Federal Register Vol. 83, No.49,

Federal Register Volume 83, Issue 49 (March 13, 2018)

Page Range10775-11128
FR Document

83_FR_49
Current View
Page and SubjectPDF
83 FR 10944 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Expand the Short Term Option Series ProgramPDF
83 FR 10946 - Sunshine Act Meetings; Unified Carrier Registration Plan Board of DirectorsPDF
83 FR 10846 - Sunshine Act Meeting NoticePDF
83 FR 10932 - Sunshine Act MeetingsPDF
83 FR 10941 - Corporate Capital Trust, Inc., et al.PDF
83 FR 10845 - Applications for New Awards; Expanding Opportunity Through Quality Charter Schools Program (CSP)-Grants to Charter School Developers for the Opening of New Charter Schools and for the Replication and Expansion of High-Quality Charter SchoolsPDF
83 FR 10814 - Air Plan Approval and Air Quality Designation; SC; Redesignation of the Greenville-Spartanburg Unclassifiable AreaPDF
83 FR 10807 - Fisheries of the Exclusive Economic Zone Off Alaska; Sablefish Managed Under the Individual Fishing Quota ProgramPDF
83 FR 10802 - Atlantic Highly Migratory Species; Commercial Blacktip Sharks, Aggregated Large Coastal Sharks, and Hammerhead Sharks in the Western Gulf of Mexico Sub-Region; ClosurePDF
83 FR 10796 - Air Plan Approval; Ohio; Redesignation of the Delta, Ohio Area to Attainment of the 2008 Lead StandardPDF
83 FR 10783 - Requirements for Insurance; National Credit Union Share Insurance Fund Equity Distributions; CorrectionPDF
83 FR 10842 - Notice of Availability for Finding of No Significant Impact for the Environmental Assessment Addressing Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center Richmond, VirginiaPDF
83 FR 10908 - Notice of Intent To Grant Partially Exclusive Patent LicensePDF
83 FR 10908 - NASA Advisory Council; MeetingPDF
83 FR 10825 - Strengthening Civil Rights ManagementPDF
83 FR 10873 - Notice of Public Meeting for the Eastern Washington Resource Advisory CouncilPDF
83 FR 10874 - Wild Horse and Burro Advisory Board MeetingPDF
83 FR 10872 - Renewal of Approved Information Collection; OMB Control Number 1004-0179 Agency Information Collection Activities; Helium ContractsPDF
83 FR 10784 - Amendment of Restricted AreasR-2907C, R-2910B, R-2910C, andR-2910E; Pinecastle, FLPDF
83 FR 10841 - Proposed Collection; Comment RequestPDF
83 FR 10942 - Nationwide Fund Advisors and ETF Series SolutionsPDF
83 FR 10945 - Notice of Availability of Categorical Exclusion and Record of Decision for Ontario International Airport JCKIE ONE RNAV Arrival ProcedurePDF
83 FR 10944 - Determination Under the Foreign Assistance Act of 1961 for Assistance for IraqPDF
83 FR 10843 - Arms Sales NotificationPDF
83 FR 10948 - Proposed Information Collections; Comment Request (No. 68)PDF
83 FR 10823 - Submission for OMB Review; Comment RequestPDF
83 FR 10929 - Excepted Service; November 2017PDF
83 FR 10928 - Submission for Review: Evidence To Prove Dependency of a Child, RI 25-37PDF
83 FR 10903 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Voluntary Protection Program InformationPDF
83 FR 10775 - National Organic Program (NOP); Organic Livestock and Poultry PracticesPDF
83 FR 10841 - Endangered and Threatened Species; Take of Anadromous FishPDF
83 FR 10824 - Submission for OMB Review; Comment RequestPDF
83 FR 10838 - Foreign-Trade Zone (FTZ) 61-San Juan, Puerto Rico; Notification of Proposed Production Activity, Janssen Ortho LLC (Pharmaceuticals), Gurabo, Puerto RicoPDF
83 FR 10839 - Foreign-Trade Zone 138-Franklin County, Ohio; Application for Subzone; International Converter, Inc., Caldwell, OhioPDF
83 FR 10839 - Stainless Steel Butt-Weld Pipe Fittings From Italy: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017PDF
83 FR 10876 - Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; Decision and OrderPDF
83 FR 10809 - Airworthiness Directives; Viking Air Limited AirplanesPDF
83 FR 10785 - Allocation of Mortgage Insurance Premiums; CorrectionPDF
83 FR 10853 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 10852 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
83 FR 10829 - Notice of Solicitation of Applications for the Rural Energy for America Program for Federal Fiscal Year 2018PDF
83 FR 10828 - Information Collection: Generic Clearance for Social Science and Economics Data Collections on Goods, Services, and Jobs Provided by Forests and Natural AreasPDF
83 FR 10945 - Agency Information Collection Activities; Renewal of an Approved Information Collection: Motor Carrier Records Change FormPDF
83 FR 10826 - Information Collection: Generic Clearance for Social Science and Economics Data Collections on Natural Disasters and DisturbancesPDF
83 FR 10827 - Information Collection: Generic Clearance for Social Science and Economics Data Collections on Natural Resource Planning and Collaborative ConservationPDF
83 FR 10950 - Exchange of CoinPDF
83 FR 10946 - Hours of Service of Drivers: Electronic Logging Devices; Application for Exemption; Truck Renting and Leasing Association, Inc.PDF
83 FR 10853 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
83 FR 10905 - Petitions for Modification of Application of Existing Mandatory Safety StandardsPDF
83 FR 10909 - National Council on the Arts 193rd MeetingPDF
83 FR 10855 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Utilization of Adequate Provision Among Low to Non-Internet UsersPDF
83 FR 10862 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Transfer of a Premarket NotificationPDF
83 FR 10864 - Agency Information Collection Activities: Proposed Collection; Comment Request; Threat and Hazard Identification and Risk Assessment (THIRA)-Stakeholder Preparedness Review (SPR) Reporting ToolPDF
83 FR 10904 - Affirmative Decisions on Petitions for Modification Granted in Whole or in PartPDF
83 FR 10846 - Combined Notice of FilingsPDF
83 FR 10848 - Records Governing Off-the-Record Communications; Public NoticePDF
83 FR 10849 - Combined Notice of Filings #1PDF
83 FR 10855 - Final National Occupational Research Agenda for Transportation, Warehousing and UtilitiesPDF
83 FR 10927 - Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Pipe Rupture Hazard and Flooding AnalysisPDF
83 FR 10911 - Withdrawal of Regulatory Issue Summary 2012-10, “NRC Staff Position on Applying Surveillance Requirements 3.0.2 and 3.0.3 to Administrative Controls Program Tests”PDF
83 FR 10801 - Revise and Streamline VA Acquisition Regulation To Adhere to Federal Acquisition Regulation Principles (VAAR Case 2014-V002); CorrectionPDF
83 FR 10951 - Special Medical Advisory Group, Notice of MeetingPDF
83 FR 10868 - Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection; Application for Travel Document (Carrier Documentation)PDF
83 FR 10950 - Notice of OFAC Sanctions ActionsPDF
83 FR 10937 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Amendment No. 3 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment Nos. 1, 2, and 3, To Adopt the Midpoint Extended Life OrderPDF
83 FR 10837 - Notice of Public Meeting of the Montana Advisory Committee to the U.S. Commission on Civil RightsPDF
83 FR 10837 - Notice of Public Meeting of the Montana Advisory CommitteePDF
83 FR 10838 - Notice of Public Meeting of the Alabama Advisory Committee To Discuss the Hearing on Access to Voting in the State of Alabama, Which Was Held in Montgomery, Alabama on February 22, 2018PDF
83 FR 10864 - Center for Substance Abuse Treatment; Notice of MeetingPDF
83 FR 10803 - Fisheries of the Northeastern United States; Framework 2 to the Tilefish Fishery Management PlanPDF
83 FR 10875 - Laminated Woven Sacks From Vietnam; Institution of Anti-Dumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase InvestigationsPDF
83 FR 10875 - Fine Denier Polyester Staple Fiber From China and India; DeterminationsPDF
83 FR 10811 - Disclosure of Returns and Return Information in Connection With Written Contracts or Agreements for the Acquisition of Property or Services for Tax Administration PurposesPDF
83 FR 10865 - Agency Information Collection Activities: Homeland Security Acquisition Regulation (HSAR) Solicitation of Proposal Information for Award of Public ContractsPDF
83 FR 10800 - Wireless Emergency Alerts; Emergency Alert System; CorrectionPDF
83 FR 10786 - Safety Zone; Tennessee River, Huntsville, ALPDF
83 FR 10785 - Drawbridge Operation Regulation; Duwamish Waterway, Seattle, WAPDF
83 FR 10934 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Adopt a New NYSE Arca Rule 8.900-E and To List and Trade Shares of the Royce Pennsylvania ETF, Royce Premier ETF, and Royce Total Return ETF Under Proposed NYSE Arca Equities Rule 8.900-EPDF
83 FR 10935 - Self-Regulatory Organizations; Miami International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee SchedulePDF
83 FR 10933 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Transaction Fees at Rule 7014 To Eliminate the Small Cap Incentive Program and the Limit Up Limit Down Pricing ProgramPDF
83 FR 11098 - Self-Regulatory Organizations; NYSE National, Inc.; Notice of Filing of Proposed Rule Change To Support the Re-Launch of the Exchange on the Pillar Trading PlatformPDF
83 FR 10863 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed MeetingsPDF
83 FR 10909 - Meetings of Humanities PanelPDF
83 FR 10869 - Endangered Species Recovery Permit ApplicationsPDF
83 FR 10850 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0022 and -0027)PDF
83 FR 10944 - 60-Day Notice of Proposed Information Collection: Statement Regarding a Lost or Stolen U.S. Passport Book and/or CardPDF
83 FR 10949 - Proposed Collection of Information: Schedule of Excess RisksPDF
83 FR 10863 - Office of the Director, National Institutes of Health; Notice of MeetingPDF
83 FR 10852 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
83 FR 10800 - Connect America FundPDF
83 FR 10788 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the Regulatory Definition of Volatile Organic CompoundPDF
83 FR 10791 - Approval and Promulgation of Air Quality Implementation Plans; Virginia; Removal of Clean Air Interstate Rule (CAIR) Trading ProgramsPDF
83 FR 10813 - Air Plan Approval; Tennessee: Volatile Organic CompoundsPDF
83 FR 10911 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
83 FR 10867 - Agency Information Collection Activities; Revision of a Currently Approved Collection: Notice of Entry of Appearance as Attorney or Accredited Representative; Notice of Entry of Appearance as Attorney in Matters Outside the Geographical Confines of the United StatesPDF
83 FR 10817 - Comprehensive Review of the Uniform System of Accounts; Jurisdictional Separations and Referral to the Federal-State Joint BoardPDF
83 FR 10954 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to the U.S. Navy Training and Testing Activities in the Atlantic Fleet Training and Testing Study AreaPDF

Issue

83 49 Tuesday, March 13, 2018 Contents Agricultural Marketing Agricultural Marketing Service RULES National Organic Program: Organic Livestock and Poultry Practices, 10775-10783 2018-05029 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Forest Service

See

Rural Business-Cooperative Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10823-10825 2018-04982 2018-05026 2018-05033 Strengthening Civil Rights Management, 10825-10826 2018-05051
Alcohol Tobacco Tax Alcohol and Tobacco Tax and Trade Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10948-10949 2018-05034 Army Army Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10841-10842 2018-05040 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10853-10855 2018-05000 Final National Occupational Research Agenda for Transportation, Warehousing and Utilities, 10855 2018-04988 Civil Rights Civil Rights Commission NOTICES Meetings: Alabama Advisory Committee, 10838 2018-04976 Montana Advisory Committee, 10837-10838 2018-04977 2018-04978 Coast Guard Coast Guard RULES Drawbridge Operations: Duwamish Waterway, Seattle, WA, 10785-10786 2018-04966 Safety Zones: Tennessee River, Huntsville, AL, 10786-10788 2018-04968 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Defense Department Defense Department See

Army Department

NOTICES Arms Sales, 10843-10845 2018-05035 Environmental Assessments; Availability, etc.: Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center Richmond, VA, 10842-10843 2018-05055
Drug Drug Enforcement Administration NOTICES Decisions and Orders: Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy, 10876-10903 2018-05020 Education Department Education Department NOTICES Applications for New Awards: Expanding Opportunity Through Quality Charter Schools Program—Grants to Charter School Developers for the Opening of New Charter Schools, etc.; Correction, 10845-10846 2018-05061 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Ohio; Redesignation of the Delta, Ohio Area to Attainment of the 2008 Lead Standard, 10796-10800 2018-05057 Virginia; Removal of Clean Air Interstate Rule Trading Programs, 10791-10796 2018-04935 Virginia; Revisions to the Regulatory Definition of Volatile Organic Compound, 10788-10791 2018-04937 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: South Carolina; Redesignation of the Greenville-Spartanburg Unclassifiable Area, 10814-10816 2018-05060 Tennessee; Volatile Organic Compounds, 10813-10814 2018-04932 Federal Aviation Federal Aviation Administration RULES Restricted Areas; Amendments: R-2907C, R-2910B, R-2910C, and R-2910E, Pinecastle, FL, 10784-10785 2018-05041 PROPOSED RULES Airworthiness Directives: Viking Air Limited Airplanes, 10809-10811 2018-05012 NOTICES Categorical Exclusions and Records of Decisions: Ontario International Airport JCKIE ONE RNAV Arrival Procedure, 10945 2018-05037 Federal Communications Federal Communications Commission RULES Connect America Fund, 10800-10801 2018-04945 Wireless Emergency Alerts: Emergency Alert System; Correction, 10800 2018-04969 PROPOSED RULES Comprehensive Review of the Uniform System of Accounts; Jurisdictional Separations and Referral to the Federal-State Joint Board, 10817-10822 2018-04563 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 10850-10852 2018-04957 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Threat and Hazard Identification and Risk Assessment-Stakeholder Preparedness Review Reporting Tool, 10864-10865 2018-04994 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 10846, 10849-10850 2018-04989 2018-04991 Meetings; Sunshine Act, 10846-10848 2018-05103 Records Governing Off-the-Record Communications, 10848-10849 2018-04990 Federal Motor Federal Motor Carrier Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Motor Carrier Records Change Form, 10945-10946 2018-05005 Hours of Service of Drivers; Exemption Applications: Electronic Logging Devices; Truck Renting and Leasing Association, Inc., 10946-10948 2018-05001 Meetings; Sunshine Act, 10946 2018-05152 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 10852-10853 2018-04953 2018-05009 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 10852 2018-04952 Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies, 10853 2018-05010 Fiscal Fiscal Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Schedule of Excess Risks, 10949-10950 2018-04955 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Species: Recovery Permit Applications, 10869-10872 2018-04959 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Transfer of a Premarket Notification, 10862-10863 2018-04995 Utilization of Adequate Provision Among Low to Non-Internet Users, 10855-10862 2018-04996 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 10950 2018-04981 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Janssen Ortho LLC, Foreign-Trade Zone 61, San Juan, PR, 10838-10839 2018-05025 Subzone Applications: International Converter, Inc.; Foreign-Trade Zone 138; Franklin County, OH, 10839 2018-05024 Forest Forest Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for Social Science and Economics Data Collections on Goods, Services, and Jobs Provided by Forests and Natural Areas, 10828-10829 2018-05006 Generic Clearance for Social Science and Economics Data Collections on Natural Disasters and Disturbances, 10826-10827 2018-05004 Generic Clearance for Social Science and Economics Data Collections on Natural Resource Planning and Collaborative Conservation, 10827-10828 2018-05003 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Citizenship and Immigration Services

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Homeland Security Acquisition Regulation (HSAR) Solicitation of Proposal Information for Award of Public Contracts, 10865-10867 2018-04970
Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

Internal Revenue Internal Revenue Service RULES Allocation of Mortgage Insurance Premiums; Correction, 10785 2018-05011 PROPOSED RULES Disclosure of Returns and Return Information in Connection with Written Contracts or Agreements for the Acquisition of Property or Services for Tax Administration Purposes, 10811-10813 2018-04971 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Stainless Steel Butt-Weld Pipe Fittings from Italy, 10839-10841 2018-05022 International Trade Com International Trade Commission NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Laminated Woven Sacks from Vietnam, 10875-10876 2018-04973 Investigations; Determinations, Modifications, and Rulings, etc.: Fine Denier Polyester Staple Fiber from China and India, 10875 2018-04972 Justice Department Justice Department See

Drug Enforcement Administration

Labor Department Labor Department See

Mine Safety and Health Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Voluntary Protection Program Information, 10903-10904 2018-05030
Land Land Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Helium Contracts, 10872-10873 2018-05044 Meetings: Eastern Washington Resource Advisory Council, 10873-10874 2018-05048 Wild Horse and Burro Advisory Board, 10874 2018-05046 Mine Mine Safety and Health Administration NOTICES Petitions for Modifications: Application of Existing Mandatory Safety Standards, 10905-10908 2018-04998 Certain Mine Operator, 10904-10905 2018-04992 NASA National Aeronautics and Space Administration NOTICES Intent to Grant Partially Exclusive Patent License, 10908 2018-05054 Meetings: Advisory Council, 10908-10909 2018-05053 National Credit National Credit Union Administration RULES Requirements for Insurance: National Credit Union Share Insurance Fund Equity Distributions; Correction, 10783-10784 2018-05056 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: National Council on the Arts, 10909 2018-04997 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

NOTICES Meetings: Humanities Panel, 10909-10911 2018-04960
National Institute National Institutes of Health NOTICES Meetings: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 10863-10864 2018-04961 Office of the Director, 10863 2018-04954 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Commercial Blacktip Sharks, Aggregated Large Coastal Sharks, and Hammerhead Sharks in the western Gulf of Mexico Sub-Region; Closure, 10802-10803 2018-05058 Fisheries of the Exclusive Economic Zone off Alaska: Sablefish Managed Under the Individual Fishing Quota Program, 10807-10808 2018-05059 Fisheries of the Northeastern United States: Framework 2 to the Tilefish Fishery Management Plan, 10803-10807 2018-04974 PROPOSED RULES Takes of Marine Mammals Incidental to Specified Activities: U.S. Navy Training and Testing Activities in the Atlantic Fleet Training and Testing Study Area, 10954-11096 2018-04517 NOTICES Permits: Endangered and Threatened Species; Take of Anadromous Fish, 10841 2018-05027 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Exemption and Combined Licenses; Amendments: Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Pipe Rupture Hazard and Flooding Analysis, 10927-10928 2018-04987 Facility Operating and Combined Licenses: Applications and Amendments Involving No Significant Hazards Considerations; Biweekly Notice, 10911-10927 2018-04827 NRC Staff Position on Applying Surveillance Requirements 3.0.2 and 3.0.3 to Administrative Controls Program Tests; Withdrawal, 10911 2018-04986 Personnel Personnel Management Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evidence to Prove Dependency of a Child, 10928-10929 2018-05031 Excepted Service, 10929-10932 2018-05032 Rural Business Rural Business-Cooperative Service NOTICES Requests for Applications: Rural Energy for America Program for Federal Fiscal Year 2018, 10829-10836 2018-05008 Securities Securities and Exchange Commission NOTICES Applications: Corporate Capital Trust, Inc., et al., 10941-10942 2018-05072 Nationwide Fund Advisors and ETF Series Solutions, 10942-10944 2018-05039 Meetings; Sunshine Act, 10932-10933 2018-05098 Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange, LLC, 10944 C1--2018--03306 Miami International Securities Exchange, LLC, 10935-10936 2018-04964 Nasdaq Stock Market, LLC, 10933-10934 2018-04963 NYSE Arca, Inc., 10934-10935 2018-04965 NYSE National, Inc., 11098-11128 2018-04962 The Nasdaq Stock Market, LLC, 10937-10941 2018-04979 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Statement Regarding a Lost or Stolen U.S. Passport Book and/or Card, 10944-10945 2018-04956 Assistance for Iraq, 10944 2018-05036 Substance Substance Abuse and Mental Health Services Administration NOTICES Meeings: Center for Substance Abuse Treatment, 10864 2018-04975 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

Treasury Treasury Department See

Alcohol and Tobacco Tax and Trade Bureau

See

Fiscal Service

See

Foreign Assets Control Office

See

Internal Revenue Service

See

United States Mint

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Travel Document (Carrier Documentation), 10868-10869 2018-04983 Entry of Appearance as Attorney or Accredited Representative; Notice of Entry of Appearance as Attorney in Matters Outside the Geographical Confines of the United States, 10867-10868 2018-04586 U.S. Mint United States Mint NOTICES Exchange of Coin, 10950 2018-05002 Veteran Affairs Veterans Affairs Department RULES Revise and Streamline VA Acquisition Regulation to Adhere to Federal Acquisition Regulation Principles; Correction, 10801 2018-04985 NOTICES Meetings: Special Medical Advisory Group, 10951 2018-04984 Separate Parts In This Issue Part II Commerce Department, National Oceanic and Atmospheric Administration, 10954-11096 2018-04517 Part III Securities and Exchange Commission, 11098-11128 2018-04962 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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83 49 Tuesday, March 13, 2018 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [Document Number AMS-NOP-15-0012; NOP-15-06] RIN 0581-AD75 National Organic Program (NOP); Organic Livestock and Poultry Practices AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule; withdrawal.

SUMMARY:

This final rule withdraws the Organic Livestock and Poultry Practices final rule published in the Federal Register on January 19, 2017, by the U.S. Department of Agriculture's Agricultural Marketing Service. The existing organic livestock and poultry regulations remain effective.

DATES:

Effective May 13, 2018, the final rule published January 19, 2017, at 82 FR 7042, delayed February 9, 2017, at 82 FR 9967, further delayed May 10, 2017, at 82 FR 21677, and further delayed November 14, 2017, at 82 FR 52643, is withdrawn.

FOR FURTHER INFORMATION CONTACT:

Paul Lewis, Ph.D., Director, Standards Division, Telephone: (202) 720-3252; Fax: (202) 720-7808.

SUPPLEMENTARY INFORMATION: I. Background

The Organic Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522), authorizes the United States Department of Agriculture (USDA or Department) to establish national standards governing the marketing of certain agricultural products as organically produced to assure consumers that organically produced products meet a consistent standard and to facilitate interstate commerce in fresh and processed food that is organically produced. USDA's Agricultural Marketing Service (AMS) administers the National Organic Program (NOP) under 7 CFR part 205.

II. Overview of Agency Action

USDA is withdrawing the OLPP rule based on its current interpretation of 7 U.S.C. 6905, under which the OLPP final rule would exceed USDA's statutory authority. Withdrawal of the OLPP rule also is independently justified based upon USDA's revised assessments of its benefits and burdens and USDA's view of sound regulatory policy. This is considered a deregulatory action under Executive Order 13771. The organic livestock and poultry regulations now published at 7 CFR part 205 remain effective.

III. Related Documents

Documents related to this final rule include: OFPA (7 U.S.C. 6501-6524) and its implementing regulations (7 CFR part 205); the OLPP proposed rule published in the Federal Register on April 13, 2016 (81 FR 21956); the OLPP final rule published in the Federal Register on January 19, 2017 (82 FR 7042); the final rule delaying the OLPP final rule's effective date until May 19, 2017, published in the Federal Register on February 9, 2017 (82 FR 9967); the final rule delaying the OLPP final rule's effective date until November 14, 2017, published in the Federal Register on May 10, 2017 (82 FR 21677); a second proposed rule presenting the four options for agency action listed in Section I, supra, published in the Federal Register on May 10, 2017 (82 FR 21742); a final rule further delaying the OLPP final rule's effective date until May 14, 2018, published in the Federal Register on November 14, 2017 (82 FR 52643); and a proposed rule explaining AMS' intent to withdraw the OLPP final rule, published in the Federal Register on December 18, 2017 (82 FR 59988).

IV. Public Comments

AMS received approximately 72,000 comments on the proposal to withdraw the OLPP final rule. The majority of comments, over 63,000, opposed the withdrawal of that final rule. This included over 56,000 comments submitted as form letters. Approximately fifty comments supported withdrawal of the OLPP final rule. This included five comments submitted as form letters. The remaining comments, about 7,800, did not state a clear opinion about the proposed withdrawal of the rule.

Commenters opposing withdrawal included consumers, organic farmers, organic handlers, organizations representing animal welfare, environmental, or farming interests, trade associations, certifying agents and inspectors, and retailers. These commenters expressed the view that the OFPA provides AMS the legal authority to implement the OLPP final rule and that withdrawal violates the Administrative Procedure Act and/or the OFPA, because AMS did not consult with the National Organic Standards Board. These commenters asserted that the organic sector requested the OLPP regulation and the rulemaking reflects consensus within the organic sector and a working public-private partnership with years of input from stakeholders. A number of commenters also opposed withdrawal because of potential negative impacts for the welfare of farm animals.

Some commenters opposing the withdrawal also challenged the Preliminary Regulatory Impact Analysis (PRIA, published December 18, 2017 at https://www.regulations.gov/document?D=AMS-NOP-15-0012-6687) for the withdrawal of the OLPP final rule. These commenters claimed that (1) organic certification is voluntary and, therefore, there are no costs associated with the OLPP final rule, (2) economic considerations are not a legally permissible basis for withdrawing the OLPP final rule and are irrelevant because OFPA is not a cost-benefit statute, and (3) the PRIA failed to consider qualitative benefits.

Some comments objected to AMS' conclusion that there is no significant market failure to justify this rulemaking and stated that consumer deception caused by inconsistent application of outdoor access requirements for poultry is the market failure that OFPA prevents by compelling AMS to develop consistent standards. These commenters argued that withdrawal of the OLPP final rule would erode consumer confidence and trust in the organic label. Commenters also requested an extension of the public comment period, from 30 to 90 days, specifically noting they needed more time to study the revisions discussed in the Preliminary Regulatory Impact Analysis (PRIA) and develop meaningful comments.

Commenters supporting withdrawal of the OLPP final rule included organic farmers, state departments of agriculture, and trade associations. These commenters agreed that the OLPP final rule exceeded the scope of authority granted to AMS through OFPA to regulate specific animal health care practices. These commenters stated that withdrawing the OLPP final rule would prevent increased costs to producers and consumers from costly structural changes and higher prices for organic eggs, respectively. Some commenters also supported the withdrawal because of concerns that the outdoor access requirements for organic poultry would heighten disease risk and interfere with biosecurity practices and Food and Drug Administration (FDA) requirements.

V. Rationale for Withdrawing Organic Livestock and Poultry Practices Final Rule A. Statutory Authority

In the notice of proposed rulemaking (NPRM), AMS proposed to withdraw the OLPP Rule due to a lack of statutory authority and to maintain consistency with USDA regulatory policy principles. The proposal stated that “the relevant language and context suggests OFPA's reference to additional regulatory standards `for the care' of organically produced livestock should be limited to health care practices similar to those specified by Congress in the statute, rather than expanded to encompass stand-alone animal welfare concerns. 7 U.S.C. 6509(d)(2).” The NPRM included a detailed analysis of the relevant legal authorities leading to the proposed action. (82 FR 59989-90).

AMS received approximately fifteen comments directly addressing AMS' proposed interpretation, of which three agreed with AMS' interpretation that OFPA does not provide statutory authority for the OLPP final rule. After reviewing these comments, AMS maintains its interpretation that OFPA does not provide authority for the OLPP final rule and has decided to withdraw it. Consequently, the existing organic livestock and poultry regulations now published at 7 CFR part 205 remain effective.

1. Analysis of Its Authority Under the OFPA To Issue Stand-Alone Animal Welfare Regulations

The OLPP final rule consisted, in large part, of rules clarifying how producers and handlers participating in the National Organic Program must treat livestock and poultry to ensure their wellbeing (82 FR 7042). AMS is withdrawing the OLPP final rule because it now believes OFPA does not authorize the animal welfare provisions of the OLPP final rule. Rather, the agency's current reading of the statute, given the relevant language and context, is that OFPA's reference in 7 U.S.C. 6509(d)(2) to additional regulatory standards “for the care” of organically produced livestock does not encompass stand-alone concerns about animal welfare, but rather is limited to practices that are similar to those specified by Congress in the statute and necessary to meet congressional objectives outlined in 7 U.S.C. 6501.

USDA believes that the Department's power to act and how it may act are authoritatively prescribed by statutory language and context; USDA believes that it may not lawfully regulate outside the boundaries of legislative text.1 Therefore, in considering the scope of its lawful authority, USDA believes the threshold question should be whether Congress has authorized the proposed action. If a statute is silent or ambiguous with respect to a specific issue, then USDA believes that its interpretation is entitled to deference and the question becomes simply whether USDA's action is based on a permissible statutory construction.2

1City of Arlington v. FCC, 133 S. Ct. 1863, 1868 (2013).

2See Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837, 843 (1984); City of Arlington, 133 S. Ct. at 1871.

The OLPP final rule is a broadly prescriptive animal welfare regulation (82 FR 7042, 7074, 7082). USDA's general OFPA implementing authority was used as justification for the OLPP final rule, which cited 7 U.S.C. 6509(g) as “convey(ing) the intent for the USDA to develop more specific standards. . . .” (82 FR 7043), and 7 U.S.C. 6509(d)(2) as authorizing regulations for animal “wellbeing” and the “care of livestock.” (82 FR 7042, 7074, 7082).

But nothing in section 6509 authorizes the broadly prescriptive, stand-alone animal welfare regulations contained in the OLPP final rule. Rather, section 6509 outlines discrete aspects of animal production practices and materials relevant to organic certification: sources of breeder stock, livestock feed, use of hormones and growth promoters, animal health care, and record-keeping. While subsection 6509(d)(2) authorizes promulgation of additional standards for the “care” of livestock, that provision is not free-standing authority for AMS to adopt any regulation conceivably related to animal “care”; rather, standards promulgated under that authority must be relevant to “ensur[ing] that [organic] livestock is organically produced.” 7 U.S.C. 6509(d)(2). Similarly, section 6509(g) is not open-ended authority to regulate any and all aspects of livestock production; rather, it authorizes AMS to promulgate regulations to “guide the implementation of the standards for livestock products provided under this section” (emphasis added); in other words, standards relevant to and necessitated by the expressed purposes of Congress in enacting the OFPA. Thus, standards promulgated pursuant to section 6509(d)(2) and section 6509(g) must be relevant to ensuring that livestock is “organically produced.”

Although Congress did not define the term “organically produced” in the OFPA, the Cambridge Dictionary defines “organic” as “not using artificial chemicals in the growing of plans and animals for food and other products.” Merriam-Webster defines “organic” as “of, relating to, yielding, or involving the use of food produced with the use of feed or fertilizer of plant or animal origin without employment of chemically formulated fertilizers, growth stimulants, antibiotics, or pesticides” (emphasis added). https://www.merriam-webster.com/dictionary/organic. The surrounding provisions in section 6509 demonstrate that Congress had a similar understanding of the term “organic.” For example, subsection 6509(d)(2)'s authority for promulgation of additional standards governing animal “care” is contained within a subsection entitled “Health care” and follows a list of three specifically prohibited health care practices that each relate to ingestion or administration of chemical, synthetic, or non-naturally-occurring substances: Use of subtherapeutic doses of antibiotics; routine use of synthetic internal parasiticides; and administration of medication, other than vaccines, absent illness. AMS believes these prohibited practices—all of which relate to ingestion of chemical, artificial, or non-organic substances—are representative of the types of practices and standards that Congress intended to limit exposure of animals to non-organic substances and thus “ensure that [organic] livestock is organically produced.” Thus, the authority provided by section 6509(d)(2) does not extend to any and all aspects of animal “care”; it is limited to those aspects of animal care that are similar to the examples provided in the statue and relate to ingestion or administration of non-organic substances, thus tracking the purposes of the OFPA.

Reading this language in context, AMS now believes that the authority granted in section 6509(d)(2) and section 6509(g) for the Secretary to issue additional regulations fairly extends only to those aspects of animal care that are similar to those described in section 6509(d)(1)—i.e., relate to the ingestion or administration of non-organic substances, thus tracking the purposes of the OFPA—and that are shown to be necessary to meet the congressional objectives specified in 7 U.S.C. 6501.

AMS finds that its rulemaking authority in section 6509(d)(2) should not be construed in isolation, but rather should be interpreted in light of section 6509(d)(1) and section 6509(g). Furthermore, AMS believes that a decision to withdraw the OLPP final rule based on § 6509's language, titles, and position within Chapter 94 of Title 7 of the United States Code; 3 controlling Supreme Court authorities; and general USDA regulatory policy, would be a permissible statutory construction.

2. Public Comments on AMS' Analysis

a. One commenter said that “Agency reconsideration of a rule . . . [previously] approved by the agency and the Office of Management and Budget under a previous administration is arbitrary, capricious, and an abuse of discretion.” Others suggested that the agency's prior consideration of “animal welfare” was binding and dispositive. However, AMS has broad discretion to reconsider a regulation at any time. Clean Air Council v. Pruitt, 862 F.3d 1, 8-9 (D.C. Cir. 2017). Furthermore, AMS' interpretation of OFPA “is not instantly carved in stone,” but may be evaluated “on a continuing basis.” Chevron U.S.A. Inc. v. NRDC, Inc., 467 U.S. 837, 863-64 (1984). This is true when, as is the case here, the agency's review is undertaken in response to a change in administrations. National Cable & Telecommunications Ass'n v. Brand X Internet Services, 545 U.S. 967, 981 (2005).

b. AMS sought comment on the proposed construction of its rulemaking authority, suggesting that the relevant OFPA text did not authorize the broadly prescriptive, stand-alone animal welfare regulations in the OLPP final rule, and noting that, even if OFPA were deemed to be silent or ambiguous with respect to the authority issue, a decision to withdraw the OLPP final rule based on section 6509's language, titles, and position within Chapter 94 of Title 7 of the United States Code; relevant legal authorities; and general USDA regulatory policy, would be a permissible statutory construction. AMS was led to this position by the Supreme Court's admonition that it may properly exercise discretion only in the interstices created by statutory silence or ambiguity and that it must always give effect to the unambiguously expressed intent of Congress.4

4See generally Utility Air Regulatory Group v. Environmental Protection Agency, 134 S. Ct. 2427, 2441, 2445-46 (2014) (citations omitted).

The U.S. Supreme Court established the legal standard for review for an agency's interpretation of a statute that it administers in Chevron, 467 U.S. at 842-43:

First, always, is the question whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute.

Several commenters challenged the proposed action based on an expansive construction of the statutory term “care” largely divorced from the surrounding context of the OFPA. This interpretation would suggest that Congress delegated the Secretary virtually un-cabined regulatory authority over organic livestock producers.

Under City of Arlington v. FCC, 569 U.S. 290 (2013), the Supreme Court held that the Chevron framework applies to an agency's interpretation of ambiguous statutory language concerning the scope of its authority. Id. at 302 (“[W]e have consistently held `that Chevron applies to cases in which an agency adopts a construction of a jurisdictional provision of a statute it administers.' 1 R. Pierce, Administrative Law Treatise § 3.5, p. 187 (2010).”). While the regulations in City of Arlington were based on an expansive construction of statutory authority, AMS is aware of no reason, and commenters cited none, suggesting deference is limited to interpretations of expansive authority. Rather, the City of Arlington decision is not a one-way ratchet; and an agency would also be entitled to deference when it interprets the scope of its authority narrowly.

Some commenters also stated that certain parts of the OLPP Rule do relate to animal health care, such as provisions concerning physical alterations. OFPA does not define the terms “care,” “health care,” “welfare,” or “wellbeing.” Accordingly, some commenters rejected the contextual construction adopted by AMS to argue that the reference in section 6509(d)(2) to additional standards “for the care of livestock to ensure that such livestock is organically produced” necessarily encompasses the statutory authority to issue stand-alone animal welfare regulations because animal health and welfare are “inextricably linked.” This requires an expansive interpretation of the direction to the National Organic Standards Board (NOSB) to “recommend to the Secretary standards in addition to those in paragraph (1) for the care of livestock” in 7 U.S.C. 6509(d)(2) to encompass stand-alone animal welfare standards. However, the regulatory authority conferred by subparagraph (d)(2) does not extend to all aspects of animal care, but rather is limited to those necessary to “ensure that such livestock is organically produced.”

Moreover, subparagraph (d)(2) specifically refers back to subparagraph (d)(1) when calling for standards of livestock care in addition to the prohibitions set forth in subparagraph (d)(1). This demonstrates that any additional standards promulgated pursuant to section (d)(2) are to be similar to those set forth in section (d)(1), all of which are related to ensuring that organic livestock is raised with minimal administration of chemical and synthetic substances. That subparagraph's reference to “care for livestock” cannot be read more expansively than the previous references to animal health care found in section 6509 generally. Thus, even if some aspects of the OLPP Rule—such as certain provisions pertaining to physical alterations—can be characterized as relating to “health care,” AMS finds that they are not related to the OFPA's overarching purpose of regulating the use of chemical and synthetic substances in organic farming. Therefore, section 6509 does not provide authority for those provisions. AMS notes that some commenters agree with this interpretation of section 6509(d).

c. Several commenters also cited certain passages from OFPA's legislative history that they claim demonstrate Congress' intention to give the Secretary authority to regulate the stand-alone welfare of organic livestock, but they either misinterpret or selectively quote the legislative history. Specifically, the commenters noted that Senate Report 101-357, which accompanied S. 2830, the Food, Agriculture, Conservation, and Trade Act of 1990, states, “[t]he Committee expects that, after due consideration and the reception of public comment, the [National Organic Standards Board or NOSB] will best determine the necessary balance between the goal of restricting livestock medications and the need to provide humane conditions for livestock rearing.” The commenters suggest that this reference to “the need to provide humane conditions for livestock rearing” is proof that OFPA authorizes USDA to promulgate wide-ranging animal welfare regulations for organic livestock to ensure “humane conditions for livestock rearing.”

However, this statement actually states that the NOSB is to weigh the fact that administering certain livestock medications to livestock may disqualify said livestock from claiming organic status against the fact that withholding these medications in order to claim organic status may in fact be inhumane; it does not direct or authorize the Secretary to issue regulations to promote animal welfare by ensuring that organic livestock are reared humanely. In other words, the Senate Report does not equate organic production with humane treatment; to the contrary, it conveys an understanding that organic production may be in tension with humane rearing. To the extent that is so, the Senate Report suggests that AMS may relax organic objectives in order to accommodate countervailing principles of humane treatment. But the Senate Report in no way suggests that AMS is permitted to regulate animal welfare as a stand-alone objective. Furthermore, the commenters were selectively quoting from the Senate Report; the full statement reads as follows:

The Committee felt strongly that organically produced feed should be required for livestock. However, on the issue of livestock medication, the Committee felt that this required further consideration by the National Organic Standards Board. Livestock parasiticides and medications must be on the National List in order to be used but in no case shall livestock be given subtherapeutic doses of antibiotics, synthetic internal parasiticides on a routine basis, or be administered medication other than vaccinations in the absence of illness. The Committee expects that, after due consideration and the reception of public comment, the Board will best determine the necessary balance between the goal of restricting livestock medications and the need to provide humane conditions for livestock rearing.

1990 U.S.C.C.A.N. 4656, 4956.

The language preceding that cited by the commenters strengthens, rather than refutes, USDA's belief that section 6509(d)(2) authorizes AMS only to establish additional medical standards for the care of livestock to ensure that these livestock are organically produced. This legislative history supports an interpretation that the Secretary does not have the authority to promulgate stand-alone animal welfare organic requirements.

Several commenters also noted that the Senate Report and the House Conference Report 101-916 on the Food, Agriculture, Conservation, and Trade Act of 1990 make references to the expectation that USDA would promulgate regulations regarding livestock standards. However, this legislative history does not specify that the referenced livestock standards go beyond the specific types of practices referenced in the statute to include animal welfare. Rather, they are general statements that do not change the statutory plain meaning or AMS's permissible interpretation of the scope of its statutory authority.

d. Several commenters argued that AMS may not withdraw the OLPP final rule because it did not consult with the NOSB prior to proposing the withdrawal. Additionally, they stated that withdrawal would be improper because it is contrary to the NOSB's recommendations.5

5 These commenters offer a constitutionally troubling construction of the OFPA. To comply with the Appointments Clause of the U.S. Constitution, National Organic Standards Board members must serve at the pleasure of the Secretary and be subordinate to him or her. The Secretary must be free to accept, reject, or revise the recommendations of an advisory committee such as the NOSB.

OFPA requires USDA to consult with the NOSB on certain matters and to receive recommendations from it, but nothing in OFPA requires AMS to consult the NOSB at every phase of the rule making process or makes the NOSB's recommendations binding on the Secretary, nor could it.6

6 OFPA requires AMS to consult with the NOSB only under limited circumstances: In developing the organic certification program (section 6503(c)), exemption for certain processed food (section 6505(c)), and certification and labeling of wild seafood (section 6506(c)). Thus, OFPA does not require AMS to consult with the NOSB prior to undertaking a rulemaking to withdraw the OLPP final rule. Additionally, requiring USDA to consult NOSB on every action that it takes with respect to organic standards and practices would be impractical. The NOSB meets only twice a year and is not available for consultation on the many steps involved in a significant rulemaking. Regardless, AMS did present to the NOSB an update concerning the status of the proposed withdrawal of the OLPP final rule. AMS participated in the NOSB's meeting in the April 2017, during which NOSB discussed the delayed effective date of the OLPP final rule and unanimously voted to “urge[ ] the Secretary to allow the [OLPP] Rule to become effective on May 19, 2017 without further delay.”

e. Several commenters argued that 7 U.S.C. 6506(a)(11) 7 and 6512 8 provided additional statutory authority for the OLPP final rule. Sections 6506(a)(11) and 6512 do not convey to the Secretary limitless and unfettered discretion to require whatever terms and conditions he or she may want. Rather, the exercise of discretion under those sections must be grounded in the statutory authority for the organic production. As discussed above for § 6509, the authority for care of organic livestock is to ensure that organic livestock is raised with minimal administration of chemical and synthetic substances. Additionally, to the extent that section 6506(a)(11) may provide authority for livestock care regulations, it does so only if the Secretary determines that they are necessary, which the OLPP final rule is not.

7 “[R]equire such other terms and conditions as may be determined by the Secretary to be necessary.”

8 “If a production or handling practice is not prohibited or otherwise restricted under this chapter, such practice shall be permitted unless it is determined that such practice would be inconsistent with the applicable organic certification program.”

f. Certain commenters noted that NOSB made recommendations concerning animal welfare standards and living conditions over a period of nearly two decades, a situation that has caused a majority of small- and medium-sized operations to have significant reliance interests in animal welfare standards under NOP rules in general, including the OLPP final rule. They further asserted that, under Encino Motorcars v. Navarro, 136 S. Ct. 2117 (2016), AMS is required to address any disruption of long standing policies upon which the industry may have relied but has failed to do so. As proof of such reliance, some commenters asserted that they have made capital expenditures based on the 2002 NOP policy statement on outdoor access and 7 CFR 205.239.

The subject matter of Encino Motorcars is distinguishable from this rule. The Court in Encino Motorcars was concerned with the Department of Labor's decision to reverse an established rule that had governed the regulated industry for over 30 years, thereby upsetting a longstanding, and therefore, settled reliance interest (“[I]n explaining its changed position, an agency must be cognizant that longstanding policies may have engendered serious reliance interests that must be taken into account (emphasis added)”).9 The commenters who claimed that USDA should consider their “reliance interests” acknowledged that they relied on a history of NOSB recommendations (which do not constitute official USDA policy) and the NOP policies and regulations that are already in effect, rather than the OLPP final rule. Indeed, they could not have relied (and did not assert specific reliance upon) the OLPP final rule because AMS published that rule in the Federal Register in January 2017 and it never went into effect. Accordingly, any capital investments or other activities that the regulated industry made in order to comply with the OLPP rule prior to its effective date were not made pursuant to that rule, but in accordance with existing NOP policies and regulations governing animal welfare standards. USDA is not proposing to withdraw existing organic animal welfare standards or the 2002 NOP policy statement on outdoor access, and they remain in effect. Therefore, withdrawal of the OLPP final rule is not a reversal of a longstanding agency policy.

9Encino Motorcars, 136 S. Ct. at 2020.

g. Finally, several commenters disagreed with USDA's current interpretation of OFPA by noting that USDA previously promulgated 7 CFR 205.238, 205.239, and 205.240, which they interpret to address the wellbeing of organic livestock. They cited those regulations as proof that USDA has authority to promulgate stand-alone animal welfare standards. In the alternative, they noted that some of these standards address animal health and they question why the OLPP final rule cannot be promulgated on the same ground.

AMS notes that the validity of §§ 205.238, 205.239, and 205.240 is not before it in the present rulemaking. As such, a detailed consideration of whether those regulations accord with AMS' statutory interpretation is not within the scope of this rulemaking. Thus, even if AMS were to decide that it does not have authority to promulgate those regulations under OFPA, it could not withdraw them through this final rule because the NPRM did not provide notice that this action was under consideration. As part of the regulatory reform review, however, AMS may seek comment in the future regarding whether the cited regulations are in accordance with AMS' statutory authority.

B. Impact of OLPP Final Rule on Producers and Lack of Market Failure

Executive Orders 12866 and 13563 require agencies to assess the costs and benefits of economically significant regulatory actions. Executive Order 12866 also generally requires that the agency “propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs,” and further, that the agency “shall tailor its regulations to impose the least burden on society . . .” Executive Order 12866 also states that “Federal agencies should promulgate only such regulations as are required by law, are necessary to interpret the law, or are made necessary by compelling need, such as material failures of private markets . . .” While participation in the NOP is technically voluntary, this fact does not neutralize the impacts of changes to the USDA organic regulations because Executive Order 12866 does not exempt regulations of voluntary programs from this evaluation. Changes to the regulations could affect voluntary participation and would have real costs.

The Office of Management and Budget (OMB) has designated OLPP as an economically significant rule. Under Executive Order 12866, AMS is obligated to consider whether the potential impacts of the OLPP rule meet the principles of Executive Order 12866 and demonstrate a need for regulation. AMS did not identify a market failure in the OLPP final rule RIA and therefore AMS has now concluded that regulation is unwarranted. In fact, several organic producers and organizations that oppose withdrawal of the OLPP rule, including a few that argued that there was market failure necessitating the OLPP final rule, purchased a full-page advertisement in a newpaper about this rulemaking. In it they recognized that “[o]rganic farmers have pioneered new practices to enhance animal welfare because consumers demand it and because it makes farms resilient and profitable.” 10 If this is true, it is additional evidence from those involved in organic production that supports AMS' conclusion that the market is working and that additional regulation is unwarranted.

10The Washington Post, January 16, 2018, Page A7.

Further, AMS maintains that the costs of the OLPP final rule outweigh potential benefits. After publication of the OLPP final rule, AMS discovered a mathematical error in the calculation of benefits. The error was related to the formula used to calculate the 7 percent and 3 percent discount rates. In addition, AMS determined that there was a more suitable willingness-to-pay estimate for outdoor access than the range used to estimated benefits in the OLPP final rule. Although there was another error correction that moved the results in the opposite direction, the estimated benefits declined overall when AMS recalculated those values based on the above findings. In summary, given the high degree of uncertainty and subjectivity in evaluating the benefits of the OLPP final rule, and the lack of any market failure to justify intervention, and the clear potential for additional regulation to distort the market or drive away consumers, even if the comparison of costs and benefits was a close call, AMS would choose not to regulate as a policy matter.

Several commenters opined that AMS did not properly account for qualitative benefits to farm animals and producers in determining that there are net costs for the OLPP final rule. AMS finds that the qualitative benefits are speculative because it is uncertain that organic farmers and consumers would see positive impacts from implementation of the OLPP rule. The assertion that the OLPP final rule would result in economic benefits from healthier animals is not supported by information or research linking outdoor access on pasture or vegetation to improved economic outcomes for producers. AMS did not use the potential outcome of healthier animals as justification for the OLPP final rule. The withdrawal of the OLPP final rule does not prevent organic producers from providing outdoor access on pasture or vegetation, communicating that to consumers, and receiving any potential benefits from those practices.

AMS concludes that the costs to consumers of implementing the OLPP final rule would outweigh any potential benefits to consumers because it anticipates that a significant portion (50 percent) of current organic egg producers would exit the organic market following implementation, resulting in supply shortages and price increases for organic eggs. The OLPP final rule RIA estimated that organic egg prices could increase by a mean of $1.25 per dozen (assuming a demand elasticity of 1.0) as a result of that rule, which exceeded the RIA's estimate of consumers' willingness to pay for the costs of implementing the OLPP final rule. Furthermore, as AMS explained in the PRIA issued in connection with this final rule on withdrawal, the initial consumer willingness-to-pay estimates for eggs from hens with outdoor access were likely overstated in the RIA for the OLPP final rule and should be lower (initial range: $0.21 to $0.49 per dozen versus revised range: $0.16 to $0.25 per dozen). Therefore, the estimated benefits in the RIA for the OLPP final rule were inflated, and there are no clear net benefits for producers or consumers from implementation of the OLPP final rule.

Ultimately, the reduction of potential qualitative benefits, as a result of recalculations due to mathematical errors, the absence of a market failure, and tenuous qualitative benefits leaves net costs that would be overly burdensome to organic producers and consumers.

Some commenters have stated that withdrawal of the rule would undermine public trust and consumer confidence in the organic label. AMS believes, based on data and experience, that this outcome will not be realized. First, the withdrawal of the OLPP final rule maintains the current organic regulations for livestock that cover health care practices and living conditions, including the requirement for year-round outdoor access. This rule does not withdraw any requirements that are currently codified in the USDA organic regulations for livestock. AMS anticipates that consumer confidence in the organic label will be preserved and that certified organic livestock producers will continue to use that label to differentiate their products in the marketplace.

Further, market data suggests that consumer perception of the USDA organic regulations, which will remain in effect upon withdrawal of the OLPP final rule, is positive. Under the current regulations, sales of organic products have increased annually. From 2007 to 2016, the number of organic layers has increased by 12.7% annually. The Organic Trade Association (OTA) 2017 Organic Industry Survey reports, “2016 was a tremendous year for organic meat and poultry, with sales growing 17.2%.” That survey further states, “Consumers have moved from conventional to natural to hormone-free or grass-fed, and now finally to organic or organic grass-fed as they understand all that organic encompasses.” Regarding organic eggs, the OTA 2017 Organic Industry Survey predicted that the organic egg market will “stabilize” by the latter half of 2017, after the supply of organic eggs spiked in response to the 2015 outbreak of Avian Influenza and the drop in demand for organic eggs in 2016 due to the wide price gap between organic and conventional.

These market data do not support commenters' assertions that the withdrawal of the OLPP final rule and maintenance of current regulations will damage consumer confidence and trust in organic products. The industry has continued to expand under the current regulations and the outlook for continued growth in the organic sector has not been predicated upon the implementation of the OLPP final rule. Further, the OTA survey indicates that consumers are choosing organic meat and poultry, demonstrating consumer validation of the sufficiency of the existing regulations; plainly, the organic label is an effective means for product differentiation in the marketplace.

A number of commenters mentioned that withrawal of the rule contradicts the “consensus” favoring new, broadly prescriptive regulations and that considerations for animal welfare should override potential costs. Commenters urged implementation of the OLPP final rule because the organic industry requested that regulation.

AMS will not regulate when statutory authority is insufficient and potential costs do not justify potential benefits, whether there is a pro-regulatory “consensus” or not. As a matter of USDA regulatory policy, AMS should not regulate simply because some industry players believe that more regulations will help their competitive position. Furthermore, AMS believes the very notion of a “consensus” is at odds with prior public comments and some data on consumer behavior around organic purchases. In response to the April 2016 OLPP proposed rule, AMS received a number of comments representing consumer and organic farmer interests that stated that the current USDA organic regulations are adequate and enforceable and new regulations are not necessary or preferable. In the 2017 OTA U.S. Families' Organic Attitudes and Behavior survey, respondents were asked to rank the importance of several “true” statements about organic products. The statement, “Animals used in the production of organic food are treated humanely, fed an organic diet and are not rasied in confinement,” was ranked fourth out of fourteen.11 This data, plus the reports of increased sales in organic livestock products, shows consumer trust in the current practices and requirements for organic livestock products.

11 The question provided a list and asked, “All of the following statements are true with regards to products certified as organic by the USDA. From this list, what is or would be most important to you, if any, when deciding whether or not to purchase organic foods specifically? The statement, “Animals used in the production of organic foods are treated humanely, fed an organic diet and not raised in confinement,” ranked 4 out of 14.

Moreover, the mere fact that some organic consumers care about animal welfare does not mean that the term “organic” should be equated with animal welfare assurances.

The current USDA organic regulations, which will remain in effect, have standards for livestock healthcare, feed, and living conditions. A central premise of these regulations, which producers must uphold and certifying agents must enforce, is for year-round living conditions that accommodate the health and natural behavior of the animals. Moreover, AMS has estimated that a sizeable portion of organic livestock producers already meet the requirements in the OLPP final rule. In the RIA for the OLPP final rule, AMS stated that the mammalian livestock provisions of the OLPP final rule largely codify existing industry practices. In addition, AMS estimated that the majority of organic egg producers and about half of organic egg production meet the outdoor access requirements in the OLPP final rule. The withdrawal of the OLPP final rule would not compel changes in organic livestock production for these producers, who can continue to cater to consumers willing to pay a premium for animal welfare guarantees if they choose. Finally, the withdrawal of the OLPP final rule does not restrict organic producers from using private certification labels to communicate additional information to consumers about production practices or product attributes.

Some commenters asserted that the voluntary nature of the organic program mitigates the potential costs of implementing the OLPP final rule. The bases for evaluating the potential costs of compliance are the requirements of Executive Order 12866 and the final rule establishing the NOP in 2002 (65 FR 80548). The 2002 final rule quantified costs of complying with that rule, e.g., voluntarily obtaining or maintaining organic certification. AMS cannot negate the costs of the OLPP final rule on the basis that obtaining organic certification is voluntary because some producers that are in compliance with current regulations would incur costs to either change practices or to exit organic production. AMS notes that participation in many regulated markets is technically voluntary, but participants nevertheless invest substantial resources in and frequently stake their livelihoods on such participation. Moreover, the voluntary nature of the market is not an answer for consumers that would like to purchase organic products but cannot afford the premium that will result from the cost of implementing the OLPP rule. These consumers could be excluded from the organic market despite their preference to participate.

A number of commenters also addressed biosecurity and disease risk, stating that some of the outdoor access requirements, such as the presence of vegetation and no roofs, conflict with FDA requirements and biosecurity practices. These comments were also submitted in response to the April 2016 OLPP proposed rule and were addressed in the OLPP final rule (p. 7068-7070; 7072). Existing USDA organic regulations allow for the temporary confinement of animals for conditions under which the health, safety, or well-being of the animal could be jeopardized. AMS acknowledges that the existing requirements for outdoor access and the provisions for temporary confinement provide organic producers with the flexibility to mitigate biosecurity and disease risks.

A comment noted that AMS must assess the impact of withdrawing the OLPP final rule on the equivalency arrangements with the European Union and Canada and the economic impacts of the potential dissolution of those agreements as a result of this action. In the OLPP final rule, AMS responded to comments concerning potential impacts on trade agreements (p. 7080). AMS' responses to these comments remains the same.

AMS provided a 30-day public comment period in order to consider the public comments received on the proposed withdrawal and make a final decision on the OLPP final rule by the current effective date of May 14, 2018. AMS did not grant requests for extension of the public comment period because interested parties had the opportunity to comment on the underlying OLPP final rule in 2016 as well as the rulemaking in 2017 that culminated in the delay of the effective of the OLPP final rule until May 14, 2018. Moreover, commenters were on notice of the proposal since November 14, 2017, when it was discussed in a final rule published on that date. Furthermore, and in light of this backdrop, the December 18, 2017 proposed rule presented discrete issues that interested parties should have been able to address within the 30-day comment period. Additionally, extending the comment period would have prevented AMS from resolving the status of the OLPP rulemaking by May 14, 2018.

For the reasons described above, AMS maintains that the OLPP final rule exceeds AMS' scope of authority under OFPA and would be overly burdensome for organic poultry producers. Therefore, AMS is withdrawing the OLPP final rule.

VI. Executive Orders 12866/13563 Review

This section provides an Executive Summary of the Regulatory Impact Analysis (RIA) for this final rule on withdrawal. A full analysis is posted on the Regulations.gov website. This rulemaking has been designated as an “economically significant regulatory action” under Executive Order 12866, and, therefore, has been reviewed by OMB. This RIA on withdrawal remains unchanged from the PRIA because AMS did not receive new information via public comments on the December 18, 2017 proposed rule that would have altered the RIA.

Executive Orders 12866, 13563, and 13771 control regulatory review. 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. Executive Order 13771 directs Agencies to identify at least two existing regulations to be repealed for every new regulation unless prohibited by law. The total incremental cost of all regulations issued in a given fiscal year must have costs within the amount of incremental costs allowed by the Director of OMB, unless otherwise required by law or approved in writing by the Director of OMB. This rule is an Executive Order 13771 deregulatory action. AMS estimates that withdrawal of the OLPP final rule will result in cost savings of $10.2 million to $32.6 million per year, discounted at 7 percent over 15 years. When factored over perpetuity and extended to account for future years, the estimated cost savings become, on an annualized basis, $8.5 million to $34.9 million. Details on the estimated cost savings of this rule over 15 years can be found in the RIA, posted separately and summarized below.

The estimated costs of implementing the OLPP final rule were based on three potential scenarios of how organic egg producers would respond. First, AMS estimated that if all organic livestock and poultry producers came into compliance, the costs would be $28.7 to $31 million each year. Second, if 50 percent of the organic egg producers moved to the cage-free egg market and the organic industry continues to grow at historical rates, the estimated costs are $11.7-$12.0 million. Plus, AMS estimated transfers in the amount of $79.5 million to $86.3 million per year for producers that move from the organic to the cage-free market and lose the organic price premium. Third, if 50 percent of the organic egg producers moved to the cage-free egg market and there were no new entrants that could not already comply, the estimated costs are $8.2 million. For this scenario, AMS estimated transfers to be $43.7 million to $47.4 million per year. These costs do not include an additional $1.95-$3.9 million associated with the estimated paperwork burden. Withdrawing the OLPP final rule prevents these potential costs from taking effect, resulting in substantial organic poultry producer cost savings.

The estimated benefits of implementing the OLPP final rule were calculated for the three scenarios above and were based on consumer willingness-to-pay for outdoor access for laying hens. If all organic livestock and poultry producers came into compliance, AMS estimated the benefits would be $13.0-$31.6 million. Second, if 50 percent of the organic egg producers moved to the cage-free egg market and the organic industry continues to grow at historical rates, the estimated benefits are $3.6-$8.7 million. Third, if 50 percent of the organic egg producers moved to the cage-free egg market and there were no new entrants that could not already comply, the estimated benefits are $3.3-$8.0 million.

For all scenarios described above, the midpoint of the cost estimates, including the estimated paperwork burden, exceeds the midpoint of the estimated benefits.

The OLPP final rule estimated the benefits from the rule's implementation as $4.1 to $49.5 million annually. The estimated benefits spanned a wider range than the estimated costs and were based on research that measured consumers' willingness-to-pay for outdoor access for laying hens. The OLPP final rule acknowledged that the benefits were difficult to quantify.

In reviewing the OLPP final rule, AMS found that the calculation of benefits contained mathematical errors in calculating the discount rates of 7% and 3%. The error resulted in overstating the value of the benefits. Using the correct discounting formula, the estimated costs and paperwork burden for the OLPP final rule exceed the estimated benefits for all producer response scenarios. AMS also found the estimated benefits over time were handled differently than were the estimated costs over time. Specifically, costs were constant over time while benefits declined by an equal amount each year corresponding to the depreciation of poultry housing. In addition, AMS determined that the range used for estimating the benefit interval should be replaced with more suitable estimates. The estimate used in the benefits calculations for the OLPP final rule were based on consumers' willingness-to-pay for eggs produced by chickens raised in a cage-free environment without induced moulting and with outdoor access. Because the first two practices are already required in organic production, AMS determined that a narrower range for the willingness-to-pay for outdoor access estimate was more precise and appropriate. The revised calculations of benefits are presented in the accompanying RIA.

As a result of reviewing the calculation of estimated benefits, AMS reassessed the economic basis for the rulemaking as well as the validity of the estimated benefits. On the basis of that reassessment, AMS finds little, if any, economic justification for the OLPP final rule.

The RIA for the OLPP final rule did not identify a significant market failure to justify the need for rule. The RIA for the OLPP final rule noted that there is wide variance in production practices within the organic egg sector and asserted that “as more consumers become aware of this disparity, they will either seek specific brands of organic eggs or seek animal welfare labels in addition to the USDA organic seal.” OLPP final rule RIA at 14. AMS also found the “majority of organic producers also participate in private, third-party verified animal welfare certification programs.” Id. Variance in production practices and participation in private, third-party certification programs, however, do not constitute evidence of significant market failure or weigh against withdrawal of the OLPP rule.

First, while AMS recognizes that the purpose of the OFPA is to assure consumers that organically produced products meet a consistent standard, that purpose does not imply that there can be no variation in organic production practices. Rather, a variety of production methods may be employed to meet the same standard. Some may be more labor intensive and others more capital intensive, and some may be appropriate for small operations while others are appropriate for large operations. Importantly, producers will adopt different production methods over time as technology evolves and enables operations to meet the same standard more efficiently. Moreover, producers may follow different standards with respect to aspects of production that are not relevant to organic certification or otherwise subject to regulation. Thus, variation in production practices is expected and does not stand as an indicator of a significant market failure.

Second, private, third-party certification programs are common in the dynamic food sector. That organic suppliers participate in such programs does not indicate a market failure with respect to the standards promulgated under the USDA NOP. Rather, the use of third-party certifications in addition to the USDA organic seal merely indicates that participants in the food sector seek ways to differentiate their products from those of their competitors. That some aspects of a private certification may overlap with the requirements underlying the USDA organic seal demonstrates that food producers, manufacturers, and retailers use multiple methods to communicate with consumers about the attributes of the foods that they produce and sell. Private, third-party certifications reflect attributes that food sellers wish to emphasize, and the existence of such certifications on organic products provides no evidence of a significant market failure relating to USDA organic standards. Nor is it clear that implementation of the OLPP final rule would reduce participation in third-party certification programs; instead, third-party certification programs may simply evolve as producers find new ways to distinguish their products.

Finally, the accompanying RIA explains several calculation errors associated with the OLPP final rule RIA. The RIA also provides additional information regarding the estimated benefits and explains why they likely were overstated in the original OLPP final rule RIA. In any case, withdrawing the OLPP final rule would prevent the negative cost impacts from taking effect, resulting in substantial organic poultry producer cost savings of $8.2 to $31 million annually, plus additional cost savings of $1.95-$3.9 million from paperwork reduction.

Consideration of Alternatives

AMS considered three alternatives in developing this rule to withdraw the OLPP final rule. The first alternative was to implement the OLPP final rule on May 14, 2018, which is the current effective date. The second alternative was to further delay the final rule. The third alternative, which is the selected alternative, was to withdraw the final rule.

For the first alternative, if the OLPP final rule were to become effective on May 14, 2018, the costs and transfers described in the RIA would be expected to occur, resulting in requirements with substantial costs not supported by evidence of significant market failure.

The second alternative was to further delay the OLPP final rule. This alternative, however, would defer the decision on whether to implement or withdraw to a future date, despite the agency having performed its review and received comments from the public. This alternative fails to achieve USDA's goal of reducing regulatory uncertainty.

AMS has selected the third alternative, to withdraw the OLPP final rule, as the preferred alternative. This alternative estimates cost savings for poultry producers of $8.2 to $31 million per year (based on 15-year costs). In addition, $1.95-$3.9 million in annual paperwork burden would not be incurred. As described in the RIA, the range of benefits could be expected to be lower than projected in the OLPP final rule RIA. Moreover, a priori, the benefits associated with any government intervention in the absence of an identifiable market failure will be lower than the required costs of imposing such an intervention. Given the unclear nature of the market failure being addressed by the OLPP final rule, AMS would give clear preference to the lower end of the benefit range, which consistently falls below the costs associated with the OLPP final rule.

VII. Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market.

Data suggest nearly all organic egg producers qualify as small businesses. OLPP final rule RIA at 140-141. Small egg producers are listed under North American Industry Classification System (NAICS) code 112310 (Chicken Egg Production) as grossing less than $15,000,000 per year, and AMS estimates that out of 722 operations reporting sales of organic eggs, only four are not small businesses. Thus, the OLPP final rule RIA found that some small egg producers and small chicken (broiler) producers would be affected by the poultry outdoor access and space provisions. See OLPP final rule RIA at 136-138, 142, 145-146. Furthermore, the RIA of the OLPP final rule noted that some small producers were particularly concerned about limited land availability for outdoor access requirements and the potential for increased mortality attendant to the new regulatory demands. These concerns were identified as sources of burdensome costs and/or major obstacles to compliance for some small businesses. See id. at 26-28. Based on surveys of organic egg producers, AMS believes approximately fifty percent of layer production will not be able to acquire additional land needed to comply with the OLPP final rule and some of this burden will be borne by small entities. Id. at 142. Also, certain existing certified organic slaughter facilities could surrender their organic certification as a result of the OLPP final rule and certain businesses currently providing livestock transport services for certified organic producers or slaughter facilities may be unwilling to meet and/or document compliance with the livestock transit requirements. Id. at 149.

Withdrawing the OLPP final rule avoids these economic impacts without introducing any incremental burdens or erecting barriers that would restrict the ability of small entities to compete in the market. This conclusion is supported by the historic growth of the organic industry without the regulatory amendments.

This rule relieves producers of the costs of complying with the OLPP final rule. The effects of withdrawal will be beneficial and not defined as significant for the specific purposes of the Regulatory Flexibility Act. Some small entities may experience time and money savings as a result of not having to change practices to comply with the OLPP final rule. Affected small entities would include organic egg and organic broiler producers. This rule will provide measurable, savings for small entities. However, for the definitional purposes of the RFA, these savings are not considered a “significant” economic impact on a substantial number of small entities.

Under these circumstances, the Administrator of AMS has determined that this action will not have a significant economic impact on a substantial number of small entities and certifies as such.

VIII. Executive Order 12988

Executive Order 12988 instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system.

Pursuant to section 6519(f) of OFPA, this final rule would not alter the authority of the Secretary under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, respectively, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399), nor the authority of the Administrator of the U.S. Environmental Protection Agency under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136-136(y)).

IX. Paperwork Reduction Act

No additional collection or recordkeeping requirements are imposed on the public by withdrawing the OLPP final rule. Accordingly, OMB clearance is not required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501), Chapter 35. Withdrawing the OLPP final rule will avoid an estimated $1.95-$3.9 million in costs for increased paperwork burden associated with that final rule.

X. 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.

AMS has assessed the impact of this rule on Indian tribes and determined that this rule would not, to our knowledge, have tribal implications that require tribal consultation under Executive Order 13175. If a Tribe requests consultation, AMS 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.

XI. Civil Rights Impact Analysis

AMS has reviewed this final rule in accordance with the Department Regulation 4300-4, Civil Rights Impact Analysis, to address any major civil rights impacts the rule might have on minorities, women, and persons with disabilities. AMS has determined that withdrawing the OLPP final rule has no potential for affecting producers in protected groups differently than the general population of producers.

XII. Conclusion

In compliance with OFPA and consistent with the regulatory policies of Executive Orders 12866 and 13563, AMS is withdrawing the OLPP final rule.

Dated: March 8, 2018. Bruce Summers, Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2018-05029 Filed 3-12-18; 8:45 am] BILLING CODE 3410-02-P
NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Part 741 RIN 3133-AE77 Requirements for Insurance; National Credit Union Share Insurance Fund Equity Distributions; Correction AGENCY:

National Credit Union Administration (NCUA).

ACTION:

Final rule; correction.

SUMMARY:

On February 23, 2018, the NCUA Board (Board) issued a final rule adopting amendments to its share insurance requirements rule to provide stakeholders with greater transparency regarding the calculation of each eligible financial institution's pro rata share of a declared equity distribution from the National Credit Union Share Insurance Fund (NCUSIF). A clerical error appeared which confuses what CFR unit is being amended. This document corrects that error.

DATES:

This correction is effective March 26, 2018.

FOR FURTHER INFORMATION CONTACT:

Benjamin M. Litchfield, Staff Attorney, Office of General Counsel, at (703) 518-6540; or Steve Farrar, Supervisory Financial Analyst, Office of Examination and Insurance, at (703) 518-6360. You may also contact them at the National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428.

SUPPLEMENTARY INFORMATION:

On February 23, 2018, at 83 FR 7954, the Board issued a final rule adopting amendments to 12 CFR part 741. In amendments to appendices A, B, and C to part 741, incorrect headings appeared above amendatory instructions 4 and 5 on page 7964 identifying the wrong CFR part. Instruction 5 omitted the part number.

Therefore, FR Rule Doc. No. 2018-03622, published on February 23, 2018, beginning on page 7954, is corrected as follows:

1. On page 7964, in the center column, the heading above amendatory instruction 4 is corrected to read as follows: Appendix A to Part 741 [Removed] 2. On page 7964, in the center column, the heading above amendatory instruction 5 and amendatory instruction 5 are corrected to read as follows: Appendices B and C to Part 741 [Redesignated as Appendices A and B to Part 741] 5. Redesignate appendix B and appendix C to part 741 as appendix A and appendix B to part 741, respectively. By the National Credit Union Administration Board on March 7, 2018. Gerard Poliquin, Secretary of the Board.
[FR Doc. 2018-05056 Filed 3-12-18; 8:45 am] BILLING CODE 7535-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA-2018-0103; Airspace Docket No. 18-ASO-1] Amendment of Restricted AreasR-2907C, R-2910B, R-2910C, andR-2910E; Pinecastle, FL AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; technical amendment.

SUMMARY:

This action updates the controlling agency information for restricted areas R-2907C, R-2910B, R-2910C, and R-2910E; Pinecastle, FL. This is an administrative change to reflect the current organizations tasked with controlling agency responsibilities for the restricted areas. It does not affect the boundaries, designated altitudes, time of designation or activities conducted within the restricted areas.

DATES:

Effective date: 0901 UTC, May 24, 2018.

FOR FURTHER INFORMATION CONTACT:

Paul Gallant, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it updates the controlling agency for restricted areas R-2907C, R-2910B, R-2910C and R-2910E; Pinecastle, FL, to reflect the current responsible organizations.

The Rule

This rule amends title 14 Code of Federal Regulations (14 CFR) part 73 by updating the controlling agency name for restricted areas R-2907C, R-2910B, R-2910C, and R-2910E; Pinecastle, FL. The controlling agency for R-2907C and R-2910E is changed from “FAA, Jacksonville ARTCC,” to “FAA, Jacksonville TRACON.” The controlling agency for R-2910B and R-2910C is changed from “FAA, Jacksonville ARTCC,” to “FAA, Central Florida TRACON.” This action is necessary in order to assign controlling agency responsibilities to the air traffic control facilities having jurisdiction over the affected airspace.

This is an administrative change that does not affect the boundaries, designated altitudes, or activities conducted within the restricted areas; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

Regulatory Notices and Analyses

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

Environmental Review

The FAA has determined that this action of updating the agency information for restricted areas R-2907C, R-2910B, R-2910C and R-2910E; Pinecastle, FL, qualifies for categorical exclusion under the National Environmental Policy Act, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5.d, “Modification of the technical description of special use airspace (SUA) that does not alter the dimensions, altitudes, or times of designation of the airspace (such as changes in designation of the controlling or using agency, or correction of typographical errors).” This airspace action is an administrative change to the description of restricted areas R-2907C, R-2910B, R-2910C and R-2910E; Pinecastle, FL, to update the controlling agency names. It does not alter the dimensions, altitudes, time of designation, or use of the airspace. Therefore, this airspace action is not expected to result in any significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment.

List of Subjects in 14 CFR Part 73

Airspace, Prohibited areas, Restricted areas.

Adoption of the Amendment

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73 as follows:

PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

§ 73.29 [Amended]
2. Section 73.29 is amended as follows: R-2907C Pinecastle, FL [Amended]

By removing the words “Controlling agency. FAA, Jacksonville ARTCC,” and adding in their place the words “Controlling agency. FAA, Jacksonville TRACON.”

R-2910B Pinecastle, FL [Amended]

By removing “Controlling agency. FAA, Jacksonville ARTCC,” and adding in its place “Controlling agency. FAA, Central Florida TRACON.”

R-2910C Pinecastle, FL [Amended]

By removing “Controlling agency. FAA, Jacksonville ARTCC,” and adding in its place “Controlling agency. FAA, Central Florida TRACON.”

R-2910E Pinecastle, FL [Amended]

By removing “Controlling agency. FAA, Jacksonville ARTCC,” and adding in its place “Controlling agency. FAA, Jacksonville TRACON.”

Issued in Washington, DC, on March 6, 2018. Leslie M. Swann, Acting Manager, Airspace Policy Group.
[FR Doc. 2018-05041 Filed 3-12-18; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9588] RIN 1545-BL87 Allocation of Mortgage Insurance Premiums; Correction AGENCY:

Internal Revenue Service (IRS), Treasury.

ACTION:

Correcting amendment.

SUMMARY:

This document contains corrections to final regulations (TD 9588) that were published in the Federal Register on Monday, May 7, 2012. The final regulations are related to allocate prepaid qualified mortgage insurance premiums to determine the amount of the prepaid premium that is treated as qualified residence interest each taxable year.

DATES:

This correction is effective on March 13, 2018 and is applicable on or after May 7, 2012.

FOR FURTHER INFORMATION CONTACT:

Regina Johnson, (202) 317-5177 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

The final regulations (TD 9588) that are the subject of this correction are issued under section 163 of the Internal Revenue Code.

Need for Correction

As published May 7, 2012 (77 FR 26698), the final regulations (TD 9588) contain an error that needs to be corrected.

List of Subjects in 26 CFR Part 1

Income taxes, reporting and recordkeeping requirements.

Correction of Publication

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendment:

PART 1—INCOME TAXES Par. 1. The authority citation for part 1 is amended by removing the sectional authority for § 1.163-11T, and the general authority continues to read as follows: Authority:

26 U.S.C. 7805 * * *

Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration).
[FR Doc. 2018-05011 Filed 3-12-18; 8:45 am] BILLING CODE 4830-01-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0067] Drawbridge Operation Regulation; Duwamish Waterway, Seattle, WA AGENCY:

Coast Guard, DHS.

ACTION:

Notice of temporary deviation from regulations; request for comments.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs the South Park highway bridge, across the Duwamish Waterway mile 3.8, at Seattle, WA. This deviation will test a change to the drawbridge operation schedule, to determine whether a permanent change to the schedule is appropriate. This deviation will allow the bridge to open during nighttime hours after receiving a 12 hour advance notice.

DATES:

This deviation is effective from 6 a.m. on March 22, 2018 to 6 a.m. on September 17, 2018.

Comments and related material must reach the Coast Guard on or before August 30, 2018.

ADDRESSES:

You may submit comments identified by docket number USCG-2018-0067 using Federal eRulemaking Portal at http://www.regulations.gov.

See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Chief Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email [email protected]

SUPPLEMENTARY INFORMATION:

I. Background, Purpose and Legal Basis

Due to infrequent drawbridge opening requests between 11 p.m. to 7 a.m., King County (the bridge owner), has requested to open the South Park highway bridge with 12 hours advances notice between the hours of 11p.m. and 7 a.m. In addition, King County requested between the hours of 11 p.m. and 7 a.m. vessels engaged in sea-trials or waterway dredging activities may request a standby drawtender, to open the bridge on demand during sea-trials and/or dredging operations, if at least a 24 hour notice is given to the drawtender. The 2017 drawbridge log book reflects the infrequent requests for drawbridge opening of the South Park highway bridge. Of the 524 openings in 2017 only 24 occurred between the hours of 11.00 p.m. and 7 a.m., this is approximately 4.5 percent. Opening from 11 p.m. to 7 a.m. for 2014, 2015, 2016 ranged from 5% to 10% of all openings. The South Park highway bridge operates per 33 CFR 117.1041(a)(2).

Vessels operating on the Duwamish Waterway range from small recreational, sailboats, tribal fishing boats, mega yachts and commercial tug and tow vessels. No navigational impacts are expected due to few vessels operating on this waterway at the stated hours. King County has discussed this test deviation and coordinating with all known waterway users. Vessels able to pass through the subject bridge with the span in the closed-to-navigation position may do so at any time.

The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the subject bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation. Duwamish Waterway does not have an immediate alternate route for vessels to pass. Therefore, in the event of an emergency requiring a bridge opening any day between 11 p.m. and 7 a.m., the standby bridge operator at the Fremont Bridge will respond to an opening request and have the South Park Bridge open within 45 minutes from initial notification.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

II. Public Participation and Request for Comments

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

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

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, visit http://www.regulations.gov/privacynotice.

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

Dated: March 7, 2018. Steven M. Fischer, Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2018-04966 Filed 3-12-18; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0006] RIN 1625-AA00 Safety Zone; Tennessee River, Huntsville, AL AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary safety zone for all navigable waters of the Tennessee River from mile marker (MM) 322.0 to MM 325.0. The safety zone is necessary to provide for the safety of life and vessels during cargo transfer operations taking place at Redstone Arsenal. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Ohio Valley (COTP) or a designated representative.

DATES:

This rule is effective without actual notice from March 13, 2018 through March 16, 2018, or until the cargo operation ceases, whichever comes first. For the purposes of enforcement, actual notice will be used from March 5, 2018 through March 13, 2018.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0006 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 Petty Officer Vera Max, MSD Nashville, U.S. Coast Guard; telephone 615-736-5421, email [email protected]

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations BNM Broadcast Notice to Mariners CFR Code of Federal Regulations COTP Captain of the Port Sector Ohio Valley DHS Department of Homeland Security LNM Local Notice to Mariners FR Federal Register MM Mile marker NPRM Notice of proposed rulemaking §  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 it is impracticable. We must establish this safety zone by March 5, 2018 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be impracticable and contrary to the public interest because the event will take place before the 30 days and this rule is necessary to provide for public safety against the potential hazards associated with this cargo transfer operation.

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 Sector Ohio Valley (COTP) has determined that potential hazards associated with a cargo transfer operation taking place at Redstone Arsenal during the period from March 5, 2018 through March 16, 2018 will be a safety concern for all navigable waters of the Tennessee River between mile markers (MMs) 322.0 and 325.0. The purpose of this rule is to ensure safety of life on the navigable waters in the temporary safety zone before, during, and after the cargo transfer operations.

IV. Discussion of the Rule

This rule establishes a temporary safety zone from March 5, 2018 through March 16, 2018, or until the cargo operation is completed, whichever comes first. The temporary safety zone will cover all navigable waters of the Tennessee River between MMs 322.0 and 325.0. Transit into and through this area is prohibited during periods of enforcement. The periods of enforcement will be prior to, during, and 30 minutes after any vessel movement and cargo transfer operations at Redstone Arsenal. The Coast Guard was informed that the operations will take place during daylight hours over approximately two days. Safety zone enforcement times will be announced via Broadcast Notice to Mariners (BNM), Local Notices to Mariners (LNM), or through other means of public notice and at least 1 hour notice will be provided before each enforcement period.

The duration of the temporary safety zone is intended to ensure the safety of life and vessels on these navigable waters before, during, and after the cargo transfer operations taking place at Redstone Arsenal. All vessels intending to transit the Tennessee River between MMs 322.0 and 325.0 from March 5, 2018 through March 16, 2018 must contact the COTP or a designated representative to request permission to transit at a time when critical operations are not taking place. Entry into this safety zone is prohibited unless specifically authorized by the COTP or a designated representative. Entry requests will be considered and reviewed on a case-by-case basis. The COTP may be contacted by telephone at 1-800-253-7465 or can be reached by VHF-FM channel 16.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

Executive Orders 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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the temporary safety zone. This safety zone prohibits transit on a three mile stretch of the Tennessee River only during critical cargo transfer operations at Redstone Arsenal over approximately two days, during a time of year that experiences lower than normal traffic. Broadcast Notices to Mariners and Local Notices to Mariners will also inform the community of the safety zone enforcement periods through BNM, LNM, and other means of public notice so that they may plan accordingly for each enforcement period restricting transit. Vessel traffic must request permission from the COTP or a designated representative to enter the restricted area.

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 Executive Order 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 Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 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 M16475.1D, 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 that would prohibit entry to vessels during cargo transfer operations at Redstone Arsenal. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is 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.T08-0006 to read as follows:
§ 165.T08-0006 Safety zone; Tennessee River, Huntsville, AL.

(a) Location. The following area is a temporary safety zone area: all navigable waters of the Tennessee River between Mile Marker (MM) 322.0 and MM 325.0, Huntsville, AL.

(b) Effective date. This section is effective from March 5, 2018 through March 16, 2018 or until the cargo operation is completed, whichever comes first.

(c) Periods of enforcement. This section will be enforced prior to and 30 minutes after all vessel movement and cargo transfer operations taking place at Redstone Arsenal. The Captain of the Port Sector Ohio Valley (COTP) or a designated representative will inform the public through Broadcast Notice to Mariners (BNM), Local Notices to Mariners (LNM), or through other means of public notice at least 1 hour in advance of each enforcement period.

(d) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into this zone is prohibited unless specifically authorized by the COTP or a designated representative. Persons or vessels desiring to enter into or pass through the zone must request permission from the COTP or a designated representative. They may be contacted by telephone at 1-800-253-7465 or on VHF-FM radio channel 16.

(2) Persons and vessels permitted to enter this safety zone must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative.

(d) Informational broadcasts. The COTP or a designated representative will inform the public through broadcast notices to mariners of the enforcement period for the temporary safety zone as well as any changes in the planned schedule.

Dated: March 5, 2018. M.B. Zamperini, Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2018-04968 Filed 3-12-18; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0544; FRL-9975-37-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Revisions to the Regulatory Definition of Volatile Organic Compound AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is approving two state implementation plan (SIP) revisions (Revision C16 and Revision I16) formally submitted by the Commonwealth of Virginia (Virginia). The revisions pertain to amendments made to the definition of “volatile organic compound” (VOC) in the Virginia Administrative Code to conform with EPA's regulatory definition of VOC. Specifically, these amendments remove the record keeping and reporting requirements for t-butyl acetate (also known as tertiary butyl acetate or TBAC); Chemical Abstracts Service [CAS] number: 540-88-5) and add 1,1,2,2,-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane (also known as HFE-347pcf2; CAS number: 406-78-0) as a compound excluded from the regulatory definition of VOC, which match actions EPA has taken. EPA is approving these revisions to update the definition of VOC in the Virginia SIP in accordance with the requirements of the Clean Air Act (CAA).

DATES:

This final rule is effective on April 12, 2018.

ADDRESSES:

EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2017-0544. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the For Further Information Contact section for additional availability information.

FOR FURTHER INFORMATION CONTACT:

Sara Calcinore, (215) 814-2043, or by email at [email protected]

SUPPLEMENTARY INFORMATION: I. Background

VOCs are organic compounds of carbon that, in the presence of sunlight, react with sources of oxygen molecules, such as nitrogen oxides (NOX) and carbon monoxide (CO), in the atmosphere to produce tropospheric ozone, commonly known as smog. Common sources that may emit VOCs include paints, coatings, housekeeping and maintenance products, and building and furnishing materials. Outdoor emissions of VOCs are regulated by EPA primarily to prevent the formation of ozone.

VOCs have different levels of volatility, depending on the compound, and react at different rates to produce varying amounts of ozone. VOCs that are non-reactive or of negligible reactivity to form ozone react slowly and/or form less ozone; therefore, reducing their emissions has limited effects on local or regional ozone pollution. Section 302(s) of the CAA specifies that EPA has the authority to define the meaning of VOC and what compounds shall be treated as VOCs for regulatory purposes. It is EPA's policy that organic compounds with a negligible level of reactivity should be excluded from the regulatory definition of VOC in order to focus control efforts on compounds that significantly affect ozone concentrations. EPA uses the reactivity of ethane as the threshold for determining whether a compound is of negligible reactivity. Compounds that are less or equally reactive as ethane under certain assumed conditions may be deemed negligibly reactive and, therefore, suitable for exemption by EPA from the regulatory definition of VOC. The policy of excluding negligibly reactive compounds from the regulatory definition of VOC was first laid out in “Recommended Policy on Control of Volatile Organic Compounds” (42 FR 35314, July 8, 1977) and was supplemented subsequently with the “Interim Guidance on Control of Volatile Organic Compounds in Ozone State Implementation Plans” (70 FR 54046, September 13, 2005). The regulatory definition of VOC as well as a list of compounds that are designated by EPA as negligibly reactive can be found at 40 CFR 51.100(s).

On September 30, 1999, EPA proposed to revise the regulatory definition of VOC in 40 CFR 51.100(s) to exclude TBAC as a VOC (64 FR 52731). In most cases, when a negligibly reactive VOC is exempted from the definition of VOC, emissions of that compound are no longer recorded, collected, or reported to states or the EPA as part of VOC emissions. However, EPA's final rule excluded TBAC from the definition of VOC for purposes of VOC emissions limitations or VOC content requirements, but continued to define TBAC as a VOC for purposes of all recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements that apply to VOC (69 FR 69298, November 29, 2004) (2004 Final Rule). This was primarily due to EPA's conclusion in the 2004 Final Rule that “negligibly reactive” compounds may contribute significantly to ozone formation if present in sufficient quantities and that emissions of these compounds need to be represented accurately in photochemical modeling analyses. Per EPA's 2004 Final Rule, Virginia partially excluded TBAC from the regulatory definition of VOC, which was approved into Virginia's SIP on August 18, 2006 (71 FR 47742).

When EPA exempted TBAC from the VOC definition for purposes of control requirements in the 2004 Final Rule, EPA created a new category of compounds and a new reporting requirement that required that emissions of TBAC be reported separately by states and, in turn, by industry. However, EPA did not issue any guidance on how TBAC emissions should be tracked and reported. Therefore, the data that was reported as result of these requirements was incomplete and inconsistent. Also, in the 2004 Final Rule, EPA stated that the primary objective of the recordkeeping and reporting requirements for TBAC was to address the cumulative impacts of “negligibly reactive” compounds and suggested that future exempt compounds may also be subject to such requirements. However, such requirements were not included in any other proposed or final VOC exemptions.

Because having high quality data on TBAC emissions alone was unlikely to be useful in assessing the cumulative impacts of “negligibly reactive” compounds on ozone formation, EPA subsequently concluded that the recordkeeping and reporting requirements for TBAC were not achieving their primary objective of informing more accurate photochemical modeling in support of SIP submissions. Also, there was no evidence that TBAC was being used at levels that would cause concern for ozone formation and that the requirements were providing sufficient information to evaluate the cumulative impacts of exempted compounds. Therefore, because the requirements were not addressing EPA's concerns as they were intended, EPA revised the regulatory definition of VOC under 40 CFR 51.100(s) to remove the recordkeeping and reporting requirements for TBAC (February 25, 2016, 81 FR 9339).

On August 1, 2016, EPA promulgated a final rule revising the regulatory definition of VOC in 40 CFR 51.100(s) to add HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC (81 FR 50330). This action was based on EPA's consideration of the compound's negligible reactivity and low contribution to ozone as well as the low likelihood of risk to human health or the environment. EPA's rationale for this action is explained in more detail in the final rule for this action. See 81 FR 50330 (August 1, 2016).

II. Summary of SIP Revision and EPA Analysis

In order to conform with EPA's current regulatory definition of VOC in 40 CFR 51.100(s), the Virginia State Air Pollution Control Board amended the definition of VOC in 9VAC5-10-20 to remove the recordkeeping and reporting requirements for TBAC and add HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC. On July 31, 2017, the Commonwealth of Virginia, through the Virginia Department of Environmental Quality (VADEQ), formally submitted these amendments as two requested revisions (Revision C16 and Revision I16) to the Virginia SIP. Revision C16 requested that the definition of VOC be updated in the Virginia SIP to conform with EPA's February 25, 2016 (81 FR 9339) final rulemaking updating EPA's regulatory definition of VOC in 40 CFR 51.100(s) to remove the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of TBAC as a VOC. Revision I16 requested that the definition of VOC be updated in the Virginia SIP to conform with EPA's August 1, 2016 (81 FR 50330) final rulemaking updating EPA's regulatory definition of VOC in 40 CFR 51.100(s) to add HFE-347pcf2 to the list of compounds excluded from EPA's regulatory definition of VOC.

Virginia's amendments to the definition of VOC in 9VAC5-10-20 are in accordance with EPA's regulatory changes to the definition of VOC in 40 CFR 51.100(s) and are therefore approvable for inclusion in the Virginia SIP in accordance with CAA section 110. Also, because EPA has made the determination that TBAC and HFE-347pcf2 are of negligible reactivity and therefore have low contributions to ozone as well as low likelihood of risk to human health or the environment, removing these chemicals from the definition of VOC in the Virginia SIP as well as the recordkeeping and reporting requirements for these chemicals will not interfere with attainment of any NAAQS, reasonable further progress, or any other requirement of the CAA. Thus, the removal of the recordkeeping and reporting requirements for TBAC and the addition of HFR-347pcf2 to the list of compounds excluded from the regulatory definition of VOC is in accordance with CAA section 110(l).

On December 27, 2017 (82 FR 61200), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Virginia. In the NPR, EPA proposed approval of Revision C16, which updated the definition of VOC in the Virginia SIP to remove the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of TBAC as a VOC, and Revision I16, which updated the definition of VOC in the Virginia SIP by adding HFE-347pcf2 to the list of compounds excluded from EPA's regulatory definition of VOC. No public comments were received on the NPR.

III. Final Action

EPA is approving both Revision C16 and Revision I16, submitted on July 31, 2017 by VADEQ, as revisions to the Virginia SIP, as the submissions meet the requirements of CAA section 110. Revision C16 updates the regulatory definition of VOC in the Virginia SIP by removing the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of TBAC as a VOC. Revision I16 updates the regulatory definition of VOC in the Virginia SIP to add HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC.

IV. General Information Pertaining to SIP Submittals From the Commonwealth of Virginia

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce federally authorized environmental programs in a manner that is no less stringent than their federal counterparts. . . . ” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

V. Incorporation by Reference

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the revisions to the definition of VOC in 9VAC5-10-20 of the Virginia Administrative Code discussed in Section II of this preamble. EPA has made, and will continue to make, these materials generally available through http://www.regulations.gov and at the EPA Region III Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.1

1 62 FR 27968 (May 22, 1997).

VI. Statutory and Executive Order Reviews A. General Requirements

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

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

• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land as defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

B. Submission to Congress and the Comptroller General

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

C. Petitions for Judicial Review

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 14, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action updating the definition of VOC in the Virginia SIP by removing the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of TBAC as a VOC and adding HFE-347pcf2 to the list of compounds excluded from the regulatory definition of VOC may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

Dated: February 26, 2018. Cosmo Servidio, Regional Administrator, Region III.

40 CFR part 52 is amended as follows:

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

42 U.S.C. 7401 et seq.

Subpart VV—Virginia 2. In § 52.2420, the table in paragraph (c) is amended by adding two entries for “Section 5-10-20” after the entry for “Section 5-10-20” (with the State effective date of 7/30/15) to read as follows:
§ 52.2420 Identification of plan.

(c) * * *

EPA-Approved Virginia Regulations and Statutes State citation Title/subject State effective date EPA approval date Explanation
  • [former SIP citation]
  • 9 VAC 5, Chapter 10 General Definitions [Part I] *         *         *         *         *         *         * 5-10-20 Terms Defined 12/15/16 3/13/18, [Insert Federal Register citation] Definition of “volatile organic compound” is revised by removing the recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements related to the use of t-butyl acetate (also known as tertiary butyl acetate or TBAC) as a VOC. 5-10-20 Terms Defined 5/19/17 3/13/18, [Insert Federal Register citation] Definition of “volatile organic compound” is revised by adding 1,1,2,2,-Tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane (also known as HFE-347pcf2) to the list of compounds excluded from the regulatory definition of VOC. *         *         *         *         *         *         *
    [FR Doc. 2018-04937 Filed 3-12-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2017-0215; FRL-9975-32-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Virginia; Removal of Clean Air Interstate Rule (CAIR) Trading Programs AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the Commonwealth of Virginia (Virginia). The revision requests EPA remove from the Virginia SIP regulations from the Virginia Administrative Code that established trading programs under the Clean Air Interstate Rule (CAIR). The EPA-administered trading programs under CAIR were discontinued on December 31, 2014, upon the implementation of the Cross-State Air Pollution Rule (CSAPR), which was promulgated by EPA to replace CAIR. CSAPR established federal trading programs for sources in multiple states, including Virginia, that replace the CAIR state and federal trading programs. The submitted SIP revision requests removal of state regulations that implemented the CAIR annual nitrogen oxides (NOX), ozone season NOX, and annual sulfur dioxide (SO2) trading programs from the Virginia SIP (as CSAPR has replaced CAIR). EPA is approving the SIP revision in accordance with the requirements of the Clean Air Act (CAA).

    DATES:

    This final rule is effective on April 12, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2017-0215. All documents in the docket are listed on the http://www.regulations.gov website. Although listed in the index, some information is not publicly available, e.g., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available through http://www.regulations.gov, or please contact the person identified in the For Further Information Contact section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Sara Calcinore, (215) 814-2043, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    In 2005, EPA promulgated CAIR (70 FR 25162, May 12, 2005) to address transported emissions that significantly contributed to downwind states' nonattainment and interfered with maintenance of the 1997 ozone and fine particulate matter (PM2.5) national ambient air quality standards (NAAQS). CAIR required 28 states, including Virginia, to revise their SIPs to reduce emissions of NOX and SO2, precursors to the formation of ambient ozone and PM2.5. Under CAIR, EPA provided model state rules for separate cap-and-trade programs for annual NOX, ozone season NOX, and annual SO2. The annual NOX and annual SO2 trading programs were designed to address transported PM2.5 pollution, while the ozone season NOX trading program was designed to address transported ozone pollution. EPA also promulgated CAIR federal implementation plans (FIPs) with CAIR federal trading programs that would address each state's CAIR requirements in the event that a CAIR SIP for the state was not submitted or approved (71 FR 25328, April 28, 2006). Generally, both the model state rules and the federal trading program rules applied only to electric generating units (EGUs), but in the case of the model state rule and federal trading program for ozone season NOX emissions, each state had the option to submit a CAIR SIP revision that expanded applicability to include certain non-EGUs 1 that formerly participated in the NOX Budget Trading Program under the NOX SIP Call.2 Virginia submitted, and EPA approved, a CAIR SIP revision based on the model state rules establishing CAIR state trading programs for annual SO2, annual NOX, and ozone season NOX emissions, with certain non-EGUs included in the state's CAIR ozone season NOX trading program. See 72 FR 73602 (December 28, 2007). Because Virginia's NOX ozone season trading program under CAIR included non-EGUs that previously participated in the NOX budget trading program under the NOX SIP Call, this CAIR program satisfied Virginia's obligations under the NOX SIP Call as to both EGUs and non-EGUs. However, even though the NOX SIP Call requirements were being met by the CAIR program, Virginia's state NOX Budget Trading Program rule also remains part of the state's approved SIP. See 76 FR 68638 (November 7, 2011).

    1 These non-EGUs are generally defined in the NOX SIP Call as stationary, fossil fuel-fired boilers, combustion turbines, or combined cycle systems with a maximum design heat input greater than 250 million British thermal units per hour (MMBtu/hr).

    2 In October 1998, EPA finalized the “Finding of Significant Contribution and Rulemaking for Certain States in the Ozone Transport Assessment Group Region for Purposes of Reducing Regional Transport of Ozone”—commonly called the NOX SIP Call. See 63 FR 57356 (October 27, 1998).

    The United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) initially vacated CAIR in 2008, but ultimately remanded the rule to EPA without vacatur to preserve the environmental benefits provided by CAIR. North Carolina v. EPA, 531 F.3d 896, modified, 550 F.3d 1176 (2008). The ruling allowed CAIR to remain in effect temporarily until a replacement rule consistent with the court's opinion was developed. While EPA worked on developing a replacement rule, the CAIR program continued as planned with the NOX annual and ozone season programs beginning in 2009 and the SO2 annual program beginning in 2010.

    On August 8, 2011 (76 FR 48208), acting on the D.C. Circuit's remand, EPA promulgated CSAPR to replace CAIR in order to address the interstate transport of emissions contributing to nonattainment and interfering with maintenance of the two air quality standards covered by CAIR as well as the 2006 PM2.5 NAAQS. CSAPR required EGUs in affected states, including Virginia, to participate in federal trading programs to reduce annual SO2, annual NOX, and/or ozone season NOX emissions. The rule also contained provisions that would sunset CAIR-related obligations on a schedule coordinated with the implementation of the CSAPR compliance requirements. CSAPR was intended to become effective January 1, 2012; however, the timing of CSAPR's implementation was impacted by a number of court actions.

    Numerous parties filed petitions for review of CSAPR in the D.C. Circuit, and on December 30, 2011, the D.C. Circuit stayed CSAPR prior to its implementation and ordered EPA to continue administering CAIR on an interim basis. On August 21, 2012, the D.C. Circuit issued its ruling, vacating and remanding CSAPR to EPA and ordering continued implementation of CAIR. EME Homer City Generation, L.P. v. EPA, 696 F.3d 7, 38 (D.C. Cir. 2012). The D.C. Circuit's vacatur of CSAPR was reversed by the United States Supreme Court on April 29, 2014, and the case was remanded to the D.C. Circuit to resolve remaining issues in accordance with the Supreme Court's ruling. EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014). On remand, the D.C. Circuit affirmed CSAPR in most respects but remanded certain state emissions budgets, including Virginia's Phase 2 budget for ozone season NOX emissions. EME Homer City Generation, L.P. v. EPA (EME Homer City II), 795 F.3d 118, 138 (D.C. Cir. 2015).

    Throughout the initial round of D.C. Circuit proceedings and the ensuing Supreme Court proceedings, the stay on CSAPR remained in place, and EPA continued to implement CAIR. Following the April 2014 Supreme Court decision, EPA filed a motion asking the D.C. Circuit to lift the stay in order to allow CSAPR to replace CAIR in an equitable and orderly manner while further D.C. Circuit proceedings were held to resolve remaining claims from petitioners. Additionally, EPA's motion requested delay, by three years, of all CSAPR compliance deadlines that had not passed as of the approval date of the stay. On October 23, 2014, the D.C. Circuit granted EPA's request, and on December 3, 2014 (79 FR 71663), in an interim final rule, EPA set the updated effective date of CSAPR as January 1, 2015, and delayed the implementation of CSAPR Phase I to 2015 and CSAPR Phase 2 to 2017. In accordance with the interim final rule, EPA stopped administering the CAIR state and federal trading programs with respect to emissions occurring after December 31, 2014, and EPA began implementing CSAPR on January 1, 2015.3

    3 EPA solicited comment on the interim final rule and subsequently issued a final rule affirming the amended compliance schedule after consideration of comments received. 81 FR 13275 (March 14, 2016).

    In October 2016, EPA promulgated the CSAPR Update (81 FR 74504, October 26, 2016) to address interstate transport of ozone pollution with respect to the 2008 ozone NAAQS, and issued FIPs that established or updated ozone season NOX budgets for 22 states, including Virginia. Starting in January 2017, the CSAPR Update budgets were implemented via modifications to the CSAPR NOX ozone season allowance trading program that was established under the original CSAPR.

    As noted above, starting in January 2015, the CSAPR federal trading programs for annual NOX, ozone season NOX, and annual SO2 were applicable in Virginia. Thus, since January 1, 2015, EPA has not administered the CAIR state trading programs for annual NOX, ozone season NOX, or annual SO2 emissions established by the Virginia regulations.

    On January 5, 2017, the Commonwealth of Virginia, through the Virginia Department of Environmental Quality (VADEQ), formally submitted a SIP revision (Revision D16) that requests removal from its SIP of Virginia Administrative Code regulations including 9 VAC 5 Chapter 140: Part II—NOX Annual Trading Program; Part III—NOX Ozone Season Trading Program; and Part IV—SO2 Annual Trading Program (Sections 5-140-1010 through 5-140-3880), which implemented the CAIR annual NOX, ozone season NOX, and annual SO2 trading programs in Virginia.4

    4 EPA notes that Virginia's January 5, 2017 SIP revision does not request removal of the regulations under 9 VAC 5 Chapter 140: Part I—NOX Budget Trading Program, which include regulations addressing the continuous emission monitoring requirements of 40 CFR part 75 for non-EGUs covered by the NOX SIP Call (Part 75 rule). Therefore, this rulemaking action does not apply to regulations under 9 VAC 5 Chapter 140: Part I—NOX Budget Trading Program, including those related to the part 75 rule.

    On September 28, 2017, EPA simultaneously published a notice of proposed rulemaking (NPR) (82 FR 45241) and a direct final rule (DFR) (82 FR 45187) for Virginia approving, as a SIP revision, the removal of the regulations under 9 VAC 5 Chapter 140: Part II—NOX Annual Trading Program; Part III—NOX Ozone Season Trading Program; and Part IV—SO2 Annual Trading Program (Sections 5-140-1010 through 5-140-3880), which implemented the CAIR annual NOX, ozone season NOX, and annual SO2 trading programs in Virginia, from the Virginia SIP. EPA received adverse comments on the rulemaking and withdrew the DFR prior to the effective date of November 27, 2017. See 82 FR 55052 (November 20, 2017). In the NPR, EPA had proposed to approve the SIP revision, which would remove from the Virginia SIP the regulations under 9 VAC 5 Chapter 140 that implemented the CAIR annual NOX, ozone season NOX, and annual SO2 trading programs. In this final rulemaking, EPA is responding to the comments submitted on the proposed revision to the Virginia SIP and is approving, as a SIP revision, the removal of these regulations from the Virginia SIP.

    II. Summary of SIP Revision and EPA Analysis

    VADEQ's January 5, 2017 SIP revision requests the removal of regulations from the Virginia SIP under 9 VAC 5 Chapter 140: Part II—NOX Annual Trading Program, Part III—NOX Ozone Season Trading Program, and Part IV—SO2 Annual Trading Program (Sections 5-140-1010 through 5-140-3880), which implemented the state's CAIR annual NOX, ozone season NOX, and annual SO2 trading programs. EPA has not administered the trading programs established by these regulations since January 1, 2015, when the CSAPR trading programs replaced the CAIR programs, and the state CAIR regulations have been repealed in their entirety from the Virginia Administrative Code. The amendments removing these regulations were adopted by the State Air Pollution Control Board on September 9, 2016, and were effective as of November 16, 2016.

    As noted previously, the CAIR annual NOX, ozone season NOX, and annual SO2 trading programs addressed interstate transport of emissions under the 1997 PM2.5 NAAQS and the 1997 ozone NAAQS. The D.C. Circuit remanded CAIR to EPA for replacement, and in response EPA promulgated CSAPR which, among other things, fully addresses Virginia's interstate transport obligation under the 1997 PM2.5 NAAQS. See 76 FR at 48210. EPA stopped administering the CAIR trading programs after 2014 and instead began implementing the CSAPR trading programs in 2015. EPA had also determined that CSAPR would fully address Virginia's interstate transport obligation under the 1997 ozone NAAQS, id., but the D.C. Circuit later remanded Virginia's CSAPR Phase 2 budget for ozone season NOX, finding that the CSAPR rulemaking record did not support EPA's determination of a transport obligation under the 1997 ozone NAAQS for Virginia in CSAPR Phase 2, EME Homer City II, 795 F.3d at 129-30, and in response to the Court's decision EPA withdrew Virginia's remanded budget.5 Thus, none of Virginia's three CAIR state rules still plays any role in addressing the transport obligations that the state initially adopted the rules to address: The CAIR trading programs are no longer being administered; the state's transport obligation under the 1997 PM2.5 NAAQS is now being addressed by the CSAPR trading programs for annual NOX and SO2; and the state no longer has a transport obligation under the 1997 ozone NAAQS.

    5 The replacement ozone season NOX budget established for Virginia in the CSAPR Update addresses (in part) the state's transport obligation under the 2008 ozone NAAQS rather than the 1997 ozone NAAQS.

    Virginia's CAIR trading programs for annual NOX and SO2 were adopted only to address Virginia's transport obligation under the 1997 PM2.5 NAAQS, one of the two NAAQS underlying EPA's CAIR rules. In contrast, Virginia's CAIR trading program for ozone season NOX was adopted to address not only Virginia's transport obligation under the 1997 ozone NAAQS (the other NAAQS underlying EPA's CAIR rules), but also Virginia's ongoing obligations under the NOX SIP Call.6 Specifically, under the NOX SIP Call the Virginia SIP, first, must include enforceable control measures for large EGUs and large non-EGUs and, second, must require those sources to monitor and report ozone season NOX emissions in accordance with 40 CFR part 75. See 40 CFR 51.121(f)(2) and (i)(4). Virginia's EGUs are currently subject to requirements under the federal CSAPR trading program for ozone season NOX that address the purpose of these NOX SIP Call requirements as to EGUs, but because Virginia's non-EGUs are not subject to that CSAPR trading program, the state must meet these requirements for non-EGUs through other SIP provisions.

    6 The NOX SIP Call addresses states' transport obligations under the 1979 ozone NAAQS.

    With respect to the NOX SIP Call requirement for the SIP to include part 75 monitoring requirements, Virginia's SIP still includes the state's NOX Budget Trading Program rules, and those rules continue to require non-EGUs to monitor and report ozone season NOX emissions under part 75 even though EPA is no longer administering the trading program provisions of the state's rules. Thus, removal of the state's CAIR rules for ozone season NOX emissions from Virginia's SIP will not eliminate the required SIP provisions for part 75 monitoring by non-EGUs under the NOX SIP Call because the SIP will still include the equivalent provisions in the state's NOX Budget Trading Program rules.

    With respect to the NOX SIP Call requirement for the SIP to include enforceable control measures for non-EGUs, Virginia formerly met the requirement by including these sources in the state's CAIR trading program for ozone season NOX emissions. When EPA initially replaced the CAIR trading programs with the CSAPR trading programs in 2015, the CSAPR regulations did not provide an option for states to expand trading program applicability to include these non-EGUs. In the CSAPR Update, EPA restored the option to include these EGUs in the current CSAPR trading program for ozone season NOX starting in 2019, but Virginia has not elected this option. Accordingly, since January 1, 2015, when the CSAPR federal trading program became effective in Virginia and EPA stopped administering the CAIR trading programs, the Virginia SIP has not contained an effective regulation addressing the NOX SIP Call requirement for enforceable control measures for non-EGUs that formerly participated in the state's NOX Budget Trading Program. However, Virginia's request in its January 5, 2017 SIP seeking removal from its SIP of 9 VAC 5 Chapter 140: Part III—NOX Ozone Season Trading Program and EPA's action to approve the January 5, 2017 submittal did not create this gap in coverage under the Virginia SIP. Rather, as described above, the gap predates the SIP submittal at issue in this action, and approval of the SIP submittal will not exacerbate or otherwise affect the gap. According to Virginia, the Commonwealth is in the process of drafting a regulation to address the Commonwealth's obligations under the NOX SIP Call (including its obligation to address these non-EGUs which formerly participated in the state's CAIR trading program for ozone season NOX emissions). In remedying its provisions to address the NOX SIP Call, Virginia must satisfy the requirements of 40 CFR 51.121(f)(2) for the SIP to include enforceable control measures for non-EGUs that are stationary, fossil fuel-fired boilers, combustion turbines, or combined cycle systems with a maximum design heat input greater than 250 MMBtu/hr. EPA expects Virginia will submit such provisions to EPA to be included in Virginia's SIP, and EPA will review and act on any such SIP submittal from Virginia addressing the Commonwealth's NOX SIP Call obligations in a separate rulemaking.

    In summary, Virginia's CAIR rules at 9 VAC 5, Chapter 140: Part II-NOX Annual Trading Program, Part III—NOX Ozone Season Trading Program, and Part IV—SO2 Annual Trading Program (sections 5-140-1010 through 5-140-3880) no longer play any role in addressing the transport obligations that the rules were adopted to address, and removal of the rules from the SIP will not introduce any new gaps with respect to the additional purposes that the rules served with respect to addressing the state's ongoing obligations under the NOX SIP Call. EPA therefore finds Virginia's January 5, 2017 SIP revision requesting removal of these CAIR rules from the SIP approvable in accordance with section 110 of the CAA. The public comments received on the NPR are discussed in Section III of this rulemaking action.

    III. Public Comments and EPA's Response

    EPA received two public comments on our September 28, 2017 action to approve Virginia's January 5, 2017 SIP submittal that requests the removal of the regulations under 9 VAC 5 Chapter 140: Part II—NOX Annual Trading Program; Part III—NOX Ozone Season Trading Program; and Part IV—SO2 Annual Trading Program (Sections 5-140-1010 through 5-140-3880), which implemented the state's CAIR annual NOX, ozone season NOX, and annual SO2 trading programs, from the Virginia SIP. The comment submitted on October 7, 2017 was not specific to this rulemaking action and will not be addressed here.

    Comment: The commenter stated that “EPA needs to ensure that the NOX SIP call sources” are addressed in the Virginia SIP. The commenter also requested that EPA not remove CAIR in Virginia, citing its public health benefits.

    EPA Response to Comment: As discussed in Section II, the CAIR trading programs are no longer being administered, and for that reason removing Virginia's CAIR rules from the state's SIP will have no consequences for any source's operations or emissions or for public health. EPA also notes that removal of the state's CAIR rules from the state's SIP does not eliminate requirements for the state's EGUs and non-EGUs to monitor and report their ozone season NOX emissions in accordance with 40 CFR part 75 as required under the NOX SIP Call. The EGUs continue to be subject to part 75 requirements under the current CSAPR trading program rules, and the non-EGUs continue to be subject to part 75 requirements under the state's NOX Budget Trading Program rules, which are still included in the state's SIP.

    EPA agrees that under the NOX SIP Call, the Virginia SIP must include enforceable control measures for ozone season NOX emissions from non-EGUs, such as stationary, fossil fuel-fired boilers, combustion turbines, or combined cycle systems with a maximum design heat input greater than 250 MMBtu/hr, that formerly participated in the state's NOX SIP Call trading program and CAIR trading program for ozone season NOX emission. This requirement for the SIP to include enforceable control measures was formerly met by the SIP provisions requiring these sources to participate in the state's NOX Budget Trading Program and then the state's CAIR trading program for ozone season NOX emissions. However, since 2015, when EPA began implementing the CSAPR trading programs and stopped administering the CAIR trading programs in response to the D.C. Circuit's remand of CAIR, Virginia's SIP has not included enforceable control measures for NOX emissions from these non-EGUs. This gap in SIP coverage was caused by the discontinuation of the CAIR trading programs and predates the SIP submittal at issue in this action. Removing the state's CAIR rules from the SIP at this time will not exacerbate or otherwise affect this pre-existing lack of enforceable control measures in the SIP. As stated above in Section II, according to Virginia, the Commonwealth is in the process of drafting a regulation to address the Commonwealth's obligation under the NOX SIP Call with respect to NOX emissions from these non-EGUs, which includes the requirement for enforceable control measures. EPA expects Virginia will submit such provisions to EPA to be included in Virginia's SIP, and EPA will review and act on any such SIP submittal from Virginia addressing the Commonwealth's NOX SIP Call obligations in a separate rulemaking.

    IV. Final Action

    EPA is approving the Virginia SIP revision submitted on January 5, 2017 that sought removal from the Virginia SIP of regulations under 9 VAC 5 Chapter 140: Part II—NOX Annual Trading Program; Part III—NOX Ozone Season Trading Program; and Part IV—SO2 Annual Trading Program (Sections 5-140-1010 through 5-140-3880), which implemented the state's CAIR annual NOX, ozone season NOX, and annual SO2 trading programs. Removal of these regulations from the Virginia SIP is in accordance with section 110 of the CAA. This rule, which responds to the adverse comments received, finalizes our proposed approval of Virginia's January 5, 2017 SIP submittal.

    V. General Information Pertaining to SIP Submittals From the Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

    On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce federally authorized environmental programs in a manner that is no less stringent than their federal counterparts. . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by federal law to maintain program delegation, authorization or approval.”

    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with federal law, which is one of the criteria for immunity.”

    Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

    VI. Statutory and Executive Order Reviews A. General Requirements

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

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

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

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

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

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

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

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

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

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

    The SIP is not approved to apply on any Indian reservation land as defined in 18 U.S.C. 1151 or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    B. Submission to Congress and the Comptroller General

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

    C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 14, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

    This action removing from the Virginia SIP regulations under Sections 5-140-1010 through 5-140-3880 of 9 VAC 5 Chapter 140 that implemented the CAIR annual NOX, ozone season NOX, and annual SO2 trading programs may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2)).

    List of Subjects in 40 CFR Part 52

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

    Dated: February 23, 2018. Cosmo Servidio, Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart VV—Virginia
    § 52.2420 [Amended]
    2. In § 52.2420, the table in paragraph (c) is amended by: a. Removing the table heading “Part II—NOX Annual Trading Program”; the table subheading “Article 1 CAIR NOX Annual Trading Program General Provisions” and the entries “5-140-1010” through “5-140-1080”; the table subheading “Article 2 CAIR-designated Representative for CAIR NOX Sources” and the entries “5-140-1100” through “5-140-1150”; the table subheading “Article 3 Permits” and the entries “5-140-1200” through “5-140-1240”; the table subheading “Article 5 CAIR NOX Allowance Allocations” and the entries “5-140-1400” through “5-140-1430”; the table subheading “Article 6 CAIR NOX Allowance Tracking System” and the entries “5-140-1510” through “5-140-1570”; the table subheading “Article 7 CAIR NOX Allowance Transfers” and the entries “5-140-1600” through “5-140-1620”; the table subheading “Article 8 Monitoring and Reporting” and the entries “5-140-1700” through “5-140-1750”; the table subheading “Article 9 CAIR NOX Opt-in Units” and the entries “5-140-1800” through “5-140-1880”. b. Removing the table heading “Part III NOX Ozone Season Trading Program”; the table subheading “Article 1 CAIR NOX Ozone Season Trading Program General Provisions” and the entries “5-140-2010” through “5-140-2080”; the table subheading “Article 2 CAIR-Designated Representative for CAIR NOX Ozone Season Sources” and the entries “5-140-2100” through “5-140-2150”; the table subheading “Article 3 Permits” and the entries “5-140-2200” through “5-140-2240”; the table subheading “Article 5 CAIR NOX Ozone Season Allowance Allocations” and the entries “5-140-2400” through “5-140-2430”; the table subheading “Article 6 CAIR NOX Ozone Season Allowance Tracking System” and the entries “5-140-2510” through “5-140-2570”; the table subheading “Article 7 CAIR NOX Ozone Season Allowance Transfers” and the entries “5-140-2600” through “5-140-2620”; the table subheading “Article 8 Monitoring and Reporting” and the entries “5-140-2700” through “5-140-2750”; the table subheading “Article 9 CAIR NOX Ozone Season Opt-in Units” and the entries “5-140-2800” through “5-140-2880”. c. Removing the table heading “Part IV—SO2 Annual Trading Program”; the table subheading “Article 1 CAIR SO2 Trading Program General Provisions” and the entries “5-140-3010” through “5-140-3080”; the table subheading “Article 2 CAIR-designated Representative for CAIR SO2 Sources” and the entries “5-140-3100” through “5-140-3150”; the table subheading “Article 3 Permits” and the entries “5-140-3200” through “5-140-3240”; the table subheading “Article 5 CAIR SO2 Allowance Allocations” and the entries “5-140-3400” through “5-140-3420”; the table subheading “Article 6 CAIR SO2 Allowance Tracking System” and the entries “5-140-3510” through “5-140-3570”; the table subheading “Article 7 CAIR SO2 Allowance Transfers” and the entries “5-140-3600” through “5-140-3620”; the table subheading “Article 8 Monitoring and Reporting” and the entries “5-140-3700” through “5-140-3750”; the table subheading “Article 9 CAIR SO2 Opt-in Units” and the entries “5-140-3800” through “5-140-3880”.
    [FR Doc. 2018-04935 Filed 3-12-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R05-OAR-2017-0256; FRL-9975-46-Region 5] Air Plan Approval; Ohio; Redesignation of the Delta, Ohio Area to Attainment of the 2008 Lead Standard AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving the State of Ohio's request to redesignate the portion of Fulton County, Ohio known as the Delta nonattainment area (Delta area) to attainment of the 2008 National Ambient Air Quality Standards (NAAQS or standard) for lead. EPA is also approving, as meeting Clean Air Act (CAA) requirements, the maintenance plan and related elements of the redesignation, reasonably available control measure (RACM)/reasonably available control technology (RACT) measures and a comprehensive emissions inventory. EPA is taking these actions in accordance with the CAA and EPA's implementation regulations regarding the 2008 lead NAAQS.

    DATES:

    This final rule is effective on March 13, 2018.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2017-0256. All documents in the docket are listed on the www.regulations.gov website. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy form. Publicly available docket materials are available either through www.regulations.gov or at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays. We recommend that you telephone Matt Rau, Environmental Engineer at (312) 886-6524 before visiting the Region 5 office.

    FOR FURTHER INFORMATION CONTACT:

    Matt Rau, Environmental Engineer, Control Strategies Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6524, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

    I. What is the background? II. What are EPA's responses to the comments? III. What action is EPA taking? IV. Statutory and Executive Order Reviews V. Judicial Review I. What is the background?

    On November 12, 2008 (73 FR 66964), EPA established the 2008 primary and secondary lead NAAQS at 0.15 micrograms per cubic meter (μg/m3) based on a maximum arithmetic three-month mean concentration for a three-year period. 40 CFR 50.16.

    On November 22, 2010 (75 FR 71033), EPA published its initial air quality designations and classifications for the 2008 lead NAAQS based upon air quality monitoring data for calendar years 2007-2009. These designations became effective on December 31, 2010. The Delta area portion of Fulton County was designated as nonattainment for lead, specifically portions of Swan Creek and York Townships. 40 CFR 81.336. On May 26, 2015 (80 FR 29964), EPA issued a Clean Data Determination, which determined that the Delta area attained the 2008 lead NAAQS prior to its attainment date of December 31, 2015.

    On April 27, 2017, Ohio requested EPA to redesignate the Delta area to attainment of the 2008 lead NAAQS and provided documentation in support of its request. On October 18, 2017 (82 FR 48442), EPA issued a direct final rule approving Ohio's request to redesignate the Delta area to attainment. However, since EPA received relevant adverse comments on this action within the prescribed period, EPA withdrew the direct final rule. EPA had also proposed to approve the request to redesignate the Delta area to attainment of the 2008 lead NAAQS on October 18, 2017 (82 FR 48474). This action is a final rule based on the October 18, 2017 proposal.

    The requirements for redesignating an area from nonattainment to attainment are found in CAA section 107 (d)(3)(E). There are five criteria for redesignating an area. First, the Administrator must determine that the area has attained the applicable NAAQS based on current air quality data. Second, the Administrator must have fully approved the applicable SIP for the area under CAA section 110(k). The third criterion is for the Administrator to determine that the air quality improvement is the result of permanent and enforceable emission reductions. Fourth, the Administrator must have fully approved a maintenance plan meeting the CAA section 175A requirements. The fifth criterion is that the state has met all of the applicable requirements of CAA section 110 and part D.

    The direct final rule published on October 18, 2017 (82 FR 48442) details how the Delta area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA. In summary, EPA's approval of the RACM/RACT measures satisfies section 172 (c)(1) of the CAA. EPA is approving Ohio's 2013 emissions inventories for the Delta area as meeting the requirement of section 172(c)(3) of the CAA. EPA finds that the other requirements of CAA section 172(c) are not applicable because the Delta area has monitored attainment of the 2008 lead NAAQS. Further, EPA is approving Ohio's maintenance plan as it adequately addresses the requirements of section 175A of the CAA.

    II. What are EPA's responses to the comments?

    EPA received an anonymous comment on November 16, 2017. The comment is discussed below along with a response from EPA.

    Comment: The commenter stated, “In 2009 the areas [sic] design value for lead was 0.18 and dropped significantly to 0.09 in 2012, but in 2014 the design value increased significantly back up to 0.12. This shows that the area hasn't maintained a consistent level that shows attainment below 0.15.” The commenter further stated that, “EPA shouldn't approve the re-designation request until the Fulton area shows better improvement in the monitored lead design values. EPA should wait until the lead levels become steady without increasing.” The commenter further states, “EPA needs to take lead violations seriously.”

    Response: EPA disagrees with the commenter that the variability in the area's design value prohibits a redesignation to attainment. The statute does not require an area's design value to “maintain a consistent level” at its lowest recorded value or “become steady without increasing,” but rather requires that the air quality in the area is attaining the standard. In this case, though there was a fluctuation in the area's design values. Those values have remained below the level of the 2008 NAAQS for the relevant period, and, contrary to commenter's suggestion, has not violated the standard. Since the Bunting Bearing Company's Delta, Ohio facility (Bunting), identified by Ohio as the only point source of lead emissions in the nonattainment area, improved its lead emission controls in 2012 by adding required inspections, leak detection systems, corrective actions, and recordkeeping, the area has been consistently attaining the standard. Those controls are permanent and federally enforceable. Thus EPA has reasonably determined that, in accordance with the statute, the area is attaining and that the attainment is due to permanent and enforceable measures.

    Comment: The commenter also asked, “what happens if the area's lead levels increase another 0.03?”

    Response: An increase from the 2014-2016 design value of 0.12 µg/m3 to 0.15 µg/m3 would mean that the area would still be in attainment of the 2008 lead NAAQS and public health would remain protected. More importantly, Ohio's maintenance plan for the Delta area has contingency measures that help prevent NAAQS violations and that address violations if they occur. As part of its contingency measures, the state has committed that a “warning” level response is triggered if the lead concentration reaches 0.135 µg/m3 on a three-month rolling average. If a warning level response is triggered, Ohio will conduct a study to determine whether the lead values indicate a trend toward exceeding the standard and what control measures would be necessary to reverse the trend within 12 months of the conclusion of the calendar year. An “action” level response is triggered if the lead concentration reaches a level at or above 0.143 µg/m3 on a three-month rolling average. The action level response will require Ohio to work with the entity found to be responsible for the ambient concentration to evaluate and implement the needed control measures to bring the area into attainment within 18 months of the conclusion of the calendar year that triggered the response. Should the 2008 lead NAAQS be violated during the maintenance period, Ohio will implement one or more contingency measures. The contingency measures will be considered based on the cause of the elevated lead levels. Potential measures include improvements to existing control devices, the addition of a secondary control device, and improvements to housekeeping and maintenance. EPA has determined that the contingency measures are adequate to promptly correct a violation of the ambient lead NAAQS.

    III. What action is EPA taking?

    EPA is approving the request from Ohio to change the legal designation of the Delta area from nonattainment to attainment for the 2008 lead NAAQS. EPA is approving Ohio's maintenance plan for the Delta area as a revision to the Ohio SIP because we have determined that the plan meets the requirements of section 175A of the CAA. EPA is approving the emission controls in Air Pollution Permits-to-Install and Operate P0108083, P0121822, P0120836, and P0121942 all issued to Bunting as meeting the RACM/RACT requirements of CAA section 172(c)(1).

    Specifically, EPA is approving the necessary elements from the permits, emission limits and Preventive Maintenance Plan conditions, into the Ohio SIP rather than the entirety of the permits. The emission limits are for units controlled with Baghouse A: 0.150 pounds per hour combined limit, Baghouse B: 0.150 pounds per hour combined limit, and Baghouse C: 0.075 pounds per hour combined limit. The approved specific required elements of the Preventive Maintenance Plan are detailed on pages 24 to 26 of Ohio's “Redesignation Request and Maintenance Plan for the Partial Fulton County, OH Annual Lead Nonattainment Area,” submitted in April 2017. In summary, the required elements are five elements of inspections, three elements of fabric filter leak detection systems, three elements of corrective actions, and five elements of records.

    EPA is approving the 2013 emissions inventory as meeting the comprehensive emissions inventory requirements of section 172(c)(3) of the CAA. EPA is taking these actions in accordance with the CAA and EPA's implementation regulations regarding the 2008 lead NAAQS.

    In accordance with 5 U.S.C. 553(d), EPA finds there is good cause for these actions to become effective immediately upon publication. This is because a delayed effective date is unnecessary due to the nature of a redesignation to attainment, which relieves the area from certain CAA requirements that would otherwise apply to it. The immediate effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rulemaking actions may become effective less than 30 days after publication if the rule “grants or recognizes an exemption or relieves a restriction,” and section 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. This rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, this rule relieves the state of planning requirements for this lead nonattainment area. For these reasons, EPA finds good cause under 5 U.S.C. 553(d)(1) and (3) for these actions to become effective on the date of publication of these actions.

    IV. Statutory and Executive Order Reviews

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

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

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

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

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

    V. Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 14, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

    List of Subjects 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Lead, Reporting and recordkeeping requirements.

    40 CFR Part 81

    Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Intergovernmental relations, Lead, Reporting and recordkeeping requirements.

    Dated: February 27, 2018. Cathy Stepp, Regional Administrator, Region 5.

    40 CFR parts 52 and 81 are amended as follows:

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

    42 U.S.C. 7401 et seq.

    2. In § 52.1870, the table in paragraph (e) is amended by adding the entry “Lead (2008)” after the entry “Lead (2008)” (with the State date of 6/29/2016) to read as follows:
    § 52.1870 Identification of plan.

    (e) * * *

    EPA-Approved Ohio Nonregulatory and Quasi-Regulatory Provisions Title Applicable geographical or non-attainment area State date EPA approval Comments *         *         *         *         *         *         * Summary of Criteria Pollutant Maintenance Plan *         *         *         *         *         *         * Lead (2008) Delta (partial Fulton County) 4/27/2017 3/13/2018, [insert Federal Register citation] Includes approval of the 2013 lead base year emissions inventory and Preventative Maintenance Plan as RACM/RACT for the Bunting Bearing LLC Delta facility. *         *         *         *         *         *         *
    3. Section 52.1893 is amended by adding paragraphs (f), (g), and (h) to read as follows:
    § 52.1893 Control strategy: Lead (Pb).

    (f) Ohio's 2013 lead emissions inventory for the Delta area, submitted on April 27, 2017, to meet the emission inventory requirements of section 172(c)(3) of the Clean Air Act for the Delta area.

    (g) Approval—The 2008 lead maintenance plan for the Delta, Ohio nonattainment area, submitted on April 27, 2017.

    (h) Existing controls and maintenance provisions in the Air Pollution Permits-to-Install and Operate P0108083, P0121822, P0120836, and P0121942 for the Bunting Bearing LLC Delta facility including the preventative maintenance plan as fulfilling the RACM/RACT 172(c)(1) requirement. Permits P0120836, P0121822, and P0121942, all issued February 28, 2017, require a combined limit of 0.150 pounds lead per hour for units P006 to P011, P013, P020 to P025, P029 to P032, P035, and P036. Permit P0108083, issued October 29, 2012, requires a combined limit of 0.150 pounds lead per hour for units P014 to P019 and P028 and a combined limit of 0.075 pounds lead per hour for unit P005.

    PART 81—DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES 4. The authority citation for part 81 continues to read as follows: Authority:

    42 U.S.C. 7401, et seq.

    5. Section 81.336 is amended by revising the entry “Delta, OH:” in the table entitled “Ohio—2008 Lead NAAQS” to read as follows:
    § 81.336 Ohio. Ohio—2008 Lead NAAQS Designated area Designation for the 2008 NAAQS a Date 1 Type *         *         *         *         *         *         * Delta, OH: 3/13/2018 Attainment. Fulton County (part) The portions of Fulton County that are bounded by: sections 12 and 13 of York Township and sections 7 and 18 of Swan Creek Township *         *         *         *         *         *         * a Includes Indian Country located in each county or area, except as otherwise specified. 1 December 31, 2011 unless otherwise noted.
    [FR Doc. 2018-05057 Filed 3-12-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 10 [PS Docket No. 15-91; PS Docket No. 15-94; FCC 18-4] Wireless Emergency Alerts; Emergency Alert System; Correction AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule; correction.

    SUMMARY:

    The Federal Communications Commission (Commission) published a document in the Federal Register of February 28, 2018, concerning revisions to Wireless Emergency Alert (WEA) rules to improve utility of WEA as a life-saving tool. The document contained an incorrect compliance date.

    DATES:

    This correction is effective April 30, 2018.

    FOR FURTHER INFORMATION CONTACT:

    James Wiley, Attorney Advisor, Cybersecurity and Communications Reliability Division, Public Safety and Homeland Security Bureau, at 202-418-2410.

    SUPPLEMENTARY INFORMATION:

    Correction

    In the Federal Register of February 28, 2018, in FR Doc. 2018-03990, on page 8619, in the third column, correct the DATES caption to read:

    DATES:

    Effective dates: The amendments to §§ 10.10 and 10.210 are effective April 30, 2018. The amendments to §§ 10.450 and 10.500 are effective November 30, 2019. The amendment to § 10.240 contains new or modified information collection requirements and will not be effective until those information collection requirements are approved by the Office of Management and Budget. The Federal Communications Commission will publish a document in the Federal Register announcing the effective date for the section.

    Compliance dates: Participating CMS Providers must comply with the new point of sale disclosure rules by November 30, 2019, or as specified by publication in the Federal Register of a document announcing approval by the Office of Management and Budget (OMB) and the relevant effective date, whichever is later. CMS Providers are required to update their WEA election status within 120 days from the date of publication in the Federal Register of a document announcing approval by the Office of Management and Budget of the modified information collection requirements.

    Applicability date: The requirement to support Spanish language Alert Messages in § 10.480 is applicable beginning May 1, 2019.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-04969 Filed 3-12-18; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket No. 10-90; FCC 14-54 and 16-64] Connect America Fund AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule; announcement of effective date.

    SUMMARY:

    In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, an information collection associated with the rules for the Connect America Fund Phase II auction (CAF-II auction) contained in the Commission's Connect America Fund Orders, FCC 14-54 and FCC 16-64. This document is consistent with the Connect America Fund Orders, which stated that the Commission would publish a document in the Federal Register announcing the effective date of the new information collection requirements.

    DATES:

    The amendment to § 54.310(e) published at 79 FR 39164, July 9, 2014, is effective March 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Alexander Minard, Wireline Competition Bureau at (202) 418-7400 or TTY (202) 418-0484. For additional information concerning the Paperwork Reduction Act information collection requirements contact Nicole Ongele at (202) 418-2991 or via email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Commission submitted new information collection requirements for review and approval by OMB, as required by the Paperwork Reduction Act (PRA) of 1995, on December 12, 2017, which were approved by the OMB on March 5, 2018. The information collection requirements are contained in the Commission's Connect America Fund Orders, FCC 14-54, published at 79 FR 39164, July 9, 2014 and FCC 16-64, published at 81 FR 44414, July 7, 2016. The OMB Control Number is 3060-1252. The Commission publishes this document as an announcement of the effective date of the rules published July 9, 2014. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1-A620, 445 12th Street SW, Washington, DC 20554. Please include the OMB Control Number, 3060-1252, in your correspondence. The Commission will also accept your comments via email at [email protected] 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).

    Synopsis

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received OMB approval on March 5, 2018, for the information collection requirements contained in 47 CFR 54.310(e) and 54.315(a), published at 79 FR 39164, July 9, 2014 and 81 FR 44414, July 7, 2016. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1252.

    The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

    The total annual reporting burdens and costs for the respondents are as follows:

    OMB Control Number: 3060-1252.

    OMB Approval Date: March 5, 2018.

    OMB Expiration Date: March 31, 2021.

    Title: Application to Participate in Connect America Fund Phase II Auction, FCC Form 183.

    Form No.: FCC Form 183.

    Respondents: Business or other for-profit, not-for-profit institutions, and state, local or tribal governments.

    Number of Respondents and Responses: 500 respondents; 500 responses.

    Estimated Time per Response: 7 hours.

    Frequency of Response: On occasion reporting requirements.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154(i), 214, 254, and 303(r).

    Total Annual Burden: 3,500 hours.

    Total Annual Cost: No Cost.

    Nature and Extent of Confidentiality: Although most information collected in FCC Form 183 will be made available for public inspection, the Commission will withhold certain information collected in FCC Form 183 from routine public inspection. Specifically, the Commission will treat certain technical information submitted in FCC Form 183 as confidential and as though the applicant has requested that this information be treated as confidential trade secrets and/or commercial information. In addition, an applicant may use the abbreviated process under 47 CFR 0.459(a)(4) to request confidential treatment of certain financial information contained in its FCC Form 183 application. However, if a request for public inspection for this technical or financial information is made under 47 CFR 0.461, and the applicant has any objections to disclosure, the applicant will be notified and will be required to justify continued confidential treatment of its request. To the extent that a respondent seeks to have other information collected in FCC Form 183 withheld from public inspection, the respondent may request confidential treatment pursuant to 47 CFR 0.459.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: The Commission will use the information collected to determine whether applicants are eligible to participate in the CAF-II auction. In its USF/ICC Transformation Order and Further Notice of Proposed Rulemaking, 76 FR 78385 (Dec. 16, 2011), WC Docket No. 10-90 et al., FCC 11-161, the Commission comprehensively reformed and modernized the high-cost program within the universal service fund to focus support on networks capable of providing voice and broadband services. The Commission created the Connect America Fund and concluded that support in price cap areas would be provided through a combination of “a new forward-looking model of the cost of constructing modern multi-purpose networks” and a competitive bidding process (the CAF-II auction). The Commission also sought comment on proposed rules governing the CAF-II auction, including options regarding basic auction design and the application process.

    In the CAF-II auction, service providers will compete to receive support of up to $1.98 billion over 10 years to offer voice and broadband service in unserved high-cost areas. To implement reform and conduct the CAF-II auction, the Commission adopted new rules for the CAF-II auction which include new information collections. In its April 2014 Connect America Order, WC Docket No. 10-90 et al., FCC 14-54, the Commission adopted certain rules regarding participation in the CAF-II auction, the term of support, and the ETC designation process. In its Phase II Auction Order, WC Docket No. 10-90 et al., FCC 16-64, the Commission adopted rules to implement the CAF-II auction, including the adoption of a two-stage application process. Based on the Commission's experience with auctions and consistent with the record, this two-stage collection of information balances the need to collect information essential to conduct a successful auction with administrative efficiency.

    Under this information collection, the Commission will collect information that will be used to determine whether an applicant is legally qualified to participate in an auction for Connect America Fund Phase II support. To aid in collecting this information, the Commission has created FCC Form 183, which the public will use to provide the necessary information and certifications. Commission staff will review the information collected on FCC Form 183 as part of the pre-auction process, prior to the start of the auction, and determine whether each applicant satisfies the Commission's requirements to participate in an auction for CAF-II support. Without the information collected on FCC Form 183, the Commission will not be able to determine if an applicant is legally qualified to participate in the auction and has complied with the various applicable regulatory and statutory auction requirements for such participation. This approach provides an appropriate screen to ensure serious participation without being unduly burdensome.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2018-04945 Filed 3-12-18; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF VETERANS AFFAIRS 48 CFR Part 828 RIN 2900-AP82 Revise and Streamline VA Acquisition Regulation To Adhere to Federal Acquisition Regulation Principles (VAAR Case 2014-V002); Correction AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule; correction.

    SUMMARY:

    On February 21, 2018, the Department of Veterans Affairs (VA) published a final rule prescribing five new Economic Price Adjustment clauses for firm-fixed-price contracts, identifying VA's task-order and delivery-order ombudsman, clarifying the nature and use of consignment agreements, adding policy coverage on bond premium adjustments and insurance under fixed-price contracts, and providing for indemnification of contractors for medical research or development contracts. It contained an erroneous amendatory instruction citing the wrong CFR section. This document corrects that error.

    DATES:

    This correction is effective on March 23, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Ricky Clark, Senior Procurement Analyst, Procurement Policy and Warrant Management Services, 003A2A, 425 I Street NW, Washington, DC 20001, (202) 632-5276 (this is not a toll-free telephone number).

    SUPPLEMENTARY INFORMATION:

    In the final rule published February 21, 2018, at 83 FR 7401, effective March 23, 2018, an amendatory instruction intended for 48 CFR 828.306 cited incorrectly 38 CFR 816.306.

    Therefore, in FR Rule Doc. No. 2018-03164, on page 7404, at the top of the third column, correct amendatory instruction 12 to read as follows:

    12. Section 828.306 is amended by revising paragraph (a) to read as follows: Dated: March 8, 2018. Consuela Benjamin, Regulations Development Coordinator, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.
    [FR Doc. 2018-04985 Filed 3-12-18; 8:45 am] BILLING CODE 8320-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 170605543-7999-02] RIN 0648-XG021 Atlantic Highly Migratory Species; Commercial Blacktip Sharks, Aggregated Large Coastal Sharks, and Hammerhead Sharks in the Western Gulf of Mexico Sub-Region; Closure AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is closing the commercial fishery for blacktip sharks, aggregated large coastal sharks (LCS), and hammerhead shark management groups in the western Gulf of Mexico sub-region. This action is necessary because the commercial landings of sharks in the aggregated LCS management group in the western Gulf of Mexico sub-region for the 2018 fishing season has reached 80 percent of the available commercial quota as of March 8, 2018, and the aggregated LCS and hammerhead shark management groups are quota-linked under the regulations. The blacktip shark fishery in the western Gulf of Mexico sub-region will be closed to help minimize regulatory discards of sharks in the aggregated LCS management group in the western Gulf of Mexico sub-region, since LCS are often caught in conjunction with blacktip sharks in the commercial shark fisheries. This closure will affect anyone commercially fishing for sharks in the western Gulf of Mexico sub-region.

    DATES:

    The commercial fishery for blacktip sharks and for the aggregated LCS and hammerhead shark management groups in the western Gulf of Mexico sub-region are closed effective 11:30 p.m. local time March 13, 2018 until the end of the 2018 fishing season on December 31, 2018, or until and if NMFS announces via a notice in the Federal Register that additional quota is available and the season is reopened.

    FOR FURTHER INFORMATION CONTACT:

    Lauren Latchford or Karyl Brewster-Geisz 301-427-8503; fax 301-713-1917.

    SUPPLEMENTARY INFORMATION:

    The Atlantic shark fisheries are managed under the 2006 Consolidated Highly Migratory Species (HMS) Fishery Management Plan (FMP), its amendments, and implementing regulations (50 CFR part 635) issued under authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq.).

    Under § 635.5(b)(1), dealers must electronically submit reports on sharks that are first received from a vessel on a weekly basis through a NMFS-approved electronic reporting system. Reports must be received by no later than midnight, local time, of the first Tuesday following the end of the reporting week unless the dealer is otherwise notified by NMFS. Under § 635.28(b)(4), the quotas of certain species and/or management groups are linked. If quotas are linked, when the specified quota threshold for one management group or species is reached and that management group or species is closed, the linked management group or species closes at the same time (§ 635.28(b)(3)). The quotas for aggregated LCS and the hammerhead shark management groups in the western Gulf of Mexico sub-region are linked (§ 635.28(b)(4)(iii)). The blacktip shark quota in the western Gulf of Mexico sub-region is not linked to the aggregated LCS or hammerhead shark quotas.

    Under § 635.28(b)(2) and (3), when NMFS calculates that the landings for any species and/or management group of either a non-linked or a linked group have reached or are projected to reach a threshold of 80 percent of the available quota, NMFS will file for publication, with the Office of the Federal Register, a notice of closure for all of the species and/or management groups of either a non-linked or linked group that will be effective no fewer than five days from date of filing. For blacktip sharks, under § 635.28(b)(5), NMFS may close the regional or sub-regional Gulf of Mexico blacktip shark management group(s) before landings reach, or are expected to reach, 80 percent of the quota, after considering specified regulatory criteria and other relevant factors.

    From the effective date and time of the closure until and if NMFS announces, via a notice in the Federal Register, that additional quota is available and the season is reopened, the fisheries for all linked species and/or management groups and specified non-linked species and/or management groups are closed, even across fishing years.

    On November 22, 2017 (82 FR 55512), NMFS announced that for 2018, the commercial western Gulf of Mexico blacktip shark sub-regional quota was 347.2 metric tons (mt) dressed weight (dw) (765,392 lb dw), the western Gulf of Mexico aggregated LCS sub-regional quota was 72.0 mt dw (158,724 lb dw), and the western Gulf of Mexico hammerhead shark sub-regional quota was 11.9 mt dw (26,301 lb dw). Dealer reports received through March 8, 2018, indicate that 86 percent (61.7 mt dw) of the available western Gulf of Mexico aggregated LCS management group sub-regional quota has been landed and that 57 percent (6.8 mt dw) of the available western Gulf of Mexico hammerhead shark sub-regional quota has been landed. Based on these dealer reports, the western Gulf of Mexico aggregated LCS management group sub-regional quota has exceeded 80 percent and meets the closure threshold. While the western Gulf of Mexico hammerhead shark sub-regional quota has reached 57 percent of the available quota, it is linked to the aggregated LCS fishery and therefore closes when the aggregated LCS management groups in the western Gulf of Mexico sub-region closes. Accordingly, NMFS is closing the commercial aggregated LCS and hammerhead management groups in the western Gulf of Mexico sub-region as of 11:30 p.m. local time March 13, 2018.

    Dealer reports received through March 8, 2018, indicate that 77 percent (265.9 mt dw) of the available western Gulf of Mexico blacktip shark sub-regional quota has been landed. Regulations at § 635.28(b)(5)(i)-(v) authorize the closure of the blacktip shark fishery before landings reach, or are expected to reach, 80 percent of the quota if warranted after considering the following criteria and other relevant factors: season length based on available sub-regional quota and average sub-regional catch rates; variability in regional and/or sub-regional seasonal distribution, abundance, and migratory patterns; effects on accomplishing the objectives of the 2006 Consolidated HMS FMP and its amendments; amount of remaining shark quotas in the relevant sub-region; and regional and/or sub-regional catch rates of the relevant shark species or management groups. NMFS has considered these criteria with respect to blacktip sharks in the western Gulf of Mexico sub-region, and in particular, considered sub-regional distribution and abundance (§ 635.28(b)(5)(ii)) and sub-regional catch rates (§ 635.28(b)(5)(v)) in determining that a closure is warranted at this time.

    The directed shark fisheries in the western Gulf of Mexico sub-region exhibit a mixed species composition, with a high abundance and distribution of aggregated LCS caught in conjunction with blacktip sharks. As a result, closing the aggregated LCS and hammerhead shark management groups while leaving only the blacktip shark fishery open in the western Gulf of Mexico sub-region could cause large numbers of regulatory discards of aggregated LCS species. Such discards could hinder the management goals and interfere with accomplishing the objectives of the 2006 Consolidated HMS FMP and its amendments (§ 635.28(b)(5)(iii)), which include preventing overfishing while achieving on a continuing basis optimum yield and rebuilding overfished shark stocks. Such discards would also be contrary to National Standard 9, which requires that management measures minimize bycatch and bycatch mortality, particularly if the discards are dead and are of overfished species. A single closure for the blacktip, aggregated LCS, and hammerhead management groups in the western Gulf of Mexico sub-region would minimize regulatory discards, and help prevent overfishing, of aggregated LCS in the western Gulf of Mexico sub-region, consistent with the Magnuson-Stevens Fishery Conservation and Management Act and the criteria at § 635.28(b)(5). Accordingly, NMFS is closing the commercial blacktip shark fishery in the western Gulf of Mexico sub-region as of 11:30 p.m. local time March 13, 2018.

    All other shark species or management groups in the western Gulf of Mexico sub-region that are currently open will remain open, including the commercial Gulf of Mexico non-blacknose small coastal sharks (SCS), blue sharks, smoothhound sharks, and pelagic sharks other than porbeagle or blue sharks.

    The boundary between the Gulf of Mexico region and the Atlantic region is defined at § 635.27(b)(1) as a line beginning on the East Coast of Florida at the mainland at 25°20.4′ N. lat, proceeding due east. Any water and land to the south and west of that boundary is considered for the purposes of monitoring and setting quotas, to be within the Gulf of Mexico region. The boundary between the western and eastern Gulf of Mexico sub-regions is drawn along 88° 00′ W. long (§ 635.27(b)(1)(ii)). Persons fishing aboard vessels issued a commercial shark limited access permit under § 635.4 may still retain blacktip sharks, aggregated LCS, and/or hammerhead sharks management groups in the eastern Gulf of Mexico sub-region (east of 88° 00′ W. long).

    During the closure, retention of blacktip sharks, aggregated LCS, and/or hammerhead sharks management groups in the western Gulf of Mexico sub-region is prohibited for persons fishing aboard vessels issued a commercial shark limited access permit under § 635.4. However, persons aboard a commercially permitted vessel that is also properly permitted to operate as a charter vessel or headboat for HMS, has a shark endorsement, and is engaged in a for-hire trip could fish under the recreational retention limits for sharks and “no sale” provisions (§ 635.22 (c)). Similarly, persons aboard a commercially permitted vessel that possesses a valid shark research permit under § 635.32 and has a NMFS-approved observer onboard may continue to harvest and sell blacktip sharks, aggregated LCS, and/or hammerhead sharks in the western Gulf of Mexico sub-region pursuant to the terms and conditions of the shark research permit.

    During this closure, a shark dealer issued a permit pursuant to § 635.4 may not purchase or receive blacktip sharks, aggregated LCS, and/or hammerhead sharks in the western Gulf of Mexico sub-region from a vessel issued an Atlantic shark limited access permit (LAP), except that a permitted shark dealer or processor may possess blacktip sharks, aggregated LCS, and/or hammerhead sharks in the western Gulf of Mexico sub-region that were harvested, off-loaded, and sold, traded, or bartered prior to the effective date of the closure and were held in storage consistent with § 635.28(b)(6). Additionally, a permitted shark dealer or processor may possess blacktip sharks, aggregated LCS, and/or hammerhead sharks in the western Gulf of Mexico sub-region that were harvested by a vessel issued a valid shark research fishery permit per § 635.32 with a NMFS-approved observer onboard during the trip the sharks were taken on as long as the LCS research fishery quota remains open. Similarly, a shark dealer issued a permit pursuant to § 635.4 may, in accordance with relevant state regulations, purchase or receive blacktip sharks, aggregated LCS, and/or hammerhead sharks in the western Gulf of Mexico sub-region if the sharks were harvested, off-loaded, and sold, traded, or bartered from a vessel that fishes only in state waters and that has not been issued an Atlantic Shark LAP, HMS Angling permit, or HMS Charter/Headboat permit pursuant to § 635.4.

    Classification

    Pursuant to 5 U.S.C. 553(b)(B), the Assistant Administrator for Fisheries, NOAA (AA), finds that providing prior notice and public comment for this action is impracticable and contrary to the public interest because the fishery is currently underway and any delay in this action would result in overharvest of the quotas for these species and management groups and thus would be inconsistent with fishery management requirements and objectives. The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of availability on the fishing grounds, the migratory nature of the species, and the regional variations. NMFS is not able to give notice sooner nor would sooner notice be practicable given the structure of the regulations, which close the fisheries under specified regulatory criteria or thresholds, and closure determinations need to be based on near real-time data to balance fishing opportunities against the management goal of preventing quota overharvests. Similarly, affording prior notice and opportunity for public comment on this action is contrary to the public interest because if a quota is exceeded, the stock may be negatively affected and fishermen ultimately could experience reductions in the available quota and a lack of fishing opportunities in future seasons. For these reasons, the AA also finds good cause to waive the 30-day delay in effective date pursuant to 5 U.S.C. 553(d)(3). This action is required under § 635.28(b)(3) and § 635.28(b)(5) and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: March 8, 2018 Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-05058 Filed 3-8-18; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 160229159-8236-02] RIN 0648-BF85 Fisheries of the Northeastern United States; Framework 2 to the Tilefish Fishery Management Plan AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This final rule implements the management measures contained in Framework Adjustment 2 to the Tilefish Fishery Management Plan and adjusts the 2018 specifications for this fishery. The Mid-Atlantic Fishery Management Council developed Framework Adjustment 2 to improve and simplify the administration of the golden tilefish fishery. These changes include removing an outdated reporting requirement, proscribing allowed gear for the recreational fishery, modifying the commercial incidental possession limit, requiring commercial golden tilefish be landed with the head and fins attached, and revising how assumed discards are accounted for when setting harvest limits. Based on new regulations implemented by this rule, this action updates previously published specifications for the commercial golden tilefish fishery for 2018 and projected specifications for 2019 and 2020.

    DATES:

    This rule is effective April 12, 2018, except for the amendment to § 648.7(b)(2)(ii), which is effective March 13, 2018.

    ADDRESSES:

    Copies of Framework 2 and the Environmental Assessment (EA), with its associated Finding of No Significant Impact (FONSI) and the Regulatory Impact Review (RIR), are available from the Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901.

    Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted to the Greater Atlantic Regional Fisheries Office, 55 Great Republic Drive, Gloucester, MA 01930, and by email to [email protected], or fax to 202-395-7285

    FOR FURTHER INFORMATION CONTACT:

    Douglas Potts, Fishery Policy Analyst, 978-281-9341.

    SUPPLEMENTARY INFORMATION: Background

    This action implements Framework Adjustment 2 to the Tilefish Fishery Management Plan (FMP). The Mid-Atlantic Fishery Management Council developed this framework to improve and simplify management measures for the golden tilefish fishery in Federal waters north of the Virginia/North Carolina border, consistent with the requirements of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). We published a proposed rule for this action on October 23, 2017 (82 FR 48967), with a comment period through November 7, 2017. See Comments and Responses section for more information.

    Framework Adjustment 2 Measures Interactive Voice Response System (IVR) Reporting Requirement Removal

    Commercial fishing vessels that land golden tilefish under the individual fishing quota (IFQ) system are currently required to report each trip within 48 hours of landing through our IVR system. The Council originally created this reporting requirement when the fishery was managed under three permit categories, each with a sector-specific annual landing limit. The IVR system provided timely landing reports to track quota use and allowed managers to close a permit category if the annual landing cap was reached. When the Council changed the management of the fishery to an IFQ system, it retained the IVR system to allow additional monitoring of landings. Improvements in electronic dealer-reported landings and other data streams have rendered this IVR report redundant, and the data are no longer used to monitor quotas. This action eliminates this unnecessary reporting requirement.

    Recreational Fishing Gear Limit

    In recent years, the Council has received reports of recreational fishermen using “mini-longline” gear with a large number of hooks to target tilefish. The Council is concerned the use of this gear could result in increased dead discards of tilefish if fishermen catch more than the eight-fish per person bag limit using this type of gear. The Magnuson-Stevens Act list of authorized gear types at 50 CFR 600.75(v) already restricts the recreational fishery to rod and reel and spear gear. However, to avoid any potential confusion and clarify the amount of gear allowed, this action codifies that rod and reel with a maximum of five hooks per rod is the only authorized recreational tilefish gear for use in the Mid-Atlantic. Anglers could use either a manual or an electric reel.

    Commercial Golden Tilefish Landing Condition

    The commercial tilefish fishery typically lands fish in a head-on, gutted condition. However, quotas and possession limits are in whole (round) weight. This requires the fishing industry to use a conversion factor to change landed weight to whole weight to comply with incidental possession limits and IFQ allocations. This action requires commercially-caught golden tilefish to be landed with the head and fins attached, although they could be gutted. By requiring this, we can more reliably specify and monitor landing limits and quotas in landed weight, eliminating the need to use a conversion factor. This will simplify catch accounting and improve compliance for individuals participating in the commercial tilefish fishery.

    Commercial Golden Tilefish Possession Limit

    When the Council created the tilefish IFQ system, it allocated a separate quota and commercial possession limit of 500 lb (227 kg) to allow small landings of tilefish caught by non-IFQ vessels targeting other species. In recent years, there have been increasing reports of non-IFQ vessels specifically targeting golden tilefish to land the maximum commercial incidental possession limit. In an effort to ensure that the incidental fishery functions as originally intended, this action modifies the commercial possession limit to ensure that vessels are targeting other species, and only incidentally catching golden tilefish. This action adjusts the commercial golden tilefish landing limit to: 500 lb (227 kg) or 50 percent, by weight, of all fish, including the golden tilefish, on board the vessel, whichever is less.

    Individual Fishing Quota Authorized Vessels

    Tilefish IFQ allocation holders may authorize one or more vessels to land tilefish under their allocation. All golden tilefish landed by those vessels are then deducted from that allocation. We do not currently have a mechanism for a vessel to attribute golden tilefish landings from a single trip to more than one IFQ allocation. To create such a system would increase reporting burden on vessels and dealers, and add complexity to the IFQ accounting and cost recovery systems. In order to maintain simple and efficient administration of the IFQ fishery, this action prohibits a vessel from being authorized to land tilefish under multiple IFQ allocations on the same trip. A vessel could still change IFQ allocations over the course of the year while only being authorized by one IFQ allocation at a time. In addition, IFQ allocation holders can lease quota to maintain flexibility in harvesting their allocation.

    Assumed Discards in Quota-Setting Process

    The current specification process sets the annual catch limit (ACL) equal to the acceptable biological catch (ABC). The ACL is adjusted to address any management uncertainty to set an annual catch target (ACT), then assumed discards of golden tilefish are deducted from the ACT to generate the total allowable landings (TAL). The incidental fishery is then allocated 5 percent of the TAL, and the remaining 95 percent of the TAL is divided among the IFQ shareholders based on their individual quota holdings. However, discarding golden tilefish is prohibited in the IFQ fishery. As a result, observed discards occur almost entirely in the incidental fishery. This action adjusts the specification process to allocate the ACT between the incidental and IFQ fisheries using the 5- and 95-percent split. Sector-specific assumed discards are then deducted to establish sector-specific TALs. The IFQ TAL is then allocated to the individual IFQ shareholders.

    Updated Specifications

    On November 7, 2017, we published a final rule (82 FR 51578) setting specifications for the 2018 commercial golden tilefish fishery and announcing projected specifications for the 2019 and 2020 fishing years. As discussed in that rule, the specifications were based on the regulations that were effective at the time but were anticipated to be revised if Framework 2 was fully implemented. Table 1 shows the 2018 golden tilefish specifications as implemented by the November 7, 2017, rule and new specification values that result from this rule. When this rule becomes effective, we will adjust each IFQ allocation based on the new higher IFQ TAL. Table 2 shows updated projected specifications for the 2019 and 2020 fishing years.

    Table 1—Changes to 2018 Golden Tilefish Specifications as a Result of This Action As implemented million lb mt Framework 2 million lb mt Overfishing Limit 2.332 1,058 2.332 1,058 ABC 1.636 742 1.636 742 ACL 1.636 742 1.636 742 IFQ ACT NA NA 1.554 705 Incidental ACT NA NA 0.082 37 TAL 1.627 738 NA NA IFQ TAL 1.546 701 1.554 705 Incidental TAL 0.081 37 0.072 33 Table 2—Updated Projected 2019 and 2020 Golden Tilefish Specifications 2019 million lb mt 2020 million lb mt Overfishing Limit 2.421 1,098 2.291 1,039 ABC 1.636 742 1.636 742 ACL 1.636 742 1.636 742 IFQ ACT 1.554 705 1.554 705 Incidental ACT 0.082 37 0.082 37 IFQ TAL 1.554 705 1.554 705 Incidental TAL 0.072 33 0.072 33 Comments and Responses

    We received two comments on the proposed rule. One comment did not mention or relate to the proposed measures or fishing in any way and is not discussed further. The other commenter supported all of the proposed measures and stated the changes would benefit all participants in the fishery.

    Changes From the Proposed Rule

    There are no changes to the measures from the proposed rule. However, a final rule published on November 15, 2017 (82 FR 52851), made changes to some of the same regulatory paragraphs as this rule. As a result, the regulatory text in this action reflects the current CFR.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the Administrator, Greater Atlantic Region, NMFS, has determined that this final rule is consistent with the Tilefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

    This final rule has been determined to be not significant for purposes of Executive Order 12866. Because this rule is not significant under Executive Order 12866, this rule is not an Executive Order 13771 regulatory action.

    Pursuant to 5 U.S.C. 553(d)(1), this rule is not subject to the 30-day delayed effectiveness provision of the Administrative Procedure Act because the change to 50 CFR 648.7(a)(2)(ii) relieves the restriction requiring tilefish IFQ vessels to report each fishing trip through the IVR system. As explained above, this reporting requirement is redundant and no longer used for monitoring catch. A delay in effectiveness of this change would unnecessarily continue this reporting burden with no benefit to the industry, the tilefish resource, or the government. All other aspects of this rule are subject to a 30-day delay in effectiveness.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification and no information has arisen leading to a different conclusion. As a result, a regulatory flexibility analysis was not required and none was prepared.

    This final rule contains a revision to a collection-of-information requirement subject to the Paperwork Reduction Act (PRA), which has been approved by OMB under control number 0648-0590. Public reporting burden for the IVR reporting requirement is estimated to average 2 minutes for each IVR response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. This rule removes this reporting burden. Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see ADDRESSES) 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 648

    Fisheries, Fishing, Reporting and recordkeeping requirements.

    Dated: March 7, 2018. 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 648 is amended as follows:

    PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    § 648.7 [Amended]
    2. In § 648.7, paragraph (b)(2)(ii) is removed and reserved. 3. In § 648.14, paragraphs (u)(2)(vi) and (viii) are revised and paragraph (u)(2)(ix) is added to read as follows:
    § 648.14 Prohibitions.

    (u) * * *

    (2) * * *

    (vi) Land or possess golden tilefish in or from the Tilefish Management Unit, on a vessel issued a valid tilefish permit under this part, after the incidental golden tilefish fishery is closed pursuant to § 648.295(a)(3), unless fishing under a valid tilefish IFQ allocation permit as specified in § 648.294(a), or engaged in recreational fishing.

    (viii) Land or possess golden or blueline tilefish in or from the Tilefish Management Unit, on a vessel issued a valid commercial tilefish permit under this part, that do not have the head and fins naturally attached to the fish.

    (ix) Engage in recreational fishing for golden tilefish with fishing gear that is not compliant with the gear restrictions specified at § 648.296.

    4. In § 648.291, paragraph (a) introductory text and paragraph (a)(1) are revised to read as follows:
    § 648.291 Tilefish Annual Catch Targets (ACT).

    (a) Golden tilefish. The Tilefish Monitoring Committee shall identify and review the relevant sources of management uncertainty to recommend ACTs for the individual fishing quota (IFQ) and incidental sectors of the fishery as part of the golden tilefish specification process. The Tilefish Monitoring Committee recommendations shall identify the specific sources of management uncertainty that were considered, technical approaches to mitigating these sources of uncertainty, and any additional relevant information considered in the ACT recommendation process.

    (1) ACT allocation. (i) The ACT shall be less than or equal to the ACL.

    (ii) The Tilefish Monitoring Committee shall include the fishing mortality associated with the recreational fishery in its ACT recommendations only if this source of mortality has not already been accounted for in the ABC recommended by the SSC.

    (iii) The Tilefish Monitoring Committee shall allocate 5 percent of the ACT to the incidental sector of the fishery and the remaining 95 percent to the IFQ sector.

    5. In § 648.292, paragraphs (a)(1) through (a)(4) are revised to read as follows:
    § 648.292 Tilefish specifications.

    (a) * * *

    (1) Annual specification process. The Tilefish Monitoring Committee shall review the ABC recommendation of the SSC, golden tilefish landings and discards information, and any other relevant available data to determine if the golden tilefish ACL, ACT, or total allowable landings (TAL) for the IFQ and/or incidental sectors of the fishery require modification to respond to any changes to the golden tilefish stock's biological reference points or to ensure any applicable rebuilding schedule is maintained. The Monitoring Committee will consider whether any additional management measures or revisions to existing measures are necessary to ensure that the IFQ and/or incidental TAL will not be exceeded. Based on that review, the Monitoring Committee will recommend golden tilefish ACL, ACTs, and TALs to the Tilefish Committee of the MAFMC. Based on these recommendations and any public comment received, the Tilefish Committee shall recommend to the MAFMC the appropriate golden tilefish ACL, ACT, TAL, and other management measures for both the IFQ and the incidental sectors of the fishery for a single fishing year or up to 3 years. The MAFMC shall review these recommendations and any public comments received, and recommend to the Regional Administrator, at least 120 days prior to the beginning of the next fishing year, the appropriate golden tilefish ACL, ACT, TAL, the percentage of TAL allocated to research quota, and any management measures to ensure that the TAL will not be exceeded, for both the IFQ and the incidental sectors of the fishery, for the next fishing year, or up to 3 fishing years. The MAFMC's recommendations must include supporting documentation, as appropriate, concerning the environmental and economic impacts of the recommendations. The Regional Administrator shall review these recommendations, and after such review, NMFS will publish a proposed rule in the Federal Register specifying the annual golden tilefish ACL, ACT, TAL, and any management measures to ensure that the TAL will not be exceeded for the upcoming fishing year or years for both the IFQ and the incidental sectors of the fishery. After considering public comments, NMFS will publish a final rule in the Federal Register to implement the golden tilefish ACL, ACTs, TALs and any management measures. The previous year's specifications will remain effective unless revised through the specification process and/or the research quota process described in paragraph (a)(5) of this section. NMFS will issue notification in the Federal Register if the previous year's specifications will not be changed.

    (2) Total Allowable Landings (TAL). (i) The TALs for both the IFQ and the incidental sectors of the fishery for each fishing year will be specified pursuant to paragraph (a)(1) of this section.

    (ii) The sum of the sector-specific TAL and the estimated sector-specific discards shall be less than or equal to the ACT for that sector of the fishery.

    (3) TAL allocation. For each fishing year, up to 3 percent of the incidental and IFQ TALs may be set aside for the purpose of funding research. The remaining IFQ TAL will be allocated to the individual IFQ permit holders as described in § 648.294(a).

    (4) Adjustments to the quota. If the incidental harvest exceeds the incidental TAL for a given fishing year, the incidental trip limit specified at § 648.295(a)(2) may be reduced in the following fishing year. If an adjustment is required, a notification of adjustment of the quota will be published in the Federal Register.

    6. In § 648.293, paragraph (a)(1) is revised to read as follows:
    § 648.293 Tilefish accountability measures.

    (a) * * *

    (1) Commercial incidental fishery closure. See § 648.295(a)(3).

    7. In § 648.294, paragraph (b)(4) is revised to read as follows:
    § 648.294 Golden tilefish individual fishing quota (IFQ) program.

    (b) * * *

    (4) IFQ vessel. (i) All Federal vessel permit numbers listed on the IFQ allocation permit are authorized to possess golden tilefish pursuant to the IFQ allocation permit.

    (ii) An IFQ allocation permit holder who wishes to authorize an additional vessel(s) to possess golden tilefish pursuant to the IFQ allocation permit must send written notification to NMFS. This notification must include:

    (A) The vessel name and permit number, and

    (B) The dates on which the IFQ allocation permit holder desires the vessel to be authorized to land golden tilefish pursuant to the IFQ allocation permit.

    (iii) A vessel listed on the IFQ allocation permit is authorized to possess golden tilefish pursuant to the subject permit, until the end of the fishing year or until NMFS receives written notification from the IFQ allocation permit holder to remove the vessel.

    (iv) A single vessel may not be listed on more than one IFQ allocation permit at the same time.

    (v) A copy of the IFQ allocation permit must be carried on board each vessel so authorized to possess IFQ golden tilefish.

    8. Amend § 648.295 by: a. Revising the section heading; b. Revising paragraphs (a) and (b)(1); and c. Adding paragraph (c).

    The revisions and addition read as follows:

    § 648.295 Tilefish commercial trip limits and landing condition.

    (a) Golden tilefish—(1) IFQ landings. Any golden tilefish landed by a vessel fishing under an IFQ allocation permit as specified at § 648.294(a), on a given fishing trip, count as landings under the IFQ allocation permit.

    (2) Incidental trip limit for vessels not fishing under an IFQ allocation. Any vessel of the United States fishing under a tilefish vessel permit, as described at § 648.4(a)(12), unless the vessel is fishing under a tilefish IFQ allocation permit, is prohibited from possessing more than:

    (i) 500 lb (226.8 kg) of golden tilefish at any time, or

    (ii) 50 percent, by weight, of the total of all species being landed; whichever is less.

    (3) In-season closure of the incidental fishery. The Regional Administrator will monitor the harvest of the golden tilefish incidental TAL based on dealer reports and other available information, and shall determine the date when the incidental golden tilefish TAL has been landed. The Regional Administrator shall publish a notice in the Federal Register notifying vessel and dealer permit holders that, effective upon a specific date, the incidental golden tilefish fishery is closed for the remainder of the fishing year.

    (b) Blueline tilefish—(1) Commercial possession limit. Any vessel of the United States fishing under a tilefish permit, as described at § 648.4(a)(12), is prohibited from possessing more than 300 lb (136 kg) of gutted blueline tilefish per trip in or from the Tilefish Management Unit.

    (c) Landing condition. Commercial golden or blueline tilefish must be landed with head and fins naturally attached, but may be gutted.

    9. In § 648.296, the section heading and paragraph (a) are revised to read as follows:
    § 648.296 Tilefish recreational possession limits and gear restrictions.

    (a) Golden tilefish. (1) Any person fishing from a vessel that is not fishing under a tilefish commercial vessel permit issued pursuant to § 648.4(a)(12), may land up to eight golden tilefish per trip. Anglers fishing onboard a charter/party vessel shall observe the recreational possession limit.

    (2) Any vessel engaged in recreational fishing may not retain golden tilefish, unless exclusively using rod and reel fishing gear, with a maximum limit of five hooks per rod. Anglers may use either a manual or an electric reel.

    [FR Doc. 2018-04974 Filed 3-12-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170816769-8162-02 and 170817779-8161-02] RIN 0648-XG019 Fisheries of the Exclusive Economic Zone Off Alaska; Sablefish Managed Under the Individual Fishing Quota Program AGENCY:

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

    ACTION:

    Temporary rule; opening.

    SUMMARY:

    NMFS is opening directed fishing for sablefish with fixed gear managed under the Individual Fishing Quota (IFQ) Program and the Community Development Quota (CDQ) Program. The season will open 1200 hours, Alaska local time (A.l.t.), March 24, 2018, and will close 1200 hours, A.l.t., November 7, 2018. This period is the same as the 2018 commercial halibut fishery opening dates adopted by the International Pacific Halibut Commission. The IFQ and CDQ halibut season is specified by a separate publication in the Federal Register of annual management measures.

    DATES:

    Effective 1200 hours, A.l.t., March 24, 2018, until 1200 hours, A.l.t., November 7, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Obren Davis, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    Beginning in 1995, fishing for Pacific halibut and sablefish with fixed gear in the IFQ regulatory areas defined in 50 CFR 679.2 has been managed under the IFQ Program. The IFQ Program is a regulatory regime designed to promote the conservation and management of these fisheries and to further the objectives of the Magnuson-Stevens Fishery Conservation and Management Act and the Northern Pacific Halibut Act. Persons holding quota share receive an annual allocation of IFQ. Persons receiving an annual allocation of IFQ are authorized to harvest IFQ species within specified limitations. Further information on the implementation of the IFQ Program, and the rationale supporting it, are contained in the preamble to the final rule implementing the IFQ Program published in the Federal Register, November 9, 1993 (58 FR 59375) and subsequent amendments.

    This announcement is consistent with § 679.23(g)(1), which requires that the directed fishing season for sablefish managed under the IFQ Program be specified by the Administrator, Alaska Region, and announced by publication in the Federal Register. This method of season announcement was selected to facilitate coordination between the sablefish season, chosen by the Administrator, Alaska Region, and the halibut season, adopted by the International Pacific Halibut Commission (IPHC). The directed fishing season for sablefish with fixed gear managed under the IFQ Program will open 1200 hours, A.l.t., March 24, 2018, and will close 1200 hours, A.l.t., November 7, 2018. This period runs concurrently with the IFQ season for Pacific halibut announced by the IPHC. The IFQ halibut season will be specified by a separate publication in the Federal Register of annual management measures pursuant to 50 CFR 300.62.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of the sablefish fishery thereby increasing bycatch and regulatory discards between the sablefish fishery and the halibut fishery, and preventing the accomplishment of the management objective for simultaneous opening of these two fisheries. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 7, 2018.

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

    This action is required by § 679.23 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: March 8, 2018. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-05059 Filed 3-12-18; 8:45 am] BILLING CODE 3510-22-P
    83 49 Tuesday, March 13, 2018 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2018-0189; Product Identifier 2017-CE-022-AD] RIN 2120-AA64 Airworthiness Directives; Viking Air Limited Airplanes AGENCY:

    Federal Aviation Administration (FAA), Department of Transportation (DOT).

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for Viking Air Limited Model DHC-3 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as pitting corrosion on the shank of the wing strut attach bolts. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by April 27, 2018.

    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 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this proposed AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; telephone: (North America) (800) 663-8444; fax: (250) 656-0673; email: [email protected]; internet: http://www.vikingair.com/support/service-bulletins. You may review this referenced service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    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-2018-0189; 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 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:

    Aziz Ahmed, Aerospace Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 287-7329; fax: (516) 794-5531; email: [email protected]

    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-2018-0189; Product Identifier 2017-CE-022-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 because of those comments.

    We will post all comments we receive, without change, to http://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, which is the aviation authority for Canada, has issued AD Number CF-2017-11, dated March 9, 2017 (referred to after this as “the MCAI”), to correct an unsafe condition for Viking Air Limited Model DHC-3 airplanes and was based on mandatory continuing airworthiness information originated by an aviation authority of another country. The MCAI states:

    Pitting corrosion has been found on the shank of the following part number wing strut attach bolts: C3W114-3, C3W129-3 and C3W128-3. These bolts are manufactured using a standard AN12 bolt. Metallurgical evaluation concluded that pitting corrosion was present on the affected AN12 bolts prior to forming of the bolt head and threads. The pitting and un-plated voids could cause a surface condition that may have a detrimental effect on fatigue and corrosion resistance, leading to bolt failure and consequent failure of the wing.

    Viking has not been able to confirm the affected batch numbers or specific manufacture date range. New wing strut bolts manufactured after 21 March 2016 are inspected for pitting during manufacturing and issued new P/Ns C3W114-5, C3W129-5 and C3W128-5 under MOD 3/1010.

    You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0189.

    Related Service Information Under 1 CFR Part 51

    Viking Air Limited has issued DHC-3 Otter Service Bulletin Number V3/0006, Revision B, dated March 9, 2017. The service information describes procedures for inspection and any necessary corrective action for pitting of the wing strut shank bolts. 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 of this NPRM.

    FAA's Determination and Requirements of the 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 this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

    Costs of Compliance

    We estimate that this proposed AD will affect 37 products of U.S. registry. We also estimate that it would take about 4 work-hours 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 the proposed AD on U.S. operators to be $12,580, or $340 per product.

    In addition, Table 1 is an estimate of possible necessary follow-on actions as a result of the required inspections. We have no way of determining the number of products that may need these actions. We estimate that any necessary follow-on replacement parts would cost as follows:

    Replacing each affected bolt is on condition and is estimated to take about 1 work-hour at $85 for a cost of $85 per bolt.

    Table 1—Parts Replacement and Total Bolt Cost Part No. Quantity
  • per wing
  • Quantity
  • per airplane
  • Price per bolt ($ USD) Total cost per bolt (labor and parts)
    C3W114-5 2 4 $284 $369 C3W128-5 1 2 275 360 C3W129-5 1 2 164 249
    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.

    This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes and domestic business jet transport airplanes to the Director of the Policy and Innovation Division.

    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 AD: Viking Air Limited: Docket No. FAA-2018-0189; Product Identifier 2017-CE-022-AD. (a) Comments Due Date

    We must receive comments by April 27, 2018.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Viking Air Limited Model DHC-3 airplanes with wing strut bolts wing strut bolts part numbers (P/N) C3W114-3, C3W129-3 and C3W128-3 (Pre MOD 3/1010), all serial numbers, certificated in any category.

    (d) Subject

    Air Transport Association of America (ATA) Code 57: Wings.

    (e) Reason

    This AD was prompted by from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as pitting corrosion on the shank of the wing strut attach bolts. We are issuing this proposed AD to detect and correct pitting and un-plated voids, which could cause a surface condition that may have a detrimental effect on fatigue and corrosion resistance, leading to bolt failure and subsequent failure of the wing.

    (f) Actions and Compliance

    Unless already done, do the following actions:

    (1) Within the next 12 months after the effective date of this AD, inspect the wing strut attach bolts installed on the airplane for pitting on the shank following paragraph A of the Accomplishment Instructions of Viking DHC-3 Otter Service Bulletin (SB) Number: V3/0006, Revision B, dated March 9, 2017.

    (2) If pitting is found after the inspection required in paragraph (f)(1) of this AD, before further flight, replace the bolt with either a post MOD 3/1010 wing strut bolt (Part Numbers (P/Ns) C3W114-5, C3W129-5 or C3W128-5 as applicable) or a new or serviceable pre MOD 3/1010 wing strut bolt that has been inspected following paragraph A of Viking DHC-3 Otter SB Number: V3/0006, Revision B, dated March 9, 2017.

    (3) After the effective date of this AD, pre MOD 3/1010 bolts may continue to be used provided these bolts are inspected for pitting immediately before installation following paragraph A of the Accomplishment Instructions of Viking DHC-3 Otter SB Number: V3/0006, Revision B, dated March 9, 2017, and the accomplishment of the inspection must be documented in the airplane maintenance records.

    (g) Credit for Actions Accomplished in Accordance With Previous Service Information

    This AD allows credit for the actions required in paragraph (f)(1) or (2) of this AD if done before the effective date of this AD following SB Viking DHC-3 Otter V3/0006 Revision NC or A.

    (h) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Aziz Ahmed, Aerospace Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 287-7329; fax: (516) 794-5531; email: [email protected] Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

    (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 Branch, FAA; or Transport Canada; or Viking Air Limited's Transport Canada Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.

    (i) Related Information

    Refer to MCAI Transport Canada AD Number CF-2017-11, dated March 9, 2017, for related information. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-0189. For service information related to this AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; telephone: (North America) (800) 663-8444; fax: (250) 656-0673; email: [email protected]; internet: http://www.vikingair.com/support/service-bulletins. You may review this referenced service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Issued in Kansas City, Missouri, on March 6, 2018. Pat Mullen, Acting Deputy Director, Policy & Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-05012 Filed 3-12-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [REG-129260-16] RIN 1545-BN96 Disclosure of Returns and Return Information in Connection With Written Contracts or Agreements for the Acquisition of Property or Services for Tax Administration Purposes AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    This document contains proposed regulations under section 6103(n) of the Internal Revenue Code (Code) to authorize the Department of State to disclose returns and return information to its contractors who assist the Department of State in carrying out its responsibilities under section 32101 of the Fixing America's Surface Transportation (FAST) Act. The FAST Act requires the IRS to notify the Department of State of certified seriously delinquent tax debts, and the Department of State procures services from outside contractors in connection with carrying out its responsibilities under the FAST Act.

    DATES:

    Written and electronic comments and requests for a public hearing must be received by April 12, 2018.

    ADDRESSES:

    Send submissions to: CC:PA:LPD:PR (REG-129260-16), Room 5207, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8:00 a.m. and 4:00 p.m. to CC:PA:LPD:PR (REG-129260-16), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW, Washington, DC 20224. Alternatively, taxpayers may submit comments electronically via the Federal eRulemaking Portal at www.regulations.gov (IRS REG-129260-16).

    FOR FURTHER INFORMATION CONTACT:

    Concerning the proposed regulations, Brittany Harrison of the Office of Associate Chief Counsel (Procedure and Administration), (202) 317-6833; concerning the submission of comments and requests for a public hearing, Regina Johnson, (202) 317-6901 (not toll-free numbers).

    SUPPLEMENTARY INFORMATION: Background and Explanation of Provisions

    This document contains proposed amendments to the Procedure and Administration Regulations (26 CFR part 301) under section 6103(n) of the Code. On December 4, 2015, the FAST Act, Public Law 114-94, 129 Stat. 1312, was enacted into law. Section 32101 of the FAST Act adds section 7345 to the Internal Revenue Code. Section 7345 requires the IRS to notify the Department of State of tax debts that the IRS certifies as seriously delinquent. Section 7345(b) generally defines a seriously delinquent tax debt as an unpaid, legally enforceable Federal tax liability of an individual that has been assessed, is greater than $50,000 (as indexed for inflation), and with respect to which a notice of lien has been filed pursuant to section 6323 and the administrative rights under section 6320 with respect to such filing have been exhausted or have lapsed, or a levy has been made pursuant to section 6331. Section 32101 of the FAST Act generally requires the Department of State to deny a passport (or the renewal of a passport) in the case of an individual if notified by the IRS that the individual has been certified as having a seriously delinquent tax debt and permits the Department of State to revoke a passport previously issued to such person.

    Under section 6103(a) of the Code, returns and return information are confidential unless the Code otherwise authorizes disclosure. The FAST Act added section 6103(k)(11), which provides that, upon certification under section 7345, the IRS is authorized to disclose return information to the Department of State with respect to a taxpayer who has a seriously delinquent tax debt. Specifically, upon certification under section 7345, section 6103(k)(11)(A) authorizes the IRS to disclose to officers and employees of the Department of State (i) the taxpayer identity information with respect to the certified taxpayer and (ii) the amount of such seriously delinquent tax debt. Section 6103(k)(11)(A). Section 6103(k)(11)(B) limits the use of return information disclosed under subparagraph (A) for the purposes of, and to the extent necessary in, carrying out the requirements of section 32101 of the FAST Act.

    The Department of State engages contractors to assist in carrying out its responsibilities with respect to passports, including responsibilities related to implementation of section 32101 of the FAST Act. Because such contractors are not “officers and employees” of the Department of State, section 6103(k)(11) of the Code does not authorize the disclosure of return information to such contractors.

    Section 6103(n) of the Code authorizes, pursuant to regulations prescribed by the Secretary, the disclosure of returns and return information to any person for purposes of tax administration to the extent necessary in connection with, among other things, a written contract for services. The definition of the term “tax administration” includes “the administration, management, conduct, direction, and supervision of the execution and application of the internal revenue laws or related statutes. . . .” Section 6103(b)(4). Because implementation of the FAST Act relates to the administration, management, conduct, direction, and supervision of the execution and application of the internal revenue laws and related statutes, disclosure of return information for the purpose of carrying out responsibilities under the FAST Act is a tax administration purpose.

    The Treasury regulations provide that, pursuant to the provisions of section 6103(n) of the Code and subject to certain conditions, officers and employees of the Treasury Department, a State tax agency, the Social Security Administration, or the Department of Justice are authorized to disclose returns and return information to any person or to an officer or employee of the person, for purposes of tax administration (as defined in section 6103(b)(4)), to the extent necessary in connection with a written contract or an agreement for the acquisition of the providing of services. Section 301.6103(n)-1(a)(1). Any person, or officer or employee of the person, who receives such disclosed returns or return information may further disclose the returns or return information to its own officers or employees whose duties or responsibilities require such information in order to provide the services. Section 301.6103(n)-1(a)(2)(i). When authorized in writing by the IRS, such person, or officer or employee of the person, may further disclose such information to the extent necessary to provide services, including to its agents or subcontractors (or such agents' or subcontractors' officers or employees). Section 301.6103(n)-1(a)(2)(ii). Agents or subcontractors (or their officers or employees) who receive such returns or return information may further disclose the returns or return information to their officers or employees whose duties or responsibilities require the returns or return information for a purpose described in § 301.6103(n)-1(a). Section 301.6103(n)-1(a)(3). The regulations under section 6103(n) of the Code provide a number of rules related to limitations on such disclosures, penalties potentially applicable to recipients of returns and return information, notification requirements applicable to recipients of returns and return information, and safeguards requirements. See section 301.6103(n)-1(b), -1(c), -1(d), -1(e).

    These proposed regulations add the Department of State to the list of agencies in current § 301.6103(n)-1(a)(1) whose officers and employees may disclose returns and return information to any person or to an officer or employee of such person for tax administration purposes to the extent necessary in connection with a written contract for the acquisition of property or services. These proposed regulations authorize the Department of State to disclose returns and return information to its contractors providing services in connection with the revocation or denial of passports pursuant to the requirements of section 7345 and the FAST Act.

    Special Analyses

    Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required.

    The purpose of these regulations is to allow the Department of State to share tax return information with its contractors for tax administration purposes. As a recipient of tax return information, the Department of State is required to comply with the reporting and other requirements under section 6103(p)(4). The Department of State is also responsible for the training and inspection of its contractors and ensuring that all safeguarding standards are met. These proposed regulations do not impose a reporting burden on the Department of State's contractors and will not require the contractors to file information with the IRS. Because the proposed regulations do not impose a collection of information on entities other than the Department of State, they do not impose a collection of information on small entities. Accordingly, it is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act (5 U.S.C. chapter 6).

    Pursuant to section 7805(f) of the Code, these proposed regulations have been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

    Comments and Requests for Public Hearing

    Before the regulations proposed herein are adopted as final regulations, consideration will be given to any electronic and written comments that are submitted timely to the IRS as prescribed in this preamble under the ADDRESSES heading. The Treasury Department and the IRS request comments on all aspects of the proposed regulations. All comments submitted will be made available at www.regulations.gov or upon request. A public hearing may be scheduled if requested in writing by a person that timely submits written comments. If a public hearing is scheduled, notice of the date, time, and place of the hearing will be published in the Federal Register.

    Drafting Information

    The principal author of these proposed regulations is Brittany Harrison of the Office of the Associate Chief Counsel (Procedure and Administration).

    List of Subjects in 26 CFR Part 301

    Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.

    Proposed Amendments to the Regulations

    Accordingly, 26 CFR part 301 is proposed to be amended as follows:

    PART 301—PROCEDURE AND ADMINISTRATION Paragraph 1. The authority citation for part 301 continues to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Sections 6103(n)-1(a)(1) and (e)(4)(i) are amended by removing the language “or the Department of Justice” and adding the language “the Department of Justice, or the Department of State” in its place. Par. 3. Section 301.6103(n)-1(g) is amended to read as follows:

    (g) Applicability date. This section is applicable on June 5, 2007, except that paragraphs (a) and (e)(4)(i) of this section apply to the Department of State on or after March 12, 2018.

    Kirsten Wielobob, Deputy Commissioner for Services and Enforcement.
    [FR Doc. 2018-04971 Filed 3-12-18; 8:45 am] BILLING CODE 4830-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2017-0395; FRL-9975-40-Region 4] Air Plan Approval; Tennessee: Volatile Organic Compounds AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a portion of a revision to the Hamilton County portion of the Tennessee State Implementation Plan (SIP) submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation from Chattanooga/Hamilton County Air Pollution Control Bureau on June 25, 2008. The revision amends the definition of “volatile organic compounds” (VOC) to be consistent with state and federal regulations. This action is being taken pursuant to the Clean Air Act (CAA or Act).

    DATES:

    Comments must be received on or before April 12, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2017-0395 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:

    Tiereny Bell, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Bell can be reached by phone at (404) 562-9088 or via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Tropospheric ozone, commonly known as smog, occurs when VOC and nitrogen oxides (NOX) react in the atmosphere in the presence of sunlight. Because of the harmful health effects of ozone, EPA and state governments limit the amount of VOC and NOX that can be released into the atmosphere. VOC are those compounds of carbon (excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate) that form ozone through atmospheric photochemical reactions. Compounds of carbon (or organic compounds) have different levels of reactivity; they do not react at the same speed or do not form ozone to the same extent.

    Section 302(s) of the CAA specifies that EPA has the authority to define the meaning of “VOC,” and hence what compounds shall be treated as VOC for regulatory purposes. It has been EPA's policy that compounds of carbon with negligible reactivity need not be regulated to reduce ozone and should be excluded from the regulatory definition of VOC. See 42 FR 35314 (July 8, 1977), 70 FR 54046 (September 13, 2005). EPA determines whether a given carbon compound has “negligible” reactivity by comparing the compound's reactivity to the reactivity of ethane. EPA lists these compounds in its regulations at 40 CFR 51.100(s) and excludes them from the definition of VOC. The chemicals on this list are often called “negligibly reactive.” EPA may periodically revise the list of negligibly reactive compounds to add or delete compounds.

    In this rulemaking, EPA is proposing action to approve Hamilton County's SIP revision which amends the definition of “Volatile Organic Compounds” in the Chattanooga Code, Chapter 4 of Part II, Section 4-2. This SIP revision also amends paragraph 3 and adds paragraphs 4 and 5 to the Chattanooga Code, Chapter 4 of Part II, Section 4-2 definition of VOC. Tennessee is updating the Hamilton County portion of its SIP to be consistent with changes to federal and other similar SIP-approved regulations.1

    1 EPA approved similar revisions to the Tennessee SIP on April 23, 2006. See 71 FR 19124. EPA also approved a Knox County portion of the Tennessee SIP on January 4, 2007. See 72 FR 265.

    II. Analysis of State's Submittal

    On June 25, 2008, Tennessee submitted a SIP revision 2 to EPA for review and approval. The revision amends the definition of VOC found in Chapter 4 of Part II, Section 4-2, of the Chattanooga Code. Specifically, the revision adds the following compounds to the list of negligibly reactive compounds to be consistent with federal and other similar SIP-approved regulations: 1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxy-butane (HFE-7100); methyl acetate; 1,1,1,2,2,3,3-heptafluoro-3-methoxy-propane (n-C3 F7OCH3, HFE-7000); 3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl) hexane (HFE-7500); 1,1,1,2,3,3,3-heptafluoropropane (HFC 227ea); and methyl formate (HCOOCH3). These compounds are excluded from the VOC definition on the basis that each of these compounds makes a negligible contribution to tropospheric ozone formation. EPA is proposing to approve this revision because it is consistent with the definition of VOC at 40 CFR 51.100(s). EPA is also proposing to approve this revision because it is consistent with other similar SIP-approved regulations.

    2 EPA will consider the other changes included in Tennessee's June 25, 2008, SIP revision in a future rulemaking.

    The revision includes minor changes to paragraph 3 of Chattanooga Code, Chapter 4 of Part II, Section 4-2 definition of VOC to be consistent with federal and other similar SIP-approved regulations. As a precondition to excluding compounds as VOCs, paragraph 3 states that: “As a precondition to excluding these compounds as VOC or at any time thereafter, the Director shall require an owner or operator to provide monitoring or testing methods and results demonstrating the amount of negligibly-reactive compounds in the source's emissions.” The SIP revision changes the precondition for the director to require this testing from “shall” to “may” and adds that any testing be “to the satisfaction of the Director” of the Chattanooga-Hamilton County Air Pollution Control Bureau. The SIP revision also adds paragraph 4 which states: “For purposes of enforcement for a specific source, the test methods specified in these regulations, in the approved SIP, or in a permit issued pursuant to these regulations shall be used to be consistent with state regulations.” EPA is proposing to approve these revisions because they are consistent with the definition of VOC at 40 CFR 51.100(s) and with other similar SIP-approved regulations.

    Finally, the SIP revision adds paragraph 5 which states: “The following compound(s) are VOC for purposes of all recordkeeping, emissions reporting, photochemical dispersion modeling and inventory requirements which apply to VOC and shall be uniquely identified in emission reports, but are not VOC for purposes of VOC emissions limitations or VOC content requirements: t-butyl acetate.” Through this revision, Hamilton County is also adding t-butyl acetate to the list of negligibly reactive compounds, but maintaining the requirements of recordkeeping, emissions reporting, and inventory. EPA is proposing to approve this revision because it is consistent with the definition of VOC at 40 CFR 51.100(s).3 4

    3 In EPA's November 29, 2004, final rulemaking, the Agency added tertiary butyl acetate to the list of excluded compounds from the definition of VOCs. See 69 FR 69298.

    4 While EPA added t-butyl acetate to the list of negligibly reactive compounds in the November 29, 2004, final rulemaking, t-butyl acetate continued to be a VOC for purposes of all recordkeeping, emissions reporting, and inventory requirements which applied to VOC. See 69 FR 69298. Subsequently, on February 25, 2016 (81 FR 9339), EPA issued a final rule removing recordkeeping, emissions reporting, and inventory requirements for t-Butyl acetate. Although EPA no longer requires recordkeeping, emissions reporting, and inventory requirements for t-butyl acetate, this SIP revision includes this requirement.

    Pursuant to CAA section 110(l), the Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in CAA section 171), or any other applicable requirement of the Act. The State's addition of the County's exemptions from the definition of VOC, addition of recordkeeping, emissions reporting, photochemical dispersion modeling, and inventory requirements for t-butyl acetate, and other changes in paragraphs 3 and 4 to Chapter 4 of Part II, Section 4-2, of the Chattanooga Code “Definitions” are approvable under section 110(l) because they reflect changes to federal regulations based on findings that the aforementioned compounds are negligibly reactive and make a negligible contribution to troposphere ozone formation.

    III. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Chapter 4 of Part II, Section 4-2, “Definitions” effective August 16, 1995, which revised the definition of VOC. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

    IV. Proposed Action

    Pursuant to section 110 of the CAA, EPA is proposing to approve the aforementioned changes to Tennessee's SIP for Chapter 4 of Part II, Section 4-2. EPA has evaluated the relevant portions of Tennessee's June 25, 2008, SIP revision and has determined that it meets the applicable requirements of the CAA and EPA regulations and is consistent with EPA policy.

    V. Statutory and Executive Order Reviews

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

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

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

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

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

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

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

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

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

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

    The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: February 20, 2018. Onis “Trey” Glenn, III, Regional Administrator, Region 4.
    [FR Doc. 2018-04932 Filed 3-12-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-R04-OAR-2018-0017; FRL-9975-52-Region 4] Air Plan Approval and Air Quality Designation; SC; Redesignation of the Greenville-Spartanburg Unclassifiable Area AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    On January 22, 2018, the State of South Carolina, through the Department of Health and Environmental Control (DHEC), submitted a request for the Environmental Protection Agency (EPA) to redesignate the Greenville-Spartanburg, South Carolina fine particulate matter (PM2.5) unclassifiable area (hereinafter referred to as the “Greenville Area” or “Area”) to unclassifiable/attainment for the 1997 primary and secondary annual PM2.5 national ambient air quality standards (NAAQS). The Greenville Area is comprised of Anderson, Greenville, and Spartanburg Counties in South Carolina. EPA now has sufficient data to determine that the Greenville Area is in attainment of the 1997 primary and secondary annual PM2.5 NAAQS. Therefore, EPA is proposing to approve the State's request and redesignate the Area to unclassifiable/attainment for the 1997 primary and secondary annual PM2.5 NAAQS based upon valid, quality-assured, and certified ambient air monitoring data showing that the PM2.5 monitors in the Area are in compliance with the 1997 primary and secondary annual PM2.5 NAAQS.

    DATES:

    Comments must be received on or before April 12, 2018.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2018-0017 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:

    Madolyn Sanchez, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303-8960. Ms. Sanchez can be reached by telephone at (404) 562-9644 or via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Clean Air Act (CAA or Act) establishes a process for air quality management through the establishment and implementation of the NAAQS. After the promulgation of a new or revised NAAQS, EPA is required to designate areas, pursuant to section 107(d)(1) of the CAA, as attainment, nonattainment, or unclassifiable. On July 18, 1997 (62 FR 38652), EPA revised the NAAQS for particulate matter to add new standards for PM2.5 (annual and 24-hour). The primary and secondary annual standards were each set at a level of 15.0 micrograms per cubic meter (µg/m3), based on a 3-year average of annual mean PM2.5 concentrations. The primary and secondary 24-hour standards were each set at a level of 65 µg/m3, based on a 3-year average of the 98th percentile of 24-hour concentrations. EPA established the standards based on significant evidence and numerous health studies demonstrating that serious health effects are associated with exposures to particulate matter.

    The process for designating areas following promulgation of a new or revised NAAQS is contained in section 107(d)(1) of the CAA. EPA and state air quality agencies initiated the monitoring process for the 1997 PM2.5 NAAQS in 1999, and deployed all air quality monitors by January 2001. On January 5, 2005 (70 FR 944), EPA designated areas across the country as nonattainment, unclassifiable, or unclassifiable/attainment 1 for the PM2.5 NAAQS based upon air quality monitoring data from these monitors for calendar years 2001-2003.

    1 For the initial PM area designations in 2005 (for the 1997 annual PM2.5 NAAQS), EPA used a designation category of “unclassifiable/attainment” for areas that had monitors showing attainment of the standard and were not contributing to nearby violations and for areas that did not have monitors but for which EPA had reason to believe were likely attaining the standard and not contributing to nearby violations. EPA used the category “unclassifiable” for areas in which EPA could not determine, based upon available information, whether or not the NAAQS was being met and/or EPA had not determined the area to be contributing to nearby violations. EPA reserves the “attainment” category for when EPA redesignates a nonattainment area that has attained the relevant NAAQS and has an approved maintenance plan.

    Greenville County, South Carolina, had a monitor with less than three years of data since the monitor had not been in operation for the full 2001-2003 period. Based upon the data that was obtained during its operation, the monitor indicated a potential to violate the 1997 annual PM2.5 NAAQS. Also, Anderson and Spartanburg Counties had emissions and population levels that potentially contributed to the elevated concentrations of PM2.5 at the Greenville monitor in question. Therefore, EPA designated all three counties—Anderson, Greenville and Spartanburg—as unclassifiable for the 1997 annual PM2.5 NAAQS.

    II. What are the criteria for redesignating an area from unclassifiable to unclassifiable/attainment?

    Section 107(d)(3) of the CAA provides the framework for changing the area designations for any NAAQS pollutants. Section 107(d)(3)(A) provides that the Administrator may notify the Governor of any state that the designation of an area should be revised “on the basis of air quality data, planning and control considerations, or any other air quality-related considerations the Administrator deems appropriate.” The Act further provides in section 107(d)(3)(D) that even if the Administrator has not notified a state Governor that a designation should be revised, the Governor of any state may, on the Governor's own motion, submit a request to revise the designation of any area, and the Administrator must approve or deny the request.

    When approving or denying a request to redesignate an area, EPA bases its decision on the air quality data for the area as well as the considerations provided under section 107(d)(3)(A).2 In keeping with section 107(d)(1)(A), areas that are redesignated to unclassifiable/attainment must meet the requirements for attainment areas and thus must meet the relevant NAAQS. In addition, the area must not contribute to ambient air quality in a nearby area that does not meet the NAAQS. The relevant monitoring data must be collected and quality-assured in accordance with 40 CFR part 58 and recorded in the EPA Air Quality System (AQS) database. The designated monitors generally should have remained at the same location for the duration of the monitoring period upon which the redesignation request is based.3

    2 While CAA section 107(d)(3)(E) also list specific requirements for redesignations, those requirements only apply to redesignations of nonattainment areas to attainment and therefore are not applicable in the context of a redesignation of an area from unclassifiable to unclassifiable/attainment.

    3See Memorandum from John Calcagni, Director, EPA Air Quality Management Division, entitled “Procedures for Processing Requests to Redesignate Areas to Attainment” (September 4, 1992).

    III. What is EPA's rationale for proposing to redesignate the Area?

    In order to redesignate the Area from unclassifiable to unclassifiable/attainment for the 1997 primary and secondary annual PM2.5 NAAQS, the 3-year average of annual arithmetic mean concentrations (i.e., design value) over the most recent 3-year period must be less than or equal to 15.0 µg/m3 at all monitoring sites in the Area over the full 3-year period, as determined in accordance with 40 CFR 50.18 and Appendix N of Part 50. EPA reviewed PM2.5 monitoring data from monitoring stations in the Greenville Area for the 1997 primary and secondary annual PM2.5 NAAQS for the 3-year period from 2014-2016. These data have been quality-assured, certified, and recorded in AQS by South Carolina, and the monitoring locations have not changed during the monitoring period. As summarized in Table 1, the design values for the monitors in the Area for the 2014-2016 period are well below the 1997 primary and secondary annual PM2.5 NAAQS.

    Table 1—1997 Annual PM2.5 Design Values for Monitors in the Greenville Area for 2014-2016 Local site name Monitoring site 2014-2016 Design value
  • (μg/m3)
  • Greenville ESC 45-045-0015 9.3 Hillcrest Middle School 45-045-0016 8.6 T.K. Gregg 45-083-0011 8.7

    Because the 3-year design values, based on valid, quality-assured data, demonstrate that the Area meets the 1997 primary and secondary annual PM2.5 standards, EPA is proposing to redesignate the Greenville Area from unclassifiable to unclassifiable/attainment for this NAAQS.

    IV. Proposed Action

    EPA is proposing to approve South Carolina's January 22, 2018, request to redesignate the Greenville Area from unclassifiable to unclassifiable/attainment for the 1997 primary and secondary annual PM2.5 NAAQS. If finalized, approval of the redesignation request would change the legal designation, found at 40 CFR part 81, of Anderson, Greenville, and Spartanburg Counties from unclassifiable to unclassifiable/attainment for the 1997 primary and secondary annual PM2.5 NAAQS.

    V. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to unclassifiable/attainment is an action that affects the status of a geographical area and does not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to unclassifiable/attainment does not in and of itself create any new requirements. Accordingly, this proposed action merely proposes to redesignate an area to unclassifiable/attainment and does not impose additional requirements. For that reason, this proposed action:

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

    • Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because redesignations are exempted under Executive Order 12866;

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

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

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

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

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

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

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

    • Will not have disproportionate human health or environmental effects under Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, this proposed action to redesignate the Greenville Area from unclassifiable to unclassifiable/attainment for the 1997 primary and secondary annual PM2.5 NAAQS does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). The Catawba Indian Nation Reservation is located within the State of South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, “all state and local environmental laws and regulations apply to the Catawba Indian Nation and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” However, because no tribal lands are located within the Area and the redesignation does not create new requirements, EPA has determined that this proposed rule does not have substantial direct effects on an Indian Tribe. EPA notes this proposed action will not impose substantial direct costs on Tribal governments or preempt Tribal law.

    List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control.

    Authority:

    42 U.S.C. 7401, et seq.

    Dated: March 5, 2018. Onis “Trey” Glenn, III, Regional Administrator, Region 4.
    [FR Doc. 2018-05060 Filed 3-12-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 36 [WC Docket No. 14-130, CC Docket No. 14-130; FCC 18-22] Comprehensive Review of the Uniform System of Accounts; Jurisdictional Separations and Referral to the Federal-State Joint Board AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    In this document, the Federal Communications Commission (Commission) seeks comment on its proposal to adopt recommendations from the Federal-State Joint Board on Jurisdictional Separations and to amend the Part 36 jurisdictional separations rules accordingly. Acknowledging the implications that reforms adopted in the Part 32 Reform Order would have on the Part 36 rules, the Commission referred to the Federal-State Joint Board on Jurisdictional Separations (Joint Board) consideration of how and when to modify Part 36 to ensure that it is consistent with the Part 32 reforms. The Joint Board issued its Recommended Decision in October 2017. The Commission proposes to adopt each of the Joint Board's recommendations using, with minor exceptions, the amendment language the Joint Board suggested, and seeks comment on these proposals.

    DATES:

    Comments are due on or before April 12, 2018. Reply comments are due on or before April 27, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this document, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    You may submit comments, identified by WC Docket Nos. 17-287, 11-42, and 09-197, by any of the following methods:

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

    Federal Communications Commission's website: http://fjallfoss.fcc.gov/ecfs2/. Follow the instructions for submitting comments.

    People with Disabilities: Contact the Commission to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: [email protected] or phone: (202) 418-0530 or TTY: (202) 418-0432.

    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:

    Edward Krachmer, Pricing Policy Division, Wireline Competition Bureau, at (202) 418-1540 or via email at [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Notice of Proposed Rulemaking, FCC 18-22, released February 22, 2018. For a full text copy of this document please go to the following internet Address: https://www.fcc.gov/document/fcc-proposes-adopt-separations-joint-boards-recommendations.

    I. Introduction

    1. In the Notice of Proposed Rulemaking (NPRM), the Commission takes steps to harmonize its rules regarding jurisdictional separations to reflect the Commission's actions in February 2017 to reduce and eliminate unnecessary accounting rules. Today, the Commission furthers its goal of updating and modernizing the Commission's rules to minimize outdated compliance burdens on carriers and to free up scarce resources that can accordingly be used to expand modern networks that bring economic opportunity, job creation and civic engagement to all Americans.

    2. In the Part 32 Reform Order, the Commission amended its Part 32 Uniform System of Accounts (USOA) to streamline or eliminate rules that had outlived their utility. Recognizing that those amendments had implications for its Part 36 jurisdictional separations rules, the Commission referred to the Federal-State Joint Board on Jurisdictional Separations (Joint Board) consideration of how and when the Part 36 rules should be modified to reflect the reforms adopted in the Part 32 Reform Order. The Commission asked the Joint Board to consider how the Part 32 reforms “impact Part 36 and consequently the rule changes necessary to ensure the jurisdictional separations rules are consistent” with changes to Part 32. The Commission also asked that the Joint Board “prepare a recommended decision . . . regarding how and when the Commission's jurisdictional separations rules should be modified to reflect the issues in the referral.” The Joint Board released its Recommended Decision on October 27, 2017.

    3. In this NPRM, the Commission proposes to adopt each of the Joint Board's recommendations and to amend the Part 36 rules consistent with those recommendations. The Commission invites comment on these proposals.

    II. Background

    4. Jurisdictional separations are the third step in a four-step regulatory process used to establish tariffed rates for interstate and intrastate regulated services for incumbent local exchange carriers (LECs). First, carriers record their costs into various accounts in accordance with the USOA prescribed by Part 32 of the Commission's rules. Second, carriers divide the costs in these accounts between regulated and nonregulated activities in accordance with Part 64 of the Commission's rules. This division ensures that the costs of nonregulated activities will not be recovered in regulated interstate service rates. Third, carriers separate the regulated costs between the intrastate and interstate jurisdictions in accordance with the Commission's Part 36 separations rules. This process begins with the carriers assigning regulated costs to various investment and expense categories. In certain instances, carriers further disaggregate costs among service categories. Finally, carriers apportion the interstate regulated costs among the interexchange services and rate elements that form the cost basis for their exchange access tariffs. Carriers subject to rate-of-return regulation perform this apportionment in accordance with Part 69 of the Commission's rules.

    5. Historically, Part 32 divided incumbent LECs into two classes for accounting purposes based on an incumbent LEC's annual regulated revenues: Class A incumbent LECs (currently those with regulated annual revenues equal to or greater than $157 million) and Class B incumbent LECs (currently those with less than $157 million in annual regulated revenues). Part 32 required Class A carriers to create and maintain substantially more accounts than it required from smaller Class B carriers. In all but one case, Class A carrier accounts could be grouped into sets that were represented by single Class B carrier accounts—that is, such Class A accounts consolidated into, or “rolled up” into Class B accounts.

    6. The reforms adopted in the Part 32 Reform Order include the elimination of Part 32's distinction between Class A and Class B incumbent LECs. Under the new rules, effective January 1, 2018, all carriers subject to Part 32 are required to keep only the less onerous Class B accounts.

    7. At the request of the Commission, the Joint Board considered the impact of the Part 32 reforms on the Part 36 rules and released a recommended decision. In the Recommended Decision, the Joint Board recommends removing all of the provisions in the Part 36 rules that deal with Class A accounts, allowing former Class A carriers (carriers with revenue equal to or greater than $157 million for calendar year 2016) to select between the former Class A and former Class B procedures for apportioning general support facilities costs, and making certain stylistic and typographical corrections to the Part 36 rules.

    III. Discussion

    8. The Commission proposes to adopt each of the Joint Board's recommendations and to amend the Part 36 rules using, with minor exceptions, the language the Joint Board suggests. The Commission invites comment on these proposals. The Commission also welcomes comment on whether it should make other changes to the Part 36 rules to harmonize them with the changes the Commission made to Part 32 in the Part 32 Reform Order.

    9. First, the Commission proposes to adopt the Joint Board's recommendation to remove from its Part 36 rules all the provisions that deal with Class A accounts, because carriers are no longer be required to keep such accounts since the revised Part 32 rules took effect on January 1, 2018. Under this approach, the Commission proposes to: (a) Delete references to Class A accounts and the phrase “Class B accounts” in Part 32 rules that contain parallel references to Class A accounts and the Class B accounts into which they roll up; (b) delete references to current-year account balances and modify references to Class A carriers in other Part 36 rules; and (c) delete references to Class A accounts in sections 36.501 and 36.505 of the rules. The Commission seeks comment on this proposal as well as on whether there is a different approach it should take in harmonizing the Part 36 rules with the newly amended Part 32 rules.

    10. Second, the Commission proposes to amend section 36.112, which concerns the apportionment of general support facilities costs. As the Joint Board observes, this is the only Part 36 rule that provides different separations procedures for Class A and Class B carriers. Consistent with the Joint Board's recommendation, the Commission proposes to allow former Class A carriers (carriers with revenue equal to or greater than $157 million for calendar year 2016) to select between these two procedures in apportioning their general support facilities costs. The Commission seeks comment on permitting such selections. The Commission also seeks comment on whether each carrier should be permitted to make an election only one time or be allowed to change the approach it takes over time. What are the practical consequences of permitting carriers to make such elections?

    11. Additionally, consistent with the Joint Board's recommendations, the Commission's proposed rule changes include certain stylistic and typographical corrections to the Part 36 rules. For example, the Commission proposes to correct a spelling error in section 36.126(b) and to hyphenate the adjective “twelve month” throughout Part 36. In addition to adopting these corrections, are there other ministerial corrections that the Commission should make to those rules?

    12. The Commission also seeks comment on the timing for making these changes to its Part 36 rules. The changes to its Part 32 rules took effect January 1, 2018. Should the Commission make harmonizing changes to its Part 36 rules as soon as practicable, as the Joint Board recommends? Should the Commission make changes effective January 1, 2019? The Commission asks commenters to explain the implications of different effective dates for any changes it makes to harmonize its Part 36 rules with its newly revised Part 32 rules.

    IV. Procedural Matters A. Comment Filing Procedures

    13. Pursuant to sections 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).

    Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: http://apps.fcc.gov/ecfs/.

    Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

    • Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.

    • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington DC 20554.

    People with Disabilities: 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 & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

    B. Ex Parte Presentations

    14. The proceeding this FNPRM initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 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 rule 1.1206(b). In proceedings governed by rule 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.

    C. Paperwork Reduction Act

    15. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    D. Initial Regulatory Flexibility Act Analysis

    16. As required by the Regulatory Flexibility Act of 1980 (RFA), the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) for this Notice of Proposed Rulemaking, of the possible significant economic impact on small entities of the policies and rules addressed in this document. The IRFA is set forth in Appendix C. 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 NPRM indicated on the first page of this document. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send a copy of this Notice of Proposed Rulemaking, including the IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA).

    V. Initial Regulatory Flexibility Analysis

    17. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the proposals in this Notice of Proposed Rulemaking (Notice). 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 and reply comments on the Notice provided above. The Commission will send a copy of the Notice, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the Notice and the IRFA (or summaries thereof) will be published in the Federal Register.

    A. Need for, and Objectives of, the Proposed Rules

    18. In the Part 32 Reform Order, the Commission amended its Part 32 Uniform System of Accounts (USOA) to streamline or eliminate rules that had outlived their utility. Recognizing that those amendments had implications for its Part 36 jurisdictional separations rules, the Commission referred to the Federal-State Joint Board on Jurisdictional Separations (Joint Board) consideration of how and when the Part 36 rules should be modified to reflect the reforms adopted in the Part 32 Reform Order. The Commission asked the Joint Board to consider how those reforms “impact Part 36 and consequently the rule changes necessary to ensure the jurisdictional separations rules are consistent” with changes to Part 32. The Commission also asked that the Joint Board “prepare a recommended decision . . . regarding how and when the Commission's jurisdictional separations rules should be modified to reflect the issues in the referral.” The Joint Board released its Recommended Decision on October 27, 2017. In this Notice of Proposed Rulemaking (Notice), the Commission invites comment on that Recommended Decision and, in particular, on the proposed amendments to the Part 36 rules recommended by the Joint Board. The purpose of those proposed amendments is to ensure that the Part 36 rules are consistent with the amendments to the Part 32 rules adopted in the Part 32 Reform Order.

    B. Legal Basis

    19. The legal basis for the Notice of Proposed Rulemaking is contained in sections 1, 2, 4(i), 201-205, 215, 218, 220, and 410 of the Communications Act of 1934, as amended.

    C. Description and Estimate of the Number of Small Entities to Which Rules May Apply

    20. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. 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). Nationwide, there are a total of approximately 27.9 million small businesses, according to the SBA.

    21. Incumbent Local Exchange Carriers. Neither the Commission nor the SBA has developed a small business size standard specifically for providers of incumbent local exchange services. The closest applicable size standard under the SBA rules is for Wired Telecommunications Carriers. Under the SBA definition, a carrier is small if it has 1,500 or fewer employees. According to the FCC's Telephone Trends Report data, 1,307 incumbent local exchange carriers (LECs) reported that they were engaged in the provision of local exchange services. Of these 1,307 carriers, an estimated 1,006 have 1,500 or fewer employees and 301 have more than 1,500 employees. Consequently, the Commission estimates that most incumbent LECs are small entities that may be affected by the rules and policies adopted herein.

    22. The Commission has included small incumbent LECs in this RFA analysis. As noted above, a “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard (e.g., a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. Because the Commission's proposals concerning the Part 36 rules will affect all incumbent LECs, some entities employing 1,500 or fewer employees may be affected by the proposals made in this Notice. The Commission has therefore included small incumbent LECs in this RFA analysis, although it emphasizes that this RFA action has no effect on the Commission's analyses and determinations in other, non-RFA contexts. The Commission notes, however, that proposals in the Notice are focused on incumbent LECs with regulated annual revenues equal to or above $157 million, a group that excludes many small incumbent LECs.

    D. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements

    23. None.

    E. Steps Taken To Minimize Significant Economic Impact on 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 (among others) the following four alternatives: (1) The establishment of differing compliance and 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 part thereof, for small entities.

    25. As discussed above, the purpose of the proposals in this Notice is to ensure that the Part 36 rules are consistent with the amendments to the Part 32 rules adopted in the Part 32 Reform Order. The Commission seeks comment on the effects its proposals would have on small entities, and whether any rules that it adopts should apply differently to small entities. The Commission requests commenters to consider the costs and burdens of possible rule amendments on small incumbent LECs and whether such amendments would disproportionately affect specific types of carriers or ratepayers.

    26. The Commission believes that the proposed rules would ease the administrative burden of regulatory compliance for incumbent LECs, including any small incumbent LECs those rules might affect. The Part 32 Reform Order reduced the number of Part 32 accounts that incumbent LECs with regulated annual revenues equal to or above $157 million are required to keep, and the proposed amendments to Part 36 would carry forward those reductions into the jurisdictional separations process. If those amendments can be said to have any effect under the RFA, it is to reduce a regulatory compliance burden for small incumbent LECs.

    F. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rules

    27. None.

    VI. Ordering Clauses

    28. Accordingly, it is ordered that, pursuant to the authority contained in sections 1, 2, 4(i), 201-205, 215, 218, 220, and 410 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i), 201-205, 215, 218, 220, 410, this Notice of Proposed Rulemaking is adopted.

    29. It is further ordered that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Notice of Proposed Rulemaking, including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

    List of Subjects in 47 CFR Part 36

    Communications common carriers; Reporting and recordkeeping requirements; Telephone; Uniform system of accounts.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary. Proposed Rules

    For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 36 as follows:

    PART 36—JURISDICTIONAL SEPARATIONS PROCEDURES; STANDARD PROCEDURES FOR SEPARATING TELECOMMUNICATIONS PROPERTY COSTS, REVENUES, EXPENSES, TAXES AND RESERVES FOR TELECOMMUNICATIONS COMPANIES 1. The authority citation for part 36 continues to read as follows: Authority:

    47 U.S.C. 151, 154(i) and (j), 205, 221(c), 254, 303(r), 403, 410, and 1302 unless otherwise noted.

    2. Revise § 36.112 to read as follows:
    § 36.112 Apportionment procedure.

    (a) The costs of the general support facilities of local exchange carriers that had annual revenues from regulated telecommunications operations equal to or greater than $157 million for calendar year 2016 are apportioned among the operations on the basis of one of the following, at the election of the local exchange carrier:

    (1) The separation of the costs of the combined Big Three Expenses which include the following accounts:

    Plant Specific Expenses Central Office Switching Expenses—Account 6210 Operators Systems Expenses—Account 6220 Central Office Transmission Expenses—Account 6230 Information Origination/Termination Expenses—Account 6310 Cable and Wire Facilities Expenses—Account 6410 Plant Non-Specific Expenses Network Operations Expenses—Account 6530 Customer Operations Expenses Marketing—Account 6610 Services—Account 6620; or

    (2) The separation of the costs of Central Office Equipment, Information Origination/Termination Equipment, and Cable and Wire Facilities, combined.

    (b) The costs of the general support facilities of local exchange carriers that had annual revenues from regulated telecommunications operations less than $157 million for calendar year 2016 are apportioned among the operations on the basis of the separation of the costs of Central Office Equipment, Information Origination/Termination Equipment, and Cable and Wire Facilities, combined.

    § 36.121 [Amended]
    3. Amend § 36.121 as follows: a. Revise paragraph (a); and b. In paragraph (c)(1)(i), remove “130 volt” and add, in its place, “130-volt”.

    The revision reads as follows:

    § 36.121 General.

    (a) The costs of central office equipment are carried in the following accounts:

    Central Office Switching Account—2210. Operator Systems Account—2220. Central Office—Transmission Account—2230.
    §  36.124 [Amended]
    4. Amend § 36.124 as follows: a. In paragraph (a), remove “Accounts 2210, 2211, and 2212” and add, in its place, “Account 2210”. b. In paragraph (c), remove “assign the average balances of Accounts 2210, 2211, and 2212” and add, in its place, “assign the average balance of Account 2210”; and remove “assignment of the average balances of Accounts 2210, 2211, and 2212,” and add, in its place, “assignment of the average balance of Account 2210 (or, if Accounts 2211 and 2212 were required to be maintained at the applicable time, the average balances of Accounts 2211 and 2212)”.
    §  36.125 [Amended]
    5. Amend § 36.125 as follows: a. In paragraph (a), remove “Accounts 2210, 2211, and 2212” and add, in its place, “Account 2210”; remove “e.g. transmitters,” and add, in its place, “e.g., transmitters,”; remove “directors” and, add in its place, “directors,”; and remove “e.g. switching” and add, in its place, “e.g., switching”. b. In paragraph (h), remove “assign the average balances of Accounts 2210, 2211, and 2212” and add, in its place, “assign the average balance of Account 2210”; and remove “assignment of the average balances of Accounts 2210, 2211, and 2212,” and add, in its place, “assignment of the average balance of Account 2210 (or, if Accounts 2211 and 2212 were required to be maintained at the applicable time, the average balances of Accounts 2211 and 2212)”.
    §  36.126 [Amended]
    6. Amend § 36.126 as follows: a. In paragraph (a), remove “Accounts 2230 through 2232 respectively” and add, in its place, “Account 2230”. b. In the introductory text of paragraph (b), remove “equiment” and add, in its place, “equipment”. c. In paragraphs (b)(5) and (6), remove “assign the average balances of Accounts 2230 through 2232” and add, in its place, “assign the average balance of Account 2230”; and remove “assignment of the average balances of Accounts 2230 through 2232” and add, in its place, “assignment of the average balance of Account 2230 (or, if Accounts 2231 and 2232 were required to be maintained at the applicable time, the average balances of Accounts 2231 and 2232)”.
    § 36.154 [Amended]
    7. Amend §  36.154 by removing “jurisdication” and adding, in its place, “jurisdiction”.
    §  36.201 [Amended]
    8. Amend § 36.201 as follows: a. Redesignate paragraph (a) as an undesignated paragraph; and b. In the table, remove “(Class B telephone companies); Basic area revenue—Account 5001 (Class A telephone companies)”.
    §  36.211 [Amended]
    9. Amend § 36.211 as follows: a. Redesignate paragraph (a) as an undesignated paragraph; and b. In the table: i. Remove “Basic local service revenue (Class B telephone companies)” and add, in its place, “Basic Local Service Revenue”; and ii. Remove the entry “Basic Area Revenue (Class A telephone companies)”. 10. Amend § 36.212 by revising the section heading to read as follows:
    §  36.212 Basic local services revenue—Account 5000.
    §  36.301 [Amended]
    11. Amend § 36.301 as follows: a. Redesignate paragraph (a) as an undesignated paragraph; and b. In the table: i. Remove “(Class B Telephone Companies); Accounts 6112, 6113, 6114, 6121, 6122, 6123, and 6124 (Class A Telephone Companies)”; ii. Remove “Accounts 6210, 6220, 6230 (Class B Telephone Companies); Accounts 6211, 6212, 6220, 6231, and 6232 (Class A Telephone Companies)” and add, in its place, “Accounts 6210, 6220, and 6230”; iii. Remove “(Class B Telephone Companies); Accounts 6311, 6341, 6351, and 6362 (Class A Telephone Companies)”; iv. Remove “(Class B Telephone Companies); Accounts 6411, 6421, 6422, 6423, 6424, 6426, 6431, and 6441 (Class A Telephone Companies)”; v. Remove “(Class B Telephone Companies); Accounts 6511 and 6512 (Class A Telephone Companies)”; vi. Remove “(Class B Telephone Companies); Accounts 6531, 6532, 6533, 6534, and 6535 (Class A Telephone Companies)”; vii. Remove “(Class B Telephone Companies); Accounts 6611 and 6613 (Class A Telephone Companies)”; viii. Remove “Local Bus. Office” and add, in its place, “Local Business Office”; and ix. Remove “(Class B Telephone Companies); Accounts 7210, 7220, 7230, 7240, and 7250 (Class A Telephone Companies)”.
    §  36.302 [Amended]
    12. Amend § 36.302 in the introductory text to paragraph (c)(1) and in paragraph (c)(1)(i), by removing “SRC” and adding, in its place, “SRCs”. 13. Amend § 36.310 by revising paragraph (a) to read as follows:
    §  36.310 General.

    (a) Plant specific operations expenses include the following accounts:

    Network Support Expenses. Account 6110 General Support Expenses. Account 6120 Central Office Switching Expenses. Account 6210 Operator System Expenses. Account 6220 Central Office Transmission Expenses. Account 6230 Information Origination/Termination Expenses. Account 6310 Cable and Wire Facilities Expenses. Account 6410
    14. Amend § 36.311 by revising the section heading to read as follows:
    §  36.311 Network Support/General Support Expenses—Accounts 6110 and 6120.
    15. Amend § 36.321 as follows: a. Revise the section heading; b. Remove, from the table in paragraph (a), “(Class B telephone companies); Accounts 6211 and 6212 (Class A telephone companies)” and “(Class B telephone companies); Accounts 6231 and 6232 (Class A telephone companies)”; and c. Remove, from paragraph (b), “equipment. Accounts” and adding, in its place, “equipment—Accounts”.

    The revision reads as follows:

    §  36.321 Central office expenses—Accounts 6210, 6220, and 6230.
    16. Amend § 36.331 by revising the section heading to read as follows:
    §  36.331 Information origination/termination expenses—Account 6310.
    17. Amend § 36.341 by revising the section heading to read as follows:
    §  36.341 Cable and wire facilities expenses—Account 6410.
    §  36.351 [Amended]
    18. Amend § 36.351 as follows: a. Redesignate paragraph (a) as an undesignated paragraph; and b. In the table: i. Remove “(Class B telephone companies); Accounts 6511 and 6512 (Class A telephone companies)”; and ii. Remove “(Class B telephone companies); Accounts 6531, 6532, 6533, 6534, and 6535 (Class A telephone companies)”. 19. Amend § 36.352 by revising the section heading to read as follows:
    §  36.352 Other property plant and equipment expenses—Account 6510.
    20. Amend § 36.353 by revising the section heading to read as follows:
    §  36.353 Network operations expenses—Account 6530.
    §  36.371 [Amended]
    21. Amend § 36.371 in the table by removing “(Class B telephone companies); Accounts 6611 and 6613 (Class A telephone companies)”. 22. Amend § 36.372 by revising the section heading to read as follows:
    §  36.372 Marketing—Account 6610.
    §  36.375 [Amended]
    23. Amend § 36.375 in paragraphs (b)(4) and (5), by removing “through (4)” and adding, in its place, “through (3)”.
    §  36.392 [Amended]
    24. Amend § 36.392(c) as follows: a. Remove “(Class B Telephone Companies); Accounts 6211 and 6212 (Class A Telephone Companies)”; b. Remove “(Class B Telephone Companies); Accounts 6231 and 6232 (Class A Telephone Companies)”; c. Remove “(Class B Telephone Companies); Accounts 6311, 6341, 6351, and 6362 (Class A Telephone Companies)”; d. Remove “(Class B Telephone Companies); Accounts 6411, 6421, 6422, 6423, 6424, 6426, 6431, and 6441 (Class A Telephone Companies)”; e. Remove “(Class B Telephone Companies); Accounts 6531, 6532, 6533, 6534, and 6535 (Class A Telephone Companies)” and f. Remove “(Class B Telephone Companies); Accounts 6611 and 6613 (Class A Telephone Companies)”. 25. Amend § 36.411 as follows: a. Revise the section heading; b. Redesignate paragraph (a) as an undesignated paragraph c. Revise the final entry in the list.

    The revisions read as follows:

    §  36.411 Operating taxes—Account 7200. Provision for Deferred Operating Income Taxes
    26. Amend § 36.501 as follows:
    §  36.501 [Amended]

    Remove “(Class B Telephone Companies); Account 3410 (Class A Telephone Companies)”.

    27. Amend § 36.505 as follows: a. Revise the section heading; b. Redesignate paragraph (a) as an undesignated paragraph.

    The revision reads as follows:

    §  36.505 Accumulated amortization—Tangible—Account 3400.
    §§ 36.3, 36.123, 36.124(c) and (d); 36.125(h) and (i); 36.126(b)(5) and (6); 36.126(c)(4), (e)(4), and (f)(2); 36.141(c); 36.142(c); 36.152(d); 36.157(b); 36.191(d); 36.374(b); 36.375(b)(4); 36.377 introductory text and (a)(1)(ix), (2)(vii), (3)(vii), (4)(vii), (5)(vii), and (6)(vii); 36.378(b)(1); 36.379(b)(1);36.380(d) and (e); 36.381(c); and36.382(a) [Amended]
    28. Remove the term “twelve-month” and add in its place “twelve-month” in: a. §§ 36.3(a) and (b); b. §§ 36.123(a)(5) and (6); c. §§ 36.124(c) and (d); d. §§ 36.125(h) and (i); e. § 36.126(b)(5) and (6); f. §§ 36.126(c)(4), (e)(4), and (f)(2); g. § 36.141(c); h. § 36.142(c); i. § 36.152(d); j. § 36.157(b); k. § 36.191(d); l. § 36.374(b); m. § 36.375(b)(4); n. §§ 36.377 introductory text and (a)(1)(ix), (2)(vii), (3)(vii), (4)(vii), (5)(vii), and (6)(vii); o § 36.378(b)(1); p. § 36.379(b)(1); q. §§ 36.380(d) and (e); r. § 36.381(c); and s. § 36.382(a).
    [FR Doc. 2018-04563 Filed 3-12-18; 8:45 am] BILLING CODE 6712-01-P
    83 49 Tuesday, March 13, 2018 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request March 8, 2018.

    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 April 12, 2018 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), [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.

    Food and Nutrition Service

    Title: Third National Survey of WIC Participants (NSWP-III).

    OMB Control Number: 0584—New.

    Summary of Collection: The Third National Survey of WIC Participants (NSWP-III) is designed to provide nationally representative estimates of improper payments in the Special Supplemental Program for Women, Infants, and Children (WIC) arising from errors in the certification or denial of WIC applicants, to investigate potential State and local agency characteristics that may correlate with these errors, and to assess WIC participants' reasons for satisfaction or dissatisfaction with the program. The NSWP-III builds on three previous studies and reports spanning several decades. The Improper Payments Elimination and Recovery Improvement Act (IPERIA) of 2012 (P.L. 112-248); 2009 Executive Order 13520—Reducing Improper Payments; the Office of Inspector General (OIG) USDA FY 2014 Compliance with Improper Payments Requirements; and the Requirements for Effective Estimation and Remediation of Improper Payments set forth the priority, mandate, and requirements for the Food and Nutrition Service to identify, estimate, and reduce erroneous payments in WIC.

    Need and use of the Information: The NSWP-III will collect data from state and local WIC agency directors, current and former WIC program participants, and recently denied WIC program participants. The surveys for the state and local WIC agency directors are mandatory, while the surveys for the WIC program participants are voluntary. The NSWP-III has two purposes: (1) To obtain the data necessary to accomplish the study objectives noted above and (2) to pilot a new methodology for future annual estimates of improper payments in the WIC program.

    Description of Respondents: State, Local, or Tribal Government; Individuals or Households.

    Number of Respondents: 6,588.

    Frequency of Responses: Reporting: On Occasion.

    Total Burden Hours: 5,110.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-04982 Filed 3-12-18; 8:45 am] BILLING CODE 3410-30-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request March 8, 2018.

    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 required 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 April 12, 2018 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.

    Farm Service Agency

    Title: Emergency Conservation Program and Biomass Crop Assistance Program.

    OMB Control Number: 0560-0082.

    Summary of Collection: The Farm Service Agency (FSA), in cooperation with the Natural Resources Conservation Service, the Forest Service, and other agencies and organizations, provides eligible producers and landowners cost-share incentives and technical assistance through several conservation and environmental programs to help farmers, ranchers, and other eligible landowners and operators conserve soil, improve water quality, develop forests, and rehabilitate farmland severely damaged by natural disasters. The authorities to collect information for this collection are found under the Agricultural Credit Act of 1978 (16 U.S.C. 2201-2205), which provides emergency funds for sharing with agricultural producers the cost of rehabilitating farmland damaged by natural disaster, and for carrying out emergency water conservation measures during periods of severe drought. FSA is also managing the Biomass Crop Assistance Program (BCAP) authorized by Section 9010 of the Agricultural Act of 2014 (Pub. L. 113-79), which amends Title 1X of the Food, Conservation and Energy Act of 008. BCAP regulations outlined the legislations parameters, program definitions and process or: (1) Establishing BCAP project areas; (2) Matching payment opportunity for eligible material wners and qualifying biomass conversion facilities; (3) Contracting acreage for producers in BCAP project areas; and (4) Establishment and annual production payments for producers in CAP projects areas.

    Need and use of the Information: FSA will collect information using several forms. The collected information will be used to determine if the person, land, and practices are eligible for participation in the respective program and to receive cost-share assistance. Information collection from eligible biomass owners, biomass conversion facilities, and producers meeting the requirements for matching payments, annual production payment assistance, establishment payments and BCAP project area designation is necessary in order to ensure the financial accountability needed to operate and administer the BCAP. Without the information, FSA will not be able to make eligibility determinations and compute payments in a timely manner.

    Description of Respondents: Farms.

    Number of Respondents: 70,000.

    Frequency of Responses: Reporting: Annually.

    Total burden hours: 77,763.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-05033 Filed 3-12-18; 8:45 am] BILLING CODE 3410-05-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request March 8, 2018.

    The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (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 April 12, 2018 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.

    Rural Utilities Service

    Title: 7 CFR 1726, Electric System Construction Policies and Procedures—Electric.

    OMB Control Number: 0572-0107.

    Summary of Collection: The Rural Electrification Act of 1936, 7 U.S.C. 901 et.seq., as amended, (RE ACT) in Sec. 4 (7 U.S.C. 904) authorizes and empowers the Administrator of the Rural Utilities Service (RUS) to make loans in the several States and Territories of the United States for rural electrification and the furnishing and improving of electric energy to persons in rural areas. These loans are for a term of up to 35 years and are secured by a first mortgage on the borrower's electric system. In the interest of protecting loan security and accomplishing the statutory objective of a sound program of rural electrification, Section 4 of the RE Act further requires that RUS make or guarantee a loan only if there is reasonable assurance that the loan, together with all outstanding loans and obligations of the borrower, will be repaid in full within the time agreed. RUS will collect information using various RUS forms.

    Need and Use of the Information: RUS will collect information to implement certain provisions of the RUS standard form of loan documents regarding the borrower's purchase of materials and equipment and the construction of its electric system by contract or force account. The use of standard forms and procurement procedures helps assure RUS that appropriate standards and specifications are maintained; agency loan security is not adversely affected; and loan and loan guarantee funds are used effectively and for the intended purposes. The information will be used by RUS electric borrowers, their contractors and by RUS. If standard forms were not used, borrowers would need to prepare their own documents at a significant expense; and each document submitted by a borrower would require extensive and costly review by both RUS and the Office of the General Counsel.

    Description of Respondents: Not-for-profit institutions; Business or other for-profit.

    Number of Respondents: 817.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 78.

    Rural Utility Service

    Title: 7 CFR 1780, Water and Waste Disposal Loan and Grant Program.

    OMB Control Number: 0572-0121.

    Summary of Collection: Section 306 of the Consolidated Farm and Rural Development Act (CONACT), 7 U.S.C. 1926, authorizes Rural Utilities Service (RUS) to make loans and grants to public entities, federally-recognized American Indian tribes, and nonprofit corporations. The loans and grants fund the development of drinking water waste water, solid waste disposal, and storm wastewater disposal facilities in rural areas with populations of up to 10,000 residents.

    Need and Use of the Information: Rural Development's field offices will collect information from applicants/borrowers and consultants to determine eligibility and project feasibility. The information will help to ensure borrowers operate on a sound basis and use loan funds for authorized purposes. There are agency forms required as well as other requirements that involve certifications from the borrower, lenders, and other parties. Failure to collect proper information could result in improper determinations of eligibility, use of funds and or unsound loans.

    Description of Respondents: State, Local or Tribal Government; Not-for-profit institutions.

    Number of Respondents: 865.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 150,339.

    Rural Utility Service

    Title: Servicing of Water Programs Loans and Grants.

    OMB Control Number: 0572-0137.

    Summary of Collection: Authority for servicing of Water Programs Loan and Grants is contained in Section 306e of the Consolidated Farm and Rural Development Act, as amended. The information collected covers loan and grant servicing regulations, 7 CFR part 1782, which prescribes policies and responsibilities for servicing actions necessary in connection with Water and Environmental Programs (WEP) loans and grants. WEP provides loans, guaranteed loans and grants for water, sewer, storm water, and solid waste disposal facilities in rural areas and towns of up to 10,000 people.

    Need and Use of the Information: The Rural Utilities Service will collect information using various forms. The collected information for the most part is financial in nature and needed by the Agency to determine if borrowers, based on their individual situations, qualify for the various servicing authorities. Servicing actions become necessary due to the development of financial or other problems and may be initiated by either a recipient which recognizes that a problem exists and wished to resolve it, or by the Agency. If a problem exists, a recipient must furnish financial information which is used to aid in resolving the problem through re-amortization, sale, transfer, debt restructuring, liquidation, or other means provided in the regulations.

    Description of Respondents: Business or other for-profit; non-profit institutions; State and local governments.

    Number of Respondents: 62.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 729.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-05026 Filed 3-12-18; 8:45 am] BILLING CODE 3410-15-P
    DEPARTMENT OF AGRICULTURE Office of the Secretary Strengthening Civil Rights Management AGENCY:

    Office of the Secretary, USDA.

    ACTION:

    Request for Information (RFI).

    SUMMARY:

    Consistent with Executive Order 13781, “Comprehensive Plan for Reorganizing the Executive Branch,” and using the authority of the Secretary to reorganize the Department under section 4(a) of Reorganization Plan No. 2 of 1953 the U.S. Department of Agriculture (USDA) is soliciting public comment on a proposed realignment of the Office of the Assistant Secretary for Civil Rights (OASCR), which will improve customer service, better align functions within the organization, and ensure improved consistency, resource management, and strategic decision-making.

    DATES:

    Comments and information are requested on or before March 25, 2018.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this notice. All submissions must refer to “Improving Civil Rights” to ensure proper delivery.

    Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal: http://www.regulations.gov. USDA strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, and ensures timely receipt by USDA. Commenters should follow the instructions provided on that site to submit comments electronically.

    Submission of Comments by Mail, Hand Delivery, or Courier. Paper, disk, or CD-ROM submissions should be submitted to the Office of the Assistant Secretary for Civil Rights, USDA, Jamie L. Whitten Building, Room 507-W, 1400 Independence Ave. SW, Washington, DC 20250.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Winona Lake Scott, Telephone Number: (202) 720-3808, [email protected]

    SUPPLEMENTARY INFORMATION:

    USDA is committed to operating efficiently, effectively, and with integrity, and minimizing the burdens on individuals, businesses, and communities for participation in and compliance with USDA programs. USDA works to support the American agricultural economy to strengthen rural communities; to protect and conserve our natural resources; and to provide a safe, sufficient, and nutritious food supply for the American people. The Department's wide range of programs and responsibilities touches the lives of every American every day.

    I. Executive Order 13781

    Executive Order 13781, “Comprehensive Plan for Reorganizing the Executive Branch”, is intended to improve the efficiency, effectiveness, and accountability of the executive branch. The principles in the Executive Order provide the basis for taking actions to enhance and strengthen the delivery of USDA programs.

    II. Reorganization Actions

    On March 9, 2018, Secretary Perdue will be announcing his intent to take actions to strengthen civil rights and customer service at USDA by taking the following actions to ensure integrity, consistency, and fairness:

    • USDA will eliminate inefficiencies in delivering civil rights services at the agency and staff office level, thereby resulting in improved civil rights management. Under the realignment, a Civil Rights Director and appropriate Equal Opportunity staff will be aligned as follows:

    (1) Departmental Administration, staff offices, and Trade and Foreign Agricultural Affairs will share civil rights resources;

    (2) Each remaining Departmental Mission Area will consolidate its sub-agency resources at the Mission Area level; and

    (3) The Office of the Inspector General (OIG) shall have an independent Civil Rights Director.

    • OASCR will direct all Departmental civil rights activities, including those of the Mission Areas, Departmental Administration, staff offices, and to the extent appropriate and lawful, OIG. The delegations for the Assistant Secretary for Civil Rights shall be revised as necessary to reflect OASCR's direct responsibility in providing civil rights policy direction to Mission Area and other Civil Rights Directors and Civil Rights staff and conveying the clear guidance of the Office of the Secretary on all civil rights issues.

    • OASCR will implement a timely, fair, transparent, and consistent approach to addressing all Equal Employment Opportunity or program complaints, including those based on discrimination, harassment, and retaliation that shall be adopted by all Mission Areas, Departmental Administration, staff offices and, to the extent appropriate and lawful, OIG.

    • OASCR will direct an effective, robust, and compliant mandatory civil rights training program for all staff, including Mission Areas, Departmental Administration, staff offices and, to the extent appropriate and lawful, OIG.

    • OASCR will monitor and evaluate the implementation of the reasonable accommodation process by the Mission Areas, Departmental Management, staff offices and, to the extent appropriate and lawful, OIG.

    • OASCR will not address matters that Office of Human Resource Management (OHRM) handles exclusively, such as setting human resources policy, investigating and evaluating harassment allegations for misconduct, and reviewing and advising on requests for reasonable accommodations, but will serve as a collaborative partner with OHRM on all appropriate issues affecting civil rights policy, implementation, and compliance.

    • OASCR will request the Mission Areas to provide a list of all civil rights positions on-board (full-time, part-time, or collateral duty) within 30 days from issuance of this Memorandum to determine staff needs to effectuate the purpose of this Memorandum.

    • Mission Areas, Departmental Administration, and the Staff Offices will implement all organizational changes necessary to effectuate the civil rights staff realignments indicated above based upon the direction of OASCR. When conducting any reorganizations, the Mission Areas, Departmental Administration, and Staff Offices will adhere to all relevant Departmental Directives, including Departmental Regulation 1010 and the corresponding Congressional notification requirements.

    • OASCR will eliminate the position of Deputy Assistant Secretary for Civil Rights (ASCR), so as to flatten the organization with the Associate Assistant Secretary for Civil Rights assuming the responsibilities of the Deputy ASCR.

    • OASCR will eliminate its Policy Division, which is no longer necessary in an era of decreased regulations, and will perform reduced policy functions with staff from other areas of the organization.

    • OASCR will eliminate its Training and Cultural Transformation Division and will develop training with staff from other areas of the organization.

    • OASCR will eliminate its Early Resolution and Complaint Division, and the Department will carry out informal counseling within each Mission Area, with coordination from a Mission Area Liaison within OASCR.

    • OASCR's career Senior Executive Service (SES) Director for the Office of Compliance, Policy, Training and Cultural Transformation will be reclassified as the career SES Executive Director for Civil Rights Operations, a position responsible for managing the Mission Area Liaison, the Compliance Division, and the Data and Records Management Division over customer service, data, and information technology. The largest component in this part of the OASCR organization is the Compliance Division, which will continue addressing compliance reporting to oversight entities as well as limited regulatory and policy review.

    • OASCR's career SES Director for the Office of Adjudication will be reclassified as the career SES Executive Director for Civil Rights Enforcement, a position responsible for leading not only the Office of Adjudication, but also the Program Planning, and Accountability Division over budget, contracting and procurement, human resources management, facilities management, strategic planning, and Continuity of Operations for OASCR. The largest component of this part of the OASCR organization is the Office of Adjudication is responsible for intake, investigation, and adjudication of employment discrimination complaints from USDA employees and program complaints of discrimination arising within any program conducted or assisted by USDA.

    III. Request for Information

    USDA is seeking public comment on these actions and notes that this notice is issued solely for information and program-planning purposes. While responses to this notice do not bind USDA to any further actions, all submissions will be reviewed by the appropriate program office, and made publicly available on http://www.regulations.gov.

    Dated: March 8, 2018. Winona Lake Scott, Acting Deputy Assistant Secretary for Civil Rights.
    [FR Doc. 2018-05051 Filed 3-12-18; 8:45 am] BILLING CODE 3410-01-P
    DEPARTMENT OF AGRICULTURE Forest Service Information Collection: Generic Clearance for Social Science and Economics Data Collections on Natural Disasters and Disturbances AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on a new generic information collection request, Social Science and Economics Data Collections on Natural Disasters and Disturbances.

    DATES:

    Comments must be received in writing on or before May 14, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Send written comments to Kenli Kim, National Program Leader for Social Science Research, Forest Service, 1400 Independence Ave., SW, Mailstop 1114, Washington, DC 20250-1114, or by electronic mail to [email protected], with “PRA comment on natural disasters and disturbances” in the subject line. If comments are sent by electronic mail, the public is requested not to send duplicate written comments via regular mail. Please confine written comments to issues pertinent to the information collection request, explain the reasons for any recommended changes, and, where possible, reference the specific section or paragraph being addressed.

    All timely submitted comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received on this information collection at the USDA Forest Service Headquarters, 201 14th St. SW, Washington, DC 20250 between the hours of 10:00 a.m. to 5:00 p.m. on business days. Those wishing to inspect comments should contact Kenli Kim ([email protected]) to facilitate an appointment and entrance to the building.

    FOR FURTHER INFORMATION CONTACT:

    Kenli Kim, National Program Leader for Social Science Research at the Forest Service ([email protected]). Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.

    SUPPLEMENTARY INFORMATION:

    Title: Generic Clearance for Social Science and Economics Data Collections on Natural Disasters and Disturbances

    OMB Number: 0596—NEW.

    Expiration Date of Approval: NEW.

    Type of Request: NEW.

    Abstract: The USDA Forest Service has broad responsibilities for caring for the forests and grasslands of the nation. This includes managing wildland fires and responding to many other threats such as droughts, floods, tree pests and diseases, invasive species, extreme weather events, effects of climate change, and other natural disasters and disturbances. The frequency, type, duration, and intensity of disturbances and disasters shape our forests and other natural ecosystems and impact people's lives. In any given year, a wide range of people living in all types of communities across the nation—rural, suburban, and urban; forested, industrical, and agricultural—are affected by natural disasters and disturbances.

    This Generic Information Collection Request (ICR) seeks Office of Management and Budget (OMB) approval to collect information that will help the Forest Service understand how individuals, communities, and organizations prepare for, respond and adapt to, and recover from natural disturbances and disasters, as well as build resilience. This information is critical to supporting the Forest Service's mission of both managing national forests and grasslands and collaborating with others to develop useful guidelines for management of the nation's forests. Under this Generic ICR, social science research methods such as surveys, interviews, and focus groups will collect information from individuals and groups who are preparing for, responding to, and/or recovering from natural disasters and disturbances. Results from the proposed research and data collections can inform prediction, preparation, response, and recovery strategies and efforts by the Forest Service and other Federal agencies, as well as related local government, civil society, and community efforts. In the long term, such knowledge can contribute to fewer societal costs from disturbance processes, more cost-effective management efforts, and more resilient communities and economies. Any specific study conducted under this Generic ICR will be posted for public comment in The Federal Register for 30 days by the USDA Forest Service.

    Estimate of Annual Burden on Respondents: 15,533 hours/year.

    Type of Respondents: Participants/respondents will be individuals, not specific entities.

    Estimated Annual Number of Respondents: 100,500 year.

    Estimated Annual Number of Responses per Respondent: 1 response/respondent is anticipated.

    Comment is Invited

    Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, 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 respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. The Forest Service will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval.

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

    Dated: February 15, 2018. Monica Lear, Associate Deputy Chief, Research & Development.
    [FR Doc. 2018-05004 Filed 3-12-18; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Information Collection: Generic Clearance for Social Science and Economics Data Collections on Natural Resource Planning and Collaborative Conservation AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on a new generic information collection request, Social Science and Economics Data Collections on Natural Resource Planning and Collaborative Conservation.

    DATES:

    Comments must be received in writing on or before May 14, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Send written comments to Kenli Kim, National Program Leader for Social Science Research, Forest Service, 1400 Independence Ave. SW, Mailstop 1114, Washington, DC 20250-1114,or by electronic mail to [email protected], with “PRA comment on planning and collaborative conservation” in the subject line. If comments are sent by electronic mail, the public is requested not to send duplicate written comments via regular mail. Please confine written comments to issues pertinent to the information collection request, explain the reasons for any recommended changes, and, where possible, reference the specific section or paragraph being addressed.

    All timely submitted comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received on this information collection at the USDA—Forest Service headquarters, 201 14th St. SW, Washington, DC 20250 between the hours of 10:00 a.m. to 5:00 p.m. on business days. Those wishing to inspect comments should contact Kenli Kim ([email protected]) to facilitate an appointment and entrance to the building.

    FOR FURTHER INFORMATION CONTACT:

    Kenli Kim, National Program Leader for Social Science Research at the Forest Service ([email protected]). Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.

    SUPPLEMENTARY INFORMATION:

    Title: Generic Clearance for Social Science Research on Natural Resource Planning and Collaborative Conservation.

    OMB Number: 0596—NEW.

    Expiration Date of Approval: NEW.

    Type of Request: NEW.

    Abstract: The USDA Forest Service's mission is “Caring for the Land and Serving People.” This includes directly managing National Forest and Grassland units and providing science-based guidelines for the management of forests, grasslands, and other natural resources in cities and towns as well as those under management by land trusts, neighborhood groups, states, and other entities. In order to fulfill this mission, the Agency needs an accurate understanding of the range of views and preferences held by stakeholders regarding the management and conservation of forests and other natural resources.

    Collaborative conservation is the process of creating and executing land and resource management decisions informed by local knowledge, community participation, and science. Collaborative conservation aims to improve the health, resilience, and sustainability of natural resources and human communities and to maximize the benefits that forests, grasslands, and other natural resources provide to society. This includes environmental benefits such as clean air and water and carbon storage; economic benefits such as energy savings and timber and other forest products; and social benefits such as improved physical health, aesthetic beauty, and stress reduction. A collaborative conservation approach to land management amendments and planning revisions for forests, grasslands, and other natural resources may also help ensure environmental justice for groups and individuals whose views and concerns have not historically been taken into account in land management planning.

    Managing forests, grasslands, and natural areas in a collaborative and sustainable way requires detailed, scientifically-based information about people's views on both conservation in general and about specific forests or other natural places that are important in their lives. A collaborative conservation approach to land management amendments and planning takes in-depth understanding of how groups and individuals work effectively together, how information and knowledge are shared, and how to incorporate multiple viewpoints in resource planning while effectively managing conflict.

    Taking all of this into account, the Forest Service and other public and private land managers need to collect information from a wide range of stakeholders in order to make informed decisions about natural resource conservation, restoration and management, land management amendments and planning revisions. To ensure that the Forest Service can meet its statutory and regulatory responsibilities and is able to inform management of forests and other natural areas, the Forest Service is seeking OMB approval to collect information from people who use, live near, manage, make policies for, or otherwise have a stake in the management of forests and other natural resources.

    Estimate of Annual Burden on Respondents: 32,183 hours/year.

    Type of Respondents: Participants/respondents will be individuals, not specific entities.

    Estimated Annual Number of Respondents: 251,050 year.

    Estimated Annual Number of Responses per Respondent: 1 response/respondent is anticipated.

    Comment Is Invited

    Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, 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 respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. The Forest Service will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval.

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

    Dated: February 15, 2018 Monica Lear, Associate Deputy Chief, Research & Development.
    [FR Doc. 2018-05003 Filed 3-12-18; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Information Collection: Generic Clearance for Social Science and Economics Data Collections on Goods, Services, and Jobs Provided by Forests and Natural Areas AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on a new generic information collection request, Social Science and Economics Data Collections on Goods, Services, and Jobs Provided by Forests and Natural Areas.

    DATES:

    Comments must be received in writing on or before May 14, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Send written comments to Kenli Kim, National Program Leader for Social Science Research, 1400 Independence Ave. SW, Mailstop 1114, Washington, DC 20250-1114, or by electronic mail to [email protected], with “PRA comment on Goods, Services, and Jobs” in the subject line. If comments are sent by electronic mail, the public is requested not to send duplicate written comments via regular mail. Please confine written comments to issues pertinent to the information collection request, explain the reasons for any recommended changes, and, where possible, reference the specific section or paragraph being addressed.

    All timely submitted comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received on this information collection at the USDA Forest Service Headquarters, 201 14th St. SW, Washington, DC 20250 between the hours of 10:00 a.m. to 5:00 p.m. on business days. Those wishing to inspect comments should contact Kenli Kim ([email protected]) to facilitate an appointment and entrance to the building.

    FOR FURTHER INFORMATION CONTACT:

    Kenli Kim, National Program Leader for Social Science Research at the Forest Service ([email protected]). Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.

    SUPPLEMENTARY INFORMATION:

    Title: Generic Clearance for Social Science and Economics Data Collections on Goods, Services, and Jobs Provided by Forests and Natural Areas.

    OMB Number: 0596—NEW.

    Expiration Date of Approval: NEW.

    Type of Request: NEW.

    Abstract: The USDA Forest Service is seeking Office of Management and Budget (OMB) approval to collect information that will help the Forest Service sustainably manage and provide guidance to others about managing the wide range of goods, services, jobs, and other values that people get from forests, grasslands, parks, and other natural areas.

    In rural, suburban, and urban parts of the country, forests, grasslands, and other natural areas provide jobs through: Logging, sawmills, and extraction of non-timber forest products; guide services, hotels, restaurants, and equipment sales that support outdoor recreation; and natural area restoration and management activities. Innovative forest products such as wood-based nano-technologies and laminated timbers are critical to the modern economies of communities large and small. Forests and natural areas provide important ecosystem services such as clean water and natural flood control and influence other critical economic factors like home and land values. Time spent in or with a view of trees, forests, and green spaces can have indirect economic impacts and provide community benefits by improving mental and physical health and well-being.

    In addition to the products and services derived from forests, grasslands, or natural areas, people may also value and appreciate the natural environment itself when they experience it directly. These experiences can have meaningful and direct impacts on quality of life, sense of self, and sense of community. While such values are sometimes hard for people to express or to quantify, they play an important role in how people respond to natural resource management proposals and actions, and can often be at the root of conflict over land management policies and practices.

    Understanding people's views on these goods, services, and values is critical to managing forests, grasslands, and other natural areas to meet the needs of American citizens—to provide the “greatest good to the greatest number of people for the longest time” as Gifford Pinchot, Founding Chief of the Forest Service, described it. Surveys, interviews, focus groups, and related methods administered under this Generic Clearance will collect information from individuals and groups who seek or benefit from a wide variety of goods, services, and other values from forests, grasslands, and other natural areas. Any specific study conducted under this Generic ICR will be posted for public comment in The Federal Register for 30 days by the USDA Forest Service.

    Estimate of Annual Burden on Respondents: 9,440 hours/year.

    Type of Respondents: Participants/respondents will be individuals, not specific entities.

    Estimated Annual Number of Respondents: 60,420 year.

    Estimated Annual Number of Responses per Respondent: 1 response/respondent is anticipated.

    Comment is Invited

    Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the Agency, including whether the information will have practical or scientific utility; (2) the accuracy of the Agency's estimate of the burden of the collection of information, 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 respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. The Forest Service will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval.

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

    Dated: February 15, 2018. Monica Lear, Associate Deputy Chief, Research & Development.
    [FR Doc. 2018-05006 Filed 3-12-18; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Notice of Solicitation of Applications for the Rural Energy for America Program for Federal Fiscal Year 2018 AGENCY:

    Rural Business-Cooperative Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    The Rural Business-Cooperative Service (the Agency) Notice of Solicitation of Applications (NOSA) is being issued prior to passage of a final appropriations act to allow potential applicants time to submit applications for financial assistance under Rural Energy for America Program (REAP) for Federal Fiscal Year (FY) 2018, and give the Agency time to process applications within the current fiscal year. This NOSA is being issued prior to enactment of full year appropriation for 2018. The Agency will publish the amount of funding received in any continuing resolution or the final appropriations act on its website at https://www.rd.usda.gov/newsroom/notices-solicitation-applications-nosas. Expenses incurred in developing applications will be at the applicant's risk.

    The REAP has two types of funding assistance: (1) Renewable Energy Systems and Energy Efficiency Improvements Assistance, and (2) Energy Audit and Renewable Energy Development Assistance Grants.

    The Renewable Energy Systems and Energy Efficiency Improvement Assistance provides grants and guaranteed loans to agricultural producers and rural small businesses to purchase and install renewable energy systems and make energy efficiency improvements to their operations. Eligible renewable energy systems for REAP provide energy from: Wind, solar, renewable biomass (including anaerobic digesters), small hydro-electric, ocean, geothermal, or hydrogen derived from these renewable resources.

    The Energy Audit and Renewable Energy Development Assistance Grant is available to a unit of State, Tribal, or local government; instrumentality of a State, Tribal, or local government; institution of higher education; rural electric cooperative; a public power entity; or a council, as defined in 16 U.S.C. 3451. The recipient of grant funds, grantee, will establish a program to assist agricultural producers and rural small businesses with evaluating the energy efficiency and the potential to incorporate renewable energy technologies into their operations.

    DATES:

    See under SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    The applicable USDA Rural Development Energy Coordinator for your respective State, as identified via the following link: https://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

    For information about this Notice, please contact Maureen Hessel, Business Loan and Grant Analyst, USDA Rural Development, Energy Division, 1400 Independence Avenue SW, Stop 3225, Room 6870, Washington, DC, 20250. Telephone: (202) 401-0142. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Program Description

    The Rural Energy for America Program (REAP) helps agricultural producers and rural small businesses reduce energy costs and consumption and helps meet the Nation's critical energy needs. REAP has two types of funding assistance: (1) Renewable Energy Systems and Energy Efficiency Improvements Assistance and (2) Energy Audit and Renewable Energy Development Assistance Grants.

    The Renewable Energy Systems and Energy Efficiency Improvements Assistance provides grants and guaranteed loans to agricultural producers and rural small businesses for renewable energy systems and energy efficiency improvements. Eligible renewable energy systems for REAP provide energy from: Wind, solar, renewable biomass (including anaerobic digesters), small hydro-electric, ocean, geothermal, or hydrogen derived from these renewable resources.

    The Energy Audit and Renewable Energy Development Assistance Grant is available to a unit of State, Tribal, or local government; instrumentality of a State, Tribal, or local government; institution of higher education; rural electric cooperative; a public power entity; or a council, as defined in 16 U.S.C. 3451. The recipient of grant funds, grantee, will establish a program to assist agricultural producers and rural small businesses with evaluating the energy efficiency and the potential to incorporate renewable energy technologies into their operations.

    A. General. Applications for REAP can be submitted any time throughout the year. This Notice announces the deadline times and dates that applications have to be received in order to be considered for REAP funds provided by the Agricultural Act of 2014, (2014 Farm Bill), and any appropriated funds that REAP may receive from the appropriation for Federal FY 2018 for grants, guaranteed loans, and combined grants and guaranteed loans to purchase and install renewable energy systems, and make energy efficiency improvements; and for grants to conduct energy audits and renewable energy development assistance.

    The Notice of Solicitation of Applications (NOSA) announces the acceptance of applications under REAP for Federal FY 2018 for grants, guaranteed loans, and combined grants and guaranteed loans for the development of renewable energy systems and energy efficiency projects as provided by the Agricultural Act of 2014 (2014 Farm Bill). The Notice also announces the acceptance of applications under REAP for Federal FY 2018 for energy audit and renewable energy development assistance grants as provided by the 2014 Farm Bill.

    The administrative requirements in effect at the time the application window closes for a competition will be applicable to each type of funding available under REAP and are described in 7 CFR part 4280, subpart B. In addition to the other provisions of this Notice:

    (1) The provisions specified in 7 CFR 4280.101 through 4280.111 apply to each funding type described in this Notice.

    (2) The requirements specified in 7 CFR 4280.112 through 4280.124 apply to renewable energy system and energy efficiency improvements project grants.

    (3) The requirements specified in 7 CFR 4280.125 through 4280.152 apply to guaranteed loans for renewable energy system and energy efficiency improvements projects. For Federal FY 2018, the guarantee fee amount is one percent of the guaranteed portion of the loan, and the annual renewal fee is one-quarter of 1 percent (0.250 percent) of the guaranteed portion of the loan.

    (4) The requirements specified in 7 CFR 4280.165 apply to a combined grant and guaranteed loan for renewable energy system and energy efficiency improvements projects.

    (5) The requirements specified in 7 CFR 4280.186 through 4280.196 apply to energy audit and renewable energy development assistance grants.

    II. Federal Award Information

    A. Statutory Authority. This program is authorized under 7 U.S.C. 8107.

    B. Catalog of Federal Domestic Assistance (CFDA) Number. 10.868.

    C. Funds Available. This Notice is announcing deadline times and dates for applications to be submitted for REAP funds provided by the 2014 Farm Bill and any appropriated funds that REAP may receive from the congressional enactment of a full-year appropriation for Federal FY 2018. This Notice is being published prior to the congressional enactment of a full-year appropriation for Federal FY 2018. The Agency will continue to process applications received under this announcement and should REAP receive appropriated funds, these funds will be announced on the following website: https://www.rd.usda.gov/programs-services/rural-energy-america-program-renewable-energy-systems-energy-efficiency, and are subject to the same provisions in this Notice.

    To ensure that small projects have a fair opportunity to compete for the funding and are consistent with the priorities set forth in the statute, the Agency will set-aside not less than 20 percent of the Federal FY 2018 funds until June 29, 2018, to fund grants of $20,000 or less.

    (1) Renewable energy system and energy efficiency improvements grant-funds. There will be allocations of grant funds to each Rural Development State Office for renewable energy system and energy efficiency improvements applications. The State allocations will include an allocation for grants of $20,000 or less funds and an allocation of grant funds that can be used to fund renewable energy system and energy efficiency improvements applications for either grants of $20,000 or less or grants of more than $20,000, as well as the grant portion of a combination grant and guaranteed loan. These funds are commonly referred to as unrestricted grant funds. The funds for grants of $20,000 or less can only be used to fund grants requesting $20,000 or less, which includes the grant portion of combination requests when applicable.

    (2) Renewable energy system and energy efficiency improvements loan guarantee funds. Rural Development's National Office will maintain a reserve of guaranteed loan funds.

    (3) Renewable energy system and energy efficiency improvements combined grant and guaranteed loan funds. Funding availability for combined grant and guaranteed loan applications are outlined in paragraphs II.(C)(1) and II.(C)(2) of this Notice.

    (4) Energy audit and renewable energy development assistance grant funds. The amount of funds available for energy audits and renewable energy development assistance in Federal FY 2018 will be 4 percent of Federal FY 2018 mandatory funds and will be maintained in a National Office reserve. Obligations of these funds will take place through March 30, 2018. Any unobligated balances will be moved to the renewable energy budget authority account, and may be utilized in any of the renewable energy system and energy efficiency improvements national competitions.

    D. Approximate Number of Awards. The estimated number of awards is 1,000 based on the historical average grant size and the anticipated mandatory funding of $50 million for Federal FY 2018, but will depend on the actual amount of funds made available and on the number of eligible applicants participating in this program.

    E. Type of Instrument. Grant, guaranteed loan, and grant/guaranteed loan combinations.

    III. Eligibility Information

    The eligibility requirements for the applicant, borrower, lender, and project (as applicable) are clarified in 7 CFR part 4280 subpart B, and are summarized in this Notice. Failure to meet the eligibility criteria by the time of the competition window may result in the Agency reviewing an application, but will preclude the application from receiving funding until all eligibility criteria have been met.

    A. Eligible Applicants. This solicitation is for applications from agricultural producers and rural small businesses for grants or guaranteed loans, or a combination grant and guaranteed loan, for the purpose of purchasing and installing renewable energy systems and energy efficiency improvements. This solicitation is also for applications for Energy Audit or a Renewable Development Assistance grants from units of State, Tribal, or local government; instrumentalities of a State, Tribal, or local government; institutions of higher education; rural electric cooperatives; public power entities; and councils, as defined in 16 U.S.C. 3451, which serve agricultural producers and rural small businesses. To be eligible for the grant portion of the program, an applicant must meet the requirements specified in 7 CFR 4280.110, and 7 CFR 4280.112, or 7 CFR 4280.186, as applicable.

    B. Eligible Lenders and Borrowers. To be eligible for the guaranteed loan portion of the program, lenders and borrowers must meet the eligibility requirements in 7 CFR 4280.125 and 7 CFR 4280.127, as applicable.

    C. Eligible Projects. To be eligible for this program, a project must meet the eligibility requirements specified in 7 CFR 4280.113, 7 CFR 4280.128, and 7 CFR 4280.187, as applicable.

    D. Cost Sharing or Matching. The 2014 Farm Bill mandates the maximum percentages of funding that REAP can provide. Additional clarification is provided in paragraphs IV.E. (1) through (3) of this Notice.

    (1) Renewable energy system and energy efficiency improvements funding. Requests for guaranteed loan and combined grant and guaranteed loan will not exceed 75 percent of total eligible project costs, with any Federal grant portion not to exceed 25 percent of total eligible project costs, whether the grant is part of a combination request or is a grant-only.

    (2) Energy audit and renewable energy development funds. Requests for the energy audit and renewable energy development assistance grants, will indicate that the grantee that conducts energy audits must require that, as a condition of providing the energy audit, the agricultural producer or rural small business pay at least 25 percent of the cost of the energy audit. The Agency recommended practice for on farm energy audits, audits for agricultural producers, ranchers, and farmers is the American Society of Agricultural and Biological Engineers S612 Level II audit. This audit conforms to program standards used by the Natural Resource Conservation Service. As per 7 CFR 4280.110(a), an applicant who has received one or more grants under this program must have made satisfactory progress towards completion of any previously funded projects before being considered for subsequent funding. The Agency interprets satisfactory progress as at least 50 percent of previous awards expended by January 31, 2018. Those who cannot meet this requirement will be determined to be a “risk” pursuant to 2 CFR 200.205 and may be determined in-eligible for a subsequent grant or have special conditions imposed.

    E. Other. Ineligible project costs can be found in 7 CFR 4280.114(d), 7 CFR 4280.129(f), and 7 CFR 4280.188(c), as applicable. The U.S. Department of Agriculture Departmental Regulations and Laws that contain other compliance requirements are referenced in paragraphs VI.B.(1) through (3), and IV.F of this Notice. Applicants who have been found to be in violation of applicable Federal statutes will be ineligible.

    IV. Application and Submission Information

    A. Address to Request Application Package. Application materials may be obtained by contacting one of Rural Development's Energy Coordinators, as identified via the following link: https://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf. In addition, for grant applications, applicants may obtain electronic grant applications for REAP from www.grants.gov.

    B. Content and Form of Application Submission. Applicants seeking to participate in this program must submit applications in accordance with this Notice and 7 CFR part 4280, subpart B. Applicants must submit complete applications by the dates identified in Section IV.C., of this Notice, containing all parts necessary for the Agency to determine applicant and project eligibility, to score the application, and to conduct the technical evaluation, as applicable, in order to be considered.

    (1) Renewable energy system and energy efficiency improvements grant application.

    (a) Information for the required content of a grant application to be considered complete is found in 7 CFR part 4280, subpart B.

    (i) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of $80,000 or less must provide information required by 7 CFR 4280.119.

    (ii) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of $200,000 or less, but more than $80,000, must provide information required by 7 CFR 4280.118.

    (iii) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of greater than $200,000 must provide information required by 7 CFR 4280.117.

    (iv) Grant applications for energy audits or renewable energy development assistance grant applications must provide information required by 7 CFR 4280.190.

    (b) All grant applications must be submitted either as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located, or electronically using the Government-wide www.grants.gov website.

    (i) Applicants submitting a grant application as a hard copy must submit one original to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link: https://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

    (ii) Applicants submitting a grant application to the Agency via www.grants.gov (website) will find information about submitting an application electronically through the website, and may download a copy of the application package to complete it off line, upload and submit the completed application, including all necessary assurances and certifications, via www.grants.gov. After electronically submitting an application through the website, the applicant will receive an automated acknowledgement from www.grants.gov that contains a www.grants.gov tracking number. USDA Rural Development strongly recommends that applicants do not wait until the application deadline date to begin the application process through www.grants.gov.

    (c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements of 7 CFR 4280.122 (a) through (h) for the grant agreement to be executed.

    (2) Renewable energy system and energy efficiency improvements guaranteed loan application.

    (a) Information for the content required for a guaranteed loan application to be considered complete is found in 7 CFR 4280.137.

    (b) All guaranteed loan applications must be submitted as a hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link: https://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

    (c) After successful applicants are notified of the intent to make a Federal award, borrowers must meet the conditions prior to issuance of loan note guarantee as outlined in of 7 CFR 4280.142.

    (3) Renewable energy system and energy efficiency improvements combined guaranteed loan and grant application.

    (a) Information for the content required for a combined guaranteed loan and grant application to be considered complete is found in 7 CFR 4280.165(c).

    (b) All combined guaranteed loan and grant applications must be submitted as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link: www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

    (c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements, including the requisite forms and certifications, specified in 7 CFR 4280.117, 4280.118, 4280.119, and 4280.137, as applicable, for the issuance of a grant agreement and loan note guarantee.

    (4) Energy audits or renewable development assistance grant applications.

    (a) Grant applications for energy audits or renewable energy development assistance must provide the information required by 7 CFR 4280.190 to be considered a complete application.

    (b) All energy audits or renewable development assistance grant applications must be submitted either as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located, electronically using the Government-wide www.grants.gov website, or via an alternative electronic format with electronic signature followed up by providing original signatures to the appropriate Rural Development office. Instructions for submission of the application can be found at section IV.B. of this Notice.

    (c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements of 7 CFR 4280.195 for the grant agreement to be executed.

    5. Dun and Bradstreet Universal Numbering System (DUNS) Number and System for Award Management (SAM). Unless exempt under 2 CFR 25.110, or who have an exception approved by the Federal awarding agency under 2 CFR 25.110 (d), applicants as applicable are required to:

    (a) Be registered in SAM prior to submitting a grant application; which can be obtained at no cost via a toll-free request line at (866) 705-5711 or online at fedgov.dnb.com/webform.

    (b) Provide a valid DUNS number in its grant or loan application.

    (c) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal grant award or a grant application under consideration by the Agency.

    (d) If an applicant has not fully complied with the requirements of IV.C. (1) through (3) at the time the Agency is ready to make an award, the Agency may determine the applicant is not eligible to receive the award.

    C. Submission Dates and Times. Grant applications, guaranteed loan-only applications, and combined grant and guaranteed loan applications for financial assistance provided by the 2014 Farm Bill for Federal FY 2018, and for appropriated funds that REAP may receive from the appropriation for Federal FY 2018, may be submitted at any time on an ongoing basis. When an application window closes, the next application window opens on the following day. This Notice establishes the deadline dates for the applications to be received in order to be considered for funding. If an application window falls on a Saturday, Sunday, or Federal holiday, the application package is due the next business day. An application received after these dates will be considered with other applications received in the next application window. In order to be considered for funds under this Notice, complete applications must be received by the appropriate USDA Rural Development State Office or via www.grants.gov. The deadline for applications to be received to be considered for funding in Federal FY 2018 are outlined in the following paragraphs and also summarized in a table at the end of this section:

    (1) Renewable energy system and energy efficiency improvements grant applications and combination grant and guaranteed loan applications. As per RD Instruction 4280-B Application deadlines for Federal FY 2018 grant funds are:

    (a) For applicants requesting a grant only of $20,000 or less or a combination grant and guaranteed loan where the grant request is $20,000 or less, that wish to have their grant application compete for the “Grants of $20,000 or less set aside,” complete applications must be received no later than:

    (i) 4:30 p.m. local time on October 31, 2017, or

    (ii) 4:30 p.m. local time on April 30, 2018.

    (b) For applicants requesting a grant only of over $20,000 (unrestricted) or a combination grant and guaranteed loan where the grant request is greater than $20,000, complete applications must be received no later than 4:30 p.m. local time on April 30, 2018.

    (2) Renewable energy system and energy efficiency improvements guaranteed loan-only applications. Eligible applications will be reviewed and processed when received for periodic competitions.

    (3) Energy audits and renewable energy development assistance grant applications. Applications must be received no later than 4:30 p.m. local time on January 31, 2018.

    Application Application window opening dates Application window closing dates Renewable Energy Systems and Energy Efficiency Improvements Grants ($20,000 or less grant only request or a combination grant and guaranteed loan where the grant request is $20,000 or less competing for up to approximately 50 percent of the set aside funds) April 1, 2017 October 31, 2017. Renewable Energy Systems and Energy Efficiency Improvements Grants ($20,000 or less grant only request or a combination grant and guaranteed loan where the grant request is $20,000 or less competing for the remaining set aside funds) November 1, 2017 April 30, 2018*. Renewable Energy Systems and Energy Efficiency Improvements Grants (Unrestricted grants, including combination grant and guaranteed loan where the grant request is greater than $20,000,) April 1, 2017 April 30, 2018*. Renewable Energy Systems and Energy Efficiency Improvements Guaranteed Loans Continuous application cycle Continuous application cycle. Energy Audit and Renewable Energy Development Assistance Grants February 1, 2017 January 31, 2018. * Applications received after this date will be considered for the next funding cycle in the subsequent Federal FY.

    D. Intergovernmental Review. REAP is not subject to Executive Order 12372, Intergovernmental Review of Federal Programs.

    E. Funding Restrictions. The following funding limitations apply to applications submitted under this Notice.

    (1) Renewable energy system and energy efficiency improvements projects.

    (a) Applicants can be awarded only one renewable energy system grant and one energy efficiency improvement grant in Federal FY 2018.

    (b) For renewable energy system grants, the minimum grant is $2,500 and the maximum is $500,000. For energy efficiency improvements grants, the minimum grant is $1,500 and the maximum grant is $250,000.

    (c) For renewable energy system and energy efficiency improvements loan guarantees, the minimum REAP guaranteed loan amount is $5,000 and the maximum amount of a guaranteed loan to be provided to a borrower is $25 million.

    (d) Renewable energy system and energy efficiency improvements guaranteed loan and grant combination applications. Paragraphs IV.E.(1)(b) and (c) of this Notice contain the applicable maximum amounts and minimum amounts for grants and guaranteed loans. Requests for guaranteed loan and combined grant and guaranteed loan will not exceed 75 percent of eligible project costs, with any Federal grant portion not to exceed 25 percent of the eligible project costs, whether the grant is part of a combination request or is a grant-only.

    (2) Energy audit and renewable energy development assistance grants.

    (a) Applicants may submit only one energy audit grant application and one renewable energy development assistance grant application for Federal FY 2018 funds.

    (b) The maximum aggregate amount of energy audit and renewable energy development assistance grants awarded to any one recipient under this Notice cannot exceed $100,000 for Federal FY 2018.

    (c) The 2014 Farm Bill mandates that the recipient of a grant that conducts an energy audit for an agricultural producer or a rural small business must require the agricultural producer or rural small business to pay at least 25 percent of the cost of the energy audit, which shall be retained by the eligible entity for the cost of the audit.

    (3) Maximum grant assistance to an entity. For the purposes of this Notice, the maximum amount of grant assistance to an entity will not exceed $750,000 for Federal FY 2018 based on the total amount of the renewable energy system, energy efficiency improvements, energy audit, and renewable energy development assistance grants awarded to an entity under REAP.

    F. Other Submission Requirements.

    (1) Environmental information. For the Agency to consider an application, the application must include all environmental review documents with supporting documentation in accordance with 7 CFR part 1970. Any required environmental review must be completed prior to obligation of funds or the approval of the application. Applicants are advised to contact the Agency to determine environmental requirements as soon as practicable to ensure adequate review time.

    (2) Felony conviction and tax delinquent status. Corporate applicants submitting applications under this Notice must include Form AD 3030, “Representations Regarding Felony Conviction and Tax Delinquent Status for Corporate Applicants.” Corporate applicants who receive an award under this Notice will be required to sign Form AD 3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.” Both forms can be found online at http://www.ocio.usda.gov/document/ad3030, and http://www.ocio.usda.gov/document/ad3031.

    (3) Original signatures. USDA Rural Development may request that the applicant provide original signatures on forms submitted through www.grants.gov at a later date.

    (4) Transparency Act Reporting. All recipients of Federal financial assistance are required to report information about first-tier sub-awards and executive compensation in accordance with 2 CFR part 170. If an applicant does not have an exception under 2 CFR 170.110(b), the applicant must then ensure that they have the necessary processes and systems in place to comply with the reporting requirements to receive funding.

    (5) Race, ethnicity, and gender. The Agency is requesting that each applicant provide race, ethnicity, and gender information about the applicant. The information will allow the Agency to evaluate its outreach efforts to under-served and under-represented populations. Applicants are encouraged to furnish this information with their applications, but are not required to do so. An applicant's eligibility or the likelihood of receiving an award will not be impacted by furnishing or not furnishing this information. However, failure to furnish this information may preclude the awarding of State Director and Administrator points in Section V.E.(3) of this Notice.

    V. Application Review Information

    A. Criteria. In accordance with 7 CFR part 4280 subpart B, the application dates published in Section IV.C. of this Notice identify the times and dates by which complete applications must be received in order to compete for the funds available.

    (1) Renewable energy systems and energy efficiency improvements grant applications. Complete renewable energy systems and energy efficiency improvements grant applications are eligible to compete in competitions as described in 7 CFR 4280.121.

    (a) Complete renewable energy systems and energy efficiency improvements grant applications requesting $20,000 or less are eligible to compete in up to five competitions within the Federal FY as described in 7 CFR 4280.121(b). If the application remains unfunded after the final national office competition for the Federal FY it must be withdrawn. Pursuant to the publication of this announcement, all complete and eligible applications will be limited to competing in the Federal FY that the application was received, versus rolling into the following Federal FY, which may result in less than five total competitions. This was effective for any application submitted on or after April 1, 2017.

    (b) Complete renewable energy systems and energy efficiency improvements grant applications, regardless of the amount of funding requested are eligible to compete in two competitions a Federal FY—a State competition and a national competition as described in 7 CFR 4280.121(a).

    (2) Renewable energy systems and energy efficiency improvements guaranteed loan applications. Complete guaranteed loan applications are eligible for periodic competitions as described in 7 CFR 4280.139(a).

    (3) Renewable energy systems and energy efficiency improvements combined guaranteed loan and grant applications. Complete combined guaranteed loan and grant applications with requests of $20,000 or less are eligible to compete in up to five competitions within the Federal FY as described in 7 CFR 4280.121(b). Combination applications where the grant request is greater than $20,000, are eligible to compete in two competitions a Federal FY—a State competition and a national competition as described in 7 CFR 4280.121(a).

    (4) Energy audit and renewable energy development assistance grant applications. Complete energy audit and renewable energy development assistance grants applications are eligible to compete in one national competition per Federal FY as described in 7 CFR 4280.193.

    B. Review and Selection Process. All complete applications will be scored in accordance with 7 CFR part 4280 subpart B and this section of the Notice. Specifically, sections C and D below outline revisions to the scoring criteria found in 7 CFR 4280.120.

    (1) Renewable energy systems and energy efficiency improvements grant applications. Renewable energy system and energy efficiency grant applications will be scored in accordance with 7 CFR 4280.120 and selections will be made in accordance with 7 CFR 4280.121. For grant applications requesting greater than $250,000 for renewable energy systems, and/or greater than $125,000 for energy efficiency improvements a maximum score of 90 points is possible. For grant applications requesting $250,000 or less for renewable energy systems and/or $125,000 or less for energy efficiency improvements, an additional 10 points may be awarded such that a maximum score of 100 points is possible. Due to the competitive nature of this program, applications are competed based on submittal date. The submittal date is the date the Agency receives a complete application. The complete application date is the date the Agency receives the last piece of information that allows the Agency to determine eligibility and to score, rank, and compete the application for funding.

    (a) Funds for renewable energy system and energy efficiency improvements grants of $20,000 or less will be allocated to the States. Eligible applications must be submitted by April 30, 2018, in order to be considered for these set-aside funds. Approximately 50 percent of these funds will be made available for those complete applications the Agency receives by October 31, 2017, and approximately 50 percent of the funds for those complete applications the Agency receives by April 30, 2018. All unused State allocated funds for grants of $20,000 or less will be pooled to the National Office.

    (b) Eligible applications received by April 30, 2018, for renewable energy system and energy efficiency improvements grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications of $20,000 or less from other States at a national competition. Obligations of these funds will take place prior to June 29, 2018.

    (c) Eligible applications for renewable energy system and energy efficiency improvements, regardless of the amount of the funding request, received by April 30, 2018, can compete for unrestricted grant funds. Unrestricted grant funds will be allocated to the States. All unused State allocated unrestricted grant funds will be pooled to the National Office.

    (d) National unrestricted grant funds for all eligible renewable energy system and energy efficiency improvements grant applications received by April 30, 2018, which include grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications from other States at a final national competition.

    (2) Renewable energy systems and energy efficiency improvements guaranteed loan applications. Renewable energy systems and energy efficiency improvements guaranteed loan applications will be scored in accordance with 7 CFR 4280.135 and selections will be made in accordance with 7 CFR 4280.139. The National Office will maintain a reserve for renewable energy system and energy efficiency improvements guaranteed loan funds. Applications will be reviewed and processed when received. Those applications that meet the Agency's underwriting requirements, are credit worthy, and score a minimum of 40 points will compete in national competitions for guaranteed loan funds periodically. All unfunded eligible guaranteed loan-only applications received that do not score at least 40 points will be competed against other guaranteed loan-only applications from other States at a final national competition, if the guaranteed loan reserves have not been completely depleted, on September 3, 2018. If funds remain after the final guaranteed loan-only national competition, the Agency may elect to utilize budget authority to fund additional grant-only applications.

    (3) Renewable energy systems and energy efficiency improvements combined grant and guaranteed loan applications. Renewable energy systems and energy efficiency improvements combined grant and guaranteed loan applications will be scored in accordance with 7 CFR 4280.120 and selections will be made in accordance with 7 CFR 4280.121. For combined grant and guaranteed loan applications requesting grant funds of $250,000 or less for renewable energy systems, or $125,000 or less for energy efficiency improvements, a maximum score of 100 points is possible. For combined grant and guaranteed loan applications requesting grant funds of more than $250,000 for renewable energy systems, or more than $125,000 for energy efficiency improvements, a maximum score of 90 points is possible.

    Renewable energy system and energy efficiency improvements combined grant and guaranteed loan applications will compete with grant-only applications for grant funds allocated to their State. If the application is ranked high enough to receive State allocated grant funds, the State will request funding for the guaranteed loan portion of any combined grant and guaranteed loan applications from the National Office guaranteed loan reserve, and no further competition will be required. All unfunded eligible applications for combined grant and guaranteed loan applications that are received by April 30, 2018, and that are not funded by State allocations can be submitted to the National Office to compete against other grant and combined grant and guaranteed loan applications from other States at a final national competition.

    (4) Energy audit and renewable energy development assistance grant applications. Energy audit and renewable energy development assistance grants will be scored in accordance with 7 CFR 4280.192 and selections will be made in accordance with 7 CFR 4280.193. Energy audit and renewable energy development assistance grant funds will be maintained in a reserve at the National Office. Applications received by January 31, 2018 will compete for funding at a national competition, based on the scoring criteria established under 7 CFR 4280.192. If funds remain after the energy audit and renewable energy development assistance national competition, the Agency may elect to transfer budget authority to fund additional renewable energy system and energy efficiency improvements grants from the National Office reserve after pooling.

    C. Size of Agricultural Producer or Rural Small Business.

    The criterion noted in 7 CFR 4280.120 (d) which allows for a maximum of 10 points to be awarded based on the size of the Applicant's agricultural operation or business concern, as applicable, compared to the SBA Small Business size standards categorized by NAICS found in 13 CFR 121.201, is being removed for applications for renewable energy systems or energy efficiency improvements effective as of the date of this publication.

    D. State Director and Administrator Points. The criterion noted in 7 CFR 4280.120(g) allows for the State Director and the Administrator to take into consideration paragraphs V.D.(1) through (5) below in the awarding of up to 10 points for eligible renewable energy systems and energy efficiency improvement grant applications submitted in Federal FY 2018:

    (1) May allow for applications for an under-represented technology to receive additional points.

    (2) May allow for applications that help achieve geographic diversity to receive additional points. This may include priority points for smaller grant requests which enhances geographic diversity.

    (3) May allow for applicants who are members of unserved or under-served populations to receive additional points if one of the following criteria are met:

    (a) Owned by a veteran, including but not limited to individuals as sole proprietors, members, partners, stockholders, etc., of not less than 20 percent. In order to receive points, applicants must provide a statement in their applications to indicate that owners of the project have veteran status; or

    (b) Owned by a member of a socially-disadvantaged group, which are groups whose members have been subjected to racial, ethnic, or gender prejudice because of their identity as members of a group without regard to their individual qualities. In order to receive points, the application must include a statement to indicate that the owners of the project are members of a socially-disadvantaged group.

    (4) May allow for applications that further a Presidential initiative, or a Secretary of Agriculture priority, including Federally declared disaster areas, to receive additional points.

    (5) The proposed project is located in an impoverished area, has experienced long-term population decline, or loss of employment.

    E. Other Submission Requirements. Grant-only applications, guaranteed loan-only applications, and combined grant and guaranteed loan applications for financial assistance may be submitted at any time. In order to be considered for funds, complete applications must be received by the appropriate USDA Rural Development State Office in which the applicant's proposed project is located, or via www.grants.gov, as identified in Section IV.C., of this Notice.

    (1) Insufficient funds. If funds are not sufficient to fund the total amount of an application:

    (a) For State allocated funds:

    (i) The applicant must be notified that they may accept the remaining funds or submit the total request for National Office reserve funds available after pooling. If the applicant agrees to lower its grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.

    (ii) If two or more grant or combination applications have the same score and remaining funds in the State allocation are insufficient to fully award them, the Agency will notify the applicants that they may either accept the proportional amount of funds or submit their total request for National Office reserve funds available after pooling. If the applicant agrees to lower its grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.

    (b) The applicant notification for national funds will depend on the competition as follows:

    (i) For an application requesting a grant of $20,000 or less or a combination application where the grant amount is $20,000 or less from set-aside pooled funds, the applicant must be notified that they may accept the remaining funds, or submit the total request to compete in the unrestricted state competition. If the applicant agrees to lower the grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project. A declined partial award counts as a competition.

    (ii) For an application requesting a grant of $20,000 or less or a combination application where the grant amount is $20,000 or less from unrestricted pooled funds, in which this is the final competition or for those applications requesting grants of over $20,000 and combined grant and guaranteed loan application, the applicant must be notified that they may accept the remaining funds or their grant application will be withdrawn. If the applicant agrees to lower the grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.

    (iii) If two or more grant or combination applications have the same score and remaining funds are insufficient to fully award them, the Agency will notify the applicants that they may either accept the proportional amount of funds or be notified in accordance with V.D.(1)(b)(i) or (ii), as applicable.

    (iv) At its discretion, the Agency may instead allow the remaining funds to be carried over to the next Federal FY rather than selecting a lower scoring application(s) or distributing funds on a pro-rata basis.

    (2) Award considerations. All award considerations will be on a discretionary basis. In determining the amount of a renewable energy system or energy efficiency improvements grant or loan guarantee, the Agency will consider the six criteria specified in 7 CFR 4280.114(e) or 7 CFR 4280.129(g), as applicable.

    (3) Notification of funding determination. As per 7 CFR 4280.111(c) all applicants will be informed in writing by the Agency as to the funding determination of the application.

    VI. Federal Award Administration Information

    A. Federal Award Notices. The Agency will award and administer renewable energy system and energy efficiency improvements grants, guaranteed loans in accordance with 7 CFR 4280.122, and 7 CFR 4280.139, as applicable. The Agency will award and administer the energy audit and renewable energy development assistance grants in accordance with 7 CFR 4280.195. Notification requirements of 7 CFR 4280.111, apply to this Notice.

    B. Administrative and National Policy Requirements.

    (1) Equal Opportunity and Nondiscrimination. The Agency will ensure that equal opportunity and nondiscrimination requirements are met in accordance with the Equal Credit Opportunity Act, 15 U.S.C. 1691 et seq. and 7 CFR part 15d, Nondiscrimination in Programs and Activities Conducted by the U.S. Department of Agriculture. The Agency will not discriminate against applicants on the basis of race, color, religion, national origin, sex, marital status, or age (provided that the applicant has the capacity to contract); because all or part of the applicant's income derives from any public assistance program; or because the applicant has in good faith exercised any right under the Consumer Credit Protection Act, 15 U.S.C. 1601 et seq.

    (2) Civil Rights Compliance. Recipients of grants must comply with the Americans with Disabilities Act of 1990, 42 U.S.C. 12101 et seq., Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d et seq., and Section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794. This may include collection and maintenance of data on the race, sex, and national origin of the recipient's membership/ownership and employees. These data must be available to conduct compliance reviews in accordance with 7 CFR 1901.204.

    (3) Environmental Analysis. Environmental procedures and requirements for this subpart are specified in 7 CFR part 1970. Prospective applicants are advised to contact the Agency to determine environmental requirements as soon as practicable after they decide to pursue any form of financial assistance directly or indirectly available through the Agency.

    (4) Appeals. A person may seek a review of an Agency decision or appeal to the National Appeals Division in accordance with 7 CFR 4280.105.

    (5) Reporting. Grants, guaranteed loans, combination guaranteed loans and grants, and energy audit and energy audit and renewable energy development assistance grants that are awarded are required to fulfill the reporting requirements as specified in Departmental Regulations, the Grant Agreement, and in 7 CFR part 4280 subpart B and paragraphs VI.B.(5)(a) through (d) of this Notice.

    (a) Renewable energy system and energy efficiency improvements grants that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.123.

    (b) Guaranteed loan applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.143.

    (c) Combined guaranteed loan and grant applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.165(f).

    (d) Energy audit and renewable energy development assistance grants grant applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.196.

    VII. Federal Awarding Agency Contacts

    For further information contact the applicable USDA Rural Development Energy Coordinator for your respective State, as identified via the following link: http://www.rd.usda.gov/files/RBS_StateEnergyCoordinators.pdf.

    For information about this Notice, please contact Maureen Hessel, Business Loan and Grant Analyst, USDA Rural Development, Energy Division, 1400 Independence Avenue SW, Stop 3225, Room 6866, Washington, DC 20250. Telephone: (202) 401-0142. Email: [email protected]

    VIII. Other Information A. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with renewable energy system and energy efficiency improvements grants and guaranteed loans, as covered in this Notice, have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0570-0050. The information collection requirements associated with energy audit and renewable energy development assistance grants have also been approved by OMB under OMB Control Number 0570-0059.

    B. Nondiscrimination Statement

    In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

    Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

    To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at http://www.ascr.usda.gov/complaint_filing_cust.html and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

    (1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410;

    (2) Fax: (202) 690-7442; or

    (3) Email: [email protected]

    USDA is an equal opportunity provider, employer, and lender.

    Dated: March 7, 2018. Bette Brand, Administrator, Rural Business-Cooperative Service.
    [FR Doc. 2018-05008 Filed 3-12-18; 8:45 am] BILLING CODE 3410-XY-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Montana Advisory Committee AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Montana Advisory Committee (Committee) to the Commission will be held at 11:00 a.m. (Mountain Time) Thursday, March 15, 2018. The purpose of the meeting is for the Committee to discuss preparations to hear testimony on border town discrimination.

    DATES:

    The meeting will be held on Thursday, March 15, 2018 at 11:00 a.m. MT.

    Public Call Information:

    Dial: 888-516-2447.

    Conference ID: 8154017.

    FOR FURTHER INFORMATION CONTACT:

    Angelica Trevino at [email protected] or (213) 894-3437.

    SUPPLEMENTARY INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-516-2447, conference ID number: 8154017. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Angelica Trevino at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://facadatabase.gov/committee/meetings.aspx?cid=259.

    Please click on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda I. Welcome and Rollcall II. Approval of minutes from February 1, 2018 meeting III. Discussion of panelists and logistics for hearing testimony on border town discrimination IV. Public Comment V. Adjournment

    Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstance of this Committee preparing for its upcoming public meeting to hear testimony.

    Dated: March 7, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-04977 Filed 3-12-18; 8:45 am] BILLING CODE P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Montana Advisory Committee to the U.S. Commission on Civil Rights AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a community forum of the Montana Advisory Committee to the Commission will convene at 9:00 a.m. (MDT) on Thursday, March 29, 2018, at the Hardin Middle School, 611 5th Street W, Hardin, MT 59034. The purpose of the community forum is to gather information from federal and tribal government officials and others regarding bordertown discrimination in Montana. Briefing topics will include discrimination that impacts Native Americans in the areas of education, employment, services, public accommodations, law enforcement, and the legal system.

    DATES:

    The meeting will be held on Thursday, March 29, 2018, from 9:00 a.m. to 5:00 p.m. (MDT).

    Location: Hardin Middle School, 611 5th Street W, Hardin MT 59034.

    Public Call Information: Dial: 1-888-293-6960, Conference ID: 4985239.

    FOR FURTHER INFORMATION CONTACT:

    David Barreras, at [email protected] or (312) 353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public may also listen to the discussion through the above listed toll free number. As well as attending in person, any interested member of the public may call the above listed number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

    Time will be set aside at the community forum from 4:00 p.m.-5:00 p.m. so that members of the public may address the Committee after the formal presentations have been completed. Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Monday, April 30, 2018. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012, faxed to (213) 894-0508, or emailed to Angelica Trevino at [email protected] Persons who desire additional information may contact the Western Regional Office at (213) 894-3437. Persons who plan to attend the community forum and require other accommodations, please contact Evelyn Bohor at ebohor @usccr.gov at the Rocky Mountain Regional Office at least ten (10) working days before the scheduled date of the meeting.

    Records and documents discussed during the meeting will be available for public viewing as they become available at https://facadatabase.gov/committee/committee.aspx?cid=259&aid=17 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Western Regional Office at the above phone number, email or street address.

    Agenda Smudging Ceremony Welcome and Introductions: Gwen Kircher, Chair, Montana Advisory Committee Community Forum Montana Advisory Committee Government and Tribal Officials, Advocates, Experts Dated: March 7, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-04978 Filed 3-12-18; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Alabama Advisory Committee To Discuss the Hearing on Access to Voting in the State of Alabama, Which Was Held in Montgomery, Alabama on February 22, 2018 AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Alabama Advisory Committee (Committee) will hold a meeting on Friday, March 23, 2018, at 11:00 a.m. (Central) for the purpose discussing the hearing on Access to Voting in Alabama, and assessment of the need for further testimony.

    DATES:

    The meeting will be held on Friday, March 23, 2018, at 11:00 a.m. (Central).

    Public Call Information: Dial: 877-879-6207, Conference ID: 2611734.

    FOR FURTHER INFORMATION CONTACT:

    David Barreras, DFO, at [email protected] or 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 877-879-6207, conference ID: 2611734. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to David Barreras at [email protected] Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

    Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Alabama Advisory Committee link (http://www.facadatabase.gov/committee/committee.aspx?cid=233&aid=17). Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

    Agenda Welcome and Roll Call Discussion of the hearing on Access to Voting in Alabama Discussion on additional testimony Next Steps Public Comment Adjournment Dated: March 7, 2018. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2018-04976 Filed 3-12-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-16-2018] Foreign-Trade Zone (FTZ) 61—San Juan, Puerto Rico; Notification of Proposed Production Activity, Janssen Ortho LLC (Pharmaceuticals), Gurabo, Puerto Rico

    Janssen Ortho LLC (Janssen) submitted a notification of proposed production activity to the FTZ Board for its facility in Gurabo, Puerto Rico. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on February 27, 2018.

    Janssen already has authority to produce certain pharmaceutical products within Subzone 61N. The current request would add a finished product and a foreign status material/component to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status material/component and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt Janssen from customs duty payments on the foreign-status material/component used in export production. On its domestic sales, for the foreign-status material/component noted below and those in the existing scope of authority, Janssen would be able to choose the duty rate during customs entry procedures that applies to ErleadaTM (apalutamide 60 mg oral tablets) (duty-free). Janssen would be able to avoid duty on foreign-status components which becomes scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    The material/component sourced from abroad is apalutamide API (duty rate 6.5%).

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is April 23, 2018.

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

    For further information, contact Christopher Wedderburn at [email protected] or (202) 482-1963.

    Dated: March 6, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-05025 Filed 3-12-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-45-2018] Foreign-Trade Zone 138—Franklin County, Ohio; Application for Subzone; International Converter, Inc., Caldwell, Ohio

    An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Columbus Regional Airport Authority, grantee of FTZ 138, requesting subzone status for the facility of International Converter, Inc. (IC), located in Caldwell, Ohio. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally docketed on March 7, 2018.

    The proposed subzone (10.29 acres) is located at 17153 Industrial Highway, Caldwell, Noble County. A notification of proposed production activity has been submitted and is being processed under 15 CFR 400.37 (Doc. B-13-2018). The proposed subzone would be subject to the existing activation limit of FTZ 138.

    In accordance with the Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.

    Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is April 23, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to May 7, 2018.

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

    For further information, contact Elizabeth Whiteman at [email protected] or (202) 482-0473.

    Dated: March 7, 2018. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2018-05024 Filed 3-12-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-475-828] Stainless Steel Butt-Weld Pipe Fittings From Italy: Preliminary Results of Antidumping Duty Administrative Review; 2016-2017 AGENCY:

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

    SUMMARY:

    The Department of Commerce (Commerce) preliminarily determines that sales of subject merchandise by Filmag Italia Spa (Filmag) were not made at less than normal value during the period of review (POR) February 1, 2016, through January 31, 2017. Interested parties are invited to comment on these preliminary results.

    DATES:

    Applicable March 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    John Drury or Kent Boydston, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0195 or (202) 482-5649, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On April 10, 2017, Commerce published in the Federal Register the notice of initiation of an administrative review of the AD order on stainless steel butt-weld pipe fittings (SSBW pipe fittings) from Italy for the period February 1, 2016, through January 31, 2017.1 Commerce initiated a review with respect to one company, Filmag. On October 31, 2017, Commerce extended the preliminary results of review until January 2, 2018.2 On December 28, 2017, Commerce extended the preliminary results of review until February 28, 2018.3

    1See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 82 FR 17188 (April 10, 2017).

    2See Memorandum to James Maeder, Senior Director performing the duties of Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, from John K. Drury, International Trade Compliance Analyst, Office VI, “Stainless Steel Butt-Weld Pipe Fittings from Italy: Extension of Deadline for Preliminary Results of Antidumping Duty Administrative Review; 2016-2017,” dated October 31, 2017.

    3See Memorandum to Edward Yang, Senior Director, Office VII, from Kent Boydston, International Trade Compliance Analyst, Office VI, “Stainless Steel Butt-Weld Pipe Fittings from Italy: Extension of Deadline for Preliminary Results of Antidumping Duty Administrative Review; 2016-2017,” dated December 28, 2017.

    Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now March 5, 2018.4

    4See Memorandum for The Record from Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, “Deadlines Affected by the Shutdown of the Federal Government” (Tolling Memorandum), dated January 23, 2018. All deadlines in this segment of the proceeding have been extended by 3 days.

    Scope of the Order

    The merchandise covered by the order is certain stainless steel butt-weld pipe fittings from Italy.5 Stainless steel butt-weld pipe fittings are under 14 inches in outside diameter (based on nominal pipe size), whether finished or unfinished. The product encompasses all grades of stainless steel and “commodity” and “specialty” fittings. Specifically excluded from the definition are threaded, grooved, and bolted fittings, and fittings made from any material other than stainless steel.

    5See Antidumping Duty Orders: Stainless Steel Butt-Weld Pipe Fittings from Italy, Malaysia, and the Philippines, 66 FR 11257 (February 23, 2001).

    The butt-weld fittings subject to the order are currently classifiable under subheading 7307.23.0000 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of the order is dispositive. A full description of the scope of the order is contained in the memorandum from Christian Marsh, Deputy Assistant Secretary for Enforcement and Compliance, to Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance, titled “Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review: Stainless Steel Butt-Weld Pipe Fittings from Italy; 2016-2017” (Preliminary Decision Memorandum), which is issued concurrent with these results and hereby adopted by this notice.

    Methodology

    Commerce is conducting this review in accordance with sections 751(a)(1)(B) and (2) of the Tariff Act of 1930, as amended (the Act). Export price has been calculated in accordance with section 772 of the Act. Normal value has been calculated in accordance with section 773 of the Act. For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum.

    The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). Access to ACCESS is available to registered users at http://access.trade.gov and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly on the internet at http://enforcement.trade.gov/frn/index.html. A list of topics discussed in the Preliminary Decision Memorandum is attached as an Appendix to this notice. The signed Preliminary Decision Memorandum and the electronic versions of the Preliminary Decision Memorandum are identical in content.

    Preliminary Results of Review

    We preliminarily determine that, for the period February 1, 2016, through January 31, 2017, the following dumping margin exists:

    Manufacturer/exporter Weighted-average margin (percent) Filmag Italia Spa 0.00 Disclosure and Public Comment

    Commerce intends to disclose to parties to the proceeding any calculations performed in connection with these preliminary results of review within five days after the date of publication of this notice.6 Interested parties may submit case briefs to Commerce in response to these preliminary results no later than 30 days after the publication of these preliminary results.7 Rebuttal briefs, the content of which is limited to the issues raised in the case briefs, must be filed within five days from the deadline date for the submission of case briefs.8

    6See 19 CFR 351.224(b).

    7See 19 CFR 351.309(c)(1)(ii).

    8See 19 CFR 351.309(d)(1) and (2).

    Parties who submit arguments in this proceeding are requested to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.9 Case and rebuttal briefs should be filed using ACCESS.10 Case and rebuttal briefs must be served on interested parties.11 Executive summaries should be limited to five pages total, including footnotes.

    9See 19 CFR 351.309(c)(2).

    10See generally 19 CFR 351.303.

    11See 19 CFR 351.303(f).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a date and time to be determined.12 Parties should confirm the date, time, and location of the hearing by telephone two days before the scheduled date.

    12See 19 CFR 351.310(d).

    Commerce intends to publish the final results of this administrative review, including the results of its analysis of issues addressed in any case or rebuttal brief, no later than 120 days after publication of these preliminary results, unless extended.13

    13See section 751(a)(3)(A) of the Act; 19 CFR 351.213(h).

    Assessment Rates

    Upon issuance of the final results in this administrative review, Commerce shall determine, and Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries.14 If Filmag's weighted-average dumping margin is not zero or de minimis in the final results of this review, we will calculate importer- or customer-specific ad valorem assessment rates for the merchandise based on the ratio of the total amount of antidumping duties calculated for the examined sales made during the period of review to the total customs value of the sales used to calculate those duties in accordance with 19 CFR 351.212(b)(1). Where an importer-specific ad valorem assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties in accordance with 19 CFR 351.106(c)(2). If the respondent's weighted-average dumping margin is zero or de minimis in the final results of review, we will instruct CBP liquidate the appropriate entries without regard to duties in accordance with the Final Modification for Reviews, i.e., “{w}here the weighted-average margin of dumping for the exporter is determined to be zero or de minimis, no antidumping duties will be assessed.” 15

    14See 19 CFR 351.212(b)(1).

    15See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Proceedings: Final Modification, 77 FR 8101, 8102 (February 14, 2012) (Final Modification for Reviews).

    We intend to issue liquidation instructions to CBP 15 days after publication of the final results of this review.

    Cash Deposit Requirements

    The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for Filmag will be that established in the final results of this administrative review; (2) for previously reviewed or investigated companies, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or in the investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent review period for the manufacturer of the merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be the all-others rate of 26.59 percent, the rate established in the investigation of this proceeding.16 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    16See Notice of Final Determination of Sales at Less Than Fair Value: Stainless Steel Butt-Weld Pipe Fittings from Italy, 65 FR 81830 (December 27, 2000).

    Notification to Importers

    This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: March 5, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance. Appendix—List of Topics Discussed in the Preliminary Decision Memorandum 1. Background 2. Scope of the Order 3. Date of Sale 4. Comparisons to Normal Value A. Product Comparisons B. Determination of Comparison Method C. Export Price D. Normal Value 1. Home Market Viability 2. Level of Trade 3. Cost of Production 4. Calculation of Normal Value Based on Comparison Market Prices 5. Price-to-Constructed Value Comparison E. Currency Conversion 5. Recommendation
    [FR Doc. 2018-05022 Filed 3-12-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XG070 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

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

    ACTION:

    Notice.

    SUMMARY:

    This notice advises the public that a direct take permit has been issued pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973 (ESA) for a program rearing and releasing summer steelhead in the Wenatchee River basin of Washington state (Columbia River basin). The permit is issued to the Public Utility District of Chelan County and the Washington Department of Fish and Wildlife.

    DATES:

    The permit was issued on December 26, 2017, subject to certain conditions set forth therein. Subsequent to issuance, the necessary countersignatures by the applicants were received. The permit expires on December 31, 2027.

    ADDRESSES:

    Requests for copies of the decision documents or any of the other associated documents should be addressed to the NMFS Sustainable Fisheries Division, 1201 NE Lloyd Blvd. #1100, Portland, OR 97232.

    FOR FURTHER INFORMATION CONTACT:

    Emi Kondo at (503) 736-4739 or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    This notice is relevant to the following species and evolutionarily significant unit (ESU)/distinct population segment (DPS):

    Steelhead (O. mykiss): Threatened, naturally produced and artificially propagated Upper Columbia River.

    Authority:

    16 U.S.C. 1531 et seq.

    Dated: March 8, 2018. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2018-05027 Filed 3-12-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army [Docket ID: USA-2018-HQ-0005] Proposed Collection; Comment Request AGENCY:

    U.S. Army Public Health Center (APHC), DoD.

    ACTION:

    Information collection notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the U.S. Army Public Health Center (APHC) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: 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; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by May 14, 2018.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Suite 08D09B, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Army Public Health Center (APHC), ATTN: Dr. Coleen Baird, 5158 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5403, or call APHC Environmental Medicine Division at (410) 436-2714.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Evaluation of Health Status of an Infantry Battalion Following Deployment in Support of Operation Iraqi Freedom in 2004-2005; OMB Control Number 0702-XXXX.

    Needs and Uses: The information collection requirement is necessary to assess and evaluate the self-reported post-deployment health status of selected soldiers who operated in the vicinity of Mosul, Iraq in 2004 (e.g., 1-24 Infantry Battalion). The data collected from the survey will be used to compare the health of current and former U.S. Army personnel after their initial deployment in support of Operation Iraqi Freedom (OIF) to that of a subset of Millennium Cohort Study participants. This evaluation is being conducted at the request of the Army Chief of Staff.

    Affected public: Individuals or Households.

    Annual burden hours: 3,500.

    Number of respondents: 3,500.

    Responses per respondent: 1.

    Annual responses: 3,500.

    Average burden per response: 60 minutes.

    Frequency: One time.

    Respondents are former soldiers who deployed in support of OIF. The post-deployment health survey will record self-reported health topics, including medical conditions, health behaviors, and exposures that may have affected the health of soldiers and veterans. The data from the completed survey will be used to compare the health status of members of the 1-24 Infantry Battalion (1-24 IN) who deployed to Mosul, Iraq in 2004-2005 and a similar exposure group consisting of other personnel in the 1st Stryker Brigade Combat Team (SBCT) to a comparable set of soldiers and veterans participating in a separate and not related Millennium Cohort Study. A deployment and environmental health surveillance investigation conducted by the APHC in 2014 was unable to discern etiologic elements connecting the multitude of health conditions and symptoms experienced by a small subset of the 1-24 IN. Deployment-associated environmental exposures which may have increased the risk of developing these conditions were not identified; however, a comprehensive comparative evaluation that includes self-reported data and all former members of the 1-24 IN who served in Mosul has not been conducted.

    Dated: March 8, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-05040 Filed 3-12-18; 8:45 am] BILLING CODE 3710-08-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0086] Notice of Availability for Finding of No Significant Impact for the Environmental Assessment Addressing Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center Richmond, Virginia AGENCY:

    Defense Logistics Agency (DLA), Department of Defense.

    ACTION:

    Notice of availability (NOA).

    SUMMARY:

    On August 17, 2016, DLA published a NOA in the Federal Register announcing the publication of the Environmental Assessment (EA) Addressing Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center Richmond, Virginia. The EA was available for a 30-day public comment period that ended September 16, 2016. DLA considered all comments prior to making the determination to proceed with this Finding of No Significant Impact (FONSI).

    FOR FURTHER INFORMATION CONTACT:

    Ira Silverberg at 703-767-0705 during normal business hours Monday through Friday, from 8:00 a.m. to 4:30 p.m. (EST) or by email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The EA was prepared as required under the National Environmental Policy Act (NEPA) of 1969. In addition, the EA complied with DLA Regulation 1000.22. DLA completed an EA to address the potential environmental consequences associated with the Proposed Action at Defense Supply Center Richmond. This FONSI incorporates the EA by reference and summarizes the results of the analyses in the EA. Additionally, this FONSI documents the decision of DLA to implement the Proposed Action at Defense Supply Center Richmond. DLA has determined that the Proposed Action is not a major federal action significantly affecting the quality of the human environment within the context of NEPA and that no significant impacts on the human environment are associated with this decision.

    DLA received two comments during the 30-day public comment period. An anonymous comment, dated September 13, 2016, concurred with DLA that the Proposed Action would not result in a significant impact. The Virginia Department of Environmental Quality (DEQ) coordinated review of the EA by state agencies, planning district commissions, and Chesterfield County and provided a consolidated comment letter dated September 15, 2016. The Virginia DEQ consolidated comment letter noted the EA did not address potential impacts to land analogous to Chesapeake Bay Preservation Areas. On September 22, 2017, DLA responded to the Virginia DEQ consolidated comment letter. DLA's response letter noted that DLA conducted a wetland delineation, stream assessment, and resource protection area (RPA) delineation and submitted a RPA Designation Application to Chesterfield County requesting redesignation of the RPA within a portion of the proposed 18.2-acre outdoor storage area on March 31, 2017. Chesterfield County confirmed DLA's perennial stream flow determination and RPA designations on April 14, 2017.

    DLA determined that the Proposed Action would be consistent, to the maximum extent practicable, with the enforceable policies of Virginia's Coastal Zone Management Program and submitted a coastal zone consistency determination for Virginia DEQ review on June 9, 2016. On August 16, 2016, Virginia DEQ concurred that the Proposed Action would be consistent with Virginia's Coastal Zone Management Program provided DLA obtains all applicable permits and approvals.

    The Proposed Action would take place within the Bellwood-Richmond Quartermaster Depot Historic District, which is eligible for listing in the National Register of Historic Places. Pursuant to the National Historic Preservation Act, DLA contacted the State Historic Preservation Officer to conduct Section 106 consultation for the Proposed Action on September 25, 2015. In a letter dated November 2, 2015, the State Historic Preservation Office concurred that the Proposed Action would not adversely affect historic properties.

    The EA includes an appendix with the public's comments and DLA's response, coastal zone consistency documentation, and State Historic Preservation Office consultation documents. The revised EA is available electronically at the Federal eRulemaking Portal at http://www.regulations.gov within Docket ID: DOD-2016-OS-0086.

    Purpose and Need for Action: The purpose of the Proposed Action is to improve the efficiency of DLA Disposition Services operations in the Eastern United States. The Proposed Action is necessary, because the DLA Disposition Services disposal network in the Eastern United States has experienced increased customer wait times, insufficient loading bays, workload and productivity imbalances between sites, aging facilities, and a lack of process optimization since DLA Distribution and DLA Disposition Services merged materiel receipt, storage, and distribution functions.

    Proposed Action and Alternatives: Under the Proposed Action, DLA would: (1) Redesign the DLA Disposition Services mid-Atlantic disposal network. This will divert incoming excess military property from DLA Disposition Services at Fort Meade, Fort Bragg, Norfolk, and Susquehanna to DLA Disposition Services at Richmond. (2) Expand DLA Disposition Services at Richmond to a full-service operation (i.e., receive, store, distribute, and sell excess military equipment; documentation of hazardous materials management; demilitarization; and scrap operations). The expansion increases the warehouse footprint from 60,000 to 340,000 square feet (an addition of 280,000 square feet) and increases the outdoor storage area footprint from 34 to 60 acres (an addition of 26 acres). (3) Create an operational test bed for research, development, testing, and evaluation of standardized disposal practices at DLA Disposition Services at Richmond.

    Description of the No Action Alternative: The No Action Alternative avoids relocation, or expansion of DLA Disposition Services at Richmond. DLA Disposition Services would continue to operate with extensive customer wait times, insufficient loading bays, workload and productivity imbalances between sites, aging facilities, and a lack of process optimization. The No Action Alternative would not meet the purpose of and need for the Proposed Action.

    Potential Environmental Impacts: No significant effects on environmental resources are expected from the Proposed Action. Insignificant, adverse effects on land use, e.g., noise, air quality, geological resources, water resources, biological resources, cultural resources, infrastructure and transportation, hazardous materials and wastes, and health and safety are to be expected. Insignificant and beneficial effects on infrastructure and socioeconomics are also to be expected. The EA covers details of the environmental consequences, which is hereby incorporated by reference.

    Determination: DLA has determined that implementation of the Proposed Action will not have a significant effect on the human environment. DLA interprets the human environment as the natural and physical environment and the relationship of people with that environment. DLA based this determination on an analysis of uncertain or controversial impacts; unique or unknown risks; and cumulative impacts of the proposed action. Implementation of the Proposed Action will not violate any Federal, State, or local laws.

    Mr. Phillip R. Dawson, Acting Director, DLA Installation Management, concludes that implementing the Proposed Action at the Defense Supply Center Richmond does not constitute a major federal action that would significantly affect the quality of the environment within the context of NEPA. This decision is based on the results of the analyses performed during the EA preparation as well as comments received from the public.

    Therefore, an environmental impact statement for the Proposed Action is not required.

    Dated: March 8, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-05055 Filed 3-12-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 17-79] Arms Sales Notification AGENCY:

    Defense Security Cooperation Agency, Department of Defense.

    ACTION:

    Arms sales notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of an arms sales notification.

    FOR FURTHER INFORMATION CONTACT:

    Pamela Young, (703) 697-9107, [email protected] or Kathy Valadez, (703) 697-9217, [email protected]; DSCA/DSA-RAN.

    SUPPLEMENTARY INFORMATION:

    This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-79 with attached Policy Justification and Sensitivity of Technology.

    Dated: March 8, 2018. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. BILLING CODE 5001-06-P EN13MR18.000 BILLING CODE 5001-06-C Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Government of Japan

    (ii) Total Estimated Value:

    Major Defense Equipment * $40 million Other $5 million Total $45 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE):

    Twenty-four (24) MK 15 Phalanx Close-in Weapon System (CIWS) Block IB Baseline 1 to MK 15 Phalanx Block IB Baseline 2 Conversion Kits.

    Non-MDE:

    Also included is support equipment, spare parts, publications, software and associated support, and logistical support services, and other related elements of logistical and program support.

    (iv) Military Department: Navy (JA-P-NBE)

    (v) Prior Related Cases, if any: None

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Attached Annex

    (viii) Date Report Delivered to Congress: March 2, 2018

    * As defined in Section 47(6) of the Arms Export Control Act.

    POLICY JUSTIFICATION Japan—MK 15 Phalanx Close-in Weapon System (CIWS) Block IB Baseline 2 Conversion Kits

    The Government of Japan has requested to buy twenty-four (24) MK 15 Phalanx Close-in Weapon System (CIWS) Block IB Baseline 1 to MK 15 Phalanx Block IB Baseline 2 conversion kits. Also included is support equipment, spare parts, publications, software and associated support, and logistical support services, and other related elements of logistical and program support. The estimated total case value is $45 million.

    This proposed sale will contribute to the foreign policy and national security of the United States by improving the security of a major ally that has been, and continues to be, a force for political stability and economic progress in the Asia-Pacific region.

    The proposed sale will improve Japan's capability in current and future defensive efforts. Japan will use the enhanced capability as a deterrent to regional threats and to strengthen homeland defense.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The principal contractor will be Raytheon Missile Systems, Tucson, AZ. There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale will not require the permanent assignment of additional U.S. Government or contractor representatives in Japan.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 17-79 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. The CIWS Block IB Baseline 2 represents an increase in threat acquisition and firepower accuracy over previous Block 1 Baseline configurations. The Baseline 2 variant includes a radar improvement upgrade and an electro-optical sensor to improve weapon system performance against low-observable, sea-skimming threats, and provides improved capability to concentrate hard-kill ordnance in a tighter pattern on the threat. The CIWS mount and spare hardware are UNCLASSIFIED. The radar improvement/upgrade is the most sensitive portion of the Baseline 2 configuration.

    2. The CIWS Block 1B Baseline 2 systems and upgrade kits will result in the transfer of a highly accurate close-in engagement technology and ship self-defense capability. The equipment, hardware, and the majority of documentation are UNCLASSIFIED. The embedded software and operational performance are classified CONFIDENTIAL. The seeker/electro-optical control section and the target detector are UNCLASSIFIED, but contain a sensitive state-of-the-art technology. Technical Manuals used to support the operation and provisioning of organizational-level maintenance are CONFIDENTIAL. The technical and operational data identified above is classified to protect vulnerabilities, design and performance parameters, and similar critical information.

    3. If a technologically advanced adversary were to obtain knowledge of specific hardware, the information could be used to develop countermeasures which might reduce weapons system effectiveness or be used in the development of a system with similar or advanced capabilities.

    4. A determination has been made that Japan can provide substantially the same degree of protection for sensitive technology being released as the U.S. Government. This proposed sustainment program is necessary to the furtherance of the U.S. foreign policy and national security objectives outlined in the policy justification.

    5. All defense articles and services listed in this transmittal are authorized for release and export to the Government of Japan.

    [FR Doc. 2018-05035 Filed 3-12-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Expanding Opportunity Through Quality Charter Schools Program (CSP)—Grants to Charter School Developers for the Opening of New Charter Schools and for the Replication and Expansion of High-Quality Charter Schools AGENCY:

    Office of Innovation and Improvement, Department of Education.

    ACTION:

    Notice; correction.

    SUMMARY:

    On March 2, 2018, we published in the Federal Register a notice inviting applications for new awards for fiscal year (FY) 2018 for CSP—Grants to Charter School Developers for the Opening of New Charter Schools and for the Replication and Expansion of High-Quality Charter Schools, Catalog of Federal Domestic Assistance (CFDA) numbers 84.282B and 84.282E. This correction notice provides a link to the application submission instructions.

    DATES:

    This correction is applicable March 13, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Eddie Moat, U.S. Department of Education, 400 Maryland Avenue SW, Room 4W259, Washington, DC 20202-5970. Telephone: (202) 401-2266 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    On March 2, 2018, we published in the Federal Register a notice inviting applications for new awards for FY 2018 for CSP—Grants to Charter School Developers for the Opening of New Charter Schools and for the Replication and Expansion of High-Quality Charter Schools (83 FR 8974). This correction notice provides a direct link to the application submission instructions.

    Correction

    In FR Doc. 2018-04294, we are revising the paragraph beginning on page 8979 in the second column, at the bottom of the page, under the heading “IV. Application and Submission Information,” to provide the link to the application submission instructions: 1. Application Submission Instructions: For information on how to submit an application please refer to our Common Instructions for Applicants to Department of Education Discretionary Grant Programs, published in the Federal Register on February 12, 2018 (83 FR 6003) and available at www.thefederalregister.org/fdsys/pkg/FR-2018-02-12/pdf/2018-02558.pdf.

    Program Authority: Title IV, part C of the ESEA (20 U.S.C. 7221-7221j).

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program 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. You may access the official edition of the Federal Register and the Code of Federal Regulations 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 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: March 8, 2018. Margo Anderson, Acting Deputy Assistant Secretary for Innovation and Improvement.
    [FR Doc. 2018-05061 Filed 3-12-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Number: PR18-35-000.

    Applicants: Enable Oklahoma Intrastate Transmission, LLC.

    Description: Tariff filing per 284.123(b),(e)+(g): Enable Revised Fuel Percentages April 1, 2018 through March 31, 2019 to be effective 4/1/2018.

    Filed Date: 2/28/18.

    Accession Number: 201802285114.

    Comments Due: 5 p.m. ET 3/21/18.

    284.123(g) Protests Due: 5 p.m. ET 4/30/18.

    Docket Number: PR18-36-000.

    Applicants: Columbia Gas of Ohio, Inc.

    Description: Tariff filing per 284.123(b),(e)/: COH SOC Rate Change Effective 3-1-2018.

    Filed Date: 3/5/18.

    Accession Number: 201803055010.

    Comments/Protests Due: 5 p.m. ET 3/26/18.

    Docket Numbers: RP18-481-000.

    Applicants: Pivotal Utility Holdings, Inc., Elkton Acquisition Corp.

    Description: Joint Petition for Temporary Waiver of Commission Capacity Release Regulations and Policies, et al.

    Filed Date: 2/27/18.

    Accession Number: 20180227-5193.

    Comments Due: 5 p.m. ET 3/12/18.

    Docket Numbers: RP18-482-000.

    Applicants: Pivotal Utility Holdings, Inc., ETG Acquisition Corp.

    Description: Joint Petition for Temporary Waiver of Commission Capacity Release Regulations and Policies, et al.

    Filed Date: 2/27/18.

    Accession Number: 20180227-5194.

    Comments Due: 5 p.m. ET 3/12/18.

    Docket Numbers: RP18-550-000.

    Applicants: Noble Energy, Inc., Fieldwood Energy LLC.

    Description: Joint Petition for Temporary Waiver of Commission Policies, Capacity Release Regulations and Related Tariff Provisions.

    Filed Date: 3/5/18.

    Accession Number: 20180305-5380.

    Comments Due: 5 p.m. ET 3/12/18.

    Docket Numbers: RP18-417-001.

    Applicants: Trailblazer Pipeline Company LLC.

    Description: Compliance filing Compliance Filing to RP18-417-000 to be effective 3/5/2018.

    Filed Date: 3/6/18.

    Accession Number: 20180306-5150.

    Comments Due: 5 p.m. ET 3/19/18.

    Docket Numbers: RP18-551-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Negotiated Rate Agreement—Tenaska Marketing Ventures to be effective 4/1/2018.

    Filed Date: 3/6/18.

    Accession Number: 20180306-5046.

    Comments Due: 5 p.m. ET 3/19/18.

    Docket Numbers: RP18-552-000.

    Applicants: Alliance Pipeline L.P.

    Description: § 4(d) Rate Filing: Negotiated Rate Contracts April—October 2018 to be effective 4/1/2018.

    Filed Date: 3/6/18.

    Accession Number: 20180306-5074.

    Comments Due: 5 p.m. ET 3/19/18.

    Docket Numbers: RP18-553-000.

    Applicants: Dominion Energy Cove Point LNG, LP.

    Description: § 4(d) Rate Filing: DECP—Liquefaction Project Implementation (RP18-419) Update to be effective 4/1/2018.

    Filed Date: 3/6/18.

    Accession Number: 20180306-5143.

    Comments Due: 5 p.m. ET 3/19/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: March 7, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-04991 Filed 3-12-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meeting Notice

    The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:

    AGENCY HOLDING MEETING:

    Federal Energy Regulatory Commission.

    DATE AND TIME:

    March 15, 2018, 10:00 a.m.

    PLACE:

    Room 2C, 888 First Street NE, Washington, DC 20426.

    STATUS:

    Open.

    MATTERS TO BE CONSIDERED:

    Agenda.

    * Note—Items listed on the agenda may be deleted without further notice.

    CONTACT PERSON FOR MORE INFORMATION:

    Kimberly D. Bose, Secretary, Telephone (202) 502-8400.

    For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.

    This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed online at the Commission's website at http://ferc.capitolconnection.org/ using the eLibrary link, or may be examined in the Commission's Public Reference Room.

    1041st—Meeting [Regular meeting; March 15, 2018; 10:00 a.m.] Item No. Docket No. Company ADMINISTRATIVE A-1 AD18-1-000 Agency Administrative Matters. A-2 AD18-2-000 Customer Matters, Reliability, Security and Market Operations. ELECTRIC E-1 RM18-12-000 Inquiry Regarding the Effect of the Tax Cuts and Jobs Act on Commission-Jurisdictional Rates. E-2 EL18-72-000 Alcoa Power Generating Inc.-Long Sault Division. EL18-73-000 Alcoa Power Generating Inc.-Tapoco Division. EL18-75-000 Avista Corporation. EL18-76-000 Black Hills/Colorado Electric Utility Company, L.P. EL18-77-000 Central Hudson Gas & Electric Corporation. EL18-79-000 Cheyenne Light, Fuel and Power Company. EL18-89-000 Consolidated Edison Company of New York, Inc. EL18-90-000 Cube Yadkin Transmission LLC. EL18-91-000 DATC Path 15, LLC. EL18-93-000 Deseret Generation and Transmission Co-operative, Inc. EL18-95-000 El Paso Electric Company. EL18-96-000 Electric Energy, Inc. EL18-97-000 Essential Power Rock Springs, LLC. EL18-98-000 Florida Power & Light Company. EL18-101-000 Monongahela Power Company. Potomac Edison Company. West Penn Power Company. EL18-102-000 Nevada Power Company. Sierra Pacific Power Company. EL18-103-000 New York State Electric & Gas Corporation. EL18-104-000 NorthWestern Corporation. EL18-105-000 Ohio Valley Electric Corporation. EL18-107-000 Orange & Rockland Utilities, Inc. EL18-108-000 Pacific Gas and Electric Company. EL18-109-000 Portland General Electric Company. EL18-110-000 Rochester Gas and Electric Corporation. EL18-111-000 Rockland Electric Company. EL18-112-000 Sky River LLC. EL18-113-000 Smoky Mountain Transmission LLC. EL18-115-000 Startrans, IO, LLC. EL18-117-000 The Dayton Power & Light Company. EL18-118-000 Trans Bay Cable LLC. EL18-119-000 (not consolidated) Tucson Electric Power Company. E-3 EL18-62-000 AEP Appalachian Transmission Company, Inc. AEP Indiana Michigan Transmission Company, Inc. AEP Kentucky Transmission Company, Inc. AEP Ohio Transmission Company, Inc. AEP West Virginia Transmission Company, Inc. EL18-63-000 AEP Oklahoma Transmission Company, Inc. AEP Southwestern Transmission Company, Inc. EL18-64-000 Baltimore Gas and Electric Company. EL18-65-000 Black Hills Power, Inc. EL18-66-000 Citizens Sunrise Transmission LLC. EL18-67-000 San Diego Gas & Electric Company. EL18-68-000 Transource Maryland, LLC. EL18-69-000 Transource Pennsylvania, LLC. EL18-70-000 Transource West Virginia, LLC. EL18-71-000 (not consolidated) UNS Electric, Inc. E-4 EL18-20-000 Indicated SPP Transmission Owners v. Southwest Power Pool, Inc. E-5 EC17-126-000 South Central MCN LLC. E-6 ER18-99-000 Southwest Power Pool, Inc. E-7 ER18-840-000 Public Service Company of Colorado. E-8 ER18-783-000 MISO Transmission Owners. E-9 OMITTED. E-10 EL10-65-005 Louisiana Public Service Commission v. Entergy Corporation. Entergy Services, Inc. Entergy Louisiana, LLC. Entergy Arkansas, Inc. Entergy Mississippi, Inc. Entergy New Orleans, Inc. Entergy Gulf States Louisiana, L.L.C. Entergy Texas, Inc. ER14-2085-001, ER11-3658-001, ER12-1920-001, ER13-1595-001, (consolidated) Entergy Services, Inc. GAS G-1 RM18-11-000 Interstate and Intrastate Natural Gas Pipelines; Rate Changes Relating to Federal Income Tax Rate. G-2 PL17-1-000 Inquiry Regarding the Commission's Policy for Recovery of Income Tax Costs. G-3 IS08-390-008, IS08-390-009 SFPP, L.P. G-4 IS09-437-008, IS09-437-009, IS09-437-010, IS10-572-005, IS10-572-006, IS10-572-007 SFPP, L.P. G-5 IS11-444-002 SFPP, L.P. G-6 OR11-13-000 ConocoPhillips Company v. SFPP, L.P. OR11-16-000 Chevron Products Company v. SFPP, L.P. OR11-18-000 Tesoro Refining and Marketing Company v. SFPP, L.P. G-7 OR14-35-002 HollyFrontier Refining & Marketing LLC, Southwest Airlines Co., Tesoro Refining and Marketing Company, US Airways, Inc., Valero Marketing and Supply Company, and Western Refining Company, L.P. v. SFPP, L.P. OR14-36-002 Chevron Products Company v. SFPP, L.P. G-8 RP18-442-000 Dominion Energy Overthrust Pipeline, LLC. G-9 RP18-441-000 Midwestern Gas Transmission Company. G-10 OR18-8-000 Blue Racer NGL Pipelines, LLC. HYDRO H-1 P-2114-293 Public Utility District No. 2 of Grant County, Washington. H-2 P-2082-062, P-14803-000 PacifiCorp. H-3 P-2426-229 California Department of Water Resources and Los Angeles Department of Water and Power. H-4 P-13762-003 FFP Missouri 15, LLC. P-13753-003 FFP Missouri 16, LLC. H-5 P-2485-074, P-1889-086 FirstLight Hydro Generating Company. CERTIFICATES C-1 CP17-409-000 DTE Midstream Appalachia, LLC. C-2 OMITTED. C-3 CP17-74-000 National Fuel Gas Supply Corporation. Dated: March 8, 2018. Kimberly D. Bose, Secretary.

    A free webcast of this event is available through http://ferc.capitolconnection.org/. Anyone with internet access who desires to view this event can do so by navigating to www.ferc.gov's Calendar of Events and locating this event in the Calendar. The event will contain a link to its webcast. The Capitol Connection provides technical support for the free webcasts. It also offers access to this event via television in the DC area and via phone bridge for a fee. If you have any questions, visit http://ferc.capitolconnection.org/ or contact Danelle Springer or David Reininger at 703-993-3100.

    Immediately following the conclusion of the Commission Meeting, a press briefing will be held in the Commission Meeting Room. Members of the public may view this briefing in the designated overflow room. This statement is intended to notify the public that the press briefings that follow Commission meetings may now be viewed remotely at Commission headquarters, but will not be telecast through the Capitol Connection service.

    [FR Doc. 2018-05103 Filed 3-9-18; 11:15 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98-1-000] Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.

    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.

    Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.

    Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).

    The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the eLibrary link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202)502-8659.

    Docket No. File date Presenter or requester Prohibited 1. EL18-61-000 2-20-2018 Robert E. Rutkowski. 2. CP15-558-000 2-20-2018 Mass Mailing.1 3. CP15-558-000 2-21-2018 Dean Escue. 4. CP15-558-000 2-21-2018 Judi Roggie. 5. CP15-558-000 2-21-2018 Karyl Patterson. 6. CP15-558-000 2-22-2018 Polly M. Clark and Martin J. Zaleshar Jr. 7. CP15-558-000 2-26-2018 Mass Mailing.2 8. CP15-558-000 2-28-2018 Mass Mailing.3 9. CP15-558-000 3-1-2018 Mass Mailing.4 10. CP15-558-000 3-5-2018 Mass Mailings.5 Exempt 1. CP16-9-000 2-22-2018 U.S. House Representative Stephen F. Lynch. 2. CP17-40-000 2-22-2018 U.S. Congress.6 3. P-2413-000 2-23-2018 U.S. House Representative Jody Hice. 4. P-2660-029 2-26-2018 U.S. Congress.7 5. P-2100-000 2-27-2018 Sutter County, California Board of Supervisors. 6. CP17-41-000 3-5-2018 FERC Staff.8 1 Seven letters have been sent to FERC Commissioners and staff under this docket number. 2 Two letters have been sent to FERC Commissioners and staff under this docket number. 3 Two letters have been sent to FERC Commissioners and staff under this docket number. 4 Four letters have been sent to FERC Commissioners and staff under this docket number. 5 Eleven letters have been sent to FERC Commissioners and staff under this docket number. 6 House Representatives Darin LaHood and Rodney Davis. 7 Senators Angus S. King, Jr. and Susan M. Collins. House Representative Bruce Poliquin. 8 Telephone Call Summary for call on February 28, 2018 with Eagle LNG and Environmental Resources Management. Dated: March 7, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-04990 Filed 3-12-18; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC18-64-000.

    Applicants: Boston Energy Trading and Marketing LLC.

    Description: Application of Boston Energy Trading and Marketing LLC for Approval Under Section 203 of the Federal Power Act and Request for Expedited Action.

    Filed Date: 3/6/18.

    Accession Number: 20180306-5152.

    Comments Due: 5 p.m. ET 3/27/18.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-3307-001.

    Applicants: NRG Energy Center Dover LLC.

    Description: Compliance filing: Informational Filing Regarding Upstream Change in Control to be effective N/A.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5080.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER16-1250-004; ER10-2822-012; ER10-2824-001; ER10-2825-002; ER10-2831-002; ER10-2957-002; ER10-2995-002; ER10-2996-001; ER10-2998-001; ER10-2999-001; ER10-3000-001; ER10-3009-003; ER10-3013-002; ER10-3014-001; ER10-3029-001; ER11-2196-009; ER10-1776-001; ER17-1243-001; ER17-1769-002.

    Applicants: Avangrid Renewables, LLC, Atlantic Renewable Projects II LLC, Big Horn Wind Project LLC, Big Horn II Wind Project LLC, Colorado Green Holdings LLC, Hay Canyon Wind LLC, Juniper Canyon Wind Power LLC, Klamath Energy LLC, Klamath Generation LLC, Klondike Wind Power LLC, Klondike Wind Power II LLC, Klondike Wind Power III LLC, Leaning Juniper Wind Power II LLC, Pebble Springs Wind LLC, San Luis Solar LLC, Solar Star Oregon II, LLC, Star Point Wind Project LLC, Twin Buttes Wind LLC, Twin Buttes Wind II LLC.

    Description: Notice of Change in Status Regarding Generation-Only Balancing Authority Formation of Avangrid Renewables, LLC, et. al.

    Filed Date: 3/5/18.

    Accession Number: 20180305-5404.

    Comments Due: 5 p.m. ET 3/26/18.

    Docket Numbers: ER17-2290-003.

    Applicants: Old Dominion Electric Cooperative.

    Description: Compliance filing: Wildcat Point Revised Rate Schedule Compliance Filing to be effective 2/15/2018.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5076.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-337-000.

    Applicants: PacifiCorp.

    Description: Report Filing: City of Hurricane Refund Report to be effective N/A.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5044.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-971-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: Amendment to Silicon Valley Power NRS and Los Esteros TFAs (SA 343) to be effective 8/1/2017.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5000.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-974-000.

    Applicants: NTE Carolinas, LLC.

    Description: Baseline eTariff Filing: Baseline new to be effective 4/1/2018.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5081.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-975-000.

    Applicants: Arizona Public Service Company.

    Description: § 205(d) Rate Filing: Revision to OATT Formula Transmission Rate to Update Tax Rate and Flow Back ADIT to be effective 5/7/2018.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5098.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-976-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-03-07_SA 3101 Summit Lake Wind-ATC GIA (J711) to be effective 2/21/2018.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5107.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-977-000.

    Applicants: Florida Power & Light Company.

    Description: § 205(d) Rate Filing: FPL Revision to the Large Generator Interconnection Agreement to be effective 3/8/2018.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5111.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-978-000.

    Applicants: Florida Power & Light Company.

    Description: § 205(d) Rate Filing: FPL Iguana Solar Large Generator Interconnection Agreement to be effective 3/8/2018 .

    Filed Date: 3/7/18.

    Accession Number: 20180307-5112.

    Comments Due: 5 p.m. ET 3/28/18.

    Docket Numbers: ER18-979-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-03-07_SA 3102 UMERC-Summit Lake-ATC MPFCA (J704 J711) to be effective 2/21/2018.

    Filed Date: 3/7/18.

    Accession Number: 20180307-5113.

    Comments Due: 5 p.m. ET 3/28/18.

    Take notice that the Commission received the following qualifying facility filings:

    Docket Numbers: QF17-987-000.

    Applicants: North American BioFuels, LLC.

    Description: Refund Report of North American BioFuels, LLC.

    Filed Date: 3/5/18.

    Accession Number: 20180305-5413.

    Comments Due: 5 p.m. ET 3/26/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: March 7, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-04989 Filed 3-12-18; 8:45 am] BILLING CODE 6717-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0022 and -0027) AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice and request for comment.

    SUMMARY:

    The FDIC, 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 the renewal of the existing information collection, as required by the Paperwork Reduction Act of 1995. On December 28, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collections described below. One comment was received and was generally supportive of the requirements in the rule but did not address the paperwork burden for this information collection. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these collections, and again invites comment on this renewal.

    DATES:

    Comments must be submitted on or before April 12, 2018.

    ADDRESSES:

    Interested parties are invited to submit written comments to the FDIC by any of the following methods:

    https://www.FDIC.gov/regulations/laws/federal.

    Email: [email protected] Include the name and number of the collection in the subject line of the message.

    Mail: Manny Cabeza, Counsel, Room MB-3007, Federal Deposit Insurance Corporation, 550 17th Street NW, Washington, DC 20429.

    Hand Delivery: Comments may be hand-delivered to the guard station at the rear of the 17th Street Building (located on F Street), on business days between 7:00 a.m. and 5:00 p.m.

    All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Manny Cabeza, at the FDIC address above.

    SUPPLEMENTARY INFORMATION:

    On December 28, 2017, the FDIC requested comment for 60 days on a proposal to renew the information collections described below. One comment was received and was generally supportive of the requirements in the rule but did not address the paperwork burden for this information collection. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of this collection, and again invites comment on this renewal.

    Proposal to renew the following currently approved collections of information:

    1. Title: Uniform Application and Termination Notice for Municipal Securities Principal or Representative Associated with a Bank Municipal Securities Dealer.

    OMB Number: 3064-0022.

    Form Number: MSD-4 and MSD-5

    Affected Public: Individuals and Insured state nonmember banks and state savings associations.

    Burden Estimate:

    Source and burden type Number of
  • respondents
  • Annual
  • frequency
  • Total
  • responses
  • Average time
  • per response
  • Estimated
  • annual burden
  • (hours)
  • Form MSD-4 Reporting 2 On Occasion 2 60 Minutes 2 Form MSD-5 Reporting 2 On Occasion 2 15 Minutes 0.5

    Total Estimated Annual Burden: 2.5 Hours.

    There is no change in the method or substance of the collection. The overall reduction in burden hours is a result of economic fluctuation. In particular, the number of respondents has decreased while the reporting frequency and the estimated time per response remain the same.

    General Description of Collection: The 1975 Amendments to the Securities Exchange Act of 1934 established a comprehensive framework for the regulation of the activities of municipal securities dealers. Under Section 15B(a) of the Securities Exchange Act, municipal securities dealers which are banks, or separately identifiable departments or divisions of banks engaging in municipal securities activities, are required to be registered with the Securities and Exchange Commission in accordance with such rules as the Municipal Securities Rulemaking Board (MSRB), a rulemaking authority established by the 1975 Amendments, may prescribe as necessary or appropriate in the public interest or for the protection of investors.

    One of the areas in which the Act directed the MSRB to promulgate rules is the qualifications of persons associated with municipal securities dealers as municipal securities principals and municipal securities representatives. The MSRB Rules require persons who are or seek to be associated with municipal securities dealers as municipal securities principals or municipal securities representatives to provide certain background information and conversely, require the municipal securities dealers to obtain the information from such persons. Generally, the information required to be furnished relates to employment history and professional background including any disciplinary sanctions and any claimed bases for exemption from MSRB examination requirements.

    The FDIC and the other two Federal bank regulatory agencies, the Comptroller of the Currency, and the Federal Reserve Board, have prescribed Forms MSD-4 to satisfy these requirements and have prescribed Form MSD-5 for notification by a bank municipal securities dealer that a municipal securities principal's or a municipal securities representative's association with the dealer has terminated and the reason for such termination. State nonmember banks and state savings associations that are municipal security dealers submit these forms, as applicable, to the FDIC as their appropriate regulatory agency for each person associated with the dealer as a municipal securities principal or municipal securities representative.

    2. Title: Request for Deregistration for Registered Transfer Agents.

    OMB Number: 3064-0027.

    Form Number: 6342/12.

    Affected Public: Insured state nonmember banks and state savings associations.

    Burden Estimate:

    Source and burden type Number of
  • respondents
  • Annual
  • frequency
  • Total
  • responses
  • Average time per response Estimated
  • annual burden
  • (hours)
  • Form 6342/12 Reporting 1 On Occasion 1 0.42 0.42

    There is no change in the method or substance of the collection. There is an overall reduction in burden hours which is the result of (1) economic fluctuation reflected by a decrease in the number of FDIC-supervised institutions and (2) a decrease in the number of requests for deregistration of a registered transfer agent forms submitted to the FDIC.

    General Description of Collection: Under the Securities Exchange Act of 1934 (15 U.S.C. 78q-1), an insured nonmember bank (or a subsidiary of such a bank) that functions as a transfer agent may withdraw from registration as a transfer agent by filing a written notice of withdrawal with the FDIC. The FDIC requires such banks to file FDIC Form 6342/12 as the written notice of withdrawal.

    Request for Comment

    Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, 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 respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

    Dated at Washington, DC, on March 7, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-04957 Filed 3-12-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 9, 2018.

    A. Federal Reserve Bank of Atlanta (Kathryn Haney, Director of Applications) 1000 Peachtree Street NE, Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. Ameris Bancorp, Moultrie, Georgia; to merge with Hamilton State Bancshares, Inc., and thereby indirectly acquire Hamilton State Bank, both of Hoschton, Georgia.

    Board of Governors of the Federal Reserve System, March 7, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-04952 Filed 3-12-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 28, 2018.

    A. Federal Reserve Bank of Philadelphia (William Spaniel, Senior Vice President) 100 North 6th Street, Philadelphia, Pennsylvania 19105-1521. Comments can also be sent electronically to [email protected]:

    1. Roger L. Dirlam, Honesdale, Pennsylvania, Honesdale, Pennsylvania, the Honat Employee Stock Ownership Plan, Honesdale, Pennsylvania, and Charles Curtin, Clarks Summit, Pennsylvania, Katherine Bryant, Honesdale, Pennsylvania, and Luke Woodmansee, Starlight, Pennsylvania, as trustees of the ESOP; to each retain more than 10 percent of the voting shares of Honat Bancorp, Inc., Honesdale, Pennsylvania, and thereby retain shares of The Honesdale National Bank, Honesdale, Pennsylvania.

    B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Alex Lin, Hong Kong, Hong Kong, Hiu Kwan Kwok, Cyber Port, Hong Kong, Jun Yang, Tianjin, China, and Yongyan Liu, Chaoyang, Beijing, China; to retain voting shares of My Anns Corporation, and thereby retain shares of Piqua State Bank, both of Piqua, Kansas.

    Board of Governors of the Federal Reserve System, March 8, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-05009 Filed 3-12-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 27, 2018.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Kelly Arnold, Wichita, Kansas; to acquire voting shares of Ramona Bankshares, Inc., and thereby acquire shares of Hillsboro State Bank, both of Hillsboro, Kansas, and to be approved as a member of the Arnold Family Group, which acting in concert controls Ramona Bankshares.

    B. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105-1579:

    1. Basswood Capital Management, LLC; Basswood Opportunity Partners, LP, Basswood Financial Fund, LP, Basswood Enhanced Long Short Fund, LP, and Basswood Financial Long Only Fund, LP, funds for which Basswood Partners, LLC, serves as General Partner and Basswood Capital Management, LLC, serves as Investment Manager; Basswood Opportunity Fund, Inc., and Basswood Financial Fund, Inc., funds for which Basswood Capital Management, LLC, serves as Investment Manager; Basswood Capital Management, LLC, as investment adviser to five managed accounts; and Bennett Lindenbaum and Matthew Lindenbaum, as Managing Members of Basswood Partners, LLC, Basswood Enhanced Long Short GP, LLC, and Basswood Capital Management, LLC; all of New York, New York; to retain and acquire voting shares of American River Bankshares, Rancho Cordova, California, and thereby indirectly retain and acquire shares of American River Bank, Sacramento, California.

    Board of Governors of the Federal Reserve System, March 7, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-04953 Filed 3-12-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 10, 2018.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. RCB Holding Company, Inc., Claremore, Oklahoma; to acquire 100 percent of the voting shares of Central Bank and Trust Co., Hutchinson, Kansas.

    Board of Governors of the Federal Reserve System, March 8, 2018. Ann E. Misback, Secretary of the Board.
    [FR Doc. 2018-05010 Filed 3-12-18; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-2018-1091; Docket No. CDC-2018-0022] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ”Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States.” CDC's goal for this generic information collection mechanism is to conduct qualitative studies to quickly identify barriers and facilitators to HIV prevention, care and treatment in specific regions with high HIV burden in the US.

    DATES:

    CDC must receive written comments on or before May 14, 2018.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2018-0022 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov.

    Please note:

    Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    The OMB is particularly interested in comments that will help:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate 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;

    3. Enhance the quality, utility, and clarity of the information to be collected; and

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    5. Assess information collection costs.

    Proposed Project

    Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States (OMB Control Number 0920-1091; expires 12/31/2018)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The CDC's National Center on HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Division of HIV/AIDS Prevention (DHAP) seeks a three-year extension to conduct qualitative studies to quickly identify barriers and facilitators to HIV prevention, care and treatment in specific regions with high HIV burden in the US. Proposed activities remain consistent with the national HIV prevention goals, the CDC Division of HIV/AIDS Prevention (DHAP) Strategic Plan, and DHAP's High-impact HIV Prevention approach.

    The purposes for each data collection study supported under this umbrella generic information collection plan will be to understand specific barriers and facilitators to local HIV prevention, care and treatment in the United States and territories. For example, each study will seek to identify ways to improve programmatic activities along the continuum of HIV prevention, treatment and care for different populations residing in different geographic settings with greatest burden of HIV.

    The target populations for the studies include, but are not limited to: (1) Persons living with HIV who are in treatment; (2) persons living with HIV who are out of treatment and who may or may not be seeking treatment at healthcare facilities; (3) persons at high risk for HIV acquisition (HIV negative) and HIV transmission (HIV positive); (4) persons from groups at high risk for HIV including gay, bisexual and other MSM, transgender persons, and injection and non-injection drug users; (5) persons from racial and ethnic minorities; and (6) healthcare providers or other professionals who provide HIV prevention, care and treatment services. Other populations may include individuals who provide non-HIV services or otherwise interact with persons living with HIV or persons at risk for HIV acquisition.

    Studies will only provide local contextual information about the barriers and facilitators to HIV prevention, care, and treatment experienced by specific communities at risk for acquiring HIV infection, by HIV-positive persons across the HIV care continuum, and by organizations or individuals providing HIV prevention, care, treatment, and related support services.

    Data collection methods used in any of the specific studies primarily will consist of rapid qualitative assessment methodologies, such as semi-structured and in-depth qualitative interviews, focus groups; direct observations; document reviews; and short structured surveys. Data will be analyzed using well-established qualitative analysis methods, such as coding interviews for themes about barriers and successes to HIV prevention, care, and treatment. Structured response surveys will be analyzed using descriptive statistics and other appropriate statistical methods.

    CDC will use the results from each specific data collection study to help identify ways to improve local programmatic activities for specific communities along the continuum of HIV prevention, treatment and care for populations and areas with the greatest HIV burden. CDC will communicate study outcomes to local stakeholders and organizations in positions to consider and implement site-specific improvements in HIV prevention, care, and treatment for each of the study sites examined. For stakeholders, organizations, or agencies outside the local affected communities, all communications will include clear discussion of the limitations of the region-specific, qualitative methods and the non-generalizability of the study outcomes.

    For a given year, each separate data collection will range from 30 (minimum) to 200 (maximum) respondents, based on the nature and scope of the research purposes. For example, if there are three data collections, the maximum combined number of expected respondents is 600. In a given year, CDC anticipates the need to screen 1,600 persons to identify 800 eligible persons, of which 600 persons will agree to participate.

    CDC anticipates that screener forms will take 5 minutes to complete each, contact information forms will take 1 minute to complete each, and consent forms will take 5 minutes to complete each. CDC anticipates study eligibility for 50 percent of the targeted populations screened. Of eligible persons, 75% will agree to participate.

    Brief structured surveys will take 15 minutes to complete. In-depth interviews or focus groups with respondents are expected to take 60 minutes (1 hour) to complete. In-depth interviews or focus groups with healthcare providers are expected to take 45 minutes to complete.

    The total annual response burden, based on an average of 600 study respondents per year (assuming three large data collections involving 200 participants each), is 918 hours.

    Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • (in hours)
  • General Public—Adults Study Screener 1,600 1 5/60 133 General Public—Adults Contact Information Form 600 1 1/60 10 General Public—Adults Consent Form 600 1 5/60 50 General Public—Adults Demographic Survey 500 1 15/60 125 General Public—Adults Interview Guide 500 1 1 500 General Public—Adults Provider Demographic Survey 100 1 15/60 25 General Public—Adults Provider Interview Guide 100 1 45/60 75 Total 918
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2018-05000 Filed 3-12-18; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2017-0114; Docket Number NIOSH-305] Final National Occupational Research Agenda for Transportation, Warehousing and Utilities AGENCY:

    National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice of availability.

    SUMMARY:

    NIOSH announces the availability of the final National Occupational Research Agenda for Transportation, Warehousing and Utilities

    DATES:

    The final document was published on March 7, 2018.

    ADDRESSES:

    The document may be obtained at the following link: https://www.cdc.gov/niosh/nora/sectors/twu/agenda.html

    FOR FURTHER INFORMATION CONTACT:

    Emily Novicki, M.A., M.P.H, ([email protected]), National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Mailstop E-20, 1600 Clifton Road NE, Atlanta, GA 30329, phone (404) 498-2581 (not a toll free number).

    SUPPLEMENTARY INFORMATION:

    On December 1, 2017, NIOSH published a request for public review in the Federal Register [82 FR 56973] of the draft version of the National Occupational Research Agenda for Transportation, Warehousing and Utilities. No comments were received.

    Dated: March 8, 2018. Frank Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
    [FR Doc. 2018-04988 Filed 3-12-18; 8:45 am] BILLING CODE 4163-19-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0493] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Utilization of Adequate Provision Among Low to Non-Internet Users AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Submit either electronic or written comments on the collection of information by April 12, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-New and title “Utilization of Adequate Provision Among Low to Non-internet Users.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Utilization of Adequate Provision Among Low to Non-Internet Users OMB Control Number 0910-NEW

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.

    Prescription drug advertising regulations require that broadcast advertisements containing product claims present the product's major side effects and contraindications in either audio or audio and visual parts of the advertisement (21 CFR 202.1(e)(1)); this is often called the major statement. The regulations also require that broadcast advertisements contain a brief summary of all necessary information related to side effects and contraindications or that “adequate provision” be made for dissemination of the approved package labeling in connection with the broadcast (§ 202.1(e)(1)). The requirement for adequate provision is generally fulfilled when a firm gives consumers the option of obtaining FDA-required labeling or other information via a toll-free telephone number, through print advertisements or product brochures, through information disseminated at health care provider offices or pharmacies, and through the internet (Ref. 1). The purpose of including all four elements is to ensure that most of a potentially diverse audience can access the information.

    Internet accessibility is increasing, but many members of certain demographic groups (e.g., older adults, low socioeconomic status individuals) nonetheless report that the internet is inaccessible to them either as a resource or due to limited knowledge, and so a website alone may not adequately serve all potential audiences (Refs. 2 and 3). Similarly, some consumers may prefer to consult sources other than a health care provider to conduct initial research, for privacy reasons or otherwise (Refs. 1, 4, and 5). In light of these considerations, the toll-free number and print ad may provide special value to consumers who are low to non-internet users and/or those who value privacy when conducting initial research on a medication, though not necessarily unique value relative to one another. As such, a primary purpose of this research is to examine the value of including both the toll-free number and print ad as part of adequate provision in direct-to-consumer (DTC) prescription drug broadcast ads. We will also investigate the ability and willingness of low to non-internet users to make use of internet resources if other options were unavailable. These questions will be assessed using a survey methodology administered via telephone.

    In addition, building on concurrent FDA research regarding drug risk information,1 we will assess risk perceptions as influenced by opening statements that could be used to introduce risks in DTC prescription drug broadcast ads. Opening statements may be used to frame risk information that follows. As such, consumers may interpret the likelihood, magnitude, and duration of risks differently depending on how those risks are introduced (Refs. 6-9). The intended outcome of this component of the research is to evaluate the influence of these opening statements within a sample of low to non-internet users. This research question will be addressed using a 1 × 3 between-subjects experimental design embedded in the previously mentioned survey. This particular component of the research will serve as an exploratory test intended to inform FDA's future research efforts.

    1https://www.federalregister.gov/documents/2015/01/13/2015-00269/agency-information-collection-activities-submission-for-office-of-management-and-budget-review.

    Sampling Frame. Given that older adults (i.e., those aged 65 and older) are among the largest consumers of prescription drugs (Ref. 10) and that approximately 41 percent of older adults do not use the internet (Ref. 2), investigating use of adequate provision in this population is especially important. Also of concern, 34 percent of those with less than a high school education do not use the internet, 23 percent of individuals with household incomes lower than $30,000 per year do not use the internet, and 22 percent of individuals living in rural areas do not use the internet (Ref. 2). These estimates capture non-internet users, and so consideration of low-internet users warrants additional concern. Consistent with these citations, the present research will utilize a nationally representative sample of low to non-internet users from these and other relevant demographic groups.

    Data collection will utilize a random digit dialing (RDD) sample that has been pre-identified as being a non-internet household, or having at least one non-internet using member. This sample solution is ideal because it relies on a dual-frame (landline and cell phone) probability sample, yet has the advantage of prior knowledge of those who are likely to be low to non-internet users (re-screening will verify this). The Social Science Research Solutions (SSRS) Omnibus, within which this survey will be embedded, utilizes a sample designed to represent the entire adult U.S. population, including Hawaii and Alaska, and including bilingual (Spanish-speaking) respondents. As reflected in the overall population of low to non-internet users, we intend to collect a small sample of Spanish-speaking individuals, which comprise a subsample of the regular landline and cell phone RDD sampling frames. We will also screen for past and present prescription drug use in order to ensure a motivated sample.

    Survey Protocol. This survey will be conducted by telephone on landline and cell phones, with an expected 50 to 60 percent of interviews conducted on cell phones. Interviewing for the pretest and main study will be conducted via SSRS's computer-assisted telephone interviewing system. We expect to achieve a roughly 40 percent survey completion rate from the pre-identified respondents to be sampled in this study, given an 8-week field period and a maximum of 10 attempts to reach respondents. The original SSRS Omnibus from which this sample is derived receives an approximately 8 to 12 percent response rate. These are not uncommon response rates for high-quality surveys and have been found to yield accurate estimates (Refs. 11 and 12).

    As communicated earlier, the primary focus of interview questions concern the ability and willingness of low to non-internet users to utilize the various components of adequate provision, particularly the toll-free number and print ad components. In addition to these questions, experimental manipulations will be embedded in the survey as an exploratory test to assess the impact of opening statements that could be used to introduce risks in DTC prescription drug broadcast ads, which is a related concept. To form the experimental manipulations, participants will be presented with a statement of major risks and side effects (“the major statement”) drawn from a real prescription drug product, but modified to include only serious and actionable risks. Preceding this description of major risks will be one of three opening statements: (1) “[Drug] can cause severe, life threatening reactions. These include . . .”; (2) “[Drug] can cause serious reactions. These include . . .”; or (3) “[Drug] can cause reactions. These include . . .” All risk statements will conclude with the following language: “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.” Participants will be randomly assigned to experimental condition, and all manipulations will be pre-recorded to allow for consistent administration. Following exposure to these manipulations, participants will respond to several questions designed to assess risk perceptions.

    Before the main study, we will execute a pretest with a sample of 25 participants from the same sampling frame as outlined. The pretest questionnaire will take approximately 15 minutes to complete. The goal of the pretest will be to assess the questionnaire's format and the general protocol to ensure that the main study is ready for execution. To test the protocol among the target groups, we will seek to recruit a mix of participants based on demographic and other characteristics of interest. We do not plan to use incentives for the pretest or main study portions of this survey. However, upon request, cell phone respondents may be offered $5 to cover the cost of their cell phone minutes.

    Questionnaire development is an iterative process and so the main study questionnaire will include any changes from pretesting, as well as other outcomes, such as OMB and public comments. Like pretesting, the main study questionnaire should take approximately 15 minutes to complete. Based on a power analyses, the main study sample will include approximately 1,996 participants. This sample size will allow us to draw statistical comparisons between the various demographic groups in the sample.

    Measurement and Planned Analyses. Consistent with the larger purpose of the study, survey questions will examine access, technical ability, and willingness to use adequate provision options; preference for and experience using adequate provision options; privacy concerns; and potentially other secondary questions of interest. In addition, to assess the impact of the experimental manipulations, survey questions will assess perceived risk likelihood, perceived risk magnitude, and perceived risk duration. Demographic information will also be collected. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. A copy of the draft questionnaire is available upon request.

    In the Federal Register of June 12, 2017 (82 FR 26934), FDA published a 60-day notice requesting public comment on the proposed collection of information. Comments received along with our responses to the comments are provided below. For brevity, some public comments are paraphrased and therefore may not reflect the exact language used by the commenter. We assure commenters that the entirety of their comments was considered even if not fully captured by our paraphrasing. The following acronyms are used here: FRN = Federal Register Notice; DTC = direct-to-consumer; FDA and “The Agency” = Food and Drug Administration; OPDP = FDA's Office of Prescription Drug Promotion.

    Comment 1a, regulations.gov tracking number 1k1-8y16-3nqx (summarized): The commenter expresses support for FDA's collective research and welcomes the Agency's current proposed survey examining adequate provision.

    Response to Comment 1a: We appreciate and thank the commenter for their support.

    Comment 1b (verbatim): Throughout the main survey questionnaire, some questions ask about ability to obtain information on prescription drugs after seeing an advertisement on television. These questions presume access to a television. If understanding this process of first seeing an ad on TV then searching for information is the key objective, we suggest in the screening criteria ensuring all respondents have access to a TV and/or watch television on a regular basis.

    Response to Comment 1b: We have added a screening question to confirm that participants watch television at least occasionally.

    Comment 1c (verbatim): As currently outlined, the sample frame is relatively broad in that it includes those who possibly do not have experience with prescription medications or experience searching for prescription medication information. Respondents without experience in this area could provide speculative responses to many questions, and thus, [the commenter] suggests that they are outside of the scope. To address this, we recommend adding a screening question or questions to include only those who have had at least one medical condition which has required prescription medication within the last 12 months.

    Response to Comment 1c: To ensure a motivated sample, we included a question to screen for past or present prescription drug use.

    Comment 1d (verbatim): The purpose of the secondary objective of the study pertaining to risk statements is not entirely clear. Since the sample frame is not restricted to those who suffer from a condition which could be helped by the mock drug, responses have the possibility to be speculative and reflect bias of people coming in to the study rather than what is intended. For instance, respondents who happen to be within a population targeted by the major statements are reasonably more likely to report a higher likelihood of experiencing a stated side effect and reporting a higher seriousness of them, biasing experiment responses.

    Response to Comment 1d: The secondary objective of the study is designed to assess the impact of opening statements that could be used to introduce risks in DTC prescription drug broadcast ads. This objective complements previously published research and adds value by newly investigating the impact of framing statements among a sample of low to non-internet users. Our approach involves random assignment to experimental conditions which should lead to approximately equal numbers of diagnosed versus undiagnosed individuals in each of the conditions, lessening any concern about bias. Nonetheless, please understand that this secondary objective is intended to provide a preliminary assessment of the stated research questions for development purposes. Procedurally, this objective will involve only a brief presentation of a short audio broadcast followed by three questions, allowing us to gather this valuable information with very low burden to participants who are already engaged in our larger survey regarding adequate provision.

    Comment 1e (verbatim): Additionally, information gained from the experimental manipulations (E-1 through E-3) will only be applicable to hearing the opening and major statement presented over the phone, rather than versus being read through print or online. Interpretations and understanding of this info could differ between the media. While this could possibly be a useful supplement to current knowledge, the learnings will likely not be directly applicable to the other media. If comparison of interpretation between the media is the goal of this section, [the commenter] suggests a stand-alone study would better address that goal rather than an addendum to this one.

    Response to Comment 1e: We appreciate this limitation of our preliminary assessment and intend to take it into consideration when interpreting results.

    Comment 1f (verbatim): Screener: The current screener terminates cell phone users who have not browsed the internet in the past month (S I). It is not readily apparent why this group should not participate in the survey. We would suggest that the termination criteria be removed from this question as it may make incremental improvement to response rates.

    Response to Comment 1f: The screener only excludes cell phone users (T1 = 2) who choose “don't know”(− 98) or refuse the question(− 99) (S1 < 0).

    Comment 1g (verbatim): As is, it is unclear what an independent variable for the questionnaire is intended to be. One possibility [the commenter] suggests is including a question aimed at understanding the overall preference for source of information, which would serve as the independent variable in the study or could be combined with the ability and access questions to make a composite variable. (e.g., “What is your preferred medium in which to receive prescription drug information: Print ads for the drug; the manufacturer's phone number or website; or asking your healthcare provider?”)

    Response to Comment 1g: Please refer to the instruction set preceding question 3. Our questionnaire attempts to learn about patient preferences through questions about participant likelihood to seek information via the various available sources, as well as past use, ability, and willingness, among other constructs. We believe these constructs to provide adequate assessment of consumer preference to obtain additional information via the various available sources. Moreover, we note that another commenter (see Comment 3n) takes the position that we should not inquire about patient preferences. We have considered both of the perspectives when deciding upon potential revisions.

    Comment 1h (verbatim): Throughout the survey, [the commenter] suggests defining each point on the 5 point scales used to avoid confusion by respondents. In our consumer research efforts, we customarily use 5 point scales that are defined at each point, such as ‘Excellent, Very Good, Good, Poor, and Very Poor'.

    Response to Comment 1h: We concur that defining each point on 5 point scales helps mitigate confusion and have revised the questionnaire to define each point of scales.

    Comment 1i (verbatim): It seems inappropriate to use a Likert scale to answer “Q1: Access to sources of information”, as it would seem access could be defined more narrowly—No access, some access, or complete access. We suggest using the pre-test to examine this question in particular to ensure either that the current scale is interpreted correctly or determine an appropriate re-wording. Additionally, it could be helpful to include the more specific options as distinct answer choices (e.g. an option for internet at a public library and a separate option for internet at a coffee shop) in order to provide more granular information which could be useful to the FDA as well as industry as a whole. We suggest using the pre-test to produce a full list of options as well as any appropriate re-wordings.

    Response to Comment 1i: We agree that defining access more narrowly may be sufficient for this question and so we have adopted this approach in our revised survey. We will also evaluate responses to this narrowed scale in our analysis of pretest data. We also appreciate the value of assessing locations of access; however, we consider such questions to be of lesser relevance to our key objectives, and we have sought to limit the duration of the survey to less than 15 minutes. Consequently, we do not adopt this recommendation.

    Comment 1j (verbatim): Throughout the survey, we suggest adding in “Talked with your doctor” as an answer choice among the options for sources of information. Physicians are a major source of product information and “talking with a doctor” are what drug advertisements generally suggest to consumers, so inclusion of this option is appropriate.

    Response to Comment 1j: We agree that health care providers are one important source for adequate provision. Nonetheless, the current investigation is designed to assess the utility of the various options for disseminating additional product risk information, and speaking with a health care provider is not under reevaluation. Consequently, we ask participants to respond under the premise that they are seeking information prior to approaching a health care professional.

    Comment 1k (verbatim): As currently worded, question 13 has the possibility to lead the respondent by stating that “Some people change their approach . . .” The current wording could bias respondents to be overly critical. [The commenter] would suggest either changing the question or adding in a new question prior to the current Q 13 to ascertain a rating of the level of privacy offered by each information source. This new question would provide the respondents current perceptions of privacy, something which the survey omits. For example, a newly worded question could be as follows: “On a 5-point scale, in which 1 is Very Low Privacy and 5 is Very High Privacy, what is the level of privacy offered by each of the following information sources when getting full prescription-drug product information?” The current question 13 could then follow this question.

    Response to Comment 1k: Our intention with this question (and its wording) is to facilitate comparisons between baseline likelihood to use the various sources of adequate provision (see Q3) and likelihood to use the various options in cases where privacy is a concern. By stating “Some people change their approach . . . ” we hoped to give participants permission to respond differently than they had in the earlier question, if they felt a change in their response was appropriate. Nonetheless, we recognize that this language could be leading and so we have eliminated it from our revised questionnaire. We are hopeful that the revised question will still allow us to draw the intended comparisons.

    Comment 1l (verbatim): In addition to our concerns regarding the goal of the experiment questions (E 1-E2), the purpose in the variations of the major statements is unclear. The objectives state that varying opening statements (E I) are the secondary focus of this research, not major statements. We suggest choosing an appropriate major statement in the pre-tests and then using that in the broader fielding of the study.

    Response to Comment 1l: The purpose of varying the major statements was to add to the generalizability of our findings. The revised version of our survey adopts this commenter's recommendation and includes only one version of the major statement.

    Comment 1m (verbatim): We suggest adding a “Don't know” option for EI-E3 as respondents might not be able to assess how long lasting, serious, or likely the side effects would be. The current range of answer choices may force inaccurate or speculative responses; a “Don't Know” answer would be a legitimate choice and informative for the study. Our standard practice is to provide a “Don't Know” option whenever it could be a valid answer.

    Response to Comment 1m: The items used in this section were developed through scale validation research and thus we prefer to retain them in their original form. Nonetheless, we have added labels to each point on the scales in response to Comment 1h, and the midpoint (“neutral”) of these scales may be treated similarly to a “Don't Know” option.

    Comment 2a, regulations.gov tracking number 1k1-8xz6-t7bj (verbatim): The practical utility of this study is unclear. Currently, industry is broadly executing on making labeling available via both IN [internet] and non-IN based options to a diverse audience. Historically, there were many options available to enable patients to locate drug-related labeling, even before the IN became available. When added to the three options mentioned above, the IN provides patients with a fourth option, one that is increasingly at a patient's fingertip via tablet, cell phone, or laptop. Hence, it is unclear how results from this study will enhance consumer access to information or be applied to modify current practices.

    Response to Comment 2a: As stated in the 60-day FRN (82 FR 26934), our intention is to assess the utility of the various sources of adequate provision among a sample of low to non-internet users. For example, it may not be necessary to include both a print ad reference and toll free number reference. We have received inquiries along these lines from stakeholders. Additionally, we may find that low to non-internet users would be willing to use the internet themselves or with the help of a friend or family member if non-internet options were unavailable. This research will provide insights to inform our approach to the adequate provision requirement.

    Comment 2b (verbatim): The sampling frame focuses on those “not likely to have IN access” as defined by FDA and includes older adults, with less than a high school education, who make less than $30,000/year, and live in rural areas; it also includes bilingual Spanish speakers. Yet it is not clear how persons not likely to have IN access would be able to inform FDA about how they would behave if they had access to the IN and other options were not available. Rather than speculate about how their behavior might change if faced with IN access and no other options, it would be better to design a study that focuses on understanding the effectiveness of non-IN options to provide information in general.

    Response to Comment 2b: To be clear, we intend to sample from the above referenced populations separately, as opposed to sampling from one population with all these attributes.

    As indicated in the 60-day FRN (82 FR 26934), we do intend to assess the effectiveness of non-internet options. However, as a secondary objective, it seems to us worthwhile to also consider how low to non-internet users may respond if non-internet options were unavailable. As another commenter indicates (see Comment 3b), internet use is widespread and technological sources of adequate provision may suffice (when combined with recommendation to speak to a health care professional). We hope to shed light on this question through our research.

    Comment 2c (verbatim): Questions 1-5 and 13: The current choices do not assess the respondent's willingness or ability to visit their healthcare provider to obtain the approved package labeling. This option should be added.

    Response to Comment 2c: Please refer to Comment 1j and our associated response.

    Comment 2d (verbatim): Question 15: Given the length of the package labeling making it impractical to receive the information verbally, it would be likely that callers would prefer an option, Mail the prescription drug product information to me, even when faced with privacy concerns.

    Response to Comment 2d: This response option has been added to our revised questionnaire.

    Comment 2e (verbatim): Instructions for Experimental Manipulations, E1/E2: E2 includes three different versions of the major statements. If the intended outcome of this component of the research is to evaluate the influence of these opening statements within a sample of low to non-IN users, and risk perceptions will be assessed as influenced by opening statements that could be used to introduce risks, it is unclear why the major statements (E2: A, B, C) differ when assessing whether or not opening statements (E1: 1, 2, 3) influence risk perceptions.

    Response to Comment 2e: Please refer to Comment 1l and our associated response.

    Comment 3a, regulations.gov tracking number 1k1-8y13-m7td: FDA is conducting too much research without “articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health.” “The Agency should publish a comprehensive list of its prescription drug advertising and promotion studies from the past five years and articulate a clear vision for its research priorities for the near future.”

    Response to Comment 3a: OPDP's mission is to protect the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated, so that patients and health care providers can make informed decisions about treatment options. OPDP's research program supports this mission by providing scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission, focusing in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues.

    Because we recognize the strength of data and the confidence in the robust nature of the findings is improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website includes links to the latest FRNs and peer-reviewed publications produced by our office. The website maintains information on all studies we have conducted, dating back to a DTC survey conducted in 1999.

    Comment 3b; the commenter provided a summary of their comments followed by a more detailed description of the same comments. For brevity, only the summary of comments (verbatim) is provided below. Full comments may be accessed at regulations.gov via tracking number 1k1-8y13-m7td.

    First, FDA's proposed research appears to offer limited practical utility in several ways:

    • The Agency proposes research based on an outdated, 18-year-old guidance document that fails to recognize adequately the societal and technological changes of the last two decades, including the many options now available to satisfy the adequate provision requirement.

    • FDA regulations require adequate, not complete, provision. Given the prevalence of the internet and smartphones across all U.S. demographic groups, we believe that biopharmaceutical manufacturers can satisfy adequate provision simply through information dissemination at health care provider offices or pharmacies, a 1-800 number, and/or the internet.

    • FDA fails to recognize existing research that demonstrates the pervasiveness of the internet and smartphones in the United States. This research limits any potential utility of the proposed study. The Agency's proposal mainly relies on data from six to 16 years ago. The smartphone is dramatically increasing internet connectivity for traditionally low to non-internet use demographic groups. Further, FDA does not acknowledge that older adults (with or without internet access) tend to rely on others, including family and health care personnel, for drug information.

    Response to Comment 3b: FDA recognizes that a large proportion of the U.S. population utilizes the internet. It is specifically for this reason that we are conducting research to inform our current guidance recommendations. Nonetheless, as indicated in the 60-day FRN (82 FR 26934), certain segments of the U.S. population are unlikely to use the internet. For example, 41 percent of individuals aged 65 and older do not use the internet, yet are the largest consumers of prescription drugs. As the commenter states, some individuals from this demographic rely on others to obtain drug information, but this perspective does not take into account the desire for privacy in obtaining such information, or the availability of these other individuals. The proposed research will provide empirical assessment of how vulnerable populations such as older adults may be impacted by changes to regulatory policy.

    The assertion that the requirement for “adequate” provision can be fulfilled by disseminating information through “health care provider offices or pharmacies, a 1-800 number, and/or the internet” may be correct, and FDA invites the commenter to submit data supportive of this perspective. FDA maintains a science-based approach to its regulatory decisionmaking, and as such, the current research is designed to inform our thinking in this area.

    We disagree with the assertion that our proposal relied mainly on data from 6 to 16 years ago. A more careful review of the FRN will show that our key citations range from 2013 to the present. By necessity, we also cite the relevant 1999 guidance, as well as a few other references which speak to general patterns of human behavior.

    Comment 3c (summarized): The commenter recommends removal of the second proposed study concerning opening statements to frame risk information on the grounds that (a) questions regarding adequate provision may impact responding in the second proposed study and (b) a low to non-internet user sample is not sufficiently diverse.

    Response to Comment 3c: Please refer to Comment 1d and our associated response.

    Comment 3d (summarized): The commenter provides several recommendations pertaining to subject enrollment. The first comment on this topic “recommends that FDA ensure that the subject sample includes representative portions of alleged subpopulations of low to non-internet users, including older adults, low socioeconomic status individuals, people with less than a high school education, and individuals living in rural areas.”

    Response to Comment 3d: To obtain a nationally representative sample of the target population of adult low to non-internet users who are also prescription drug users, the research team will use a sample sourced from a dual frame. This approach involves using a random digit dialing sample that has been pre-identified as being a non-internet household (or having at least one non-internet using member). The demographics within this frame of low to non-internet users fall within the expected range of subpopulations with respect to older adults, low socioeconomic status, and people with less than a high school education or some college. The sample is designed to represent the adult U.S. population (including Hawaii and Alaska) and will include rural areas. This sample solution is ideal because it relies on a dual-frame probability-sample, yet has the advantage of already knowing who are likely to be low to non-internet users.

    Comment 3e (summarized): In the second comment pertaining to subject enrollment, the commenter recommends that participants reached via smartphone not be included in the sample.

    Response to Comment 3e: We agree that smartphone use is increasing internet access for traditionally low to non-internet use demographics and appreciate the importance of confirming our sample are low to non-internet users. Notwithstanding, we are screening based on self-reported internet browsing, such that individuals who report browsing the internet three or more times in the past month—regardless of medium—will not be asked to participate in the survey. Further, the current approach supports that only households which have been pre-identified as having at least one non-internet using member will be screened for participation, adding an additional layer of assurance that only low to non-internet users will be asked to participate in the questionnaire.

    Comment 3f (summarized): In the third comment pertaining to subject enrollment, the commenter recommends collecting data in-person because data collection via phone may impact responses regarding the 1-800 number.

    Response to Comment 3f: We acknowledge that in-person data collection would add value to the proposed research but cost implications bar us from pursuing it. We will consider implications of our protocol for survey administration when interpreting results.

    Comment 3g (summarized): In the final comment pertaining to subject enrollment, the commenter indicates agreement with the proposed approach to screen for past and present prescription drug use in order to ensure a motivated sample.

    Response to Comment 3g: We appreciate the support for this planned approach.

    Comment 3h: Remaining comments pertain to the draft study questionnaire. The first comment on this topic suggests that certain items may lead participants to respond in certain ways. Examples (abbreviated for brevity) include:

    • The instructions for Q3 of the Main Study Survey state: “Prescription drugs advertised on television provide only limited product information. For example, not all of the product's risks and side effects are described. Imagine you wanted to obtain additional product information before seeing your health care provider.” As previously mentioned, while research “reveal[s] consumers engage in some prescription drug information seeking . . . most takes place after visiting a doctor, not before” (emphasis added [by commenter]). The question prompt does not reflect common practice and may lead to a misleading answer. Both the prompt and question itself should be revised to reflect that subjects may look specifically to their healthcare provider for this information.

    • Further, the Main Study Survey introduces questions about privacy by stating: “Next, I will ask about privacy concerns you might have when getting full prescription-drug product information.” Such phrasing suggests that a subject should have “concerns” in this context. Q12 asks subjects to “rate the extent to which you value privacy . . . ” (emphasis added [by commenter]). Such language suggests subjects should indeed “value” privacy.

    • The prompt for Q13 is also leading by introducing the question with: “Some people change their approach to getting information about prescription drugs when privacy is a concern.”

    Response to Comment 3h: As the commenter indicates in the first comment, there is evidence to suggest that consumers seek information both before and after visiting with a health care professional. Moreover, the ubiquity of DTC prescription drug advertising suggests that pharmaceutical companies are well aware of the advantages of introducing products to consumers prior to the consumer-health care provider interaction. The proposed research is concerned with how low to non-internet users access full product information prior to approaching a health care professional. As such, we need to provide this context to participants before they can respond regarding their interest and experiences within this context. We disagree that our presentation here is leading as the commenter describes, and consequently, we retain our current approach with these questions.

    Likewise, in response to the second comment, we cannot inquire about privacy concerns without referencing privacy concerns. Nonetheless, we have revised Q12 to read “How much value do you place on privacy . . .”

    In response to the third comment, please see Comment 1k and our associated response.

    Comment 3i (summarized): The second comment pertaining to the study questionnaire concerned definitions and terms. The commenter states, “The questionnaires do not define certain key terms (e.g., side effect, risk, serious, reference, full product information, partial information). Subjects may interpret these terms based on different standards. For example, for Q16 of the Main Study Survey, FDA may wish to provide context for what could constitute “complete prescription-drug product information. FDA should consider providing user-friendly definitions or terms throughout the questionnaires.”

    Response to Comment 3i: We appreciate the importance of ensuring uniform interpretation of terms. In cognitive interviews preceding this work, we assessed whether individuals interpret key terms similarly and made revisions where necessary. We have also considered the additional time (burden) that would be required to complete the survey if every term were defined in the pretest and main study. We have targeted to keep the current information collection to under 15 minutes per respondent. With these factors in mind, we have chosen not to provide additional definitions.

    Comment 3j (summarized): The third comment pertaining to the study questionnaire concerned the sliding scale format of certain questions: “FDA should consider replacing the sliding scale format (especially for Q1-Q3 of the Main Study Survey) with a binary or “Yes-No-Neutral” scheme. The sliding-scale format is at times confusing in form, inappropriately frames certain questions, and could potentially introduce error.”

    Response to Comment 3j: Please see Comment 1i and our associated response.

    Comment 3k: The final comments pertaining to the questionnaire were characterized by the commenter as miscellany. The first comment read, “As previously mentioned in Section II.A, E1-E3 of the Main Study Survey should be eliminated. (reference omitted) Similarly, we would also recommend that elimination of “Other Questions of Interest” (Q16-Q20) of the Main Study Survey, which appear to have limited applicability to the study of adequate provision.”

    Response to Comment 3k: In regards to E1-E3, please see Comment 1d and our associated response. In regards to Q16-Q20, all these items provide potentially valuable information relevant to the topic of interest, and therefore we prefer to retain them.

    Comment 3l: The next comment characterized as miscellany read: “The Study Screener introduction should not state that the survey is being conducted “on behalf of the Food and Drug Administration” and that study results “will be used in the consideration of important policy decisions.” These statements could potentially influence subjects' responses to study questions. Instead, this information might be provided at the conclusion of the study.”

    Response to Comment 3l: Such statements are intended to communicate the legitimacy of the study to potential participants, and thus validate participation. Upon further consideration, we concur that these statements may potentially influence responses, and we have removed them.

    Comment 3m: The next comment characterized as miscellany read: “The Main Study Survey should include a similar question to Q5, inquiring about if a toll-free number was not available.”

    Response to Comment 3m: We acknowledge the potential value of this question, but given the key objectives of the research, and concerns about participant burden, we decline to adopt this recommendation. We have targeted to keep the current information collection to under 15 minutes per respondent.

    Comment 3n: Continuing under the miscellany category: “There are several questions of the Main Study Survey (e.g., questions associated with Instructions_2) that inquire about a subject's preferences regarding the provision of product labeling. We do not understand the utility of these questions. Again, FDA's regulation concerns adequate, not preferred, provision.”

    Response to Comment 3n: In deciding upon potential revisions, we have considered both this commenter's views and those of another commenter (see Comment 1g) which recommend utilizing consumer preferences as an independent variable. We agree with the first commenter that consumer preferences are crucial for understanding the issues at hand as articulated in the 60-day FRN (82 FR 26934). Consequently, we have retained these questions.

    Comment 3o: The next miscellany comment read: “Certain questions, like Q4 and Q5 of the Main Study Survey, should include the option of asking a health care provider. Such a choice is part of FDA's adequate provision recommendation in the Guidance Document.”

    Response to Comment 3o: Please see Comment 1j and our associated response.

    Comment 3p: The next miscellany comment read: “The ordering of the questions (web page, toll-free number, print ad) of the Main Study Survey could potentially introduce bias. FDA may want to randomize the ordering of questions (e.g., Q6-Q11) to eliminate such bias.”

    Response to Comment 3p: We accept this recommendation and will randomize the ordering of questions Q6 to Q11 pertaining to web page, toll-free number, and print ad.

    Comment 3q: The final comment characterized as miscellany read: “Q15 of the Main Study Survey should include an option of mailing information to the customer.”

    Response to Comment 3q: Please see Comment 2d and our associated response.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Pretest Screener 63 1 63 .05 (3 minutes) 3.15 Pretest Survey 25 1 25 .25 (15 minutes) 6.25 Main Study Screener 4,990 1 4,990 .05 (3 minutes) 249.5 Main Study Survey 1,996 1 1,996 .25 (15 minutes) 499 Total Hours 757.9 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    II. References

    The following references are on display in the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

    1. U.S. Department of Health and Human Services, Food and Drug Administration (1999). “Guidance for Industry: Consumer-Directed Broadcast Advertisements.” Available at https://www.fda.gov/RegulatoryInformation/Guidances/ucm125039.htm. 2. Anderson, M. and A. Perrin (2016). “13% of Americans Don't Use the internet: Who Are They?” Pew Research Center. Available at http://www.pewresearch.org/fact-tank/2016/09/07/some-americans-dont-use-the-internet-who-are-they/. 3. U.S. Department of Commerce, U.S. Census Bureau (2013). “Computer and internet Use in the United States: Population Characteristics.” Available at https://www.census.gov/prod/2013pubs/p20-569.pdf. 4. Fox, S. and L. Rainie (2002). “Vital Decisions: How internet Users Decide What Information to Trust When They or Their Loved Ones Are Sick. Pew internet & American Life Project.” Available at http://www.pewinternet.org/2002/05/22/main-report-the-search-for-online-medical-help/. 5. DeLorme, D.E., J. Huh, and L.N. Reid (2011). “Source Selection in Prescription Drug Information Seeking and Influencing Factors: Applying the Comprehensive Model of Information Seeking in an American Context.” Journal of Health Communication, 16: pp. 766-787. 6. O'Donoghue, A.C., H.W. Sullivan, K.J. Aikin, et al. (2014). “Important Safety Information or Important Risk Information? A Question of Framing in Prescription Drug Advertisements.” Therapeutic Innovation and Regulatory Science, 48: pp. 305-307. doi: 10.1177/2168479013510306 7. Kahneman, D. (2011). Thinking, Fast and Slow. New York, NY: Farrar, Straus, and Giroux. 8. Rothman, A.J. and P. Salovey (1997). “Shaping Perceptions To Motivate Healthy Behavior: The Role of Message Framing.” Psychological Bulletin, 121: pp. 3-19. 9. Armstrong, K., J.S. Schwartz, G. Fitzgerald, et al. (2002). “Effect of Framing as Gain Versus Loss on Understanding and Hypothetical Treatment Choices: Survival and Mortality Curves.” Medical Decision Making, 22: pp. 76-83. 10. National Center for Health Statistics (2016). “Health, United States, 2015: With Special Feature on Racial and Ethnic Health Disparities.” Hyattsville, MD. 11. Brick, J.M. and D. Williams (2013). “Explaining Rising Nonresponse Rates in Cross-Sectional Surveys.” The Annals of the American Academy of Political and Social Science, 645: pp. 36-59. 12. Groves, R.M. (2006). “Nonresponse Rates and Nonresponse Bias in Household Surveys.” Public Opinion Quarterly, 70: pp. 646-675. 13. Betts, K.R., V. Boudewyns, K.J. Aikin, C. Squire, et al. (2017). “Serious and Actionable Risks, Plus Disclosure: Investigating an Alternative Approach for Presenting Risk Information in Prescription Drug Television Advertisements.” Research in Social & Administrative Pharmacy. doi: 10.1016/j.sapharm.2017.07.015. Dated: March 7, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-04996 Filed 3-12-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-1837] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Transfer of a Premarket Notification AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by April 12, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-New and title “Transfer of a Premarket Notification.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Transfer of a Premarket Notification OMB Control Number 0910-New

    The draft guidance “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” is intended to provide information on how to notify FDA of the transfer of a 510(k) clearance from one person to another, and the procedures FDA and industry should use to ensure public information in FDA's databases about the current 510(k) holder for a specific device(s) is accurate and up-to-date. The proposed information collection seeks to provide information to notify FDA of the transfer of a premarket notification (510(k)) clearance.

    The respondents to this collection of information are 510(k) holders and parties claiming to be 510(k) holders.

    In the Federal Register of December 22, 2014 (79 FR 76331), FDA published a 60-day notice requesting public comment on the proposed collection of information. While FDA received comments on the draft guidance document, none were related to the information collection.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Voluntary reporting of transfer of 510(k) clearance on FDA's Unified Registration and Listing System (FURLS) (outside of annual listing reporting requirement) 4,080 1 4,080 0.25 1,020 Submission of 510(k) transfer documentation when more than one party lists the same 510(k) 2,033 1 2,033 4 8,132 Total 9,152 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that 78 percent of 510(k)s are listed outside of the annual registration cycle based on numbers in the FURLS database from fiscal year 2009 through fiscal year 2014. Fiscal year 2008 was left out of this cohort as it was the first year that registrants were required to report the 510(k) number on their listings and, therefore, an unusually high number of listings were created. An average of 5,231 510(k)s have been listed each year since 2008. Because listing outside of the annual requirement is voluntary, FDA estimates that annually 78 percent of 510(k)s will continue to be listed outside of the annual requirement. FDA estimates that 4,080 510(k)s may be listed outside of the annual registration cycle. FDA estimates that it will take approximately 15 minutes for each listing, for a total reporting burden of 1,020 hours.

    FDA estimates it will have 2,033 instances of more than one party claiming to be a 510(k) holder for a specific device as part of annual registration and listing. FDA reached this estimate by identifying the number of unique 510(k) device listings entered in FURLS between fiscal years 2009 and 2014 that conflict with a listing already entered by another party (5,304), dividing that number by the number of years (6), and multiplying by the average number of parties claiming to be the 510(k) holder when there is a conflict in the current FURLS database (2.3). The draft guidance identifies potential documentation a party could submit to FDA to establish the transfer of a 510(k) clearance. FDA estimates it will take a party approximately 4 hours to locate and submit information to establish the transfer of the 510(k) clearance, resulting in 8,132 burden hours for those 2,033 parties claiming to be 510(k) holders. FDA reached this estimate based on its expectation of the amount of time it will take a party to locate the information, copy it, and submit a copy to FDA.

    The burden estimate does not include the maintenance of records used to document transferring a premarket notification (510(k)) clearance. Based on available information, FDA believes that the maintenance of these records is a usual and customary part of normal business activities. For example, in the ordinary course of business, supporting documents should be kept to verify asset information for calculating the annual depreciation or calculating gain or loss on sale of an asset on a businesses' tax return. Therefore, this recordkeeping requirement creates no additional paperwork burden.

    The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 807 (registration and listing) are approved under OMB control number 0910-0625; the collections of information in 21 CFR part 807 subpart E (premarket notification submission) have been approved under OMB control number 0910-0120, and collections of information in 42 CFR 493.17 have been approved under OMB control number 0910-0607.

    Dated: March 7, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-04995 Filed 3-12-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Advisory Committee on Research on Women's Health.

    The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    A portion of the meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Advisory Committee on Research on Women's Health.

    Closed: April 17, 2018, 2:30 p.m. to 4:45 p.m.

    Agenda: To evaluate the Sex/Gender Administrative Supplements program proposed for ORWH's Strategic Plan.

    Open: April 18, 2018, 9:00 a.m. to 1:30 p.m.

    Agenda: Opening Remarks, Director's Report, NIH Legislative Update, Strategic Plan Update, and Scientific Presentations.

    Place: National Institutes of Health, Building 31, 6th Floor, Conference Room 10, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Elizabeth Spencer, R.N., Deputy Director, Office of Research on Women's Health, Executive Secretary, ACRWH, National Institutes of Health, 6707 Democracy Blvd., Room 7W444, Bethesda, MD 20817, 301-402-1770 [email protected].

    Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.

    Information is also available on the Institute's/Center's home page: www4.od.nih.gov/orwh/, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS)
    Dated: March 6, 2018. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-04954 Filed 3-12-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel—R41 applications.

    Date: April 4, 2018.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 20892, (301) 435-6680, [email protected].

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel.

    Date: April 9, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Ave, Bethesda, MD 20814.

    Contact Person: Kimberly Lynette Houston, MD, Scientific Review Officer, Division of Scientific Review, OD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 20892, 301.827.4902, [email protected].

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel.

    Date: April 10, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda Downtown, 7335 Wisconsin Ave, Bethesda, MD 20814.

    Contact Person: Kimberly Lynette Houston, MD, Scientific Review Officer, Division of Scientific Review, OD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, DHHS, National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 20892, 301.827.4902, [email protected].

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel.

    Date: April 10, 2018.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate contract proposals.

    Place: National Institutes of Health, 6710B Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Sathasiva B. Kandasamy, Ph.D., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, 6710B Rockledge Drive, Bethesda, MD 20892, (301) 435-6680, [email protected].

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel.

    Date: April 13, 2018.

    Time: 8:30 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Peter Zelazowski, Ph.D., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Bethesda, MD 20892-7510, 301-435-6902, [email protected].

    Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel.

    Date: April 16-17, 2018.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Dennis E. Leszczynski, Ph.D., Scientific Review Administrator, Division of Scientific Review, National Institute of Child Health and Human Development, NIH, 6710B Rockledge Drive, Bethesda, MD 20892, (301) 435-6884, [email protected].

    (Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS)
    Dated: March 7, 2018. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-04961 Filed 3-12-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment; Notice of Meeting

    Pursuant to Public Law 92-463, notice is hereby given that the Substance Abuse and Mental Health Services Administration's (SAMHSA's) Center for Substance Abuse Treatment (CSAT) National Advisory Council will meet on March 26, 2018, 2:00 p.m.-3:00 p.m. (EDT) in a closed teleconference meeting.

    The meeting will include discussions and evaluations of grant applications reviewed by SAMHSA's Initial Review Groups, and involve an examination of confidential financial and business information as well as personal information concerning the applicants. Therefore, the meeting will be closed to the public as determined by the SAMHSA Assistant Secretary for Mental Health and Substance Use in accordance with Title 5 U.S.C § 552b(c)(4) and (6) and Title 5 U.S.C. App. 2, 10(d).

    Meeting information and a roster of Council members may be obtained by accessing the SAMHSA Committee website at http://www.samhsa.gov/about-us/advisory-councils/csat-national-advisory-council or by contacting the CSAT National Advisory Council Designated Federal Officer; Tracy Goss (see contact information below).

    Council Name: SAMHSA's Center for Substance Abuse Treatment National Advisory Council.

    Date/Time/Type: March 26, 2018, 2:00 p.m.-3:00 p.m. EDT, Closed.

    Place: SAMHSA, 5600 Fishers Lane, Rockville, Maryland 20857.

    Contact: Tracy Goss, Designated Federal Officer, CSAT National Advisory Council, 5600 Fishers Lane, Rockville, Maryland 20857 (mail), Telephone: (240) 276-0759, Fax: (240) 276-2252, Email: [email protected].

    Carlos Castillo, Committee Management Officer, SAMHSA.
    [FR Doc. 2018-04975 Filed 3-12-18; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA-2018-0018; OMB No. 1660-0131] Agency Information Collection Activities: Proposed Collection; Comment Request; Threat and Hazard Identification and Risk Assessment (THIRA)—Stakeholder Preparedness Review (SPR) Reporting Tool AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning this annual requirement for the U.S. Department of Homeland Security (DHS), FEMA to identify current capability levels for all States, Territories, urban areas, and Tribes receiving non-disaster preparedness grant funds administered by DHS.

    DATES:

    Comments must be submitted on or before May 14, 2018.

    ADDRESSES:

    To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:

    (1) Online. Submit comments at www.regulations.gov under Docket ID FEMA-2018-0018. Follow the instructions for submitting comments.

    (2) Mail. Submit written comments to Docket Manager, Office of Chief Counsel, DHS/FEMA, 500 C Street SW, 8NE, Washington, DC 20472-3100.

    All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to read the Privacy Act notice that is available via the link in the footer of www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Dante Randazzo, Supervisory Emergency Management Specialist, FEMA, National Preparedness Assessment Division, [email protected] You may contact the Information Management Division for copies of the proposed collection of information at email address: FEM[email protected]

    SUPPLEMENTARY INFORMATION:

    This package is a revision to the collection titled THIRA/SPR, OMB Control Number: 1660-0131. Although initially titled the State Preparedness Report (SPR), FEMA changed the name of the collection to the THIRA/SPR Unified Reporting Tool to more accurately reflect the information gathered and method of collection. The Post-Katrina Emergency Management Reform Act of 2006 (PKEMRA), as amended by the Implementing Recommendations of the 9/11 Commission Act of 2007, established an annual requirement for the 56 States and Territories to submit a State Preparedness Report. Because this reporting now includes States, Territories, urban areas, and Tribes, FEMA has revised the name of the report as the Stakeholder Preparedness Review (SPR). States, Territories, urban areas and Tribes receiving non-disaster preparedness grant funds administered by DHS submit the SPR annually, and this encompasses the requirements of the State Preparedness Report while also reflecting the updated reporting needs. The legislation requires a report on current capability levels and a description of targeted capability levels from all States, Territories, urban areas and Tribes receiving non-disaster preparedness grant funds administered by DHS. Each report must also include a discussion of the extent to which target capabilities identified in the applicable State homeland security plan and other applicable plans are unmet, and an assessment of resources needed to meet the preparedness priorities established under PKEMRA Section 646(e), including: (i) An estimate of the amount of expenditures required to attain the preparedness priorities; and (ii) the extent to which the use of Federal assistance during the preceding fiscal year achieved the preparedness priorities. To meet this requirement, States, Territories, Tribes, and urban areas first identify capability targets through the Threat and Hazard Identification and Risk Assessment (THIRA) and then assess against these targets in the SPR. Through the SPR, these jurisdictions estimate their current capabilities, identify and describe gaps between current capabilities and targets, indicate their intended approach for addressing gaps in the future, and report on the impact of Federal grant dollars in building and sustaining capabilities. It is also important to note that completing the THIRA and SPR are allowable expenses under the grant awards.

    Collection of Information

    Title: Threat and Hazard Identification and Risk Assessment (THIRA)—Stakeholder Preparedness Review (SPR) Reporting Tool.

    Type of Information Collection: Revision of a currently approved information collection.

    OMB Number: 1660-0131.

    FEMA Forms: FEMA Form 008-0-19 (THIRA), Threat and Hazard Identification and Risk Assessment (THIRA) Reporting Tool; FEMA Form 008-0-20 (SPR), Stakeholder Preparedness Review (SPR) Reporting Tool; FEMA Form 008-0-23, THIRA/SPR After-Action Call Questions.

    Abstract: The assessment is structured by the 32 core capabilities from the 2015 National Preparedness Goal. States, Territories, urban areas, and Tribes provide information on capability targets, their current capability levels and capability gaps for each core capability. Respondent States, Territories, Tribes and urban areas gather the information and complete the THIRA and SPR following the “Comprehensive Preparedness Guide (CPG) 201, Third Edition.”

    Affected Public: State, Local or Tribal Government.

    Estimated Number of Respondents: 113.

    Estimated Number of Responses: 113.

    Estimated Total Annual Burden Hours: 84,414.

    Estimated Total Annual Respondent Cost: $4,328,749.92.

    Estimated Respondents' Operation and Maintenance Costs: $12,404,962.

    Estimated Respondents' Capital and Start-Up Costs: $0.

    Estimated Total Annual Cost to the Federal Government: $2,648,063.63.

    Comments

    Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate 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) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Dated: March 7, 2018. William H. Holzerland, Senior Director for Information Management, Office of the Chief Administrative Officer, Mission Support, Federal Emergency Management Agency, Department of Homeland Security.
    [FR Doc. 2018-04994 Filed 3-12-18; 8:45 am] BILLING CODE 9111-46-P
    DEPARTMENT OF HOMELAND SECURITY [DHS-2018-0012] Agency Information Collection Activities: Homeland Security Acquisition Regulation (HSAR) Solicitation of Proposal Information for Award of Public Contracts AGENCY:

    Office of the Chief Procurement Officer, Department of Homeland Security (DHS).

    ACTION:

    60-Day Notice and request for comments; Extension of a Currently Approved Collection, 1600-0005.

    SUMMARY:

    The DHS Office of the Chief Procurement Officer, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection is necessary for compliance with the HSAR and the Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs.

    DATES:

    Comments are encouraged and will be accepted until May 14, 2018. This process is conducted in accordance with 5 CFR 1320.1.

    ADDRESSES:

    You may submit comments, identified by docket number DHS-2018-0012, at:

    Federal eRulemaking Portal: http://www.regulations.gov. Please follow the instructions for submitting comments.

    Instructions: All submissions received must include the agency name and docket number DHS-2018-0012. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Harvey, (202) 447-0956, [email protected]

    SUPPLEMENTARY INFORMATION:

    DHS collects information, when necessary, when inviting firms to submit bids, proposals, and offers for public contracts for supplies and service. Using solicitation methods such as requests for proposals (RFP), requests for information (RFI), and broad agency announcements (BAA), the Government requests information from prospective offerors such as pricing information, delivery schedule compliance, and evidence that the offeror has the resources (both human and financial) to accomplish requirements. The information collection is necessary for compliance with the HSAR, 48 CFR Chapter 30, and the SBIR and STTR programs, 15 U.S.C. 628. The collections under the HSAR include:

    • 3052.209-70 Prohibition on Contracts with Corporate Expatriates (Required in all solicitations and contracts). The offeror must disclose whether it is a foreign incorporated entity that should be treated as an inverted domestic corporation.

    • 3052.209-71 Reserve Officer Training Corps and Military Recruiting on Campus (Required in all solicitations and contracts with institutions of higher education) Requires that the Contractor represent that it does not now have, and agrees that during performance of the contract that it will not adopt, any policy or practice described in paragraph (b) of the clause.

    • 3052.209-72 Organizational Conflict of Interest, paragraphs (c), (d) and (e) (Required in all solicitations and contracts where a potential organizational conflict of interest exists and mitigation may be possible). The offeror must disclose whether it is aware of any facts which create any actual or potential organizational conflicts of interest; and, provide information as required by the Government and a mitigation plan relating to the conflict, if applicable.

    • 3052.209-74 Limitations on Contractors Acting as Lead System Integrators (Required in solicitations for the acquisition of a major system when the acquisition strategy envisions the use of a lead system integrator). The offeror must disclose whether it proposes to perform this contract as a lead system integrator with system responsibility, and whether it has a direct financial interest in the system that is the subject of the solicitation; and, provide evidence, as needed.

    • 3052.209-76 Prohibition on Federal Protective Service (FPS) Guard Services Contracts with Business Concerns Owned, Controlled, or Operated by an Individual Convicted of a Felony, paragraphs (a) through (g) (Required in in all solicitations and contracts for FPS guard services). The offeror must disclose whether it is owned, operated or controlled by an individual convicted of any felony. A business concern owned, operated or controlled by an individual convicted of any felony may submit an award request to the Government. The request must include information that is considered personally identifiable information, and any additional information the Government deems necessary.

    • 3052.215-70 Key Personnel and Facilities (Required in solicitations and contracts when the selection for award is substantially based on the offeror's possession of special capabilities regarding personnel or facilities). Before removing or replacing any of the specified individuals or facilities, the offeror must notify the Government, in writing, before the change becomes effective.

    • 3052.219-72 Evaluation of Prime Contractor Participation in the DHS Mentor-Protégé Program (Required in all solicitations containing (HSAR) 48 CFR 3052.219-71, DHS Mentor-Protégé Program and (FAR) 48 CFR 52.219-9 Small Business Subcontracting Plan). The offeror must provide a signed letter of mentor-protégé agreement, if it wishes to receive credit under the source selection factor.

    • 3052.247-70 F.o.b. Origin Information (Required in solicitations as appropriate) the offeror must provide information related to the offeror's shipping point.

    The DHS Science and Technology (S&T) Directorate issues BAAs soliciting when white papers and proposals from the public. DHS S&T evaluates white papers and proposals received in response to a DHS S&T BAA using the evaluation criteria specified in the BAA through a peer or scientific review process in accordance with FAR 35.016(d). Unclassified white papers and proposals are typically collected via the DHS S&T BAA secure website, while classified white papers and proposals must be submitted via proper classified courier or proper classified mailing procedures as described in the National Industrial Security Program Operating Manual (NSPOM).

    Federal agencies with an annual extramural research and development (R&D) budget exceeding $100 million are required to participate in the SBIR Program. Similarly, Federal agencies with an extramural R&D budget exceeding $1 billion are required to participate in the STTR Program. Federal agencies who participate in the SBIR and STTR programs must collect information from the public to meet:

    1. Applicable reporting requirements under 15 U.S.C. 638 (b)(7), (g)(8), (i), (j)(1)(E), (j)(3)(C), (l), (o)(10), and (v);

    2. The requirement to maintain both a publicly accessible database of SBIR/STTR award information and a government database of SBIR/STTR award information for SBIR and STTR program evaluation under 15 U.S.C. 638 g(10), (k), (o)(9), and (o)(15); and

    3. Requirements for public outreach under 15 U.S.C. 638 (j)(2)(F), (o)(14), and (s).

    The prior information collection request for OMB No. 1600-0005 was approved through June 30, 2018 by OMB in a Notice of OMB Action.

    The information being collected is used by the Government's contracting officers and other acquisition personnel, including technical and legal staff to determine the adequacy of technical and management approach, experience, responsibility, responsiveness, and expertise of the firms submitting offers; the identification of members of the public (i.e., small businesses) who qualify for and are interested in participating in the DHS SBIR Program; and, provide the DHS SBIR Program Office necessary and sufficient information to determine whether proposals submitted by the public to the DHS SBIR Program meet the criteria for consideration under the program.

    Failure to collect this information would adversely affect the quality of products and services DHS receives from contractors. Potentially, contracts would be awarded to firms without sufficient experience and expertise, thereby placing the Department's operations in jeopardy. Defective and inadequate contractor deliverables would adversely affect DHS's fulfillment of the mission requirements in all areas. Additionally, the Department would be unsuccessful in identifying small businesses with R&D capabilities, which would adversely affect the mission requirements in this area.

    Many sources of the requested information use automated word processing systems, databases, and web portals to facilitate preparation of material to be submitted and to post and collect information. It is common place within many of DHS's Components for submissions to be electronic as a result of implementation of e-Government initiatives.

    Information technology (i.e., electronic web portal) is used in the collection of information to reduce the data gathering and records management burden. DHS uses a secure website the public can use to propose SBIR research topics and submit proposals in response to SBIR solicitations. In addition, DHS uses a web portal to review RFIs and register to submit a white paper or proposal in response to a specific BAA. The data collection forms standardize the collection of information that is necessary and sufficient for the DHS SBIR Program Office to meet its requirements under 15 U.S.C. 638.

    DHS/ALL/PIA-006 General Contact Lists dated June15, 2007 covers the basic contact information that must be collected for DHS. Other information collected will typically pertain to the contract itself, and not individuals. All information for this information collection is submitted voluntarily. However, sensitive information (e.g., felony conviction information) may also be collected through this information collection. Due to this sensitivity, and the sensitivities regarding the procurement process as a whole, a new PIA is required to document and identify any potential risks associated with collecting this information. There is no assurance of confidentiality provided to the respondents.

    The burden estimates provided in response to Item 12 above are based upon definitive proposals reported by DHS and its Components to the Federal Procurement Data System (FPDS) for Fiscal Year 2016. No program changes occurred and there have been no changes to the information being collected. However, the burden was adjusted to reflect an agency adjustment increase of 103,600 in the number of respondents within DHS for Fiscal Year 2016, as well as an increase in the average hourly wage rate. In addition, the average response per respondent went from 7 to 3.5 per response, a difference of 3.5 hours. The change is a result of the DHS Heads of Contracting Activities' reassessment of the response time required for each of the applicable clauses.

    This is an extension of a currently approved collection, 1600-0005. OMB is particularly interested in comments which:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate 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;

    3. Enhance the quality, utility, and clarity of the information to be collected; and

    4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    Analysis

    Agency: Office of the Chief Procurement Officer, DHS.

    Title: Agency Information Collection Activities: Homeland Security Acquisition Regulation (HSAR) Solicitation of Proposal Information for Award of Public Contracts.

    OMB Number: 1600-0005.

    Frequency: Annually.

    Affected Public: Private and Public Sector.

    Number of Respondents: 117,212.

    Estimated Time per Respondent: 3.5 hours.

    Total Burden Hours: 1,230,726.

    Dated: March 1, 2018. Melissa Bruce, Executive Director, Enterprise Business Management Office.
    [FR Doc. 2018-04970 Filed 3-12-18; 8:45 am] BILLING CODE 9110-9B-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0105] Agency Information Collection Activities; Revision of a Currently Approved Collection: Notice of Entry of Appearance as Attorney or Accredited Representative; Notice of Entry of Appearance as Attorney in Matters Outside the Geographical Confines of the United States AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    30-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.

    DATES:

    Comments are encouraged and will be accepted until April 12, 2018.

    ADDRESSES:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at [email protected] All submissions received must include the agency name and the OMB Control Number [1615-0105] in the subject line.

    You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, Telephone number (202) 272-8377 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at (800) 375-5283; TTY (800) 767-1833.

    SUPPLEMENTARY INFORMATION: Comments

    The information collection notice was previously published in the Federal Register on December 6, 2017, at 82 FR 57604, allowing for a 60-day public comment period. USCIS did receive 6 comments in connection with the 60-day notice.

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0037 in the search box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) Evaluate 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;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection Request: Revision of a Currently Approved Collection.

    (2) Title of the Form/Collection: Notice of Entry of Appearance as Attorney or Accredited Representative; Notice of Entry of Appearance as Attorney in Matters Outside the Geographical Confines of the United States.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: G-28, G-28I; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Business or other for-profit. The data collected on Forms G-28 and G-28I is used by DHS to determine eligibility of the individual to appear as a representative. Form G-28 is used by attorneys admitted to practice in the United States and accredited representatives of certain non-profit organizations recognized by the Department of Justice. Form G-28I is used by attorneys admitted to the practice of law in countries other than the United States and only in matters in DHS offices outside the geographical confines of the United States. If the representative is eligible, the form is filed with the case and the information is entered into DHS systems for whatever type of application or petition it may be.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection G-28 is 2,778,700 and the estimated hour burden per response is 0.833 hours. The estimated total number of respondents for the information collection G-28 online filing is 281,950 and the estimated hour burden per response is 0.667 hours. The estimated total number of respondents for the information collection G-28I is 25,057 and the estimated hour burden per response is 0.700 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection of information is 2,520,258.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $0. Any costs associated with this collection of information would be included in the forms that provide the catalyst for the filing of Forms G-28 or G-28I.

    Dated: March 1, 2018. Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-04586 Filed 3-12-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0135] Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection; Application for Travel Document (Carrier Documentation) AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until May 14, 2018.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0135 in the body of the letter, the agency name and Docket ID USCIS-2015-0004. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal website at http://www.regulations.gov under e-Docket ID number USCIS-2015-0004;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW, Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION:

    Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2015-0004 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) Evaluate 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;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of this information collection:

    (1) Type of Information Collection: Extension, Without Change, of a Currently Approved Collection.

    (2) Title of the Form/Collection: Application for Travel Document (Carrier Documentation).

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-131A; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses the information provided on Form I-131A to verify the status of permanent or conditional residents, and determine whether the applicant is eligible for the requested travel document.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection Form I-131A is 4,110 and the estimated hour burden per response is .92 hours; biometrics processing is 4,110 and the estimated hour burden per response is 1.17 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 8,590 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $704,620.

    Dated: March 7, 2018. Samantha Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-04983 Filed 3-12-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R8-ES-2017-N165; FXES11130800000-178-FF08E00000] Endangered Species Recovery Permit Applications AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of receipt of permit applications; request for comments.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, invite the public to comment on applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered and threatened species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing recovery permits to conduct certain activities with endangered species.

    DATES:

    Comments on these permit applications must be received on or before April 12, 2018.

    ADDRESSES:

    Written data or comments should be submitted to the Endangered Species Program Manager, U.S. Fish and Wildlife Service, Region 8, 2800 Cottage Way, Room W-2606, Sacramento, CA 95825 (telephone: 916-414-6464; fax: 916-414-6486). Please refer to the respective permit number for each application when submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Marquez, Fish and Wildlife Biologist; see ADDRESSES (telephone: 760-431-9440; fax: 760-431-9624).

    SUPPLEMENTARY INFORMATION:

    The following applicants have applied for scientific research permits to conduct certain activities with endangered species under section 10(a)(1)(A) of the Act (16 U.S.C. 1531 et seq.). We seek review and comment from local, State, and Federal agencies and the public on the following permit requests.

    Applicants Permit No. TE-168927 Applicant: Bradford Hollingsworth, San Diego, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, photograph, and release) the arroyo toad (arroyo southwestern) (Anaxyrus californicus) in conjunction with survey and scientific research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-58829C Applicant: Benjamin Ruiz, Bakersfield, California.

    The applicant requests a new permit to take (harass by survey, capture, handle, and release) the Fresno kangaroo rat (Dipodomys nitratoides exilis), Tipton kangaroo rat (Dipodomys nitratoides nitratoides), and giant kangaroo rat (Dipodomys ingens) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-58844C Applicant: Phillip Peters, San Francisco, California.

    The applicant requests a permit amendment to take (harass by survey) the California Clapper rail (California Ridgway's rail) the California Ridgway's rail, formerly known as the California Clapper rail (Rallus longirostris obsoletus, or R. obsoletus o.) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-58847C Applicant: Steven Manley, San Diego, California.

    The applicant requests a new permit to take (harass by survey, locate and monitor nests, capture, band, and release) the California least tern (Sternula antillarum browni) (Sterna a. browni) in conjunction with survey, population monitoring, and research activities throughout the range of the species for the purpose of enhancing the species' survival.

    Permit No. TE-221295 Applicant: Angelica Mendoza, Fontana, California.

    The applicant requests a permit renewal to take (pursuit by survey) the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species for the purpose of enhancing the species' survival.

    Permit No. TE-115370 Applicant: Gage Dayton, Santa Cruz, California.

    The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, mark, collect tissues samples, photograph, release, collect a limited number of voucher specimens, and conduct habitat restoration for) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) and take (harass by survey, capture, handle, mark, photograph, release, collect a limited number of voucher specimens, and conduct habitat restoration for) the Santa Cruz long-toed salamander (Ambystoma macrodactylum croceum) in conjunction with survey, population monitoring, genetic sampling, research, and habitat restoration activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-54716A Applicant: Christine Harvey, San Diego, California.

    The applicant requests a permit renewal and amendment to take (locate and monitor nests) the least Bell's vireo (Vireo bellii pusillus) and take (harass by survey, and locate and monitor nests) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey and population monitoring activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-200339 Applicant: Sarah Foster, Sacramento, California.

    The applicant requests a permit renewal to take (harass by survey) the California Clapper rail (California Ridgway's rail) (Rallus longirostris obsoletus) (R. obsoletus o.) and take (harass by survey, capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-022649 Applicant: Joseph Messin, Temecula, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, mark, and release) the Stephens' kangaroo rat (Dipodomys stephensi) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-92799B

    Applicant: Karl Fairchild, Fullerton, California.

    The applicant requests a permit amendment to take (harass by survey) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-70880B

    Applicant: Michael Hobbs, San Jose, California.

    The applicant requests a permit amendment to take (harass by survey, capture, handle, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-59233C

    Applicant: University of California Merced, Merced, California.

    The applicant requests a new permit to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio) and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and educational activities in Merced County, California, for the purpose of enhancing the species' survival.

    Permit No. TE-59234C Applicant: Advanced Solutions for Earth's Future, Los Angeles, California.

    The applicant requests a new permit to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-053598 Applicant: Nicole Kimball, Spring Valley, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); and take (pursuit by survey) the Quino checkerspot butterfly (Euphydryas editha quino) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-192702 Applicant: Jaime Kneitel, Sacramento, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-808242 Applicant: Scott Cameron, Palmdale, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, and release) the Pacific pocket mouse (Perognathus longimembris pacificus) and arroyo toad (arroyo southwestern) (Anaxyrus californicus) and take (pursue by survey) the Delhi Sands flower-loving fly (Rhaphiomidas terminatus abdominalis) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-72044A Applicant: Carl Demetropoulos, Thousand Oaks, California.

    The applicant requests a permit amendment to take (harass by survey, capture, mark, and release) the Mohave tui chub (Gila bicolor mohavensis), in conjunction with survey and population monitoring activities on Naval Air Weapons Station China Lake, in California, for the purpose of enhancing the species' survival.

    Permit No. TE-02737B Applicant: Susan Dewar, Rocklin, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-59680C Applicant: Thea Wang, Los Angeles, California.

    The applicant requests a new permit to take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus), Stephens' kangaroo rat (Dipodomys stephensi), and Pacific pocket mouse (Perognathus longimembris pacificus) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-095896 Applicant: Phillip Richards, Laguna Hills, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus), Stephens' kangaroo rat (Dipodomys stephensi), and Pacific pocket mouse (Perognathus longimembris pacificus) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-59924C Applicant: Land Trust of Santa Cruz County, Santa Cruz, California.

    The applicant requests a new permit to take (harass by survey, capture, and release) the Ohlone tiger beetle (Cicindela ohlone) in conjunction with survey and habitat enhancement activities in Santa Cruz County, California, for the purpose of enhancing the species' survival.

    Permit No. TE-839213 Applicant: David Muth, Martinez, California.

    The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, and conduct instructional workshops involving field survey methods) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) and take (harass by survey, capture, handle, release, collect vouchers, collect branchiopod cysts, process vernal pool soil samples, and conduct instructional workshops involving field survey methods) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey and educational activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-797234 Applicant: LSA Associates, Point Richmond, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, collect branchiopod cysts, and process vernal pool soil samples) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (harass by survey, capture, handle, and release) the San Francisco garter snake (Thamnophis sirtalis tetrataenia) and California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense); and take (harass by survey) the California Clapper rail (California Ridgway's rail) (Rallus longirostris obsoletus) (R. obsoletus o.) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-028223 Applicant: Jonathan Stead, Oakland, California.

    The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi) in conjunction with survey activities throughout the range of the species in California and Oregon for the purpose of enhancing the species' survival.

    Permit No. TE-203081 Applicant: John Labonte, Goleta, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (harass by survey, capture, handle, take tissue samples, remove hybrids from the wild, temporarily keep hybrids in captivity, euthanize hybrids, and release) the California tiger salamander (Santa Barbara County Distinct Population Segment) (Ambystoma californiense); and take (pursuit by survey) the El Segundo blue butterfly (Euphilotes battoides allyni) in conjunction with survey and research activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-207873 Applicant: Carol Thompson, Riverside, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (harass by locating and monitoring nests) the least Bell's vireo (Vireo bellii pusillus); and take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus) and Stephens' kangaroo rat (Dipodomys stephensi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-60358C Applicant: California Department of Fish and Wildlife, San Diego, California.

    The applicant requests a new permit to take (harass by survey, capture, handle, release, collect vouchers, and collect branchiopod cysts) the San Diego fairy shrimp (Branchinecta sandiegonensis), and Riverside fairy shrimp (Streptocephalus woottoni) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-083348 Applicant: San Bernardino County Department of Public Works, San Bernardino, California.

    The applicant requests a permit renewal to take (harass by survey, capture, handle, and release) the San Bernardino Merriam's kangaroo rat (Dipodomys merriami parvus) and take (harass by survey) the southwestern willow flycatcher (Empidonax traillii extimus) in conjunction with survey activities in San Bernardino County, California, for the purpose of enhancing the species' survival.

    Permit No. TE-53771B Applicant: Erin Bergman, La Mesa, California.

    The applicant requests a permit amendment and renewal to take (harass by survey, capture, handle, release, collect adult vouchers, and collect branchiopod cysts) the Conservancy fairy shrimp (Branchinecta conservatio), longhorn fairy shrimp (Branchinecta longiantenna), San Diego fairy shrimp (Branchinecta sandiegonensis), Riverside fairy shrimp (Streptocephalus woottoni), and vernal pool tadpole shrimp (Lepidurus packardi); take (pursuit by survey) the Quino checkerspot butterfly (Euphydryas editha quino) and mission blue butterfly (Icaricia icarioides missionensis); and take (harass by survey, capture, handle, release) the Casey's june beetle (Dinacoma caseyi) in conjunction with survey activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-091857 Applicant: Denise Duffy and Associates, Inc., Monterey, California.

    The applicant requests a permit renewal and amendment to take (harass by survey, capture, handle, take tissue samples, conduct habitat restoration for, and release) the California tiger salamander (Santa Barbara County and Sonoma County Distinct Population Segment (DPS)) (Ambystoma californiense) in conjunction with survey, research, and habitat enhancement activities throughout the range of the species in California for the purpose of enhancing the species' survival.

    Permit No. TE-837308 Applicant: John Konecny, Valley Center, California.

    The applicant requests a permit renewal to take (harass by locating and monitoring nests, capture, handle, band, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the least Bell's vireo (Vireo bellii pusillus), take (harass by survey, locate and monitor nests, capture, handle, band, and remove brown-headed cowbird (Molothrus ater) eggs and chicks from parasitized nests) the southwestern willow flycatcher (Empidonax traillii extimus), take (harass by survey) the light-footed clapper rail (light-footed Ridgway's rail) (Rallus longirostris levipes) (R. obsoletus l.) and Yuma clapper rail (Yuma Ridgway's rail) (Rallus longirostris yumanensis) (R. obsoletus y.), take (harass by survey, locate and monitor nests, capture, handle, and band) the California least tern (Sternula antillarum browni) (Sterna a. browni), and take (harass by survey, capture, handle, and release) the arroyo toad (arroyo southwestern) (Anaxyrus californicus) in conjunction with survey and population monitoring activities throughout the range of the species in California and Nevada for the purpose of enhancing the species' survival.

    Public Comments

    We invite public review and comment on each of these recovery permit applications. Comments and materials we receive will be available for public inspection, by appointment, during normal business hours at the address listed in the ADDRESSES section of this notice.

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Karen A. Jensen, Acting Regional Director, Pacific Southwest Region, Sacramento, California.
    [FR Doc. 2018-04959 Filed 3-12-18; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLNM006200 L99110000.EK0000 XXX L4053RV] Renewal of Approved Information Collection; OMB Control Number 1004-0179 Agency Information Collection Activities; Helium Contracts AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of information collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM), are proposing to renew an information collection request to the Office of Management and Budget (OMB), to renew control number 1004-0179, “Helium Contracts.”

    DATES:

    Interested persons are invited to submit comments on or before May 14, 2018.

    ADDRESSES:

    Send your comments on this information collection request (ICR) by mail to the U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW, Room 2134LM, Washington, DC 20240, Attention: Jean Sonneman; or by email to [email protected]. Please reference OMB Control Number 1004-0179 in the subject line of your comments.

    FOR FURTHER INFORMATION CONTACT:

    To request additional information about this ICR, contact Samuel R.M. Burton by email at [email protected], or by telephone at 806-356-1002.

    SUPPLEMENTARY INFORMATION:

    In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

    We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.

    Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Abstract: The BLM needs to collect information in order to implement in-kind sales of helium in accordance with the Helium Stewardship Act (50 U.S.C. 167-167q) and 43 CFR part 3195.

    Title of Collection: Helium Contracts.

    OMB Control Number: 1004-0179.

    Form Numbers: 3195-1, 3195-2, 3195-3, and 3195-4.

    Type of Review: Extension of a currently approved collection.

    Respondents/Affected Public: Private helium merchants that sell a major helium requirement (i.e., an amount of refined helium greater than 200,000 standard cubic feet of refined gaseous helium or 7,510 liters of liquid helium) to a Federal agency or to private helium purchasers for use in Federal Government contracts.

    Total Estimated Number of Annual Respondents: 22.

    Total Estimated Number of Annual Responses: 60.

    Estimated Completion Time per Response: Varies from 4-8 hours, depending on activity.

    Total Estimated Number of Annual Burden Hours: 272.

    Respondent's Obligation: Required to obtain or retain a benefit.

    Frequency of Collection:

    • Quarterly for the Refined Helium Deliveries Detail;

    • Annually for the Calculation of Excess Refining Capacity and Refiners' Annual Tolling Report; and

    • On occasion for the Refiners' Tolling Occurrence Report.

    Total Estimated Annual Nonhour Burden Cost: None.

    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 authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq).

    Jean Sonneman, Bureau of Land Management, Information Collection Clearance Officer.
    [FR Doc. 2018-05044 Filed 3-12-18; 8:45 am] BILLING CODE 4310-84-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLORW00000.L10200000.DF0000.18XL1109AF.LXSSH1070000.HAG 18-0048] Notice of Public Meeting for the Eastern Washington Resource Advisory Council AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Eastern Washington Resource Advisory Council (EWRAC) will meet as indicated below.

    DATES:

    The EWRAC will hold a public meeting on Thursday, March 22, 2018. The meeting will run from 8:00 a.m. to 2:30 p.m. Pacific Time. A public comment period will be available from 1 until 1:30 p.m. There will be an EWRAC field trip to the Juniper Dunes Recreation Area on Wednesday, March 21, 2018, from 1:00 p.m. to 4:00 p.m.

    ADDRESSES:

    The EWRAC meeting will be held in the Oak Room at the Red Lion Inn, 2525 N 20th Ave., Pasco, WA 99301. The EWRAC field trip to the Juniper Dunes Recreation Area will depart from Country Mercantile, 232 Crestloch Rd., Pasco, WA 99301.

    FOR FURTHER INFORMATION CONTACT:

    Jeff Clark, Public Affairs Officer, 1103 N Fancher, Spokane Valley, WA 99212; 509-536-1297; [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The 15-member EWRAC was chartered to provide information and advice regarding the use and development of the lands administered by the Spokane District in central and eastern Washington. Members represent an array of stakeholder interests in the land and resources from within the local area and statewide.

    All meetings are open to the public in their entirety. The field trip on Wednesday, March 21, 2018, will be to the Juniper Dunes Recreation Area. Members of the public wanting to attend must provide their own transportation. The EWRAC meeting agenda on Thursday, March 22, 2018, includes a discussion of the the Juniper Dunes field trip and updates on Juniper Dunes public access and the BLM Eastern Washington Resource Management Plan. There will be a public comment period from 1:00 p.m. to 1:30 p.m. Persons wishing to make comments during the public comment period should register in person with the BLM by noon on the meeting day, at the meeting location. Depending on the number of persons wishing to comment, the length of comments may be limited. The public may send written comments to the EWRAC at BLM Spokane District, Attn. EWRAC, 1103 N. Fancher, Spokane Valley, WA 99212. Before including your address, phone number, email address, or other personal identifying information in your comments, please be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Authority:

    43 CFR 1784.4-2.

    Linda Clark, Spokane District Manager.
    [FR Doc. 2018-05048 Filed 3-12-18; 8:45 am] BILLING CODE 4310-33-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWO260000.L10600000.PC0000.18X.LXSIADVSBD00] Wild Horse and Burro Advisory Board Meeting AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of Advisory Board meeting.

    SUMMARY:

    In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Wild Horse and Burro Advisory Board (Advisory Board) will meet as indicated below.

    DATES:

    The Advisory Board will hold a public meeting on Tuesday, March 27, 2018, from 8 a.m. to 5 p.m. and Wednesday, March 28, 2018, from 8 a.m. to 12:00 p.m. MDT.

    ADDRESSES:

    The meeting will be held at the Radisson Hotel Salt Lake City Downtown, 215 West South Temple, Salt Lake City, UT 84101. The final agenda for the March 27-28, 2018, public meeting will be posted on the BLM web page at: https://www.blm.gov/programs/wild-horse-and-burro/get-involved/advisory-board. Written comments pertaining to the meeting and written statements that will be presented to the Advisory Board may be filed in advance of the meeting and sent to the U.S. Department of the Interior, BLM, Attention: Advisory Board (WO-260), 20 M Street SE (Room 2134 LM), Washington, DC 20003 or emailed to: [email protected] no later than March 20, 2018. Please include “Advisory Board Comment” in the subject line of the email.

    FOR FURTHER INFORMATION CONTACT:

    Dorothea Boothe, Acting Wild Horse and Burro Outreach Specialist at 202-912-7654 or by email at [email protected] Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The Advisory Board advises the Secretary of the Interior, the BLM Director, the Secretary of Agriculture, and the Chief of the U.S. Forest Service on matters pertaining to the management and protection of wild, free-roaming horses and burros on the Nation's public lands. The tentative agenda for the meeting is:

    I. Advisory Board Public Meeting Agenda Tuesday, March 27, 2018 (8 a.m.-5 p.m.) Welcome, Introductions, and Agenda Review Advisory Board October 2017 Meeting Minutes Review/Approval BLM Responses to Board Recommendations—September 2016 and October 2017 Meetings BLM Utah WHB Program Update BLM National WHB Program Overview and Status BLM National WHB Research Update BLM National WHB Program Budget Update U.S. Forest Service WHB Program Update Public Comment Period (3 p.m.-5 p.m.) Adjourn Wednesday, March 28, 2018 (8 a.m.-Noon) Welcome, Introductions, and Agenda Review Building Collaborative Partnerships Advisory Board Discussion and Recommendations to the BLM Adjourn

    The meeting will be live-streamed at www.blm.gov/live. The meeting site is accessible to individuals with disabilities. An individual with a disability needing an auxiliary aid or service to participate in the meeting, such as an interpreting service, assistive listening device, or materials in an alternate format, must notify Ms. Boothe one week before the scheduled meeting date. Although the BLM will attempt to meet a request received after that date, the requested auxiliary aid or service may not be available because of insufficient time to arrange for it.

    II. Public Comment Procedures

    On Tuesday, March 27 at 3 p.m., members of the public will have the opportunity to make comments to the Advisory Board on the WHB Program. Persons wishing to make comments during the meeting should register in person with the BLM prior to 2:30 p.m. on March 27, at the meeting location. Depending on the number of commenters, the Advisory Board may limit the length of comments. At previous meetings, comments have been limited to 3 minutes in length; however, this time may vary. Public commenters are requested to submit a written copy of their statement to the addresses listed in the ADDRESSES section above, or bring a written copy to the meeting to be included and posted as part of the Advisory Board's record of the meeting. There will be a webcam present during the entire meeting, and individual comments may be recorded.

    Participation in the Advisory Board meeting is not required to submit written comments. The BLM invites written comments from all interested parties. We request that written comments be specific and explain the reason for any recommendation. The Advisory Board considers comments that are either supported by quantitative information or studies, or those that include citations to and analysis of applicable laws and regulations to be the most useful in developing its advice and recommendations on the management and protection of wild horses and burros.

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask in your comment that the BLM withhold your personal identifying information from public review, the BLM cannot guarantee that it will be able to do so.

    Authority:

    43 CFR 1784.4-2.

    Steve Tryon, Deputy Assistant Director, Resources and Planning.
    [FR Doc. 2018-05046 Filed 3-12-18; 8:45 am] BILLING CODE 4310-84-P
    INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701-TA-579-580 (Final)] Fine Denier Polyester Staple Fiber From China and India; Determinations

    On the basis of the record 1 developed in the subject investigations, the United States International Trade Commission (`Commission”) determines, pursuant to the Tariff Act of 1930 (“the Act”), that an industry in the United States is materially injured by reason of imports of fine denier polyester staple fiber (“fine denier PSF”) from China and India, provided for in subheading 5503.20.00 of the Harmonized Tariff Schedule of the United States, that have been found by the U.S. Department of Commerce (“Commerce”) to be subsidized by the governments of China and India.

    1 The record is defined in sec. 207.2(f) of the Commission's Rules of Practice and Procedure (19 CFR 207.2(f)).

    Background

    The Commission, pursuant to section 705(b) of the Act (19 U.S.C. 1671d(b)), instituted these investigations effective May 31, 2017, following receipt of a petition filed with the Commission and Commerce by DAK Americas LLC, Charlotte, NC; Nan Ya Plastics Corporation, America, Lake City, SC; and Auriga Polymers Inc., Charlotte, NC. The final phase of the investigations was scheduled by the Commission following notification of preliminary determinations by Commerce that imports of fine denier PSF from China and India were being subsidized within the meaning of section 703(b) of the Act (19 U.S.C. 1671b(b)). Notice of the scheduling of the final phase of the Commission's investigations and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register of November 27, 2017 (82 FR 56050). The hearing was held in Washington, DC, on January 17, 2018, and all persons who requested the opportunity were permitted to appear in person or by counsel.

    The Commission made these determinations pursuant to section 705(b) of the Act (19 U.S.C. 1671d(b)). It completed and filed its determinations in these investigations on March 7, 2018. The views of the Commission are contained in USITC Publication 4765 (March 2018), entitled Fine Denier Polyester Staple Fiber from China and India: Investigation Nos. 701-TA-579-580 (Final).

    By order of the Commission.

    Issued: March 7, 2018. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2018-04972 Filed 3-12-18; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION [Investigation Nos. 701-TA-601 and 731-TA-1411 (Preliminary)] Laminated Woven Sacks From Vietnam; Institution of Anti-Dumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase Investigations AGENCY:

    United States International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-601 and 731-TA-1411 (Preliminary) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of laminated woven sacks from Vietnam, provided for in subheading 6305.33.00 (statistical reporting number 6305.33.0040) of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of Vietnam. Unless the Department of Commerce (“Commerce”) extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by April 23, 2018. The Commission's views must be transmitted to Commerce within five business days thereafter, or by April 30, 2018.

    DATES:

    March 7, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Drew Dushkes (202-205-3229), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (https://www.usitc.gov). The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at https://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    Background.—These investigations are being instituted, pursuant to sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)), in response to a petition filed on March 7, 2018, by the Laminated Woven Sacks Fair Trade Coalition, which is comprised of Polytex Fibers Corporation (Houston, Texas) and ProAmpac, LLC (Cincinnati, Ohio).

    For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).

    Participation in the investigations and public service list.—Persons (other than petitioners) wishing to participate in the investigations as parties must file an entry of appearance with the Secretary to the Commission, as provided in sections 201.11 and 207.10 of the Commission's rules, not later than seven days after publication of this notice in the Federal Register. Industrial users and (if the merchandise under investigation is sold at the retail level) representative consumer organizations have the right to appear as parties in Commission antidumping duty and countervailing duty investigations. The Secretary will prepare a public service list containing the names and addresses of all persons, or their representatives, who are parties to these investigations upon the expiration of the period for filing entries of appearance.

    Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in these investigations available to authorized applicants representing interested parties (as defined in 19 U.S.C. 1677(9)) who are parties to the investigations under the APO issued in the investigations, provided that the application is made not later than seven days after the publication of this notice in the Federal Register. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

    Conference.—The Commission's Director of Investigations has scheduled a conference in connection with these investigations for 9:30 a.m. on Wednesday, March 28, 2018, at the U.S. International Trade Commission Building, 500 E Street SW, Washington, DC. Requests to appear at the conference should be emailed to [email protected] (DO NOT FILE ON EDIS) on or before March 26, 2018. Parties in support of the imposition of countervailing and antidumping duties in these investigations and parties in opposition to the imposition of such duties will each be collectively allocated one hour within which to make an oral presentation at the conference. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the conference.

    Written submissions.—As provided in sections 201.8 and 207.15 of the Commission's rules, any person may submit to the Commission on or before April 2, 2018, a written brief containing information and arguments pertinent to the subject matter of the investigations. Parties may file written testimony in connection with their presentation at the conference. All written submissions must conform with the provisions of section 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on E-Filing, available on the Commission's website at https://edis.usitc.gov, elaborates upon the Commission's rules with respect to electronic filing.

    In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

    Certification.—Pursuant to section 207.3 of the Commission's rules, any person submitting information to the Commission in connection with these investigations must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that any information that it submits to the Commission during these investigations may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of these or related investigations or reviews, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

    Authority: These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules.

    By order of the Commission.

    Dated: March 7, 2018. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2018-04973 Filed 3-12-18; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 15-17] Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy; Decision and Order

    On February 23, 2015, the former Deputy Assistant Administrator of the then-Office of Diversion Control, Drug Enforcement Administration (hereinafter, DEA or Government) issued an Order to Show Cause to Pharmacy Doctors Enterprises d/b/a Zion Clinic Pharmacy (hereinafter, Respondent). ALJX 1. The Show Cause Order proposed the revocation of Respondent's registration pursuant to 21 U.S.C. 824(a)(4) and 823(f) on the ground that Respondent's registration is inconsistent with the public interest. ALJX 1, at 1. For the same reason, the Show Cause Order also proposed the denial of any pending application by Respondent for renewal or modification of its registration, and the denial of any application by Respondent for any other DEA registration. Id. (citing 21 U.S.C. 823(f)).

    As the jurisdictional basis for the proceeding, the Show Cause Order alleged that Respondent's DEA Certification of Registration No. FP1049546 authorized it to dispense controlled substances in schedules II through V as a retail pharmacy at the registered location of 205 E. Hallandale Beach Blvd., Hallandale Beach, Florida 33009. Id. Respondent's registration was to expire on March 31, 2017. Id.

    As the substantive grounds for the proceeding, the Show Cause Order contained seven categories of violations. First, it alleged that “Zion dispensed controlled substances where it knew, or should have known, that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose and therefore failed to exercise its corresponding responsibility regarding the proper prescribing and dispensing of controlled substances.” Id. (citing 21 CFR 1306.04(a)). The Show Cause Order stated that Respondent's failure to exercise its corresponding responsibility was evidenced by its “dispensing of controlled substances despite the presence of red flags of diversion that Zion failed to clear prior to dispensing the drugs.” Id. at 1-2. The Show Cause Order listed seven red flags of diversion that Respondent allegedly did not resolve prior to filling prescriptions.Id. at 2-7. It cited Holiday CVS, L.L.C., d/b/a CVS/Pharmacy Nos. 219 and 5195, 77 FR 62,316 (2012) (hereinafter, Holiday CVS) as support for these allegations.

    The Show Cause Order listed 13 prescriptions, for customers who allegedly traveled long round-trip distances of approximately 166 to 661 miles from home to physician to Respondent and back home, and alleged that Respondent filled them without having resolved the long distance red flags of diversion. ALJX 1, at 2-3. Each of the 13 prescription examples was for a controlled substance written some time during the period of February 2012 through January 2013. Id.; see also Government Exhibit (hereinafter, GX) 8/8a.

    The Show Cause Order cited five prescriptions written by the same doctor on June 27, 2012 for five different customers for “1 ML Testosterone Cypionate 210mg/mL IM,” a controlled substance, that Respondent allegedly filled without first having resolved the red flags of diversion. ALJX 1, at 3-4; see also GX 10.

    The Show Cause Order referenced two prescriptions for Dilaudid 8 mg., a controlled substance, written by the same doctor on June 22, 2012 for two individuals with the same last name and the exact same street address that Respondent allegedly filled without first having resolved the red flags of diversion. ALJX 1, at 4; see also GX 11. The Show Cause Order alleged that Respondent filled the two prescriptions on July 13, 2012 at 2:35 p.m. and 2:39 p.m., respectively. ALJX 1, at 4.

    The Order to Show Cause alleged that Respondent filled two prescriptions for the same customer on the same day for the same immediate release controlled substance, but for different strengths, without first having resolved the red flags of diversion. Id. The two pairs of prescriptions listed in the Show Cause Order to illustrate this allegation were issued for Dilaudid 8 mg. and Dilaudid 4 mg. Id.; see also GX 12. They were written during the period of September 2012 through November 2012. ALJX 1, at 4.

    The Show Cause Order alleged that Respondent filled opiate (hydromorphone) and benzodiazepine (alprazolam, clonazepam, diazepam, or lorazepam) prescriptions, a “common `drug cocktail' popular with drug abusers,” for the same customer on the same day at about the same time without first having resolved the red flags of diversion. Id. The Show Cause Order cited 14 prescriptions, or seven pairs of “drug cocktail” prescriptions, that Respondent allegedly filled during the period of October 2012 through January 2013. ALJX 1, at 4-5; see also GX 13.

    The Order to Show Cause alleged that “[c]ustomers paying for their prescriptions with cash, where other red flags of diversion were present,” were red flags of diversion that Respondent did not resolve prior to having filled the prescriptions. ALJX 1, at 5. The Show Cause Order listed 50 examples of prescriptions paid for with cash, costing as much as $1,008 for one prescription. Id.; see also GX 8, GX 10, GX 11, and GX 13.

    The Show Cause Order alleged that Respondent filled prescriptions for “[c]ustomers [who] present[ed] new prescriptions for controlled substances when they should not have finished their previous prescription for that drug (`early fills' or `early refills')” without first having resolved the red flags of diversion. ALJX 1, at 5. The Order to Show Cause provided seven sets of examples of prescriptions that Respondent allegedly filled as many as 15 days early. Id. at 5-7; see also GX 14. The Show Cause Order specifically cited Holiday CVS, 77 FR at 62,318 as precedent for this charge. ALJX 1, at 7.

    Next, the Order to Show Cause alleged that Respondent “was unable to readily retrieve prescriptions it had dispensed.” Id. (citing subsections (a) and (h)(3) and (4) of 21 CFR 1304.04). Specifically, the Show Cause Order alleged that, on April 11, 2013, DEA investigators conducted an on-site inspection of Respondent and requested specific prescriptions that Florida's Prescription Drug Monitoring Program showed Respondent had filled.1 Id. The Show Cause Order listed 12 testosterone prescriptions that Respondent filled from February 2012 through January 2013 and DEA investigators requested, but that Respondent's staff was allegedly “unable to produce.” Id. at 7-8.

    1 Florida's Prescription Drug Monitoring Program is called the Electronic-Florida Online Reporting of Controlled Substance Evaluation Program (hereinafter, E-FORCSE).

    The Show Cause Order further alleged that Respondent filled controlled substance prescriptions and shipped them to Alabama, Georgia, Illinois, Kentucky, Massachusetts, and Vermont without meeting the out-of-state pharmacy requirements of four of those states.2 Id. at 8. It detailed eight prescriptions that Respondent allegedly filled and shipped out-of-state, though it did not allege that all eight were shipped in violation of a State's non-resident pharmacy requirements. Id. at 8-9; see also GX 15.

    2 The Order to Show Cause cited the allegedly violated state legal requirements as Alabama: Rules of Ala. State Bd. of Pharm. § 680-x-2-.07(2); Illinois: Ill. Admin Code tit. 68, § 1330.550(a); Kentucky: Ky. Rev. Stat. § 315.0351(1); and Vermont: Admin. Rules Vt. Bd. of Pharm., Part 16.

    The Order to Show Cause next alleged that Respondent filled controlled substance prescriptions that did not contain all of the required information, such as directions for use, patient address, prescriber name, prescriber address, prescriber DEA number, and prescriber signature. ALJX 1, at 9 (citing 21 CFR 1306.05(a) and (f)). It specified eight prescriptions and the required information each one allegedly lacked. Id. at 9-10; see also GX 16.

    Next, the Show Cause Order alleged that Respondent filled prescriptions written for “office use” in violation of 21 CFR 1306.04(b). ALJX 1, at 10. It provided two examples of such prescriptions. Id. at 10; see also GX 17.

    The Show Cause Order also alleged that Respondent filled prescriptions written by physicians for their personal use in violation of Florida law. ALJX 1, at 10 (citing Fla. Stat. § 458.331(r)). It referenced six examples of prescriptions where the name of the prescribing physician was the same name as the patient. Id.; see also GX 18.

    And, lastly, the Order to Show Cause alleged that Respondent violated Florida law by “failing to report some prescriptions to E-FORCSE, in violation of Fla. Stat. § 893.055(4).” ALJX 1, at 10. It listed six prescriptions that Respondent allegedly did not report to E-FORCSE. Id. at 11; see also GX 19.

    The Show Cause Order notified Registrant of its right to request a hearing on the allegations or to submit a written statement while waiving its right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. ALJX 1, at 11 (citing 21 CFR 1301.43).

    On February 25, 2015, the DEA Diversion Investigator (hereinafter, DI) assigned to the investigation of Respondent, personally served the Order to Show Cause on Respondent's owner and operator, Veronica Taran (hereinafter, Respondent's Owner and PIC).3 ALJX 5 (Government's Prehearing Statement dated March 27, 2015 (hereinafter, Govt. Prehearing Statement)), at 2; ALJX 7 (Respondent's Prehearing Statement dated April 10, 2015), at 2; see also Stipulation No. 4, ALJX 10, at 2.

    3 She variously testified that she was “the owner of the respondent pharmacy” and that she was “an owner and a Pharmacist-in-Charge” of Respondent. Transcript Page (hereinafter, Tr.) 795, 798 (respectively); see also Stipulation No. 2, ALJX 10, at 1.

    Her testimony cited in this Decision and Order is quoted verbatim from the hearing transcript, without correction or “[sic]” notations in addition to those already in the transcript.

    By letter from its attorneys dated March 12, 2015, Respondent timely requested a hearing and asked that a “reasonable extension to respond to an Order to Show Cause” be granted. ALJX 3 (Hearing Request dated March 12, 2015), at 1; ALJX 4 (Order for Prehearing Statements dated March 17, 2015), at 1. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ). On March 17, 2015, the CALJ established the schedule for the filing of prehearing statements and granted Respondent's request for additional time “to the extent that the hearing date set in the OSC . . . will be continued as directed at the prehearing conference scheduled by this order.” ALJX 4 (Order for Prehearing Statements), at 1, 2.

    On March 27, 2015, the Government filed its Prehearing Statement. ALJX 5. On April 10, 2015, Respondent served its Prehearing Statement. ALJX 7. The April 14, 2015 Prehearing Ruling and Protective Order found that four “stipulations have been mutually agreed to and are conclusively accepted as facts.” ALJX 10, at 1.

    On May 6, 2015, the Government and Respondent filed Supplemental Prehearing Statements. ALJX 6 and ALJX 9, respectively. The parties' joint filing dated May 26, 2015 included their 11 additional joint stipulations. ALJX 20, at 1-2.

    On June 9 through 11, 2015 and on August 4, 2015, the CALJ conducted an evidentiary hearing in Miami, Florida. Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge dated October 16, 2015 (hereinafter, R.D.), at 2. At the hearing, both parties called witnesses to testify and offered documents into evidence. Following the hearing, both parties submitted briefs containing proposed findings of fact, proposed conclusions of law, and argument.

    On October 16, 2015, the CALJ issued his Recommended Decision, including that all but two of the Show Cause Order's allegations, the sixth (prescriptions written for “office use”) and the seventh (prescriptions written for the prescriber's personal use), be sustained. Id. at 33-36, 38-39 (respectively). Regarding those two allegations, the CALJ's recommendations were that there were substantive violations, but that the allegations should not be sustained “based exclusively on the lack of adequate notice under current Agency precedent.” Id. at 36, 39 (respectively).

    The CALJ found that the Government “supplied sufficient evidence to make out a prima facie case.” Id. at 57. He also found that Respondent's acceptance of responsibility was insufficient. Id. at 58. Concerning remedial steps, he explained that Respondent's “intentional decision to decline to notice evidence of remedial steps resulted in their preclusion from consideration.” Id. In sum, he concluded that the record supported imposition of a sanction. Id.

    The CALJ included in his R.D. an assessment of the degree and extent of Respondent's misconduct and concluded that Respondent had not “accepted anything meaningful in terms of responsibility or learned anything.” Id. at 59. “Where no understanding is acquired about how the regulated conduct fell short of professional and federal and state legal standards,” he wrote, “it would be difficult (even illogical) to predict improvement.” Id. He determined that the Registrant “is likely to proceed in the future as it has in the past if not curtailed in its ability to do so.” Id. He concluded that the “sheer number of established transgressions of various types, coupled with the refusal to admit that issues existed, would render a sanction less than revocation as a message to the regulated community that due diligence is not a required condition precedent to operating as a registrant.” Id. at 59. He recommended revocation of Registrant's registration and the denial of any pending applications for renewal. Id. at 60.

    On November 5, 2015, both parties filed Exceptions to the R.D. Respondent served supplemental Exceptions to the R.D. on November 16, 2015. By letter dated November 10, 2015, the record was forwarded to me for Final Agency Action.4

    4 By correspondence dated February 29, 2016, Respondent's counsel gave notice of “termination of legal representation and an attorney/client relationship with the Respondent.”

    Having considered the record in its entirety, including all of the Exceptions filed by Respondent and the Government, I agree with the CALJ that Respondent's registration should be revoked and that any pending applications for its renewal or modification should be denied. I further agree with the CALJ's conclusions that Respondent dispensed controlled substances knowing that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose and, therefore, violated the corresponding responsibility rule of 21 CFR 1306.04(a). I agree with the CALJ that Respondent was unable to readily retrieve prescriptions it had dispensed and, therefore, violated 21 CFR 1304.04. I agree with the CALJ that Respondent filled controlled substance prescriptions and shipped them out-of-state in violation of four States' non-resident pharmacy requirements. I agree with the CALJ that Respondent violated 21 CFR 1306.05 by filling controlled substance prescriptions that did not contain all of the required information. Based on Respondent's admissions, I find that Respondent filled prescriptions written for “office use,” although I do not sustain this allegation due to the Government's failure to comply with the notice requirements for a Show Cause Order. 21 CFR 1301.37(c). I find that Respondent filled at least one controlled substance prescription written by a physician for the physician's personal use, although I do not sustain this allegation due to the Government's failure to comply with the notice requirements for a Show Cause Order. 21 CFR 1301.37(c). I agree with the CALJ's conclusion that Respondent failed to report controlled substance prescriptions to E-FORCSE in violation of Fla. Stat. § 893.055(4) (2012). I agree with the CALJ that Respondent's acceptance of responsibility was insufficient and that Respondent did not provide sufficient notice of remedial measures.

    Accordingly, I find the record as a whole established by substantial evidence that Respondent committed acts which render its continued registration inconsistent with the public interest. I conclude that revocation of Respondent's registration and denial of any pending application to renew or modify Respondent's registration are appropriate sanctions. I make the following findings.

    Findings of Fact Respondent's DEA Registration

    Respondent is registered with the DEA as a retail pharmacy in schedules II through V under DEA Certificate of Registration No. FP1049546 at 205 E. Hallandale Beach Blvd., Hallandale Beach, Florida 33009. ALJX 1, at 1; see also Stipulation No. 1; ALJX 10, at 1. Respondent's registration was to expire on March 31, 2017. Stipulation No. 1; ALJX 10, at 1. According to DEA's registration records, however, on January 31, 2017, Respondent timely filed a renewal application. I take official notice of that pending registration renewal application. 5 U.S.C. 556(e).5 Respondent's registration, therefore, remains in effect pending the issuance of this Decision and Order. 5 U.S.C. 558(c).

    5 Under the Administrative Procedure Act, an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” United States Department of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e), “[w]hen an agency decision rests on official notice of a material fact not appearing in the evidence in the record, a party is entitled, on timely request, to an opportunity to show the contrary.” Accordingly, Respondent or the Government may dispute my finding by filing a properly supported motion for reconsideration within 10 calendar days of the date of this Order. Any such motion shall be filed with the Office of the Administrator and a copy shall be served on the other party; in the event either party files a motion, the other party shall have 10 calendar days to file a response.

    The Investigation of Respondent

    According to the testimony of the DI, he decided to investigate Respondent after learning that it had ordered 41,700 dosage units of hydromorphone in 2012. Tr. 28. This raised his suspicion because the average pharmacy in the United States ordered approximately 5,900 dosage units of hydromorphone in the same time period. Id. at 28.

    On April 11, 2013, the DI presented Ms. Veronica Taran, Respondent's Owner and PIC, with a Notice of Inspection. Id. at 38; see also Stipulation No. 3; ALJX 10, at 2. The DI testified that Respondent's Owner and PIC read the notice of inspection, did not have any questions for the DI about it, signed it, and consented to the inspection. Tr. 38. The DI then asked Respondent's Owner and PIC for various records, including order forms and prescriptions filled for schedule II through V controlled substances. Id. The DI stated that “I asked Mrs. Taran if we could take records for further review, so we boxed them up and took them with us. She consented to that.” Id. at 52-53. When he left Respondent on the unannounced inspection day, he took with him “2011 to 2013 Schedule II through V prescriptions, . . . any invoices or receipts covering the same timeframe, and executed DEA 222 forms and . . . [Respondent's] biennial inventory.” Id. at 50.

    The DI also testified about approximately a dozen problematic prescriptions he had identified from E-FORCSE that Respondent's Owner and PIC “was never able to locate . . . for me.” Id. at 42, 43. “They were written for different anabolic steroid substances to patients that were not in the State of Florida,” he testified. Id. at 42.

    The DI testified that he asked Respondent's Owner and PIC questions, including how she would verify controlled substance prescriptions. Id. at 39. According to the DI, Respondent's Owner and PIC said that she used two forms, one to verify the prescription and a doctor-patient affidavit “that she makes the patient fill out,” and she checked the prescriber's DEA number on the DEA website and the prescriber's license on the Florida Department of Health website. Id. at 39-40. According to the DI, Respondent's Owner and PIC told him that she was familiar with her patients and visited the doctors and their offices. Id. at 40.

    The DI testified that Respondent's Owner and PIC had posted lists: “[o]ne was for doctors she would fill prescriptions for, another list of doctors that she wouldn't fill prescriptions for, and ones that were pending verification.” Id. at 40; see also id. at 41. The DI stated that Respondent's Owner and PIC specifically told him “she does not check” E-FORCSE, she had never shipped a controlled substance out of state, and “the pharmacy was not licensed in any other state.” Id. at 40-41, 44. Regarding E-FORCSE, the DI testified that he asked Respondent's Owner and PIC to “go onto” it to “check a prescription for me” and that “she wasn't able to do that.” Id. at 48-49. When asked for elaboration on the meaning of “she wasn't able to do that,” the DI responded that she did not have access. He testified, “She had access to enter her data into, but not to query a patient. . . . I was standing next to her when she was logged onto the computer attempting to query a patient.” Id. at 49.

    The Allegations of Dispensing and Non-Dispensing Violations

    The Order to Show Cause alleged seven bases for the revocation of Respondent's registration pursuant to 21 U.S.C. 824(a)(4) and 823(f). One of them had seven subparts.

    Witnesses

    Four witnesses testified at the hearing: The DI and Dr. Tracey J. Gordon for the Government, and Louis Fisher and Respondent's Owner and PIC called by Respondent. There was factual agreement among the witnesses on a number of issues. When there was factual disagreement, I applied the CALJ's credibility recommendations. See R.D., at 5-25.

    Regarding the DI, the CALJ stated that he “presented as an objective regulator with no stake in the outcome of the proceedings” and provided “testimony [that] was sufficiently detailed, plausible, consistent, and cogent to be fully credited.” R.D., at 8. I agree with the CALJ's assessment of the DI's credibility.

    At the hearing, the Government also offered testimony from Dr. Tracey Gordon, a pharmacist licensed in Florida who had practiced pharmacy for 21 years. Dr. Gordon testified to “ten-plus years of retail” experience in “at least 200” Florida retail pharmacies serving as a clerk, tech, intern, assistant manager, and manager. Tr. 282, 284. She testified to having experience dispensing controlled substances for the treatment of chronic pain. Id. at 289. She stated that she has served as a pharmacist-in-charge. Id. at 351. She testified to training in, and experience with, issues regarding the use and diversion of controlled substances, and to familiarity with the pharmaceutical practice aspects of the use and abuse of controlled substances. Id. at 289-90. She stated that she was a licensed Consultant Pharmacist and, at the time, was serving as a clinical Hospice pharmacist. Id. at 278-79.

    Dr. Gordon was accepted, without objection, “as an expert in the practice of pharmacy in the [S]tate of Florida regarding the dispensing of controlled substance prescriptions.” R.D., at 8; see also Tr. 294-95.6 The CALJ found that Dr. Gordon's testimony was “internally consistent and logically persuasive” and her qualifications “reflected a wide breadth of pharmacy experience, including working in many pharmacies as a line pharmacist and a pharmacist in charge,” and as a consultant and teacher. R.D., at 11. I agree with the CALJ that Dr. Gordon's “answers rang of sufficient clarity, authority, and candor to merit controlling weight in these proceedings regarding the practice of pharmacy in Florida.” Id. at 11.

    6 On cross-examination, Respondent elicited that, although Dr. Gordon had helped her father in his store before she was a pharmacist, she never worked as a pharmacist in a small independent pharmacy. Tr. 477-78. Respondent further elicited that Dr. Gordon was “never in charge of purchasing controlled substances for resale for a small independent pharmacy.” Id. at 482. Respondent's first Exception to the R.D. also asserts “[a]s evident from the record” that “Respondent challenged Dr. Gordon's qualifications to testify about dispensing patterns . . . for a small sized, independent pharmacy such as Respondent.” Respondent's Exceptions to the ALJ's Recommended Ruling dated Nov. 5, 2015 (hereinafter, Resp. Exceptions), at 2. Respondent did not, however, provide a citation to the record for its assertion and my review found none. 21 CFR 1316.66(a). Regardless, given that the Show Cause Order did not raise “dispensing patterns . . . for a small sized, independent pharmacy,” Respondent's assertion is not germane to the resolution of this matter.

    Respondent offered the testimony of Louis Fisher, who graduated in 1971 from the Hampden College of Pharmacy and worked for DEA or its predecessor agency from 1971 to 2003. Tr. 565. Mr. Fisher testified that, during his government service, his positions included compliance investigator, quota operation staff assistant, diversion investigator, diversion program manager, and group supervisor. Id. at 565, 570. He stated that he was “familiar with a procedure of dispensing controlled medications pursuant to prescriptions in Florida,” even though he never practiced pharmacy, or was a licensed pharmacist, in Florida. Id. at 571-72, 574-75. He testified that he was a consultant in the field of “controlled substances abuse and diversion” at the time. Id. at 572. Respondent sought to qualify Mr. Fisher as a “specialist in preventing drug diversion.” Id. at 561.

    The CALJ accepted Mr. Fisher as an expert on the issue of dispensing in Florida. R.D., at 11 n.74, at 17. I agree with the CALJ that it is appropriate to “afford . . . diminished weight [to Mr. Fisher's testimony] where it conflicts with other, more persuasive evidence of record, including the testimony of Dr. Gordon.” 7 Id. at 17; see also id. at 11 n.74.

    7 The CALJ explained that Mr. Fisher's “discrepant testimony regarding his licensure and experience was disquieting. . . . On this record, the issue of Mr. Fisher's qualifications to render an expert opinion is uniquely dependent upon his own representations of his experience and, thus, his credibility. Either Mr. Fisher was careless . . . and reckless . . ., or he was engaged in an intentional effort to inflate his own qualifications. Either option undermines the weight that can be logically afforded to his opinions, and where these opinions conflict with other opinions or evidence, they cannot be relied upon.” R.D., at 16 (footnote omitted).

    At the hearing, Respondent also offered testimony from Respondent's Owner and PIC. Tr. 798. Respondent's Owner and PIC testified that she had been, at the time, a practicing pharmacist in Florida for about ten years. Id. at 798. She testified that she was familiar with the Florida provision specifically addressing the dispensing of controlled substances, and that she had taken “[m]ultiple courses” on “red flag of diversions” as well as “read many articles online about the situation in Florida with the pain management.” Id. at 799. Respondent's Owner and PIC also testified that she was a custodian of records for Respondent and supervised, at the time, one technician, one intern, and one student. Id. at 798-99.

    I agree with the CALJ's conclusion that, while “[t]here were, undoubtedly, aspects of . . . [the testimony of Respondent's Owner and PIC] during which she presented as generally credible, . . . on the present record, her testimony was not sufficiently consistent or plausible to be afforded full credibility.” R.D., at 25.

    Florida Pharmacists' Standard of Practice

    Dr. Gordon, Mr. Fisher, and Respondent's Owner and PIC testified about a Florida pharmacy's/pharmacist's standard of practice when presented with a controlled substance prescription.8 There were some areas of agreement by at least two of the three witnesses on some aspects of that standard.

    8 The DI also addressed the standard of practice. For example, he testified that his investigation identified issues concerning Respondent's compliance with the Controlled Substances Act and its implementing regulations. See, e.g., Tr. 51, 54, 68, 71, 73, 74-75, 76-77, 99, 102, and 124.

    According to Dr. Gordon, upon a customer's presentation of a controlled substance prescription, the pharmacist should protect the safety of the patient and the community by looking for red flags of diversion, or “something that makes a pharmacist pause and think about” whether the prescription was “really for a legitimate medical purpose.” Tr. 296, 303. She discussed red flags including the quantity and dosage of the controlled substance, the doctor and practice specialty, and the patient's geographic location, doctor/pharmacy patronage, and payment (insurance/cash) method. Id. at 295-97.

    Regarding the quantity and dosage of a controlled substance used for pain management, Dr. Gordon explained that “I look . . . [for] a long-acting with the prescription . . . [because] [i]t helps the patient to be more adherent to therapy.” Id. at 296.

    Regarding the doctor and practice specialty, Dr. Gordon explained that, “I feel pretty comfortable filling a prescription for a large quantity of pain medication” if an oncologist wrote it. Id. at 298. “But if it's from a general practitioner or an ob-gyn,” she continued, “then that causes me to take pause and reevaluate the legitimacy of the prescription.” Id. She testified that the National Provider Identification website showed physicians' specialties and helped the pharmacist evaluate prescriptions. Id. at 297-98, 345. She also testified that a pharmacist should routinely check the status of a controlled substance prescriber's State medical license and DEA registration. Id. at 301, 345.

    Regarding the patient, Dr. Gordon stated that a chain pharmacy's computer would show if the customer had filled the prescription at another branch, and Florida's prescription drug monitoring program, E-FORCSE, would show what other controlled substances the customer had received from other pharmacies or doctors. Id. at 301-02, 345. She explained that E-FORCSE “gives you the date . . . [the prescription] was written, the date it was filled, the name of the drug, the quantity, the doctor, the pharmacy, and how the patron paid for the medication” which would tell the pharmacy “if the patient was either doctor-hopping or pharmacy-hopping.” Id. at 302.

    Dr. Gordon testified about the importance of the customer's payment method, explaining that “[a] lot of drug-seekers only want to pay for their medications in cash because . . . the insurance company will actually create your red flag for you to say if a prescription is refilled too soon, which means they've . . . obtained a prescription from another pharmacy.” Id. at 297; see also id. at 298-99.

    Dr. Gordon stated that what constituted a red flag “changed all the time. It's like the drug community gets smarter.” Id. at 303. She indicated that, when confronted with a red flag, a pharmacist would make further inquiries of the doctor, the customer, or the caregiver. Id. at 305. She noted that “some of the red flags really can't be resolved, especially if you see patterns.” Id. at 304-05. She testified that, if she could not resolve a prescription's red flags, she would not fill it. Id. at 305. She would either give the prescription back to the customer or, with the doctor's authorization, shred it. Id.

    Dr. Gordon testified that, although there is no codified Florida rule specifying where a pharmacist must document resolution of a red flag, the standard practice in Florida was for the resolution of a red flag to be documented on the front of the prescription. Id. at 346-48. As a pharmacist-in-charge, she would check the face of the prescription to see if a subordinate pharmacist resolved a concern about the prescription. Id. at 351-52. She testified that any notes about the patient, as opposed to notes about a specific prescription, would appear in the patient profile. Id. at 350, 352.

    Mr. Fisher testified that red flags “are part of the pharmacist's responsibility.” Id. at 616. Regarding what a pharmacist should do to resolve a red flag, Mr. Fisher first stated that the pharmacist should “[c]heck the state E-FORCSE system to see if this person is a doctor-shopper.” Id. at 604; see also id. at 608-09. He also stated that he would check the doctor's license to make sure it was valid, check if the customer had any history in the pharmacy of previous prescriptions being filled, and “then talk to the doctor and see . . . what the—maybe the diagnosis is on this prescription.” Id. at 604. When asked “where would you see if these things were done, if they were documented,” Mr. Fisher responded that the documentation could be written on the back of the prescription, in a notebook, in a logbook “of any kind” or “whatever system they want to be put into effect.” Id. at. 604-05. When asked whether the red flags “would have to be documented someplace,” Mr. Fisher responded affirmatively. Id. at 605; see also id. at 598-600 (Mr. Fisher's testimony that a pharmacist needs to resolve a red flag before dispensing the prescription, and resolution of the red flag must be documented somewhere.). Mr. Fisher testified that he did not know if the red flags he had identified on the prescriptions in the Government's exhibit had been resolved. Id. at 605; see also id. at 766 (Mr. Fisher's testimony that the prescriptions contained no notations evidencing that Respondent had resolved any of their red flags.).

    The testimony of Respondent's Owner and PIC about diversion and what a pharmacy needed to do when presented with a controlled substance prescription was largely inconsistent with the testimony of Dr. Gordon and Mr. Fisher. Further, her testimony admitted that Respondent did not even follow the steps she described. It also, though, evidenced her knowledge and awareness that schedule II controlled substances were prone to diversion. For example, Respondent's Owner and PIC testified that “[e]ach prescription it comes with chronic nonmalignant pain, has to be addressed as a highly risky—high risk medication. It has to be addressed with proper steps.” Id. at 1129. Also regarding prescriptions for schedule II controlled substances, she testified that “on schedule II, each time it's presented it has to be—there's a lot of diversion.” Id. at 1116. Specifically, Respondent's Owner and PIC identified Dilaudid 8mg. and Dilaudid 4 mg. prescriptions as “highly risky.” Id. at 1129; GX 12, at 5 and 7. When asked whether she recalled identifying “any red flags” when she filled a prescription for 174 tablets of Dilaudid 8 mg., Respondent's Owner and PIC responded that “the major red flag of that prescription is for Schedule II medication, Dilaudid, 8 milligram. Also, prescribed on the quantities.” Tr. 880-81.

    According to Respondent's Owner and PIC, Respondent, and she as its PIC, needed to implement specific procedures unique to schedule II prescriptions due to the diversion associated with them. Her “specific procedures” consisted of a series of steps. See id. at 883-897 (using as an example GX 19, at 1). First, according to her testimony, she would “talk to doctor on each [schedule II] prescription” because “there's a lot of diversion” of schedule II controlled substances. Id. at 1116. Her testimony underlined the importance of talking to the prescribing doctor “each time” a schedule II prescription was presented by comparing the diversion of schedule II controlled substances with schedule III controlled substances:

    When all the schedule II prescriptions—I would talk to doctor on each prescription. On schedule III I would talk to doctor when there's initial prescriptions for it. But there's not that much schedule III situations. But on schedule II, each time it's presented it has to be—there's a lot of diversion.

    Id.

    Respondent's Owner and PIC described the conversation she had regarding the first prescription in GX 19, a prescription for 174 tablets of Dilaudid 8 mg. She stated that she called the office and asked to speak with the doctor. “[H]onestly,” she admitted, the “doctor not always were available. But I spoke with the manager.” Id. at 895. The “honest” admission of Respondent's Owner and PIC that she did not always speak with the prescribing doctor about a schedule II prescription contradicted other testimony she gave that she always spoke with the doctor regarding such prescriptions. See, e.g., id. at 1116.

    Respondent's Owner and PIC continued to describe her conversation with the doctor's office. She testified that she “would ask a manager to tell me more what was happening with the patient; was he seen on that day?” Id. at 895.

    So if the patient was seen on the day that the prescription was issued, and the quantity—the reason why he had prescribed that quantity this month? And they would tell me that he has diagnosis in the proper—that doctor has a note in his chart to consider alternative treatments . . . . I would ask them, What did you prescribe today for that patient? . . . So they have to spell out what did they write this day, the quantity, to make sure there is no alteration on the way—there is no forging of the prescription. Then I would say, Is it okay for me to fill it? And they would give me approval to fill.

    Id. at 896. Respondent's Owner and PIC testified that after these steps, including “verify[ing] all the information, the address, the phone number, the complete date of birth, the doctor DEA number on the front, the quantities and the medications, the signature . . . [a]nd that medication was hand signed by the doctor,” she filled the prescription. Id. at 897.

    Despite her testimony and her stated awareness of the high risk nature of schedule II prescriptions and the risk of diversion associated with them, including the “red flag” of schedule II controlled substances being prescribed in large quantities, Respondent's Owner and PIC again admitted that she did not always follow her first step. Instead, she testified that she would have to “go one-by-one each [schedule II] prescription” before answering questions about whether or not she spoke with the doctor about any of them. Id. at 1137; see also id. at 1133-39. Thus, Respondent's Owner and PIC admitted more than once to not implementing her own requirement of speaking to the prescriber of every schedule II prescription.9 In making this admission, she did not explain why she deviated from her own procedure. Nor did she justify that deviation.

    9 In the context of describing the uses of the “approved” stamp and the name/telephone number stamp, Respondent's Owner and PIC also testified she verified that the prescriptions were issued within the scope of the prescriber's practice when she talked “to the [prescriber's] office.” Tr. 1132.

    [The stamps mean that] I talk to the office and I spoke with the patient. And I fill out documentation appropriate for—I verified—and most important, I verified this prescription was issued within scope of the doctor's practice. The doctor was allowed to treat chronic pain. It was the scope of his practice. He made the decision to write this prescription according to his practice.

    Id. at 1132-33; contra id. at 1225-27. It is noteworthy that Respondent's quoted testimony concerned her calling “the office” as opposed to her “speak[ing] with the doctor.” Id. at 1138, 1132, respectively. It was the further admission of the Respondent's Owner and PIC that she did not always “speak with the doctor” as she had testified was appropriate due to the high risk nature of schedule II prescriptions and the risk of diversion associated with them. Given her testimony that she did not necessarily speak with the “doctor” about schedule II prescriptions, it also raises the question of whether Respondent's Owner and PIC actually “verified” that prescriptions were “issued within [the] scope of the doctor's practice.” Id. at 1133.

    Second, Respondent's Owner and PIC testified that she made sure the prescriber's State medical license was active, and the prescription was within the scope of the prescriber's DEA registration. Regarding a prescriber's State license, she testified that she would make sure that “the doctor actually licensed in the State of Florida to prescribe controlled substances.” 10 Id. at 894. Regarding a DEA registration, she testified that she “was instructed . . . [by DEA] to go on the website—diversion site and verify the physician DEA number” and “[s]ince that instruction I religiously did that.” Id. at 892; see also id. at 1131-32 (Pharmacies should “make sure that . . . [the] doctor[ ] . . . [was] legitimate, I mean, . . . has a DEA license.”).

    10 Regarding the doctor who prescribed the first prescription in GX 19, Respondent's Owner and PIC testified that he was “licensed in the State of Florida to prescribe medication for chronic pain management.” Tr. 894-95. “He was actually special trained in the pain management,” she stated. Id. at 895.

    According to Respondent's Owner and PIC, “[t]he decision of prescribing lies upon the physicians and the state who govern his practice.” Id. at 1108. She elaborated, asserting that a pharmacy must fill a controlled substance prescription issued by a practitioner with the appropriate State and DEA licenses unless there is “a very good reason not to fill it.” Id. at 1168.

    The doctor tells you it's okay to fill, just by the filling—the filling prescription. When the patient comes to the office—to the doctor, he's seen by the doctor. Doctor asking how many pills you have, what are you taking? Then he decide to issue another prescription. Once he issue the prescription, it's an order for a pharmacy—keep in mind, we still working in the medical system here. The prescription is an order for the pharmacist to fill. For me not to fill that prescription, I have to have a very good reason not to fill it, because it's an order from the doctor to me to fill that prescription for that patient.

    Id. at 1167-68. Respondent's Owner and PIC did not explain what she meant by “a very good reason not to fill it.” Nevertheless, I found in the record evidence of numerous controlled substance prescriptions that Respondent's Owner and PIC admitted Respondent filled without having documented the existence or resolution of any of the red flags of diversion identified in the testimony of Dr. Gordon and Mr. Fisher.

    Third, Respondent's Owner and PIC testified that her “main concern would be if this patient was checked and have relation with the doctor.” Id. at 885. In the context of GX 19, the six Dilaudid 8 mg. prescriptions the Show Cause Order alleged that Respondent did not report to E-FORCSE, Respondent's Owner and PIC testified about how she would establish the requisite doctor-patient relationship.11 She testified that she would “ask . . . [the customers] to fill out the [“Pain Management Physician-Patient Relationship Affidavit,” hereinafter, Relationship Affidavit] form, and sign . . . written affidavit” and “then I would call to the office and start questioning the office about whether this—to substantiate the truth about it.” Id. at 885. She testified that the Relationship Affidavit was to be completed the “first time only” that a customer came to Respondent pharmacy. Id. at 1016. She testified as to what the Relationship Affidavit would “do to alleviate . . . [her] concerns that this prescription was not diverted.” Id. at 887. She stated that “the major red flag at that time” was “whether patient actually be seen by doctor, not just come to the office and have the prescription ready for them.” Id. She continued by stating that “[i]t was not about . . . whether this prescription written for Dilaudid or prescription written for—or quantities, it was a concern, but not the main concern.” Id. According to Respondent's Owner and PIC, “[t]he main concern—the problem at the time was the patient going and the doctor's [sic] are not properly executing the practice that's reflected in the medical practice law.” 12 Id. Her testimony continued: “So we would check, . . . would require for the patient has issues . . . [a]nd she has a medical history and there is a logical connection between her and the doctor, there's relationship, it's not just to get a prescription for major narcotics.” Id. at 887-88. According to Respondent's Owner and PIC, the Relationship Affidavit “resolve[d]” these concerns. Id. at 889. She stated, “That form would resolve . . . that he's not attempted to fraudulently—to illegally get access to the controlled pain medication.” Id.; see also id. at 1149.13

    11 The six Dilaudid 8 mg. prescriptions in GX 19 were written by the same doctor for six different customers in the July-August-November 2012 time period. Specifically, the six Dilaudid 8 mg. prescriptions were for: (1) 174 tablets for a customer from Pompano Beach at a cash price of $870; (2) 96 tablets for a customer from Fort Lauderdale at a cash price of $480; (3) 150 tablets for a customer from Miami at a cash price of $750; (4) 180 tablets for a customer from Pompano Beach at a cash price of $900; (5) 168 tablets for a customer from Pompano Beach at a cash price of $840; and (6) 168 tablets for a customer from Coral Springs at a cash price of $840. Respondent's Owner and PIC had identified the first prescription for 174 Dilaudid 8 mg. tablets as showing a “major red flag” because it was for a schedule II medication and for 174 tablets. Tr. 881.

    12 Apparently, the “medical practice law” Respondent's Owner and PIC referenced was the “Ryan Act.” She testified that the purpose of the Relationship Affidavit was to “establish the patient-doctor relationships and the legitimate ill of the patients” in compliance with the “Ryan Act.” Tr. 1015-16. According to Respondent's Owner and PIC, “by that law is rely if the patient actually has a logical relation with the doctor.” Id. at 1016.

    She testified further about the “state statute and federal statutes”: “For . . . me was most important thing was to go to references of the state statute and federal statutes. So federal statute says, has to be clear relationship to establish the legitimate medical purpose. You rely on the doctors to establish the appropriateness of therapies. It's not on the pharmacy to establish the appropriateness of pharmacy. . . , that's how I understood the law. The pharmacist is just to establish that the prescription was valid—the validity of prescription based that the prescription as a requirement, and the doctor allowed to prescribe, and the doctor actually see the patients. Unless there's some issues that arise with that, like, for instance, if the patient is—not that the doctor overly treated or the patient has issues — or the doctor has issues with the patient, or I feel something suspicious, then I call the doctors. . . . Because standards only tell you that you have to actually establish the patient is not coming here for wrong reasons. That's only what the statute says. The statute says if the patient come for wrong reason you don't fill it. If the patient come from appropriate reason, you fill.” Id. at 1018-19, 1021.

    13 She also testified that she interacted with Respondent's customers by asking them questions.

    I would talk to the patient, ask him about why did he come to my pharmacy? Where did he fill before? What is the reason he doesn't use previous pharmacy? And also, what is the reason for—how long has he been on that medication? And whether he was checked by—and then I would ask him to look at the affidavit form and sign the affidavit form for the patient. . . . I have not written those questions out. But they would be the same questions that I would ask to establish . . . the history of the patient.

    Tr. 882-83, 884. When asked whether she would “essentially” ask every customer the same questions, she responded affirmatively and identified other questions she asked. Id. at 884-85. Respondent's Owner and PIC, however, did not explain the purpose of these questions given her testimony that the signed Relationship Affidavits “resolved” the issue of whether customers were attempting to fraudulently or illegally get access to controlled pain medication.

    The Relationship Affidavit was a one-page form with Respondent's name at the top, and name and contact information at the bottom. See, e.g., Respondent Exhibit (hereinafter, RX) 5, at 2. Text on the Relationship Affidavit stated that individuals “who are receiving medications to treat chronic intractable pain are required to be seen and examined by the physician on the same date the prescription for pain has been issued.” Id. According to the Relationship Affidavit, a customer had to sign it before Respondent would fill a prescription. The Relationship Affidavit stated that:

    In order for prescriptions to be filled by . . . [Respondent] patients are required to sign this affidavit to ensure the following elements exist. By affirming and satisfying the conditions mentioned below . . . [Respondent] assumes that the prescription is valid pursuant to a legal Physician Patient Relationship.14

    14 The referenced “elements” apparently were listed in the last section of the form, which stated: “By signing below, I ________agree that the following elements of a legal Pain Management Physician-Patient Relationship exist: 1. There is no fraudulent representation to illegally gain access to controlled pain medications 2. There are no multiple doctors “doctor shopping” treating me for pain management 3. A physician has seen and conducted a physical examination 4. A physician has reviewed the patient's medical history 5. The patient has a medical complaint 6. MRI has been conducted within 24 months of the prescription 7. There is a logical correlation between the following a. Medical Complaint b. Medical History c. Physical Exam d. Prescriptions. __________Patient Name ________Date of Birth ________Signature ________Date.” RX 5, at 2.

    Id. Notably, Respondent stated its “assumption” that a prescription was valid when customers affirmed and satisfied the Relationship Affidavit's “conditions mentioned below,” presumably the “elements.” Id.

    Also of note was the “Warning” on the Relationship Affidavit: “In the event . . . [Respondent] has reasons to believe that prescriptions for pain medication have been prescribed and/or received fraudulently we have a legal responsibility to report such activity and individuals to local and federal authorities. These authorities will handle such individual in the manner prescribed by law.” Id. Respondent's Owner and PIC discussed the Relationship Affidavit's “warning” in her testimony. She stated that “it was actually warning that's in the case if I find something which would jeopardize or compromise my belief in the validity of the prescription, we have responsibility to report such activity to local and federal police. And the patient knew about it.” Tr. 888. She testified that, “I would say if I . . . find something . . .—. . . like Your Honor giving me the benefit of the doubt, I would give the patient the benefit of the doubt. If I find out that you have a problem, it's fraudulent, I will report you. So you better not start that process.” Id.

    In sum, Respondent's Owner and PIC testified that (1) she assumed the legality of a prescription based on customers' completion of the Relationship Affidavit, (2) she gave customers “the benefit of the doubt” concerning their completion of the Relationship Affidavit, and (3) she warned customers to “better not start” the process of her “find[ing] out” that a prescription is “fraudulent.” She did not explain why it was reasonable to expect drug seekers to understand what they read, let alone be honest and truthful as they completed and signed the Relationship Affidavit. She also did not explain how giving customers “the benefit of the doubt” was consistent with the requirements of the corresponding responsibility regulation. 21 CFR 1306.04(a).

    Fourth, Respondent's Owner and PIC testified that she “validate[d] that . . . it's a signature . . . not rubber signed, . . . [the prescription] was actually signed by the physician.” Tr. 892; see also id. at 1116-17 (“[T]he issue at the time was not the strength. The issue they were looking for was actually the prescription legitimate . . . , it's not fake . . . . Make sure the doctor actually issue it. He didn't buy it from—on the side, on the street. He didn't get his prescription from other sources, and actually get it from the doctor.”).

    Respondent's Owner and PIC testified that the concept of “red flags” stood in the way of getting medicine to deserving individuals. She testified that, “by strictly following these red flags, it will prevent legitimate patient from obtaining the medication.” Id. at 1108. She testified that she decided not to fill prescriptions for schedule II controlled substances altogether because “following the red flags will prevent me from filling the . . . prescriptions for legitimate medical purposes . . . and be unfair to the patient.” Id. 15

    15 She added, “Except two instances when I had this overstock and the patient was patient of mine for other reasons, we decide to fill. . . . And I don't purchase them [schedule II controlled substances].” Tr. 1108-09.

    Before the time she testified to having decided not to fill schedule II prescriptions, Respondent's Owner and PIC testified that her “liability was to prevent the diversion the best that I can, considering it was very, very little guidelines was provided to us at that time. We tried to update it, it was confusing, the red flags was changing.” Id. at 890. Apparently based on the individual perspective of Respondent's Owner and PIC concerning what pharmacies should do, Respondent designed its own forms “to support the establishment of legitimate medical purpose to fill” prescriptions. Id. at 981.16

    16See, e.g., RX 6 and RX 10. These exhibits include various items of documentation with respect to fourteen customers which Respondent represented were obtained to determine the validity of the prescriptions. Tr. 824. Each of the exhibits contains a copy of each customer's driver's license, and copies of the Pain Management Physician-Patient Relationship Affidavit for 11 of the customers. There are also copies of printouts from the DEA registration web page with respect to five of the customers. RX 6, at 3, 18, 35; RX 10, at 6, 12.

    There are also copies of a “CII/CIII Rx Verification Form” for four customers in these two exhibits. This was a one-page form on which Respondent would document the date and time of a phone call to a prescriber's office and list the name of the person providing the information. See RX 6, at 6. The form was then used to document “yes” or “no” as to whether: (1) The prescription was written by the prescriber, (2) whether the patient was seen by the prescriber at the prescriber's office, and (3) whether the patient was physically examined by the prescriber, after which the form provided a space for writing the diagnosis. Id. The form then included boxes to check whether the prescription was approved or denied, three lines for notes, and a line for the pharmacist to initial. While Respondent's Owner and PIC testified that she used this one-page form “[i]nstead of writing scribbles on the back of the prescription,” Tr. 1002, and on each of the four forms, checked “yes” with respect to each question, listed diagnoses codes, and indicated that each prescription was “approve[d],” none of the forms contains additional notes and only two of the forms were initialed by the pharmacist. See RX 6, at 6, 10, 21, 29.

    Finally, the exhibits contain copies of E-FORCSE printouts for five of the fourteen patients. See RX 6, at 4, 7, 17, 20, 30. Of note, three E-FORSCE printouts were not obtained until the middle of April 2013, see id. at 4, 7, 30, one was obtained on May 13, 2013, see id. at 20, and one was obtained on August 23, 2013. Id. at 17. As found above, the DI served the Notice of Inspection on Respondent on April 11, 2013.

    Respondent's Owner and PIC offered multiple comments about these timing issues: She “would not necessarily print out every time,” “the record that I kept in the file obviously was the latest one,” and “every time I check, I would check with the PDMP—with the PMP report.” Id. at 994. When questioned further by the CALJ about the E-FORCSE printout for patient G.A., Respondent's Owner and PIC testified that the State of Florida “would not give us the access” and “for a while I relied on the physician offices to provide me that information. I would call the physician to run the PMP report until I actually were able to get the access myself . . . .” Id. at 996. Respondent's Owner and PIC stated that she got access to E-FORCSE “sometime during 2013.” Id. at 997-98.

    Respondent's Owner and PIC testified that this information was important to her because it told her “that this patient . . . was seen by the same doctor for over . . . [a] seven-month period. And so this patient requires therapy. And the doctor was a very local doctor . . . [a]nd he was going only to my pharmacy. So [the customer] relied on me to fill her prescription.” Id. at 986-87. Yet, with respect to patient S.B., her E-FORCSE printout showed that she had filled her controlled substance prescriptions at three different pharmacies as well as through a mail order service, RX 6, at 7, and with respect to patient D.K., his E-FORSCE printout showed that he had filled his prescriptions for both oxycodone and hydromorphone at four pharmacies in addition to Respondent. Id. at 20.

    While Respondent's Owner and PIC also testified that G.A.'s “established relationship” with the doctor was “one of the thing that you use—one of the tools that you use with—to establish legitimate medical purpose . . . [because] you can fairly assume that the patients are being taken [sic] by the physician properly,” id. at 988-89, Dr. Gordon testified that “[t]he first . . . [red flag] that is really bold to me is the doctor. I've worked on other cases, and I've seen this doctor [R.T.] write lots of illegitimate prescriptions.” Id. at 360-61. Notably, each of the seven prescriptions listed on G.A.'s E-FORCSE printout was written by Dr. R.T., and each prescription was for 150 or 160 dosage units of hydromorphone 8 mg. RX 6, at 4. Dr. R.T. also wrote five of the prescriptions listed on S.B.'s E-FORCSE printout (including all four hydromorphone prescriptions, three of these being for 160 dosage units or more of the 8mg. dosage), see RX 6, at 7, and all four hydromorphone prescriptions listed on T.S.'s E-FORCSE printout, each of these being for 150 or more dosage units of the 8 mg. dosage. Id. at 30.

    Respondent submitted a further exhibit, RX 11, which contained documentation related to other customers. Respondent's Owner & PIC testified that this exhibit was “generated . . . [t]o show in good faith that we are actually conducting best practices. . . . That we document good practice when we fill the patient—we're filling pain medication for sick patient.” Tr. 1173-74. The exhibit consist of a photocopy of the driver's licenses of three of the six customers for whom the prescriptions in GX 14 were written; a Relationship Affidavit signed by two of the six customers; and a one page E-FORCSE printout dated months after the corresponding prescriptions in GX 14 were written and filled.

    I afford Dr. Gordon's statement of the pharmacy's/pharmacist's standard of practice regarding controlled substances controlling weight in this proceeding. I find that the requirements incumbent on pharmacies/pharmacists espoused by Respondent's Owner and PIC are only entitled to credit as I determine what actions Respondent took and Respondent's suitability to be a registrant. Essentially, the views of Respondent's Owner and PIC about a pharmacy's/pharmacist's obligations with respect to dispensing controlled substances reflect an abdication of her legal responsibility to a prescriber with a valid State license and whose DEA registration covered the schedule of the prescribed medication when the customer simply signed the Relationship Affidavit. Significant aspects of the pharmacy's/pharmacist's obligations espoused by Respondent's Owner and PIC were contrary to statute, regulation, and Agency precedent. I categorically reject them.

    Allegations That Respondent Failed To Exercise Its Corresponding Responsibility When It Dispensed Controlled Substances Pursuant to Prescriptions Not Issued in the Usual Course of Professional Practice or for a Legitimate Medical Purpose

    The Show Cause Order alleged that Respondent failed to exercise its corresponding responsibility under 21 CFR 1306.04(a) as evidenced by its having dispensed controlled substances without resolving “red flags of diversion” that were present. The Government alleged seven “red flags of diversion” in the Show Cause Order: Prescriptions presented by customers who traveled long distances to Respondent; multiple customers filling prescriptions written by the same prescriber, for the same drugs, in the same quantities, on the same day; multiple customers from the same address coming to Respondent at the same time with prescriptions from the same doctor for the same drug and strength; customers presenting two prescriptions, both for the same immediate release controlled substance, but for different strengths; customers presenting prescriptions with a combination of an opiate and a benzodiazepine or “drug cocktail” popular among drug abusers; customers paying for their prescriptions with cash, when other red flags of diversion were present; and customers presenting new prescriptions for controlled substances when they should not have finished their previous prescription for that drug (“early fills” or “early refills”).

    Prescriptions Presented by Customers Who Traveled Long Distances to Respondent

    The Government alleged that customers traveling long distances to fill their prescriptions was a “red flag of diversion,” and that Respondent dispensed controlled substances to customers who traveled long round-trip distances, from their homes, to the prescribers, to Respondent, and then back home, without addressing or resolving the distance red flags. To support this allegation, the Government submitted 13 such prescriptions filled by Respondent. See GX 8/8a; 17 see also Tr. 53 (DI testifying that GX 8 contained fair and accurate copies of the documents Respondent provided to him). Of the 13 prescriptions in GX8/8a, nine were for Dilaudid 8mg.18

    17 The materials in GX 8 and GX 8a, 13 prescriptions and corresponding prescription labels, were identical. There were driver's licenses associated with nine of the 13 prescriptions/prescription labels. GX 8a contained better copies of most of the driver's licenses than GX 8. Tr. 793. Those better copies were added to GX 8 as GX 8a during the hearing on June 11, 2015. Id. at 794.

    18 The other four were for buprenorphine (2), Xanax, and testosterone.

    The DI testified that he initially identified the prescriptions in GX 8/8a as “problematic” because they showed “[p]eople traveling long distance[s] to the pharmacy.” Tr. 50-51. The parties stipulated to sets of round-trip (by road) miles within the State of Florida. ALJX 20, at 1-2. Those sets of round-trip miles corresponded to miles traveled by customers for whom Respondent filled prescriptions listed in the Show Cause Order and included in GX 8/8a. In sum, the round-trips ranged from 184 miles to 661 miles. I make the following findings:

    • One bottle of Buprenorphine Hydrochloride 0.3 mg/mL issued to FW of Deltona by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Deltona to Hallandale Beach and back to Deltona is 504 miles.

    • 150 tables of Dilaudid 8 mg. issued to GA of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to Hallandale Beach and back to Fort Pierce is 261 miles.

    • 168 tablets of Dilaudid 8 mg. issued to SB of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to

    Hallandale Beach and back to Fort Pierce is 261 miles.

    • 150 tablets of Dilaudid 8 mg. issued to CW of Fort Pierce by Dr. RT of Miami. The parties stipulated that the distance by road from Fort Pierce to Miami to Hallandale Beach and back to Fort Pierce is 261 miles.

    • One bottle of Buprenorphine Hydrochloride 0.3 mg/mL issued to MW of Hobe Sound by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Hobe Sound to Hallandale Beach and back to Hobe Sound is 166 miles.

    • 140 tablets of Dilaudid 8 mg. issued to DK of Jensen Beach by Dr. NG of Hallandale Beach. The parties stipulated that the distance by road from Jensen Beach to Hallandale Beach and back to Jensen Beach is 195 miles.

    • 56 tablets of Dilaudid 8 mg. issued to BS of Port St. Lucie by Dr. ML of Hollywood. The parties stipulated that the distance from Port Saint Lucie to Hollywood to Hallandale Beach and back to Port Saint Lucie is 201 miles.

    • 150 tablets of Dilaudid 8 mg. issued to TS of Sebastian by Dr. RT of Miami. The parties stipulated that the distance from Sebastian to Miami to Hallandale Beach and back to Sebastian is 318 miles.

    • One bottle of testosterone cypionate 210 mg/mL issued to RV of Sebring by Dr. AF of Hallandale Beach. The parties stipulated that the distance by road from Sebring to Hallandale Beach and back to Sebring is 312 miles.

    • 112 tablets of Dilaudid 8 mg. issued to BR of St. Pete Beach by Dr. DJ of Deerfield Beach. The parties stipulated that the distance by road from Saint Pete Beach to Deerfield Beach to Hallandale Beach and back to Saint Pete Beach is 538 miles.

    • 112 tablets of Dilaudid 8 mg. issued to WP of Stuart by Dr. GF of Pembroke Park. The parties stipulated that the distance by road from Stuart to Pembroke Park to Hallandale Beach and back to Stuart is 184 miles.

    GX 8/8a.

    Dr. Gordon testified that the long distances the customers traveled in connection with obtaining and filling all of the prescriptions in GX 8/8a were red flags. Tr. 353-62, 365, 368, 370, 372, 374-77, 380-82, 384-85, 387-92. She explained: “Pharmacies that dispense prescriptions that are not for legitimate medical purpose, they have a tendency to develop a reputation. And then the other drug seekers find out about it, and they'll go to any distance to get what they need for their—to satisfy their addiction.” Id. at 355.

    For 12 of the 13 prescriptions, Dr. Gordon was asked to look for notations on the prescriptions evidencing that the filling pharmacist had taken steps to attempt to resolve the prescriptions' red flags, or she looked for notations herself. She found none. Id. at 356, 364, 369, 371, 373, 374, 377, 381-82, 384, 387-88, 389-90, 391. On cross examination, Dr. Gordon testified to the absence of documentation on the other prescription. Id. at 494. Dr. Gordon was asked whether the distance red flags on 12 of the prescriptions were resolvable. She testified they were not. Id. at 355, 367, 369, 371, 373, 374, 377-78, 382, 384, 388, 390, 391. She was not asked about the resolvability of the distance red flag on the other prescription, but said that its red flag had not been “resolved.” Id. at 364. Of that prescription, she also stated: “That's a very long distance [261 miles from Fort Pierce to Miami to Hallandale Beach to Fort Pierce] for somebody that has pain to be driving—sitting in a car for that long to obtain Dilaudid 8, which is the highest milligrams it comes in.” Id. at 361.

    In sum, Dr. Gordon concluded that none of the 13 prescriptions was legitimate and that the pharmacist who filled the prescriptions had not exercised her corresponding responsibility to make sure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 357, 364-65, 367-78, 370, 371, 373, 375, 378, 382, 385, 388, 390, 391-92.

    Mr. Fisher's testimony about whether distance was a red flag was inconsistent. At one point, Mr. Fisher testified that the prescriptions included in GX 8 evidenced distance red flags, and that he believed they could have been resolved. Id. at 596-97. “Usually,” he stated, “a prescription is going to be filled close to where the physician is or close to where the person lives.” Id. at 597; see also id. at 601 (Mr. Fisher's testimony that Fort Pierce is a “distance from the area.”). At another point, however, Mr. Fisher appeared to testify that distance was a red flag only when Respondent was asked to fill prescriptions for intrastate customers, as opposed to out-of-state customers, even though out-of-state customers would be located further from Respondent than intrastate customers. Id. at 745. The CALJ sought clarification, asking: “[I]f a person was a long distance but they were in Florida, that would be a red flag. But if a person was living a long distance . . . in Georgia, that's not a red flag? . . . So what's your final answer; that it is a distance red flag or it's not.” Id. at 745-46. Mr. Fisher responded: “It's a distance red flag, which is resolvable.” 19 Id. at 746; see also id. at 754. Thus, Mr. Fisher eventually agreed with the testimony of the Government's expert that customers who traveled long distances to fill controlled substance prescriptions were red flags.

    19 When Respondent's counsel argued that Mr. Fisher “did not testify in all other cases that the distance was a factor and testified in this case—. . . I'm talking about as out-of-state prescriptions, that distance is not a factor” and that “[t]he method of delivery is completely different . . . [s]o those two are not even analogous,” the CALJ responded: “The record will stand as it is.” Tr. 746-47.

    Respondent's Owner and PIC admitted that Respondent filled the prescriptions in GX 8/8a. Id. at 979. She testified that it was not a red flag “by itself” for customers within the State of Florida to come over 100 miles from their homes to fill a controlled substance prescription at her pharmacy. Id. at 1028; see also id. at 1021-22 (In 2012 and 2013, “the fact that a patient traveled a long distance . . . was not a major red flag, no.” There were “other red flags that I was concentrating on.”).

    Respondent submitted CII/CIII Rx Verification Forms for four of the 13 prescriptions in GX 8/8a.20 RX 6, at 6, 10, 21, and 29. According to Respondent's Owner and PIC, these four forms were part of Respondent's “patient files,” the “documents—prescriptions, prescription labels, and corresponding documents which assisted me to resolve the red flags made by . . . [Respondent] and kept in the regular course of business.” Tr. 824-25. She asserted that the CII/CIII Rx Verification Form was a “step ahead,” and “above and beyond” the “general practice of most of the pharmacies in the State of Florida.” Id. at 1001. She further testified that “[i]nstead of writing scribbles on the back of the prescription, . . . you have, more or less, here on form.” Id. at 1002.

    20 The CII/CIII Rx Verification Forms concern the prescriptions in GX 8/8a written for SB, CW, DK, and TS.

    While the forms contained diagnosis codes, only two of the forms were initialed by the pharmacist, and none of the forms contained any notes explaining how Respondent's pharmacist resolved whatever prompted her to call the prescriber even though the form contained three lines for this purpose. RX 6, at 6, 10, 21, 29. Regarding the incompletions, Respondent's Owner and PIC testified both that: (1) “Sometime we get busy, I know the office is called” and “I did look at the paper, because I would not fill the prescription unless I look at the paper;” and (2) “[i]f it's a routine patient who comes—who's been already established by me, . . . same prescription that's filled before, we would just—probably would be a little bit more routine in the call.” Id. at 1004, 1005-06 (respectively). This testimony of Respondent's Owner and PIC was inconsistent with her testimony that “When all the schedule II prescriptions—I would talk to doctor on each prescription.” Id. at 1116.

    Respondent's Owner and PIC stated that she did not document all her conversations with doctors because “it's my kind of internal—I did it to make a proper, sound clinical judgment whether this patient appropriate to get . . . these filled prescriptions.” Id. at 1010. Notably, she stated that, “I do accept responsibility for that and I don't do it any more. Now I document every little thing that it's concerned to the conversation and the dispensing of controlled substances.” Id. She also said that, “again, like I said, I accept responsibility for that and I improve my practice now. I do document everything that's possible to. However, like I said, this happens all the time.” Id. at 1011. She added that “we cannot have 100 percent even if it's red flag. . . . You try to do the best that you can, but sometimes it happens.” Id. at 1012.

    The CALJ noted that “it seems to me that on the form that you're giving me, the place that that should have been noted is down at the bottom where it says `notes,' and also the pharmacist's initials if you had made the call.” 21 Id. at 1013. Respondent's Owner and PIC, correlating the exercise of her corresponding responsibility with her practice in school of “taking very little notes,” admitted that “I do have a tendency not to take too many notes” and confirmed that “I should learn how to take better notes.” Id. at 1014. She said that she “took remedial steps for it” by “hir[ing] new person who actually specifically look if I leaving the notes . . . and everything is properly taken right now.” Id. Further, Respondent's Owner and PIC admitted that red flags identified from E-FORCSE were not noted, nor was their resolution documented, on the corresponding CII/CIII Rx Verification Form. Id. at 1010.

    21 Two of the forms' “Pharmacist's Initials” sections were completed. No form's “Notes” section contained a note.

    Based on the testimony of both Dr. Gordon and Mr. Fisher, I reject the testimony of Respondent's Owner and PIC that “the fact that a patient traveled a long distance . . . was not a major red flag.” I further find not credible the testimony of Respondent's Owner and PIC that she did not consider a controlled substance prescription presented by a customer who travelled a long distance to be a red flag and conclude the exact opposite to be the case.

    I find that each of the prescriptions in GX 8/8a raised at least one red flag that required resolution in that customers traveled long distances to obtain controlled substances, including schedule II controlled substances that even Respondent's Owner and PIC admitted were “highly risky” and subject to “a lot of diversion.” Id. at 1129, 1116, respectively. I find that Respondent admitted filling the prescriptions in GX 8/8a. Based on the testimony of both Dr. Gordon and Mr. Fisher, I find that, at a minimum, the distances the patients traveled to present the prescriptions in GX 8/8a required Respondent to resolve the distance red flags before dispensing controlled substances. I further find that Respondent did not address or resolve the red flags before filling the prescriptions in GX 8/8a.

    Multiple Customers Filling Prescriptions Written by the Same Prescriber, for the Same Drugs, in the Same Quantities, on the Same Day

    The Government alleged that prescriptions written by the same prescriber, for the same drugs, in the same quantities, and on the same day was a “red flag of diversion,” and that Respondent filled such prescriptions without resolving that red flag. As support for this allegation, the Government submitted five prescriptions that were written by the same doctor (Dr. A.F.) on the same day (June 27, 2012), and for the same strength of the same medication (testosterone cypionate). See GX 10; see also Tr. 394 (testimony of Dr. Gordon), Tr. 67 (DI testifying that GX 10 contained fair and accurate copies of documents he obtained from Respondent on April 11, 2013), and Tr. 68. Respondent filled them all on June 28, 2012, between 11:24 a.m. and 12:56 p.m., a period of about an hour and a half. GX 10.

    In Dr. Gordon's view, “[t]hese prescriptions present a big red flag.” Tr. 394. “[I]t's odd,” she testified, “that a compounded script would be made exactly the same for each of these patients, which means there's not individualized therapy.” Id. The lack of individualized treatment meant to Dr. Gordon that “the prescriptions were not written for a legitimate medical purpose.” Id. at 396. She testified that she did not see any notations on the prescriptions evidencing that a pharmacist attempted to address the red flags. Id.; see also R.D., at 49 (Respondent's Owner and PIC “conceded that the paperwork furnished to the DIs at the April 11th Inspection did not memorialize any attempts to resolve this red flag and agreed that she did not have any paperwork documenting her identification or resolution of the issue.”). Dr. Gordon's testimony was that this red flag was not resolvable. Tr. 396. She testified that the pharmacist who filled the prescriptions did not exercise her corresponding responsibility to ensure that the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 396-97.

    At first, the “only comment” that Mr. Fisher had about the prescriptions in GX 10 was that “there doesn't seem to be a quantity that's identifiable.” Id. at 618. When asked specifically about the fact that the prescriptions came from the same doctor and for the same drug, Mr. Fisher testified that, “[i]f the doctor is specializing in men's health . . . , he could have multiple patients on the same regimen of drugs.” Id. at 619. On cross examination, however, Mr. Fisher admitted that the five prescriptions were an example of “pattern prescribing,” or when “a doctor . . . writes the same thing for every single patient that comes in.” Id. at 769. Mr. Fisher then testified that pattern prescribing was a “red flag for diversion.” Id.

    Respondent's Owner and PIC testified that the prescriptions raised a red flag because they were for a “schedule [sic] medication, testosterone.” 22 Id. at 1084. She testified that she resolved this red flag by asking the prescribing doctor “if she knows the purpose of this . . . treatment, and if the patient are . . . taking it for an appropriate use.” Id.

    22 Respondent's Owner and PIC testified that the red flag for the testosterone prescription on page 3 of GX 10 was the customer's age, 27 years old. Tr. 1086. She stated that she spoke with the doctor about this prescription and the “doctor assured me that this patient has low testosterone and he needs because he feels very tired and he's not going to use it for athletic purposes. He was not an athlete.” Id.

    Respondent's Owner and PIC also testified that these five prescriptions raised red flags because “[t]hey came on the same day with the same medication at the same . . . dose . . . [a]nd the same doctor.” Id. at 1092. At this juncture, her testimony about how she resolved the red flags was that she spoke with the doctor. Id. at 1092-93. She testified that, “The reason . . . they come on the same day, because the doctor designated that day to see patients who need hormonal replacement. . . . [I]t helps her to keep the records straight . . . . [T]hey start out on the same dose. This way it's easier to achieve the day to day concentration of the dose.” Id. In response to whether she had any notes “anywhere” documenting her conversation with the physician, Respondent's Owner and PIC replied, “Not here, no.” Id. at 1094.

    Based on all of the evidence in the record, I find that Respondent filled prescriptions that raised the red flag of multiple customers presenting prescriptions written by the same prescriber on the same day for the same medication in the same quantity. I further find that, even if these red flags were resolvable, there was no credible evidence that Respondent addressed or resolved them before filling the prescriptions. I cannot, and do not, place any weight on the testimony of Respondent's Owner and PIC that she resolved these red flags because she produced no documentary evidence to support her claim that she attempted to and, in fact, did resolve them before filling the prescriptions.

    Multiple Customers From the Same Address Coming to Respondent at the Same Time With Prescriptions From the Same Doctor for the Same Drug and Strength

    The Government alleged that multiple customers from the same address coming to Respondent at the same time with prescriptions written by the same doctor for the same drug and strength was a “red flag of diversion,” and that Respondent filled such prescriptions without resolving that red flag. To support this allegation, the Government submitted two prescriptions for Dilaudid 8 mg. that Respondent filled within five minutes of each other. See GX 11. The prescriptions were written by the same doctor on the same day with the same use directions to two individuals with the same last name and street address in Hollywood, Florida. See Tr. 397-98; see also id. at 70 (DI testifying that GX 11 consisted of true and accurate copies of prescriptions and labels he took from Respondent on April 11, 2013) and id. at 71 (DI testifying that the prescriptions in GX 11 were for two customers living at the same address, who saw the same doctor, were prescribed the exact same drug and strength, and then took those prescriptions to Respondent at the same time). The difference between the two prescriptions was that one was for 80 tablets and the other was for 85 tablets. Id. at 397; see also GX 11, at 1, 3.

    In Dr. Gordon's opinion, these prescriptions raised multiple red flags that were not resolvable. Tr. 397-98. She testified that: “This to me is what's called rubber-stamping from a physician, and is not individualized therapy. . . . It's unusual that two patients that live at the same address would receive the same exact therapy. There's always an exception to the rule, but this is common in the drug-seeking community . . . .” Id. Dr. Gordon also testified that there were no notations on the prescriptions addressing the red flags. Id. at 398. Her opinion was that the prescriptions were not legitimate and that the pharmacist who filled the prescriptions had not exercised her corresponding responsibility to ensure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 398-99.

    Mr. Fisher agreed with Dr. Gordon that the prescriptions raised red flags. He testified that the “same address for two different people” and the “same drug” were red flags associated with these prescriptions. Id. at 620. He considered it “very possible” that the prescriptions were for husband and wife who had a reason for going to the same doctor at the same time. Id. He suggested that “[s]peaking to the physician would be the easiest way” to resolve those red flags. Id. On cross-examination, Mr. Fisher agreed that a pharmacist's “due diligence . . . [and] the standard way to try to prevent diversion of drugs” required the pharmacist to “check the other things available . . . [l]ike the E-FORCSE system, . . . the doctor's license number, and all that. The routine things you do with a Schedule II prescription.” Id. at 771. He also contradicted his earlier testimony when he admitted that, in this situation, a “simple phone call to the doctor” might not achieve the level of satisfaction concerning the prescriptions' legitimacy the “pharmacist has to get . . . before they can fill the prescription,” because “the doctor, himself, may not have issued . . . [the prescriptions] for legitimate medical purpose[s] in the course of his professional practice.” Id. at 771-72.

    According to Respondent's Owner and PIC, the fact that the prescriptions were written by the same doctor, for the same drug and dosage, for individuals living at the same address who had the same last name and presented the prescriptions on the same day did not raise a red flag. Id. at 1097-98. She testified that she “would treat . . . [the prescriptions] the same way I treat every other schedule II medication.” Id. at 1098. She also stated that she filled the prescriptions because, at the time, “I thought the circumstances of the prescriptions were understandable.” Id. at 1103-04. She then stated that, as of 2015, she would not fill them “[b]ecause the DEA have restriction on filling those prescriptions[,] . . . [n]ot because the patient are not legitimate and not because of doctor not legitimate or not legitimate medical purpose. Only because DEA said do not fill those prescriptions.” Id. at 1104. When asked if someone at DEA told her not to fill schedule II prescriptions, Respondent's Owner and PIC responded: “Obviously, if they bring me that case, that what they saying to me. They will try to take—intend to revoke my license for filling those prescriptions. . . . The[y] didn't tell me—not until they come with this order to show cause.” Id. at 1104-05.

    Based on all of the evidence in the record, I find that the prescriptions in GX 11 raised red flags because customers with the same last name and street address presented them, and they were written on the same day by the same doctor for the same drug and strength. Further, I find that Respondent admitted filling the prescriptions even though these red flags were not resolvable, according to Dr. Gordon's testimony. I find that, even if these red flags were resolvable, there was no credible evidence in the record that Respondent addressed or resolved them before it filled the prescriptions. Respondent's Owner and PIC offered no evidence to substantiate her testimony that the circumstances of the prescriptions were “understandable” and did not raise red flags. I afford her testimony no weight.

    Customers Presenting Two Prescriptions, Both for the Same Immediate Release Controlled Substance, but for Different Strengths

    The Government alleged that a “red flag of diversion” was raised when customers presented two prescriptions for the same immediate release controlled substance, but for different strengths, and that Respondent filled such prescriptions without addressing or resolving the red flag. As support for this allegation, the Government submitted four such prescriptions filled by Respondent. See GX 12. The four prescriptions consisted of two prescriptions each for Dilaudid 8 mg. and Dilaudid 4 mg. written for two different people. Tr. 399, 405-06; see also id. at 72 (DI testifying that GX 12 contained true and accurate copies of documents he took from Respondent on April 11, 2013) and id. at 73 (DI testifying that the prescriptions in GX 12 belonged to two patients for the same immediate-release drugs and strengths). Dr. Gordon testified that the prescriptions raised red flags. Id. at 399-400, 403-04. The first red flag she identified was that the two prescriptions were written for the same immediate release controlled substance, but for different strengths. Id. at 399. The second red flag she identified was the diagnosis of “lumbar radiculopathy.” Id. at 400.

    Dr. Gordon explained that giving one person two prescriptions for two immediate release opioids was not necessary because the Dilaudid 8 mg. could be broken in half to get a 4-milligram dose. Id. at 399. She pointed out that there was no long-acting medication accompanying the prescriptions in GX 12 and that “[t]wo immediate-release opioids is . . . a common red flag for diverted prescriptions.” Id.; see also id. at 399-400. She explained: “In pain management . . . you start out with a short-acting. Then based on the amount of short-acting, you prescribe a long-acting, because if you were in pain, I wouldn't want you to have to take something every four hours. . . . So what we do is we recommend . . . a long-acting . . . with a break-through.” Id. at 401. Her testimony further explained that “it looks like the practitioner was trying to say that you could only take Dilaudid, 4 milligrams, one, three times a day . . . [but] [i]t won't last eight hours. So that's the first red flag.” Id. at 403. She continued, asking rhetorically “why would you take a higher dose of a break-through? It doesn't make any sense.” Id. Drawing from her experience, she testified that “it would have made more sense for him to schedule the eight[;] . . . it's usually the same dose for break-through.” Id.

    Dr. Gordon also testified that the diagnosis of “lumbar radiculopathy” was “a red flag to take pause for any reasonable pharmacist to make sure the prescriptions are legit.” Id. at 400. See GX 12, at 1-2. She explained that, “on prescriptions that are not legit, that's the pattern I've seen—lumbago is big on illegitimate prescriptions—and most of my colleagues as well.” Tr. 404.

    When asked if she would “reach out to the prescriber” if she “were in a retail pharmacy and . . . saw a prescription like this coming in with two short-actings,” Dr. Gordon responded “[n]o. . . . I would give the prescriptions back to the patron.” Id. at 402. She stated that the red flags raised by the prescriptions were not resolvable. Id. at 405, 406. Dr. Gordon testified that there were no notations on the prescriptions addressing the red flags, and gave her opinion that the prescriptions were not legitimate and that the pharmacist who filled the prescriptions did not exercise her corresponding responsibility to ensure the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 404-05, 406-07; see GX 12, at 1-8.

    Mr. Fisher agreed that “two prescriptions written for the same person for the same drug but different strengths” was a red flag. Tr. 620-21. He testified that he would speak to the doctor to resolve it because it's “[c]ommonly done” to “try[ ] to achieve a certain therapeutic level by combining the two doses . . . [because] [t]he 8 milligrams is not enough for the patient, so they do 12.” Id. at 621. Mr. Fisher testified that a consistent therapeutic level would be achieved if the medication were taken as directed during a 24-hour cycle. See id. at 624. He stated that “three times a day, you're going to take it probably . . . . You're not taking it in the middle of the night. You're probably going to take it morning, noontime, and suppertime. And then he goes to work and he needs something stronger and he takes the stronger dose. . . . It is common.” Id. at 624-25.

    Respondent's Owner and PIC testified that the only red flag she associated with the prescriptions in GX 12 was that they were for schedule II controlled substances. Id. at 1115, 1129. When asked if “the fact that there was two different strengths of the same medication, issued to the same patient on the same day by the same doctor . . . constitutes a red flag,” Respondent's Owner and PIC replied in the negative “because there is a logical explanation to it.” Id. at 1115. “That's done . . . to achieve certain dosage variance,” she stated. Id. After further questioning on the subject, Respondent's Owner and PIC stated that she “spoke with the doctor about it and doctor approved the dose.” Id. at 1121; see also id. at 1132-33. She added that the doctor was “still practicing . . . [a]nd the patient tells me that's how he benefits the most.” Id. at 1121. She testified similarly regarding the prescriber of the other prescriptions in GX 12. Id. at 1126.

    When asked whether she had, for these prescriptions, “the same documentation that you've shown before . . . [l]ike . . . the patient agreement and the PMP report and a note that somebody checked with the doctor,” Respondent's Owner and PIC answered affirmatively. Id. at 1121-22. She admitted that she had not, however, provided the same documentation. Instead, she stated that the existence of the “approved” stamp and “my personal stamp with my signature on it” meant that “I spoke with the doctors. . . . And documents were obviously generated when he comes—visiting the pharmacy, otherwise I would not dispense it.” Id. at 1122. When asked, however, whether “[e]very time you see that stamp, you spoke with the doctor,” Respondent's Owner and PIC declined to respond in the affirmative. Id. at 1136-37. She stated, “I have to go each prescription by—let's go one-by-one each prescription, I tell you each one I spoke with.” Id. at 1137. She testified that, “I called—as far as I remember, on each prescription, every time it's presented to me, I called the office. Not necessarily I would speak every time with the doctor. . . . But the practice was at the pharmacy, we verify every prescription.” Id. at 1138. During cross-examination, Respondent's Owner and PIC testified that the absence of the stamps would not mean that a prescription was not valid “[b]ecause, again, there's sometimes human distractions and errors, some paper can be missed. . . . Again, I was not obligated by either the State or law to stamp those prescriptions.” Id. at 1226. She testified that, “I did my best attempt to make sure there's no fraudulent prescription I fill there. Or there's no valid DEA numbers or there's, like, no major violation or diversion with the prescriptions.” Id. at 1227.

    Respondent's Owner and PIC was satisfied, she testified, when she filled the prescriptions in GX 12 that each “prescription was filled for medical purpose within the scope of a physician practice.” Id. at 1139.

    Based on all of the evidence in the record, I find that Respondent, without addressing or resolving the red flags, filled prescriptions that raised the red flag of customers presenting two prescriptions for the same immediate release controlled substance but for different strengths. The testimony of Respondent's Owner and PIC, including her testimony that she filled each prescription in GX 12 only after being satisfied they were for a medical purpose within the scope of a physician practice, was not credible. First, it directly conflicted with her original testimony denying that the circumstances raised a red flag and, second, she did not produce any documentary evidence to corroborate her statements.

    Customers Presenting Prescriptions With a Combination of an Opiate and a Benzodiazepine or “Drug Cocktail” Popular with Drug Abusers

    The Government alleged that prescriptions with a combination of an opiate and a benzodiazepine are “drug cocktails” popular with drug abusers and, therefore, raise “red flags of diversion,” and that Respondent filled such prescriptions without addressing or resolving those red flags. To support this allegation, the Government submitted seven sets of prescriptions (a total of 14 prescriptions) that Respondent filled and dispensed to its customers containing an opiate and a benzodiazepine. Id. at 407, 412, 414-15, 417, 421, 422-23, 424; see GX 13; see also Tr. 73-74 (DI testifying that GX 13 consisted of true and accurate copies of documents he took from Respondent during the unannounced inspection) and Tr. 74-75 (DI testifying that the prescriptions in GX 13 were for a common drug cocktail of a narcotic pain reliever and a benzodiazepine, both at their highest strengths).

    Drug Number of tablets Date written Customer's initials Dilaudid 8 mg 116 11/20/12 D.C. Xanax 2 mg 43 11/20/12 D.C. Dilaudid 8 mg 140 12/27/12 D.C. Xanax 2 mg 42 12/27/12 D.C. Dilaudid 8 mg 140 1/24/13 D.C. Xanax 2 mg 42 1/24/13 D.C. Dilaudid 8 mg 162 10/26/12 L.F. clonazepam 2 mg 30 10/26/12 L.F. Dilaudid 8 mg 162 12/21/12 L.F. clonazepam 2 mg 30 12/21/12 L.F. Dilaudid 8 mg 70 10/12/12 B.K. Valium 10 mg 42 10/12/12 B.K. Dilaudid 8 mg 35 11/9/12 B.K. Valium 10 mg 42 11/9/12 B.K.

    According to Dr. Gordon, these seven pairings of prescriptions were considered “cocktail medications,” red flags, because they were multiple drugs that suppressed the central nervous system and, when taken together, could give euphoria. Tr. 408, 412, 414-15 (maximum strength of Dilaudid and Xanax), 417, 421, 422 (highest Valium dose available), 424 (highest doses available), 546, 547. She elaborated on what makes a drug cocktail by testifying that it consisted of “drugs that cause you to have a high.” Id. at 547. “So it could be an opioid, it could be an upper and a downer,” she stated. Id. She explained that the “person could be taking the drugs to get a high during the day and then a low at night. . . . “[I]t's not being used for what it's intended to be used for.” 23 Id. She explained that “these two drugs are very highly sought after on the street.” Id. at 409. In her opinion, the drug pairings were “surrounded by diversion.” 24 Id. at 410; see also id. at 413-14.

    23 Dr. Gordon testified that the prescriptions would not raise a red flag for her if they were written by a “Hospice doctor [or] oncologist.” Tr. 545.

    24 Dr. Gordon identified additional red flags regarding the prescriptions in GX 13: First, the prescriptions on pages 13 and 15 were written for a male (LF) living in Davie and traveling a long distance to Miami to see an OB/GYN (Dr. R.T.); second, the diagnosis written on the prescription on page 13 was lumbago, a common diagnosis that doctors used on diverted prescriptions; and third, the repeat customer (LF) for the prescriptions on pages 13 through 19 written by Dr. R.T. was receiving the same cocktail medications with no long-acting medication present. Tr. 16-17, 418, 420-21.

    Dr. Gordon addressed whether a muscle relaxant had to be present to constitute a drug cocktail. She stated that, “Cocktail medications usually . . . are a combination of an opioid plus or minus a benzo plus or minus a muscle relaxant.” Id. at 408. Then she explained: “But what I've seen . . . lately is the doctors have stopped the Soma, and they are just doing, now, high doses of Dilaudid, high doses of benzos. It used to be Oxys. Now they've switched to hydromorphone. So you see . . . the flags change.” Id. She added that, “I see the physicians and drug diverters trying to eliminate one of the components of the cocktail to try to get away with diverted drugs.” Id. at 538.

    Dr. Gordon testified that she saw no notations by the pharmacist on the prescriptions attempting to resolve the red flags and, in her opinion, the “cocktail” red flags were not resolvable. Id. at 411, 414, 416, 418, 421, 423, 424-25. She specifically testified that the prescriptions were not legitimate and that the pharmacist who filled the prescription pairings did not exercise her corresponding responsibility to ensure that the prescriptions were issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 411-12, 414, 416, 418-19, 421-22, 423, 425.

    Mr. Fisher stated that he did not consider the drugs in the prescriptions in GX 13 to be cocktails. Id. at 629, 631, 632, 633. He elaborated: “To me a cocktail is when you have a combination of three drugs: alprazolam, oxycodone or hydrocodone, and carisoprodol. This to me looks like a simple case of a patient getting pain medication and some Xanax for anxiety.” Id. 629; see also id. at 630 (“[I]n everything I have read and have seen and talked to and have heard at meetings, it's a combination of the three drugs represents the cocktail.”). Mr. Fisher agreed that “[a]s things have changed, yes, other drugs have been added like the hydromorphone that's come into play.” Id. at 629-30. He testified that what makes a cocktail is “more the street value of the drugs.” Id. at 630.

    On cross-examination, Mr. Fisher reaffirmed his opinion that a cocktail involves an opioid, a benzodiazepine, and carisoprodol. Id. at 772. He acknowledged that a customer could obtain the opioid and the benzodiazepine from one pharmacy and the carisoprodol from a second pharmacy. Id. at 772-73. He agreed that “the only way to check for that would be through use of . . . E-FORCSE.” Id. at 773. Mr. Fisher also agreed that Respondent, “not having access to query E-FORCSE, would not be able to . . . check for that, those instances of drug seekers using other pharmacies or doctors to obtain a third drug that could be used in this cocktail.” Id. On re-direct, Mr. Fisher stated that, beside using E-FORCSE, other ways to resolve any red flags associated with GX 13 were “[c]all the physician, discuss their treatment modality for the patient, [c]heck the patient's profile if you maintain one[,] . . . [and] [i]f you have a computer system you could check and see if there's a history of the patient getting other prescriptions filled.” Id. at 779.

    Respondent's Owner and PIC did not agree that the prescriptions in GX 13 constituted a drug cocktail because, in her view, a drug cocktail had four components: two opioids, carisoprodol, and a benzodiazepine. Id. at 1142. “It's multiple—it's two—for instance, oxycodone and Vicodin together with Soma and benzodiazepine,” she stated. Id. According to Respondent's Owner and PIC, she “didn't fill those prescriptions for the Soma, benzodiazepine, carisoprodol,” and she did not recall ever filling a benzodiazepine, Soma, and opiate combination for any patients. Id. at 1144, 1145.

    Respondent produced an exhibit containing various documents concerning the three customers who asked Respondent to fill the prescriptions in GX 13. RX 10. According to the testimony of Respondent's Owner and PIC, Respondent compiled or generated the documents in RX 10 “at that time in 2013” because “[w]e tried to implement as much possible steps and follow them through as much as possible to make sure that . . . steps are taken . . . that's preventing. . . . Also, . . . that's why . . . when the patient knows the pharmacy takes extra steps and scrutinize the prescriptions, people who has non-valid prescription not come to me.” Tr. 1157-58.

    Page 2 of RX 10 was the Relationship Affidavit signed by DC, the same DC associated with six prescriptions in GX 13 (pages 1 through 12). See id. at 1145-46. Similarly, the Relationship Affidavit on page 5 of RX 10 was signed by LF, the same LF associated with pages 13 through 20 of GX 13.25 See id. at 1148-49.

    25 LF did not complete the Relationship Affidavit in full.

    Respondent also provided registration validation pages purportedly printed from DEA's website. According to Respondent's Owner and PIC, the DEA registration validation website satisfied her that, on the day she filled LF's Dilaudid and clonazepam prescriptions, the prescribing physician was “allowed to prescribe the pain medications.” Id. at 1149; see RX 10, at 6; GX 13, at 17, 19. Likewise, according to Respondent's Owner and PIC, the DEA registration validation website showed her that the physician who prescribed prescriptions for BK “was actually scheduled to prescribe schedule II narcotics.” Tr. 1156; see RX 10, at 12; GX 13, at 21-27.

    Respondent also submitted a hand-written note on a piece of prescription paper belonging to the doctor who issued Dilaudid and Valium prescriptions for BK. See RX 10, at 10; GX 13, at 21, 23, 25, and 27. The note was not addressed to anyone. It showed BK's name in the “patient” space, and an age, partial address, and date in the lines of the prescription paper calling for that information. It did not include a diagnosis. The note contained a signature which, according to Respondent's Owner and PIC, was the prescribing doctor's signature. Tr. 1152. The note stated that “the patient cannot tolerate for long periods of kneel, more than 20 minutes of sitting or standing.” Id. Significantly, the date on the note (August 9, 2011) was more than a year and two months before the date on the earliest prescription issued to BK and included in GX 13 as filled by Respondent (October 12, 2012). Compare RX 10, at 10 with GX 13, at 21. Yet, Respondent's Owner and PIC testified that: “Because I've been calling to the doctor and asking about this patient few times . . .[,] [w]e make sure the doctor just write a note.” 26 Tr. 1152. She continued, stating, “[T]his patient has such a difficult time to fill his prescriptions. . . . This patient could not fill prescription anywhere, and then he come to me.” Id. She did not explain how this note led her to conclude that the prescriptions issued to BK were legitimate.

    26 She did not address the timing of how Respondent could have “made sure” the doctor wrote a note more than a year before Respondent filled the earliest prescription in the record.

    Respondent also submitted a “Verification of legitimate purpose of prescribing CII-CV medications To establish legitimate Physician-patient relationship.” RX 10, at 11. It purported to be signed by BK, the individual for whom the Dilaudid and Valium prescriptions on pages 21, 23, 25, and 27 of GX 13 were written. This one-page sheet had space for the customer's name, signature, birth date, and appointment date, for the physician's name and address, and for “yes” or “no” responses to whether the physician or “qualified medical professional” conducted a medical examination, took a blood sample, and had an “MRI on file.” Id.

    I find, based on Dr. Gordon's testimony and consistent with my credibility determinations giving Dr. Gordon's testimony regarding the practice of pharmacy in Florida more weight than any other witness's testimony in these proceedings, that the prescriptions in GX 13 were “drug cocktails” popular with drug abusers. Based on all of the evidence in the record, I find that Respondent filled prescriptions without having resolved the red flags of customers presenting prescriptions with a combination of an opiate and a benzodiazepine which is a common “drug cocktail” popular with drug abusers.

    Customers Paying for Their Prescriptions With Cash, When Other Red Flags of Diversion Were Present

    The Government alleged that customers paying cash for their prescriptions when other red flags of diversion were present was a “red flag of diversion,” and that Respondent dispensed controlled substances to customers without resolving the red flags those prescriptions presented. As support for this allegation, the Government listed 50 prescriptions in the Show Cause Order. ALJX 1, at 5. No testimony disputed the allegations that Respondent filled the 50 prescriptions and that those prescriptions were purchased with cash. I reviewed those 50 prescriptions. Thirty-two of them were for Dilaudid 8 mg. GX 8, 11, 12, 13, 14.

    Drug Number of tablets Date written Cash paid Customer Dilaudid 8 mg 150 12/10/12 $750.00 G.A. Dilaudid 8 mg 168 11/20/12 840.00 S.B. Dilaudid 8 mg 150 12/19/12 750.00 C.W. Dilaudid 8 mg 56 7/9/12 280.00 J.S. Dilaudid 8 mg 140 1/21/13 840.00 D.K. Dilaudid 8 mg 56 9/6/12 40.00 B.S. Dilaudid 8 mg 150 12/28/12 750.00 T.S. Dilaudid 8 mg 112 4/26/12 560.00 B.R. Dilaudid 8 mg 112 11/14/12 560.00 W.P. Dilaudid 8 mg 80 6/22/12 400.00 D.S. Dilaudid 8 mg 85 6/22/12 425.00 B.S. Dilaudid 8 mg 75 9/27/12 375.00 J.F. Dilaudid 8 mg 168 11/29/12 840.00 B.M. Dilaudid 8 mg 116 11/20/12 580.00 D.C. Dilaudid 8 mg 140 12/27/12 28.00 D.C. Dilaudid 8 mg 140 1/24/13 840.00 D.C. Dilaudid 8 mg 162 10/26/12 810.00 L.F. Dilaudid 8 mg 162 12/21/12 810.00 L.F. Dilaudid 8 mg 70 10/12/12 320.00 B.K. Dilaudid 8 mg 35 11/9/12 175.00 B.K. Dilaudid 8 mg 128 10/5/12 640.00 B.K. Dilaudid 8 mg 40 11/2/12 200.00 B.K. Dilaudid 8 mg 180 8/15/12 900.00 J.B. Dilaudid 8 mg 150 9/6/12 750.00 J.B. Dilaudid 8 mg 180 8/30/12 900.00 J.F. Dilaudid 8 mg 150 9/27/12 750.00 J.F. Dilaudid 8 mg 168 3/13/13 1,008.00 L.B. Dilaudid 8 mg 168 4/10/13 1,008.00 L.B. Dilaudid 8 mg 168 12/28/12 840.00 J.S. Dilaudid 8 mg 168 1/23/13 1,008.00 J.S. Dilaudid 8 mg 180 9/7/12 900.00 H.H. Dilaudid 8 mg 180 10/5/12 900.00 H.H.

    The evidence shows that customers paid as much as $1,008.00 for a month's worth of Dilaudid 8 mg.

    Dr. Gordon's testimony explained that payment in cash for a controlled substance was always a red flag, even if a significant sector of the public did not have health insurance. Tr. 363. Paying in cash was a red flag, she testified, because it enabled evasion of processes established to alert a pharmacy that a prescription was being filled too soon. She stated, “A lot of drug-seekers only want to pay for their medications in cash because . . . the computer systems, the insurance company will actually create your red flag for you to say if a prescription is refilled too soon, which means they've gone—obtained a prescription from another pharmacy.” Id. at 297. She elaborated and provided a specific example: “[T]he insurance company will give you that red flag. Because they'll have a claim . . . and they'll . . . say, . . . the patient just got this prescription yesterday from Walgreen's . . . . So . . . the patrons will say, `I don't want you to charge my insurance company.' That way it kind of eliminates that flag.” Id. at 298-99.

    In Dr. Gordon's opinion, the cash prices that Respondent charged its customers were as high as five times the cost Dr. Gordon would have expected. Id. at 362; see also id. at 417, 424, 502, 512. As Dr. Gordon concluded, “that to me means that maybe the pharmacist knew what was going on, and they were taking advantage of these patrons that were drug seeking.” Id. at 362; see also id. at 464-65 (Concerning Respondent's initial charge of $840 for a prescription and subsequent charge of $1,008 for the same exact prescription on the next visit, Dr. Gordon suggested that “the pharmacist actually knew the prescriptions were diverted and . . . was taking advantage of that patron . . . [b]ecause they knew they would pay whatever they needed to pay . . . .”). She explained that “the cost of that medication is high compared to what I've seen out in the field. That's a very high cost. And between Fort Pierce, Miami, and Hallandale, you pass like a zillion pharmacies. . . . It doesn't make sense.” Id. at 362. According to Dr. Gordon, there was no notation made by the pharmacist on the prescriptions showing any attempt to resolve the red flags. See, e.g., id. at 364, 369, 371, 373, 374, 377, 389-90, 398, 404-05, 406, 411, 416, 421, 423, 424-25, 467; see also id. at 133 (DI testimony that he did not see notations on the prescriptions from Respondent “clearing” any red flags).

    Mr. Fisher agreed that “[c]ustomers paying for their prescriptions with cash where other red flags of diversion are present” was a red flag. Id. at 756.

    Respondent challenged Dr. Gordon's cash price-level testimony based on her not having been in charge of purchasing controlled substances for resale for a small independent pharmacy. Id. at 502. Yet, I find Dr. Gordon's testimony to be credible because she “actually looked up the national . . . price.” Id. at 503. Respondent also challenged Dr. Gordon by stating that pharmacies where Dr. Gordon worked “like Walgreens, are getting discounts from the supplier on purchasing controlled medication.” Id. at 502. However, Dr. Gordon testified she was “99 percent sure” that discounts are not available for generic opioids. Id. at 503. Respondent presented no pricing data or other evidence refuting Dr. Gordon's characterization of the higher-than-expected level of cash prices Respondent's customers paid for controlled substance prescriptions. Further, Respondent did not present evidence to establish that its cash prices for controlled substances were consistent with the prices charged by other pharmacies similar to Respondent. Nor did it present evidence to establish that it set the level of its cash prices for controlled substances for a reason other than that its customers were willing to pay those prices. Thus, I find no reason to reject Dr. Gordon's testimony. Rather, I shall credit it consistent with the CALJ's credibility determinations.

    Based on all of the evidence in the record, I find that Respondent, without resolving the red flags, filled prescriptions that raised the red flag of customers paying cash for their prescriptions when other red flags were present. I further find that Respondent's customers were charged, and paid, exorbitantly high prices for their controlled substance prescriptions.

    Customers Presenting New Prescriptions for Controlled Substances When They Should Not Have Finished Their Previous Prescription for That Drug (“Early Fills” or “Early Refills”)

    The last red flag the Government alleged in the Show Cause Order concerned early fills. According to the Government, Respondent filled prescriptions for controlled substances that the customers presented before the customers' previous prescription for that controlled substance should have been consumed. To support this allegation, the Government submitted 22 prescriptions. GX 14, at 1-33, 37-47.27 Twelve of the prescriptions concerned one customer. The other ten prescriptions concerned five different customers. All 22 prescriptions were for Dilaudid 8 mg.

    27 GX 14 included 24 prescriptions, but there were two copies of two of the prescriptions.

    I reviewed the prescriptions the Government submitted and analyzed them according to the standard Dr. Gordon described in her testimony. GX 14; Tr. 436 (“[W]hat most pharmacies do . . . [to determine whether a prescription is an early fill is] they start at when the first prescription was filled.”); see also Tr. 429-67 (Dr. Gordon's testimony concerning GX 14), Tr. 75-76 (DI testifying that GX 14 consisted of true and accurate copies of documents he took from Respondent during the unannounced inspection), and Tr. 76-77 (DI testifying that GX 14 showed Respondent filled new schedule II controlled substance prescriptions before the customers' previous prescriptions should have been exhausted). I make these findings.

    First, Respondent filled 12 prescriptions for BK, dispensing a total of 840 Dilaudid 8 mg. tablets, from July 26, 2012 through November 8, 2012. GX 14, at 1-33, 37-47.

    Customer B.K. Drug Number of tablets/SIG Date written Date filled Dilaudid 8 mg 168—1 every 4 hrs. for pain 7/16/12 7/26/12 Dilaudid 8 mg 168—1 every 4 hrs. for pain 8/13/12 8/13/12 Dilaudid 8 mg 40—1 every 4 hrs. for pain 9/7/12 9/10/12 Dilaudid 8 mg 128—1 every 4 hrs. for pain 9/7/12 9/13/12 Dilaudid 8 mg 40—1 every 4 hrs. for pain 10/12/12 10/12/12 Dilaudid 8 mg 40—1 every 4 hrs. for pain 10/12/12 10/15/12 Dilaudid 8 mg 40—1 every 4 hrs. for pain 10/12/12 10/17/12 Dilaudid 8 mg 8—1 every 4 hrs. for pain 10/12/12 10/17/12 Dilaudid 8 mg 128—1 every 4 hrs. for pain 10/5/12 10/22/12 Dilaudid 8 mg 40—1 every 4 hrs. for pain 11/2/12 11/2/12 Dilaudid 8 mg 40—1 every 4 hrs. for pain 11/2/12 11/5/12 Dilaudid 8 mg 40—1 every 4 hrs. for pain 11/2/12 11/9/12

    I note that Respondent filled all four of the prescriptions that were written on the same day, October 12, 2012.

    Further, one prescription for “chronic pain due to trauma,” among other things, was written on July 16, 2012, yet BK did not have it filled until July 26, 2012. GX 14, at 1-2. Similarly, BK waited up to 16 days before filling another prescription for “chronic pain due to trauma,” among other things. GX 14, at 17-18. BK's delay in filling such Dilaudid 8 mg. prescriptions casts doubt on the prescriptions' legitimacy.

    Based on the dosing instructions, six tablets each day, 840 tablets should have lasted 140 days. The number of days from July 26, 2012 through November 8, 2012, the day before BK filled the last prescription in GX 14, was 105 days. Thus, in this period, Respondent dispensed to BK a 140-day supply of Dilaudid 8 mg. in 105 days. According to my analysis, Respondent filled all but one of them significantly early, from about at least 6 days early to up to about at least 29 days early. Id.

    Second, concerning the two Dilaudid 8 mg. prescriptions in GX 14 issued to JB, Respondent filled the second prescription at least one week early. Id. at 25-28.

    Customer J.B. Drug Number of tablets/SIG Date written Date filled Dilaudid 8 mg 180—1 every 3 hrs. as needed 8/15/12 8/22/12 Dilaudid 8 mg 150—1 every 3 hrs. as needed 9/6/12 9/6/12

    Third, concerning the two Dilaudid 8 mg. prescriptions in GX 14 issued to LB, Respondent filled the second prescription at least 5 days early.

    Customer L.B. Drug Number of tablets/SIG Date written Date filled Dilaudid 8 mg 168—1 every 4 hrs. as needed 3/13/13 3/18/13 Dilaudid 8 mg 168—1 every 4 hrs. as needed 4/10/13 4/10/13

    Fourth, Respondent filled the second Dilaudid 8 mg. prescription in GX for JS at least 5 days early.

    Customer J.S. Drug Number of tablets/SIG Date written Date filled Dilaudid 8 mg 168—1 every 4 hrs. as needed 12/28/12 12/31/12 Dilaudid 8 mg 168—1 every 4 hrs. as needed 1/23/13 1/23/13

    Fifth, Respondent filled the second Dilaudid 8 mg. prescription in GX 14 for HH at least six days early.

    Customer H.H. Drug Number of tablets/SIG Date written Date filled Dilaudid 8 mg 180—1 every 4-6 hrs. as needed 9/7/12 9/14/12 Dilaudid 8 mg 180—1 every 4-6 hrs. as needed 10/5/12 10/8/12

    According to Dr. Gordon, the prescriptions in GX 14 exhibited multiple red flags, yet Respondent filled them all. Tr. 429-67. For none of the prescriptions in GX 14 did Dr. Gordon testify that it included any notation recognizing or addressing red flags, that its red flags were resolvable, that it was a legitimate prescription, or that the pharmacist had exercised her corresponding responsibility to ensure that the prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Id. at 437-38, 441, 442, 445-46, 446-47, 448-49, 450-51, 456, 458-59, 460-61, 464, 467.

    Regarding these prescriptions and labels, Dr. Gordon testified that “the pharmacist was not exercising her corresponding responsibility, that most of these prescriptions should not have been filled or at least held until it was due to be filled.” Id. at 450. “However,” Dr. Gordon continued, “I wouldn't have filled any of these to begin with.” Id. at 451. She explained: “The multiple red flags would alert any pharmacist that none of these prescriptions were legit because of the distance, that certain physician is a well-known pill mill writer, the Dilaudid 8, the odd quantities, . . . the diagnosis of lumbago . . . and paying cash . . . And the early fills.” Id. Specifically regarding the multiple prescriptions for BK that Respondent filled on October 17, 2012 and why, in Dr. Gordon's experience, a patient would present two prescriptions for the same drug but different quantities on the same day, she testified: “I have no idea. That's very unusual. I would not fill either one of these scripts. . . . It's a huge red flag for any pharmacist to get the same exact Dilaudid 8 from the same doctor on the same date. Huge red flag. No reasonable pharmacist would fill this.” Id. at 443.

    Mr. Fisher agreed that an early fill was a red flag for diversion. Id. at 774. He identified early fill red flags in GX 14 on at least 13 occasions. Id. at 635-36, 637-38, 685, 692-93, 696 (two prescriptions filled on the same day), 698, 703, 704, 711, 714, 718, 721, 725, 727. Mr. Fisher testified that filling the two prescriptions on October 17, 2012 was “highly unusual.” Id. at 696. His testimony was that it was “reasonable” to fill a prescription two to three days early and that a pharmacy can do so. Id. at 700.

    In Mr. Fisher's view, early fill red flags were “resolvable,” meaning “there's a number of explanations for an early fill.” Id. at 686; see also id. at 693, 704-05, 711, 715, 719, 722-23, 725-26. Being “honest,” as he prefaced his statement, he acknowledged that an attempt to secure more drugs was one of those explanations. Id. at 687. Regarding the prescriptions for BK, he testified: “A patient taking this medicine . . . is not going to want to run out . . . [T]he pharmacy might . . . only have 40 tablets . . . on the twelfth, and they got some more in so they call the patient . . . It also—. . . to be honest, . . . could be an attempt by a patient to secure more drugs.” Id. at 686-87. When asked if an early fill “can be reasonably explained where there is diversion or where there is no diversion,” Mr. Fisher responded that, “It could be either way.” Id. at 687. Mr. Fisher did not explain, however, why the physician would write all four of the prescriptions on the same day, let alone break them up into smaller quantities. Mr. Fisher also suggested that “the patient . . . [may] only come down to that area once in a while for shopping, and they fill their prescriptions whenever they get down there.” Id. at 711. Mr. Fisher agreed that resolution of an early fill red flag “could be” and “should be” documented. Id. at 688.

    Respondent's Owner and PIC testified that an “early refill” is a red flag that “requires definite investigation.” Id. at 1165. She then stated, however, that the term “early refill” does not apply to a schedule II controlled substance and stated, regardless, that pharmacies are “obligated by the physician order.” Id. at 1167, 1170. She testified, “[T]here are two issues here, because why . . . the patient is prevented early prescriptions? It's not a refill on schedule IIs, so it's not early refill, it's an early fill. . . . The doctor fills [sic] the order, you have to fill it. You're obligated by the physician order.” Id.

    In sum, both Dr. Gordon and Mr. Fisher identified about the same number of early fills in GX 14. They disagreed on how many days early a pharmacy could fill a controlled substance prescription without needing to resolve the suspicion. They also disagreed about the resolvability of early fills in general and in GX 14. Dr. Gordon testified that an early fill was not legitimate and was not resolvable. Mr. Fisher testified that red flags due to early fills were resolvable, but admitted that an attempt to secure more drugs was one of the reasons for early fill requests. Mr. Fisher agreed that a pharmacist's resolution of an early fill should be documented.

    Based on the testimony of Dr. Gordon and Mr. Fisher, I find that Respondent, without resolving the red flags, filled prescriptions early on at least 13 occasions. I find that the early fill-related testimony of Respondent's owner and PIC, that a prescription is a doctor's order and a pharmacist is “obligated” to fill a doctor's order, was Respondent's admission to an abdication of her corresponding responsibility.

    Allegation That Respondent Was Unable to Readily Retrieve Prescriptions It Had Dispensed

    The Show Cause Order alleged that Respondent committed six other violations, including that Respondent was unable to readily retrieve prescriptions it had dispensed. ALJX 1, at 7.

    As already discussed, the DI testified that he conducted an unannounced inspection of Respondent on April 11, 2013. Tr. 36. At that time, he stated, he asked Respondent to retrieve 12 “problematic prescriptions” he had identified from a Florida Prescription Drug Monitoring Program query. Id. at 41-42. Those dozen prescriptions were for “anabolic steroid substances to patients that were not in the State of Florida.” Id. at 42. The Show Cause Order alleged that the prescriptions were filled from February 15, 2012 to April 11, 2013, or less than two years before the date of the unannounced inspection. ALJX 1, at 7-8.

    The DI testified that GX 21 consisted of Respondent's daily prescription log reports he obtained on the day of the unannounced inspection. Tr. 128. According to the DI, pages 1, 4, 6, 9, 13, and 16 of Respondent's daily prescription logs showed that Respondent had dispensed nine of the 12 prescriptions referenced in the Show Cause Order. Id. at 129-131; GX 21, at 1, 4, 6, 9, 13, and 16; ALJX 1, at 7-8. The DI further testified that the other three prescriptions appeared in the E-FORCSE report. Tr. 131; see also GX 20 (E-FORCSE query results).

    The DI testified that Respondent “was never able to locate these prescriptions for me.” Tr. 42; see also id. at 49, 125. Instead, he testified that he learned of Respondent's having located many of the missing prescriptions when he saw them in Respondent's exhibits. Id. at 270-71; see also RX 12. Two of the requested prescriptions, he testified, were never located. Tr. 1185. According to Respondent's Owner and PIC, “[t]hey was misfiled.” Id. at 1189. She testified that “if the number is assigned, it means that was prescription presented to the pharmacy. . . . I know across the board, that it's common that some prescriptions do get misfiled in pharmacies.” Id. at 1189-90.

    The testimony of Respondent's Owner and PIC confirmed Respondent's failure to retrieve and provide the requested prescriptions to the DI on April 11, 2013. See id. at 846; see also id. at 1186 (The first time the prescriptions were provided to the Government was as an exhibit in this proceeding.). Respondent's Owner and PIC offered excuses for that failure. Id. at 847-850.

    I find that Respondent never provided the 12 requested prescriptions to the DI. I find that Respondent included ten of the 12 prescriptions in an exhibit for the hearing in this proceeding more than two years after they were requested during the unannounced inspection. I find that Respondent has still not provided the Government with two of the prescriptions that the DI requested on April 11, 2013.

    Allegation That Respondent Shipped Controlled Substances Out-of-State Without Complying With Those States' Non-Resident Pharmacy Requirements

    Next, the Show Cause Order alleged that Respondent shipped controlled substances to four States (Alabama, Illinois, Kentucky, and Vermont) without complying with those States' non-resident pharmacy requirements. ALJX 1, at 8. As support for the allegation, the Government submitted prescriptions for schedule III controlled substances (testosterone cypionate, testosterone cream, and stanozolol) that Respondent filled for seven customers whose addresses were in Alabama, Georgia, Illinois, Kentucky, Massachusetts, or Vermont. See GX 15; see also Tr. 87-88 (DI), Tr. 392-93 (Dr. Gordon), Tr. 731-32, 734 (Mr. Fisher). The Government also submitted seven FedEx shipping reports showing that Respondent shipped the prescriptions to customers outside the State of Florida. GX 15.

    In further support of the allegation, the Government obtained certifications from Alabama, Illinois, Kentucky, and Vermont that Respondent had not complied with those States' out-of-state pharmacy requirements. See GX 24 (Alabama Board of Pharmacy Certification of Non-Licensure of Respondent for the period July 1, 1989 through April 29, 2015), GX 25 (Certification of the Division of Professional Regulation of the Illinois Department of Financial and Professional Regulation that Respondent “does not now hold nor has ever held a license under the Pharmacy Practice Act of 1987” dated April 16, 2015), GX 26 (Kentucky Board of Pharmacy Executive Director letter dated April 14, 2015 stating that, “I have searched the Board records and do not find that . . . [Respondent] has or ever has been issued a license/permit”), and GX 27 (Vermont Board of Pharmacy's Licensing Board Specialist Certification of Non-Licensure of Respondent for the period July 1, 1989 through April 13, 2015).

    Respondent's Owner and PIC asserted that “out-of-state patients was out of question. That was for me,” indicating that she would not have filled out-of-state prescriptions “[u]nder any circumstances, even the patient was really, really sick.” Tr. 1023; see also id. at 44, 88-89 (DI's testimony that Respondent's Owner and PIC told him that Respondent never shipped a controlled substance out-of-state.). Yet, Respondent's Proposed Findings of Fact and Conclusions of Law admitted that “[f]actually, . . . Respondent was not registered in Alabama, Illinois, Kentucky and Vermont when it shipped control [sic] substances to these states.” Respondent's Proposed Findings of Fact and Conclusions of Law dated August 28, 2015 (hereinafter, Resp. Br.), at 4.

    Based on the uncontroverted documentary evidence, which I find to be more persuasive than the testimony and statements of Respondent's Owner and PIC to the contrary, and Respondent's admission, I find that Respondent shipped controlled substances out-of-state to customers in Alabama, Illinois, Kentucky, and Vermont. Further, I find that, when Respondent shipped those controlled substances to out-of-state customers, it was not licensed or permitted to do so by the States of Alabama, Illinois, Kentucky, or Vermont.

    Allegation That Respondent Filled Controlled Substance Prescriptions Not Containing All of the Information Required By 21 CFR 1306.05(a) and (f)

    Next, the Show Cause Order alleged that Respondent filled controlled substance prescriptions that did not contain all of the information required by 21 CFR 1306.05(a). ALJX 1, at 9. As support for the allegation, the Government submitted nine prescriptions. GX 16. The DI testified that the patient's full address was missing from six of the prescriptions. Tr. 99-101; see also GX 16, at 1, 3, 5, 7, 9, and 15. He testified that the prescriber's DEA registration number was missing from four of the prescriptions. Tr. 99-101; see also GX 16, at 1, 11, 13, and 15. The DI testified that the directions for use were missing from one of the prescriptions. Tr. 99; see also GX 16, at 1. He testified that the prescriber's address was missing from four of the prescriptions. Tr. 100-01; see also GX 16, at 7, 9, 11, and 13. The DI testified that the prescriber's name was missing from two of the prescriptions, and that the prescriber's signature was missing from one of them. Tr. 100-01; see also GX 16, at 11, 13, and 15, respectively.

    My review and analysis of the 13 prescriptions in GX 8/8a identified information missing from prescriptions and discrepancies between information on some of the prescriptions and/or prescription labels and information on the customers' driver's licenses. See, e.g., GX 8, at 15 and 17 (missing information in customer address); id. at 3-4 and 5-6 (discrepancies between the customer's address shown on the driver's license and shown on the prescription label); id. at 9-10 (discrepancies between the customer's address shown on the prescription and shown on the prescription label and driver's license); see also Tr. 614-15 (testimony of Mr. Fisher concerning missing information), Tr. 761-65 (testimony of Mr. Fisher concerning information discrepancies). In Mr. Fisher's opinion, Respondent did not exercise due care in entering customer addresses. Tr. 766.

    Respondent's Owner and PIC admitted that Respondent filled the prescriptions in GX 16. Id. at 1196. She admitted that the patient's address was missing from five prescriptions. Id. at 1194-96; see also GX 16, at 3, 5, 7, 9, and 15. Respondent's Owner and PIC testified that the prescriber's DEA registration number was missing from three prescriptions, but that those numbers appeared on the prescription fill labels. Tr. 1195-96; see also GX 16, at 11, 13, and 15, and GX 16, at 14 and 16, respectively. Respondent did not dispute the facts underlying this allegation. See, e.g., Resp. Exceptions, at 18 (“[I]t is true that twelve out of many hundreds of scripts lacked some of the information required.”).

    Having examined the prescriptions and all of the other evidence in the record concerning this allegation, I find the Respondent filled controlled substance prescriptions that did not contain all of the information required by 21 CFR 1306.05(a). I also find that Respondent's Owner and PIC admitted Respondent filled prescriptions not containing all of the information required by 21 CFR 1306.05(a).

    Allegation That Respondent Filled Prescriptions Written for “Office Use” in Violation of 21 CFR 1306.04(b)

    Next, the Show Cause Order alleged that Respondent filled prescriptions written for “office use” in violation of 21 CFR 1306.04(b). ALJX 1, at 10. To support this allegation, the Government submitted two Respondent “RX Order Forms,” one for testosterone and one for testosterone propionate, for which “Office Use” was written on the line designated for the patient name. See GX 17. The DI testified that these pages were controlled substance prescriptions written for “office use.” Tr. 252-53.

    Respondent's Owner and PIC testified that page 1 of GX 17 was a “prescription” for testosterone. Id. at 1200. She agreed that page 3 of GX 17 was a “copy of a prescription” for testosterone. Id. at 1202; see also Resp. Br., at 10 (“Factually, Respondent did fill the prescriptions alleged in OSC ¶ 6 for `office use.' ”). Respondent's Owner and PIC further testified that the entity that completed and submitted the “RX Order Forms” was engaged in hormone replacement therapy and wanted to “see how the patient responds” and “make sure that the patient don't have allergic reaction on the prescription before they dispense it.” Tr. 1199; see also id. at 1201. Her testimony acknowledged that Respondent “delivered” the testosterone “prescribed” on page 1 of GX 17. Id. at 1200. Regarding the prescription depicted on page 3 of GX 17, however, Respondent's Owner and PIC testified to having “a flashback,” stating that, “I really remember that I don't give them that cypionate.” Id. at 1203.

    I find that Respondent admitted filling at least two controlled substance “prescriptions” for “office use” and delivering at least one of them to an entity engaged in hormone replacement therapy for the purpose of allergy testing.

    Allegation That Respondent Filled Prescriptions Written by Physicians for the Physicians' Personal Use in Violation of Florida Statute § 458.331(r)

    Next, the Show Cause Order alleged that Respondent filled prescriptions written by physicians for the physicians' personal use in violation of Florida Statute § 458.331(r). ALJX 1, at 10. As support for this allegation, the Government submitted 12 documents that, according to the DI, included “controlled substance prescriptions” which doctors wrote “to themselves.” Tr. 106; see also GX 18. One prescription was written on Respondent's “RX Order Form” and had nothing written in the “patient” information boxes. GX 18, at 3. The labels associated with this “prescription” showed the same name for the patient and the prescriber. Id. at 4. Respondent admitted that, “Factually, Respondent did fill the prescriptions alleged in OSC, ¶ 7 written by physicians for the physicians' personal use.” Resp. Br., at 16.

    I find that Respondent admitted filling six “prescriptions” which doctors wrote “to themselves,” and that the “prescriptions” were for controlled substances.

    Allegation That Respondent Violated Florida State Law by Failing To Report Some Prescriptions to E-FORCSE in Violation of Florida Statute § 893.055(4)

    Finally, the Show Cause Order alleged that Respondent failed to comply with Florida law by failing to report some prescriptions to E-FORCSE. ALJX 1, at 10-11; see Fla. Stat. § 893.055(4) (2012). In support of this allegation, the Government submitted six Dilaudid 8 mg. prescriptions written by the same doctor from July through November of 2012. See GX 19. The DI obtained these prescriptions during his unannounced inspection of Respondent. Tr. 107; ALJX 1, at 11. The DI testified that none of these six prescriptions was reported to E-FORCSE according to his analysis of the results of his E-FORCSE query for the period February 14, 2012 to February 4, 2013. Tr. 108-10, 115; see also GX 20 (E-FORCSE query results).

    Further, in addition to doing his own query, the DI explained that he asked the E-FORCSE program manager to “do a back-end query to see if these prescriptions were ever uploaded or any errors or . . . any attempts were made for these prescriptions.” Tr. 109; see also id. at 119. As further support for this allegation, the Government introduced the certified response the DI received from the program manager stating that, “I certify, none of the prescriptions . . . were uploaded.” GX 23, at 1 (Letter from E-FORCSE Program Manager to DI dated April 2, 2015); see also Tr. 118. The Program Manager's letter, the DI explained, “shows . . . that . . . [the six prescriptions] were never uploaded” to E-FORCSE and that there were no uploading attempts that failed due to an error. Tr. 118. The DI also testified that the second page of GX 23 “shows the uploads that . . . [Respondent] did in that timeframe, and where those [six] prescriptions should have fallen into if . . . [Respondent] had, in fact, uploaded them.” Id. The DI concluded from this evidence that “these [six] prescriptions were never entered” into E-FORCSE. Id. at 123.

    Respondent's Owner and PIC did not challenge the Government's contention that the six prescriptions in GX 19 did not appear in E-FORCSE. Her testimony included that “I fully believe it was actually entered”; “I do not know. I did the fair attempt to provide all Schedule prescriptions, and if other prescription was in E-FORCSE, this prescription should be in E-FORCSE”; “I know that I made a fair attempt to submit this prescription along with other prescription that was accumulated for that week. That was in a compiled file”; and “I can fairly testify that I did the best effort to submit the prescription to the E-FORCSE.” Id. at 898, 914-15, 922-23, 935, respectively.

    I find that Respondent did not present evidence contesting the Government's allegation that six of the controlled substance prescriptions it filled did not appear in E-FORCSE. I find that Respondent filled, but did not report to E-FORCSE, six controlled substance prescriptions for Dilaudid 8 mg. written by the same doctor from July through November of 2012.

    Discussion

    Under Section 304 of the Controlled Substances Act (hereinafter, CSA or Act), “[a] registration . . . to . . . distribute[ ] or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined by such section.” 21 U.S.C. 824(a)(4). In the case of a retail pharmacy, which is a “practitioner” under 21 U.S.C. 802 (21), Congress directed the Attorney General to consider the following factors in making the public interest determination:

    (1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

    (2) The applicant's experience in dispensing . . . controlled substances.

    (3) The applicant's conviction record under Federal or State laws relating to the . . . distribution[ ] or dispensing of controlled substances.

    (4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

    (5) Such other conduct which may threaten the public health and safety.

    21 U.S.C. 823(f). [T]hese factors are . . . considered in the disjunctive. Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (2003).

    It is well settled that I “may rely on any one or a combination of factors and may give each factor the weight [I] deem[ ] appropriate in determining whether” to revoke a registration. Id.; see also MacKay v. Drug Enforcement Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U. S. Drug Enforcement Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug Enforcement Admin., 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I “need not make explicit findings as to each one.” MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482. “In short, . . . the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct.” Jayam Krishna-Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.

    Under DEA's regulation, “[a]t any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to . . . 21 U.S.C. [§ ] 824(a) . . . are satisfied.” 21 CFR 1301.44(e). In this matter, while I have considered all of the factors, the Government's evidence in support of its prima facie case was confined to Factors Two and Four.28 I find that the Government's evidence with respect to Factors Two and Four satisfies its prima facie burden of showing that Respondent's continued registration would be “inconsistent with the public interest.” 21 U.S.C. 823(f). I further find that Respondent failed to produce sufficient evidence to rebut the Government's prima facie case.

    28 As to Factor One, there is no evidence that the Florida Department of Health or the Florida Board of Pharmacy made a recommendation concerning Respondent and the matter before me. Respondent provided several filings, from administrative proceedings and from Respondent's lawsuit against the Florida Department of Health, involving its permit to function as a community pharmacy and the compounding side of its business at its registered location and elsewhere in Florida. According to Respondent's cover letter, it provided this material due to an Order during the Prehearing Conference on April 14, 2015. ALJX 12, at 1. Material in Respondent's submission indicated that the Florida Board of Pharmacy (1) found Respondent had waived the right to request a hearing by failing to respond in a timely manner to the Administrative Complaint against it, (2) approved, adopted, and incorporated the Administrative Complaint's factual allegations, and (3) disciplined Respondent, placing it on probation for two years and requiring quarterly inspections. Id. at 20-21. The materials do not establish that Respondent lacks State authority or contain a recommendation one way or another.

    While there is no evidence that Florida has revoked Respondent's license, DEA has held repeatedly that a registrant's possession of a valid State license is not dispositive of the public interest inquiry. Lon F. Alexander, M.D., 82 FR 49,704, 49,724 n.42 (2017) (citing Mortimer Levin, D.O., 57 FR 8680, 8681 (1992)). As DEA has long held, “[t]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.” Alexander, 82 FR at 49,724 n.42 (citing Levin, 57 FR at 8681).

    As to Factor Three, there is no evidence that Respondent has a “conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.” 21 U.S.C. 823(f)(3). However, as the Agency has noted, there are any number of reasons why a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, M.D., 75 FR 49,956, 49,973 (2010), pet. for rev. denied, MacKay v. Drug Enforcement Admin., 664 F.3d 808 (10th Cir. 2011). The DEA has therefore held that “the absence of such a conviction is of considerably less consequence in the public interest inquiry” and is therefore not dispositive. Id.

    Specifically, I find that the record contains substantial evidence that Respondent's pharmacists violated their corresponding responsibility when they dispensed multiple prescriptions. I also find there is substantial evidence in the record that Respondent was unable to readily retrieve prescriptions it had dispensed, shipped controlled substances out-of-state without complying with States' non-resident pharmacy requirements, and filled controlled substance prescriptions that did not contain all the information required by 21 CFR 1306.05. Accordingly, I agree with the CALJ that Respondent's registration should be revoked. Further, I agree with the CALJ's conclusions concerning Respondent's non-acceptance of responsibility and the appropriate disposition of Respondent's efforts to show its remedial measures. R.D., at 58. For the reasons set out below, I will order that Respondent's registration be revoked and that any pending application of Respondent be denied.

    Factors Two and/or Four—The Registrant's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances Allegations That Respondent Failed To Exercise Its Corresponding Responsibility When It Dispensed Controlled Substances Pursuant to Prescriptions Not Issued in the Usual Course of Professional Practice or for a Legitimate Medical Purpose

    Under the CSA, it is “unlawful for any person knowingly or intentionally . . . to . . . distribute[ ] or dispense, or possess with intent to . . . distribute[ ] or dispense, a controlled substance” “[e]xcept as authorized” by the Act. 21 U.S.C. 841(a)(1). A pharmacy's registration authorizes it to “dispense,” or “deliver a controlled substance to an ultimate user . . . by, or pursuant to the lawful order of . . . a practitioner.” 21 U.S.C. 802(10).

    According to the CSA's implementing regulations, a lawful controlled substance order or prescription is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). While the “responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, . . . a corresponding responsibility rests with the pharmacist who fills the prescription.” Id. The regulations establish the parameters of the pharmacy's corresponding responsibility.

    An order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [§ ] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

    Id. As the Supreme Court has explained in the context of the Act's requirement that schedule II controlled substances may be dispensed only by written prescription, “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse . . . [and] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.” Gonzales v. Oregon, 546 U.S. 243, 274 (2006).

    The Government must show that the pharmacist acted with the requisite degree of scienter to prove a violation of the corresponding responsibility regulation.29 See Hills Pharmacy, LLC, 81 FR 49,816, 49,835 (2016). According to Agency precedent, the Government may prove a violation by showing either that: (1) The pharmacist filled a prescription notwithstanding her actual knowledge that the prescription lacked a legitimate medical purpose; or (2) the pharmacist was willfully blind or deliberately ignorant to the fact that the prescription lacked a legitimate medical purpose. Id. To establish that a pharmacist acted with willful blindness, the Government must prove that the pharmacist had a subjective belief that there was a high probability that a fact existed and she took deliberate actions to avoid learning of that fact. Id. (quoting Global-Tech Applications, Inc., v. SEB S.A., 563 U.S. 754, 769 (2011)); see also United States v. Henry, 727 F.2d 1373, 1378 (5th Cir. 1984) (citing United States v. Hayes, 595 F.2d 258 (5th Cir.), cert. denied, 444 U.S. 866 (1979) (rejecting challenge that the regulation was unconstitutionally vague)) (“What is required by him [the pharmacist] is the responsibility not to fill an order that purports to be a prescription but is not a prescription within the meaning of the statute because he knows that the issuing practitioner issued it outside the scope of medical practice. . . . [A] pharmacist can know that prescriptions are issued for no legitimate medical purpose without his needing to know anything about medical science.”).

    29 The Show Cause Order alleged that “Respondent” violated its corresponding responsibility. Respondent and the Government stipulated that: “The Respondent is owned and operated by Veronica Taran.” Further, Respondent's Owner and PIC admitted that she is Respondent's pharmacist-in-charge and Respondent's only pharmacist. Tr. 1012 (“[I]n this particular practice, because there's only me, there's nobody else there, like, there's no other pharmacist there.”). When asked by her counsel whose responsibility it was to resolve any red flags, she testified that “[u]ltimate responsibility lies up me as the pharmacist and pharmacist-in-charge.” Id. at 1045. Thus, for purposes of finding and attributing liability in this case, I find that the actions and inactions of Respondent's Owner and PIC were the actions and inactions of Respondent.

    The Government did not allege that Respondent dispensed the prescriptions having actual knowledge that the prescriptions lacked a legitimate medical purpose. Instead, the Government alleged that Respondent violated the corresponding responsibility regulation as “evidenced” by its “dispensing of controlled substances despite the presence of red flags of diversion that . . . [it] failed to clear prior to dispensing the drugs.” ALJX 1, at 1-2 (citing Holiday CVS); see also Government's Proposed Findings of Fact and Conclusions of Law dated August 28, 2015 (hereinafter, Govt. Br.), at 15-16.

    As discussed above, the testimony of Dr. Gordon, as well as testimony offered by Respondent's own witness, Mr. Fisher, supported the Government's allegations that the seven different factual circumstances the Government alleged to be “red flags of diversion” existed as alleged, and that Respondent did not resolve them before dispensing controlled substances.30 See also R.D., at 9 (“Dr. Gordon testified that she will not dispense a controlled medication in the face of an unresolved red flag . . ..”) and at 13 (“Mr. Fisher acknowledged that none of the Respondent's pharmacy paperwork reflected any documentation that red flags were resolved prior to dispensing and that he did not know whether they were ever resolved.”). Further, as discussed above, the CALJ recommended crediting that documentary and testimonial evidence. I find credible the testimony of Dr. Gordon and, to the extent he agreed with Dr. Gordon, Mr. Fisher that Respondent filled controlled substance prescriptions that raised “red flags” without resolving, and documenting the resolution of, those red flags.

    30 For example, Respondent's Owner and PIC even testified that it was not a red flag “by itself” for a customer to travel over 100 miles from their Florida home to Respondent to fill a controlled substance prescription. Tr. 1028. Indeed, regarding red flags, her testimony was that red flags were a stumbling block. Respondent's Owner and PIC said that “just by strictly following these red flags, it will prevent legitimate patient from obtaining the medication.” Id. at 1108.

    Prior Agency decisions found that prescriptions with the same “red flags” at issue here were so suspicious as to support a finding that the pharmacists who filled them violated the Agency's corresponding responsibility rule due to actual knowledge of, or willful blindness to, the prescriptions' illegitimacy.31 21 CFR 1306.04(a). See, e.g., Hills Pharmacy, 81 FR at 49,836-39 (multiple customers filling prescriptions written by the same prescriber for the same drugs in the same quantities; customers with the same last name and street address presenting similar prescriptions on the same day; two short-acting opiates prescribed together; long distances; drug cocktails; payment by cash); The Medicine Shoppe, 79 FR 59,504, 59,507, 59,512-13 (2014) (unusually large quantity of a controlled substance; pattern prescribing; irregular dosing instructions; drug cocktails); Holiday CVS, 77 FR 62,316, 62,317-22 (2012) (long distances; multiple customers filling prescriptions written by the same prescriber for the same drugs in the same quantities; customers with the same last name and street address presenting virtually the same prescriptions within a short time span; payment by cash); East Main Street Pharmacy, 75 FR 66,149, 66,163-65 (2010) (long distances; lack of individualized therapy or dosing; drug cocktails; early fills/refills; other pharmacies' refusals to fill the prescriptions).

    31 Agency precedent has defined the term “red flag” to mean “a circumstance that does or should raise a reasonable suspicion as to the validity of a prescription.” Hills Pharmacy, 81 FR at 49,839. This precedent, in conjunction with the terms of the corresponding responsibility regulation, means that the suspicious circumstances presented by the red flags must rise to the level necessary to support a finding that the pharmacist acted with willful blindness.

    Agency precedent has made clear that, when presented with a prescription clearly not issued for a legitimate medical purpose, a pharmacist may not intentionally close her eyes and thereby avoid positive knowledge of the real purpose of the prescription. JM Pharmacy Group, Inc., d/b/a Farmacia Nueva and Best Pharma Corp., 80 FR 28,667, 28,670 (2015). Yet, that is exactly what Respondent's Owner and PIC did.

    As I detailed above, the testimony of Respondent's Owner and PIC acknowledged that schedule II controlled substances are highly risky and are subject to “a lot of diversion.” Tr. 1129, 1116 (respectively). She also specifically testified that a prescription for a large quantity of a schedule II controlled substance raised red flags. Id. at 881, 882, 887. Yet, she admitted failing to address such schedule II prescriptions presented to her pharmacy in a fashion consistent with her testimony. Id. at 1132-39. She did not explain or justify her conscious and deliberate choice to avoid learning legitimacy-related information about schedule II prescriptions that she knew were “highly risky,” prone to diversion, and raised red flags. These acknowledgements and failures clearly show her subjective belief of a high probability that the various schedule II prescriptions presented to her were not legitimate and her deliberate actions to avoid learning of their illegitimacy.

    Further, although Respondent challenged Dr. Gordon's expertise to testify that it charged exorbitantly high prices for controlled substances, Respondent did not offer any price-related evidence disputing Dr. Gordon's testimony. The evidence in the record that Respondent charged exorbitantly high prices for controlled substance prescriptions is further proof that Respondent knew or subjectively believed that there was a high probability that its customers were either abusing or diverting those controlled substances. See also id. at 362 (Dr. Gordon's testimony that “maybe the pharmacist knew what was going on, and they were taking advantage of these patrons that were drug seeking.”) and id. at 465 (Dr. Gordon's testimony suggesting that Respondent “knew . . . prescriptions were [being] diverted” and “was taking advantage of that patron . . . [b]ecause they knew they would pay whatever they needed to pay” to fill the prescription.)

    The so-called “proper steps” for handling schedule II prescriptions that Respondent's Owner and PIC constructed were actually abdications of her corresponding responsibility. According to Respondent's Owner and PIC, her responsibility, when presented with a controlled substance prescription, was limited to (1) making sure the prescriber's medical license was current; (2) checking the prescriber's DEA registration against the controlled substance in the prescription; (3) obtaining the patient's signature on the Relationship Affidavit as alleged verification of a bona fide doctor-patient relationship; and (4) validating that the prescriber actually signed the prescription, as opposed to its having been rubber stamped. These steps, however, do not constitute an independent exercise of professional judgment by a pharmacist evaluating the legitimacy of highly suspicious controlled substance prescriptions such as those at issue here. They were clearly insufficient to determine the legitimacy of schedule II prescriptions that Respondent's Owner and PIC herself characterized as “highly risky” and prone to diversion. Instead, they constituted a pharmacist's abdication of responsibility for a legitimacy assessment.

    As for checking the currency of the prescriber's medical license and DEA registration, this is not enough as a prescriber must generally hold both a license and registration to even issue a prescription under the CSA. 21 CFR 1306.03(a). The fact that a practitioner possesses the requisite authority does not, however, mean that he/she acted in the usual course of professional practice in issuing any particular prescription and that the prescription was issued for a legitimate medical purpose. Cf. Krishna-Iyer, 74 FR at 463.

    As for the “proper step” of having a customer sign the Relationship Affidavit, Respondent's Owner and PIC did not explain why it was reasonable for her to expect customers who were drug seekers to understand the content of that document. Moreover, even if the customers did understand the document, she offered no explanation as to why her customers would be honest and truthful in answering the questions if they were seeking controlled substances to either personally abuse or divert to others.32

    32 Further, I find that the high prices Respondent charged for controlled substances, as discussed above, suggest that Respondent knew its customers were either abusing or diverting them.

    Lastly, the “proper step” of ensuring that the prescription was not “signed” by a rubber stamp might have showed that the prescription was not an outright fraud, but it did nothing to ensure that the prescription was issued for a legitimate medical purpose. 21 CFR 1306.04(a).

    Respondent's Owner and PIC also testified regarding the five CII/CIII Rx Verification Forms which were part of Respondent's “patient files” (see RXs 6 and 10) and “kept in the regular course of business.” 33 Tr. 824-25. She also stated that they “assisted . . . [her] to resolve the red flags.” Id. at 824. Yet, neither she nor Respondent explained why Respondent submitted only five such forms from its “patient files” when the Government's evidence included 60 prescriptions and 29 patients. Moreover, while the forms indicated that the prescriptions were actually written by a physician, that the physician saw and physically examined the patient, and that there were diagnosis codes, the forms contained no additional documentation as to what circumstance prompted Respondent to contact the physician and what information the physician's office provided which led the pharmacist to approve and fill the prescription. Thus, at most, the forms establish with respect to these five patients that Respondent verified each prescription with its issuer. However, long-standing case law has explained that “[v]erification by the issuing practitioner on request of the pharmacist . . . is not an insurance policy against a fact finder's concluding that the pharmacist had the requisite knowledge despite a purported but false verification.” United States v. Henry, 727 F.2d at 1378 (quoting United States v. Hayes, 595 F.2d 258, 261 (5th Cir. 1979)). In sum, Respondent's CII/CIII Rx Verification Forms are insufficient and do not alter my finding that Respondent violated the corresponding responsibility regulation.

    33 Respondent submitted one other CII/CIII Rx Verification Form. RX 5, at 9.

    The Government also submitted prescriptions, in support of the Show Cause Order's corresponding responsibility allegation, that did not involve schedule II controlled substances. As discussed above, the controlled substance was testosterone cypionate and the same doctor wrote all of the prescriptions on the same day. GX 10. Respondent filled all of those prescriptions within the period of about an hour and a half. Id. Dr. Gordon, Mr. Fisher, and Respondent's Owner and PIC agreed that these prescriptions raised red flags. Although Respondent's Owner and PIC stated that she resolved the red flags, she did not produce any documentary evidence to support her statement and, thus, I did not afford her statement any weight. As discussed above, I found that Respondent also filled these prescriptions in the face of their red flags. The fact that Respondent's Owner and PIC acknowledged these prescriptions' red flags clearly evidenced her subjective belief of a high probability that these schedule III prescriptions were not legitimate. The fact that she simply filled them showed that she took deliberate actions to avoid learning of their illegitimacy.

    Accordingly, I find the Government has proved by substantial evidence that controlled substance prescriptions Respondent, by Respondent's Owner and PIC, filled were not prescriptions issued in the usual course of professional treatment, yet Respondent, by Respondent's Owner and PIC, knowingly filled, or filled with willful blindness, those prescriptions in violation of the corresponding responsibility regulation. 21 CFR 1306.04(a); see also Hills Pharmacy, 81 FR at 49,835; Superior Pharmacy I and Superior Pharmacy II, 81 FR 31,310, 31,335 (2016); The Medicine Shoppe, 79 FR at 59,515-16; East Main Street Pharmacy, 75 FR at 66,163-65.34

    34 This case is different from Superior Pharmacy I and Superior Pharmacy II where the Government's evidence was insufficient to establish a corresponding responsibility violation even though Respondent dispensed controlled substance prescriptions in the face of unresolved red flags such as long distances, multiple people presenting identical or very similar prescriptions from the same prescriber on the same day, drug cocktails, two people in the same household or with the same address needing the exact same drugs, and payment by cash. 81 FR at 31,336. The Government's evidence in that case consisted only of the prescriptions allegedly dispensed without documentation of the resolution of red flags. As explained in that decision, there was no applicable law or rule requiring that documentation of the resolution of a red flag be placed on the prescription. Here, by contrast, the documentary and testimonial evidence made abundantly clear that Respondent did not carry out its corresponding responsibility.

    I considered Respondent's claim that Dr. Gordon's testimony should not be credited because “she never worked as a pharmacist in an independent pharmacy” such as Respondent and, therefore, “her dispensing, managing and purchasing experience is not comparable to those of [Respondent's Owner and PIC].” Resp. Br., at 37-38. I reject this claim. I have already set out my credibility determinations, which are based on the credibility recommendations of the CALJ. Those determinations afford Dr. Gordon's testimony the appropriate weight in these proceedings regarding the practice of pharmacy in Florida. Further, Respondent's claim is simply incorrect. The corresponding responsibility of a pharmacist is the same whether the pharmacist practices at an independent pharmacy or in a chain pharmacy. In other words, the size or corporate status of the pharmacy in which a pharmacist practices does not dictate the scope of a pharmacist's obligation under federal law.

    I reject Respondent's claim that the Government arbitrarily designated customers as having travelled long distances “since it is not relying on any statutory enactment, federal or state to make such a designation.” Id. at 33. Even Respondent's witness, Mr. Fisher, agreed that customers traveling long distances to fill prescriptions is a red flag. Tr. 754; see also R.D., at 47.

    I considered Respondent's claim that Dr. Gordon's testimony about pattern prescribing created “an unrecognized standard under, both, case law and the Florida statutory law.” Resp. Br., at 38. I find that Respondent's claim is without merit. Numerous agency and court cases have recognized that pattern prescribing is a red flag. See, e.g., The Medicine Shoppe, 79 FR at 59,512; see also United States v. Durante, No. 11-277, 2011 WL 6372775, at *3 (D.N.J. Dec. 20, 2011) (“This is sufficient to establish probable cause to believe that Defendant was engaged in an extensive pattern of prescribing controlled substances without a legitimate medical purpose to a broad group of patients in his medical practice.”). Further, as already discussed, even Respondent and Respondent's own witness, Mr. Fisher, eventually admitted that pattern prescribing was a red flag of diversion.

    During the hearing, Dr. Gordon testified about the level of the cash price Respondent charged for some prescriptions, including in comparison to what another pharmacy might charge. See, e.g., Tr. 400, 406, 410-11, 413, 415, 417-18. Respondent's Counsel objected, stating that “the expert is testifying in price difference against what a normal pharmacist, quote, unquote, would charge versus what . . . [Respondent] charged for certain drugs, drug being Dilaudid.” Id. at 419. He continued his objection by stating that, “I just reviewed the prehearing statement provided by the Government, and there is no mention that their expert is going to get into the price . . . differentiation . . . between a normal pharmacy and . . . [Respondent].” Id. at 419-20. Respondent's Counsel subsequently elicited from Dr. Gordon that she was “never in charge of purchasing controlled substances for resale for a small independent pharmacy.” Id. at 482; see also Resp. Exceptions, at 2. The CALJ's recommendation was that “the Government did not adequately notice the relative price charged for the medication . . . [because] [t]he Agency recently imposed an increasingly rigorous standard of notice.” R.D., at 10 n.60.

    I reject the Exception. As to the issue of notice, for reasons previously explained, the Agency has rejected the notion that the “Agency recently imposed an increasingly rigorous standard of notice on its administrative prosecutors.” See, e.g., Wesley Pope, M.D., 82 FR 14,944, 14,946 n.4 (2017). Here, the Government in its Prehearing Statement gave notice that Dr. Gordon would testify about “patients willing to pay exorbitant prices” as well as the relative price charged for the medication by Respondent. ALJX 5 (Govt. Prehearing Statement), at 11. Accordingly, I find that the Government provided adequate notice that the prices charged by Respondent would be at issue in the proceeding.

    To the extent Respondent argues that I should give no weight to Dr. Gordon's testimony, I reject its argument that I should reject her testimony because she has never purchased controlled substances for a small pharmacy. Indeed, Dr. Gordon specifically testified that she “actually looked up the national . . . price.” Id. at 503.

    In its Exceptions, Respondent argues that the “absence of Respondent's corresponding exhibit should not be interpreted as an absence of records,” and that “it simply means that . . . the records in Respondent's possession are the same records as contained in a corresponding Government's exhibit.” Resp. Exceptions, at 8 n.10. In this Exception, Respondent indicates its dispute with the Government's allegation that “Respondent failed to exercise its corresponding responsibility under the regulations by failing to acknowledge and resolve red flags related to a pattern of a doctor prescribing the exact same medication in a cookie-cutter fashion to multiple patients on the same day.” Resp. Exceptions, at 8. As the CALJ noted, however, Respondent's Owner and PIC “conceded that the paperwork furnished to the DIs at the April 11th Inspection did not memorialize any attempts to resolve this red flag and agreed that she did not have any paperwork documenting her identification or resolution of the issue.” R.D., at 49 (citing Tr. 1094). While Respondent's Exception purports to correlate its “corresponding exhibit” with the Government's evidence, Respondent fails to explain the many instances in which Respondent simply did not offer documentary evidence to support the bald assertions of Respondent's Owner and PIC that Respondent complied with the corresponding responsibility regulation. See, e.g., R.D., at 49-50 (“[I]t is difficult to reconcile the multiple areas where the Respondent's recordkeeping system . . . had the capacity to note details such as red flag resolution with the absence of any documented indication that this, or any other red flags, were analyzed and resolved.”).

    Further, this Agency has applied, and I apply here, the “adverse inference rule.” As the DC Circuit explained, “Simply stated, the rule provides that when a party has relevant evidence within his control which he fails to produce, that failure gives rise to an inference that the evidence is unfavorable to him.” Int'l Union, United Auto., Aerospace & Agric. Implement Workers of Am. (UAW) v. Nat'l Labor Relations Bd., 459 F.2d 1329, 1336 (DC Cir. 1972). The Court reiterated this rule in Huthnance v. District of Columbia, 722 F.3d 371, 378 (DC Cir. 2013). According to this legal principle, Respondent's decision not to provide records gives rise to an inference that any such evidence is unfavorable to Respondent. In any event, as explained above, the records Respondent did provide concerning the Government's allegations were insufficient to rebut those allegations.

    Respondent suggested throughout the hearing and in its briefs that the Government's case was deficient. See, e.g., Resp. Exceptions, at 9-10, 11, 13, 14, 15, and 16-17. Having reviewed and considered all of Respondent's claims and arguments, I find that none of them has merit. Adoption of any of them would undermine this Agency's regulatory mission, and I decline to rule against long-standing precedent.

    For example, in its Exceptions, Respondent argues that the Government's Expert “admitted that she has no evidence that . . . any of the prescriptions . . . were diverted or somehow used for or with illicit purposes.” Resp. Exceptions, at 11. Notwithstanding the Government's Expert's testimony, there is ample circumstantial evidence that the prescriptions at issue in this proceeding were issued by a physician acting outside of the usual course of professional practice. The circumstantial evidence includes that the prescriptions were for large quantities of Dilaudid 8 mg., a highly abused narcotic; that customers were traveling long distances; and that many of the customers were paying cash and exorbitantly high prices. In other instances, the evidence showed that customers were obtaining early fills of prescriptions.

    Second, Respondent suggests that the Government's failure to prove the prescribing doctors were not licensed or registered at the relevant time, or otherwise “unable to lawfully issue the prescription[s],” somehow exonerated Respondent. See, e.g., Resp. Exceptions, at 13. Respondent cites no legal authority for this Exception. Indeed, it is fatally flawed because it suggests that Respondent's corresponding responsibility is alleviated by the prescriber's medical license, controlled substances registration, or other credential. As the language of the regulation makes clear, while the prescribing practitioner is responsible for the proper prescribing and dispensing of a controlled substance, a corresponding responsibility rests with the pharmacist who fills a controlled substance prescription, and the pharmacist who knowingly fills a “purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” 21 CFR 1306.04(a). Thus, contrary to Respondent's suggestion, the good order of the prescribing practitioner's license, registration, or other credential does not alleviate the pharmacist's corresponding responsibility or exonerate the pharmacist in any way. I reject Respondent's Exception.

    Third, Respondent claims that the Government failed to prove the existence of any indicator of controlled substance abuse specified in Fla. Admin. Code r. 64K-1.007 (adopted May 21, 2012).35 See, e.g., Resp. Exceptions, at 14-17. Respondent cites no legal basis for its claim that the provisions of this State Administrative Code section, that were not even in effect during the entire period covered by the Show Cause Order, are determinative of liability under Federal law. I reject Respondent's Exception.

    35 According to this provision, the E-FORCSE Program Manager “may provide relevant information to the identified health care practitioners who have prescribed or dispensed controlled substances” to an individual “who within a 90-day time period . . . obtains a prescription for a controlled substance . . . from more than one prescriber . . . and . . . is dispensed a controlled substance . . . from five or more pharmacies.”

    Finally, Respondent suggested that the Government's case must fail because the DI did not meet with any prescriber or speak with any customer. See, e.g., Resp. Br., at 35, 37. Respondent did not elaborate on its argument or cite any legal precedent for it. Again, Agency precedent has made clear that Respondent's argument is mistaken.36 Accordingly, I reject it.

    36 “While it is true that a pharmacist cannot violate his corresponding responsibility if a prescription was nonetheless issued for a legitimate medical purpose, Respondent ignores that the invalidity of a prescription can be proved by circumstantial evidence.” Hills Pharmacy, 81 FR at 49,836, n.33.

    Allegation That Respondent Filled Controlled Substance Prescriptions Not Containing All of the Information Required by 21 CFR 1306.05(a) and (f)

    The Show Cause Order alleged that Respondent filled controlled substance prescriptions that did not contain all the information required by 21 CFR 1306.05(a) and (f). According to that regulation, a “corresponding liability rests upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations.” 21 CFR 1306.05(f). Among other things, those DEA regulations require that controlled substance prescriptions be “dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.” 21 CFR 1306.05(a). As found above, Respondent filled controlled substance prescriptions that did not contain all of the information required by 21 CFR 1306.05.

    As discussed above, the uncontroverted evidence is not only that Respondent violated this regulation, but that Respondent admitted violating this regulation. I find, based on all of the evidence in the record, that Respondent violated 21 CFR 1306.05(a) by filling multiple controlled substance prescriptions that were not prepared in the form prescribed by DEA regulation.

    Allegation That Respondent Filled Prescriptions Written for “Office Use” in Violation of 21 CFR 1306.04(b)

    The Show Cause Order alleged that Respondent violated 21 CFR 1306.04(b) when it filled prescriptions issued for “an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.” ALJX 1, at 10. As explained above, GX 17 included two “RX Order Forms” that Respondent referred to as “prescriptions” and, pursuant to at least one of them, admitted delivering controlled substances to an entity engaged in hormone replacement therapy for the purpose of allergy testing. Based on Respondent's admissions, I find that Respondent filled prescriptions issued in violation of 21 CFR 1306.04(b).37 I note, however, that 21 CFR 1306.04(b), the provision the Government cited in the Show Cause Order, prohibits the issuance, not the filling, of prescriptions.

    37 After admitting that it filled “the prescriptions alleged” in the Show Cause Order, Respondent argued that its actions were “legal and proper” under 21 CFR 1307.11(a), the so-called 5% Rule. Resp. Br., at 15-16. Since I find that the Government did not allege a legal basis for the “office use” allegation, I need not address Respondent's argument concerning 21 CFR 1307.11(a).

    Neither the Show Cause Order nor the Government Prehearing Statement cited a statutory or regulatory provision that prohibited the filling of a prescription issued in violation of 21 CFR 1306.04(b). In addition, the Government did not discuss the “office use” allegation, let alone address the legal sufficiency of this allegation in the Show Cause Order or in the Government Prehearing Statement. I find that the Government did not allege a legal basis for the revocation or suspension of Registrant's registration upon a finding that Registrant “filled” prescriptions issued in violation of 21 CFR 1306.04(b).

    Thus, while I find that Respondent admitted filling prescriptions issued in violation of 21 CFR 1306.04(b), I also find that the Government did not comply with the requirement that the Show Cause Order “contain a statement of the legal basis for . . . the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.” 21 CFR 1301.37(c). Thus, I will not give any weight in the public interest assessment to Respondent's admission that it filled prescriptions issued in violation of 21 CFR 1306.04(b).

    Allegation That Respondent Filled Prescriptions Written by Physicians for the Physicians' Personal Use in Violation of Florida Statute § 458.331(r)

    According to the Show Cause Order, Respondent “filled prescriptions written by physicians for the physicians' personal use, in violation of Fla. Stat. § 458.331(r) which prohibits `[p]rescribing, dispensing, or administering any medicinal drug appearing in any schedule set forth in chapter 893 by the physician to himself or herself.'” ALJX 1, at 10. The Show Cause Order also alleged that Respondent “violated Florida law by dispensing controlled substances pursuant to these invalid prescriptions.” Id. Neither it nor the Government Prehearing Statement, however, specified the provision of the allegedly violated Florida law. The CALJ referenced the corresponding responsibility provision of 21 CFR 1306.04(a) but that, of course, cannot be the provision of “Florida law” that the Show Cause Order referenced.

    During the time period covered by the Show Cause Order, Florida law required that a pharmacist, before dispensing a controlled substance listed in schedules II through IV, first determine “in the exercise of her or his professional judgment . . . that the order is valid.” Fla. Stat. § 893.04(2)(a) (2009). The substances that Respondent admitted dispensing to physicians for their personal use, testosterone and phentermine, were listed in Florida law as controlled substances under schedules III and IV, respectively. Fla. Stat. § 893.03 (2011) (“Standards and schedules”). See also Fla. Stat. § 893.02(22) (2011) (defining a “prescription” as an order for drugs “issued in good faith and in the course of professional practice . . . and meeting the requirements of s. 893.04.”).

    The Respondent's argument against liability was that the Florida statute referenced in the Order to Show Cause was not sufficiently related to preventing the diversion of controlled substances. Resp. Br., at 17-18. According to Respondent, the “primary purpose behind § 458.331 . . . is to regulate the practice of medicine and discipline physicians that have engaged in unethical and/or unprofessional behavior.” Id. at 17. It argued that “[c]learly, the primary purpose behind § 458.331 . . . in general and § 458.331(r) specifically is not `control[ling] the supply and demand of controlled substances in both lawful and unlawful drug markets' . . . or preventing drug diversion, but disciplinary actions and remedies against offending physicians.” Id. at 18 (quoting Gonzales v. Raich, 545 U.S. 1, 19 (2005)).

    Respondent's argument fails as does its similar argument concerning its admitted interstate shipment of controlled substances in violation of four States' non-resident pharmacy requirements. The Florida statutes at issue concerned exactly what Respondent argued they did not. As the CALJ stated, the Florida provision cited in the Show Cause Order “prohibits an activity that `increases the opportunity for those persons who are self-abusing or engaged in diversion to obtain controlled substances.'” R.D., at 38 n.159 (citing Fred Samimi, M.D., 79 FR 18,698, 18,710 (2014)). Further, Chapter 893, referenced in the Florida statute listed in the Show Cause Order, is entitled “Drug Abuse Prevention and Control.” These provisions of Florida law concern much more than physician discipline; by their very title, they go to the heart of the controlled substance anti-diversion mission—drug abuse prevention and control.

    The dilemma posed by this Show Cause Order allegation is whether it, in its and the hearing record's brevity concerning this charge, sufficiently noticed Respondent of the charge being levied against it. The CALJ thought not. See R.D., at 39. However, Respondent defended against this charge and, in doing so, purported to understand the charge being levied against it.

    I find that neither the Show Cause Order nor the Government Prehearing Statement specified a statutory provision that Respondent allegedly violated.38 21 CFR 1301.37(c). Thus, even though there is evidence in the record that Respondent violated Florida law when it filled prescriptions for the personal use of the prescriptions' prescribers, I did not consider this evidence when I conducted the public interest analysis of 21 U.S.C. 823(f).39

    38 Neither did the Government Brief specify a statutory provision that Respondent allegedly violated.

    39 Fla. Stat. § 458.331(r) (which prohibited “[p]rescribing, dispensing, or administering any medicinal drug appearing in any schedule set forth in chapter 893 by the physician to himself or herself”) in conjunction with Fla. Stat. § 893.04(2)(a) (which prohibited a pharmacist from dispensing a controlled substance without first determining, in the exercise of her professional judgment, that the order was valid).

    Other Allegations Allegation That Respondent Was Unable To Readily Retrieve Prescriptions It Had Dispensed

    The Show Cause Order alleged that Respondent was unable to “readily retrieve prescriptions it had dispensed” in violation of 21 CFR 1304.04(h)(3) and (4). ALJX 1, at 7-8. The Show Cause Order cited 12 examples of prescriptions that Respondent allegedly did not retrieve and provide to the DI as required by law.

    According to the regulation, which is applicable to inventories and records of controlled substances in schedules III through V, “[p]aper prescriptions for Schedules III, IV, and V controlled substances shall be maintained at the registered location . . . in such form that they are readily retrievable from the other prescription records of the pharmacy.” 21 CFR 1304.04(h)(4). The regulatory definition of “readily retrievable” calls for locating the records “in a reasonable time.” 21 CFR 1300.01(b). Agency precedent states that “what constitutes `a reasonable time' necessarily depends on the circumstances.” Edmund Chein, M.D., 72 FR 6580, 6593 (2007), pet. for rev. denied, Chein v. Drug Enforcement Admin., 533 F.3d 828, 832 n.6 (DC Cir 2008), cert. denied, 555 U.S. 1139 (2009). According to that precedent, “under normal circumstances if a practice is open for business, it should be capable of producing a complete set of records within several hours of the request.” Id. The decision explained that “[t]o allow a registrant an even greater period of time to produce the records would create an incentive for those who are engaged in illegal activity to obstruct investigations by stalling for time in the hopes that DEA personnel would eventually give up and leave.” Id.

    As found above, Respondent never provided the 12 requested prescriptions to the DI. Respondent included ten of the 12 prescriptions in an exhibit for the hearing in this proceeding more than two years after the unannounced inspection, but this is insufficient to comply with the “readily retrievable” requirement. As of the final day of the hearing in this proceeding, or about 28 months after the unannounced inspection, Respondent still had not provided the Government with two of the prescriptions. Accordingly, I find that the Government has proved by substantial evidence that Registrant failed to comply with the requirements of 21 CFR 1304.04(h)(3) and (4).

    Allegation That Respondent Shipped Controlled Substances Out-of-State Without Complying With Those States' Non-Resident Pharmacy Requirements

    The Order to Show Cause alleged that Respondent shipped controlled substances to customers in Alabama, Illinois, Kentucky, and Vermont without complying with those States' non-resident pharmacy requirements.40 As found above, Respondent shipped controlled substances to customers in Alabama, Illinois, Kentucky, and Vermont without being licensed in, or permitted by, those States to do so. Accordingly, I find that the Government has proved by substantial evidence that Registrant failed to comply with the non-resident pharmacy requirements of four States.

    40 Alabama (prescription shipped Jan. 14, 2013): Ala. Admin. Code r. 680-X-2-.07(2) (2005) (“No nonresident pharmacy shall ship, mail or deliver prescription drugs and/or devices to a patient in this state unless registered by the Alabama State Board of Pharmacy.”); Illinois (prescription shipped Jan. 27, 2012): Ill. Admin. Code tit. 68 § 1330.550(a) (2012) (“The Division shall require and provide for an annual nonresident special pharmacy registration for all pharmacies located outside of this State that dispense medications for Illinois residents and mail, ship or deliver prescription medications into this State. . . .”); Kentucky (prescription shipped March 19, 2012): Ky. Rev. Stat. § 315.0351(1) (2007) (“Every person or pharmacy located outside this Commonwealth which does business, physically or by means of the internet, facsimile, phone, mail, or any other means, inside this Commonwealth . . . shall hold a current pharmacy permit . . . issued by the Kentucky Board of Pharmacy.”); and Vermont (prescription shipped Jan. 10, 2013): Vt. Stat. Ann. tit. 26 § 2061(a) (2013) (“All drug outlets shall biennially register with the board of pharmacy.”); Vt. Stat. Ann. tit. 26 § 2022(7) (2013) (“ Drug outlet' means all pharmacies, . . . and mail order vendors which are engaged in dispensing, delivery, or distribution of prescription drugs.”); see also 20-4-1400 Vt. Code R. § 16.1 et seq. (2013) (“ Non-resident pharmacy' means a drug outlet . . . located outside of Vermont which dispenses prescription drugs . . . for Vermont residents . . . and which mails, ships, or delivers such prescription drugs . . . into this state. . . .”).

    Respondent admitted that it was not in compliance with any of these four States' non-resident pharmacy requirements when it shipped controlled substances to customers at addresses in those States. Further, Respondent did not challenge the Government's contention that it violated these four States' non-resident pharmacy requirements when it argued that “[i]t should be note [sic] that other than the out-of-state dispensing instances . . . [alleged], there was no evidence that . . . [Respondent] is engaged in shipping medications to states where it does not hold a Non-resident pharmacy license.” Resp. Br., at 9. Instead, Respondent argued that its noncompliance with these four States' non-resident pharmacy statutes was insufficiently related to preventing the diversion of controlled substances to be considered under Factor Four of 21 U.S.C. 823(f). Id. at 4-9 (citing Fred Samimi, 79 FR at 18,710). The CALJ disagreed and concluded that the out-of-state pharmacy provisions had a “sufficient nexus” to the Act's “core purpose of preventing drug abuse and diversion to warrant consideration under the Public Interest Factors.” R.D., at 43. I agree with the result the CALJ recommended.

    The second public interest factor is “experience in dispensing . . . controlled substances.” 21 U.S.C. 823(f)(2). “Dispense,” according to 21 U.S.C. 802(10), means “deliver a controlled substance to an ultimate user . . . pursuant to the lawful order of . . . a practitioner.” Despite the testimony of Respondent's Owner and PIC and her statements to the DI, Respondent admitted that it “dispensed” controlled substances in violation of four States' legal requirements. Thus, I find that Respondent's experience in dispensing controlled substances includes the dispensing of controlled substances to customers living in four States in which Respondent was not licensed or legally authorized to dispense those controlled substances. Id. This result is consistent with Agency precedent. Sun & Lake Pharmacy, Inc.; d/b/a the Medicine Shoppe, 76 FR 24,523, 24,532 (2011) (finding that Respondent committed actionable misconduct when it dispensed prescriptions to residents of States in which it was not licensed.). See also 21 U.S.C. 802(21) (defining “practitioner” as meaning, in relevant part, a “pharmacy . . . licensed, registered or otherwise permitted . . . by the . . . jurisdiction in which . . . [it] practices . . . to . . . dispense a controlled substance”).

    Allegation That Respondent Violated Florida State Law by Failing To Report Some Prescriptions to E-FORCSE in Violation of Florida Statute § 893.055(4)

    The Show Cause Order alleged that Respondent failed to comply with Florida State law by not reporting specified prescriptions to E-FORCSE. As discussed above, I found that Respondent did not challenge the Government's assertion that six controlled substance prescriptions it dispensed did not appear in E-FORCSE. The CALJ found “not persuasive” Respondent's argument that the non-reportings “had their genesis in a good-faith technical glitch.” R.D., at 46 n.184. He recommended finding the testimony of Respondent's Owner and PIC on this allegation “wholly unpersuasive,” “even if assumed, arguendo, to be credible.” Id.

    The Florida statute that the Respondent allegedly violated required the reporting to E-FORCSE of each controlled substance dispensed “as soon thereafter as possible, but not more than 7 days after the date the controlled substance is dispensed unless an extension is approved.” Fla. Stat. § 893.055(4) (2012). Respondent, a covered “dispenser” under the provision, did not claim that it had been granted an extension under the statute. Fla. Stat. § 893.055(1)(c) (“ ‘Dispenser' means a pharmacy . . . [or] dispensing pharmacist. . . .”).

    I disagree with Respondent's claim that the Florida Statute did “not provide for any penalties for non-compliance, partial compliance or reporting errors.” Resp. Br., at 25. To the contrary, the Florida Statute contained a criminal sanction for a willful and knowing failure to report the dispensing of controlled substances. Fla. Stat. § 893.055(9) (2011) (“Any person who willfully and knowingly fails to report the dispensing of a controlled substance as required by this section commits a misdemeanor of the first degree.”); see also Fla. Stat. § 893.13(7)(a)(2) and (c) (2011) (A person who refuses or fails to keep any required record commits a misdemeanor of the first degree for a first violation and a felony of the third degree for a second or subsequent violation).

    Based on all of the evidence in the record, I find that Respondent did not comply with the controlled substance reporting requirements of Fla. Stat. 893.055(4). Respondent's non-compliance is appropriate for consideration under Factor Four. In this case, due to the overwhelming egregiousness of other violations that Respondent committed, my consideration of Respondent's non-compliance with the controlled substance reporting requirements of Fla. Stat. 893.055(4) did not have a determinative impact on my public interest assessment.

    Summary of Factors Two and Four

    As discussed above, the Government presented a prima facie case that Respondent, with a subjective belief of a high probability that controlled substance prescriptions were not legitimate and while taking deliberate actions to avoid learning of their illegitimacy, filled multiple prescriptions for controlled substances which lacked a legitimate medical purpose. The Government also presented a prima facie case that Respondent was unable to readily retrieve prescriptions it had dispensed, filled controlled substance prescriptions and shipped them without meeting the out-of-state pharmacy requirements of four States, filled controlled substance prescriptions that did not contain all of the required information, and failed to report controlled substance prescriptions to E-FORCSE in violation of Florida law. Thus, I conclude that Respondent engaged in egregious misconduct which supports the revocation of its registration. See Wesley Pope, 82 FR 14,944, 14,985 (2017) (collecting cases).

    I therefore hold that the Government has established a prima facie case that Respondent's continued registration “would be inconsistent with the public interest.” 21 U.S.C. 823(f).

    Sanction

    Where, as here, the Government has met its prima facie burden of showing that Respondent's continued registration is inconsistent with the public interest due to its numerous violations pertaining to its dispensing and recordkeeping practices and its non-compliance with State laws, the burden shifts to the Respondent to show why its continued registration would nonetheless be consistent with the public interest. Medicine Shoppe-Jonesborough, 73 FR 364, 387, pet. for rev. denied sub nom. Medicine Shoppe-Jonesborough v. Drug Enforcement Admin., 300 F. App'x 409 (6th Cir. 2008). Under Agency precedent, the Respondent must “present sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility carried by such a registration.” Hills Pharmacy, 81 FR at 49,845 (citing Medicine Shoppe-Jonesborough, 73 FR at 387 (quoting Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (2007)) (quoting Leo R. Miller, M.D., 53 FR 21,931, 21,932 (1988))). Moreover, because past performance is the best predictor of future performance, DEA has repeatedly held that when a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for those actions and demonstrate that it will not engage in future misconduct. East Main Street Pharmacy, 75 FR at 66,162 (quoting Medicine Shoppe-Jonesborough, 73 FR at 387); see also MacKay, 664 F.3d at 820 (DEA may properly consider whether a physician admits fault in determining if the physician's registration should be revoked.). That acceptance of responsibility must be unequivocal. Lon F. Alexander, M.D., 82 FR 49,704, 49,728 (2017) (collecting cases).

    Moreover, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19,386, 19,387-88 (2011) (explaining that a respondent can “argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation”); Paul H. Volkman, 73 FR 30,630, 30,644 (2008); see also Paul Weir Battershell, 76 FR 44,359, 44,369 (2011) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and “manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant”); Gregory D. Owens, 74 FR 36,751, 36,757 n.22 (2009).

    Finally, the Agency has also held that “ `[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be [suspended or] revoked' ” or an application should be denied. Wesley Pope, 82 FR 14,944, 14,985 (2017) (quoting Joseph Gaudio, 74 FR 10,083, 10,094 (2009) (quoting Southwood Pharmaceuticals, Inc., 72 FR 36,487, 36,504 (2007))). See also Robert Raymond Reppy, 76 FR 61,154, 61,158 (2011); Michael S. Moore, 76 FR 45,867, 45,868 (2011). This is so both with respect to the respondent in a particular case and the community of registrants. See Pope, 82 FR at 14,985 (quoting Gaudio, 74 FR at 10,095 (quoting Southwood, 71 FR at 36,503)). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of “deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions”).

    In this case, the CALJ found that Respondent's acceptance of responsibility was “limited in scope and can be fairly characterized as minimal.” R.D., at 58. Specifically, the CALJ found that Respondent's Owner and PIC, on behalf of Respondent, accepted responsibility in “only three carefully circumscribed” areas: (1) that she did not document every single conversation with every single prescriber; (2) that she, as the pharmacist-in-charge, shouldered ultimate responsibility for ensuring required documentation was properly completed; and (3) that Respondent filled controlled substance prescriptions for patients who lived a significant distance from the pharmacy. R.D., at 58.

    At the hearing, Respondent's counsel asked Respondent's Owner and PIC “[w]hat is it that you're accepting responsibility for in this case?” Tr. 1025. Respondent's Owner and PIC testified: “That I don't have any intention to violate DEA rules.” Tr. 1025. This is in no sense a meaningful acknowledgement of Respondent's misconduct.

    In its Exceptions, Respondent contends that it “accepted responsibility for filling long-distance prescriptions and, as remedial measures, stopped dispensing schedule II substances all together.” Resp. Exceptions, at 8. Respondent also argues that, through Respondent's Owner and PIC, it “accepted the responsibility for not documenting in every instance, its efforts in resolving the red flags and as [a] remedial measure stated that it `document[s] everything that's possible.' ” Id. It further contends that, “[a]lthough . . . [Respondent's Owner and PIC] accepted responsibility for the misfiling of the prescriptions, it is easily deuced [sic] from the record and from the instituted corrective measures that the Respondent accepted the responsibility for the missing information as well.” Id. at 18 n.19.

    I reject Respondent's contentions. Most significantly, Respondent's Owner and PIC has entirely failed to acknowledge that Respondent violated the CSA when it knowingly dispensed numerous controlled substance prescriptions which were clearly issued outside of the usual course of professional practice and which lacked a legitimate medical purpose. And even as to the factual matters for which the CALJ found she accepted responsibility, such as failing to adequately document her conversations with prescribers, Respondent's Owner and PIC immediately equivocated by making excuses for not doing so in the future. She stated, “Now I document every little thing that it's concerned to the conversation and the dispensing of controlled substances. However, there's a lot of conversation going on on a daily basis between doctors and offices.” Tr. 1010-11. Similarly, after acknowledging that she filled controlled substance prescriptions for patients who lived a significant distance from the pharmacy, Respondent's Owner and PIC justified her filling of the prescriptions, asserting, without any evidence to corroborate her claim, that “some of them are working locally and they all had a local doctor.” Id. at 1026.

    Respondent's Owner and PIC also testified that, “If the DEA provide me, do not fill for 100 miles, like—that's why I said, I accepted my responsibility, I took remedial measures. I do not fill schedule II prescriptions in my pharmacy because of these conflicting red flags. Because it's a practice of Florida to travel.” Id. at 1023-24. Respondent characterized this testimony as meaning that Respondent's Owner and PIC accepted responsibility for filling long-distance prescriptions. Resp. Br., at 36; see also Resp. Exceptions, at 8. I specifically reject Respondent's argument. Notably, this testimony began with the word “if” and in any event, it does not constitute an acceptance of responsibility for violating the corresponding responsibility rule. Further, the testimony was not offered in the context of addressing Respondent's filling prescriptions from its Florida customers who travelled long distances to patronize Respondent. Rather, the testimony was offered to address Respondent's filling of prescriptions for out-of-state customers, specifically customers from Kentucky about whom Respondent's Owner and PIC testified she had been “clearly instructed” by DEA. Tr. 1023.

    Notably, at no point in the hearing did Respondent's Owner and PIC accept responsibility, let alone accept responsibility unequivocally, for violating the corresponding responsibility regulation. Notably, the testimony of Respondent's Owner and PIC manifests that she still does not acknowledge the scope of a pharmacist's obligation under 21 CFR 1306.04(a). As one example, she testified that “[t]he prescription is an order for the pharmacist to fill. For me not to fill that prescription, I have to have a very good reason not to fill it, because it's an order from the doctor to me to fill that prescription for that patient.” Id. at 1168. As the Agency has previously recognized, a registrant cannot accept responsibility for its misconduct when it does not even understand what the law requires of it. Alexander, 82 FR at 49,729. I agree with the CALJ's conclusion that “there is no unequivocal acceptance of responsibility on this record that would be particularly helpful to the Respondent's efforts to avoid a sanction.” R.D., at 58.

    Here, the CALJ concluded that “the paltry nature of the Responde