In addition the information required in paragraphs (b)(1), (2) and (3) of this section, FNS may require additional information to be included in a State's quarterly report. FNS reserves the right to require the information it needs to determine the impact of a major change on integrity and access in SNAP. FNS will work with States to determine what additional information is practicable and require only the data that is necessary and not otherwise available from ongoing reporting mechanisms. While the data elements outlined in paragraph (b)(2) of this section will generally be required to be reported on a statewide basis and at a sub-state level, major changes that are limited to localized areas, such as a county or project area, may only require localized reporting. Depending upon the nature of the major change, States will be required to report more specific or timely information concerning the impact of the major change within the following areas:

    (i) Payment accuracy. FNS will use Quality Control (QC) data when possible, but may require data from case reviews focused on households with specific characteristics, to obtain greater local reliability, or to provide more timely data.

    (ii) Negative error rates. FNS will use QC data when possible, but may require data from case reviews focused on households with specific characteristics, to obtain greater local reliability or to provide more timely data on the causes of incorrect denials.

    (iii) Impact on households with specific characteristics. In addition to the information required by paragraph (b)(2) of this section, a major change that could disproportionately impact the households identified at paragraph (a)(3)(ii)(E) of this section may require additional information on the impact of the change on the participation of these households. The nature of the change and its potential impact would dictate how this information would need to be reported.

    (iv) Impact of certain major changes on customer service. Some major changes may require specific information that is not typically available from a States automated SNAP system. For example, if a State implements a major change that allowed (or required) households to report changes in their individual circumstances through a change center or allows applicants to apply or reapply for SNAP through the use of call center, the following data may be required:

    (A) The total number of calls made to the center;

    (B) The average time a caller has to wait to talk to a SNAP worker (includes hold time for transfers);

    (C) Based upon the call centers standards and negotiation with FNS, the percentage of calls with excessive wait times;

    (D) The percentage of calls abandoned by callers prior to and after being answered by the call center;

    (E) The total number of calls dropped by the call center system and the number of callers that received a busy signal; and

    (F) Customer satisfaction (based upon survey results).

    (5) States shall submit reports containing monthly data on a quarterly basis. As practicable, and based upon consultation with the State, FNS may require any additional information under paragraph (b)(4) of this section regarding the State's operation to be reported for the quarter just prior to implementation of the major change.

    (6) States shall submit reports for one year after the major change is fully in place. FNS may extend this timeframe as it deems necessary.

    (7) If FNS becomes aware that a State appeared to be implementing a major change that had not been formally reported, FNS would work with the State to determine if it is a major change, and if so proceed as required by this section.

    (8) If the data a State submits regarding its major change or other information FNS obtains indicates an adverse impact on SNAP access or integrity, FNS would work with the State to correct the cause of the problem and provide relevant technical assistance, and will require the State to provide additional information as it deems appropriate. Depending upon the severity of the problem, FNS may also require a formal corrective action plan as identified in § 275.16 and § 275.17 of this chapter. States agencies that fail to comply with reporting requirements may be subject to the suspension or disallowance of Federal Financial Participation administrative funds per § 276.4 of this chapter.

    PART 275—PERFORMANCE REPORTING SYSTEM 5. The authority citation for Part 275 continues to read as follows: Authority:

    7 U.S.C. 2011-2036.

    6. In § 275.7: a. Revise paragraph (a) to read as set forth below. c. Remove paragraphs (b), (c) and (d). d. Redesignate paragraph (e) as paragraph (b). e. Amend newly redesignated paragraph (b) by removing the word “on-site”.
    § 275.7 Selection of sub-units for review.

    (a) Definition of sub-units. Sub-units are the physical locations of organizational entities within project areas responsible for operating various aspects of SNAP and include but are not limited to certification offices, call centers, and employment and training offices.

    7. In § 275.9: a. Revise paragraph (b)(1)(iii) to read as set forth below. b. Amend paragraph (b)(1)(iv) by removing the first sentence.
    § 275.9 Review process.

    (b) * * *

    (1) * * *

    (iii) Identification of the sub-units selected for review and the techniques used to select them;

    8. In § 275.16 revise paragraph (b)(3) to read as follows:
    § 275.16 Corrective action planning.

    (b) * * *

    (3) Are identified by FNS reviews, GAO audits, contract audits, reports to FNS regarding the implementation of major changes (as discussed in § 272.15) or USDA audits or investigations at the State agency or project area level (except deficiencies in isolated cases as indicated by FNS); and,

    Dated: December 10, 2015. Audrey Rowe, Administrator, Food and Nutrition Service.
    [FR Doc. 2016-00674 Filed 1-15-16; 8:45 am] BILLING CODE 3410-30-P
    FEDERAL TRADE COMMISSION 16 CFR Part 1 Administrative Debt Collection Procedures AGENCY:

    Federal Trade Commission (FTC).

    ACTION:

    Final rule.

    SUMMARY:

    The FTC is publishing procedures for the administrative collection of debts, including those arising under judgments and orders of the Commission. These procedures, where applicable, will allow the use of administrative offset and tax refund offset to satisfy such debts. The use of these tools is expected to enhance the FTC's enforcement and collection efforts. The FTC is also making a technical revision to its existing rule for administrative garnishment of non-Federal wages to update the name of the Treasury Department agency responsible for cross-servicing debts.

    DATES:

    This rule is effective on January 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Stephen Dowdell, Enforcement Division, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Stop CC-9528, Washington, DC 20580, (202) 326-2814.

    SUPPLEMENTARY INFORMATION:

    The FTC is issuing final rules to publish procedures to use debt collection tools authorized by Government-wide Federal Claims Collection Standards (“FCCS”) and applicable Federal debt collection statutes for amounts owed to the United States. These rules supplement and complement the Commission's existing administrative wage garnishment rule for non-Federal wages, 16 CFR 1.100, to collect amounts that may be owed to the FTC, including amounts owed under Commission orders and judgments. These additional procedures, where applicable, will enable the use of administrative offset against other Federal payments that may be due to the debtor, including a tax refund offset, to satisfy such debts. These rules are not intended to, and do not create, any separate or additional rights to notice or opportunity to challenge the amount or validity of debts that have already been reduced to judgment or are otherwise legally final and binding, such as debts arising from judgments or orders entered upon the consent or agreement of the debtor. (In addition, the FTC is updating 16 CFR 1.100 to substitute the “Bureau of the Fiscal Service” for the former name of that agency, the “Financial Management Service.”) These rules do not require notice and public comment under the Administrative Procedure Act, because they are agency rules of practice and adopt applicable Government-wide regulations without material change. See 5 U.S.C. 553(b)(A) & (B). Similarly, the Commission also finds good cause to dispense with the 30-day delay in the effective date normally required by the Administrative Procedure Act. 5 U.S.C. 553(d). No hardship will be imposed on debtors by the rules' immediate implementation. Rather, the public will benefit because the rule revisions codify procedures governing the use of debt collection tools authorized by the FCCS and applicable Federal debt collection statutes.

    The rules have two parts. Under Subpart P, the Commission's administrative debt collection activities shall be conducted in accordance with applicable Government-wide debt collection regulations, including the Federal Claims Collection Standards (FCCS), 31 CFR parts 900-904, jointly promulgated by the Departments of Justice and Treasury, and related Treasury debt collection regulations, 31 CFR part 285, utilized when the Commission refers a debt to Treasury for collection, including the centralized offset of Federal payments by Treasury. Furthermore, consistent with 31 U.S.C. 3716(b)(1), Subpart P expressly adopts, without change, applicable FCCS provisions governing the use of administrative offset in Federal debt collection activities. Subpart Q applies to tax refund offsets, and sets forth the procedures that shall apply when the Commission refers a debt to Treasury for collection by such means, consistent with the Federal statutes governing administrative offset generally (31 U.S.C. 3716) and tax refund offset specifically (31 U.S.C. 3720A), and the corresponding provisions of the FCCS and Treasury part 285 regulations, supra.

    List of Subjects in 16 CFR Part 1

    Administrative practice and procedure, Claims, Debts, Garnishment of wages, Hearing and appeal procedures, Pay administration, Salaries, Wages.

    For the reasons stated in the preamble, the Federal Trade Commission amends part 1, title 16, Code of Federal Regulations, as follows:

    PART 1—GENERAL PROCEDURES 1. The authority citation for part 1 continues to read as follows: Authority:

    Sec. 6, 38 Stat. 721 (15 U.S.C. 46), unless otherwise noted.

    § 1.100 [Amended]
    2. Amend § 1.100 by removing from paragraph (a) the phrase “Financial Management Service” and adding in its place the phrase “Bureau of the Fiscal Service”.
    § 1.102-1.109 [Added and Reserved]
    3. In subpart O, add and reserve §§ 1.102-1.109. 4. Add new subparts P and Q to read as follows: Subpart P—Administrative Debt Collection, Including Administrative Offset Sec. 1.110 Application of Government-wide administrative claims collections standards and adoption of administrative offset regulations. 1.111-1.119 [Reserved] Subpart Q—Tax Refund Offset 1.120 Purpose. 1.121 Notification of intent to collect. 1.122 Commission action as a result of consideration of evidence submitted in response to the notice of intent. 1.123 Change in notification to Bureau of the Fiscal Service. 1.124 Interest, penalties, and costs. Subpart P—Administrative Debt Collection, Including Administrative Offset Authority:

    31 U.S.C. 3701 et seq.

    § 1.110 Application of Government-wide administrative claims collections standards and adoption of administrative offset regulations.

    (a) The Commission shall apply the Federal Claims Collection Standards (FCCS), 31 CFR parts 900-904, in the administrative collection, offset, compromise, suspension, termination, and referral of collection activity for civil claims for money, funds, or property, as defined by 31 U.S.C. 3701(b), unless specific Federal agency statutes or regulations apply to such activities or, as provided for by Title 11 of the United States Code, when the claims involve bankruptcy. The Commission shall also follow Department of Treasury regulations set forth at 31 CFR part 285, as applicable, for administrative debt collection, including centralized offset of federal payments to collect non-tax debts that may be owed to the Commission, 31 CFR 285.5. Nothing in this subpart shall be construed to supersede or require the Commission to provide additional notice or other procedures that may have already been provided or afforded to a debtor in the course of administrative or judicial litigation or otherwise.

    (b) For purposes of 31 U.S.C. 3716(b)(1), the Commission adopts without change the regulations on collection by administrative offset set forth at 31 CFR 901.3 and other relevant sections of the FCCS applicable to such offset.

    §§ 1.111-1.119 [Reserved]
    Subpart Q—Tax Refund Offset Authority:

    31 U.S.C. 3716 and 3720A, 31 CFR 285.2(c).

    § 1.120 Purpose.

    This subpart establishes procedures for the Commission's referral of past-due legally enforceable debts to the Department of the Treasury's Bureau of the Fiscal Service (Fiscal Service) for offset against the tax refund payments of the debtor, consistent with applicable Fiscal Service regulations and definitions set forth in 31 CFR 285.2 and 285.5.

    § 1.121 Notification of intent to collect.

    (a) Notification before tax refund offset. Reduction of a tax refund payment will be made only after the Commission makes a determination that an amount is owed and past-due and gives or makes a reasonable attempt to give the debtor 60 days written notice of the intent to collect by tax refund offset.

    (b) Contents of notice. The Commission's notice of intent to collect by tax refund offset will state:

    (1) The amount of the debt;

    (2) That unless the debt is repaid within 60 days from the date of the notice, the Commission intends to collect the debt by requesting a reduction of any amounts payable to the debtor as a Federal tax refund payment by an amount equal to the amount of the debt and all accumulated interest and other charges;

    (3) That the debtor, within 60 days from the date of the notice, has an opportunity to make a written agreement to repay the amount of the debt, unless such opportunity has previously been provided;

    (4) A mailing address for forwarding any written correspondence and a contact name and a telephone number for any questions; and

    (5) That the debtor may present evidence to the Commission that all or part of the debt is not past due or legally enforceable by:

    (i) Sending a written request for a review of the evidence to the address provided in the notice;

    (ii) Stating in the request the amount disputed and the reasons why the debtor believes that the debt is not past due or is not legally enforceable; and

    (iii) Including in the request any documents that the debtor wishes to be considered or stating that the additional information will be submitted within the remainder of the 60-day period.

    (c) A debtor may dispute the existence or amount of the debt or the terms of repayment, except with respect to debts established by a judicial or administrative order. In those cases, the debtor may not dispute matters or issues already settled, litigated, or otherwise established by such order, including the amount of the debt or the debtor's liability for that debt, except to the extent that the debtor alleges that the amount of the debt does not reflect payments already made to repay the debt in whole or part.

    § 1.122 Commission action as a result of consideration of evidence submitted in response to the notice of intent.

    (a) Consideration of evidence. If, in response to the notice provided to the debtor under § 1.121, the Commission is notified that the debtor will submit additional evidence, or the Commission receives additional evidence from the debtor within the prescribed time, tax refund offset will be stayed until the Commission can:

    (1) Consider the evidence presented by the debtor;

    (2) Determine whether all or a portion of the debt is still past due and legally enforceable; and

    (3) Notify the debtor of its determination, as set forth in paragraph (b) of this section.

    (b) Commission action on the debt. (1) If, after considering any additional evidence from the debtor, the Commission determines that the debt remains past-due and legally enforceable, the Commission will notify the debtor of its intent to refer the debt to the Fiscal Service for offset against the debtor's Federal tax refund payment, including whether the amount of the debt remains the same or is modified; or

    (2) If, after considering any additional evidence from the debtor, the Commission determines that no part of the debt remains past-due and legally enforceable, the Commission will so notify the debtor and will not refer the debt to the Fiscal Service for offset against the debtor's Federal tax refund payment.

    § 1.123 Change in notification to Bureau of the Fiscal Service.

    After the Commission sends the Fiscal Service notification of a debtor's liability for a debt, the Commission will promptly notify the Fiscal Service if the Commission:

    (a) Determines that there is a material error or other material change in the information contained in the notification, including in the amount of the debt, subject to any additional due process requirements, where applicable, under this subpart or the Federal Claims Collection Standards, if the amount of debt has increased;

    (b) Receives a payment or credits a payment to the account of the debtor named in the notification that reduces the amount of the debt referred to Fiscal Service for offset; or

    (c) Otherwise concludes that such notification is appropriate or necessary.

    § 1.124 Interest, penalties, and costs.

    To the extent permitted or required by 31 U.S.C. 3717 or other law, regulation, or order, all interest, penalties, and costs applicable to the debt or incurred in connection with its referral for collection by tax refund offset will be assessed on the debt and thus increase the amount of the offset.

    By direction of the Commission.

    Donald S. Clark, Secretary.
    [FR Doc. 2016-00313 Filed 1-15-16; 8:45 am] BILLING CODE 6750-01-P
    SECURITIES AND EXCHANGE COMMISSION 17 CFR PARTS 229 and 239 [Release No. 33-10003; File No. S7-01-16] RIN 3235-AL88 Simplification of Disclosure Requirements for Emerging Growth Companies and Forward Incorporation by Reference on Form S-1 for Smaller Reporting Companies AGENCY:

    Securities and Exchange Commission.

    ACTION:

    Interim final rule; request for comment.

    SUMMARY:

    The Securities and Exchange Commission (“Commission”) is adopting interim final amendments to its rules and forms to implement Sections 71003 and 84001 of the Fixing America's Surface Transportation (“FAST”) Act, which require that the Commission revise Forms S-1 and F-1 to permit emerging growth companies to omit financial information for certain historical periods and revise Form S-1 to permit forward incorporation by reference for smaller reporting companies.

    DATES:

    Effective date: The interim final rule is effective on January 19, 2016.

    Comment date: Comments on the interim final rules should be received on or before February 18, 2016.

    ADDRESSES:

    Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's Internet comment form (http://www.sec.gov/rules/proposed.shtml); or

    • Send an email to [email protected] Please include File Number S7-01-16 on the subject line; or

    • Use the Federal eRulemaking Portal (http://www.regulations.gov). Follow the instructions for submitting comments.

    Paper Comments

    • Send paper comments to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

    All submissions should refer to File Number S7-01-16. This file number should be included on the subject line if email is used. To help us process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Web site (http://www.sec.gov/rules/proposed.shtml). Comments are also available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. All comments received will be posted without change; we do not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. FOR FURTHER INFORMATION CONTACT:

    Peggy Kim, Attorney-Adviser, Office of Rulemaking, Division of Corporation Finance, at (202) 551-3430, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549.

    SUPPLEMENTARY INFORMATION:

    We are adopting interim final amendments to Forms S-1 1 and F-1 2 under the Securities Act of 1933 3 and Item 512 of Regulation S-K.4

    1 17 CFR 239.11.

    2 17 CFR 239.31.

    3 15 U.S.C. 77a et seq.

    4 17 CFR 229.512.

    I. Discussion of Amendments

    Form S-1 is the form used by domestic issuers to register the offer and sale of securities under the Securities Act of 1933 when no other form is authorized or prescribed, and Form F-1 is the corresponding form used by foreign private issuers.5 Item 512 of Regulation S-K describes the undertakings that an issuer must include in a registration statement.

    5 A “foreign private issuer” is defined in Rule 405 [17 CFR 230.405] under the Securities Act to mean any foreign issuer other than a foreign government, except for an issuer that has more than 50% of its outstanding voting securities held of record by U.S. residents and any of the following: A majority of its officers and directors are citizens or residents of the United States, more than 50 percent of its assets are located in the United States, or its business is principally administered in the United States.

    Section 71003 of the FAST Act 6 amends Section 102 of the Jumpstart Our Business Startups (“JOBS”) Act 7 to allow an emerging growth company 8 that is filing a registration statement (or submitting a draft registration statement 9 for confidential review) under Section 6 of the Securities Act on Form S-1 or Form F-1 to omit financial information 10 for historical periods 11 otherwise required by Regulation S-X 12 if it reasonably believes the omitted information will not be required to be included in the filing at the time of the contemplated offering, so long as the issuer amends the registration statement prior to distributing a preliminary prospectus to include all financial information required by Regulation S-X at the time of the amendment. This provision takes effect 30 days after the date of enactment of the FAST Act. In addition, Section 71003 directs the Commission to revise the general instructions to Form S-1 and Form F-1 to reflect this self-executing change.

    6 Pub. L. 114-94 (Dec. 4, 2015).

    7 Pub. L. 112-106, 126 Stat. 306 (Apr. 5, 2012).

    8 An “emerging growth company” is defined in Section 2(a)(19) of the Securities Act [15 U.S.C. 77b(a)(19)] to mean an issuer with less than $1 billion in total annual gross revenues during its most recently completed fiscal year. If an issuer qualifies as an emerging growth company on the first day of its fiscal year, it maintains that status until the earliest of the last day of the fiscal year of the issuer during which it has total annual gross revenues of $1 billion or more; the last day of its fiscal year following the fifth anniversary of the first sale of its common equity securities pursuant to an effective registration statement; the date on which the issuer has, during the previous 3-year period, issued more than $1 billion in non-convertible debt; or the date on which the issuer is deemed to be a “large accelerated filer” (as defined in Exchange Act Rule 12b-2 [17 CFR 240.12b-2]). Section 71002 of the FAST Act amends Section 6(e)(1) of the Securities Act [15 U.S.C. 77f(e)(1)] to provide that an issuer that qualifies as an emerging growth company at the time it initiates the registration process, either by submitting a draft registration statement or by filing it publicly, but which subsequently ceases to be an emerging growth company, will continue to be treated as an emerging growth company until the earlier of the date on which the issuer consummates its initial public offering pursuant to that registration statement or the end of the 1-year period beginning on the date the company ceases to be an emerging growth company. Section 71002 became effective upon enactment.

    9 Prior to filing a Form S-1 or F-1 for an initial public offering, emerging growth companies can submit draft registration statements to the Commission for confidential review.

    10 The historical financial statements that may be omitted are not limited to the financial statements of the emerging growth company. For example, an emerging growth company may also omit the historical financial statements of an acquired business from its filing or submission if the company reasonably believes those financial statements will not be required at the time of the offering.

    11 Emerging growth companies must include two years of audited financial statements in a registration statement for an initial public offering of common equity securities. [15 U.S.C. 77g (a)(2)(A)]

    12 Form F-1 filers are subject to the financial reporting requirements of Regulation S-X and Form 20-F. Item 8.A. of Form 20-F [17 CFR 249.220f] contains the requirements for the historical periods applicable to foreign private issuers filing on Form F-1.

    Section 84001 of the FAST Act requires the Commission to revise Form S-1 to permit a smaller reporting company 13 to incorporate by reference into its registration statement any documents filed by the issuer subsequent to the effective date of the registration statement. We are adding a new paragraph to Item 12 of Form S-1 to effect this provision.14

    13 A “smaller reporting company” is defined in Rule 405 under the Securities Act to mean an issuer that had a public float of less than $75 million as of the last business day of its most recently completed second fiscal quarter or had annual revenues of less than $50 million during the most recently completed fiscal year for which audited financial statements are available.

    14 New paragraph (b) to Item 12 of Form S-1.

    Currently, there are eligibility requirements for any issuer to use historical incorporation by reference on Form S-1 for documents filed before the effective date of the registration statement. These requirements will not be affected as a result of these amendments.15 Smaller reporting companies must meet each of these existing eligibility requirements and conditions to use forward incorporation by reference on Form S-1.16 For example, to be eligible to use forward incorporation by reference, smaller reporting companies will be required to be current by having filed (a) an annual report for its most recently completed fiscal year and (b) all required Exchange Act reports and materials during the 12 months immediately preceding filing of the Form S-1 (or such shorter period that the smaller reporting company was required to file such reports and materials). Smaller reporting companies that are blank check companies, shell companies (other than business combination related shell companies) or issuers for offerings of penny stocks will not be permitted to forward incorporate by reference into a Form S-1. In addition, the ability to forward incorporate by reference will be conditioned on the smaller reporting company making its incorporated Exchange Act reports and other materials readily available and accessible on a Web site maintained by or for the issuer and disclosing in the prospectus that such materials will be provided upon request.

    15 General Instruction VII to Form S-1 sets forth the eligibility requirements for incorporation by reference.

    16 Currently, forward incorporation by reference is not permitted for any issuers on Form S-1.

    Finally, we are making a conforming change to Item 512(a) of Regulation S-K to provide for forward incorporation by reference of Exchange Act reports filed or furnished after the effective date of the registration statement on Form S-1.17 Our revised forms will be effective for disclosure made on or after January 19, 2016.18

    17 The undertakings in Item 512(b) of Regulation S-K will also be required in Form S-1 registration statements filed by smaller reporting companies that use forward incorporation by reference.

    18 The amendments being adopted today apply to emerging growth companies omitting financial information from Form S-1 or Form F-1 and to smaller reporting companies using forward incorporation by reference in Form S-1. The staff will consider whether the amendments discussed in this release should be made available to a larger group of registrants, and for additional form types. Any future rulemaking proposal that may stem from the staff's consideration would be subject to notice and public comment.

    II. Request for Comment

    We invite comment on whether the interim final rules should be extended to other registrants or forms. In addition, we request and encourage any interested person to submit comments on any aspect of our interim final rules, other matters that might have an impact on the rules, and any suggestions for additional changes. With respect to any comments, we note that they are of greatest assistance if accompanied by supporting data and analysis of the issues addressed in those comments.

    III. Procedural and Other Matters

    Under the Administrative Procedure Act (“APA”), a notice of proposed rulemaking is not required when the agency, for good cause, finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest.19 Because these amendments merely conform the specified forms to the requirements of a newly enacted statute, the FAST Act, the Commission finds that notice and public comment are unnecessary.20 These amendments revise the Commission's forms to make them consistent with the provisions of the FAST Act pertaining to simplified disclosure requirements for emerging growth companies and forward incorporation by reference for smaller reporting companies on Form S-1 and therefore do not involve the exercise of Commission discretion.

    19 5 U.S.C. 553(b).

    20 This finding also satisfies the requirements of 5 U.S.C. 808(2), allowing the rule amendment to become effective notwithstanding the requirement of 5 U.S.C. 801 (if a federal agency finds that notice and public comment are impractical, unnecessary or contrary to the public interest, a rule shall take effect at such time as the federal agency promulgating the rule determines). The amendments also do not require analysis under the Regulatory Flexibility Act. See 5 U.S.C. 604(a) (requiring a final regulatory flexibility analysis only for rules required by the APA or other law to undergo notice and comment).

    The APA generally requires publication of a rule at least 30 days before its effective date.21 The Commission finds there is good cause for the amendments to take effect on January 19, 2016 because without the amendments the Commission's applicable forms do not conform to the requirements of Section 102 of the JOBS Act, as amended by Section 71003 of the FAST Act and Section 84001 of the FAST Act.22 Additionally, the Commission finds that the amendments relieve restrictions in the Commission's forms.

    21See 5 U.S.C. 553(d)(3).

    22 Section 71003 of the FAST Act takes effect 30 days after enactment, and Section 84001 of the FAST Act requires the Commission to revise Form S-1 within 45 days of enactment.

    The amendments to Form S-1, Form F-1, and Item 512 of Regulation S-K will have an effect on existing “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995.23 We estimate the total annual decrease in the paperwork burden for all affected companies to comply with the collection of information requirements in these amendments is approximately 70,214 hours of company personnel time and approximately $84,256,400 for the services of outside professionals.24

    23 44 U.S.C. 3501 et seq.

    24 We are seeking emergency approval from the Office of Management and Budget for the revised burden estimates associated with the final rule amendments to Forms S-1 and F-1 in accordance with the procedures of the Paperwork Reduction Act of 1995. In a separate notice, we are seeking public comment on the revised burden estimates as well as a three-year extension of the same collections of information.

    IV. Economic Analysis

    We are mindful of the costs imposed by and the benefits obtained from our rules and amendments.25 The Commission is adopting amendments to implement the specific statutory mandates of Sections 71003 and 84001 of the FAST Act. Accordingly, the costs and benefits of these amendments stem entirely from the statutory mandates of Sections 71003 and 84001.26

    25 Section 2(b) of the Securities Act [15 U.S.C. 77b(b)] requires the Commission, when engaging in rulemaking where it is required to consider or determine whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action will promote efficiency, competition and capital formation.

    26 As the intent of this rulemaking is to implement the specific regulatory changes mandated by Congress, this analysis focuses on the economic effects arising from those changes. We recognize that these amendments could be made available to a larger group of registrants, and for additional form types. However, such discretionary amendments would be beyond the scope of this rulemaking. See supra note 18.

    A. Baseline

    The baseline for our economic analysis is the filing requirements prior to passage of the FAST Act and the amendments being adopted today. The amendments will impact disclosure requirements for emerging growth companies (“EGCs”) that file Forms S-1 and F-1 and smaller reporting companies (“SRCs”) that file Form S-1 for conducting a registered public securities offering and elect to use forward incorporation by reference. Investors who rely on issuer disclosures for making investment decisions will also be affected by the amendments mandated by Sections 71003 and 84001 of the FAST Act.

    Prior to the effectiveness of Section 71003, EGCs were required, when filing or submitting Form S-1 or Form F-1 with the Commission prior to an initial public offering (“IPO”), to provide all financial statements for historical periods required by Regulation S-X at the time of the filing or submission, even though information for some historical periods may not be required to be included in the prospectus contained in the registration statement at the time of the contemplated offering. For example, prior to the effectiveness of Section 71003, an EGC that intended to conduct an IPO during early 2016 and that submitted or filed its registration statement in December 2015 would need to include audited financial statements for 2013 and 2014 in that registration statement to comply with the rules, even though at the time the issuer intended to market the offering only 2014 and 2015 audited financial statements would be required.

    The amendment pursuant to Section 71003 of the FAST Act will impact Form S-1 and F-1 filings and draft registration statement submissions by domestic and foreign EGCs that conduct initial public offerings. An analysis of EDGAR filings indicates that 504 EGCs filed Form S-1 for an IPO during calendar year 2014, compared to 363 EGCs that filed a Form S-1 during calendar year 2015, through December 28th. The number of Form F-1 filings for an IPO by EGCs totaled 65 and 51 for calendar years 2014 and 2015, respectively (Table 1).27 Additionally, 299 and 133 EGCs submitted a draft registration statement during 2014 and 2015, respectively, for confidential Commission review.28

    27 The Commission staff derived these estimates by analyzing filings made with the Commission during calendar years. Data for 2015 is for the period January 1 to December 28, 2015. The Forms S-1 and F-1 filings include filings for offerings that were later withdrawn or abandoned. Until October 2012, a significant number of EGCs submitted draft registration statements through email and as a result are not included in EDGAR filings for that year.

    28 Some of the issuers that submitted a draft registration statement may have also filed a Form S-1 or F-1.

    Table 1—EGCs Submissions of Draft Registration Statements, and Filings of Forms S-1 and F-1 for Initial Public Offerings, 2012-2015 Number of EGCs submitting draft registration
  • statement
  • Number of EGCs filing Form S-1 Number of EGCs filing Form F-1
    2012 41 295 25 2013 231 404 31 2014 299 504 65 2015 133 363 51

    Currently, forward incorporation by reference is not permitted for any issuers on Form S-1,29 and issuers are required to file a post-effective amendment to disclose material information, including updates required as a result of Section 10(a)(3) of the Securities Act,30 that may have occurred prior to the completion of the offering. Forward incorporation by reference is available under Form S-3,31 the short-form registration statement for a follow-on offering, but only issuers that meet specific registrant and transaction requirements can utilize that form. Because many SRCs are ineligible to use Form S-3, they are required to use Form S-1 for conducting a registered securities offering.32 As Table 2 presents, approximately 448 SRCs filed Form S-1 for conducting a follow-on offering while 150 SRCs filed Form S-3 during calendar year 2014.33

    29 Forward incorporation by reference allows an issuer to automatically incorporate by reference reports filed pursuant to the Exchange Act, such as reports on Forms 10-K, 10-Q and 8-K, subsequent to the effectiveness of the registration statement.

    30 15 U.S.C. 77j(a)(3). When a prospectus is used more than nine months after the effective date of the registration statement, the information contained therein cannot be dated more than sixteen months prior to such use.

    31 17 CFR 239.13.

    32 SRCs may be eligible to use Form S-3 for secondary offerings if the securities are listed on a national securities exchange or are quoted on the automated quotation system of a national securities association. See Instruction I.B.3 of Form S-3. In addition, SRCs may be eligible to use Form S-3 for limited primary offerings if the SRC has at least one class of common equity securities listed on a national securities exchange. See Instruction I.B.6. of Form S-3.

    33 The Commission staff derived these estimates by analyzing filings made with the Commission during calendar years. SRCs status was determined based on the filer status checked on the cover page of Form 10-K filed during the year.

    Table 2—SRC Filings of Forms S-1 and S-3 for Follow-on Offerings, 2012-2015 Number of Form 10-Ks indicating SRC status Number of SRCs filing Form S-1 Number of SRCs filing Form S-3 2012 4,062 394 106 2013 3,773 432 116 2014 3,508 448 150 2015 3,107 269 112

    The amendment pursuant to Section 84001 of the FAST Act will impact the number and disclosure content of post-effective amendments filed by eligible SRCs. Analysis of EDGAR filings indicates that approximately 204 SRCs filed 379 post-effective amendments during 2014, while another 217 filed 404 such amendments during calendar year 2015, through December 15th.34 Some SRCs could have avoided at least some post-effective amendment filings if forward incorporation had been available.

    34 Some of these filings may relate to non-Section 10(a)(3) updates, such as for deregistering securities. These filings will not be affected by an SRC's new ability to forward incorporate by reference. Additionally, some filings may comprise Section 10(a)(3) updates, as well as updates that will continue to be required as post-effective amendments.

    B. Analysis of the Amendments

    The statutory change to Section 102 of the JOBS Act and the corresponding amendment to our forms pursuant to Section 71003 of the FAST Act allow EGCs to omit certain historical financial statements required under Regulation S-X from their pre-initial public offering registration statement, which simplifies and reduces disclosure requirements for those EGCs. As Table 1 shows, up to 569 EGCs filing Form S-1 or F-1 and 299 EGCs submitting draft registration statements during calendar year 2014 could possibly have benefitted from such scaled down disclosure requirements. These amendments to the statute and our forms will ease the filing requirements for EGCs, which could promote small business capital formation through initial public offerings.

    The amendments that implement Section 71003 will enable EGCs to provide only information that they reasonably expect will be required at the time they are marketing their initial public offerings. This will lower the regulatory burden and thereby reduce the registration costs for EGCs. The amendments may also shorten the time necessary to complete the initial registration statement of an IPO, which could improve an issuer's ability to raise capital in a timely manner. To the extent issuers have sensitive material in their historical financial information, the amendments may also enable EGCs to protect their competitive position by not publicly disseminating information beyond what is required when the securities offering is conducted.35 Such benefits are more likely to accrue to EGCs that have higher proprietary costs of disclosure.36

    35 For example, R&D-intensive firms may have competitive incentives to provide limited disclosure about their R&D investments, material agreements or acquisitions in previous years.

    36See Jesse Ellis, C. Edward Fee & Shawn Thomas, Proprietary Costs and the Disclosure of Information about Customers, 50 J. ACCT. RES. 685-727 (2012).

    At the same time, the amendments may reduce the amount and quality of public information, thereby potentially increasing the level of information asymmetry and adversely impacting the informational efficiency of the securities market.37 As a result, investors could become more risk averse and require a higher rate of return to compensate for such loss in disclosure. This would lower the amount of potential issuer proceeds, which would offset the lower disclosure costs stemming from the simplified disclosure requirements.38 We believe, however, that the amendment's potential adverse impact on investors would be marginal because such omitted financial information is not expected to be used by issuers in marketing their offering and also because investors will have access to more recent and updated information.

    37 Market participants also can obtain information from Commission staff comment letters (publicly available after the IPO) sent in connection with the staff's review of a draft or filed registration statement. To the extent the lower level of disclosure affects the information content of Commission staff comment letters, the post-IPO liquidity and stock price volatility outcomes of EGCs could also be impacted.

    38See Susan Chaplinsky, Kathleen Weiss Hanley & S. Katie Moon, The JOBS Act and the Costs of Going Public (Working Paper, Oct. 2015), available at http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2492241.

    The amendment pursuant to Section 84001 of the FAST Act to permit forward incorporation by reference by SRCs in Form S-1 will further integrate disclosures under the Securities Act and the Exchange Act and increase regulatory simplification. Forward incorporation by reference will eliminate the need to update information in a filing that has become stale or is incomplete. The amendment should decrease the existing filing burdens by reducing multiple disclosure filings, thereby allowing SRCs to satisfy Form S-1 disclosure requirements and access capital markets at a lower cost. As discussed above, during 2014 almost half of the SRCs that filed a Form S-1 also filed a post-effective amendment to update information in that form. In addition to the reduced audit and legal costs of not having to file post-effective amendments, cost savings could also result from lower printing and delivery costs for a smaller sized prospectus. Such reduction in costs could be offset, to some extent, by ongoing costs related to the issuer's new obligations to make the incorporated Exchange Act reports and other materials readily available and accessible to investors on a Web site maintained by or for the issuer, or provided upon request.

    The revision to Form S-1 will make its requirements more consistent with those of Form S-3, which will particularly benefit SRCs that cannot use Form S-3 and have to rely on the longer Form S-1 to register their securities offering. The amendment will be most effective for continuous offerings, and those involving resales of securities, that often require repeated informational updates. By avoiding the need to file certain post-effective amendments, SRCs may be able to move quickly to raise capital when a `market window' is open. Easing the filing burden for such issuers may promote efficiency in SRC capital formation.

    At the same time, revising Form S-1 to allow SRCs to forward incorporate by reference could increase the analytical burden and search costs for potential investors. Instead of having all the information available in one location, investors may need to separately access on a Web site or request the incorporated reports in order to price the offering security. As a result, costs to investors for assembling and assimilating necessary information could increase. We do not have data to assess if, and to what extent, the Form S-1 revision will be burdensome to investors. To the extent that investors previously benefitted from the Commission staff's selective review of post-effective amendment filings, allowing forward incorporation by reference may eliminate such reviews and, as a result, possibly increase the costs to investors.

    As discussed above, the same eligibility requirements that currently apply to any issuer to use historical incorporation by reference on Form S-1 will apply to forward incorporation by reference by SRCs. Using these well-established eligibility requirements should provide certainty to issuers and investors about when forward incorporation by reference may be used. Requiring the SRCs to be current in their filing requirements will ensure that only issuers with a demonstrated ability to comply with Exchange Act reporting requirements are eligible to forward incorporate by reference, which will help to address concerns about investors being able to readily procure updated information through Exchange Act filings that would otherwise have been available through a post-effective amendment.

    V. Statutory Basis

    The amendments described in this release are made under the authority set forth in Sections 6, 7, 8, 10, and 19 of the Securities Act, Section 102 of the JOBS Act and Sections 71003 and 84001 of the FAST Act.

    List of Subjects in 17 CFR Parts 229 and 239

    Reporting and recordkeeping requirements, Securities.

    In accordance with the foregoing, the Commission is amending Title 17, Chapter II of the Code of Federal Regulations as follows:

    PART 229—STANDARD INSTRUCTIONS FOR FILING FORMS UNDER SECURITIES ACT OF 1933, SECURITIES EXCHANGE ACT OF 1934 AND ENERGY POLICY AND CONSERVATION ACT OF 1975—REGULATION S-K 1. The authority citation for part 229 is revised to read as follows: Authority:

    15 U.S.C. 77e, 77f, 77g, 77h, 77j, 77k, 77s, 77z-2, 77z-3, 77aa(25), 77aa(26), 77ddd, 77eee, 77ggg, 77hhh, 77iii, 77jjj, 77nnn, 77sss, 78c, 78i, 78j, 78j-3, 78l, 78m, 78n, 78n-1, 78o, 78u-5, 78w, 78ll, 78 mm, 80a-8, 80a-9, 80a-20, 80a-29, 80a-30, 80a-31(c), 80a-37, 80a-38(a), 80a-39, 80b-11 and 7201 et seq. 18 U.S.C. 1350; Sec. 953(b), Pub. L. 111-203, 124 Stat. 1904; Sec. 102(a)(3), Pub. L. 112-106, 126 Stat. 309; and Sec. 84001, Pub. L. 114-94, 129 Stat. 1312.

    2. Section 229.512 is amended by revising paragraph (a)(1)(iii)(B) to read as follows:
    § 229.512 (Item 512) Undertakings.

    (a) * * *

    (1) * * *

    (iii) * * *

    (B) Paragraphs (a)(1)(i), (ii), and (iii) of this section do not apply if the registration statement is on Form S-1 (§ 239.11 of this chapter), Form S-3 (§ 239.13 of this chapter), Form SF-3 (§ 239.45 of this chapter) or Form F-3 (§ 239.33 of this chapter) and the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)) that are incorporated by reference in the registration statement, or, as to a registration statement on Form S-3, Form SF-3 or Form F-3, is contained in a form of prospectus filed pursuant to § 230.424(b) of this chapter that is part of the registration statement.

    PART 239—FORMS PRESCRIBED UNDER THE SECURITIES ACT OF 1933 3. The general authority citation for part 239 is revised to read as follows: Authority:

    15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3, 77sss, 78c, 78l, 78m, 78n, 78o(d), 78o-7 note, 78u-5, 78w(a), 78ll, 78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a-13, 80a-24, 80a-26, 80a-29, 80a-30, 80a-37, and Sec. 71003 and Sec. 84001, Pub. L. 114-94, 129 Stat. 1312, unless otherwise noted.

    4. Form S-1 (referenced in § 239.11) is amended by adding General Instructions II.C., re-designating paragraph (b) to Item 12 as paragraph (c), re-designating the Note to Item 12(b)(1) as the Note to Item 12(c)(1), and adding new paragraph (b) to Item 12 to read as follows: Note:

    The text of Form S-1 does not, and this amendment will not, appear in the Code of Federal Regulations.

    Form S-1 Registration Statement Under the Securities Act of 1933 General Instructions II. Application of General Rules and Regulations

    C. A registration statement filed (or submitted for confidential review) under Section 6 of the Securities Act (15 U.S.C. 77f) by an emerging growth company, defined in Section 2(a)(19) of the Securities Act (15 U.S.C. 77b(a)(19)), prior to an initial public offering may omit financial information for historical periods otherwise required by Regulation S-X (17 CFR part 210) as of the time of filing (or confidential submission) of the registration statement, provided that:

    1. The omitted financial information relates to a historical period that the registrant reasonably believes will not be required to be included in this Form at the time of the contemplated offering; and

    2. Prior to the registrant distributing a preliminary prospectus to investors, the registration statement is amended to include all financial information required by Regulation S-X at the date of the amendment.

    Item 12. Incorporation of Certain Information by Reference

    (b) In addition to the incorporation by reference permitted pursuant to paragraph (a) of this Item, a smaller reporting company, as defined in Rule 405 (17 CFR 230.405), may elect to incorporate by reference information filed after the effective date of the registration statement. A smaller reporting company making this election must state in the prospectus contained in the registration statement that all documents subsequently filed by the registrant pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, prior to the termination of the offering shall be deemed to be incorporated by reference into the prospectus.

    5. Form F-1 (referenced in § 239.31) is amended by adding General Instruction II.E. to read as follows: Note:

    The text of Form F-1 does not, and this amendment will not, appear in the Code of Federal Regulations.

    Form F-1 Registration Statement Under the Securities Act of 1933 General Instructions

    II. * * *

    E. A registration statement filed (or submitted for confidential review) under Section 6 of the Securities Act (15 U.S.C. 77f) by an emerging growth company, defined in Section 2(a)(19) of the Securities Act (15 U.S.C. 77b(a)(19)), prior to an initial public offering may omit financial information for historical periods otherwise required by Regulation S-X (17 CFR part 210) and Item 8.A. of Form 20-F (17 CFR 249.220f) as of the time of filing (or confidential submission) of the registration statement, provided that:

    1. The omitted financial information relates to a historical period that the registrant reasonably believes will not be required to be included in this Form at the time of the contemplated offering; and

    2. Prior to the registrant distributing a preliminary prospectus to investors, the registration statement is amended to include all financial information required by Regulation S-X at the date of the amendment.

    By the Commission.

    Dated: January 13, 2016. Brent J. Fields, Secretary.
    [FR Doc. 2016-00872 Filed 1-13-16; 4:15 pm] BILLING CODE 8011-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 381 [Docket No. RM16-2-000] Annual Update of Filing Fees AGENCY:

    Federal Energy Regulatory Commission.

    ACTION:

    Final rule; annual update of Commission filing fees.

    SUMMARY:

    In accordance with the Commission's regulations, the Commission issues this update of its filing fees. This document provides the yearly update using data in the Commission's Financial System to calculate the new fees. The purpose of updating is to adjust the fees on the basis of the Commission's costs for Fiscal Year 2015.

    DATES:

    Effective Date: February 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Raymond D. Johnson Jr., Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street NE., Room 42-66, Washington, DC 20426, 202-502-8402.

    SUPPLEMENTARY INFORMATION:

    Document Availability: In addition to publishing the full text of this document in the Federal Register, the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE., Room 2A, Washington DC 20426.

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

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

    Annual Update of Filing Fees (Issued January 12, 2016)

    The Federal Energy Regulatory Commission (Commission) is issuing this document to update filing fees that the Commission assesses for specific services and benefits provided to identifiable beneficiaries. Pursuant to 18 CFR 381.104, the Commission is establishing updated fees on the basis of the Commission's Fiscal Year 2015 costs. The adjusted fees announced in this document are effective February 18, 2016. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, that this final rule is not a major rule within the meaning of section 251 of Subtitle E of Small Business Regulatory Enforcement Fairness Act, 5 U.S.C. 804(2). The Commission is submitting this final rule to both houses of the United States Congress and to the Comptroller General of the United States.

    The new fee schedule is as follows:

    Fees Applicable to the Natural Gas Policy Act 1. Petitions for rate approval pursuant to 18 CFR 284.123(b)(2). (18 CFR 381.403) $12,430 Fees Applicable to General Activities 1. Petition for issuance of a declaratory order (except under Part I of the Federal Power Act). (18 CFR 381.302(a)) $24,980 2. Review of a Department of Energy remedial order: Amount in controversy $0-9,999. (18 CFR 381.303(b)) $100 $10,000-29,999. (18 CFR 381.303(b)) $600 $30,000 or more. (18 CFR 381.303(a)) $36,460 3. Review of a Department of Energy denial of adjustment: Amount in controversy $0-9,999. (18 CFR 381.304(b)) $100 $10,000-29,999. (18 CFR 381.304(b)) $600 $30,000 or more. (18 CFR 381.304(a)) $19,120 4. Written legal interpretations by the Office of General Counsel. (18 CFR 381.305(a)) $7,160 Fees Applicable to Natural Gas Pipelines 1. Pipeline certificate applications pursuant to 18 CFR 284.224. (18 CFR 381.207(b)) * $1,000 Fees Applicable to Cogenerators and Small Power Producers 1. Certification of qualifying status as a small power production facility. (18 CFR 381.505(a)) $21,480 2. Certification of qualifying status as a cogeneration facility. (18 CFR 381.505(a)) $24,310 * This fee has not been changed. List of Subjects in 18 CFR Part 381

    Electric power plants, Electric utilities, Natural gas, reporting and recordkeeping requirements.

    Issued: January 12, 2016. Anton C. Porter, Executive Director.

    In consideration of the foregoing, the Commission amends part 381, chapter I, title 18, Code of Federal Regulations, as set forth below.

    PART 381—FEES 1. The authority citation for part 381 continues to read as follows: Authority:

    15 U.S.C. 717-717w; 16 U.S.C. 791-828c, 2601-2645; 31 U.S.C. 9701; 42 U.S.C. 7101-7352; 49 U.S.C. 60502; 49 App. U.S.C. 1-85.

    § 381.302 [Amended]
    2. In § 381.302, paragraph (a) is amended by removing “$24,730” and adding “$24,980” in its place.
    § 381.303 [Amended]
    3. In § 381.303, paragraph (a) is amended by removing “$36,100” and adding “$36,460” in its place.
    § 381.304 [Amended]
    4. In § 381.304, paragraph (a) is amended by removing “$18,920” and adding “$19,120” in its place.
    § 381.305 [Amended]
    5. In § 381.305, paragraph (a) is amended by removing “$7,090” and adding “$7,160” in its place.
    § 381.403 [Amended]
    6. Section 381.403 is amended by removing “$12,310” and adding “$12,430” in its place.
    § 381.505 [Amended]
    7. In § 381.505, paragraph (a) is amended by removing “$21,260” and adding “$21,480” in its place and by removing “$24,070” and adding “$24,310” in its place.
    [FR Doc. 2016-00842 Filed 1-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2015-1101] RIN 1625-AA00 Safety Zone; RICHLAND, Apra Harbor/Philippine Sea, GU AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary moving safety zone for navigable waters within a 1000-yards ahead of the Dry-Dock RICHLAND and its towing vessel and 500 yards abeam and 500 yards astern of the dry-dock. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the movement of the drydock from Guam waters. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Guam.

    DATES:

    This rule is effective without actual notice from January 19, 2016 through 6:00 p.m. January 31, 2016. For the purposes of enforcement, actual notice will be used from 8:00 a.m. December 30, 2015 through January 19, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-1101 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 Chief Kristina Gauthier, Waterways Management Office, Sector Guam, U.S. Coast Guard; telephone 671-355-4866, 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 doing so would be impracticable. The final details for this removal of this dry-dock were not known to the Coast Guard until there was insufficient time remaining before the operation to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be impracticable because it would inhibit the Coast Guard's ability to protect vessels and waterway users from the hazards associated with this operation.

    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. For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable.

    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 Guam (COTP) has determined that potential hazards associated with the movement of the Dry-Dock RICHLAND starting 8:00 a.m. December 30, 2015 will be a safety concern for anyone within 1000-yards ahead of the Dry-Dock RICHLAND and its towing vessel and 500 yards abeam and 500 yards astern while transiting Guam waters. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the Dry-Dock RICHLAND and its towing vessel are in transit in Guam waters.

    IV. Discussion of the Rule

    This rule establishes a safety zone from 8:00 a.m. December 30, 2015 through 6:00 p.m. January 31, 2016. The safety zone will cover all navigable waters within 1000 yards ahead of the Dry-Dock RICHLAND and its towing vessel and 500 yards abeam and 500 yards astern while transiting Guam waters. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the Dry-Dock RICHLAND and its towing vessel are in transit. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

    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.

    This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone during the majority of this evolution which will impact a small designated area of Apra Harbor, Guam and the Philippine Sea for less than 24 hours. The transit through the mouth of the entrance to Apra Harbor will be the most restricted portion due to the limited space for maneuvering. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

    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 to be enforced for less than 24 hours that will prohibit entry within 1000 yards ahead of the Dry-Dock RICHLAND and its towing vessel and 500 yards abeam and 500 yards astern. 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.

    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, and 160.5; Department of Homeland Security Delegation No. 0170.1.

    2. Add § 165.T14-1101 to read as follows:
    § 165. T14-1101 Safety Zone; RICHLAND, Apra Harbor/Philippine Sea, GU.

    (a) Location. The following areas, within the Guam Captain of the Port (COTP) Zone (See 33 CFR 3.70-15), from the surface of the water to the ocean floor, is a moving safety zone: All navigable waters within 1000 yards ahead of the Dry-Dock RICHLAND and its towing vessel and 500 yards abeam and 500 yards astern from departure from Wharf “P” to 12 miles from Orote Point, Guam.

    (b) Effective period. This section is effective from 8 a.m. on December 30, 2015 through 6 p.m. on January 31, 2016.

    (c) Enforcement period. This section is enforced from the time the vessel departs Wharf “P” until it is 12 miles from Orote Point, Guam.

    (d) Regulations. The general regulations governing safety zones contained in § 165.23 apply. No vessels may enter or transit the safety zone unless authorized by the COTP or a designated representative thereof.

    (e) Enforcement. Any Coast Guard commissioned, warrant, or petty officer, and any other COTP representative permitted by law, may enforce these temporary safety zones.

    (f) Waiver. The COTP may waive any of the requirements of this section for any person, vessel, or class of vessel upon finding that application of the safety zone is unnecessary or impractical for the purpose of maritime security.

    (g) Penalties. Vessels or persons violating this rule are subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192.

    Dated: December 23, 2015. James B. Pruett, Captain, U.S. Coast Guard, Captain of the Port Guam.
    [FR Doc. 2016-00863 Filed 1-15-16; 8:45 am] BILLING CODE 9110-04-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 13-249; FCC 15-142] Revitalization of the AM Radio Service AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    In this document, the Commission adopted a number of procedures and procedural changes designed to assist AM broadcasters to better serve the public, thereby advancing the Commission's fundamental goals of localism, competition, and diversity in broadcast media.

    DATES:

    Effective February 18, 2016, except for the amendment to 47 CFR 73.1560, which contains new or modified information collection requirements that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), and which will become effective after the Commission publishes a document in the Federal Register announcing such approval and the relevant effective date.

    FOR FURTHER INFORMATION CONTACT:

    Peter Doyle, Chief, Media Bureau, Audio Division, (202) 418-2700 or [email protected]; Thomas Nessinger, Senior Counsel, Media Bureau, Audio Division, (202) 418-2700 or [email protected] For additional information concerning the Paperwork Reduction Act information collection requirements contained in this document, contact Cathy Williams at 202-418-2918, or via the Internet at [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a synopsis of the Commission's First Report and Order (First R&O), FCC 15-142, adopted October 21, 2015, and released October 23, 2015. The full text of the First R&O is available for inspection and copying during regular business hours in the FCC Reference Center, 445 Twelfth Street SW., Room CY-A257, Portals II, Washington, DC 20554. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Paperwork Reduction Act of 1995 Analysis

    This First Report and Order (First R&O) adopts new or revised information collection requirements, subject to the Paperwork Reduction Act of 1995 (PRA) (Pub. L. 104-13, 109 Stat 163 (1995) (codified in 44 U.S.C. 3501-3520)). These information collection requirements were submitted to the Office of Management and Budget (OMB) for review under Section 3507(d) of the PRA. The Commission received OMB preapproval for the information collection requirements on January 28, 2014. The information collection requirements were adopted as proposed. The Commission will activate the burden hours in OMB's inventory. These information collection requirements are preapproved under OMB control number 3060-1194, Section 73.1560(a)(1) and FCC Form 338. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

    Synopsis of Order

    1. With this First R&O, the Commission addresses the proposals set forth in the Notice of Proposed Rule Making in this proceeding, FCC 13-139, 28 FCC Rcd 15221 (2013) (NPRM). The Commission proposed in the NPRM to open a one-time filing window, open to AM licensees and permittees only, to apply for and receive authorizations for one new FM translator station per AM station, for the sole and limited purpose of re-broadcasting the AM signal to provide fill-in and/or nighttime service. The Commission further proposed that such translator stations must strictly comply with the existing fill-in coverage area technical restrictions on FM translators re-broadcasting AM stations, that any translator acquired through this one-time window could be used only to re-broadcast the signal of the AM station acquiring it, and that such a translator could not be assigned or transferred except in conjunction with the commonly owned AM primary station. The Commission sought comment on this proposal and its limitations. The Commission opted to continue allowing so-called “Mattoon waivers,” which allow broadcasters to relocate FM translators intended to rebroadcast AM stations farther than would be allowed under the Commission's rules for minor modifications of translator stations.

    2. Although there was strong support for the AM-only new FM translator auction filing window proposed in the NPRM, the Commission found that there are issues that call into question whether it should limit the approach to opening such a window as proposed. Chief among its concerns was the time it would take for such a window to open. Commenters in this proceeding discuss the need for immediate relief, but given other auction commitments, the Commission determined that it is not possible at this time to provide such relief in the short term with a new FM translator station auction filing window. However, it is possible to provide short-term relief to AM broadcasters by providing a window where AM stations would be provided greater flexibility to move FM translators. This window would take advantage of the availability of existing FM translators that can be obtained by many AM broadcasters seeking to enhance their local service. Based upon a staff analysis of applications available in the Media Bureau's Consolidated Data Base System (CDBS), since 2003 the number of FM translator stations has increased by 65 percent (from approximately 3,800 to approximately 6,300). This number is likely to grow in the next 12 to 18 months, as more FM translator permits are awarded from the Auction 83 filing window, to the point where there could be up to twice the number of translators that existed in 2003. Further, the secondary market for FM translator stations is robust: Since the Commission's 2009 decision to allow AM stations to be rebroadcast over FM translators, almost 4,000 translators have changed hands, of which over 600 were sold to AM stations for use as cross-service fill-in translators. A staff review of “stand alone” FM translator assignment applications granted over the past year has determined that the vast majority of stations have sold for under $100,000, and a substantial majority of those for less than $50,000. Providing AM broadcasters with a greater opportunity to benefit from this secondary market will provide them with tangible and immediate relief. Accordingly, the Commission adopted a two-pronged approach to enable more AM stations to acquire FM translators. First, the Commission directed the Media Bureau to administer in 2016 a process where an AM licensee or permittee seeking to rebroadcast on an FM translator may acquire and relocate one and only one authorized non-reserved band FM translator station up to 250 miles, and specify any rule-compliant non-reserved band FM channel, as a minor modification application. Second, the Commission directed the Media Bureau, in conjunction with the Wireless Telecommunications Bureau (Bureaus), to open new FM translator application auction windows, beginning in 2017, for AM stations that do not file a modification application in 2016. Class C and D stations will be able to take advantage of the modification window and the auction window first, prior to second windows that will be available to all classes.

    3. The Commission also asked in the NPRM whether, between expanding the number of FM translators eligible to re-broadcast AM stations and opening the window proposed in this proceeding, there would continue to be a need for so-called Mattoon waivers and, if not, when the policy of granting such waivers should be eliminated. Most commenters favored retention of Mattoon waivers, adoption of the proposed Tell City waivers and, for some cases, codifying the Mattoon waiver policy in our Rules. Although there has been and will likely continue to be an expansion of the number of FM translator stations available to rebroadcast AM stations, the decision to delay opening an exclusive AM-new FM translator window in favor of opening a modification window may limit FM translator acquisition options for some AM licensees. Because of this, some flexibility in relocating such fill-in FM translators will continue to be necessary. The Mattoon waiver policy requires satisfaction of three criteria: (1) The applicant does not have a history of filing serial minor modification applications; (2) the proposed site is mutually exclusive with the licensed translator facility; and (3) the translator will rebroadcast the proposed AM primary station for a period of four years of on-air operation, exclusive of silent periods, commencing with the initiation of on-air service at the new location. Under the circumstances, the Commission directed the Media Bureau to continue granting Mattoon waivers, including the four-year operating condition, in appropriate cases. Until and unless a different procedure is announced on review of the pending Tell City waiver case (Way Media, Inc., Letter, 29 FCC Rcd 11287, 11287 (MB 2014), review pending), however, the Mattoon waiver policy will not be extended beyond its current limits as described above, including as proposed by the Tell City applicant, except as discussed below for the limited purpose of the modification window adopted in this First R&O.

    4. Although the availability of existing and to-be-authorized FM translator stations and the use of Mattoon waivers should provide an ample supply of translators for fill-in use by many AM stations, the Commission recognized that the availability of such translator stations may not, in many cases, completely satisfy demand. Some AM broadcasters might enjoy a sufficient supply of translators that conform with Commission siting rules, while others may have more difficulty in locating potentially rule-compliant translators. Still other AM broadcasters, particularly those whose stations have limited power (Class C) or lack protected nighttime service (Class D), might need additional time to arrange the financing necessary to enter the market for an FM translator station. For this reason, the Commission directed the Media Bureau to announce, by Public Notice, two modification windows during which an AM licensee or permittee seeking to rebroadcast on an FM translator may, on a first-come, first-served basis, acquire and relocate one and only one authorized non-reserved band FM translator station up to 250 miles, and specify any rule-compliant non-reserved band FM channel, as a minor modification application, notwithstanding 47 CFR 74.1233(a)(1), which defines major and minor modifications of FM translator facilities. This distance limitation is designed to substantially expand purchase options for AM stations, particularly those serving smaller markets and rural areas. It is also designed to not disrupt the current secondary market for translator authorizations.1 In this regard the Commission noted that spectrum congestion in the largest markets will significantly limit opportunities for translator station relocations. The Commission will accept applications to modify authorized FM translator stations that the AM station licensee or permittee either owns, for which it is the proposed assignee or transferee in a pending application (a proposed assignee or transferee may file in its own name an application to modify the subject translator authorization. See 47 CFR 73.3517(a)), or for which it has a rebroadcasting agreement. The Commission further directed the Bureau to open the first modification window for six months, and to make the first window available only to applications to modify and/or relocate FM translator stations rebroadcasting Class C and D AM stations, on a one translator per AM station basis. Class C and D stations, because of their limited power or lack of protected nighttime service, will benefit most from the acquisition of a cross-service translator, and thus should be afforded the first opportunity to obtain one. The second window, to open at the end of the initial six-month window, would be open for an additional three-month period, and would be available to applications to modify and/or relocate FM translator stations rebroadcasting any AM station of any class, including Class C and D stations that did not file an application in the initial window, also on a one translator per AM station basis. In return for this one-time rule waiver, the Media Bureau was directed to impose on translators relocated and/or modified using the waiver the same four-year operating condition currently attached to FM translators relocated using Mattoon waivers. Thus, the modified FM translator must rebroadcast the FM translator modification applicant's specified AM primary station for a period of four years of on-air operation, exclusive of silent periods, commencing with the initiation of on-air service at the new location. The Commission also directed the Media Bureau to expeditiously initiate a three-month outreach effort to promote Class C and Class D participation in this modification window filing process; to develop, as practicable, technical tools similar to those created for the LPFM window to assess spectrum availability and potential FM translator acquisition options; and to establish streamlined procedures for handling inquiries from the AM and FM translator broadcast community. The modification windows are to be opened upon completion of this outreach.2

    1 A substantial majority of the approximately 1300 outstanding Auction 83 construction permits are scheduled to expire in 2016. Modification applicants in one of these two modification windows may seek waivers of these construction deadlines. See 47 CFR 1.3. Waivers can expand cross-service broadcasting opportunities for AM stations, will allow AM licensees to realize service improvements quickly, will incentivize FM translator permittee participation in the modification window process, and will provide a means to avoid the delays and administrative burdens of re-auctioning this spectrum. Accordingly, the Commission found that a waiver of an Auction 83 FM translator construction deadline is presumptively in the public interest for applicants participating in one of the modification windows, provided that the AM station licensee proposing to use the FM translator for rebroadcasting its AM station commits to prompt FM translator station construction and initiation of broadcast operations.

    2 The pending Tell City waiver request could likely qualify for processing under the waiver procedures announced herein. However, in order to promote a fair process for all AM stations in reallocating FM translator spectrum, including to spectrum limited markets, the Commission will not afford that proposal cut-off rights over other filings. The Commission also directed the Media Bureau to dismiss, without further consideration, waiver requests filed prior to and in anticipation of the opening of the modification application filing windows.

    5. The modification windows, as noted above, can provide near-term relief to AM broadcasters. However, some AM stations may not be successful in locating translators, notwithstanding the availability of rule-compliant FM translator channels in their communities. Therefore, to further promote the long-term viability of the AM service, the Commission also directed the Bureaus to open two new FM translator application auction windows, beginning in 2017,3 for those AM licensees and permittees that do not participate, i.e., file an application, in one of the modification windows.4 The first FM translator auction window, as with the initial modification window, shall be limited to Class C and D AM permittees and licensees that have not participated in either modification window. The second FM translator auction window, to be opened as soon as possible after the first window has closed and applicants in the first window have had an opportunity to resolve mutual exclusivity through settlement or technical resolution, will be open to all AM permittees and licensees that have not participated in any of the prior modification or auction windows. The Commission believed that the threshold qualification of affording relief first to Class C and D stations, with limited power or no protected nighttime service, represented the best approach among the many proposed by commenters. The FM translator auction windows will otherwise follow the NPRM proposal, insofar as participation will be limited to AM permittees and licensees, each applicant may apply for one and only one translator station that must comply with Commission siting rules for FM fill-in translators rebroadcasting AM stations, and any translator acquired through the FM translator auction windows will be permanently linked to the AM primary station acquiring it. See NPRM, 28 FCC Rcd at 15227. Just as in FM Translator Auction 83, these new FM translator auction windows will include opportunities for mutually exclusive applicants to resolve their mutual exclusivity through settlements or technical resolutions. See FM Translator Auction 83 Mutually Exclusive Applications Subject to Auction, Public Notice, 28 FCC Rcd 9716 (MB 2013); 47 CFR 73.5002(c), (d).

    3 In order to ensure the efficient processing of these auction applications, the Commission directed the Bureaus to undertake and complete all revisions to Form 175 necessary to collect the FM translator technical specifications, and also directed the Bureaus to hold an auction for all remaining mutually exclusive commercial Auction 83 applications following the completion of the Incentive Auction, Auction 1000, and prior to the first FM translator auction window.

    4 The NPRM proposed a “one-to-a-customer” FM translator window to provide limited, targeted relief to AM stations. See NPRM, 28 FCC Rcd at 15228. Thus, the Commission declined to permit one class of eligible applicants to double the number of FM translator authorizations that they could acquire under these window procedures. Given the supply of translator authorizations, the palpable demand for FM translator licensees by other stakeholders, and the relief afforded by the modification windows, AM licensees and permittees will be eligible to participate in either one modification or one auction window, but not both. AM station assignments or transfers during the multi-window process will not create an opportunity for new owners to participate in an auction window when the former licensee participated in a modification window.

    6. The Commission also adopted the NPRM proposal to modify the daytime community coverage requirement contained in 47 CFR 73.24(i), for existing licensed AM facilities only, to require that the daytime 5 mV/m contour encompasses either 50 percent of the area, or 50 percent of the population of the principal community to be served. This rule modification is intended to provide relief to existing broadcasters—some of which have held AM licenses for many decades—that may find themselves lacking the flexibility to relocate their transmission facilities in order to meet the rule's community coverage requirements, due to expansion of community boundaries and/or lack of available land to which to relocate antennas. However, in order to preserve the limited intent of this rule modification, the Commission authorized the Media Bureau to inquire into the facts justifying any modification that would reduce the percentage of community population or area coverage within the first four years of licensed on-air operation of the applicant station, exclusive of any periods of reduced operations or silence pursuant to special temporary authorizations. Should the Bureau find there is no compelling reason warranting reduced community coverage during this period, it may dismiss the modification application.

    7. Likewise, the Commission adopted the NPRM proposal to eliminate the nighttime community coverage requirement for existing licensed AM stations, and modify the nighttime community coverage requirement in 47 CFR 73.24(i) to require that applicants for new AM stations and those AM stations seeking a change to their communities of license cover either 50 percent of the population or 50 percent of the area of the communities of license with a nighttime 5 mV/m signal or a nighttime interference-free contour, whichever value is higher. It declined to eliminate completely nighttime community of license coverage requirements for new AM stations and those changing community of license, as well as for permittees of unbuilt stations seeking to modify their authorizations, in the interest of striking the appropriate balance between the need to provide relief to AM broadcasters with few siting options (amplified by the added complexity of AM nighttime skywave signal propagation and concomitant signal restrictions), and the need to provide the community of license with some kind of service at night. As with the change to daytime community coverage requirements, the Commission instructed the Media Bureau to examine closely any request by a station to reduce nighttime community coverage during its first four years of licensed on-air operation, and granted the Bureau discretion to dismiss any such application absent a compelling reason warranting reduced nighttime service.

    8. The Commission proposed in the NPRM to delete the so-called “ratchet rule,” which effectively requires that a Class A or B AM broadcaster, seeking to make facility changes that modify its AM signal, demonstrate that the improvements will result in an overall reduction in the amount of skywave interference that it causes to certain other AM stations (primarily by “ratcheting back” radiation in the direction of certain other AM stations). 47 CFR 73.182(q) n.1. Two engineering firms filed a 2009 petition to eliminate the ratchet rule, contending that the rule's practical effect was to discourage station improvements, because compliance with the rule more often than not required the modifying station to reduce power to the point that net nighttime interference-free (NIF) service was reduced. Most commenters supported this proposal. Accordingly, the Commission deleted the ratchet rule, as proposed in the NPRM, agreeing with the commenters that confirmed the rule's negative consequences recited in the NPRM, as well as with long- and short-term benefits identified by commenters, including cost reduction to AM broadcasters making station improvements, economic benefits to local AM stations and their communities served through expanded nighttime broadcasting and consequent expansion to local advertising platforms, and the ability of communities served by AM stations affected by the ratchet rule to receive information concerning local events, or emergencies at night, among others.

    9. In the NPRM, the Commission also proposed modifications to the rules affecting AM stations using Modulation Dependent Carrier Level (MDCL) control technologies. MDCL control technologies vary either the carrier or the carrier and sideband power levels as a function of the modulation level, thus allowing the licensee to reduce transmitter power consumption while maintaining audio quality and signal coverage. Both basic types of MDCL control technologies and various systems reduce the station's antenna input power to levels not permitted by 47 CFR 73.1560(a). The Commission proposed to: (1) Amend 47 CFR 73.1560(a) of the Rules to provide that an AM station may commence MDCL control operation without prior Commission authority, provided that the AM station licensee notifies the Commission of the station's MDCL control operation within 10 days after commencement of such operation using the Media Bureau's Consolidated Database System (CDBS) Electronic Filing System; (2) require, regardless of the MDCL control technology employed, that the AM station's transmitter must achieve full licensed power at some audio input level, or when the MDCL control technology is disabled; and (3) require an AM station using MDCL control technology to disable it before field strength measurements on the station are taken by the licensee or others. Most commenters supported these proposals, although some noted that MDCL control technologies generally benefit only those AM stations using newer transmitters, which are the only ones with which MDCL control technologies are compatible. The Commission adopted the proposals as set forth in the NPRM. AM stations must electronically notify the Media Bureau of the station's MDCL control operation within 10 days after commencement of such operation using FCC Form 338—AM Station MDCL Notification, available in the CDBS Electronic Filing System. The Commission declined to impose additional requirements regarding certification of third-party MDCL products, or any other rule changes with regard to MDCL operation. The Commission continues to hold broadcasters responsible for their signals, and for any interference resulting from those signals (interference that has not to this point been reported from those broadcasters currently employing MDCL control technologies). The Commission stated it would revisit this position if interference from third-party MDCL products were to become a problem, but noted that it would be up to the broadcaster employing such a product to remedy the situation should interference arise.

    10. In the NPRM the Commission discussed a proposal by the Multicultural Media, Telecom, and Internet Council (MMTC), in which MMTC argued for the elimination of the Commission's minimum efficiency standards for AM transmission systems (found in 47 CFR 73.182 and 73.189), replacing them with a “minimum radiation” standard. In MMTC's view, the minimum efficiency standards hindered AM broadcasters, because they require a certain height antenna and length of ground radials for a station at a given frequency, causing difficulties in finding compliant sites for towers and ground systems. MMTC argued that an AM broadcaster should be able to use a less efficient—but also less space-intensive—transmission system, driving the system with more power to offset the lack of efficiency. The Commission observed in the NPRM that MMTC's proposal lacked specifics as to the appropriate replacement “minimum radiation” standard, noting that the Rules contained similar provisions for applicants seeking to avoid the minimum antenna efficiency standards. The Commission also stated that it did not believe the record was sufficiently developed to propose wholesale rule changes to the minimum antenna efficiency standards. In order to provide some relief to AM broadcasters finding it increasingly difficult to locate rule-compliant antenna sites, however, the Commission proposed to reduce the AM antenna efficiency standards by 25 percent. The Commission also encouraged commenters to provide specifics as to any proposed replacement or alternative standard for AM transmission systems. Commenters, for the most part, expressed support for relaxing the AM efficiency standards, but did not provide the specificity requested in the NPRM. Additionally, several commenters offered cautions regarding potential problems with shorter, less efficient radiators, including decreased signal stability and increased skywave interference. The Commission therefore adopted the proposal as set forth in the NPRM, reducing the existing AM antenna efficiency standards by 25 percent as a means to provide relief to AM broadcasters. The Commission did, however, agree with some commenters who suggested that it should collect more real-world data on alternative and less-efficient AM transmission systems. Accordingly, the Commission also directed the Media Bureau to entertain requests by existing AM broadcasters for experimental authorizations to operate with antenna systems that do not meet the modified antenna efficiency rules, provided that they can establish that such operation will not increase interference to other domestic or international AM stations and can demonstrate the stability of such systems. Such applications may be made by informal application pursuant to 47 CFR 5.203, and shall be subject to the monitoring and reporting requirements in that section and such other conditions as the Media Bureau may require.

    Final Regulatory Flexibility Analysis

    11. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), 5 U.S.C. 603, an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the NPRM to this proceeding (24 FCC Rcd 5239 (2009)). The Commission sought written public comment on the proposals in the NPRM, including comment on the IRFA. The Commission received no comments on the IRFA. This Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA (5 U.S.C. 604).

    Need for, and Objectives of, the First Report and Order

    12. This First Report and Order (First R&O) adopts changes to certain technical rules and processes relating to the AM broadcast radio service. In the First R&O, the Commission modified daytime and nighttime community coverage requirements for certain AM stations; eliminated the so-called AM Ratchet Rule; adopted a new form notification procedure for stations implementing Modulation Dependent Carrier Level Control Technologies; and modified the rules relating to AM antenna system efficiency.

    13. In the First R&O, the Commission addressed issues raised in the NPRM. The Commission, in the NPRM, explained that it had not done a comprehensive review of the AM service in almost 25 years. Moreover, in the years since the last comprehensive review of the AM service, listenership had declined due to several factors, including: The introduction of new media with higher audio fidelity, such as CDs, digital media players, and FM digital radio; increased interference among AM stations; and increased interference from non-broadcast sources, such as computers, LED light bulbs, power supplies, and utility lines. Based in part on separate pleadings and petitions for rule making filed by stakeholders, the Commission in the NPRM outlined six proposals designed to offer assistance to AM broadcasters in light of the various difficulties surrounding the AM service.

    14. After considering the comments filed in response to the NPRM, the Commission determined that there were impediments to the immediate opening of a filing window limited to AM licensees and permittees wishing to obtain FM translator stations, including the time it would take to open such a window, and the wide availability of FM translator stations including the number expected to be authorized in the near future. It concluded that the correct approach, to offer near-term relief to AM broadcasters, was to open two windows allowing the modification and/or relocation of FM translators to rebroadcast AM stations. These windows would be preceded by a three-month period of outreach by the Media Bureau to AM stations with limited power and/or no protected nighttime service (Class C and D stations). Following this period of outreach, the Media Bureau will open a six-month window in which an AM station seeking to rebroadcast on an FM translator may, on a first-come, first-served basis, apply to acquire and relocate one and only one authorized non-reserved band FM translator station up to 250 miles, and specify any rule-compliant non-reserved band FM channel, as a minor modification application notwithstanding 47 CFR 74.1233(a)(1), which defines major and minor modifications of FM translators. This first modification window will be available only to applications to modify and/or relocate an FM translator station rebroadcasting a Class C or D AM station, on a one translator per AM station basis. The first modification window will be followed by a second, three-month modification window, open for applications to modify and/or relocate an FM translator rebroadcasting any AM station of any class, including a Class C or D station that did not participate (i.e., file an application) in the initial modification window, also on a one translator per AM station basis. FM translator stations modified and/or relocated during these modification windows will be subject to the same four-year operating condition currently attached to FM translators relocated using Mattoon waivers.

    15. To further promote the long-term viability of the AM service, the Commission also directed the Bureaus to open, in 2017 after completion of the Incentive Auction, Auction 1000, two auction windows for new FM translator stations to rebroadcast AM stations, open to AM licensees and permittees that did not file applications in either of the modification windows. As with the modification windows, the first new FM translator auction window will be limited to applications filed by licensees or permittees of Class C and D AM stations, on a one translator per station basis, that did not file applications in the modification windows. After close of the first new FM translator auction window, and after applicants in that window have had the opportunity to resolve mutual exclusivity through settlement or technical resolution, the Bureaus will open a second new FM translator auction window, which will be open to all AM licensees and permittees, of any class, that did not participate in either of the modification windows or the first auction window. The new FM translator auction windows will otherwise follow the proposal in the NPRM: Participation will be limited to AM licensees and permittees, each applicant may apply for one and only one translator station that must comply with our siting rules for FM fill-in translators rebroadcasting AM stations, and any translator acquired through the FM translator auction windows will be permanently linked to the AM primary station acquiring it. Both new FM translator auction windows will include opportunities for mutually exclusive applicants to resolve their mutual exclusivity through settlements or technical resolutions.

    16. In the NPRM, the Commission also proposed to change the daytime and nighttime community coverage requirements for AM stations. It noted that MMTC had filed a 2009 petition for rule making, which it styled a “Radio Rescue Petition,” in which among other things it sought some flexibility in transmitter siting for AM stations. MMTC's reasoning was that some existing stations were unable to comply with the requirements that an AM station place a 5 mV/m daytime signal over at least 80 percent of its community of license, and that at least 80 percent of the community of license be encompassed by either a 5 mV/m nighttime signal or an NIF signal (except in the case of Class D stations, which have no protected nighttime service). MMTC argued that, as communities grow and boundaries expand farther from an AM transmitter site, it becomes impossible for the station to comply with the community coverage rules, and further argued that scarcity of land suitable for AM transmission systems makes it difficult or impossible for such stations to find rule-compliant transmitter sites. MMTC thus suggested, and the Commission proposed, that the rule be changed to allow an existing AM station to cover only 50 percent of either the population or the area of its community of license with a 5 mV/m signal during the day, and to eliminate the community of license coverage requirement at night. Additionally, the Commission proposed to allow a new AM station or one changing its community of license to encompass only 50 percent of either the population or area of the community of license within its nighttime 5 mV/m contour or its NIF contour, whichever value is higher. Based on substantially favorable commenter support, the Commission adopted these proposals, adding the proviso that any request to utilize the new community coverage standards within the first four years of on-air operations, exclusive of any periods of reduced operation or silence, would be met with increased scrutiny and granted only upon a compelling showing.

    17. The Commission also proposed, in the NPRM, to eliminate the so-called “ratchet rule.” This rule required a Class A or B AM station proposing signal modifications to demonstrate an overall reduction in the amount of skywave interference it caused to other AM stations; in other words, the modifying station was required to “ratchet back” radiation in the direction of certain other AM stations. Two engineering firms filed a 2009 petition for rulemaking to eliminate the ratchet rule, claiming that the rule's practical effect was not, as intended, to reduce nighttime skywave interference, but rather to discourage station improvements and NIF service by the modifying station. The Commission adopted this proposal after near-universal approval by commenters. Likewise, there was little opposition in the comments to the NPRM proposal to allow AM stations to initiate MDCL control technologies by simply notifying the Commission, rather than seeking authorization to do so, as had been the procedure. MDCL control technologies vary a station's radiated power with carrier modulation, enabling power savings. The Commission adopted this proposal.

    18. The last of the proposals set forth in the NPRM was to modify the AM antenna efficiency standards set forth in the Commission's Rules. MMTC had, in its 2009 Radio Rescue Petition, argued that the Commission's long-standing rules mandating minimum lengths for AM radiators and ground systems, to assure efficient transmission, were outdated and limited AM stations' flexibility in choosing transmission system sites in an era of diminished property availability for such sites. MMTC suggested replacing the minimum efficiency standards with a “minimum radiation” standard, its contention being that a station should be allowed to choose to operate a less efficient, less space-intensive transmission system, making up for the lack of system efficiency by using more input power to the system to yield the same amount of radiated power. The Commission questioned some of the assumptions underlying MMTC's proposal, but agreed that some reduction in the antenna efficiency standards might provide some relief to AM broadcasters. Accordingly, the Commission proposed a 25 percent reduction in the antenna efficiency standards, and requested comment on the technical underpinnings to any further reduction in, or elimination of, those standards.

    Summary of Significant Issues Raised by Public Comments in Response to the IRFA

    19. There were no comments filed that specifically addressed the rules and policies proposed in the IRFA.

    Description and Estimate of the Number of Small Entities to Which the Proposed Rules Will Apply

    20. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the rules adopted herein. 5 U.S.C. 603(b)(3). The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” small organization,” and “small government jurisdiction.” 5 U.S.C. 601(6). In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. 5 U.S.C. 601(3) (incorporating by reference the definition of “small business concern” in 15 U.S.C. 632). A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). 15 U.S.C. 632.

    21. The subject rules and policies potentially will apply to all AM radio broadcasting licensees and potential licensees. A radio broadcasting station is an establishment primarily engaged in broadcasting aural programs by radio to the public. 15 U.S.C. 632. Included in this industry are commercial, religious, educational, and other radio stations. Radio broadcasting stations which primarily are engaged in radio broadcasting and which produce radio program materials are similarly included. However, radio stations that are separate establishments and are primarily engaged in producing radio program material are classified under another NAICS number. The SBA has established a small business size standard for this category, which is: Firms having $38.5 million or less in annual receipts. 13 CFR 121.201, NAICS code 515112 (updated for inflation in 2008). According to the BIA/Kelsey, MEDIA Access Pro Database on October 15, 2015, 4,691 (99.94%) of 4,694 AM radio stations have revenue of $38.5 million or less. Therefore, the majority of such entities are small entities. The Commission noted, however, that, in assessing whether a business concern qualifies as small under the above definition, business (control) affiliations must be included. 13 CFR 121.103(a)(1). Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies.

    22. The proposed policies could affect licensees of FM translator stations, as well as potential licensees in this radio service. The same SBA definition that applies to radio broadcast licensees would apply to these stations. The SBA defines a radio broadcast station as a small business if such station has no more than $38.5 million in annual receipts. Currently, there are approximately 6,312 licensed FM translator and booster stations. In addition, there are approximately 225 applicants with pending applications filed in the 2003 translator filing window. Given the nature of these services, the Commission will presume that all of these licensees and applicants qualify as small entities under the SBA definition.

    Description of Projected Reporting, Record Keeping and Other Compliance Requirements

    23. As described, certain rules and procedures will change, although the changes will not result in substantial increases in burdens on applicants. The Commission has added a new form, FCC Form 338, which an AM station must use to notify the Commission that it is initiating operation using MDCL control technologies. Use of FCC Form 338, however, replaces the current procedure whereby an AM station makes a request to use MDCL control technologies. Use of the form is not only less burdensome than the previous request process, but enables the applicant to initiate MDCL operation immediately, rather than waiting for Commission approval. The remaining rule changes adopted in the First R&O are substantive and do not involve application changes, reporting requirements, or record keeping requirements beyond what is already required. For example, currently applicants for AM construction permits or modifications are required only to certify that they comply with the community coverage requirements of 47 CFR 73.24(i). Such applicants will continue to do so, but under a less stringent rule standard in some cases.

    Steps Taken To Minimize Significant Impact of Small Entities, and Significant Alternatives Considered

    24. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. 5 U.S.C. 603(c)(1)-(c)(4).

    25. With regard to the proposals in the NPRM, the Commission received many comments proposing different plans for an FM translator window limited to applicants that hold AM station authorizations. Most of these comments centered around whether the window could be limited to certain AM broadcasters, and to whom it should be limited. Ultimately, while recognizing that an exclusive window limited to some or all AM station licensees and permittees would assist those entities, the Commission concluded that immediately opening such a window would be impractical, and could disrupt the robust secondary market in FM translators. It decided instead to implement, first, a period of outreach to Class C and D AM station licensees and permittees, which have lower power and/or no protected nighttime service, to assist them in locating existing translators that could meet their needs. Immediately following a three-month outreach period, the Commission will open two windows in which applicants may propose to relocate an existing FM translator up to 250 miles, and/or modify a translator to specify any rule-compliant non-reserved FM channel. This procedure is expected to lower prices for FM fill-in translators for AM stations by opening up the available market, thus benefiting AM station owners, and would also benefit small businesses owning FM translator stations. The first, six-month modification window would be open only to applicants proposing to modify FM translators rebroadcasting Class C and D AM stations, followed by a second, three-month window open to applicants to modify translators to rebroadcast any class of AM station, including for Class C and D stations for which there were no applications in the first window. All modification applications filed in the windows will be on a one translator-per-AM station basis, and any translator stations modified pursuant to modification window applications will be subject to the same four-year operating condition currently attached to translators modified pursuant to Mattoon waivers. The modification windows will provide short-term relief to AM broadcasters. They will be followed, upon completion of the Commission's Incentive Auction proceeding, by two auction windows for AM licensees and permittees seeking to obtain new FM translator stations. The two new FM translator auction windows will follow a similar pattern to the modification windows: the first will be open only to Class C and D AM licensees and permittees whose stations were not participants in either modification window, while the second will be open to all AM licensees and permittees whose stations were not participants in either modification window or the first auction window. The new FM translator auction windows will otherwise be subject to the same conditions set forth in the NPRM, including the limitation of one and only one application per applicant, for an FM translator station that must comply with our siting rules for FM fill-in translators rebroadcasting AM stations, which will be permanently linked to the AM primary station acquiring it. Both new FM translator auction windows will include opportunities for mutually exclusive applicants to resolve their mutual exclusivity through settlements or technical resolutions. In adopting this process of modification windows followed by new translator auction windows, the Commission intends to provide immediate relief through a modified secondary translator market for AM broadcasters that are small businesses, while providing some of those businesses an opportunity to acquire a new fill-in FM translator at a later time, if that better comports with their situation.

    26. With regard to the other, more technical proposals in the NPRM, the Commission's proposals were in most cases supported by a majority of commenters, giving little reason to consider alternatives. The proposals to reduce community coverage requirements for existing AM broadcasters were grounded in the idea that such broadcasters, small businesses that in some cases had occupied their transmitter sites for decades, could not easily change transmitter sites because their communities of license had grown, and land had become increasingly expensive, thus making it difficult or impossible to locate new, rule-compliant sites. Relaxing the community coverage standards for existing AM stations reduces burdens on such businesses by relieving them of the obligation to locate other, more expensive transmitter sites or upgrading their equipment to meet those standards. Some commenters suggested that the Commission abandon community coverage rules altogether, or re-define “community” to mean something other than geographic boundaries. While such re-definitions would provide further relief to AM broadcasters, the Commission rejected them in part because 47 U.S.C. 307(b) requires that radio stations be assigned fairly and equitably among the several States and communities, and that any re-definition of “community” would run counter to the Commission's historic expectation that a radio station meet its local service obligations, that is, provide service to the designated community, and adapt its programming to the shifting needs of that community. The principle of broadcast localism, which derives from Section 307(b), requires that there be certain minimum service requirements. Additionally, it is not necessarily a burden on radio stations to require that they cover as much population as possible, because increased listenership typically translates into increased advertising revenue. Thus, while the Commission considered these alternatives, it concluded that the proposals as adopted provided the most relief to AM broadcasters while still adhering to the requirements of the Communications Act and the expectation that a station will provide local service.

    27. As for the proposed repeal of the ratchet rule, the vast majority of commenters favored that repeal because of the burdens the rule placed on broadcasters seeking to improve their facilities and, thus, their signal coverage. There were no significant alternatives to consider other than leaving the rule in effect, which was only favored by a few commenters. Those favoring retention of the rule did so in order to retain the interference reduction benefits for which it was designed. The Commission, however, agreed with those commenters, including many broadcasters, who argued that the benefits of increased flexibility in facility improvement outweighed the minimal interference reduction resulting from the ratchet rule's application.

    28. The Commission's proposal regarding notification procedures for MDCL control technology use by AM broadcasters did not involve a substantive change in the rules, merely a procedural change whereby AM broadcasters wishing to use such technologies would no longer have to seek leave to do so, but would notify the Commission of the fact. Those commenters opposed to the proposal did not oppose it as much as question the benefits of MDCL control technologies, observing that they are only available to stations with newer transmitters, that in some cases the power savings are minimal, and that the fluctuations in signal power could result in decreased listenability. These objections, however, do not go to the Commission's proposal, which merely makes it easier for those AM stations opting to use MDCL control technologies to do so. Although the proposal does introduce a new notification form, this form replaces the former system of requesting leave to use MDCL control technologies, and should result in an overall decrease in the burden on AM stations electing to use the technologies. The Commission thus decided that adoption of the proposal should be favored over retention of the prior procedure.

    29. The Commission also received many comments on its proposal to relax, but not eliminate, AM antenna system efficiency rules. The Commission proposed a 25 percent reduction in the minimum standards for radiators. The most significant alternative to this proposal, put forward by many commenters, was to eliminate the efficiency standards for AM transmission systems altogether, leaving it to the individual broadcaster to decide how much power to feed into the system in order to achieve the level of signal radiation needed to provide rule-compliant coverage. Such a proposal, while power-intensive, would allow AM broadcasters to install less-efficient transmission systems in smaller plots of land, using radiators (towers) short enough to avoid zoning or FAA strictures. In considering this alternative, however, the Commission was also informed by those commenters pointing out that inefficient AM transmission systems, with short towers and/or ground systems, tend to be unstable, and might also result in greater levels of high-angle skywave interference to other stations. The Commission seeks to reduce burdens on AM broadcasters, but must also protect the integrity of the service, including minimizing inter-station interference. After considering the alternatives, the Commission concluded that adopting its proposed 25 percent reduction of AM antenna system efficiency standards represented the best accommodation between those considerations. It also decided, however, that more real-world data on inefficient AM transmission systems was called for, and therefore indicated that it would be willing to allow the installation of alternative or inefficient systems on an experimental basis, upon a showing that such systems are stable and will not cause excessive interference to other AM stations, and subject to the monitoring and reporting requirements in Part 5 of the Commission's Rules. Data gleaned from such experimental operations, it is hoped, will allow the Commission to consider, in the future, whether the AM antenna system efficiency rules could be relaxed further or eliminated.

    Report to Congress

    30. The Commission will send a copy of the First R&O, including this FRFA, in a report to be sent to Congress and the Government Accountability Office pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996. 5 U.S.C. 801(a)(1)(A). In addition, the Commission will send a copy of the First R&O, including the FRFA, to the Chief Counsel for Advocacy of the Small Business Administration. A copy of the First R&O and FRFA (or summaries thereof) will also be published in the Federal Register. (See 5 U.S.C. 604(b)).

    Ordering Clauses

    31. Accordingly, it is ordered that pursuant to the authority contained in Sections 1, 2, 4(i), 303, 307, and 309(j) of the Communications Act of 1934, 47 U.S.C. 151, 152, 154(i), 303, 307, and 309(j), that this First Report and Order is adopted.

    32. It is further ordered that, pursuant to the authority found in Sections 1, 2, 4(i), 303, 307, and 309(j) of the Communications Act of 1934, 47 U.S.C. 151, 152, 154(i), 303, 307, and 309(j), the Commission's Rules are hereby amended as set forth herein and in Appendix A to the First R&O.

    33. It is further ordered that the rules adopted herein will become effective February 18, 2016, except for 47 CFR 73.1560, which contains new or modified information collection requirements that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), and which will become effective after the Commission publishes a document in the Federal Register announcing such approval and the relevant effective date.

    List of Subjects in 47 CFR Part 73

    Communications equipment, Radio, Reporting and recordkeeping requirements, Federal Communications Commission.

    Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary. Rule Changes

    For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:

    PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority:

    47 U.S.C. 154, 303, 334, 336, and 339.

    2. Section 73.14 is amended by adding in alphabetical order the definition for “Modulation dependent carrier level (MDCL) control technologies” to read as follows:
    § 73.14 AM broadcast definitions.

    Modulation dependent carrier level (MDCL) control technologies. Transmitter control techniques that vary either the carrier power level or both the carrier and sideband power levels as a function of the modulation level.

    3. In § 73.21 revise paragraphs (a)(2) and (3) to read as follows:
    § 73.21 Classes of AM broadcast channels and stations.

    (a) * * *

    (2) Class B station. Class B stations are authorized to operate with a minimum power of 0.25 kW (or, if less than 0.25 kW, an equivalent RMS antenna field of at least 107.5 mV/m at 1 kilometer) and a maximum power of 50 kW, or 10 kW for stations that are authorized to operate in the 1605-1705 kHz band.

    (3) Class D station. A Class D station operates either daytime, limited time or unlimited time with nighttime power less than 0.25 kW and an equivalent RMS antenna field of less than 107.5 mV/m at 1 kilometer. Class D stations shall operate with daytime powers not less than 0.25 kW nor more than 50 kW. Nighttime operations of Class D stations are not afforded protection and must protect all Class A and Class B operations during nighttime hours. New Class D stations that had not been previously licensed as Class B will not be authorized.

    4. In § 73.24 revise paragraph (i) to read as follows:
    § 73.24 Broadcast facilities; showing required.

    (i) That, for all proposals for new stations, applications to modify a construction permit for an unlicensed station, and all applications to change a station's community of license, the daytime 5 mV/m contour encompasses the entire principal community to be served. That, for all other applications for modification of licensed stations, the daytime 5 mV/m contour encompasses either 50 percent of the area, or 50 percent of the population, of the principal community to be served. That, for all proposals for new stations in the 535-1605 kHz band, applications to modify a construction permit for an unlicensed station, or applications to change a station's community of license, either 50 percent of the area, or 50 percent of the population of the principal community is encompassed by the nighttime 5 mV/m contour or the nighttime interference-free contour, whichever value is higher. That, for stations in the 1605-1705 kHz band, 50 percent of the principal community is encompassed by the nighttime 5 mV/m contour or the nighttime interference-free contour, whichever value is higher. That Class D stations with nighttime authorizations need not demonstrate such coverage during nighttime operation.

    5. In § 73.182 revise the first sentence in paragraph (a)(1)(ii) introductory text; revise paragraph (a)(4); revise the second sentence in paragraph (m), the table, and Note (2) to paragraph (m); and revise paragraph (q) to read as follows:
    § 73.182 Engineering standards of allocation.

    (a) * * *

    (1) * * *

    (ii) Class A stations in Alaska operate on the channels allocated by § 73.25 with a minimum power of 10 kW, a maximum power of 50 kW and an antenna efficiency of 215 mV/m/kW at 1 kilometer. * * *

    (4) Class D stations operate on clear and regional channels with daytime powers of not less than 0.25 kW (or equivalent RMS field of 107.5 mV/m at 1 kilometer if less than 0.25 kW) and not more than 50 kW. Class D stations that have previously received nighttime authority to operate with powers of less 0.25 kW (or equivalent RMS fields of less than 107.5 mV/m at 1 kilometer) are not required to provide nighttime coverage in accordance with § 73.24(i) and are not protected from interference during nighttime hours. Such nighttime authority is permitted on the basis of full nighttime protection being afforded to all Class A and Class B stations.

    (m) * * * Certain approximations, based on the curve or other appropriate theory, may be made when other than such antennas and ground systems are employed, but in any event the effective field to be employed shall not be less than the following:

    Class of station Effective
  • field
  • (at 1 km)
  • All Class A (except Alaskan) 275 mV/m. Class A (Alaskan), B and D 215 mV/m. Class C 180 mV/m.
    Note (2):

    For Class B stations in Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands, 180 mV/m shall be used.

    (q) Normally protected service contours and permissible interference signals for broadcast stations are as follows (for Class A stations, see also paragraph (a) of this section):

    Class of station Class of channel used Signal strength contour of area protected from
  • objectionable interference [remove footnote reference]
  • (μV/m)
  • Day 1 Night Permissible interfering signal
  • (μV/m)
  • Day 1 Night 2
    A Clear SC 100 SC 500 50% SW SC 5 SC 25. AC 500 AC 500 GW AC 250 AC 250. A (Alaskan) ......do SC 100 SC 100 50% SW SC 5 SC 5. AC 500 AC 500 GW AC 250 AC 250. B Clear 500 2000 1 25 25. Regional AC 250 250. C Local 500 No presc.3 SC 25 Not presc. D Clear 500 Not presc. SC 25 Not presc. Regional AC 250 1 Groundwave. 2 Skywave field strength for 10 percent or more of the time. 3 During nighttime hours, Class C stations in the contiguous 48 States may treat all Class B stations assigned to 1230, 1240, 1340, 1400, 1450, and 1490 kHz in Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands as if they were Class C stations.
    Note:

    SC = Same channel; AC = Adjacent channel; SW = Skywave; GW = Groundwave

    6. In § 73.189 revise paragraph (b)(2) to read as follows:
    § 73.189 Minimum antenna heights or field strength requirements.

    (b) * * *

    (2) These minimum actual physical vertical heights of antennas permitted to be installed are shown by curves A, B, and C of Figure 7 of § 73.190 as follows:

    (i) Class C stations, and stations in Alaska, Hawaii, Puerto Rico and the U.S. Virgin Islands on 1230, 1240, 1340, 1400, 1450 and 1490 kHz that were formerly Class C and were redesignated as Class B pursuant to § 73.26(b), 45 meters or a minimum effective field strength of 180 mV/m for 1 kW at 1 kilometer (90 mV/m for 0.25 kW at 1 kilometer). (This height applies to a Class C station on a local channel only. Curve A shall apply to any Class C stations in the 48 conterminous States that are assigned to Regional channels.)

    (ii) Class A (Alaska), Class B and Class D stations other than those covered in § 73.189(b)(2)(i), a minimum effective field strength of 215 mV/m for 1 kW at 1 kilometer.

    (iii) Class A stations, a minimum effective field strength of 275 mV/m for 1 kW at 1 kilometer.

    5. In § 73.1560 revise paragraph (a)(1) to read as follows:
    § 73.1560 Operating power and mode tolerances.

    (a) AM stations. (1) Except for AM stations using modulation dependent carrier level (MDCL) control technology, or as provided for in paragraph (d) of this section, the antenna input power of an AM station, as determined by the procedures specified in § 73.51, must be maintained as near as practicable to the authorized antenna input power and may not be less than 90 percent nor greater than 105 percent of the authorized power. AM stations may, without prior Commission authority, commence MDCL control technology use, provided that within 10 days after commencing such operation, the licensee submits an electronic notification of commencement of MDCL control operation using FCC Form 338. The transmitter of an AM station operating using MDCL control technology, regardless of the MDCL control technology employed, must achieve full licensed power at some audio input level or when the MDCL control technology is disabled. MDCL control operation must be disabled before field strength measurements on the station are taken.

    [FR Doc. 2015-31950 Filed 1-15-16; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF THE TREASURY 48 CFR Parts 1022 and 1052 Department of the Treasury Acquisition Regulation; Correction AGENCY:

    Office of the Procurement Executive, Treasury.

    ACTION:

    Correcting amendments.

    SUMMARY:

    On March 20, 2014 and March 4, 2015, the Department of the Treasury published in the Federal Register amendments to the Department of the Treasury Acquisition Regulation (DTAR). This document includes correcting amendments to address inadvertent errors.

    DATES:

    Effective date: January 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Thomas O'Linn, Procurement Analyst, Office of the Procurement Executive, at (202) 622-2092.

    SUPPLEMENTARY INFORMATION:

    The DTAR, which supplement the Federal Acquisition Regulation, are codified at 48 CFR chapter 10. In order to update certain elements in 48 CFR chapter 10, the Department issued final rules on March 20, 2014 (79 FR 15551) and March 4, 2015 (80 FR 11595). In the final rules, a correction to the heading of section 1052.201-70 and paragraph (f) of the section were inadvertently omitted. In addition, section 1052.222-70 was not incorporated and the heading for subpart 1022.70 was incorrectly listed as subpart 1022.7. These items are corrected in this document.

    List of Subjects in 48 CFR Parts 1022 and 1052

    Government procurement.

    Accordingly, the Department of the Treasury amends 48 CFR chapter 10 as follows:

    PART 1022—MINORITY AND WOMEN INCLUSION 1. The authority citation for part 1022 continues to read as follows: Authority:

    12 U.S.C. 5452.

    Subpart 1022.7 [Redesignated as subpart 1022.70] 2. Redesignte subpart 1022.7 as subpart 1022.70. PART 1052—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 3. The authority citation for part 1052 continues to read as follows: Authority:

    41 U.S.C. 1707.

    4. In section 1052.201-70, revise the section heading and add paragraph (f) to read as follows:
    1052.201-70 Contracting Officer's Representative (COR) appointment and authority.

    (f) Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

    5. Add § 1052.222-70 to read as follows:
    1052.222-70 Minority and Women Inclusion.

    As prescribed in 1022.7000, insert the following clause:

    Minority and Women Inclusion (Jan 2016)

    (a) Contractor confirms its commitment to equal opportunity in employment and contracting. To implement this commitment, the Contractor shall ensure, to the maximum extent possible consistent with applicable law, the fair inclusion of minorities and women in its workforce. The Contractor shall insert the substance of this clause in all subcontracts awarded under this contract whose dollar value exceeds $150,000. Within ten business days of a written request from the Contracting Officer, or such longer time as the Contracting Officer determines, and without any additional consideration required from the Agency, the Contractor shall provide documentation, satisfactory to the Agency, of the actions it (and as applicable, its subcontractors) has undertaken to demonstrate its good faith effort to comply with the aforementioned provisions. For purposes of this contract, “good faith effort” may include actions by the Contractor intended to identify and, if present, remove barriers to minority and women employment or expansion of employment opportunities for minorities and women within its workforce. Efforts to remove such barriers may include, but are not limited to, recruiting minorities and women, providing job-related training, or other activity that could lead to those results.

    (b) The documentation requested by the Contracting Officer to demonstrate “good faith effort” may include, but is not limited to, one or more of the following—

    (1) The total number of Contractor's employees, and the number of minority and women employees, by race, ethnicity, and gender (e.g., an EEO-1);

    (2) A list of subcontract awards under the contract that includes: Dollar amount, date of award, and subcontractor's race, ethnicity, and/or gender ownership status;

    (3) Information similar to that required in paragraph (b)(1) of this clause, with respect to each subcontractor; and/or

    (4) The Contractor's plan to ensure that minorities and women have appropriate opportunities to enter and advance within its workforce, including outreach efforts.

    (c) Consistent with Section 342(c)(3) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Pub. L. 111-203) (Dodd-Frank Act), a failure to demonstrate to the Director of the Agency's Office of Minority and Women Inclusion such good faith efforts to include minorities and women in the Contractor's workforce (and as applicable, the workforce of its subcontractors), may result in termination of the contract for default, other contractual remedies, or referral to the Office of Federal Contract Compliance Programs (OFCCP). Compliance with this clause does not, however, necessarily satisfy the requirements of Executive Order 11246, as amended, nor does it preclude OFCCP compliance evaluations and/or enforcement actions undertaken pursuant to that Executive Order.

    (d) For purposes of this clause, the terms “minority,” “minority-owned business,” and “women-owned business” shall have the meanings set forth in Section 342(g) of the Dodd-Frank Act.

    Iris Cooper, Senior Procurement Executive.
    [FR Doc. 2016-00853 Filed 1-15-16; 8:45 am] BILLING CODE 4810-25-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 665 RIN 0648-XE393 Pacific Island Fisheries; 2016 Northwestern Hawaiian Islands Lobster Harvest Guideline AGENCY:

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

    ACTION:

    Notification of lobster harvest guideline.

    SUMMARY:

    NMFS establishes the annual harvest guideline for the commercial lobster fishery in the Northwestern Hawaiian Islands for calendar year 2016 at zero lobsters.

    DATES:

    January 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Bob Harman, NMFS PIR Sustainable Fisheries, tel 808-725-5170.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the Northwestern Hawaiian Islands (NWHI) commercial lobster fishery under the Fishery Ecosystem Plan for the Hawaiian Archipelago. The regulations at 50 CFR 665.252(b) require NMFS to publish an annual harvest guideline for lobster Permit Area 1, comprised of Federal waters around the NWHI.

    Regulations governing the Papahanaumokuakea Marine National Monument in the NWHI prohibit the unpermitted removal of monument resources (50 CFR 404.7), and establish a zero annual harvest guideline for lobsters (50 CFR 404.10(a)). Accordingly, NMFS establishes the harvest guideline for the NWHI commercial lobster fishery for calendar year 2016 at zero lobsters. Harvest of NWHI lobster resources is not allowed.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: January 12, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-00770 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    81 11 Tuesday, January 19, 2016 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 331 9 CFR Part 121 [Docket No. APHIS-2014-0095] RIN 0579-AE08 Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List; Amendments to the Select Agent and Toxin Regulations AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    In accordance with the Agricultural Bioterrorism Protection Act of 2002, we are proposing to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. The Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action would implement the findings of the fourth biennial review of the list. In addition, we are proposing several amendments to the regulations, including the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records. These changes would increase the usability of the select agent regulations as well as provide for enhanced program oversight.

    DATES:

    We will consider all comments that we receive on or before March 21, 2016.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2014-0095, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Freeda Isaac, National Director, Agriculture Select Agent Services, APHIS, 4700 River Road Unit 2, Riverdale, MD 20737-1231; (301) 851-3300, Option 3.

    SUPPLEMENTARY INFORMATION:

    The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (referred to below as the Bioterrorism Response Act) provides for the regulation of certain biological agents that have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within the United States Department of Agriculture (USDA). Veterinary Services (VS) select agents and toxins are those that have been determined to have the potential to pose a severe threat to animal health or animal products. Plant Protection and Quarantine (PPQ) select agents and toxins are those that have the potential to pose a severe threat to plant health or plant products. Overlap select agents and toxins are those that have been determined to pose a severe threat to both human and animal health or to human health and animal products. Overlap select agents are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), which has the primary responsibility for implementing the provisions of the Bioterrorism Response Act for the Department of Health and Human Services (HHS).

    Subtitle B (which is cited as the “Agricultural Bioterrorism Protection Act of 2002” and referred to below as the Act), section 212(a), provides, in part, that the Secretary of Agriculture (the Secretary) must establish by regulation a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. Paragraph (a)(2) of section 212 requires the Secretary to review and republish the list every 2 years and to revise the list as necessary. In this document, we are proposing to amend and republish the list of select agents and toxins based on the findings of our fourth biennial review of the list.

    In determining whether to include an agent or toxin on the list, the Act requires that the following criteria be considered:

    • The effect of exposure to the agent or the toxin on animal and plant health, and on the production and marketability of animal or plant products;

    • The pathogenicity of the agent or the toxin and the methods by which the agent or toxin is transferred to animals or plants;

    • The availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and

    • Any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.

    We use the term “select agents and toxins” throughout the preamble of this proposed rule. Unless otherwise specified, the term “select agents and toxins” will refer to all agents or toxins listed by APHIS. When it is necessary to specify the type of select agent or toxin, we will use the following terms: “PPQ select agents and toxins” (for the plant agents and toxins listed in 7 CFR 331.3), “VS select agents and toxins” (for the animal agents and toxins listed in 9 CFR 121.3), or “overlap select agents and toxins” (for the overlap agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).

    On February 27, 2015, we published in the Federal Register (80 FR 10627, Docket No. APHIS-2014-0095) an advance notice of proposed rulemaking and request for comments (ANPR) 1 in order to announce our intention to review the select agent list. We solicited comments regarding potential additions and deletions from the list of select agents and toxins for 60 days ending April 28, 2015. We received 20 comments by that date. They were from scientists, scientific organizations, a State government, private individuals, and industry groups. Suggestions in these comments were used in order to inform our discussions on the content of the select agent list.

    1 To view the ANPR and the comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0095.

    PPQ Select Agents and Toxins

    APHIS's PPQ program convened an interagency working group to review the list of PPQ select agents and toxins and develop recommendations regarding possible changes to that list. Using the four criteria for listing found in the Act, economic crop data, current Federal quarantine notices, and new scientific information, the working group revisited the currently listed PPQ select agents and toxins and evaluated a number of new plant pathogens for inclusion on the list. Based on this review, APHIS is proposing to amend the list of PPQ select agents and toxins listed in 7 CFR 331.3 by removing three PPQ select agents and toxins from the list. Specifically, we are proposing to remove the following:

    Peronosclerospora philippinensis (Peronosclerospora sacchari) and Sclerophthora rayssiae: There are no viable cultures of these corn pathogens currently held in U.S. laboratories, they are difficult to grow or maintain, difficult to keep viable during transport, and would require a large amount of inoculum to infect fields by artificial means due to the fact that they must spread via infected plant material; and

    Phoma glycinicola (formerly Pyrenochaeta glycines): This soybean pathogen's natural distribution is limited to two countries in Africa, it does not spread rapidly in the field, soybean importation pathways into the United States by which the pathogen might enter are limited, and while no U.S. soybean variety is immune to this pathogen, Environmental Protection Agency-approved fungicides are available to treat any infestation.

    VS Select Agents and Toxins

    APHIS' VS program also convened an interagency working group to review the list of VS select agents and toxins and the list of overlap select agents and toxins in 9 CFR part 121 in order to consider changes to the lists. Based on the review, APHIS is proposing to remove three overlap select agents and toxins from the list set out in § 121.4(b):

    Bacillus anthracis (Pasteur strain): Historically, the B. anthracis Pasteur strain has been retained as a select agent to allow for continued oversight of laboratories in which the accidental (or intentional) combination of this strain with the excluded Sterne strain could occur to produce the wild type phenotype B. anthracis de novo. However, a recent study 2 indicates that bacterial transformation of B. subtilis with plasmid DNA is inefficient; indicating that transformation with bacteria such as B. anthracis (e.g., pXO1 into B. anthracis Pasteur strain) would also be inefficient. Given that B. anthracis Pasteur strain does not encode the plasmid which carries the pathogenic toxin genes, analogous to the Sterne strain which was excluded from Select Agent oversight in 2003, we believe there is no potential for high animal mortality rates or for misuse that might result in social or economic disruption. Therefore, we are proposing that the Pasteur strain be removed from the overlap select agent list.

    2 C. Johnston, B. Martin, G. Fichant, P. Polard, and J.P. Claverys. “Bacterial transformation: distribution, shared mechanisms and divergent control.” Nature Reviews Microbiology. 2014. 12: 181-196.

    Brucella abortus and Brucella suis: While both of these organisms have been eradicated from the domestic livestock industry, they are currently endemic in wildlife and feral swine populations in the United States. However, there is an extensive regulatory control program in place for B. abortus in the remaining affected Designated Surveillance Area. APHIS has also recently enacted a national program to control feral swine that will include surveillance and disease monitoring for swine brucellosis. Therefore, we believe the effect of exposure to these agents on animal health and on the production and marketability of animal products is minimized. We are proposing that these two Brucella species be removed from the overlap select agent list. However, Brucella melitensis, as a foreign animal disease agent not currently found in the United States, would be kept as a VS select agent.

    Accordingly, CDC will also be proposing a parallel change to its overlap select agent regulations.

    Additional Changes

    We are proposing to make several changes to the regulations, including the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records. These changes, which are described in detail below, would increase the usability of the select agent regulations as well as provide for enhanced program oversight.

    Definitions

    In 7 CFR 331.1 and 9 CFR 121.1, we are proposing to add definitions for inactivation and kill curve. We believe these definitions are necessary as they are included in the additional biocontainment and biosafety language we are proposing to add to the regulations.

    The definition of inactivation would be established as “a method to render a select agent non-viable but retain characteristic of interest for future use, or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.” This definition draws a distinction between inactivation for waste treatment and inactivation of regulated material for future purposes such as research. The definition of kill curve would be established as “the results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.”

    Exclusions and Inactivation

    We are proposing to amend 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and 9 CFR 121.4(d)(2), which currently exclude nonviable select agents or nonfunctional toxins from the requirements of the regulations, in order to clarify our policy that an entity must use a validated method to render a select agent nonviable or regulated nucleic acids non-infectious for future use. This means that the method must be scientifically sound and that it will produce consistent results each time it is used.

    We are proposing that inactivation include the use of one of the following: The exact conditions of a commonly accepted method that has been validated as applied (e.g., autoclaving), a published method with adherence to the exact published conditions (i.e., extrapolations or deductions are to be avoided), or in-house methods, only if validation testing includes the specific conditions used and appropriate controls.

    We are also proposing that the entity develop a site-specific kill curve in order to define conditions of inactivation for each select agent or regulated nucleic acid. If there are strain-to-strain variations in the resistance of a select agent to the inactivation procedure, then a specific kill curve would have to be developed for each strain that undergoes the inactivation procedure. A new kill curve would have to be created upon any change in procedure or inactivation equipment. In addition, a validated sterility testing protocol would have to be conducted in order to ensure that the inactivation method has rendered a select agent nonviable or regulated nucleic acids non-infectious.

    In addition, we are proposing that an entity be required to report any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was subjected to a validated inactivation protocol to APHIS or CDC.

    We are also proposing to require that an entity review annually, and revise as necessary, the following: (1) The kill curve procedure and results; (2) site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent virus are inactivated by a safety margin; and (3) the validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent viruses non-infectious.

    Finally, we are proposing that written records be kept for any select agent that has been rendered nonviable or regulated nucleic acids that have been rendered non-infectious. We are particularly requesting comments regarding whether there are more specific measures available to demonstrate that a select agent has been rendered nonviable, or a regulated infectious nucleic acid has been rendered non-infectious.

    We are also proposing to add to 7 CFR 331.3(e), 9 CFR 121.3(e), and 9 CFR 121.4(e) a paragraph stating that an individual or entity may make a written request to the Administrator for reconsideration of a decision denying an exclusion application. The written request for reconsideration would have to state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator would grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. This language was included in previous versions of the regulations and was erroneously removed by an earlier rulemaking.

    Exemptions for Select Agents and Toxins

    Sections 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 concern conditions under which entities may be exempted from the requirements of the regulations. Paragraph (a) requires that the identification of the agent or toxin be reported to APHIS or CDC. Since select agents and toxins have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products, clinical and diagnostic laboratories typically have their initial results confirmed by a registered or certified reference laboratory. We are proposing to require that in addition to notifying APHIS or CDC, the reference laboratory inform the specimen provider upon confirmation of the identification of a select agent or toxin. This change would clarify our expectations regarding communication and notification between the reference laboratory and the specimen provider.

    We are also proposing to add language to paragraph (a) in sections 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 that specifies that entities may be required to report identification of agents or toxins to other appropriate authorities when required by Federal, State, or local law. This language was added to the CDC select agent regulations in a previous rulemaking, but not to the APHIS regulations and this change is necessary in order to achieve uniformity across all regulations associated with the diagnosis and care for individuals infected with a select agent or toxin. Specifically, we are proposing to add provisions that state that we do not regulate material containing select agents or toxins when it is in a patient care setting and is not being collected or otherwise tested or retained, nor do we regulate waste generated during delivery of patient care. However, once delivery of patient care for the select agent or toxin infection has concluded, these specimens would become subject to the requirements of the regulations. If an entity cannot meet these requirements, then the material may be transferred to another entity according to the select agent regulations or destroyed using an approved method. The decision to retain, transfer, or destroy any specimens must be made within 7 calendar days of the conclusion of patient care. These requirements would be set out in new paragraphs 9 CFR 121.3(d)(4) and 9 CFR 121.4(d)(4).

    Registration and Related Security Risk Assessments

    The regulations in 7 CFR 331.7 and 9 CFR 121.7 set out registration requirements for those entities that wish to work with select agents and toxins and stipulates the individuals within those entities that must undergo a security risk assessment by the Attorney General.

    We are proposing to state that an entity registered to possess, use, or transfer a select agent or toxin would have to meet the requirements of the regulations for those select agents and toxins listed on the entity's official registration regardless of whether the entity is in possession of those select agents or toxins and without regard to the amount of select agents or toxins in the entity's possession. This change would serve to codify existing policy and would be added as a new paragraph (b).

    Responsible Official

    The regulations in 7 CFR 331.9 and 9 CFR 121.9 set out requirements for entities requesting to work with select agents and toxins to designate a responsible official, who ensures that the entity continues to meet the requirements of the regulations.

    Paragraph (a)(6) requires the responsible official to ensure that annual inspections are conducted for each location where select agents or toxins are stored or used in order to determine compliance with the regulations. The responsible official also must document the results of each inspection and identify and address any deficiencies.

    We are proposing to require that any corrections of deficiencies found must also be documented. This change is necessary to improve recordkeeping practices and to provide a more complete account of facility containment and security procedures. We are also proposing to replace the word “laboratory” with the phrase “registered space.” This terminology is more accurate, as registered spaces are not always laboratories.

    We are also proposing to add a new paragraph (a)(7), which would require the entity's responsible official to provide contact information for the USDA or HHS Office of Inspector General Hotline, so that employees and other individuals may anonymously report any containment or security concerns they may have. Although the select agent program has established a whistleblower portal on its Web site, there is currently no requirement for employees at registered entities to be made aware of its existence or how to use it. Adding this requirement would allow for increased worker involvement in biosafety/biocontainment and security programs at registered entities and may also enhance the quality of Federal oversight in this area.

    Security Risk Assessments

    We are proposing to amend the regulations in 7 CFR 331.10 and 9 CFR 121.10. These regulations establish parameters for restricting access to select agents and toxins and the process by which individuals may be approved for access to select agents and toxins after the completion of a security risk assessment by the Attorney General.

    Paragraph (e) states that a person with valid approval from the HHS Secretary or Administrator to have access to select agents or toxins may request, through his or her responsible official, that the HHS Secretary or APHIS Administrator provide their approved access status to another registered individual or entity for a specified period of time. We are proposing to also require that the responsible official at the visiting person's home entity notify the host entity if that person's approved access to select agents or toxins has been terminated. This would ensure that an individual whose permissions have been terminated would not be allowed further access to select agents and toxins.

    Security, Biocontainment/Biosafety, and Incident Response Plans

    The regulations require registered entities to develop and implement a number of plans in order to ensure the safety and security of the select agents they handle. These are:

    • A security plan, as described by the regulations in 7 CFR 331.11 and 9 CFR 121.11, that provides for measures sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release;

    • A biocontainment plan, in the case of PPQ select agents, or a biosafety plan, in the case of VS and overlap select agents, as described in the regulations in 7 CFR 331.12 and 9 CFR 121.12, that provides for measures sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards); and

    • An incident response plan, as described in the regulations in 7 CFR 331.14 and 9 CFR 121.14, that provides for measures that the registered entity will implement in the event of theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, etc. The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such agent or toxin.

    All of these plans require annual review and revision as necessary. Drills or exercises must also be conducted at least annually to test and evaluate the effectiveness of the plans. The plans must be reviewed and revised, as necessary, after any drill or exercise and after any incident. We are proposing to require that these drills or exercises be documented to include how the drill or exercise tested and evaluated the plan, any problems identified, any corrective action taken, and the names of the individuals who participated in the drill or exercise. This will provide a more thorough accounting of required activities as well as increasing the efficacy of the plans via testing and entity-directed improvements. We are proposing to add these requirements to 7 CFR 331.11(h), 331.12(e), 331.14(f), 9 CFR 121.11(h), 121.12(e), and 121.14(f).

    We are also proposing to add a requirement that the biocontainment, biosafety, and incident response plans be submitted for initial registration, renewal of registration, or when requested. These additions would be located in 7 CFR 331.12(a), 331.14(a), 9 CFR 121.12(a), and 121.14(a). This change is necessary in order to bring the requirements for these plans in line with existing requirements for the security plan.

    Details of the changes we are proposing to the security, biosecurity, and biosafety plans individually may be found below.

    Security Plan

    Paragraph (c)(5) of 7 CFR 331.11 and 9 CFR 121.11 requires that the security plan describe procedures for addressing loss or compromise of keys, passwords, combinations, etc. and protocols for changing access numbers or locks following staff changes. We are proposing to add keycards to that list as they are commonly used. We are also proposing to use the term “access permissions” instead of the term “access numbers,” as it covers a broader range of topics.

    We are also proposing to add a new paragraph (c)(11) to the regulations in 7 CFR 331.11 and 9 CFR 121.11. This would require that the security plan contain a description of how the entity authorizes the means of entry into areas where select agents or toxins are stored or used, which would include a description of all centralized access control management systems (e.g., keycards) and/or mechanical key management. This requirement would allow us to directly ascertain the way in which entities allow individuals entry to areas containing select agents and toxins and potentially identify any weaknesses in that process.

    In the same sections, paragraphs (d)(7)(i) through (d)(7)(v) encompass a list of activities that individuals with access approval from the Administrator or the HHS Secretary must immediately report to the responsible official. We are proposing to add a new paragraph (d)(7)(vi) to require that the responsible official must be notified of any loss of computer, hard drive, or other data storage device containing information that can be used to gain access to select agents or toxins. Such notification will facilitate notification of the Federal Bureau of Investigation if deemed necessary by the responsible official as the loss of such equipment may be criminal in nature.

    Biocontainment/Biosafety Plan

    Paragraph (a) of 7 CFR 331.12 and 9 CFR 121.12 requires that the biocontainment or biosafety plan contain sufficient information and documentation to describe the biosafety and containment procedures for each select agent or toxin that the registered entity will possess. The plan must also include a description of the biosafety and containment procedures for any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. We are proposing to additionally require that laboratory-specific biocontainment and/or biosafety manuals must be accessible to individuals working in those laboratories. This change would help to foster an enhanced culture of responsibility by ensuring that appropriate biocontainment and/or biosafety resources are available to all staff with access to select agents and toxins within a select agent laboratory.

    In the aftermath of recent biosafety incidents involving an unintentional release of potentially viable anthrax within the CDC's Roybal Campus, in Atlanta, GA, and the inadvertent cross-contamination and shipment of a laboratory specimen of low-pathogenic avian influenza virus with the VS select agent highly pathogenic avian influenza virus, we believe that the biocontainment and biosafety plans should be designed according to a site-specific risk assessment in accordance with the risk posed by a select agent or toxin. Therefore, we are proposing to add specific provisions to the biocontainment and biosafety plans that would require completion of a written risk assessment for each procedure. This risk assessment would have to include the following elements: A description of the safeguards in place to protect entity personnel, the public, and the environment from exposure to the select agent or toxin; decontamination procedures; waste management procedures; and procedures for handling select agents and toxins in the same spaces as non-select agents and toxins in order to prevent unintentional cross-contamination.

    We are specifically requesting comments regarding any specific biocontainment or biosafety measures to prevent laboratory acquired infections or accidental or intentional release of the select agents and toxins from an entity into the community.

    Finally, paragraph (c)(2) of 9 CFR 121.12 requires that entities should consider the guidance found in the Occupational Safety and Health Administration regulations in 29 CFR 1910.1200 and 1910.1450. We are proposing to remove this reference as the information in those regulations is also contained in the CDC/National Institutes of Health publication, “Biosafety in Microbiological and Biomedical Laboratories,” which is referenced in paragraph (c)(1) and a second reference is therefore duplicative.

    Training

    We are proposing to amend the regulations in 7 CFR 331.15 and 9 CFR 121.15, which concern provision of mandatory training for staff and visitors who work in or visit areas where select agents or toxins are handled or stored. We are proposing to require that all individuals who have received approval to have access to select agents and toxins must undergo training regardless of whether they have access to those select agents or toxins. The training would have to be completed within a year of that individual's approval or prior to entry into an area where select agents and toxins are used or stored, whichever occurs first. This change is necessary in order to codify our position regarding which individuals at registered entities are required to receive training.

    Transfers

    We are proposing to amend the regulations in 7 CFR 331.16 and 9 CFR 121.16, which concern the transfer of select agents and toxins to a registered entity. Specifically, paragraph (b) states that select agents and toxins may need a permit issued in accordance with 7 CFR part 330 or 9 CFR part 122. We have determined that a permit for the importation or interstate movement of a select agent or toxin listed in 7 CFR 331.3, 9 CFR 121.3, or 121.4 is not required for such importation and/or interstate movement provided that the select agent or toxin is authorized for transfer in accordance with 7 CFR 331.16(b) or 9 CFR 121.16(b).

    Records

    The regulations in 7 CFR 331.17 and 9 CFR 121.17 concern required recordkeeping procedures for regulated entities as those records relate to select agents and toxins. Paragraph (a)(3)(x) requires that registered entities record the destruction of any toxins by specifically noting the quantity of toxin destroyed, the date of such action, and by whom. However, there is not an equivalent requirement regarding the destruction of select agents. We are proposing to add this requirement in order to ensure consistency with the toxin provisions and ensure proper tracking of select agents from acquisition to destruction. These requirements would be added in a new paragraph (a)(1)(ix).

    We are also proposing to require that regulated entities maintain records concerning those select agents that have been rendered nonviable or regulated nucleic acids that have been rendered non-infectious. These records would specifically capture the activities detailed under the heading “Exclusions and Inactivation” above. Such recordkeeping is necessary in order to confirm that an entity has performed the procedures necessary. The select agent program would then have the ability to review those records in order to ensure that the entity is performing all procedures necessary for nonviability or inactivation. The requirements would be added in a new paragraph (a)(8) in 7 CFR 331.17 and 9 CFR 121.17.

    We are also proposing to state that any records created that contain information related to an entity's registration or its select agents and toxins must be provided promptly upon request. This requirement would be added to revised paragraph (c). Given the wide variety of entities regulated under the Federal Select Agent Program, the scope of records readily available for program review will enhance the ability of the program to evaluate entity biosafety, biocontainment, security, and incident response programs. Paragraph (c) in both 7 CFR 331.17 and 9 CFR 121.17 would also be revised to specify that such records may include, but are not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs.

    Finally, paragraph (b) in both 7 CFR 331.17 and 9 CFR 121.17 requires that regulated entities implement a system to ensure that all records and databases created under this part are accurate, have controlled access, and that their authenticity may be verified. To ensure the accuracy of handwritten records, we are proposing to specify that such records must be legible.

    Records for Select Agents in Long-Term Storage

    Paragraph (a)(1) in both 7 CFR 331.17 and 9 CFR 121.17 requires entities to maintain an accurate, current inventory for each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and organisms containing recombinant and/or synthetic nucleic acids) held in long-term storage. We continue to receive comments critical of that portion of the regulations. Criticism is typically focused on the belief that a container-based inventory requirement is not a useful mechanism to track inventory of biological agents, since small amounts could be stolen without detection and used to grow larger quantities.

    However, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 obliges APHIS and CDC to include a requirement for “the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins” in the regulations. We are therefore soliciting comment regarding what regulatory requirement or requirements should be implemented such that a registered entity could quickly determine whether a select agent had been lost or stolen from long-term storage without that registered entity first having an accurate, current inventory for each select agent held in long-term storage. Additionally, we are soliciting ideas concerning ways in which the current regulations could be amended to address the possibility of theft of a select agent from a container held in long-term storage.

    Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

    In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

    The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to human, animal, or plant health, or to animal or plant products. APHIS has completed its fourth biennial review of select agent regulations and is proposing changes that would increase their usability as well as provide for enhanced program oversight. The proposed amendments include provisions to address the inactivation of select agents, provisions addressing biosafety, and clarification of regulatory language concerning security, training, incident response, and records.

    The proposed rule would require that entities develop an agent-specific kill curve in order to define conditions of inactivation for each select agent or regulated infectious nucleic acid and maintain written records of having done so.3 Costs of complying with this amendment are therefore expected to be modest.

    3 The definition of kill curve would be “the results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.”

    Currently, there are 291 entities registered with APHIS and CDC. Of these entities, there are 240 registered to possess Tier 1 select agents and toxins, including 78 academic, 29 commercial, 80 State government, 37 Federal government, and 16 private (non-profit) institutions, most of which are considered to be small entities. Based on proposed record keeping and reporting requirements, an additional 10 to 20 hours per year may be required. At an imputed cost of $33.40 per hour (GS-12, step 2), this additional time requirement per entity would cost between $334 and $668 per year, or in total for all registered entities between $80,000 and $160,000.

    Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

    Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

    Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

    Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), we have determined that there is burden associated with this action. We will publish a separate document in the Federal Register, announcing our determination of burden and soliciting comments on it.

    E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act 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. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

    List of Subjects 7 CFR Part 331

    Agricultural research, Laboratories, Plant diseases and pests, Reporting and recordkeeping requirements.

    9 CFR Part 121

    Agricultural research, Animal diseases, Laboratories, Medical research, Reporting and recordkeeping requirements.

    Accordingly, we propose to amend 7 CFR part 331 and 9 CFR part 121 as follows:

    TITLE 7—AGRICULTURE PART 331—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS 1. The authority citation for part 331 continues to read as follows: Authority:

    7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.3.

    2. Section 331.1 is amended by adding, in alphabetical order, definitions of inactivation and kill curve to read as follows:
    § 331.1 Definitions.

    Inactivation. A method to render a select agent non-viable but retain characteristic of interest for future use, or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

    Kill curve. The results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable, or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.

    3. Section 331.3 is amended as follows: a. In paragraph (b), by removing the words “Peronosclerospora philippinensis (Peronosclerospora sacchari);”, “Phoma glycinicola (formerly Pyrenochaeta glycines);”, and “Sclerophthora rayssiae;” b. By revising paragraph (d)(2). c. By adding paragraph (e)(3).

    The addition and revision read as follows:

    § 331.3 PPQ select agents and toxins.

    (d) * * *

    (2) Nonviable select agents or nonfunctional toxins.

    (i) Unless waived by the Administrator, a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation process to remove viability or infectious form (i.e., the ability to reproduce or produce disease, while maintaining cellular structure) is not excluded from the requirements of this part until an individual or entity:

    (A) Develops a site-specific kill curve to define conditions of inactivation for each select agent or regulated nucleic acids that can produce infectious forms of any select agent virus. If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve must be developed for each strain that undergoes the inactivation procedure. A new kill curve must be created upon any change in procedure or inactivation equipment.

    (B) Develops site-specific standard operating inactivation procedures to ensure that the material is inactivated by a safety margin determined by the kill curve.

    (C) Subjects representative samples of inactivated select agents or any nucleic acids that can produce infectious forms of any select agent viruses to a validated sterility testing protocol to ensure that the inactivation method has rendered the select agent non-viable or regulated nucleic acids non-infectious.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was subjected to a validated inactivation protocol is reported to APHIS.

    (E) Reviews annually, and revises as necessary, the following:

    (1) The kill curve procedure and results;

    (2) Site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent virus are inactivated by a safety margin; and

    (3) The validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus sample non-infectious.

    (F) Reviews, and revises as necessary, documents listed in paragraph (d)(2)(i)(E) of this section after any change in principal investigator, change in protocol, or any reported viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent viruses previously assessed as inactive.

    (ii) Unless waived by the Administrator, an extract from a select agent is not excluded from the requirements of this part until an individual or entity meets the following requirements:

    (A) Any extract is subjected to a process that removes all viable cells, spores, or virus particles.

    (B) Any extract is subjected to a validated sterility testing protocol to ensure that the inactivation method has rendered the extract free of a select agent.

    (C) Any viability of an extract that was subjected to a validated inactivation protocol is reported to the responsible official.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was previously assessed as inactive by their validated sterility testing protocol is reported to APHIS.

    (e) * * *

    (3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

    4. In § 331.5, paragraph (a)(3) is revised to read as follows:
    § 331.5 Exemptions.

    (a) * * *

    (3) The identification of the agent or toxin is reported to APHIS, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS within 7 calendar days after identification.

    5. Section 331.7 is amended as follows: a. By redesignating paragraphs (b) through (k) as paragraphs (c) through (l), respectively. b. By adding a new paragraph (b).

    The addition reads as follows:

    § 331.7 Registration and related security risk assessments.

    (b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. In regard to toxins, the entity registered for possession, use, or transfer of toxins must be in compliance with the requirements of this part regardless of the amounts of toxins currently in possession.

    6. Section 331.9 is amended as follows: a. In paragraph (a)(6), by removing the word “laboratory” and adding the words “registered space” in its place and by adding the words “and the corrections documented” at the end of the second sentence after the words “must be corrected”. b. By adding paragraph (a)(7).

    The addition reads as follows:

    § 331.9 Responsible official.

    (a) * * *

    (7) Ensure that individuals are provided the contact information for the USDA or HHS Office of Inspector General Hotline so that they may anonymously report any biosafety/biocontainment or security concerns related to select agents and toxins.

    7. In § 331.10, paragraph (e) is amended by adding a sentence at the end of the paragraph to read as follows:
    § 331.10 Restricting access to select agents and toxins; security risk assessments.

    (e) * * * A responsible official must immediately notify the responsible official of the visiting entity if the person's access to select agents or toxins has been terminated.

    8. Section 331.11 is amended as follows: a. In paragraph (c)(5), by adding the word “keycards,” after the word “keys,” and by removing the word “numbers” and adding the word “permissions” in its place. b. By adding paragraph (c)(11). c. In paragraph (d)(7)(iv), by removing the word “and”. d. By adding paragraph (d)(7)(vi). e. By adding a sentence at the end of paragraph (h).

    The additions read as follows:

    § 331.11 Security.

    (c) * * *

    (11) Describe how the entity authorizes the means of entry into areas where select agents or toxins are stored or used to include centralized access control management systems (e.g., keycards) and/or mechanical key management.

    (d) * * *

    (7) * * *

    (vi) Any loss of computer, hard drive or other data storage device containing information that can be used to gain access to select agents or toxins.

    (h) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and all individuals who participated in the drill or exercise.

    9. Section 331.12 is amended as follows: a. By revising paragraph (a). b. By adding a sentence at the end of paragraph (e).

    The addition and revision read as follows:

    § 331.12 Biocontainment.

    (a) An individual or entity required to register under this part must develop and implement a written biocontainment plan that is commensurate with the risk of the select agent or toxin, given its intended use.4 The biocontainment plan must contain sufficient information and documentation to describe the biocontainment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. The biocontainment procedures specific to each registered laboratory must be available to each individual working in that laboratory. The current biocontainment plan must be submitted for initial registration, renewal of registration, or when requested. The biocontainment plan must include the following provisions:

    4 Technical assistance and guidance may be obtained by contacting APHIS.

    (1) A written risk assessment for each prescribed procedure involving a select agent or toxin.

    (i) The hazardous characteristics of the agent or toxin listed on the entity's registration, including probable routes of transmission in the laboratory and in the environment, infective dose (if known), stability in the environment, host range, contribution of any genetic manipulations, and endemicity.

    (ii) Hazards associated with laboratory procedures related to the select agent or toxin.

    (2) Safeguards in place with associated containment procedures to protect registered entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Safety training requirements for registered entity personnel performing the procedure; required personal protective equipment; required containment equipment including, but not limited to, biological safety cabinets, arthropod caging systems, and centrifuge safety containers; and required physical plant engineering controls.

    (3) Written procedures for decontamination, with a validated method, of all contaminated or potentially contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents or toxins, personal protective equipment, arthropod caging systems and extracted plant and/or arthropod tissues.

    (4) Written procedures for decontamination, with a validated method, of laboratory surfaces and equipment using manufacturer's specification.

    (5) Effluent decontamination procedures, with a validated method, that describe the treatment of effluent material contaminated with select agents or toxins.

    (6) Procedures to respond to emergencies such as spills, sharps injury, or any other incident involving select agents and toxins.

    (7) Procedures for handling of select agents and toxins in the same spaces as non-select agents and toxins in order to prevent unintentional contamination.

    (e) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and all individuals who participated in the drill or exercise.

    10. Section 331.14 is amended as follows: a. By adding a sentence at the end of paragraph (a). b. By adding a sentence at the end of paragraph (f).

    The additions read as follows:

    § 331.14 Incident response.5

    5 Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations.

    (a) * * * The current incident response plan must be submitted for initial registration, renewal of registration, or when requested.

    (f) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and all individuals who participated in the drill or exercise.

    11. Section 331.15 is amended as follows: a. By revising paragraph (a), introductory text. b. By revising paragraph (a)(1).

    The revisions read as follows:

    § 331.15 Training.

    (a) An individual or entity required to register under this part must provide information and training on biocontainment, security (including security awareness), incident response, and agent- and toxin-specific training to:

    (1) Each individual with access approval from the Administrator, within 12 months of that individual's anniversary of receiving such approval or prior to his or her entry into an area where select agents or toxins are used or stored, whichever occurs first; and

    12. In § 331.16, paragraph (b), introductory text, is revised as follows:
    § 331.16 Transfers.

    (b) A transfer may be authorized if:

    13. Section 331.17 is amended as follows: a. In paragraph (a)(1)(iii), by adding the words “or other storage container” after the word “freezer”. b. By adding paragraph (a)(1)(ix). c. In paragraph (a)(3)(v), by adding the words “or other storage container” after the word “freezer”. d. By adding paragraph (a)(8). e. By adding a sentence at the end of paragraph (b). f. By revising paragraph (c).

    The additions and revision read as follows:

    § 331.17 Records.

    (a) * * *

    (1) * * *

    (ix) If destroyed, the quantity (e.g., containers, vials, tubes, etc.) of select agent destroyed, the date of such action, and by whom.

    (8) For a select agent or an extract from a select agent that has been rendered nonviable or regulated nucleic acids that have been rendered non-infectious:

    (i) A written description of the inactivation process used for rendering a select agent or an extract from a select agent nonviable or regulated nucleic acids non-infectious;

    (ii) The sterility testing protocol used to verify nonviability of a select agent or an extract from a select agent or non-infectivity of regulated nucleic acids and the results of the test, including investigation, of any inactivation process failures and the corrective actions taken;

    (iii) The name of each individual performing the inactivation method and sterility testing protocols;

    (iv) The date(s) the inactivation method and sterility testing protocols were completed;

    (v) The location where the inactivated method and sterility testing protocols were performed; and

    (vi) An inactivation certificate that includes the date of inactivation, method of inactivation, date of final sterility testing protocol result, and the name of the person performing the inactivation. A copy of the inactivation certificate must accompany any transfer of inactivated material.

    (b) * * * All written records created under this part are legible.

    (c) Any records that contain information related to the requirements of the regulations. Such records may include, but are not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years.

    TITLE 9—ANIMALS AND ANIMAL PRODUCTS
    PART 121—POSSESSION, USE, AND TRANSFER OF SELECT AGENTS AND TOXINS 14. The authority citation for part 121 continues to read as follows: Authority:

    7 U.S.C. 8401; 7 CFR 2.22, 2.80, and 371.4.

    15. Section 121.1 is amended by adding, in alphabetical order, definitions of inactivation and kill curve to read as follows:
    § 121.1 Definitions.

    Inactivation. A method to render a select agent non-viable but retain characteristic of interest for future use, or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

    Kill curve. The results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable, or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.

    16. Section 121.3 is amended as follows: a. By revising paragraphs (d)(2) and (d)(3). b. By adding paragraph (d)(4). c. By adding paragraph (e)(3).

    The additions and revisions read as follows:

    § 121.3 VS select agents and toxins.

    (d) * * *

    (2) Nonviable VS select agents or nonfunctional VS toxins.3

    3 However, the importation and interstate movement of these nonviable select agents may be subject to the permit requirements under part 122 of this subchapter.

    (i) Unless waived by the Administrator, a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation process to remove viability or infectious form (i.e., the ability to reproduce or produce disease, while maintaining cellular structure) is not excluded from the requirements of this part until an entity:

    (A) Develops a site-specific kill curve to define conditions of inactivation for each select agent or regulated nucleic acids that can produce infectious forms of any select agent virus. If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve must be developed for each strain that undergoes the inactivation procedure. A new kill curve must be created upon any change in procedure or inactivation equipment.

    (B) Develops site-specific standard operating inactivation procedures to ensure that the material is inactivated by a safety margin determined by the kill curve.

    (C) Subjects representative samples of inactivated select agents or any nucleic acids that can produce infectious forms of any select agent viruses to a validated sterility testing protocol to ensure that the inactivation method has rendered the select agent non-viable or regulated nucleic acids non-infectious.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was subjected to a validated inactivation protocol is reported to APHIS or CDC.

    (E) Reviews annually, and revises as necessary, the following:

    (1) The kill curve procedure and results;

    (2) Site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent virus are inactivated by a safety margin; and

    (3) The validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent viruses non-infectious.

    (F) Reviews, and revises as necessary, documents listed in paragraph (d)(2)(i)(E) of this section after any change in principal investigator, change in protocol, or any reported viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent viruses previously assessed as inactive.

    (ii) Unless waived by the Administrator, an extract from a select agent is not excluded from the requirements of this part until an individual or entity meets the following requirements:

    (A) Any extract is subjected to a process that removes all viable cells, spores, or virus particles.

    (B) Any extract is subjected to a validated sterility testing protocol to ensure that the inactivation method has rendered the extract free of a select agent.

    (C) Any viability of an extract that was subjected to a validated inactivation protocol is reported to the responsible official.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was previously assessed as inactive by their validated sterility testing protocol is reported to APHIS or CDC.

    (E) Reviews annually, and revises as necessary, the following:

    (1) The kill curve procedure and results;

    (2) Site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent viruses are inactivated by a safety margin; and

    (3) The validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent viruses non-infectious.

    (F) Reviews, and revises as necessary, documents listed in paragraph (d)(2)(ii)(E) of this section after any change in principal investigator, change in protocol, or any reported viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus previously assessed as inactive.

    (3) Any low pathogenic strains of avian influenza virus, avian paramyxovirus serotype-1 (APMV-1) viruses which do not meet the criteria for Newcastle disease virus,4 including those identified as pigeon paramyxovirus-12 5 isolated from a non-poultry species, all subspecies Mycoplasma capricolum except subspecies capripneumoniae (contagious caprine pleuropneumonia), and all subspecies Mycoplasma mycoides except subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), provided that the individual or entity can identify that the agent is within the exclusion category.

    4 An APMV-1 virus isolated from poultry which has an intracerebral pathogenicity index in day‐old chicks (Gallus gallus) of 0.7 or greater or has an amino acid sequence at the fusion (F) protein cleavage site that is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.

    5 Pigeon paramyxovirus (PPMV-1) is a species-adapted APMV-1 virus which is endemic in pigeons and doves in the United States and can be identified through monoclonal antibody testing and demonstration of their characteristic amino acid signature at the fusion gene cleavage site.

    (4) Waste generated during the delivery of patient care from a patient infected with a select agent that is decontaminated with a validated method within 7 calendar days of the conclusion of patient care.

    (e) * * *

    (3) An individual or entity may make a written request to the Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

    17. Section 121.4 is amended as follows: a. In paragraph (b), by removing the words “Bacillus anthracis (Pasteur strain);”, “Brucella abortus;”, and “Brucella suis;”. b. In paragraph (c)(1), by redesignating footnote 4 as footnote 6. c. By revising paragraph (d)(2). d. By adding paragraph (d)(4). e. By adding paragraph (e)(3).

    The additions and revision read as follows:

    § 121.4 Overlap select agents and toxins.

    (d) * * *

    (2) Nonviable overlap select agents or nonfunctional overlap toxins.7

    7 However, the importation and interstate movement of these nonviable overlap select agents may be subject to the permit requirements under part 122 of this subchapter.

    (i) Unless waived by the APHIS Administrator or HHS Secretary, a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation process to remove viability or infectious form (i.e., the ability to reproduce or produce disease, while maintaining cellular structure) is not excluded from the requirements of this part until an individual or entity:

    (A) Develops a site-specific kill curve to define conditions of inactivation for each select agent or regulated nucleic acids that can produce infectious forms of any select agent virus. If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve must be developed for each strain that undergoes the inactivation procedure. A new kill curve must be created upon any change in procedure or inactivation equipment.

    (B) Develops site-specific standard operating inactivation procedures to ensure that the material is inactivated by a safety margin determined by the kill curve.

    (C) Subjects representative samples of inactivated select agents or any regulated nucleic acids that can produce infectious forms of any select agent viruses to a validated sterility testing protocol to ensure that the inactivation method has rendered the select agent non-viable or regulated nucleic acids non-infectious.

    (D) Reports any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was subjected to a validated inactivation protocol to the responsible official.

    (E) Reviews annually, and revises as necessary, the following:

    (1) The kill curve procedure and results;

    (2) Site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent virus are inactivated by a safety margin; and

    (3) The validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent viruses non-infectious.

    (F) Reviews, and revises as necessary, documents listed in paragraph (d)(2)(i)(E) of this section after any change in principal investigator, change in protocol, or any reported viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus previously assessed as inactive.

    (ii) Unless waived by the APHIS Administrator or HHS Secretary, an extract from a select agent is not excluded from the requirements of this part until an individual or entity meets the following requirements:

    (A) Any extract is subjected to a process that removes all viable cells, spores, or virus particles.

    (B) Any extract is subjected to a validated sterility testing protocol to ensure that the inactivation method has rendered the extract free of a select agent.

    (C) Any viability of an extract that was subjected to a validated inactivation protocol is reported to the responsible official.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was previously assessed as inactive by the validated sterility testing protocol is reported to APHIS or CDC.

    (4) Waste generated during the delivery of patient care from a patient infected with a select agent that is decontaminated with a validated method within 7 calendar days of the conclusion of patient care.

    (e) * * *

    (3) An individual or entity may make a written request to the Administrator or HHS Secretary for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator or HHS Secretary will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

    18. Section 121.5 is amended as follows: a. By revising paragraphs (a)(2) and (a)(3). b. By adding paragraph (a)(4).

    The addition and revisions read as follows:

    § 121.5 Exemptions for VS select agents and toxins.

    (a) * * *

    (2) The agent or toxin is secured against theft, loss, or release during the period between identification of the agent or toxin and transfer or destruction of such agent or toxin, and any theft, loss, or release of such agent or toxin is reported;

    (3) Unless directed otherwise by the Administrator, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 121.16 or destroyed on-site by a recognized sterilization or inactivation process within 7 calendar days after delivery of patient care has concluded; and

    (4) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.

    19. Section 121.6 is amended as follows: a. In paragraph (a)(2), by removing the word “and” at the end of the paragraph. b. By redesignating paragraph (a)(3) as paragraph (a)(4). c. By adding new paragraph (a)(3). d. By revising newly redesignated paragraph (a)(4).

    The addition and revision read as follows:

    § 121.6 Exemptions for overlap select agents and toxins.

    (a) * * *

    (3) Unless directed otherwise by the Administrator or HHS Secretary, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 121.16, or destroyed on-site by a recognized sterilization or inactivation process within 7 calendar days after delivery of patient care has concluded;

    (4) The identification of the agent or toxin is reported to APHIS or CDC, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS within 7 calendar days after identification.

    20. Section 121.7 is amended as follows: a. By redesignating paragraphs (b) through (k) as paragraphs (c) through (l), respectively. b. By adding a new paragraph (b). c. In paragraph (c)(3), introductory text, by redesignating footnote 6 as footnote 8. d. In paragraph (h)(1), by redesignating footnote 7 as footnote 9.

    The addition reads as follows:

    § 121.7 Registration and related security risk assessments.

    (b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use, or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxin currently in possession.

    § 121.8 [Amended]
    21. In § 121.8, footnote 8 is redesignated as footnote 10. 22. Section 121.9 is amended as follows: a. In paragraph (a)(6), by removing the word “laboratory” and adding the words “registered space” in its place and by adding the words “and the corrections documented” at the end of the second sentence after the words “must be corrected”. b. By adding paragraph (a)(7).

    The addition reads as follows:

    § 121.9 Responsible official.

    (a) * * *

    (7) Ensure that individuals are provided the contact information for the USDA or HHS Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.

    23. In § 121.10, paragraph (e) is amended by adding a sentence at the end of the paragraph to read as follows:
    § 121.10 Restricting access to select agents and toxins; security risk assessments.

    (e) * * * A responsible official must immediately notify the responsible official of the visited entity if the person's access to select agents and toxins has been terminated.

    24. Section 121.11 is amended as follows: a. In paragraph (c)(5), by adding the word “keycards,” after the word “keys,” and by removing the word “numbers” and adding the word “permissions” in its place. b. By adding paragraph (c)(11). c. In paragraph (d)(7)(iv), by removing the word “and”. d. By adding paragraph (d)(7)(vi). e. By adding a sentence at the end of paragraph (h).

    The additions read as follows:

    § 121.11 Security.

    (c) * * *

    (11) Describe how the entity authorizes the means of entry into areas where select agents or toxins are stored or used to include centralized access control management systems (e.g., keycards) and/or mechanical key management.

    (d) * * *

    (7) * * *

    (vi) Any loss of computer, hard drive or other data storage device containing information that could be used to gain access to select agents or toxins.

    (h) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and all individuals who participated in the drill or exercise.

    25. Section 121.12 is amended as follows: a. By revising paragraph (a). b. By removing paragraph (c)(2). c. By redesignating paragraph (c)(3) as paragraph (c)(2), and removing the words “NIH Guidelines for Research Involving Recombinant DNA Molecules” and replacing them with the words “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules”. d. By adding a sentence at the end of paragraph (e).

    The addition and revision read as follows:

    § 121.12 Biosafety.

    (a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use.11 The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. Biosafety and containment procedures specific to each registered laboratory must be available to each individual working in that laboratory. The current biosafety plan must be submitted for initial registration, renewal of registration, or when requested. The biosafety plan must include the following provisions:

    11 Technical assistance and guidance may be obtained by contacting APHIS.

    (1) A written risk assessment for each procedure involving a select agent or toxin that addresses the hazards associated with the agent or toxin.

    (i) The hazardous characteristics of each agent or toxin listed on the entity's registration, including probable routes of transmission in the laboratory and in the environment, infective dose (if known), stability in the environment, host range, contribution of any genetic manipulations, and endemicity.

    (ii) Hazards associated with laboratory procedures related to the select agent or toxin.

    (2) Safeguards in place with associated work practices to protect registered entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Safety training requirements for registered entity personnel performing the procedure; required personal protective equipment and other safety equipment; required containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and required engineering controls and other facility safeguards.

    (3) Written procedures for decontamination, with a validated method, of all contaminated or potentially contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, animal caging systems and bedding, and animal carcasses or extracted tissues.

    (4) Written procedures for decontamination, with a validated method, of laboratory surfaces and equipment using manufacturer's specification.

    (5) Effluent decontamination procedures, with a validated method, that describe the treatment of effluent material contaminated with select agents and toxins.

    (6) Procedures to respond to emergencies such as spills, sharps injury, or animal bites involving select agents and toxins.

    (7) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins in order to prevent unintentional contamination.

    (e) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems identified and corrective action(s) that were taken, and all individuals who participated in the drill or exercise.

    26. Section 121.14 is amended as follows: a. In paragraph (a), by redesignating footnote 11 as footnote 13, and by adding a sentence at the end of the paragraph. b. In paragraph (f), by adding a sentence at the end of the paragraph.

    The additions read as follows:

    § 121.14 Incident response.12

    12 Nothing in this section is meant to supersede or preempt incident response requirements imposed by other statutes or regulations.

    (a) * * * The current incident response plan must be submitted for initial registration, renewal of registration, or when requested.

    (f) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems identified and corrective action(s) that were taken, and all individuals who participated in the drill or exercise.

    27. Section 121.15 is amended as follows: a. By revising paragraphs (a), introductory text, and (a)(1). b. By adding paragraph (e).

    The addition and revisions read as follows:

    § 121.15 Training.

    (a) An individual or entity required to register under this part must provide information and training on biocontainment, biosafety, security (including security awareness), incident response, and agent- and toxin-specific training to:

    (1) Each individual with access approval from the HHS Secretary or Administrator, within 12 months of that individual's anniversary of receiving such approval or prior to his or her entry into an area where select agents or toxins are used or stored, whichever occurs first; and

    (e) The responsible official must ensure and document that individuals are provided the contact information of the HHS or USDA Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.

    28. Section § 121.16 is amended as follows: a. In paragraph (a), by redesignating footnote 12 as footnote 14. b. By revising paragraph (b), introductory text. c. By adding paragraph (l).

    The addition and revision read as follows:

    § 121.16 Transfers.

    (b) A transfer may be authorized if:

    (l) Transfer the amounts only after the transferor uses due diligence and documents that the recipient has a legitimate need (i.e., prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins. Information to be documented includes, but is not limited, to the recipient information, toxin and amount transferred, and declaration that the recipient has legitimate purpose to store and use such toxins.

    29. Section 121.17 is amended as follows: a. In paragraph (a)(1)(iii), by adding the words “or other storage container” after the word “freezer”. b. By adding paragraph (a)(1)(ix). c. In paragraph (a)(3)(v), by adding the words “or other storage container” after the word “freezer”. d. By adding paragraph (a)(8). e. By adding a sentence at the end of paragraph (b). f. By revising paragraph (c).

    The additions and revision read as follows:

    § 121.17 Records.

    (a) * * *

    (1) * * *

    (ix) If destroyed, the quantity (e.g., containers, vials, tubes, etc.) of select agent destroyed, the date of such action, and by whom.

    (8) For a select agent or an extract from a select agent that has been rendered non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus that have been rendered non-infectious through inactivation:

    (i) A written description of the inactivation process used for rendering a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious;

    (ii) The sterility testing protocol used to verify non-viability of a select agent or non-infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus and the results of the test, including investigation, of any inactivation process failures and the corrective actions taken;

    (iii) The name of each individual performing the inactivation method and sterility testing protocols;

    (iv) The date(s) the inactivation method and sterility testing protocols were completed;

    (v) The location where the inactivated method and sterility testing protocols were performed; and

    (vi) An inactivation certificate that includes the date of inactivation, method of inactivation, date of final sterility testing protocol result, and the Principal Investigator. A copy of the inactivation certificate must accompany any transfer of inactivated material.

    (b) * * * All written records created under this part are legible.

    (c) Any records that contain information related to the requirements of the regulations. Such records may include, but are not limited to, certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years.

    Done in Washington, DC, this 8th day of January 2016. Kevin Shea, Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2016-00681 Filed 1-14-16; 4:15 pm] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration 7 CFR Part 810 United States Standards for Sunflower Seed AGENCY:

    Grain Inspection, Packers and Stockyards Administration, USDA.

    ACTION:

    Request for information.

    SUMMARY:

    The United States Department of Agriculture's (USDA) Grain Inspection, Packers, and Stockyards Administration (GIPSA) is seeking comment from the public regarding the United States (U.S.) Standards for Sunflower Seed under the United States Grain Standards Act (USGSA). To ensure that standards and official grading practices remain relevant, GIPSA invites interested parties to comment on whether the current sunflower seed standards and grading practices need to be changed.

    DATES:

    We will consider comments we receive by April 18, 2016.

    ADDRESSES:

    You may submit written or electronic comments on this proposed rule to:

    Mail: Irene Omade, GIPSA, USDA, STOP 3642, 1400 Independence Avenue SW., Room 2530-B, Washington, DC 20250-3604.

    Fax: (202) 690-2173

    Internet: Go to http://www.regulations.gov and follow the on-line instruction for submitting comments.

    All comments will become a matter of public record and should be identified as “U.S. Standards for Sunflower Seed request for information comments,” making reference to the date and page number of this issue of the Federal Register. All comments received become the property of the Federal government, are a part of the public record, and will generally be posted to www.regulations.gov without change. If you send an email comment directly to GIPSA without going through www.regulations.gov, or you submit a comment to GIPSA via fax, the originating email address or telephone number will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. Also, all personal identifying information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    Electronic submissions should avoid the use of special characters, avoid any form of encryption, and be free of any defects or viruses, since these may prevent GIPSA from being able to read and understand, and thus consider your comment.

    GIPSA will post a transcript or report summarizing each substantive oral comment that we receive. This would include comments made at any public meetings hosted by GIPSA during the comment period, unless GIPSA publically announces otherwise.

    All comments will also be available for public inspection at the above address during regular business hours (7 CFR 1.27(b)). Please call the GIPSA Management and Budget Services support staff (202) 720-8479 for an appointment to view the comments.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Greenfield at GIPSA, USDA, 1400 Independence Avenue SW., Washington. DC 20250; Telephone (202) 720-0277; Fax Number (202) 720-1015; email [email protected].

    SUPPLEMENTARY INFORMATION:

    Under the authority of the USGSA (7 U.S.C. 76), GIPSA establishes standards for sunflower seed and other grains regarding kind, class, quality and condition. The sunflower seed standards, established by USDA on September 1, 1984, were last revised in 1988 and appear in the USGSA regulations at 7 CFR 810.1801 through 810.1804. The standards facilitate sunflower seed marketing and define U.S. sunflower seed quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in GIPSA's Grain Inspection Handbook, Book II, Chapter 11, “Sunflower Seed” which also includes standardized procedures for additional quality attributes not used to determine grade, such as moisture content and official criteria. Together, the grading standards and testing procedures allow buyers and sellers to communicate quality requirements, compare sunflower seed quality using equivalent forms of measurement and assist in price discovery.

    GIPSA's grading and inspection services are provided through a network of federal, state, and private laboratories that conduct tests to determine the quality and condition of sunflower seed. These tests are conducted in accordance with applicable standards using approved methodologies and can be applied at any point in the marketing chain. Furthermore, the tests yield rapid, reliable and consistent results. In addition, GIPSA-issued certificates describing the quality and condition of graded sunflower seed are accepted as prima facie evidence in all Federal courts. U.S. Standards for Sunflower Seed and the affiliated grading and testing services offered by GIPSA verify that a seller's sunflower seed meets specified requirements, and ensure that customers receive the quality of sunflower seed they purchased.

    In order for U.S. standards and grading procedures for sunflower seed to remain relevant, GIPSA is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U.S. Standards for Sunflower Seed and inspection procedures.

    Authority:

    7 U.S.C. 71-87K.

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2016-00958 Filed 1-15-16; 8:45 am] BILLING CODE 3410-KD-P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration 7 CFR Part 810 United States Standards for Oats AGENCY:

    Grain Inspection, Packers and Stockyards Administration, USDA.

    ACTION:

    Request for information.

    SUMMARY:

    The United States Department of Agriculture's (USDA) Grain Inspection, Packers, and Stockyards Administration (GIPSA) is seeking comment from the public regarding the United States (U.S.) Standards for Oats under the United States Grain Standards Act (USGSA). To ensure that standards and official grading practices remain relevant, GIPSA invites interested parties to comment on whether the current oats standards and grading practices need to be changed.

    DATES:

    We will consider comments we receive by April 18, 2016.

    ADDRESSES:

    You may submit written or electronic comments on this proposed rule to:

    Mail: Irene Omade, GIPSA, USDA, STOP 3642, 1400 Independence Avenue SW., Room 2530-B, Washington, DC 20250-3604.

    Fax: (202) 690-2173

    Internet: Go to http://www.regulations.gov and follow the on-line instruction for submitting comments.

    All comments will become a matter of public record and should be identified as “U.S. Standards for Oats request for information comments,” making reference to the date and page number of this issue of the Federal Register. All comments received become the property of the Federal government, are a part of the public record, and will generally be posted to www.regulations.gov without change. If you send an email comment directly to GIPSA without going through www.regulations.gov, or you submit a comment to GIPSA via fax, the originating email address or telephone number will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. Also, all personal identifying information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    Electronic submissions should avoid the use of special characters, avoid any form of encryption, and be free of any defects or viruses, since these may prevent GIPSA from being able to read and understand, and thus consider your comment.

    GIPSA will post a transcript or report summarizing each substantive oral comment that we receive. This would include comments made at any public meetings hosted by GIPSA during the comment period, unless GIPSA publically announces otherwise.

    All comments will also be available for public inspection at the above address during regular business hours (7 CFR 1.27(b)). Please call the GIPSA Management and Budget Services support staff (202) 720-8479 for an appointment to view the comments.

    FOR FURTHER INFORMATION CONTACT:

    Greg Giese at GIPSA, USDA, 10383 N. Ambassador Drive, Kansas City, MO 64153; Telephone (816) 891-0460; Fax Number (816) 872-1258; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the authority of the USGSA (7 U.S.C. 76), GIPSA establishes standards for oats and other grains regarding kind, class, quality and condition. The oats standards, established by USDA on June 16, 1919, were last revised in 1988 and appear in the USGSA regulations at 7 CFR 810.1001 through 810.1005. The standards facilitate oats marketing and define U.S. oats quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in GIPSA's Grain Inspection Handbook, Book II, Chapter 7, “Oats” which also includes standardized procedures for additional quality attributes not used to determine grade, such as dockage and moisture content. Together, the grading standards and testing procedures allow buyers and sellers to communicate quality requirements, compare oats quality using equivalent forms of measurement and assist in price discovery.

    GIPSA's grading and inspection services are provided through a network of federal, state, and private laboratories that conduct tests to determine the quality and condition of oats. These tests are conducted in accordance with applicable standards using approved methodologies and can be applied at any point in the marketing chain. Furthermore, the tests yield rapid, reliable and consistent results. In addition, GIPSA-issued certificates describing the quality and condition of graded oats are accepted as prima facie evidence in all Federal courts. U.S. Standards for Oats and the affiliated grading and testing services offered by GIPSA verify that a seller's oats meets specified requirements, and ensure that customers receive the quality of oats they purchased.

    In order for U.S. standards and grading procedures for oats to remain relevant, GIPSA is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U.S. Standards for Oats and inspection procedures.

    Authority:

    7 U.S.C. 71-87K

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2016-00848 Filed 1-15-16; 8:45 am] BILLING CODE 3410-KD-P
    DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 996 [Doc. No. AMS-FV-15-0066; FV16-996-1 PR] Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States; Change to the Quality and Handling Requirements AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would implement a recommendation from the Peanut Standards Board (Board) to revise the minimum quality and handling standards for domestic and imported peanuts marketed in the United States (Standards). The Board advises the Secretary of Agriculture regarding potential changes to the Standards and is comprised of producers and industry representatives. This proposed rule would revise the minimum quality, positive lot identification, and reporting and recordkeeping requirements under the Standards. It would also make numerous other changes to better reflect current industry practices and to revise outdated language. The Board believes these changes would make additional peanuts available for sale, help increase efficiencies, and reduce costs to the industry.

    DATES:

    Comments must be received by March 21, 2016.

    ADDRESSES:

    Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet: http://www.regulations.gov. All comments should reference the document number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: http://www.regulations.gov. All comments submitted in response to this proposal will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above.

    FOR FURTHER INFORMATION CONTACT:

    Jennie M. Varela, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3775, Fax: (863) 291-8614, or Email: [email protected] or [email protected]

    Small businesses may request information on complying with this regulation by contacting Antoinette Carter, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This proposed rule is issued under the Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States (Standards), as amended (7 CFR part 996), as established pursuant to Public Law 107-171, the Farm Security and Rural Investment Act of 2002 (Act). The Standards regulate the quality and handling of domestic and imported peanuts marketed in the United States.

    Executive Order 12866 and Executive Order 13563

    Executive Orders 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action has been designated as a “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has waived the review process.

    Executive Order 13175

    This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.

    Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect and shall not abrogate nor nullify any other statute, whether State or Federal, dealing with the same subjects as this Act; but is intended that all such statutes shall remain in full force and effect except in so far as they are inconsistent herewith or repugnant hereto (7 U.S.C. 587).

    There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.

    The Act requires that USDA take several actions with regard to peanuts marketed in the United States. These include ensuring mandatory inspection on all peanuts marketed in the United States; developing and implementing peanut quality and handling requirements; establishing the Board comprised of producers and industry representatives to advise USDA regarding the quality and handling requirements under the Standards; and modifying those quality and handling requirements when needed. USDA is required by the Act to consult with the Board prior to making any changes to the Standards.

    Pursuant to the Act, USDA has consulted with Board members in its review of the changes to the Standards included in this proposed rule. This proposed rule invites comments on revisions to the minimum quality, positive lot identification, and reporting and recordkeeping requirements under the Standards. This proposal would also make numerous other changes to the Standards to better reflect current industry practices and to revise outdated language. The Board believes these changes would make additional peanuts available for sale, increase efficiencies, and reduce industry costs. These changes were recommended by the Board at its meetings on June 24, 2015, and November 18, 2015.

    The Standards establish minimum incoming and outgoing quality requirements for domestic and imported peanuts marketed in the United States. Mandatory inspection is required to ensure that the quality regulations are met. The Standards also require positive lot identification (PLI) of peanuts so they can be identified and tracked during processing and disposition. Finally, the Standards specify reporting and recordkeeping requirements for handlers and importers.

    Sections 996.30 and 996.31 of the Standards outline the incoming and outgoing quality standards, respectively, for peanuts. The incoming standards currently prescribe specific requirements for segregation, moisture content, and foreign material (stones, dirt, sticks, etc.). The outgoing standards include specific requirements for damage, foreign material, and moisture for both shelled and inshell peanuts. The outgoing standards also require peanuts to be positive lot identified and tested and certified as negative for aflatoxin. Both the incoming and outgoing standards require inspection and certification by the Federal-State Inspection Service.

    Section 996.15 establishes a definition for PLI. Section 996.31 requires PLI on all peanuts designated for human consumption as part of the outgoing standards. Section 996.40 establishes handling standards for peanuts and includes specifics on how PLI will be used throughout the handling process, from initial identification through the sampling and testing process. Section 996.50 outlines the process for reconditioning failing lots and establishes PLI requirements to track and identify the peanuts throughout the reconditioning process. Section 996.74 outlines the compliance requirements for the Standards and includes penalties for failing to maintain proper PLI.

    Sections 996.71 and 996.73 establish the reporting and recordkeeping requirements under the Standards. These sections specify, in part, the reports required and establish what records need to be maintained and for how long.

    The Standards were last revised in 2005. In 2014, the American Peanut Shellers Association (APSA) started a review of the current Standards and developed a proposal to revise the Standards to reflect changes in the industry and to make other changes to bring the Standards up to date. These recommended revisions were shared with USDA and industry representatives and were then presented to the Board at its meeting on June 24, 2015. The Board voted to approve the recommendations from APSA in their entirety. In addition, a subcommittee was created to work with USDA to review and recommend any additional conforming changes to the Standards necessary to facilitate the revisions requested by the industry. At a meeting on November 18, 2015, the Board reviewed the modifications and conforming changes from the subcommittee and USDA, and approved them unanimously. Consequently, this proposed rule would make the following recommended changes.

    This proposed rule would revise the minimum quality requirements under both the incoming and outgoing standards. The industry originally thought the presence of foreign material in incoming peanuts could promote the growth of aflatoxin. Therefore, a limit on the amount of foreign material in incoming peanuts was established. However, the industry no longer believes there to be a correlation between foreign material and aflatoxin. In addition, due to advances in technology, foreign material is easily removed from incoming peanuts, and handlers are able to remove foreign material from incoming peanuts to a level that is lower than the limit currently specified in the incoming standards. Further, most handlers are setting their own tolerances for the presence of foreign material. Eliminating the maximum amount of foreign material that incoming farmers stock peanuts may contain from the Standards would provide additional flexibility by allowing individual handlers to determine the amount of foreign material they would be willing to accept. As such, this proposal would remove the current limit of 10.49 percent on the amount of foreign material that incoming farmers stock peanuts may contain.

    The outgoing quality standards include a table that outlines, in part, requirements for damage, minor defects, foreign material, and moisture. Two of the columns of the table deal with damage and defects. The first of these columns provides the allowance for major damage to unshelled peanuts and kernels, and the second column provides the allowance for minor defects. Currently, the allowance for major damage is 1.5 percent for lots excluding splits and 2 percent for lots of splits. The current allowance for minor defects is 2.5 percent, except for No. 2 Virginia peanuts, for which the allowance for minor defects is 3 percent.

    Under the proposal from APSA, the two columns on damage would be merged into one column and would set one overall allowance for damage for unshelled peanuts, cleaned-inshell peanuts, and kernels of 3.5 percent. Over the years, the industry has found that growing practices such as no till farming and modern harvesting practices have increased the amount of damage to individual kernels. In addition, the shift to new peanut varieties that produce larger kernels has impacted the sampling of peanuts for damage. The larger kernels reduce the number of peanuts in the sample such that damaged kernels have a larger impact on the percentage of damage in the sample size. Increasing the allowable damage would allow additional peanuts to meet the Standards and be shipped for human consumption. In addition, relaxing the damage allowance would allow more lots of peanuts to move without being remilled, helping to reduce handling costs.

    Peanuts are also used for many different products, including outlets where cosmetic damage is not as important, such as peanut butter, where the manufacturers are willing to purchase lots with a higher percentage of damage. Most manufacturers are setting their own tolerance levels for damage based on the products they manufacture. By increasing the amount of allowable damage, more peanuts would be available to be manufactured for human consumption, helping to maximize shipments and improving returns. Therefore, this proposed rule would relax the allowance for damage and defects to 3.5 percent for all unshelled peanuts, kernels, and for cleaned-inshell peanuts.

    This rule would also make changes to the PLI requirements and the recordkeeping and reporting requirements under the Standards. In the Standards, the PLI requirements are used to help maintain the identity of peanuts throughout the handling process, thus maintaining the integrity of lots being shipped to human consumption outlets, lots that are subject to the reconditioning process, and lots that are disposed of in non-human consumption outlets. PLI also helps ensure that peanuts certified for human consumption meet the outgoing requirements for grade and aflatoxin. In addition, the PLI requirements are a useful tool in product traceability and helping to ensure compliance with the Standards.

    The reporting and recordkeeping requirements also play a role in ensuring compliance. Handlers and importers are required to maintain all relevant documentation on the disposition of inedible peanuts. The documentation maintained must be sufficient to document and substantiate the proper disposition of all peanut lots failing grade or aflatoxin quality standards. Reports and records are used to track and document the disposition of peanuts and to substantiate handler and importer compliance with the Standards.

    In 2009, the peanut industry began the process of completely restructuring its tracking and reporting systems under an industry-wide food safety system, utilizing industry experts as well as guidance from the Food and Drug Administration, the Grocery Manufacturers Association, and finished product manufacturers. The industry also decided to work toward meeting the Global Food Safety Initiative (GFSI) standards that were being mandated by many major food manufacturers. GFSI certification requires, in part, that a company shall be able to trace all raw material product lots, including packaging, from its suppliers through all stages of processing and dispatch to its customers. The industry reports that in 2010, the industry had its first audits performed against the GFSI standards, and many in the industry are now certified under a GFSI scheme.

    The purpose of this effort was to reduce the need for multiple audits while providing ongoing assurance of compliance within the industry with food safety initiatives. Under these new industry procedures, all raw peanuts are lot coded, and there is a traceability system in place to track them throughout the handling process. Handlers currently trace all peanuts from the warehouse to final disposition, including edible, blanched, and oil stock. Further, lots are segregated throughout the handling process in order to maintain identity should there be a recall notice issued.

    In reviewing the Standards, the APSA thought it is important to maintain PLI on all lots meeting outgoing requirements. This preserves the integrity of these lots and provides assurance to buyers that the peanuts have met all requirements, have not been commingled with lower grade peanuts, and are ready to be utilized for human consumption. In addition, all peanut manufacturers require the official grade and aflatoxin certificate before taking possession of the peanuts to confirm that the analytical and physical tests required by law have been conducted.

    However, given the industry's new requirements for tracking and traceability, the APSA found the remaining PLI requirements in the Standards to be redundant and no longer necessary. When the Standards were implemented in 2002, the current industry traceability systems had not yet been developed, and PLI was an important tool in maintaining compliance. The new traceability systems are used by the industry to help maintain the identity of peanuts throughout the handling process, the same way PLI is used. These systems are also used to track peanuts that are to be reconditioned or disposed of in non-human consumption outlets, such as for seed or animal feed. The industry reports that each peanut handler has designed a traceability system that is specifically integrated into their operations, and the industry believes that these systems largely perform all the same functions as PLI. Further, these systems were also designed to meet the new demands under food safety requirements, such as the Food Safety and Modernization Act, and the food safety and handling requirements set by the manufacturers. The industry believes having to utilize PLI in addition to its own tracking systems requires additional time and recordkeeping to follow peanuts that already have documented traceability.

    The APSA proposal, as approved by the Board, recommends revision of the Standards to reflect current industry traceability programs. The industry believes that these changes would reduce handling and inspection costs and help improve the efficiency of handling operations. Consequently, this proposed rule would add language to § 996.73 of the Standards to define the necessary requirements for an industry-based traceability system and would provide allowances for systems meeting these requirements to be used in place of PLI prior to inspection and certification. The existing PLI system would also remain in place as a requirement for any handler who does not have a system in place that would meet the requirements for an industry-based traceability system and for any handler who would like to use PLI in conjunction with their own traceability system. However, PLI would still continue to be required for all peanuts meeting the outgoing standards.

    This proposed rule would also revise the reporting and recordkeeping requirements under the Standards. All handlers and importers are currently required to submit to USDA a monthly report documenting their monthly farmers stock acquisitions. Under the proposed changes, the requirement to submit this monthly report would be eliminated. The industry stated that the information contained within the form was already being submitted to USDA on a daily basis as part of the farmers stock inspection process. Further, industry representatives stated that this data is maintained as part of the traceability systems now in place. Therefore, the industry supported the removal of this requirement.

    Additional changes were recommended to recognize the reporting and recordkeeping done by the industry to meet the tracking and traceability requirements now required of the industry for food safety initiatives. In addition to records relating to peanuts meeting the outgoing standards, handlers and importers are required to maintain all relevant documentation on the disposition of inedible peanuts as part of their food safety traceability requirements. Given the traceability and recordkeeping requirements recommended to be added to the Standards and the recordkeeping requirements demanded under food safety requirements, the industry questioned the continued need for USDA to have access to all such records under the Standards. Industry representatives stated that they no longer saw a need for USDA to require regular access to records other than those pertaining to peanuts meeting the outgoing requirements. Consequently, pursuant to the Board-approved recommendation, this proposed rule would modify the reporting requirements to specify that USDA would be permitted to inspect any peanuts meeting outgoing requirements and any and all records pertaining to peanuts meeting outgoing quality regulations. However, pursuant to the Act, the Secretary shall work to provide adequate safeguards regarding all quality concerns related to peanuts. Therefore, this change would not preclude USDA from having access to all materials and records necessary should there be a situation necessitating an investigation or review to ensure compliance. The documentation maintained must still be sufficient to document and substantiate the proper disposition of all peanuts failing grade or aflatoxin quality standards.

    The APSA proposal as approved by the Board also recommended revising the Standards to clarify that handlers and importers are not producing a finished product and that the peanuts would require further processing prior to human consumption. This would include amending the definition for peanuts in the Standards to indicate that the peanuts covered under the Standards are raw peanuts and intended for further processing by manufacturers prior to human consumption. The definitions for inshell and shelled peanuts would also be revised to reflect that the peanuts covered by the Standards are in their raw, natural state. The definition of peanuts would continue to provide that green peanuts, which are raw, for consumption as boiled peanuts are not subject to regulation under the Standards. However, these green peanuts are sold mostly by producers, not by handlers and importers, and make up a small share of the peanut market. The change to the definition for peanuts would also provide that peanuts intended for wildlife are also not subject to regulation under the Standards.

    This change would also eliminate all references to roasting in the Standards to further clarify that handlers and importers are not producing a finished product. At one time, roasting was used to reduce levels of aflatoxin and was included in the Standards for that purpose. However, roasting is no longer used to treat aflatoxin. The Board supported these proposed changes to reduce any confusion that handlers and importers under the Standards are delivering a finished product ready for human consumption.

    Finally, this proposed rule would also make numerous other changes throughout the Standards to update language and to reflect current industry practices and changes. Such changes include a change to the crop year, eliminating language relating to the old quota system, and updating outdated information, such as incorrect addresses, titles, and other contact information. It would also remove the requirement that peanuts testing at or above 301 ppb of aflatoxin can only be disposed of through crushing or export, as cleaning technology has improved to the point that peanuts testing at or above this level may possibly be cleaned to meet the outgoing standards.

    The proposed changes approved by the Board also included a recommendation to remove the lot size limit of 200,000 pounds on peanuts presented for outgoing inspection. However, the 200,000 pound limit is required by USDA and the inspection service to ensure an accurate sampling protocol. Therefore, the 200,000 pound lot limit would be maintained.

    USDA is also adding an additional change under this proposed rule that would revise the requirements for imported peanuts under § 996.60(a). This change would modify how importers submit their entry information to USDA. This section currently references the “stamp and fax” entry process, which is being replaced by the International Trade Data System, a system that will automate the filing of import and export information. This proposed change would revise this section to reflect the new electronic entry process.

    The Board believes these changes would bring the Standards closer in line with current industry practices, make additional peanuts available for sale, help reduce costs, and make operations more efficient. These proposed changes are consistent with the Standards and the Act.

    Initial Regulatory Flexibility Analysis

    Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

    The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened.

    Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms, including handlers and importers, are defined as those having annual receipts of less than $7,000,000 (13 CFR 121.201).

    There are approximately 7,500 peanut producers; 65 peanut handlers, operating approximately 70 shelling plants; and 25 importers subject to regulation under this peanut program.

    An approximation of the number of peanut farms that could be considered small agricultural businesses under the SBA definition can be obtained from the 2012 Agricultural Census, which is the most recent information on the number of farms categorized by size. There were 3,066 peanut farms with annual agricultural sales valued at less than $500,000 in 2012, representing 47 percent of the total number of peanut farms in the U.S. (6,561). According to the National Agricultural Statistics Service (NASS), peanut production for the 2014 and 2015 crop years averaged 5.756 billion pounds. The average value of production for the two-year period was $1.088 billion. The average grower price over the two-year period was $0.25 per pound. Dividing the two-year average production value of $1.088 billion by the approximate number of peanut producers (7,500) results in an average revenue per producer of approximately $145,000, which is well below the SBA threshold for small producers. Based on information and reports received by USDA, more than 50 percent of handlers may be considered small entities. Further, the estimated value of peanuts imported into the United States in 2014 was approximately $64 million. Based on that number, the majority of importers would meet the SBA definition for small agricultural service firms. Consequently, a majority of handlers, importers and producers may be classified as small entities.

    The current 10 custom blanchers, 4 custom remillers, 3 oil mill operators, and 1 USDA and 17 USDA-approved private chemical (aflatoxin) laboratories are subject to this rule to the extent that they must comply with reconditioning provisions under § 996.50 and reporting and recordkeeping requirements under § 996.71. These requirements are applied uniformly to these entities, whether large or small.

    This proposed rule would revise the minimum quality, positive lot identification, and reporting and recordkeeping requirements under the Standards. This proposal would also make numerous other changes to the Standards to better reflect current industry practices and to revise outdated language. The Board believes these changes would make additional peanuts available for sale, help increase efficiencies, and reduce costs to the industry.

    This proposed rule is issued under the Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States, as amended (7 CFR part 996), as established pursuant to Public Law 107-171, the Farm Security and Rural Investment Act of 2002.

    It is not anticipated that this action would impose additional costs on handlers, producers, or importers, regardless of size. Rather, these changes should help the industry reduce costs by helping to increase efficiencies. The industry believes the requirement that they continue to use PLI in addition to its own internal traceability systems creates redundancy and additional costs. By recognizing its internal traceability programs as an alternative to PLI, this should improve efficiencies and reduce costs. In addition, this proposal should also make additional peanuts available for sale, helping to maximize shipments and improving industry returns.

    This proposed rule is expected to benefit the industry. The effects of this rule are not expected to be disproportionately greater or less for small handlers, producers or importers than for larger entities.

    USDA has considered alternatives to these changes. The Act requires USDA to consult with the Board on changes to the Standards. An alternative would be to continue the Standards in their current form. However, the industry believes the proposed changes would increase efficiencies, make additional peanuts available for sale, and help update the Standards. Therefore, because of the anticipated benefits of the recommended changes, this alternative was rejected. USDA has met with the Board, which is representative of the industry, and has included nearly all of its recommendations in this proposed rule.

    The Act specifies in § 1601(c)(2)(A) that the Standards established pursuant to it may be implemented without regard to the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). However, USDA has considered the reporting and recordkeeping burden on handlers and importers under this program. Handlers and importers are only required currently to complete one form, the monthly acquisition of farmers stock peanuts. Under this proposed rule, this requirement would be removed, reducing the reporting burden. Recordkeeping requirements would remain the same. Accordingly, this rule will not impose any additional reporting or recordkeeping requirements on either small or large handlers or importers.

    Section 1601 of the Act also provides that amendments to the Standards may be implemented without extending interested parties an opportunity to comment. However, due to the nature of the proposed changes, interested parties are provided with a 60-day comment period.

    AMS is committed to complying with the E-Government Act 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.

    USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.

    The Board's meetings were widely publicized throughout the peanut industry, and all interested persons were invited to attend and participate in Board deliberations on all issues. Like all Board meetings, the June 26, 2015, and the November 18, 2015, meetings were public meetings, and all entities, both large and small, were able to express views on these issues. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.

    A 60-day comment period is provided to allow interested persons an opportunity to respond to this proposal. All written comments timely received will be considered before a final determination is made on this matter.

    List of Subjects in 7 CFR Part 996

    Food grades and standards, Marketing agreements, Peanuts, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, 7 CFR part 996 is proposed to be amended as follows:

    PART 996—MINIMUM QUALITY AND HANDLING STANDARDS FOR DOMESTIC AND IMPORTED PEANUTS MARKETED IN THE UNITED STATES 1. The authority citation for 7 CFR part 996 continues to read as follows: Authority:

    7 U.S.C. 7958.

    2. Section 996.3 is revised to read as follows:
    § 996.3 Crop year.

    Crop year means the calendar year in which the peanuts were planted as documented by the applicant for inspection.

    3. Section 996.9 is revised to read as follows:
    § 996.9 Inshell peanuts.

    Inshell peanuts means peanuts, the kernel or edible portions of which are contained in the shell in their raw or natural state which are milled but unshelled.

    4. Section 996.10 is revised to read as follows:
    § 996.10 Inspection Service.

    Inspection Service means the Federal Inspection Service, Specialty Crops Program, Agricultural Marketing Service, USDA, or the Federal-State Inspection Service.

    5. Section 996.12 is revised to read as follows:
    § 996.12 Outgoing inspection.

    Outgoing inspection means the sampling, inspection, and certification of either: shelled peanuts which have been cleaned, sorted, sized, and otherwise prepared for further processing; or inshell peanuts which have been cleaned, sorted, and otherwise prepared for further processing.

    6. The introductory paragraph of § 996.13 is revised to read as follows:
    § 996.13 Peanuts.

    Peanuts means the seeds of the legume Arachis hypogaea and includes both inshell and shelled peanuts produced in the United States or imported from foreign countries and intended for further processing prior to consumption by humans or animals, other than those intended for wildlife or those in green form for consumption as boiled peanuts.

    7. Section 996.15 is revised to read as follows:
    § 996.15 Positive lot identification.

    Positive lot identification is a means of identifying those peanuts meeting outgoing quality regulations as defined in § 996.31 and relating the inspection certificate issued by the Inspection Service, as defined in § 996.10, to the lot covered so that there is no doubt that the peanuts in the lot are the same peanuts described on the inspection certificate.

    § 996.17 [Removed and reserved]
    8. Section 996.17 is removed and reserved. 9. Section 996.19 is revised to read as follows:
    § 996.19 Shelled peanuts.

    Shelled peanuts means the kernels or portions of kernels of peanuts in their raw or natural state after the shells are removed.

    § 996.30 [Amended]
    10. Section 996.30 is amended by removing paragraphs (c) and (d). 11. Section 996.31 is amended by revising the table under paragraph (a), and paragraph (b)(2) to read as follows:
    § 996.31 Outgoing quality standards.

    (a) * * *

    Minimum Quality Standards—Peanuts for Human Consumption [Whole kernels and splits: Maximum limitations] Type and grade category Unshelled peanuts and damaged
  • kernels and
  • minor defects
  • (percent)
  • Total fall through Sound whole kernels and/or sound split and broken kernels Foreign
  • materials
  • (percent)
  • Moisture
  • (percent)
  • Excluding Lots of “splits Runner 3.50 6.00%; 17/64 inch round screen .20 9.00 Virginia (except No. 2) 3.50 6.00%; 17/64 inch round screen .20 9.00 Spanish and Valencia 3.50 6.00%; 16/64 inch round screen .20 9.00 No. 2 Virginia 3.50 6.00%; 17/64 inch round screen .20 9.00 Runner with splits (not more than 15% sound splits) 3.50 6.00%; 17/64 inch round screen .20 9.00 Virginia with splits (not more than 15% sound splits) 3.50 6.00%; 17/64 inch round screen .20 9.00 Spanish and Valencia with splits (not more than 15% sound splits) 3.50 6.00%; 16/64 inch round screen .20 9.00 Lots of “splits” Runner (not less than 90% splits) 3.50 6.00%; 17/64 inch round screen .20 9.00 Virginia (not less than 90% splits) 3.50 6.00%; 17/64 inch round screen .20 9.00 Spanish and Valencia (not less than 90% splits) 3.50 6.00%; 16/64 inch round screen .20 9.00

    (b) * * *

    (1) * * *

    (2) Not more than 3.50 percent peanuts with damaged or defective kernels;

    12. In § 996.40, paragraph (a), the last sentence of paragraph (b)(2), and paragraphs (b)(5) and (b)(6) are revised to read as follows:
    § 996.40 Handling standards.

    (a) Identification: Each lot of shelled or cleaned-inshell peanuts intended for human consumption shall be identified by positive lot identification prior to being shipped or otherwise disposed of. Positive lot identification (PLI) methods are tailored to the size and containerization of the lot, by warehouse storage or space requirements, or by necessary further movement of the lot prior to certification. Positive lot identification is established by the Inspection Service and includes the following methods of identification. For domestic lots and repackaged import lots, PLI includes PLI stickers, tags or seals applied to each individual package or container in such a manner that is acceptable to the Inspection Service and maintains the identity of the lot. For imported lots, PLI tape may be used to wrap bags or boxes on pallets, PLI stickers may be used to cover the shrink-wrap overlap, doors may be sealed to isolate the lot, bags or boxes may be stenciled with a lot number, or any other means that is acceptable to the Inspection Service. The crop year means the calendar year in which the peanuts were planted as documented by the applicant. All lots of shelled and cleaned-inshell peanuts shall be shipped under positive lot identification procedures. However, peanut lots failing to meet quality requirements may be moved from a handler's facility to another facility owned by the same handler or another handler without PLI so long as such handler maintains a satisfactory records system for traceability purposes as defined in § 996.73.

    (b) * * *

    (2) * * * Both Subsamples 1-AB and 1-CD shall be accompanied by a notice of sampling or grade certificate, signed by the inspector, containing, at least, identifying information as to the handler or importer, and the positive lot identification of the shelled peanuts.

    (5) Handlers and importers may make arrangements for required inspection and certification by contacting the Inspection Service office closest to where the peanuts will be made available for sampling. For questions regarding inspection services, a list of Federal or Federal-State Inspection Service offices, or for further assistance, handlers and importers may contact: Specialty Crops Inspection Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., Room 1536-S, (STOP 0240), Washington, DC, 20250-0240; Telephone: (202) 720-5870; Fax: (202) 720-0393.

    (6) Handlers and importers may make arrangements for required chemical analysis for aflatoxin content at the nearest USDA or USDA-approved laboratory. For further information concerning chemical analysis and a list of laboratories authorized to conduct such analysis contact: Science and Technology Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0270, Washington, DC 20250-0270; Telephone (202) 690-0621; Fax (202) 720-4631.

    13. In § 996.50: a. Revise paragraph (a); b. Remove paragraph (b)(2); c. Redesignate paragraph (b)(1) as new paragraph (b)(2); Redesignate paragraph (b) introductory text as (b)(1) and revise it; d. Remove paragraph (e); e. Redesignate paragraphs (f), (g), (h), and (i) as paragraphs (e), (f), (g), and (h), respectively; and d. Revise newly redesignated paragraphs (e) and (f).

    The revisions read as follows:

    § 996.50 Reconditioning failing quality peanuts.

    (a) Lots of peanuts which have not been certified as meeting the requirements for disposition to human consumption outlets may be disposed for non-human consumption uses: Provided, That each such lot is positive lot identified using red tags, identified using a traceability system as defined in § 996.73, or other methods acceptable to the Inspection Service, and certified as to aflatoxin content (actual numerical count), unless they are designated for crushing. However, on the shipping papers covering the disposition of each such lot, the handler or importer shall cause the following statement to be shown: “The peanuts covered by this bill of lading (or invoice, etc.) are not to be used for human consumption.”

    (b)(1) Sheller oil stock residuals shall be positive lot identified using red tags, identified using a traceability system as defined in § 996.73, or other methods acceptable to the Inspection Service, and may be disposed of domestically or to the export market in bulk or bags or other suitable containers. Disposition to crushing may be to approved crushers. However, sheller oil stock residuals may be moved from a handler's facility to another facility owned by the same handler or another handler without PLI so long as such handler maintains a satisfactory records system for traceability purposes as defined in § 996.73.

    (e) Lots of shelled peanuts moved for remilling or blanching shall be positive lot identified and accompanied by valid grade inspection certificate, Except That, a handler's shelled peanuts may be moved without PLI and grade inspection to the handler's blanching facility that blanches only the handler's peanuts. Lots of shelled peanuts may be moved for remilling or blanching to another handler without PLI if the handler uses a traceability system as defined in § 996.73, Except That, any grade inspection certificates associated with these lots would no longer be valid. The title of such peanuts shall be retained by the handler or importer until the peanuts have been certified by the Inspection Service as meeting the outgoing quality standards specified in the table in § 996.31(a). Remilling or blanching under the provisions of this paragraph shall be performed only by those remillers and blanchers approved by USDA. Such approved entities must agree to comply with the handling standards in this part and to report dispositions of all failing peanuts and residual peanuts to USDA, unless they are designated for crushing.

    (f) Residual peanuts resulting from remilling or blanching of peanuts shall be red tagged, identified using a traceability system as defined in § 996.73, or identified by other means acceptable to the Inspection Service, and returned directly to the handler for further disposition or, in the alternative, such residual peanuts shall be positive lot identified by the Inspection Service and shall be disposed of to handlers who are crushers, or to approved crushers, Except That, a handler may move the residual peanuts without PLI to a facility for crushing owned by the handler. Handlers who are crushers and crushers approved by USDA must agree to comply with the terms and conditions of this part.

    14. In § 996.60: a. Revise paragraph (a); b. Remove paragraphs (b) and (c); and c. Redesignate paragraph (d) as paragraphs (b).

    The revisions read as follows:

    § 996.60 Safeguard procedures for imported peanuts.

    (a) Prior to arrival of a foreign-produced peanut lot at a port-of-entry, the importer, or customs broker acting on behalf of the importer, shall submit information electronically to the United States Customs and Border Protection, which includes the following: the Customs Service entry number; the container number(s) or other identification of the lot(s); the volume of the peanuts in each lot being entered; the inland shipment destination where the lot will be made available for inspection; and a contact name or telephone number at the destination.

    15. In § 996.71: a. Remove paragraph (a); b. Redesignate paragraphs (b) and (c) as paragraphs (a) and (b), respectively; c. Revise newly redesignated paragraph (a); and d. Revise the last sentence in newly redesignated paragraph (b).

    The revisions read as follows:

    § 996.71 Reports and recordkeeping.

    (a) Each handler and importer shall maintain a satisfactory records system for traceability purposes as defined in § 996.73.

    (b) * * * USDA and USDA-approved laboratories shall file copies of all aflatoxin certificates completed by such laboratories with the Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1124 1st Street South, Winter Haven, Florida 33880; Telephone (863) 324-3375, Fax: (863) 291-8614, or other address as determined by USDA.

    16. Section 996.73 is revised to read as follows:
    § 996.73 Verification of reports.

    (a) For the purpose of checking and verifying reports kept by handlers and importers and the operation of handlers and importers under the provisions of this Part, the officers, employees or duly authorized agents of USDA shall have access to any premises where peanuts may be held at any time during reasonable business hours and shall be permitted to inspect any peanuts that meet outgoing quality regulations, so held by such handler or importer and any and all records of such handler with respect to the acquisition, holding, or disposition of all peanuts meeting outgoing quality regulations, which may be held or which may have been disposed by handler.

    (b) Reports shall be maintained by the handler for nonconforming products to assure traceability throughout the supply chain. The traceability system must include documented records, which enable a full product history to be produced in a timely manner and must ensure product can be traced forward (raw material to distribution) and backwards from distribution to the warehouse feeding the shelling plant, and ensure that all associated tests and all relevant records have been completed. The traceability system shall include identification of all raw materials, process parameters (for specific lot), packaging and final disposition. The handler shall be able to identify the warehouse in which the peanuts were stored immediately prior to shelling. Traceability must be maintained throughout production runs with specific lot codes, and there shall be complete linkage from raw material receipt through final disposition.

    17. In § 996.74: a. Remove paragraph (a)(1); b. Redesignate paragraphs (a)(2) through (7) as paragraphs (a)(1) through (6), respectively; c. Revise newly redesignated paragraphs (a)(3) and (a)(5); and d. Revise paragraph (b).

    The revisions read as follows:

    § 996.74 Compliance.

    (a) * * *

    (3) Commingles failing quality peanuts with certified edible quality peanuts and ships the commingled lot for human consumption use without meeting outgoing quality regulations;

    (5) Fails to maintain and provide access to records, pursuant to § 996.71, and the standards for traceability and nonconforming product disposition pursuant to § 996.73, on the reconditioning or disposition of peanuts acquired by such handler or importer; and on lots that meet outgoing quality standards; or

    (b) Any peanut lot shipped which fails to meet the outgoing quality standards specified in § 996.31, and is not reconditioned to meet such standards, or is not disposed to non-human consumption outlets as specified in § 996.50, shall be reported by USDA to the Food and Drug Administration and listed on an Agricultural Marketing Service Web site.

    18. Section 996.75 is revised to read as follows:
    § 996.75 Effective time.

    The provisions of this part, as well as any amendments, shall apply to current crop year peanuts, subsequent crop year peanuts, and prior crop year peanuts not yet inspected, or failing peanut lots that have not met disposition standards, and shall continue in force and effect until modified, suspended, or terminated.

    Dated: January 13, 2016. Erin Morris, Associate Administrator, Agricultural Marketing Service.
    [FR Doc. 2016-00843 Filed 1-15-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-8465; Directorate Identifier 2014-NM-239-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.) AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2001-12-18, for certain CASA Model CN-235 series airplanes. AD 2001-12-18 currently requires modification of the rigging of the engine control cable assembly and replacement of either the entire engine control cable assembly or a segment of the control cables. Since we issued AD 2001-12-18, we have received reports of new occurrences of cable disruption on a certain part number; the disruption is caused by microcracks along the cable surface. This proposed AD would retain the requirements of AD 2001-12-18. This proposed AD would also require repetitive replacements of each power lever and condition lever Teleflex cable with a new or serviceable part and would remove airplanes from the applicability. We are proposing this AD to prevent fatigue of the engine control cables, leading to breakage of the cables, which could result in reduced controllability of the airplane.

    DATES:

    We must receive comments on this proposed AD by March 4, 2016.

    ADDRESSES:

    You may send comments by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-493-2251.

    Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this proposed rule, contact EADS-CASA, Military Transport Aircraft Division (MTAD), Integrated Customer Services (ICS), Technical Services, Avenida de Aragón 404, 28022 Madrid, Spain; telephone +34 91 585 55 84; fax +34 91 585 55 05; email [email protected]; Internet http://www.eads.net. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8465; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-8465; Directorate Identifier 2014-NM-239-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    On June 11, 2001, we issued AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001). AD 2001-12-18 requires actions intended to address an unsafe condition on certain CASA Model CN-235 series airplanes.

    Since we issued AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001), we have received reports of new occurrences of cable disruption on part number (P/N) 72830-20; the disruption is caused by microcracks along the cable surface.

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0262, dated December 5, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Defense and Space S.A. Model CN-235-100 and -200 airplanes. The MCAI states:

    Three occurrences of cable disruption were reported in 1999. The failed parts, having a part number (P/N) 7-44728-20, were part of the engine control system assembly P/N 7-44728-12. Two cables were connected to the Power Lever and one cable to the Condition Lever control. Service records of the affected parts showed that each cable accumulated more than 14,000 flight cycles (FC).

    The subsequent investigation determined that the disruption was attributed to fatigue related crack.

    This condition, if not corrected, could lead to failure of the engine control system resulting in a loss of the affected engine control.

    Prompted by this unsafe condition, DGAC [Dirección General de Aviación Civil] Spain issued AD 03/00 [which corresponds to FAA AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001] to require rigging of the throttle stops, and one-time replacement of the affected engine control cable assembly (P/N 7-44728-12), or the affected cable (P/N 7-44728-20) before exceeding 12,000 FC.

    After that [DGAC Spain] AD was issued, a new occurrence of cable (P/N 72830-20) disruption was reported. In that case, the affected cable was part of the Condition Lever control and had accumulated 8,497 flight hours (FH) and 8,858 FC. Fractographic analysis of the affected cable identified that the fatigue nucleation seemed to have been induced by microcracks along the cable surface. Additionally, another case of control cable (P/N 72830-20) failure was reported, where the affected part accumulated 9,936 FH and 10,552 FC and was part of the Power Lever control. Investigation of the latter case identified again a fatigue nucleation to be the cause of the cable failure.

    To address this potentially unsafe condition, Airbus Military issued Alert Operators Transmission (AOT) AOT-CN235-76-0001 to provide a repetitive replacement interval and instructions.

    For the reasons described above, this [EASA] AD retains the requirements of DGAC Spain AD No. 03/00, which is superseded, but requires repetitive replacement [at reduced thresholds] of the affected Teleflex cables.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8465.

    Related Service Information Under 1 CFR Part 51

    Airbus Defense and Space S.A. has issued Airbus Military Alert Operators Transmission, dated May 27, 2014. The service information describes repetitive replacements of each power lever and condition lever Teleflex cable with a new or serviceable part. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

    Differences Between This Proposed AD and the MCAI or Service Information

    EASA Airworthiness Directive 2014-0262, dated December 5, 2014, specifies an applicability for Airbus Defense and Space S.A. Model CN-235-100 and -200 airplanes, serial numbers C-016 through C-073. This AD specifies an applicability for Model CN-235 airplanes, serial numbers C-001 through C-015 inclusive and serial number C-074; and Model CN-235-100 and -200 airplanes, serial numbers C-016 through C-073 inclusive. The retained one-time action in paragraph (g) of this proposed AD is also applicable to Model CN-235 airplanes, serial numbers C-001 through C-015 inclusive and serial number C-074, which are missing from EASA AD 2014-0262, dated December 5, 2014. We understand EASA considered Model CN-235 airplanes with these serial numbers that have already performed this one-time action. For this reason, Model CN-235 airplanes, serial numbers C-001 through C-015 inclusive and serial number C-074 are added to this proposed AD. This issue has been coordinated with EASA.

    Costs of Compliance

    We estimate that this proposed AD affects 3 airplanes of U.S. registry.

    The rigging required by AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001), and retained in this proposed AD takes about 8 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the rigging required by AD 2001-12-18 is $680 per product.

    The replacement required by AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001), and retained in this proposed AD takes about 47 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $1,444 per product. Based on these figures, the estimated cost of the replacement required by AD 2001-12-18 is $5,439 per product.

    We also estimate that it would take about 47 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $6,480 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $31,425, or $10,475 per product.

    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

    We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    1. Is not a “significant regulatory action” under Executive Order 12866;

    2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

    3. Will not affect intrastate aviation in Alaska; and

    4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001) and adding the following new AD: Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.): Docket No. FAA-2015-8465; Directorate Identifier 2014-NM-239-AD. (a) Comments Due Date

    We must receive comments by March 4, 2016.

    (b) Affected ADs

    This AD replaces AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001).

    (c) Applicability

    This AD applies to Airbus Defense and Space S.A. (Formerly Known as Construcciones Aeronauticas, S.A.) Model CN-235 airplanes, serial numbers C-001 through C-015, inclusive and serial number C-074; and Model CN-235-100 and -200 airplanes, serial numbers C-001 through C-074, inclusive; certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 76, Engine Controls.

    (e) Reason

    This AD was prompted by reports of new occurrences of cable disruption on a certain part number; the disruption is caused by microcracks along the cable surface. We are issuing this AD to prevent fatigue of the engine control cables, leading to breakage of the cables, which could result in reduced controllability of the airplane.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Retained Action for the Power Lever and Condition Lever Control Stops, With No Changes

    This paragraph restates the requirements of paragraph (a) of AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001). Within 15 days after July 25, 2001 (the effective date of AD 2001-12-18): Rig the power lever and condition lever control stops, in accordance with CASA COM 235-140, Revision 01, dated March 21, 2000.

    (h) New Requirement of This AD: Replacement

    At the applicable compliance times specified in table 1 to paragraph (h) of this AD: Replace each power lever and condition lever Teleflex cable having part number (P/N) 72830-20 with a new or serviceable part, in accordance with Airbus Military Alert Operators Transmission AOT-CN235-76-0001, dated May 27, 2014. Repeat the replacement thereafter at intervals not to exceed an accumulation of 5,000 total flight cycles on each Teleflex cable having P/N 72830-20.

    Table 1 to Paragraph (h) of This AD—Replacement Compliance Time Total flight cycles accumulated on the Teleflex cable having P/N 72830-20 (since first installation on an airplane) as of the effective date of this AD Compliance time Fewer than 4,700 total flight cycles Before accumulating 5,000 total flight cycles. 4,700 or more, but fewer than 6,000 total flight cycles Within 300 flight cycles or 12 months after the effective date of this AD, whichever occurs first. Equal to or more than 6,000 total flight cycles but fewer than 7,000 total flight cycles Within 200 flight cycles or 6 months after the effective date of this AD, whichever occurs first. Equal to or more than 7,000 total flight cycles Within 100 flight cycles or 3 months after the effective date of this AD, whichever occurs first. (i) Parts Installation Limitations

    As of the effective date of this AD, no person may install, on any airplane, a Teleflex cable having P/N 72830-20, unless the cable has accumulated fewer than 5,000 total flight cycles since its first installation on an airplane.

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

    (2) Contacting the Manufacturer: As of the effective date of this AD, for any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or EADS CASA's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2014-0262, dated December 5, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8465.

    (2) For service information identified in this AD, contact EADS-CASA, Military Transport Aircraft Division (MTAD), Integrated Customer Services (ICS), Technical Services, Avenida de Aragón 404, 28022 Madrid, Spain; telephone +34 91 585 55 84; fax +34 91 585 55 05; email [email protected]; Internet http://www.eads.net. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on December 31, 2015. Phil Forde, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-00377 Filed 1-15-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-8464; Directorate Identifier 2015-NM-050-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc. Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all Bombardier, Inc. Model DHC-8-400 series airplanes. This proposed AD was prompted by a revision by the manufacturer to the Certification Maintenance Requirements (CMR) of the Airworthiness Limitation Items (ALI), in the Maintenance Requirement Manual (MRM), that introduces a new CMR task that requires repetitive operational checks of the propeller overspeed governor. This proposed AD would require revising the airplane maintenance program or inspection program, as applicable, to incorporate a new CMR task. We are proposing this AD to prevent dormant failure of the propeller overspeed governor, which may lead to a loss of propeller overspeed protection and result in high propeller drag in-flight.

    DATES:

    We must receive comments on this proposed AD by March 4, 2016.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-493-2251.

    Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8464; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Mazdak Hobbi, Aerospace Engineer, Propulsion and Services Branch, ANE-173, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7330; fax 516-794-5531.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2015-8464; Directorate Identifier 2015-NM-050-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2014-43, dated December 18, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Bombardier, Inc. Model DHC-8-400 series airplanes. The MCAI states:

    Bombardier Inc. has revised the Maintenance Requirement Manual PSM-1-84-7, Airworthiness Limitation Items (ALI), Part 2, Section 1, Certification Maintenance Requirements (CMR). This revision introduces a new CMR task, task number 612000-109, for the Operational Check of the Propeller Overspeed Governor to be performed every 200 flight hours.

    This new task was introduced to minimize the probability of dormant failure of the propeller overspeed governor, which may lead to a loss of propeller overspeed protection and result in high propeller drag in-flight.

    This [Canadian] AD is issued to mandate the incorporation of a new CMR task for the Propeller Overspeed Governor.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8464.

    FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

    This AD requires revisions to certain operator maintenance documents to include new actions (e.g., inspections). Compliance with these actions is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (h)(1) of this AD. The request should include a description of changes to the required inspections that will ensure the continued operational safety of the airplane.

    Costs of Compliance

    We estimate that this proposed AD affects 82 airplanes of U.S. registry.

    We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $6,970, or $85 per product.

    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

    We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    1. Is not a “significant regulatory action” under Executive Order 12866;

    2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

    3. Will not affect intrastate aviation in Alaska; and

    4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Bombardier, Inc.: Docket No. FAA-2015-8464; Directorate Identifier 2015-NM-050-AD. (a) Comments Due Date

    We must receive comments by March 4, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all Bombardier, Inc. Model DHC-8-400, -401, and -402 airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 61, Propellers/propulsors.

    (e) Reason

    This AD was prompted by a revision by the manufacturer to the Certification Maintenance Requirements (CMR) of the Airworthiness Limitation Items (ALI), in the Maintenance Requirement Manual (MRM), that introduces a new CMR task that requires repetitive operational checks of the propeller overspeed governor. We are issuing this AD to prevent dormant failure of the propeller overspeed governor, which may lead to a loss of propeller overspeed protection and result in high propeller drag in-flight.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Maintenance Program or Inspection Program Revision

    Within 30 days after the effective date of this AD, revise the maintenance program or inspection program, as applicable, to incorporate an operational check of the propeller overspeed governor, CMR task number 612000-109, to be performed every 200 flight hours, using a method approved by the Manager, New York Aircraft Certification Office (ACO), ANE-170, FAA.

    Note 1 to paragraph (g) of this AD:

    CMR task number 612000-109, Operational Check of the Propeller Overspeed Governor, in the MRM PSM-1-84-7, ALI, Part 2, Section 1, CMR, is an additional source of guidance for the operational check of the propeller overspeed governor specified in paragraph (g) of this AD.

    (h) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO, ANE-170, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE-170, Engine and Propeller Directorate, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (i) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2014-43, dated December 18, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8464.

    Issued in Renton, Washington, on December 31, 2015. Phil Forde, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-00375 Filed 1-15-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF LABOR Office of Workers' Compensation Programs 20 CFR Part 30 RIN 1240-AA08 Claims for Compensation Under the Energy Employees Occupational Illness Compensation Program Act AGENCY:

    Office of Workers' Compensation Programs, Department of Labor.

    ACTION:

    Notice of proposed rulemaking; extension of comment period.

    SUMMARY:

    The Department of Labor is extending the comment period for the notice of proposed rulemaking it published on November 18, 2015 (80 FR 72296). The original deadline to submit comments on the proposed regulations was January 19, 2016. That comment period is being extended for an additional 30 days. The comment period for the information collection requirements in the proposed rule ended on December 18, 2015, and that period is not being extended.

    DATES:

    The comment period for the notice of proposed rulemaking published on November 18, 2015 (80 FR 72296) is extended. Comments on the notice of proposed rulemaking must be received by February 18, 2016.

    ADDRESSES:

    Parties may submit comments on the regulations in the proposed rule, identified by Regulatory Information Number (RIN) 1240-AA08, by any ONE of the following methods:

    Federal e-Rulemaking Portal: The Internet address to submit comments on the regulations in the proposed rule is www.regulations.gov. Follow the Web site instructions for submitting comments. Comments will also be available for public inspection on the Web site.

    Mail or Hand Delivery: Submit written comments by mail to Rachel P. Leiton, Director, Division of Energy Employees Occupational Illness Compensation, Office of Workers' Compensation Programs, U.S. Department of Labor, Room C-3321, 200 Constitution Avenue NW., Washington, DC 20210. The Department will only consider mailed comments that have been postmarked by the U.S. Postal Service or other delivery service on or before the deadline for comments.

    Instructions: All comments must cite RIN 1240-AA08 that has been assigned to this rulemaking. Receipt of any comments, whether by Internet, mail or hand delivery, will not be acknowledged.

    FOR FURTHER INFORMATION CONTACT:

    Rachel P. Leiton, Director, Division of Energy Employees Occupational Illness Compensation, Office of Workers' Compensation Programs, U.S. Department of Labor, Room C-3321, 200 Constitution Avenue NW., Washington, DC 20210, Telephone: 202-693-0081 (this is not a toll-free number).

    Individuals with hearing or speech impairments may access this telephone number via TTY by calling the toll-free Federal Information Relay Service at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    In response to requests from members of the public, the Department has decided to extend the public comment period for the notice of proposed rulemaking it published on November 18, 2015 (80 FR 72296). The 60-day comment period that was originally scheduled to close on January 19, 2016 is being extended for another 30 days through February 18, 2016.

    The notice of proposed rulemaking contains changes to the regulations governing the administration of the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA or Act), 42 U.S.C. 7384 et seq., which was originally enacted on October 30, 2000. The initial version of EEOICPA established a compensation program (known as Part B of the Act) to provide a uniform lump-sum payment of $150,000 and medical benefits as compensation to covered employees who had sustained designated illnesses due to their exposure to radiation, beryllium or silica while in the performance of duty for DOE and certain of its vendors, contractors and subcontractors. Part B of the Act also provides for payment of compensation to certain survivors of these covered employees, and for payment of a smaller uniform lump-sum ($50,000) to individuals (who would also receive medical benefits), or their survivors, who were determined to be eligible for compensation under section 5 of the Radiation Exposure Compensation Act (RECA), 42 U.S.C. 2210 note, by DOJ. Primary responsibility for the administration of Part B of the Act was assigned to DOL by Executive Order 13179 (“Providing Compensation to America's Nuclear Weapons Workers”) of December 7, 2000 (65 FR 77487).

    The initial version of EEOICPA also created a second program (known as Part D of the Act) that required DOE to establish a system by which DOE contractor employees (and their eligible survivors) could seek assistance from DOE in obtaining state workers' compensation benefits if a Physicians Panel determined that the employee in question had sustained a covered illness as a result of work-related exposure to a toxic substance at a DOE facility. A positive panel finding that was accepted by DOE required DOE, to the extent permitted by law, to order its contractor not to contest the claim for state workers' compensation benefits. However, Congress amended EEOICPA in Subtitle E of Title XXXI of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005, Public Law 108-375, 118 Stat. 1811, 2178 (October 28, 2004), by abolishing Part D of the Act and creating a new Part E (codified at 42 U.S.C. 7385s through 7385s-15) that it assigned to DOL for administration. Part E established a new system of variable federal payments for DOE contractor employees, uranium workers covered by section 5 of RECA, and eligible survivors of such employees.

    Leonard J. Howie III, Director, Office of Workers' Compensation Programs.
    [FR Doc. 2016-00835 Filed 1-15-16; 8:45 am] BILLING CODE 4510-CR-P
    DEPARTMENT OF AGRICULTURE Forest Service 36 CFR Part 261 RIN 0596-AD24 Prohibitions in Region 8, Southern Region AGENCY:

    Forest Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Chattooga Wild and Scenic River is located in the Nantahala National Forest in North Carolina, the Sumter National Forest in South Carolina and the Chattahoochee National Forest in Georgia. Forest Service regulations generally prohibit floating activities on the Chattooga Wild and Scenic River unless authorized by a permit. On January 31, 2012, the U.S. Department of Agriculture (USDA), Forest Service issued decisions to change some of the locations where, and conditions under which, boating would be allowed. Consequently, the Forest Service proposes to amend the regulations to more accurately reflect the new management direction for the Chattooga Wild and Scenic River.

    DATES:

    Comments on this proposed rule must be received in writing by March 21, 2016.

    ADDRESSES:

    Send written comments to Proposed Rule Amendment, c/o USDA Forest Service, R8 Planning, 1720 Peachtree Street NW., Suite 811N, Atlanta, GA 30309. Electronic comments may be sent to [email protected]; or by facsimile to 404-347-5401. If comments are sent electronically, do not duplicate via regular mail. Comments should only address issues relevant to this proposed regulation.

    All comments, including names and addresses when provided, will be placed in the rulemaking record and will be available for public inspection and copying. The public may inspect comments received on this proposed rule in the USDA, Forest Service Regional Office, 1720 Peachtree Street, Suite 811N, Atlanta, GA, on business days between the hours of 8:30 a.m. and 4:30 p.m. Those wishing to inspect comments should call ahead at 404-347-4984 to schedule a time and to facilitate entry into the office.

    FOR FURTHER INFORMATION CONTACT:

    Paul Arndt, Regional Planner, Planning Unit, Southern Region, 404-347-4984. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION: Background and Purpose for the Amendment

    In 1974, Congress designated the 57-mile Chattooga River (and its 15,432-acre corridor) as a component of the National Wild and Scenic River System. The uppermost portion of the Chattooga Wild and Scenic River is located in the Nantahala National Forest (NF) in North Carolina. The river then flows in a southerly, south-westerly direction to form the boundary between Georgia and South Carolina, and also the boundary between the Chattahoochee NF (in Georgia) and the Sumter NF (in South Carolina).

    In the initial 1976 river management plan for the Chattooga River, the U.S. Forest Service used zoning to manage the upper and lower segments of the river for different recreational opportunities. As part of the initial zoning effort, management direction prohibited floating on the upper segment above GA/SC Highway 28 (which includes a section of the river in the Sumter NF in South Carolina, a section of the river in the Chattahoochee NF in Georgia, and all of the sections of the river in the Nantahala NF in North Carolina).

    Under the authority of 36 CFR 261.70(a)(7), these prohibitions were codified at 36 CFR 261.77 (Federal Register, 43 FR 3706, January 27, 1978). In general terms, 36 CFR 261.77 prohibits floating activities on the Chattooga Wild and Scenic River unless authorized by a permit. Consistent with the river management plan that is incorporated into the forest plans, the original terms and conditions of the permits issued pursuant to 36 CFR 261.77 allowed floating on the Chattooga Wild and Scenic River but only on that portion of the river located downstream of GA/SC Highway 28. Therefore, due to the combination of 36 CFR 261.77 and the terms of the self-registration permit issued pursuant to that regulation, floating was allowed on that section of the river downstream of GA/SC Highway 28 and prohibited upstream from that location. However, that management direction has changed, allowing for an increase in boating opportunities upstream of GA/SC Highway 28. To be consistent with this new management direction, the agency proposes to amend 36 CFR 261.77.

    On January 31, 2012, the Chattahoochee, Nantahala and Sumter National Forests issued Decision Notices that amended their Forest Plans to incorporate new management direction for the Chattooga Wild and Scenic River. These changes are based upon an Environmental Assessment titled “Managing Recreation Uses in the Upper Segment of the Chattooga Wild and Scenic River Corridor”. Generally, these new decisions allow floating above GA/SC Highway 28 with certain restrictions.

    In the existing regulations at 36 CFR 261.77, the sections of the river that lie within the Nantahala NF in North Carolina are not addressed. This area is instead regulated by Forest Supervisor's closure order pursuant to subpart B of 36 CFR part 261. In the interest of efficiency and clarity, and to be consistent with the new management direction, the Forest Service proposes to amend 36 CFR 261.77 to include sections of the river that lie within the Nantahala NF. Consistent with the new management direction, the Forest Service also proposes to amend 36 CFR 261.77 to include the Sumter and Nantahala NFs in certain provisions that currently only include the Chattahoochee NF. In the interest of further consistency and clarity, and to better serve the public, the Forest Service also proposes to amend 36 CFR 261.77 by eliminating reference to specific locations where self-registration permits are made available to the public. Instead, the Agency will use other means to inform the public of the variety of places where it can go to obtain permits to float the Chattooga Wild and Scenic River. Lastly, in an effort to use more accurate and consistent terminology, the Forest Service proposes to replace the term “special use permit” with the term “special use authorization.”

    Section-by-Section Analysis of the Proposed Rule Part 261, Subpart C—Prohibitions in Regions § 261.77 Prohibitions in Region 8, Southern Region. Revisions to § 261.77(a)

    Currently, § 261.77(a) applies to the Sumter National Forest and the Chattahoochee National Forest abutting the Chattooga River. However, this regulation is silent about that section of the Chattooga Wild and Scenic River Corridor that is located upstream of the Sumter and Chattahoochee NFs which lies within the Nantahala NF in North Carolina. The January 31, 2012, decision by the Forest Service allows for additional boating to occur under permit in the upper section of the Chattooga River which in-part is located in North Carolina on the Nantahala NF. Therefore, the regulation needs to be revised to include the Nantahala NF. The Agency proposes that § 261.77(a) now be applicable to “any area of National Forest land abutting the Chattooga River.” A parenthetical sentence will then be added to clarify that “(The Chattooga River is located in the Nantahala National Forest in North Carolina, the Sumter National Forest in South Carolina and the Chattahoochee National Forest in Georgia.)”

    Due to the allowance of additional floating on the Chattooga River, the Agency must be able to issue permits in a flexible and efficient manner that is consistent with the new management direction and in a manner that best serves the public. Rather than codifying the specific locations of self-registration permit stations in the regulations, these locations will be identified by the local Forest Service officials administering the different sections of the Chattooga River. Locations of the registration stations may need to be changed from time to time to better serve the public. In addition, the Forest Service may, in the future, develop an option where permits could be obtained online or through other more efficient and effective means. To achieve this need, the specific locations of the “Forest Service Registration Stations” are being removed and the regulation will simply state that the use will need to be “authorized by permit or through a special use authorization”.

    Revisions to § 261.77(b)

    Similar to § 261.77(a), § 261.77(b) currently applies to “. . . the Sumter National Forest and the Chattahoochee National Forest abutting the Chattooga River.” However, this regulation is also silent about that section of the Chattooga Wild and Scenic River Corridor that lies within the Nantahala NF in North Carolina. Again, since the January 31, 2012, decision by the US Forest Service allows for additional boating to occur under permit in the upper section of the Chattooga River, the regulation needs to be revised to include the Nantahala NF. The agency proposes that § 261.77(b) now is applicable to “any area of National Forest System land abutting the Chattooga River.” As noted above, a parenthetical sentence will then be added to clarify that “(The Chattooga River is located in the Nantahala National Forest in North Carolina, the Sumter National Forest in South Carolina and the Chattahoochee National Forest in Georgia.)” Finally, the term “unless authorized by special use permit” is also being replaced with the term “unless permitted under a special use authorization”.

    Revisions to § 261.77(c)

    Section 261.77(c) currently only applies to “. . . the terms or conditions of any permit authorizing the occupancy and use . . .” However, in § 261.77(a) and (b), a distinction is now being made between a “permit” and a “special use authorization”. So proposed § 261.77(c) is revised to apply to “. . .the terms or conditions of any special use authorization or permit authorizing the occupancy and use . . .”

    Revisions to § 261.77(d)

    Section 261.77(d) applies to “. . . any portion or segment of the Chattooga River within the boundaries of the Chattahoochee National Forest . . .” However, as stated above, the Chattooga Wild and Scenic River flows through all three forests; the Chattahoochee NF, the Sumter NF and the Nantahala NF. In addition, the new management direction applies to all three forests. Therefore, this provision needs to be revised to include all three forests. So, proposed § 261.77(d) is revised to apply to “. . . any portion or segment of the Chattooga River within National Forest System land . . .”

    In addition, as discussed above, in the interest of consistency, efficiency and clarity, to best serve the public, specific locations to obtain self-registration permits will no longer be codified. Rather, these locations will be identified by the local Forest Service officials administering the different sections of the Chattooga River. The locations of the registration stations may need to be changed from time to time to better serve the public. It should also be recognized that the Forest Service may, in the future, develop an option where permits could be obtained online or in some other efficient manner that better serves the public. In order to address this, the specific locations of the “Forest Service Registration Stations” are being removed and the proposed regulation will simply state that the use will need to be “authorized by permit or through a special use authorization.”

    Revisions to § 261.77(e)

    Similar to § 261.77(d), the scope of the commercial or business operation prohibitions currently in § 261.77(e) only applies to “. . . any portion or segment of the Chattooga River within the boundaries of the Chattahoochee National Forest . . .” As described above, the regulation needs to be revised to also include all three national forests. Therefore, § 261.77(e) is revised to read, “Entering, going, riding, or floating . . . upon any portion or segment of the Chattooga River within National Forest System land . . .” Finally, the term “unless authorized by special use permit” is also being replaced with the term “unless permitted under a special use authorization.”

    Revisions to § 261.77(f)

    Section 261.77(f) currently only applies to “. . . the terms or conditions of any permit authorizing the occupancy and use . . .” However, in § 261.77(d) and (e), a distinction is now being made between a “permit” and a “special use authorization”. So proposed § 261.77(f) is revised to apply to “. . .the terms or conditions of any special use authorization or permit authorizing the occupancy and use . . .”

    Regulatory Certifications Environmental Impact

    This proposed rule is to amend an existing regulation to make it consistent with a USDA, Forest Service decision on the management of the Chattooga Wild and Scenic River, which lies within the Chattahoochee, Nantahala and Sumter National Forests. The Decision Notices (one for each National Forest) were signed on January 31, 2012, which were based upon an Environmental Assessment (EA) titled “Managing Recreation Uses in the Upper Segment of the Chattooga Wild and Scenic River Corridor.” The social and environmental effects of this decision are documented in this EA. This proposed rule amendment is to update the Forest Service regulations to now be consistent with this new management decision.

    Regulatory Impact

    This proposed rule has been reviewed under USDA procedures and Executive Order 12866 on regulatory planning and review. It has been determined that this is not a significant proposed rule. This rulemaking will not have an annual effect of $100 million or more on the economy, nor will it adversely affect productivity, competition, jobs, the environment, public health and safety, or State or local governments. This rulemaking will not interfere with an action taken or planned by another agency, nor will it raise new legal or policy issues. Finally, this proposed rule will not alter the budgetary impact of entitlement, grant, user fee, or loan programs or the rights and obligations of beneficiaries of such programs. Accordingly, this rulemaking is not subject to Office of Management and Budget (OMB) review under Executive Order 12866.

    Regulatory Flexibility Act

    This proposed rule has been considered in light of the Regulatory Flexibility Act (5 U.S.C. 602 et seq.). The proposed rule makes minor, technical changes to the Forest Service's regulations. This rulemaking will not have a significant economic impact on a substantial number of small entities as defined by the act because the rulemaking will not impose recordkeeping requirements on them; it will not affect their competitive position in relation to large entities; and it will not affect their cash flow, liquidity, or ability to remain in the market.

    No Takings Implications

    This proposed rule has been analyzed in accordance with the principles and criteria contained in Executive Order 12630. It has been determined that the rulemaking will not pose the risk of a taking of private property.

    Civil Justice Reform

    This proposed rule has been reviewed under Executive Order 12988 on civil justice reform. After adoption of this proposed rule, (1) all State and local laws and regulations that conflict with this rulemaking or that impede its full implementation will be preempted; (2) no retroactive effect will be given to this rule; and (3) it will not require administrative proceedings before parties may file suit in court challenging its provisions.

    Federalism and Consultation and Coordination With Indian Tribal Governments

    The Department has considered this proposed rule under the requirements of Executive Order 13132 on federalism, and has determined that the rulemaking conforms with the federalism principles set out in this Executive Order; will not impose any compliance costs on the States; and will not have substantial direct effects on the States, the relationship between the Federal government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the Department has determined that no further assessment of federalism implications is necessary.

    Moreover, this proposed rule is not expected to have Tribal implications as defined by Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The Department does recognize that one or more Indian Tribes may have direct interest in the management of Chattooga Wild & Scenic River. Therefore, the Department will request consultation with all potentially affected Indian Tribes on this proposed rule. The tribal consultation will be held concurrently with the public comment period.

    Energy Effects

    This proposed rule has been reviewed under Executive Order 13211 of May 18, 2001, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. It has been determined that this proposed rule does not constitute a significant energy action as defined in the Executive Order.

    Unfunded Mandates

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), which the President signed into law on March 22, 1995, the Department has assessed the effects of this proposed rule on State, local, and Tribal governments and the private sector. This rulemaking will not compel the expenditure of $100 million or more by any State, local, or Tribal government or anyone in the private sector. Therefore, a statement under section 202 of the act is not required.

    Controlling Paperwork Burdens on the Public

    This proposed rule does not contain any recordkeeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or not already approved for use. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and its implementing regulations at 5 CFR part 1320 do not apply.

    List of Subjects in 36 CFR Part 261

    Prohibitions, Law enforcement, National forests.

    Therefore, for the reasons set out in the preamble, we propose to amend part 261 of title 36 of the Code of Federal Regulations as follows:

    PART 261—PROHIBITIONS 1. The authority citation for part 261 continues to read as follows: Authority:

    7 U.S.C. 1011(f); 16 U.S.C. 4601-6d, 472, 551, 620(f), 1133(c)-(d)(1), 1246(i).

    Subpart C—Prohibitions in Regions 2. Revise § 261.77 to read as follows:
    § 261.77 Prohibitions in Region 8, Southern Region.

    (a) Using or occupying any area of National Forest System land abutting the Chattooga River for the purpose of entering or going upon the River in, on, or upon any floatable object or craft of every kind or description, unless authorized by permit or through a special use authorization. (The Chattooga River is located in the Nantahala National Forest in North Carolina, the Sumter National Forest in South Carolina and the Chattahoochee National Forest in Georgia.)

    (b) Using or occupying within the scope of any commercial operation or business any area of National Forest System land abutting the Chattooga River for the purpose of entering or going upon the River in, on, or upon any floatable object or craft of every kind or description, unless permitted under a special use authorization.

    (c) Violating or failing to comply with any of the terms or conditions of any special use authorization or permit authorizing the occupancy and use specified in paragraph (a) or (b) of this section is prohibited.

    (d) Entering, going, riding, or floating upon any portion or segment of the Chattooga River within National Forest System land in, on, or upon any floatable object or craft of every kind or description, unless authorized by a permit or through a special use authorization.

    (e) Entering, going, riding, or floating within the scope of any commercial operation or business upon any portion or segment of the Chattooga River within National Forest System land in, on, or upon any floatable object or craft of every kind or description, unless permitted under a special use authorization.

    (f) Violating or failing to comply with any of the terms or conditions of any special use authorization or permit authorizing the occupancy and use specified in paragraph (d) or (e) of this section is prohibited.

    Dated: December 21, 2015. Thomas L. Tidwell, Chief, Forest Service.
    [FR Doc. 2016-00888 Filed 1-15-16; 8:45 am] BILLING CODE 3411-15-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 130 [EPA-HQ-OW-2014-0622; FRL-9941-33-OW] RIN 2040-AF52 Treatment of Indian Tribes in a Similar Manner as States for Purposes of Section 303(d) of the Clean Water Act AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    In section 518(e) of the Clean Water Act (CWA), Congress authorized EPA to treat eligible federally recognized Indian tribes in a similar manner as states for purposes of administering section 303 and certain other provisions of the CWA, and directed the agency to promulgate regulations effectuating this authorization. EPA has issued regulations establishing a process for federally recognized tribes to obtain treatment in a similar manner as states (TAS) for several provisions of the CWA; 50 tribes, for example, have obtained TAS authority to issue water quality standards under CWA section 303(c). EPA, however, has not yet promulgated regulations expressly establishing a process for such tribes to obtain TAS authority to administer the water quality restoration provisions of CWA section 303(d), including issuing lists of impaired waters and developing total maximum daily loads (TMDLs) under CWA section 303(d), as states routinely do. EPA is now proposing to remedy this gap. By establishing regulatory procedures for eligible tribes to obtain TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program, the proposed rule would enable eligible tribes to obtain authority to identify impaired waters on their reservations and to establish TMDLs, which serve as plans for attaining and maintaining applicable water quality standards (WQS). The proposal is comparable to similar regulations that EPA issued in the 1990s for the CWA Section 303(c) WQS and CWA Section 402 and 404 Permitting Programs, and includes features designed to minimize paperwork and unnecessary reviews. EPA requests comments on all aspects of the proposed rule.

    DATES:

    EPA must receive comments on or before March 21, 2016. EPA will discuss this proposed rule and answer questions about it in one or more webinars during the above comment period. If you are interested, see EPA's Web site at http://www2.epa.gov/tmdl/tribal-consultation-rulemaking-provide-more-opportunities-tribes-engage-clean-water-act for the date and time of the webinar(s) and instructions on how to register and participate. Additionally, under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before February 18, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket identification (ID) No. EPA-HQ-OW-2014-0622, at 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:

    Sarah Furtak, Assessment and Watershed Protection Division, Office of Wetlands, Oceans and Watersheds (4503T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 566-1167; fax number: (202) 566-1331; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    This supplementary information is organized as follows:

    I. General Information A. Does this action apply to me? B. Over what area may tribes apply for TAS for the CWA Section 303(d) impaired water listing and TMDL program? C. What should I consider as i prepare my comments for EPA? 1. Resubmitting Relevant Comments From Consultations and Listening Sessions 2. Submitting CBI 3. Tips for Preparing Your Comments II. What is the statutory and regulatory history of TAS under the CWA? A. Statutory History B. Regulatory History III. Why might a tribe be interested in seeking TAS authority for the CWA Section 303(d) impaired water listing and TMDL program? IV. What program responsibilities would tribes have upon obtaining TAS for the CWA Section 303(d) impaired water listing and TMDL program? A. Identification of Impaired Waters and Submission of Section 303(d) Lists B. Establishment and Submission of TMDLs C. EPA Review of Lists and TMDLs V. What are EPA's proposed procedures for a tribe to seek TAS for the CWA Section 303(d) impaired water listing and TMDL program? VI. What special circumstances may exist regarding qualification for TAS for the CWA Section 303(d) impaired water listing and TMDL program? VII. What procedure would EPA follow in reviewing a tribe's TAS application? A. Notice to Appropriate Governmental Entities B. Avoidance of Duplicative Notice and Comment Procedures C. Treatment of Competing or Conflicting Claims D. EPA's Decision Process VIII. What is an example of a stepwise approach for tribes applying for TAS for CWA programs? IX. What financial and technical support is available from EPA to tribes as they choose to develop and implement a CWA Section 303(d) impaired water listing and TMDL program? X. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act (PRA) C. Regulatory Flexibility Act (RFA) D. Unfunded Mandates Reform Act (UMRA) E. Executive Order 13132: Federalism F. Executive Order 13175: Tribal Consultation and Coordination G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations I. General Information A. Does this action apply to me?

    This proposed rule applies to federally recognized tribal governments with reservations interested in seeking TAS eligibility to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program. Although this proposed rule would not apply directly to any other entity, state and local governments or other Indian tribes, as well as other entities, may be interested to the extent they are adjacent to the Indian reservation1 lands of TAS applicant tribes, share water bodies with such tribes, and/or discharge pollutants to waters of the United States located within or adjacent to such reservations. The table below provides examples of entities that could be affected by this action or have an interest in it.

    1 See “Over What Area May Tribes Apply for TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program?” below.

    Category Examples of potentially affected or interested entities Tribes Federally recognized tribes with reservations that are interested in applying for TAS for CWA Section 303(d) impaired water listing and TMDL Program, and other interested tribes. States States adjacent to reservations of potential applicant tribes. Industry dischargers Industrial and other commercial entities discharging pollutants to waters within or adjacent to reservations of potential applicant tribes. Municipal dischargers Publicly owned treatment works or other facilities discharging pollutants to waters within or adjacent to reservations of potential applicant tribes.

    If you have questions regarding the effect of this proposed rule on a particular entity, please consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

    B. Over what area may tribes apply for TAS for the CWA Section 303(d) impaired water listing and TMDL program?

    Under section 518(e) of the CWA, 33 U.S.C. 1377(e), Indian tribes may seek TAS authorization to administer certain CWA programs pertaining to water resources of their reservations. Tribes are not eligible to administer CWA programs pertaining to any non-reservation Indian country 2 or any other type of non-reservation land. The term “federal Indian reservation” is defined at CWA section 518(h)(1) to include all land within the limits of any Indian reservation under the jurisdiction of the United States Government notwithstanding the issuance of any patent, and including rights-of-way running through the reservation. See CWA sections 518(e)(2), (h)(1); see also 40 CFR 131.3(k). EPA's longstanding position is that reservations include both formal reservations (e.g., named reservations established through federal treaties with tribes, federal statutes, or Executive Orders of the President) as well as tribal trust lands that may not be formally designated as reservations, but that qualify as informal reservations. See, e.g., 56 FR 64876, 64881 (December 12, 1991); Arizona Public Service Co. v. EPA, 211 F.3d 1280, 1292-1294 (D.C. Cir. 2000), cert. denied sub nom., Michigan v. EPA, 532 U.S. 970 (2001). Tribes may seek TAS authorization for both formal and informal reservations, and both types of lands are referred to herein as “reservations.”

    2 The term Indian country is defined at 18 U.S.C. 1151.

    Although this proposal would facilitate eligible tribes' administration of an additional regulatory program, nothing in this proposed rule changes, expands, or contracts the geographic scope of potential tribal TAS eligibility under the CWA.

    C. What should I consider as I prepare my comments for EPA?

    1. Resubmitting Relevant Comments from Consultations and Listening Sessions. EPA held multiple consultations and listening sessions with tribes and states concerning TAS for CWA section 303(d) lists and TMDLs, and considered views and comments received from these sessions in developing this proposal. This proposed rule has evolved from the materials EPA shared at the time. Therefore, if you submitted comments based on these sessions and want EPA to consider them as part of the public comment opportunity for this proposed action, you must resubmit your comments to EPA in accordance with the instructions outlined in this document.

    2. Submitting CBI. Do not submit CBI to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disc that you mail to EPA, mark the outside of the disc as CBI and then identify electronically within the disc the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. EPA will not disclose information so marked except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

    3. Tips for Preparing Your Comments. When submitting comments, remember to:

    • Identify the proposed action by docket number and other identifying information (subject heading, Federal Register date and page number).

    • Explain why you agree or disagree, suggest alternatives, substitute language for your requested changes.

    • Describe any assumptions and provide any technical information and/or data that you used.

    • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

    • Provide specific examples that help to illustrate your concerns.

    • Explain your views as clearly as possible.

    • Submit your comments consistent with the DATES section of this document.

    II. What is the statutory and regulatory history of TAS under the CWA? A. Statutory History

    Congress added section 518 to the CWA as part of amendments made in 1987. Section 518(e) authorizes EPA to treat eligible Indian tribes in the same manner as it treats states for a variety of purposes, including administering each of the principal CWA regulatory programs and receiving grants under several CWA funding authorities. Section 518(e) is commonly known as the “TAS” provision. Section 303 is expressly identified in section 518(e) as one of the provisions available for TAS.

    Section 518(e) also requires EPA to promulgate regulations specifying the TAS process for applicant tribes. Section 518(h) defines “Indian tribe” to mean any Indian tribe, band, group, or community recognized by the Secretary of the Interior and exercising governmental authority over a federal Indian reservation.

    B. Regulatory History

    Pursuant to section 518(e), EPA promulgated several final regulations establishing TAS criteria and procedures for Indian tribes interested in administering programs under the Act. The relevant regulations addressing TAS requirements for the principal CWA regulatory programs are:

    • 40 CFR 131.8 for section 303(c) water quality standards, published at 56 FR 64876 (December 12, 1991) (final rule);

    • 40 CFR 131.4(c) for CWA section 401 water quality certification, published at 56 FR 64876 (December 12, 1991);

    • 40 CFR 123.31-34 for CWA section 402 National Pollutant Discharge Elimination System (NPDES) permits and other provisions, and 40 CFR 501.22-25 for the sewage sludge management program. Final rule published December 22, 1993 (58 FR 67966); and

    • 40 CFR 233.60-62 for CWA section 404 dredge or fill permits. Final rule published February 11, 1993 (58 FR 8172).

    In 1994, EPA amended the above regulations to simplify the TAS process and eliminate unnecessary and duplicative procedural requirements. See 59 FR 64339 (December 14, 1994) (the “Simplification Rule”). For example, the Simplification Rule eliminated the need for a tribe to prequalify for TAS before applying to administer the section 402 and section 404 permit programs. Instead, the rule provided that a tribe would seek to establish its TAS eligibility at the program approval stage (subject to notice and comment procedures in the Federal Register). However, the rule retained the separate TAS prequalification requirement (including local notice and comment procedures) for section 303(c) water quality standards and section 401 water quality certifications. Id.; see also, 40 CFR 131.8(c)(2), (3).3 The TAS regulations for CWA regulatory programs have remained intact since promulgation of the Simplification Rule. EPA is now proposing to address a gap in its current TAS regulations, by proposing regulations that would specify how tribes may seek TAS for the Section 303(d) Impaired Water Listing and TMDL Program.

    3 Under the CWA and EPA's regulations, tribes may simultaneously (1) apply for TAS under CWA section 518 for the purpose of administering water quality standards and (2) submit actual standards for EPA review under section 303(c). Although they may proceed together, a determination of TAS eligibility and an approval of actual water quality standards are two distinct actions.

    III. Why might a tribe be interested in seeking TAS authority for the CWA Section 303(d) Impaired Water Listing and TMDL Program?

    TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program would provide a tribe with the opportunity to participate directly in restoring and protecting its reservation waters through implementing the Program, as Congress authorized under CWA section 518(e). In the rest of this document, EPA refers to the functions identified in CWA section 303(d) regarding listing of impaired waters and establishment of TMDLs as the “Section 303(d) Impaired Water Listing and TMDL Program” or “303(d) Program.” Section 303(d) provides for states and authorized tribes to: (1) Develop lists of impaired waters (and establish priority rankings for waters on the lists) and (2) establish TMDLs for these waters. By listing impaired waters, a state or authorized tribe identifies those waters in its territory that are not currently meeting EPA-approved or EPA-promulgated WQS (collectively referred to as “applicable WQS”). A TMDL is a planning document intended to address impairment of waters, including the calculation and allocation to point and nonpoint sources of the maximum amount of a pollutant that a water body can receive and still meet applicable WQS, with a margin of safety.

    By obtaining TAS for section 303(d), tribes can take the lead role in identifying and establishing a priority ranking for impaired water bodies on their reservations and in establishing TMDLs and submitting them to EPA for approval. These are important informational and planning steps that tribes can take to restore and maintain the quality of reservation waters.

    TMDLs must allocate the total pollutant load among contributing point sources (“waste load allocations” or “WLAs”) and nonpoint sources (“load allocations” or “LAs”) (40 CFR 130.2). Point source WLAs are addressed through the inclusion of water quality-based effluent limits in national pollutant discharge elimination system (NPDES) permits issued to such sources. Under EPA's regulations, NPDES permitting authorities shall ensure that “[e]ffluent limits developed to protect a narrative water quality criterion, a numeric water quality criterion, or both, are consistent with the assumptions and requirements of any available wasteload allocation for the discharge prepared by the State and approved by EPA pursuant to 40 CFR 130.7.” 40 CFR 122.44(d)(1)(vii)(B). WLAs under 40 CFR 122.44(d)(1)(vii)(B) would include WLAs developed by a tribe with TAS authorization and approved by EPA pursuant to 40 CFR 130.7. For water bodies impaired by pollutants from nonpoint sources, authorized tribes would not acquire new or additional implementation authorities when listing such impaired water bodies and establishing TMDLs. Instead, the mechanisms for implementing the nonpoint source pollutant reductions (LAs) identified in any tribal TMDLs would include existing tribal authorities, other federal agencies' policies and procedures, as well as voluntary and incentive-based programs.

    This proposed rule would not require anything of tribes that are not interested in TAS for the 303(d) Program. Based on pre-proposal input, not all tribes will be interested in obtaining TAS for 303(d), and some may consider other approaches that might benefit their reservation waters. Clean Water Act section 319 watershed-based plans, for example, may help tribes protect and restore water resources threatened or impaired by nonpoint source pollution.4

    4 See Handbook for Developing and Managing Tribal Nonpoint Source Pollution Programs under Section 319 of the Clean Water Act, February 2010, available at http://www2.epa.gov/sites/production/files/2015-09/documents/2010_02_19_nps_tribal_pdf_tribal_handbook2010.pdf.

    IV. What program responsibilities would tribes have upon obtaining TAS for the CWA Section 303(d) impaired water listing and TMDL program?

    The goal of the CWA is “to restore and maintain the chemical, physical, and biological integrity of the Nation's waters.” CWA section 101(a). Identification of impaired waters and TMDLs are important tools for achieving that goal. After a tribe receives EPA approval of its eligibility to implement a CWA Section 303(d) Impaired Water Listing and TMDL Program, it is treated in a manner similar to a state and, for purposes of list and TMDL development, it would become an “authorized tribe.” Generally, the federal statutory and regulatory requirements for state 303(d) programs would be applicable to authorized tribes (see proposed § 130.16(c)(5)). The following paragraphs identify important 303(d) Program responsibilities that tribes with TAS would assume and implement.

    A. Identification of Impaired Waters and Submission of Section 303(d) Lists

    Under section 303(d) of the CWA, every two years authorized tribes would be required to develop lists of waters not meeting, or not expected to meet, applicable water quality standards. 40 CFR 130.7(d). These lists are commonly called “impaired waters lists” or “303(d) lists.” Impaired waters are waters for which technology-based limitations and other required controls are not stringent enough to meet applicable CWA water quality standards. Threatened waters are waters that currently attain applicable WQS, but for which existing and readily available data and information indicate that applicable WQS will likely not be met by the time the next list of impaired or threatened waters is due to EPA.5 The authorized tribe's section 303(d) list would include all impaired and threatened waters. In this document, EPA uses the term “impaired waters” to refer to both impaired and threatened waters.6 The authorized tribe would be required to “assemble and evaluate all existing and readily available information” in developing its section 303(d) list. 40 CFR 130.7(b)(5). EPA's regulations include a non-exhaustive list of water quality-related data and information to be considered. Id. The tribe would establish priorities for development of TMDLs for waters on its section 303(d) list based on the severity of the pollution and the uses to be made of the waters. 40 CFR 130.7(b)(4). The tribe would then submit its list of impaired waters to EPA for review and approval.

    5Guidance for 2006 Assessment, Listing and Reporting Requirements Pursuant to Sections 303(d), 305(b) and 314 of the Clean Water Act, July 29, 2005, available at http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/upload/2006irg-report.pdf.

    6 Under EPA's regulations, “water quality limited segments” include both impaired waters and threatened waters, and are defined as “any segment where it is known that water quality does not meet applicable water quality standards, and/or is not expected to meet applicable water quality standards, even after the application of the technology-based effluent limitations required by sections 301(b) and 306 of the Act.” 40 CFR 130.2(j).

    Like states, authorized tribes would be required to submit their “303(d) lists” to EPA for approval every two years on April 1 (lists are due April 1 of even-numbered years). As indicated in § 130.16(c)(5) of the proposed rule, a tribe gaining TAS status would be provided at least 24 months to submit its first impaired waters list to EPA. The tribe's first impaired waters list would be due to EPA the next listing cycle due date that is at least 24-months from the later of (1) the date the tribe's TAS application for 303(d) is approved, or (2) the date EPA-approved/promulgated WQS for the tribe's waters are effective. (See section VII for the procedure EPA would follow in reviewing a tribe's TAS application.). Thus, for example, if EPA approves a tribe's TAS application on March 15, 2016, and the tribe's WQS on June 30, 2016, the tribe's first list would be due on April 1, 2020. The tribe could submit its list to EPA prior to that date, if it chooses.

    Most tribes that would be eligible for TAS authorization under today's proposed rule are likely to be recipients of CWA section 106 grants and would thus be required to submit section 106 grant work plans annually. If a tribe's CWA section 106 grant work plan includes ambient water quality monitoring activities, the tribe is also required to develop an assessment report pursuant to the CWA section 106 grant reporting requirements.7 EPA encourages tribes that obtain TAS for the CWA Section 303(d) Program and also develop CWA section 106 assessment reports to combine their CWA section 303(d) impaired waters list with their CWA section 106 assessment report, and submit the combined report electronically through the Assessment TMDL Tracking and Implementation System (ATTAINS).8 In this way such tribes could create a combined CWA 303(d)/106 report that is similar to a state's CWA 303(d)/305(b) 9 “Integrated Report.” 10

    7 See Final Guidance on Awards of Grants to Indian Tribes under Section 106 of the Clean Water Act (http://www2.epa.gov/sites/production/files/2014-09/documents/final-tribal-guidance.pdf) at page 8-1.

    8 See “Water Quality Assessment and TMDL Information,” available at http://ofmpub.epa.gov/waters10/attains_index.home.

    9 CWA section 305(b) requires states to provide every two years an assessment of the quality of all their waters. EPA explicitly exempted tribes from the section 305(b) reporting requirement. See 40 CFR 130.4(a); 54 FR 14354, 14357 (April 11, 1989).

    10See Guidance for 2006 Assessment, Listing and Reporting Requirements Pursuant to Sections 303(d), 305(b) and 314 of the Clean Water Act, July 29, 2005, (available at http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/upload/2006irg-report.pdf) for more information on the Integrated Report.

    B. Establishment and Submission of TMDLs

    Under the CWA, each state and authorized tribe must, “from time to time,” establish and submit TMDLs for pollutants causing impairments in all the waters on its 303(d) list. CWA sections 303(d)(1)(C) and 303(d)(2). States and authorized tribes set priorities for developing TMDLs for their impaired and listed waters.

    TMDLs must be established “at a level necessary to implement the applicable water quality standards with seasonal variations and a margin of safety which takes into account any lack of knowledge concerning the relationship between effluent limitations and water quality.” CWA section 303(d)(1)(C). Where a TMDL makes allocation tradeoffs between point and nonpoint sources, the TMDL record must also demonstrate “reasonable assurance” that the nonpoint source allocations will be achieved. 40 CFR 130.2(i). Calculations to establish TMDLs must be subject to public review. 40 CFR 130.7(c)(1)(ii). Once established, the state or authorized tribe submits the TMDL to EPA for review.

    C. EPA Review of Lists and TMDLs

    Once EPA receives a list or TMDL, it must either approve or disapprove that list or TMDL within 30 days. CWA section 303(d)(2). If EPA disapproves the list or TMDL, EPA must establish a replacement list or TMDL within 30 days of disapproval. 40 CFR 130.7(d)(2).

    V. What are EPA's proposed procedures for a tribe to seek TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program?

    Consistent with the statutory requirement in section 518 of the CWA, the proposed rule would establish the procedures by which an Indian tribe may apply and qualify for TAS for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program. Such procedures would be codified in a new section 130.16 of the water quality planning and management regulation. Section 130.16 would identify (1) the criteria an applicant tribe would be required to meet to be treated in a similar manner as states, (2) the information the tribe would be required to provide in its application to EPA, and (3) the procedure EPA would use to review the tribal application. Proposed section 130.16 is intended to ensure that tribes treated in a similar manner as states for the purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program are qualified, consistent with CWA requirements, to conduct a Listing and TMDL Program. The procedures are meant to provide more opportunities for tribes to engage fully in the Program and are not intended to act as a barrier to tribal assumption of the 303(d) Program.

    The TAS procedures in this proposed rule are closely based on the existing TAS regulation at 40 CFR 131.8, which establishes the TAS process for the CWA Section 303(c) WQS Program. EPA established the TAS process for WQS in 1991, and that program has been the focus of the great majority of TAS activity for regulatory programs under the CWA as well as all of the other environmental statutes administered by the Agency. The WQS TAS rule has proven very effective in ensuring that applicant tribes satisfy statutory TAS criteria and are prepared to administer WQS programs under the Act. It thus served as a useful model for this proposed TAS rule.

    The TAS criteria tribes would be required to meet for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program originate in CWA section 518. As reflected in the proposed regulatory language, the tribe must: (1) Be federally recognized and meet the definitions in § 131.3(k) and (l); (2) carry out substantial governmental duties and powers; (3) have appropriate authority to regulate the quality of reservation waters; and (4) be reasonably expected to be capable of administering the Impaired Water Listing and TMDL Program. These criteria are discussed below.

    The first criterion for TAS would require the tribe to be federally recognized by the U.S. Department of the Interior (DOI) and meet the definitions in § 131.3(k) and (l). The tribe may address the recognition requirement either by stating that it is included on the list of federally recognized tribes published periodically by DOI, or by submitting other appropriate documentation (e.g., if the tribe is federally recognized but is not yet included on the DOI list). The definition of “tribe” in § 131.3(l), along with requiring federal recognition, additionally requires that the tribe is exercising governmental authority over a Federal Indian reservation. “Federal Indian reservation” is defined in § 131.3(k) as “all land within the limits of any Indian reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and including rights-of-way running through the reservation.” (See further discussion of the term “reservation” in section I B. of this preamble.). The governmental authority and reservation aspects of these definitions would be addressed in the tribe's application, including as part of its descriptive statements that it currently carries out substantial governmental duties and powers over a defined area, and that it has authority to regulate water quality over a reservation.

    The second criterion would require the tribe to have a governing body “carrying out substantial governmental duties and powers.” The Agency considers “substantial governmental duties and powers” to mean that the tribe is currently performing governmental functions to promote the health, safety, and welfare of the affected population within a defined geographical area. See 54 FR at 39101. Examples of such functions may include, but are not limited to, the power to tax, the power of eminent domain, and police power. Federal recognition by DOI would not, in and of itself, satisfy this criterion. EPA expects that most tribes should be able to meet this criterion without much difficulty. Id.

    To address the second criterion, the tribe would be required to submit a descriptive statement demonstrating that the tribal governing body is currently carrying out substantial governmental duties and powers over a defined area. The descriptive statement should: (1) Describe the form of tribal government; (2) describe the types of essential governmental functions currently performed, such as those listed above; and (3) identify the sources of authorities to perform these functions (e.g., tribal constitutions and codes).

    The third criterion, concerning tribal authority, means that a tribe seeking TAS for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program must adequately demonstrate authority to manage and protect water resources within the borders of the tribe's reservation. To verify authority and satisfy the third criterion of the proposed rule, a tribe would be required to include a statement signed by the tribal legal counsel, or an equivalent official, explaining the legal basis for the tribe's regulatory authority, and appropriate additional documentation (e.g., maps, tribal codes and ordinances).

    In promulgating prior CWA TAS regulations, EPA took an initial cautious approach that required tribes applying for eligibility to administer regulatory programs under the statute to demonstrate their inherent tribal authority over the relevant regulated activities on their reservations. See, e.g., 56 FR at 64877-81. This included a demonstration of inherent regulatory authority over the activities of non-tribal members on lands they own in fee within a reservation under the principles of Montana v. United States, 450 U.S. 544 (1981), and its progeny. Montana held that, absent a federal grant of authority, tribes generally lack inherent jurisdiction over nonmember activities on nonmember fee land, but retain inherent civil jurisdiction over nonmember activities within the reservation where (i) nonmembers enter into “consensual relationships with the tribe or its members, through commercial dealing, contracts, leases, or other arrangements” or (ii) “. . . [nonmember] conduct threatens or has some direct effect on the political integrity, the economic security, or the health or welfare of the tribe.” Montana, 450 U.S. at 565-66.

    In addressing the second exception of Montana regarding the effects of nonmember conduct, EPA has previously described the Agency's operating approach to require a showing that the potential impacts of regulated activities on the tribe are serious and substantial. 56 FR at 64878. EPA also explained that the activities regulated under the various environmental statutes, including the CWA, generally have serious and substantial potential impacts on human health and welfare. Id. EPA described the Agency's expert assessment regarding the critical importance of water quality management to self-government and also explained that because of the mobile nature of pollutants in surface waters and the relatively small size of water bodies on reservations, it would be very likely that any water quality impairment on non-Indian fee land within a reservation would also impair water quality on tribal lands. Id. at 64878-79. EPA stated that its generalized findings regarding the relationship of water quality to tribal health and welfare would supplement the factual showing tribes would make in applying for TAS. Id. EPA reiterates the generalized statutory and factual findings set forth in those prior TAS rulemakings and believes they apply equally to TAS applications for the CWA Section 303(d) Program. As discussed below, EPA has also separately proposed to revise its interpretation of the CWA tribal provision by conclusively determining that Congress intended to delegate authority to eligible tribes to regulate their entire reservations under the CWA irrespective of land ownership. If and when this revised interpretation is finalized, it will be applied in reviewing any TAS application submitted under the regulations proposed today. Unless and until that revised interpretation is finalized, however, EPA will continue to evaluate TAS applications consistent with the Agency's current approach and will continue to apply the generalized findings set forth in prior CWA TAS rulemakings in making case-by-case determinations regarding tribes' inherent regulatory authority.

    In prior CWA TAS promulgations, EPA recognized that there was significant support for the view that Congress had intended to delegate authority to eligible Indian tribes to administer CWA regulatory programs over their entire reservations, irrespective of land ownership, and EPA expressly stated that the issue of tribal authority under the CWA remained open for further consideration in light of additional congressional or judicial guidance. See, e.g., 56 FR at 64878-81. On August 7, 2015, EPA published in the Federal Register a proposed rule to reinterpret the CWA tribal provision as including such an express delegation of authority by Congress. 80 FR 47430. If EPA finalizes that reinterpretation, applicant Indian tribes would no longer be required to demonstrate inherent authority to regulate their reservation waters under the CWA. Among other things, tribes would thus no longer be required to meet the test established in Montana v. United States, 450 U.S. 544 (1981), and its progeny with regard to exercises of inherent tribal regulatory authority over nonmember activity. Id. Instead, a tribe would be able to rely on the congressional delegation of authority included in section 518 of the statute as the source of authority to administer CWA regulatory programs over its entire reservation as part of its legal statement.

    The proposed TAS rule for the CWA Section 303(d) Impaired Water Listing and TMDL Program is intended to provide appropriate TAS application and review procedures irrespective of which interpretation of tribal authority under the Act applies. As explained in EPA's proposed reinterpretation, EPA's existing TAS regulations—including 40 CFR 131.8, upon which this proposed rule is modeled—accommodate either interpretation of tribal authority under the CWA and provide appropriate application procedures to ensure that relevant jurisdictional information is provided to EPA and made available for comment. 80 FR 47430. EPA thus proposes to establish the basic TAS application and review procedures proposed today notwithstanding that the proposed reinterpretation remains pending. Once these rules are finalized, EPA will review any TAS applications for the CWA Section 303(d) Program in accordance with the interpretation of CWA tribal jurisdiction that applies at the time.

    The fourth criterion would require that the tribe, in the Regional Administrator's judgment, be reasonably expected to be capable of administering an effective CWA Section 303(d) Impaired Water Listing and TMDL Program. To meet this requirement, tribes would either: (1) show that they have the necessary management and technical skills, or (2) submit a plan detailing steps for acquiring the necessary management and technical skills. When considering tribal capability, EPA would also consider whether the tribe can demonstrate the existence of institutions that exercise executive, legislative, and judicial functions, and whether the tribe has a history of successful managerial performance of public health or environmental programs.

    The specific information required for tribal applications to EPA is described in proposed § 130.16 (a) and (b). The application would be required, in general, to include a statement regarding federal recognition by DOI, documentation that the tribal governing body is exercising substantial duties and powers, documentation of tribal authority to regulate water quality on the reservation, a narrative statement of tribal capability to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program, and any other information requested by the Regional Administrator.

    Consistent with EPA's other TAS regulations, the proposed rule also provides that where a tribe has previously qualified for TAS for purposes of a different EPA program, the tribe is only required to provide information that has not been submitted as part of a prior TAS application. To facilitate review of tribal applications, EPA would request that a tribal application inform EPA whether the tribe has been approved for TAS or deemed eligible to receive authorization for any other EPA program. See 59 FR at 64340.

    The TAS application procedures and criteria for the CWA Sections 303(c) WQS and 303(d) Impaired Water Listing and TMDL Programs are similar in many respects, and a tribe interested in both programs may wish to streamline the application process by combining a request for TAS eligibility for 303(c) and 303(d) into a single application. Although a tribe would not be required to do so, EPA's proposed approach would allow a tribe to submit a combined application, which addresses the criteria and application requirements of § 131.8 and proposed § 130.16, to EPA if the tribe is interested in applying for TAS for both the CWA Section 303(c) and 303(d) Programs.

    VI. What special circumstances may exist regarding qualification for TAS for the CWA Section 303(d) impaired water listing and TMDL program?

    There could be rare instances where special circumstances limit or preclude a particular tribe's ability to be authorized to administer the 303(d) Program over its reservation. For example, there could be a separate federal statute establishing unique jurisdictional arrangements for a specific state or a specific reservation that could affect a tribe's ability to exercise authority under the CWA. It is also possible that provisions in particular treaties or tribal constitutions could limit a tribe's ability to exercise relevant authority.11

    11 EPA takes no position in this proposal regarding whether any particular tribe or Indian reservation is subject to any potential impediment relating to authority to take on the 303(d) Program. Any such issue would need to be addressed on a case-by-case basis and with the benefit of a full record of relevant information that would be developed during the processing of a particular TAS application. To the extent EPA is ever called upon to make a decision regarding this type of issue, such a decision would be rendered in the context of EPA's final action on a specific TAS application, and any judicial review of that decision would occur in that context.

    The application requirements of § 130.16 (a) and (b) would require tribes to submit a statement of their legal counsel (or equivalent official) describing the basis for their assertion of authority. The statement can include copies of documents such as tribal constitutions, by-laws, charters, executive orders, codes, ordinances, and resolutions. If EPA finalizes this proposed action, the requirement for a legal counsel's statement would ensure that applicant tribes appropriately describe the bases of their authority and address any special circumstances regarding their assertion of authority to administer the 303(d) Program. The proposed rule would provide an appropriate opportunity for “appropriate governmental entities” (i.e., states, tribes and other federal entities located contiguous to the reservation of the applicant tribe) to comment on an applicant tribe's assertion of authority and, among other things, inform EPA of any special circumstances that they believe could affect a tribe's ability to administer the 303(d) Program.

    EPA is also aware that section 10211(b) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act of 2005 (“SAFETEA”), Public Law 109-59, 119 Stat. 1144 (August 10, 2005) established a unique TAS requirement with respect to Indian tribes located in the State of Oklahoma. Under section 10211(b) of SAFETEA, tribes in Oklahoma seeking TAS under a statute administered by EPA for the purpose of administering an environmental regulatory program must, in addition to meeting applicable TAS requirements under the relevant EPA-administered environmental statute, enter into a cooperative agreement with the state that is subject to EPA approval and that provides for the tribe and state to jointly plan and administer program requirements. This requirement of SAFETEA applies apart from, and in addition to, existing TAS criteria, including the TAS criteria set forth in section 518 of the CWA. EPA's proposal relates solely to the CWA TAS requirement; it would thus have no effect on the separate requirement of section 10211(b) of SAFETEA.

    VII. What procedure would EPA follow in reviewing a tribe's TAS application? A. Notice to Appropriate Governmental Entities

    The proposed EPA review procedure, included in § 130.16(c), specifies that the Regional Administrator, following receipt of tribal applications, would process such applications in a timely manner. EPA would promptly notify the tribe that the complete application has been received. Within 30 days after receipt of a tribe's complete TAS application for 303(d), EPA would provide notice to appropriate governmental entities (i.e., states, tribes, and other federal entities located contiguous to the reservation of the applicant tribe) of the complete application and the substance of and basis for the tribe's assertion of authority over reservation waters, and would provide a 30 day opportunity to comment to EPA on the tribe's assertion of authority. See, e.g., 56 FR at 64844. EPA would also provide, consistent with prior practice, sufficiently broad notice (e.g., through local newspapers, electronic media, or other appropriate media) to inform other potentially interested entities of the applicant tribe's complete application and of the opportunity to provide relevant information regarding the tribe's assertion of authority. As described below, this aspect of EPA's review procedure would apply unless such process would be duplicative of a notice and comment process already performed in connection with the same tribe's prior application for TAS for another CWA regulatory program.

    B. Avoidance of Duplicative Notice and Comment Procedures

    EPA is proposing to include provisions intended to help avoid unnecessary and wasteful duplication of the notice and comment procedures described in VII A. Specifically, EPA proposes that, where a tribe has previously qualified for TAS for a CWA regulatory program12 and EPA has provided notice and an opportunity to comment on the tribe's assertion of authority as part of its review of the prior application, no further notice would be provided with regard to the same tribe's application for the 303(d) Program, unless the section 303(d) TAS application presents different jurisdictional issues or significant new factual or legal information relevant to jurisdiction to the Regional Administrator. Proposed § 130.16(c)(4). This proposed approach would apply to all tribes that have previously obtained TAS for the CWA Section 303(c) WQS Program, CWA Section 402 NPDES Program or Sewage Sludge Management Program, or CWA Section 404 Dredge and Fill Permit Program.

    12 Specifically, the CWA Section 303(c) WQS Program, CWA Section 402 NPDES Program or Sewage Sludge Management Program, or CWA Section 404 Dredge and Fill Permit Program.

    Where different jurisdictional issues or information are not present, additional notice and comment are likely to be duplicative of the process already undertaken during EPA's review of the prior TAS application. Under these circumstances, the proposed rule would avoid such duplication of efforts by authorizing the relevant EPA Regional Administrator to process a TAS application for the 303(d) Program without a second notice and comment process.

    Where different jurisdictional issues or new or changed information is present, the notice and comment process described in § 130.16(c)(2) would apply. For example, if the geographic reservation area over which an applicant tribe asserts authority is different from the area covered by a prior TAS application or EPA approval, the process proposed in § 130.16(c)(2) would apply and would provide an appropriate opportunity for comment on the tribe's assertion of authority over the new area. In such circumstances, a tribe may find it appropriate and useful to update its prior TAS application at the same time it applies for TAS for 303(d). This would help ensure that the tribe's TAS eligibility for the various CWA programs covers the same geographic area. Such a combined TAS application would be subject to the § 130.16(c)(2) notice and comment process.

    EPA requests comment on its proposed approach or alternative approaches. In addition, we request comment on whether the § 130.16(c)(4) notice and comment exemption should instead be available only prospectively—i.e., only where the applicant tribe obtains TAS for the CWA Section 303(c) WQS Program, CWA Section 402 NPDES Program or Sewage Sludge Management Program, or CWA section 404 Dredge and Fill Permit Program after this proposed rule is finalized (and, again, only if different jurisdictional issues or significant new factual or legal information relevant to jurisdiction are not present in the tribe's 303(d) TAS application). One practical result of this alternative approach would be that if one of the 50 tribes that has previously obtained TAS for the CWA Section 303(c) WQS Program were to apply for TAS for the 303(d) Program after this proposed rule is finalized, the notice and comment process would be required.

    C. Treatment of Competing or Conflicting Claims

    Where a tribe's assertion of authority is subject to a competing or conflicting claim, the proposed procedures provide that the Regional Administrator, after due consideration and in consideration of any other comments received, would determine whether the tribe has adequately demonstrated authority to regulate water quality on the reservation for purposes of the 303(d) Program. Where the Regional Administrator concludes that a tribe has not adequately demonstrated its authority with respect to an area in dispute, then tribal assumption of the CWA Section 303(d) Impaired Water Listing and TMDL Program may be restricted accordingly. If a dispute is focused on a limited area, this would not necessarily delay EPA's decision to treat the tribe in a similar manner as a state for non-disputed areas.

    This proposed procedure does not imply that states, tribes, other federal agencies, or any other entity have veto power over tribal TAS applications. Rather, it is intended to assist EPA in gathering information that may be relevant to the Agency's determination whether the applicant tribe has the necessary authority to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program. EPA would not rely solely on the assertions of a commenter who challenges a tribe's assertion of authority, but rather make an independent evaluation of the tribal showing.

    D. EPA's Decision Process

    The proposed rule requires EPA to process a tribe's TAS application in a timely manner, but does not specify a precise time frame for review of tribal TAS applications. Each TAS application will present its own set of legal and factual issues, and EPA anticipates that in some cases it may be necessary to request additional information when examining tribal TAS applications. Similarly, the Agency's experience with states applying for various EPA programs and with tribes applying for TAS for the WQS Program indicates that additional engagement between EPA and the applicant may be necessary before final decisions are made. EPA expects that similar exchanges with tribes will often be helpful and enhance EPA's processing of tribal TAS applications for the CWA Section 303(d) Impaired Water Listing and TMDL Program.

    Where the Regional Administrator determines that a tribal TAS application satisfies the requirements of proposed § 130.16(a) and (b), the Regional Administrator would promptly notify the tribe that the tribe has qualified for TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. A decision by the Regional Administrator that a tribe does not meet the requirements for TAS for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program would not preclude the tribe from resubmitting the application at a future date. If the Regional Administrator determines that a tribal application is deficient or incomplete, EPA will identify such deficiencies and gaps so the tribe can make changes as appropriate or necessary.

    VIII. What is an example of a stepwise approach for tribes applying for TAS authority for CWA programs?

    EPA expects that the tribes most likely to be interested in applying for TAS for the 303(d) Program will be those that also have TAS for CWA section 303(c) and have applicable WQS for their reservation waters. EPA has taken final action approving TAS for WQS for 50 tribes. Forty-two of those tribes have EPA-approved WQS, and one tribe without TAS for WQS has federally promulgated WQS.13 By virtue of their involvement in the WQS Program, these tribes will already have demonstrated an interest in directly administering certain fundamental elements of the CWA as well as the resources and capacity to do so. Since applicable WQS are a foundation of the approach to protecting water quality under the CWA, establishing EPA-approved/EPA-promulgated WQS for reservation water bodies will be an important first step for tribes interested in protecting and restoring their reservation waters. As tribes gain experience developing and administering applicable WQS on their reservations, they may become interested in greater involvement in additional programs—such as the 303(d) Program—designed to ensure that applicable WQS are achieved. Obtaining TAS to implement a CWA Section 303(d) Impaired Water Listing and TMDL Program for its reservation waters is one potential next step for interested tribes. Under section 303(d), a tribe would use applicable WQS as the basis for identifying impaired waters and calculating TMDLs, which quantify the maximum amount of a pollutant that a water body can receive and still meet the WQS.

    13 A chart listing EPA approvals for tribes to administer a WQS program, and EPA's approvals of tribes' WQS is available at http://water.epa.gov/scitech/swguidance/standards/wqslibrary/approvtable.cfm.

    Table 1, below, is an example of one step-wise approach that tribes may follow in developing their water quality programs under the CWA and ultimately seeking TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. This is only one possible approach, and, under this approach, not all the identified steps would need to be taken sequentially (e.g., some could be completed in parallel).

    Table 1—Example of a Step-Wise Approach to Regulatory Activities for Tribes Interested in Applying for TAS Authority To Implement the CWA Section 303(d) Impaired Water Listing and TMDL Program Step 1: Tribe seeks TAS for CWA 303(c): WQS • Tribe decides to evaluate and address water quality within its reservation by establishing WQS under the CWA. • Tribe identifies and inventories reservation water bodies. • Tribe applies for TAS for WQS. Step 2: Tribe Adopts WQS • Tribe develops its water quality goals.
  • • Tribe drafts WQS for EPA approval.
  • • EPA approves tribal WQS. Step 3: Tribe seeks TAS for CWA Section 303(d): Impaired Water Listing and TMDL Program • Tribe decides to assess water quality conditions (i.e., comparing water quality monitoring data and information against applicable WQS), identify impaired waters, and develop TMDLs.
  • • Tribe applies for TAS to implement a 303(d) program under the CWA.
  • • EPA approves TAS for 303(d). Step 4: Tribe implements the CWA Section 303(d) Impaired Water Listing and TMDL Program Tribe conducts activities required by 40 CFR 130.7, including but not limited to:
  • • Assembles and evaluates all existing and readily available water quality-related data and information on reservation water bodies (data may have been gathered by an established, comprehensive monitoring program).
  • • Develops section 303(d) list of impaired waters (that is, reservation water bodies that do not meet or are not likely to meet applicable WQS). • Prioritizes list of impaired water bodies for TMDL development. • Submits section 303(d) list to EPA for approval. • Develops TMDLs for listed waters. • Submits TMDLs to EPA for approval. Step 5: Tribe implements TMDLs (not required by 40 CFR 130.7) • Carry out watershed-specific plans to implement TMDLs.
  • • Monitors TMDL implementation and effectiveness.
  • Step 6: Tribe seeks other CWA regulatory programs Possibilities include:
  • • CWA Section 402 NPDES Program.
  • • CWA Section 405 Sewage Sludge Management Program. • CWA Section 404 Dredge and Fill Permit Program.

    The proposed rule does not require tribes to have applicable WQS in place on their reservations prior to applying for TAS eligibility for the 303(d) Program. Under section 303(d), however, states and authorized tribes must develop lists of impaired waters and TMDLs based on applicable WQS. CWA sections 303(d)(1) and (2). Although EPA expects that the tribes most likely to be interested in administering the 303(d) Program are those that do have such WQS, the proposed rule would not preclude other tribes from obtaining TAS status for section 303(d) purposes and thus ensuring that TAS eligibility requirements are satisfactorily addressed prior to expending resources on developing WQS. This approach would also allow tribes, at their discretion, to streamline and minimize expenditures on TAS procedures by combining TAS requests for sections 303(c) and 303(d) into a single application. Since authorized tribes must list waters and develop TMDLs based on applicable WQS, however, EPA also specifically invites public comment on whether applicable WQS should instead be a prerequisite for obtaining TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program.

    The proposed rule also does not require tribes seeking TAS eligibility for the 303(d) Program to have previously obtained EPA approval for TAS for the WQS Program. EPA specifically invites public comment on whether a tribe applying for TAS for the 303(d) Program should instead be required to have already received EPA approval—or at least simultaneously apply—for TAS for CWA Section 303(c) WQS Program.

    IX. What financial and technical support is available from EPA to tribes as they choose to develop and implement a CWA Section 303(d) impaired water listing and TMDL program?

    Pre-proposal input from tribes indicates that resources and funding available for TMDL development will be important considerations for tribes in deciding whether to apply for TAS for CWA section 303(d) purposes. The Impaired Water Listing and TMDL Program is not a grant program, and no federal grant funds are available directly from the Impaired Water Listing and TMDL Program. A tribe may be able to use its General Assistance Program (GAP) Grant under the Indian Environmental General Assistance Program Act to support development of a section 303(d) program and capacity to implement such a program, but GAP funds are not available for ongoing program implementation. Tribes interested in this approach would need to contact their Regional GAP Program coordinator. In addition, existing sources of tribal funding such as CWA section 319 grants and section 106 grants are already tightly constrained and may not be available to support additional work under section 303(d). Some tribes that receive CWA funding may be able to identify program activities that could also support 303(d) activities (e.g., assessing water quality to develop impaired water lists, developing a nonpoint source watershed plan that would also implement the nonpoint source portions of a TMDL), but the availability of such opportunities is uncertain.

    As resources allow, EPA may be able to work cooperatively with tribes, as appropriate, on impaired water listing and TMDL issues in Indian country. For example, EPA may develop training and/or provide other technical support to tribes interested in obtaining TAS for 303(d) and implementing a CWA Section 303(d) Impaired Water Listing and TMDL Program if EPA staff and other resources are available to do so. As a general matter, however, EPA cannot assure that funding will be available for a tribe developing or implementing the 303(d) Program, and a tribe considering whether to apply to administer the Program will need to carefully assess its priorities and the availability of EPA assistance or other resources.

    X. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

    A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget for review.

    B. Paperwork Reduction Act (PRA)

    EPA has submitted the information collection requirements in this proposed legislative rule to OMB for approval under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR number 2515.01. You can find a copy of the ICR in the docket for this proposed rule, and it is briefly summarized here. If EPA finalizes the proposed rule, this ICR would supplement the current information collection requirements in EPA ICR number 1560.10 (National Water Quality Inventory Reports (Renewal)) and address the tribes' CWA Section 303(d) Impaired Water Listing and TMDL TAS application and 303(d) Program implementation burden, as well as EPA's burden for reviewing the tribes' applications and 303(d) Program submittals. OMB approved the existing ICR number 1560.10 in December 2012.

    This proposed legislative rule would establish a process for tribes to obtain TAS for the 303(d) Program. As described in the ICR, EPA estimates the total burden on tribes to apply for TAS for the 303(d) Program would be 3,240 staff hours annually for an estimated 12 tribes that would apply for and receive TAS approval per year.

    Tribes that receive TAS approval would then need to implement the requirements of section 303(d) to list impaired waters, set TMDL priorities, and develop TMDLs. EPA estimates that such 303(d) Program implementation burden would entail 86,664 staff hours for the estimated 12 tribes. ICR 1560.10 already includes the estimated burden for states to implement section 303(d), but does not include estimates for tribes. Therefore, the ICR for this proposed rule includes tribal section 303(d) implementation burden as well as the TAS application burden described in the previous paragraph.

    As discussed in section V, EPA's regulations require that a tribe seeking to administer a CWA regulatory program must submit information to EPA demonstrating that the tribe meets the statutory criteria described in section V. EPA requires this information in order to determine that the tribe is eligible to administer the program. Similarly, EPA requires the information—in this case, the lists of impaired waters and the TMDLs—from the authorized tribes once they begin implementing the program.

    Respondents/affected entities: Any federally recognized tribe with a reservation can potentially apply to administer a regulatory program under the CWA. Tribes with TAS for the 303(d) Program would then implement the Program, as described in section IV.

    Respondent's obligation to respond: The information discussed in this proposed rule is required from a tribe only if the tribe seeks and is found eligible to administer a CWA Section 303(d) Impaired Water Listing and TMDL Program. See EPA's proposed regulations cited in section V of this document.

    Estimated number of respondents: The total potential pool of respondents is the over 300 tribes with reservations. Although there are 566 federally recognized Indian tribes in the United States, the CWA allows only those tribes with reservations to apply for authority to administer programs. EPA estimates that an average of 12 tribes per year would apply under this proposed rule, and an average of 12 tribes per year would implement the 303(d) Program over the three year period of the ICR.

    Frequency of response: Application by a tribe to be eligible to administer the 303(d) Program is a one-time collection of information. Tribes submit impaired water lists to EPA every two years, and submit TMDLs to EPA from time to time as described in section IV of this document.

    Total estimated burden: 89,904 tribal staff hours per year for TAS for 303(d) Program application activities and 303(d) Program implementation activities. Burden is defined at 5 CFR 1320.3(b).

    This estimate may overstate actual burden because EPA used a conservatively high estimate of the annual rate of tribal applications. This estimate was used to ensure that the ICR does not underestimate tribal burden, given that EPA used a simplifying steady-state assumption in estimating annualized tribal application costs. Also, EPA used conservatively high estimates of 303(d) implementation burden (i.e., 303(d) listing and number of TMDLs that tribes would submit to EPA annually), as further described in the draft ICR number 2515.01.

    Total estimated cost: $4,185,269, including staff salaries and the cost of support contractors for an annual average of 12 tribes to apply for TAS and implement the 303(d) Program. This action does not entail capital or operation and maintenance costs.

    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's regulations in 40 CFR are listed in 40 CFR part 9.

    Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified in the ADDRESSES section at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than February 18, 2016. EPA will respond to any ICR-related comments in the final rule.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action affects only Indian tribes that seek TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    This proposed action would only apply to tribal governments that seek eligibility to administer the 303(d) Program. Although it could be of interest to some state governments, it would not apply directly to any state government or to any other entity.

    In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and state and local governments, EPA consulted with state associations and representatives of state governments to obtain meaningful and timely input for consideration in this proposal. By letter dated September 19, 2014, EPA invited 10 national and regional state associations to an October 1, 2014, informational meeting at EPA in Washington, DC.14 As a result of this meeting and other outreach, EPA participated in two follow-on meetings with a subset of these associations and their members as well as certain individual states during the month of October 2014. Records of these meetings and copies of written comments and questions submitted by states and state associations are included in the docket for this proposed rule.

    14 The ten associations were: the National Governors Association, the National Conference of State Legislatures, the Council of State Governments, the Western Governors' Association, the Southern Governors' Association, the Midwestern Governors Association, the Coalition of Northeastern Governors, the Environmental Council of the States, the Association of Clean Water Administrators, and the Western States Water Council.

    Some participants expressed interest in: (1) the nature of comments received from tribes during the pre-proposal tribal consultation and coordination (April 8-June 6, 2014); (2) where they could find the list of tribes having TAS for the WQS Program; (3) whether the TAS process for CWA Section 303(d) Impaired Water Listing and TMDL Program would be consistent with other TAS processes; and (4) whether there is a process in place to consult with states where a tribe applies for TAS for 303(d). Some states also had questions about issues unique to their situations. EPA considered this input in developing the proposed rule, particularly in developing sections V to IX. EPA specifically solicits additional comment on this proposed action from state officials.

    F. Executive Order 13175: Tribal Consultation and Coordination

    This action has tribal implications because it will directly affect tribes interested in administering the CWA Section 303(d) Impaired Water Listing and TMDL Program. However, it would neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. Tribes are not required to administer a 303(d) program. Where a tribe chooses to do so, the proposed rule will provide a regulatory process for the tribe to apply and for EPA to act on the tribe's application.

    EPA consulted and coordinated with tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this proposed regulation to permit them to have meaningful and timely input into its development. A summary of that consultation and coordination follows.

    EPA initiated a tribal consultation and coordination process for this action by sending a “Notification of Consultation and Coordination” letter on March 28, 2014, to all 566 federally-recognized tribes. The letter invited tribal leaders and designated consultation representative(s) to participate in the tribal consultation and coordination process. EPA held a webinar concerning this matter for tribal representatives on April 29, 2014. A total of 46 tribal representatives participated. Additionally, tribes and tribal organizations sent five comment letters to EPA. Records of this webinar and copies of written comments and questions submitted by tribes and intertribal consortia are included in the docket for this proposed rule.

    Tribal comments generally supported EPA's plan to propose a TAS rule for the 303(d) Program. Some comments expressed the need for additional financial and technical support as tribes obtain TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. EPA considered the tribal comments in developing this proposal, and intends to remain sensitive to tribal resource issues in its budgeting and planning process. However, EPA cannot assure or assume that additional funding will be available for a tribe developing or implementing the 303(d) Program. A tribe choosing to administer such programs will need to carefully weigh its priorities and any available EPA assistance as described in section IX above.

    EPA specifically solicits additional comment on this proposed action From tribal officials.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to think could disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health or safety risk.

    H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

    J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations

    The proposed rule would not have potential to cause disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. This proposed rule would have no direct impacts on human health or the environment. The proposed rule would affect processes and information collection only. The proposed rule would put in place the procedures interested tribes would follow to seek TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. The action is likely to result in the collection of information or data that could be used to assess potential impacts on the health or environmental conditions in Indian country (see sections III and IV). As described in sections III and IV, above, under CWA section 303(d), authorized tribes would be required to develop lists of impaired waters, submit these lists to EPA, and develop TMDLs for pollutants causing impairments in the waters on the 303(d) lists. TAS for 303(d) would provide authorized tribes the opportunity to participate directly in protecting their reservation waters through the Section 303(d) Impaired Water Listing and TMDL Program, as Congress intended through CWA section 518(e). EPA also expects this proposed rule would advance the goals of the CWA as interested tribes apply for TAS to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program for reservation water bodies.

    The action is likely to increase the availability of information to indigenous populations as interested tribes obtain TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program and begin implementing the Program. In short, tribes with TAS assume the primary role in deciding (1) what waters on their reservations are impaired and in need of restoration, (2) the priority ranking for TMDL development, and (3) what the TMDLs and pollutant source allocations for those waters should look like.

    EPA provided meaningful participation opportunities for tribes in the development of this proposed rule, as described in “F. Executive Order 13175: Tribal Consultation and Coordination,” above.

    List of Subjects in 40 CFR Part 130

    Environmental protection, Grant programs-environmental protection, Indians-lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water pollution control, Water supply.

    Dated: January 6, 2016. Gina McCarthy, Administrator.

    For the reasons stated in the preamble, the U.S. Environmental Protection Agency proposes to amend 40 CFR part 130 as follows:

    PART 130—WATER QUALITY PLANNING AND MANAGEMENT 1. The authority citation for part 130 continues to read as follows: Authority:

    33 U.S.C. 1251 et seq.

    2. Add § 130.16 to read as follows:
    § 130.16 Treatment of Indian Tribes in a similar manner as States for purposes of section 303(d) of the Clean Water Act.

    (a) The Regional Administrator may accept and approve a tribal application for purposes of administering the Clean Water Act (CWA) Section 303(d) Impaired Water Listing and Total Maximum Daily Load (TMDL) Program if the tribe meets the following criteria:

    (1) The Indian tribe is recognized by the Secretary of the Interior and meets the definitions in § 131.3 (k) and (l) of this chapter;

    (2) The Indian tribe has a governing body carrying out substantial governmental duties and powers;

    (3) The CWA Section 303(d) Impaired Water Listing and TMDL Program to be administered by the Indian tribe pertains to the management and protection of water resources that are within the borders of the Indian reservation and held by the Indian tribe, within the borders of the Indian reservation and held by the United States in trust for Indians, within the borders of the Indian reservation and held by a member of the Indian tribe if such property interest is subject to a trust restriction on alienation, or otherwise within the borders of the Indian reservation; and

    (4) The Indian tribe is reasonably expected to be capable, in the Regional Administrator's judgment, of carrying out the functions of an effective CWA Section 303(d) Impaired Water Listing and TMDL Program in a manner consistent with the terms and purposes of the Act and applicable regulations.

    (b) Requests by Indian tribes for administration of the CWA Section 303(d) Impaired Waters Listing and TMDL Program should be submitted to the appropriate EPA Regional Administrator. The application shall include the following information, provided that where the tribe has previously qualified for eligibility or “treatment as a state” (TAS) under another EPA-administered program, the tribe need only provide the required information that has not been submitted in a previous application:

    (1) A statement that the tribe is recognized by the Secretary of the Interior.

    (2) A descriptive statement demonstrating that the tribal governing body is currently carrying out substantial governmental duties and powers over a defined area. The statement should:

    (i) Describe the form of the tribal government;

    (ii) Describe the types of governmental functions currently performed by the tribal governing body such as, but not limited to, the exercise of police powers affecting (or relating to) the health, safety, and welfare of the affected population, taxation, and the exercise of the power of eminent domain; and

    (iii) Identify the source of the tribal government's authority to carry out the governmental functions currently being performed.

    (3) A descriptive statement of the tribe's authority to regulate water quality. The statement should include:

    (i) A map or legal description of the area over which the tribe asserts authority to regulate surface water quality;

    (ii) A statement by the tribe's legal counsel (or equivalent official) that describes the basis for the tribe's assertion of authority and may include a copy of documents such as tribal constitutions, by-laws, charters, executive orders, codes, ordinances, and/or resolutions that support the tribe's assertion of authority; and

    (iii) An identification of the surface waters that the tribe proposes to assess for potential impaired water listing and TMDL development.

    (4) A narrative statement describing the capability of the Indian tribe to administer an effective CWA Section 303(d) Impaired Water Listing and TMDL Program. The narrative statement should include:

    (i) A description of the Indian tribe's previous management experience that may include the administration of programs and services authorized by the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450, et seq.), the Indian Mineral Development Act (25 U.S.C. 2101, et seq.), or the Indian Sanitation Facility Construction Activity Act (42 U.S.C. 2004a);

    (ii) A list of existing environmental or public health programs administered by the tribal governing body and copies of related tribal laws, policies, and regulations;

    (iii) A description of the entity (or entities) that exercise the executive, legislative, and judicial functions of the tribal government;

    (iv) A description of the existing, or proposed, agency of the Indian tribe that will assume primary responsibility for establishing, reviewing, implementing and revising impaired water lists and TMDLs;

    (v) A description of the technical and administrative capabilities of the staff to administer and manage an effective CWA Section 303(d) Impaired Water Listing and TMDL Program or a plan that proposes how the tribe will acquire the needed administrative and technical expertise. The plan must address how the tribe will obtain the funds to acquire the administrative and technical expertise.

    (5) Additional documentation required by the Regional Administrator that, in the judgment of the Regional Administrator, is necessary to support a tribal application.

    (c) Procedure for processing a tribe's application. (1) The Regional Administrator shall process an application of a tribe submitted pursuant to paragraph (b) of this section in a timely manner. The Regional Administrator shall promptly notify the tribe of receipt of the application.

    (2) Except as provided below in paragraph (c)(4) of this section, within 30 days after receipt of the tribe's application the Regional Administrator shall provide appropriate notice. Notice shall:

    (i) Include information on the substance and basis of the tribe's assertion of authority to regulate the quality of reservation waters; and

    (ii) Be provided to all appropriate governmental entities.

    (iii) Provide 30 days for comments to be submitted on the tribal application. Comments shall be limited to the tribe's assertion of authority.

    (3) If a tribe's asserted authority is subject to a competing or conflicting claim, the Regional Administrator, after due consideration, and in consideration of other comments received, shall determine whether the tribe has adequately demonstrated that it meets the requirements of paragraph (a)(3) of this section.

    (4) Where EPA has previously determined that a tribe qualifies for TAS for the CWA Section 303(c) Water Quality Standards Program, CWA Section 402 National Pollutant Discharge Elimination System Program, or CWA Section 404 Dredge and Fill Permit Program, and EPA has provided notice and an opportunity to comment on the tribe's assertion of authority to appropriate governmental entities as part of its review of the prior application, no further notice to governmental entities, as described in paragraph (c)(2) of this section, shall be provided with regard to the same tribe's application for the CWA Section 303(d) Impaired Water Listing and TMDL Program, unless the application presents to the EPA Regional Administrator different jurisdictional issues or significant new factual or legal information relevant to jurisdiction.

    (5) Where the Regional Administrator determines that a tribe meets the requirements of this section, he or she shall promptly provide written notification to the tribe that the tribe is authorized to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program. Such tribe shall be considered a “State” for purposes of CWA section 303(d) and its implementing regulations. With respect to the timing requirement for submittal of an authorized tribe's first list of impaired waters pursuant to § 130.7(d)(1), the tribe's first list is due on the next listing cycle due date that is 24 months after the later of either:

    (i) The date EPA approves the tribe's TAS application pursuant to this section or

    (ii) The date EPA-approved or EPA-promulgated water quality standards become effective for the tribe's reservation waters.

    [FR Doc. 2016-00736 Filed 1-15-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0032; FRL-9939-32] Withdrawal of Pesticide Petitions for Establishment or Modification of Pesticide Chemical Tolerances or Tolerance Exemptions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of withdrawal of pesticide petitions.

    SUMMARY:

    This document announces the withdrawal of pesticide petitions requesting the establishment or modification of tolerances or tolerance exemptions for residues of pesticide chemicals in or on various commodities. The petitions were either withdrawn voluntarily by the petitioners or by the Agency.

    DATES:

    The pesticide petitions in this document are withdrawn as of January 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Susan Lewis, Registration Division (RD) (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected] The mailing address for each contact person is: Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

    SUPPLEMENTARY INFORMATION:

    I. General Information A. Does this action apply to me?

    Although this action only applies to the petitioners in question, it is directed to the public in general. Since various individuals or entities may be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, please consult the person listed at the end of the withdrawal summary for the pesticide petition of interest.

    B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0008, is available at http://www.regulations.gov or at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. 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 OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    II. What action is the agency taking?

    EPA is announcing the withdrawal of pesticide petitions received under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of tolerances or tolerance exemptions in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities.

    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions covered by this document, prepared by the petitioner, was included in a docket EPA created for each rulemaking. The docket for each of the petitions is available online at http://www.regulations.gov.

    Withdrawals by Petitioners

    1. PP 0E7820 (spirodiclofen). EPA issued a notice in the Federal Register of February 4, 2010 (76 FR 17374) (EPA-HQ-OPP-2011-0087), which announced the filing of a pesticide petition (PP 0E7820) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to establish tolerances in 40 CFR part 180 for residues of the insecticide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, persimmon and acerola at 0.45 ppm; and lychee, longan, Spanish lime, rambutan and pulasan at 3.5 ppm. On April 17, 2014, IR-4 notified EPA that it was withdrawing this petition.

    2. PP 9E7632 (spirodiclofen). EPA issued a notice in the Federal Register of February 4, 2010 (75 FR 5790) (EPA-HQ-OPP-2009-0861), which announced the filing of a pesticide petition (PP 9E7632) by Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to amend the tolerances in 40 CFR 180.608 by revising the tolerance expression under paragraphs (a)(1) and (a)(2) to read as follows: (a)(1). Tolerances are established for residues of the insecticide spirodiclofen, including its metabolites and degradates. Compliance with the tolerance levels specified is to be determined by measuring only spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate). (a)(2). Tolerances are established for residues of the insecticide spirodiclofen, including its metabolites and degradates. Compliance with the tolerance levels specified is to be determined by measuring only the sum of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate) and its metabolite 3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one, calculated as the stoichiometric equivalent of spirodiclofen. On April 17, 2014, IR-4 notified EPA that it was withdrawing this petition.

    3. PP 4G8247 (flutriafol). EPA issued a notice in the Federal Register of October 24, 2014 (79 FR 63594) (EPA-HQ-OPP-2014-0379), which announced the filing of a pesticide petition (PP 4G8247) by Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510. The petition proposed to establish tolerances in the 40 CFR part 180 for residues of the fungicide flutriafol, (±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1 H-1,2,4-triazole-1-ethanol, including its metabolites and degradates, in or on corn, sweet, forage at 5 parts per million (ppm); corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and corn, sweet, stover at 15 ppm. On February 25, 2015, Cheminova, Inc., notified EPA that it was withdrawing this petition.

    4. PP 1E7923 (clothianidin). EPA issued a notice in the Federal Register of December 8, 2011 (76 FR 76674) (EPA-HQ-OPP-2011-0860), which announced the filing of a pesticide petition (PP 1E7923) by Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08450. The petition proposed to establish tolerances in 40 CFR part 180 for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on strawberry at 1.4 parts per million (ppm); citrus fruit group 10-10 at 0.5 ppm; citrus, dried pulp at 1 ppm; and pistachio at 0.01 ppm. On April 7, 2015, IR-4 notified EPA that it was withdrawing this petition.

    5. PP 3E8226 (gamma-cyhalothrin). EPA issued a notice in the Federal Register of May 23, 2014 (79 FR 29729) (EPA-HQ-OPP-2014-0207), which announced the filing of a pesticide petition (PP 3E8226) by Cheminova A/S, 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510. The petition proposed to establish import tolerances in the 40 CFR part 180 for residues of the insecticide gamma-cyhalothrin, in or on fruit, citrus, group 10-10 at 0.07 ppm; citrus, dried pulp at 0.2 ppm; and citrus, oil at 3.5 ppm. On April 8, 2015, Cheminova A/S notified EPA that it was withdrawing this petition.

    6. PP 3E8183 (1,3-dichloropropene). EPA issued a notice in the Federal Register of September 12, 2013 (78 FR 56185) (EPA-HQ-OPP-2013-0496), which announced the filing of a pesticide petition (PP 3E8183) by Interregional Research ProjectNumber 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to establish a tolerance in 40 CFR part 180 for the combined residues of the fungicide, cis- and trans-1,3-dichloropropene, including its metabolites and degradates, in or on pineapple at 0.02 ppm. It is proposed that compliance with the tolerance levels specified in § 180.636 is to be determined by measuring cis- and trans-1,3-dichloropropene and its metabolites cis- and trans-3-chloroacrylic acid, and cis-and trans-3-chloroallylalcohol, in or on the commodity. The proposed tolerances are to support post plant use in pineapple, similar to the established drip irrigation use of 1,3-dichloropropene in grapes. On May 20, 2015, IR-4 notified EPA that it was withdrawing this petition.

    7. PP 2F8008 (clothianidin). EPA issued a notice in the Federal Register of September 28, 2012 (77 FR 59578) (EPA-HQ-OPP-2010-0217), which announced the filing of a pesticide petition (PP 2F8008) by Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596. The petition requested to establish tolerances in the 40 CFR part 180 for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on fruiting, vegetables, group 8-10, except pepper/eggplant subgroup 8-10B at 0.2 ppm; and pepper/eggplant subgroup 8-10B at 0.7 ppm. The petition also requested to amend the tolerance in 40 CFR 180.586 (a) by deleting the tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on the vegetable, fruiting group 8 at 0.2 ppm, upon approval of fruiting, vegetables, group 8-10, except pepper/eggplant subgroup 8-10B at 0.2 ppm under “New Tolerance” for PP 2F8008; and replacing the tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on fruit, pome at 1.0 ppm with fruit, pome group (11-10) at 1.0 ppm due to the expansion of crop groups. On June 24, 2015, Valent U.S.A. Corporation notified EPA that it was withdrawing this petition.

    8. PP 4E8311 (flubendiamide). EPA issued a notice in the Federal Register of March 4, 2015 (80 FR 11611) (EPA-HQ-OPP-2014-0784), which announced the filing of a pesticide petition (PP 4E8311) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to establish a tolerance in 40 CFR part 180 for residues of the insecticide, flubendiamide, (N2-1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N1-2-methyl-4-1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethylphenyl-1,2-benzenedicarboxamide) in or on the following: Bushberry subgroup 13-07B at 8.0 ppm; vegetable, fruiting group 8-10 at 0.60 ppm; fruit, pome, group 11-10 at 1.5 ppm; fruit, stone, group 12-12 at 1.6 ppm; nut, tree, group 14-12 at 0.06 ppm; and sunflower, subgroup 20B at 5.0 ppm. Upon the approval of the aforementioned tolerances, the petitioner requests to remove the established tolerances for flubendiamide in or on fruit, pome, group 11 at 1.5 ppm; fruit, stone, group 12 at 1.6 ppm; nut, tree, group 14 at 0.06 ppm; safflower, seed at 5.0 ppm; and sunflower, seed at 5.0 ppm. On September 3, 2015, IR-4 notified EPA that it was withdrawing this petition.

    List of Subjects in 40 CFR Part 180

    Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: December 23, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.
    [FR Doc. 2016-00431 Filed 1-15-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. CDC-2015-0006] 42 CFR Part 73 RIN 0920-AA59 Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety Requirements AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of Proposed Rulemaking (NPRM).

    SUMMARY:

    In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and proposes to amend and republish the list. Specifically, we are proposing to remove six biological agents; add provisions to address the inactivation of select agents; add specific provisions to the section of the regulations addressing biosafety; and clarify regulatory language concerning security, training, incident response, and records.

    DATES:

    Submit written or electronic comments by March 21, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2015-0006 or RIN 0920-AA59 by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-A46, Atlanta, Georgia 30329, Attn: Docket CDC-2015-0006.

    Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this rulemaking. All relevant comments received will be posted without change to http://regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

    Comments will also be available for public inspection from Monday through Friday, except for legal holidays, from 9 a.m. to 5 p.m., Eastern Time, at 1600 Clifton Road NE., Atlanta, Georgia, 30329. Please call ahead to (404) 718-2000 and ask for a representative from the Division of Select Agents and Toxins to schedule your visit.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Dan Sosin, Acting Director, Division of Select Agents and Toxins, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-A46, Atlanta, Georgia 30329. Telephone: (404) 718-2000.

    SUPPLEMENTARY INFORMATION:

    The NPRM is organized as follows:

    I. Public Participation II. Background A. Legal Authority B. Historical background to this rulemaking III. Summary of Proposed Changes to 42 CFR part 73 A. Definitions B. Proposed changes to the list of select agents C. Inactivation of a Select Agent D. Toxins E. Exemptions for select agents and toxins F. Registration G. Responsible Official H. Visitor Access to Select Agents and Toxins I. Security, Biosafety, and Incident Response Plans J. Training K. Records IV. Alternatives Considered V. Required Regulatory Analyses A. Executive Orders 12866 and 13563 B. The Regulatory Flexibility Act C. Paperwork Reduction Act of 1995 D. EO 12988: Civil Justice Reform E. EO 13132: Federalism F. Plain Language Act of 2010 VI. References I. Public Participation

    Interested persons or organizations are invited to participate in this rulemaking by submitting written views, recommendations, and data. Comments are invited on any topic related to this rulemaking.

    In addition, HHS/CDC invites comments specifically as to whether there are biological agents or toxins that should be added or removed from the HHS list of select agents and toxins based on the following criteria:

    (1) The effect on human health of exposure to the agent or toxin;

    (2) The degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;

    (3) The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or exposure to the toxin; and

    (4) Any other criteria, including the needs of children and other vulnerable populations that the commenter considers appropriate.

    HHS/CDC also invites comments on the following questions:

    (1) Are there other methods that should be required to validate the rendering of a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious?

    (2) Should there be changes to the toxin permissible limits for excluded toxins?

    (3) Should Diacetoxyscirpenol (DAS) and T-2 be removed from the select toxin list because they do not have the potential to pose a severe threat to public health and safety?

    (4) Does seven calendar days provide a sufficient amount of time for the entity to destroy or transfer the select agents or toxins after identification?

    (5) Are there any specific biosafety measures that should be required to prevent laboratory acquired infections (LAIs) or accidental release of the select agents and toxins from an entity into the community?

    (6) What alternative regulatory requirement could be constructed such that a registered entity would know whether it had a theft or loss of a select agent or toxin without that registered entity first having “an accurate, current inventory for each select agent . . . held in long term storage”?

    Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. HHS/CDC will carefully consider all comments submitted in preparation of a final rule.

    II. Background A. Legal Authority

    HHS/CDC is promulgating this rule under the authority of sections 201-204 and 221 of Title II of Public Law 107-188, 116 Stat 637 (42 U.S.C. 262a).

    B. Historical Background to This Rulemaking

    Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (42 U.S.C. 262a), requires HHS to regulate the possession, use, and transfer of biological agents or toxins that have the potential to pose a severe threat to public health and safety (select agents and toxins). Subtitle B of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (which may be cited as the Agricultural Bioterrorism Protection Act of 2002), (7 U.S.C. 8401), requires the United States Department of Agriculture (USDA) to regulate the possession, use, and transfer of biological agents or toxins that have the potential to pose a severe threat to animal or plant health, or animal or plant products (select agents and toxins). Accordingly, HHS and USDA have promulgated regulations requiring individuals or entities that possess, use, or transfer select agents and toxins to register with the CDC or the Animal and Plant Health Inspection Service (APHIS). See 42 CFR part 73, 7 CFR part 331, and 9 CFR part 121 (the select agent regulations). The Federal Select Agent Program (FSAP) is the collaboration of the CDC, Division of Select Agents and Toxins (DSAT) and the APHIS Agriculture Select Agent Services (AgSAS) to administer the select agent regulations in a manner that minimizes the administrative burden on persons subject to the select agent regulations. The FSAP administers the select agent regulations in close coordination with the Federal Bureau of Investigation's Criminal Justice Information Services Division (CJIS).

    The Bioterrorism Response Act also requires the HHS Secretary to establish by regulation a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. In determining whether to include an agent or toxin on the list, the HHS Secretary considers criteria such as the effect on human health of exposure to an agent or toxin; the degree of contagiousness of the agent and the methods by which the agent or toxin is transferred to humans; the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent illnesses resulting from an agent or toxin; and the needs of children and other vulnerable populations. The current list of HHS select agents and toxins can be found at 42 CFR 73.3 (HHS select agents and toxins) and 42 CFR 73.4 (Overlap select agents and toxins). The list of HHS and Overlap select agents and toxins is also available at: http://www.selectagents.gov/SelectAgentsandToxinsList.html.

    The HHS Secretary last republished the list of HHS select agents and toxins in the Federal Register on October 5, 2012 (77 FR 61084). The list of HHS select agents and toxins is divided into two sections. The select agents and toxins listed in section 73.3 (HHS select agents and toxins) are those regulated only by HHS under the authority of the Bioterrorism Response Act (42 U.S.C. 262a). The select agents and toxins listed in section 73.4 (Overlap select agents and toxins) are those regulated by HHS under the authority of the Bioterrorism Response Act and also regulated by the U.S. Department of Agriculture under the authority of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401).

    The Bioterrorism Response Act requires the HHS Secretary to review and republish the list of select agents and toxins on at least a biennial basis. Using government subject matter experts, HHS/CDC conducts the biennial review process in consultation with the HHS/CDC Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC). The ISATTAC is comprised of Federal government employees from CDC, Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Department of Homeland Security (DHS), the Department of Defense (DOD), the USDA/Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), and USDA Center for Veterinary Biologics (CVB). Based on the criteria outlined in the Bioterrorism Response Act, the ISATTAC considered the following criteria in their review of the HHS and Overlap lists of select agents and toxins: The degree of pathogenicity (ability of an organism to cause disease), communicability (ability to spread from infected to susceptible hosts), ease of dissemination, route of exposure, environmental stability, ease of production in the laboratory, ability to genetically manipulate or alter, long-term health effects, acute morbidity (illness), mortality, available treatment, status of host immunity, vulnerability of special populations, and the burden or impact on the health care system.

    On February 27, 2015, HHS/CDC published an advance notice of proposed rulemaking (80 FR 10656) in which we requested public comment on (1) whether there are biological agents or toxins that should be added or removed from the HHS list of select agents and toxins; and (2) whether HHS/CDC should remove the following six select agents from the HHS list of select agents and toxins: Coxiella burnetti, Rickettsia prowazekii, Bacillus anthracis Pasteur strain, Brucella abortus, Brucella melitensis, and Brucella suis.

    III. Summary of Proposed Changes

    The following changes to the list of HHS select agents and toxins are proposed based on comments received to the advance notice of proposed rulemaking (80 FR 10656) referenced above, recommendations from the ISATTAC, information from the DHS Material Threat Determinations (DHS-MTD) of biological agents and toxins (https://www.medicalcountermeasures.gov/phemce/dhs.aspx), and the expertise of federal agencies and staff responsible for the oversight of the possession, use, and transfer of select agents and toxins. We are also proposing specific changes to the current regulations, as discussed below, addressing biosafety; clarifying regulatory language concerning security, training, incident response, and records; correcting an omission from the technical amendment (appeal process for exclusion); and revision of the select agent list with current taxonomic names.

    A. Definitions

    We are proposing to add two new terms to section 73.1 (Definitions) of the regulations. We are proposing to define the term “Inactivation” as “a method to render a select agent non-viable but retain characteristic of interest for future use, or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.” We are also proposing to define the term “Kill curve” as “the results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.” The new definitions will help clarify proposed regulatory language in section 73.12 (Biosafety).

    B. Proposed Changes to the List of Select Agents

    On February 27, 2015, HHS/CDC published an advance notice of proposed rulemaking (ANPRM) (80 FR 10656) in which we requested public comment specifically on whether there are biological agents or toxins that should be added or removed from the HHS list of select agents and toxins.

    In that same docket, HHS/CDC also requested public comments as to whether biological agents specifically listed in the February 27, 2015 ANPRM should be removed or remain on the list. The listed agents were Coxiella burnetti, Rickettsia prowazekii, Bacillus anthracis Pasteur strain, Brucella abortus, Brucella melitensis, and Brucella suis. We are now proposing that these agents be removed from the HHS list of select agents based on the twenty-two comments received in response to the February 27, 2015 ANPRM, recommendations from the ISATTAC, and our review of current scientific data regarding these biological agents.

    Coxiella burnetii (42 CFR 73.3)

    In response to the February 27, 2015 ANPRM, we received 11 comments concerning Coxiella burnetii. Only two commenters recommended that C. burnetii remain on the list because “antibiotic treatment should not be considered for removing the agent.” The other nine commenters argued that C. burnetii should not be included as a select agent based on the following assertions:

    • Five commenters stated it is not easily transmitted from person to person.

    • Three commenters referenced that even in the absence of antibiotic treatment, Q fever (the disease with acute and chronic stages caused by the bacteria C. burnetii) is generally a self-limited flu-like illness with low mortality (Ref. 1).

    • All commenters acknowledged that most infections are inapparent and most seropositive individuals cannot remember an infection consistent with Q fever.

    • Six commenters agreed that Coxiella is susceptible to a number of readily available antibiotics. Preferred treatments include tetracycline or doxycycline. Quinolones have also been used successfully and Co-trimoxazole is recommended in specific situations such as pregnancy.

    The ISATTAC recommended the removal of C. burnetii from the HHS list of select agents and toxins because:

    • It has a low mortality rate with antibiotic treatment and most seropositive individuals cannot remember an infection consistent with Q fever (Ref. 2); and

    • A whole-cell killed vaccine (Q-Vax) with nearly 100% efficacy is licensed in Australia and has been used to vaccinate U.S. researchers whom were at risk (Ref. 3).

    We are now proposing to remove C. burnetii from the HHS list of select agents (42 CFR 73.3). As discussed above, our proposal is supported by comments we received in response to the February 27, 2015 ANPRM and the recommendations of the ISATTAC. Both the commenters and the ISATTAC supported their recommendations with the scientific references noted above. We further conclude that, based on recent information provided by DHS-MTD, C. burnetii does not pose a severe threat to public health and safety. We are, however, still seeking comment from those who may believe that C. burnetii remains a severe threat to public health and safety and accordingly should be retained as a HHS select agent.

    Rickettsia prowazekii (42 CFR 73.3)

    In response to the February 27, 2015 ANPRM, we received eight comments concerning Rickettsia prowazekii. Only one commenter recommended to retain Rickettsia prowazekii because “antibiotic treatment should not be considered for removing the agent.” The other seven commenters supported removal based on the following reasons:

    • The risk of mass casualties is low because R. prowazekii can be treated with a single dose of doxycycline when symptoms are present;

    • Transmissibility from person to person is low due to the fact that R. prowazekii is usually transmitted via blood, although it can be spread through inhalation of louse feces;

    • The agent has poor environmental stability; and

    • The difficulty in growing and purifying substantial quantities of these agents in vitro.

    The ISATTAC recommended the removal of R. prowazekii from the HHS list of select agents and toxins because:

    • It is treatable with available antibiotics (Ref. 4 and 5);

    • The risk of mass casualties is low because R. prowazekii can be treated with a single dose of doxycycline when symptoms are present (Ref. 4 and 5); and

    • Transmissibility from person to person is low due to the fact that R. prowazekii is usually transmitted via blood, although it can be spread through inhalation of louse feces (Ref. 5).

    We are now proposing to remove R. prowazekii from the HHS list of select agents (42 CFR 73.3). As discussed above, our proposal is supported by the comments we received in response to the February 27, 2015 ANPRM and the recommendations of the ISATTAC. Both the commenters and the ISATTAC supported their recommendations with the scientific references noted above. We further conclude that, based on recent information provided by DHS-MTD, R. prowazekii does not pose a severe threat to public health and safety. We are, however, still seeking comment from those who may believe that R. prowazekii remains a severe threat to public health and safety and accordingly should be retained as a HHS select agent.

    Bacillus anthracis Pasteur Strain (42 CFR 73.4)

    We received six comments to the February 27, 2015 ANPRM with all commenters agreeing that Bacillus anthracis Pasteur strain should not be included as a select agent based on B. anthracis Pasteur strain lacks the plasmid that encodes the toxin genes causing disease. The B. anthracis Sterne strain, which lacks the plasmid that encodes for the capsule, was excluded from the requirements of the regulations effective on February 27, 2003.

    The ISATTAC recommended the removal of B. anthracis Pasteur strain from the overlap list of select agents and toxins because:

    B. anthracis Pasteur strain lacks the plasmid that encodes the toxin genes causing disease (Ref. 6);

    B. anthracis Sterne strain, which lacks the plasmid that encodes for the capsule, was excluded from the requirements of the regulations effective on February 27, 2003 (Ref. 7-8); and

    • Historically, the B. anthracis Pasteur strain has been retained as a select agent to allow for continued oversight of laboratories in which the accidental (or intentional) combination of this strain with the Sterne strain could occur to produce de novo the wild type phenotype B. anthracis. However, a recent study indicates that bacterial transformation of B. subtilis with plasmid DNA is inefficient; indicating that transformation with plasmid pXO1 into closely related bacteria such as the Bacillus anthracis Pasteur strain would also be inefficient (Ref. 9).

    We agreed with the commenters and ISATTAC. We propose to remove B. anthracis Pasteur strain because the transformation of a virulence plasmid from one Bacillus strain to another is difficult.

    Brucella abortus, B. melitensis, and B. suis (42 CFR 73.4)

    Responses were received from 16 commenters to the February 27, 2015 ANPRM, that addressed the retention of the three Brucella species (B. abortus, B. melitensis, and B. suis) currently on the overlap select agent list. Only two commenters recommended to retain these species because “antibiotic treatment should not be considered for removing the agent.” The other 14 commenters supported removal based on the rationale provided in the ANPRM.

    The ISATTAC recommended the removal of B. abortus, B. melitensis, and B. suis from the overlap list of select agents and toxins because:

    B. abortus has a low human mortality rate (Ref. 10);

    B. abortus, B. melitensis, and B. suis are treatable with antibiotics (Ref. 10); and

    • Human-to-human transmission is extremely rare, and wildlife carriers in the United States often come into contact with humans without significant transmission (Ref. 10).

    We agreed with the commenters and ISATTAC. We propose to remove B. abortus, B. melitensis, and B. suis because although Brucella has a low infectious dose, it is treated, mortality is low, efficacy of treatment is good for all three Brucella strains.

    C. Inactivation of a Select Agent

    We are proposing to add specific requirements to the biosafety section of the regulations (42 CFR 73.12) to address the requirements for rendering a select agent or an nucleic acids that can produce infectious forms of any select agent virus “non-viable.”

    Sections 73.3 (HHS select agents and toxins) and 73.4 (Overlap select agents and toxins) both provide that a “non-viable” select agent is excluded from the requirements of the select agent regulations. We are proposing that for an agent to be “non-viable,” or to render a nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use, an entity must use a validated method. A validated method means that the method must be scientifically sound such that method will produce consistent results each time the method is used. As outlined in our guidance for “Non-viable Select Agents and Nonfunctional Select Toxins and Rendering Samples Free of Select Agents and Toxins” (http://www.selectagents.gov/guidance-nonviable.html), an inactivation procedure may include (1) use of the exact conditions of an accepted method that has been validated, such as autoclaving, (2) a published method with adherence to the exact published conditions, or (3) for in-house methods, validation testing should include the specific conditions used and appropriate controls.

    As part of the inactivation procedure, an entity would be required to develop a site specific kill curve to identify conditions of inactivation for each select agent or regulated nucleic acids that can produce infectious forms of any select agent virus. If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve would be required to be developed for each strain that undergoes the inactivation procedure. A new kill curve would also be required to be created upon any change in procedure or inactivation equipment. In addition, a validated sterility testing protocol to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious would be required to be conducted.9ij

    We are also proposing that written records be kept for a select agent or extracts that have been subjected to a procedure to render them non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a procedure to render them non-infectious.

    We are also soliciting ideas as to whether there are other methods that should be required to validate the rendering of a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious.

    D. Toxins Due Diligence

    Section 73.3(d)(3) of the select agent regulations (42 CFR 73.(d)(3))specifies the select toxin amounts under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor that are excluded from the requirements of the select agent regulations. However, this exclusion applies to the transfer of select toxins “only after the transferor uses due diligence and documents that the recipient has a legitimate need . . . to handle or use such toxins” (42 CFR 73.3(d)(3)(i)). This provision was added to the select agent regulations to address the concern that someone might be able to covertly stockpile toxins by receiving multiple orders below the excluded amount. The toxin “due diligence” provision requires a person transferring toxins in amounts which would otherwise be excluded from the provisions to: (1) Use due diligence to assure that the recipient has a legitimate need to handle or use such toxins; and (2) report to the FSAP if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.

    “Due diligence” is generally understood to be such a measure of prudence, activity, or assiduity, as is properly to be expected from, and ordinarily exercised by, a reasonable and prudent person under the particular circumstances; not measured by any absolute standard, but depending on the relative facts of the specific case.

    We are proposing to add a more specific documentation requirement to the toxin exclusion provision to require the transferor to document the identity of the recipient and the legitimate need (i.e., prophylactic, protective, bona fide research, or other peaceful purpose) claimed by the transferee. Information required to be documented would also include the name of the toxin and the total amount transferred. Identity information of the person requesting and using the toxins would include the individual's name, institution name, address, telephone number, and email address.

    Toxin Permissible Limits

    In conjunction with this biennial review, the FSAP solicited input from biological toxin subject matter experts to review the listed exclusion limits for select toxins in the HHS select agent regulations. To assess the amount necessary to weaponize a biological toxin, DHS developed toxin parameters and attack scenarios for potential inhalation and ingestion exposures to select toxins. DHS used the formulas described below to estimate ingestion scenarios while employing the “NIST CONTAM Multizone Modeling” software (http://www.bfrl.nist.gov/IAQanalysis/) for inhalation scenarios. To estimate the amount of toxin for each scenario, DHS analyzed a range of release sizes (in mg) for each biological toxin in order to estimate the number of people that would be exposed to LD-50 (lethal dose, 50% or median lethal dose, the amount of the substance required (usually per body weight) to kill 50% of the test population); or TD-50 (the median toxic dose of a toxin is the dose at which toxicity occurs in 50% of cases) levels of each toxin amount by ingestion of milk (using published TD-50 or LD-50) and/or indoor inhalation (using published LD-50). The inhalation models analyzed toxin releases in three different indoor public facilities that experience heavy commuter volume (population details for these facilities are given in Table 1). One hundred scenarios were generated for each facility using 1-10µm particle sizes. The models used 10 random locations within each facility (potential release locations and population evenly spaced throughout occupied area) at 10 random times. The inhalation models assumed:

    • No immediate symptoms, so no changes in population movement due to attack

    • Respiration rate 10L/min

    • All people assumed to have the same mass = 70 kg (e.g., did not account for lower doses required for children)

    Table 1—Summary of Facility Population and Residence Times Facility 2008 Annual passenger traffic
  • (people)
  • Simulation transient
  • hourly
  • population
  • Simulation transient
  • average
  • residence time
  • (minutes)
  • High throughput transportation facilities 255,500,000 43,750 10 High throughput transportation facilities 219,000,000 37,500 15 High throughput transportation facilities 64,300,000 11,005 60

    The ingestion models investigated biological toxins introduced into a fluid (e.g., milk) that was purchased and consumed by consumers over a two day period. Production details and specifics of how the toxins were introduced were not considered. In particular, the largest scenarios involve contaminating greater than ten million servings, which was determined to be implausible in practice. The ingestion models made the following assumptions:

    • Milk containing specified quantity of active toxin (1 mg to 1 kg) reaches store shelves.

    • Milk is consumed over six days at a uniform rate.

    • Contaminated milk is consumed daily until supply is depleted or a health advisory is issued.

    • Milk contamination discovered and health advisory issued a minimum of one day, and a maximum of >1 week post attack (at which point all contaminated milk has been consumed).

    • For toxins other than saxitoxin and tetrodotoxin, the attacker chooses a toxin concentration such that a person in the 45+ years old age group will consume 1 LD-50 (or TD-50) over 6 day consumption period.

    • Since saxitoxin and tetrodotoxin are largely excreted in approximately one day after consumption, the attacker chooses a saxitoxin or tetrodotoxin concentration such that a person in the 45+ years old age group will consume 1 LD-50 (or TD-50) over a one day consumption period.

    • Total volume of milk contaminated equals the number of grams of toxin available divided by the toxin concentration (i.e., total volume of milk contaminated depends on the mass of toxin assumed to be available (which varies from 1 mg to 1 kg) and the toxin ingestion LD-50 (or TD-50)).

    • If the toxin ingestion LD-50 (or TD-50) is given by a range, the geometric mean of this range is used.

    • Range of total volumes of milk contaminated is less than 1 L to approximately 108 L.

    • The amount of milk contaminated is assumed to depend on how much toxin the attacker has available (i.e., the total volume of milk contaminated equals the number of grams of toxin available divided by the toxin concentration). For example, for a 1 g attack, with a toxin that has an LD-50 of 1mg/kg, the volume of milk contaminated would be 1000 mg/(0.056 mg/mL*1000 mL/L) = 18 L of milk.

    • For small attack sizes, it is assumed the attacker would target appropriately-sized small holding tanks or containers, while for large attack sizes, the attacker would target large holding tanks or silos.

    • If the toxin is degraded due to pasteurization or storage, the amount of toxin introduced pre-processing would have to be correspondingly larger than these masses.

    Proposed Increase of Regulatory Exclusion Limits

    Based on the data generated by the models described above, we are proposing the following exclusion limits based on the amounts estimated to expose less than 10 people by inhalation or less than 100 people by ingestion to the LD-50 or TD-50 levels of toxin:

    • Increase the regulatory exclusion limit of Botulinum neurotoxin (BoNT) from 0.5 mg to 1 mg;

    • Increase the regulatory exclusion limit of Staphylococcal enterotoxins from 5 mg to 100 mg;

    • Increase the regulatory exclusion limit of saxitoxin from 100 mg to 500 mg;

    • Increase the regulatory exclusion limit of tetrodotoxin from 100 mg to 500 mg;

    • Increase the regulatory exclusion limit of abrin from 100 mg to 1,000 mg;

    • Increase the regulatory exclusion limit of ricin from 100 mg to 1,000 mg; and

    • Increase the regulatory exclusion limit of DAS from 1,000 mg to 10,000 mg.

    • Increase the regulatory exclusion limit of T-2 from 1,000 mg to 10,000 mg.

    We are, however, still seeking comment from those who may believe that we should retain the current exclusion limits. In addition, we are interested in receiving comments from the public on whether DAS and T-2 have the potential to pose a severe threat to public health and safety or whether these two toxins should be removed from the select toxin list given the high exclusion limit for DAS and T-2.

    Proposed Removal of Select Toxins Short, Paralytic Alpha-Conotoxins

    We are proposing short, paralytic alpha-conotoxins containing the following amino acid sequence (X1CCX2PACGX3X4X5X6CX7) be removed as a select toxin for the following reasons:

    • The DHS model reported LD-50 value for inhalation delivery of alpha-conotoxin is 20 µg/kg, which is a low toxicity compared to other select toxins;

    • A regulatory exclusion limit of 10,000 mg would require the depletion of the cone snail population to achieve this quantity.

    Therefore, based on the low toxicity of short, paralytic alpha-conotoxins and the high dosage required for inhalation exposure, we are proposing that the alpha-conotoxin be removed from the select toxin list (Ref. 32).

    Toxins: Exclusion of Original Food Samples and Clinical Samples

    Original food samples and clinical samples are those specimens that are submitted to laboratories for diagnosis or verification purposes to identify or verify a biological agent or toxin. For example, an original food sample could be a container of potato salad or juice. An original clinical sample could be serum or stool from a patient. Laboratories that test food sample and clinical samples for the presence of toxins generally do not know the level of toxin in a sample and do not extract and purify a toxin as part of their studies. Therefore, we are proposing to exclude the original food sample or clinical sample identified to contain an HHS select toxin to be consistent with the rationale for the current exclusion for animals exposed to toxins (42 CFR 73.3(d)(4)). The proposed exclusion is based upon input from biological toxin subject matter experts and our determination that quantifying the amount of toxin in these samples is problematic because (1) the amount of toxin is highly variable, which would require large amounts of food and clinical samples to quantify or purify, (2) laboratory procedures to extract toxin from samples are inefficient with most extractions producing low yields; (3) the resources that would be required to quantify toxins in clinical samples and food samples make sample quantification prohibitively expensive; and (4) procedures in these laboratories, based on the requirements of their public health mission, are designed only for toxin detection and not for purification and quantification. Therefore, we are interested in comments regarding our rationale that the original food sample or clinical sample identified to contain an HHS select toxin should be excluded from the select agent regulation.

    Exclusion of Toxin Produced as a Byproduct

    Laboratories that are only registered for BoNT-producing species of Clostridium do not normally have a need to account for BoNT produced during the culturing of Clostridium since studying the toxin is not part of their work objective. Therefore, we propose to exclude toxins that are produced only as a byproduct to a study of the toxin producing host organism so long as the toxin has not been intentionally collected, purified, or otherwise extracted, and the material containing the toxin is inactivated and properly disposed of within 30 days of the initiation of the culture. The 30 day disposal time was recommended by biological toxin subject matter experts based on the time it would take to grow the organism and perform the extraction process. This exclusion allows laboratories whose purpose does not include purification of the toxin to more effectively conduct outbreak investigations, food studies, and molecular characterization of agents which produce toxin. In the case of BoNT, these laboratories would still be regulated for the BoNT-producing species of Clostridium and in the case of all other HHS select toxins the laboratories would be regulated if they wished to keep the material containing toxins for longer than 30 days from the initiation of culture of the toxin producing host organism. If at any time an entity manipulated the material that contains the select toxin, such as intentional collection, purification or extraction of the toxin from culture supernatant, such activities would void this exemption, and the entity would be required to be registered for the select toxin and meet all applicable select agent and toxin regulatory requirements.

    E. Exemptions for Select Agents and Toxins Informing Specimen Provider

    Since a registered or certified reference laboratory typically confirms the identification of a select agent or toxin for public health and agriculture, clinical and diagnostic laboratories, we are proposing to require the registered or certified reference laboratory inform the specimen provider of the identification. This will ensure that the reference laboratory notifies the specimen provider of the identification of the select agent or toxin so that the specimen provider is aware that they are in possession of the agent or toxin and must meet the requirements outlined in 42 CFR 73.5, 73.6.

    Identification of Toxin

    Once a clinical or diagnostic laboratory has identified a select toxin-positive specimen, an APHIS/CDC Form 4 (Report of the Identification of a Select Agent or Toxin) must be submitted to the FSAP. The select agent regulations currently require the laboratory to transfer or destroy the material within seven days of identification (42 CFR 73.5(a), 73.6(a)) because we determined through input from technical experts that the seven calendar days provides a sufficient amount of time for the entity to destroy or transfer the select agents or toxins after identification. In the past, we have received comments that argued that the seven day requirement for transferring or destroying select agents or toxins used for diagnosis or testing is too short a time limit. Therefore, we are seeking comments to determine if seven calendar days provides a sufficient amount of time for the entity to destroy or transfer the select agents or toxins after identification.

    In addition, we are seeking comments to extend the exemption time period to 30 days for BoNT and Staphylococcal enterotoxin (Subtypes A-E) to allow clinical and diagnostic laboratories sufficient time to complete their investigations without having to transfer or destroy the sample. Laboratories would still be required to report the identification of BoNT immediately and Staphylococcal enterotoxin (Subtypes A-E) within seven days. We are proposing to amend the language in 42 CFR 73.5(a), and 42 CFR 73.6(a)to read: “Unless directed otherwise by the HHS Secretary, within seven calendar days after identification of the select agent and toxin (except for Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E)), or within thirty calendar days after identification of Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E), the select agent or toxin is transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process,”

    Patient Care

    To clarify how the select agent regulations apply to activities associated with the diagnosis and care for individuals infected with a select agent or exposure to a select toxin, we are proposing to add provisions that HHS/CDC will not regulate material containing a select agent or toxin when it is in a patient care setting and is not being otherwise collected, tested or retained for non-patient care purposes. However, once delivery of patient care for an illness associated with a select agent or toxin has concluded these specimens would become subject to the regulatory requirements. An entity unable to meet all of the regulatory requirements necessary to retain the material will then have the option of transferring the material containing the select agent or toxin in accord with the select agent regulations or destroying the materials within seven calendar days of the conclusion of patient care.

    We also are proposing to clarify that FSAP does not regulate waste generated during the delivery of patient care.

    F. Registration

    We are codifying in regulations the current FSAP policy that an entity is required to meet all of the regulatory requirements for those select agents and toxins listed on the entity's registration regardless of whether the select agent or toxin is in the actual possession of the entity; and without regard to the actual amounts of toxins in the possession of the entity.

    G. Responsible Official (RO)

    Section 73.9(a)(6) of the select agent regulations currently states that the Responsible Official must ensure that an annual inspection is conducted for each laboratory where select agents and toxins are stored or used. This requirement also provides that the results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected. We are adding a requirement that the Responsible Official must also document the corrective actions taken by the entity to address any identified deficiencies.

    HHS or USDA Office of the Inspector General Hotline

    In response to a recommendation in the December 2014 Federal Experts Security Advisory Panel report, we are adding a requirement that the Responsible Official must ensure that individuals are provided the contact information of the HHS or USDA Office of Inspector General Hotline so that individuals are able to anonymously report a safety or security concern related to select agents and toxins. In its December 2014 report, the Federal Experts Security Advisory Panel recommended adding a specific requirement to include how individuals are informed so that they can access the HHS or USDA Office of Inspector General Hotline to anonymously report a safety or security concern.

    H. Visitor Access to Select Agents and Toxins

    Section 73.10(e) of the select agent regulations currently provides that a person with a valid approval from the HHS Secretary or APHIS Administrator to have access to select agents and toxins may request, through his or her Responsible Official, that the HHS Secretary or APHIS Administrator provide their approved access status to another registered individual or entity for a specified period of time. This allows a scientist registered to work with a select agent at a registered entity to work with the select agent at another registered entity. To ensure that the Responsible Official of the entity hosting the visitor is aware if a visiting individual loses approval for access to select agents and toxins, we are proposing to add a requirement that the Responsible Official at the home entity must immediately notify the Responsible Official of the visiting entity if the person's access to select agents or toxins has been terminated.

    I. Security, Biosafety, and Incident Response Plans

    The select agent regulations require a registered entity to develop and implement a number of plans in order to ensure the safety and security of the select agents they handle. These are:

    • A security plan that provides for measures sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release (42 CFR 73.11);

    • A biosafety plan that provides for measures sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards) (42 CFR 73.12); and

    • An incident response plan that provides for measures that the registered entity will implement in the event of theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, etc. The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such agent or toxin. (42 CFR 73.14)

    Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plans. The plans must be reviewed and revised, as necessary, after any drill or exercise and after any incident. We are proposing to require that these drills or exercises be documented to include how the drill or exercise tested and evaluated the plan, any problems identified and corrective actions that were taken, and the names of the individuals who participated in the drill or exercise. This will provide a more thorough accounting of required activities via testing and entity-directed improvements.

    Similar to the existing requirement for the security plan, we are also proposing to add a requirement that the biosafety and incident response plans be submitted for initial registration, renewal of registration, or when requested by FSAP.

    Biosafety

    We are proposing to amend the regulatory language in section 73.12 to update the name change of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Ref. 31).

    Prior to the publication of the 5th edition of CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (Ref. 3), the Occupational Safety and Health Administration (OSHA) regulations in 29 CFR 1910.1200 and 1910.1450 provided specific requirements for handling hazardous chemicals in the laboratories. This regulation also provided recommendations for safely working with chemical including toxins and gave non-mandatory recommendations for prudent practices in laboratories handling chemical hazards. As such, we included this reference for entities to consider when developing biosafety plans for those facilities working with toxins. Since the current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Appendix I provides guidelines for work with toxins of biological origin, we have removed the reference to the OSHA regulations in 29 CFR 1910.1200 and 1910.1450. It should be noted that regulated entities must still meet the OSHA regulatory requirements where applicable.

    In addition, we want to ensure that laboratory personnel that are working with select agents and toxins are aware of the risks associated with these agents. As such, we are proposing to add a requirement that a laboratory-specific biosafety manual must be accessible to individuals. This is consistent with guidance provided by the CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories. This requirement is proposed to foster an enhanced culture of responsibility by ensuring that appropriate biosafety resources are available to all staff with access to select agents and toxins within a select agent laboratory.

    The current regulations require that the biosafety plan be written using performance standards. In the aftermath of recent biosafety incidents involving select agents, we are proposing that the biosafety plan should be designed according to a site-specific risk assessment in accordance with the risk of a select agent, given its intended use by adding specific provisions to the biosafety section that would require a written risk assessment for each registered select agent or toxin; written safety procedures to protect entity personnel, the public, and the environment from exposure to the select agent or toxin; written decontamination procedures; and written waste management procedures.

    The FSAP would also like to solicit ideas regarding any specific biosafety measures that should be required to prevent LAIs or accidental or intentional release of the select agents and toxins from an entity into the community.

    Security

    We are proposing to amend the requirement that the security plan contain a description of how the entity authorizes the means of entry into areas where select agents or toxins are stored or used, to include a requirement that the security plan must include a description of centralized access control management systems (e.g., keycards) and/or key management (mechanical keys).

    Paragraphs (d)(7)(i) through (d)(7)(v) of section 11 of the select agent regulations encompass a list of events that individuals with access approval from the APHIS Administrator or the HHS Secretary must immediately report to the Responsible Official. We are proposing to add a new requirement that the Responsible Official must be notified of any loss of computer, hard drive, or other data storage device containing information that could be used to gain access to select agents or toxins. We believe that such notification will facilitate notification of the Federal Bureau of Investigation if deemed necessary by the Responsible Official as the loss of such equipment may be criminal in nature.

    J. Training

    We are proposing to amend section 15 of the select agent regulations which concerns the provision of training for staff and visitors who work in or visit areas where select agents or toxins are handled or stored. Since individuals need to understand hazards associated with the select agents and toxins that they will be working with in the laboratory or are in the area they will be visiting, we are proposing to require that all individuals who have received approval to have access to select agents and toxins have training that address the particular needs of the individual and the risks posed by the select agent or toxin regardless of whether they have access to the select agents or toxins. The training would have to be completed within 12 months of that individual's anniversary of receiving access approval or prior to his or her entry into an area where any select agents and toxins are used or stored, whichever occurs first. This change is necessary in order to codify our policy regarding which individuals at registered entities are required to receive training.

    We are also proposing to add a new paragraph (e) to section 15, which would require the entity's Responsible Official to provide contact information for the USDA or HHS Office of the Inspector General Hotline. Details of the proposed addition may be found under the heading “Responsible Official.”

    K. Records

    Based on inspections of registered entities, we observed that entities are maintaining records of the destruction of select agents even though section 73.17 of the select agent regulations currently does not include a requirement for documenting when a select agent is destroyed. To ensure the proper tracking of a select agent from acquisition to destruction and to incorporate into the regulations what entities are currently doing, we are proposing to add the requirement for records to be created and maintained for the destruction of a select agent held in long-term storage to include the quantity (i.e., number of vials) of select agent destroyed, the date of such action, and by whom.

    Section 73.17 of the select agent regulations currently states that records and databases need to be accurate. To ensure that handwritten records are accurate, we are proposing to clarify that hand-written record must be legible (i.e., capable of being read).

    We are proposing to expand the scope of records required to be maintained to include any records that contain information related to the requirements of the regulations. Such records may include, but would not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. We propose revision to the regulations will enhance the ability of FSAP to evaluate biosafety, security, and incident response programs and includes any record created under sections 73.5, 73.7, 73.9, 73.11, 73.12, 73.14, 73.15, 73.16, 73.17, and 73.19 of the select agent regulations.

    Records for Long-term Storage

    The FSAP continues to receive comments that are critical of that portion of the select agent regulations that require a registered entity to maintain “an accurate, current inventory for each select agent . . . held in long term storage.” The comments typically focus on the belief that a container based inventory requirement is not useful to track inventory of biological agents of which small amounts of samples from the container could be stolen without detection and used to grow larger quantities. In the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Congress requires the Secretaries of Health and Human Services and Agriculture to include in the select agent regulations a requirement for “the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins.” HHS/CDC is soliciting ideas on any alternative regulatory requirement that could be constructed such that a registered entity would know whether it had a theft or loss of a select agent or toxin without that registered entity first having “an accurate, current inventory for each select agent . . . held in long term storage.”

    V. Required Regulatory Analyses A. Executive Orders 12866 and 13563

    Under Executive Order 12866 (EO 12866), Regulatory Planning and Review (58 FR 51735, October 4, 1993) HHS/CDC is required to determine whether this regulatory action would be “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Orders. This order defines “significant regulatory action” as any regulatory action that is likely to result in a rule that may:

    • Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities;

    • Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    • Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients; or,

    • Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in EO 12866.

    Executive Order 13563 (EO 13563), Improving Regulation and Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the provisions of EO 12866 in order to promote more streamlined regulatory actions. This EO charges, in part, that, while protecting “public health, welfare, safety, and our environment” that regulations must also “promote predictability and reduce uncertainty” in order to promote economic growth. Further, regulations must be written in plain language and be easy to understand.

    HHS/CDC has determined that this NPRM is a significant regulatory action as defined in EO 12866. However, the Office of Management and Budget has waived their review of the document.

    B. The Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA)

    We have examined the impacts of the proposed rule under the Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that the proposed rule is not expected to have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. We certify that this proposed rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.

    This regulatory action is not a major rule as defined by Sec. 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This proposed rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

    C. Paperwork Reduction Act of 1995

    In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), HHS/CDC has determined that the Paperwork Reduction Act does apply to information collection and recordkeeping requirements included in this rule. We note that the information collection and recordkeeping requirements are already approved by the Office of Management and Budget (OMB) under OMB Control Number 0920-0576.

    D. EO 12988: Civil Justice Reform

    This rule has been reviewed under E.O. 12988, Civil Justice Reform. Once the final rule is in effect, HHS/CDC notes that: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) No retroactive effect will be given to this rule; and (3) Administrative proceedings will not be required before parties may file suit in court challenging this rule.

    E. EO 13132: Federalism

    HHS/CDC has reviewed this proposed rule in accordance with Executive Order 13132 regarding Federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

    In accordance with section 361(e) of the PHSA [42 U.S.C. 264(e)], nothing in this rule would supersede any provisions of State or local law except to the extent that such a provision conflicts with this rule.

    F. Plain Language Act of 2010

    Under the Plain Language Act of 2010 (P.L. 111-274, October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS/CDC has attempted to use plain language in promulgating this rule consistent with the Federal Plain Writing Act guidelines.

    VI. References

    1. M. Maurin and D. Raoult. Q fever. Clin Microbiol Rev. Oct. 1999;12(4):518-53.

    2. R. Eibach, F. Bothe, M. Runge, S. F. Fischer, W. Philipp, and M. Ganter. Q fever: baseline monitoring of a sheep and a goat flock associated with human infections. Epidemiol Infect. Nov. 2012 140(11): 1939-1949.

    3. D.M. Waag. Coxiella burnetii: Host and bacterial responses to infection. Vaccine. Oct. 2007; 25 (42): 7288-7295.

    4. C. Rovery and D. Raoult. Meditteranean Spotted Fever. Infect Dis Clin N Am. Sept 2008. 22:515-530.

    5. D.H. Walker. Rickettsiae and rickettsial infections: the current state of knowledge. Clin Infect Dis. 2007 Jul 15. 45 Suppl 1:S39-44.

    6. B.E. Ivins, J.W. Ezzell, J. Jemski, K.W. Hedlund, J.D. Ristroph, and S.H. Leppla. Immunization Studies with Attenuated Strains of Bacillus anthracis. Infection and Immunity. May 1986; 52(2):454-458.

    7. Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases “Anthrax Sterne strain (34F2) of Bacillus anthracis,” http://www.cdc.gov/nczved/divisions/dfbmd/diseases/anthrax_sterne/.

    8. Federal Select Agent Program, “Select Agents and Toxins Exclusions,” http://www.selectagents.gov/SelectAgentsandToxinsExclusions.html.

    9. C. Johnston, B. Martin, G. Fichant, P. Polard, and J.P. Claverys. Bacterial transformation: distribution, shared mechanisms and divergent control. Nature Rev. Microbiol. 2014; 12: 181-196.

    10. C. Lecaroz, M.J. Blanco-Prieto, M.A. Burrell. Intracellular killing of Brucella melitensis in human macrophages with microsphere-encapsulated gentamicin. J Antimicrob Chemother. 2006 Sep. 58(3): 549-56.

    11. Biodefense Modeling Parameters Review Workshop, 2013: Ventura, California.

    12. E.A.E. Garber. Effects of Pasteurization on Detection and Toxicity of the Beans from Abrus precatorius, in Intentional and Unintentional Contaminants in Food and Feed. 2009, American Chemical Society. 143-151.

    13. E.A.E. Garber. Toxicity and detection of ricin and abrin in beverages. Journal of Food Protection, 2008. 71(9): 1875-1883.

    14. C. Millard. Final Recommendations to the CDC Select Agent Inter-Agency Workgroup from the Chairman of the Subcommittee on Toxins, Memorandum for Record, 2002.

    15. C.J. Malizio, M.C. Goodnough, and E.A. Johnson. Purification of Clostridium botulinum Type A Neurotoxin, in Bacterial Toxins: Methods and Protocols, O. Holst, Editor. 2000, Humana Press Inc.: Totowa, NJ.

    16. S. Sugii and G. Sakaguchi Molecular Construction of Clostridium-Botulinum Type-a Toxins. Infection and Immunity, 1975. 12(6): 1262-1270.

    17. R. Wannernacher and B. Anderson. Inhalation Ricin: Aerosol Procedures, Animal Toxicology, and Therapy, Inhalation Toxicology 2nd edition, 2006: 973—982.

    18. S. George. DHS Science and Technology Directorate Chemical-Biological Defense Division (CBD), Biothreat Agent Factbook, August 2010.

    19. Department of Defense, Office of the Surgeon General, US Army, Borden Institute. Medical Aspects of Biological Warfare. 2007. 672.

    20. D.R. Franz and N.K. Jaax. Ricin Toxin, in Medical Aspects of Chemical and Biological Warfare, F.R. Sidell, E.T. Takafuji, and D.R. Franz, Editors. 1997, Office of The Surgeon General at TMM Publications: Washington, D.C. 631-642.

    21. R.W. Wannemacher and J.B. Anderson. Inhalation Ricin: Aerosol Procedures, Animal Toxicology, and Therapy. Inhalation Toxicology, 2007. 19(10): 873-887.

    22. F.E. Ahmed. Seafood Safety. 1991, Institute of Medicine. Committee on Evaluation of the Safety of Fishery Products: National Academy Press.

    23. A. Alfonso, M.C. Louzao, M.R. Vieytes, and L.M. Botana. Comparative-Study of the Stability of Saxitoxin and Neosaxitoxin in Acidic Solutions and Lyophilized Samples. Toxicon, 1994. 32(12): 1593-1598.

    24. L.M. Botana, ed. Seafood and Freshwater Toxins, Pharmacology, Physiology and Detection. CRC Press: Boca Raton, FL.

    25. V.M. Bricelj and SW. Shumway. Paralytic shellfish toxins in bivalve molluscs: occurence, transfer kinetics, and biotransformation. Reviews in Fisheries Science, 1998. 6(4): 315-383.

    26. W.D. Burrows and S.E. Renner. Biological warfare agents as threats to potable water. Environmental Health Perspectives, 1999. 107(12): 975-984.

    27. J. Patockaa and L. Stredab, Brief review of natural nonprotein neurotoxins. ASA Newsletter, 2002. 89(16).

    28. C.E. Whalley. Toxins of Biological Origin, in CRDEC-SP-0211990: Aberdeen Proving Ground, Maryland.

    29. S.A. Morse, R.A. Mah, and W.J. Dobrogosz, Regulation of staphylococcal enterotoxin B. J Bacteriol, 1969. 98(1): 4-9.

    30. H.D. Raj and M.S. Bergdoll, Effect of Enterotoxin B on Human Volunteers. Journal of Bacteriology, 1969. 98(2): 833-834.

    31. U.S. Department of Health and Human Services, National Institutes of Health. (2013). NIH Guidelines for Research Involving Recombinant Or Synthetic Nucleic Acid Molecules (NIH Guidelines). Available at: http://osp.od.nih.gov/sites/default/files/NIH_Guidelines.html.

    32. P. Thapa, M.J. Espiritu, C.C. Cabalteja, and J.P. Bingham. Conotoxins and their regulatory considerations. Regulatory and Toxicology and Pharmacology, July 2014. 70: 197-202.

    List of Subjects in 42 CFR Part 73

    Biologics, Packaging and containers, Penalties, Reporting and recordkeeping requirements, Transportation.

    For the reasons discussed in the preamble, we propose to amend 42 CFR part 73 as follows:

    PART 73—SELECT AGENTS AND TOXINS 1. The authority citation for part 73 continues to read as follows: Authority:

    42 U.S.C. 262a; sections 201-2014, 221 and 231 of Title II of Public Law 107-188, 116 Stat 637 (42 U.S.C. 262a).

    2. Section 73.1 is amended by adding in alphabetical order, definitions of inactivation and kill curve to read as set forth below.
    § 73.1 Definitions.

    Inactivation means a method to render a select agent non-viable but retain characteristic of interest for future use, or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

    Kill curve means the results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.

    3. Section 73.3 is amended as follows: a. By revising paragraph (b). b. By adding new paragraphs (d)(2)(i), (ii), and (iii). c. By revising paragraphs (d)(3) introductory text and (d)(3)(i). d. By redesignating paragraph (d)(5) as paragraph (d)(7). e. By adding new paragraphs (d)(5), (d)(6), and (d)(8). f. By adding paragraph (e)(3) to read as set forth below.

    The additions and revisions read as follows:

    § 73.3 HHS select agents and toxins.

    (b) HHS select agents and toxins:

    Abrin Botulinum neurotoxins* Botulinum neurotoxin producing species of Clostridium* Crimean-Congo hemorrhagic fever virus Diacetoxyscirpenol Eastern equine encephalitis virus Ebola virus* Francisella tularensis* Lassa fever virus Lujo virus Marburg virus* Monkeypox virus Reconstructed replication competent forms of the 1918 pandemic influenza A virus containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 influenza A virus) Ricin SARS coronavirus (SARS-CoV) Saxitoxin South American hemorrhagic fever viruses: Chapare Guanarito Junin Machupo Sabia Staphylococcal enterotoxins (subtypes A-E) T-2 toxin Tetrodotoxin Tick-borne encephalitis virus Far Eastern subtype Siberian subtype Kyasanur Forest disease virus Omsk haemorrhagic fever virus Variola major virus (Smallpox virus) * Variola minor virus (Alastrim) * Yersinia pestis*

    (d)* * *

    (2) Non-viable HHS select agents or nonfunctional HHS toxins.

    (i) Unless waived by the HHS Secretary, a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation process to remove viability or infectious form (i.e., the ability to reproduce or produce disease, while maintaining cellular structure) is not excluded from the requirements of this part until an individual or entity:

    (A) Develops a site-specific kill curve to define conditions of inactivation for each select agent or regulated nucleic acids that can produce infectious forms of any select agent virus. If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve must be developed for each strain that undergoes the inactivation procedure. A new kill curve must be created upon any change in procedure or inactivation equipment.

    (B) Develops site-specific standard operating inactivation procedures to ensure that the material is inactivated by a safety margin determined by the kill curve.

    (C) Subjects representative samples of inactivated select agents or any nucleic acids that can produce infectious forms of any select agent viruses to a validated sterility testing protocol to ensure that the inactivation method has rendered the select agent non-viable or regulated nucleic acids non-infectious.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was subjected to a validated inactivation protocol is reported to APHIS or CDC.

    (E) Reviews annually, and revises as necessary, the following:

    (1) The kill curve procedure and results;

    (2) Site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent virus are inactivated by a safety margin; and

    (3) The validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus sample non-infectious.

    (F) Reviews, and revises as necessary, documents listed in paragraph (d)(2)(i)(E) of this section after any change in principal investigator, change in protocol, or any reported viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent viruses previously assessed as inactive.

    (ii) Unless waived by the HHS Secretary, an extract from a select agent is not excluded from the requirements of this part until an individual or entity meets the following requirements:

    (A) Any extract is subjected to a process that removes all viable cells, spores, or virus particles.

    (B) Any extract is subjected to a validated sterility testing protocol to ensure that the inactivation method has rendered the extract free of a select agent.

    (C) Any viability of an extract that was subjected to a validated inactivation protocol is reported to the Responsible Official.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was previously assessed as inactive by their validated sterility testing protocol is reported to APHIS or CDC.

    (3) Except as required in § 73.16(l), the aggregate amount of the toxin under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor does not, at any time, exceed the following amounts: 1000 mg of Abrin; 1 mg of Botulinum neurotoxins; 10,000 mg of Diacetoxyscirpenol; 1000 mg of Ricin; 500 mg of Saxitoxin; 100 mg of Staphylococcal enterotoxins (subtypes A-E); 10,000 mg of T-2 toxin; or 500 mg of Tetrodotoxin.

    (i) The toxin is transferred only after the transferor uses due diligence and documents the identification of the recipient and the legitimate need (i.e., prophylactic, protective, bona fide research, or other peaceful purpose) claimed by the recipient to use such toxin. Information to be documented includes, but is not limited to, the recipient identity information, including the recipient's name, institution name, address, telephone number and email address; name of the toxin and the total amount transferred, and the legitimate need claimed by the recipient. Notwithstanding the provisions of paragraph (d) of this section, the HHS Secretary retains the authority to, without prior notification, inspect and copy or request the submission of the due diligence documentation to the CDC.

    (5) An HHS select toxin identified in an original food sample or clinical sample.

    (6) Select toxins that are produced as a byproduct in the study of the toxin producing host organism so long as the toxin has not been intentionally cultivated, collected, purified, or otherwise extracted, and the material containing the toxin is rendered non-functional and disposed of within 30 days of the initiation of the culture.

    (8) Waste generated during the delivery of patient care from a patient infected with a select agent that is decontaminated with a validated method within seven calendar days of the conclusion of patient care,

    (e) * * *

    (3) An individual or entity may make a written request to the HHS Secretary for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The HHS Secretary will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

    4. Section 73.4 is amended as follows: a. By revising paragraph (b). b. By adding new paragraphs (d)(2)(i), (ii), and (iii). c. By adding paragraph (d)(4). d. By adding paragraph (e)(3).

    The revision and additions read as follows:

    § 73.4 Overlap select agents and toxins.

    (b) Overlap select agents and toxins:

    Bacillus anthracis* Burkholderia mallei* Burkholderia pseudomallei* Hendra virus Nipah virus Rift Valley fever virus Venezuelan equine encephalitis virus

    (d) * * *

    (2) * * *

    (i) Unless waived by the APHIS Administrator or HHS Secretary, a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation process to remove viability or infectious form (i.e., the ability to reproduce or produce disease, while maintaining cellular structure) is not excluded from the requirements of this part until an individual or entity:

    (A) Develops a site-specific kill curve to define conditions of inactivation for each select agent or regulated nucleic acids that can produce infectious forms of any select agent viruses. If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve must be developed for each strain that undergoes the inactivation procedure. A new kill curve must be created upon any change in procedure or inactivation equipment.

    (B) Develops site-specific standard operating inactivation procedures to ensure that the material is inactivated by a safety margin determined by the kill curve.

    (C) Subjects representative samples of inactivated select agents or nucleic acids that can produce infectious forms of any select agent viruses to a validated sterility testing protocol to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids non-infectious.

    (D) Reports any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was subjected to a validated inactivation protocol to the Responsible Official.

    (E) Reviews annually, and revises as necessary, the following:

    (1) The kill curve procedure and results;

    (2) Site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent viruses are inactivated by a safety margin; and

    (3) The validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent viruses non-infectious.

    (F) Reviews, and revises as necessary, documents listed in paragraph (d)(2)(i)(E) of this section after any change in principal investigator, change in protocol, or any reported viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus previously assessed as inactive.

    (ii) Unless waived by the APHIS Administrator or HHS Secretary, an extract from a select agent is not excluded from the requirements of this part until an individual or entity meets the following requirements:

    (A) Any extract is subjected to a process that removes all viable cells, spores, or virus particles.

    (B) Any extract is subjected to a validated sterility testing protocol to ensure that the inactivation method has rendered the extract free of a select agent.

    (C) Any viability of an extract that was subjected to a validated inactivation protocol is reported to the Responsible Official.

    (D) Any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was previously assessed as inactive by the validated sterility testing protocol is reported to APHIS or CDC.

    (d) * * *

    (4) Waste generated during the delivery of patient care from a patient infected with a select agent that is decontaminated with a validated method within seven calendar days of the conclusion of patient care.

    (e) * * *

    (3) An individual or entity may make a written request to the HHS Secretary or APHIS Administrator for reconsideration of a decision denying an application for the exclusion of an attenuated strain of a select agent or a select toxin modified to be less potent or toxic. The written request for reconsideration must state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The HHS Secretary or APHIS Administrator will grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision.

    5. Section 73.5 is amended as follows: a. By revising paragraph (a)(1). b. By redesignating paragraph (a)(3) as paragraph (a)(4) and revising newly redesignated paragraph (a)(4). c. By adding new paragraph (a)(3).

    The revisions and addition read as follows:

    § 73.5 Exemptions for HHS select agents and toxins.

    (a) * * *

    (1) Unless directed otherwise by the HHS Secretary, within seven calendar days after identification of the select agent and toxin (except for Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E)), or within thirty calendar days after identification of Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E), the select agent or toxin is transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process,

    (3) Unless otherwise directed by the HHS Secretary, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process within seven days after delivery of patient care has concluded, and

    (4) The identification of the agent or toxin is reported to CDC or APHIS, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.

    6. Section 73.6 is amended as follows: a. By redesignating paragraph (a)(3) as paragraph (a)(4) and revising newly redesignated paragraph (a)(4). b. By adding paragraph (a)(3).

    The revision and addition read as follows:

    § 73.6 Exemptions for overlap select agents and toxins.

    (a) * * *

    (3) Unless otherwise directed by the HHS Secretary or Administrator, the clinical or diagnostic specimens collected from a patient infected with a select agent are transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process within seven days after delivery of patient care has concluded, and

    (4) The identification of the agent or toxin is reported to CDC or APHIS, the specimen provider, and to other appropriate authorities when required by Federal, State, or local law by telephone, facsimile, or email. This report must be followed by submission of APHIS/CDC Form 4 to APHIS or CDC within 7 calendar days after identification.

    7. Section 73.7 is amended as follows: a. By redesignating paragraphs (b) through (k) as paragraphs (c) through (l), respectively. b. By adding a new paragraph (b) to read as follows:
    § 73.7 Registration and related security risk assessments.

    (b) As a condition of registration, each entity is required to be in compliance with the requirements of this part for select agents and toxins listed on the registration regardless of whether the entity is in actual possession of the select agent or toxin. With regard to toxins, the entity registered for possession, use or transfer of a toxin must be in compliance with the requirements of this part regardless of the amount of toxin currently in possession.

    8. Section 73.9 is amended as follows: a. In paragraph (a)(6) by removing “laboratory” and adding in its place “registered space” and adding “and the corrections documented” after “corrected” at the end of the sentence. b. By adding paragraph (a)(7) to read as set forth below.
    § 73.9 Responsible Official.

    (a) * * *

    (7) Ensure that individuals are provided the contact information for the HHS or USDA Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.

    9. Section 73.10 is amended by adding a new sentence to the end of paragraph (e) to read as follows:
    § 73.10 Restricting access to select agents and toxins; security risk assessments.

    (e) * * * A Responsible Official must immediately notify the Responsible Official of the visited entity if the person's access to select agents and toxins has been terminated.

    10. Section 73.11 is amended as follows: a. In paragraph (c)(5) by adding “keycards,” between “keys,” and “passwords” and removing “numbers” and adding in its place “permissions”. b. By adding paragraph (c)(11). c. By adding paragraph (d)(7)(vi). d. By adding a sentence to the end of paragraph (h).

    The additions read as follows:

    § 73.11 Security.

    (c) * * *

    (11) Describe how the entity authorizes the means of entry into areas where select agents or toxins are stored or used, to include centralized access control management systems (e.g., keycards) and/or mechanical key management.

    (d) * * *

    (7) * * *

    (vi) Any loss of computer, hard drive or other data storage device containing information that could be used to gain access to select agents or toxins.

    (h) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and all individuals who participated in the drill or exercise.

    11. Section 73.12 is amended as follows: a. By revising paragraph (a). b. By removing paragraph (c)(2), redesignating paragraph (c)(3) as (c)(2), and in newly redesignated paragraph (c)(2), removing “NIH Guidelines for Research Involving Recombinant DNA Molecules” and adding in its place “NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules”. c. By adding a new sentence to the end of paragraph (e).

    The revision and addition read as follows:

    § 73.12 Biosafety.

    (a) An individual or entity required to register under this part must develop and implement a written biosafety plan that is commensurate with the risk of the select agent or toxin, given its intended use. The biosafety plan must contain sufficient information and documentation to describe the biosafety and containment procedures for the select agent or toxin, including any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. Biosafety and containment procedures specific to each registered laboratory must be available to each individual working in that laboratory. The current biosafety plan must be submitted for initial registration, renewal of registration, or when requested. The biosafety plan must include the following provisions:

    (1) A written risk assessment for each procedure involving a select agent or toxin that addresses the hazards associated with the agent or toxin.

    (i) The hazardous characteristics of each agent or toxin listed on the entity's registration, including probable routes of transmission in the laboratory and in the environment, infective dose (if known), stability in the environment, host range, contribution of any genetic manipulations, and endemicity.

    (ii) Hazards associated with laboratory procedures related to the select agent or toxin;

    (2) Safeguards in place with associated work practices to protect registered entity personnel, the public, and the environment from exposure to the select agent or toxin including, but not limited to: Safety training requirements for registered entity personnel performing the procedure; required personal protective equipment and other safety equipment; required containment equipment including, but not limited to, biological safety cabinets, animal caging systems, and centrifuge safety containers; and required engineering controls and other facility safeguards.

    (3) Written procedures for decontamination with a validated method, of all contaminated or potentially contaminated materials including, but not limited to: Cultures and other materials related to the propagation of select agents or toxins, items related to the analysis of select agents and toxins, personal protective equipment, animal caging systems and bedding, and animal carcasses or extracted tissues.

    (4) Written procedures for decontamination, with a validated method, of laboratory surfaces and equipment using manufacturer's specification.

    (5) Effluent decontamination procedures, with a validated method, that describe the treatment of effluent material contaminated with select agents and toxins.

    (6) Procedures to respond to emergencies such as spills, sharps injury, or animal bites involving select agents and toxins.

    (7) Procedures for the handling of select agents and toxins in the same spaces with non-select agents and toxins in order to prevent unintentional contamination.

    (e) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and all individuals who participated in the drill or exercise.

    12. Section 73.14 is amended as follows: a. By adding a new sentence to the end of paragraph (a). b. By adding a new sentence to the end of paragraph (f).

    The additions read as follows:

    § 73.14 Incident response.

    (a) * * * The current incident response plan must be submitted for initial registration, renewal of registration, or when requested.

    (f) * * * Drills or exercises must be documented to include how the drill or exercise tested and evaluated the plan, any problems that were identified and corrective action(s) taken, and all individuals who participated in the drill or exercise.

    13. Section 73.15 is amended as follows: a. In paragraph (a)(1) by removing “before that individual has such access to select agents and toxins” and adding in its place “, within 12 months of that individual's anniversary of receiving such approval or prior to his or her entry into an area where select agents or toxins are used or stored, whichever occurs first.”. b. By adding paragraph (e) to read as set forth below.
    § 73.15 Training.

    (e) The Responsible Official must ensure and document that individuals are provided the contact information of the HHS or USDA Office of Inspector General Hotline so that they may anonymously report any safety or security concerns related to select agents and toxins.

    14. Section 73.16 is amended by revising paragraph (l)(1) to read as follows:
    § 73.16 Transfers.

    (l) * * *

    (1) Transfer the amounts only after the transferor uses due diligence and documents that the recipient has a legitimate need (i.e., prophylactic, protective, bona fide research, or other peaceful purpose) to handle or use such toxins. Information to be documented includes, but is not limited, to the recipient information, toxin and amount transferred, and declaration that the recipient has legitimate purpose to store and use such toxins.

    15. Section 73.17 is amended as follows: a. In paragraphs (a)(1)(iii) and (a)(3)(v) by adding “or other storage container” after “freezer”. b. By adding paragraph (a)(1)(ix). c. By adding paragraph (a)(8). d . In paragraph (b) by adding “legible,” after “are”. e. By revising paragraph (c).

    The revision and additions read as follows:

    § 73.17 Records.

    (a) * * *

    (1) * * *

    (ix) If destroyed, the quantity (e.g., containers, vials, tubes, etc.) of select agent destroyed, the date of such action, and by whom.

    (8) For a select agent or an extract from a select agent that has been rendered non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus that have been rendered non-infectious through inactivation:

    (i) A written description of the inactivation process used for rendering a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious;

    (ii) The sterility testing protocol used to verify non-viability of a select agent or non-infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus and the results of the test, including investigation, of any inactivation process failures and the corrective actions taken;

    (iii) The name of each individual performing the inactivation method and sterility testing protocols;

    (iv) The date(s) the inactivation method and sterility testing protocols were completed;

    (v) The location where the inactivated method and sterility testing protocols were performed; and

    (vi) An inactivation certificate that includes the date of inactivation, method of inactivation, date of final sterility testing protocol result, and the Principal Investigator. A copy of the inactivation certificate must accompany any transfer of inactivated material.

    (c) Any records that contain information related to the requirements of the regulations. Such records may include, but are not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. All records created under this part must be maintained for 3 years.

    Dated: January 12, 2016. Sylvia M. Burwell, Secretary.
    [FR Doc. 2016-00758 Filed 1-14-16; 4:15 pm] BILLING CODE 4163-18-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 73 and 74 [MB Docket No. 13-249; FCC 15-142] Revitalization of the AM Radio Service AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    In this document, the Commission adopted a Further Notice of Proposed Rulemaking (FNPRM), in which it sought comment on several proposals designed to revitalize the AM broadcast radio service, or to reduce burdens on AM broadcasters. The Commission further adopted a Notice of Inquiry (NOI), in which it sought comment on two proposals designed to revitalize the AM broadcast radio service. One of the proposals, regarding increased utilization of the AM expanded band, was suggested by several commenters in response to the NPRM in this proceeding, The second proposal, for relaxation of the Commission's main studio rules for AM stations, was suggested by a commenter and supported by others.

    DATES:

    Comments may be filed on or before March 21, 2016 and reply comments may be filed on or before April 18, 2016. Written comments on the Paperwork Reduction Act proposed information collection requirements must be submitted by the public, Office of Management and Budget (OMB), and other interested parties on or before March 21, 2016.

    ADDRESSES:

    You may submit comments, identified by MB Docket No. 13-249, by any of the following methods:

    Electronic Filers: Comments may be filed electronically using the Internet by accessing the Commission's Electronic Comment Filing System (ECFS), through the Commission's Web site http://fjallfoss.fcc.gov/ecfs2/. Filers should follow the instructions provided on the Web site for submitting comments. For ECFS filers, in completing the transmittal screen, filers should include their full name, U.S. Postal service mailing address, and MB Docket No. 13-249.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although the Commission continues to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.
    FOR FURTHER INFORMATION CONTACT:

    Peter Doyle, Chief, Media Bureau, Audio Division, (202) 418-2700; Thomas Nessinger, Senior Counsel, Media Bureau, Audio Division, (202) 418-2700. For additional information concerning the Paperwork Reduction Act (PRA) information collection requirements contained in this document, contact Cathy Williams at 202-418-2918, or via the Internet at [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Further Notice of Proposed Rulemaking, FCC 15-142, adopted October 21, 2015, and released October 23, 2015.

    Initial Paperwork Reduction Act of 1995 Analysis

    The FNPRM contains proposed information collection requirements subject to the PRA, Public Law 104-13. OMB, the general public, and other Federal agencies are invited to comment on the proposed new and modified information collection requirements contained in this FNPRM.

    Comments on the proposed information collection requirements should address: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

    In addition to filing comments with the Secretary, a copy of any Paperwork Reduction Act comments on the information collection requirements contained herein should be submitted to Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554, or via the Internet to [email protected], and to Nicholas A. Fraser, Office of Management and Budget (OMB), via the Internet to [email protected]

    To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the Title of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

    The proposed information collections are as follows:

    OMB Control Number: 3060-0075.

    Title: Application for Transfer of Control of a Corporate Licensee or Permittee, or Assignment of License or Permit, for an FM or TV Translator Station, or a Low Power Television Station, FCC Form 345.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities; Not for profit institutions; Local or Tribal Government.

    Number of Respondents and Responses: 1,700 respondents; 2,700 responses.

    Estimated Time per Response: 0.084-1.25 hours.

    Frequency of Response: Third party disclosure requirement and on occasion reporting requirement.

    Total Annual Burden: 2,667 hours.

    Total Annual Cost: $3,958,125.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 154(i) and 310 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: Filing of the FCC Form 345 is required when applying for authority for assignment of license or permit, or for consent to transfer of control of a corporate licensee or permittee for an FM or TV translator station, or low power TV station.

    This collection also includes the third party disclosure requirement of 47 CFR 73.3580 (OMB approval was received for Section 73.3580 under OMB Control Number 3060-0031). 47 CFR 73.3580 requires local public notice in a newspaper of general circulation in the community in which the station is located or providing notice over the air of the filing of all applications for assignment of license/permit. This notice must be completed within 30 days of the tendering of the application. A copy of the newspaper notice or a record of the broadcast notice and the application must be placed in the public inspection file.

    On June 29, 2009, the Commission adopted a Report and Order, Amendment of Service and Eligibility Rules for FM Broadcast Translator Stations, MB Docket No. 07-172, FCC 09-59, 24 FCC Rcd 9642 (2009), 74 FR 45126,Sept. 1, 2009, 74 FR 46382, Sept. 9, 2009. In the 2009 Report and Order, the Commission adopted changes to the FM translator rules that allowed AM stations to use authorized FM translator stations to rebroadcast the AM signal locally, retransmitting their AM programming as a “fill-in” service. The adopted cross-service translating rules limited FM translators to providing “fill-in” service only, specifically within the AM primary station's authorized service area.

    AM radio stations use Form 345 to apply for authority to assign or transfer such fill-in FM translator stations. Consistent with actions taken by the Commission in the 2009 Report and Order, the following changes were made to Form 345: Section III of Form 345 included a new certification concerning compliance with the AM station “fill-in” service requirements. Specifically, in the AM service, applicants certify that the coverage contour (1 mV/m) of the FM translator station is contained within the lesser of: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site.

    On October 21, 2015, the Commission adopted a First Report and Order, Further Notice of Proposed Rulemaking, and Notice of Inquiry, in Revitalization of the AM Radio Service, MB Docket No. 13-249, FCC 15-142. In the Further Notice of Proposed Rulemaking component of this rulemaking proceeding (FNPRM), the Commission proposes to make the following rule (and Form) changes to this information collection: Modify Section 74.1201(g) of the rules to provide that the coverage contour (1 mV/m) of an FM translator station rebroadcasting an AM radio station as its primary station must be contained within the greater of either the 2 mV/m daytime contour of the AM station, or a 25-mile radius centered at the AM station's transmitter site, but that in no event may the FM translator's 1 mV/m coverage contour extend beyond a 40-mile (64 km) radius centered at the AM station's transmitter site.

    Consistent with actions proposed by the Commission in the FNPRM, the following change is made to Form 345: Section III of Form 345 includes a new certification concerning compliance with the new AM station “fill-in” service requirements. Specifically, applicants will now certify that the 1 mV/m coverage contour of the FM translator station is contained within the greater of either: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site, but the FM translator's 1 mV/m contour may not extend beyond a 40-mile radius centered at the AM station's transmitter site. The instructions for Section III—Assignee/Transferee have been revised to assist applicants with completing the modified question.

    With this submission, the Commission is currently seeking to obtain OMB approval for the proposed revisions to 47 CFR 74.1201(g) and FCC Form 345 for this information collection. These revisions will not increase the number of respondents, number of responses, annual burden hours and annual cost for this collection.

    OMB Control Number: 3060-0405.

    Title: Application for Authority to Construct or Make Changes in an FM Translator or FM Booster Station, FCC Form 349.

    Form Number: FCC Form 349.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit; State, Local or Tribal Government; Not-for-profit institutions.

    Number of Respondents and Responses: 1,200 respondents; 2,400 responses.

    Estimated Time per Response: 1-1.5 hours.

    Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in Sections 154(i), 303 and 308 of the Communications Act of 1934, as amended.

    Total Annual Burden: 4,500 hours.

    Total Annual Cost: $4,674,600.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality with this information collection.

    Needs and Uses: FCC Form 349 is used to apply for authority to construct a new FM translator or FM booster broadcast station, or to make changes in the existing facilities of such stations.

    Form 349 also contains a third party disclosure requirement, pursuant to 47 CFR 73.3580. This rule requires stations applying for a new broadcast station, or to make major changes to an existing station, to give local public notice of this filing in a newspaper of general circulation in the community in which the station is located. This local public notice must be completed within 30 days of the tendering of the application. This notice must be published at least twice a week for two consecutive weeks in a three-week period. In addition, a copy of this notice must be placed in the station's public inspection file along with the application, pursuant to 47 CFR 73.3527. This recordkeeping information collection requirement is contained in OMB Control No. 3060-0214, which covers Section 73.3527.

    On June 29, 2009, the Commission adopted a Report and Order, Amendment of Service and Eligibility Rules for FM Broadcast Translator Stations, MB Docket No. 07-172, FCC 09-59, 24 FCC Rcd 9642 (2009), 74 FR 45126, Sept. 1, 2009, 74 FR 46382, Sept. 9, 2009. In the 2009 Report and Order, the Commission adopted changes to the FM translator rules that allowed AM stations to use authorized FM translator stations to rebroadcast the AM signal locally, retransmitting their AM programming as a “fill-in” service. The adopted cross-service translating rules limited FM translators to providing “fill-in” service only, specifically within the AM primary station's authorized service area.

    AM radio stations use Form 349 to apply for authorizations to operate such fill-in FM translator stations. Consistent with actions taken by the Commission in the 2009 Report and Order, the following changes were made to Form 349: Sections II and III of Form 349 included new certifications concerning compliance with the AM station “fill-in” service requirements. Specifically, in the AM service, applicants certify that the coverage contour (1 mV/m) of the FM translator station is contained within the lesser of: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site.

    On October 21, 2015, the Commission adopted a First Report and Order, Further Notice of Proposed Rulemaking, and Notice of Inquiry, in Revitalization of the AM Radio Service, MB Docket No. 13-249, FCC 15-142. In the Further Notice of Proposed Rulemaking component of this rulemaking proceeding (FNPRM), the Commission proposes to make the following rule (and Form) changes to this information collection: Modify 47 CFR 74.1201(g) of the rules to provide that the coverage contour (1 mV/m) of an FM translator station rebroadcasting an AM radio station as its primary station must be contained within the greater of either the 2 mV/m daytime contour of the AM station, or a 25-mile radius centered at the AM station's transmitter site, but that in no event may the FM translator's 1 mV/m coverage contour extend beyond a 40-mile (64 km) radius centered at the AM station's transmitter site.

    Consistent with actions proposed by the Commission in the FNPRM, the following changes are made to the Form 349: Sections II and III of Form 349 include new certifications concerning compliance with the new AM station “fill-in” service requirements. Specifically, applicants will certify that the 1 mV/m coverage contour of the FM translator station is contained within the greater of either: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site, but the FM translator's 1 mV/m contour may not extend beyond a 40-mile radius centered at the AM station's transmitter site. The instructions for Sections II and III have been revised to assist applicants with completing the modified questions.

    With this submission, the Commission is currently seeking to obtain OMB approval for the proposed revisions to 47 CFR 74.1201(g) and FCC Form 349 for this information collection. These revisions will not increase the number of respondents, number of responses, annual burden hours and annual cost for this collection.

    Synopsis of Further Notice of Proposed Rulemaking

    1. A number of commenters in this proceeding advocated reducing daytime, nighttime, and critical hours protection afforded to Class A AM stations, which operate with up to 50 kilowatts of power, day and night, and have large extended service areas, especially at night when skywave propagation allows signals to travel hundreds of miles. As a result, during daytime hours, over 200 licensed Class B and Class D AM stations are required to reduce power and/or change to a directional antenna system to meet the required critical hours protection afforded to Class A stations. During nighttime hours—if permitted nighttime operation at all—other stations often must invest in complex directional arrays to protect one of the 73 Class A stations, and/or must substantially reduce their power, sometimes resulting in their having only secondary nighttime facilities. Even for those Class B stations that are protected from interference by other AM stations at night, this often results in sub-standard nighttime coverage, in order to protect the secondary service area of a larger station a considerable distance, and often many states away. Commenters argue that they could provide better service, with more power to overcome the local noise floor, if the protections to Class A stations were relaxed.

    2. Class A stations have traditionally provided wide-area service to different regions of the United States, including rural areas, and to travelers driving through their relatively large coverage areas. The high power and large extended service areas of these stations have also proved invaluable in emergencies, such as Hurricane Katrina and its aftermath. Some commenters, however, note that the utility of high-powered, wide-area AM stations has waned since the early days of radio, when the FM service was nonexistent or underutilized, more of the population lived outside of major metropolitan areas, and there were significantly fewer media choices than there are today. Because of this, many commenters believe that the current protection afforded to Class A stations should be reduced, in order to allow other, more local stations to add or increase day and nighttime power to their listening areas. The tradeoff between commenters urging caution in taking any steps that would diminish protection to Class A stations and those arguing that large protected coverage areas for Class A stations are unnecessary appears to be whether the Commission should take steps that would deprive Class A stations of listeners far outside of their primary service areas, if those steps would allow substantial numbers of other stations to improve their service, both day and night, to their communities of license and adjacent areas.

    3. While the wide-area service of Class A stations has historically proved to be beneficial, the Commission has seen fit in the past to reduce protection to their skywave service (see, e.g., Clear Channel Broadcasting in the AM Broadcast Band, Report and Order, 78 F.C.C.2d 1345, 1364 (1980), in which the Commission noted that increasing spectrum demands required that protection of such stations (then designated Class I-A stations) beyond the nighttime 0.5 mV/m-50 percent contour, as well as certain restrictions on adjacent-channel stations, be abolished). In this proceeding, the overriding concern is the need for existing AM stations to overcome an increasing noise floor that inhibits local service, both day and night. While reducing protection to a Class A AM station may, in fact, reduce the coverage of that station, the areas of reduced coverage would be located at great distances from the transmitter and from the metropolitan area that constitutes the station's primary service area. At the same time, the reduction in protection may well allow other stations to increase their power to better serve their communities and, in the case of some stations, allow for the first-ever fulltime AM service to those communities. The Commission's goal of localism suggests that service from a local news and information source should be preferred over better reception of a more distant signal.

    4. The Commission tentatively concludes, therefore, that (1) all Class A stations should be protected, both day and night, to their 0.1 mV/m groundwave contour, from co-channel stations; (2) all Class A stations should continue to be protected to the 0.5 mV/m groundwave contour, both day and night, from first adjacent channel stations; and (3) the critical hours protection of Class A stations should be eliminated completely. The Commission seeks comment on these proposals, specifically on the populations that would lose service from Class A stations under this proposal and, to the extent ascertainable, whether such populations currently avail themselves of the service that would be lost. The Commission also seeks data on areas and populations in the United States, if any, that receive service only from Class A AM stations, whether day or night. Conversely, it requests specific comment as to the numbers of stations that would be able to increase power, daytime and nighttime, under this proposal and what populations would gain service from those power increases. Additional comment is sought concerning the net effect on listeners that could result from the combination of reduced protection to Class A stations and power increases by co- and adjacent-channel stations that this proposal would allow. Would, in fact, such power increases cause more loss of service to listeners of Class A stations than gains in such service to listeners of upgrading stations? Would current listeners of Class A skywave service, not located near stations able to avail themselves of power increases due to this proposal, nevertheless experience a reduction in skywave service from Class A stations? Would the proposed changes disproportionately affect listeners in rural and/or tribal areas? What effects, if any, would changes in protection to Class A stations have on EAS Primary Entry Point stations during emergencies? Alternatively, should the Commission consider another level of protection to Class A stations, whether greater or less than that proposed and, if so, what should that protection be? The Commission also seeks comment on whether critical hours protection, if not eliminated, should alternatively be modified? Finally, the Commission seeks comment on any costs that are likely to result from adoption of these proposals or from any alternatives proposed by commenters.

    5. Several commenters to the NPRM also proposed that the Commission return to the nighttime root-sum-square (RSS) prediction method in existence before the Commission's 1991 rule changes. These prediction methods are used to calculate values of both interfering field strengths from other AM stations and nighttime interference-free (NIF) coverage. Prior to 1991, nighttime RSS values of interfering field strengths and nighttime interference-free coverage were based on calculating the RSS of all interfering signals using the 50 percent exclusion method, considering only co-channel interfering signals. In the 1991 Technical Assignment Criteria order (6 FCC Rcd 6273 (1991)), the Commission changed its method of calculation to include adjacent-channel signals, and to use a tiered system of RSS calculations. Some commenters observed that, despite the Commission's intentions in Technical Assignment Criteria, which were to decrease station-to-station interference in the AM service, in practice the effect was to stifle facility improvements, resulting in very little in the way of decreased interference. They contend, for example, that the 25 percent exclusion method complicates nighttime allocation calculations and protection requirements and reduces flexibility for AM station improvement and relocation; that consideration of adjacent-channel stations in making interference calculations is unnecessary, claiming that the Commission instituted this rule in anticipation of wide-band AM receivers that never made it to market; and that a return to the 50 percent exclusion method used prior to 1991, considering only the skywave contributions to RSS calculations of co-channel stations, would enable AM broadcasters to improve their facilities and signals and, thus, overcome the increasing noise floor.

    6. The Commission agreed that the 1991 nighttime skywave interference regulations were well-intentioned but, in retrospect, did not achieve their intended goals and have resulted in unintended adverse consequences, chiefly by impeding facility improvements that are more necessary now than 24 years ago, because the noise floor has increased as much as or more than station-to-station interference, and increasing signal strength to a station's primary service area has become more of a priority than maintenance of rules that offer a small return on interference reduction, compared to the burden they impose on signal improvement. The Commission therefore tentatively concluded that it should roll back the 1991 rule changes as they pertain to calculation of nighttime RSS values of interfering field strengths and NIF service, by amending 47 CFR 78.182(k) to return to predicting the NIF coverage area using only the interference contributions from co-channel stations and the 50 percent exclusion method. The Commission seeks comment on this proposal, and invites in particular comment from parties with differing views, or that have technical evidence demonstrating the effects on inter-station interference of a return to the pre-1991 rules for calculating nighttime skywave interference. In addition, the Commission seeks comment on any costs that commenters believe would result from this proposal.

    7. Commenters also proposed changes to 47 CFR 73.37(a), the rule providing daytime protection to AM stations. The rule currently specifies a 26 dB daytime desired to undesired (D/U) protection ratio for co-channel stations, a 6 dB D/U daytime protection ratio for first adjacent channel stations, and a 0 dB daytime D/U protection ratio for second and third adjacent channel stations. Commenters proposed that the Commission return to the pre-1991 0 dB daytime 1:1 protection ratio for first adjacent channels; change second adjacent channel groundwave protection; and eliminate third adjacent channel groundwave protection. Additionally, several commenters suggested changes to the daytime protected contours for Class B, C, and D stations.

    8. The Commission tentatively concludes that these rule changes should be adopted. The proposed 0 dB daytime 1:1 first adjacent channel protection ratio was the pre-1991 standard, and the post-1991 protection ratio does not appear to allow for sufficient signal strength to overcome current levels of environmental noise. Likewise, because third adjacent channel interference is relatively insignificant compared to environmental sources of interference, it would seem prudent to eliminate third adjacent channel groundwave protection and change second adjacent channel groundwave protection to match the current levels for third adjacent channel protection, thus allowing AM stations to increase power to overcome increased levels of environmental noise. Changing the daytime primary service contour for Class B, C, and D stations to the 2 mV/m contour harmonizes the protection with the definition of service area that was adopted in the Second Order on Reconsideration in the Rural Radio proceeding (27 FCC Rcd 12829, 12838 (2012)), and would allow AM broadcasters greater flexibility to make station modifications designed to increase signal strength to their primary service areas. The Commission therefore proposes to revise 47 CFR 73.37(a) to reflect the aforementioned changes to daytime protected contours for Class B, C, and D AM stations, and seeks comment on this proposal. Would the proposed reductions in protection result in greater flexibility for AM stations to improve their signals, or would they merely increase inter-station interference? Would the net effect be beneficial or harmful to AM broadcasters and listeners? To the extent possible, commenters should provide technical data in support of their arguments. In addition, commenters should discuss and, if possible, quantify any costs they believe the proposal would entail.

    9. Several commenters to the NPRM request that the Commission reconsider the rules for locating cross-service fill-in FM translators. Currently, such translators must be located such that the 60 dBµ contour of any such FM translator station must be contained within the lesser of (a) the 2 millivolts per meter (mV/m) daytime contour of the AM station, or (b) a 25-mile radius centered at the AM transmitter site. Commenters argue that the current rule is too restrictive. Some commenters maintain that the 25-mile limitation is arbitrary, or that it unfairly penalizes stations located far from cities due to land costs or those that have deep nulls in their directional patterns. Others advocate eliminating the 25-mile restriction and would have us allow the translator to be sited anywhere within the 2 mV/m contour, and others suggest even more flexibility.

    10. When the Commission adopted the current limits on siting of cross-service translators re-broadcasting AM stations, it re-affirmed that FM translators re-broadcasting AM stations were intended to fill service voids rather than to expand service, and that the adopted limits were to “ensure that fill-in cross-service translators are used in the AM station's core market area, rather than in a fringe area that may be part of or near another radio market.” Amendment of Service and Eligibility Rules for FM Broadcast Translator Stations, Report and Order, 24 FCC Rcd 9642, 9658-59 (2009). In the FNPRM, however, the Commission agreed that some additional degree of flexibility is appropriate, especially given the factual situations (e.g., highly directional antenna patterns with deep signal nulls) described by some commenters. The Commission also wished to continue to limit cross-service translator use to an AM station's core market. It therefore proposes to modify 47 CFR 74.1201(g) to provide that the coverage contour (1 mV/m) of an FM translator rebroadcasting an AM radio broadcast station as its primary station must be contained within the greater of either the 2 mV/m daytime contour of the AM station or a 25-mile (40 km) radius centered at the AM transmitter site, but that in no event may the translator's 1 mV/m coverage contour extend beyond a 40-mile (64 km) radius centered at the AM transmitter site. The Commission stated that this proposal provides sufficient flexibility to provide useful signal coverage, while not allowing a cross-service fill-in translator to extend the station's coverage beyond its core service area. The Commission invites further comment on this proposal, including comment on any costs that commenters believe are likely to arise from the proposal.

    11. Partial proof of performance measurements are required for AM stations using directional antennas whenever the licensee has reason to believe that the radiated fields may be exceeding the limits for which the station is authorized, and whenever minor directional antenna system repairs are made that result in certain changes to the station's licensed operating parameters. Some commenters request that 47 CFR 73.154, the current rule governing partial proof of performance field strength measurements for AM directional antenna arrays, be modified to require measurements only on radials containing a monitoring point. Currently, the rule requires field strength measurements on all radials with a monitoring point, as well as on radials from the latest complete field strength proof of performance that are adjacent to the monitored radials, if the array has fewer than four monitored radials. Proponents claim that eliminating the requirement to take measurements on non-monitored radials will reduce the cost to maintain AM directional antenna systems in working order. The Commission agreed that the proposed reduction in measured radials would result in a cost savings for directional antenna system maintenance for AM broadcasters, and would not result in more AM directional antenna systems being out of adjustment. It therefore tentatively concludes, and proposes, that 47 CFR 73.154(a) be modified accordingly. The Commission seeks comment on this proposal, including comment on whether and to what extent the proposed rule modification would reduce costs to AM broadcasters employing directional antenna systems.

    12. In 2008, the Commission adopted rules permitting use of Method of Moments (MoM) computer modeling to verify the performance of AM station directional antenna systems. Since then, over 220 MoM directional antenna proofs of performance have been prepared by AM station licensees and their engineers and submitted to the Commission in support of AM station applications for license. Based on their experience gained in the seven years since the adoption of the MoM proof rules, several technical commenters propose the following changes to the AM MoM proof rules: (1) eliminate or modify the recertification measurements requirements and removal of base sampling devices for periodic testing in 47 CFR 73.155; (2) eliminate the requirement for reference field strength measurements (47 CFR 73.151(c)(3)); (3) eliminate the requirement for surveying existing directional antenna arrays as long as tower geometry is not being modified and no new towers are being added to the array; (4) clarify that 47 CFR 73.151(c)(1)(viii) applies only when total capacitance used to model base region effects exceeds 250 pF and modify same to apply only when base current sampling is used; (5) Permit use of MoM modeling for skirt-fed towers; (6) Change MoM rules with regard to re-proofing when antennas are added to towers; and (7) Eliminate requirement for current distribution measurements for top-loaded or other unusual antenna configurations when MoM or other numerical analysis method is used to determine antenna characteristics.

    13. Based on the Commission's experience with MoM proofs over the past seven years, it believed that, except as noted below, the changes listed above are well-founded, would improve the quality of the MoM proofs submitted to the Commission, would not result in inferior adjustments of AM directional antenna arrays, and would eliminate some unnecessary expenses for directional antenna array maintenance by AM station licensees. It therefore tentatively concludes that the above-listed procedural and rule changes, with the exception of the elimination of reference field strength measurements, should be adopted, and invites comment on these changes, particularly from AM broadcasters operating with directional antenna arrays. Rather than eliminate reference field strength measurements, which provide the only external verification that a directional antenna array is operating properly, the Commission tentatively concludes and proposes that 47 CFR 73.151(c)(3) be modified to require reference field strength measurements when the initial license application is submitted for a directional antenna system based on computer modeling and sample system verification. Subsequent licenses for the same directional antenna system and physical facilities will not require submission of new reference field strength measurements. The Commission seeks comment on whether, instead of eliminating recertification measurements, it should modify the rules to require them within a specific time period near, but prior to, the submission of the station's license renewal application, or at some other time interval. What constraints should the Commission impose on the physical model of a skirt-fed antenna element in the MoM computer program? Due to the complexity of modeling a skirt-fed tower, should it require use of specific MoM software to model them? What requirements should it specify for sampling systems for skirt-fed antenna elements? What costs, if any, are likely to arise as a result of any of the foregoing proposals?

    14. In 1991, the Commission adopted rules and procedures for initial licensing of stations in the 1605-1705 kHz AM band (Expanded Band). In opening up the Expanded Band, the Commission's intent was to selectively open the ten Expanded Band frequencies to those existing AM stations that most significantly contributed to congestion and interference in the standard AM band, removing interference from the standard band and providing those stations with more robust, interference-free service in the Expanded Band. To ease the financial uncertainty of migrating to the then-new and untested Expanded Band, the Commission established a five-year transition period, during which migrating stations would hold licenses in both the Expanded Band and standard AM band, and could simulcast programming over both. This five-year period was set forth in a condition to each Expanded Band license, and began to run as of the date of initial licensing in the Expanded Band. After the five-year transition period, each dual-station licensee would be required to surrender either its standard band or its Expanded Band license. The Commission has never abandoned the requirement that the dual standard/Expanded band stations relinquish one of their authorizations, and many such stations have done so. The 25 remaining such station pairs, listed in Appendix F to the FNPRM, negate the Commission's goal to reduce interference in the standard AM band, and their retention of both authorizations disserves the other licensees who complied with the relinquishment requirement. A number of the stations still holding dual standard band/Expanded Band authorizations have filed requests for waiver of the surrender condition and prohibition against sale of one of the authorizations.

    15. Given the Commission's consideration, in a Notice of Inquiry that follows the FNPRM, of further utilization of the Expanded Band, along with its general concern for revitalization of the AM service, there is no justification for allowing licensee retention of high-interfering standard band stations along with the Expanded Band stations meant to replace them. The Commission therefore tentatively concludes that any licensee with dual standard/Expanded Band authorizations should be required to surrender one of the two authorizations within one year of release of a future Report and Order in this proceeding adopting this proposal. The Commission tentatively concludes that the required election should be made by the station licensee in writing, by letter delivered to the Office of the Secretary, with copy to the Media Bureau, Audio Division, not later than twelve months following release of a future Report and Order adopting this proposal, or such other date as is established in the Report and Order and/or in any notice delivered to the licensee by the Media Bureau. The Commission further tentatively concludes that, should a station not make the election regarding which of the two authorizations it wishes to retain within the required time period, its standard band authorization should be canceled, and the station required to operate only as authorized in the Expanded Band. The Commission seeks comment on these proposals, including any comments in favor of licensee retention of dual authorizations, comments on whether it should adopt a shorter or longer deadline for the required election, comments regarding the effect of such retention of dual authorizations on the AM service generally and the Expanded Band specifically, and comments on any costs associated with surrender of these authorizations.

    Synopsis of Notice of Inquiry

    16. Utilization of AM Expanded Band. In Review of the Technical Assignment Criteria for the AM Broadcast Service, Report and Order, 6 FCC Rcd 6273, 6302-23 (1991), 56 FR 64842 (Dec. 12, 1991) (Technical Assignment Criteria), the Commission established rules and policies for stations initially licensed in the Expanded AM Band (1605-1705 kHz) (Expanded Band), including technical rules. See generally Technical Assignment Criteria, 6 FCC Rcd at 6311-14, 6321-23. For example, it decided to administer channels in the Expanded Band on an allotment basis based on fixed technical parameters, similar to allotments in the FM broadcast band, rather than on an assignment basis as in the standard AM band, in which the technical facilities of each station are uniquely designed to avoid interference to other stations on the band. 47 CFR 73.30. A total of 88 Expanded Band channels were originally allotted, and licenses were granted to 54 stations that migrated from the standard AM band to the Expanded Band. The Commission proposed, in the Further Notice of Proposed Rule Making (FNPRM) in this proceeding, to require the remaining 25 dual standard-Expanded Band station pairs to surrender one authorization each. Now that it has had experience with actual, operating Expanded Band AM stations, the Commission inquires whether to open up the Expanded Band to additional stations, and under what conditions.

    17. Several commenters remark that the Expanded Band is underutilized and should be opened up to more stations. Some prefer, as before, that the Expanded Band be used for stations migrating from the standard band; others believe that preference should first be given to applicants for new AM stations, licensed daytime-only AM stations, or licensed or new AM stations proposing all-digital operation. Most who address the Expanded Band state that stations in that band should be assigned in the same way they are assigned in the standard AM band, rather than continuing the allotment procedures currently used in the Expanded Band. Commenters also urge that a station migrating from the standard band to the Expanded Band relinquish its standard band license shortly after initiating Expanded Band service. Although many commenters address the use of the Expanded Band in helping to revitalize the AM service, there are a number of procedural and practical decisions to be made before proposing rules for further utilization of that band. The Commission believes that a more complete record is needed before proposing rules regarding further expansion of the 1605-1705 kHz band.

    18. As a threshold matter, the Commission asks commenters whether they believe that opening the Expanded Band to further development would be beneficial to revitalization of the AM service. Assuming agreement with that premise, who should be allowed to receive authorizations in the Expanded Band? Should preference be given to new stations, to migrators from the standard band, to stations planning all-digital operation, or should some other criterion be established? If the Expanded Band were opened to new stations, an auction filing window would need to be opened, and mutually exclusive applications would be subject to all competitive bidding procedures, including threshold Section 307(b) comparisons and possible auctions. Additionally, if the Expanded Band were opened to major modifications, any mutually exclusive groups including major modification applications would have the opportunity for settlements or technical resolutions. 47 CFR 73.5002(d)(1), (2). If the Commission were to reserve the Expanded Band for migrators from the standard AM band, should it open a window, waive the major change rule, and allow migrators to apply as minor modifications on a first-come, first-served basis, or use some other mechanism (as, for example, the initial assignment of stations to the Expanded Band by prioritizing major interferers)? With regard to migrating stations, the Commission tentatively agrees with those commenters who have suggested that, in the event such migration is allowed, a “flash cut” from the standard band authorization to the Expanded Band operation should take place, that is, the standard band authorization would be relinquished upon commencing Expanded Band transmissions. The Commission seeks other views on this matter, however.

    19. With regard to Expanded Band technical facilities, currently stations in the Expanded Band are allotted on a minimum distance separation standard similar to FM stations, rather than the contour-protection procedures used for standard band AM stations. As noted in Technical Assignment Criteria, assigning channels based on contour protection maximizes the number of stations on each channel, whereas allotting stations based on spacing was believed to promote a higher-quality technical service in the Expanded Band. 6 FCC Rcd at 6311-12. Commenters favoring opening up the Expanded Band overwhelmingly prefer instituting contour protection standards. The Commission seeks comment on the relative merits of each method of channel assignment or allotment. Additionally, to the extent commenters favor contour protection, they should also address whether compliance with contour protection standards should be limited to use of M3 ground conductivity for contour prediction, or should the Commission allow use of measured ground conductivities in predicting contours?

    20. The Commission also seeks comment on whether to allow other classes and powers of stations (except for Class D stations, which are no longer authorized), to the extent permitted by our international agreements, or whether it should authorize the same power (e.g., 10 kW day/1 kW night) for all new Expanded Band stations. A related question would be whether to allow complex directional patterns in the Expanded Band or limit applications to non-directional and simple directional (i.e., no more than three-tower array) stations. If commenters were to favor limiting the Expanded Band to all-digital stations, the Commission would seek comment as to the contour protections and allocation standards for all-digital operation. At the moment, testing is continuing with regard to all-digital (as opposed to hybrid digital) AM operations, and the record is not yet established on the technical standards needed to establish interference protection for digital-to-digital stations, much less digital-to-analog or digital-to-hybrid. The absence of a technical record leads the Commission to believe that it may be premature to discuss limiting the Expanded Band to all-digital operation; however it welcomes comments that include technical data that would further inform it on this issue.

    21. Relaxed Main Studio Requirements. 47 CFR 73.1125(a) provides, in pertinent part, that “each AM, FM, and TV broadcast station shall maintain a main studio” at a location complying with paragraphs (a)(1)-(a)(3) of that section.1 Moreover, the Commission has long held that a station must, at a minimum, maintain full-time managerial and full-time staff personnel at its main studio. Jones Eastern of the Outer Banks, Inc., Memorandum Opinion and Order, 6 FCC Rcd 3615, 3616 (1991). Commenters Blount Masscom, Inc., et al. (Blount), note that the Commission often grants waivers of the main studio requirement to noncommercial educational (NCE) stations, allowing them to co-locate a station's main studio at the studio of another station licensed to the same licensee that may be outside the locations allowed by 47 CFR 73.1125(a), and that the rule language contemplates such waivers for commercial stations, although such waivers are seldom if ever granted. Blount proposes that AM station owners be allowed to request such waivers, or at a minimum that certain classes of AM stations, notably Class D stations, be allowed to do so. Blount further proposes that AM stations without co-owned main studios available should be allowed to adopt relaxed staffing requirements, such as requiring staffing only during part of the day or week, or allowing the use of technology to permit members of the public to contact station personnel who are not physically present at the main studio. Three other commenters support Blount's proposals.

    1 The acceptable locations of a main studio are: (1) Within the station's community of license; (2) at any location within the principal community contour of any AM, FM, or TV broadcast station licensed to the station's community of license; or (3) within 25 miles from the reference coordinates of the center of the station's community of license as described in 47 CFR 73.208(a)(1).

    22. The Commission has historically considered a station's main studio to constitute the location from which the station can adequately meet its function of serving the needs and interests of the residents of the station's community of license. This includes being adequately equipped to transmit programming, having a meaningful management and staff presence, and serving as a location for the station's public file. The Commission continues to emphasize a station's function of meeting the needs and interests of its community. At the same time, however, it is aware of the financial strain on many AM broadcasters. Moreover, advances in technology (e.g., email, mobile telephone, Internet) can enable members of the community to contact station personnel without having to physically visit the main studio. In fact, the Commission has recently proposed requiring AM and FM broadcast stations to post their public files to the Commission's online database, which would make them accessible without the need for visiting a station's offices or main studio. Expansion of Online Public File Obligations, Notice of Proposed Rule Making, 29 FCC Rcd 15943 (2014).

    23. Despite these advances in accessibility to broadcast stations and their personnel, the Commission is reluctant to eliminate main studio requirements entirely, because of the aforementioned importance of the main studio to the goal of ensuring station compliance with local service obligations. The Commission therefore seeks comment on whether, and how, to modify the main studio rule in light of its goal in this proceeding to revitalize the AM service. Should it continue to address waivers of the main studio rule on a case-by-case basis, but be more open to such requests by commercial stations that can co-locate in studio facilities used by co-owned stations in a given market? Assuming that the Commission were to allow relaxation of the requirement that each station maintain a separate main studio, is there a maximum number of co-located stations that it should allow under one roof? If it were to allow co-location of two or more stations, should it further relax the requirements by allowing one or more of the stations to be located outside of the area dictated by 47 CFR 73.1125(a)(1) through (a)(3)? If one or more co-located stations are allowed to locate outside the rule requirements, should there be an absolute restriction on the distance a co-locating station may move its studio from its community of license? Moreover, should the Commission, as Blount suggests, relax the staffing requirement of full-time management and staff presence for AM stations that do not have co-owned stations with which to co-locate studio facilities? Should any such relaxation of staffing requirements necessarily be limited to such “stand alone” AM stations? If the Commission were to relax staffing requirements, what if any conditions should be put in place to ensure that members of the public could contact station personnel and receive timely responses? Should it require that local mobile phone numbers for station management and staff be posted or otherwise publicized? Should any relaxation of main studio or staffing rules be linked to a station's posting of its public file to the Commission online database? The Commission seeks comment addressing these and any other matters pertaining to AM stations' maintenance of fully staffed local main studios. In particular, the Commission invites comment on the cost reductions that may result from modification of the main studio rule.

    Comments and Reply Comments

    24. Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th Street SW., Room TW-A325, Washington, DC 20554. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.

    • Commercial Mail sent by overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

    • U.S. Postal Service first-class, Express, and Priority mail should be addressed to 445 12th Street SW., Washington, DC 20554.

    25. This is a summary of the Commission's document FCC 15-142, Revitalization of the AM Radio Service, Further Notice of Proposed Rulemaking (FNPRM) and Notice of Inquiry (NOI), adopted on October 21, 2015 and released on October 23, 2015, in MB Docket No. 13-249. The full text of document FCC 15-142 will be available for public inspection and copying via ECFS, and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. Document FCC 15-142 can also be downloaded in Word or Portable Document Format (PDF) at http://www.fcc.gov/ndbedp.

    Ex Parte Rules

    26. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 47 CFR 1.1200 et seq. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with 47 CFR 1.1206(b). In proceedings governed by 47 CFR 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    Initial Regulatory Flexibility Analysis

    27. The Regulatory Flexibility Act of 1980, as amended (RFA), requires that a regulatory flexibility analysis be prepared for notice and comment rule making proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.” The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

    28. As required by the RFA (5 U.S.C. 603), Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the FNPRM. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the FNPRM provided in paragraph 94 of the FNPRM. The Commission will send a copy of this entire FNPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the FNPRM and the IRFA (or summaries thereof) will be published in the Federal Register.

    Need for, and Objectives of, the Proposed Rules

    29. This rulemaking proceeding is initiated to obtain further comments concerning certain proposals designed to revitalize the AM broadcast radio service. It is based in substantial part on proposals raised by commenters in this rulemaking proceeding, in response to the Commission's call in the original NPRM in this proceeding for further ideas and proposals.

    30. Specifically, the Commission seeks comment on the following: (1) Whether to change the nighttime and critical hours signal protection to Class A AM stations; (2) whether to change the methodology for calculating nighttime root sum square (RSS) values; (3) whether to change daytime signal protection to Class B, C, and D stations; (4) whether to revise the rule on where an FM cross-service translator station, re-broadcasting an AM station's signal, may be located relative to the AM station's transmitter; (5) whether to modify the rules governing partial proofs of performance of directional AM antenna arrays; (6) whether to modify the rules for method of moments proofs for directional AM antenna arrays; and (7) whether to require licensees holding dual standard band-Expanded Band AM licenses to surrender one of the licenses within one year of release of the Second Report and Order in this proceeding.

    Legal Basis

    31. The authority for this proposed rulemaking is contained in Sections 1, 2, 4(i), 303, 307, and 309(j) of the Communications Act of 1934, 47 U.S.C. 151, 152, 154(i), 303, 307, and 309(j).

    Description and Estimate of the Number of Small Entities to Which the Proposed Rules Will Apply

    32. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed rules. The RFA generally defines the term “small entity” as encompassing the terms “small business,” “small organization,” and “small governmental entity.” In addition, the term “small Business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

    Radio Stations

    33. The proposed rules and policies could apply to AM radio broadcast licensees, and potential licensees of the AM radio service. A radio broadcasting station is an establishment primarily engaged in broadcasting aural programs by radio to the public. Included in this industry are commercial, religious, educational, and other radio stations. Radio broadcasting stations which primarily are engaged in radio broadcasting and which produce radio program materials are similarly included. However, radio stations that are separate establishments and are primarily engaged in producing radio program material are classified under another NAICS number. The SBA has established a small business size standard for this category, which is: Firms having $38.5 million or less in annual receipts. 13 CFR 121.201, NAICS code 515112 (updated for inflation in 2008). According to the BIA/Kelsey, MEDIA Access Pro Database on October 15, 2015, 4,691 (99.94%) of 4,694 a.m. radio stations have revenues of $38.5 million or less. Therefore, the majority of such entities are small entities. The Commission noted, however, that, in assessing whether a business concern qualifies as small under the above definition, business (control) affiliations must be included. See 13 CFR 121.103(a)(1). This estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, an element of the definition of “small business” is that the entity not be dominant in its field of operation. The Commission is unable at this time to define or quantify the criteria that would establish whether a specific radio station is dominant in its field of operation. Accordingly, the estimate of small businesses to which rules may apply do not exclude any radio station from the definition of a small business on this basis and therefore may be over-inclusive to that extent. Also as noted, an additional element of the definition of “small business” is that the entity must be independently owned and operated. It is difficult at times to assess these criteria in the context of media entities and Commission estimates of small businesses to which they apply may be over-inclusive to this extent.

    FM Translator Stations and Low-Power FM Stations

    34. The proposed policies could affect licensees of FM translator stations, as well as potential licensees in this radio service. The same SBA definition that applies to radio broadcast licensees would apply to these stations. The SBA defines a radio broadcast station as a small business if such station has no more than $38.5 million in annual receipts. See 13 CFR 121.201, NAICS code 515112. Currently, there are approximately 6,422 licensed FM translator and booster stations. In addition, there are approximately 225 applicants with pending applications filed in the 2003 translator filing window. Given the nature of these services, it is presumed that all of these licensees and applicants qualify as small entities under the SBA definition.

    Description of Projected Reporting, Recordkeeping and Other Compliance Requirements

    35. The proposed rule and procedural changes may, in some cases, impose different reporting, recordkeeping, or other requirements on existing and potential AM radio licensees and permittees. In the case of proposed changes to the technical rules regarding calculation of daytime and nighttime interfering contours, and changes to daytime, nighttime, and critical hours protection to some stations, there would be changes in the calculation of inter-station interference and reporting of same. However, the information to be filed is already familiar to broadcasters, and the nature of the interference calculations would not change, only the values that are acceptable, so any additional burdens would be minimal. Likewise, the proposed revision to the rules on where an FM translator providing fill-in service for an AM station may be sited will not require any additional calculations on the part of the AM station proposing to locate or relocate the translator. The proposal merely relaxes the siting requirement and expands the area in which such a cross-service fill-in translator may be located. Thus, there should be no additional reporting or recordkeeping burdens, and compliance with the siting rules will be easier. The proposed modifications to the partial proof of performance and Method of Moments rules would not change any reporting or compliance requirements, insofar as AM licensees and applicants would not be required to submit such proofs or models more frequently than is now the case. The only changes would be to relax the requirements for making proofs of performance or method of moments models. Thus, the required submissions of such proofs and models would be less burdensome on AM broadcasters with directional antenna arrays that are required to submit such information. Finally, the proposal to require surrender of licenses held by broadcasters with paired standard band-Expanded Band AM stations will not change any reporting, recordkeeping, or other compliance requirements, and will in fact reduce such requirements for such licensees by 50 percent.

    Steps Taken To Minimize Significant Impact on Small Entities, and Significant Alternatives Considered

    36. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. 5 U.S.C. 603(b). In the FNPRM, the Commission seeks to assist AM broadcasters by changing certain daytime, nighttime, and critical hours interference protection standards as they apply to certain classes of AM stations; proposes relaxing the rules on siting of FM translators providing fill-in service for AM broadcast stations; proposes to modify the measurement requirements for AM directional antenna system partial proofs of performance in order to make them less burdensome; and proposes to modify the rules for submitting method of moments models of proposed AM directional antenna systems, in order to make those rules less burdensome. The Commission also seeks either to reduce interference in the standard AM band or, alternatively, to create more spectrum in the Expanded AM Band, by requiring that the 25 remaining licensees holding paired authorizations in both bands surrender one of the paired licenses. Under the Commission's proposal, such a licensee would be given one year from adoption of this proposal in which to elect which authorization it would surrender. The Commission seeks comment as to whether its goal of revitalizing the AM service could be effectively accomplished through these means. The Commission is open to consideration of alternatives to the proposals under consideration, as set forth herein, including but not limited to alternatives that will minimize the burden on AM broadcasters, most of which are small businesses. There may be unique circumstances these entities may face, and the Commission will consider appropriate action for small broadcasters when preparing a Second Report and Order in this matter.

    Federal Rules Which Duplicate, Overlap, or Conflict With, the Commission's Proposals

    37. None.

    38. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Ordering Clauses

    39. Accordingly, it is ordered that, pursuant to sections 4(i), 301, 303(r), 316, and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 303(r), 316, 403, this Further Notice of Proposed Rulemaking is adopted.

    40. It is further ordered that, pursuant to Sections 1, 303(g), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 303(g), and 403, and Section 1.430 of the Commission's rules, 47 CFR 1.430, that this Notice of Inquiry is adopted.

    List of Subjects 47 CFR Part 73

    Communications equipment, Radio, Reporting and recordkeeping requirements.

    47 CFR Part 74

    Communications equipment, Radio.

    Federal Communications Commission.

    Gloria J. Miles, Federal Register Liaison Officer. Office of the Secretary.
    Proposed Rule Changes

    For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 73 and 74 as follows:

    PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority:

    47 U.S.C. 154, 303, 334, 336, and 339.

    2. In § 73.21 revise paragraphs (a) introductory text and (a)(1) to read as follows:
    § 73.21 Classes of AM broadcast channels and stations.

    (a) Clear channel. A clear channel is one on which stations are assigned to serve wide areas. These stations are protected from objectionable interference within their primary service areas. Stations operating on these channels are classified as follows:

    (1) Class A station. A Class A station is an unlimited time station that operates on a clear channel and is designed to render primary service over an extended area at relatively long distances from its transmitter. Its primary service area is protected from objectionable interference from other stations on the same and adjacent channels. The operating power shall not be less than 10 kW nor more than 50 kW. (Also see § 73.25(a)).

    § 73.24 [Amended]
    3. In § 73.24 remove paragraph (h) and redesignate paragraphs (i) and (j) as paragraphs (h) and (i), respectively. 4. In § 73.37 revise the table following paragraph (a) to read as follows:
    § 73.37 Applications for broadcast facilities, showing required.

    (a) * * *

    Frequency separation
  • (kHz)
  • Contour of
  • proposed
  • station (classes B, C and D)
  • (mV/m)
  • Contour of any other station
  • (mV/m)
  • 0 0.005 0.100 (Class A). 0.100 2.0 (Other classes). 2.0 0.100 (Other classes). 10 0.500 0.500 (Class A). 2.0 2.0 (Other classes). 20 25.0 25.0 (All classes).
    5. In § 73.151 revise paragraph (c)(3) to read as follows:
    § 73.151 Field strength measurements to establish performance of directional antennas.

    (c) * * *

    (3) When the application for an initial license for a directional antenna system is submitted that is based on computer modeling and sample system verification, reference field strength measurement locations shall be established in the directions of pattern minima and maxima. On each radial corresponding to a pattern minimum or maximum, there shall be at least three measurement locations. The field strength shall be measured at each reference location at the time of the proof of performance. The license application shall include the measured field strength values at each reference point, along with a description of each measurement location, including GPS coordinates and datum reference. New reference field strength measurements are not required for subsequent license applications for the same directional antenna system and physical facilities.

    6. In § 73.154, revise paragraph (a) to read as follows:
    § 73.154 AM directional antenna partial proof of performance measurements.

    (a) A partial proof of performance consists of at least 8 field strength measurements made on each of the radials that includes a monitoring point.

    § 73.155 [Removed]
    7. Remove § 73.155. 8. Revise § 73.182 to read as follows:
    § 73.182 Engineering standards of allocation.

    (a) Sections 73.21 to 73.37, inclusive, govern allocation of facilities in the AM broadcast band 535-1705 kHz. § 73.21 establishes three classes of channels in this band, namely, clear, regional and local. The classes and power of AM broadcast stations which will be assigned to the various channels are set forth in § 73.21. The classifications of the AM broadcast stations are as follows:

    (1) Class A stations operate on clear channels with powers between 10 kW and 50 kW. These stations are designed to render primary service over a large area protected from objectionable interference from other stations on the same and adjacent channels. Class A stations may be divided into two groups: Those located in any of the conterminous United States and those located in Alaska.

    (i) Class A stations in the conterminous United States operate on the channels assigned by § 73.25 with minimum power of 10 kW, maximum power of 50 kW, and minimum antenna efficiency of 275 mV/m/kW at 1 kilometer. The Class A stations in this group are afforded protection, both daytime and nighttime, to the 0.1 mV/m groundwave contour from other stations on the same channel, and are afforded both daytime and nighttime protection to the 0.5 mV/m groundwave contour from other stations on first adjacent channels.

    (ii) Class A stations in Alaska operate on the channels assigned by § 73.25 with minimum power of 10 kW, maximum power of 50 kW, and minimum antenna efficiency of 215 mV/m/kW at 1 kilometer. The Class A stations in this group are afforded protection, both daytime and nighttime, to the 0.1 mV/m groundwave contour from other stations on the same channel and to the 0.5 mV/m groundwave contour from other stations on first adjacent channels.

    (2) Class B stations are stations which operate on clear and regional channels with powers not less than 0.25 kW or greater than 50 kW. These stations render primary service, the area of which depends on their geographic location, power, and frequency. It is recommended that Class B stations be located so that the interference received from other stations will not limit the service area to a groundwave contour value greater than 2.0 mV/m groundwave contour both daytime and nighttime, which are the values for the mutual protection between this class of stations and other stations of the same class.

    (3) Class C stations operate on local channels, normally rendering primary service to a community and the suburban or rural areas immediately contiguous thereto, with powers not less than 0.25 kW or greater than 1 kW, except as provided in § 73.21(c)(1). Such stations are normally protected to the daytime 2.0 mV/m contour. On local channels the separation required for the daytime protection shall also determine the nighttime separation. Where directional antennas are employed daytime by Class C stations operating with power equal to or greater than 0.25 kW, the separations required shall in no case be less than those necessary to afford protection assuming nondirectional operation with power of 0.25 kW. In no case will nighttime power of 0.25 kW or greater be authorized to a station unable to operate nondirectionally with power of 0.25 kW during daytime hours. The actual nighttime limitation will be calculated. For nighttime protection purposes, Class C stations in the 48 conterminous United States may assume that stations in Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands operating on 1230, 1240, 1340, 1400, 1450, and 1490 kHz are Class C stations.

    (4) Class D stations operate on clear and regional channels with daytime powers of not less than 0.25 kW (or equivalent RMS field of 107.5 mV/m at 1 kilometer if less than 0.25 kW) and not more than 50 kW. Class D stations that have previously received nighttime authority to operate with powers of less 0.25 kW (or equivalent RMS fields of less than 107.5 mV/m at 1 kilometer) are not required to provide nighttime coverage in accordance with § 73.24(i) and are not protected from interference during nighttime hours. Such nighttime authority is permitted on the basis of full nighttime protection being afforded to all Class A and Class B stations.

    Note to paragraph (a): See §§ 73.21(b)(1) and 73.26(b) concerning power restrictions and classifications relative to Class B, Class C, and Class D stations in Alaska, Hawaii, Puerto Rico and the U.S. Virgin Islands. Stations in the above-named places that are reclassified from Class C to Class B stations under § 73.26(b) shall not be authorized to increase power to levels that would increase the nighttime interference-free limit of co-channel Class C stations in the conterminous United States.

    (b) When a station is already limited by interference from other stations to a contour value greater than that normally protected for its class, the individual received limits shall be the established standard for such station with respect to interference from each other station.

    (c) All classes of AM broadcast stations have in general three types of service areas, i.e., primary, secondary and intermittent. (See § 73.14 for the definitions of primary, secondary and intermittent service areas.) All classes of AM stations render service to a primary area but the secondary and intermittent service areas may be materially limited or destroyed due to interference from other stations, depending on the station assignments involved.

    (d) The groundwave signal strength required to render primary service is 2 mV/m for communities with populations of 2,500 or more and 0.5 mV/m for communities with populations of less than 2,500. Because only Class A stations have protected primary service extending beyond the 2 mV/m contour, the groundwave signal strength constituting primary service for Class A stations is that set forth in paragraphs (a)(1)(i) and (ii) of this section. See § 73.184 for curves showing distance to various groundwave field strength contours for different frequencies and ground conductivities, and also see § 73.183, “Groundwave signals.”

    (e) A Class C station may be authorized to operate with a directional antenna during daytime hours providing the power is at least 0.25 kW. In computing the degrees of protection which such antenna will afford, the radiation produced by the directional antenna system will be assumed to be no less, in any direction, than that which would result from non-directional operation using a single element of the directional array, with 0.25 kW.

    (f) All classes of broadcast stations have primary service areas subject to limitation by fading and noise, and interference from other stations to the contours set out for each class of station.

    (g) Broadcast stations are licensed to operate unlimited time, limited time, daytime, share time, and specified hours. (See §§ 73.1710, 73.1725, 73.1720, 73.1715, and 73.1730.) Applications for new stations shall specify unlimited time operation only.

    (h) Section 73.24 sets out the general requirements for modifying the facilities of a licensed station and for establishing a new station. Sections 73.24(b) and 73.37 include interference related provisions that be considered in connection with an application to modify the facilities of an existing station or to establish a new station. Section 73.30 describes the procedural steps required to receive an authorization to operate in the 1605-1705 kHz band.

    (i) Objectionable nighttime interference from a broadcast station occurs when, at a specified field strength contour with respect to the desired station, the field strength of an undesired co-channel station exceeds for 10% or more of the time the values set forth in these standards. The value derived from the root-sum-square of all interference contributions represents the extent of a station's interference-free coverage.

    (1) With respect to the root-sum-square (RSS) values of interfering field strengths referred to in this section, calculation of nighttime interference-free service is accomplished by considering co-channel signals in order of decreasing magnitude, adding the squares of the values and extracting the square root of the sum, excluding those signals which are less than 50% of the RSS values of the higher signals already included. This is known as the “50% Exclusion Method.”

    (2) The RSS value will not be considered to be increased when a new interfering signal is added which is less than the appropriate exclusion percentage as applied to the RSS value of the interference from existing stations, and which at the same time is not greater than the smallest signal included in the RSS value of interference from existing stations.

    (3) It is recognized that application of the 50% Exclusion Method for calculating the RSS interference may result in some cases in anomalies wherein the addition of a new interfering signal or the increase in value of an existing interfering signal will cause the exclusion of a previously included signal and may cause a decrease in the calculated RSS value of interference. In order to provide the Commission with more realistic information regarding gains and losses in service (as a basis for determination of the relative merits of a proposed operation) the following alternate method for calculating the proposed RSS values of interference will be employed wherever applicable.

    (4) In cases where it is proposed to add a new interfering signal which is not less than 50% of the RSS value of interference from existing stations or which is greater than the smallest signal already included to obtain this RSS value, the RSS limitation after addition of the new signal shall be calculated without excluding any signal previously included. Similarly, in cases where it is proposed to increase the value of one of the existing interfering signals which has been included in the RSS value, the RSS limitation after the increase shall be calculated without excluding the interference from any source previously included.

    (5) If the new or increased signal proposed in such cases is ultimately authorized, the RSS values of interference to other stations affected will thereafter be calculated by the 50% Exclusion Method without regard to this alternate method of calculation.

    (6) Examples of RSS interference calculations:

    (i) Existing interferences:

    Station No. 1—1.00 mV/m.

    Station No. 2—0.60 mV/m.

    Station No. 3—0.59 mV/m.

    Station No. 4—0.58 mV/m.

    The RSS value from Nos. 1, 2 and 3 is 1.31 mV/m; therefore interference from No. 4 is excluded for it is less than 50% of 1.31 mV/m.

    (ii) Station A receives interferences from:

    Station No. 1—1.00 mV/m.

    Station No. 2—0.60 mV/m.

    Station No. 3—0.59 mV/m.

    It is proposed to add a new limitation, 0.68 mV/m. This is more than 50% of 1.31 mV/m, the RSS value from Nos. 1, 2 and 3. The RSS value of Station No. 1 and of the proposed station would be 1.21 mV/m which is more than twice as large as the limitation from Station No. 2 or No. 3. However, under the above provision the new signal and the three existing interferences are nevertheless calculated for purposes of comparative studies, resulting in an RSS value of 1.47 mV/m. However, if the proposed station is ultimately authorized, only No. 1 and the new signal are included in all subsequent calculations for the reason that Nos. 2 and 3 are less than 50% of 1.21 mV/m, the RSS value of the new signal and No. 1.

    (iii) Station A receives interferences from:

    Station No. 1—1.00 mV/m.

    Station No. 2—0.60 mV/m.

    Station No. 3—0.59 mV/m.

    No. 1 proposes to increase the limitation it imposes on Station A to 1.21 mV/m. Although the limitations from stations Nos. 2 and 3 are less than 50% of the 1.21 mV/m limitation, under the above provision they are nevertheless included for comparative studies, and the RSS limitation is calculated to be 1.47 mV/m. However, if the increase proposed by Station No. 1 is authorized, the RSS value then calculated is 1.21 mV/m because Stations Nos. 2 and 3 are excluded in view of the fact that the limitations they impose are less than 50% of 1.21 mV/m.

    (j) Objectionable nighttime interference from a station shall be considered to exist to a station when, at the field strength contour specified in paragraph (o) of this section with respect to the class to which the station belongs, the field strength of an interfering station operating on the same channel exceeds for 10% or more of the time the value of the permissible interfering signal set forth opposite such class in paragraph (o) of this section.

    (k) For the purpose of estimating the coverage and the interfering effects of stations in the absence of field strength measurements, use shall be made of Figure 8 of § 73.190, which describes the estimated effective field (for 1 kW power input) of simple vertical omnidirectional antennas of various heights with ground systems having at least 120 quarter-wavelength radials. Certain approximations, based on the curve or other appropriate theory, may be made when other than such antennas and ground systems are employed, but in any event the effective field to be employed shall not be less than the following:

    Class of station Effective field
  • (at 1 km)
  • All Class A (except Alaskan) 275 mV/m. Class A (Alaskan), B and D 215 mV/m. Class C 180 mV/m.
    Note (1) to paragraph (k):

    When a directional antenna is employed, the radiated signal of a broadcasting station will vary in strength in different directions, possibly being greater than the above values in certain directions and less in other directions depending upon the design and adjustment of the directional antenna system. To determine the interference in any direction, the measured or calculated radiated field (unattenuated field strength at 1 kilometer from the array) must be used in conjunction with the appropriate propagation curves. (See § 73.185 for further discussion and solution of a typical directional antenna case.)

    Note (2) to paragraph (k):

    For Class B stations in Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands, 180 mV/m shall be used.

    (l) The existence or absence of objectionable groundwave interference from stations on the same or adjacent channels shall be determined by actual measurements made in accordance with the method described in § 73.186, or in the absence of such measurements, by reference to the propagation curves of § 73.184. The existence or absence of objectionable interference due to skywave propagation shall be determined by reference to Formula 2 in § 73.190.

    (m) Computation of skywave field strength values:

    (1) Fifty percent skywave field strength values. To compute fifty percent skywave field strength values, Formula 1 of § 73.190, entitled “Skywave field strength, 50% of the time (at SS+6)” shall be used.

    (2) Ten percent skywave field strength values. In computing the 10% skywave field strength for stations on a single signal or an RSS basis, Formula 2 in § 73.190 shall be used.

    (3) Determination of angles of departure. In calculating skywave field strength for stations on all channels, the pertinent vertical angle shall be determined by use of the formula in § 73.190(d).

    (n) The distance to any specified groundwave field strength contour for any frequency may be determined from the appropriate curves in § 73.184 entitled “Ground Wave Field Strength vs. Distance.”

    (o) Normally protected service contours and permissible interference signals for broadcast stations are as follows (for Class A stations, see also paragraph (a) of this section):

    Class of station Class of channel used Signal strength contour of area protected from objectionable interference
  • (μV/m)
  • Day 1 Night 1 Permissible interfering signal
  • (μV/m)
  • Day 1 Night
    A Clear SC 100 SC 100 SC 5 SC 5.1 AC 500 AC 500 AC 500 AC 500.1 B Clear 2000 2000 SC 100 25.2 Regional AC 2000 Not presc. C Local 2000 Not presc 3 SC 100 Not presc. D Clear 2000 Not presc SC 100 Not presc. Regional AC 2000 Not presc. 1 Groundwave. 2 Skywave field strength for 10 percent or more of the time. 3 During nighttime hours, Class C stations in the contiguous 48 States may treat all Class B stations assigned to 1230, 1240, 1340, 1400, 1450, and 1490 kHz in Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands as if they were Class C stations. Note: SC = Same channel; AC = Adjacent channel; SW = Skywave; GW = Groundwave.

    (p) The following table of logarithmic expressions is to be used as required for determining the minimum permissible ratio of the field strength of a desired to an undesired signal. This table shall be used in conjunction with the protected contours specified in paragraph (q) of this section.

    Frequency separation of desired to undesired signals
  • (kHz)
  • Desired Groundwave to: Undesired groundwave
  • (dB)
  • Undesired 10% Skywave
  • (dB)
  • 0 26 26 10 0 0

    (q) Two stations, one with a frequency twice of the other, should not be assigned in the same groundwave service area unless special precautions are taken to avoid interference from the second harmonic of the station operating on the lower frequency. Additionally, in selecting a frequency, consideration should be given to the fact that occasionally the frequency assignment of two stations in the same area may bear such a relation to the intermediate frequency of some broadcast receivers as to cause “image” interference, However, since this can usually be rectified by readjustment of the intermediate frequency of such receivers, the Commission, in general, will not take this kind of interference into consideration when authorizing stations.

    (r) The groundwave service of two stations operating with synchronized carriers and broadcasting identical programs will be subject to some distortion in areas where the signals from the two stations are of comparable strength. For the purpose of estimating coverage of such stations, areas in which the signal ratio is between 1:2 and 2:1 will not be considered as receiving satisfactory service.

    Note to paragraph (r):

    Two stations are considered to be operated synchronously when the carriers are maintained within 0.2 Hz of each other and they transmit identical programs.

    § 73.187 [Removed]
    9. Remove § 73.187. PART 74—EXPERIMENTAL RADIO, AUXILIARY, SPECIAL BROADCAST AND OTHER PROGRAM DISTRIBUTIONAL SERVICES 10. The authority citation for part 74 continues to read as follows: Authority:

    47 U.S.C. 154, 302a, 303, 307, 309, 336 and 554.

    11. In § 74.1201, revise paragraph (g) to read as follows:
    § 74.1201 Definitions.

    (g) Translator coverage contour. For a fill-in FM translator rebroadcasting an FM radio broadcast station as its primary station, the FM translator's coverage contour must be contained within the primary station's coverage contour. For purposes of this rule section, the coverage contour of the FM translator has the same field strength value as the protected contour of the primary FM station (i.e., for a commercial Class B FM station it is the predicted 0.5 mV/m field strength contour, for a commercial Class B1 FM station it is the predicted 0.7 mV/m field strength contour, and for all other classes of FM stations it is the predicted 1 mV/m field strength contour). The coverage contour of an FM translator rebroadcasting an AM radio broadcast station as its primary station must be contained within the greater of either the 2 mV/m daytime contour of the AM station or a 25-mile (40 km) radius centered at the AM transmitter site, but the translator's 1 mV/m coverage contour may not extend beyond a 40-mile (64 km) radius centered at the AM transmitter site. The protected contour for an FM translator station is its predicted 1 mV/m contour.

    [FR Doc. 2015-31949 Filed 1-15-16; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 660 [Docket No. 151005920-5999-01] RIN 0648-BF39 Fisheries Off West Coast States; Pacific Coast Groundfish Fishery Management Plan; Trawl Rationalization Program; Flow Scale Requirements AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    This proposed rule would revise scale requirements for processing vessels that are required to weigh fish at sea, i.e. mothership and catcher/processor vessels, and Shorebased Individual Fishery Quota Program (IFQ) first receivers. For motherships and catcher/processors that weigh fish at sea, the proposed action would require the use of updated scale technology, require enhanced daily scale testing for flow scales (also known as belt scales), and require the use of video to monitor the flow scale and the area around the flow scale. For Shorebased IFQ first receivers, the proposed action would add criteria for inseason flow scale tests. In addition, the action includes housekeeping changes that are intended to better align the regulations with defined terms, and to provide clarity and consistency between paragraphs. Action is needed to provide precise and accurate catch estimates and to reduce the likelihood that vessels will under report harvests.

    DATES:

    Comments on this proposed rule must be received by February 18, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2015-0150, by any of the following methods:

    Electronic Submissions: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2015-0150, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: William W. Stelle, Jr., Regional Administrator, West Coast Region, NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070; Attn: Becky Renko.

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

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this proposed rule may be submitted to William W. Stelle Jr., Regional Administrator, West Coast Region NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070 and to OMB by email to [email protected] or fax to (202) 395-7285.

    SUPPLEMENTARY INFORMATION:

    Motherships and Catcher/Processors

    An at-sea scale program was developed for the Alaska groundfish fishery in 1998 to provide catch accounting that was more precise and verifiable at the individual haul level and less dependent on estimates generated by at-sea observers (February 4, 1998; 63 FR 5836). The at-sea scale program supported implementation of a large-scale quota share program that required verifiable and defensible estimates of harvest. Since implemenation of those weighing requirements in 1998, at-sea scales have been used to provide reliable, precise and accurate estimates of catch in the Alaskan groundfish fisheries. At the same time, scale technology has evolved and NMFS has developed greater expertise in monitoring processing activity.

    Recent fraud on some vessels was found to have resulted in systematic underestimates of scale weights used for catch accounting. As a result, at-sea flow scale regulations for the Alaska Region at 50 CFR 679.28 were revised on December 18, 2014 (November 18, 2014; 79 FR 68610) to improve scale accuracy and reduce bias. Revisions to the Alaska regulations included a suite of modifications to the at-sea scales program that included the use of flow scales capable of logging and printing the frequency and magnitude of scale calibrations relative to previous calibrations as well as the time and date of each scale fault (or error) and scale startup time; revised daily scale test methods; and new requirements for video monitoring.

    In 2011, a trawl rationalization program was implemented for the Pacific Coast groundfish fishery which included scale requirements specified in regulation at § 660.15(b) (December 15, 2010; 75 FR 78344). These regulations require mothership and catcher/processor vessels to use scales certified for the Alaska groundfish fisheries. Modifying the Pacific Coast groundfish fishery regulations to be consistent with the Alaska Region's 2014 regulation updates would bring the regulations up to date with current technology, reduce the potential for scale tampering, and improve catch accounting accuracy. Catch estimates based on inaccurate scale weights could systematically underestimate harvests. Given the importance of using accurate and reliable catch accounting data for management of the groundfish stocks, NMFS is proposing revisions consistent with the revisions made for the Alaska groundfish fishery and with the intent of enforcement and monitoring provisions implemented under Amendment 20 to the Pacific Coast groundfish fishery management plan (FMP).

    This proposed rule would update the requirements for scales consistent with the Alaska regulations at § 679.28. Improved scale technology includes features that allow NMFS to determine how well the flow scales are performing, and improve the accuracy and reliability of flow scale measurements. Because the mothership and catcher/processor vessels already have upgraded scale systems for the Alaska Fisheries, and the scales are certified through annual testing provided by the Alaska Region, aligning the performance and technical requirements is reasonable and not expected to result in added costs to the vessels.

    Regulatory revisions would include improvements to daily scale tests. The types of material used for the daily scale test would be limited to test materials (i.e., pre-weighed sand bags) supplied by the scale manufacturer or approved by a NMFS-authorized scale inspector. The minimum amount of weight for each test and the number of runs would be clearly stated in regulations. In addition, new requirements for documenting failed scale tests, and printing audit and calibration reports would be specified.

    Regulatory revisions would require that all mothership and catcher/processors vessels use video monitoring systems that meet the Alaska fishery system requirements, specified at § 679.28(e), when they are fishing in the Pacific Coast groundfish fishery. The video monitoring systems allow the activities around the flow scale to be monitored to ensure that the flow scale is functioning properly (e.g., that the flow scale is not running while in a fault (error) state); ensure that all fish are being weighed; detect when crew members are working on the flow scale; and ensure that daily flow scale tests are being conducted on the required schedule and with the appropriate test weights. The video systems would be required to capture imagery of areas where the catch enters, moves across and leaves the scale; of any access points that may be adjusted or modified by crew; and of the scale display and the indicator of when the scale is operating in a fault state. Consistent with the Alaska requirements, the vessel operator would be required to maintain the video imagery for at least 120 days and make the imagery available to NMFS upon request. All of the vessels subject to at-sea scales requirements are already required to have video systems for the Alaska fisheries. Therefore, the increased burden to the processing vessels would primarily be the time to operate the systems while fishing in the Pacific whiting fishery.

    IFQ First Receivers

    Regulations at § 660.15(c) define the performance and technical requirements for scales used to weigh fish at Shorebased IFQ first receivers. Since the Shorebased IFQ program was implemented in 2011, some Shorebased IFQ first recievers located in Oregon and Washington have installed flow scales. The states of Oregon and Washington test the flow scales consistent with national weights and measures standards. This action would revise regulations to include performance and technical requirements for flow scales used at IFQ first receivers. In addition, several minor technical changes would be made. The regulatory changes for first receivers would include revisions to inseason scale test requirements specific to flow scales; adding catch monitors to the list of individuals that have access to scale displays and printouts; revisions to inseason scale test requirements specific to flow scales; and the correction of a value for maximum error in scale divisions.

    Housekeeping

    Numerous minor changes would be made throughout the regulations at 50 CFR 660.15, 660.113, 660.150 and 660.160 for clarity, to better align different sections of the regulations, to update cross references, and for consistency in the use of terms. Paragraph 660.15(a) is revised to remove reporting requirements that are repeated in other more appropriate sections of the regulations. Regulatory language originally adopted from the Alaska Groundfish fisheries is not consistent with language used for the Pacific Coast groundfish fishery; therefore, minor revisions are made to paragraph § 660.15(b) for clarity and to be consistent with other sections of the Pacific Coast groundfish regulations. Minor changes are made at § 660.15(c) to revise terms for consistent use throughout the regulations. Minor changes are made at § 660.113 to revise terms for consistent use throughout the regulations and update cross references. Minor changes are made §§ 660.150(b) and 660.160(b) to revise terms for consistent use throughout the regulations, and update cross references, to add missing references for cease fishing reports and to add clarity to the vessel responsibilities relative to observer platform scale.

    Classification

    NMFS has made a preliminary determination that the proposed action is consistent with FMP, the Magnuson Stevens Conservation and Management Act, and other applicable laws. In making its final determination, NMFS will take into account the complete record, including the data, views, and comments received during the comment period.

    The Office of Management and Budget has determined that this proposed rule is not significant for purposes of Executive Order 12866.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities.

    The SBA has established size criteria for all major industry sectors in the United States, including fish harvesting and fish processing businesses. A business involved in fish harvesting is a small business if it is independently owned and operated and not dominant in its field of operation (including its affiliates) and if it has combined annual receipts not in excess of $20.5 million for all its affiliated operations worldwide. For commercial shellfish harvesters, the other qualifiers apply and the receipts threshold is $5.5 million. For other marine fishing, a small business is one with annual receipts not in excess of $7.5 million. For purposes of rulemaking, NMFS is applying the $20.5 million standard to catcher/processors because they are involved in the commercial harvest of finfish. A seafood processor is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 500 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. A wholesale business servicing the fishing industry is a small business if it employs 100 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide.

    The mothership and catcher/processor vessels affected by the proposed action have gross revenues that exceed $20.5 million and thus are not considered to be small entities.

    IFQ first receivers receive, purchase, or take custody, control, or possession of fish onshore directly from IFQ vessels. In 2012, a total of 26 companies accepted IFQ fish as first receivers: nine accepted Pacific whiting, 25 accepted fish from the IFQ non-whiting trawl, and 19 accepted fish from the non-trawl IFQ. Sixteen of the 26 IFQ first receivers are independently owned and operated, not dominant in their field of operation, and employ 500 or fewer persons on a full time, part time, temporary, or other basis, at all affiliated operations worldwide, and are considered small businesses under the SBA guidelines. First receiver earnings are comprised of fish sales, offloading revenue, custom processing revenue, and revenue from leasing or selling quota.

    Although the inclusion of inseason flow scale testing criteria affects all first receivers, it is unlikely that smaller non-whiting first receivers will have the need to install flow scales. To date, flow scales have been used by Pacific whiting first receivers to weigh large volumes of unsorted fish. The only groundfish fishery allowed to land large volumes of unsorted fish is the Pacific whiting fishery. Two of the nine first receivers who accept and purchase Pacific whiting would be considered small according to the SBA guidelines. Some of the Pacific whiting first receivers share ownership of vessels and some companies own multiple first receiver facilities. In addition to Pacific whiting, the Pacific whiting first receivers process other Pacific Coast species including: Pink shrimp, non-whiting groundfish, crab, and coastal pelagic species.

    Current regulations require IFQ first receivers to use scales that are tested for accuracy and approved for use by the state where the scale is located. During the fishing season NMFS staff, NMFS-authorized personnel, and authorized officers conduct accuracy tests on scales used to weigh IFQ fish. Inseason test criteria are needed to determine if the scales are functioning accurately between state testings. A scale that does not pass an inseason test may not be used to weigh IFQ catch fish until the scale passes an inseason test or is approved for continued use by the weights and measures authorities of the State in which the scale is located. Since the start of the Shorebased IFQ Program in 2011, three of the nine Pacific Whiting IFQ first receivers have installed flow scales. Two of the three Pacific whiting IFQ first receivers that have installed flow scales are considered small businesses.

    The testing criteria defined by this action for flow scales are consistent with the National Institute of Standards and Technology and the criteria used by the states. Because state laws already require commercial scales to meet accuracy standards set out by the National Institute of Standards and Technology, the cost of inseason testing to ensuring compliance between state testings is expected to be minimal. The proposed action is not expected to result in a significant economic effect on a substantial number of small entities. Establishing inseason scale test criteria for this new type of scale would result in inseason scale test requirements that are more equitable between all first receivers. The proposed action is primarily administrative in bringing the regulations up to date with current practices. An initial regulatory flexibility analysis is not required and none has been prepared because this proposed rule would not have a significant economic impact on a substantial number of small entities.

    This proposed rule contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval as revisions to OMB collection 0648-0619. The public reporting burden for the at-sea scale requirements, including daily test reports (30 minute per response), daily catch and cumulative weight reports (10 min per response), the audit trail (1 minute per response), calibration log (1 minute per response), fault log (1 minute per response) and video monitoring (0 minute per response), is estimated to average 43 minutes per response.

    Public comment is sought regarding whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to West Coast Region at the ADDRESSES above, and by email to [email protected] or fax to (202) 395-7285.

    Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

    List of Subjects in 50 CFR Part 660

    Fisheries, Fishing, and Indian fisheries.

    Dated: January 8, 2016. Samuel D. Rauch III, Deputy Assistant Administrator For Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 660 is proposed to be amended as follows:

    PART 660—FISHERIES OFF WEST COAST STATES 1. The authority citation for part 660 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq., 16 U.S.C. 773 et seq., and 16 U.S.C. 7001 et seq.

    2. In § 660.15, revise paragraphs (a), (b), (c), and add paragraph (e) to read as follows:
    § 660.15 Equipment requirements.

    (a) Applicability. This section contains the equipment and operational requirements for scales used to weigh fish at sea, scales used to weigh fish at IFQ first receivers, video monitoring systems, computer hardware for electronic fish ticket software, and computer hardware for electronic logbook software.

    (b) Scales used to weigh fish at sea. Vessel owners, operators, and managers are jointly and severally responsible for their vessel's compliance with the requirements specified in this section.

    (1) Performance and technical requirements for scales in the MS and C/P Coop Programs. A scale used to weigh fish in the MS and C/P Coop Programs must meet the type evaluation, initial inspection, and annual reinspection requirements set forth in 50 CFR 679.28(b)(1) and (2), and must be approved by NMFS to weigh fish at sea.

    (2) Annual inspection. Once a scale is installed on a vessel and approved by NMFS for use to weigh fish at sea, it must be reinspected annually within 12 months of the date of the most recent inspection to determine if the scale meets all of the applicable performance and technical requirements as described in 50 CFR 679.28(b).

    (3) Daily testing. Each scale used to weigh fish must be tested at least once each calendar day to ensure that each scale meets the maximum permissible error requirements described at paragraph (b)(4) of this section.

    (4) Daily at-sea scale tests. To verify that the scale meets the maximum permissible errors specified in this paragraph, each scale used to weigh fish must be tested at least one time during each calendar day when use of the scale is required. The tests must be performed in an accurate and timely manner.

    (i) Flow or Belt scales.

    (A) Maximum permissible errors. The maximum permissible errors for the daily at-sea scale test is plus or minus 3 percent of the known weight of the test material.

    (B) Test Procedure. A test must be conducted by weighing no less than 400 kg (882 lb) of test material, supplied by the scale manufacturer or approved by a NMFS-authorized scale inspector, on the scale under test. The test material may be run across the scale multiple times in order to total 400 kg; however, no single run of test material across the scale may weigh less than 40 kg (88.2 lb). The known weight of test material must be determined at the time of each scale test by weighing it on a platform scale approved for use under 50 CFR 679.28(b)(7).

    (ii) Platform scales required for observer sampling or to determine known weight of test material on mothership and catcher/processor vessels.

    (A) Maximum permissible errors. The maximum permissible errors for the daily at-sea scale test for platform scales is plus or minus 0.5 percent of the weight tested.

    (B) Test Procedure. A platform scale used for observer sampling must be tested at 10, 25, and 50 kg (or 20, 50, and 100 lb if the scale is denominated in pounds) using approved test weights. Any combination of test weights that will allow the scale to be tested at 10 kg, 25 kg, and 50 kg may be used. A platform scale used to weigh fish must be tested at a weight equal to the largest amount of fish that will be weighed on the scale in one weighing.

    (C) Approved test weights. Each test weight must have its weight stamped on or otherwise permanently affixed to it. The weight of each test weight must be annually certified by a National Institute of Standards and Technology-approved metrology laboratory or approved for continued use by the NMFS authorized inspector at the time of the annual scale inspection.

    (iii) Requirements for all at-sea scale tests. The following conditions must be met:

    (A) Notify the observer at least 15 minutes before the time that the test will be conducted, and conduct the test while the observer is present.

    (B) Conduct the scale test by placing the test material or test weights on or across the scale and recording the following information on the at-sea scale test report form:

    (1) Vessel name;

    (2) Month, day, and year of test;

    (3) Time test started to the nearest minute in local time;

    (4) Known weight of test materials or test weights;

    (5) Weight of test material or test weights recorded by scale;

    (6) Percent error as determined by subtracting the known weight of the test material or test weights from the weight recorded on the scale, dividing that amount by the known weight of the test material or test weights, and multiplying by 100; and

    (7) Signature of operator.

    (C) Maintain the scale test report form from all at-sea scale tests, including test report forms from failed scale tests on board the vessel until the end of the fishing year during which the tests were conducted, and make the report forms available to observers, NMFS staff, or authorized officers. In addition, the scale test report forms must be retained for 3 years after the end of the fishing year during which the tests were performed. Each scale test report form must be signed by the operator immediately following completion of each scale test.

    (5) Scale maintenance. The scale must be maintained in proper operating condition throughout its use; adjustments made to the scale must be made to bring the performance errors as close as practicable to a zero value; and no adjustment may be made that will cause the scale to weigh fish inaccurately.

    (6) Printed reports from the scale (not applicable to observer sampling scales). Printed reports are provided to NMFS as required by this paragraph. Printed reports from the scale must be maintained on board the vessel until the end of the year during which the reports were made, and made available to observers, NMFS staff or authorized officers. In addition, printed reports must be retained for 3 years after the end of the year during which the printouts were made.

    (i) Printed reports of catch weight and cumulative weight. Reports must be printed at least once every calendar day when use of the scale is required. Reports must also be printed before any information stored in the scale computer memory is replaced. Scale weights must not be adjusted by the scale operator to account for the perceived weight of water, slime, mud, debris, or other materials. Scale printouts must show:

    (A) The vessel name and Federal vessel permit number;

    (B) The date and time the information was printed;

    (C) The haul number;

    (D) The total weight of the haul; and

    (E) The total cumulative weight of all fish and other material weighed on the scale since the last annual inspection.

    (ii) Printed report from the audit trail. The printed report must include the information specified in sections 2.3.1.8, 3.3.1.7, and 4.3.1.8 of appendix A to 50 CFR part 679. The printed report must be provided to the authorized scale inspector at each scale inspection and must also be printed at any time upon request of the observer, NMFS personnel or an authorized officer.

    (iii) Printed report from calibration log. The operator must print the calibration log on request by NMFS staff or an authorized officer, or person authorized by NMFS. The calibration log must be printed and retained before any information stored in the scale computer memory is replaced. The calibration log must detail either the prior 1,000 calibrations or all calibrations since the scale electronics were first put into service, whichever is less. The printout from the calibration log must show:

    (A) The vessel name and Federal fisheries or processor permit number;

    (B) The month, day, and year of the calibration;

    (C) The time of the calibration to the nearest minute in local time;

    (D) The weight used to calibrate the scale; and

    (E) The magnitude of the calibration in comparison to the prior calibration.

    (iv) Printed reports from the fault log. The operator must print the fault log on request by NMFS staff, an authorized officer or person authorized by NMFS. The fault log must be printed and retained before any information stored in the scale computer memory is replaced. The fault log must detail either the prior 1,000 faults and startups, or all faults and startups since the scale electronics were first put into service, whichever is less. A fault, for the purposes of the fault log, is any condition other than underflow detected by the scale electronics that could affect the metrological accuracy of the scale. The printout from the fault log must show:

    (A) The vessel name and Federal fisheries or processor permit number;

    (B) The month, day, year, and time of each startup to the nearest minute in local time;

    (C) The month, day, year, and time that each fault began to the nearest minute in local time; and

    (D) The month, day, year, and time that each fault was resolved to the nearest minute in local time.

    (v) Platform scales used for observer sampling. A platform scale used for observer sampling is not required to produce a printed record.

    (7) Video monitoring for scales used by the vessel crew to weigh catch. Mothership or Catcher/Processor vessels required to weigh fish under the regulations in this section must provide and maintain a NMFS-approved video monitoring system as specified in paragraph (e) of this section.

    (c) Scales used to weigh fish at IFQ first receivers—performance and technical requirements. Scale requirements in this paragraph are in addition to those requirements set forth by the State in which the scale is located, and nothing in this paragraph may be construed to reduce or supersede the authority of the State to regulate, test, or approve scales within the State. Scales used to weigh fish that are also required to be approved by the State must meet the following requirements:

    (1) Verification of approval. The scale must display a valid sticker indicating that the scale is currently approved in accordance with the laws of the state where the scale is located.

    (2) Visibility. The IFQ first receiver must ensure that the scale and scale display are visible simultaneously to the catch monitor. Catch monitors, NMFS staff, NMFS-authorized personnel, or authorized officers must be allowed to observe the weighing of fish on the scale and be allowed to read the scale display at all times.

    (3) Printed scale weights.

    (i) An IFQ first receiver must ensure that printouts of the scale weight of each delivery or offload are made available to the catch monitor, NMFS staff, to NMFS-authorized personnel, or to authorized officers at the time printouts are generated. An IFQ first receiver must maintain printouts on site until the end of the fishing year during which the printouts were made and make them available upon request by the catch monitor, NMFS staff, NMFS-authorized personnel, or authorized officers for 3 years after the end of the fishing year during which the printout was made.

    (ii) All scales identified in a catch monitoring plan (see § 660.140(f)(3)) must produce a printed record for each landing, or portion of a landing, weighed on that scale. NMFS may exempt, through approval of the NMFS-accepted catch monitoring plan, scales not designed for automatic bulk weighing from part or all of the printed record requirements. IFQ first receivers that receive no more than 200,000 pounds of groundfish in any calendar month may be exempt under § 660.140(j)(2). For scales that must produce a printed record, the printed record must include:

    (A) The IFQ first receiver's name;

    (B) The weight of each load in the weighing cycle;

    (C) The total weight of fish in each landing, or portion of the landing that was weighed on that scale;

    (D) For belt scales and weight belts, the total cumulative weight of all fish or other material weighed on the scale since the last inspection;

    (E) The date the information is printed; and

    (F) The name and vessel registration or documentation number of the vessel making the landing. The person operating the scale may write this information on the scale printout in ink at the time of printing.

    (4) Inseason scale testing. IFQ first receivers must allow, and provide reasonable assistance to NMFS staff, NMFS-authorized personnel, and authorized officers to test scales used to weigh IFQ fish. A scale that does not pass an inseason test may not be used to weigh IFQ fish until the scale passes an inseason test or is approved for continued use by the weights and measures authorities of the State in which the scale is located.

    (i) Inseason testing criteria. To pass an inseason test, NMFS staff or authorized officers must be able to verify that:

    (A) The scale display and printed information are clear and easily read under all conditions of normal operation;

    (B) Weight values are visible on the display until the value is printed;

    (C) The scale does not exceed the maximum permissible errors specified in this paragraph:

    (1) Flow scales (also known as belt scales and weight belts). The maximum permissible error is plus or minus 0.25 percent of the known weight of the test material with repeatability between tests of no more than 0.25 percent. Percent error is determined by subtracting the known weight of the test material or test weights from the weight recorded on the scale, dividing that amount by the known weight of the test material or test weights, and multiplying by 100.

    (2) All other scales.

    Test load in scale divisions Maximum error in scale divisions (i) 0-500 1 (ii) 501-2,000 2 (iii) 2,001-4,000 3 (iv) >4,000 5

    (D) Automatic weighing systems. An automatic weighing system must be provided and operational that will prevent fish from passing over the scale or entering any weighing hopper unless the following criteria are met:

    (1) No catch may enter or leave a weighing hopper until the weighing cycle is complete;

    (2) No product may be cycled and weighed if the weight recording element is not operational; and

    (3) No product may enter a weighing hopper until the prior weighing cycle has been completed and the scale indicator has returned to a zero.

    (ii) [Reserved]

    (e) Video monitoring systems used monitor at-sea scales.

    (1) Performance and technical requirements for video monitoring systems for the MS and C/P Coop Programs. A video monitoring system used to monitor at-sea scales must meet the system requirements and system inspections, set forth in 50 CFR 679.28(e)(1) through (4) and be issued a Video Monitoring Inspection Report verifying that the video system meets all applicable requirements for use in the Alaska Pollock fishery. Any change to the system must meet the requirements specified at 50 CFR 679.28(e)(7) and be approved by the Alaska Regional Administrator in writing before any changes are made.

    (i) MS or C/P vessels required to weigh fish at sea under the regulations in this section must:

    (A) Provide and maintain a video monitoring system that provides sufficient resolution and field of view to monitor: All areas where catch enters the scale, moves across the scale and leaves the scale; any access point to the scale from which the scale may be adjusted or modified by vessel crew while the vessel is at sea; and the scale display and the indicator for the scale operating in a fault state.

    (B) Record and retain video for all periods when catch that must be weighed is on board the vessel.

    (ii) [Reserved]

    (2) Video Monitoring System Inspection Report. A current NMFS-issued Video Monitoring System Inspection Report must be maintained on board the vessel at all times the vessel is required to have an approved video monitoring system. The Video Monitoring System Inspection Report must be made available to the observer, NMFS staff, or to an authorized officer upon request.

    (3) Retention of records. Consistent with the requirements set forth at 50 CFR 679.28(e)(1), the video data must be maintained on the vessel and made available on request by NMFS staff, or any individual authorized by NMFS. The data must be retained on board the vessel for no less than 120 days after the date the video is recorded, unless NMFS has notified the operator in writing that the video data may be retained for less than this 120-day period.

    3. In § 660.112, add paragraphs (c)(5) and (c)(6) to read as follows:
    § 660.112 Trawl fishery—prohibitions.

    (c) * * *

    (5) Fail to weigh all fish taken and retained aboard the vessel on a scale that meets the performance and technical requirements specified at § 660.15(b).

    (6) Weigh fish taken and retained aboard the vessel without operating and maintaining a video monitoring system that meets the performance and technical requirements specified at § 660.15(e).

    4. In § 660.113, revise paragraphs (c)(2) and (d)(2) to read as follows:
    § 660.113 Trawl fishery—recordkeeping and reporting.

    (c) * * *

    (2) NMFS-approved scale.

    (i) Scale test report form. Mothership vessel operators are responsible for conducting scale tests and for recording the scale test information on the scale test report form as specified at § 660.15(b), for mothership vessels.

    (ii) Printed scale reports. Requirements pertaining to printed scale reports and scale weight printouts are specified at § 660.15(b), for mothership vessels.

    (iii) Retention of scale records and reports. Vessels must maintain scale test report forms on board until the end of the fishing year during which the tests were conducted, and make the report forms available to observers, NMFS staff, or authorized officers. In addition, the scale test report forms must be maintained for 3 years after the end of the fishing year during which the tests were performed. All scale test report forms must be signed by the operator.

    (d) * * *

    (2) NMFS-approved scales.

    (i) Scale test report form. Catcher/processor vessel operators are responsible for conducting scale tests and for recording the scale test information on the scale test report form as specified at § 660.15(b), for catcher/processor vessels.

    (ii) Printed scale reports. Specific requirements pertaining to printed scale reports and scale weight printouts are specified at § 660.15(b), for catcher/processor vessels.

    (iii) Retention of scale records and reports. The vessel must maintain the scale test report form on board until the end of the fishing year during which the tests were conducted, and make the report forms available to observers, NMFS staff, or authorized officers. In addition, the scale test report forms must be maintained for 3 years after the end of the fishing year during which the tests were performed. All scale test report forms must be signed by the operator.

    5. In § 660.150, revise paragraphs (b)(1)(ii) introductory text, (b)(1)(ii)(A) and (C) to read as follows:
    § 660.150 Mothership (MS) Coop Program.

    (b) * * *

    (1) * * *

    (ii) Mothership vessel responsibilities. The owner and operator of a mothership vessel must:

    (A) Recordkeeping and reporting. Maintain a valid declaration as specified at § 660.13(d); maintain records as specified at § 660.113(a); and maintain and submit all records and reports specified at § 660.113(c) including, economic data, scale tests records, cease fishing reports, and cost recovery.

    (C) Catch weighing requirements. The owner and operator of a mothership vessel must:

    (1) Ensure that all catch is weighed in its round form on a NMFS-approved scale that meets the requirements described in section § 660.15(b);

    (2) Provide a NMFS-approved platform scale, belt scale, and test weights that meet the requirements described in section § 660.15(b).

    6. In § 660.160, revise paragraphs (b)(1)(ii)(A) and (C) to read as follows:
    § 660.160 Catcher/processor (C/P) Coop Program.

    (b) * * *

    (1) * * *

    (ii) Catcher/processor vessel responsibilities. The owner and operator of a catcher/processor vessel must:

    (A) Recordkeeping and reporting. Maintain a valid declaration as specified at § 660.13(d); maintain records as specified at § 660.113(a); and maintain and submit all records and reports specified at § 660.113(d) including, economic data, scale tests records, cease fishing reports, and cost recovery.

    (C) Catch weighing requirements. The owner and operator of a catcher/processor vessel must:

    (1) Ensure that all catch is weighed in its round form on a NMFS-approved scale that meets the requirements described in § 660.15(b);

    (2) Provide a NMFS-approved platform scale, belt scale, and test weights that meet the requirements described in § 660.15(b).

    [FR Doc. 2016-00585 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    81 11 Tuesday, January 19, 2016 Notices DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-NOP-14-0062; NOP-14-01] National Organic Program: Notice of Final Guidance for Accredited Certifying Agents and Certified Operations on Natural Resources and Biodiversity Conservation AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Notice of availability of final guidance.

    SUMMARY:

    The National Organic Program (NOP) is announcing the availability of a final guidance document intended for use by accredited certifying agents and certified operations. The guidance document is entitled: Natural Resources and Biodiversity Conservation (NOP 5020). This guidance document is intended to inform the public of NOP's current thinking on this topic.

    DATES:

    The final guidance document announced by this notice is effective on January 20, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Paul Lewis, Ph.D., Standards Division, National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2642-S., Ag Stop 0268, Washington, DC 20250-0268. Telephone: (202) 720-3252, Email: [email protected]; Telephone: (202) 260-9294.

    SUPPLEMENTARY INFORMATION:

    I. Background

    On December 29, 2014, the National Organic Program (NOP) published in the Federal Register a notice of availability with request for public comment on a draft guidance document addressing Natural Resources and Biodiversity Conservation for Certified Organic Operations and Accredited Certifying Agents (ACA's) (79 FR 78025). The NOP selected the topic for the draft guidance in response to a May 2009 National Organic Standards Board (NOSB) request that AMS clarify the requirements and limitations codified at 7 CFR 205.200.1

    1 NOSB Recommendation: Implementation of Biodiversity Conservation in Organic Agriculture Systems. Issued on March 5, 2009. Available on the NOP Web site at: http://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Biodiversity.pdf.

    The general natural resources and biodiversity conservation requirement of the U.S. Department of Agriculture (USDA) organic regulations at 7 CFR 205.200 requires operations to “maintain or improve the natural resources of the operation, including soil and water quality.” Section 205.2 of the regulations defines “natural resources of the operation” as the “physical, hydrological, and biological features of a production operation, including soil, water, wetlands, woodlands, and wildlife.” The May 2009 NOSB recommendation asked the NOP to establish: (1) Consistent discussion and review of biodiversity protection and enhancement in all certified operations' organic system plans; (2) increased education and information for certified operations, inspectors, and certifiers; (3) uniformity of inspection and certification procedures with regard to how certified operations implement the biodiversity standards; (4) incorporation of biodiversity standards into the procedures for accreditation and certifier audits; and (5) use of materials evaluation criteria that foster consideration of biodiversity conservation when adding or deleting materials from the National List of Allowed and Prohibited Substances. The draft NOP guidance can be viewed on the NOP Web site at http://www.ams.usda.gov/sites/default/files/media/NOP-5020.pdf. The 60-day comment period closed on February 27, 2015.

    NOP received approximately 964 individual comments on the draft guidance document. Based upon the comments received, the NOP revised and is publishing a final guidance document on Natural Resources and Biodiversity Conservation (NOP 5020). The guidance document includes an appendix (NOP 5020-1) where the NOP provides a complete discussion of the comments received and the rationale behind any changes made to the guidance documents.

    This final guidance provides examples of production practices that support conservation principles and demonstrate compliance with 7 CFR 205.200. This guidance also clarifies: (1) The certified organic operator's responsibility to select, carry out, and record production practices that “maintain or improve the natural resources of the operation;” (2) the accredited certifying agent's (certifier) responsibility to verify operator compliance with this requirement; and (3) how domestic organic operations that participate in a USDA Natural Resources Conservation Service (NRCS) program and the NOP can reduce their paperwork burdens. This final guidance is available from the NOP through “The Program Handbook: Guidance and Instructions for Accredited Certifying Agents (ACAs) and Certified Operations”. This Handbook provides those who own, manage, or certify organic operations with guidance and instructions that can assist them in complying with the USDA organic regulations. The current edition of the Program Handbook is available online at http://www.ams.usda.gov/rules-regulations/organic/handbook.

    II. Significance of Guidance

    This final guidance document is being issued in accordance with the Office of Management and Budget (OMB) Bulletin on Agency Good Guidance Practices (GGPs) (January 25, 2007, 72 FR 3432-3440). The purpose of GGPs is to ensure that program guidance documents are developed with adequate public participation, are readily available to the public, and are not applied as binding requirements. This guidance represents the NOP's current thinking on the topic. It does not create or confer any rights for, or on, any person and does not operate to bind the NOP or the public. Guidance documents are intended to provide a uniform method for operations to comply with the Organic Foods Production Act (OFPA) and the USDA organic regulations that can reduce the burden of developing their own methods and simplify audits and inspections. Alternative approaches that can demonstrate compliance with the OFPA, as amended (7 U.S.C. 6501-6522), and its implementing regulations are also acceptable. As with any alternative compliance approach, the NOP strongly encourages industry to discuss alternative approaches with the NOP before implementing them to avoid unnecessary or wasteful expenditures of resources, and to ensure the proposed alternative approach complies with the OFPA and its implementing regulations.

    Electronic Access

    Persons with access to Internet may obtain the final guidance at the NOP's Web site at http://www.ams.usda.gov/nop. Request for hard copies of the final guidance document can be obtained by submitting a written request to the person listed in the FOR FURTHER INFORMATION CONTACT section of this Notice.

    Authority:

    7 U.S.C. 6501-6522.

    Dated: January 13, 2016. Erin Morris, Associate Administrator, Agricultural Marketing Service.
    [FR Doc. 2016-00862 Filed 1-15-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration Request for Public Comment on Services Currently Offered or Needed To Facilitate the Marketing of Grain and Related Products AGENCY:

    Grain Inspection, Packers and Stockyards Administration, USDA.

    ACTION:

    Request for Information.

    SUMMARY:

    The U.S. Department of Agriculture's (USDA) Grain Inspection, Packers and Stockyards Administration (GIPSA) is informing the public that it is soliciting comments to ensure that current services reflect market needs to facilitate the marketing of grain and related commodities. Specifically, GIPSA is inviting comments from producers, handlers, processors, food manufacturers, exporters, importers, consumers, scientists, academicians, industry stakeholders, and other interested persons on how GIPSA can best facilitate the marketing of grains, oilseeds, rice, pulses, and related products or products made from them, including co-products of ethanol production, commonly referred to as distillers' grains, based on market-identified quality attributes. To ensure that standards and official grading practices remain relevant in the market, GIPSA invites interested parties to comment on the relevance of current standards, methods, and grading practices, and on potential market needs for new standards or services.

    DATES:

    Comments must be received on or before April 18, 2016.

    ADDRESSES:

    You may submit your written or electronic comments on this notice to:

    Mail: R. Dexter Thomas, GIPSA, USDA, 1400 Independence Avenue SW., Room 2530, Washington, DC 20250-3604.

    Fax: (202) 690-2173

    Internet: Go to http://www.regulations.gov and follow the on-line instruction for submitting comments.

    Instructions: All comments will become a matter of public record and should be identified as “U.S. Services Offered for Grains Notice Comments,” making reference to the date and page number of this issue of the Federal Register. All comments received become the property of the Federal government, are made a part of the public record, and will generally be posted to www.regulations.gov without change. Comments may also be viewed in the above office during regular business hours (7 CFR 1.27(b)). Please call the GIPSA Management Support Staff at (202) 720-6529 to make an appointment to read comments received. If you send a comment directly to GIPSA without going through www.regulations.gov, or you submit a comment to GIPSA via fax, the originating address or telephone number will be captured automatically and included as part of the comment that is placed in the public docket and made available on the Internet. Also, all personal identifying information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    Electronic submissions should avoid the use of special characters, avoid any form of encryption, and be free of any defects or viruses, since these may prevent GIPSA from being able to read and understand, and thus consider your comment.

    FOR FURTHER INFORMATION CONTACT:

    Anthony Goodeman at GIPSA, USDA, 1400 Independence Avenue SW., Washington, DC, 20250; Telephone (202)-720-0228; Fax Number (202) 720-1015; email [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    Under the authority of the United States Grain Standards Act, as amended, and the Agricultural Marketing Act of 1946, as amended, GIPSA establishes standards for grains, oilseeds, rice, pulses, and related graded and processed commodities, regarding kind, class, quality and condition. The standards facilitate marketing and define U.S. grain and commodity quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; specify grades, grade requirements, special grades; and special grade requirements. Official procedures for determining grading factors are provided in GIPSA's Inspection Handbooks, which also include standardized procedures for additional quality attributes not used to determine grade, such as protein content and falling number. Together, the grade standards and inspection procedures allow buyers and sellers to communicate quality requirements, compare quality using equivalent forms of measurement, and assist in price discovery.

    GIPSA periodically reviews the standards to ensure they reflect marketplace needs. In 2007, when the U.S. ethanol industry was expanding rapidly, GIPSA issued an Advance Notice of Proposed Rulemaking (ANPR) titled “The Role of USDA in Differentiating Grain Inputs for Ethanol Production and Standardizing Testing of the Co- Products of Ethanol Production” (72 FR 39762). The ANPR sought comments from the marketplace asking if there were any additional services GIPSA should offer to facilitate the marketing of ethanol co-products. Commenters overwhelmingly agreed that GIPSA should not intervene in standardizing testing of ethanol inputs and outputs. Commenters did state that an appropriate role for GIPSA was to continue approving rapid test kits for determining the concentration of mycotoxins. Accordingly, GIPSA did not initiate any rulemaking action related to the matters presented in the ANPR. However, GIPSA did agree to monitor the industry and remain actively engaged with the ethanol and co-product markets and to support the industry, as appropriate, in its efforts to successfully market ethanol co-products. Further, GIPSA has continued to approve rapid test kits for mycotoxins.

    The production of distillers' grains has continued to grow in recent years concurrent with increased ethanol production. GIPSA will broadly refer to “distillers' grains” as being any of the plethora of co-products generated by dry-mill ethanol plants, including distillers' wet grains (DWG), distillers' dried grains (DDG), distillers' wet grains with solubles (DWGS), distillers' dried grains with solubles (DDGS), and condensed distillers' solubles (CDS), unless otherwise specified. According to USDA's Economic Research Service, the United States produced an estimated 44.6 million metric tons of DDGS in the 2014/15 crop year, compared to 12.4 million metric tons of DDGS in 2006/07, when GIPSA's previous ANPR was first published. Increasing supply, two years of higher prices for competing feeds (soybean meal and corn), and successful foreign market development efforts by USDA and trade associations have led to a surge in DDGS exports from the United States. Exports now constitute nearly 25 percent of domestic DDGS production, totaling 11.0 million metric tons in the 2014/15 crop year, compared to exports of only 14.5 percent of production, totaling 1.8 million metric tons in 2006/07.

    In order for U.S. standards and grading procedures to remain relevant, GIPSA is issuing this Request for Information to invite interested parties to submit comments, ideas, and recommendations on GIPSA's role in the marketing of grain, oilseeds, and related agricultural products, including distillers' grains. All interested persons are specifically encouraged to comment on the following issues related to this notice:

    1. Are there any market-identified quality attributes that GIPSA does not currently describe (or provide testing) that would facilitate the marketing of grain, oilseeds, and related products?

    2. What role should GIPSA take, if any, in standardizing the testing of inputs and outputs of ethanol co-product processing? Has anything changed in the marketing of ethanol and ethanol co-products since GIPSA's last ANPR in 2007 related to standardization, product description, or quality assessment?

    3. Are there any other services that GIPSA could offer to facilitate the marketing of grain, oilseeds, or related products?

    Authority:

    7 U.S.C. 71-87K; 7 U.S.C. 1621-1638D

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2016-00847 Filed 1-15-16; 8:45 am] BILLING CODE 3410-KD-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Submission for OMB Review; Comment Request January 13, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by February 18, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW., Washington, DC, 20503. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8681.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    National Agricultural Statistics Service

    Title: Local Food Marketing Practices Survey

    OMB Control Number: 0535-NEW

    Summary of Collection: Data will be collected under the authority of 7 U.S.C. 2204(a). Section 10016(a)(1)(A) of the 2014 Farm Bill (Public Law 113-79) directs the Department of Agriculture (USDA) to collect data on “the production and marketing of locally or regionally produced agricultural food products,” while Section 10016(b)(2) requires USDA to “conduct surveys and analysis and publish reports relating to the production, handling, distribution, retail sales, and trend studies. . . of or on locally or regionally produced agricultural food products.” The survey will gather data on production, risk management, and marketing practices. Contingent upon the availability of funding, the Local Foods Survey will be a Census follow-on-survey.

    Need and Use of the Information: A growing interest in support of local agricultural economies through the purchase of foods from sources that are geographically close to the consuming areas, via channels that are direct from farm to consumer or at most one step removed. The institution of the USDA Know Your Farmer, Know Your Food Initiative was designed to eliminate organizational barriers to improve coordination and availability of resources for the promotion of local food systems. The primary purpose of the survey is to produce benchmark statistics on the number of operations that produce local foods, the value of local foods sales (in total and by specific marketing channel), and marketing practices and expenses. Farms in all 50 states will be asked to provide these data. Statistics from this survey will be used by state agencies to better understand, support, and promote their local food markets, as well as by researchers studying local foods.

    Description of Respondents: Farmers and Ranchers.

    Number of Respondents: 28,000.

    Frequency of Responses: Reporting: Annually.

    Total Burden Hours: 21,000.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-00914 Filed 1-15-16; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF AGRICULTURE National Institute of Food and Agriculture Submission for OMB Review; Comment Request January 13, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by February 18, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    National Institute of Food and Agriculture

    Title: Application for Authorization to Use the 4-H Name and/or Emblem.

    OMB Control Number: 0524-0034.

    Summary of Collection: Use of the 4-H Club Name and/or Emblem is authorized by an Act of Congress, (Pub. L. 772, 80th Congress, 645, 2nd Session). Use of the 4-H Club Name and/or Emblem by anyone other than the 4-H Clubs and those duly authorized by them, representatives of the Department of Agriculture, the Land-Grant colleges and universities, and person authorized by the Secretary of Agriculture is prohibited by the provisions of 18 U.S.C. 707. The Secretary has delegated authority to the Administrator of the National Institute of Food and Agriculture (NIFA) to authorize others to use the 4-H Name and Emblem. Therefore, anyone requesting, authorization from the Administrator to use the 4-H Name and Emblem is asked to describe the proposed use in a formal application. NIFA will collect information using form NIFA-01 “Application for Authorization to Use the 4-H Club Name or Emblem.

    Need and Use of the Information: The information collected by NIFA will be used to determine if those applying to use the 4-H name and emblem are meeting the requirements and quality of materials, products and/or services provided to the public. If the information were not collected, it would not be possible to ensure that the products, services, and materials meet the high standards of 4-H, its educational goals and objectives.

    Description of Respondents: Not-for-profit institutions; Business or other for-profit; Individuals or households.

    Number of Respondents: 60.

    Frequency of Responses: Reporting: Other (every 3 years).

    Total Burden Hours: 30.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-00912 Filed 1-15-16; 8:45 am] BILLING CODE 3410-09-P
    DEPARTMENT OF COMMERCE Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: U.S. Census Bureau.

    Title: Current Population Survey, Fertility Supplement.

    OMB Control Number: 0607-0610.

    Form Number(s): There are no forms. We conduct all interviews on computers.

    Type of Request: Regular Submission.

    Number of Respondents: 30,000.

    Average Hours per Response: 1.0 minutes.

    Burden Hours: 500.

    Needs and Uses: This survey provides information used mainly by government and private analysts to project future population growth, to analyze child spacing, and to aid policymakers in their decisions affected by changes in family size and composition. Past studies have discovered noticeable changes in the patterns of fertility rates and the timing of the first birth. Potential needs for government assistance, such as aid to families with dependent children, child care, and maternal health care for single parent households, can be estimated using Current Population Survey characteristics matched with fertility data.

    Affected Public: Individuals or households.

    Frequency: Biennial.

    Respondent's Obligation: Voluntary.

    Legal Authority: Title 13 U.S.C. Sections 141, 182 authorize the collection of this information on individuals and households.

    This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: January 13, 2016. Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2016-00830 Filed 1-15-16; 8:45 am] BILLING CODE 3510-07-P
    DEPARTMENT OF COMMERCE [Docket No. 151028999-6030-02] Privacy Act of 1974, Amended System of Records AGENCY:

    National Oceanic and Atmospheric Administration, U.S. Department of Commerce.

    ACTION:

    Notice of Proposed Amendment to Privacy Act System of Records: COMMERCE/NOAA-1, Applicants for the NOAA Corps.

    SUMMARY:

    The Department of Commerce publishes this notice to announce the effective date of a Privacy Act System of Records notice entitled Notice of Proposed Amendment to COMMERCE/NOAA-1, Applicants for the NOAA Corps.

    DATES:

    The system of records becomes effective on January 19, 2016.

    ADDRESSES:

    For a copy of the system of records please mail requests to: Sarah Brabson, NOAA Office of the Chief Information Officer, Room 9856, 1315 East-West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Director, NOAA Corps, 8403 Colesville Road, Suite 500, National Oceanic and Atmospheric Administration, Silver Spring, Maryland 20910.

    SUPPLEMENTARY INFORMATION:

    On November 25, 2015 (80 FR 73698), the Department of Commerce published a notice in the Federal Register, entitled “COMMERCE/NOAA-1, Applicants for the NOAA Corps,” requesting comments on proposed amendments to the system of records. The November 25, 2015, notice stated that the amended system of records will become effective on the date of publication of a subsequent notice, unless comments are received. No comments were received in response to the request for comments. Accordingly, by this notice, the Department of Commerce is adopting the proposed changes to the system as final without changes effective January 19, 2016.

    Dated: January 12, 2016. Michael J. Toland, Department of Commerce, Freedom of Information and Privacy Act Officer.
    [FR Doc. 2016-00833 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE [Docket No. 151109999-5999-01] Privacy Act of 1974, New System of Records AGENCY:

    National Oceanic and Atmospheric Administration, U.S. Department of Commerce.

    ACTION:

    Notice of a New Privacy Act System of Records: COMMERCE/NOAA-22, NOAA Health Services Questionnaire (NHSQ) and Tuberculosis Screening Document (TSD).

    SUMMARY:

    In accordance with the Privacy Act of 1974, as amended, Title 5 of the United States Code (U.S.C.) sections 552a(e)(4) and (11); and Office of Management and Budget (OMB) Circular A-130, Appendix I, “Federal Agency Responsibilities for Maintaining Records About Individuals,” the Department of Commerce is issuing a notice of intent to establish a new system of records entitled, “COMMERCE/NOAA-22, NOAA Health Services Questionnaire and Tuberculosis Screening Document.” We invite the public to comment on the items noted in this publication. The purpose of this system of records is to document information related to medical clearance, which is required for all persons sailing on Office of Marine and Aviation Operations (OMAO) vessels. The National Oceanic and Atmospheric Administration (NOAA) Health Services is responsible for medically evaluating and providing clearance for persons who will be sailing on these vessels. The completed NHSQ and TSD provide specific and select medical information on individuals who wish to embark on OMAO vessels and need medical clearance. The completed forms also contain personal identifiable information that is required to be protected by the Privacy Act.

    DATES:

    To be considered, written comments must be submitted on or before February 18, 2016. Unless comments are received, the new system of records will become effective as proposed on the date of publication of a subsequent notice in the Federal Register.

    ADDRESSES:

    Comments may be mailed to: Director of Health Services, CAPT P. Jane Powers, 2002 SE Marine Science Drive, Newport, OR, 97365.

    FOR FURTHER INFORMATION CONTACT:

    CAPT P. Jane Powers, 2002 SE Marine Science Drive, Newport, OR, 97365.

    SUPPLEMENTARY INFORMATION:

    OMAO is creating a system of records for health information and other personal identifiable information required for medical clearance of individuals, both NOAA staff and others who are not employees, who plan to sail on OMAO vessels. Collection of information on the NHSQ and the TSD are consistent with the support for research and education under the National Marine Sanctuaries Act. See e.g., 16 U.S.C. 1440 and the NOAA Administrative Order 209-124.

    COMMERCE/NOAA-22 System name:

    COMMERCE/NOAA-22, NOAA Health Services Questionnaire (NHSQ) and Tuberculosis Screening Document (TSD).

    Security classification:

    None.

    System location:

    U.S. Department of Commerce, National Oceanic and Atmospheric Administration (NOAA), Office of Marine and Aviation Operations, 8403 Colesville Road, Silver Spring, MD 20910-3282. Satellite addresses are: NOAA Health Services-Pacific, 2002 SE Marine Science Drive, Newport, OR 97365; NOAA Health Services-Atlantic, 439 West York Street, Norfolk, VA 23510-1114.

    Categories of individuals covered by the system:

    Individuals who wish to embark on OMAO vessels and need medical clearance.

    Categories of records in the system:

    Personal Identifiable Information: name; date of birth (year only); work address; email address; position in program; home, work and cell telephone numbers; cruise dates; emergency contact (name, address and telephone number) and their relationship to the individual; names of NOAA ships NHSQ and TSD needs to be forwarded to; whether individual is regularly seeing a doctor for any reason; medications currently being taken; allergies; health problems; major surgeries/hospitalizations/emergency room visits; general/cardiac screening questions; date of last tetanus booster; functional abilities screening questions; awareness of medical condition which could affect their suitability for sea duty; type of test and result of most recent tuberculosis test; information on a previous positive skin test; date of last chest X-ray, if applicable; date of last BCG vaccine (tuberculosis vaccine), if applicable; date prescribed TB medication completed, if applicable; contact with any other person(s) infected with TB; occurrence of a positive HIV test; use of illegal intravenous drugs; any current treatment with steroids, chemotherapy, or cancer treating drugs; any incidence of homelessness; any incidence of incarceration; possession of fever, weight loss, night sweats, chronic cough, chronic fatigue, coughing up blood; statement to accuracy and truth of information provided; signature of applicant and date signed; signature of medical officer reviewing the forms; date of clearance; and any additional information supplied from the individual's medical provider(s).

    Authority for maintenance of the system:

    This system of records is consistent with the support for research monitoring and education under the National Marine Sanctuaries Act. 16 U.S.C. 1440) See also Office of Personnel Management regulations: 5 CFR 339.102—Purpose and Effect; 5 CFR 339.202—Medical Standards; 5 CFR 339.205—Medical Evaluation Programs; 5 CFR 339.206—Disqualification on the Basis of Medical History; 5 CFR 229.301—Authority to Require an Examination; 5 CFR part 339—Medical Qualification Determinations.

    Purposes:

    The records are maintained and used to fulfill OMAO's responsibility of medically clearing embarking personnel on OMAO vessels. The NHSQ and TSD system will provide medical personnel with faster access to more complete data; this will enhance their effectiveness.

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    1. Electronic NHSQ and TSD medical information is shared only with authorized users who have a legitimate need to know. These medical records, contained therein, may be disclosed as stated below:

    a. A record in the medical department may be disclosed to the Department of Commerce legal department to determine legal sufficiency of a denial for embarkation or in response to litigation.

    b. A record in the medical department may be disclosed in response to a court order.

    c. A record in the medical department may be disclosed to other health care providers that are involved in cases concerning person(s)/employee(s) with a specific disease or injury.

    d. A record in the medical department may be disclosed to the applicable medical psychiatric and/or state authority(ies) in response to statute (e.g., sexually transmitted disease, homicidal ideation, suicidal ideation, child abuse, elder abuse, etc.).

    e. A record in the medical department may be disclosed to the OMAO leadership involved in the medical evaluation process.

    f. A record in the medical department may be disclosed to the individual involved.

    2. In the event that a system of records maintained by the Department to carry out its functions indicates a violation or potential violation of law or contract, whether civil, criminal or regulatory in nature and whether arising by general statute or particular program statute or contract, rule, regulation, or order issued pursuant thereto, or the necessity to protect an interest of the Department, the relevant records in the system of records may be referred to the appropriate agency, whether Federal, State, local, or foreign, charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing the statute or contract, rule, regulation or order issued pursuant thereto, or protecting the interest of the Department.

    3. A record from this system of records may be disclosed in the course of presenting evidence to a court, magistrate, or administrative tribunal, including disclosures to opposing counsel in the course of settlement negotiations.

    4. A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an individual when the individual has requested assistance from the Member with respect to the subject matter of the record.

    5. A record in this system of records may be disclosed to the Department of Justice in connection with determining whether the Freedom of Information Act (5 U.S.C. 552) requires disclosure thereof.

    6. A record in this system will be disclosed to the Department of Treasury for the purpose of reporting and recouping delinquent debts owed the United Sates pursuant to the Debt Collection Improvement Act of 1996.

    7. A record in this system of records may be disclosed to appropriate agencies, entities, and persons when: (1) It is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised; (2) the Department has determined that, as a result of the suspected or confirmed compromise, there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that relies upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    Disclosure to consumer reporting agencies:

    Disclosure to consumer reporting agencies pursuant to 5 U.S.C. 552a(b)(12) may be made from this system to “consumer reporting agencies” as defined in the Fair Credit Reporting Act (15 U.S.C. 1681a(f)) and the Federal Claims Collection Act of 1966 (31 U.S.C. 3701(a)(3)).

    Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage:

    NHSQ and TSD medical information is stored and maintained in electronic form in system folders and/or databases, within a controlled environment with access restricted to authorized personnel. Other medical information in a hardcopy format is stored in locked storage facilities at OMAO regional facilities or on OMAO vessels with access restricted to authorized personnel.

    Retrievability:

    Records are retrieved through inquires based on the name of individual or the name of the NOAA vessel.

    Safeguards:

    The NHSQ and TSD can only be accessed by authorized OMAO medical personnel. Access to electronic medical data will be through a secure OMAO network and requires a password for entry, which is based on DOC password standards. Passwords are granted to authorized medical personnel. Hard/completed electronic copies are stored in OMAO headquarters or regional facilities. Entry to these facilities requires an approved NOAA-issued badge and electronic access to completed NHSQs and TSDs requires proper authorization and a password. Storage within the OMAO facilities are locked and under surveillance of administrative personnel. Hard copy medical records related to NHSQ and TSD shall be stored in locked file cabinets in all regional and headquarter offices. Access to these medical records shall be limited to authorized personnel only.

    Retention and disposal:

    OMAO shall maintain its records in accordance with NOAA's Records Management Guide and Records Disposition Handbook. Upon closure of a case, all medical information on the case contained in the NHSQ and TSD shall be retained for at least 6 years, and destroyed 6 years after date of last entry. See National Archives and Records Administration General Records Schedule 1 Civilian Personnel Records, Section 19, Individual Non-Occupational Health Record Files: “Forms, correspondence, and other records, including summary records, documenting an individual employee's medical history, physical condition, and visits to Government health facilities, for nonwork-related purposes, EXCLUDING records covered by item 21 of this schedule. Destroy 6 years after date of last entry. (NC1-64-77-10 item 19).” http://www.archives.gov/records-mgmt/grs/grs01.html.

    System manager(s) and address:

    CAPT Priscilla J. Powers, Director, Health Services, 2002 SE Marine Science Drive, Newport, OR 97365.

    Notification procedure:

    In accordance with the Department of Commerce regulations implementing the Privacy Act, at Title 15 of the Code of Federal Regulations, part 4, subpart B-Privacy Act, individuals interested in determining if the system contains their name should direct their Privacy Act request to the National Oceanic and Atmospheric Administration, Public Reference Facility, OFA56, 1315 East West Highway (SSMC3), Room 10730, Silver Spring, Maryland 20910.

    Record access procedures:

    Same as Notification procedures above.

    Contesting record procedures:

    Same as Notification procedures above.

    Record source categories:

    Information that may be entered into the NHSQ and TSD will come from the following sources:

    1. The individual involved in the medical record.

    2. The authorized medical reviewer.

    3. Other documentation submitted by medical providers of the individual.

    4. Medical events that occur while on OMAO vessels.

    Exemptions claimed for the system:

    None.

    Dated: January 12, 2016. Michael J. Toland, Department of Commerce, Freedom of Information and Privacy Act Officer.
    [FR Doc. 2016-00834 Filed 1-15-16; 8:45 am] BILLING CODE 3510-12-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-57-2015] Correction Notice; Authorization of Production Activity; Foreign-Trade Zone 265; Bauer Manufacturing Inc.; (Stationary Oil/Gas Drilling Rigs); Conroe, Texas

    On August 19, 2015, the City of Conroe, Texas, grantee of FTZ 265, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of Bauer Manufacturing Inc., within FTZ 265, in Conroe, Texas.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (80 FR 54520, September 10, 2015). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the FTZ Board's regulations, including Section 400.14, and further subject to a restriction requiring that foreign status textile-based cotton transport straps (classified within HTSUS Subheading 5806.31) be admitted to the zone in privileged foreign status (19 CFR 146.41).

    Dated: January 12, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-00918 Filed 1-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Notice of Court Decision Not in Harmony With the Final Results of Review and Amended Final Results of the Antidumping Duty Administrative Review AGENCY:

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

    SUMMARY:

    On October 21, 2015, the United States Court of International Trade (Court) sustained our final remand redetermination pertaining to the administrative review of the antidumping duty order on diamond sawblades and parts thereof from the People's Republic of China covering the period November 1, 2010, through October 31, 2011.1 Consistent with the decision of the United States Court of Appeals for the Federal Circuit (CAFC) in Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (Timken), as clarified by Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (Diamond Sawblades), the Department of Commerce (the Department) is notifying the public that the Court's final judgment in this case is not in harmony with the AR2 Final Results  2 and that the Department is amending the AR2 Final Results with respect to the ATM Single Entity 3 and the PRC-wide entity.

    1See Final Remand Redetermination pursuant to Diamond Sawblades Manufacturers Coalition v. United States, Court No. 13-00241, slip op. 14-112 (Ct. Int'l Trade Sept. 23, 2014), dated May 18, 2015, and available at http://enforcement.trade.gov/remands/14-112.pdf (AR2 Remand), aff'd, Diamond Sawblades Manufacturers' Coalition v. United States, Court No. 13-00241, slip op. 15-116 (Ct. Int'l Trade Oct. 21, 2015).

    2See Diamond Sawblades and Parts Thereof From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2010-2011, 78 FR 36166 (June 17, 2013), as amended in Diamond Sawblades and Parts Thereof From the People's Republic of China: Amended Final Results of Antidumping Duty Administrative Review; 2010-2011, 78 FR 42930 (July 18, 2013) (collectively, AR2 Final Results).

    3 The ATM Single Entity includes Advanced Technology & Materials Co., Ltd., Beijing Gang Yan Diamond Products Co., HXF Saw Co., Ltd., AT&M International Trading Co., Ltd., and Cliff International Ltd. See Diamond Sawblades and Parts Thereof From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2009-2010, 78 FR 11143, 11144-45 n.9 (February 15, 2013), and Diamond Sawblades and Parts Thereof From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review: 2010-2011, 77 FR 73417, 73418 (December 10, 2012), unchanged in AR2 Final Results.

    DATES:

    Effective Date: October 31, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Yang Jin Chun or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-5760 or (202) 482-1690, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On June 17, 2013, as amended on July 18, 2013, the Department published the AR2 Final Results. The Diamond Sawblades Manufacturers' Coalition (DSMC) challenged certain aspects of the Department's AR2 Final Results. On September 23, 2014, the Court remanded the AR2 Final Results to the Department to: (1) Reconsider the ATM Single Entity's separate rate status; (2) explain where in the statute or other authority the Department finds the non-ministerial discretion not to determine if there is a pattern of differing export price or constructed export price for the purposes of using an alternate comparison methodology, regardless of whether an allegation is raised to that effect; and (3) explain how the methodology for valuing Weihai Xiangguang Mechanical Industrial Co., Ltd.'s (Weihai) steel cores is consistent with the first review, why Weihai's NME experience better reflects Weihai's experience of purchasing cores even though it is located in an NME country, and provide a full explanation of its chosen methodology.4 On remand, the Department (1) denied the ATM Single Entity a separate rate and revised the PRC-wide rate; (2) explained that the Department's practice is to require targeted dumping allegations before the preliminary results and, because DSMC filed the targeted dumping allegation after the preliminary results, the targeted dumping allegation in this review was untimely; and (3) explained the Department's methodology for valuing Weihai's steel cores.5 On October 21, 2015, the Court upheld our final remand redetermination for this review in its entirety.6

    4See Diamond Sawblades Manufacturers Coalition v. United States, Court No. 13-00241, slip op. 14-112 (Ct. Int'l Trade Sept. 23, 2014).

    5See AR2 Remand.

    6See Diamond Sawblades Manufacturers' Coalition v. United States, Court No. 13-00241, slip op. 15-116 (Ct. Int'l Trade Oct. 21, 2015).

    Timken Notice

    In its decision in Timken, as clarified by Diamond Sawblades, the CAFC held that, pursuant to section 516A(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 Court's final judgment affirming the final remand redetermination constitutes the Court's final decision which is not in harmony with the AR2 Final Results. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, the Department will continue the suspension of liquidation of the subject merchandise pending a final and conclusive court decision.

    Amended Final Results of Review

    Because there is now a final court decision, the Department is amending the AR2 Final Results with respect to the PRC-wide entity, which includes the ATM Single Entity, as follows:

    Exporter Weighted-
  • average
  • dumping margin
  • (percent)
  • PRC-Wide Entity (which includes the ATM Single Entity) 82.05

    In the event the Court's ruling is upheld by a final and conclusive court decision, the Department will instruct the U.S. Customs and Border Protection to assess antidumping duties on unliquidated entries of subject merchandise based on the revised rate the Department determined and listed above.

    Cash Deposit Requirements

    Since the AR2 Remand, the Department has established a new cash deposit rate for the PRC-wide entity, which includes the ATM Single Entity.7 Therefore, the cash deposit rate for the PRC-wide entity does not need to be updated as a result of these amended final results.

    7See Diamond Sawblades and Parts Thereof From the People's Republic of China; Final Results of Antidumping Duty Administrative Review; 2012-2013, 80 FR 32344 (June 8, 2015).

    Notification to Interested Parties

    This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.

    Dated: January 12, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-00917 Filed 1-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Notice of Court Decision Not in Harmony With the Final Results of Review and Amended Final Results of the Antidumping Duty Administrative Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Commerce.

    SUMMARY:

    On September 23, 2015, the United States Court of International Trade (Court) sustained our final remand redetermination pertaining to the administrative review of the antidumping duty order on diamond sawblades and parts thereof from the People's Republic of China covering the period January 23, 2009, through October 31, 2010.1 Consistent with the decision of the United States Court of Appeals for the Federal Circuit (CAFC) in Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (Timken), as clarified by Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (Diamond Sawblades), the Department of Commerce (the Department) is notifying the public that the Court's final judgment in this case is not in harmony with the AR1 Final Results2 and that the Department is amending the AR1 Final Results with respect to the ATM Single Entity 3 and the PRC-wide entity.

    1See Final Results of Redetermination pursuant to Diamond Sawblades Manufacturers' Coalition v. United States, Court No. 13-00078, slip op. 14-50 (Ct. Int'l Trade April 29, 2014), dated April 10, 2015, and available at http://enforcement.trade.gov/remands/14-50.pdf (AR1 Remand), aff'd, Diamond Sawblades Manufacturers' Coalition v. United States, Court No. 13-00078, slip op. 15-105 (Ct. Int'l Trade September 23, 2015).

    2See Diamond Sawblades and Parts Thereof From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2009-2010, 78 FR 11143 (February 15, 2013) (AR1 Final Results).

    3 The ATM Single Entity includes Advanced Technology & Materials Co., Ltd., Beijing Gang Yan Diamond Products Co., HXF Saw Co., Ltd., AT&M International Trading Co., Ltd., and Cliff International Ltd. See AR1 Final Results, 78 FR at 11144-45 n.9.

    DATES:

    Effective Date: October 3, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Yang Jin Chun or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-5760 or (202) 482-1690, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On February 15, 2013, the Department published the AR1 Final Results. The Diamond Sawblades Manufacturers' Coalition challenged the Department's decisions to grant the ATM Single Entity a separate rate and to not collapse the state-owned enterprise, China Iron & Steel Research Institute, within the ATM Single Entity.4 The Department requested a voluntary remand to reconsider the separate rate eligibility for the ATM Single Entity in this review and the Court granted the Department's request.5 On remand, the Department determined that the ATM Single Entity was ineligible for a separate rate and also revised the PRC-wide rate.6 On September 23, 2015, the Court entered judgment sustaining the final remand redetermination for this review in its entirety.7

    4See Diamond Sawblades Manufacturers' Coalition v. United States, Court No. 13-00078, slip op. 14-50 (Ct. Int'l Trade April 29, 2014).

    5Id.

    6See AR1 Remand.

    7See Diamond Sawblades Manufacturers' Coalition v. United States, Court No. 13-00078, slip op. 15-105 (Ct. Int'l Trade Sept. 23, 2015).

    Timken Notice

    In its decision in Timken, as clarified by Diamond Sawblades, the CAFC held that, pursuant to section 516A(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 Court's final judgment affirming the final remand redetermination constitutes the Court's final decision which is not in harmony with the AR1 Final Results. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, the Department will continue the suspension of liquidation of the subject merchandise pending a final and conclusive court decision.

    Amended Final Results of Review

    Because there is now a final court decision, the Department is amending the AR1 Final Results with respect to the PRC-wide entity, which includes the ATM Single Entity, as follows:

    Exporter Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • PRC-Wide Entity (which includes the ATM Single Entity) 82.12

    In the event the Court's ruling is upheld by a final and conclusive court decision, the Department will instruct the U.S. Customs and Border Protection to assess antidumping duties on unliquidated entries of subject merchandise based on the revised rate the Department determined and listed above.

    Cash Deposit Requirements

    Since the AR1 Remand, the Department has established a new cash deposit rate for the PRC-wide entity, which includes the ATM Single Entity.8 Therefore, the cash deposit rate for the PRC-wide entity does not need to be updated as a result of these amended final results.

    8See Diamond Sawblades and Parts Thereof From the People's Republic of China; Final Results of Antidumping Duty Administrative Review; 2012-2013, 80 FR 32344 (June 8, 2015).

    Notification to Interested Parties

    This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.

    Dated: January 12, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-00923 Filed 1-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-918] Steel Wire Garment Hangers From the People's Republic of China; 2014-2015; Partial Rescission of the Seventh Antidumping Duty Administrative Review AGENCY:

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

    SUMMARY:

    On December 3, 2015, the Department of Commerce (“Department”) published a notice of initiation of an administrative review of the antidumping duty order on steel wire garment hangers from the People's Republic of China (“PRC”). Based on M&B Metal Products Co., Ltd.'s (“Petitioner”) timely withdrawal of the requests for review of certain companies, we are now rescinding this administrative review with respect to 44 companies.

    DATES:

    Effective January 19, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Jessica Weeks, 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) 482-4877.

    Background

    On October 1, 2015, the Department published a notice of “Opportunity to Request Administrative Review” of the antidumping order on steel wire garment hangers from the PRC.1 In November 2015, the Department received multiple timely requests to conduct an administrative review of the antidumping duty order on steel wire garment hangers from the PRC.2 Based upon these requests, on December 3, 2015, the Department published a notice of initiation of an administrative review of the Order covering the period October 1, 2014, to September 30, 2015.3 The Department initiated the administrative review with respect to 46 companies.4 On December 16, 2015, Petitioner withdrew its request for an administrative review on 44 companies.5

    1See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Request Administrative Review, 80 FR 59135 (October 1, 2015).

    2See Notice of Antidumping Duty Order: Steel Wire Garment Hangers From the People's Republic of China, 73 FR 58111 (October 6, 2008) (“Order”).

    3See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 75657 (December 3, 2015).

    4Id.

    5See Letter to the Secretary of Commerce from Petitioner “Seventh Administrative Review of Steel Wire Garment Hangers from China—Petitioner's Withdrawal of Review Request” (December 16, 2015).

    Partial Rescission

    Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if a party who requested the review withdraws the request within 90 days of the date of publication of notice of initiation of the requested review. All requests for administrative reviews on the 44 companies listed in the Appendix were withdrawn.6 Accordingly, we are rescinding this review, in part, with respect to these entities, in accordance with 19 CFR 351.213(d)(1).

    6 As stated in Change in Practice in NME Reviews, the Department will no longer consider the non-market economy (“NME”) entity as an exporter conditionally subject to administrative reviews. See 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).

    This administrative review will continue with respect to Shanghai Wells Hanger Co., Ltd. and Hong Kong Wells Ltd.

    Assessment

    The Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on all appropriate entries. For the companies for which this review is rescinded, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.

    Notification to Importers

    This notice serves as the only reminder to importers for whom this review is being rescinded, as of the publication date of this notice, 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 the antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Notification Regarding Administrative Protective Orders

    This notice also serves as a reminder to parties subject to administrative protective orders (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. 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 violation which is subject to sanction.

    Notification to Interested Parties

    This notice is issued and published in accordance with sections 751 and 777(i)(l) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).

    Dated: January 11, 2016. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations. Appendix

    1. Da Sheng Hanger Ind. Co., Ltd.

    2. Feirongda Weaving Material Co. Ltd.

    3. Hangzhou Qingqing Mechanical Co. Ltd.

    4. Hangzhou Yingqing Material Co. Ltd.

    5. Hangzhou Yinte

    6. Hongye (HK) Group Development Co. Ltd.

    7. Liaoning Metals & Mineral Imp/Exp Corp.

    8. Nantong Eason Foreign Trade Co., Ltd.

    9. Ningbo Bingcheng Import & Export Co. Ltd.

    10. Ningbo Dasheng Daily Products Co., Ltd.

    11. Ningbo Dasheng Hanger Ind. Co. Ltd.

    12. Ningbo Peacebird Import & Export Co. Ltd.

    13. Shang Zhou Leather Shoes Plant

    14. Shanghai Bao Heng Relay Making Co., Ltd.

    15. Shanghai Ding Ying Printing & Dyeing Co. Ltd.

    16. Shanghai Ganghun Beddiry Clothing Factory

    17. Shanghai Guangwei Shoes Co., Ltd.

    18. Shanghai Guoxing Metal Products Co. Ltd.

    19. Shanghai Jianhai International Trade Co. Ltd.

    20. Shanghai Lian Development Co. Ltd.

    21. Shanghai Shuang Qiang Embroidery Factory Co. Ltd.

    22. Shanghai Tonghui.

    23. Shangyu Baoli Electro Chemical Aluminum Products Co., Ltd.

    24. Shangyu Baoxiang Metal Manufactured Co. Ltd.

    25. Shangyu Tongfang Labour Protective Articles Co., Ltd.

    26. Shaoxing Andrew Metal Manufactured Co. Ltd.

    27. Shaoxing Dingli Metal Clotheshorse Co. Ltd.

    28. Shaoxing Gangyuan Metal Manufactured Co. Ltd.

    29. Shaoxing Guochao Metallic Products Co., Ltd.

    30. Shaoxing Liangbao Metal Manufactured Co. Ltd.

    31. Shaoxing Meideli Hanger Co. Ltd.

    32. Shaoxing Shunji Metal Clotheshorse Co., Ltd.

    33. Shaoxing Shuren Tie Co. Ltd.

    34. Shaoxing Tongzhou Metal Manufactured Co. Ltd.

    35. Shaoxing Zhongbao Metal Manufactured Co. Ltd.

    36. Shaoxing Zhongdi Foreign Trade Co. Ltd.

    37. Tianjin Innovation International

    38. Tianjin Tailai Import and Export Co. Ltd.

    39. Wahfay Industrial (Group) Co., Ltd.

    40. Wesken International (Kunshan) Co. Ltd.

    41. Xia Fang Hanger (Cambodia) Co., Ltd.

    42. Zhejiang Hongfei Plastic Industry Co. Ltd.

    43. Zhejiang Jaguar Import & Export Co. Ltd.

    44. Zhejiang Lucky Cloud Hanger Co. Ltd.

    [FR Doc. 2016-00920 Filed 1-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD856 Marine Mammals; File No. 18902 AGENCY:

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

    ACTION:

    Notice; issuance of permit.

    SUMMARY:

    Notice is hereby given that a permit has been issued to Colleen Reichmuth, Ph.D., Long Marine Laboratory, University of California at Santa Cruz, 100 Shaffer Road, Santa Cruz, CA 95060, to conduct research on pinnipeds in captivity.

    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:

    Amy Sloan, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On August 31, 2015, notice was published in the Federal Register (80 FR 52452) that a request for a permit to conduct research on pinniped species in captivity had been submitted by the above-named applicant. The requested permit has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216).

    Dr. Reichmuth is authorized to conduct comparative psychological and physiological studies with captive California sea lions (Zalophus californianus), harbor seals (Phoca vitulina), spotted seals (Phoca largha), ringed seals (Pusa hispida), and bearded seals (Erignathus barbatus) at Long Marine Laboratory (Santa Cruz, CA) and the Alaska SeaLife Center (Seward, AK). Up to four individuals per species may be studied at both facilities combined over the duration of the permit. The permit expires on October 15, 2020.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Dated: January 6, 2016. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-00821 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE400 Endangered Species; File No. 19637 AGENCY:

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

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that Allen Foley, Florida Fish and Wildlife Conservation Commission, Fish and Wildlife Research Institute, 370 Zoo Parkway, Jacksonville, FL 32218, has applied in due form for a permit to take green (Chelonia mydas), loggerhead (Caretta caretta), hawksbill (Eretmochelys imbricata) and Kemp's ridley (Lepidochelys kempii) sea turtles for purposes of scientific research.

    DATES:

    Written, telefaxed, or email comments must be received on or before February 18, 2016.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 19637 from the list of available applications.

    These documents are also available 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.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Arturo Herrera or Amy Hapeman, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested 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 applicant requests a five-year permit to conduct research in Southwest Florida Bay to monitor the abundance of loggerhead and green sea turtles, characterize the aggregations of loggerheads, Kemp's ridleys, and hawksbills, and determine the movements, behaviors, and habitat-use of loggerheads. The research will be late-spring to late-summer (May-August) in southwestern Florida Bay and within the boundaries of the Everglades NP in the vicinity of Arsnicker, Rabbit, and Twin Keys. The applicant expects to approach and count up to 100 green sea turtles annually during vessel surveys and to capture up to 125 loggerheads, 10 Kemp's ridleys, and 5 hawksbills annually. Sea turtles will be captured by hand and the following procedures would be performed before release: Measure, photograph, weigh, flipper tagging, passive integrated transponder tagging, temporary carapace marking, and blood sample. Up to 10 of the loggerheads also would have tumors tissue sampled annually.

    Dated: January 12, 2016. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-00806 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE402 Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The Mid-Atlantic Fishery Management Council (Council) will hold a meeting to develop recreational blueline tilefish catch estimates.

    DATES:

    The meeting will be held on Thursday, February 4, 2016, beginning at 8:30 a.m. For agenda details, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will at the DoubleTree by Hilton Baltimore-BWI Airport; 890 Elkridge Landing Rd, Linthicum Heights, MD 21090.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State Street, Suite 201, Dover, DE 19901; telephone: (302) 674-2331 or on their Web site at www.mafmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.

    SUPPLEMENTARY INFORMATION:

    The Council will host a panel of fishermen to help develop recreational blueline tilefish catch estimates in the Mid-Atlantic. Briefing documents will be posted to http://www.mafmc.org/actions/blueline-tilefish when available. The meeting will begin at 8:30 a.m. and should finish by 5 p.m.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

    Dated: January 13, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-00839 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Marine Recreational Information Program, Access-Point Angler Intercept Survey.

    OMB Control Number: 0648-0659.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 95,000.

    Average Hours Per Response: 5 minutes.

    Burden Hours: 7,917.

    Needs and Uses: This request is for extension of a currently approved information collection.

    Marine recreational anglers are surveyed to collect catch and effort data, fish biology data, and angler socioeconomic characteristics. These data are required to carry out provisions of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.), as amended, regarding conservation and management of fishery resources.

    Marine recreational fishing catch and effort data are collected through a combination of mail surveys, telephone surveys and on-site intercept surveys with recreational anglers. Amendments to the Magnuson-Stevens Fishery Conservation and Management Act (MSA) require the development of an improved data collection program for recreational fisheries. To partially meet these requirements, NOAA Fisheries designed and implemented a new Access-Point Angler Intercept Survey (APAIS) in 2013 to ensure better coverage and representation of recreational fishing activity.

    The APAIS intercepts marine recreational fishers at public-access sites in coastal counties from Maine to Louisiana, Hawaii, and Puerto Rico, to obtain information about the just-completed day's fishing activity. Respondents are asked about the time and type of fishing, the angler's avidity and residence location, and details of any catch of finfish. Species identification, number, and size are collected for any available landed catch. Data collected from the APAIS are used to estimate the catch per angler of recreational saltwater fishers. These APAIS estimates are combined with estimates derived from independent but complementary surveys of fishing effort, the Coastal Household Telephone Survey and the For-Hire Survey, to estimate total, state-level fishing catch, by species, and participation. These estimates are used in the development, implementation, and monitoring of fishery management programs by the NMFS, regional fishery management councils, interstate marine fisheries commissions, and state fishery agencies.

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: January 12, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-00757 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD527 Marine Mammals; File No. 18727 AGENCY:

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

    ACTION:

    Notice; issuance of permit.

    SUMMARY:

    Notice is hereby given that a permit has been issued to University of Alaska Museum of the North, 907 Yukon Drive, Fairbanks, AK 99775-6960 (Aren Gunderson, Responsible Party), to collect, import and export specimens of marine mammals for scientific research.

    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:

    Brendan Hurley or Jennifer Skidmore, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    On Dec 8, 2014, notice was published in the Federal Register (79 FR 72630) that a request for a permit to receive, import, and export specimens of marine mammals for scientific research purposes had been submitted by the above-named applicant. The requested permit has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq.), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq.).

    The permit authorizes the permit holder to (1) import/export marine mammal parts (bones and organ tissue samples) from dead beach-cast carcasses, (2) receive/archive and export samples of marine mammals taken by Alaskan Native subsistence hunters, and (3) receive, import/export specimens from scientists in academic, federal, and state institutions involved in marine mammal research under their own permits. Unlimited samples from up to 2,000 pinnipeds (excluding walrus) and 600 cetaceans would be collected, received, imported, or exported annually. Import/export activities would occur world-wide. No live animals would be harassed or taken, lethally or otherwise, under the requested permit. The permit is valid through December 31, 2020.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    As required by the ESA, issuance of this permit 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 species; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

    Dated: January 13, 2016. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-00857 Filed 1-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Proposed Information Collection; Comment Request; State and Local Implementation Grant Program Reporting Requirements AGENCY:

    National Telecommunications and Information Administration, Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before March 21, 2016.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instruments and instructions should be sent to Michael Dame, Telecommunications Policy Specialist, Office of Public Safety Communications, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4078, Washington, DC 20230 (or via email at [email protected]).

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    The Middle Class Tax Relief and Job Creation Act of 2012 (Act, Pub. L. 112-96, 126 Stat. 156 (2012)) was signed by the President on February 22, 2012. The Act meets a long-standing priority of the Administration, as well as a critical national infrastructure need, to create a single, interoperable, nationwide public safety broadband network (NPSBN) that will, for the first time, allow police officers, fire fighters, emergency medical service professionals, and other public safety officials to effectively communicate with each other across agencies and jurisdictions. Public safety workers have long been hindered in their ability to respond in a crisis situation because of incompatible communications networks and often outdated communications equipment. The Act establishes the First Responder Network Authority (FirstNet) as an independent authority within NTIA and authorizes it to take all actions necessary to ensure the design, construction, and operation of the NPSBN, based on a single, national network architecture.

    FirstNet is responsible for, at a minimum, ensuring nationwide standards for the use of and access to the network; issuing open, transparent, and competitive requests for proposals (RFPs) to build, operate, and maintain the network; encouraging these RFPs to leverage, to the maximum extent economically desirable, existing commercial wireless infrastructure to speed deployment of the network; and overseeing contracts with non-federal entities to build, operate, and maintain the network.

    The Act also charges NTIA with establishing a grant program, the State and Local Implementation Grant Program (SLIGP), to assist state, regional, tribal, and local jurisdictions with identifying, planning, and implementing the most efficient and effective means to use and integrate the infrastructure, equipment, and other architecture associated with the NPSBN to satisfy the wireless broadband and data services needs of their jurisdictions. The SLIGP program office awarded $116.5 million in grant funds to 54 active state and territorial recipients between July 2013 and June 2014.

    Moreover, the Act's framework contemplates that FirstNet will coordinate its activities with state, regional, tribal, and local governments and imposes a statutory requirement that FirstNet consult with these entities as it takes all actions necessary to build, deploy, and operate the NPSBN. Specifically, the Act requires FirstNet to consult with state, regional, tribal, and local governments about the distribution and expenditure of any amounts required to carry out its responsibilities, including: (i) The construction of a core network and any radio access network build-out; (ii) placement of towers; (iii) coverage areas of the network; (iv) adequacy of hardware, security, reliability, and resiliency requirements; (v) assignment of priority to local users and selection of entities seeking network access; and (vi) training needs of local users.

    Additionally, the Act specifies that these required consultations are to occur between FirstNet and the single point of contact that the State was required to designate in its application for grant funds under SLIGP or that the governor has since designated. Thus, progress in meeting FirstNet's responsibilities under the Act, including its required consultations, is inextricably linked to SLIGP. FirstNet must rely on NTIA to utilize SLIGP as the principal means to facilitate its required consultations. At the same time, without funding assistance from SLIGP, the states would lack the resources to consult effectively with FirstNet and provide it with information needed for it to proceed with the design and construction of a NPSBN in an effective and timely manner, as required by the Act.

    To ensure effective grant oversight and management, SLIGP developed a quarterly performance progress report (PPR) form for recipients to complete as part of post-award monitoring throughout the period of performance. The PPRs are critical to the success of the program and provide key insights into how grant funds are being used. Recipients are asked to report on progress toward program priority areas, which include stakeholders engaged, individuals sent to broadband conferences, staff hired, contracts executed, governance meetings held, and outreach materials distributed, as well as financial expenditures by cost category. The original approval of the performance progress report form was obtained on August 1, 2013, and the current form has an expiration date of August 31, 2016. NTIA seeks to extend the approval of this form, with a minor adjustment to the wording on the form to more clearly indicate to recipients how they are to report each measure. Currently the form includes a line for “Stakeholder Meetings,” but this metric is actually intended to capture the number of stakeholders engaged. The SLIGP program office proposes changing the wording to “Stakeholders Engaged.” The SLIGP program office also proposes to change the current line for “Education and Outreach Materials” to “Education and Outreach Materials Distributed.” The proposed minor revisions will not affect the amount of time needed to complete the form; rather, the proposed minor revisions will provide more clarity to recipients and reduce the time needed for revisions. NTIA will use the collection of information to ensure that SLIGP grant recipients are effectively monitored and evaluated against the core purposes of the program established by the Act. The publication of this notice allows NTIA to begin the process to extend the approval for the standard three years.

    II. Method of Collection

    Paper format.

    III. Data

    OMB Control Number: 0660-0038.

    Form Number(s): None.

    Type of Review: Regular submission (extension of a currently approved information collection with a minor adjustment to the form. The minor adjustments will not impact the time needed to complete the form).

    Affected Public: State, regional, local, and tribal government organizations.

    Frequency: Quarterly.

    Number of Respondents: 54.

    Average Time per Response: 12.5 hours.

    Estimated Total Annual Burden Hours: 2,700.

    Estimated Total Annual Cost to Public: $105,246.

    IV. Request for Comments

    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 (including hours and cost) 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 respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they will also become a matter of public record.

    Dated: January 12, 2016. Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2016-00764 Filed 1-15-16; 8:45 am] BILLING CODE 3510-06-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No. CFPB-2016-0001] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, “Generic Information Collection Plan for Information on Compliance Costs and Other Effects of Regulations.”

    DATES:

    Written comments are encouraged and must be received on or before February 18, 2016 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:

    • Electronic: http://www.regulations.gov. Follow the instructions for submitting comments.

    • OMB: Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503 or fax to (202) 395-5806. Mailed or faxed comments to OMB should be to the attention of the OMB Desk Officer for the Bureau of Consumer Financial Protection. Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Documentation prepared in support of this information collection request is available at www.reginfo.gov (this link active on the day following publication of this notice). Select “Information Collection Review,” under “Currently under review, use the dropdown menu “Select Agency” and select “Consumer Financial Protection Bureau” (recent submissions to OMB will be at the top of the list). The same documentation is also available at http://www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435-9575, or email: [email protected] Please do not submit comments to this email box.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Generic Information Collection Plan for Information on Compliance Costs and Other Effects of Regulations.

    OMB Control Number: 3170-0032.

    Type of Review: Extension without change of an existing information collection.

    Affected Public: Private Sector.

    Estimated Number of Annual Respondents: 8,150.

    Estimated Total Annual Burden Hours: 9,008.

    Abstract: The Dodd-Frank Wall Street Reform and Consumer Protection Act requires or authorizes the Consumer Financial Projection Bureau to implement new consumer protections in certain sectors of financial markets, including the mortgage and remittance industries. The information collected is required in order to effectively incorporate information from providers concerning compliance costs and other effects of regulations into potential rulemakings.

    Request for Comments: The Bureau issued a 60-day Federal Register notice on October 29, 2015, (80 FR 66495). Comments were solicited and continue to be invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (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 respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.

    Dated: January 12, 2016. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-00850 Filed 1-15-16; 8:45 am] BILLING CODE 4810-AM-P
    COURT SERVICES AND OFFENDER SUPERVISION AGENCY FOR THE DISTRICT OF COLUMBIA SES Performance Review Board AGENCY:

    Court Services and Offender Supervision Agency for the District of Columbia.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given of the appointment of new members to the Court Services and Offender Supervision Agency (CSOSA) and the Pretrial Services Agency for the District of Columbia (PSA), Senior Executive Service Performance Review Board. PSA is an independent agency within CSOSA. The Performance Review Board assures consistency, stability, and objectivity in the appraisal process.

    DATES:

    Effective: January 25, 2016.

    FOR FURTHER INFORMATION CONTACT:

    William Layne, Assistant Director Human Capital Planning and Executive Resources, Court Services and Offender Supervision Agency, 800 North Capitol Street NW., Suite 700, Washington, DC 20005 (202) 220-5637.

    SUPPLEMENTARY INFORMATION:

    Section 4314(c)(1) through (5) of Title 5 of the United States Code, requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. Section 4314(c)(4) of Title 5 requires that notice of appointment of board members be published in the Federal Register. The Performance Review Board is responsible for making recommendations to the appointing and awarding authority on the performance appraisal ratings and performance awards for the Senior Executive Service employees. Members of the board will serve a 12-month term that shall begin on January 25, 2016. The following executives have been designated as members of the Performance Review Board for CSOSA and PSA:

    James Berry, Deputy Director for CSOSA Leslie Cooper, Deputy Director for PSA Catherine Terry-Crusor, Associate Director for the Office of Operations for PSA Mindy Ginsburg, Deputy Managing Director for the Federal Communications Commission Paul Girardo, Associate Director for the Office of Financial Management for CSOSA Cedric Hendricks, Associate Director of Office of Legislative, Intergovernmental and Public Affairs for CSOSA David Huffer, Associate Director for the Office of Research and Evaluation for CSOSA Reginald James, Associate Director for Management and Administration for CSOSA Clifford Keenan, Director for PSA William Kirkendale, Chief Information Officer for CSOSA Linda Mays, Associate Director of the Office of Human Resources for CSOSA Keith Nakasone, Senior Procurement Executive for the Federal Communications Commission Jasper Ormond, Associate Director for the Community Justice Programs for CSOSA Barry Socks, Chief Operating Officer for the National Capital Planning Commission Sheila Stokes, General Counsel for CSOSA and PSA Authority:

    Section 4314(c)(1) through (5) of Title 5, United States Code

    Dated: January 12, 2016. Diane Bradley, Federal Register Liaison.
    [FR Doc. 2016-00832 Filed 1-15-16; 8:45 am] BILLING CODE 3129-04-P
    DEPARTMENT OF DEFENSE Office of the Secretary Charter Renewal of Department of Defense Federal Advisory Committees AGENCY:

    Department of Defense.

    ACTION:

    Charter Amendment of Federal Advisory Committee.

    SUMMARY:

    The Department of Defense is publishing this notice to announce that it is amending the charter for the National Commission on the Future of the Army (“the Commission”).

    FOR FURTHER INFORMATION CONTACT:

    Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.

    SUPPLEMENTARY INFORMATION:

    This committee's charter is being amended pursuant to Section 1702 of the Carl Levin and Howard P. “Buck” McKeon National Defense Authorization Act for Fiscal Year 2015 (“the FY 2015 NDAA”) (Publ. L. 113-291), as amended by Section 1061 of the National Defense Authorization Act for Fiscal Year 2016 (“the FY 2016 NDAA”) (Pub. L. 114-92), and in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(a).

    Pursuant to section 1061 of the FY 2016 NDAA, Section 10 of FACA shall not apply to a meeting of the Commission unless the meeting is attended by five or more members of the Commission.

    Dated: January 13, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-00829 Filed 1-15-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No. ED-2016-ICCD-0008] Agency Information Collection Activities; Comment Request; Parent Information and School Choice Evaluation AGENCY:

    Institute of Education Sciences (IES), 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 21, 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-2016-ICCD-0008. 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 2E105, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Meredith Bachman, (202) 245-7494.

    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: Parent Information and School Choice Evaluation.

    OMB Control Number: 1850-NEW.

    Type of Review: A new information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 3,525.

    Total Estimated Number of Annual Burden Hours: 2,306.

    Abstract: Sponsored by the Institute of Education Sciences (IES), U.S. Department of Education, the Parent Information and School Choice Evaluation (PISCE) is an important first step toward filling the wide gap in knowledge about how to present school choice information to parents. This research is needed to provide guidance to districts where school choice is expanding. PISCE seeks to identify the format, amount, and organization of information that is most comprehensible and usable to parents. The study will target low-income parents of school-age children and will evaluate perceptions of different presentations of school information. The results of the study will be used to create a reader-friendly guide for school districts.

    IES has contracted with Mathematica Policy Research to conduct the needed research. Most of the experiment will be conducted with members of a standing panel who already complete surveys on a regular basis for a variety of purposes. This approach provides a low-cost and quick turnaround method to obtain findings related to the understandability of school choice information, which does not require respondents to be making actual school choices for their children. To enhance what can be learned from the standing panel, the research team also intends to recruit a sample of low-income parents of school-age children from locations where a public school choice marketplace with unified enrollment has been active for at least two years. Parents who have experienced public school choice or are at least exposed to open enrollment in their district may experience the experiment differently than the standing panel members, for whom considering schools other than one's default neighborhood school may be unfamiliar. This augmented sample of, presumably, less survey-savvy low-income parents will be used to provide a sensitivity check of the findings based on the standing panel alone.

    Dated: January 13, 2016. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-00845 Filed 1-15-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [ED-2015-IES-0100] Privacy Act of 1974; System of Records—Impact Evaluation of Data-Driven Instruction Professional Development for Teachers AGENCY:

    Institute of Education Sciences, Department of Education.

    ACTION:

    Notice of a new system of records; extension of comment period.

    SUMMARY:

    On December 2, 2015, we published in the Federal Register (80 FR 75452) a notice of a new system of records entitled “Impact Evaluation of Data-Driven Instruction Professional Development for Teachers” (#18-13-39). That notice established a 30-day comment period beginning on December 2, 2015, and closing on January 4, 2016. We are extending the public comment period for an additional 30 days, until February 18, 2016.

    DATES:

    We must receive your comments on or before February 18, 2016.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via U.S. mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under the “help” tab.

    U.S. Mail, Commercial Delivery, or Hand Delivery: If you mail or deliver your comments about the proposed system of records, address them to Dr. Audrey Pendleton, U.S. Department of Education, 550 12th Street SW., Suite 4160, Washington, DC 20202.

    Privacy Note: The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Audrey Pendleton, Associate Commissioner, Evaluation Division, National Center for Education Evaluation and Regional Assistance, Institute of Education Sciences, U.S. Department of Education, 555 12th Street SW., Suite 4160, Washington, DC 20202. Telephone: (202) 245-8385.

    If you use a telecommunications device for the deaf or a text telephone, call the Federal Relay Service, toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Due to a technical problem with this particular docket in www.regulations.gov, interested parties were not able to submit comments through www.regulations.gov during the 30-day comment period. Therefore, we are extending the comment period for an additional 30 days to give any interested party an opportunity to submit comments through www.regulations.gov.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the contact person listed under FOR FURTHER INFORMATION CONTACT.

    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 Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at this 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: January 13, 2016. Ruth Curran Neild, Deputy Director for Policy and Research, Delegated Duties of the Director of the Institute of Education Sciences.
    [FR Doc. 2016-00919 Filed 1-15-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-38-001] Kingbird Solar A, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Kingbird Solar A, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 1, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: January 12, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-00810 Filed 1-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2428-007] Aquenergy Systems, LLC; Notice of Application Tendered for Filing With the Commission and Soliciting Additional Study Requests and Establishing Procedural Schedule for Relicensing and a Deadline for Submission of Final Amendments

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: Minor New License.

    b. Project No.: P-2428-007.

    c. Date filed: December 31, 2015.

    d. Applicant: Aquenergy Systems, LLC.

    e. Name of Project: Piedmont Hydroelectric Project.

    f. Location: On the Saluda River, in Anderson and Greenville Counties, South Carolina. The project does not occupy lands of the United States.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).

    h. Applicant Contact: Beth E. Harris, P.E., Regional Operations Manager, Enel Green Power North America, Inc., 11 Anderson St., Piedmont, SC 29674; (864) 846-0042; [email protected]

    i. FERC Contact: Sean Murphy, (202) 502-6145 or [email protected]

    j. Cooperating agencies: Federal, state, local, and tribal agencies with jurisdiction and/or special expertise with respect to environmental issues that wish to cooperate in the preparation of the environmental document should follow the instructions for filing such requests described in item l below. Cooperating agencies should note the Commission's policy that agencies that cooperate in the preparation o