Federal Register Vol. 81, No.159,

Federal Register Volume 81, Issue 159 (August 17, 2016)

Page Range54709-55104
FR Document

81_FR_159
Current View
Page and SubjectPDF
81 FR 54717 - Providing an Order of Succession Within the National Endowment for the HumanitiesPDF
81 FR 54715 - Designation of Officers of the Office of Personnel Management To Act as Director of the Office of Personnel ManagementPDF
81 FR 54713 - Providing an Order of Succession Within the Environmental Protection AgencyPDF
81 FR 54711 - Providing an Order of Succession Within the Department of Veterans AffairsPDF
81 FR 54709 - Providing an Order of Succession Within the Department of the TreasuryPDF
81 FR 54857 - In the Matter of Neuromama, Ltd.; Order of Suspension of TradingPDF
81 FR 54916 - Petition for Waiver of CompliancePDF
81 FR 54803 - MAVL Capital, Inc., IAM & AL Group Inc., and Maxim Ostrovskiy V. Marine Transport Logistics, Inc. and Dimitry Alper: Notice of Filing of Complaint and AssignmentPDF
81 FR 54739 - Special Local Regulations; Tall Ships Duluth 2016 Parade of Sail, Lake Superior, Duluth, MNPDF
81 FR 54913 - Commission Meeting; CorrectionPDF
81 FR 54789 - Approval of Subzone Status: Westlake Chemical Corporation, Geismar, LouisianaPDF
81 FR 54803 - Plant-Incorporated Protectants: Proposed Modifications of Registration Procedures for Plant-Incorporated Protectants in Breeding Line Intermediates; Notice of Availability; Extension of Comment PeriodPDF
81 FR 54853 - Arts Advisory Panel MeetingsPDF
81 FR 54809 - Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request; Voluntary Qualified Importer Program Guidance for IndustryPDF
81 FR 54818 - 30-Day Notice of Proposed Information Collection: Energy and Performance Information Center (EPIC)PDF
81 FR 54818 - 30-Day Notice of Proposed Information Collection: Public Housing Agency (PHA) Lease and Grievance RequirementsPDF
81 FR 54802 - Proposed Consent Decree, Clean Air Act Citizen SuitPDF
81 FR 54800 - Proposed Consent Decree, Clean Air Act Citizen SuitPDF
81 FR 54819 - 60-Day Notice of Proposed Information Collection: Uniform Physical Standards & Physical Inspection RequirementsPDF
81 FR 54790 - Department of Defense Military Family Readiness Council (MFRC); Notice of Federal Advisory Committee MeetingPDF
81 FR 54804 - Notice of Agreements FiledPDF
81 FR 54913 - 30-Day Notice of Proposed Information Collection: Shrimp Exporter's/Importer's DeclarationPDF
81 FR 54856 - Sunshine Notice-September 7, 2016 Public HearingPDF
81 FR 54849 - Notice of Federal Advisory Committee MeetingPDF
81 FR 54853 - Notice of Centennial Challenges Space Robotics ChallengePDF
81 FR 54917 - Proposed Agency Information Collection Activities; Comment RequestPDF
81 FR 54719 - Almonds Grown in California; Change in Quality Control RequirementsPDF
81 FR 54748 - Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Increased Assessment RatePDF
81 FR 54789 - Credit Union Advisory Council MeetingPDF
81 FR 54721 - Energy Conservation Program: Test Procedures for Ceiling Fans; CorrectionPDF
81 FR 54804 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 54805 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 54795 - Carib Energy (USA) LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations in Central America, South America, or the CaribbeanPDF
81 FR 54787 - [Docket No. 160714611-6611-01] HEADOffice of Administration; Commerce Alternative Personnel SystemPDF
81 FR 54850 - Notice of a Public Meeting of the Advisory Committee on Apprenticeship (ACA)PDF
81 FR 54852 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Death GratuityPDF
81 FR 54851 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Prohibited Transaction Class Exemption for Certain Transactions Between Investment Companies and Employee Benefit Plans (PTE 1977-4)PDF
81 FR 54807 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 54792 - Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Federal Advisory Committee MeetingPDF
81 FR 54794 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and approval; Comment Request; Application for Grants Under the Upward Bound ProgramPDF
81 FR 54786 - Revision of the Land Management Plan for Francis Marion National ForestPDF
81 FR 54856 - Proposed Collection; Comment RequestPDF
81 FR 54791 - National Security Education Board; Notice of Federal Advisory Committee MeetingPDF
81 FR 54915 - Ninety-Sixth Meeting Special Committee 159 Global Positioning SystemPDF
81 FR 54918 - Notice and Request for CommentsPDF
81 FR 54744 - Fisheries of the Northeastern United States; Northeast Skate Complex Fishery; Framework Adjustment 3 and 2016-2017 SpecificationsPDF
81 FR 54737 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972PDF
81 FR 54768 - Notice of Intent To Establish a Negotiated Rulemaking CommitteePDF
81 FR 54806 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 54814 - National Indian Health Outreach and Education II Program; CorrectionPDF
81 FR 54808 - Regulatory Classification of Pharmaceutical Co-Crystals; Draft Guidance for Industry; AvailabilityPDF
81 FR 54822 - Lawrence E. Stewart, M.D.; Decision and OrderPDF
81 FR 54914 - Request for Comments and Notice of Public Hearing Concerning Russia's Implementation of Its WTO CommitmentsPDF
81 FR 54849 - Bulk Manufacturer of Controlled Substances Application: Stepan CompanyPDF
81 FR 54919 - Privacy Act of 1974PDF
81 FR 54813 - Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
81 FR 54811 - Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; AvailabilityPDF
81 FR 54901 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change Amending Rule 12904 (Awards) of the Code of Arbitration Procedure for Customer Disputes and Rule 13904 (Awards) of the Code of Arbitration Procedure for Industry Disputes To Permit Award Offsets in Arbitration, as Modified by Amendment No. 1PDF
81 FR 54877 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change Amending the Co-location Services Offered by the Exchange To Add Certain Access and Connectivity FeesPDF
81 FR 54897 - Self-Regulatory Organizations: Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Conform to Rules of the Financial Industry Regulatory AuthorityPDF
81 FR 54870 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to COPSPDF
81 FR 54888 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Amending Rule 12504 of the Code of Arbitration Procedure for Customer Disputes and Rule 13504 of the Code of Arbitration Procedure for Industry Disputes Relating to Motions To Dismiss in ArbitrationPDF
81 FR 54905 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing and Order Approving and Declaring Effective an Amendment to the Plan for the Allocation of Regulatory Responsibilities Between Bats BZX Exchange, Inc., Bats BYX Exchange, Inc., BOX Options Exchange LLC, Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, Chicago Stock Exchange, Inc., Bats EDGA Exchange, Inc., Bats EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange, LLC, Investors Exchange LLC, ISE Gemini, LLC, ISE Mercury, LLC, Miami International Securities Exchange, LLC, The NASDAQ Stock Market LLC, NASDAQ BX, Inc., NASDAQ PHLX, Inc., National Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc.PDF
81 FR 54873 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Related to Transaction and Regulatory FeesPDF
81 FR 54858 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Amending the Code of Arbitration Procedure for Customer Disputes and the Code of Arbitration Procedure for Industry Disputes to Require All Parties Other Than Pro SePDF
81 FR 54887 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Modify the NYSE Amex Options Fee SchedulePDF
81 FR 54911 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 517PDF
81 FR 54867 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Amending Rule 6.91(b) To Provide for the Rejection of Certain Electronic Complex OrdersPDF
81 FR 54891 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services Related to Tier 1 and Cross Asset Tier 2 Fees and Credits for Orders Executed on the Exchange, and Eliminate the Routable Retail Order TierPDF
81 FR 54893 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Amending Rule 980NY(d) To Provide for the Rejection of Certain Electronic Complex OrdersPDF
81 FR 54904 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Logical Port FeesPDF
81 FR 54896 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Logical Port FeesPDF
81 FR 54797 - Notice of FERC Staff Attendance at the Entergy Regional State Committee MeetingPDF
81 FR 54796 - Notice of Institution of Section 206 Proceeding and Refund Effective Date: Elwood Energy, LLC, Exelon Generation Company, LLCPDF
81 FR 54798 - Northern Natural Gas Company; Notice of ApplicationPDF
81 FR 54799 - Notice of Application Millennium Pipeline Company, LLCPDF
81 FR 54796 - Combined Notice of Filings #1PDF
81 FR 54804 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
81 FR 54783 - Remove NASA FAR Supplement Clause, Engineering Change Proposals (2016-N030)PDF
81 FR 54791 - Defense Acquisition University Board of Visitors; Notice of Federal Advisory Committee MeetingPDF
81 FR 54805 - Maximum Per Diem Reimbursement Rates for the Continental United States (CONUS)PDF
81 FR 54854 - Conduct of OperationsPDF
81 FR 54820 - Certain Foam Footwear; Institution of an Advisory Opinion ProceedingPDF
81 FR 54821 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 54855 - Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Normal Atmosphere Cleanup Systems in Light Water Cooled Nuclear Power PlantsPDF
81 FR 54790 - Notice of Availability (NOA) of an Environmental Assessment (EA) Addressing Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center, Richmond, VirginiaPDF
81 FR 54752 - Proposed Amendment of Class C Airspace; El Paso International Airport, TXPDF
81 FR 54793 - Submission for OMB Review; Comment RequestPDF
81 FR 54721 - Revisions to the Export Administration Regulations (EAR): Harmonization of the Destination Control StatementsPDF
81 FR 54732 - Amendment to the International Traffic in Arms Regulations: Procedures for Obtaining State Department Authorization To Export Items Subject to the Export Administration Regulations; Revision to the Destination Control Statement; and Other ChangesPDF
81 FR 54817 - Prospective Grant of Exclusive Patent License: Development of T Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the Treatment of CancerPDF
81 FR 54816 - National Institute of Environmental Health Sciences; Notice of MeetingPDF
81 FR 54815 - National Institute on Aging; Notice of Closed MeetingsPDF
81 FR 54817 - National Institute on Aging; Notice of Closed MeetingPDF
81 FR 54816 - National Heart, Lung, and Blood Institute; Notice of MeetingPDF
81 FR 54817 - National Cancer Institute; Amended Notice of MeetingPDF
81 FR 54815 - National Cancer Institute; Notice of MeetingPDF
81 FR 54815 - National Center for Advancing Translational Sciences; Notice of Closed MeetingPDF
81 FR 54742 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Control of Volatile Organic Compound Emissions From Fiberglass Boat Manufacturing MaterialsPDF
81 FR 54780 - Air Plan Approval; Kentucky; Removal of Stage II Gasoline Vapor Recovery ProgramPDF
81 FR 54741 - Drawbridge Operation Regulation; Rockaway Inlet, Queens, NYPDF
81 FR 54795 - Environmental Management Site-Specific Advisory Board, PaducahPDF
81 FR 55058 - Endangered and Threatened Wildlife and Plants; Threatened Status for Lepidium papilliferumPDF
81 FR 54789 - Submission for OMB Review; Comment RequestPDF
81 FR 54750 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 54754 - Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain PlasticsPDF
81 FR 54960 - Substances Generally Recognized as SafePDF
81 FR 54926 - Energy Conservation Program: Test Procedure for Walk-in Coolers and Walk-in FreezersPDF
81 FR 54763 - Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission StandardsPDF
81 FR 55086 - World Trade Center Health Program; Amendments to Definitions, Appeals, and Other RequirementsPDF
81 FR 54770 - Revision of the DOL FOIA RegulationsPDF

Issue

81 159 Wednesday, August 17, 2016 Contents Agricultural Marketing Agricultural Marketing Service RULES Quality and Handling Requirements: Almonds Grown in California, 54719-54721 2016-19625 PROPOSED RULES Increased Assessment Rates: Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas, 54748-54750 2016-19624 Agriculture Agriculture Department See

Agricultural Marketing Service

Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Meetings: Credit Union Advisory Council, 54789-54790 2016-19622 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Agency Forms Undergoing Paperwork Reduction Act Review, 54806-54807 2016-19598 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Migrant and Seasonal Head Start Study, 54807-54808 2016-19611 Coast Guard Coast Guard RULES Drawbridge Operations: Rockaway Inlet, Queens, NY, 54741-54742 2016-19535 Special Local Regulations: Tall Ships Duluth 2016 Parade of Sail, Lake Superior, Duluth, MN, 54739-54741 2016-19652 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

National Oceanic and Atmospheric Administration

NOTICES Commerce Alternative Personnel System, 54787-54789 2016-19616
Consumer Product Consumer Product Safety Commission PROPOSED RULES Determinations Regarding Certain Plastics: Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates, 54754-54762 2016-19464 Defense Department Defense Department See

Navy Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54793-54794 2016-19555 Environmental Assessments; Availability, etc.: Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center Richmond, VA, 54790 2016-19558 Meetings: Defense Acquisition University Board of Visitors, 54791-54792 2016-19565 Military Family Readiness Council, 54790-54791 2016-19635 National Security Education Board, 54791 2016-19605 Strategic Environmental Research and Development Program, Scientific Advisory Board, 54792-54793 2016-19610
Drug Drug Enforcement Administration NOTICES Decisions and Orders: Lawrence E. Stewart, M.D., 54822-54848 2016-19595 Manufacturers of Controlled Substances; Applications: Stepan Co., 54849 2016-19592 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Grants under the Upward Bound Program, 54794 2016-19609 Employment and Training Employment and Training Administration NOTICES Meetings: Advisory Committee on Apprenticeship, 54850-54851 2016-19615 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Energy Conservation Program: Test Procedures for Ceiling Fans; Correction, 54721 2016-19621 PROPOSED RULES Energy Conservation Program: Test Procedure for Walk-in Coolers and Walk-in Freezers, 54926-54958 2016-19104 NOTICES Applications to Export Liquefied Natural Gas: Carib Energy (USA) LLC, 54795-54796 2016-19618 Meetings: Environmental Management Site-Specific Advisory Board, Paducah; Cancellations, 54795 2016-19529
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Pennsylvania; Control of Volatile Organic Compound Emissions from Fiberglass Boat Manufacturing Materials, 54742-54744 2016-19540 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Kentucky; Removal of Stage II Gasoline Vapor Recovery Program, 54780-54783 2016-19538 NOTICES Consent Decrees: Clean Air Act Citizen Suit, 54800-54801 2016-19638 Plant-Incorporated Protectants: Registration Procedures for Plant-Incorporated Protectants in Breeding Line Intermediates, 54803 2016-19646 Proposed Consent Decrees: Clean Air Act Citizen Suit, 54802-54803 2016-19639 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: The Boeing Company Airplanes, 54750-54752 2016-19487 Amendment of Class C Airspace: El Paso International Airport, TX, 54752-54754 2016-19556 NOTICES Meetings: Special Committee 159 Global Positioning System, 54915-54916 2016-19604 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Millennium Pipeline Co., LLC, 54799-54800 2016-19569 Northern Natural Gas Co., 54798-54799 2016-19570 Combined Filings, 54796-54797 2016-19568 Institution of Section 206 Proceeding and Refund Effective Date: Elwood Energy, LLC; Exelon Generation Company, LLC, 54796 2016-19571 Staff Attendances, 54797-54798 2016-19572 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed: Transpacific Stabilization Agreement, 54804 2016-19633 Complaints and Assignments: Mavl Capital, Inc., Iam and Al Group Inc., and Maxim Ostrovskiy v. Marine Transport Logistics, Inc. and Dimitry Alper, 54803 2016-19653 Federal Railroad Federal Railroad Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54917-54918 2016-19626 Petitions for Waivers of Compliance: Norfolk Southern Corp., 54916-54917 2016-19654 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54804-54805 2016-19567 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 54805 2016-19619 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 54804 2016-19620 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Threatened Status for Lepidium papilliferum (Slickspot Peppergrass) throughout its Range, 55058-55084 2016-19528 Food and Drug Food and Drug Administration RULES Substances Generally Recognized as Safe, 54960-55055 2016-19164 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Voluntary Qualified Importer Program Guidance for Industry, 54809-54811 2016-19643 Guidance for Industry: Classification of Pharmaceutical Co-Crystals, 54808-54809 2016-19596 Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 54811-54813 2016-19588 Meetings: Pediatric Advisory Committee, 54813-54814 2016-19589 Foreign Trade Foreign-Trade Zones Board NOTICES Subzone Approvals: Westlake Chemical Corp., Geismar, LA, 54789 2016-19647 General Services General Services Administration NOTICES Maximum Per Diem Reimbursement Rates for the Continental United States, 54805-54806 2016-19563 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

Indian Health Service

See

National Institutes of Health

PROPOSED RULES World Trade Center Health Program, 55086-55104 2016-18679
Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Energy and Performance Information Center, 54818-54819 2016-19641 Public Housing Agency Lease and Grievance Requirements, 54818 2016-19640 Uniform Physical Standards & Physical Inspection Requirements, 54819-54820 2016-19637 Indian Affairs Indian Affairs Bureau PROPOSED RULES Intent to Establish a Negotiated Rulemaking Committee, 54768-54770 2016-19599 Indian Health Indian Health Service NOTICES National Indian Health Outreach and Education II Program; Correction, 54814-54815 2016-19597 Industry Industry and Security Bureau RULES Revisions to the Export Administration Regulations—Harmonization of the Destination Control Statements, 54721-54732 2016-19551 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54789 2016-19517 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

International Trade Com International Trade Commission NOTICES Complaints: Certain Athletic Footwear, 54821-54822 2016-19560 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Foam Footwear; Institution of an Advisory Opinion Proceeding, 54820 2016-19561 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Meetings: National Commission on Forensic Science, 54849-54850 2016-19628
Labor Department Labor Department See

Employment and Training Administration

PROPOSED RULES Revision of the DOL FOIA Regulations, 54770-54780 2016-18594 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Death Gratuity, 54852-54853 2016-19614 Prohibited Transaction Class Exemption for Certain Transactions Between Investment Companies and Employee Benefit Plans, 54851-54852 2016-19613
NASA National Aeronautics and Space Administration PROPOSED RULES Remove NASA FAR Supplement Clause, Engineering Change Proposals, 54783-54785 2016-19566 NOTICES Centennial Challenges Space Robotics Challenge, 54853 2016-19627 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: Arts Advisory Panel, 54853-54854 2016-19644 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Highway National Highway Traffic Safety Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54918-54919 2016-19603 National Institute National Institutes of Health NOTICES Meetings: National Cancer Institute, 54815-54816 2016-19543 National Cancer Institute; Amendments, 54817 2016-19544 National Center for Advancing Translational Sciences, 54815 2016-19542 National Heart, Lung, and Blood Institute, 54816-54817 2016-19545 National Institute of Environmental Health Sciences, 54816 2016-19548 National Institute on Aging, 54815, 54817-54818 2016-19546 2016-19547 Prospective Grant of Exclusive Patent License: Development of T Cell Receptors Targeting the KRAS G12D Mutation for the Treatment of Cancer, 54817 2016-19549 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Northeast Skate Complex Fishery; Framework Adjustment and Specifications, 54744-54747 2016-19601 Navy Navy Department RULES Certifications and Exemptions Under the International Regulations: Preventing Collisions at Sea, 1972, 54737-54739 2016-19600 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Guidance: Conduct of Operations, 54854-54855 2016-19562 Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Normal Atmosphere Cleanup Systems in Light Water Cooled Nuclear Power Plants, 54855-54856 2016-19559 Overseas Overseas Private Investment Corporation NOTICES Meetings; Sunshine Act, 54856 2016-19630 Presidential Documents Presidential Documents EXECUTIVE ORDERS Government Agencies and Employees: Environmental Protection Agency; Providing an Order of Succession (EO 13737), 54713-54714 2016-19725 Treasury, Department of the; Providing an Order of Succession (EO 13735), 54709-54710 2016-19723 Veterans Affairs, Department of; Providing an Order of Succession (EO 13736), 54711-54712 2016-19724 ADMINISTRATIVE ORDERS Government Agencies and Employees: Humanities, National Endowment for the; Providing an Order of Succession (Memorandum of August 12, 2016), 54717-54718 2016-19728 Personnel Management, Office of; Designation of Officers To Act as Director (Memorandum of August 12, 2016), 54715-54716 2016-19726 Railroad Retirement Railroad Retirement Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 54856-54857 2016-19606 Securities Securities and Exchange Commission NOTICES Plan for the Allocation of Regulatory Responsibilities; Order: Bats BZX Exchange, Inc., Bats BYX Exchange, Inc., BOX Options Exchange LLC, etc., 54905-54911 2016-19582 Self-Regulatory Organizations; Proposed Rule Changes: Bats BYX Exchange, Inc., 54896-54897 2016-19573 Bats BZX Exchange, Inc., 54904-54905 2016-19574 Chicago Board Options Exchange, Inc., 54870-54873 2016-19584 Financial Industry Regulatory Authority, Inc., 54858-54867, 54888-54891, 54901-54904 2016-19580 2016-19583 2016-19587 Investors Exchange LLC, 54873-54877, 54897-54901 2016-19581 2016-19585 Miami International Securities Exchange LLC, 54911-54912 2016-19578 New York Stock Exchange LLC, 54877-54887 2016-19586 NYSE Arca, Inc., 54867-54870, 54891-54893 2016-19576 2016-19577 NYSE MKT LLC, 54887-54888, 54893-54896 2016-19575 2016-19579 Trading Suspension Orders: Neuromama, Ltd., 54857-54858 2016-19718 State Department State Department RULES Amendment to the International Traffic in Arms Regulations: Procedures for Obtaining State Department Authorization to Export Items Subject to the Export Administration Regulations; Revision to the Destination Control Statement; and Other Changes, 54732-54737 2016-19550 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Shrimp Exporter's/Importer's Declaration, 54913 2016-19631 Susquehanna Susquehanna River Basin Commission NOTICES Meetings: Susquehanna River Basin Commission; Correction, 54913-54914 2016-19649 Trade Representative Trade Representative, Office of United States NOTICES Hearings: Russia's Implementation of WTO Commitments, 54914-54915 2016-19593 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department PROPOSED RULES Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards, 54763-54768 2016-18761 Customs U.S. Customs and Border Protection PROPOSED RULES Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards, 54763-54768 2016-18761 Veteran Affairs Veterans Affairs Department NOTICES Privacy Act; Systems of Records, 54919-54923 2016-19591 Separate Parts In This Issue Part II Energy Department, 54926-54958 2016-19104 Part III Health and Human Services Department, Food and Drug Administration, 54960-55055 2016-19164 Part IV Interior Department, Fish and Wildlife Service, 55058-55084 2016-19528 Part V Health and Human Services Department, 55086-55104 2016-18679 Reader Aids

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

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81 159 Wednesday, August 17, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 981 [Doc. No. AMS-SC-16-0047; SC16-981-3 IR] Almonds Grown in California; Change in Quality Control Requirements AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Interim rule with request for comments.

SUMMARY:

This rule implements a recommendation from the Almond Board of California (Board) to change the quality control requirements currently prescribed under the California almond marketing order (order). The order regulates the handling of almonds grown in California. The Board locally administers the order and is comprised of growers and handlers operating within California. This rule relaxes incoming quality requirements by increasing the inedible kernel tolerance from 0.50 percent to 2 percent. This relaxation decreases California almond handlers' disposition obligation. This change also allows handlers more flexibility in their operations while continuing to maintain quality control and ensuring compliance with the order's requirements.

DATES:

Effective August 18, 2016; comments received by October 17, 2016 will be considered prior to issuance of a final rule.

ADDRESSES:

Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet: http://www.regulations.gov. All comments should reference the document number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: http://www.regulations.gov. All comments submitted in response to this rule will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above.

FOR FURTHER INFORMATION CONTACT:

Andrea Ricci, Marketing Specialist or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email: [email protected] or [email protected]

Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

SUPPLEMENTARY INFORMATION:

This rule is issued under Marketing Order No. 981, as amended (7 CFR part 981), regulating the handling of almonds grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule implements a recommendation from the Almond Board of California (Board) to change the quality control requirements currently prescribed under the order. This rule relaxes incoming quality requirements by increasing the inedible kernel tolerance from 0.50 percent to 2 percent. This relaxation would decrease California almond handler's disposition obligation. This will allow handlers more flexibility in their operations while continuing to maintain quality control. In addition, this change will ensure that the reporting and outgoing quality requirements of the order are met. The Board unanimously recommended this change at its April 12, 2016, meeting.

Section 981.42 of the almond marketing order provides authority for quality control regulations. Paragraph (a) of that section requires that almonds must be inspected prior to processing to determine the percentage of inedible kernels in each lot. Inedible kernels are defined in § 981.408. The Board, with the approval of the Secretary, may change the approved percentage of inedible kernels for any crop year. Inedible kernels in excess of the approved percentage of the kernel weight constitute the handlers' inedible disposition weight obligation. Handlers must satisfy their obligation by disposing of inedible kernels in Board-accepted, non-human outlets such as animal feed or oil.

Section 981.442(a)(4)(i) of the order's rules and regulations currently specifies that the weight of inedible kernels in excess of 0.50 percent of kernel weight shall constitute the handler's disposition obligation. Pursuant to § 981.442(a)(5), handlers must meet their disposition obligation by delivering inedible kernels to crushers, feed manufacturers, feeders, or dealers in nut wastes on record with the Board as accepted users.

In the past several years, the total inedible kernel percentages have been trending lower. This is partially due to good agricultural practices used by growers and better technologies in handler facilities. At the same time, the market value of almonds has increased significantly. As a result, some Board-accepted outlets have started to clean and repurpose the disposition obligation delivered by handlers. After the inedible disposition is delivered to Board-accepted outlets, these accepted outlets provide to the Board a record of disposition receipt, which indicates what was received by the accepted outlet from handlers and how the accepted outlet disposed of the inedible disposition. However, such record of disposition receipt does not indicate whether the almonds have been pasteurized or treated for human consumption. Thus the action of repurposing has led to concern that the order's outgoing quality requirements are not being met.

By increasing the inedible kernel tolerance, handlers' disposition obligation will decrease or become zero, therefore reducing the quantity of product delivered to those specified outlets. This action will also provide handlers with more control over low quality product allowing one handler the flexibility to transfer the larger portion of low quality product to another handler for further cleaning. This action will require completion of an interhandler transfer form and help with traceability of low quality product. It also will help ensure that any product destined for human consumption was in compliance with the pertinent regulations under the order.

Initial Regulatory Flexibility Analysis

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 6,800 almond growers in the production area and approximately 100 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

The National Agricultural Statistics Service (NASS) reported in its 2012 Agricultural Census that there were 6,841 almond farms in the production area (California), of which 6,204 had bearing acres. The following computation provides an estimate of the proportion of producers (farms) and agricultural service firms (handlers) that would be considered small under the SBA definitions.

The NASS Census data indicates that out of the 6,204 California farms with bearing acres of almonds, 4,471 (72 percent) have fewer than 100 bearing acres.

For the almond industry's most recently reported crop year (2014), NASS reported an average yield of 2,150 pounds per acre, and a season average grower price of $3.19 per pound. A 100-acre farm with an average yield of 2,150 pounds per acre would produce about 215,000 pounds of almonds. At $3.19 per pound, that farm's production would be valued at $685,850. Since Census of Agriculture indicates that the majority of California's almond farms are smaller than 100 acres, it could be concluded that the majority of growers had annual receipts from the sale of almonds in 2014-15 of less than $685,850, which is below the SBA threshold of $750,000. Thus, over 70 percent of California's almond growers would be considered small growers according to SBA's definition.

According to information supplied by the Board, approximately 30 percent of California's almond handlers shipped almonds valued under $7,500,000 during the 2014-15 crop year, and would, therefore, be considered small handlers according to the SBA definition.

This rule revises § 981.442(a)(4)(i) of the order's administrative rules and regulations regarding inedible kernel tolerance. Specifically, this action increases the inedible kernel tolerance from 0.50 percent to 2 percent, effectively decreasing handler's disposition obligation. Authority for this action is provided in § 981.42(a) of the order.

Regarding the impact of this action on affected entities, increasing the inedible kernel tolerance reduces disposition obligation on handlers and provides handlers with more flexibility and control over the poor quality product. This rule is not expected to change handler inspection costs, as handlers currently are required to have all lots inspected to determine the percentage of inedible kernels.

The Board considered alternatives to this action. It formed a taskforce to examine the current inedible program and investigate alternatives. The taskforce reviewed the program and recent data, surveyed handlers, and reported their findings to the Almond Quality and Food Safety Committee (Committee). Recent data showed that the overall inedible kernel percentages have been trending lower, regardless of crop size. Surveyed handlers who did not agree with the change raised the concern that increasing the tolerance could result in more poor quality almonds entering the market. The Committee discussed the concerns raised and concluded that changing the tolerance would give handlers more flexibility in maintaining quality. After discussing the taskforce's findings, the Committee unanimously recommended this increase in inedible tolerance to the Board.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops.) No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large almond handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.

Further, the Board's meeting was widely publicized throughout the almond industry and all interested persons were invited to attend the meeting and participate in Board deliberations. Like all Board meetings, the April 12, 2016, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.

Also, the Board has a number of appointed committees to review certain issues and make recommendations to the Board. The Board's Almond Quality and Food Safety Committee met on April 5, 2016, and discussed this issue in detail. That meeting was also a public meeting, and both large and small entities were able to participate and express their views. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

This rule invites comments on a change to the quality control requirements currently prescribed under the order. Any comments timely received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the Board's recommendation, and other information, it is found that this interim rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) This rule relaxes the current rules and regulations; (2) this rule should be in place in time for the beginning of the crop year on August 1; (3) the Board unanimously recommended these changes at a public meeting and interested parties had an opportunity to provide input; and (4) this rule provides a 60-day comment period and any comments timely received will be considered prior to finalization of this rule.

List of Subjects in 7 CFR Part 981

Almonds, Marketing agreements, Nuts, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 981 is amended as follows:

PART 981—ALMONDS GROWN IN CALIFORNIA 1. The authority citation for 7 CFR part 981 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. Section 981.442(a)(4)(i) is revised to read as follows:
§ 981.442 Quality Control.

(a) * * *

(4) Disposition obligation. (i) Beginning August 1, 2016, the weight of inedible kernels in excess of 2 percent of kernel weight reported to the Board of any variety received by a handler shall constitute that handler's disposition obligation. For any almonds sold inshell, the weight may be reported to the Board and the disposition obligation for that variety reduced proportionately.

Dated: August 12, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-19625 Filed 8-16-16; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF ENERGY 10 CFR Part 430 [Docket No. EERE-2013-BT-TP-0050] RIN 1904-AD10 Energy Conservation Program: Test Procedures for Ceiling Fans; Correction AGENCY:

Office of Energy Efficiency and Renewable Energy, Department of Energy.

ACTION:

Final rule; technical correction.

SUMMARY:

On July 25, 2016, the U.S. Department of Energy published a final rule amending test procedures for ceiling fans. 81 FR 48619. This correction addresses an amendatory term error in that final rule.

DATES:

The correction is effective August 24, 2016.

FOR FURTHER INFORMATION CONTACT: Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-2J, 1000 Independence Avenue SW., Washington, DC, 20585-0121. Telephone: (202) 287-1604. Email: [email protected] Ms. Elizabeth Kohl, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC, 20585-0121. Telephone: (202) 586-7796. Email: [email protected]
SUPPLEMENTARY INFORMATION:

The U.S. Department of Energy (DOE) published a final rule in the Federal Register on July 25, 2016 (“the July 2016 final rule”) amending test procedures for ceiling fans. 81 FR 48619. This correction addresses an amendatory term error in that final rule. Specifically, the instructions amending appendix U to subpart B of part 430—Uniform Test Method for Measuring the Energy Consumption of Ceiling Fans, stated that appendix U is “added”. Since 10 CFR part 430 already includes appendix U, the instruction amending appendix U should use the amendatory term “revised.” This document corrects appendix U instructions to use the correct amendatory term “revised.”

Correction In FR Doc. 2016-17139, appearing on page 48640, in the issue of Monday, July 25, 2016, amendatory instruction 7. is corrected to read as follows: Appendix U to Subpart B of Part 430 [Corrected] 7. Appendix U to subpart B of part 430 is revised to read as follows: Issued in Washington, DC on August 11, 2016. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.
[FR Doc. 2016-19621 Filed 8-16-16; 8:45 am] BILLING CODE 6450-01-P
DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 758 [Docket No. 150107020-6464-02] RIN 0694-AG47 Revisions to the Export Administration Regulations (EAR): Harmonization of the Destination Control Statements AGENCY:

Bureau of Industry and Security, Department of Commerce.

ACTION:

Final rule.

SUMMARY:

This final rule implements changes that were proposed on May 22, 2015, in a proposed rule entitled Revisions to the Export Administration Regulations (EAR): Harmonization of the Destination Control Statements. This final rule revises the destination control statement in § 758.6 of the Export Administration Regulations (EAR) to harmonize the statement required for the export of items subject to the EAR with the destination control statement in § 123.9(b)(1) of the International Traffic in Arms Regulations (ITAR).

DATES:

This rule is effective November 15, 2016.

ADDRESSES:

Commerce's full retrospective regulatory review plan can be accessed at: http://open.commerce.gov/news/2015/03/20/commerce-plan-retrospective-analysis-existing-rules-0.

FOR FURTHER INFORMATION CONTACT:

For questions about this rule, contact Timothy Mooney, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security, at 202-482-2440 or email: [email protected]

SUPPLEMENTARY INFORMATION:

This final rule is published in conjunction with the publication elsewhere in this issue of the Federal Register of a Department of State, Directorate of Defense Trade Controls final rule revising § 123.9(b)(1) of the ITAR. Both final rules are part of the President's Export Control Reform Initiative. This final rule is also part of Commerce's retrospective regulatory review plan under Executive Order (E.O.) 13563 (see below for availability of the plan).

Background

Prior to the effective date of this final rule, the EAR required exporters to include a destination control statement (“DCS”), specified in § 758.6 (Destination control statement and other information furnished to consignees) of the EAR, on certain export control documents that accompanied a shipment for most exports. The purpose of the DCS was to alert parties outside the United States that receive the item that the item was subject to the EAR, the item was exported in accordance with the EAR, and that diversion contrary to U.S. law was prohibited.

Prior to the effective date of the State final rule, the ITAR, under § 123.9(b)(1), included the same type of DCS requirement, but with slightly different text than that which was required by the EAR. The purpose of the DCS requirements was the same under both sets of export control regulations. As a general principle of the Export Control Reform (ECR) effort, wherever the ITAR and EAR have provisions that are intended to achieve the same purpose, the U.S. Government will harmonize the corresponding provisions.

As was stated in the Commerce and State proposed rules, the DCS under the ITAR and the EAR were an example of requirements that could and should be harmonized to reduce the burden on exporters, improve compliance, and ensure that the regulations are achieving their intended purpose for use under the U.S. export control system, specifically under the transactions “subject to the ITAR” and “subject to the EAR.” This final rule is revising § 758.6 of the EAR to harmonize the DCS requirement text with § 123.9(b)(1) of the ITAR.

Under the existing provisions, both regulations have a mandatory DCS that must be on the export control documents for shipments that include items subject to those regulations. This had caused confusion to exporters as to which statement to include on such mixed shipments, or whether to include both. The harmonization of these statements in this final rule will ease the regulatory burden on exporters, which, based on the public comments described below and the additional changes made in the Commerce and State final rules in response to those comments, will further the objectives of the DCS requirements.

The change is also being made in this final rule to harmonize the two sets of regulations, the EAR and the ITAR, per the President's instructions. While the creation of a single export control list and licensing agency would require legislation, the President has directed BIS and the Directorate of Defense Trade Controls at the Department of State to undertake all available actions to prepare for consolidation as a single agency with a single set of regulations. Harmonization, to the extent possible, of the existing export control regulations is one important step for preparing both regulators and the regulated public for the work that will be needed to create such regulations.

Public Comments and BIS Responses

The public comment period on the May 22, 2015, proposed rule (80 FR 29551) closed on July 6, 2015. BIS received 17 public comments on the EAR proposed rule. Most of the commenters sent the same comments to Commerce and State expressing their support or concerns regarding the DCS related provisions included in the Commerce and State proposed rules. There were slightly different points of emphasis that were specific to the Commerce and State proposed rules, but substantively the comments were not different in any meaningful way in what the commenters thought needed to be changed in order to achieve the stated objectives in the Commerce and State proposed rules. The following describes the public comments and BIS's responses. After making changes to what was proposed to address the public comments and better achieve the stated objectives, Commerce and State are concurrently publishing final rules to harmonize the DCS provisions under the EAR and ITAR. Commerce and State agree with the public commenters that, as proposed, the harmonization did not go far enough and in order to have true harmonization and achieve the stated objectives that additional harmonization was needed. In addition, certain clarifications and refinements of what was originally proposed were needed in order to clarify and alleviate perceived concerns, in particular for exporters of non-600 series and non-9x515 items under the EAR. Where BIS has made regulatory changes to address the public comments, a description of those changes is included beneath the respective public comments and BIS responses. BIS has made these regulatory changes to § 758.6 to address the public comments and to better achieve the stated objectives of the rule. The public comment process was helpful in identifying areas where changes needed to be made to fully achieve the intended objectives for the DCS for use under the EAR and the ITAR. The following are the BIS responses to the comments:

Supportive

Comment 1: Several commenters were supportive of the plan to harmonize the DCS and noted the proposed changes: (1) Will minimize confusion as to which DCS must be used depending on the jurisdiction of item, (2) will exclude EAR and ITAR-specific text—meaning it can be used under both sets of regulations; and (3) will help to achieve the stated intent of the ECR initiative principles, which includes elimination of unnecessary export compliance burdens.

BIS response: BIS agrees. These commenters support that the key objectives of the rule have been met.

Not Supportive

Comment 2: Expresses significant concern and requests clarification, but also wishes to note that in general supports BIS's efforts to harmonize the DCS and thereby reduce the burden on exporters, promote consistency, improve compliance, and ensure the regulations are achieving the intended purpose for use under the U.S. export control system.

BIS response: BIS was encouraged that even for the commenters that raised significant concerns about certain aspects of the proposed rule that most of these same commenters still supported the general objective of harmonization of the DCS under the EAR and ITAR. Once BIS made changes to address their concerns on certain aspects of the proposed rule, these commenters would likely fully support the final rule because they viewed harmonization of the DCS as a positive step and their support was only qualified because of certain aspects of the proposed rule, which BIS has addressed in this final rule, as described further below.

Comment 3: Proposed DCS language focuses too much on harmonizing the EAR's language with the ITAR's DCS. While this is a potentially positive outcome for companies involved in defense trade, this approach does not take into account non-military exporters and the nature of commercial transactions.

BIS response: BIS is addressing these concerns by defining some of the key terms used in the DCS as they are interpreted in the EAR context, including providing some specific application examples in this final rule. These changes will address the various concerns in this area that were raised by various commenters as it related to NLR shipments or multi-step transactions that consist of discrete controlled events (e.g., “exported” to a distributor as one discrete controlled event, and then a subsequent “reexport” as another discrete controlled event under the EAR). The proposed rule did not change any of the obligations of the parties to the transaction in these situations under the EAR, but the text of the DCS made some people worry how the DCS text would be applied in the EAR context, which BIS is addressing with some clarifying examples and defining how some of these key terms used in the DCS text is interpreted in the EAR context in this final rule. This final rule makes the following regulatory changes to address this public comment:

In § 758.6, addition of Note 1 to paragraph (a). This final rule adds Note 1 to paragraph (a) to clarify the term “authorized” includes exports, reexports and transfers (in-country) designated under No License Required (NLR), which was explained in the preamble of the proposed rule, but one commenter requested this be added to the regulatory text. In addition, several other commenters did not understand that in the context of paragraph (a) the term “authorized” also includes NLR. BIS agrees that specifying this for purposes of this section is helpful and therefore this final rule is adding the new Note to paragraph (a). Because NLR is specific to the EAR, no changes are being made to the ITAR's DCS to address this comment. Similarly, the Note 2 to paragraph (a) described in the next paragraph is specific to the application under the EAR, so no changes are being made in the ITAR rule to add similar clarifying notes.

In § 758.6, addition of Note 2 to paragraph (a). This final rule adds Note 2 to paragraph (a) to specify the phrase `country of ultimate destination' means the country specified on the commercial invoice where the ultimate consignee or end user will receive the items as an “export.” The term “export” is a long established and well understood term under the EAR, so the use of this term in Note 2 will assist exporters' understanding of the use of the phrase `country of ultimate destination” in the DCS requirements in the context of the EAR. This final rule provides two examples here for using Note 2 to paragraph (a) to determine the `country of ultimate destination.' Example 1: If the exporter is “exporting” directly to an end user, such as generally permitted pursuant to § 750.7(c)(1)(ix) under a BIS license, the commercial invoice must be provided to the end user, which in this scenario is in the `country of ultimate destination.' Example 2: If the exporter is exporting to an ultimate consignee, such as a distributor, the `country of ultimate destination' in these exports is the destination of the ultimate consignee. This was a major concern that several commenters raised on the proposed rule, in particular for exporters of non-600 series and non-9x515 items. The addition of Note 2 addresses those comments and will improve understanding of the DCS in the EAR.

Comment 4: We applaud the U.S. government's attempt to simplify and improve the export clearance process (export clearance process refers to the regulatory requirements that need to be followed under the EAR and ITAR at the time of export to clear the final steps in exporting an item, e.g., filing Electronic Export Information (EEI)); however, you are proposing changes that will require every organization that exports products from the U.S. to revise their systems, when the need is appropriate only for ITAR or EAR license-required 9x515 and 600-series shipments. The proposed changes will impose a regulatory burden on all U.S. exporters without any apparent enhancement to compliance; and increase the uncertainty among foreign recipients.

BIS response: BIS does not agree. There are benefits that this harmonization will bring for exporters of “600 series” (what the commenters refers to as defense exporters) and 9x515 items. However, all exporters will benefit from a reduction in the number of documents that the DCS needs to be placed on under the EAR and the ITAR. In addition, as was noted in the support for not requiring the DCS on transportation documents (such as the air waybill), the existing DCS provisions imposed a requirement on many transportation related documents that in many cases were not reaching the consignees for which the statement was intended. The EAR were imposing a requirement to place the DCS on transportation documents that, although important to a transaction, do not in most cases reach the ultimate consignee or end-user(s). Requirements that do not achieve their objectives should be revised or removed. The objectives of the DCS are to ensure that the statement reaches the ultimate destination and ultimate consignee and/or end-user(s) of the item. The DCS helps such parties understand that the items were exported under the U.S. export control system, so they will understand their responsibilities under the U.S. export control system. Ensuring that the DCS is placed on the document that has the greatest likelihood of reaching the parties that will ultimately receive and use the item is the best way to protect the interest of all parties that participate in exports that are subject to the EAR and ITAR. This includes exporters of non-600 series and non-9x515 items under the EAR. An effective DCS is important for protecting U.S. national security and foreign policy interests. Parties outside the United States that will receive and use an item that is “subject to the EAR” or “subject to the ITAR” must be aware that the item was exported to them under the U.S. export control system in order to be able to comply with the EAR or the ITAR.

Objectives Achieved

Comment 5: Several commenters indicated the objectives of the proposed rule were achieved because of the following reasons: (1) Will eliminate confusion regarding which statement to use for shipments that include both items subject to the ITAR and items subject to the EAR, (2) incorporating the DCS into the commercial invoice will be much more likely to achieve the intended purpose of the DCS; and (3) having common text for the DCS will significantly simplify the export process.

BIS response: BIS agrees.

Objectives Partially Achieved

Comment 6: Better to create a second DCS for use with ITAR and “600 series” and mixed shipments.

BIS response: BIS disagrees. This suggestion would create unneeded complexity. The concerns raised by exporters of non-600 series and non-9x515 items can be addressed without creating separate forms for different types of items.

Comment 7: Harmonized text right step. But DCS requirements need to be identical to achieve the intended objective.

BIS response: BIS agrees. The intent was to have the DCS text be identical, so any slight differences are being harmonized. This final rule makes the following regulatory changes to address this public comment:

In § 758.6, introductory text of paragraph (a), this final rule makes a conforming edit for text used to ensure the text is the same under the EAR and ITAR DCS. In the first sentence of paragraph (a) introductory text, this final rule is removing the term “shall” and adding in its place the term “must.” This change is being made to harmonize the EAR text with the text used in the ITAR DCS rule. Commerce and State intended for these words to be the same, but the Commerce and State proposed rules differed, so BIS is making this change in the Commerce final rule. This inconsistency was identified in one of the comments, including the suggestion of adopting State's text because it was clearer regarding it being a requirement. BIS agrees.

Objectives Not Achieved

Comment 8: There should be some way to ensure that this DCS information is communicated to all parties involved and not just to the first party the items will be exported to in the transaction. Often the export occurs to a sales agent/reseller in the foreign country who will first receive the shipment, but they may not be the actual end-user and may be in a country that is not the ultimate destination.

BIS response: BIS agrees. BIS has added text as described below to address such scenarios, along with also providing guidance on how the DCS provisions interact with other EAR provisions, which was noted by several other comments as a concern with potential overreach.

Comment 9: This appears to be a case of harmonization for the sake of harmonization, and would appear to have the potential to create substantial confusion among recipients, impose significant burdens without a correspondingly significant benefit to the government.

BIS response: BIS disagrees. Several other commenters noted the concern in particular over mixed shipments and that the objectives of the rule would be met. BIS disagrees that there would not be benefits to the United States Government. An effective U.S. export control system requires effective reexport controls, which at its most basic level means reexporters understand that an item is subject to U.S. reexport controls. Ensuring that the DCS actually goes out of the U.S. and reaches the parties that will receive the items is key to the United States Government's ability to achieve its objectives in this area with the DCS.

Comment 10: Statement that commercial invoice and contractual documentation would be most likely to travel with shipment not necessarily correct.

BIS response: BIS disagrees. For the commercial invoice, several other commenters disagreed with this commenter's assertion. Requiring the DCS on contractual documentation was not adopted in this final rule, so that part of the comment is no longer applicable.

Decreases Burden

Comment 11: Single DCS statement will make it easier to automate because the same DCS will be used for EAR and ITAR shipments.

BIS response: BIS agrees.

Increases Burden

Comment 12: Changes to the DCS can be costly because it requires recoding the logic for each enterprise resource planning (ERP) system printing the DCS in the export control documentation. Some companies may have several different ERPs, which further increases the burden.

BIS response: The delayed effective date is intended to ease this initial burden of transitioning to the new DCS, which BIS expects will subside quickly and that over the mid to long term the DCS text will ease the burden. BIS acknowledges that there will be a minimal one-time burden on exporters as they need to update the DCS text on an existing document that already requires the DCS, but BIS expects this to be a one-time cost, not a recurring one. The delayed effective date of 90 days will also ease the cost on exporters who have already pre-printed the DCS on their commercial invoice documents by allowing such exporters to use that remaining stock of commercial invoices during the transition period prior to the effective date. In addition, several commenters noted that their systems are set up to prepopulate the commercial invoice, so limiting the requirement to the commercial invoice should ease the burden significantly. Current EAR DCS requirements already extend to the invoice (which has the same meaning as commercial invoice), so exporters' ERP systems should already be set up for this requirement and the extent of the change is limited to updating the text of the statement. Not adopting the proposed requirement to include the DCS on the contractual documentation will significantly reduce the amount of changes needed to ERP systems. This commenter also wanted the ability to continue to include the DCS on the shipping documents. Nothing in the final rule would prohibit continuing that practice, which will also reduce the number of changes needed to ERP systems, except for updating the text used.

Comment 13: Extending to intangible exports would create a significant burden.

BIS Response: BIS agrees. BIS has added changes in this final rule to clarify the EAR DCS is only required on the items exported in tangible form. This final rule makes the following regulatory changes to address this public comment:

In § 758.6, introductory text of paragraph (a), this final rule clarifies that paragraph (a) applies only to items shipped, i.e., exported in tangible form. As discussed above in response to the public comments, several commenters were concerned that the use of the defined term “export” would be a significant expansion of the DCS requirement by requiring the DCS for tangible as well as intangible exports. BIS had intended this broader scope when using the term “export,” instead of the undefined term shipment, in the proposed rule. However, in reviewing the public comments and in discussing the practice under the ITAR, BIS accepts the public comments on the Commerce rule to clarify that the scope of the DCS requirement only applies to items on the Commerce Control List that are shipped (exported in tangible form). Therefore, this final rule adopts in paragraph (a)(1) the term “shipped (i.e., exported in tangible form)” rather than the term “export.”

In § 758.6, paragraph (a)(2), this final rule removes the term “exported” and adds in its place the phrase “shipped (i.e., exported in tangible form).” This clarification is made for the same reasons why, as described above, the similar changes were made to paragraph (a)(1) in response to public comments.

Concerns About Costs To Implement

Comment 14: Large and small exporters will incur costs that are dependent on size, but significant in any case. Large exporters will have to retool their ERP systems to collect information they are not presently collecting (e.g., end-user) and insert it into documents they do not currently generate with a DCS.

BIS response: The commenter is concerned about having to account for changes in the ERP system, but this concern is not warranted because the proposed rule did not change any of the obligations of the parties to the transaction in these situations under the EAR. BIS is clarifying that these obligations of the parties to the transactions will not change, which also addresses the ERP changes concern. These concerns about the extent of changes required to the ERP systems were based on an incorrect understanding that the obligations of the parties to the transactions were also proposed to change in addition to the DCS proposed changes. As discussed elsewhere in this final rule, BIS is clarifying that this is not the case.

Concerns With Proposed DCS Text

Comment 15: There is no justification for requiring the inclusion of the new DCS on documentation associated with NLR exports, as such exports require no authorization from the U.S. Government. Such a requirement would be unnecessarily burdensome and should be eliminated.

BIS response: BIS disagrees. The requirement to include the DCS for most NLR shipments is an existing EAR DCS requirement. An item that can be exported NLR to one country or one end user or end use may require an EAR license for subsequent transfers (in-country) or reexports. For example, NS1, RS1, or MT1 controlled items could go NLR to Canada, but would be subject to a worldwide license requirement for any subsequent reexport. Further, there are certain persons in Canada on the Entity List who are subject to a license requirement for all items subject to the EAR, including a license requirement for transfers (in-country). Merely because the initial export can be made under the NLR designation does not preclude that subsequent reexporters or transfers (in-country) will require a license. Accordingly, no new burden is being imposed because the existing DCS requirements require it for NLR designated shipments and the policy rationale for why a DCS is needed for NLR shipments has not changed.

Comment 16: Proposed rulemaking requires a DCS to be included whenever any item on the CCL is exported. Because exports are defined to include both tangible and intangible transfers, this requirement can be construed to require the DCS to be included on both physical shipments as well as intangible transfers (e.g., when software is downloaded). They propose that the requirements should be limited to physical (tangible) exports only.

BIS response: BIS agrees. BIS has made changes in this final rule to clarify the DCS only applies to shipments (exports in tangible form). This final rule makes the following regulatory changes to address this public comment:

In § 758.6, paragraph (a)(1), this final rule removes an unneeded phrase. Specifically, this final rule removes at the beginning of paragraph (a)(1) the phrase “For any item on the Commerce Control List being exported” because the text is not needed. The text is not needed because the same text is already stated in the introductory text of paragraph (a). This will shorten and simplify the text of paragraph (a)(1) without changing the requirements of this paragraph, or the requirements specified in paragraph (a)(2).

Comment 17: Clarifying that the DCS provisions are limited to shipments (tangible exports).

BIS response: After reviewing the public comments, this final rule limits the requirement to shipments, i.e., tangible exports, but notes that when a commercial invoice does exist for intangible exports that BIS recommends as a good compliance practice to include a DCS or other export control related information that may be relevant.

Comment 18: Retain the phrase “excluding EAR99 items” in the text of § 758.6 for maximum clarity.

BIS response: BIS agrees. This final rule makes the following regulatory changes to address this public comment:

In § 758.6, introductory text of paragraph (a), this final rule clarifies that items designated as EAR99 do not require a DCS. The proposed rule in the preamble explained that items designated as EAR99 did not require the DCS, and several of the public commenters agreed. However, some of the commenters suggested that this clarification also needed to be added to the regulatory text in paragraph (a)(1). BIS believes the reference in the text of paragraph (a) to “items on the Commerce Control List” already clarifies that the requirement would not extend to items designated as EAR99. However, BIS does agree with the commenters that for people not familiar with the EAR, such as certain foreign purchasers or consignees that would be receiving commercial invoices with this DCS, that this nuance of the Commerce Control List may not be well understood and could lead to misunderstanding. BIS agrees that although the text may be slightly redundant that it will be helpful in particular for those not as familiar to the EAR, so the final rule is adding the phrase “or the item is designated as EAR99” to the introductory text of paragraph (a) to clarify items designated as EAR99 do not require a DCS.

Comment 19: Clarify whether the use of the term “end-user” in the proposed language implies the creation of a new regulatory requirement to identify all potential end-users on all documents for which a DCS is required.

BIS response: The term “end user” does not create a new regulatory requirement. This final rule makes the following regulatory changes to address this public comment:

In § 758.6, paragraph (a)(1), this final rule removes the term “specified” before the phrase “country of ultimate destination.” The use of the term “specified,” raised concerns for several of the commenters regarding whether the inclusion of this term would change other obligations of the parties to the transaction in these situations under the EAR for how exports are treated, in particular for subsequent reexports or transfers (in-country). BIS did not intend to change the obligations of the parties to the transaction in these situations under the EAR. In order to address these concerns, BIS has removed the term “specified.” BIS, to address the public comments in this area, in particular misunderstandings for how the text of paragraph (a)(1) would be applied in the EAR context, is including Note 2 to paragraph (a)(1) to clarify the application of the phrase “country of ultimate destination,” along with adding two other notes for paragraph (a)(1) to address misunderstandings for how paragraph (a)(1) would be applied in the EAR context.

In § 758.6, paragraph (a)(1), this final rule is also adding the term “ultimate consignee” before the term “end-user,” along with making the term “end-user” plural by adding an “s” to clarify that the requirement applies to the “ultimate consignee” or “end-user(s).” This final rule did not adopt the term “or consignee” that followed the term “end-user” in the proposed rule. Certain commenters requested clarification regarding to which consignees the requirement specified in paragraph (a)(1) was intended to apply, which the more specific text of “ultimate consignee or end-user(s)” addresses. To achieve the objectives of the DCS, the commercial invoice must be provided to those two types of consignees: ultimate consignee and end-user(s), as applicable.

Comment 20: Commercial invoice and shipping documents currently in most cases do not include end users.

BIS response: BIS is aware of this, but the commercial invoice is still deemed to be the most appropriate document to achieve the objectives of the DCS. BIS will be adding FAQs to the BIS Web site to provide additional application guidance on applying the DCS in different scenarios.

Comment 21: Insert the phrase “ultimate consignee or” before the term end user.

BIS response: BIS accepts this suggestion which may mitigate the concerns people have with needing to include the end user on every document that requires the DCS.

Comment 22: Delete the term “ultimate” before the term “destination” and delete the term “ultimate end user.”

BIS response: BIS will delete the term ultimate before those two terms.

DCS Text Is Too ITAR Specific and Will Be Difficult To Understand in EAR Context

Comment 23: Clarify the application of the DCS text in the EAR context as it relates to other EAR provisions, such as shipments to distributors and NLR and multi-step shipments.

BIS response: Many of the commenters that raised concerns regarding the burden or other major concerns were focused on how the DCS text seemed more appropriate for the ITAR regulatory construct than the EAR regulatory construct. These commenters thought that this rule proposed broader changes than intended, and therefore several of them raised significant concerns. For example, they raised concerns about how shipments to distributors would be handled in light of the proposed DCS text. In order to address these concerns, BIS is defining some of the key terms used in the DCS text as they are interpreted in the EAR context, including providing some specific application examples, along with adding notes to clarify the applicability of the DCS requirements in the context of the EAR. These changes will address the various concerns in this area that commenters raised related to NLR shipments or multi-step transactions that consist of discrete controlled events (e.g., “exported” to a distributor as one discrete controlled event, and then a subsequent “reexport” as another discrete controlled event under the EAR). The proposed rule did not change any of these other provisions under the EAR, but the proposed text of the DCS made some people worry how the text would be applied in the EAR context.

Comment 24: The proposed inclusion of the phrase “or as otherwise authorized by U.S. law and regulations” is more likely to cause confusion than the current DCS with respect to items that can be reexported NLR or under a license exception, and lead recipients erroneously to believe that all U.S.-origin items require a specific reexport license. Some exporters have tried to use phrases in export control contractual clauses that limit reexports “unless otherwise approved in writing by the U.S. government or authorized by U.S. law or regulation.” Such phrases are understood by sophisticated reexporters, but they inevitably lead to questions about why a reexport license is required, when no export license was required in the first place.

BIS Response: To address this commenter's concern, this final rule includes several clarifications to key terms used, including a new note to define what is meant by “or as otherwise authorized by U.S. law and regulations.” This final rule makes the following regulatory changes to address this public comment:

In § 758.6, addition of Note 3 to paragraph (a). This final rule adds Note 3 to paragraph (a) to clarify what is meant in the EAR context by the phrase “or as otherwise authorized by U.S. law and regulations.” The note as of the effective date of this final rule will now acknowledge that the phrase includes not just license exceptions, but also shipments made under `no license required' as well as reexports of foreign made items containing less than de minimis U.S. origin controlled content. Some of the commenters acknowledged that the use of this phrase was also explained in the preamble of the proposed rule. However, other commenters did not understand this nuance of this proposed regulatory text. Most of those commenters also requested that BIS make this nuance of the EAR more explicit in regulatory text, in particular to avoid people outside the United States incorrectly believing that the new Commerce DCS provisions were intended to change or limit the applicability of the EAR de minimis provisions, or the EAR direct product rule provisions. The Commerce DCS proposed rule did not intend to change any EAR related provisions related to de minimis or the direct product rule, which is also the case with the Commerce final rule published today. BIS agrees with the commenters that making the intended meaning of the phrase “or as otherwise authorized by U.S. law and regulations” clearer will help understanding of the DCS provisions in the EAR. Therefore, this final rule is adding Note 3 to paragraph (a)(1) to address these comments.

Concern That State and Commerce Documents Are Not Harmonized for DCS

Comment 25: Commerce and State should require the DCS on the same document(s).

BIS response: Commerce and State agree that, in addition to harmonizing the text of the DCS, the requirements regarding the documents on which it needs to be placed should be harmonized as well. Commenters supported the Commerce proposal of including it on the commercial invoice. After reviewing the public comments, Commerce and State agree that using the same document for the requirement is the best approach.

Comment 26: Export clearance phase of corporate export controls compliance programs relies heavily on information technology (IT) as standardization conserves resources and improves compliance. By having different DCS implementation requirements for the ITAR and EAR, the proposed regulation will force companies to have two different IT systems—one for the ITAR and one for the EAR. Companies will have to re-train their compliance staff to be able to determine which commercial document to insert the required DCS statement. This proposal will increase compliance costs. Different documents for DCS will increase likelihood of violations.

BIS Response: BIS agrees. BIS will require the DCS on the same document, the commercial invoice, as required by State.

Supports Using Commercial Invoice

Comment 27: Supports this proposed requirement and recognizes this change as a key element to reinforcing the intent of the regulation which is to provide the foreign consignee with needed information to ensure compliance with the EAR. The foreign consignee is far more likely to receive the commercial invoice and contractual documents between the shipper/USPPI and consignee/buyer than any transportation documentation produced by the carrier/forwarder for any such contract of carriage.

BIS response: BIS agrees. However, as noted elsewhere in this final rule, BIS is limiting the documentation requirement to the commercial invoice.

Comment 28: Exporters generate commercial invoices, but freight forwarders and/or carriers generate bills of lading and air waybills. Imposing requirements on exporters that they must then flow to other parties to a shipping transaction adds complexity and compliance risk.

BIS response: BIS agrees. The Commerce proposed rule already took these factors into account in proposing that the DCS be placed on the commercial invoice and contractual documentation (documents created by exporter). As described elsewhere in this final rule, the requirement is limited to the commercial invoice (document created by exporter).

Comment 29: Supports the approach taken by BIS for using commercial invoice and contractual documentation, and in particular for recognizing that this lengthy statement does not offer value on the transport document (bill of lading, air waybill) and that the DCS should be required only on the commercial and contractual documents that relate to the transactions between the vendors, purchasers and other parties that may be involved in the commercial relationship for exports.

BIS response: BIS agrees, but as noted elsewhere in the final rule the requirement will be limited to the commercial invoice.

Concerns With Using Commercial Invoice

Comment 30: Invoices are usually filed by the finance function that is responsible for payment and they may not take any action on this information (e.g., restriction on further re-sale/transfer to the end-user); explicitly stating export restriction on the contractual documents would be a more effective way to communicate the importance of compliance with the U.S. exports regulation and use of the items.

BIS response: Other commenters did not support using contractual documentation. BIS notes that although the personnel involved in financial management of a company (e.g., those in accounts payable) may receive the commercial invoice either at the time the items shipped (exported in tangible form) are received or before, at some point in the process typically the commercial invoice is matched up with what was received. If the DCS reaches the ultimate consignee or end-user(s) before the item is subsequently reexported or transferred (in-country) to another party, it helps to achieve the objective of putting the reexporter or transferor on notice that the items are subject to U.S. export controls.

Comment 31: BIS uses the term “commercial invoice” but DDTC uses the term “invoice.” For some exporters, the term “invoice” refers to the final billing document that moves electronically, whereas the commercial invoice moves with the freight.

BIS response: BIS agrees that the terms should be harmonized. Based on other comments received, the term commercial invoice is well understood by industry, as well as by BIS's Office of Export Enforcement, so this final rule adopts the term commercial invoice.

Comment 32: Commercial invoices do not accompany items during shipment. In today's business processes, invoices are sent either electronically (the preferred method) or in hard copy directly to the buyer's accounts payable department. The invoice is not sent to those who might divert the items. In compliance with the EAR, the DCS is currently printed on the invoice, but doing so arguably does not serve the purpose BIS intends.

BIS response: Several other commenters supported BIS's position that the commercial invoice is the document most likely to travel to the end of the export. However, BIS acknowledges and understands that in certain cases a commercial invoice may be sent prior to the items being shipped (exported in tangible form), so this final rule does not specify the timing of when the commercial invoice must be sent, but simply specifies the requirement that the commercial invoice must include the DCS. BIS intends to add FAQs to the BIS Web site once this final rule is published to provide additional application guidance to exporters.

Comment 33: Changing requirement from “accompanies the shipment” to when “such documentation exists” is a significant expansion of the DCS requirement for little benefit to U.S. national security.

BIS response: BIS disagrees. As was noted by several commenters the DCS requirements under the EAR and ITAR we need to take into account how business is conducted in order for exporters to effectively comply and to achieve the export control objectives of protecting U.S. national security and foreign policy interests. Because the phrase “accompanies the shipment” is limiting and does not take into full account how documents are transmitted related to exports in certain cases, BIS does not accept the suggestion, which conflicts with the larger objectives of what the DCS provisions are trying to achieve.

Supports Using Contractual Documentation

Comment 34: The contractual documents and commercial invoice are intended to detail the entirety of the transaction between the parties that are engaging in the transfer of the items. Incorporating the DCS into those documents is much more likely to achieve the intended purpose of the DCS than is including that information on the air waybill.

BIS response: BIS agrees. However, as noted elsewhere in this final rule, BIS is limiting the documentation requirement to the commercial invoice.

Concerns for Using Contractual Documentation

Comment 35: The proposed requirement to include the DCS on contractual documentation raised significant concerns among the majority of commenters, even those that strongly supported the proposed rule. These commenters included a number of well supported reasons for why the use of contractual documentation would be needlessly burdensome and not achieve the stated objectives in the proposed rule. These reasons included the following: (1) The term “contractual documentation” was not defined and could be overinclusive of documents, including contractual documentation that are not related directly to items that would be exported, but would still create a significant administrative burden in keeping track of certain contractual documentation that would require the DCS from those that would not; (2) grandfathering of existing contractual documentation, where some commenters noted that amending existing contracts to include the DCS would require amending thousands of contractual documents; (3) would require a U.S. company to have prior knowledge during negotiations for what the item that is subject to the contract that will actually be exported, which often is unknown at the time a contract is signed; (3) handling changes in classification that may impact previous contracts would require contractual documents to be revised; (4) including the DCS in contractual documentation may exacerbate foreign parties' concerns over acknowledging U.S. extraterritoriality; and (5) if the ultimate goal of the proposed rule is to avoid diversion, most commenters noted that requiring the DCS to be included on the commercial invoice will suffice—meaning the objectives of the DCS could be achieved more efficiently by only requiring it on the commercial invoice without creating the significant burdens that would be required to include it on contractual documentation.

BIS response: Commerce and State agree with the public commenters that removing the requirement to include the DCS on the contractual documentation is warranted. The public comments were persuasive that including a requirement to include the DCS on the contractual documentation would create a significant amount of unneeded complexity and in most cases would not achieve the stated objectives in the Commerce and State proposed rules. Based on the public comments received and additional review by Commerce and State, limiting the requirement to include the DCS on the commercial invoice is sufficient to meet the stated objectives in the Commerce and State proposed rules, and therefore this final rule does not adopt the proposed requirement to include the DCS on contractual documentation. This final rule makes the following regulatory changes to address this public comment:

In § 758.6, introductory text of paragraph (a), this final rule removes the undefined term “contractual documentation.” As discussed above, there was considerable concern raised regarding the inclusion of the undefined term “contractual documentation.” BIS is not including the undefined term “contractual documentation” and instead, as explained above, is limiting the requirement under the EAR to the commercial invoice. The Department of State will only require the DCS to be placed on the commercial invoice under the ITAR.

Create a New Document Specific To Export Controls for Use With DCS

Comment 36: Provide the DCS and other export control information (e.g., as “600 series” or a 9x515 ECCN classification) on a completely separate document that can serve multiple purposes and can be sent with the items being shipped or separately in order to convey to the consignees that the items are U.S. export regulated and are intended only for the designated end user and the destination identified. This should be similar to a certificate of compliance or documents of similar nature (usually from a quality perspective) that are usually sent to customers.

BIS response: BIS appreciates the effort this commenter put into the idea, including the templates they created, but ultimately BIS believes that it would be unduly burdensome to create a requirement to generate a wholly new document. Therefore, although we acknowledge there would be some benefits to what the commenter had in mind, BIS believes that it is still preferable to require the DCS on an existing document (the commercial invoice) that is created in the normal course of business. Other public comments support this conclusion.

Allow Flexibility for Exporters To Decide Which Document To Include DCS on, but Require It on One Document That Accompanies Physical Shipment

Comment 37: The regulations should not prescribe the specific document that must include the DCS, but instead require that it appear on one document that accompanies the item to the ultimate destination. Which document will contain the DCS should be determined by the exporter in light of its shipping practices.

BIS response: BIS disagrees. This would create a burden on exporters and other parties to the transaction, as well as the United Stated Government in conducting checks to confirm that exporters are in compliance. Allowing for exporters to pick and choose the document would create more burden than benefits that would come from allowing that level of flexibility because exporters and other parties to the transaction would need to adopt processes to identify on a transaction by transaction basis, which document contained the required DCS. Variability would provide flexibility, but also impose implementation costs. Requiring and identifying a single document, the commercial invoice, creates predictability, will facilitate the adoption of standardized processes and will reduce implementation costs. In addition, exporters are free to place the DCS on additional documents, but at a minimum the final rules published today by Commerce and State require the DCS to be placed on the commercial invoice.

Suggested Notes To Add to DCS Section

Comment 38: In the Supplementary Information, BIS states that, “. . . in the context of this EAR paragraph “authorized” would also include exports that were designated under No License Required (NLR).” This would be useful information to include in § 758.6.

BIS response: BIS agrees. BIS has added a note to specify this concept as described earlier in the BIS response above to Comment 6.

Other Changes To Enhance Usefulness of DCS in Preventing Diversions

Comment 39: A requirement should be added that all the parties (consignees involved in the transaction between the U.S. exporter and the ultimate end user) should somehow be communicated to about the U.S. regulations restricting further export/transfer to anyone or to any country other than the end user and ultimate destination should be considered in the final export process.

BIS response: Based on other comments received there would likely be significant concern about the burden created and the complexity of compliance programs caused by implementing such a requirement. The parties helping to facilitate the movement of the item to the end of the export are simply moving the item to the ultimate consignee or end user(s). The focus of the DCS on the commercial invoice is to ensure that it reaches the ultimate consignee and/or end user(s) that will be in a position to make a subsequent reexport or transfer (in-country), so they are aware the item in question is subject to U.S. reexport controls. As discussed in other parts of this rule, BIS is defining some of the terms used in the DCS text and adding some clarifying notes to provide additional context for how the DCS is applied in the EAR context.

Request for Delayed Effective Date

Comment 40: Requests that BIS strongly consider setting the implementation date 180-240 days after publication of the final rule to allow sufficient time for all affected parties to make the required changes to system programming, document revision and related procedural tasks. Other commenters had requested a 180 day delayed effective date, along with a delayed compliance date.

BIS response: Commerce and State agree that a delayed effective date is warranted and will delay the effective date of this final rule for 90 days after publication. This delay of effective date will allow exporters, as well as other parties to which these revised DCS requirements will apply, to make any needed changes to their export compliance systems and business processes.

Request for Public Meetings or Additional Proposed Rules Prior to Final Rule Publication

Comment 41: Request for public meetings for public to comment and requests for Commerce and State outreach for the new changes to be implemented.

BIS response: BIS values public participation in the rulemaking process. Through the public comment process, BIS has provided adequate opportunity for comment and has addressed the concerns that were raised. Therefore, BIS does not accept the request to conduct public meetings prior to publishing a final rule. In regard to the request for conducting outreach, BIS agrees that this is a good idea and intends to add updated DCS information to our already robust ECR related outreach activities, including to instruction at seminars and to the Frequently Asked Questions on the BIS Web site.

Comment 42: A public comment period with relevant meetings will provide the necessary fora to engage with the government and discuss mutually‐beneficial alternatives to accomplish the government's objectives without putting any sector of the trade at an inappropriate disadvantage.

BIS response: Commerce and State already provided an opportunity for public review and comment on the proposed rules. Commerce and State have considered those public comments, which were generally supportive of the rule, and for those commenters that raised concerns, Commerce and State were able to refine what was proposed to address those comments and better achieve the stated objectives. Therefore, there is no need for an additional proposed rule or engaging in public meetings before moving forward with final rules, which would delay the reductions in burdens included in the Commerce and State final rules, as well as delaying the benefits for better protecting U.S. national security and foreign policy interests by adopting these more effective DCS requirements under the EAR and the ITAR. No party will be placed at an inappropriate disadvantage as a result of this rule being published in final form because all interested parties had an opportunity to review the proposed rule and make comments for improving the proposed DCS requirements. BIS by addressing those comments in this final rule has led to an improved rule that better achieves the stated objectives. As noted above, Commerce and State have a robust outreach program for ECR related changes and intend to conduct robust outreach regarding the new DCS requirements included in the final rules published today, in particular during the 90 day transition period prior to the effective date.

Including “600 Series” and 9x515 ECCNs on Same Documents as DCS

Comment 43: Require the items level classification for 9x515 and “600 series” items. In consideration that sub-categories of a same ECCN may not be subject to the same controls (for instance 9A610.x and 9A610.y.1), we suggest that the text be amended to request not only the ECCN, but also the corresponding subcategory.

BIS response: This comment is outside the scope of the proposed DCS rule.

Comment 44: While the requirement to place the DCS found in § 758.6(a)(1) on the commercial invoice is reasonable, the requirement to place the DCS and the ECCN for “600 series” or 9x515 item, when required, on contractual documentation, when such contractual documentation exits, may require a level of specificity that is not available at the time of contracting. The suggested change would clarify that the contract itself need not contain each “600 series” or 9x515 ECCN if subsequent contract implementing documentation will be the vehicle by which actual commitments for shipment of such items are made.

BIS response: As noted elsewhere in this final rule (see BIS response above to Comment 35 under the heading Concerns for using contractual documentation), BIS is not including contractual documents in the final rule, so this comment is no longer applicable.

Broadening Scope of DCS To Also Alert People Receiving Incorporated 9x515 and “600 Series” of Such Content

Comment 45: There is no requirement to include a DCS for end items that include ECCN 9x515/600 series de minimis content. This creates a risk related to restrictions on the use of de minimis for Country Group D:5 countries. For example, a non-U.S. prime may receive a system or sub-assembly from an Asian or European supplier for integration into an end-item. That system or sub-assembly may contain ECCN 9x515/600 series de minimis content from another supplier. The non-U.S. prime may never know about the ECCN 9x515/600 series content since there is no requirement for the re-exporter to disclose this information, which may raise a compliance issue when considering further retransfer to Country Group D:5 countries.

BIS response: This comment is outside the scope of the DCS proposed rule, but it is something that BIS will evaluate further. However, as a best practice, BIS does encourage companies to work together to assist each other in complying with the EAR requirements, whether that is in the United States or outside the United States when items that may be subject to the EAR are involved.

Add Provisions To Rescind Previous License Conditions for Currently Valid Licenses That Include a Condition That Current DCS Needed To Be Included on Current DCS Required Documents

Comment 46: Recommend a statement in a final rule to clarify that for existing, valid licenses previously issued by BIS, any license condition to place a DCS on any shipping documentation (e.g., on all bills of lading or air waybills) not specifically required in the revised EAR is rescinded. A common current license condition is as follows: “Place a Destination Control Statement on all bills of lading, air waybills, and commercial invoices.” This clarification will relieve exporters with numerous licenses, wherein the license condition to apply DCS to shipping documentation appears, from the need to petition the Commerce Department for relief from the condition.

BIS response: BIS confirms that a condition on a license issued prior to August 17, 2016 to place a destination control statement on documents other than the commercial invoice would no longer be applicable as of November 15, 2016.

Summary of the Regulatory Changes Being Made in This Final Rule to § 758.6

The heading of § 758.6 of the EAR remains the same. However, the provisions that were under paragraph (b) prior to the effective date of this final rule are being moved to a new paragraph (a)(2). Further, new paragraph (a)(2) specifies that the ECCN for each 9x515 or “600 series” item being shipped (exported in tangible form) must be included. This is the same requirement that was in paragraph (b) prior to the effective date of this final rule, although it is slightly shortened because the introductory text of paragraph (a) is specifying some of the requirements that previously were included in paragraph (b), specifically the documents for which the 9x515 and “600 series” classification must be included under this section. The commercial invoice is the same document that the DCS is included on, so this change is shortening and simplifying this section by moving the text of paragraph (b) to paragraph (a)(2). This change will reduce the number of documents upon which this classification needs to be included on to conform with the DCS changes described below.

The introductory text paragraph (a) in this final rule specifies that the exporter shall incorporate the information specified under paragraphs (a)(1) (destination control statement) and (a)(2) (ECCN for 9x515 or “600 series” item being shipped (exported in tangible form)) as an integral part of the commercial invoice. The changes in this final rule mean this section of the EAR no longer includes, as of the effective date of this final rule, a requirement to include the DCS on the air waybill, bill of lading or other export control documents, and instead is limiting the requirement to the commercial invoice.

Consistent with the DCS provisions prior to the effective date of this final rule, this final rule is not requiring an EAR DCS for exports of EAR99 items or items exported under License Exception BAG or GFT. Any other shipment (tangible export) from the United States of any item on the CCL would require the DCS as specified in paragraph (a)(1) and any shipment (tangible export) of a 9x515 or “600 series” ECCN would also need to be specified on the commercial invoice as specified in paragraph (a)(2).

The text of the harmonized DCS in this final rule is being specified under revised paragraph (a)(1) of § 758.6 of the EAR. The new DCS this final rule adds does not include EAR-specific language, but rather adopts text that is equally applicable under the ITAR as well as the EAR. However, this final rule adds several clarifying notes to clarify how the DCS provisions are applied in the EAR context. The first sentence of the statement added by this final rule specifies that “these items are controlled by the U.S. Government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified.” For clarification this final rule moved the position of the phrase “by the United States Government” to the first sentence. This is a clarification to ensure that exporters understand that “only” modifies “authorized” and not “controlled.” This first sentence is intended to alert the person outside the United States receiving the item that the item is subject to U.S. export laws and regulations and was authorized by the U.S. Government for export. In addition, the first sentence in this final rule specifies that the items are authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s). The new DCS included in this final rule uses the term authorized, but in the context of this EAR paragraph “authorized” would also include exports that were designated under No License Required (NLR). This final rule adds a new Note 1 to paragraph (a) to specify this in the regulatory text in regards to the applicability of NLR. This final rule adds Note 2 to paragraph (a) to specify the phrase “country of ultimate destination” means the country specified on the commercial invoice where the ultimate consignee or end user will receive the items as an “export.” This note will assist the exporter's understanding of the use of this phrase in the context of the EAR.

The second sentence of the new harmonized DCS being added in this final rule focuses on alerting the persons receiving the items that they may not be resold, transferred, or otherwise be disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations. Similar to the first sentence, this second sentence is adopting common text that can be used under the ITAR and the EAR. The application of this second sentence is different under the ITAR and the EAR due to the different types of authorizations and other approvals in the respective regulations, as well as other differences, such as the de minimis requirements in the EAR, which is not provided for in the ITAR. The final rule adds a new Note 3 to paragraph (a) to make this clearer in regards to how this is applied in the EAR context.

The advantage of the text included in this final rule is that it adopts a new harmonized DCS, while at the same time is still flexible enough to not impact other ITAR or EAR provisions that do warrant differentiation, such as the availability of de minimis provisions, which are available under the EAR.

Adopting a new harmonized DCS in the final rule will simplify export clearance requirements for exporters because they will not have to decide which DCS to include, especially for mixed shipments containing both ITAR and EAR items.

As of the effective date of the Commerce and State final rules, an exporter will still need to go through all of the steps to determine jurisdiction, classification, and license requirements, and to obtain and use the proper authorization under the respective regulations, prior to moving on to the respective export clearance requirements under the ITAR or EAR. It is important to remember when reviewing the changes included in the Commerce and State final rules that the regulations still need to be reviewed and evaluated in the context in which they are intended to be applied, including the steps for determining the applicable export control requirements under the ITAR and the EAR. For those parties outside the United States that will be receiving items under this new DCS once this final rule becomes effective on November 15, 2016, although the new DCS is not ITAR or EAR specific, in the case of the ITAR the classification of USML items will be required on the commercial invoice. This classification will alert the parties that the items are subject to the ITAR. For military items under the EAR, because of the requirement this final rule is including in paragraph (a)(2) (which was required under paragraph (b) prior to the effective date of this final rule) of § 758.6 of the EAR, anyone receiving a “600 series” military item or an ECCN 9x515 item will know that item is subject to the EAR because the classification information will also need to be included on the commercial invoice. For other EAR items, there is not a requirement to include the classification information, although BIS does encourage the inclusion of that information as an export compliance best practice.

Removal of Paragraph (c)

BIS in this final rule removes the text that was in paragraph (c) of § 758.6 prior to the effective date of this final rule. BIS did not receive any comments on this proposed change and therefore is implementing this change in this final rule. Paragraph (c) was added recently (January 23, 2015, 80 FR 3463) and required prior to the effective date of this final rule a special DCS for items controlled under ECCNs for crime control columns 1 and 3 reasons or regional stability column 2 reasons when those items are destined to India. BIS proposed removing this requirement because the benefit of this requirement in paragraph (c) is outweighed by the added complexity to the EAR of including this country specific requirement. Therefore, consistent with the purpose of the retrospective regulatory review, BIS removes paragraph (c).

This final rule is the same as the May 22, 2015 proposed rule except for the refinements explained above. These changes address the public comments and will achieve the objectives of adopting a harmonized DCS requirement under the EAR and ITAR. These changes will help to further achieve the objectives of ECR to harmonize provisions between the EAR and the ITAR where warranted.

The changes in this final rule will ease the regulatory burden and complexity for exporters, in particular those with mixed shipments, which as noted above is now a much more common occurrence because of ECR. These changes and the corresponding reduction of documents that will require the DCS (now limited to the commercial invoices) will benefit all exporters under the EAR, not just exporters of “600 series” and 9x515 items. The DCS provisions in this final rule will better achieve their stated objectives—meaning all exporters will benefit because the appropriate parties (consignees in a position to make a subsequent reexport or transfer (in-country)) further down the line in export transactions will be receiving the DCS and other export control information required under this section as applicable.

These changes to the DCS provisions under the EAR and the ITAR move beyond harmonization for the sake of harmonization, which as discussed above was a concern of several of the commenters in response to the proposed rule. The changes in this final rule achieve true harmonization in this area of the U.S. export control system under the EAR and the ITAR, while at the same time improving the effectiveness of these provisions under the EAR and the ITAR, which ultimately will lead to better informed parties to transactions that are subject to U.S. export controls and better protecting U.S. national security and foreign policy interests. For the reasons described above, Commerce and State are publishing these final rules today.

As required by Executive Order (E.O.) 13563, BIS intends to review this rule's impact on the licensing burden on exporters. Commerce's full retrospective regulatory review plan is available at: http://open.commerce.gov/news/2011/08/23/plan-analysis-existing-rules. Data are routinely collected on an ongoing basis, including through the comments to be submitted and through new information and results from Automated Export System data. These results and data have formed, and will continue to form, the basis for ongoing reviews of the rule and assessments of various aspects of the rule. As part of its plan for retrospective analysis under E.O. 13563, BIS intends to conduct periodic reviews of this rule and to modify, or repeal, aspects of this rule, as appropriate, and after public notice and comment. With regard to a number of aspects of this rule, assessments and refinements may be made on an ongoing basis. This is particularly the case with regard to possible modifications that will be considered based on public comments described above.

Export Administration Act

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.

Rulemaking Requirements

1. Executive Orders 13563 and 12866 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, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been determined to be significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid OMB control number. This regulation involves collections previously approved by the OMB under control number 0694-0122, “Licensing Responsibilities and Enforcement.” This rule does not alter any information collection requirements; therefore, total burden hours associated with the PRA and OMB control number 0694-0122 are not expected to increase as a result of this rule. BIS acknowledges that there will be a minimal one-time burden on exporters as they need to update the DCS text on an existing document that already requires the DCS, but BIS expects this to be a one-time cost, not a recurring one. The scope of the text change, which is very similar in length to the current DCS, should be easy to implement based on the public comments received that strongly favored using the commercial invoice for the DCS requirement. You may send comments regarding the collection of information associated with this rule, including suggestions for reducing the burden, to Jasmeet K. Seehra, Office of Management and Budget (OMB), by email to [email protected], or by fax to (202) 395-7285.

3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.

4. The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to the notice and comment rulemaking requirements under the Administrative Procedure Act (5 U.S.C. 553) or any other statute, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Under section 605(b) of the RFA, however, if the head of an agency certifies that a rule will not have a significant impact on a substantial number of small entities, the statute does not require the agency to prepare a regulatory flexibility analysis. Pursuant to section 605(b), the Chief Counsel for Regulation, Department of Commerce, certified to the Chief Counsel for Advocacy, Small Business Administration that the May 22 proposed rule, if promulgated, will not have a significant impact on a substantial number of small entities. A summary of the factual basis for the certification was provided in the May 22 proposed rule that is being finalized in this rule and is not repeated here. No comments were received regarding the economic impact of this final rule. Consequently, BIS has not prepared a regulatory flexibility analysis for this final rule.

List of Subjects in 15 CFR Part 758

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

Accordingly, part 758 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

PART 758—[AMENDED] 1. The authority citation for part 758 is revised to read as follows: Authority:

50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 4, 2016, 81 FR 52587 (August 8, 2016).

2. Section 758.6 is revised to read as follows:
§ 758.6 Destination control statement and other information furnished to consignees.

(a) The exporter must incorporate the following information as an integral part of the commercial invoice whenever items on the Commerce Control List are shipped (i.e., exported in tangible form), unless the shipment (i.e., the tangible export) may be made under License Exception BAG or GFT (see part 740 of the EAR) or the item is designated as EAR99:

(1) The following statement: “These items are controlled by the U.S. Government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations” and

(2) The ECCN(s) for any 9x515 or “600 series” “items” being shipped (i.e., exported in tangible form).

Note 1 to paragraph (a).

In paragraph (a)(1), the term `authorized' includes exports, reexports and transfers (in-country) designated under No License Required (NLR).

Note 2 to paragraph (a).

The phrase `country of ultimate destination' means the country specified on the commercial invoice where the ultimate consignee or end user will receive the items as an “export.”

Note 3 to paragraph (a).

The phrase `or as otherwise authorized by U.S. law and regulations' is included because the EAR contain specific exemptions from licensing (e.g., EAR license exceptions and NLR designations) and do not control the reexport of foreign-made items containing less than a de minimis amount of controlled content. See § 734.4 and Supplement No. 2 to part 748.

(b) [Reserved]

Dated: August 8, 2016. Kevin J. Wolf, Assistant Secretary of Commerce for Export Administration.
[FR Doc. 2016-19551 Filed 8-16-16; 8:45 am] BILLING CODE 3510-33-P
DEPARTMENT OF STATE 22 CFR Parts 120, 123, 124, 125, and 126 [Public Notice: 9606] RIN 1400-AC88 Amendment to the International Traffic in Arms Regulations: Procedures for Obtaining State Department Authorization To Export Items Subject to the Export Administration Regulations; Revision to the Destination Control Statement; and Other Changes AGENCY:

Department of State.

ACTION:

Final rule.

SUMMARY:

As part of the President's Export Control Reform (ECR) initiative, the Department of State is amending the International Traffic in Arms Regulations (ITAR) to clarify rules pertaining to the export of items subject to the Export Administration Regulations (EAR), revise the destination control statement in ITAR § 123.9 to harmonize the language with the EAR, make conforming changes to ITAR §§ 124.9 and 124.14, and make several minor edits for clarity.

DATES:

This rule is effective November 15, 2016.

FOR FURTHER INFORMATION CONTACT:

Mr. C. Edward Peartree, Director, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663-2792; email [email protected] ATTN: Regulatory Change, Destination Control Statement.

SUPPLEMENTARY INFORMATION:

The Department published a proposed rule on May 22, 2015 (80 FR 29565) and received 17 public comments on the proposed changes to the ITAR. The Department makes the following revisions in this final rule:

Items Subject to the EAR

This final rule adds clarifying language to various provisions of the ITAR pertaining to the use of exemptions to the license requirements and the export of items subject to the EAR, when the EAR items are shipped with items subject to the ITAR. These revisions include guidance on the use of license exemptions for the export of such items, as well as clarification that items subject to the EAR are not defense articles, even when exported under a license or other approval, such as an exemption, issued by the Department of State. The Department received the following comments on the proposed changes, which are summarized here, along with the Department's responses:

One commenter raised a concern that the proposed revised language restricts industry's exemption options for items subject to the EAR to situations only when related USG authorization exists for the end item. The Department accepts the comment and has revised § 120.5(b) to state that items subject to the EAR may be exported pursuant to an ITAR exemption if exported with defense articles. ITAR exemptions may not be used for the independent export of items subject to the EAR, i.e., a single physical shipment of EAR item(s) that does not include any USML item with which the EAR item may be used. If the items subject to the EAR will be transferred separately from a defense article, license exceptions available under the EAR may be used to authorize the transfer.

One commenter noted that, the proposed § 120.5(b) inadvertently excluded the exemptions at Part 123 of the ITAR from the parenthetical list of applicable ITAR parts. The Department concurs with this comment and adds a reference to part 123 into the parenthetical phrase.

One commenter noted that the Department should provide clarification and guidance on the proper classification to be entered into the Automated Export System (AES) for items subject to the EAR shipped under an ITAR exemption. The commenter noted that proposed edits to § 123.9(b)(2) did not address AES filings. The Department notes that the Department of Commerce (U.S. Census Bureau and Bureau of Industry and Security) has already clarified this. The EAR classification needs to be provided in the export control information on the Electronic Export Information (EEI) filing in AES for all items subject to the EAR, including EAR99 designated items that are authorized for export under a State Department authorization.

One commenter noted that the changes in this rule require that if a shipment includes both ITAR and EAR controlled items then the Export Control Classification Number (ECCN) of items in the shipments must be listed, including any EAR99 designation (if the authorization for the export was through an approved State Department license), and requires the country of ultimate destination, end-user, licensee information to be provided on the export documents. The flexibility of exporting items subject to the EAR under a State Department authorization does warrant this additional level of identification for all of the items subject to the EAR that the Department authorizes for export. Therefore, although the Department understands the comment, given the hybrid nature of the ITAR authorization under the § 120.5(b) process, the Department has determined the requirements are warranted.

One commenter noted that the text under § 120.5(b) does not specify that “items subject to the EAR” exported under an exemption must be exported with the specific defense article. They recommend clarifying that this is the intent of the modification or if not, to change the text, so it comports with the requirements for “items subject to the EAR” exported under a license or other approval. The Department concurs with this comment. This final rule adds clarifying text to § 120.5(b) to specify that in order to use a Department of State license exemption the item subject to the EAR must be exported with a defense article.

Items Exported To or On Behalf of an Agency of the U.S. Government

This final rule does not revise the licensing exemption language in § 126.4. This section will be addressed in a separate rulemaking and comments submitted in response to the proposed rule on that topic will be addressed in that rulemaking.

Revision to the Destination Control Statement

This final rule revises the Destination Control Statement (DCS) in ITAR § 123.9 to harmonize the text with the text of the DCS in EAR § 758.6, which is the subject of a companion rule to be published by the Department of Commerce. The DCS revision is also reflected in § 124.9 and 124.14. This change is being made to facilitate the President's Export Control Reform initiative, which has transferred thousands of formerly ITAR-controlled defense article parts and components, along with other items, to the Commerce Control List in the EAR, which is under the jurisdiction of the Department of Commerce. This change in jurisdiction for many parts and components of military systems has increased the incidence of exporters shipping articles subject to both the ITAR and the EAR in the same shipment. Both regulations have a mandatory Destination Control Statement that must be on the export control documents for shipments that include items subject to both sets of regulations. This had previously caused confusion to exporters as to which statement to include on mixed shipments, or whether to include both. Harmonizing these statements will ease the regulatory burden on exporters.

Summary of Public Comments on the Destination Control Statement

Most of the public comments fell into one of four areas: (1) Harmonization of DCS language between the ITAR and the EAR; (2) harmonization of documentation between the ITAR and EAR; (3) providing exporters a sufficient implementation period to adjust to the new DCS requirements; and (4) consideration of the different documents required for shipping, with the commercial invoice being the clear favorite and most appropriate for the DCS to be included on.

This final rule includes an effective date 90 days after publication in the Federal Register for the DCS provisions. It also specifies that the exporter is responsible for including the DCS on the commercial invoice. Additionally, the DCS text adopted in this final rule is identical to the DCS text adopted in a companion rule by Commerce.

The Department received a small number of comments on the proposed rule which were specific to the Commerce proposed rule, and Commerce is addressing these comments in its final rule.

Public Comments and the Department's Responses

Several commenters noted that harmonization represents a step in the right direction and will minimize confusion as to which DCS must be used depending on the jurisdiction of the item. The Department concurs with this comment.

Several commenters objected that the Department's requirements for placement of the DCS were out of step with Commerce and not harmonized in the proposed rule. The Department agrees, and the requirement for placement of the DCS is being harmonized by the Departments of State and Commerce.

Several commenters stated that the government should not specify the documents that require the DCS, but rather should impose a high level requirement and leave it to parties to choose which document(s) to include. The Department disagrees. Specifying which documents the DCS will be placed on will create greater transparency, as well as make it easier for various United States government agencies, as well as exporters and other consignees, to identify whether the DCS has been properly included.

One commenter noted that this appears to be a case of harmonization for the sake of harmonization, and would appear to have the potential to create substantial confusion among recipients, and impose significant burdens without a correspondingly significant benefit to the government. The Department disagrees. Ensuring the DCS reaches the parties that will receive items exported and/or reexported is key to the United States achieving its policy objectives.

One commenter stated that it was confusing that Commerce uses the term “commercial invoice” whereas the Department uses “invoice.” For some exporters, the term “invoice” refers to the final billing document that moves electronically, whereas the commercial invoice moves with the freight. The Department agrees that the terms should be harmonized. Based on other comments received, the term “commercial invoice” is well understood by industry, so this final rule adopts the term “commercial invoice” to reference the document that moves with the freight.

One commenter objected to the DCS, as it imposed additional burdens and costs on the public and trade. Further, the commenter noted that to add this information separately to the bill of lading, air waybill and other transportation documentation could have the unintended effect of signaling the package contents to third parties. The Department disagrees with the commenter's characterization as these statements are already required and the harmonization of the DCS will lower the administrative burden on exporters and re-exporters. In addition, and as noted elsewhere in this final rule, the Department is removing the requirement to include the DCS on transportation documents.

One commenter stated that the air waybill imposed a severe space limitation with regard to including the DCS. According to the commenter, including information regarding a country of ultimate destination, end-user, and license or other approval number or exemption citation information could be unduly burdensome. The Department concurs, as noted elsewhere in this final rule, and the requirement to include the DCS on transportation documents has been removed.

One commenter noted that the State Department should consider a shorter DCS, such as: “This shipment contains goods under the jurisdiction of the ITAR.” This statement could more easily be converted to an electronic format than the complete DCS. The Department disagrees, as an ITAR specific DCS would defeat the purpose of harmonization between the Departments of State and Commerce and would not address mixed shipments.

One commenter suggested that the DCS and other export control related information (e.g., USML category) be placed on a separate document that serves multiple purposes, and can be sent with the items being shipped or separately in order to convey to the consignees that the items are U.S. export regulated and are intended only for the designated end user and the destination identified. The Department acknowledges there would be some benefits to such an approach, but it is preferable to require the DCS on an existing document (the commercial invoice) that is created in the normal course of business. Other public comments support this conclusion.

Numerous commenters requested a delay in the implementation date of between 180-240 days after publication of the final rule to allow sufficient time for affected parties to make the required changes to system programming, document revision and related procedural tasks. Other commenters requested a 180 day delayed effective date, along with a delayed compliance date. The Department agrees that industry will need time to update their systems and has included a delayed effective date of 90 days after publication of this final rule.

One commenter requested public meetings in order to comment on the proposed changes, and that State and Commerce also conduct outreach prior to new changes being implemented. The Department values public participation in the rulemaking process and has provided an opportunity for public review and comment on the proposed rules. For those commenters that raised concerns, the Department was generally able to refine what was proposed to address those comments and better achieve the stated objectives. Therefore, the Department does not see a need to conduct public meetings prior to publishing this final rule. In regards to outreach, the Department agrees that this is a good idea and intends to add updated DCS information to our already robust ECR related outreach activities.

Overview of Regulatory Changes To Address Public Comments

The Department of State has revised the proposed changes to § 123.9 to address the public comments and to better achieve its stated objectives in this final rule. The public comment process was helpful in identifying areas where changes needed to be made to fully achieve the intended objectives for the DCS for use under the ITAR and the EAR.

Placement of Destination Control Statement. This final rule removes the requirement to place the Destination Control State on the bill of lading, air waybill, or other shipping documents and retains the requirement for the invoice, which will now be more clearly described as the commercial invoice. As stated elsewhere in this final rule, the commercial invoice is the document that is most likely to achieve the purpose of this section and therefore the Department is limiting the requirement to this one document, which also will reduce the burden on exporters.

Clarifying the scope of paragraph 123.9(a) applies to items shipped (exported in tangible form), retransferred (in tangible form), or reexported (in tangible form). This final rule clarifies that the requirement applies to tangible defense articles when exported, reexported, or retransferred.

Addition of Note to paragraph 123.9(b)(1)(iv). This final rule also adds a Note to proposed paragraph (b)(1)(iv) to clarify what is meant in the DCS by the phrase “or as otherwise authorized by U.S. law and regulations.” The note clarifies that the phrase “or as otherwise authorized by U.S. law and regulations” is included to advise that U.S. regulations contain specific license exemptions, provisions that allow shipments to be made “no license required,” as well as reexports of foreign made items containing less than de minimis U.S. origin controlled content (see 15 CFR 734). This note reflects that an individual license is not required in all cases.

Procedures for Obtaining State Department Authorization To Export Items Subject to the EAR

This final rule adds a new paragraph (d) to § 123.9 to clarify the requirements for retransferring items subject to the EAR pursuant to a request for written approval from DDTC.

Other changes in this rule. The Department makes a number of minor edits to the ITAR that address reporting requirements. This final rule removes the requirement to provide seven paper copies for various requests in §§ 124.7, 124.12, 124.14, 125.2, 125.7 and 126.9. The Department did not receive any comments on the proposed changes, except for one commenter that expressed support for the removal of unnecessary submission requirements (e.g., seven paper copies). Therefore, this final rule revises §§ 124.7, 124.12, 124.14, 125.2, 125.7 and 126.9 as proposed.

This final rule imposes the Code of Federal Regulations paragraph structure on § 124.8. The Department received no comments on § 124.8, and the provision is adopted as proposed.

This final rule replaces the previous Destination Control Statement in § 124.9(a)(6) with the new language found at § 123.9(b)(1)(iv). The Department received only one comment on this issue, which did not propose substantive changes, but advised that § 124.9(a)(6) needed to reflect the new Destination Control Statement language. The Department notes that the proposed rule did not revise the Destination Control Statement language of § 124.14(c)(7). Therefore, this final rule revises §§ 124.9 and 124.14 accordingly.

This final rule also changes the identification of the agency responsible for permanent import authorizations in § 123.4 from the Department of the Treasury to Department of Justice. The Department did not receive any comments on the proposed changes. Therefore, this final rule revises § 123.4 as proposed.

This final rule removes the pilot filing requirement found in § 123.13, given that, as noted in the proposed rule, it did not take into account the practices of modern airport operations and is no longer necessary. The Department did not receive any comments on the proposed change. Therefore, this final rule revises § 123.13 as proposed.

This final rule revises § 124.12(b) to correct the citations contained in the parenthetical from §§ 124.9 and 124.10 to §§ 124.8 and 124.9. This revision was not included in the proposed rule.

Additionally, the Department amends § 126.9, Advisory Opinions and Related Authorizations, to add a new paragraph (c) for requests to interpret ITAR requirements. This revision was not included in the proposed rule but is added to clarify the Department's practice. The Department is undertaking a review of the advisory opinion process which will be addressed in a future rule.

Finally, the Department notes that this final rule does not revise the NATO special retransfer authorizations language in § 124.16, which was contained in the proposed rule. By separate Federal Register notice (81 FR 35611, June 3, 2016) effective September 1, 2016, the provisions of § 124.16 will be incorporated into § 126.18 and the section will be removed and reserved.

Regulatory Analysis and Notices Administrative Procedure Act

The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States government and that rules implementing this function are exempt from §§ 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act (APA). Although the Department is of the opinion that this rule is exempt from the rulemaking provisions of the APA, the Department published this rule with a 45-day provision for public comment and without prejudice to its determination that controlling the import and export of defense services is a foreign affairs function. The Department has made additional refinements to what was proposed based on the public comments received, which helps to further the objectives described in the proposed rule that is published as a final rule today. The Department is also adopting a delayed effective date of 90 days.

Regulatory Flexibility Act

Since this final rule is exempt from the provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.

Unfunded Mandates Reform Act of 1995

This rulemaking does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

The Department does not believe this rulemaking is a major rule as defined in 5 U.S.C. 804.

Executive Orders 12372 and 13132

This rulemaking will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this proposed rulemaking.

Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess 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, distributed impacts, and equity). These executive orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” under Executive Order 12866. Accordingly, this final rule has been reviewed by the Office of Management and Budget (OMB).

Executive Order 12988

The Department of State has reviewed this rulemaking in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

Executive Order 13175

The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the provisions of Executive Order 13175 do not apply to this rulemaking.

Paperwork Reduction Act

This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35. This rule removes provisions that previously required the applicant to provide seven additional copies for various export license requests. As noted in the proposed rule, the Department believes that there would be little or no practical burden reduction since the use of electronic methods of filing has made the requirement for “seven copies” obsolete. The Department requested public comment on its estimate that there will be little or no change in the burdens associated with effected information collections as a result of this rulemaking. The Department received no public comments with respect to the information collections.

List of Subjects 22 CFR Parts 120 and 125

Arms and munitions, Classified information, Exports.

22 CFR Part 123

Arms and munitions, Exports, Reporting and recordkeeping requirements.

22 CFR Part 124

Arms and munitions, Exports, Technical assistance.

22 CFR Part 126

Arms and munitions, Exports.

Accordingly, for the reasons set forth above, title 22, chapter I, subchapter M, is amended as follows:

PART 120—PURPOSE AND DEFINITIONS 1. The authority citation for part 120 continues to read as follows: Authority:

Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2794; 22 U.S.C. 2651a; Pub. L. 105-261, 112 Stat. 1920; Pub. L. 111-266; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.

2. Section 120.5 is amended by revising the section heading and paragraph (b) to read as follows:
120.5 Relation to regulations of other agencies; export of items subject to the EAR.

(b) A license or other approval (see § 120.20) from the Department of State granted in accordance with this subchapter may also authorize the export of items subject to the EAR (see § 120.42). An exemption (see parts 123, 124, 125, and 126 of this subchapter) may only be used to export an item subject to the EAR that is for use in or with a defense article and is included in the same shipment as any defense article. No exemption under this subchapter may be utilized to export an item subject to the EAR if not accompanied by a defense article. Separate approval from the Department of Commerce is not required for these items. Those items subject to the EAR exported pursuant to a Department of State license or other approval would remain under the jurisdiction of the Department of Commerce for any subsequent transactions. The inclusion of items subject to the EAR on a Department of State license or other approval does not change the licensing jurisdiction of the items. (See § 123.1(b) of this subchapter for guidance on identifying items subject to the EAR in a license application to the Department of State.)

PART 123—LICENSES FOR THE EXPORT AND TEMPORARY IMPORT OF DEFENSE ARTICLES 3. The authority citation for part 123 continues to read as follows: Authority:

Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2753; 22 U.S.C. 2651a; 22 U.S.C. 2776; Pub. L. 105-261, 112 Stat. 1920; Sec. 1205(a), Pub. L. 107-228; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.

4. Section 123.4 is amended by revising paragraph (a)(4) to read as follows:
§ 123.4 Temporary import license exemptions.

(a) * * *

(4) Has been rejected for permanent import by the Department of Justice and is being returned to the country from which it was shipped; or

5. Section 123.9 is amended by revising paragraphs (b)(1) and (2) and adding paragraph (d) to read as follows:
§ 123.9 Country of ultimate destination and approval of reexports or retransfers.

(b) * * *

(1) The exporter must incorporate the following information as an integral part of the commercial invoice, whenever defense articles are to be shipped (exported in tangible form), retransferred (in tangible form), or reexported (in tangible form) pursuant to a license or other approval under this subchapter:

(i) The country of ultimate destination;

(ii) The end-user;

(iii) The license or other approval number or exemption citation; and

(iv) The following statement: “These items are controlled by the U.S. government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations.”

Note to paragraph (b)(1)(iv):

The phrase “or as otherwise authorized by U.S. law and regulations” is included because U.S. regulations contain specific exemptions from licensing requirements (e.g., ITAR exemptions, and EAR license exceptions and No License Required designations) and allow for certain amounts of U.S. origin content in foreign made items (see 15 CFR 734).

(2) When exporting items subject to the EAR (see §§ 120.5, 120.42 and 123.1(b) of this subchapter) pursuant to a Department of State license or other approval, the U.S. exporter must also provide the end-user and consignees with the appropriate EAR classification information for each item. This includes the Export Control Classification Number (ECCN) or EAR99 designation.

(d) The Directorate of Defense Trade Controls may authorize reexport or retransfer of an item subject to the EAR provided that:

(1) The item was initially exported, reexported or transferred pursuant to a Department of State license or other approval;

(2) The item is for end-use in or with a defense article; and

(3) All requirements of paragraph (c) of this section are satisfied for the item subject to the EAR, as well as for the associated defense article.

6. Revise § 123.13 to read as follows:
§ 123.13 Domestic aircraft shipments via a foreign country.

A license is not required for the shipment by air of a defense article from one location in the United States to another location in the United States via a foreign country.

PART 124—AGREEMENTS, OFF SHORE PROCUREMENT, AND OTHER DEFENSE SERVICES 7. The authority citation for part 124 continues to read as follows: Authority:

Sec. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2651a; 22 U.S.C. 2776; Pub. L. 105-261; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.

8. Section 124.7 is amended by redesignating the introductory text as paragraph (a) introductory text, revising newly designated paragraph (a)(1), and adding reserved paragraph (b).

The revision reads as follows:

§ 124.7 Information required in all manufacturing license agreements and technical assistance agreements.

(a) * * *

(1) The agreement must describe the defense article to be manufactured and all defense articles to be exported, including any test and support equipment or advanced materials. They should be described by military nomenclature, contract number, National Stock Number, nameplate data, or other specific information. Only defense articles listed in the agreement will be eligible for export under the exemption in § 123.16(b)(1) of this subchapter.

§ 124.8 [Amended]
9. Section 124.8 is amended by redesignating the introductory text as paragraph (a) introductory text and adding reserved paragraph (b). 10. Section 124.9 is amended by revising paragraph (a)(6) to read as follows:
§ 124.9 Additional clauses required only in manufacturing license agreements.

(a) * * *

(6) (Licensee) agrees to incorporate the following statement as an integral provision of a contract, commercial invoice or other appropriate document whenever the licensed articles are sold or otherwise transferred:

These items are controlled by the U.S. government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations.

11. Section 124.12 is amended by revising paragraph (a) introductory text and paragraph (b)(4) to read as follows:
§ 124.12 Required information in letters of transmittal.

(a) An application for the approval of a manufacturing license or technical assistance agreement with a foreign person must be accompanied by an explanatory letter. The explanatory letter shall contain:

(b) * * *

(4) “If this agreement grants any rights to sub-license, it will be amended to require that all sub-licensing arrangements incorporate all the provisions of the basic agreement that refer to the U.S. Government and the Department of State (i.e., 22 CFR 124.8 and 124.9).”

12. Section 124.14 is amended by revising paragraphs (c)(7) and (e) introductory text to read as follows:
§ 124.14 Exports to warehouses or distribution points outside the United States.

(c) * * *

(7) “(Licensee) agrees to incorporate the following statement as an integral provision of a contract, invoice or other appropriate document whenever the articles covered by this agreement are sold or otherwise transferred: `These items are controlled by the U.S. government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations.' ”

(e) Transmittal letters. Requests for approval of warehousing and distribution agreements with foreign persons must be made by letter. The letter shall contain:

PART 125—LICENSES FOR THE EXPORT OF TECHNICAL DATA AND CLASSIFIED DEFENSE ARTICLES 13. The authority citation for part 125 continues to read as follows: Authority:

Secs. 2 and 38, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778); 22 U.S.C. 2651a; E.O. 13637, 78 FR 16129.

14. Section 125.2 is amended by revising paragraph (a) to read as follows:
§ 125.2 Exports of unclassified technical data.

(a) License. A license (DSP-5) is required for the export of unclassified technical data unless the export is exempt from the licensing requirements of this subchapter. In the case of a plant visit, details of the proposed discussions must be transmitted to the Directorate of Defense Trade Controls for an appraisal of the technical data.

15. Section 125.7 is amended by revising paragraph (b) to read as follows:
§ 125.7 Procedures for the export of classified technical data and other classified defense articles.

(b) An application for the export of classified technical data or other classified defense articles must be accompanied by a completed form DSP-83 (see § 123.10 of this subchapter). All classified materials accompanying an application must be transmitted to the Directorate of Defense Trade Controls in accordance with the procedures contained in the Department of Defense National Industrial Security Program Operating Manual (unless such requirements are inconsistent with guidance provided by the Directorate of Defense Trade Controls, in which case the latter guidance must be followed).

PART 126—GENERAL POLICIES AND PROVISIONS 16. The authority citation for part 126 continues to read as follows: Authority:

Secs. 2, 38, 40, 42, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2780, 2791, and 2797); 22 U.S.C. 2651a; 22 U.S.C. 287c; E.O. 12918, 59 FR 28205; 3 CFR, 1994 Comp., p. 899; Sec. 1225, Pub. L. 108-375; Sec. 7089, Pub. L. 111-117; Pub. L. 111-266; Section 7045, Pub. L. 112-74; Section 7046, Pub. L. 112-74; E.O. 13637, 78 FR 16129.

17. Section 126.9 is amended by revising the heading and the first sentence of paragraph (a) and adding paragraph (c) to read as follows:
§ 126.9 Advisory opinions and related authorizations.

(a) Preliminary authorization determinations. A person may request information from the Directorate of Defense Trade Controls on whether it would likely grant a license or other approval for a particular defense article or defense service to a particular country. * * *

(c) Interpretations of the ITAR. Any person may request an interpretation of the requirements set forth in this subchapter in the form of an advisory opinion. A request for an advisory opinion must be made in writing. Any response to an advisory opinion provided by the Directorate of Defense Trade Controls pursuant to this paragraph shall not be an authorization to export and shall not bind the Department to grant or deny any such authorization.

Rose E. Gottemoeller, Under Secretary, Arms Control and International Security, Department of State.
[FR Doc. 2016-19550 Filed 8-16-16; 8:45 am] BILLING CODE 4710-25-P
DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY:

Department of the Navy, DoD.

ACTION:

Final rule.

SUMMARY:

The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime Law) has determined that USS GABRIELLE GIFFORDS (LCS 10) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.

DATES:

This rule is effective August 17, 2016 and is applicable beginning August 9, 2016.

FOR FURTHER INFORMATION CONTACT:

Commander Theron R. Korsak, JAGC, U.S. Navy, Admiralty Attorney, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone number: 202-685-5040.

SUPPLEMENTARY INFORMATION:

Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS GABRIELLE GIFFORDS (LCS 10) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2(a)(i), pertaining to the height of the forward masthead light above the hull; Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead light; Annex I, paragraph 3(c), pertaining to the task light's horizontal distance from the fore and aft centerline of the vessel in the athwartship direction. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

List of Subjects in 32 CFR Part 706

Marine safety, Navigation (water), Vessels.

For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read as follows: Authority:

33 U.S.C. 1605.

2. Section 706.2 is amended by: a. In Table One, adding, in alpha numerical order, by vessel number, an entry for USS GABRIELLE GIFFORDS (LCS 10); b. In Table Four, under paragraph 15, adding, in alpha numerical order, by vessel number, an entry for USS GABRIELLE GIFFORDS (LCS 10); c. In Table Four, under paragraph 16, adding, in alpha numerical order, by vessel number, an entry for USS GABRIELLE GIFFORDS (LCS 10); and d. In Table Five, adding, in alpha numerical order, by vessel number, an entry for USS GABRIELLE GIFFORDS (LCS 10).

The additions read as follows:

§ 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Table One Vessel No. Distance in meters of
  • forward masthead
  • light below
  • minimum required
  • height § 2(a)(i) annex I
  • *         *         *         *         *         *         * USS GABRIELLE GIFFORDS LCS 10 4.91 *         *         *         *         *         *         *

    15. * * *

    Table Four Vessel No. Horizontal distances from
  • the fore and aft centerline
  • of the vessel in the
  • athwartship direction
  • (meters)
  • *         *         *         *         *         *         * USS GABRIELLE GIFFORDS LCS 10 Upper—0.16.
  • Middle—1.2.
  • Lower—1.2.
  • 16. * * *

    Vessel No. Obstruction angle relative ship's headings *         *         *         *         *         *         * USS GABRIELLE GIFFORDS LCS 10 71° thru 73°.
  • 76° thru 78°.
  • 287° thru 289°.
  • *         *         *         *         *         *         *
    Table Five Vessel No. Masthead
  • lights not
  • over all other
  • lights and
  • obstructions;
  • annex I,
  • sec. 2(f)
  • Forward
  • masthead light
  • not in forward
  • quarter of ship;
  • annex I,
  • sec. 3(a)
  • After
  • masthead
  • light
  • less than 1/2
  • ship's length
  • aft of forward
  • masthead
  • light, annex I,
  • sec. 3(a)
  • Percentage
  • horizontal
  • separation
  • attained
  • *         *         *         *         *         *         * USS GABRIELLE GIFFORDS LCS 10 X X 17.9
    Approved: August 9, 2016. C.J. Spain, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), Acting. Dated: August 11, 2016. N.A. Hagerty-Ford, Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer.
    [FR Doc. 2016-19600 Filed 8-16-16; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2016-0797] RIN 1625-AA08 Special Local Regulations; Tall Ships Duluth 2016 Parade of Sail, Lake Superior, Duluth, MN AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing temporary special local regulations on the navigable waters of Lake Superior and Duluth Harbor, Minnesota for the Tall Ships Duluth 2016 Parade of Sail. This action is necessary to provide for the safety of life and property on the navigable waters of Lake Superior and Duluth, Minnesota, during Tall Ships Duluth 2016 Parade of Sail on August 18, 2016. These temporary special local regulations would restrict vessel traffic in portions of Lake Superior and Duluth Harbor, Minnesota, unless authorized by the Captain of the Port (COTP) Duluth.

    DATES:

    This rule is effective from 9:00 a.m. through 5:00 p.m. August 18, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0797 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 Lieutenant Junior Grade John Mack, Waterways management, MSU Duluth, Coast Guard; telephone 218-725-3818, email [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register 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 doing so would be impracticable. Amplifying information regarding event schedule, plan, and vessel participants was not provided by the event sponsor with sufficient time to accommodate the comment period prior to the August 18, 2016 event. Thus, delaying the effective date of this rule to wait for the comment period to run would be both impracticable because it would be impossible to have the rule implemented before the date of the event.

    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to public interest as it would inhibit the Coast Guard's ability to protect spectator and vessels from the hazards associated with the event.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. These temporary special local regulations will provide for the safety of life and protection of property on the navigable waters of Lake Superior and Duluth Harbor, Minnesota, by providing for the organized viewing of Tall Ships and preventing the large number of spectator vessels from interfering with the organized and controlled Parade of Sail.

    IV. Discussion of the Rule

    Duluth, Minnesota will host the Tall Ships Duluth 2016 from August 18-21, 2016. This visit of sailing vessels is part of a recurring series of sail training races, rallies, cruises, and port festivals organized by Tall Ships America in conjunction with host ports in the United States and Canada. The Tall Ships Duluth 2016, including a Parade of Sail, is akin to similar events held several times in the past in Duluth, Minnesota, the most recent being in 2013.

    The Tall Ships visit to Duluth, which will occur from August 18-21, 2016, will include a Parade of Sail on August 18, 2016. About 9 vessels are expected to participate in the Parade of Sail. These temporary special local regulations will provide for the safety of life and protection of property on the navigable waters of Lake Superior and Duluth Harbor, Minnesota, by providing for the organized viewing of Tall Ships and by preventing the large number of spectator vessels from interfering with the organized and controlled Parade of Sail. There may be vessels participating in the event from several foreign countries and the high visibility of this event warrants that temporary special local regulations be established to ensure the safety of vessels and spectators from hazards associated with Tall Ships Duluth 2016.

    The participating vessels will berth at assigned facilities in Duluth, Minnesota, from August 18-21, 2016. On August 19, 2016, visitors will be permitted to board the berthed vessels from shore. On the morning of August 22, 2016, the Tall Ships will depart the Duluth Harbor.

    The Coast Guard believes that vessel congestion due to the large number of participating and spectator vessels may pose a significant hazard to navigation. To reduce the risk associated with congested waterways the Coast Guard is proposing to establish regulated areas to restrict vessel movement around the location of the participating Tall Ships while participating in the Parade of Sail in Duluth Harbor. These temporary special local regulations would be in effect from 9:00 a.m. through 5:00 p.m. August 18, 2016.

    Area “Duluth Harbor”: This Area includes all waters of Lake Superior and Duluth Harbor bounded by Rice's Point to the west and Duluth to the north, within the following boundaries: Beginning at position 46°49′11″ N., 92°02′20″ W., then due south to position 46°45′12″ N., 92°02′20″ W., and then west to position 46°45′12″ N., 92°05′40″ W. (Duluth Marine Terminal South Light (LLNR 15935)). This area is needed to protect the maritime public and participating vessels from hazards to navigation associated with numerous spectator craft during the Parade of Sail on August 18, 2016.

    Area “Parade of Sail”: This Area includes all waters of Lake Superior and Duluth Harbor bounded by Duluth to the north, within the following boundaries: Beginning at position 46°46′51.54″ N., 92°05′17.03″ W. (North Pier Light (LLNR 15855)), then northeast to position 46°47′18.96″ N., 92°4′0.84″ W., then south to position 46°47′11.04″ N., 92°03′55.08″ W., then southwest to position 46°46′48.46″ N., 92°05′15.02″ W. (South Breakwater Outer Light (LLNR 15845)), then to position 46°46′40.66″ N., 92°05′36.59″ W. near the Duluth Lift Bridge, then to position 46°46′34.04″ N., 92°05′39.64″ W. (Basin Buoy 1 (LLNR 15865)), and then west to position 46°46′36.42″ N., 92°06′07.86″ W. This area is needed to enhance navigation safety by facilitating the organized and controlled transit of participating vessels through the parade route and minimizing the impact on the maritime community.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and Executive order 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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

    This regulatory action determination is based on the size, location, duration, and time-of-year of the special local regulations. These proposed regulations involve only the Duluth portion of Duluth/Superior Harbor and would close the Duluth Entry Channel to commercial traffic only for several hours during the actual Parade of Sail on August 18, 2016. The Superior Entry would remain open to vessel traffic at all times. The impact of these proposed regulations will not be significant because these regulations would be in effect for only a portion of one day centered on the Parade of Sail, and most vessel traffic can pass safely around affected areas of Duluth Harbor by transiting through the Superior Entry.

    Notice of these special local regulations will be provided prior to the event through Local Notice to Mariners and Broadcast Notice to Mariners. In addition, the sponsoring organization, Draw Events, LLC., is planning to publish information of the event in local newspapers, pamphlets, and Internet sites.

    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 regulated areas 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 (Public Law 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.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves special local regulations lasting no more than 12 hours. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

    PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for Part 100 continues to read as follows: Authority:

    33 U.S.C. 1233.

    2. Add § 100.T09-0797 to read as follows:
    § 100.T09-0797 Special Local Regulations; Tall Ships Duluth 2016 Parade of Sail, Duluth, MN.

    (a) Regulated Areas. (1) Area Duluth Harbor: This Area includes all waters of Lake Superior and Duluth Harbor bounded by Rice's Point to the west and Duluth to the north, within the following boundaries: Beginning at position 46°49′11″ N., 92°02′20″ W., then due south to position 46°45′12″ N., 92°02′20″ W., and then west to position 46°45′12″ N., 92°05′40″ W. (Duluth Marine Terminal South Light (LLNR 15935)).

    (2) Area Parade of Sail: This Area includes all waters of Lake Superior and Duluth Harbor bounded by Duluth to the north, within the following boundaries: Beginning at position 46°46′51.54″ N., 92°05′17.03″ W. (North Pier Light (LLNR 15855)), then northeast to position 46°47′18.96″ N., 92°4′0.84″ W., then south to position 46°47′11.04″ N., 92°03′55.08″ W., then southwest to position 46°46′48.46″ N., 92°05′15.02″ W. (South Breakwater Outer Light (LLNR 15845)), then to position 46°46′40.66″ N., 92°05′36.59″ W. near the Duluth Lift Bridge, then to position 46°46′34.04″ N., 92°05′39.64″ W. (Basin Buoy 1 (LLNR 15865)), and then west to position 46°46′36.42″ N., 92°06′07.86″ W.

    (b) Special Local Regulations. (1) In accordance with the general regulations in § 100.35 of this part, entry into, transiting, or anchoring within the regulated areas is prohibited unless designated for vessels of that type or entry is authorized by the Captain of the Port (COTP) Duluth or on-scene representatives.

    (2) All persons and vessels are authorized by the COTP Duluth to enter areas of these special local regulations in accordance with the following restrictions:

    (i) Area Duluth Harbor: Vessels transiting this Area must do so at a speed of not more than six (6) knots or at no wake speed, whichever is less. Vessels proceeding under sail will not be allowed in this Area unless also propelled by machinery, due to limited maneuvering ability around numerous other spectator craft viewing the Tall Ships.

    (ii) Area Parade of Sail: This Area will be closed to all vessel traffic, except those vessels designated as participants.

    (3) The Coast Guard will provide notice of the regulated areas prior to the event through Local Notice to Mariners and Broadcast Notice to Mariners. Notice will also be provided by on-scene representatives.

    (4) The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant, or petty officer and any Federal, State, or local officer designated by the Captain of the Port to act on his behalf.

    (5) Vessel operators desiring to enter or operate within the regulated areas shall contact the Captain of the Port Duluth by telephone at 218-725-3818, or on-scene representative via VHF radio on channel 16, to obtain permission to do so. Vessel operators given permission to enter, operate, transit through, anchor in, or remain within the regulated areas must comply with all instructions given by COTP Duluth or on-scene representatives.

    Dated: August 12, 2016. E.E. Williams, Commander, U.S. Coast Guard, Captain of the Port Duluth.
    [FR Doc. 2016-19652 Filed 8-16-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0778] Drawbridge Operation Regulation; Rockaway Inlet, Queens, NY AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Marine Parkway Bridge across the Rockaway Inlet, mile 3.0, at Queens, New York. This deviation is necessary to allow the bridge owner to replace mechanical and electrical components for the lift span operation.

    DATES:

    This deviation is effective from 7 a.m. on November 15, 2016 to 5 p.m. on May 13, 2017.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0778] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Marine Parkway Bridge, mile 3.0, across the Rockaway Inlet, has a vertical clearance in the closed position of 55 feet at mean high water and 59 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.795(a).

    The waterway is transited by commercial barge traffic of various sizes.

    The bridge owner, MTA Bridges and Tunnels, requested a temporary deviation from the normal operating schedule to replace mechanical and electrical components for the lift span operation.

    Under this temporary deviation, the Marine Parkway Bridge shall remain in the closed position from 7 a.m. on November 15, 2016 to 5 p.m. May 13, 2017.

    Vessels able to pass under the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

    The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation. The Coast Guard notified various companies of the commercial oil and barge vessels and they have no objections to the temporary deviation.

    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.

    Dated: August 11, 2016. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
    [FR Doc. 2016-19535 Filed 8-16-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2016-0189; FRL-9950-69-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Control of Volatile Organic Compound Emissions From Fiberglass Boat Manufacturing Materials AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving a revision to the Pennsylvania state implementation plan (SIP) submitted by the Commonwealth of Pennsylvania. This SIP revision pertains to Pennsylvania's regulation for fiberglass boat manufacturing materials found in section 129.74 of the Pennsylvania Code. This regulation meets the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) standards for fiberglass boat manufacturing materials. EPA is, therefore, approving this revision to the Pennsylvania SIP in accordance with the requirements of the Clean Air Act (CAA).

    DATES:

    This final rule is effective on September 16, 2016.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2016-0189. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the electronic docket, 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 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:

    Irene Shandruk, (215) 814-2166, or by email at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Section 172(c)(1) of the CAA provides that SIPs for nonattainment areas must include reasonably available control measures (RACM), including RACT, for sources of emissions. Section 182(b)(2)(A) provides that for certain nonattainment areas, states must revise their SIPs to include RACT for sources of volatile organic compound (VOC) emissions covered by a CTG document issued after November 15, 1990 and prior to the area's date of attainment. Furthermore, pursuant to section 184(b)(1)(B) of the CAA, all areas in the Ozone Transport Region (OTR), such as Pennsylvania, must submit SIP revisions that include implementation of RACT with respect to all sources of VOCs in the states covered by a CTG. EPA defines RACT as “the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.” 44 FR 53761 (September 17, 1979).

    CTGs are intended to provide state and local air pollution control authorities information that should assist them in determining RACT for VOCs from various sources. The CTG for fiberglass boat manufacturing materials (Publication No. EPA 453/R-08-004; September 2008) provides control recommendations for reducing VOC emissions from the use of gel coats, resins, and materials used to clean application equipment in fiberglass boat manufacturing operations. This CTG applies to facilities that manufacture hulls or decks of boats from fiberglass, or build molds to make fiberglass boat hulls or decks. EPA's 2008 CTG recommends that the following operations should be covered: Open molding resin and gel coat operations (these include pigmented gel coat, clear gel coat, production resin, tooling gel coat, and tooling resin); resin and gel coat mixing operations; and resin and gel coat application equipment cleaning operations.

    EPA's 2008 CTG recommends the following VOC reduction measures: VOC emission limits for molding resins and gel coats; work practices for resin and gel coat mixing containers; and VOC content and vapor pressure limits for cleaning materials. Recommended VOC emission limits for open molding resin and gel coat operations are shown in Table 1. A more detailed explanation for determining the VOC emission limits for molding resin and gel coats can be found in the Technical Support Document (TSD) for this rulemaking under Docket ID Number EPA-R03-OAR-2016-0189 and available online at http://www.regulations.gov.

    Table 1—Monomer VOC Content Limitations for Open Molding Resin and Gel Coat Operations Materials Application method Individual monomer VOC content or weight average monomer VOC content limit
  • (weight percent)
  • Production Resin Atomized (spray) 28 Production Resin Nonatomized 35 Pigmented Gel Coat Any Method 33 Clear Gel Coat Any Method 48 Tooling Resin Atomized 30 Tooling Resin Nonatomized 39 Tooling Gel Coat Any Method 40
    II. Summary of SIP Revision

    On March 2, 2016, the Pennsylvania Department of Environmental Protection (PADEP) submitted to EPA a SIP revision concerning implementation of RACT requirements for the control of VOC emissions from fiberglass boat manufacturing materials. Pennsylvania is adopting EPA's CTG standards for fiberglass boat manufacturing materials, including the emission limits found in Table 1. The regulation is contained in 25 Pa. Code Chapter 129 (relating to standards for sources), and this SIP revision seeks to add 25 Pa. Code section 129.74 (control of VOC emissions from fiberglass boat manufacturing materials) to the Pennsylvania SIP. EPA finds the provisions in 25 Pa. Code section 129.74 identical to the CTG standards for fiberglass boat manufacturing materials and is therefore approvable in accordance with sections 172(c)(1), 182(b)(2)(A), and 184(b)(1)(B) of the CAA.

    On May 20, 2016 (81 FR 31885), EPA published a notice of proposed rulemaking (NPR) proposing to approve Pennsylvania's March 2, 2016 SIP revision. Other specific requirements and the rationale for EPA's approval action are explained in the NPR and TSD under Docket ID Number EPA-R03-OAR-2016-0189 and will not be restated here. No public comments were received on the NPR.

    III. Final Action

    EPA is approving the March 2, 2016 Pennsylvania SIP revision concerning the addition of 25 Pa. Code section 129.74 to the Pennsylvania SIP because section 129.74 meets the requirement to adopt RACT for sources covered by EPA's CTG standards for fiberglass boat manufacturing materials.

    IV. Incorporation by Reference

    In this rulemaking action, 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 Pennsylvania rule discussed in section II of this preamble. 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 EPA has made, and will continue to make, these materials generally available through http://www.regulations.gov and/or at the EPA Region III Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

    1 62 FR 27968 (May 22, 1997).

    V. 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);

    • 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 (Publ. 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

    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 October 17, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

    This action concerning Pennsylvania's control of VOC emissions from fiberglass boat manufacturing materials 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, Ozone, Volatile organic compounds.

    Dated: August 2, 2016. Shawn M. Garvin, 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 NN—Pennsylvania 2. In § 52.2020, the table in paragraph (c)(1) is amended by adding an entry for “Section 129.74” in numerical order to read as follows:
    § 52.2020 Identification of plan.

    (c) * * *

    (1) * * *

    State citation Title/subject State effective date EPA approval date Additional
  • explanation/
  • § 52.2063 citation
  • Title 25—Environmental Protection Article III—Air Resources *         *         *         *         *         *         * Section 129.74 Control of VOC emissions from fiberglass boat manufacturing materials 12/19/15 8/17/16 [Insert Federal Register citation] New section is added; the requirements of section 129.74 supersede the requirements of a RACT permit issued under sections 129.91-95 prior to December 19, 2015, to the owner or operator of a source subject to section 129.74 to control, reduce or minimize VOCs from a fiberglass boat manufacturing process, except to the extent the RACT permit contains more stringent requirements. *         *         *         *         *         *         
    [FR Doc. 2016-19540 Filed 8-16-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 160301164-6694-02] RIN 0648-BF87 Fisheries of the Northeastern United States; Northeast Skate Complex Fishery; Framework Adjustment 3 and 2016-2017 Specifications AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This rule approves regulations to implement Northeast Skate Complex Fishery Management Plan Framework Adjustment 3 management measures, including fishing year 2016-2017 specifications, and implements a new seasonal quota allocation for the skate wing fishery. This rule is necessary because it updates the Skate Fishery Management Plan to be consistent with the most recent scientific information and it improves management of the skate fisheries. The intended effect of this rule is to help conserve skate stocks while maintaining economic opportunities for the skate fisheries.

    DATES:

    Effective on August 17, 2016.

    ADDRESSES:

    Copies of Framework 3, including the Environmental Assessment and Regulatory Impact Review (EA/RIR), and other supporting documents for the action are available from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. The framework is also accessible via the Internet at: http://www.greateratlantic.fisheries.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    William Whitmore, Fishery Policy Analyst, (978) 281-9182.

    SUPPLEMENTARY INFORMATION:

    Background Approved Measures

    On June 6, 2016, we proposed in the Federal Register (81 FR 36251) management modifications to implement Framework Adjustment 3 to the Northeast Skate Complex Fishery Management (FMP), which includes catch specifications for fishing years 2016-2017. After reviewing public comments in response to the proposed rule, we are approving Framework 3 and the 2016-2017 specifications as detailed in our proposed rule.

    Specifications for Fishing Years 2016-2017

    Specifications including the acceptable biological catch (ABC), annual catch limit (ACL), annual catch target (ACT), and total allowable landings (TALs) for the skate wing and bait fisheries, as well as possession limits, may be specified for up to 2 years. The 2016-2017 skate complex ABC and ACL is 31,081 metric tons (mt). After removing management uncertainty from the ABC, the ACT that remains is 23,311 mt. After removing discards and state landings from the ACT, the TAL that remains is 12,872 mt. Tables 1 and 2 (below) detail TALs and possession limits for the skate wing and skate bait fisheries—there are no possession limit changes from last year. These specifications and possession limits remain in effect until they are replaced.

    Table 1—Total Allowable Landings for Fishing Years 2016-2017 Total Allowable Landings (TAL) mt Skate Wing Fishery: Season 1 (May 1-Aug 31) 4,722 Season 2 (Sept 1-Apr 30) 3,600 Skate Bait Fishery: Season 1 (May 1-Jul 31) 1,299 Season 2 (Aug 1-Oct 31) 1,565 Season 3 (Nov 1-Apr 30) 1,354 Table 2—Possession Limits for Fishing Years 2016-2017 Skate possession limits * Trip limits Skate wings Whole skates Whole skate
  • w/bait
  • letter of
  • authorization
  • NE Multispecies, Scallop, or Monkfish Day-At-Sea (DAS): Season 1 (May 1-Aug 31) 2,600 lb
  • 1,179 kg
  • 5,902 lb
  • 2,677 kg
  • 25,000 lb.
  • 11,340 kg.
  • Season 2 (Sept 1-Apr 30) 4,100 lb
  • 1,860 kg
  • 9,306 lb
  • 4,221 kg
  • NE Multispecies B DAS: May 1-Apr 30 220 lb
  • 100 kg
  • 500 lb
  • 227 kg
  • 500 lb.
  • 227 kg.
  • Non-DAS: May 1-Apr 30 500 lb
  • 227 kg
  • 1,135 lb
  • 515 kg
  • 1,135 lb.
  • 515 kg.
  • * Possession limits may be modified in-season in order to prevent catch from exceeding quotas.
    Skate Wing Adjustment Measures

    Framework 3 modifies the skate wing TAL so that 57 percent of the skate wing TAL is allocated in Season 1 (May 1-August 31) with the remainder allocated in Season 2 (September 1-April 30). This modification was made because skate fishing effort is higher earlier in the fishing year and a seasonal apportionment with in-season change authority should ensure year-round fishing opportunities. Any portion of the Season 1 TAL that is unused is rolled over into Season 2. From May 1 through August 17, the Regional Administrator is required to reduce the directed skate wing possession limit for vessels fishing under a day-at-sea (DAS) from 2,600 lb (1,179 kg) to an incidental catch level of 500 lb (227 kg) when the fishery is projected to land 85 percent of its Season 1 quota. However, if harvest levels are projected to reach 85 percent sometime between August 18 and August 31 (the last two weeks of Season 1), the Regional Administrator maintains discretion on whether or not to reduce the directed possession limit. This option is included because it is difficult and sometimes impracticable for the agency to rapidly close a fishery immediately prior to the end of a season.

    The DAS possession limit increases to 4,100 lb (1,860 kg) at the start of Season 2 (September 1) with the remainder of the annual skate wing TAL available in Season 2. In Season 2, the Regional Administrator may reduce the possession limit to 500 lb (227 kg) when 85 percent of the annual skate wing TAL is projected to have been landed, consistent with previous regulations. These in-season possession limit reductions are designed to mitigate the potential for prolonged closures for the directed skate fishery while still allowing some incidental catches to be landed.

    Comments and Responses on Measures Proposed in Framework 3

    We received four public comments on the proposed rule, including submissions on behalf of the Cape Cod Commercial Fishermen's Alliance and Shark Advocates International.

    Comment 1: The Cape Cod Commercial Fishermen's Alliance and Shark Advocates International support the proposed seasonal specifications and possession limits.

    Response 1: We are approving Framework 3 and the accompanying specifications and possession limits because these measures promote optimum yield, fishery conservation, and are based upon the best available science.

    Comment 2: One commenter argued for a dramatic increase in quota while one commenter contended a dramatic decrease in quota is needed.

    Response 2: The ABC, ACL, and TAL are based on the best available science with advice from the Council's Scientific and Statistical Committee. Therefore, we are approving this action because it is based on the best available science consistent with National Standard 2 of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and with the Council recommendation. The proposed rule (81 FR 36251, June 6, 2016) details the justifications for modifying the specifications. These specifications are expected to result in optimum yield while ensuring that the stocks are not overfished or subject to overfishing (except for thorny skate, which is a prohibited species), consistent with National Standard 1 of the Magnuson-Stevens Act.

    Comment 3: Shark Advocates International urged us to elevate the priority of examining and addressing the severe depletion of thorny skates.

    Response 3: Although this comment does not directly apply to Framework 3, we are concerned with the stock status of thorny skates. In May 2015, we received a petition to list thorny skates as threatened or endangered. We found that the petition to list thorny skate presented substantial scientific or commercial information indicating that the petitioned action may be warranted and solicited information from the public that could be included in a candidate species status review (80 FR 65175, October 26, 2015). A thorny skate status review occurred on May 19, 2016, in Gloucester, MA. A report from the review is currently being developed and will undergo peer-review prior to being shared with the public.

    Comment 4: The Cape Cod Commercial Fishermen's Alliance offered support for the Council's decision to further pursue limited access for the skate fishery.

    Response 4: The Council has prioritized consideration of limiting access to the skate fishery. We will continue working with the Council so that it can research, review, and address its management priorities.

    Changes From the Proposed Rule

    After further review of the regulatory text deemed by the Council and included in the proposed rule, we are revising the regulatory language previously proposed at § 648.322(b)(2) to be consistent with the Regional Administrator's discretion to reduce the Season 2 skate-wing possession limit as provided in Framework Adjustment 1 to the FMP (76 FR 28328; May 17, 2011). These regulatory language changes do not alter the management measures specified in the proposed rule and are consistent with the intent of Framework 3.

    Classification

    The Administrator, Greater Atlantic Region, NMFS, determined that Framework 3 to the FMP is necessary for the conservation and management of the northeast skate complex and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

    There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date. This final rule reduces TALs which are administered through different fishing seasons. Season 1 for the skate wing fishery began on May 1 and ends on August 31. It is possible that the fishery could approach a seasonal landing limit which would require possession limits to be reduced to avoid overharvesting. Waiving the 30-day implementation delay is necessary to ensure timely implementation of the reduced catch limits. Retaining a 30-day delay in implementation would be contrary to the public interest because it could result in a catch limit being exceeded. Immediate implementation of the new TALs, including the new seasonal measures, will benefit fishermen by helping to prevent overages and potentially providing fishing opportunities more evenly throughout the fishing year. For these reasons, NMFS finds it both contrary to the public interest and unnecessary to provide a 30-day delay in implementation.

    This final rule has been determined to be not significant for the purpose of E.O. 12866.

    A final regulatory flexibility analysis (FRFA) was prepared. The FRFA incorporates the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, and NMFS responses to those comments. A copy of this analysis is available from the Council [or NMFS] (see ADDRESSES).

    A Summary of the Significant Issues Raised by the Public in Response to the IRFA, a Summary of the Agency's Assessment of Such Issues, and a Statement of Any Changes Made in the Final Rule as a Result of Such Comments

    A description of the action, why it is being considered, and the legal basis were contained in the preamble of the proposed rule (81 FR 36251, June 6, 2016) and are not repeated here. The public did not provide any comments on the IRFA; therefore, there are no changes made in this final rule with regards to the economic analyses and impacts.

    Description and Estimate of Number of Small Entities To Which the Rule Would Apply

    This final rule would impact fishing vessels, including commercial fishing entities. In 2014, there were 2,012 vessels that held an open access skate permit. However, only 431 of those permit holders were active participants in the commercial skate fishery (i.e., landed any amount of skates). Because there are several ownership affiliate groups (as explained in greater detail in the proposed rule) there are actually 364 active vessels in the skate fishery, only 3 of which qualified as large businesses.

    On December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. Small Business Administration's (SBA) previous standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors, respectively, of the U.S. commercial fishing industry.

    An IRFA was developed for this regulatory action prior to July 1, 2016, using SBA's previous size standards. Under the SBA's size standards, 3 of 364 skate fishing entities were determined to be large. NMFS has qualitatively reviewed the analyses prepared for this action using the new size standard. The new standard could result in a few more commercial shellfish businesses being considered small (due to the increase in small business size standards). In addition, the new standard could result in fewer commercial finfish businesses being considered small (due to the decrease in size standards). Skates are only responsible for a small fraction of total landings and revenue for any of these vessels so it is unlikely that these size-standard changes would have any impact on the previously conducted analyses.

    Description of the Projected Reporting, Record-Keeping, and Other Compliance Requirements of This Final Rule

    This final rule does not introduce any new reporting, recordkeeping, or other compliance requirements.

    Description of the Steps the Agency Has Taken To Minimize the Significant Economic Impact on Small Entities Consistent With the Stated Objectives of Applicable Statutes

    The ACL alternative described in the preambles of the proposed rule and this rule represents an ACL reduction in comparison to previous years' ACLs (maintaining the status quo measures). However, we do not anticipate any significant economic impacts on small entities to result from this action. While there is an overall reduction in the TAL, Framework 3 analyses indicate that actual skate landings in recent years have been close to the TAL we are approving for fishing years 2016-2017. This suggests that it is unlikely that potential revenue losses would be directly commensurate with the TAL reduction. By contrast, maintaining the status quo ACL is inconsistent with the stated objectives because it does not represent the best available science or the goals and objectives of the FMP. The seasonal allocation for the skate-wing fishery effected by this rule was developed to coincide with fishing effort so that more quota is allocated during the months when there is greater fishing effort. This is expected to reduce the risk of the fishery approaching a seasonal quota and having its possession limits reduced. The Council considered reducing the skate-wing possession limits due to the reduced TAL but elected to keep the status quo possession limits to further mitigate economic impacts from the ACL reductions. For these reasons, we do not expect revenues to be significantly impacted.

    Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide was prepared. Copies of this final rule are available from the Greater Atlantic Regional Fisheries Office (GARFO), and the compliance guide, i.e., permit holder letter, will be sent to all holders of permits for the skate fishery. The guide and this final rule will be posted or publically available on the GARFO Web site.

    List of Subjects in 50 CFR Part 648

    Fisheries, Fishing, Reporting and recordkeeping requirements.

    Dated: August 11, 2016. Paul Doremus, Deputy Assistant Administrator for Operations, National Marine Fisheries Service.

    For the reasons set out in the preamble, NMFS amends 50 CFR part 648 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.

    2. In § 648.322, revise paragraphs (a)(1) and (b)(2) to read as follows:
    § 648.322 Skate allocation, possession, and landing provisions.

    (a) * * *

    (1) A total of 66.5 percent of the annual skate complex TAL shall be allocated to the skate wing fishery. All skate products that are landed in wing form, for the skate wing market, or classified by Federal dealers as food as required under § 648.7(a)(1)(i), shall count against the skate wing fishery TAL. The annual skate wing fishery TAL shall be allocated in two seasonal quota periods as follows:

    (i) Season 1—May 1 through August 31, 57 percent of the annual skate wing fishery TAL shall be allocated;

    (ii) Season 2—September 1 through April 30, the remainder of the annual skate wing fishery TAL not landed in Season 1 shall be allocated.

    (b) * * *

    (2) In-season adjustment of skate wing possession limits. The Regional Administrator has the authority, through a notice in the Federal Register consistent with the Administrative Procedure Act, to reduce the skate wing possession limit to 500 lb (227 kg) of skate wings (1,135 lb (515 kg) whole weight or any prorated combination of the allowable landing forms defined at paragraph (b)(4) of this section) for the remainder of the applicable quota season, under the following circumstances:

    (i) When 85 percent of the Season 1 skate wing quota is projected to be landed between May 1 and August 17, the Regional Administrator shall reduce the skate wing possession limit to the incidental level described in paragraph (b)(2) of this section.

    (ii) When 85 percent of the Season 1 skate wing quota is projected to be landed between August 18 and August 31, the Regional Administrator may reduce the skate wing possession limit to the incidental level described in paragraph (b)(2) of this section.

    (iii) When 85 percent of the annual skate wing fishery TAL is projected to be landed in Season 2, the Regional Administrator may reduce the skate wing possession limit to the incidental level described in this paragraph, unless such a reduction would be expected to prevent attainment of the annual TAL.

    [FR Doc. 2016-19601 Filed 8-16-16; 8:45 am] BILLING CODE 3510-22-P
    81 159 Wednesday, August 17, 2016 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 906 [Doc. No. AMS-SC-16-0059; SC16-906-2 PR] Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Increased Assessment Rate AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would implement a recommendation from the Texas Valley Citrus Committee (Committee) to increase the assessment rate established for the 2016-17 and subsequent fiscal periods from $0.08 to $0.09 per 7/10-bushel carton or equivalent of oranges and grapefruit handled under the marketing order (order). The Committee locally administers the order and is comprised of producers and handlers of oranges and grapefruit operating within the area of production. Assessments upon orange and grapefruit handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period begins August 1 and ends July 31. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.

    DATES:

    Comments must be received by September 16, 2016.

    ADDRESSES:

    Interested persons are invited to submit written comments concerning this proposed rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet: http://www.regulations.gov. Comments should reference the document number and the date and page number of this issue of the Federal Register and will be available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: http://www.regulations.gov. All comments submitted in response to this proposed rule will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above.

    FOR FURTHER INFORMATION CONTACT:

    Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email: [email protected] or [email protected]

    Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This proposed rule is issued under Marketing Agreement and Order No. 906, as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

    The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 13175.

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, orange and grapefruit handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable oranges and grapefruit beginning on August 1, 2016, and continue until amended, suspended, or terminated.

    The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

    This proposed rule would increase the assessment rate established for the Committee for the 2016-17 and subsequent fiscal periods from $0.08 to $0.09 per 7/10-bushel carton or equivalent of oranges and grapefruit.

    The Texas orange and grapefruit marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of Texas oranges and grapefruit. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

    For the 2015-16 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

    The Committee met on June 2, 2016, and unanimously recommended 2016-17 expenditures of $751,148 and an assessment rate of $0.09 per 7/10-bushel carton or equivalent of oranges and grapefruit. In comparison, last year's budgeted expenditures were $701,148. The assessment rate of $0.09 is $0.01 higher than the rate currently in effect. At the current assessment rate, assessment income would equal around $640,000, an amount insufficient to cover the Committee's anticipated expenditures, which include a $50,000 increase in funding for compliance. The Committee considered the proposed expenses and recommended increasing the assessment rate.

    The major expenditures recommended by the Committee for the 2016-17 year include $600,248 for the Mexican fruit fly control program, $77,200 for management, and $50,000 for compliance. Budgeted expenses for these items in 2015-16 were $600,248, $77,200, and $0, respectively.

    The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of Texas oranges and grapefruit. Orange and grapefruit shipments for the 2016-17 year are estimated at 8 million 7/10-bushel cartons or equivalent, which should provide $720,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, would be adequate to cover budgeted expenses. Funds in the reserve (currently around $367,000) would be kept within the maximum permitted by the order (approximately one fiscal period's expenses as stated in § 906.35).

    The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

    Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2016-17 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

    Initial Regulatory Flexibility Analysis

    Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

    The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

    There are approximately 170 producers of oranges and grapefruit in the production area and 13 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

    According to Committee data and information from the National Agricultural Statistics Service, the weighted average grower price for Texas citrus during the 2014-15 season was around $9.53 per box and total shipments were near 7.8 million boxes. Using the weighted average price and shipment information, and assuming a normal distribution of production, the majority of producers would have annual receipts of less than $750,000. In addition, based on Committee information, the majority of handlers have annual receipts of less than $7,500,000 and could be considered small businesses under SBA's definition. Thus, the majority of Texas citrus producers and handlers may be classified as small entities.

    This proposal would increase the assessment rate established for the Committee and collected from handlers for the 2016-17 and subsequent fiscal periods from $0.08 to $0.09 per 7/10-bushel carton or equivalent of Texas oranges and grapefruit. The Committee unanimously recommended 2016-17 expenditures of $751,148 and an assessment rate of $0.09 per 7/10-bushel carton or equivalent handled. The proposed assessment rate of $0.09 is $0.01 higher than the 2015-16 rate. The quantity of assessable oranges and grapefruit for the 2016-17 season is estimated at 8 million 7/10-bushel cartons or equivalent. Thus, the $0.09 rate should provide $720,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, would be adequate to meet this year's expenses.

    The major expenditures recommended by the Committee for the 2016-17 year include $600,248 for the Mexican fruit fly control program, $77,200 for management, and $50,000 for compliance. Budgeted expenses for these items in 2015-16 were $600,248, $77,200, and $0, respectively.

    At the current assessment rate, assessment income would only equal around $640,000, an amount insufficient to cover the Committee's anticipated expenditures, which include a $50,000 increase in funding for compliance. The Committee considered the proposed expenses and recommended increasing the assessment rate.

    Prior to arriving at this budget and assessment rate, the Committee considered information from various sources, such as the Committee's Budget and Personnel Committee, and Committee management. Alternative expenditure levels were discussed by these groups, based upon the relative value of various activities to the Texas citrus industry. Based on estimated shipments, the recommended assessment rate of $0.09 should provide $720,000 in assessment income. The Committee determined that the assessment revenue, along with funds from interest income and funds from reserves, would be adequate to cover budgeted expenses for the 2016-17 fiscal period.

    A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the average grower price for the 2016-17 season could be around $13.50 per 7/10-bushel carton or equivalent of oranges and grapefruit. Therefore, the estimated assessment revenue for the 2016-17 crop year as a percentage of total grower revenue would be around 0.6 percent.

    This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. However, these costs would be offset by the benefits derived by the operation of the marketing order.

    The Committee's meeting was widely publicized throughout the Texas citrus industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 2, 2016, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0189 Generic Fruit Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

    This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large Texas orange and grapefruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

    USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action.

    A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Richard Lower at the previously-mentioned address in the FOR FURTHER INFORMATION CONTACT section.

    A 30-day comment period is provided to allow interested persons to respond to this proposed rule. Thirty days is deemed appropriate because: (1) The 2016-17 fiscal period begins on August 1, 2016, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable Texas oranges and grapefruit handled during such fiscal period; (2) the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and (3) handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years.

    List of Subjects in 7 CFR Part 906

    Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, 7 CFR part 906 is proposed to be amended as follows:

    PART 906—ORANGES AND GRAPEFRUIT GROWN IN LOWER RIO GRANDE VALLEY IN TEXAS 1. The authority citation for 7 CFR part 906 continues to read as follows: Authority:

    7 U.S.C. 601-674.

    2. Section 906.235 is revised to read as follows:
    § 906.235 Assessment rate.

    On and after August 1, 2016, an assessment rate of $0.09 per 7/10-bushel carton or equivalent is established for oranges and grapefruit grown in the Lower Rio Grande Valley in Texas.

    Dated: August 12, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
    [FR Doc. 2016-19624 Filed 8-16-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-8844; Directorate Identifier 2016-NM-026-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 airplanes. This proposed AD was prompted by a report indicating that the fire block in the video control station and closets, and fire blocking tape in the floor panel opening in the forward and aft main passenger cabin, might be missing on some airplanes. This proposed AD would require installing fire block in the video control station and closets, as applicable, and installing fire blocking tape in the floor panel openings in the forward and aft main passenger cabin. We are proposing this AD to prevent propagation of a fire in the lower lobe cheek area outboard of a video control station and closet. Such propagation could result in an increased risk of smoke and/or fire propagation into the passenger cabin.

    DATES:

    We must receive comments on this proposed AD by October 3, 2016.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

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

    Fax: 202-493-2251.

    Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8844.

    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-2016-8844; 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 (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Francis Smith, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-8844; Directorate Identifier 2016-NM-026-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://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    We have received a report from Boeing indicating that the fire block in the video control station and closets, and fire blocking tape in the floor panel opening in the forward and aft main passenger cabin might be missing on some airplanes. The materials were not installed during production. We are proposing this AD to prevent propagation of a fire in the lower lobe cheek area outboard of a video control station and closet. Such propagation could result in an increased risk of smoke and/or fire in the passenger cabin.

    Related Service Information Under 1 CFR Part 51

    We reviewed the following service information:

    Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013. The service information describes procedures for installing fire block in the video control station and closets.

    Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015. The service information describes procedures for installing fire block in the video control station.

    Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013. The service information describes procedures for installing fire blocking tape in the floor panel openings in the forward and aft main passenger cabin.

    This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8844.

    Costs of Compliance

    We estimate that this proposed AD affects 6 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S.
  • operators
  • Fire blocking tape installation in the floor panel openings Up to 23 work-hours × $85 per hour = $1,955 per installation $0 Up to $1,955 per installation Up to $11,730 per installation. Fire block installation in the video control closet 5 work-hours × $85 per hour = $425 per installation 489 $914 per installation $5,484 per installation. Fire block installation in the video control station 5 work-hours × $85 per hour = $425 per installation 276 $701 per installation $4,206 per installation.

    According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

    We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    (1) Is not a “significant regulatory action” under Executive Order 12866,

    (2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

    (3) Will not affect intrastate aviation in Alaska, and

    (4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

    The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): The Boeing Company:

    Docket No. FAA-2016-8844; Directorate Identifier 2016-NM-026-AD.

    (a) Comments Due Date

    We must receive comments by October 3, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to The Boeing Company Model 787-8 airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013; Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013; and Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015.

    (d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/furnishings; 53, Fuselage.

    (e) Unsafe Condition

    This AD was prompted by a report indicating that the fire block in the video control station and closets, and fire blocking tape in the floor panel opening in the forward and aft main passenger cabin, might be missing on some airplanes. We are issuing this AD to prevent propagation of a fire in the lower lobe cheek area outboard of a video control station and closet. Such propagation could result in an increased risk of smoke and/or fire propagation into the passenger cabin.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Installation of Fire Block and Fire Blocking Tape, as Applicable

    Within 72 months after the effective date of this AD, do the actions specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, as applicable.

    (1) For airplanes specified in Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013: Install fire block in the video control station and closets, as applicable, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013.

    (2) For airplanes specified in Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015: Install fire block in the video control station, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015.

    (3) For airplanes specified in Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013: Install fire blocking tape in the floor panel opening in the forward and aft main passenger cabin, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013.

    (h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (i)(1) of this AD. Information may be emailed to: [email protected]

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (i) Related Information

    (1) For more information about this AD, contact Francis Smith, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on August 5, 2016. Chris L. Spangenberg, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-19487 Filed 8-16-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-7417; Airspace Docket No. 16-AWA-4] RIN 2120-AA66 Proposed Amendment of Class C Airspace; El Paso International Airport, TX AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to modify Class C airspace at El Paso International Airport, El Paso, TX, by removing a cutout from the Class C airspace area that excludes the airspace within a 2-mile radius of West Texas Airport and the airspace beyond an 8-mile arc from the El Paso International Airport beginning at the 115° bearing from the airport clockwise to the Rio Grande River. Additionally, this proposal would update the El Paso International Airport geographic coordinates to reflect the current airport reference point (ARP) information in the FAA's aeronautical database and remove the West Texas Airport and geographic coordinate references from the Class C airspace description. The FAA is proposing this action to enable more efficient operations at El Paso International Airport.

    DATES:

    Comments must be received on or before October 17, 2016.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; telephone: 1 (800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2016-7417 and Airspace Docket No. 16-AWA-4 at the beginning of your comments. You may also submit comments through the Internet at http://www.regulations.gov.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1(800) 647-5527), is on the ground floor of the building at the above address.

    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call (202) 741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html. FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    Colby Abbott, 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 would modify terminal airspace as required to preserve the safe and efficient flow of air traffic in the El Paso, TX, area.

    Comments Invited

    Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers (FAA Docket No. FAA-2016-7417 and Airspace Docket No. 16-AWA-4) and be submitted in triplicate to the Docket Management Facility (see ADDRESSES section for address and phone number). You may also submit comments through the internet at http://www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2016-7417 and Airspace Docket No. 16-AWA-4.” The postcard will be date/time stamped and returned to the commenter.

    All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the internet at http://www.regulations.gov.

    You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Operations Support Group, Central Service Center, Federal Aviation Administration, 10101 Hillwood Blvd., Fort Worth, TX, 76177.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to modify the El Paso International Airport, TX, Class C airspace area. The proposal would remove a cutout and reduced perimeter boundary arc that excludes the airspace within a 2-mile radius of the West Texas Airport and the airspace beyond an 8-mile arc from the El Paso International Airport beginning at the 115° bearing from the airport clockwise to the Rio Grande River. These exclusions from the Class C airspace area were established to accommodate operations at West Texas Airport, which was located approximately 9 nautical miles (NM) southeast of El Paso International Airport. The West Texas Airport (renamed Horizon Airport in 2004) is now permanently closed and the property sold for non-aviation uses. Since the original purpose for the exclusions no longer exists, the FAA is proposing to remove the words “. . . that airspace beyond an 8-mile arc from the El Paso International Airport beginning at the 115° bearing from the airport clockwise to the Rio Grande River, and that airspace within a 2-mile radius of the West Texas Airport, and . . .” from the regulatory text. The West Texas Airport and geographic coordinate references would also be removed from the Class C airspace description. These changes would restore the Class C airspace that extends upward from 5,200 feet MSL to 8,000 feet MSL to a standard configuration 10-NM radius boundary southeast of the El Paso International Airport and enhance the management of aircraft operations to and from the airport.

    Additionally, the FAA would change the exclusion language pertaining to the Class C airspace extending upward from 5,200 feet MSL from “. . . that airspace within Mexico, and that airspace west of long 106°27′02″ W.” to “. . . that airspace west of long. 106°27′02″ W., and that airspace within Mexico.” This change would be editorial for format and clarity to standardize the exclusion information associated with the Class C airspace surface area and shelf.

    Lastly, this action would update the El Paso International Airport geographic coordinates to reflect the current ARP information in the FAA's aeronautical database from “lat. 31°48′24″ N., long. 106°22′40″ W.” to “lat. 31°48′26″ N., long. 106°22′35″ W.”

    Class C airspace areas are published in paragraph 4000 of FAA Order 7400.9Z, dated August 6, 2015 and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class C airspace area modification proposed in this document would be published subsequently in the Order.

    Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation 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 Department of Transportation (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 will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 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.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: Paragraph 4000—Subpart C—Class C Airspace ASW TX C El Paso International Airport, TX [Amended] El Paso International Airport, TX (Lat. 31°48′26″ N., long. 106°22′35″ W.)

    That airspace extending upward from the surface to and including 8,000 feet MSL within a 5-mile radius of the El Paso International Airport, excluding that airspace west of long. 106°27′02″ W., and that airspace within Mexico; and that airspace extending upward from 5,200 feet MSL to and including 8,000 feet MSL within a 10-mile radius of the El Paso International Airport, excluding that airspace west of long. 106°27′02″ W., and that airspace within Mexico.

    Issued in Washington, DC, on August 10, 2016. M. Randy Willis, Acting Manager, Airspace Policy Group.
    [FR Doc. 2016-19556 Filed 8-16-16; 8:45 am] BILLING CODE 4910-13-P
    CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1308 [Docket No. CPSC-2016-0017] Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics AGENCY:

    U.S. Consumer Product Safety Commission.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Consumer Product Safety Commission (Commission, or CPSC) is proposing a rule to determine that certain plastics with specified additives would not contain the specified phthalates prohibited in children's toys and child care articles. Based on these determinations, the specified plastics with specified additives would not require third party testing for compliance with the mandatory phthalates prohibitions on children's toys and child care articles.

    DATES:

    Submit comments by October 31, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CPSC-2016-0017, by any of the following methods:

    Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.

    Written Submissions: Submit written comments by mail/hand delivery/courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

    Instructions: All submissions received must include the agency name and docket number. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing by mail/hand delivery/courier.

    FOR FURTHER INFORMATION CONTACT:

    Randy Butturini, Project Manager, Office of Hazard Identification and Reduction U.S. Consumer Product Safety Commission, 4330 East West Hwy., Room 814, Bethesda, MD 20814; 301-504-7562: email; [email protected]

    SUPPLEMENTARY INFORMATION: A. Background 1. Third Party Testing and Burden Reduction

    Section 14(a) of the Consumer Product Safety Act, (CPSA), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires that manufacturers of products subject to a consumer product safety rule or similar rule, ban, standard, or regulation enforced by the CPSC, must certify that the product complies with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). For children's products, certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body. Id. Public Law 112-28 (August 12, 2011) directed the CPSC to seek comment on “opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation.” Public Law 112-28 also authorized the Commission to issue new or revised third party testing regulations if the Commission determines “that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.” Id. 2063(d)(3)(B).

    2. Prohibitions in Section 108 of the CPSIA

    Section 108 of the CPSIA prohibits children's toys and child care articles that contain six specified phthalates in concentrations above 0.1 percent in “accessible plasticized component parts and other component parts made of materials that may contain phthalates.” The prohibited phthalates in section 108 of the CPSIA are listed in Table 1. Children's toys and child care articles subject to the content limits in section 108 of the CPSIA require third party testing for compliance with the phthalate content limits before the manufacturer can issue a Children's Product Certificate (CPC) and enter the children's toys or child care articles into commerce.

    Table 1—Statutorily Prohibited Phthalates Permanent prohibition on phthalates in children's toys and child care articles DEHP: di-(2-ethylhexyl) phthalate DBP: dibutyl phthalate BBP: benzyl butyl phthalate Interim prohibition on phthalates in children's toys and child care articles DINP: diisononyl phthalate DIDP: diisodecyl phthalate DnOP: di-n-octyl phthalate

    The CPSIA required the Commission to appoint a Chronic Hazard Advisory Panel (CHAP) to “study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles.” The CHAP issued its report in July 2014.1 Based on the CHAP report, the Commission published a notice of proposed rulemaking (NPR) 2 proposing to make the interim prohibition on DINP in children's toys and child care articles permanent, and proposing to lift the interim statutory prohibitions on DIDP and DnOP in children's toys and child care articles. In addition, the NPR proposed adding four new phthalates to the prohibited list of phthalates that cannot exceed 0.1 percent concentration in accessible component parts of children's' toys and child care articles. Table 2 contains the list of phthalates that the NPR proposed to prohibit in children's toys and child care articles.

    1http://www.cpsc.gov/PageFiles/169902/CHAP-REPORT-With-Appendices.pdf.

    2https://www.federalregister.gov/articles/2014/12/30/2014-29967/prohibition-of-childrens-toys-and-child-care-articles-containing-specified-phthalates.

    Table 2—Proposed Prohibited Phthalates Phthalates DEHP: di-(2-ethylhexyl) phthalate DBP: dibutyl phthalate BBP: benzyl butyl phthalate DINP: diisononyl phthalate DIBP: diisobutyl phthalate DPENP: di-n-pentyl phthalate DHEXP: di-n-hexyl phthalate DCHP: dicyclohexyl phthalate B. Contractor's Research on Phthalates in Consumer Products

    CPSC contracted with Toxicology Excellence for Risk Assessment (TERA) to conduct research on phthalates and provide CPSC with two research reports on phthalates relevant to this rulemaking. TERA conducted a literature search on the production and use of 11 specified phthalates in consumer products (Task 11 Report).3 The 11 phthalates researched by TERA are based on the phthalates assessed by the CHAP and the recommendations made in the CHAP report. Additionally, the CPSC contracted with TERA to conduct a literature search on whether specified plastics could be determined not to contain any of the 11 phthalates in concentrations above the CPSIA limit of 0.1 percent (Task 12 Report).4

    3http://www.cpsc.gov//Global/Research-and-Statistics/Technical-Reports/Other%20Technical%20Reports/TERAReportPhthalates.pdf. The work was conducted as a task order (Task 11) under CPSC contract CPSC-D-12-0001.

    4http://www.cpsc.gov//Global/Research-and-Statistics/Technical-Reports/Other%20Technical%20Reports/ReportonPhthalatesinFourPlastics.pdf. The work was conducted as a task order (Task 12) under CPSC contract CPSC-D-12-0001.

    TERA used a tiered literature research approach to identify sources for review from among the “universe” of available data. The tiers were used to provide a structured search method to locate relevant sources and eliminate unrelated material. TERA used books, factsheets, journal articles, patents, and other sources as primary and secondary literature sources. The use of this tiered approach resulted in a comprehensive review of the available literature that is representative of the information available on the potential for the presence of any of the 11 phthalates in the 4 specified plastics.

    TERA screened over 119,800 studies identified by the above described tiered search method for relevance to the 11 phthalates and 4 plastics. CPSC staff reviewed the information provided in the contractor report and formulated recommendations for Commission consideration based on TERA's research.

    The plastics researched by TERA were:

    • Polypropylene (PP);

    • Polyethylene (PE);

    • High-impact polystyrene (HIPS); and

    • Acrylonitrile butadiene styrene (ABS).

    TERA's research included the following factors:

    • The raw materials used in the production of the specified plastics;

    • The manufacturing processes used worldwide to produce the plastics;

    • Typical applications for the specified plastics in consumer products, especially toys and child care articles, focusing on circumstances where the plastic could contain phthalates at concentrations greater than 0.1 percent;

    • The potential use of recycled materials containing the specified phthalates in the production of the plastics; and

    • The potential for phthalate contamination during packaging, storage, use, or other factors.

    C. CPSC Staff Analysis 1. Polypropylene (PP)

    TERA's research indicated the production of PP plastic uses a PP monomer, ethylene, and other monomers, a hydrocarbon solvent, catalysts, nucleating agents or fillers, and a number of other additives, depending on the type of PP and other manufacturing considerations. Additives can be included in PP to achieve various chemical and mechanical characteristics. PP can include the following additives:

    Hydrocarbon solvents: Examples of solvents used are hexane and heptane;

    Catalysts:  5 Catalysts used in producing PP are the Ziegler-Natta catalysts; 6

    5 The Merriam-Webster online dictionary defines a “catalyst” as “a substance that causes or accelerates a chemical reaction without itself being affected.” A catalyst is not consumed, altered, or incorporated into one of the reaction's products.

    6 A Ziegler-Natta catalyst, named after Karl Ziegler and Giulio Natta, is a class of catalyst used in the production of some plastics.

    Fillers: Fillers are added to plastics to enhance their performance (e.g., impact resistance, shrink resistance), and reduce manufacturing costs. Examples of fillers used in PP include talc, calcium carbonate, and fiberglass;

    Primary antioxidants: Antioxidants inhibit oxidative deterioration of a material. Primary antioxidants donate hydrogen atoms to prevent free radical creation. Examples of primary antioxidants include hindered phenol, such as butylated hydroxytoluene, and hindered amine light stabilizers;

    Secondary antioxidants: Secondary antioxidants prevent degradation by breaking down free radicals and hydroperoxides, and synergize with the primary antioxidants. Examples of secondary antioxidants include phosphites and thioesters;

    Neutralizing agents: Neutralizing agents adjust the acidity of the chemicals during production, and can include calcium and zinc stearate, zeolites, calcium and zinc oxides, and metallic salts of lactic or benzoic acid;

    Antistatic agents: Antistatic agents reduce the buildup of static electricity, and can include cationic compounds, anionic compounds, and nonionic compounds;

    Slip agents: Slip agents are added to reduce a plastic surface's coefficient of friction. Examples of slip agents include modified fatty acids or fatty amides;

    Metal deactivators: Transition metals like copper and iron can accelerate plastic degradation. Metal deactivators, such as N,N′-dibenzaloxaldihydrazide, combine with the metal ions and prevent catalytic degradation of the plastic;

    Quenchers: Quenchers scavenge stray free radicals and decompose unwanted peroxides. Examples of quenchers are organic nickel complexes, nickel salts of thiocarbamate, and nickel complexes with alkylated phenol phosphonates;

    UV stabilizers: Ultraviolet (UV) stabilizers are added to PP to protect the plastic from degradation in sunlight. Examples of UV stabilizers are hindered amine light stabilizers, carbon black, titanium dioxide, zinc oxide, derivatives of benzophenone, benzotriazoles, phenyl, aryl, or acrylic esters, formamidines, and oxanilides;

    Nucleating agents: Nucleating agents are additives that increase the crystallization of a plastic from a liquid solution. Examples of nucleating agents for PP include carboxylic acids, benzyl sorbitols, and salts of organic phosphates;

    Flame retardants: Examples of flame retardants include brominated flame retardants, cycloaliphatic chlorines; antimony trioxide, ferric oxide, zinc oxide, zinc borate, barium metaborates; phosphorus flame retardants, magnesium hydroxide, and aluminum hydroxide;

    Blowing or foaming agents: Blowing and foaming agents create gas bubbles during molding, resulting in a foamed plastic. Examples of blowing and foaming agents include sodium bicarbonate, sodium borohydride, polycarbonic acid, citric acid, 4,4′oxybis(benzenesulfonyl hydrazide), azodicarbonamide, or para-toluenesulfonyl semicarbazide;

    Antiblocking agents: Antiblocking agents are used to prevent plastic films from sticking together through cold flow or static electricity. Examples of antiblocking agents include natural and manufactured waxes, metallic salts of fatty acids, silica compounds, and some polymers (e.g., polyvinyl alcohol, polyamides, polyethylene, polysiloxanes, and fluoroplastics);

    Lubricants: Lubricants are used in PP (and other plastics) to lower the molten material's coefficient of viscosity and prevent the plastic from sticking to metal surfaces. The lubricants allow the plastic's hydrocarbon chains to slip past each other in the melt. Examples of lubricants include metal soaps, hydrocarbon waxes, polyethenes, amide waxes, fatty acids, and fatty alcohols, (e.g., calcium or zinc stearates); or

    Colorants: Colorants for plastics typically consist of dyes, in which the color-producing material is dissolved in a carrier medium, and pigments, in which very small particles of the color-producing material are suspended in the carrier medium. Examples of colorants used in PP include heavy metal-based oxides, sulfides, chromates, and other complexes, including cadmium, zinc, titanium, lead, molybdenum; and ultramines (sulfide-silicate complexes containing sodium and aluminum; azo pigments).

    The research showed that among all of these raw materials and additives, only Ziegler-Natta catalysts may contain one or more of the prohibited phthalates. Ziegler-Natta catalysts are generally titanium-based catalyst systems in combination with an organoaluminum co-catalyst, and an internal donor (a molecule that contributes an electron to the chemical reaction), such as DBP, DIBP or DEHP. As described in the Task 12 Report, these catalysts may survive the plastic's polymerization process, and the phthalates may be present in the final plastic pellets, theoretically at concentrations of about 1 mg/kg (1 part per million, “ppm”). The Task 12 Report references an industry analysis in the context of European regulations that indicates that phthalate concentrations in PP do not exceed 0.15 mg/kg (0.15 ppm) and are often below the measurement threshold of the analytical method of 0.01 mg/kg (0.01 ppm).

    2. Polyethylene (PE)

    TERA's research indicated that PE is manufactured using PE monomers or certain copolymers or other monomers, and a number of additives. Additives can be included in PE to achieve various chemical and mechanical characteristics. PE can include the following additives:

    Plasticizers:7 Examples of plasticizers for PE include glyceryl tribenzoate, polyethylene glycol, sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM rubber, EVA polymer, DOP; 8

    7 The Task 12 Report indicated that several prohibited phthalates are used as plasticizers in PE. CPSC staff reviewed the report's references for this information. As cited in the Task 12 Report, Bhunia et al. (2013) reported several phthalates used in food packaging plastic films, including PE, referencing Sablani and Rahman (2007). In the latter reference, staff did not find any support for the claimed uses of phthalates. In fact, in the section on plasticizers, Sablani and Rahman (2007) stated that most plasticizers are used in PVC and that as a result of studies on migration of plasticizers from food packaging, “. . . industry has replaced PVC with other polymers, such as PE or regenerated cellulose not associated with plasticizers.” (emphasis added)

    8 The isomer of DOP was not specified. DOP can include DEHP.

    Initiators: Initiators help form the plastic macromolecules from the solution. Examples of PE initiators are benzoyl peroxide, azodi-isobutyronitrile, and oxygen;

    Promoters: Promoters in PE improve paint adhesion and resistance to some solvents. PE promoters include sodium and calcium (in metal or hydride form);

    Catalysts: Catalysts for PE include the Ziegler-Natta catalysts, and metallocene catalysts (e.g., zirconium, titanium);

    Fillers: silane and titanate coupling agents are used as fillers in PE;

    Antistatic agents: PE antistatic agents include polyethylene glycol alkyl esters;

    Flame retardants: PE flame retardants include antimony trioxide, and halogenated substances;

    Anti-blocking agents: Fine silicas are an example of a PE antiblocking agent;

    Slip agents: PE slip agents include fatty acid amides such as oleamide and erucamide;

    Blowing agents: PE blowing agents include 4,4′-oxybisbenzenesulfono- hydrazine and azocarbonamide;

    Cross-linking agents: Cross-linking agents set up chemical bonds between the plastic macromolecules and assists in “curing” the plastic. Examples of cross-linking agents include dicumyl peroxide, and vinyl silanes;

    Antioxidants: PE antioxidants include 4-methyl-2,6-t-butyl phenol, 1,1,3-tris-(4-hydroxy-2-methyl-5-butylphenyl)butane, bis-[2-hydroxy-5-methyl-3-(1-methylcyclohexyl)phenyl]- methane, and dilauryl-β,β′-thiodipropionate;

    Carbon black; or

    Colorants: PE colorants are often based on cobalt, cadmium, and manganese.

    As with PP, PE catalysts include an internal donor, such as DBP, DIBP, or DEHP, although the phthalate concentration in the final plastic is generally well below 0.15 mg/kg (0.15 ppm).

    One reference in the Task 12 report indicated that DOP can be used as a plasticizer in PE. Staff reviewed the cited references, as well as citations within the references, and found that uses of DOP in PE are mentioned in patents for specialized materials with no known current consumer product application, or may be used in materials, such as pavement marking, which are not children's products. One cited patent described use of phthalates in a PE microporous film used as an internal separator for lithium ion batteries.

    The Task 12 Report cited a patent for a material made with PE plastic and DBP for use as a surface for outdoor athletic track, basketball, volleyball, and playgrounds. CPSC staff found no information indicating that such a product has been manufactured and marketed for consumer use. Furthermore, the applications for the material do not include children's toys or child care articles that are subject to the phthalate content restrictions.

    3. High-Impact Polystyrene (HIPS)

    TERA's research indicated that HIPS is a plastic blend generally produced from styrene, polybutadiene rubber, benzene, and a number of other substances. Additives can be included in HIPS to achieve various chemical and mechanical characteristics. HIPS can include the following additives:

    Catalysts: The Ziegler-Natta catalysts;

    Internal lubricant: Zinc stearate is a lubricant for HIPS;

    Chain transfer/transition agent: Chain transfer/transition agents regulate the length of the HIPS macromolecules. HIPS chain transfer/transition agents include tertdocecylmercaptan and liquid paraffin;

    Stabilizer: Tert-butylcatechol is a stabilizer for HIPS;

    Diluents: Diluents are used to reduce the concentration of a plastic as a means to reduce the plastic's viscosity and to modify its processing conditions. Examples of HIPS diluents include ethylbenzene, and toluene; or

    Colorants: HIPS colorants include azo dyes, anthraquinone dyes, perinone dyes, or xanthene dyes.

    Other additives: Additional materials used in the manufacture of HIPS include:

    ○ Aluminum chloride, ethyl chloride, hydrochloric acid;

    ○ Iron oxide, potassium oxide, chromium oxide; and

    ○ Bifunctional peroxides.

    As with PP and PE, the polybutadiene used in HIPS production is made with the use of catalysts that include an internal donor, such as DBP, DIBP, or DEHP. Although no testing for phthalate content was located, because the use of phthalate in HIPS is as a catalyst, the concentration in the final product is expected to be well below 0.1 percent.

    4. Acrylonitrile Butadiene Styrene (ABS)

    TERA's research indicated that ABS plastic is manufactured with specific monomers, such as acrylonitrile, butadiene, and styrene, trans-1,4-butadiene, cis-1,4-butadiene, and 1,2-butadiene. Additives are included in ABS to achieve various chemical and mechanical characteristics. ABS can include the following additives:

    Plasticizers: ABS plasticizers include hydrocarbon processing oil, triphenyl phosphate, resorcinol bis(diphenyl phosphate), oligomeric phosphate, long chain fatty acid esters, and aromatic sulfonamide;

    Hydrocarbon solvents: hexane, heptane, and ethyl benzene;

    Stabilizers against heat or light degradation: Stabilizer examples include phenolic antioxidants, thiol-containing antioxidants, phosphites, thioesters, substituted benzophenones and benzotriazoles, and hindered amines;

    Lubricants: ABS lubricants include metallic stearates, montan waxes or amide waxes; 9

    9 The TERA Task 12 Report did not specify ABS lubricants. CPSC staff supplemented the Task 12 Report with additional research.

    Antioxidants: Phenolic-based or phosphate-based antioxidants are used in the manufacture of ABS;

    Molecular weight regulator: An example of an ABS molecular-weight regulator is tert-dodecyl mercaptan;

    Initiators/catalysts: ABS initiators and catalysts include potassium persulfate, sodium persulfate, oil-soluble initiators in a redox system (cumene hydroperoxide, sodium pyrophosphate, dextrose, and iron (II) sulfate);

    Activators: Activators prepare the ABS surface for electroplating. The activators in ABS are often palladium and tin salts in an acid solution; 10

    10 The TERA Task 12 Report did not specify ABS activators. CPSC staff supplemented the Task 12 Report with additional research.

    Emulsifiers: Emulsifiers are chemicals that promote the mixing of hydrophilic and hydrophobic materials. ABS emulsifiers include salts of rosin, fatty sodium lauryl sulfate, and oleate;

    Colorants: ABS colorants include phthalocyanines, perylenes, cromophtals, titanium dioxide, carbon black, black iron oxide, ultramarine blue, red iron oxide, and aluminum flake.11

    11 The TERA Task 12 Report did not specify ABS colorants. CPSC staff supplemented the Task 12 Report with additional research.

    5. Additional CPSC Staff Research

    TERA's research did not include an examination of the colorants in polyethylene, high-impact polystyrene, or acrylonitrile butadiene styrene. TERA's research also did not include an examination of the lubricants, activators, and antioxidants that could be used in the production of ABS. CPSC staff conducted additional research into these component parts of the plastics.

    6. Potential Phthalate Use in the Four Plastics

    The Task 11 Report indicates that phthalates are used generally as plasticizers or softeners of certain plastics, primarily polyvinyl chloride (PVC), as solvents, and as components of inks, paints, adhesives, and sealants. Except for the general category of inks and colorants, the Task 11 Report did not indicate uses of the prohibited phthalates in any of the four plastics, in the raw materials, or in the types of additives that might be used in the four plastics.

    The four plastics may also be used as ingredients in a variety of materials. For example, PP may be used in formulations for concrete, paints, and lubricating grease. These materials would not be considered to be PP plastic. PE, HIPS, ABS also may be used as additives in materials that would not be considered plastics.

    The TERA Task 11 and Task 12 Reports indicate that the phthalates researched are not associated with the chemistry and applications of the plastics PP, PE, HIPS, or ABS. When these plastics are plasticized, materials other than the phthalates are used as plasticizers (e.g., hydrocarbon processing oil, phosphate esters, long chain fatty acid esters, and aromatic sulfonamide for ABS). TERA found one reference in which DnOP (also referred to as DOP) was used as a plasticizer for PE. However, the only application cited was a patent for a microporous plastic film used in the production of lithium-ion batteries. TERA's research included references prior to and after the enactment of the CPSIA, none of which indicated any phthalate use in the four plastics.

    7. Studies Where Phthalates Were Detected

    TERA's investigation of the uses of the four plastics shows that all four are used to make plastic consumer products and component parts. None of these applications specifically includes phthalates, although a few studies of the phthalate content of products were located.

    Several studies evaluated food, beverage, and cosmetics packaging made with PP, PE, and polystyrene (PS). These studies generally measured migration of specified chemicals, including phthalates, from products purchased in retail stores. The references provided few or no details about all the materials used in the products, including whether other plastics were present, whether other component parts were present such as coatings, finishes, inks, or adhesives, or whether residues of the contained products were present.

    The Task 12 Report also cited a Korean study of various products that reported low levels of phthalates in a toy car made with ABS. The study provided no details about other materials used in the product, including whether other plastics were present, or whether other component parts were present such as coatings, finishes, inks, or adhesives.

    The Task 12 Report's detailed description of the raw materials and manufacturing processes for PP, PE, HIPS, and ABS plastics showed that phthalates are not present after these plastics are produced. However, the Task 11 Report describes uses of phthalates in materials on these plastics, such as coatings, inks, and adhesives. Because consumer products purchased in stores likely consist of a number of different component parts, some of which may have contained phthalates, the studies described above should not be considered to be evidence that phthalates were used in the manufacture of the PP, PE, HIPS, or ABS plastic component parts of consumer products subject to the phthalate content restrictions.

    8. Phthalates in Recycled Materials

    All four plastics may be recycled and reprocessed into new products. However, degradation of the original plastics during the recycling process and mixing with other plastics or materials in the recycling steam can reduce the quality of the recovered plastic and limit further commercial uses. In some cases, recovered plastics are mixed with virgin plastics to improve the products' quality and utility. The Task 12 Report indicated that few studies were located for analysis of phthalates in recycled plastics. One study found no phthalates in recycled PP carpet. Two studies analyzed solid waste consisting of PP or PE. One study reported detection of phthalates in recovered waste PP and PE material, but not in samples of virgin PP or PE plastic. The other study reported phthalates in recovered PE. The authors of the latter study suggested that the source of phthalates could have been the products that had been in contact with the plastic.

    HIPS and ABS are generally used as rigid materials; available information does not indicate use of phthalates in such materials or associated with recycled HIPS or ABS.

    Some studies indicated the potential for low, but detectable, levels of phthalates in plastics, such as PP or PE packaging that contained or had been in contact with a phthalate-containing product. Products made with such materials could contain residual phthalates, although at levels well below the maximum allowed concentration in children's products.12

    12 The highest level recorded by Huber and Franz was 200 ppm for one sample of DBP. The other samples' concentrations ranged from 3.1 to 96.3 ppm.

    9. Staff Conclusions Based on TERA Research

    With the exception of the catalysts for polymerization, and certain, specific uses of phthalates in products without consumer product applications, neither of the TERA task reports, nor research by CPSC staff found that phthalates are used as a component part of the four plastics. In the case of the phthalate catalysts used in plastics manufacturing, the phthalate concentration in finished plastics is significantly below the maximum allowable concentration.

    The two TERA task reports and CPSC staff research show that very little information exists that indicates that manufactured PP, PE, HIPS, and ABS plastics could contain the researched phthalates. The research located references, including patents, for uncommon and specialized products, and products that generally do not have applications to children's toys and child care articles.

    Staff found no evidence that phthalates are present at concentrations above 0.1 percent in any of the four plastics (either virgin or using recycled material) for consumer products, especially children's products.

    D. Determinations for Specified Plastics 1. Legal Requirements for a Determination

    As noted above, section 14(a)(2) of the CPSA requires third party testing for children's products that are subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Children's toys and child care articles must comply with the phthalates prohibitions in section 108 of the CPSIA. 15 U.S.C. 2057c. In response to statutory direction, the Commission has investigated approaches that would reduce the burden of third party testing while also assuring compliance with CPSC requirements. As part of that endeavor, the Commission has considered whether certain materials used in children's toys and child care articles would not require third party testing.

    To issue a determination that a plastic (including specified additives) does not require third party testing, the Commission must have sufficient evidence to conclude that the plastic and specified additives would consistently comply with the CPSC requirement to which the plastic (and specified additives) is subject so that third party testing is unnecessary to provide a high degree of assurance of compliance. Under 16 CFR part 1107 section 1107.2, “a high degree of assurance” is defined as “an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.”

    For a material determination, a high degree of assurance of compliance means that the material will comply with the specified chemical limits due to the nature of the material or due to a processing technique that reduces the chemical concentration below its limit. For materials determined to comply with a chemical limit, the material must continue to comply with that limit if it is used in a children's product subject to that requirement. A material on which a determination has been made cannot be altered or adulterated to render it noncompliant and then used in a children's product.

    Phthalates are not naturally occurring materials, but are intentionally created and used in specific applications (e.g., plastics, surface coatings, solvents, inks, adhesives, and some rubberized materials). One application of phthalates in children's toys and child care articles is as a plasticizer, or softener for plastic component parts.13 The addition of a plasticizer converts an otherwise rigid plastic into a more flexible form, such as in a child's rubber duck or a soft plastic doll. Because plastics can contain the prohibited phthalates, third party testing is required before a CPC can be issued for children's toys and child care articles with accessible plastic component parts. However, some specific plastics with certain additives might not use any of the prohibited phthalates as a plasticizer, or for any other purpose. For these specific plastics and accompanying additives, compliance with the requirements of section 108 of the CPSIA can be assured without requiring third party testing. As a means to reduce the third party testing burden on children's product certifiers while continuing to ensure compliance, the CPSC is proposing to make determinations that specified plastics with certain additives comply with the phthalate content requirements of section 108 of the CPSIA based on evidence indicating that such materials will not contain the prohibited phthalates.

    13 The Merriam-Webster online dictionary defines a plasticizer as “a chemical added especially to rubbers and resins to impart flexibility, workability, or stretchability.”

    Based on the discussion in section C of this preamble, the Commission proposes to determine that the specified four plastics and accompanying additives would comply with the phthalates prohibitions with a high degree of assurance. These determinations mean that third party testing for compliance with the phthalates prohibitions is not required for certification purposes for the specified four plastics. The Commission proposes to make these determinations to reduce the third party testing burden on children's product certifiers while continuing to assure compliance.

    2. Statutory Authority

    Section 3 of the CPSIA grants the Commission general rulemaking authority to issue regulations, as necessary, to implement the CPSIA. Public Law 110-314, sec. 3, Aug. 14, 2008. As noted previously, section 14 of the CPSA, which was amended by the CPSIA, requires third party testing for children's products subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the CPSA, as amended by Public Law 112-28, gives the Commission the authority to “prescribe new or revised third party testing regulations if it determines that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.” Id. 2063(d)(3)(B). These statutory provisions authorize the Commission to issue a rule determining that specified plastics and additives will not exceed the phthalates prohibitions of section 108 of the CPSIA, and therefore, specified plastics do not require third party conformity assessment body testing to assure compliance with the phthalates limits in section 108 of the CPSIA.

    The proposed determinations would relieve the four specified plastics and accompanying additives from the third party testing requirement of section 14 of the CPSA for purposes of supporting the required certification. However, the proposed determinations would not be applicable to any other plastic or additives beyond those listed in the proposed rule.

    The proposed determinations would only relieve the manufacturers' obligation to have the specified plastics and accompanying additives tested by a CPSC accepted third party conformity assessment body. Children's toys and child care articles must still comply with the substantive phthalates content limits in section 108 of the CPSIA regardless of any relief on third party testing requirements.

    3. Description of the Proposed Rule

    This proposed rule would create a new Part 1308 for “Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics.” The proposed rule would determine that the specified four plastics and accompanying additives do not contain the statutorily prohibited phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP) in concentrations above 0.1 percent, and thus, are not required to be third party tested to assure compliance with section 108 of the CPSIA. As discussed in section A.2 of the preamble, the agency is currently involved in rulemaking to determine whether to continue the interim prohibitions in section 108 and whether to prohibit any other children's products containing any other phthalates. TERA's examination covered all phthalates that are subject to the current permanent and interim prohibitions, as well as the additional phthalates the Commission proposed restricting in the phthalates proposed rule. If the Commission issues a final rule in the phthalates rulemaking before finalizing this determinations rulemaking, the Commission would modify the determinations proposed rule so that the determinations rule covers the same phthalates restricted by the final phthalates rule.

    Section 1308.1 of the proposed rule explains the statutorily-created requirements for children's toys and child care articles under section 108 of the CPSIA and the third party testing requirements for children's products.

    Section 1308.2(a) of the proposed rule would establish the Commission's determinations that the following plastics do not exceed the phthalates content limits with a high degree of assurance as that term is defined in 16 CFR part 1107:

    • Polypropylene, with any of the following additives:

    ○ the plasticizers polybutenes, dioctyl sebacate, paraffinic oil, isooctyl tallate, mineral plasticizing oils, and polyol;

    ○ hydrocarbon solvents;

    ○ catalysts;

    ○ fillers;

    ○ nucleating agents;

    ○ primary and secondary antioxidants;

    ○ neutralizing agents;

    ○ antistatic agents;

    ○ slip agents;

    ○ metal deactivators;

    ○ quenchers;

    ○ UV stabilizers;

    ○ flame retardants;

    ○ blowing or foaming agents;

    ○ antiblocking agents;

    ○ lubricants; or

    ○ colorants.

    • Polyethylene, with any of the following additives:

    ○ the plasticizers glyceryl tribenzoate, polyethylene glycol, sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM rubber, and EVA polymer;

    ○ catalysts;

    ○ initiators;

    ○ promoters;

    ○ antistatic agents;

    ○ fillers;

    ○ flame retardants;

    ○ anti-blocking agents;

    ○ slip agents;

    ○ blowing agents;

    ○ cross-linking agents;

    ○ antioxidants;

    ○ carbon black; or

    ○ colorants.

    • High-impact polystyrene, with any of the following additives:

    ○ catalysts;

    ○ internal lubricants;

    ○ chain transfer/transition agents;

    ○ stabilizers;

    ○ diluents;

    ○ colorants;

    ○ aluminum chloride, ethyl chloride, hydrochloric acid;

    ○ iron oxide, potassium oxide, chromium oxide; or

    ○ bifunctional peroxides.

    • Acrylonitrile butadiene styrene, with any of the following additives:

    ○ the plasticizers phosphate esters, long chain fatty acid esters and aromatic sulfonamide;

    ○ hydrocarbon solvents;

    ○ stabilizers;

    ○ lubricants;

    ○ antioxidants;

    ○ molecular weight regulators;

    ○ initiators/catalysts,

    ○ activators;

    ○ emulsifiers; or

    ○ colorants.

    Section C.2 of the preamble provides a more detailed discussion of the additives for each of the four plastics with the specified additives including definitions of the additives and various examples of the types of additives.

    Section 1308.2(b) of the proposed rule states that accessible component parts of children's toys and child care articles made with the specified plastics, and specified additives listed in paragraph (a) of that section, are not required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107. Proposed § 1308.2(b) is included in the rule to make clear that when the listed plastics and accompanying additives are used in children's toys and child care articles, manufacturers and importers are not required to conduct the third party testing required in section 14(a)(2) of the CPSA and 16 CFR part 1107. Section 1308.2(c) of the proposed rule states that accessible component parts of children's toys and child care articles made with a plastic or additives not listed in paragraph (a) of this section are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107. Proposed § 1308.2(c) is intended to make clear that if a manufacturer or importer uses any other plastic or additive in a children's toy or child care article not listed in proposed § 1308.1(a), that children's toy or child care article must be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107. Finally, the determinations in proposed § 1308.2(a) would only remove the obligation to have children's toys and child care articles tested by a third party conformity assessment body. Regardless of any third party testing relief that the proposed rule would provide, the manufacturer or importer must still comply with the underlying phthalates content prohibitions in section 108 of the CPSIA.

    E. Effective Date

    The Administrative Procedure Act (APA) generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). Because the proposed rule would provide relief from existing testing requirements under the CPSIA, the Commission proposes a 30 day effective date for the final rule.

    F. Regulatory Flexibility Act 1. Introduction

    The Regulatory Flexibility Act (RFA) requires that agencies review a proposed rule for the rule's potential economic impact on small entities, including small businesses. Section 603 of the RFA generally requires that agencies prepare an initial regulatory flexibility analysis (IRFA) and make the analysis available to the public for comment when the agency is required to publish a notice of proposed rulemaking, unless the agency certifies that the NPR will not have a significant economic impact on a substantial number of small entities. The IRFA must describe the impact of the proposed rule on small entities and identify any alternatives which accomplish the statutory objectives and may reduce the significant economic impact of the proposed rule on small entities. Specifically, the IRFA must contain:

    • A description of the reasons why action by the agency is being considered;

    • a succinct statement of the objectives of, and legal basis for, the proposed rule;

    • a description of, and where feasible, an estimate of the number of small entities to which the proposed rule will apply;

    • a description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities subject to the requirements and the types of professional skills necessary for the preparation of reports or records; and

    • an identification, to the extent possible, of all relevant federal rules which may duplicate, overlap, or conflict with the proposed rule.

    2. Reason for Agency Action and Legal Basis for the Proposed Rule

    The Commission is proposing this NPR to reduce the burden of third party testing on toy and child care article manufacturers, especially the burden on those that are small entities. Based on an extensive literature review seeking information on the raw materials used in the manufacture of the specified plastics, the worldwide manufacturing practices of the plastics, the typical applications, and the potential for exposure to the specified phthalates through the use of recycled materials or due to contamination, the Commission concludes that there is a high degree of assurance that polypropylene, polyethylene, high impact polystyrene, and acrylonitrile butadiene styrene with the accompanying additives in the proposed rule will not contain any of the prohibited phthalates in concentrations above 0.1 percent when used in children's toys and child care articles. Therefore, third party testing is not necessary to assure that children's toys and child care articles with accessible component parts made from these plastics and accompanying additives do not contain the prohibited phthalates.

    3. Small Entities To Which the Proposed Rule Would Apply

    The proposed rule would apply to small entities that manufacture or import children's toys or child care articles that contain accessible polyethylene, polypropylene, high impact polystyrene, or acrylonitrile butadiene styrene and any accompanying additives in component parts. Toy manufacturers are classified in North American Industry Classification System (NAICS) category 33993 (“Doll, Toy, and Game Manufacturing”). According to the U.S. Bureau of the Census, in 2012 there were 559 toy manufacturers in the United States, of which 552 had fewer than 500 employees and would be considered small entities according to the Small Business Administration (SBA) criteria.14 Of the small manufacturers, 326 had fewer than five employees.

    14 2012 County Business Patterns.

    Toy importers may be either wholesale merchants or retailers. The proposed rule would not apply to toy wholesalers or retailers if they obtain their merchandise from domestic manufacturers or importers. Toy wholesalers are classified in NAICS category 42392 (“Toy and Hobby Goods and Supplies Merchant Wholesalers”). According to the U.S. Bureau of the Census, there were 2,096 firms in this category.15 Of these, 2,021 had fewer than 100 employees and would be considered small businesses according to SBA criteria. Toy retailers are classified in NAICS category 45112 (“Hobby, Toy, and Game Stores”). There could be about 5,800 toy retailers that would meet the SBA criteria to be considered a small entity.16 The number of these small toy retailers that import toys, as opposed to obtaining their product from domestic sources is not known.

    15 2012 County Business Patterns.

    16 The SBA considers a toy retailer (NAICS 45112) to be a small entity if its annual sales are less than $27.5 million. According to the U.S. Bureau of the Census, in 2007, the average receipts for toy manufacturers with more than 500 employees was almost $500 million. The average receipts for the next largest category for which summary data was published, toy retailers with at least 100 but fewer than 500 employees were about $12 million. There were 5,864 firms in this NAICS category, of which 5,839 had fewer than 500 employees. (U.S. Census Bureau, Number of Firms, Number of Establishments, Employment, Annual Payroll, and Estimated Receipts by Enterprise Employment Size for the United States, All Industries: 2007.)

    The phthalate regulations also apply to manufacturers and importers of child care articles. Child care articles include many types of products for which the CPSC has recently promulgated or proposed new or amended mandatory safety standards. These include toddler beds, full size and non-full size cribs, bassinets and cradles, bedside sleepers, high chairs, hook-on-chairs, and booster seats. Other child care articles include sleepwear, and crib or cradle bumpers. In its ongoing market research, CPSC staff has identified 364 suppliers of these products that would be considered small according to criteria established by the SBA. Additionally, there could be other child care articles, not listed above, for which CPSC has not yet developed a mandatory or proposed standard, but which nevertheless are covered by the phthalate requirements.

    Child care articles would also include products such as teethers (if they are not medical devices), pacifiers, and bottle nipples. Manufacturers of these products are classified in NAICS category 326299 (“All other rubber product manufacturing”). There are 617 firms classified in this NAICS code of which 573 are considered to be small.17 However, this NAICS category includes many other products and most of these firms probably do not manufacture child care articles.

    17 U.S. Bureau of the Census, “Number of Firms, Number of Establishments, Employment, and Annual Payroll by Enterprise Employment Size for the United States, All Industries: 2011,” 2011 County Business Patterns.

    Although, as discussed above, the number of small companies that supply children's toys or child care articles to the U.S. market might be close to 10,000, the number that actually supply products with accessible polyethylene, polypropylene, high impact polystyrene, or acrylonitrile, butadiene styrene component parts is not known. Also not known is the number of children's toys and child care articles that contain these plastics. To develop comprehensive estimates of the number of products that contain these plastics and the number of firms that supply the products it would probably be necessary to survey a representative sample of toy and child care article suppliers to solicit information on their use of the four plastics or to collect a representative sample of children's toys and child care articles and analyze the accessible components to determine which ones contained one or more of the four plastics.

    Although comprehensive estimates of the number of children's toys and child care articles that contain components made from the four plastics are not available, there is some evidence that these plastics are extensively used in children's toys. One source stated that polypropylene and high density polyethylene are used in 38 and 25 percent, respectively, of injection molded toys. Low density polyethylene and acrylonitrile butadiene styrene, are each used in less than 10 percent of the injection molded toys. Polystyrene may also be used in injection molded toys, but the source does not specify the proportion that is high impact polystyrene.18 The Commission requests comments to better determine the impact the proposed determinations would have on small entities.

    18 Donald V. Rosato, Plastics End Use Applications, Springer, New York, (2011).

    4. Reporting, Recordkeeping, and Other Compliance Requirements and Impact on Small Businesses

    The proposed rule would determine that there is a high degree of assurance that four specific plastics with any of the accompanying additives will not contain any prohibited phthalates at concentrations above 0.1 percent prohibition level. As a result of the proposed determinations, manufacturers, importers, and private labelers of children's toys and child care articles that have accessible components that consist of these plastics and any accompanying additives will not have to obtain third party tests to certify that the accessible components do not contain the prohibited phthalates in concentrations above 0.1 percent.

    The proposed rule would not impose any additional reporting, recordkeeping, or other compliance requirements on small entities. In fact, because the proposed rule would eliminate a testing requirement, there would be a small reduction in some of the recordkeeping burden under 16 CFR part 1107 and 16 CFR part 1109 because manufacturers would no longer have to maintain records of third party phthalate tests for the component parts manufactured from these four plastics.

    A determination that specified plastics with accompanying additives used in children's toys and child care articles do not require third party testing is expected to be entirely beneficial to manufacturers and importers using those plastics in accessible component parts because manufacturers and importers could forego testing they otherwise would be required to conduct. However, staff believes the magnitude of that benefit is uncertain and could depend on factors such as:

    • The extent to which manufacturers have already reduced their testing costs by using component part testing (as allowed in 16 CFR part 1109);

    • the volume of children's toys and child care articles that contain PE, PP, HIPS, or ABS;

    • whether importers who certify children's products are unsure what plastics are being used in the toys and child care articles they import, so they could not take advantage of the determinations without additional testing to assure that a component part is composed of one of the four plastics.

    The Commission welcomes comments on the potential impact of the proposed rule on small entities. Comments are especially welcome on the following topics:

    • The extent to which PP, PE, HIPS, or ABS are used in children's toys and child care articles, especially those manufactured or imported by small firms;

    • The potential reduction in third party testing costs that might be provided by the Commission making the determinations, including the extent to which component part testing is already being used;

    • Any situations or conditions in the proposed rule that would make it difficult to make use of the determinations to reduce third party testing costs; and

    • Although the Commission expects that the impact of the proposed rule will be entirely beneficial, any potential negative impacts of the proposed rule.

    5. Other Federal Rules

    We have not identified any Federal rules that duplicate or conflict with the proposed rule.

    6. Alternatives Considered To Reduce the Burden on Small Entities

    Under section 603(c) of the RFA, an initial regulatory flexibility analysis should “contain a description of any significant alternatives to the proposed rule which accomplish the stated objectives of the applicable statutes and which minimize any significant impact of the proposed rule on small entities.” Because the proposed rule is intended to reduce the cost of third party testing on small businesses and will not impose any additional burden, the Commission did not consider alternatives to the proposed rule that would reduce the burden of this rule on small businesses.

    G. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for Commission rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required. The Commission's regulations state that safety standards for products normally have little or no potential for affecting the human environment. 16 CFR 1021.5(c)(1). Nothing in this rule alters that expectation.

    List of Subjects in 16 CFR Part 1308

    Business and industry, Consumer protection, Imports, Infants and children, Product testing and certification, Toys.

    Accordingly, the Commission proposes to amend Title 16 of the Code of Federal Regulations by adding part 1308 to read as follows: PART 1308—PROHIBITION OF CHILDREN'S TOYS AND CHILD CARE ARTICLES CONTAINING SPECIFIED PHTHALATES: DETERMINATIONS REGARDING CERTAIN PLASTICS Sec. 1308.1 Prohibited children's toys and child care articles containing specified phthalates and testing requirements. 1308.2 Determinations for specified plastics. Authority:

    Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C. 2063(d)(3)(B).

    § 1308.1 Prohibited children's toys and child care articles containing specified phthalates and testing requirements.

    Section 108(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) permanently prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of di-(2-ethylhexl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). Section 108(b)(1) of the CPSIA prohibits on an interim basis any children's toy that can be placed in a child's mouth or child care article that contains concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP). Materials used in children's toys and child care articles subject to section 108(a) and (b)(1) of the CPSIA must comply with the third party testing requirements of section 14(a)(2) of the Consumer Product Safety Act (CPSA), unless listed in § 1308.2.

    § 1308.2 Determinations for specified plastics.

    (a) The following plastics do not exceed the phthalates content limits with a high degree of assurance as that term is defined in 16 CFR part 1107:

    (1) Polypropylene (PP), with any of the following additives:

    (i) The plasticizers polybutenes, dioctyl sebacate, paraffinic oil, isooctyl tallate, mineral plasticizing oils, and polyol;

    (ii) Hydrocarbon solvents;

    (iii) Catalysts;

    (iv) Fillers;

    (v) Primary and secondary antioxidants;

    (vi) Neutralizing agents;

    (vii) Antistatic agents;

    (viii) Slip agents;

    (ix) Metal deactivators;

    (x) Quenchers;

    (xi) UV stabilizers;

    (xii) Nucleating agents;

    (xiii) Flame retardants;

    (xiv) Blowing or foaming agents;

    (xv) Antiblocking agents;

    (xvi) Lubricants; or

    (xvii) Colorants.

    (2) Polyethylene (PE), with any of the following additives:

    (i) The plasticizers glyceryl tribenzoate, polyethylene glycol, sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM rubber, and EVA polymer;

    (ii) Initiators;

    (iii) Promoters;

    (iv) Catalysts;

    (v) Fillers;

    (vi) Antistatic agents;

    (vii) Flame retardants;

    (viii) Anti-blocking agents;

    (ix) Slip agents;

    (x) Blowing agents;

    (xi) Ccross-linking agents;

    (xii) Antioxidants;

    (xiii) Carbon black; or

    (xiv) Colorants.

    (3) High-impact polystyrene (HIPS), with any of the following additives:

    (i) Catalysts;

    (ii) Internal lubricants;

    (iii) Chain transfer/transition agents;

    (iv) Stabilizers;

    (v) Diluents;

    (vi) Colorants;

    (vii) Aluminum chloride, ethyl chloride, hydrochloric acid;

    (viii) Iron oxide, potassium oxide, chromium oxide; or

    (ix) Bifunctional peroxides.

    (4) Acrylonitrile butadiene styrene (ABS), with any of the following additives:

    (i) The plasticizers phosphate esters, long chain fatty acid esters and aromatic sulfonamide;

    (ii) Hydrocarbon solvents

    (iii) Stabilizers;

    (iv) Lubricants;

    (v) Antioxidants;

    (vi) Molecular weight regulators;

    (vii) Initiators/catalysts,

    (viii) Activators;

    (ix) Emulsifiers; or

    (x) Colorants.

    (b) Accessible component parts of children's toys and child care articles made with the specified plastics, and specified additives, listed in paragraph (a) of this section are not required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.

    (c) Accessible component parts of children's toys and child care articles made with a plastic or additives not listed in paragraph (a) of this section are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.

    Dated: August 11, 2016. Todd A. Stevenson, Secretary, Consumer Product Safety Commission.
    [FR Doc. 2016-19464 Filed 8-16-16; 8:45 am] BILLING CODE 6355-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Part 12 [USCBP-2016-0011] RIN 1515-AE11 Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    This document proposes amendments to the U.S Customs and Border Protection (CBP) regulations relating to the importation into the United States of certain vehicles and engines subject to federal antipollution emission standards under the Clean Air Act (CAA). Compliance with these emission standards must be demonstrated to CBP by either filing, or retaining and producing upon request, the appropriate U.S. Environmental Protection Agency (EPA) declaration form or by establishing that the subject imports are exempt from this requirement. CBP is proposing to amend its regulations to harmonize the documentation requirements applicable to different classes of vehicles and engines that are subject to the CAA's emission standards. This document also proposes to permit the required EPA emission compliance forms to be filed with CBP electronically. CBP is proposing other non-substantive amendments to update regulatory citations and delete obsolete provisions. The proposed changes set forth in this document support consistency in the administration of CBP's vehicle and engine imports program. In addition, electronic filing of EPA declaration forms will support key modernization initiatives, expedite the entry and clearance process, enhance targeting and enforcement objectives, and connect CBP with partner government agencies and the trade community through a single window access point.

    DATES:

    Comments on the proposed rule must be received on or before September 16, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number, by one of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments via docket number USCBP 2016-0011.

    Mail: Trade and Commercial Regulations Branch, Office of Trade, Regulations and Rulings, U.S. Customs and Border Protection, 90 K Street NE., 10th Floor, Washington, DC 20229-1177.

    Instructions: All submissions received must include the agency name and docket number for this proposed rulemaking. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided. For detailed instructions on submitting comments and additional information on the proposed rulemaking process, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov. Submitted comments may also be inspected during regular business days between the hours of 9 a.m. and 4:30 p.m. at the Trade and Commercial Regulations Branch, Office of Trade, Regulations and Rulings, U.S. Customs and Border Protection, 90 K Street NE., 10th Floor, Washington, DC. Arrangements to inspect submitted comments should be made in advance by calling Joseph Clark at (202) 325-0118.

    FOR FURTHER INFORMATION CONTACT:

    For questions related to the filing of EPA forms with CBP, please contact William Scopa, Partner Government Agencies Interagency Collaboration Division, Office of Trade, Customs and Border Protection, at [email protected] For questions related to EPA's vehicle and engine imports program, please contact Holly Pugliese at [email protected]

    SUPPLEMENTARY INFORMATION:

    Public Participation

    Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. CBP also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rule. If appropriate to a specific comment, the commenter should reference the specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority that supports such recommended change.

    Background

    The Clean Air Act (CAA), as amended (42 U.S.C. 7401 et. seq.), is the comprehensive federal law that regulates air emissions from stationary and mobile sources. Section 203(a) of the CAA, 42 U.S.C. 7522, prohibits, inter alia, importation into the United States of new motor vehicles and new motor vehicle engines unless they are covered by a certificate of conformity as prescribed by regulation authorized by the CAA. Section 203(b)(2) of the CAA provides that a new motor vehicle or new motor vehicle engine offered for importation in violation of section 203(a) will be refused admission into the United States. In this situation, however, the Secretary of the Treasury and the Administrator of the U.S. Environmental Protection Agency (EPA) may, by joint regulation, provide for a deferred final determination as to admission and authorize delivery of the goods to the importer or consignee upon such conditions (including the furnishing of a bond) as may be deemed appropriate. Section 208 of the CAA, 42 U.S.C. 7542, provides that the Administrator of the EPA may require a manufacturer to produce, among other items, all records, files, and papers necessary to demonstrate compliance with applicable CAA provisions. Section 213(d) of the CAA, 42 U.S.C. 7547, requires that nonroad vehicle and engine standards be enforced in the same manner as those applicable to onroad vehicles and engines.

    These statutory provisions are implemented in the CBP regulations at §§ 12.73 and 12.74 of title 19 of the Code of Federal Regulations (19 CFR 12.73 and 12.74). Section 12.73 provides for “[M]otor vehicle and engine compliance with Federal antipollution emission requirements.” Corresponding EPA regulations for motor vehicles and engines are promulgated at 40 CFR parts 85 and 86. Section 12.74 provides for “[N]onroad and stationary engine compliance with Federal antipollution emission requirements.” Corresponding EPA regulations for nonroad and stationary engine compliance are promulgated at 40 CFR parts 1033 through 1068.

    EPA requires the submission of certain documents for purposes of compliance with the CAA. EPA makes available EPA Declaration Form 3520-1 for the importation of passenger vehicles, highway motorcycles, and their corresponding engines into the United States, and EPA Declaration Form 3520-21 for the importation of heavy-duty highway engines and nonroad engines (gas, diesel, marine, stationary) into the United States, including engines already installed in vehicles or equipment. Both forms can be found in fillable .pdf format on EPA's “Imports Program” Web site at http://www.epa.gov/otaq/imports/forms-resources.htm.

    Current CBP Filing Requirements for Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards I. 19 CFR 12.73/EPA Declaration Form 3520-1

    For importations that are covered by EPA Declaration Form 3520-1, existing § 12.73(i) of the CBP regulations (19 CFR 12.73(i)) requires importers to file the requisite information with CBP at the time of entry. An exemption from this requirement exists for motor vehicle imports that are covered by an EPA Certificate of Conformity (COC) which are labeled accordingly (see 19 CFR 12.73(b)(1)); for these vehicles, an importer does not have to file the EPA Declaration Form 3520-1 with CBP at the time of entry, nor is the importer required to prepare and retain the form as part of its recordkeeping obligations. Section 12.73(g) also exempts motor vehicles imported by diplomats, foreign military personnel, and nonresidents from applicable emission requirements on the condition that the vehicles are not to be resold in the United States, and provided diplomats and foreign military personnel meet applicable documentation requirements set forth in paragraph (i)(4) of this section. In all other instances, the form is required to be completed and filed with CBP at the time of entry.

    II. 19 CFR 12.74/EPA Declaration Form 3520-21

    For importations that are covered by EPA Declaration Form 3520-21, existing § 12.74(b) (19 CFR 12.74(b)) requires importers to prepare the form and keep it on file for a period of at least five years from the date of entry in accordance with § 163.4 (19 CFR 163.4). The form must be made available upon request by CBP. Unlike motor vehicle manufacturers subject to § 12.73 (19 CFR 12.73), manufacturers that import products covered by EPA Declaration Form 3520-21 are not exempt from preparing this form even if the subject goods are covered by an EPA COC; they are required to prepare EPA Declaration Form 3520-21 and keep it on file for a period of at least five years from the date of entry.

    Explanation of Proposed Amendments to CBP Regulations III. Harmonization of Filing Requirements Applicable to EPA Declaration Forms 3520-1 and 3520-21

    In an effort to provide consistency in the administration of CBP's vehicle and engine imports program so that importers of both road vehicles and engines, as well as stationary and nonroad engines (including engines incorporated into vehicles or equipment), are subject to the same filing and recordkeeping requirements, CBP is proposing to conform the entry filing requirements applicable to the EPA Declaration Form 3520-21 to those that currently exist for EPA Declaration Form 3520-1. Specifically, CBP is proposing to amend 19 CFR 12.74(b) to require that importers of stationary, nonroad or heavy-duty highway engines (including engines incorporated into vehicles or equipment) file EPA Declaration Form 3520-21 at the time of entry, unless exempt. CBP is proposing to exempt an importer that manufactures nonroad or stationary engines, including engines incorporated into vehicles and equipment, from the requirement to file an EPA Declaration Form 3520-21 at the time of entry if that importer holds a valid EPA COC for those engines and the engines are labeled to show compliance with applicable emission requirements.

    IV. Electronic Filing of EPA Declaration Forms 3520-1 and 3520-21

    This document proposes to amend §§ 12.73 and 12.74 to permit the electronic filing of EPA Declaration Forms 3520-1 and 3520-21 to CBP in the Automated Commercial Environment (ACE) or to any other CBP-authorized electronic data interchange system. The EPA declaration forms may also still be filed with CBP in paper with a paper entry filing at the time of entry.

    The electronic filing of these forms will support key modernization and compliance initiatives of the International Trade Data System, as established by section 405 of the Security and Accountability for Every (SAFE) Port Act of 2006, Public Law 109-347, 120 Stat. 1884, by utilizing a single portal system (ACE) for the collection and distribution of standard electronic import and export data required by participating Federal agencies. The electronic transmission to CBP of EPA declaration forms will automate and enhance the interaction between the EPA and CBP by facilitating electronic collection, processing, sharing, and review of requisite trade data and documents during the cargo import and export process. Electronic filing of these EPA declaration forms at the time of entry will provide for a quicker and more efficient clearance process and enhance CBP's ability to conduct targeting and enforcement of importation requirements. Electronic filing will also permit CBP to analyze and flag problems immediately, whereas paper filings result in an ad-hoc process that requires a physical inspection by a CBP or EPA inspector. CBP is of the view that requiring EPA Declaration Forms 3520-1 and 3520-21 to be filed with every appropriate entry (with the exception of certain importing manufacturers, as described above) will expedite the clearing of vehicles and engines that are compliant with applicable emissions requirements.

    V. Other Proposed Changes

    CBP is proposing other changes to §§ 12.73 and 12.74 to update regulatory citations, delete provisions that are no longer relevant, and provide non-substantive re-statements of existing regulatory text to enhance readability. CBP is also updating regulatory language to ensure that electronic filing can be accommodated. The proposed changes are described below:

    • CBP is proposing to amend § 12.73(a) to reflect updated EPA regulatory citations and to provide a non-substantive re-statement of the existing regulatory text to enhance readability.

    • This document proposes to remove § 12.73(c)(3) from the CBP regulations. Paragraph (c)(3) sets forth requirements for vehicles participating in EPA-approved catalytic converter or oxygen sensor control programs. EPA no longer has such programs.

    • This document proposes to remove § 12.73(c)(4) from the CBP regulations. Paragraph (c)(4) pertains to vehicles of United States or foreign origin manufactured with a catalytic converter or oxygen sensor, or any previously imported vehicle subsequently modified with a catalytic converter or oxygen sensor. Under this provision, these vehicles are not considered to be in compliance with applicable emission requirements if used outside of the United States, Canada, Mexico, or other countries as EPA may designate, until the catalytic converter and/or oxygen sensor is replaced. This provision was intended to address vehicles that may have traveled to countries where only leaded fuel was available, which could have a detrimental effect on catalytic converters and/or oxygen sensors. Since leaded fuel is no longer available in most countries, it is proposed to delete this provision.

    • CBP is proposing amendments to § 12.73(d) that further clarify the role of an Independent Commercial Importer, re-designate “working” days as “business” days, and provide a re-statement of existing regulatory text for enhanced readability.

    • CBP is proposing amendments to § 12.73(e), in the introductory paragraph and paragraph (e)(4), that enhance readability and clarify that motorcycles are “highway” vehicles.

    • CBP is proposing to amend § 12.73(f) by requiring that the designated motor vehicles be “new” in order to conform to the EPA regulatory requirements set forth in 40 CFR 85.1709. CBP also proposes editorial changes to enhance readability.

    • In § 12.73(g)(2), CBP is proposing to change the existing reference to paragraph “(i)(4)” to “(i)(6)” to reflect that provision's proposed redesignation.

    • The proposed amendments to § 12.73(h) enhance readability, reflect updated regulatory citations, and remove the word “motor” from the introductory text and from the regulatory text in paragraph (h)(5) pertaining to racing cars.

    • CBP is proposing to amend § 12.73(i) by adding new paragraphs that prescribe methods of filing the EPA declaration forms and set forth applicable recordkeeping requirements, and by redesignating existing paragraph (i)(4) as new paragraph (i)(6).

    • CBP is proposing to amend existing § 12.73(i)(4), redesignated in this proposed rule as paragraph (i)(6), by removing the requirement that diplomats and foreign military personnel must submit the emission declarations specified in existing 19 CFR 12.73(i)(2) (redesignated as 19 CFR 12.73(i)(3) in this proposed rule) with their entry, a copy of the motor vehicle importer's official orders or the name of the embassy to which the importer is accredited, if applicable. Pursuant to 19 CFR 148.82, the baggage and effects of diplomatic, consular, and other privileged personnel representing foreign governments are admitted free of duty without the filing of an entry upon the request of the Department of State. As State Department policy is to require that importation occur through the DS-1504 (“Request for Customs Clearance of Merchandise”) process and not through the entry process, it is proposed to amend existing § 12.73(i)(4)—redesignated as proposed 19 CFR 12.73(i)(6)—to no longer require the submission of emission documentation, official orders, or embassy information. Instead, it is proposed that a claim by diplomats and foreign military personnel for exemption from § 12.73(g)(2) emission requirements must be supported by a Department of State-approved form DS-1504 or its electronic equivalent.

    • Section 12.73(m) is proposed to be amended to reflect updated EPA regulatory citations.

    • CBP is proposing to amend §§ 12.73(j) and 12.74(c)(1) by adding language stating that bonds may be submitted to CBP electronically and may be filed by a surety.

    • This document proposes to remove § 12.74(a)(1)-(3) from the CBP regulations as these paragraphs refer to obsolete EPA regulatory sections, and to add language clarifying the scope of the applicable EPA emission regulations.

    • This document proposes to remove § 12.74(c)(3)(iv) from the CBP regulations. Paragraph (c)(3)(iv) prescribes precertification for vehicles, engines and equipment. This provision refers to obsolete requirements found in EPA regulation 40 CFR 89.611(b)(3) regarding Independent Commercial Importers. EPA will make conforming amendments to its regulations to delete this provision.

    • CBP is proposing to amend § 12.74(c)(3) to add exemptions that conditionally allow for the importation of nonconforming vehicles, engines, and equipment. Exemptions for diplomatic and military personnel (40 CFR 1068.325(e)), partially complete engines (40 CFR 1068.325(f)), and delegated assembly (40 CFR 1068.325(g)) were codified in EPA regulations since changes were last made to 19 CFR 12.74(c)(3) and are being proposed to be added to 19 CFR 12.74(c)(3) to ensure consistency with EPA regulations.

    • CBP is proposing editorial amendments to § 12.74(d) to enhance readability.

    VI. Conforming Changes to EPA Regulations

    EPA regulations at 40 CFR parts 85 and 1068 also contain provisions related to the importation of vehicles, engines, and equipment. To the extent necessary to reflect the changes to the CBP regulations proposed in this document, EPA will make conforming amendments to its regulations in a separate action.

    Executive Orders 12866 and 13563

    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 (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, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is not a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has not reviewed this regulation.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et. seq.), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996, requires agencies to assess the impact of regulations on small entities. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people).

    This rule proposes modifications to the requirements for the submission of EPA Declaration Form 3520-21. Currently, importers are required to fill out the form, but are only required to submit it to CBP upon request. This proposed rule, if finalized, would require importers to file EPA Declaration Form 3520-21 with CBP at the time of entry, unless the importer is a manufacturer of nonroad or stationary engines, including engines incorporated into vehicles and equipment, and holds a valid EPA certificate of conformity for those engines and the engines are labeled to show compliance with applicable emission requirements. As this form is already complete at the time of entry, the cost of submitting it to CBP is negligible. This rule would also explicitly add electronic filing as an accepted method of form submission. Importers will still be able to file the form by paper if they so choose. This change will affect all importers who are covered by EPA Declaration Form 3520-21, including small importers. Therefore, it is likely to have an impact on a substantial number of small entities. However, the only costs to the public are the negligible costs of submitting the already completed form to CBP along with other required entry documents. These costs do not rise to the level of significance. Therefore, CBP certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities.

    Paperwork Reduction Act

    The collection of information contained in this proposed rule was previously reviewed and approved by OMB in accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) under control numbers OMB 2060-0104 (EPA Declaration Form 3520-1, “Importation of Motor Vehicles and Motor Vehicle Engines Subject to Federal Air Pollution Standards”), OMB 2060-0320 (EPA Declaration Form 3520-21, “Importation of Engines, Vehicles and Equipment Subject to Federal Air Pollution Standards”), and OMB 1405-0105 (Department of State form DS-1504, “Request for Customs Clearance of Merchandise”). As importers are already required under existing regulations to complete the EPA declaration forms and either submit them to CBP or retain them in their records, and the burden estimates in the above-identified OMB approved information collection requests presume the forms are submitted to CBP, there are no new collections of information proposed in this document. In this regard, it is noted that although existing 19 CFR 12.73 does not expressly require the submission of the EPA Declaration Form 3520-1, it does require that the same information captured by that form be submitted to CBP. Similarly, shipments sent from abroad to foreign diplomatic or consular missions in the U.S., or their personnel, currently must be cleared by respondents submitting to CBP a Department of State-approved form DS-1504; therefore, this document does not impose any new collections of information by requiring the DS-1504 to be presented to CBP for purposes of claiming an exemption from emission documentation requirements.

    Signing Authority

    This proposed regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.

    List of Subjects in 19 CFR Part 12

    Air pollution control, Customs duties and inspection, Entry of merchandise, Imports, Labeling, Reporting and recordkeeping requirements, Restricted merchandise, Vehicles.

    Proposed Amendments to Part 12 of the CBP Regulations

    For the reasons set forth in the preamble, CBP proposes to amend 19 CFR part 12 as set forth below:

    PART 12—SPECIAL CLASSES OF MERCHANDISE 1. The general authority citation for part 12, and the specific authority citation for sections 12.73 and 12.74, continue to read as follows: Authority:

    5 U.S.C. 301, 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States), 1624.

    Sections 12.73 and 12.74 also issued under 19 U.S.C. 1484, 42 U.S.C. 7522, 7601; 2. Revise the undesignated center heading preceding § 12.73 to read as follows: Entry of Motor Vehicles, Engines, and Equipment Containing Engines Under the Clean Air Act, as Amended 3. Section 12.73 is amended by: a. Revising the section heading; b. Revising paragraph (a); c. Removing in paragraph (b)(1) the word “shall” and adding in its place the word “will”; removing the word “Customs” and adding in its place the term “CBP”, and; removing the term “ICI's” and adding in its place the words, “Independent Commercial Importers”; d. Removing in paragraph (b)(2) the word “Customs” and adding in its place the term “CBP”; e. Removing paragraphs (c)(3) and (4); f. Revising paragraphs (d), (e) introductory text, (e)(4), and (f); g. Removing in paragraph (g)(2) the reference “(i)(4)” and adding in its place the reference “(i)(6)”; h. Removing in paragraph (h) introductory text the word “motor”; i. Removing in the first sentence of paragraph (h)(1) the word “Any” and adding in its place the words “A motor vehicle imported for repairs is any”; j. Removing in the first sentence of paragraph (h)(2) the word “Any” and adding in its place the words, “A test vehicle is any”; k. Removing in the first sentence of paragraph (h)(3) the word “Any” and adding in its place the words, “A prototype vehicle is any”, in the second sentence, removing the word “shall” and adding in its place the word “will”, and removing the words “paragraph (1)” and adding in its place the words “paragraph (l)”; l. Removing in the first sentence of paragraph (h)(4) the word “Any” and adding in its place the following words, “A display vehicle is any”; m. Revising paragraphs (h)(5) through (7); n. Revising paragraphs (i) through (k); o. Removing in paragraph (l) the word “shall” and adding in its place the word “will”, and; removing the word “Customs” and adding in its place the word “CBP”; and p. Revising paragraph (m).

    The revisions read as follows:

    § 12.73 Importation of motor vehicles and motor vehicle engines.

    (a) Applicability of EPA requirements. This section is ancillary to the regulations of the U.S. Environmental Protection Agency (EPA) issued under the Clean Air Act, as amended (42 U.S.C. 7401 et seq.), and found in 40 CFR parts 85, 86, 1036, 1037, and 1068. The EPA regulations should be consulted for more detailed information concerning EPA emission requirements. This section applies to imported motor vehicles; this section also applies to separately imported engines only if they will be installed in heavy-duty motor vehicles. All references in this section to “motor vehicles” include these heavy-duty engines. Nothing in this section should be construed as limiting or changing in any way the applicability of the EPA regulations.

    (d) Importation of vehicles by an Independent Commercial Importer (ICI). An ICI is generally an importer that does not have a contract with a foreign or domestic motor vehicle manufacturer for distributing products into the United States market (see 40 CFR 85.1502). ICIs act independently of motor vehicle manufacturers, but are required to bring motor vehicles into compliance with all applicable emissions requirements found in 40 CFR part 86 and any other applicable requirements of the Clean Air Act. Before the vehicle is deemed to be in compliance with applicable emission requirements and finally admitted into the United States, the ICI must keep the vehicle in storage for a 15-business day period. This period follows notice to EPA of completion of the compliance work to give EPA the opportunity to conduct confirmatory testing and inspect the vehicle and records. The 15-business day period is part of the 120-day period in which an ICI must bring the vehicle into compliance with applicable emission requirements. A motor vehicle may also be conditionally admitted by an ICI if it meets the requirements in 40 CFR 85.1505 or 85.1509. Individuals and businesses not entitled to enter nonconforming motor vehicles may arrange for their importation through an ICI certificate holder. In these circumstances, the ICI will not act as an agent or broker for CBP transaction purposes unless it is otherwise licensed or authorized to do so.

    (e) Exemptions and exclusions from emission requirements based on age of vehicle. The following motor vehicles may be imported by any person and do not have to be shown to be in compliance with emission requirements before they are entitled to admissibility:

    (4) Highway motorcycles manufactured before January 1, 1978;

    (f) Exemption for exports. A new motor vehicle intended solely for export to a country not having the same emission standards applicable in the United States is not required to be covered by an EPA certificate of conformity if both the vehicle and its container bear a label or tag indicating that it is intended solely for export. 40 CFR 85.1709.

    (h) * * *

    (5) Racing cars. A racing car is any vehicle that meets one or more of the criteria found at 40 CFR 85.1703(a), and that will not be registered or licensed for use on or operated on public roads or highways in the United States. See also 40 CFR 85.1511(e).

    (6) National security importations. A national security importation includes any motor vehicle imported for purposes of national security by a manufacturer. 40 CFR 85.1511(c)(1), 85.1702(a)(2) and 85.1708; and

    (7) Hardship exemption. A hardship exemption includes any motor vehicle imported by anyone qualifying for a hardship exemption. 40 CFR 85.1511(c)(2).

    (i) Documentation requirements—(1) Exception for certain companies that manufacture and import motor vehicles. The special documentation requirements of this paragraph (i) do not apply to the importation of motor vehicles by the company that manufactures the motor vehicles if the motor vehicles are covered by a valid EPA Certificate of Conformity (COC) held by the manufacturer and the motor vehicles are labeled to show compliance with applicable emission requirements pursuant to paragraph (b)(1) of this section.

    (2) Release. CBP will not release a motor vehicle from custody unless the importer has submitted all documents necessary to demonstrate compliance with all applicable laws and regulations.

    (3) Required EPA documentation. Unless otherwise exempt, importers of motor vehicles must submit one of the following EPA declaration forms to CBP at the time of entry:

    (i) For heavy-duty motor vehicle engines, whether they are installed in a vehicle or separately imported as loose engines, submit EPA Declaration Form 3520-21, “Importation of Engines, Vehicles, and Equipment Subject to Federal Air Pollution Regulations;”

    (ii) For all other motor vehicles, submit EPA Declaration Form 3520-1, “Importation of Motor Vehicles and Motor Vehicle Engines Subject to Federal Air Pollution Regulations.”

    (4) Filing method. The EPA declaration forms required to be submitted to CBP pursuant to paragraph (i)(3) of this section may be filed with CBP electronically in the Automated Commercial Environment (ACE) or via any other CBP-authorized electronic data interchange system, or as a paper filing at the time of entry.

    (5) Recordkeeping. Documents supporting the information required in EPA Declaration Form 3520-1 must be retained by the importer for a period of at least five (5) years in accordance with § 163.4 of this chapter and must be provided to CBP upon request.

    (6) Documentation for diplomatic or foreign military personnel exemption. In order for a diplomat or foreign military personnel to claim an exemption pursuant to paragraph (g)(2) of this section, CBP must receive a Department of State-approved form DS-1504 (“Request for Customs Clearance of Merchandise”) or its electronic equivalent.

    (j) Release under bond. If an EPA declaration form filed in accordance with paragraph (i)(3) of this section states that the entry is being filed under circumstances described in either paragraphs (h)(1), (2), (3) or (4) of this section, the entry will be accepted only if the importer, consignee, or surety, as appropriate, files a bond containing the bond conditions set forth in § 113.62 of this chapter, or files a bond electronically in ACE or via any other CBP-authorized electronic data interchange system, for the production of an EPA document stating that the vehicle or engine is in conformity with Federal emission requirements. The importer or consignee must deliver to the port director documentation of EPA approval before the exemption expires, or before some later deadline specified by the port director based on good cause. If the EPA statement is not delivered to the port director within the specified period, the importer or consignee must deliver or cause to be delivered to the port director those vehicles which were released under a bond required by this paragraph. In the event that the vehicle or engine is not redelivered within five (5) days following the date the exemption expires or any later deadline specified by the port director, whichever is later, liquidated damages will be assessed in the full amount of the bond, if it is a single entry bond, or if a continuous bond is used, in the amount that would have been assessed under a single entry bond.

    (k) Notices of inadmissibility or detention. If a motor vehicle is determined to be inadmissible before or after release from CBP custody, the importer or consignee will be notified in writing of the inadmissibility determination and/or redelivery requirement. However, if a motor vehicle cannot be released from CBP custody merely because the importer has failed to attach to the entry the documentation required by paragraph (i) of this section, the vehicle will be held in detention by the port director for a period not to exceed 30-calendar days after filing of the entry at the risk and expense of the importer pending submission of the missing documentation. An additional 30-calendar day extension may be granted by the port director upon application for good cause shown. If the requisite EPA declaration form required pursuant to paragraph (i)(3) of this section has not been filed within this deadline, which must not exceed 60 days from the date of entry, CBP will issue a notice of inadmissibility.

    (m) Prohibited importations. The importation of motor vehicles other than in accordance with this section and the EPA regulations in 40 CFR parts 85, 86, 600, 1036, 1037, and 1068 is prohibited.

    4. Section 12.74 amended by: a. Revising the section heading and paragraphs (a) through (d); and b. In paragraph (e) removing the word “shall' and adding in its place the word “must”.

    The revisions read as follows:

    § 12.74 Importation of nonroad and stationary engines, vehicles, and equipment.

    (a) Applicability of EPA regulations. The requirements governing the importation of nonroad and stationary engines subject to conformance with applicable emission standards of the U.S. Environmental Protection Agency (EPA) are contained in 40 CFR parts 1033 through 1068. These EPA regulations should be consulted for detailed information as to the admission requirements for subject nonroad and stationary engines. EPA emission regulations also apply to vehicles and equipment with installed engines and all references in this section to nonroad or stationary engines include the vehicles and equipment in which the engines are installed. Nothing in this section may be construed as limiting or changing in any way the applicability of the EPA regulations.

    (b) Documentation requirements—(1) Exception for certain companies that manufacture and import nonroad or stationary engines, including engines incorporated into vehicles and equipment. The special documentation requirements of this paragraph (b) do not apply to the importation of nonroad or stationary engines, including engines incorporated into vehicles or equipment, by the company that manufactures the engines, provided that the engines are covered by a valid EPA Certificate of Conformity (COC) held by the importing manufacturer and bear the manufacturer's label showing such conformity and other EPA-required information.

    (2) Release. CBP will not release engines, vehicles, or equipment from custody unless the importer has submitted all required documents to demonstrate that the engines, vehicles, or equipment meet all applicable requirements.

    (3) Required EPA documentation. Importers of nonroad or stationary engines, including engines incorporated into vehicles and equipment, must submit EPA Declaration Form 3520-21, “Importation of Engines, Vehicles, and Equipment Subject to Federal Air Pollution Regulations,” to CBP at the time of entry.

    (4) Filing method. EPA Declaration Form 3520-21 may be filed with CBP electronically in the Automated Commercial Environment (ACE) or via any other CBP-authorized electronic data interchange system, or as a paper filing at the time of entry.

    (5) Recordkeeping. Documents supporting the information required in EPA Declaration Form 3520-21 must be retained by the importer for a period of at least five (5) years in accordance with § 163.4 of this chapter and must be provided to CBP upon request.

    (c) Release under bond—(1) Conditional admission. If the EPA declaration form states that the entry for a nonconforming nonroad engine is being filed under one of the exemptions described in paragraph (c)(3) of this section, under which the engine may be conditionally admitted under bond, the entry will be accepted only if the importer, consignee, or surety, as appropriate, files a bond containing the bond conditions set forth in § 113.62(c) of this chapter, or files a bond electronically in ACE or via any other CBP-authorized electronic data interchange system, for the production of an EPA statement that the vehicle or engine is in conformity with Federal emission requirements.

    (2) Final admission. Should final admission be sought and granted pursuant to EPA regulations for an engine conditionally admitted initially under one of the exemptions described in paragraph (c)(3) of this section, the importer or consignee must deliver to the port director the prescribed statement. The statement must be delivered within the period authorized by EPA for the specific exemption, or such additional period as the port director of CBP may allow for good cause shown. Otherwise, the importer or consignee must deliver or cause to be delivered to the port director the subject engine, either for export or other disposition under applicable CBP laws and regulations (see paragraph (e) of this section). If such engine is not redelivered within five (5) days following the allotted period, liquidated damages will be assessed in the full amount of the bond, if a single entry bond, or if a continuous bond, the amount that would have been assessed under a single entry bond (see 40 CFR 1068.335).

    (3) Exemptions. The specific exemptions under which a nonconforming nonroad engine may be conditionally admitted, and for which a CBP bond is required, are as follows:

    (i) Repairs or alterations (see 40 CFR 1068.325(a)).

    (ii) Testing (see 40 CFR 1068.325(b)).

    (iii) Display (see 40 CFR 1068.325(c)).

    (iv) Export (see 40 CFR 1068.325(d)).

    (v) Diplomatic or military (see 40 CFR 1068.325(e)).

    (vi) Delegated assembly (see 40 CFR 1068.325(f)).

    (vii) Partially complete engines, vehicles, or equipment (see 40 CFR 1068.325(g).

    (d) Notice of inadmissibility or detention. If an engine is found to be inadmissible either before or after release from CBP custody, the importer or consignee will be notified in writing of the inadmissibility determination and/or redelivery requirement. If the inadmissibility is due to the fact that the importer or consignee did not file the EPA Declaration Form 3520-21 at the time of entry, the port director may hold the subject engine in detention at the importer's risk and expense for up to 30 days from the entry filing date. The port director may grant the importer's request for a 30-day extension for good cause. The port director will issue a notice of inadmissibility if documentation is still incomplete after this deadline, which must not exceed 60 days from the filing date for importation.

    R. Gil Kerlikowske, Commissioner. Approved: August 3, 2016. Timothy E. Skud, Deputy Assistant Secretary of the Treasury.
    [FR Doc. 2016-18761 Filed 8-16-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs 25 CFR Part 30 [167A2100DD/AAKC001030/A0A501010.999900 253G] Notice of Intent To Establish a Negotiated Rulemaking Committee AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Extension of comment and nomination periods.

    SUMMARY:

    On November 9, 2015, the Bureau of Indian Education (BIE) published a notice of intent requesting comments and nominations for Tribal representatives for the Accountability Negotiated Rulemaking Committee (Committee). The comment period for that notice of intent closed December 24, 2015. On April 14, 2016, the BIE reopened the comment and nomination period with a new deadline of May 31, 2016. The BIE is further extending the comment period for Tribes to nominate individuals for membership on the Committee. The BIE also solicits comments on the proposal to establish the Committee, including comments on additional interests not identified in this notice of intent and comments on the expansion of the scope of the Committee. The BIE is also correcting a drafting error in the April 14, 2016 Notice that omitted from Section III the central purpose of the Committee under the requirements of the Every Student Succeeds Act (ESSA), which requires the Secretary of the Interior, using a negotiated rulemaking process, to develop regulations for implementation no later than the 2017-2018 academic year. It also requires the Secretary to define the standards, assessments, and accountability system consistent with Section 1111 of the Elementary and Secondary Education Act (ESEA) for the schools funded by BIE on a national, regional, or tribal basis.

    DATES:

    Submit nominations for Committee members or written comments on this notice of intent on or before October 3, 2016.

    ADDRESSES:

    You may submit nominations for Committee members or written comments on this notice of intent to Ms. Jackie Cheek, Bureau of Indian Education, by any of the following methods:

    • (Preferred method) Email to: [email protected];

    • Mail, hand-carry or use an overnight courier service to Ms. Jackie Cheek, Bureau of Indian Education, 1849 C Street NW., Mail Stop 3642, Washington, DC 20240.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Jackie Cheek, Bureau of Indian Education; telephone: (202) 208-6983.

    SUPPLEMENTARY INFORMATION: I. Background

    On November 9, 2015, BIE published a notice of intent requesting nominations for a negotiated rulemaking committee to recommend revisions to the existing regulations for BIE's accountability system (80 FR 69161). In that notice of intent, the BIE solicited nominations from Tribes whose students attend BIE-funded schools operated either by the BIE or by the Tribe through a contract or grant, to nominate Tribal representatives to serve on the Committee and Tribal alternates to serve when the representative is unavailable.

    Since that time, the Every Student Succeeds Act (ESSA), Public Law 114-95, became law requiring an update to the subject, scope, and issues that the Committee will address. On April 14, 2016, BIE then announced its intent to expand the scope of the committee and reopened the comment and nomination period, requesting comments and nominations by May 31, 2016. 81 FR 22039 (April 14, 2016).

    II. Every Student Succeeds Act (ESSA)

    The ESSA reauthorizes and amends the Elementary and Secondary Education Act of 1965 (ESEA). ESSA Section 8007(2) directs the Secretary of the Interior, in consultation with the Secretary of Education, if so requested, to use a negotiated rulemaking process to develop regulations for implementation no later than the 2017-2018 academic year. The regulations will define the standards, assessments, and accountability system consistent with Section 1111 of the ESEA, for BIE-funded schools on a national, regional, or Tribal basis. The regulations will be developed in a manner that considers the unique circumstances and needs of such schools and the students served by such schools.

    ESSA Section 8007(2) also provides that if a Tribal governing body or school board of a BIE-funded school determines the requirements established by the Secretary of the Interior are inappropriate, they may waive, in part or in whole, such requirements. Where such requirements are waived, the Tribal governing body or school board shall, within 60 days, submit to the Secretary of the Interior a proposal for alternative standards, assessments, and an accountability system, if applicable, consistent with ESEA Section 1111. The proposal must take into account the unique circumstances and needs of the school or schools and the students served. The proposal will be approved by the Secretary of the Interior and the Secretary of Education, unless the Secretary of Education determines that the standards, assessments, and accountability system do not meet the requirements of ESEA Section 1111. Additionally, a Tribal governing body or school board of a BIE-funded school seeking a waiver may request, and the Secretary of the Interior and the Secretary of Education will provide, technical assistance.

    Due to the statutory changes described above, BIE expanded the scope of the negotiated rulemaking committee to receive recommendations and revise our current regulations (25 CFR part 30). This document provides notice that BIE is extending the comment period for: (1) Nominations of individuals for membership on the Committee and (2) comments on the proposal to establish the Committee, including comments on additional interests not identified in this notice of intent and comments on the expansion of the scope of the Committee.

    III. The Committee and Its Process

    The BIE encourages Tribal self-determination in Native education, encouraging Tribes to develop alternative standards, assessments, and an accountability system and providing technical assistance.

    The negotiated rulemaking committee would be charged, consistent with ESSA Section 8007, with developing regulations, no later than the 2017-2018 academic year, for implementation of the Secretary's responsibility to define the standards, assessments, and an accountability system consistent with ESEA Section 1111, for schools funded by the BIE on a national, regional, or tribal basis, as appropriate, taking into account the unique circumstances and needs of such schools and the students served by such schools. Additionally, the Committee will be asked to provide recommendations that encourage the exercise of the authority of Tribes to adopt their own standards, assessments, and an accountability system and also to provide recommendations on how BIE could best provide technical assistance under ESSA Section 8007(2).

    IV. Nominations

    Each nomination is expected to include a nomination for a representative and an alternate who can fulfill the obligations of membership should the representative be unable to attend. The Committee membership should also reflect the diversity of Tribal interests, and Tribes should nominate representatives and alternates who will:

    • Have knowledge of school assessments and accountability systems;

    • Have relevant experience as past or present superintendents, principals, teachers, or school board members, or possess direct experience with Adequate Yearly Progress (AYP);

    • Be able to coordinate, to the extent possible, with other Tribes and schools who may not be represented on the Committee;

    • Be able to represent the Tribe(s) with the authority to embody Tribal views, communicate with Tribal constituents, and have a clear means to reach agreement on behalf of the Tribe(s);

    • Be able to negotiate effectively on behalf of the Tribe(s) represented;

    • Be able to commit the time and effort required to attend and prepare for meetings; and

    • Be able to collaborate among diverse parties in a consensus-seeking process.

    The BIE will consider nominations for Tribal committee representatives only if they are nominated through the process identified in this notice of intent and in the Federal Register notices of intent at 80 FR 69161 and 81 FR 22040. The BIE will not consider any nominations that it receives in any other manner. The BIE will not consider nominations for Federal representatives. Only the Secretary may nominate Federal employees to the Committee.

    Based upon the proportionate share of students (see Section V of Federal Register notice of intent at 80 FR 69161), some Tribes similar in affiliation or geography are grouped together for one seat. It will be necessary for such nominating Tribes either to co-nominate a single Tribal representative to represent the multi-Tribal jurisdiction or for each Tribe in the multi-Tribal jurisdiction to nominate a representative with the knowledge that BIE will be able to appoint only one of the nominees who will then be responsible for representing the entire multi-Tribal jurisdiction on the Committee.

    Nominations must include the following information about each nominee:

    (1) A letter from the Tribe supporting the nomination of the individual to serve as a Tribal representative for the Committee;

    (2) A resume reflecting the nominee's qualifications and experience in Indian education; resume to include the nominee's name, Tribal affiliation, job title, major job duties, employer, business address, business telephone and fax numbers (and business email address, if applicable);

    (3) The Tribal interest(s) to be represented by the nominee (see Section IV, Part F of Federal Register notice of intent at 80 FR 69161) and whether the nominee will represent other interest(s) related to this rulemaking, as the Tribe may designate; and

    (4) A brief description of how the nominee will represent Tribal views, communicate with Tribal constituents, and have a clear means to reach agreement on behalf of the Tribe(s) they are representing.

    (5) A statement on whether the nominee is only representing one Tribe's views or whether the expectation is that the nominee represents a specific group of Tribes.

    To be considered, nominations must be received by the close of business on the date listed in the DATES section, at the location indicated in the ADDRESSES section.

    If you already submitted a nomination prior to the December 24, 2015, deadline or May 31, 2016 deadline, your application will still be considered.

    V. Certification

    For the above reasons, I hereby certify that the Accountability Negotiated Rulemaking Committee is in the public interest.

    Dated: August 8, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-19599 Filed 8-16-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF LABOR Office of the Secretary 29 CFR Part 70 RIN 1290-AA30 Revision of the DOL FOIA Regulations AGENCY:

    Office of the Secretary, Department of Labor.

    ACTION:

    Notice of proposed rulemaking, request for comments.

    SUMMARY:

    This rule proposes revisions to the Department of Labor's regulations under the Freedom of Information Act (FOIA), found in our regulations. The regulations are being revised to update and streamline the language of several procedural provisions, and to incorporate changes brought about by amendments to the FOIA under the OPEN Government Act of 2007 and the FOIA Improvement Act of 2016.

    DATES:

    Written comments must be postmarked and electronic comments must be submitted on or before October 17, 2016. Comments received by mail will be considered timely if they are postmarked on or before that date. The electronic Federal Docket Management System (https://www.regulations.gov) will accept comments until Midnight Eastern Time at the end of that day.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Federal eRulemaking Portal: https//www.regulations.gov.

    FAX: (202) 693-5389. Send your comments to the attention of Ramona Branch Oliver.

    Mail: Ramona Branch Oliver, Director, Office of Information Services, MALS Division, Office of the Solicitor, U.S. Department of Labor, Suite N-2420, 200 Constitution Avenue NW., Washington, DC 20210.

    E-mail: [email protected] Please indicate “Comments on FOIA Rule” in the subject line.

    • To ensure proper handling, please reference Docket No. DOL-2016-007 on your correspondence.

    FOR FURTHER INFORMATION CONTACT:

    Ramona Branch Oliver, Director, Office of Information Services, 202-693-5391.

    Discussion: This rule proposes revisions to the Department's regulations under the FOIA, found at 29 CFR part 70, to update and streamline the language of several procedural provisions and to incorporate certain of the changes brought about by the amendments to the FOIA under the OPEN Government Act of 2007, Public Law 110-175, 121 Stat. 2524 and the FOIA Improvement Act of 2016, Public Law 114-185,130 Stat. 538 (enacted June 30, 2016). The Department of Labor last published FOIA regulations on May 30, 2006.

    The proposed revisions to the Department's FOIA regulations in 29 CFR part 70 incorporate changes to the language and structure of the regulations. Revised provisions include § 70.1 (General provisions), § 70.2 (Definitions), § 70.3 (Policy), § 70.4 (Proactive disclosure of Department records), § 70.19 (Requirements for making a request), § 70.20 (Responsibility for responding to requests), § 70.21 (Responses to requests), § 70.25 (Time limits and order in which requests must be processed), § 70.38 (Definitions related to costs), and § 70.40 (Charges assessed for the production of records). Current sections have been renamed § 70.1 (from Purpose and scope to General provisions), § 70.4 (from Public reading rooms to Proactive disclosure of Departmental records), § 70.19 (from Requests for access to records to Requirements for making requests), § 70.21 (from Form and content of responses to Responses to requests), and § 70.26 (from Business information to Confidential commercial information). Also, in lieu of using the term “disclosure officer,” DOL is using the word “component” to refer to the decentralized agency FOIA components throughout the draft regulation.

    As the Department of Labor was completing preparation of this Notice of Proposed Rulemaking to update its FOIA regulation, Congress passed on June 13, 2016 and the President signed on June 30, 2016, the FOIA Improvement Act of 2016. The Department has incorporated changes to this proposed rule to address provisions of the FOIA Improvement Act of 2016. Specifically, the following sections of this NPRM were revised to reflect statutory changes: Section 70.1(d) and (f); Sec. 70.3; Sec. 70.4; Sec. 70.19(d); Sec. 70.21(d) and (e); Sec. 70.25(c); and Sec. 70.40(e). Comments on these proposed provisions based on the text of the amended statute are welcomed. The Department will consider those comments, along with any other comments received, and if appropriate will revise the regulation to ensure the rule aligns with the amended statute.

    Regulatory Flexibility Act: The Secretary of Labor, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Under the FOIA, agencies may recover only the direct costs of searching for, reviewing, and duplicating the records processed for requesters, and only for certain classes of requester and when particular conditions are satisfied. Thus, fees assessed by the Department are nominal. Further, the “small entities” that make FOIA requests, as compared with individual requesters and other requesters, are relatively few in number.

    EO 12866: This regulation has been drafted and reviewed in accordance with Executive Order 12866, § 1(b), Principles of Regulation. The Office of Management and Budget has determined that this rule is not a “significant regulatory action” under Executive Order 12866, § 3(f), Regulatory Planning and Review, and accordingly this rule has not been reviewed by that Office.

    Unfunded Mandates Reform Act of 1995: This rule will not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    Small Business Regulatory Enforcement Fairness Act of 1995: This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (as amended), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

    List of Subjects in 29 CFR Parts 70

    Administrative practice and procedure; Freedom of Information Act; Privacy.

    For the reasons stated in the preamble, the Department of Labor proposes to amend 29 CFR part 70, as follows:

    PART 70—PRODUCTION OR DISCLOSURE OF INFORMATION OR MATERIALS Subpart A—General Sec. 70.1 General provisions. 70.2 Definitions. 70.3 Policy. 70.4 Proactive disclosure of Departmental records. 70.5 Compilation of new records. 70.6 Disclosure of originals. 70.7-70.18 [Reserved] Subpart B—Procedures for Disclosure of Records Under the Freedom of Information Act 70.19 Requirements for making a request. 70.20 Responsibility for responding to requests. 70.21 Responses to requests. 70.22 Appeals from denial of requests. 70.23 Action on appeals. 70.24 Form and content of action on appeals. 70.25 Time limits and order in which requests and appeals must be processed. 70.26 Confidential commercial information. 70.27 Preservation of records. 70.28-70.37 [Reserved] Subpart C—Costs for Production of Records 70.38 Definitions related to costs. 70.39 Statutes specifically providing for setting of fees. 70.40 Charges assessed for the production of records. 70.41 Reduction or waiver of fees. 70.42 Consent to pay fees. 70.43 Payment of fees. 70.44 Other rights and services. 70.45-70.52 [Reserved] Subpart D—Public Records and Filings 70.53 Office of Labor-Management Standards. 70.54 Employee Benefits Security Administration. Appendix A to Part 70—FOIA Components Appendix B to Part 70—[Reserved] Authority:

    5 U.S.C. 301, 29 U.S.C. 551 et seq., 5 U.S.C. 552, as amended; Reorganization Plan No. 6 of 1950, 5 U.S.C. Appendix, 29 U.S.C. 1026 (106), 5 U.S.C. app. 11., E.O. 12600, 52 FR 23781, 3 CFR, 1988 Comp., p. 235. This part also implements the public information provisions of the Labor-Management Reporting and Disclosure Act (LMRDA), 29 U.S.C. 435, see § 70.53 below; the Employee Retirement Income Security Act of 1974 (ERISA), 29 U.S.C. 1026 (106), see § 70.54 below; and the Federal Advisory Committee Act (FACA), 5 U.S.C. app. 11, see § 70.40(i) below.

    Subpart A—General
    § 70.1 General provisions.

    (a) This part is organized as follows: subpart A contains general information about Department of Labor policies and procedures; subpart B sets forth the procedures for obtaining access to records of the Department; subpart C contains the Department's regulations on fees; and subpart D sets forth the procedures for obtaining access to certain public records. Appendix A contains a list of all Department of Labor FOIA components from whom records may be obtained.

    (b) This part contains the rules that the Department of Labor follows in processing requests for records under the Freedom of Information Act (FOIA), as amended, 5 U.S.C. 552. The rules in this part should be read together with the text of the FOIA, which provides additional information about access to records maintained by the Department. Additionally, the Department's “Guide to Submitting Requests under the FOIA” and related documents contain helpful information about the specific procedures particular to the Department with respect to making FOIA requests, and descriptions of the types of records maintained by different components of the Department. These references are available at http://www.dol.gov/dol/foia/guide6.html.

    (c) Requests made by individuals for records about themselves under the Privacy Act of 1974, 5 U.S.C. 552a, are processed under 29 CFR part 71 as well as under this part. Information routinely provided to the public as part of a regular Department activity (for example, press releases issued by the Office of Public Affairs (OPA)) may be provided to the public without following this subpart.

    (d) As set forth in Sec. 70.3, the Department operates its FOIA program with a presumption of openness and withholds records or information under the FOIA only when the Department reasonably foresees that disclosure would harm an interest protected by a FOIA exemption or when disclosure is prohibited by law.

    (e) The Department has a decentralized system for processing requests, with each component handling requests for its own records. Each component has a FOIA Customer Service Center that can assist individuals in locating records and address questions regarding pending FOIA requests. A list of the Department's Customer Service Centers is available at http://www.dol.gov/dol/foia/RequestorServiceCenters.htm.

    (f) The Secretary has designated a Chief FOIA Officer for the Department. Contact information for the Chief FOIA Officer is available on the Department's FOIA Web site, http://www.dol.gov/dol/foia/. The Office of Information Services (OIS), which is located within the Office of the Solicitor, provides Department level guidance and oversight for the Department's FOIA program and supports the statutorily-based responsibilities of the DOL Chief FOIA Officer.

    (g) The Department has a designated FOIA Public Liaison who can assist individuals in locating records of a particular component and with resolving issues relating to the processing of a pending FOIA request. Information concerning the DOL FOIA Public Liaison is available at http://www.dol.gov/sol/foia/liaison.htm. The DOL FOIA Public Liaison is responsible for assisting in reducing delays in FOIA processing, increasing transparency and understanding, providing information concerning the status of requests, and assisting in the resolution of disputes.

    § 70.2 Definitions.

    As used in this part:

    (a) The terms agency, person, party, rule, order, and adjudication have the meaning attributed to these terms by the definitions in 5 U.S.C. 551.

    (b) Confidential commercial information means commercial or financial information received or obtained by the Department from a submitter, directly or indirectly, that arguably may be protected from disclosure under Exemption 4 of the FOIA.

    (c) The Department means the Department of Labor.

    (d) FOIA Component means an official component of the Department that has authority to disclose or withhold records under the FOIA and to whom requests to inspect or copy records in its custody should be addressed. Department of Labor components are listed in Appendix A to this part.

    (e) Record means any information that would be an agency record subject to the requirements of this part when maintained by an agency in any format, including an electronic format, and any information described under this part that is maintained for an agency by an entity under Government contract, for the purposes of records management.

    (f) Request means any written request for records made pursuant to 5 U.S.C. 552(a)(3) and which meets the requirements of this part.

    (g) Requester means any person who makes a request.

    (h) Search means to look for, manually or by automated means, Department records for the purpose of locating them in response to a pending request.

    (i) The Secretary means the Secretary of Labor.

    (j) Submitter means any person or entity from whom the Department receives or obtains confidential commercial or financial information, directly or indirectly. The term submitter includes, but is not limited to corporations, labor organizations, non-profit organizations, and local, state, and tribal and foreign governments.

    (k) Unusual circumstances means, to the extent reasonably necessary for the proper processing of a FOIA request:

    (1) The need to search for and collect the requested records from physically separate facilities;

    (2) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records that are demanded in a single request; or

    (3) The need for consultation, which will be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request.

    § 70.3 Policy.

    All agency records, except those exempt from mandatory disclosure by one or more provisions of 5 U.S.C. 552(b), will be made promptly available to any person submitting a written request in accordance with the procedures of this part. The Department will withhold records under the FOIA only when the Department reasonably foresees that disclosure would harm an interest protected by a FOIA exemption or is prohibited by law. Whenever the Department determines that full disclosure of a requested record is not possible, the Department will consider whether partial disclosure is possible and will take reasonable steps to segregate and release nonexempt material. As set forth in Sec. 70.4, the Department proactively identifies and discloses records of interest to the public.

    § 70.4 Proactive disclosure of Departmental records.

    Records that are required by the FOIA, 5 U.S.C. 552 (a)(2), to be made available for public inspection in an electronic format may be accessed through the Department's Web site at http://www.dol.gov/dol/foia/. Each component is responsible for determining which of its records are required to be made publicly available, as well as identifying additional records of interest to the public that are appropriate for public disclosure, and for posting and indexing such records. Each component must review and update its Web site of posted records and indices on an ongoing basis.

    § 70.5 Compilation of new records.

    Nothing in 5 U.S.C. 552 or this part requires that any agency or component create a new record in order to respond to a request for records. A component must, however, make reasonable efforts to search for records that already exist in electronic form or format, except when such efforts would significantly interfere with the operation of the component's automated information systems. The component will determine what constitutes a reasonable effort on a case-by-case basis.

    § 70.6 Disclosure of originals.

    (a) No original record or file in the custody of the Department of Labor, or of any component or official thereof, will on any occasion be given to any agent, attorney, or other person not officially connected with the Department without the written consent of the Secretary, the Solicitor of Labor or the Inspector General.

    (b) The individual authorizing the release of the original record or file must ensure that a copy of the document or file is retained in the component that had custody and/or control when an original document or file is released pursuant to this subpart.

    § 70.7-70.18 [Reserved]
    Subpart B—Procedures for Disclosure of Records Under the Freedom of Information Act
    § 70.19 Requirements for making a request.

    (a) General information. The Department of Labor has a decentralized system for responding to requests submitted under the FOIA. Each agency component has the ability to receive FOIA requests in writing by mail, delivery service/courier or facsimile at its designated mailing address. Any FOIA request submitted electronically, by email, must be submitted to [email protected] Requests under this part submitted to any other email address will not be accepted.

    (b) To make a request for records of the Department, whenever possible, a requester should write directly to the FOIA office of the component that maintains the records sought. Submitting the request directly to the FOIA office of the component that maintains the records sought will facilitate the quickest response. The requester must provide a mailing address to receive correspondence, and it may facilitate processing if telephone and email contact information are provided.

    (1) The Department's components for the purposes of the FOIA are listed in Appendix A to this part. The function and mailing address of each Department of Labor component is available on the Department's FOIA Web site at http://www.dol.gov/dol.foia. This page also provides other information that is helpful in determining where to make a request.

    (2) Requesters who cannot determine the proper FOIA office component or who are requesting records from multiple components may also send requests to the Office of the Solicitor, Office of Information Services, 200 Constitution Avenue NW., Room N-2420, Washington, DC 20210 or by email to [email protected] Note that, pursuant to Sec. 70.25(a), the time for the component to respond to a request begins to run when the request is received by the proper component, but no later than 10 working days after receipt in any component identified in Appendix A.

    (c) Description of records sought. Requesters must describe the record or records sought in sufficient detail to enable Department personnel to locate them with a reasonable amount of effort. To the extent possible, the request should provide enough identifying information to help the component identify the requested records, such as the subject of the record, the date or approximate date when the record was created, the record's title or name, case or file number, reference number, the person or office or the office location that created it, and any other pertinent identifying details. Prior to submitting the request, a requester may wish to consult the references provided in Sec. 70.1, the relevant FOIA Requester Service Center or the FOIA Public Liaison to discuss the records they are seeking and to receive assistance on how to describe the records.

    (d) Deficient descriptions and revised requests. If the description is insufficient, so that a knowledgeable employee who is familiar with the subject area of the request cannot identify the record with a reasonable amount of effort, the component processing the request will notify the requester and describe what additional information is needed to process the request.

    (1) Requesters who are attempting to modify or reformulate their requests may discuss their requests with the component's designated FOIA contact, the FOIA Public Liaison, or a representative of OIS, each of whom is available to assist the requester in reasonably describing the records sought. Every reasonable effort will be made to assist a requester in the identification and location of the records sought. If the requester fails to reasonably describe the records sought, the agency's response to the request may be delayed.

    (2) Any amended request must be confirmed in writing and meet the requirements for a request under this part.

    (3) While an agency component awaits a requester's modified FOIA request, the processing time limits described in Sec. 70.25(a)(1) will be tolled (that is, the processing time clock will be stopped) until clarification is received from the requester.

    § 70.20 Responsibility for responding to requests.

    (a) In general. Except in the instances stated in paragraph (d) of this section, the component that first receives a request for a record and maintains that record is the component responsible for responding to the request. In determining which records are responsive to a request, a component ordinarily will include only records in its possession as of the date that the component begins the search; if any other date is used, the component will inform the requester of that date. A record that is excluded from the requirements of the FOIA pursuant to 5 U.S.C. 552(c), is not considered responsive to a request. When it is determined that records responsive to a request may be located in multiple components of the Department, the Office of Information Services may coordinate the Department's response. If the Office of Information Services deems a consolidated response appropriate, it will issue such a response on behalf of the Department.

    (b) Authority to grant or deny requests. Pursuant to relevant exemptions under 5 U.S.C. 552(b), the head of a component, or designee, is authorized to grant or to deny any requests for records that are maintained by that component.

    (c) Re-routing of misdirected requests. Where a component's FOIA office determines that a request was misdirected within the Department, the receiving component's FOIA office will work with OIS to facilitate the routing of the request to the FOIA office of the proper component(s).

    (d) Consultations and referrals. When a component receives a request for a record, it will determine if another component of the Department, or of the Federal Government, is better able to determine whether the record can be disclosed or is exempt from disclosure under the FOIA. If the receiving component determines that it is not best able to process the record, then the receiving component will either:

    (1) Respond to the request after consulting with the component or agency best able to determine whether to disclose the record and with any other component or agency that has a substantial interest in the record; or

    (2) Refer the responsibility for responding to the request regarding that record to the component best able to determine whether to disclose it, or to another agency that originated the record (but only if that entity is subject to the FOIA). Ordinarily, the component or agency that originated the record will be presumed to be best able to determine whether to disclose it.

    (e) Notice of referral. Whenever a component refers all or any part of the responsibility for responding to a request to another component or agency, the component will notify the requester of the referral and inform the requester of the name of each component or agency to which the request has been referred and provide contact information for that component or agency.

    (f) Classified records. Any request for classified records which are in the custody of the Department of Labor will be referred to the classifying agency under paragraphs (d) and (e) of this section.

    § 70.21 Responses to requests.

    (a) In general. Components should, to the extent practicable, communicate with requesters using the method that is most likely to increase the speed and efficiency of the communication, including by electronic means, such as by email.

    (b) Acknowledgements of requests. A component will acknowledge each new request and assign it an individualized tracking number. Components will include in the acknowledgment a brief description of the records sought to allow the requesters to more easily keep track of their requests.

    (c) Granting a request. After a component makes a determination to grant a request in full or in part, the component will notify the requester in writing. The component will provide the record in the form or format requested if the record is readily reproducible in that form or format, provided the requester has agreed to pay and/or has paid any fees required by subpart C of this part. The component will determine on a case-by-case basis what constitutes a readily reproducible format. Each component should make reasonable efforts to maintain its records in commonly reproducible forms or formats.

    (d) Adverse determinations of requests. A component making an adverse determination denying a request in any respect must notify the requester in writing. Adverse determinations, or denials of requests, include decisions that: the requested record is exempt, in whole or in part, from release pursuant to one or more exemptions under the FOIA, 5 U.S.C. 552; the request does not reasonably describe the records sought; the information requested is not a record subject to the FOIA; the requested record does not exist, cannot be located, or has been destroyed; or the requested record is not readily producible in the form or format sought by the requester. Adverse determinations also include denials involving fees or fee waiver matters or denials for requests for expedited processing.

    (e) Content of the denial. The denial notice must be signed by the component agency head or a designee and will include:

    (1) The name and title or position of the person responsible for the denial;

    (2) A brief statement of the reason or reasons for the denial, including any FOIA exemption or exemptions applied or procedural reasons relied upon by the component in denying the request;

    (3) An estimate of the volume of records or information withheld, in number of pages or in some other reasonable form of estimation. This estimate does not need to be provided if the volume is otherwise indicated through deletions on records disclosed in part, or if providing an estimate would harm an interest protected by the exemption under which the deletion was made;

    (4) The right of the requester to seek assistance from the FOIA Public Liaison; and

    (5) In the case of an adverse determination:

    (i) a statement that the denial may be appealed as described under Sec. 70.22; and

    (ii) a statement notifying the requester of the right to seek dispute resolution services from the Department's FOIA Public Liaison or the Office of Government Information Services (within the National Archives and Records Administration).

    (f) Markings on released documents. Markings on released documents must be clearly visible to the requester. Records disclosed in part shall be marked to show the amount of information deleted and the exemption(s) under which the deletion was made unless doing so would harm an interest protected by an applicable exemption. The location of the information deleted shall also be indicated on the records, if technically feasible.

    § 70.22 Appeals from denial of requests.

    (a) A requester may appeal to the Solicitor of Labor when one or more of the following has occurred: A request for access to records has been denied in whole or in part; a requester disputes a determination that records cannot be located or have been destroyed; a requester disputes a determination by a component concerning the assessment or waiver of fees; a requester disputes the denial of a request for expedited processing or a component fails to respond to a request within the time limits set forth in the FOIA. The appeal must be filed within 90 days of the date of the action being appealed.

    (b) The appeal must state in writing the grounds for appeal, and it may include any supporting statements or arguments, but such statements are not required. In order to facilitate processing of the appeal, the appeal must include the assigned request number (if applicable), appellant's mailing address and daytime telephone number, as well as copies of the initial request and the component's response. If mailed, the envelope and the letter of appeal should be clearly marked: “Freedom of Information Act Appeal.” Any amendment to the appeal must be in writing and received prior to a decision on the appeal.

    (c) The appeal should be addressed to the Solicitor of Labor, Office of the Solicitor, FOIA Appeals Unit, Division of Management and Administrative Legal Services, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-2420, Washington, DC 20210. Appeals also may be submitted by fax to 202-693-5538 or by email to [email protected] Appeals submitted to any other email address will not be accepted.

    § 70.23 Action on appeals.

    The Solicitor of Labor, or designee, will review the appellant's appeal and make a determination de novo whether the action of the component was proper and in accordance with the applicable law.

    § 70.24 Form and content of action on appeals.

    The disposition of an appeal will be issued by the Solicitor of Labor or designee in writing. A decision affirming, in whole or in part, the decision below will include a brief statement of the reason or reasons for the affirmance, including the FOIA exemption or exemptions relied upon, and its relation to each record withheld. Consistent with the statute, the appeal determination will also advise the requester of the availability of the mediation services of the Office of Government Information Services as a non-exclusive alternative to litigation, and the statutory right to judicial review of the denial by the United States District Court for the judicial district in which the requester resides or maintains his or her principal place of business, the judicial district in which the requested records are located, or the District of Columbia. If it is determined on appeal that a record should be disclosed, the record will be provided in accordance with the decision on appeal. If it is determined that records should be denied in whole or in part, the appeal determination will include an estimate of the volume of records or information withheld, in number of pages or in some other reasonable form of estimation. This estimate does not need to be provided if the volume is otherwise indicated through deletions on records disclosed in part, or if providing an estimate would harm an interest protected by an applicable exemption.

    § 70.25 Time limits and order in which requests and appeals must be processed.

    (a) Time limits. The FOIA establishes a 20 business day deadline for regular requests and appeals, and a 10 calendar day time limit for making determinations regarding expedited processing. Components of the Department of Labor will comply with the time limits required by the FOIA for responding to and processing requests and appeals, unless there are exceptional circumstances within the meaning of 5 U.S.C. 552(a)(6)(C). A component or the designated appeal authority will notify a requester whenever they are unable to respond to or process the request or appeal within the time limits established by the FOIA.

    (b) Multitrack processing. All components must designate a specific track for requests that are granted expedited processing, in accordance with the standards set forth in paragraph (d) of this section. A component may also designate additional processing tracks that distinguish between simple and complex requests based on the estimated amount of work and/or time needed to process the request, including based on the number of pages involved and the need for consultations or referrals. Components shall advise the requesters of the track into which their request falls and, when appropriate, shall offer the requester an opportunity to limit the scope of their requests in order to qualify for faster processing within the specified limits of the component's faster track.

    (c) Unusual circumstances.

    (1) Where the statutory time limits for processing a request cannot be met because of “unusual circumstances,” as set forth in the FOIA at 5 U.S.C. 552(a)(6)(B)(i-iii), and the component determines to extend the time limits on that basis, the component shall, before the expiration of the 20 working day deadline to respond, notify the requester in writing of the unusual circumstances and of the date by which processing of the request can be expected to be completed. This extension should not ordinarily exceed ten business days. If the component intends to extend the deadline to respond by more than ten working days, the component must:

    (i) Provide the requester with an opportunity either to modify the request so that it may be processed within the time limits or to arrange an alternative time period with the component for processing the request or a modified request;

    (ii) Make available to the requester the contact information for the designated FOIA contact and the FOIA Public Liaison to assist the requester; and

    (iii) Notify the requester of the right to seek dispute resolution services from the Office of Government Information Services (OGIS).

    (d) Aggregating requests. Where a component reasonably believes that multiple requests submitted by a requester, or by a group of requesters acting in concert, constitute a single request that would otherwise involve unusual circumstances, and the requests involve clearly related matters, they may be aggregated. Components shall not aggregate multiple requests involving unrelated matters.

    (e) Expedited processing.

    (1) Requests and appeals will be taken out of order and given expedited treatment whenever it is determined that they involve:

    (i) Circumstances in which the lack of expedited treatment could reasonably be expected to pose an imminent threat to the life or physical safety of an individual;

    (ii) An urgency to inform the public about an actual or alleged federal government activity, if made by a person primarily engaged in disseminating information;

    (iii) The loss of substantial due process rights; or

    (iv) A matter of widespread and exceptional media interest in which there exists possible questions about the government's integrity which affect public confidence.

    (2) A request for expedited processing may be made at the time of the initial request for records or at any later time. For a prompt determination, a request for expedited processing must be received by the proper component. Requests based on paragraphs (e)(1)(i), (ii), (iii), and (iv) of this section must be submitted to the component that maintains the records requested.

    (3) A requester who seeks expedited processing must submit a statement, certified to be true and correct to the best of that person's knowledge and belief, explaining in detail the basis for requesting expedited processing. For example, a requester within the category in paragraph (e)(1)(ii) of this section, if not a full-time member of the news media, must establish that he or she is a person whose main professional activity or occupation is information dissemination, though it need not be his or her sole occupation. Such a requester also must establish a particular urgency to inform the public about the government activity involved in the request—one that goes beyond the public's general right to know about government activity. The existence of numerous articles published on a given subject can be helpful in establishing the requirement that there be an “urgency to inform” the public on a topic. As a matter of administrative discretion, a component may waive the formality of certification.

    (4) Within ten calendar days of its receipt of a request for expedited processing, the proper component will decide whether to grant the request and will notify the requester of the decision. If a request for expedited treatment is granted, the request will be given priority and will be processed as soon as practicable. If a request for expedited processing is denied, any appeal of that decision will be acted on expeditiously.

    § 70.26 Confidential commercial information.

    (a) In general. Confidential commercial information will be disclosed under the FOIA only in accordance with this section and E.O. 12,600, “Predisclosure Notification Procedures for Confidential Commercial Information.”

    (b) Designation of confidential commercial information. A submitter of confidential commercial information will use good-faith efforts to designate, by appropriate markings, either at the time of submission or at a reasonable time thereafter, any portions of its submission that it considers to be protected from disclosure under Exemption 4. These designations will expire ten years after the date of the submission unless the submitter requests, and provides justification for, a longer designation period.

    (c) Notice to submitters. A component will provide a submitter with prompt written notice of a FOIA request that seeks its confidential commercial information whenever required under paragraph (d) of this section, except as provided in paragraph (g) of this section, in order to give the submitter an opportunity to object in writing to disclosure of any specified portion of that information under paragraph (e) of this section. The notice will either describe the confidential commercial information requested or include copies of the requested records or record portions containing the information. When notification to a voluminous number of submitters is required, notification may be made by posting or publishing notice reasonably likely to accomplish such notification.

    (d) When notice is required. Notice will be given to a submitter whenever:

    (1) The information requested under the FOIA has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or

    (2) A component has reason to believe that the information requested under the FOIA may be protected from disclosure under Exemption 4, but has not yet determined whether the information is protected from disclosure under that exemption or any other applicable exemption.

    (e) Opportunity to object to disclosure. A component will allow a submitter a reasonable time to respond to the notice described in paragraph (c) of this section taking into account the amount of material the submitter has to review and the deadlines imposed by the FOIA or agreed to with the requester. If a submitter has any objection to disclosure, it is required to submit a detailed written statement. The statement must show why the information is a trade secret or commercial or financial information that is privileged or confidential. In the event that a submitter fails to respond to the notice within the time specified, the submitter will be considered to have no objection to disclosure of the information. Information provided by a submitter under this paragraph may itself be subject to disclosure under the FOIA.

    (f) Notice of intent to disclose. A component will consider a submitter's timely objections and specific grounds for non-disclosure in deciding whether to disclose confidential commercial information. Whenever a component decides to disclose confidential commercial information over the objection of a submitter, the component will give the submitter written notice, which will include:

    (1) A statement of the reason(s) why each of the submitter's disclosure objections were not sustained;

    (2) A description of the confidential commercial information to be disclosed; and

    (3) A specified disclosure date, which will be a reasonable time subsequent to the notice.

    (g) Exceptions to notice requirements. The notice requirements of paragraphs (c) and (f) of this section will not apply if:

    (1) The component determines that the information should not be disclosed;

    (2) The information lawfully has been published or has been officially made available to the public;

    (3) Disclosure of the information is required by statute (other than the FOIA) or by a regulation issued in accordance with the requirements of Executive Order 12,600 (3 CFR 1988 Comp., p. 235); or

    (4) The designation made by the submitter under paragraph (b) of this section appears obviously frivolous or such a designation would be unsupportable—except that, in such a case, the component will, within a reasonable time prior to a specified disclosure date, give the submitter written notice of any final decision to disclose the information.

    (h) Notice of a FOIA lawsuit. Whenever a requester files a lawsuit seeking to compel the disclosure of confidential commercial information, the component will promptly notify the submitter.

    (i) Corresponding notice to requesters. Whenever a component provides a submitter with notice and an opportunity to object to disclosure under paragraphs (d) and (e) of this section, the component will also notify the requester(s). Whenever a component notifies a submitter of its intent to disclose requested information under paragraph (f) of this section, the component will also notify the requester(s). Whenever a submitter files a lawsuit seeking to prevent the disclosure of confidential commercial information, the component will notify the requester(s).

    (j) Notice requirements. The component will fulfill the notice requirements of this section by addressing the notice to the confidential commercial submitter or its legal successor at the address indicated on the records, or the last known address. If the notice is returned, the component will make a reasonable effort to locate the confidential commercial submitter or its legal successor. Where notification of a voluminous number of submitters is required, such notification may be accomplished by posting and publishing the notice in a place reasonably calculated to accomplish notification.

    § 70.27 Preservation of records.

    Each component will preserve all correspondence relating to the requests it receives under this part, and all records processed pursuant to such requests, until disposition or destruction of such correspondence and records is authorized by Title 44 of the United States Code or the National Archives and Records Administration's General Records Schedule 14. Records are not to be destroyed while they are the subject of a pending request, appeal, or lawsuit under the Act.

    § 70.28-70.37 [Reserved]
    Subpart C—Costs for Production of Records
    § 70.38 Definitions related to costs.

    The following definitions apply to this subpart:

    (a) Request, in this subpart, includes any request, as defined by Sec. 70.2(f), as well as any appeal filed in accordance with Sec. 70.22.

    (b) Direct costs means those expenditures which a component actually incurs in searching for and duplicating (and in the case of commercial use requests, reviewing) records to respond to a FOIA request. Direct costs include, for example, the salary of the Federal employee performing work (the basic rate of pay for the Federal employee plus 16 percent of that rate to cover benefits) and the cost of operating duplication machinery. Not included in direct costs are overhead expenses such as costs of space, heating or lighting the facility in which the records are kept.

    (c) Reproduction means the process of making a copy of a record necessary to respond to a request. Such copy can take the form of paper, microform, audio-visual materials or electronic records (such as a CD or other media).

    (d) Search means the process of looking for and retrieving records or information that is responsive to a FOIA request. It includes page-by-page or line-by-line identification of information within records and also includes reasonable efforts to locate and retrieve information from records maintained in electronic form or format. FOIA components will ensure that searches are done in the most efficient and least expensive manner reasonably possible. A search does not include the review of material, as defined in paragraph (e) of this section, which is performed to determine whether material is exempt from disclosure.

    (e) Review means the process of examining records, including audio-visual, electronic mail, etc., located in response to a request to determine whether any portion of the located record is exempt from disclosure, and accordingly may be withheld. It also includes the act of preparing materials for disclosure, i.e., doing all that is necessary to excise them and otherwise prepare them for release. Review time includes time spent contacting any submitter, and considering and responding to any objections to disclosure made by a submitter under Sec. 70.26, but does not include time spent resolving general legal or policy issues regarding the application of exemptions.

    (f) Commercial use request means a request from or on behalf of a person who seeks information for a use or purpose that furthers his or her commercial, trade or profit interests, which can include furthering those interests through litigation. When considering fee issues, components will determine, whenever reasonably possible, the use to which a requester will put the requested records. When it appears that the requester will put the records to a commercial use, either because of the nature of the request itself or because a component has reasonable cause to doubt a requester's stated use, the component will provide the requester a reasonable opportunity to submit further clarification.

    (g) Educational institution means an institution which:

    (1) Is a preschool, public or private elementary or secondary school, an institution of undergraduate higher education, an institution of graduate higher education, an institution of professional education, or an institution of vocational education, or

    (2) Operates a program or programs of scholarly research. To qualify under this definition, the program of scholarly research in connection with which the information is sought must be carried out under the auspices of the academic institution itself as opposed to the individual scholarly pursuits of persons affiliated with an institution. For example, a request from a professor for information that will assist in writing of a book, independent of his or her institutional responsibilities, would not qualify under this definition, whereas a request predicated upon research funding granted to the institution would meet its requirements. A request from a student enrolled in an individual course of study at an educational institution would not qualify as a request from the institution.

    (h) Non-commercial scientific institution means an institution that is not operated on a commercial basis and that is operated solely for the purpose of conducting scientific research, the results of which are not intended to promote any particular product or industry.

    (i) Representative of the news media means any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. Examples of news media entities include television or radio stations that broadcast “news” to the public at large and publishers of periodicals that disseminate “news” and make their products available through a variety of means to the general public, as well as news organizations that operate solely on the Internet. Alternative media may be considered to be news-media entities. These examples are not all inclusive.

    (1) Factors indicating status as a news media representative include press accreditation, guild membership, a history of continuing publication, business registration, and/or Federal Communication Commission licensing, among others.

    (2) For purposes of this definition, news contemplates information that is about current events or that would be of current interest to the public.

    (3) A freelance journalist will be treated as a representative of the news media if the person can demonstrate a solid basis for expecting publication of matters related to the requested information through a qualifying news media entity. A publication contract with a qualifying news media entity satisfies this requirement. An individual's past publication record with such organizations is also relevant in making this determination.

    § 70.39 Statutes specifically providing for setting of fees.

    This subpart will not apply to fees charged under any statute, other than the FOIA, that specifically requires an agency to set and collect fees for particular types of records.

    § 70.40 Charges assessed for the production of records.

    (a) General. Components shall charge for processing requests under the FOIA in accordance with the provisions of this section and with the OMB Guidelines. In order to resolve any fee issues that arise under this section, a component may contact a requester for additional information. Components will ensure that searches, review, and duplication are conducted in the most efficient and least expensive manner. A component ordinarily will collect all applicable fees before sending copies of records to the requester.

    (b) There are three types of charges assessed in connection with the production of records in response to a request, specifically, charges for costs associated with:

    (1) Searching for or locating responsive records (search costs),

    (2) Reproducing such records (reproduction costs), and

    (3) Reviewing records to determine whether any materials are exempt (review costs).

    (c)(1) There are four types of requesters:

    (i) Commercial use requesters,

    (ii) Educational and non-commercial scientific institutions,

    (iii) Representatives of the news media, and

    (iv) All other requesters.

    (2) Depending upon the type of requester, as set forth in paragraph (c)(1) of this section, the charges outlined in paragraph (d) of this section may be assessed.

    (d) Types of charges that will be assessed for each type of request.

    (1) Commercial use request. When a requester makes a commercial use request, search costs, reproduction costs and review costs will be assessed in their entirety.

    (2) Educational or non-commercial scientific institution request. When an educational or non-commercial scientific institution makes a request, only reproduction costs will be assessed, excluding charges for the first 100 pages.

    (3) Request by representative of news media. When a representative of the news media makes a request, only reproduction costs will be assessed, excluding charges for the first 100 pages.

    (4) All other requesters. Requesters making a request which does not fall within paragraphs (d)(1), (2), or (3) of this section will be charged search costs and reproduction costs, except that the first 100 pages of reproduction and the first two hours of search time will be furnished without charge. Where computer searches are involved, the monetary equivalent of two hours of search time by a professional employee will be deducted from the total cost of computer processing time.

    (e) Charges for each type of activity.

    (1) Search costs.

    (i) When a search for records is performed by a clerical employee, a rate of $5.00 per quarter hour will be applicable. When a search is performed by professional or supervisory personnel, a rate of $10.00 per quarter hour will be applicable. Components will charge for time spent searching even if they do not locate any responsive records or they withhold the records located as exempt from disclosure.

    (ii) For computer searches of records, requesters will be charged the direct costs of conducting the search, except as provided in paragraph (e)(4) of this section.

    (iii) If the search for requested records requires transportation of the searcher to the location of the records or transportation of the records to the searcher, all transportation costs in excess of $5.00 may be added to the search cost.

    (2) Reproduction costs. The standard copying charge for records in black and white paper copy is $0.15 per page. This charge includes the operator's time to duplicate the record. When responsive information is provided in a format other than 81/2 × 11 or 11 × 14 inch black and white paper copy, such as computer tapes, disks and color copies, the requester may be charged the direct costs of the tape, disk, audio-visual or whatever medium is used to produce the information, as well as the direct cost of reproduction, including operator time. The component may request that if a medium is requested other than paper, the medium will be provided by the requester.

    (3) Review costs. Costs associated with the review of records, as defined in § 70.38(e), will be charged for work performed by a clerical employee at a rate of $5.00 per quarter hour when applicable. When professional or supervisory personnel perform work, a rate of $10.00 per quarter hour will be charged, when applicable. Except as noted in this paragraph, charges may only be assessed for review the first time the records are analyzed to determine the applicability of specific exemptions to the particular record or portion of the record. Thus a requester would not be charged for review at the administrative appeal level with regard to the applicability of an exemption already applied at the initial level. When, however, a record has been withheld pursuant to an exemption which is subsequently determined not to apply and is reviewed again at the appellate level to determine the potential applicability of other exemptions, the costs attendant to such additional review will be assessed.

    (4) Limitations on charging fees. If a component fails to comply with the time limits in which to respond to a request it shall not assess certain fees except:

    (i) If there are unusual circumstances (as that term is defined in Sec. 70.25(c)) and the component has provided timely written notice, the component is permitted ten additional days to respond to the request. After the expiration of the ten additional days, the component is no longer permitted to assess search fees or, in the instances of requests from requesters described in Sec. 70.38 (h) and (i), duplication fees.

    (ii) If there are unusual circumstances (as that term is defined in Sec. 70.25(c)), and more than 5,000 pages of documents are deemed to be responsive to the request, the component may continue to charge assessable fees for as long as it takes to process the request, provided that the component has provided timely written notice and discussed with the requester via telephone, email, or written mail (or made at least three good-faith attempts to do so) how the requester could effectively limit the scope of the pending request.

    (iii) If a court has determined that exceptional circumstances exist, as defined in the FOIA, 5 U.S.C. 552(a)(6)(C) the agency's failure to comply with any time limits of the FOIA are excused for the length of time provided by the court order.

    (5) Mailing cost. Where requests for copies are sent by mail, no postage charge will be made for transmitting by regular mail a single copy of the requested record to the requester, or for mailing additional copies where the total postage cost does not exceed $5.00. However, where the volume of paper copy or method of transmittal requested is such that transmittal charges to the Department are in excess of $5.00, the transmittal costs will be added.

    (f) Aggregating requests for purposes of assessing costs.

    (1) Where a component reasonably believes that a requester or a group of requesters acting together is attempting to divide a request into a series of requests for the purpose of avoiding fees, the disclosure officer may aggregate those requests and charge accordingly.

    (2) Components may presume that multiple requests of this type made within a 30-day period have been submitted in order to avoid fees. Where requests are separated by a longer period, disclosure officers will aggregate them only where a solid basis exists for determining that aggregation is warranted under all of the circumstances involved. Multiple requests involving unrelated matters will not be aggregated.

    (g) Interest charges. Components will assess interest on an unpaid bill starting on the 31st day following the date of billing the requester. Interest charges will be assessed at the rate provided in 31 U.S.C. 3717 and will accrue from the date of the billing until payment is received by the component. Components will follow the provisions of the Debt Collection Act of 1982 (Pub. L. 97-365, 96 Stat. 1749), as amended, and its administrative procedures, including the use of consumer reporting agencies, collection agencies, and offset.

    (h) Authentication of copies.

    (1) Fees. The FOIA does not require certification or attestation under seal of copies of records provided in accordance with its provisions. Pursuant to provisions of the general user-charger statute, 31 U.S.C. 9701 and Subchapter II of title 29 U.S.C., the following charges will be made when, upon request, such services are rendered by the agency in its discretion:

    (i) For certification of true copies, $10.00 each certification.

    (ii) For attestation under the seal of the Department, $10.00 each attestation under seal.

    (2) Authority and form for attestation under seal. Authority is hereby given to any officer or officers of the Department of Labor designated as authentication officer or officers of the Department to sign and issue attestations under the seal of the Department of Labor.

    (i) Transcripts. Fees for transcripts of an agency proceeding, as defined in the Administrative Procedure Act, 5 U.S.C. 5521(12) will be assessed in accordance with the provisions of this subpart.

    (j) Privacy Act requesters. A request from an individual or on behalf of an individual for a record maintained by that individual's name or other unique identifier which is contained within a component's system of records, will be treated under the fee provisions at 29 CFR 71.6.

    § 70.41 Waiver or reduction of fees.

    (a) Requirements for waiver or reduction of fees.

    (1) Records responsive to a request will be furnished without charge or at a charge reduced below that established under paragraph (e) of Sec. 70.40, where a Component determines, based on all available information, that the requester has demonstrated that:

    (i) Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government, and

    (ii) Disclosure of the information is not primarily in the commercial interest of the requester.

    (2) To determine whether the requirement of paragraph (a)(1)(i) of this section is met, components will consider the following factors:

    (i) The subject of the request: Whether the subject of the requested records concerns “the operations or activities of the government.” The subject of the requested records must concern identifiable operations or activities of the federal government, with a connection that is direct and clear, not remote or attenuated.

    (ii) The informative value of the information to be disclosed: Whether the disclosure is “likely to contribute” to an understanding of government operations or activities. The disclosable portions of the requested records must be meaningfully informative about government operations or activities in order to be “likely to contribute” to an increased public understanding of those operations or activities. The disclosure of information that already is in the public domain, in either a duplicative or a substantially identical form, would not be as likely to contribute to such understanding where nothing new would be added to the public's understanding.

    (iii) The contribution to an understanding of the subject by the public likely to result from disclosure: Whether disclosure of the requested information will contribute to “public understanding.” The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area and ability and intention to effectively convey information to the public will be considered. It will be presumed that a representative of the news media will satisfy this consideration.

    (iv) The significance of the contribution to public understanding: Whether the disclosure is likely to contribute “significantly” to the public understanding of government operations or activities. The public's understanding of the subject in question must be enhanced by the disclosure to a significant extent.

    (3) To determine whether the requirement of paragraph (a)(1)(ii) of this section is met, components will consider the following factors:

    (i) The existence and magnitude of a commercial interest: Whether the requester has a commercial interest that would be furthered by the requested disclosure. The component will consider any commercial interest of the requester (with reference to the definition of “commercial use request” in Sec. 70.38(f)), or of any person on whose behalf the requester may be acting, that would be furthered by the requested disclosure. Requesters will be given an opportunity in the administrative process to provide explanatory information regarding this consideration.

    (ii) The primary interest in disclosure: Whether any identified commercial interest of the requester is sufficiently large, in comparison with the public interest in disclosure, that disclosure is “primarily in the commercial interest of the requester.” A fee waiver or reduction is justified where the public interest standard is satisfied and that public interest is greater in magnitude than that of any identified commercial interest in disclosure. The component ordinarily will presume that where a news media requester has satisfied the public interest standard, the public interest will be the interest primarily served by disclosure to that requester. Disclosure to data brokers or others who merely compile and market government information for direct economic return will not be presumed to primarily serve the public interest.

    (4) Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver will be granted only for those records.

    (5) Requests for the waiver or reduction of fees should address the factors listed in paragraph (a) of this section, insofar as they apply to each request.

    (b) Submission. Requests for a waiver or reduction of fees should be made when the request is first submitted to the component and should address the criteria referenced above. A requester may submit a fee waiver request at a later time so long as the underlying record request is pending or on administrative appeal. When a requester who has committed to pay fees subsequently asks for a waiver of those fees and that waiver is denied, the requester will be required to pay any costs incurred up to the date the fee waiver request was received.

    (c) Appeal rights. Requesters dissatisfied with treatment of fee waiver or reduction requests may follow the procedures for appeal under Sections 70.22 and 70.23.

    § 70.42 Consent to Pay Fees.

    (a) The Department will not assess or collect fees where the fee to be assessed, after deducting any free pages and/or search time, is less than $25.00. When making a request, a requester may specify a willingness to pay up to a certain amount, e.g., $50.00 or $200.

    (b) No request will be processed if a component reasonably believes that the fees are likely to exceed the amount to which the requester has originally consented, absent supplemental written consent by the requester to proceed after being notified of this determination.

    (c) When a component determines or estimates that the fees to be assessed in accordance with this section will exceed $25.00, the component shall notify the requester of the actual or estimated amount of the fees, including a breakdown of the fees for search, review or duplication, unless the requester has indicated a willingness to pay fees as high as those anticipated. If only a portion of the fee can be estimated readily, the component must advise the requester accordingly. Such notice may invite the requester to reformulate the request to satisfy his or her needs at a lower cost.

    (d) Components must make available their FOIA contact to assist any requester in reformulating a request to meet the requester's needs at a lower cost.

    § 70.43 Payment of fees.

    (a) De minimis costs. As noted in Sec. 70.42(a), the Department has determined it will not assess or collect fees below $25.00. In these cases, the cost of collecting and processing a fee equals or exceeds the amount of the fee which would otherwise be assessed. The Department will assess fees where the costs to be assessed, after deduction of any free pages and/or search time, is $25.00 or higher.

    (b) How payment will be made. Requesters will pay fees assessed by check or money order made payable to the Treasury of the United States, and sent to the component that is processing the request.

    (c) Advance payments and billing.

    (1) Prior to beginning to process a request, the component will make a preliminary assessment of the amount that can properly be charged to the requester for search and review time and copying costs. Where a component determines or estimates that a total fee to be charged under this section will be more than $250.00, the component will require the requester to make an advance payment of an amount up to the entire anticipated fee before beginning to process the request. The component may waive the advance payment where the component receives a satisfactory assurance of full payment from a requester who has a history of prompt payment of an amount similar to the one anticipated by the request.

    (2) Where a requester has previously failed to pay a properly charged FOIA fee to any component of the Department of Labor within 30 days of the date of billing, a component will require the requester to pay the full amount due, plus any applicable interest as provided in Sec. 70.40(f) and to make an advance payment of the full amount of any anticipated fee, before the component begins to process a new request or appeal or continues to process a pending request or appeal from that requester.

    (3) For a request other than those described in paragraphs (c)(1) and (2) of this section, a component will not require the requester to make an advance payment before beginning to process a request. Payment owed for work already completed on a request pursuant to consent of the requester is not an advance payment and a component may require the requester to make a payment for such work prior to releasing any records to the requester.

    (d) Time limits to respond extended when advance payments are requested. When a component has requested an advance payment of fees in accordance with paragraph (c) of this section, the time limits prescribed in Sec. 70.25 will only begin to run after the component has received the advance payment.

    § 70.44 Other rights and services.

    Nothing in this subpart will be construed to entitle any person, as of right, to any service or to the disclosure of any records to which such person is not entitled under the FOIA.

    § 70.45-70.52 [Reserved]
    Subpart D—Public Records and Filings
    § 70.53 Office of Labor-Management Standards.

    (a) The following documents in the custody of the Office of Labor-Management Standards are public information available for inspection and/or purchase of copies in accordance with paragraphs (b) and (c) of this section.

    (1) Data and information contained in any report or other document filed pursuant to sections 201, 202, 203, 211, 301 of the Labor-Management Reporting and Disclosure Act of 1959 (73 Stat. 524-28, 530, 79 Stat. 888, 73 Stat. 530, 29 U.S.C. 431-433, 441, 461).

    (2) Data and information contained in any report or other document filed pursuant to the reporting requirements of 29 CFR part 458, which are the regulations implementing the standards of conduct provisions of the Civil Service Reform Act of 1978, 5 U.S.C. 7120, and the Foreign Service Act of 1980, 22 U.S.C. 4117. The reporting requirements are found in 29 CFR 458.3.

    (3) Data and information contained in any report or other document filed pursuant to the Congressional Accountability Act of 1995, 2 U.S.C. 1351, 109 Stat. 19.

    (b) The documents listed in paragraph (a) of this section are available from: U.S. Department of Labor, Office of Labor-Management Standards, Public Disclosure Room, N-5608, 200 Constitution Avenue NW., Washington, DC 20210. Reports filed pursuant to section 201 of the Labor-Management Reporting and Disclosure Act of 1959 and pursuant to 29 CFR 458.3 implementing the Civil Service Reform Act of 1978 and the Foreign Service Act of 1980 for the year 2000 and thereafter are also available at http://www.union-reports.dol.gov.

    (c) Pursuant to 29 U.S.C. 435(c) which provides that the Secretary will by regulation provide for the furnishing of copies of the documents listed in paragraph (a) of this section, upon payment of a charge based upon the cost of the service, these documents are available at a cost of $ .15 per page for record copies furnished. Authentication of copies is available in accordance with the fee schedule established in Sec. 70.40. In accordance with 5 U.S.C. 552(a)(4)(A)(vi), the provisions for fees, fee waivers and fee reductions in subpart C of this part do not supersede these charges for these documents.

    (d) Upon request of the Governor of a State for copies of any reports or documents filed pursuant to sections 201, 202, 203, or 211 of the Labor-Management Reporting and Disclosure Act of 1959 (73 Stat. 524-528, 79 Stat. 888; 29 U.S.C. 431-433, 441), or for information contained therein, which have been filed by any person whose principal place of business or headquarters is in such State, the Office of Labor-Management Standards will:

    (1) Make available without payment of a charge to the State agency designated by law or by such Governor, such requested copies of information and data, or

    (2) Require the person who filed such reports and documents to furnish such copies or information and data directly to the State agency thus designated.

    § 70.54 Employee Benefits Security Administration.

    (a) The annual financial reports (Form 5500) and attachments/schedules as filed by employee benefit plans under the Employee Retirement Income Security Act (ERISA) are in the custody of the Employee Benefits Security Administration (EBSA) at the address indicated in paragraph (b) of this section, and the right to inspect and copy such reports, as authorized under ERISA, at the fees set forth in this part, may be exercised at such office.

    (b) The mailing address for the documents described in this section

    is: U.S. Department of Labor, Employee Benefits Security Administration, Public Documents Room, 200 Constitution Avenue NW., Washington, DC 20210. Appendix A to Part 70—FOIA Components

    The following list identifies the individual agency components of the Department of Labor for the purposes of the FOIA. Each component is responsible for making records in its custody available for inspection and copying, in accordance with the provisions of the FOIA and this part. Unless otherwise specified, the mailing addresses for the following national office components are listed below. Updated contact information for national and regional offices can be found on the DOL Web site at http://www.dol.gov/dol/foia.

    U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. 1. Office of the Secretary (OSEC) 2. Office of the Solicitor (SOL) 3. Office of Administrative Law Judges (ALJ), 800 K Street NW., Suite N-400, Washington, DC 20001-8002 4. Office of the Assistant Secretary for Administration and Management (OASAM), 5. Office of the Assistant Secretary for Policy (OASP). 6. Office of the Chief Financial Officer (OCFO). 7. Office of Congressional and Intergovernmental Affairs (OCIA). 8. Office of Disability Employment Policy (ODEP). 9. Office of Federal Contract Compliance Programs (OFCCP). 10. Office of the Inspector General (OIG). 11. Office of Labor Management Standards (OLMS). 12. Office of Public Affairs (OPA). 13. Office of Workers' Compensation Programs (OWCP). 14. Bureau of International Labor Affairs (ILAB). 15. Bureau of Labor Statistics (BLS), Postal Square Building, Room 4040, 2 Massachusetts Avenue NE., Washington, DC 20212-0001. 16. Employment and Training Administration (ETA). Job Corps (part of ETA). 17. Mine Safety and Health Administration (MSHA), 201 12th Street, South, Arlington, Virginia 22202. 18. Occupational Safety and Health Administration (OSHA). 19. Employee Benefits Security Administration (EBSA). 20. Veterans' Employment and Training Service (VETS). 21. Employees' Compensation Appeals Board (ECAB). 22. Administrative Review Board (ARB). 23. Benefits Review Board (BRB). 24. Wage and Hour Division (WHD). 25. Women's Bureau (WB). Signed at Washington, DC, on August 1, 2016. Thomas E. Perez, Secretary of Labor.
    [FR Doc. 2016-18594 Filed 8-16-16; 8:45 am] BILLING CODE P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2016-0312; FRL-9950-81-Region 4] Air Plan Approval; Kentucky; Removal of Stage II Gasoline Vapor Recovery Program AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve changes to the Kentucky State Implementation Plan (SIP) submitted by the Commonwealth of Kentucky through its Energy and Environment Cabinet (EEC) on May 3, 2016. This SIP revision seeks to remove Stage II vapor control requirements for new and upgraded gasoline dispensing facilities in the State and allow for the decommissioning of existing Stage II equipment in Boone, Campbell and Kenton Counties in Kentucky. EPA has preliminarily determined that Kentucky's May 3, 2016, SIP revision is approvable because it is consistent with the Clean Air Act (CAA or Act).

    DATES:

    Written comments must be received on or before September 16, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2016-0312 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:

    Kelly Sheckler, 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. Sheckler's phone number is (404) 562-9222. She can also be reached via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background for Federal Stage II Requirements

    Stage I vapor recovery is a type of emission control system that captures gasoline vapors that are released when gasoline is delivered to a storage tank. The vapors are returned to the tank truck as the storage tank is being filled with fuel, rather than released to the ambient air. Stage II and onboard refueling vapor recovery (ORVR) are two types of emission control systems that capture fuel vapors from vehicle gas tanks during refueling. Stage II systems are specifically installed at gasoline dispensing facilities and capture the refueling fuel vapors at the gasoline pump nozzle. The system carries the vapors back to the underground storage tank at the gasoline dispensing facility to prevent the vapors from escaping to the atmosphere. ORVR systems are carbon canisters installed directly on automobiles to capture the fuel vapors evacuated from the gasoline tank before they reach the nozzle. The fuel vapors captured in the carbon canisters are then combusted in the engine when the automobile is in operation.

    Under section 182(b)(3) of the CAA, each state was required to submit a SIP revision to implement Stage II for all ozone nonattainment areas classified as moderate, serious, severe, or extreme, primarily for the control of volatile organic compounds (VOC)—a precursor to ozone formation.1 However, section 202(a)(6) of the CAA states that the section 182(b)(3) Stage II requirements for moderate ozone nonattainment areas shall not apply after the promulgation of ORVR standards.2 ORVR standards were promulgated by EPA on April 6, 1994. See 59 FR 16262 and 40 CFR parts 86, 88 and 600. As a result, the CAA no longer requires moderate areas to impose Stage II controls under section 182(b)(3), and such areas were able to submit SIP revisions, in compliance with section 110(l) of the CAA, to remove Stage II requirements from their SIPs. EPA's policy memoranda related to ORVR, dated March 9, 1993, and June 23, 1993, provide further guidance on removing Stage II requirements from certain areas. The policy memorandum dated March 9, 1993, states that “[w]hen onboard rules are promulgated, a State may withdraw its Stage II rules for moderate areas from the SIP (or from consideration as a SIP revision) consistent with its obligations under sections 182(b)(3) and 202(a)(6), so long as withdrawal will not interfere with any other applicable requirement of the Act.” 3

    1 Section 182(b)(3) states that each State in which all or part of an ozone nonattainment area classified as moderate or above shall, with respect to that area, submit a SIP revision requiring owners or operators of gasoline dispensing systems to install and operate vapor recovery equipment at their facilities. Specifically, the CAA specifies that the Stage II requirements must apply to any facility that dispenses more than 10,000 gallons of gasoline per month or, in the case of an independent small business marketer (ISBM), as defined in section 324 of the CAA, any facility that dispenses more than 50,000 gallons of gasoline per month. Additionally, the CAA specifies the deadlines by which certain facilities must comply with the Stage II requirements. For facilities that are not owned or operated by an ISBM, these deadlines, calculated from the time of State adoption of the Stage II requirements, are: (1) 6 months for facilities for which construction began after November 15, 1990, (2) 1 year for facilities that dispense greater than 100,000 gallons of gasoline per month, and (3) by November 15, 1994, for all other facilities. For ISBMs, section 324(a) of the CAA provides the following three-year phase-in period: (1) 33 percent of the facilities owned by an ISBM by the end of the first year after the regulations take effect; (2) 66 percent of such facilities by the end of the second year; and (3) 100 percent of such facilities after the third year.

    2 ORVR is a system employed on gasoline-powered highway motor vehicles to capture gasoline vapors displaced from a vehicle fuel tank during refueling events. These systems are required under section 202(a)(6) of the CAA and implementation of these requirements began in the 1998 model year. Currently they are used on all gasoline-powered passenger cars, light trucks and complete heavy trucks of less than 14,000 pounds GVWR. ORVR systems typically employ a liquid file neck seal to block vapor escape to the atmosphere and otherwise share many components with the vehicles' evaporative emission control system including the onboard diagnostic system sensors.

    3 Memorandum from John S. Seitz, Director, Office of Air Quality Planning and Standards, to EPA Regional Air Directors, Impact of the Recent Onboard Decision on Stage II Requirements in Moderate Areas (March 9, 1993), available at: http://www.epa.gov/ttn/naaqs/aqmguide/collection/cp2/19930309_seitz_onboard_impact_stage2_.pdf.

    CAA section 202(a)(6) also provides discretionary authority to the EPA Administrator to, by rule, revise or waive the section 182(b)(3) Stage II requirement for serious, severe, and extreme ozone nonattainment areas after the Administrator determines that ORVR is in widespread use throughout the motor vehicle fleet. On May 16, 2012, in a rulemaking entitled “Air Quality: Widespread Use for Onboard Refueling Vapor Recovery and Stage II Waiver,” EPA determined that ORVR technology is in widespread use throughout the motor vehicle fleet for purposes of controlling motor vehicle refueling emissions. See 77 FR 28772. By that action, EPA waived the requirement for states to implement Stage II gasoline vapor recovery systems at gasoline dispensing facilities in nonattainment areas classified as serious and above for the ozone NAAQS. Effective May 16, 2012, states implementing mandatory Stage II programs under section 182(b)(3) of the CAA were allowed to submit SIP revisions to remove this program. See 40 CFR 51.126(b).4 On April 7, 2012, EPA released the guidance entitled “Guidance on Removing Stage II Gasoline Vapor Control Programs from State Implementation Plans and Assessing Comparable Measures” for states to consider in preparing their SIP revisions to remove existing Stage II programs from state implementation plans.5

    4 As noted above, EPA found, pursuant to CAA section 202(a)(6), that ORVR systems are in widespread use in the motor vehicle fleet and waived the CAA section 182(b)(3) Stage II vapor recovery requirement for serious and higher ozone nonattainment areas on May 16, 2012. Thus, in its implementation rule for the 2008 ozone NAAQS, EPA removed the section 182(b)(3) Stage II requirement from the list of applicable requirements in 40 CFR 51.1100(o). See 80 FR 12264 for additional information.

    5 This guidance document is available at: http://www.epa.gov/groundlevelozone/pdfs/20120807guidance.pdf.

    II. Kentucky's Stage II Requirements for the Northern Kentucky Area

    On November 6, 1991, EPA designated and classified Boone, Campbell and Kenton Counties in Kentucky (hereinafter referred to as the “Northern Kentucky Area” or “Area”) as part of the seven-county area in and around the Cincinnati-Hamilton, OH-KY, area as a moderate nonattainment area for the 1-hour ozone NAAQS.6 See 56 FR 56694, 56764. As mentioned above, the “moderate” classification triggered various statutory requirements for this Area, including the requirement pursuant to section 182(b)(3) of the CAA for the Area to require all owners and operators of gasoline dispensing systems to install and operate a system for gasoline vapor recovery of emissions from the fueling of motor vehicles known as “Stage II.” 7

    6 The other counties in this nonattainment area were Butler, Clermont, Hamilton and Warren Counties in Ohio. See 56 FR 56813.

    7 As discussed above, Stage II is a system designed to capture displaced vapors that emerge from inside a vehicle's fuel tank when gasoline is dispensed into the tank. There are two basic types of Stage II systems, the balance type and the vacuum assist type.

    On February 3, 1998, the Commonwealth of Kentucky submitted a SIP revision to address the Stage II requirements for the Northern Kentucky Area. EPA approved that SIP revision, containing Kentucky regulation 401 KAR 59:174—Stage II controls at gasoline dispensing facilities, in a notice published on February 8, 1999. 63 FR 67586. Northern Kentucky's Stage II rule, as currently incorporated into the SIP, requires that Stage II systems be tested and certified to meet a 95 percent emission reduction efficiency by using a system approved by the California Air Resources Board (CARB). The rule requires sources to verify proper installation and function of Stage II equipment through use of a liquid blockage test and a leak test prior to system operation and every five years or upon major modification of a facility (i.e., 75 percent or more equipment change). The Commonwealth also established an inspection program consistent with that described in EPA's Stage II guidance and has established procedures for enforcing violations of the Stage II requirements.

    On December 13, 1999, Kentucky submitted to EPA a request to redesignate the Northern Kentucky Area to attainment for the 1-hour ozone standard and an associated maintenance plan. The maintenance plan, as required under section 175A of the CAA, showed that nitrogen oxides and VOC emissions in the Area would remain below the 1996 “attainment year” levels through the greater than ten-year period from 1996-2010. In making these projections, Kentucky factored in the emissions benefit of the Area's Stage II program, thereby maintaining this program as an active part of its 1-hour ozone SIP. Originally, the redesignation request and maintenance plan were approved by EPA, effective July 5, 2000. See 65 FR 37879. However, the United States Court of Appeals for the Sixth Circuit vacated EPA's approval of this redesignation request and maintenance plan and remanded it back to EPA after the Court concluded that EPA erred in one respect pertaining only to the Ohio portion of the Area. On July 31, 2002, EPA reinstated the approval of the redesignation request and maintenance plan for Kentucky. See 67 FR 49600.

    Subsequently, Boone, Campbell and Kenton Counties in Kentucky (or portions thereof) were designated nonattainment as a part of a larger tri-state nonattainment area which included Kentucky, Ohio and Indiana counties in and around the Cincinnati area for both the 1997 8-hour ozone and 2008 8-hour ozone NAAQS. On August 5, 2010, the Area (i.e., the Kentucky portion of the tri-state Cincinnati-Hamilton Area) was redesignated to attainment of the 1997 8-hour ozone NAAQS. See 75 FR 47218. The tri-state Cincinnati-Hamilton Area is attaining the 2008 8-hour ozone NAAQS, and the Commonwealth is in the process of submitting a redesignation request and maintenance plan for the 2008 8-hour ozone NAAQS.

    III. Analysis of the Commonwealth's Submittal

    On May 3, 2016, the Commonwealth of Kentucky submitted a SIP revision to EPA seeking modifications of the Stage II requirements in the Northern Kentucky Area. Specifically, it seeks the removal of the Stage II requirements in Kentucky regulation 401 KAR 59:174—Stage II Controls at gasoline dispensing facilities. These modifications would remove Stage II vapor control requirements for new and upgraded gasoline dispensing facilities in the State and allow for the decommissioning of existing Stage II equipment.

    EPA's primary consideration for determining the approvability of the Commonwealth of Kentucky's request is whether this requested action complies with section 110(l) of the CAA.8 Section 110(l) requires that a revision to the SIP not interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171), or any other applicable requirement of the Act. EPA evaluates each section 110(l) noninterference demonstration on a case-by-case basis, considering the circumstances of each SIP revision. EPA interprets 110(l) as applying to all NAAQS that are in effect, including those that have been promulgated but for which the EPA has not yet made designations. The degree of analysis focused on any particular NAAQS in a noninterference demonstration varies depending on the nature of the emissions associated with the proposed SIP revision. EPA's analysis of Kentucky's May 3, 2016, SIP revision pursuant to section 110(l) is provided below.

    8 CAA section 193 is not relevant because Kentucky's Stage II rule was not included in the SIP before the 1990 CAA amendments.

    In its May 3, 2016, SIP revision, Kentucky used EPA's guidance entitled “Guidance on Removing Stage II Gasoline Vapor Control Programs from State Implementation Plans and Assessing Comparable Measures” to conduct a series of calculations to determine the potential impact on air quality of removing the Stage II program.9 Kentucky's analysis focused on VOC emissions because, as mentioned above, Stage II requirements affect VOC emissions and because VOC are a precursor for ozone formation.10 The results of Kentucky's analysis are provided in the table below.

    9 EPA, Guidance on Removing Stage II Gasoline Vapor Control Programs from State Implementation Plans and Assessing Comparable Measures, EPA-457/B-12-001 (Aug. 7, 2012), available at https://www.epa.gov/ozone-pollution/ozone-stage-two-vapor-recovery-rule-and-guidance. This guidance document notes that “the potential emission control losses from removing Stage II VRS are transitional and relatively small. ORVR-equipped vehicles will continue to phase in to the fleet over the coming years and will exceed 80 percent of all highway gasoline vehicles and 85 percent of all gasoline dispensed during 2015. As the number of these ORVR-equipped vehicles increase, the control attributed to Stage II VRS will decrease even further, and the potential foregone Stage II VOC emission reductions are generally expected to be no more than one percent of the VOC inventory in the area.”

    10 Two counties in Kentucky are currently designated nonattainment for the 1997 Annual fine particulate matter (PM2.5) standard: Bullitt and Jefferson. While VOC is one of the precursors for particulate matter (NAAQS) formation, studies have indicated that, in the southeast, emissions of direct PM2.5 and the precursor sulfur oxides are more significant to ambient summertime PM2.5 concentrations than emissions of nitrogen oxides and anthropogenic VOC. See, e.g., Quantifying the sources of ozone, fine particulate matter, and regional haze in the Southeastern United States, Journal of Environmental Management (2009), available at: http://www.sciencedirect.com/science/article/pii/S0301479709001893.

    Table 1—VOC Emissions Difference Between Stage II VRS in Place and Removed Year VOC
  • emissions
  • (tons per day)
  • 2011 N/A 2014 −0.21 2017 −0.15 2020 −0.10

    Table 1 shows that the removal of Stage II vapor recovery systems in the Northern Kentucky Area starting in 2014 would have resulted and will result in a VOC emission decrease. If instead Stage II requirements are kept in place, VOC emissions will decrease by less, and it will less beneficial to air quality in Northern Kentucky to keep Stage II systems in operation.11

    11 The emissions-reduction disbenefit associated with continued implementation of Stage II requirements is due to the incompatibility of some Stage II and ORVR systems. Compatibility problems can result in an increase in emissions from the underground storage tank (UST) vent pipe and other system fugitive emissions related to the refueling of ORVR vehicles with some types of vacuum assist-type Stage II systems. This occurs during refueling an ORVR vehicle when the vacuum assist system draws fresh air into the UST rather than an air vapor mixture from the vehicle fuel tank. Vapor flow from the vehicle fuel tank is blocked by the liquid seal in the fill pipe which forms at a level deeper in the fill pipe than can be reached by the end of the nozzle spout. The fresh air drawn into the UST enhances gasoline evaporation in the UST which increases pressure in the UST. Unless it is lost as a fugitive emission, any tank pressure in excess of the rating of the pressure/vacuum valve is vented to the atmosphere over the course of a day. See EPA, Guidance on Removing Stage II Gasoline Vapor Control Programs from State Implementation Plans and Assessing Comparable Measures, EPA-457/B-12-001 (Aug. 7, 2012), available at: https://www.epa.gov/ozone-pollution/ozone-stage-two-vapor-recovery-rule-and-guidance. Thus, as ORVR technology is phased in, the amount of emission control that is gained through Stage II systems decreases.

    The affected sources covered by Kentucky's Stage II vapor recovery requirements are sources of VOC. Other criteria pollutants (carbon monoxide, sulfur dioxide, nitrogen dioxide, particulate matter, and lead) are not emitted by gasoline dispensing facilities and will not be affected by the removal of Stage II controls.

    The proposed revisions to 401 KAR 59:174 include that gasoline dispensing facilities located in Boone, Campbell and Kenton Counties shall decommission and remove the systems no later than December 31, 2018. Kentucky noted in its submission that the decommissioning procedures in the revised version of 401 KAR 59:174 follow Petroleum Equipment Institute (PEI) guidance, “Recommended Practices for Installation and Testing of Vapor Recovery Systems at Vehicle Refueling Sites,” PEI/RP300-09.

    EPA is proposing to determine that Kentucky's technical analysis is consistent with EPA's guidance on removing Stage II requirements from a SIP, including as it relates to the decommissioning and phasing out of the Stage II requirements for the Northern Kentucky Area. EPA is also making the preliminary determination that Kentucky's SIP revision is consistent with the CAA and with EPA's regulations related to removal of Stage II requirements from the SIP and that these changes will not interfere with any applicable requirement concerning attainment or any other applicable requirement of the CAA, and therefore satisfy section 110(l).

    IV. 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 Kentucky Regulation 401 KAR 59:174—Stage II controls at gasoline dispensing facilities, effective March 4, 2016. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 4 office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    V. Proposed Action

    EPA is proposing to approve the Commonwealth of Kentucky's May 3, 2016, SIP revision that changes Kentucky's Stage II rule, 401 KAR 59:174, to allow for the removal of the Stage II requirement and the orderly decommissioning of Stage II equipment. EPA is proposing this approval because the Agency has made the preliminary determination that the Commonwealth of Kentucky's May 3, 2016, SIP revision related to the Commonwealth's Stage II rule is consistent with the CAA and with EPA's regulations and guidance.

    VI. 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. Accordingly, this proposed 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);

    • 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 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, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: August 8, 2016. Heather McTeer Toney, Regional Administrator, Region 4.
    [FR Doc. 2016-19538 Filed 8-16-16; 8:45 am] BILLING CODE 6560-50-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Parts 1801, 1815, and 1852 RIN 2700-AE35 Remove NASA FAR Supplement Clause, Engineering Change Proposals (2016-N030) AGENCY:

    National Aeronautics and Space Administration.

    ACTION:

    Proposed rule.

    SUMMARY:

    National Aeronautics and Space Administration (NASA) is proposing to amend the NASA FAR Supplement (NFS) to remove NFS clause 1852.243-70, Engineering Change Proposals (ECPs) basic clause with its Alternate I & II and associated information collection from the NFS.

    DATES:

    Comments on the proposed rule should be submitted in writing to the address shown below on or before October 17, 2016 to be considered in formulation of the final rule.

    ADDRESSES:

    Submit comments identified by NFS Case 2016-N030, using any of the following methods:

    Regulations.gov: http://www.regulations.gov. Submit comments via the Federal eRulemaking portal by entering “NFS Case 2016-N030” under the heading “Enter keyword or ID” and selecting “Search.” Select the link “Submit a Comment” that corresponds with “NFS Case 2016-N030.” Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “NFS Case 2016-N030” on your attached document.

    Email: [email protected]. Include NFS Case 2016-N030 in the subject line of the message.

    Fax: (202) 358-3082.

    Mail: National Aeronautics and Space Administration, Headquarters, Office of Procurement, Contract and Grant Policy Division, Attn: Andrew O'Rourke, LP-011, Suite 5L32, 300 E. Street SW., Washington, DC 20546-0001.

    FOR FURTHER INFORMATION CONTACT:

    Andrew O'Rourke, NASA, Office of Procurement, Contract and Grant Policy Division, Suite 5L32, 300 E. Street SW., Washington, DC 20456-0001. Telephone (202) 358-4560; facsimile (202) 358-3082; email: [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    NASA FAR Supplement clause 1852.243-70, Engineering Change Proposals, requires NASA contractors and vendors to submit contract change proposal information. The Office of Management and Budget (OMB) has approved the collection of this information via OMB Control Number 2700-054 that expires on September 30, 2017. In processing the request for renewal of this information collection under OMB Control Number 2700-054 and as part of NASA's continuing retrospective review of existing regulations to reduce unnecessary, outdated and/or burdensome requirements, NASA Office of Procurement (OP) surveyed its procurement offices to ascertain whether or not NFS clause 1852.243-70, Engineering Change Proposals, was necessary. The results of the review indicated that NFS clause 1852.243-70 was no longer utilized in procurements. Instead, the FAR Changes clauses (FAR 52.243-1 through 52.243-5) were being utilized to process engineering change proposals in lieu of this NFS clause. Thus, NASA is proposing to delete NFS clause 1852.243-70, Engineering Change Proposals, with its Alternate I & II and the corresponding information collection under OMB Control Number 2700-054.

    II. Discussion

    NASA is proposing the following revisions to eliminate unnecessary NFS requirements:

    • Delete NFS segment 1843 and OMB Control Number 2700-054 from 1801.106-1.

    • Remove the prescription at NFS 1843.205-70(a).

    • Delete NFS clause 1852.243-70, Engineering Change Proposals.

    III. Executive Orders 12866 and 13563

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

    IV. Regulatory Flexibility Act

    NASA does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., because we are removing a NFS clause and its associated information collection requirements for contractors. By removing this clause, the information collection requirement on contractors will be eliminated, thus providing all entities, both large and small, with a positive benefit. However, an initial regulatory flexibility analysis has been performed and is summarized as follows:

    In preparing the request for renewal of this information collection under OMB Control Number 2700-054 and as part of NASA's continuing retrospective review of existing regulations to reduce unnecessary, outdated and/or burdensome requirements, NASA Office of Procurement its procurement offices to ascertain whether or not NFS clause 1852.243-70, Engineering Change Proposals, was necessary. The results of the review indicated that NFS clause 1852.243-70 was no longer utilized in procurements. Instead, the FAR changes clauses were being utilized to process engineering change proposals in lieu of this NFS clause. Thus, NASA is proposing to delete NFS clause 1852.243-70, Engineering Change Proposals, with its Alternate I & II and the corresponding information collection under OMB Control Number 2700-054. This proposed rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses. The proposed rule does not duplicate, overlap, or conflict with any other Federal rules. No alternative approaches were considered.

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

    NASA will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (NFS case 2016-N030) in correspondence.

    C. Paperwork Reduction Act

    The rule contains information collection requirements that require the approval of the OMB under the Paperwork Reduction Act (44 U.S.C chapter 35); however, the proposed changes to the NFS would remove the information collection requirements previously approved under OMB Control Number 2700-0054, entitled NFS 1843 Contract Modifications for Engineering Change Proposals (ECP).

    List of Subjects in 48 CFR Parts 1801, 1843, and 1852

    Government procurement.

    Manuel Quinones, NASA FAR Supplement Manager.

    Accordingly, 48 CFR parts 1801, 1843, and 1852 are proposed to be amended as follows:

    1. The authority citation for parts 1801, 1843 and 1852 continues to read as follows: Authority:

    51 U.S.C. 20113(a) and 48 CFR chapter 1.

    PART 1801—FEDERAL ACQUISITION REGULATIONS SYSTEM 2. Revise Section 1801.106 to read as follows:
    1801.106 OMB approval under the Paperwork Reduction Act.

    The following OMB control numbers apply:

    NFS segment OMB Control No. 1823 2700-0089 1827 2700-0052 1852.223-70 2700-0160 NF 533 2700-0003 NF 1018 2700-0017
    PART 1843—CONTRACT MODIFICATIONS 3. Revise Section 1843.205-70 to read as follows:
    1843.205-70 NASA contract clauses.

    The contracting officer may insert a clause substantially as stated at 1852.243-72, Equitable Adjustments, in solicitations and contracts for—

    (a) Dismantling, demolishing, or removing improvements; or

    (b) Construction, when the contract amount is expected to exceed the simplified acquisition threshold and a fixed-price contract is contemplated.

    PART 1852—SOLICITATION PROVISIONS AND CONTRACT CLAUSES
    1852.243-70 [Removed and reserved]
    4. Section 1852.243-70 is removed and reserved.
    1852.243-72 [Amended]
    5. Amend section 1852.243-72 by removing “1843.205-70(b)” and adding “1843.205-70” in its place in the introductory text.
    [FR Doc. 2016-19566 Filed 8-16-16; 8:45 am] BILLING CODE 7510-13-P
    81 159 Wednesday, August 17, 2016 Notices DEPARTMENT OF AGRICULTURE Forest Service Revision of the Land Management Plan for Francis Marion National Forest AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of the opportunity to object to the Revised Land Management Plan for the Francis Marion National Forest prior to approval

    SUMMARY:

    The Francis Marion National Forest, located in South Carolina, has prepared an environmental impact statement, a revised land management plan and a draft record of decision. This notice is to inform the public that a 60-day period is being initiated where individuals or entities with specific concerns on the Francis Marion's Revised Land Management Plan and its associated Final Environmental Impact Statement may file an objection for a Forest Service review prior to the approval of the Revised Land Management Plan.

    DATES:

    The Francis Marion's Revised Land Management Plan, Final Enviromental Impact Statement, Draft Record of Decision, and other supporting information, will be available for review at http://www.fs.usda.gov/detail/scnfs/landmanagement/planning/?cid=stelprdb5393142 starting August 19, 2016.

    A legal notice of the initiation of the 60-day objection period is also being published in the Francis Marion and Sumter National Forests newspaper of record, which is The State. The date of the publication of the legal notice in The State will determine the actual date of initiation of the 60-day objection period. A copy of the legal notice that is published in The State will be posted on the Web site described above.

    ADDRESSES:

    Copies of the Revised Land Mangement Plan for the Francis Marion National Forest, Final Environment Impact Statement, and Draft Record of Decision can be obtained online at: http://www.fs.usda.gov/detail/scnfs/landmanagement/planning/?cid=stelprdb5393142 or at the following offices:

    • Supervisor's Office, 4931 Broad River Road, Columbia, SC 29212 (Telephone: 803-561-4000)

    • Francis Marion District Office, 2967 Steed Creek Road, Huger, SC 29450 (Telephone: 843-336-3248)

    Objections must be submitted to the Reviewing Officer Tony Tooke, Regional Forester, at USDA-Forest Service, ATTN: Objection Reviewing Officer, 1720 Peachtree Street, Atlanta, GA 30309 (Telephone: 404-347-4177; Fax: 404-347-4821). Or objections may be submitted electronically at [email protected]

    Note that the office hours for submitting a hand-delivered objection are 8:00 a.m. to 4:30 p.m. Monday through Friday, excluding Federal holidays. Electronic objections must be submitted in a commonly used format such as an email message, plain text (.txt), rich text format (.rtf) or Microsoft Word® (.doc or .docx).

    FOR FURTHER INFORMATION CONTACT:

    Mary Morrison, Forest Planner, Francis Marion National Forest at 803-561-4000. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m. (Eastern time), Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The Forest Service, Southern Region, Francis Marion National Forest, has prepared a Revised Land Mangement Plan, Final Environmental Impact Statement, and a Draft Record of Decision. This notice is to inform the public that a 60-day period is being initiated where individuals or entities with specific concerns on the Francis Marion's Revised Land Management Plan and its associated Final Environmental Impact Statement may file an objection for a Forest Service review prior to the approval of the Revised Land Management Plan. The publication date of the legal notice in the Francis Marion and Sumter National Forests newspaper of record, The State, will initiate the 60-day objection period and is the exclusive means for calculating the time to file an objection (36 CFR 219.16 and 219.52). An electronic scan of the notice with the publication date will be posted at the Francis Marion National Forest Web site at: http://www.fs.usda.gov/detail/scnfs/landmanagement/planning/?cid=stelprdb5393142.

    The objection process under 36 CFR 219 subpart B, provides an opportunity for members of the public who have participated in the planning process for the Francis Marion National Forest to have any unresolved concerns reviewed by the Forest Service prior to a final decision by the Responsible Official. Only those who provided substantive formal comments during opportunities for public comment during the planning process are eligible to file an objection. Regulations at 36 CFR 219.62 define substantive formal comments as:

    “Written comments submitted to, or oral comments recorded by, the responsible official or his designee during an opportunity for public participation provided during the planning process, and attributed to the individual or entity providing them. Comments are considered substantive when they are within the scope of the proposal, are specific to the proposal, have a direct relationship to the proposal, and include supporting reasons for the responsible official to consider.”

    How to File an Objection

    The Forest Service will accept mailed, emailed, faxed, and hand-delivered objections concerning the Revised Land Management Plan and associated Final Environmental Impact Statement for 60 calendar days following the date of the publication of the legal notice of this objection period in newspaper of record, The State. It is the responsibility of the objector to ensure that the Reviewing Officer receives the objection in a timely manner. The regulations prohibit extending the length of the objection filing period.

    Objections must be submitted to the Reviewing Officer, who will be Tony Tooke, Regional Forester for the Southern Region, at the address shown in the ADDRESSES section of this notice. Objections or objection content specific to the identification of species of conservation concern will be forwarded to Brian Ferebee, Associate Deputy Chief, delegated Reviewing Officer for the Chief of the Forest Service.

    An objection must include the following (36 CFR 219.54(c)):

    (1) The objector's name and address along with a telephone number or email address if available—in cases where no identifiable name is attached to an objection, the Forest Service will attempt to verify the identity of the objector to confirm objection eligibility;

    (2) Signature or other verification of authorship upon request (a scanned signature for electronic mail may be filed with the objection);

    (3) Identification of the lead objector, when multiple names are listed on an objection. The Forest Service will communicate to all parties to an objection through the lead objector. Verification of the identity of the lead objector must also be provided if requested;

    (4) The name of the plan revision being objected to, and the name and title of the Responsible Official;

    (5) A statement of the issues and/or parts of the plan revision to which the objection applies;

    (6) A concise statement explaining the objection and suggesting how the proposed plan decision may be improved. If the objector believes that the plan revision is inconsistent with law, regulation, or policy, an explanation should be included;

    (7) A statement that demonstrates the link between the objector's prior substantive formal comments and the content of the objection, unless the objection concerns an issue that arose after the opportunities for formal comment; and

    (8) All documents referenced in the objection (a bibliography is not sufficient), except that the following need not be provided:

    a. All or any part of a Federal law or regulation,

    b. Forest Service Directive System documents and land management plans or other published Forest Service documents,

    c. Documents referenced by the Forest Service in the planning documentation related to the proposal subject to objection, and

    d. Formal comments previously provided to the Forest Service by the objector during the plan revision comment period.

    Responsible Official

    The responsible official for the revision of the land management plan for the Francis Marion National Forest is Rick Lint, Forest Supervisor, Francis Marion and Sumter National Forests, 4931 Broad River Road, Columbia, SC 29212.

    Dated: August 10, 2016. John Richard Lint, Forest Supervisor.
    [FR Doc. 2016-19608 Filed 8-16-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE [Docket No. 160714611-6611-01] Office of Administration; Commerce Alternative Personnel System AGENCY:

    Office of Administration, Office of Human Resources Management, Department of Commerce.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces modifications to the provisions of the Commerce Alternative Personnel System, formerly the Department of Commerce Personnel Management Demonstration Project, published in the Federal Register on December 24, 1997.

    As published on January 2, 2015 (80 FR 25), the Commerce Alternative Personnel System implemented direct-hire authority, under section 3304(a)(3) of Title 5 of the United States Code, for recruitment of certain scientific and engineering positions in the ZP career path at the Pay Band IV and above. Direct-hire authority was authorized for positions located in the National Telecommunications and Information Administration (NTIA), employed under the First Responder Network Authority (FirstNet). The System was modified again, as published on June 22, 2016 (81 FR 40653), to increase the number of positions FirstNet could fill under direct-hire authority and to include certain occupational series in the ZP career path at the Pay Band III level and above.

    This notice serves to make changes to the System to expand the use of direct-hire authority to the NTIA, Institute for Telecommunication Sciences (ITS), and authorizes ITS to fill certain ZP positions, on a limited basis, at the Pay Band III level and above. This notice also serves to announce the addition of the 1520—Mathematics occupational series to the Commerce Alternative Personnel System.

    DATES:

    The amended Commerce Alternative Personnel System is effective August 17, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Department of Commerce—Sandra Thompson, U.S. Department of Commerce, 14th and Constitution Avenue NW., Room 51020, Washington, DC 20230, (202) 482-0056 or Valerie Smith at (202) 482-0272.

    SUPPLEMENTARY INFORMATION: 1. Background

    The Office of Personnel Management (OPM) approved the Department of Commerce (DoC) demonstration project for an alternative personnel management system and published the approval of the final plan in the Federal Register on Wednesday, December 24, 1997 (62 FR 67434). The demonstration project was designed to simplify current classification systems allowing greater flexibility in classifying work and paying employees; establish a performance management and rewards system for improving individual and organizational performance; and improve recruiting and examining to attract highly-qualified candidates. The purpose of the project was to strengthen the contribution of human resources management and test whether the same innovations conducted under the National Institute of Standards and Technology alternative personnel management system would produce similarly successful results in other DoC environments. The project was implemented on March 29, 1998. The project plan has been modified ten times to clarify certain DoC Demonstration Project authorities, and to extend and expand the project: 64 FR 52810 (September 30, 1999); 68 FR 47948 (August 12, 2003); 68 FR 54505 (September 17, 2003); 70 FR 38732 (July 5, 2005); 71 FR 25615 (May 1, 2006); 71 FR 50950 (August 28, 2006); 74 FR 22728 (May 14, 2009); 80 FR 25 (January 2, 2015); 81 FR 20322 (April 7, 2016); 81 FR 40653 (June 22, 2016). With the passage of the Consolidated Appropriations Act, 2008, Public Law 110-161, on December 26, 2007, the project was made permanent (extended indefinitely) and renamed the Commerce Alternative Personnel System (CAPS).

    CAPS provides for modifications to be made as experience is gained, results are analyzed, and conclusions are reached on how the system is working. This notice announces that the DoC implements ITS' use of direct-hire authority under 5 U.S.C. 3304(a)(3) to fill specific scientific and engineering positions announced through this notice in the ZP career path and adds the occupational series: 1520—Mathematics to the ZP career path. The DoC will follow the CAPS plan, as published in the Federal Register on December 24, 1997, and subsequent modifications as listed in the Background Section of this notice.

    Kevin E. Mahoney, Director for Human Resources Management and Chief Human Capital Officer. Table of Contents I. Executive Summary II. Basis for CAPS Expansion III. Changes to the Project Plan I. Executive Summary

    CAPS is designed to (1) improve hiring and allow DoC to compete more effectively for high-quality candidates through direct hiring, selective use of higher entry salaries, and selective use of recruitment incentives; (2) motivate and retain staff through higher pay potential, pay-for-performance, more responsive personnel systems, and selective use of retention incentives; (3) strengthen the manager's role in personnel management through delegation of personnel authorities; and (4) increase the efficiency of personnel systems through the installation of a simpler and more flexible classification system based on pay banding through reduction of guidelines, steps, and paperwork in classification, hiring, and other personnel systems, and through automation.

    The current participating organizations include 7 offices of the Chief Financial Officer/Assistant Secretary for Administration in the Office of the Secretary; the Bureau of Economic Analysis; the Institute for Telecommunication Sciences—National Telecommunications and Information Administration; the First Responder Network Authority—National Telecommunications and Information Administration; and 12 units of the National Oceanic and Atmospheric Administration: Office of Oceanic and Atmospheric Research, National Marine Fisheries Service, the National Environmental Satellite, Data, and Information Service, National Weather Service—Space Environment Center, National Ocean Service, Program Planning and Integration Office, Office of the Under Secretary, Marine and Aviation Operations, Office of the Chief Administrative Officer, Office of the Chief Financial Officer, the Workforce Management Office, and the Office of the Chief Information Officer.

    This amendment modifies the June 22, 2016, Federal Register notice (81 FR 40653). Specifically, it expands and implements direct-hire authority for ITS and enables ITS to hire, after public notice is given, any qualified applicants in the ZP career path series as defined in the Basis for CAPS Expansion section without regard to 5 U.S.C. 3309-3318, 5 CFR part 211, or 5 CFR part 337, subpart A on a limited basis.

    II. Basis for CAPS Expansion A. Purpose

    CAPS is designed to provide managers at the lowest organizational level the authority, control, and flexibility to recruit, retain, develop, recognize, and motivate its workforce, while ensuring adequate accountability and oversight.

    ITS is responsible for providing core telecommunications research and engineering services to promote enhanced domestic competition and new technology deployment; advancing telecommunications and information services; improving foreign trade opportunities for U.S. telecommunication firms and more efficient use of the radio frequency spectrum. ITS also serves as a principal Federal resource for investigating the telecommunications challenges of other Federal agencies, state and local governments, private corporations and associations, and international organizations. In particular, this includes assisting Federal public safety agencies, the Federal Communications Commission, and agencies that use Federal spectrum. As specified in the June 28, 2010, Presidential Memorandum, “Unleashing the Wireless Broadband Revolution” NTIA is responsible for exploring innovative spectrum-sharing technologies. As the research and engineering laboratory for NTIA, ITS supports NTIA by performing research that enables the U.S. Government, national and international standards organizations, and many aspects of private industry to manage the radio spectrum and ensure that innovative, new technologies are recognized and effective. To continue to advance strategic initiatives to make additional spectrum available for commercial wireless use and to meet the increasing radio spectrum needs of both Federal and commercial users in the U.S. as efficiently and effectively as possible, ITS must quickly hire qualified individuals, for specialized roles, to advance communication technologies.

    Section 3304(a)(3) of Title 5 United States Code provides agencies with the authority to appoint candidates directly to jobs for which the OPM determines that there is a severe shortage of candidates or a critical hiring need. OPM's direct-hire authority enables agencies to hire, after public notice is given, any qualified applicant without regard to 5 U.S.C. 3309-3318, 5 CFR part 211, or 5 CFR part 337, subpart A.

    This notice implements ITS' use of direct-hire authority to fill up to 20 positions in the ZP career path, at Pay Band III or higher, in the following occupational series: 0854—Computer Engineering; 0855—Electronics Engineering; 1310—Physics; 1550—Computer Science; or 1520—Mathematics. The use of direct-hire authority to fill these positions will not exceed 20 positions in the ZP career path at any one time. ITS will track the number of hires made under direct-hire authority, ensuring numbers specified for the occupational series are not exceeded.

    In 1997, with the approval of the DoC's Demonstration Project (62 FR 67434, December 24, 1997), OPM concurred that some occupations in the ZP career path at the Pay Band III and above constitute a shortage category, and some occupations for which there is a special rate under the General Schedule pay system constitute a shortage category. Past recruitment efforts have demonstrated a critical shortage of candidates possessing specialized technical expertise in spectrum measurements, spectrum monitoring, propagation modeling, 4G Long Term Evolution (LTE) technologies, mobile systems development, computer security, systems engineering, scientific software development, as well as expertise in public safety organizational operations and infrastructure capabilities. ITS will use direct-hire authority to recruit Computer Engineers, Electronics Engineers, Computer Scientists, Physicists and Mathematicians in the ZP career path, Pay Band III or higher, with efforts focused on recruiting individuals possessing the above listed specialized technical areas of expertise. Recruitment of individuals possessing this expertise is critical in order to measure, analyze, monitor, and evaluate cutting edge technologies and methods that will make spectrum sharing possible.

    DoC's CAPS allows for modifications of procedures if no new waiver from law or regulation is added. Given that this expansion and modification is in accordance with existing law and regulation and CAPS is a permanent alternative personnel system, the DoC is authorized to make the changes described in this notice.

    III. Changes to the Project Plan

    The CAPS at DoC, originally published in the Federal Register on December 24, 1997 (62 FR 67434), and subsequently expanded as discussed above, Section III (81 FR 40653, June 22, 2016), is modified as follows:

    1. The following series is added to Table 2:

    Scientific and Engineering (ZP) Career Path 1520, Mathematics Series

    2. Section III Personnel System Changes, (B) Staffing: Replace the paragraph in subsection titled: “Direct-Hire Authority: Critical Shortage Occupations” to state:

    DoC FirstNet and ITS use direct-hire procedures for categories of occupations that require skills that are in short supply. The following occupations and series constitute a shortage category at the Pay Band III and above in the ZP Career Path: Emergency Management Specialists (Public Safety) (0089), Electrical Engineers (0850), Computer Engineers (0854), Electronics Engineers, (0855), Physicists (1310), Computer Scientists (1550), and Mathematicians (1520). FirstNet is authorized to fill positions in the following occupational series using direct-hire procedures: 0089, 0850, 0854, 0855, and 1550 in all duty locations. ITS is authorized to fill positions in the following occupational series: 0854, 0855, 1310, 1550, and 1520 in all duty locations. Positions in these categories may be filled by FirstNet and ITS through direct-hire procedures in accordance with 5 U.S.C. 3304(a)(3). DoC FirstNet and ITS advertise the availability of job opportunities in direct-hire occupations by posting on the OPM USAJOBS Web site. DoC FirstNet and ITS will follow internal direct-hire procedures for accepting applications.

    [FR Doc. 2016-19616 Filed 8-16-16; 8:45 am] BILLING CODE 3510-EA-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-75-2016] Approval of Subzone Status: Westlake Chemical Corporation, Geismar, Louisiana

    On May 25, 2016, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Greater Baton Rouge Port Commission, grantee of FTZ 154, requesting subzone status subject to the existing activation limit of FTZ 154, on behalf of Westlake Chemical Corporation in Geismar, Louisiana.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (81 FR 35297, June 2, 2016). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval.

    Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 154C is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 154's 2,000-acre activation limit.

    Dated: August 11, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-19647 Filed 8-16-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Industry and Security Bureau Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: Bureau of Industry and Security.

    Title: International Import Certificate.

    Form Number(s): BIS-645P.

    OMB Control Number: 0694-0017.

    Type of Request: Regular.

    Burden Hours: 52 hours.

    Number of Respondents: 195 respondents.

    Average Hours per Response: 16 minutes per response.

    Needs and Uses: The United States and several other countries have increased the effectiveness of their respective controls over international trade in strategic commodities by means of an Import Certificate procedure. For the U.S. importer, this procedure provides that, where required by the exporting country, the importer submits an international import certificate to the U.S. Government to certify that he/she will import commodities into the United States and will not reexport such commodities, except in accordance with the export control regulations of the United States. The U.S. Government, in turn, certifies that such representations have been made.

    Affected Public: Businesses and other for-profit institutions.

    Frequency: On occasion.

    Respondent's Obligation: Required to obtain benefits.

    This information collection request may be viewed at www.reginfo.gov. Follow the instructions to view the Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to OIRA [email protected] or fax to (202) 395-5806.

    Dated: August 11, 2016. Glenna Mickelson, Management Analyst, Office of the Chief Information Officer.
    [FR Doc. 2016-19517 Filed 8-16-16; 8:45 am] BILLING CODE 3510-33-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Credit Union Advisory Council Meeting AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    This notice sets forth the announcement of a public meeting of the Credit Union Advisory Council (CUAC or Council) of the Consumer Financial Protection Bureau (CFPB or Bureau). The notice also describes the functions of the Council. Notice of the meeting is permitted by section 9 of the CUAC Charter and is intended to notify the public of this meeting. Specifically, section 9(d) of the CUAC Charter states:

    (1) Each meeting of the Council shall be open to public observation, to the extent that a facility is available to accommodate the public, unless the Bureau, in accordance with paragraph (4) of this section, determines that the meeting shall be closed. The Bureau also will make reasonable efforts to make the meetings available to the public through live recording. (2) Notice of the time, place and purpose of each meeting, as well as a summary of the proposed agenda, shall be published in the Federal Register not more than 45 or less than 15 days prior to the scheduled meeting date. Shorter notice may be given when the Bureau determines that the Council's business so requires; in such event, the public will be given notice at the earliest practicable time. (3) Minutes of meetings, records, reports, studies, and agenda of the Council shall be posted on the Bureau's Web site (www.consumerfinance.gov). (4) The Bureau may close to the public a portion of any meeting, for confidential discussion. If the Bureau closes a meeting or any portion of a meeting, the Bureau will issue, at least annually, a summary of the Council's activities during such closed meetings or portions of meetings.

    DATES:

    The meeting date is Thursday, September 1, 2016, 3:30 p.m. to 5:00 p.m. eastern daylight time.

    ADDRESSES:

    The meeting location is the Consumer Financial Protection Bureau, 1275 First Street NE., Washington, DC 20002.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, 202-435-9588, [email protected], Consumer Advisory Board and Councils Office, External Affairs, 1275 First Street NE., Washington, DC 20002.

    SUPPLEMENTARY INFORMATION: I. Background

    Section 2 of the CUAC Charter provides: “Pursuant to the executive and administrative powers conferred on the Consumer Financial Protection Bureau by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Credit Union Advisory Council to consult with the Bureau in the exercise of its functions under the Federal consumer financial laws as they pertain to credit unions with total assets of $10 billion or less.”

    Section 3 of the CUAC Charter states: “a) The CFPB supervises depository institutions and credit unions with total assets of more than $10 billion and their respective affiliates, but other than the limited authority conferred by section 1026 of the Dodd-Frank Act, the CFPB does not have supervisory authority regarding credit unions and depository institutions with total assets of $10 billion or less. As a result, the CFPB does not have regular contact with these institutions, and it would therefore be beneficial to create a mechanism to ensure that their unique perspectives are shared with the Bureau. Small Business Regulatory Enforcement Fairness Act (SBREFA) panels provide one avenue to gather this input, but participants from credit unions must possess no more than $175 million in assets, which precludes the participation of many. b) The Advisory Council shall fill this gap by providing an interactive dialogue and exchange of ideas and experiences between credit union employees and Bureau staff. c) The Advisory Council shall advise generally on the Bureau's regulation of consumer financial products or services and other topics assigned to it by the Director. To carry out the Advisory Council's purpose, the scope of its activities shall include providing information, analysis, and recommendations to the Bureau. The output of Advisory Council meetings should serve to better inform the CFPB's policy development, rulemaking, and engagement functions.”

    II. Agenda

    The Credit Union Advisory Council will discuss youth financial capability and debt collection. Persons who need a reasonable accommodation to participate should contact CFPB_504Re[email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Individuals who wish to attend the Credit Union Advisory Council meeting must RSVP to [email protected] by noon, Wednesday, August 31, 2016. Members of the public must RSVP by the due date and must include “CUAC” in the subject line of the RSVP.

    III. Availability

    The Council's agenda will be made available to the public on Wednesday, August 17, 2016, via consumerfinance.gov. Individuals should express in their RSVP if they require a paper copy of the agenda.

    A recording and transcript of this meeting will be available after the meeting on the CFPB's Web site consumerfinance.gov.

    Dated: August 11, 2016. Christopher D'Angelo, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-19622 Filed 8-16-16; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0086] Notice of Availability (NOA) of an Environmental Assessment (EA) 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) of an Environmental Assessment (EA) Addressing Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center, Richmond, Virginia.

    SUMMARY:

    Defense Logistics Agency (DLA) announces the availability of an environmental assessment (EA) documenting the potential environmental effects associated with the Proposed Action to relocate and expand DLA Disposition Services at Richmond, which is at Defense Supply Center, Richmond, Virginia. The EA has been prepared as required under the National Environmental Policy Act (NEPA) (1969). In addition, the EA complies with DLA Regulation 1000.22. DLA has determined that the Proposed Action would not have a significant impact on the human environment within the context of NEPA. Therefore, the preparation of an environmental impact statement is not required.

    DATES:

    The public comment period will end on September 16, 2016. Comments received by the end of the 30-day period will be considered when preparing the final version of the document. The Draft EA is available electronically at the Federal eRulemaking Portal at http://www.regulations.gov, and in hardcopy at the main branch of the Chesterfield Central Library, 9501 Lori Road, Chesterfield, VA 23832.

    ADDRESSES:

    You may submit comments to one of the following:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    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. (EDT) or by email: [email protected]

    Dated: August 11, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-19558 Filed 8-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Department of Defense Military Family Readiness Council (MFRC); Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Department of Defense Military Family Readiness Council. This meeting will be open to the public.

    DATES:

    Wednesday, September 14, 2016, from 1:00 p.m. to 3:00 p.m.

    ADDRESSES:

    Pentagon Conference Center Room B6 (escorts will be provided from the Pentagon Metro entrance).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Melody McDonald or Ms. Betsy Graham, Office of the Deputy Assistant Secretary of Defense (Military Community & Family Policy), Office of Family Readiness Policy, 4800 Mark Center Drive Alexandria, VA 22350-2300, Room 3G15. Telephones (571) 372-0880; (571) 372-0881 and/or email: OSD Pentagon OUSD P-R Mailbox Family Readiness Council, osd.pentagon.ousd-[email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The purpose of the Council is to review and make recommendations to the Secretary of Defense regarding policy and plans supporting military family readiness; monitor requirements for the support of military family readiness by the Department of Defense; and evaluate and assess the effectiveness of the military family readiness programs and activities of the Department of Defense.

    Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space. Members of the public who are entering the Pentagon should arrive at the visitor center next to the Metro entrance 30 minutes before the scheduled meeting time to allow time to pass through the security check points. Members of the public need to email the Council at [email protected] no later than 5:00 p.m., on Thursday, September 8, 2016 to arrange for an escort from the security check point to the Conference Room area. Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, interested persons may submit a written statement for consideration by the Council. Persons desiring to submit a written statement to the Council must submit to the email address [email protected], no later than 5:00 p.m., on Wednesday, September 7, 2016.

    The purpose of this meeting is to develop Fiscal Year 2016 recommendations for the Secretary of Defense regarding topics discussed at the June 16, 2016 meeting of the Council, including military family health and family financial readiness; and to determine Council focus items for Fiscal Year 2017.

    Wednesday, September 14, 2016 Meeting Agenda Welcome & Administrative Remarks Discuss and develop recommendations concerning military family health and family financial readiness Discuss focus items for FY2017 Closing Remarks Note: Exact order may vary Dated: August 12, 2016. Aaron Siegel, Alternate OSD <E T="04">Federal Register</E> Liaison Officer, Department of Defense.
    [FR Doc. 2016-19635 Filed 8-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary National Security Education Board; Notice of Federal Advisory Committee Meeting AGENCY:

    The Office of the Under Secretary of Defense for Personnel and Readiness, Defense Language and National Security Education Office (DLNSEO), DoD.

    ACTION:

    Meeting notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce that the following Federal advisory committee meeting of the National Security Education Board (NSEB) will take place. This meeting is open to the public.

    DATES:

    Thursday, September 8, 2016, from 10:30 a.m. to 4:45 p.m.

    ADDRESSES:

    Capital Hilton Hotel, 1001 16th Street NW., Washington, DC 20036.

    FOR FURTHER INFORMATION CONTACT:

    Alison Patz, telephone (571) 256-0771, [email protected], fax (703) 692-2615.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the Meeting: The purpose of the meeting is to review and make recommendations to the Secretary of Defense concerning requirements established by the David L. Boren National Security Education Act, Title VII of Public Law 102-183, as amended.

    Agenda:

    10:30 a.m.—Opening Remarks and Key Updates. 10:45 a.m.—Board's Role in the National Language Service Corps. 11:30 a.m.—Integrating Culture into the Language Classroom. 12:30 p.m.—Working Lunch. 2:00 p.m.—Flagship Recruitment: Best Practices. 3:00 p.m.—Break. 3:15 p.m.—Updates on Diversity. 3:30 p.m.—NSEP Awardees and the Security Clearance Process. 4:15 p.m.—Board Discussion. 4:45 p.m.—Adjourn.

    Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis.

    Committee's Point of Contact: Alison Patz, Alternate Designated Federal Official, (571) 256-0771, [email protected]

    Pursuant to 102-3.140 and sections 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Department of Defense National Security Education Board about its mission and functions. Written statements may be submitted at any time or in response to the stated agenda of the planned meeting.

    All written statements shall be submitted to the Designated Federal Official for the National Security Education Board, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Designated Federal Official can be obtained from the GSA's FACA Database—http://facadatabase.gov/.

    Statements being submitted in response to the agenda mentioned in this notice must be received by the Designated Federal Official at the address listed in FOR FURTHER INFORMATION CONTACT at least five calendar days prior to the meeting that is the subject of this notice. Written statements received after this date may not be provided to or considered by the National Security Education Board until its next meeting.

    The Designated Federal Official will review all timely submissions with the National Security Education Board and ensure they are provided to all members of the National Security Education Board before the meeting that is the subject of this notice.

    Dated: August 12, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-19605 Filed 8-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Defense Acquisition University Board of Visitors; Notice of Federal Advisory Committee Meeting AGENCY:

    Defense Acquisition University, DoD.

    ACTION:

    Meeting notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Defense Acquisition University Board of Visitors. This meeting will be open to the public.

    DATES:

    Wednesday, September 14, 2016, from 9:00 a.m. to 4:00 p.m.

    ADDRESSES:

    DAU Headquarters, Bldg. 202, 9820 Belvoir Road, Ft. Belvoir, VA 22060.

    FOR FURTHER INFORMATION CONTACT:

    Caren Hergenroeder, Protocol Director, DAU. Phone: 703-805-5134. Fax: 703-805-5940. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.

    Purpose of the Meeting: The purpose of this meeting is to report back to the Board of Visitors on continuing items of interest.

    Agenda 9:00 a.m. Welcome and Announcements 9:05 a.m. Dialogue with Industry Representatives 11:00 a.m. Board Discussion 12:00 p.m. Lunch 1:00 p.m. Feedback Session: Scenario-based Strategic Planning 1:30 p.m. Transition Planning 2:00 p.m. DAU Update 3:30 p.m. Summary Discussion 4:00 p.m. Adjourn

    Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. However, because of space limitations, allocation of seating will be made on a first-come, first served basis. Persons desiring to attend the meeting should call Ms. Caren Hergenroeder at 703-805-5134.

    Written Statements: Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Defense Acquisition University Board of Visitors about its mission and functions. Written statements may be submitted at any time or in response to the stated agenda of a planned meeting of the Defense Acquisition University Board of Visitors.

    All written statements shall be submitted to the Designated Federal Officer for the Defense Acquisition University Board of Visitors, and this individual will ensure that the written statements are provided to the membership for their consideration.

    Statements being submitted in response to the agenda mentioned in this notice must be received by the Designated Federal Officer at least five calendar days prior to the meeting which is the subject of this notice. Written statements received after this date may not be provided to or considered by the Defense Acquisition University Board of Visitors until its next meeting. Committee's Designated Federal Officer or Point of Contact: Ms. Christen Goulding, 703-805-5412, [email protected]

    Dated: August 11, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-19565 Filed 8-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Federal Advisory Committee Meeting AGENCY:

    Department of Defense.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce an open meeting of the Strategic Environmental Research and Development Program, Scientific Advisory Board (SAB). This meeting will be open to the public.

    DATES:

    Tuesday, September 13, 2016, from 9:00 a.m. to 4:40 p.m. and Wednesday, September 14, 2016, from 8:30 a.m. to 4:15 p.m.

    ADDRESSES:

    901 N. Stuart Street Suite 200, Arlington, VA 22203.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Herb Nelson, SERDP Office, 4800 Mark Center Drive, Suite 17D08, Alexandria, VA 22350-3605; or by telephone at (571) 372-6565.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. This notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463).

    Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis.

    The purpose of the September 13-14, 2016 meeting is to review new start research and development projects requesting Strategic Environmental Research and Development Program funds as required by the SERDP Statute, U.S. Code—Title 10, Subtitle A, Part IV, Chapter 172, § 2904. The full agenda follows:

    Agenda for September 13, 2016. 9:10 a.m. Program Update Dr. Herb Nelson, Acting Executive Director. 9:25 a.m. Munitions Response Overview Dr. Herb Nelson, Munitions Response, Program Manager. 9:30 a.m. 17 MR01-008 (MR-2728): Enhanced EMI Models and Systems for Underwater UXO Detection and Discrimination (FY17 New Start) Dr. Fridon Shubitidze, Dartmouth College, Hanover, NH. 10:15 a.m. Munitions Response Overview Dr. Herb Nelson, Munitions Response, Program Manager. 10:25 a.m. 17 MR01-009 (MR-2729): Rapid Response Surveys of Mobility, Burial and Re-Exposure of Underwater Munitions in Energetic Surf-Zone Environments and Object Monitoring Technology Development (FY17 New Start) Dr. Peter Traykovski, Woods Hole Oceanographic Institution, Woods Hole, MA. 11:10 a.m. Break 11:25 a.m. 17 MR01-023 (MR-2732): Three-Dimensional Computational Modeling of Turbulent Flow Field, Bed Morphodynamics and Liquefaction Adjacent to Munitions, (FY17 New Start) Dr. Xiaofeng Liu, Pennsylvania State University, University Park, PA. 12:10 p.m. Lunch 1:10 p.m. 17 MR01-021 (MR-2731): Resolving the Role of the Dynamic Pressure in the Burial, Exposure, Scour, and Mobility of Underwater Munitions (FY17 New Start) Dr. Diane Foster, University of New Hampshire, Durham, NH. 1:55 p.m. Munitions Response Overview Dr. Herb Nelson, Munitions Response, Program Manager. 2:00 p.m. 17 MR01-027 (MR-2733): Probabilistic Environmental Forecasting System for Munitions Mobility (FY17 New Start) Dr. Margaret Palmsten, Naval Research Laboratory, Stennis Space Center, MS. 2:45 p.m. Break 3:00 p.m. Weapons Systems and Platforms Overview Dr. Robin Nissan, Weapons Systems and Platforms, Program Manager. 3:10 p.m. 17 WP01-003 (WP- 2738): Fluorine-Free Aqueous Film Forming Foam (FY17 New Start) Dr. John Payne, National Foam, West Chester, PA. 3:55 p.m. 17 WP01-005 (WP- 2739): Fluorine-Free Foams with Oleophobic Surfactants and Additives for Effective Pool Fire Suppression (FY17 New Start) Dr. Ramagopal Ananth, U.S. Naval Research Laboratory, Washington, DC. 4:40 p.m. Public Discussion/Adjourn for the day Agenda for September 14, 2016 8:40 a.m. Environmental Restoration Overview Dr. Andrea Leeson, Environmental Restoration, Program Manager. 8:50 a.m. 17 ER02-015 (ER-2722): Development and Optimization of Analytical Methods for Simultaneous Determination of IM and Legacy Explosive Compounds, (FY17 New Start) Dr. Anthony Bednar, U.S. Army Engineer Research and Development Center, Vicksburg, MS. 9:35 a.m. 17 ER03-026 (ER-2726): Application of Carbon and Nitrogen Stable Isotope Analysis to Evaluate Biotic and Abiotic Degradation of DNAN and NTO (FY17 New Start) Dr. Neil Sturchio, University of Delaware, Newark, DE. 10:20 a.m. Break 10:35 a.m. 17 ER03-034 (ER-2727): Phototransformation, Sorption, Transport, and Fate of Mixtures of NTO, DNAN, and Traditional Explosives as a Function of Climatic Conditions (FY17 New Start) Dr. Katerina Dontsova, University of Arizona, Tucson, AZ. 11:20 a.m. 17 ER03-013 (ER-2724): Determination of Fate and Toxicological Effects of Insensitive Munitions Compounds in Terrestrial Ecosystems (FY17 New Start) Dr. Roman Kuperman, U.S. Army Edgewood Chemical Biological Center, Aberdeen Proving Ground, MD. 12:05 p.m. Lunch 1:05 p.m. 17 ER03-010 (ER-2723): Environmental Impact of DNAN and NTO on Plants, (FY17 New Start) Mr. Timothy Cary, U.S. Army ERDC-CRREL, Hanover, NH. 1:50 p.m. Resource Conservation & Climate Change Overview Dr. Herb Nelson, Resource Conservation & Climate Change, Program Manager. 2:00 p.m. 17 RC01-063 (RC-2703): Variation in Phenological Shifts: How do Annual Cycles and Genetic Diversity Constrain or Enable Responses to Climate Change? (FY17 New Start) Dr. Katherine O'Donnell, U.S. Geological Survey, Gainsville, FL. 2:45 p.m. Break 3:00 p.m. 17 RC01-035 (RC-2701): Incorporating Photoperiodism in Insect Phenology Models with Application for Biological Control of Weeds on Department of Defense Lands, (FY17 New Start) Dr. Fritzi Grevstad, Oregon State University, Corvallis, OR. 3:45 p.m. Strategy Session Dr. Herb Nelson, Acting Executive Director. 4:05 p.m. Public Discussion/Adjourn

    Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Strategic Environmental Research and Development Program, Scientific Advisory Board. Written statements may be submitted to the committee at any time or in response to an approved meeting agenda.

    All written statements shall be submitted to the Designated Federal Officer (DFO) for the Strategic Environmental Research and Development Program, Scientific Advisory Board. The DFO will ensure that the written statements are provided to the membership for their consideration. Contact information for the DFO can be obtained from the GSA's FACA Database at http://www.facadatabase.gov/.

    Time is allotted at the close of each meeting day for the public to make comments. Oral comments are limited to 5 minutes per person.

    Dated: August 12, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-19610 Filed 8-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID DOD-2014-OS-0073] Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by September 16, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB No: Department of Defense Application for Priority Rating for Production or Construction Equipment, DD Form 691, OMB Control Number 0704-0055.

    Type of Request: Reinstatement, with change, of a previously approved collection for which approval has expired.

    Number of Respondents: 610.

    Responses per Respondent: 1.

    Annual Responses: 610.

    Average Burden per Response: 1 hour.

    Annual Burden Hours: 610.

    Needs and Uses: Executive Order 12919 delegates to DoD authority to require certain contracts and orders relating to approved Defense Programs to be accepted and performed on a preferential basis. This program helps contractors acquire industrial equipment in a timely manner, thereby facilitating development and support of weapons systems and other important Defense Programs.

    Affected Public: Business or other for-profit.

    Frequency: On occasion.

    Respondent's Obligation: Required to obtain or retain benefits.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

    Instructions: All submissions received must include the agency name, Docket ID 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.

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.

    Dated: August 11, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-19555 Filed 8-16-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No. ED-2016-ICCD-0090] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and approval; Comment Request; Application for Grants Under the Upward Bound Program AGENCY:

    Office of Postsecondary Education (OPE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a reinstatement of a previously approved information collection.

    DATES:

    Interested persons are invited to submit comments on or before September 16, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0090. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Ken Waters, 202-453-6273.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Application for Grants Under the Upward Bound Program.

    OMB Control Number: 1840-0550.

    Type of Review: A reinstatement of a previously approved information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

    Total Estimated Number of Annual Responses: 1,240.

    Total Estimated Number of Annual Burden Hours: 40,880.

    Abstract: The Department of Education is requesting a reinstatement with change of the application for grants under the Upward Bound (UB) Program. The Department is requesting a reinstatement with change because the previous UB application was discontinued in September 2014 and the application will be needed for a Fiscal Year (FY) 2017 competition for new awards. The FY 2017 application incorporates a competitive preference priority and an invitational priority and removes previously-used competitive preference priorities.

    Dated: August 12, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-19609 Filed 8-16-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY:

    Department of Energy.

    ACTION:

    Notice of cancellation of open meeting.

    SUMMARY:

    On August 2, 2016, the Department of Energy (DOE) published a notice of open meeting announcing a meeting on August 18, 2016, of the Environmental Management Site-Specific Advisory Board, Paducah. This notice announces the cancellation of this meeting. The meeting is being cancelled because the board will not have a quorum due to scheduling conflicts by members. The next regular meeting will be held on September 15, 2016.

    DATES:

    The meeting scheduled for August 18, 2016, announced in the August 2, 2016, issue of the Federal Register (FR Doc. 2016-18186, 81 FR 50693), is cancelled. The next regular meeting will be held on September 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Jennifer Woodard, Deputy Designated Federal Officer, Department of Energy Paducah Site Office, Post Office Box 1410, MS-103, Paducah, Kentucky 42001, (270) 441-6825.

    Issued at Washington, DC, on August 11, 2016. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2016-19529 Filed 8-16-16; 8:45 am] BILLING CODE 6405-01-P
    DEPARTMENT OF ENERGY [FE Docket No. 16-98-LNG] Carib Energy (USA) LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations in Central America, South America, or the Caribbean AGENCY:

    Office of Fossil Energy, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application, filed on March 25, 2016 (Application), by Carib Energy (USA) LLC (Carib). Carib requests long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in a volume equivalent to approximately 1.3 billion cubic feet (Bcf) per year (0.0036 Bcf per day) of natural gas.1 Carib Energy seeks to export the LNG by use of approved IMO7/TVAC-ASME LNG (ISO) containers transported on ocean-going carriers to any country within Central America, South America, or the Caribbean that has, or in the future develops, the capacity to import LNG delivered by ocean-going container vessels carrying ISO containers,2 provided that trade is not prohibited by U.S. law or policy with that country, and provided further that the country has not entered into a free trade agreement with the United States requiring national treatment for trade in natural gas (non-FTA countries). Carib seeks to purchase the LNG for export from any of the existing natural gas liquefaction facilities listed in Appendix D of the Application (Facilities),3 which are owned and operated by Pivotal LNG, Inc. (Pivotal) or by one of Pivotal's affiliates.4 Carib states that delivery of LNG will be taken at the Facilities, and the LNG transported within the United States over highways using approved ISO containers. Carib intends to export the LNG from the ports of Jacksonville, Florida; Port Everglades, Florida; Gulfport, Mississippi; and any port in the southeastern United States capable of accommodating LNG exports by ISO containers transported on ocean-going container vessels. Carib seeks authorization to export this LNG for a 20-year period, commencing on the earlier of the date of first export or five years from the date the requested authorization is granted. The Application was filed under section 3 of the Natural Gas Act (NGA). Additional details can be found in Carib's Application, posted on the DOE/FE Web site at: http://energy.gov/sites/prod/files/2016/07/f33/CaribEnergy16_98_LNGapp.pdf.

    1 Carib clarified this requested quantity in an email to DOE/FE dated July 18, 2016.

    2 Carib clarified its proposed mode of transport in an email to DOE/FE dated August 9, 2016.

    3 The Facilities include the following: The Trussville LNG facility (Trussville, Alabama), the Chattanooga LNG facility (Chattanooga, Tennessee), the Riverdale LNG facility (Riverdale, Georgia), the Cherokee LNG facility (Ball Ground, Georgia), and the Macon LNG facility (Macon, Georgia). Specifically, Carib states that it “will purchase” LNG from the Trussville and Chattanooga LNG facilities, and that, in the future, Pivotal “also would have the ability to source LNG” for sale to Carib from the other three Facilities, subject to any applicable regulatory approvals. App. at 4.

    4 In Appendix C to the Application, Carib provides a summary of the Master LNG Purchase and Sale Agreement between Carib and Pivotal, dated March 12, 2014. According to Carib, that Agreement provides Carib the right to purchase a firm or interruptible supply of LNG from the Facilities of up to 1.3 Bcf/d of natural gas for a term of 20 years.

    Protests, motions to intervene, notices of intervention, and written comments are invited.

    DATES:

    Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, October 17, 2016.

    ADDRESSES:

    Electronic Filing by email: [email protected].

    Regular Mail: U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, P.O. Box 44375, Washington, DC 20026-4375.

    Hand Delivery or Private Delivery Services (e.g., FedEx, UPS, etc.): U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Howard, or Larine Moore, U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9387; (202) 586-9478.

    Edward Myers, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-3397.

    SUPPLEMENTARY INFORMATION:

    DOE/FE Evaluation

    The Application will be reviewed pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. To the extent determined to be relevant, these issues will include the domestic need for the natural gas proposed to be exported, the adequacy of domestic natural gas supply, and U.S. energy security. DOE may also consider other factors bearing on the public interest, including the impact of the proposed exports on the U.S. economy, international considerations, and whether the authorization is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of exporting domestically produced LNG:

    Effect of Increased Levels of Liquefied Natural Gas on U.S. Energy Markets, conducted by the U.S. Energy Information Administration upon DOE's request (2014 EIA LNG Export Study); 5 and

    5 The 2014 EIA LNG Export Study, published on Oct. 29, 2014, is available at: https://www.eia.gov/analysis/requests/fe/.

    The Macroeconomic Impact of Increasing U.S. LNG Exports, conducted jointly by the Center for Energy Studies at Rice University's Baker Institute for Public Policy and Oxford Economics, on behalf of DOE (2015 LNG Export Study).6

    6 The 2015 LNG Export Study, dated Oct. 29, 2015, is available at: http://energy.gov/sites/prod/files/2015/12/f27/20151113_macro_impact_of_lng_exports_0.pdf.

    Additionally, DOE will consider the following environmental document:

    Addendum to Environmental Review Documents Concerning Exports of Natural Gas From the United States, 79 FR 48132 (Aug. 15, 2014).7

    7 The Addendum and related documents are available at http://energy.gov/fe/addendum-environmental-review-documents-concerning-exports-natural-gas-united-states.

    Parties that may oppose this Application should address these issues in their comments and/or protests, as well as other issues deemed relevant to the Application.

    The National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., requires DOE to give appropriate consideration to the environmental effects of its proposed decisions. No final decision will be issued in this proceeding until DOE has met its environmental responsibilities.

    Public Comment Procedures

    In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Due to the complexity of the issues raised by the Applicant, interested persons will be provided 60 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention.

    Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.

    Filings may be submitted using one of the following methods: (1) Emailing the filing to [email protected], with FE Docket No. 16-98-LNG in the title line; (2) mailing an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES; or (3) hand delivering an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES. All filings must include a reference to FE Docket No. 16-98-LNG. PLEASE NOTE: If submitting a filing via email, please include all related documents and attachments (e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner. Any hardcopy filing submitted greater in length than 50 pages must also include, at the time of the filing, a digital copy on disk of the entire submission.

    A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.

    The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

    The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address: http://www.fe.doe.gov/programs/gasregulation/index.html.

    Issued in Washington, DC, on August 11, 2016. John A. Anderson, Director, Office of Regulation and International Engagement, Office of Oil and Natural Gas.
    [FR Doc. 2016-19618 Filed 8-16-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-98-000] Notice of Institution of Section 206 Proceeding and Refund Effective Date: Elwood Energy, LLC, Exelon Generation Company, LLC

    On August 10, 2016, the Commission issued an order in Docket No. EL16-98-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of the Elwood Facility's reactive power rates. Elwood Energy, LLC, et al., 156 FERC ¶ 61,104 (2016).

    The refund effective date in Docket No. EL16-98-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

    Any interested person desiring to be heard in Docket No. EL16-98-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.

    Dated: August 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-19571 Filed 8-16-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2398-004; ER10-2399-004; ER10-2423-007; ER10-2404-007; ER14-1933-004; ER10-2406-005; ER10-2408-004; ER10-2409-004; ER10-2410-004; ER10-2411-005; ER10-2412-005; ER10-2414-005; ER11-2935-006; ER13-1816-004.

    Applicants: Blackstone Wind Farm, LLC, Blackstone Wind Farm II LLC, Flat Rock Windpower LLC, Flat Rock Windpower II LLC, Headwaters Wind Farm LLC, High Trail Wind Farm, LLC, Marble River, LLC, Meadow Lake Wind Farm II LLC, Meadow Lake Wind Farm III LLC, Meadow Lake Wind Farm IV LLC, Meadow Lake Wind Farm LLC, Old Trail Wind Farm, LLC, Paulding Wind Farm II LLC, Sustaining Power Solutions LLC.

    Description: Notice of Non-Material Change in Status of Blackstone Wind Farm, LLC, et al.

    Filed Date: 8/10/16.

    Accession Number: 20160810-5257.

    Comments Due: 5 p.m. ET 8/31/16.

    Docket Numbers: ER10-2564-006; ER10-2600-006; ER10-2289-006.

    Applicants: Tucson Electric Power Company, UNS Electric, Inc., UniSource Energy Development Company.

    Description: Second Supplement to December 31, 2015 Triennial Market Power Update for the Southwest Region of the Fortis, Inc. subsidiaries, et al.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5192.

    Comments Due: 5 p.m. ET 10/11/16.

    Docket Numbers: ER16-736-004.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Compliance filing to July 11, 2016 order in Docket Nos. ER16-736 and EL16-96 to be effective 4/14/2016.

    Filed Date: 8/10/16.

    Accession Number: 20160810-5207.

    Comments Due: 5 p.m. ET 8/31/16.

    Docket Numbers: ER16-1827-001.

    Applicants: GenOn Energy Management, LLC.

    Description: Tariff Amendment: Response to Deficiency Letter to be effective 6/1/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5090.

    Comments Due: 5 p.m. ET 9/1/16.

    Docket Numbers: ER16-2400-000.

    Applicants: PacifiCorp.

    Description: Compliance filing: OATT Revised Attachments N & O (Orders 827 & 828) to be effective 10/14/2016.

    Filed Date: 8/10/16.

    Accession Number: 20160810-5208.

    Comments Due: 5 p.m. ET 8/31/16.

    Docket Numbers: ER16-2401-000.

    Applicants: PJM Interconnection, LLC.

    Description: Compliance filing: Compliance filing to July 11, 2016 order in Docket Nos. ER16-736 and EL16-96 to be effective 10/10/2016.

    Filed Date: 8/10/16.

    Accession Number: 20160810-5217.

    Comments Due: 5 p.m. ET 8/31/16.

    Docket Numbers: ER16-2402-000.

    Applicants: UGI Utilities Inc.

    Description: Market-Based Triennial Review Filing: Triennial Market Power Analyses and Change in Status to be effective 10/10/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5051.

    Comments Due: 5 p.m. ET 10/11/16.

    Docket Numbers: ER16-2403-000.

    Applicants: UGI Development Company.

    Description: Market-Based Triennial Review Filing: Triennial Market Power Analyses and Change in Status to be effective 10/10/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5054.

    Comments Due: 5 p.m. ET 10/11/16.

    Docket Numbers: ER16-2404-000.

    Applicants: UGI Energy Services, Inc.

    Description: Market-Based Triennial Review Filing: Triennial Market Power Analyses and Change in Status to be effective 10/10/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5056.

    Comments Due: 5 p.m. ET 10/11/16.

    Docket Numbers: ER16-2405-000.

    Applicants: NRG Rockford II LLC.

    Description: Section 205(d) Rate Filing: Notice of Succession and Revisions to Market-Based Rate Tariff to be effective 7/14/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5123.

    Comments Due: 5 p.m. ET 9/1/16.

    Docket Numbers: ER16-2406-000.

    Applicants: NRG Rockford LLC.

    Description: § 205(d) Rate Filing: Notice of Succession and Revisions to Market-Based Rate Tariff to be effective 7/13/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5124.

    Comments Due: 5 p.m. ET 9/1/16.

    Docket Numbers: ER16-2407-000.

    Applicants: Consumers Energy Company, Midcontinent Independent System Operator, Inc.

    Description: Section 205(d) Rate Filing: 2016-08-11_SA 2913 WPSC-Consumers Amended FCA (J392) to be effective 4/8/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5141.

    Comments Due: 5 p.m. ET 9/1/16.

    Docket Numbers: ER16-2408-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Notice of Termination of Large Generator Interconnection Agreement designated Project No. G686, Original Service Agreement No. 1882 of Midcontinent Independent System Operator, Inc.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5152.

    Comments Due: 5 p.m. ET 9/1/16.

    Docket Numbers: ER16-2409-000.

    Applicants: Aurora Generation, LLC.

    Description: Section 205(d) Rate Filing: Notice of Succession and Revised Rate Schedule to be effective 7/12/2016.

    Filed Date: 8/11/16.

    Accession Number: 20160811-5191.

    Comments Due: 5 p.m. ET 9/1/16.

    Take notice that the Commission received the following public utility holding company filings:

    Docket Numbers: PH16-12-000.

    Applicants: New Jersey Resources Corporation.

    Description: New Jersey Resources Corporation submits FERC 65-A Notice of Non Material Change in Facts of Exemption Notification.

    Filed Date: 8/10/16.

    Accession Number: 20160810-5224.

    Comments Due: 5 p.m. ET 8/31/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 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: August 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-19568 Filed 8-16-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of FERC Staff Attendance at the Entergy Regional State Committee Meeting

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of its staff may attend the meeting noted below. Their attendance is part of the Commission's ongoing outreach efforts.

    Entergy Regional State Committee August 19, 2016 (9:30 a.m.-12:30 p.m. Central)

    This meeting will be held at the Capital Hotel, 111 West Markham St., Little Rock, AR 72201.

    The discussions may address matters at issue in the following proceedings:

    Docket No. EL95-33—Louisiana Public Service Commission et al. v. Entergy Corp. et al.

    Docket No. EL00-66—Louisiana Public Service Commission, et al. v. Entergy Corp., et al.

    Docket No. EL01-88—Louisiana Public Service Commission v. Entergy Services, Inc.

    Docket No. EL09-61—Louisiana Public Service Commission v. Entergy Services, Inc.

    Docket No. EL10-65—Louisiana Public Service Commission v. Entergy Services, Inc.

    Docket No. EL14-19—Midcontinent Independent System Operator and Entergy Services, Inc.

    Docket No. EL16-7—City of Osceola, Arkansas v. Entergy Arkansas, Inc.

    Docket No. ER10-1350—Entergy Arkansas, Inc.

    Docket No. ER13-432—Entergy Arkansas, Inc.

    Docket No. ER13-948—Entergy Arkansas, Inc.

    Docket No. ER13-1195—Entergy Arkansas, Inc.

    Docket No. ER13-1508—Entergy Arkansas, Inc.

    Docket No. ER13-1509—Entergy Gulf States Louisiana, L.L.C.

    Docket No. ER13-1510—Entergy Louisiana, LLC.

    Docket No. ER13-1511—Entergy Mississippi, Inc.

    Docket No. ER13-1512—Entergy New Orleans, Inc.

    Docket No. ER13-1513—Entergy Texas, Inc.

    Docket No. ER14-649—Midcontinent Independent System Operator, Inc.

    Docket No. ER14-693—Entergy Services, Inc.

    Docket No. ER14-694—Entergy Services, Inc.

    Docket No. ER14-695—Entergy Services, Inc.

    Docket No. ER14-696—Entergy Services, Inc.

    Docket No. ER14-697—Entergy Services, Inc.

    Docket No. ER14-699—Entergy Services, Inc.

    Docket No. ER14-700—Entergy Services, Inc.

    Docket No. ER14-701—Entergy Services, Inc.

    Docket No. ER14-702—Entergy Arkansas, Inc.

    Docket No. ER14-703—Entergy Services, Inc.

    Docket No. ER14-704—Entergy Services, Inc.

    Docket No. ER14-1640—Entergy Gulf States Louisiana, L.L.C

    Docket No. ER14-1641—Entergy Louisiana, LLC.

    Docket No. ER14-1642—Entergy Mississippi, Inc.

    Docket No. ER14-1643—Entergy New Orleans, Inc.

    Docket No. ER14-1644—Entergy Texas, Inc.

    Docket No. ER14-2850—Southwest Power Pool, Inc.

    Docket No. ER14-2851—Southwest Power Pool, Inc.

    Docket No. ER15-1436—Entergy Gulf States Louisiana, L.L.C.

    Docket No. ER15-1453—Entergy Arkansas, Inc.

    Docket No. ER15-1826—Entergy Services, Inc.

    Docket No. ER16-227—Entergy Arkansas, Inc.

    Docket No. ER16-1087—Entergy New Orleans, Inc.

    Docket No. ER16-1251—Entergy Louisiana, LLC.

    Docket No. ER16-1316—Entergy Services, Inc.

    Docket No. ER16-1528—Entergy Arkansas, Inc.

    Docket No. ER16-1806—Entergy Services, Inc.

    Docket No. ER16-1965—Entergy Louisiana, LLC.

    Docket No. ER16-2034—Entergy Louisiana, LLC.

    Docket No. ER16-2124—Entergy New Orleans, Inc.

    Docket No. ER16-2125—Entergy Louisiana, LLC.

    Docket No. ER16-2199—Entergy Arkansas, Inc.

    Docket No. ER16-2200—Midcontinent Independent System Operator, Inc.

    These meetings are open to the public.

    For more information, contact Patrick Clarey, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (317) 249-5937 or [email protected]

    Dated: August 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-19572 Filed 8-16-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP16-487-000, PF15-32-000] Northern Natural Gas Company; Notice of Application

    Take notice that on July 29, 2016, Northern Natural Gas Company (Northern), 1111 South 103rd Street, Omaha, Nebraska 68124-1000, filed in Docket No. CP16-487-000 an application pursuant to section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's Regulations, requesting authorization to construct and operate 7.86-mile-long 20-inch-diameter pipeline with appurtenances located in Dakota County, Minnesota (Cedar Station Upgrade Project). Northern also requests a predetermination of rolled-in rate treatment, all as more fully set forth in the application which is on file with the Commission and open to public inspection.

    The filing may also be viewed on the web 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 TTY, contact (202) 502-8659.

    Any questions concerning this application may be directed to Michael T. Loeffler, Senior Director, Certificates and External Affairs for Northern, 1111 South 103rd Street, Omaha, Nebraska 68124, or by calling (402) 398-7103.

    Specifically, Northern designed the Cedar Station Upgrade Project to increase the delivery pressure at Northern's existing Cedar Station located in Eagan, Minnesota, in accordance with a contractual obligation for Northern States Power Company (NSP-MN). The proposed pipeline will originate at Northern's existing Rosemount Junction facility in Rosemount, Minnesota and extend to its existing Cedar Station. Northern states that due to mainline constraints upstream of the branch line, the proposed project is not expected to generate incremental capacity that can be sold. The requested order date and proposed in-service date are March 17, 2017 and November 1, 2017 respectively. The project cost is estimated at $49,865,629.

    On October 9, 2015, the Commission staff granted Northern's request to utilize the Pre-Filing Process and assigned Docket No. PF15-32-000 to staff activities involved in the above referenced project. Now, as of the filing of the July 29, 2016 application, the Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP16-487-000, as noted in the caption of this Notice.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit original and five copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Comment Date: 5:00 p.m. Eastern Time on September 1, 2016.

    Dated: August 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-19570 Filed 8-16-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP16-486-000, PF16-3-000] Notice of Application Millennium Pipeline Company, LLC

    Take notice that on July 29, 2016, Millennium Pipeline Company (Millennium), One Blue Hill Plaza, Pearl River, New York 10965, filed in Docket No. CP16-486-000 an application pursuant to section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's Regulations, requesting a certificate of public convenience and necessity authorizing their Eastern System Upgrade Project. This project will provide an additional 223 million cubic feet per day (MMcf/d) of firm transportation capacity from Millennium's Corning Compressor Station (CS) to an existing interconnection with Algonquin Gas Transmission, LLC located in Ramapo, New York, all as more fully set forth in the application which is on file with the Commission and open to public inspection.

    The filing may also be viewed on the web 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 TTY, contact (202) 502-8659.

    Any questions concerning this application may be directed to Georgia Carter, Vice President and General Counsel, Millennium Pipeline Company, LLC, 109 North Post Oak Lane, Suite 210, Houston, TX 77024, by calling 804-921-1408, or emailing [email protected]

    Specifically, Millennium proposes to construct, operate, and maintain (1) Approximately 7.8-miles of 30- and 36-inch-diameter pipeline loop in Orange County, New York; (2) a new 22,400 horsepower (HP) compressor station in Sullivan County, New York; (3) additional 22,400 HP at the existing Hancock Compressor Station in Delaware County, New York; (4) modifications to the existing Ramapo Meter and Regulator Station in Rockland County, New York; (5) modifications to the Wagoner Interconnect in Orange County, New York; (6) additional pipeline appurtenant facilities at the existing Huguenot and Westtown Meter and Regulating Stations in Orange County, New York; and (7) an alternate interconnect to the 16-inch-diameter Valley Lateral at milepost 7.6 of the Project.

    Millennium states that 202.5 MMcf/d of project capacity is committed under precedent agreements with local distribution companies and municipalities. Millennium requests that that the Commission issue the requested authorizations by July 31, 2017, in order to allow Millennium sufficient time to meet a targeted in-service date in September 2018. Millennium proposes to charge negotiated rates to its project shippers and existing Rate Schedule FT-1 rates for service on the expansion capacity created by the project. The cost of the project is $275,000,000.

    On February 5, 2016, the Commission staff granted Millennium's request to utilize the Pre-Filing Process and assigned Docket No. PF16-3-000 to staff activities involved in the above referenced project. Now, as of the filing of the July 29, 2016 application, the Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP16-486-000, as noted in the caption of this Notice.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit original and five copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Comment Date: 5 p.m. Eastern Time on September 1, 2016.

    Dated: August 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-19569 Filed 8-16-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9950-99-OGC; EPA-HQ-OGC-2016-0364] Proposed Consent Decree, Clean Air Act Citizen Suit AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Supplemental notice of proposed consent decree; request for public comment.

    SUMMARY:

    Supplemental notice is hereby given for the Wyoming portions of a proposed consent decree to address a lawsuit filed by the Sierra Club (“Plaintiff”) in the United States District Court for the Northern District of California: Sierra Club v. Gina McCarthy, No. 3:15-cv-04328-JD (N.D. Cal.). On September 22, 2015, Plaintiffs filed this matter against Gina McCarthy, in her official capacity as Administrator of the United States Environmental Protection Agency (“EPA”). On February 9, 2016, Plaintiff filed a first amended complaint alleging that, with respect to the 2008 ozone national ambient air quality standards (“NAAQS”), EPA has failed to perform non-discretionary duties to take final action on portions of the state implementation plan (“SIP”) submission from Wyoming intended to address various interstate transport requirements. The proposed consent decree would establish a deadline for EPA to take certain specified actions.

    DATES:

    Written comments on the Wyoming portions of the proposed consent decree must be received by September 1, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID number EPA-HQ-OGC-2016-0364, online at www.regulations.gov. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the “For Further Information Contact” section. For 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:

    Zachary Pilchen, Air and Radiation Law Office, Office of General Counsel, U.S. Environmental Protection Agency; telephone: (202) 564-2812; fax number (202) 564-5603; email address: [email protected]

    SUPPLEMENTARY INFORMATION: I. Additional Information About the Proposed Consent Decree and This Supplemental Notice With Regard to Wyoming

    This proposed consent decree would resolve a lawsuit filed by Plaintiffs seeking to compel the Administrator to take action under Clean Air Act (“CAA”) section 110(k)(2)-(4). As relevant to this supplemental notice, Plaintiffs allege that the Administrator has failed to perform a non-discretionary duty to take final action on portions of Wyoming's SIP submission intended to address the requirements of 42 U.S.C. 7410(a)(2)(D)(i) for the 2008 ozone NAAQS.

    EPA previously published notice of this proposed consent decree on June 29, 2016.1 The “Summary” section of that notice listed a number of states with SIP submissions relevant to the proposed consent decree and notice, including Wyoming. The proposed consent decree itself—to which the notice directed readers for more details—included the specific claims and dates relevant to Wyoming. The Wyoming Department of Environmental Quality (“WDEQ”) submitted comments on the proposed consent decree, including with respect to those proposed consent decree dates, which WDEQ accurately characterized as “Proposed Consent Decree Deadlines Applicable to Wyoming's Submittal.” 2

    1 81 FR 42351 (June 29, 2016).

    2See Comment of WDEQ at 1, Docket No. EPA-HQ-OGC-2016-0364-0004.

    A separate part of that June 29, 2016 notice, however, included a scrivener's error. In the “Supplementary Information” section, the notice briefly summarized (in alphabetical order by state) the allegations regarding SIP submissions. As WDEQ noted in its comment letter, despite Wyoming's inclusion in the “Summary” section of the notice, the “Supplementary Information” section did not list Wyoming, and instead listed Wisconsin as both of the two final states.3 The second reference to Wisconsin was a scrivener's error that should have referred to Wyoming, as WDEQ correctly concluded in its comments on the proposed consent decree deadlines for Wyoming.

    3See 81 FR at 42351, col. 3.

    WDEQ commented, however, that as a result of this error the notice was “unclear” about “what allegation details” apply to Wyoming.4 CAA section 113(g) requires notice of a proposed consent decree; supplementary information about the allegations is not required. However, as a courtesy and out of an abundance of caution, for a period of fifteen (15) days following the date of publication of this supplemental notice, the Agency will accept written comments relating solely to the Wyoming portions of the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the Wyoming portions of the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn, the terms of the consent decree will be affirmed.

    4 Comment of WDEQ at 1.

    II. Additional Information About Commenting on the Proposed Consent Decree A. How can I get a copy of the proposed consent decree?

    The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2016-0364) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

    An electronic version of the public docket is available through www.regulations.gov. You may use the www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

    It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at www.regulations.gov without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute is not included in the official public docket or in the electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.

    B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

    If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

    Use of the www.regulations.gov Web site to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment. In contrast to EPA's electronic public docket, EPA's electronic mail (email) system is not an “anonymous access” system. If you send an email comment directly to the Docket without going through www.regulations.gov, your email address is automatically captured and included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

    Dated: August 10, 2016. Lorie J. Schmidt, Associate General Counsel.
    [FR Doc. 2016-19638 Filed 8-16-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9951-00-OGC; EPA-HQ-OGC-2016-0480] Proposed Consent Decree, Clean Air Act Citizen Suit AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of proposed consent decree; request for public comment.

    SUMMARY:

    In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), 42 U.S.C. 7413(g), notice is hereby given of a proposed consent decree to address a lawsuit filed by Concerned Citizens of Seneca County, Inc. and Dixie D. Lemmon, (collectively “Plaintiffs”): Concerned Citizens of Seneca County, Inc. v. McCarthy, No. 6:16-cv-06196 (W.D.N.Y.). On March 25, 2016, Plaintiffs filed the complaint in this case alleging that Gina McCarthy, in her official capacity as Administrator of the United States Environmental Protection Agency (“EPA”), failed to perform a non-discretionary duty to grant or deny within 60 days a petition submitted by Plaintiffs. In their petition, Plaintiffs requested that EPA object to a CAA Title V permit issued by the New York State Department of Environmental Conservation to the Seneca County Landfill Gas-to-Energy Facility, for purposes of operating a landfill gas-to-energy facility in Seneca Falls, New York. The proposed consent decree would establish a deadline for EPA to respond to this petition.

    DATES:

    Written comments on the proposed consent decree must be received by September 16, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID number EPA-HQ-OGC-2016-0480, online at www.regulations.gov (EPA's preferred method); by email to [email protected]; by mail to EPA Docket Center, Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; or by hand delivery or courier to EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday, excluding legal holidays. Comments on a disk or CD-ROM should be formatted in Word or ASCII file, avoiding the use of special characters and any form of encryption, and may be mailed to the mailing address above.

    FOR FURTHER INFORMATION CONTACT:

    Zachary Pilchen, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW. Washington, DC 20460; telephone: (202) 564-2812; fax number (202) 564-5603; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Additional Information About the Proposed Consent Decree

    This proposed consent decree would resolve a lawsuit filed by Plaintiffs seeking to compel the Administrator to take actions under CAA section 505(b)(2). Under the terms of the proposed consent decree, EPA would agree to sign a response to the petition by December 9, 2016. The proposed consent decree also provides for the possibility that certain circumstances could delay compliance with the December 9, 2016 deadline, and provides a framework for extending that deadline. In addition, the proposed consent decree also establishes a framework for resolving any request for costs of litigation, including attorney fees, and provides that after such resolution the proposed consent decree will be terminated and the case dismissed.

    For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn or withheld, the terms of the consent decree will be affirmed.

    II. Additional Information About Commenting on the Proposed Consent Decree A. How can I get a copy of the proposed consent decree?

    The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2016-0480) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

    An electronic version of the public docket is available through www.regulations.gov. You may use the www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

    It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at www.regulations.gov without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. Information claimed as CBI and other information whose disclosure is restricted by statute is not included in the official public docket or in the electronic public docket. EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.

    B. How and to whom do I submit comments?

    You may submit comments as provided in the ADDRESSES section. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

    If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

    Use of the www.regulations.gov Web site to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment. In contrast to EPA's electronic public docket, EPA's electronic mail (email) system is not an “anonymous access” system. If you send an email comment directly to the Docket without going through www.regulations.gov, your email address is automatically captured and included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.

    Dated: August 10, 2016. Lorie J. Schmidt, Associate General Counsel.
    [FR Doc. 2016-19639 Filed 8-16-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2016-0310; FRL-9950-76] Plant-Incorporated Protectants: Proposed Modifications of Registration Procedures for Plant-Incorporated Protectants in Breeding Line Intermediates; Notice of Availability; Extension of Comment Period AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; extension of comment period.

    SUMMARY:

    EPA issued a notice in the Federal Register of June 30, 2016, concerning the availability for public comment of a White Paper describing how the Agency is proposing to modify its current approach to plant-incorporated protectants in breeding line intermediates under section 3 of the Federal Insecticide, Fungicide and Rodenticide Act. This document extends the comment period for 45 days, from August 15, 2016 to September 29, 2016. Stakeholders have expressed a desire to comment on EPA's proposal and have requested additional time to review the proposal and respond.

    DATES:

    Comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0310, must be received on or before September 29, 2016.

    ADDRESSES:

    Follow the detailed instructions provided under ADDRESSES in the Federal Register document of June 30, 2016 (81 FR 42704) (FRL-9947-25).

    FOR FURTHER INFORMATION CONTACT:

    Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    This document extends the public comment period established in the Federal Register document of June 30, 2016 (81 FR 42704) (FRL-9947-25). In that document, EPA makes available for public comment a White Paper describing how the Agency is proposing to modify its current approach to plant-incorporated protectants in breeding line intermediates under Section 3, Registration of Pesticides, of the Federal Insecticide, Fungicide and Rodenticide Act. EPA is hereby extending the comment period, which was set to end on August 15, 2016, to September 29, 2016.

    To submit comments, or access the docket, please follow the detailed instructions provided under ADDRESSES in the Federal Register document of June 30, 2016. If you have questions, consult the person listed under FOR FURTHER INFORMATION CONTACT.

    Authority:

    7 U.S.C. 136 et seq.

    Dated: August 11, 2016. Robert C. McNally, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.
    [FR Doc. 2016-19646 Filed 8-16-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL MARITIME COMMISSION [Docket No. 16-16] MAVL Capital, Inc., IAM & AL Group Inc., and Maxim Ostrovskiy V. Marine Transport Logistics, Inc. and Dimitry Alper: Notice of Filing of Complaint and Assignment

    Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by MAVL Capital, Inc. (“MAVL”), IAM & AL GROUP INC. (“IAM”), and Maxim Ostrovskiy, hereinafter “Complainants,” against Marine Transport Logistics, Inc. (“MTL”) and Dimitry Alper, hereinafter “Respondents.” Complainants allege that Respondents are a non-vessel-operating common carrier (“NVOCC”) licensed by the Commission and its director of operations, “engaged in the business of exporting used cars, motorcycles, and other cargo . . . from the United States to ports abroad.” Complainants allege that they had a business relationship with Respondents, having hired Respondents to ship Complainants' vehicles.

    Complainants allege that Respondents violated provisions of the Shipping Act of 1984, including 46 U.S.C. 41102, 41101 and 46 CFR part 515, by:

    “i. Failing to establish, observe, and enforce just and reasonable regulations and practices relating to or connected with receiving, handling, storing, or delivering property;

    ii. Unreasonably refusing to deal or negotiate;

    iii. Retaliating against Complainants because the Complainants had patronized another carrier;

    iv. Knowingly misdelivering Complainants' cargo; and

    v. Converting Complainants' cargo under the false premise of having exercised a maritime lien.”

    Complainants allege damages “in excess of $180,000” and request the following relief:

    “(1) Respondents be required to answer the charges herein; (2) that after due hearing, an order be made commanding said respondent to pay to Complainants by way of reparations for the unlawful conduct hereinabove described, the sums described herein, with interest and attorney's fees, costs and expenses, or such other sum as the Commission may determine to be proper as an award of reparation; (3) that the Commission issue an Order holding that the respondents Dimitry Alper individually, and Marine Transport Logistics, Inc. violated the Shipping Act of 1984; and (4) that the Commission issue such other and further order or orders as the Commission determines to be just and proper.”

    The full text of the complaint can be found in the Commission's Electronic Reading Room at www.fmc.gov/16-16.

    This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by August 11, 2017 and the final decision of the Commission shall be issued by February 26, 2018.

    Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2016-19653 Filed 8-16-16; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL MARITIME COMMISSION Notice of Agreements Filed

    The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of the agreements are available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or [email protected]

    Agreement No.: 011223-053.

    Title: Transpacific Stabilization Agreement.

    Parties: American President Lines, Ltd. and APL Co. PTE Ltd.; (operating as a single carrier); Maersk Line A/S; CMA CGM, S.A.; COSCO Container Lines Company Ltd; Evergreen Line Joint Service Agreement; Hanjin Shipping Co., Ltd.; Hapag-Lloyd AG; Hyundai Merchant Marine Co., Ltd.; Mediterranean Shipping Company; Nippon Yusen Kaisha; Orient Overseas Container Line Limited; Yangming Marine Transport Corp.; and Zim Integrated Shipping Services, Ltd.

    Filing Party: David F. Smith, Esq.; Cozen O'Conner; 1200 Nineteenth Street NW.; Washington, DC 20036.

    Synopsis: The amendment removes Kawasaki Kisen Kaisha Ltd. as a party to the Agreement effective August 19, 2016.

    By Order of the Federal Maritime Commission.

    Dated: August 12, 2016. Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2016-19633 Filed 8-16-16; 8:45 am] BILLING CODE 6731-AA-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 September 12, 2016.

    A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528. Comments can also be sent electronically to or [email protected]:

    1. First Bancorp, Southern Pines, North Carolina; to acquire 100 percent of the voting securities of Carolina Bank Holdings, Inc., Greensboro, North Carolina, and thereby indirectly acquire Carolina Bank, Greensboro, North Carolina.

    Board of Governors of the Federal Reserve System, August 12, 2016. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2016-19620 Filed 8-16-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.

    Final approval under OMB delegated authority of the extension for three years, with revision, of the following reports:

    1. Report title: Savings and Loan Holding Company Registration Statement.

    Agency form number: FR LL-10(b).

    OMB control number: 7100-0337.

    Frequency: As needed.

    Respondents: Newly Formed Savings and Loan Holding Companies.

    Estimated number of respondents: 3.

    Estimated average hours per response: 8 hours.

    Estimated annual burden hours: 24.

    General Description of Report: The FR LL-10(b) includes information on the financial condition, ownership, operations, management, and intercompany relationships of the SLHC and its subsidiaries.

    Federal Reserve staff review the FR LL-10(b) to assess the adequacy of responses to items, disclosure of pertinent facts, and completeness in all material respects. This includes information concerning the date of consummation of transactions and the number of shares acquired.

    Legal authorization and confidentiality: The Boards' Legal Division has determined that FR LL-10(b) is authorized by section 10(b)(1) of the HOLA and Regulation LL, 12 CFR 238.4(c). Section 10(b) of the Home Owners' Loan Act, as amended (HOLA), 12 U.S.C. 1467a(b)(1), provides that each SLHC is required to register with the Federal Reserve within 90 days of becoming an SLHC on forms prescribed by the Board that contain such information as the Board may deem necessary or appropriate. The Board is therefore authorized to collect information on this form pursuant to section 10(b) of HOLA. The obligation to respond is mandatory, as described in the previous paragraph. Information contained in the FR LL-10(b) is not considered confidential. If an SLHC wishes to claim confidential treatment for any information submitted on or with the form, it would need to describe the circumstances and provide a justification for the withholding of the information consistent with the Freedom of Information Act, 5 U.S.C. 552.

    Current Actions: On June 1, 2016, the Federal Reserve published a notice in the Federal Register (81 FR 35015) requesting public comment for 60 days on the extension of the FR LL-10(b). The comment period for this notice expired on August 1, 2016. The Federal Reserve did not receive any comments. The revisions will be implemented as proposed.

    2. Report title: Notice of Proposed Declaration of Dividend.

    Agency form number: FR 1583.

    OMB control number: 7100-0339.

    Frequency: As needed.

    Respondents: Savings and Loan Holding Companies.

    Estimated number of respondents: 133.

    Estimated average hours per response: 16.5 minutes.

    Estimated annual burden hours: 73.

    General Description of Report: Savings association subsidiaries of SLHCs provide prior notice of a dividend by filing form FR 1583 that requires information on (1) the date of the filing, (2) the nature and amount of the proposed dividend declaration, and (3) the names and signatures of the executive officer and secretary of the savings association that have provided the notice. The savings association subsidiary must file this prior notice at least 30 days before the proposed declaration of a dividend by its board of directors. This notice may include a schedule proposing dividends of over a specified period, up to 12 months. The statute also provides that the 30-day period commences on the date of receipt of the complete record of the notice by the Federal Reserve. The Federal Reserve Board may request additional information or may impose conditions for the dividend and may determine that such dividend does not comply with the requirements of 12 CFR part 238, subpart K.

    Legal authorization and confidentiality: The Board's Legal Division determined that FR 1583 is authorized by section 10(f) of the Home Owners' Loan Act (HOLA) and section 238.103 of Regulation LL (12 CFR 238.103). Section 10(f) of the Home Owners' Loan Act, as amended (HOLA), 12 U.S.C. 1467a(f), provides that every subsidiary savings association of an SLHC shall give the Board at least 30 days' advance notice of the proposed declaration by its directors of any stock dividend. The obligation to respond is mandatory, as described in the previous paragraph, and the Federal Reserve is authorized to collection this information by section 10(f) of HOLA. The FR 1583 collects information concerning the amount of capital that an SLHC's subsidiary savings association intends to distribute. Specifically, the form asks for the name and address of the savings association, the date of the filing, the nature and amount of the proposed dividend declaration, and the names and signatures of the executive officer and secretary of the savings association. The information collected on the FR 1583 is generally not considered confidential. It is possible that a savings association or SHLC could seek confidential treatment under FOIA exemption 4 for the nature and amount of the proposed dividend declaration, in which case the institution would need to submit a request stating that disclosure of the specific information would likely result in substantial harm to its competitive position and demonstrating the specific nature of the harm that would result from public release of the information. FOIA exemption 4 covers commercial or financial information obtained from a person that is privileged or confidential. The determination of whether confidential treatment should be granted will have be made on a case-by-case basis.

    Current Actions: On June 1, 2016, the Federal Reserve published a notice in the Federal Register (81 FR 35015) requesting public comment for 60 days on the extension, with revision, of the FR 1583. The comment period for this notice expired on August 1, 2016. The Federal Reserve did not receive any comments. The revisions will be implemented as proposed.

    Board of Governors of the Federal Reserve System, August 11, 2016. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2016-19567 Filed 8-16-16; 8:45 am] BILLING CODE 6210-01-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 September 1, 2016.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. John Ruan III, Des Moines, Iowa; Suku Radia, West Des Moines, Iowa; David J. Fisher, West Des Moines, Iowa, Thomas R. Schaefer, Stuart, Florida; and J. Landis Martin, Denver, Colorado; together as a control group acting in concert to retain the authority to vote for all of the voting shares of BTC Financial Corporation, Des Moines, Iowa, and thereby indirectly control Bankers Trust Company, Des Moines, Iowa. Messrs. Ruan, Radia, Fisher, Schaefer and Martin constitute the Family Business Advisory Board of both The Ruan Trust and The Ruan BTC Trust, both of Des Moines, Iowa, which own all of the voting shares of BTC Financial Corporation. John Ruan III is the trustee of both Trusts.

    Board of Governors of the Federal Reserve System, August 12, 2016. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2016-19619 Filed 8-16-16; 8:45 am] BILLING CODE 6210-01-P
    GENERAL SERVICES ADMINISTRATION [Notice-MA-2016-06; Docket No. 2016-0002; Sequence 21] Maximum Per Diem Reimbursement Rates for the Continental United States (CONUS) AGENCY:

    Office of Government-wide Policy (OGP), General Services Administration (GSA).

    ACTION:

    Notice of GSA Per Diem Bulletin FTR 17-01, Fiscal Year (FY) 2017 Continental United States (CONUS) per diem reimbursement rates.

    SUMMARY:

    The General Services Administration's Fiscal Year (FY) 2017 per diem reimbursement rates review has resulted in lodging and meal allowance changes for certain locations within CONUS to provide for reimbursement of Federal employees' subsistence expenses while on official travel.

    DATES:

    Effective: August 17, 2016.

    Applicability: This notice applies to travel performed on or after October 1, 2016, through September 30, 2017.

    FOR FURTHER INFORMATION CONTACT:

    For clarification of content, contact Ms. Jill Denning, Program Analyst, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202-208-7642, or by email at [email protected] Please cite Notice of GSA Per Diem Bulletin FTR 17-01.

    SUPPLEMENTARY INFORMATION:

    Background: The CONUS per diem reimbursement rates prescribed in Bulletin 17-01 may be found at www.gsa.gov/perdiem. GSA bases the maximum lodging allowance rates on the average daily rate that the lodging industry reports to an independent organization. If a maximum lodging allowance rate, and/or a meals and incidental expenses (M&IE) per diem reimbursement rate, is insufficient to meet necessary expenses in any given location, Federal executive agencies can request that GSA review that location.

    Please review numbers six and seven of GSA's per diem Frequently Asked Questions at (www.gsa.gov/perdiemfaqs) for more information on the special review process. In addition, the Federal Travel Regulation (FTR) allows for actual expense reimbursement as provided in §§ 301-11.300 through 301-11.306. For FY2017, no new non-standard area locations were added. The standard CONUS lodging allowance rate will increase from $89 to $91. The M&IE reimbursement rate tiers were not revised for FY2017. GSA issues and publishes the CONUS per diem rates, formerly published in Appendix A to 41 CFR Chapter 301, solely on the Internet at www.gsa.gov/perdiem.

    GSA also now solely publishes the M&IE meal breakdown table, which is used when employees are required to deduct meals from their M&IE reimbursement pursuant to FTR § 301-11.18, at www.gsa.gov/mie. This process, implemented in 2003 for per diem reimbursement rates, and in 2015 for the M&IE breakdown table, ensures more timely changes in per diem reimbursement rates established by GSA for Federal employees on official travel within CONUS. Notices published periodically in the Federal Register, such as this one, now constitute the only notification of revisions in CONUS per diem reimbursement rates to agencies, other than the changes posted on the GSA Web site.

    Dated: August 11, 2016. Troy Cribb, Associate Administrator, Office of Government-wide Policy.
    [FR Doc. 2016-19563 Filed 8-16-16; 8:45 am] BILLING CODE 6820-14-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-16-0199] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Importation of Etiologic Agents (42 CFR 71.54) (OMB Control No. 0920-0199, exp. 1/31/2017)—Extension—Office of Public Health Preparedness and Response (OPHPR), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Section 361 of the Public Health Service Act (42 U.S.C. 264), as amended, authorizes the Secretary of Health and Human Services to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Part 71 of Title 42, Code of Federal Regulations (Foreign Quarantine) sets forth provisions to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the United States. Subpart F—Importations—contains provisions for the importation of infectious biological agents, infectious substances, and vectors (42 CFR 71.54); requiring persons that import these materials to obtain a permit issued by the CDC.

    CDC requests Office of Management and Budget approval to collect information for three years using the Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human Disease into the United States and Application for a Permit to Import or Transport Live Bats. We are also requesting a title change to read—Application for Permit to Import Infectious Biological Agents into the United States.

    The Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human Disease into the United States form is used by laboratory facilities, such as those operated by government agencies, universities, and research institutions to request a permit for the importation of biological agents, infectious substances, or vectors of human disease. This form currently requests applicant and sender contact information; description of material for importation; facility isolation and containment information; and personnel qualifications. CDC plans to make no changes to this application.

    The Application for Permit to Import or Transport Live Bats form is used by laboratory facilities such as those operated by government agencies, universities, research institutions, and for educational, exhibition, or scientific purposes to request a permit for the importation, and any subsequent distribution after importation, of live bats. This form currently requests the applicant and sender contact information; a description and intended use of bats to be imported; and facility isolation and containment information. CDC plans to make no changes to this application.

    Estimates of burden for the survey are based on information obtained from the CDC import permit database on the number of permits issued on annual basis since 2010. The total estimated burden for the one-time data collection is 545 hours. There are no costs to respondents except their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden per
  • response
  • (in hrs.)
  • Applicants Requesting to Import Biological Agents, Infectious Substances and Vectors Application for Permit to Import Infectious Biological Agents into the United States 1625 1 20/60 Applicants Requesting to Import Live Bats Application for a Permit to Import Live Bats 10 1 20/60
    Jeffrey M. Zirger, Health Scientist, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-19598 Filed 8-16-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Title: Migrant and Seasonal Head Start Study.

    OMB No.: New Collection.

    Description: The Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing an information collection activity for the Migrant and Seasonal Head Start (MSHS) Study.

    The MSHS Study is a nationally representative study that will describe the characteristics and experiences of the children and families who enroll in MSHS and the practices and services of the MSHS programs that serve them. The findings will provide essential up-to-date information to the Office of Head Start, other federal government agencies, local MSHS programs, and the public. The study will be the first national MSHS study to include direct child assessments, which will provide valuable information about MSHS children that programs can use to inform program, center and classroom practices.

    Data collection will involve mail surveys to selected MSHS center directors and all MSHS program directors nationwide about operational characteristics, program- and center-level policies and practices, and services and resources offered to MSHS families. The study will also conduct on-site data collection with children, parents, teachers, and classrooms in a nationally-representative sample of MSHS centers. The on-site data collection will include classroom observations, teacher surveys, child reports and child assessments to obtain information on classroom instruction and practices, children's abilities and families' well-being.

    Respondents: MSHS program directors, center directors, teachers, assistant teachers, parents, and children.

    Annual Burden Estimates Instrument Total
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Estimated
  • annual
  • burden hours
  • Program Director survey 53 1 0.67 36 Center Director survey 253 1 0.67 170 Call script for Program Directors 24 1 1 24 Form for Program Directors to verify key information for selected centers 24 1 0.5 12 Call script for Center Directors 53 1 1 53 Call script for On Site Coordinators 53 1 1 53 Classroom sampling form 53 1 0.5 27 Data collection coordination efforts 53 1 20 1,060 Child roster form 53 3 0.25 40 Teacher survey 159 1 0.67 107 Teacher child report 159 8 0.17 216 Assistant Teacher survey 159 1 0.33 52 Parent consent form 1,018 1 0.25 255 Child assessments (preschoolers and older toddlers only) 848 1 0.67 568 Parent interview (including Parent child report) 1,018 1 1 1,018 Estimated Total Annual Burden Hours: 3,689

    In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, ACF Certifying Officer.
    [FR Doc. 2016-19611 Filed 8-16-16; 8:45 am] BILLING CODE 4184-22-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800] Regulatory Classification of Pharmaceutical Co-Crystals; Draft Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This draft guidance revises the guidance for industry entitled “Regulatory Classification of Pharmaceutical Co-Crystals” issued in April 2013.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 17, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2011-D-0800 for “Regulatory Classification of Pharmaceutical Co-Crystals.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Richard (Rik) Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301-796-1697.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is announcing the availability of a draft guidance for industry entitled “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance provides NDA and ANDA applicants with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.

    Co-crystals are crystalline materials composed of two or more different molecules, typically drug and co-crystal formers (“coformers”), in the same crystal lattice. Pharmaceutical co-crystals have opened up opportunities for engineering solid-state forms beyond conventional solid-state forms of an active pharmaceutical ingredient (API), such as salts and polymorphs. Co-crystals can be tailored to enhance drug product bioavailability and stability and to enhance the processability of APIs during drug product manufacture. Another advantage of co-crystals is that they generate a diverse array of solid-state forms for APIs that lack ionizable functional groups, which is a prerequisite for salt formation.

    This guidance revises the guidance for industry “Regulatory Classification of Pharmaceutical Co-Crystals” issued in April 2013, which classifies co-crystals as a drug product intermediate (or as an in-process material). This classification has contributed to uncertainty regarding the interpretation of the guidance because in a commercial setting, co-crystals are typically manufactured in drug substance facilities, yet when classified as a drug product intermediate, additional current good manufacturing practice requirements apply. Therefore, the guidance has not been conducive to the development of co-crystals. In response to this and other feedback from stakeholders, FDA has reconsidered the appropriate classification of co-crystals. This revision addresses the concern by providing information on the appropriate classification of co-crystal solid-state forms, the data that should be submitted to support the classification, and the regulatory implications of such a classification.

    This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on regulatory classification of pharmaceutical co-crystals. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. This guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 314.50(d)(1) and 314.94(a)(5) and (a)(9) have been approved under OMB control number 0910-0001.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 11, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2016-19596 Filed 8-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0144] Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request; Voluntary Qualified Importer Program Guidance for Industry 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 September 16, 2016.

    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, “Voluntary Qualified Importer Program Guidance for Industry.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A63, North Bethesda, MD 20852, [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.

    FDA's Voluntary Qualified Importer Program (VQIP); Guidance for Industry OMB Control Number 0910—NEW

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Under FSMA, those that import food have a responsibility to ensure that their suppliers produce food that meets U.S. safety standards.

    FSMA also requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods by importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified under FDA's accredited third-party audit program, as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

    Section 302 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding new section 806, Voluntary Qualified Importer Program (21 U.S.C. 384b). Section 806(a)(1) of the FD&C Act directs FDA to establish this voluntary program for the expedited review and importation of food, and to establish a process for the issuance of a facility certification to accompany food offered for importation by importers participating in VQIP. Section 806(a)(2) directs FDA to issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with VQIP.

    Accordingly, in the Federal Register of June 5, 2015 (80 FR 32136), FDA published a notice announcing the availability of a draft guidance entitled “FDA's Voluntary Qualified Importer Program,” and invited public comment regarding the guidance as well as the information collection provisions associated with the guidance (80 FR 32136 at 32138). In response to the solicitation of comments regarding the information collection provisions, the Agency received multiple comments. Two comments suggested that FDA's recordkeeping and reporting estimates were too low. Because neither comment provided justification for why the burden calculation might be too low or offered alternative calculations, we have retained our original estimates noting that, upon implementation of the program, we will again invite public comment on the information collection burden and make adjustments to our estimates accordingly. One comment attributed costs to the information collection but did not provide a basis for the calculations provided. We therefore have not adopted the comment, but again note that public input will be solicited on the information collection upon implementation of the program.

    Finally, one comment objected to the provision regarding respondents obtaining a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number and providing it to the Agency. We have determined that the DUNS number is an appropriate unique facility identifier during Foreign Supplier Verification Program (FSVP) rulemaking. We expect that most VQIP importers will also be FSVP importers and will have obtained a DUNS number.

    Description of Respondents: Respondents to the collection are importers of human or animal food.

    We estimate the burden for the collection of information as follows:

    Table 1—Estimated One-Time Recordkeeping Burden 1 Information collection activity Number of recordkeepers Number of records per recordkeeper Total one-time records Average
  • burden per
  • recordkeeping
  • Total hours
    Quality Assurance Program (QAP) preparation 200 1 200 160 32,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate it will take a VQIP applicant no longer than 10 hours to develop its QAP, including compiling its company profile, organizational structure, corporate quality policy statement, procedures for QAP implementation, food safety and food defense policies and procedures, and procedures for record retention. On average, the preparation of a QAP by a VQIP applicant is estimated at approximately 160 hours (110 + 40 + 10). In estimation of the one-time recordkeeping burden to prepare a QAP manual, we assume that VQIP importers do not already have a similar manual in place (e.g., food safety plan under the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117); food defense plan under the Focused Mitigation Strategies to Protect Food Against Intentional Adulteration regulation (IA regulation) (21 CFR part 121)). The one-time recordkeeping burden for 200 VQIP applicants to prepare QAPs is estimated at 32,000 hours (200 applicants × 160 hours/applicant) (see table 1). To the extent that some importers do have QAP manuals in place, the burden would be overestimated.

    Table 2—Estimated Annual Recordkeeping Burden 1 Information collection activity Number of recordkeepers Number of records per recordkeeper Total annual records Average
  • burden per
  • recordkeeping
  • Total hours
    QAP modification 200 1 200 16 3,200 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    A VQIP importer is expected to update its QAP on an ongoing basis. We estimate it would take 10 percent of the effort to prepare the QAP, or 16 hours, to update the QAP each year. Therefore, we estimate the annual recordkeeping burden of modification of the QAP for 200 VQIP importers at 3,200 hours (200 importers × 16 hours/importer). The VQIP food defense security criterion is similar to the Food Defense Plan requirement under § 121.126 (21 CFR 121.126) in the IA regulation. Under the IA regulation, the food defense plan must include the written identification of actionable process steps, focused mitigation strategies, procedures for monitoring, corrective action procedures, and verification procedures. Therefore, we estimate that, on average, it would take 40 hours for an applicant to prepare the food defense portion of the VQIP QAP.

    Table 3—Estimated One-Time Reporting Burden 1 Information collection activity Number of
  • respondents
  • Number of
  • responses per respondent
  • Total one-time responses Average
  • burden per
  • response
  • Total hours
    Initial VQIP application 100 1 100 80 8,000 Initial VQIP application w/additional information 100 1 100 100 10,000 Total 18,000 1 There are no capital or operating and maintenance costs associated with the collection of information.

    The guidance will inform food importers of application procedures for VQIP. We estimate that up to 200 qualified importers will be accepted in the first year of VQIP. We estimate that it will take 80 person-hours to compile all the relevant information and complete the application for the VQIP program. For the purpose of this analysis, we assume that 50 percent of all applications received will require additional information and it would take an additional 20 person-hours by the importer to provide that information. Therefore, we estimate that 100 importers will spend 8,000 hours (80 hours/importer × 100 importers) and 100 importers will spend 10,000 hours (100 hours/importer × 100 importers) to submit their initial VQIP applications for a total one-time reporting burden of 18,000 hours (see table 3).

    Table 4—Estimated Annual Reporting Burden 1 Information collection activity Number of
  • responses
  • Number of
  • responses per respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Subsequent year VQIP application 200 1 200 20 4,000 Request to reinstate participation 2 1 2 10 20 Total 4,020 1 There are no capital or operating and maintenance costs associated with the collection of information.

    The guidance states that each VQIP participant will submit to FDA a notice of intent to participate in VQIP on an annual basis. We expect that each of the expected 200 importers in VQIP would apply in the subsequent year to participate in VQIP. We expect that an application to participate in VQIP in a subsequent year will take significantly less time to prepare than the initial application. We use 25 percent of the amount of effort to prepare and submit the initial application for acceptance in VQIP. Therefore, it is expected that, on average, each VQIP importer will spend 20 hours to complete and submit a VQIP application for each subsequent year. The annual burden of completing a subsequent year application to participate in VQIP status by 200 importers is estimated at 4,000 hours (200 applications × 20 hours/application) (see table 4).

    Finally, we have added to the VQIP estimated annual reporting burden an estimate of the burden associated with importers' requests to reinstate participation in VQIP after their participation is revoked. We believe most participants will not need to use this provision, and we have included an estimate that reflects this. Upon implementation of the VQIP, we will reevaluate our estimate for future OMB submission and revise it accordingly.

    Dated: August 12, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2016-19643 Filed 8-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-5073] Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.” The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The guidance finalizes the draft guidance of the same title dated January 2016 and supplements previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” dated August 2007 (2007 Donor Eligibility Guidance).

    DATES:

    Submit either electronic or written comments on Agency guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2015-D-5073 for “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit written requests for single copies of the guidance to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

    FOR FURTHER INFORMATION CONTACT:

    Angela Moy, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background

    FDA is announcing the availability of a document entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.” The guidance provides establishments that make donor eligibility determinations for donors of HCT/Ps, with recommendations concerning the use of FDA-licensed NAT in donor testing for HBV DNA. FDA considers the use of FDA-licensed HBV NAT in testing HCT/P donors to be necessary to adequately and appropriately reduce the risk of transmission of HBV. The FDA-licensed HBV NAT can detect evidence of the viral infection at an earlier stage than the HBsAg and total anti-HBc tests. Therefore, FDA recommends the use of FDA-licensed HBV NAT for testing donors of HCT/Ps for evidence of infection with HBV.

    HBV is a major global public health concern and has been transmitted by blood transfusions and tissue transplantation. Available literature has indicated possible transmissions of HBV by hematopoietic stem cells and blood with HBV NAT positive/hepatitis B surface antibody (anti-HBs) positive/HBsAg negative blood, irrespective of anti-HBc test results. In blood donors, adding the HBV NAT testing for HBV reduces the residual risk of transmission of HBV infection beyond that which can be achieved by screening donors using only HBsAg and total anti-HBc tests. In addition, it can detect breakthrough infections in previously vaccinated individuals who are exposed to the virus, and HBV mutants appear to be more likely detected by HBV NAT than by HBsAg assays.

    In the United States, there are currently FDA-licensed HBV NAT assays intended to screen blood samples from donors of whole blood and blood components, other living donors (individual organ donors when specimens are obtained while the donor's heart is still beating), and blood specimens from cadaveric (non-heart-beating) donors. Some of these are multiplex assays that can simultaneously detect HIV, HCV, and HBV in a single blood specimen, thus improving the feasibility of routine NAT testing for HBV. By analogy to the experience in the blood donor setting, it is reasonable to expect that the residual risk of transmission of HBV infection would be reduced by adding HBV NAT to the testing strategy for HCT/P donors. HBV NAT's potential utility in further reducing risk of HBV transmission by transplantation is mainly restricted to the early HBsAg-negative phase of infection. In summary, the available scientific data and the availability of FDA-licensed assays support a recommendation that all HCT/P donors should be tested using an FDA-licensed HBV NAT.

    In the Federal Register of January 8, 2016 (81 FR 937), FDA announced the availability of the draft guidance of the same title dated January 2016. FDA received a few comments on the draft guidance and those comments were considered as the guidance was finalized. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2016 and supplements previous FDA recommendations to HCT/P establishments concerning donor testing for HBsAg and total antibody to anti-HBc, in the 2007 Donor Eligibility Guidance.

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    II. Electronic Access

    Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 11, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
    [FR Doc. 2016-19588 Filed 8-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0567] Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice, establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee of the Pediatric Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The meeting will be held on September 14, 2016, from 8 a.m. to 5:30 p.m.

    ADDRESSES:

    DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 Wisconsin Ave., Bethesda, MD 20814, 301-652-2000. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at www.doubletreebethesda.com/. You may submit your comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party many not wish to be posted, such as medical information, you or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions”.

    Instructions: All submissions received must include either the Docket No. FDA-2016-N-0567 for the “Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments”; or the Docket No. FDA-2016-N-2470 for the “Pediatric-focused Safety Reviews”, which will be posted on the Internet, but not presented at the Pediatric Advisory Committee meeting. Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information thatyou do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential”. Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, [email protected] or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

    SUPPLEMENTARY INFORMATION:

    Agenda: On September 14, 2016, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act (Pub. L. 108-155). Comments about the up-coming September advisory committee meeting should be submitted to Docket No. FDA-2016-N-0567.

    The PAC will meet to discuss the following products (listed by FDA Center):

    1. Center for Biologics Evaluation and Research a. MENVEO (Meningococcal (groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) b. IXIARO (Japanese encephalitis vaccine) 2. Center for Drug Evaluation and Research a. ASACOL & ASACOL HD (mesalamine) b. BLOXIVERZ (neostigmine methylsulfate) c. DELZICOL (mesalamine) d. DORYX (doxycycline hyclate) e. KARBINAL ER (carbinoxamine maleate) f. KEPIVANCE (palifermin) g. SUSTIVA (efavirenz) h. TOPAMAX (topiramate) i. XOLAIR (omalizumab) 3. Center for Devices and Radiological Health a. ELANA SURGICAL KIT (HUD) b. BERLIN HEART EXCOR® Pediatric Ventricular Assist Device (VAD) c. ENTERRATM THERAPY SYSTEM d. CONTEGRA PULMONARY VALVED CONDUIT e. PLEXIMMUNE

    FDA will also provide an update of their additional ongoing analysis of a possible safety signal regarding the use of the drug product Exjade (deferasirox) in children with fever and dehydration that was discussed at the September 2015 PAC meeting.

    For the products to be discussed at the PAC meeting, FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material will be available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 7, 2016. Oral presentations from the public will be scheduled between approximately 8:30 a.m. to 9:30 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 30, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 31, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA is establishing a docket for public comment for the PAC meeting. The docket number is FDA-2016-N-0567. The docket will close on August 31, 2016. Comments received on or before August 31, 2016, will be provided to the committee. Comments received after the date will be taken into consideration by the Agency.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Marieann Brill at least 7 days in advance of the meeting.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Additional Pediatric-focused Safety Reviews: FDA will make available additional pediatric safety review reports for selected products at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm510701.htm. FDA is establishing a second public docket to receive input on additional pediatric-focused safety reviews that will be posted on the Internet. The docket number is FDA-2016-N-2470; the docket will open on September 12, 2016, and remain open until September 23, 2016. These safety review reports are for the following products:

    1. BARACLUDE (entecavir) 2. ISENTRESS (raltegravir potassium) 3. LYSTEDA (tranexamic acid) 4. SALONPAS Pain Relief Patch (methyl salicylate 10% and l-menthol 3%). Dated: August 11, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs.
    [FR Doc. 2016-19589 Filed 8-16-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service National Indian Health Outreach and Education II Program; Correction AGENCY:

    Indian Health Service, HHS.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Indian Health Service published a document in the Federal Register on July 15, 2016, for the Fiscal Year 2016 National Indian Health Outreach and Education II Program. The notice contained an incorrect Announcement Number.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Michelle EagleHawk, Deputy Director, Office of Direct Service and Contracting Tribes, 5600 Fishers Lane, Mail Stop: 8E17, Rockville, Maryland 20857, Telephone: (301) 443-1104, email: [email protected] (This is not a toll-free number.)

    Correction

    In the Federal Register of July 15, 2016, FR Doc. 2016-16819, on page 46100, in the second column at the top of the page, the correct Announcement Number should read as follows:

    Announcement Number: HHS-2016-IHS-NIHOE-2-BH-HIV-AIDS-0001.

    Dated: August 4, 2016. Elizabeth A. Fowler, Deputy Director for Management Operations, Indian Health Service.
    [FR Doc. 2016-19597 Filed 8-16-16; 8:45 am] BILLING CODE 4165-16-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Special Emphasis Panel; Worm Intervention Test Data Sharing.

    Date: September 19, 2016.

    Time: 3:00 p.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7701, [email protected]

    Name of Committee: National Institute on Aging Special Emphasis Panel; Worm Intervention Test One.

    Date: September 19, 2016.

    Time: 12:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301-402-7701, [email protected]

    Name of Committee: National Institute on Aging Special Emphasis Panel; NIH Phase III Clinical Trials for Alzheimer's Disease and Other Age-Related Cognitive Declines.

    Date: October 13, 2016.

    Time: 12:01 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Maurizio Grimaldi, MD, Ph.D., Scientific Review Officer, National Institute on Aging, National Institutes of Health, 7201 Wisconsin Avenue, Room 2C218, Bethesda, MD 20892, 301-496-9374, [email protected]

    Name of Committee: National Institute on Aging Special Emphasis Panel; Alzheimer's Disease Drug Development.

    Date: October 14, 2016.

    Time: 12:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, National Institute on Aging, Gateway Building 2C/212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301-496-9666, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS).
    Dated: August 11, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-19547 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Center for Advancing Translational Sciences Special Emphasis Panel; CTSA Review.

    Date:September 22-23, 2016.

    Time: 8:00 a.m. to 2:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Hilton Washington DC/Rockville Hotel, Plaza 2 and 3, 1750 Rockville Pike, Rockville, MD 20852.

    Contact Person: Carol Lambert, Ph.D., Acting Deputy Director, Office of Scientific Review, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, 6701 Democracy Blvd., Democracy 1, Room 1076, Bethesda, MD 20892, 301-435-0814, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.350, B—Cooperative Agreements; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
    Dated: August 11, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-19542 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee.

    The meeting will be open to the public, 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. The meeting will also be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (http://videocast.nih.gov/).

    Name of Committee: National Cancer Institute Clinical Trials and Translational Research Advisory Committee.

    Date: November 2, 2016.

    Time: 8:00 a.m. to 4:00 p.m.

    Agenda: Strategic Discussion of NCI's Clinical and Translational Research Programs.

    Place: National Institutes of Health, Building 31, C-Wing, 6th Floor, Room 9 and 10, 31 Center Drive, Bethesda, MD 20892.

    Contact Person: Sheila A. Prindiville, MD, MPH, Director, Coordinating Center for Clinical Trials, National Institutes of Health, National Cancer Institute, 9609 Medical Center Drive, Room 6W136, Rockville, MD 20850, 240-276-6173, [email protected]

    Any interested person may file written comments with the committee by forwarding the 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: http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: August 11, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-19543 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Environmental Health Sciences Council.

    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.

    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: National Advisory Environmental Health Sciences Council.

    Date: September 13, 2016.

    Closed: September 13, 2016, 8:30 a.m. to 9:30 a.m.

    Agenda: To review and evaluate grant applications.

    Place: Nat. Inst. of Environmental Health Sciences, Building 101, Rodbell Auditorium, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709.

    Open: September 13, 2016, 9:30 a.m. to 4:15 p.m.

    Agenda: Discussion of program policies and issues.

    Place: Nat. Inst. of Environmental Health Sciences, Building 101, Rodbell Auditorium, 111 T. W. Alexander Drive, Research Triangle Park, NC 27709.

    Contact Person: Gwen W. Collman, Ph.D., Director, Division of Extramural Research & Training, National Institutes of Health, Nat. Inst. of Environmental Health Sciences, 615 Davis Dr., KEY615/3112, Research Triangle Park, NC 27709, (919) 541-4980, [email protected]

    Any interested person may file written comments with the committee by forwarding the 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.

    Information is also available on the Institute's/Center's home page: http://www.niehs.nih.gov/about/boards/naehsc/, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: August 10, 2016. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-19548 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council.

    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.

    Name of Committee: National Heart, Lung, and Blood Advisory Council.

    Date: September 20, 2016.

    Open: 1:00 p.m. to 5:00 p.m.

    Agenda: To discuss program policies and issues.

    Place: National Institutes of Health, Building 35A, Porter Building, Room 640, 35A Convent Drive, Bethesda, MD 20892.

    Contact Person: Valerie L. Prenger, Ph.D., MPH, Acting Division Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7214, Bethesda, MD 20892-7924, 301-435-0270, [email protected]

    Any interested person may file written comments with the committee by forwarding the 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: www.nhlbi.nih.gov/meetings/nhlbac/index.htm, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: August 11, 2016. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-19545 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, September 07, 2016, 09:00 a.m. to September 07, 2016, 5:00 p.m., National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892 which was published in the Federal Register on August 08, 2016, 81 FR 52452.

    This meeting notice has been amended to change the end time of the open session to 2:45 p.m. The closed session has also been amended to begin at 3:00 p.m. and end at 4:15 p.m. The meeting is partially closed to the public.

    Dated: August 11, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-19544 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive Patent License: Development of T Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the Treatment of Cancer AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc. (“Kite”) located in Santa Monica, CA to practice the inventions embodied in the following patent applications:

    Intellectual Property

    United States Provisional Patent Application No. 62/084,654, filed November 26, 2014, entitled “Anti-mutated KRAS T Cell Receptors” [HHS Reference No. E-028-2015/0-US-01]; and

    PCT Application No. PCT/US2015/062269 filed November 24, 2015 entitled “Anti-mutated KRAS T Cell Receptors” [HHS Reference No. E-028-2015/1-PCT-01].

    The patent rights in these inventions have been assigned to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the development, manufacture and commercialization of retrovirally-engineered mutated KRAS TCR-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment of human cancers.

    DATES:

    Only written comments and/or applications for a license which are received by the National Cancer Institute on or before September 1, 2016 will be considered.

    ADDRESSES:

    Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, MSC 9702, Rockville, MD 20852; Telephone: (240) 276-5484; Email [email protected]

    SUPPLEMENTARY INFORMATION:

    The present invention describes an isolated T cell receptor (TCR) which recognizes the G12D mutation of the Kristen rat sarcoma viral oncogene homolog (KRAS) protein within the context of major histocompatibility complex HLA-A11 presentation.

    KRAS is an oncogene with a well-characterized role in the formation of several human cancers, including: Pancreatic, colorectal and lung. Certain mutations, such as the substitution of aspartic acid or valine for glycine at codon 12 (termed G12D and G12V, respectively), occur at relatively high frequency and may represent amenable targets for immunotherapies. Due to the restricted expression of KRAS G12D in pre-cancerous and malignant cells, engineered T cell therapies based on the present invention may be useful for the treatment of select cancers.

    The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the NCI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

    Complete applications for a license in an appropriate field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    Dated: August 8, 2016. Richard U. Rodriguez, Associate Director, Technology Transfer Center, National Cancer Institute.
    [FR Doc. 2016-19549 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Initial Review Group; Neuroscience of Aging Review Committee.

    Date: September 29-30, 2016.

    Time: 4:00 p.m. to 12:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: DoubleTree by Hilton Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814.

    Contact Person: Jeannette L. Johnson, Ph.D., Deputy Review Branch Chief, National Institutes of Health, National Institute on Aging, Gateway Building, Bethesda, MD 20892, 301-402-7705, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: August 11, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-19546 Filed 8-16-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5909-N-60] 30-Day Notice of Proposed Information Collection: Public Housing Agency (PHA) Lease and Grievance Requirements AGENCY:

    Office of the Chief Information Officer, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

    DATES:

    Comments Due Date: September 16, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at [email protected] or telephone 202-402-3400. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on March 4, 2016 at 81 FR 11584.

    A. Overview of Information Collection

    Title of Information Collection: Public Housing Agency (PHA) Lease and Grievance Requirements.

    OMB Approval Number: 2577-0006.

    Type of Request: Reinstatement of currently approved collection.

    Form Number: None.

    Description of the need for the information and proposed use: The Public Housing lease and grievance procedures are a recordkeeping requirement on the part of Public Housing agencies (PHAs) as they are required to enter into and maintain lease agreements for each individual or family that occupies a Public Housing unit. Also, both PHAs and tenants are required to follow the protocols set forth in the grievance procedures for both an informal and formal grievance hearing. This information collection is a revision of the previous submission. The reduction in burden hours is attributable to a fewer number of tenants in public housing covered by these lease and grievance procedures.

    Respondents (i.e., affected public): Public Housing Authorities (PHAs).

    Estimated Number of Respondents: 945,539.

    Estimated Number of Responses: 1,359,284.

    Frequency of Response: 1.

    Average Hours per Response: .25.

    Total Estimated Burden: 330,939 hours.

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;

    (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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: August 9, 2016. Colette Pollard, Department Reports Management Officer, Office of the Chief Information Officer.
    [FR Doc. 2016-19640 Filed 8-16-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5909-N-59] 30-Day Notice of Proposed Information Collection: Energy and Performance Information Center (EPIC) AGENCY:

    Office of the Chief Information Officer, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.

    DATES:

    Comments Due Date: September 16, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at [email protected] or telephone 202-402-3400. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    The Federal Register notice that solicited public comment on the information collection for a period of 60 days was published on April 4, 2016 at 81 FR 19234.

    A. Overview of Information Collection

    Title of Information Collection: Energy and Performance Information Center (EPIC).

    OMB Approval Number: 2577-0274.

    Type of Request: Revision of currently approved collection.

    Form Number: None—all information collected electronically.

    Description of the need for the information and proposed use: The Department has recognized the need for improving energy efficiency in affordable housing and has prioritized this in Agency Priority Goal #4, Measure #13. The energy efficiency data collected through EPIC gives the Department a more comprehensive dataset regarding energy efficiency. The EPIC data system will gradually automate the collection of the five year plan and annual statement forms from grantees. These are required forms presently collected in hard copy on Forms HUD 50075.1 and HUD 50075.2 under collection OMB control number 2577-0226. These forms also collect data on the eventual, actual use of funds; this data will be gradually collected electronically through the EPIC data system as well. Electronic collection will enable the Department to aggregate information about the way grantees are using Federal funding. Additionally, PHA grantees will be able to submit Replacement Housing Factor fund plans, the mechanism by which PHAs are allowed to accumulate special funds received based on units removed from the inventory from year to year. This information is presently collected in hard copy at the field office level; the EPIC data system will automate and centralize this collection in order to streamline the process and improve transparency. Furthermore, the EPIC data system will be loaded with Physical Needs Assessment (“PNA”) data. This data being in the system coupled with the electronic planning process will streamline grantee planning. The EPIC data system will collect information about the Energy Performance Contract (“EPC”) process, including the energy efficiency improvements. As the Department moves to shrink its energy footprint in spite of rising energy costs, clear and comprehensive data on this process will be crucial to its success. Finally, the Department has prioritized in Agency Performance Goal #2, Measure #5 making housing more available for more families. In the light of the recent housing crisis, this goal has become simultaneously more challenging and more important. Tracking of the use of Federal funds paid through the Public Housing Capital Fund, the only Federal funding stream dedicated to the capital needs of the nation's last resort housing option, is crucial to understanding how the Department can properly and efficiently assist grantees in meeting this goal as well as assessing the Department's own progress. The EPIC data system will track development of Public Housing with Federal funds and through other means, including mixed-finance development.

    Respondents (i.e. affected public): Members of Affected Public: State, Local or Local Governments and Non-profit organizations.

    Estimated Number of Respondents: 3,150.

    Estimated Number of Responses: 31,800 annual responses.

    Frequency of Response: 1.

    Average Hours per Response: 2.19.

    Total Estimated Burdens: 69,645 hours.

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;

    (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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: August 9, 2016. Colette Pollard, Department Reports Management Officer, Office of the Chief Information Officer.
    [FR Doc. 2016-19641 Filed 8-16-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5913-N-19] 60-Day Notice of Proposed Information Collection: Uniform Physical Standards & Physical Inspection Requirements AGENCY:

    Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

    DATES:

    Comments Due Date: October 17, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at [email protected] for a copy of the proposed forms or other available information. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    FOR FURTHER INFORMATION CONTACT:

    Harry Messner, Program Analyst, Program Administration Office: Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email [email protected] or telephone 202-402-2626. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    A. Overview of Information Collection

    Title of Information Collection: Uniform Physical Standards & Physical Inspection Requirements.

    OMB Approval Number: 2502-0369.

    Type of Request: Extension of currently approved collection.

    Form Number: N/A.

    Description of the need for the information and proposed use: All multifamily properties owned by HUD or with HUD-insured mortgages must be inspected regularly to ensure that they are maintained in a condition that is decent, safe, sanitary, and in good repairs.

    Respondents: Affected public.

    Estimated Number of Respondents: 12,125.

    Estimated Number of Responses: 12,125.

    Frequency of Response: Annual.

    Average Hours per Response: 6.

    Total Estimated Burden: 26,706.

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (1) 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) The accuracy of the agency's estimate of the burden of the proposed collection of information;

    (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 collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: August 9, 2016. Janet M. Golrick, Associate General Deputy Assistant Secretary for Housing—Associate Deputy Federal Housing Commissioner.
    [FR Doc. 2016-19637 Filed 8-16-16; 8:45 am] BILLING CODE 4210-67-P
    INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-567 (Advisory Opinion Proceeding)] Certain Foam Footwear; Institution of an Advisory Opinion Proceeding AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has determined to institute an advisory opinion proceeding in the above-captioned investigation.

    FOR FURTHER INFORMATION CONTACT:

    Clint Gerdine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2310. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at http://www.usitc.gov. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission instituted this investigation on May 11, 2006, based on a complaint, as amended, filed by Crocs, Inc. (“Crocs”) of Niwot, Colorado. 71 FR 27514-15 (May 11, 2006). The complaint alleged, inter alia, violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain foam footwear, by reason of infringement of claims 1-2 of U.S. Patent No. 6,993,858 (“the '858 patent”) and U.S. Patent No. D517,789 (“the '789 patent”). The notice of investigation named several respondents including Double Diamond Distribution Ltd. (“Double Diamond”) of Saskatoon, Canada.

    On July 25, 2008, the Commission issued its final determination finding no violation of section 337 based on non-infringement and non-satisfaction of the technical prong of the domestic industry requirement with respect to the '789 patent, and invalidity of the '858 patent as obvious under 35 U.S.C. 103. 73 FR 45073-74 (Aug. 1, 2008). On July 15, 2011, after an appeal to the U.S. Court of Appeals for the Federal Circuit and subsequent remand vacating the Commission's previous finding of no violation, the Commission found a violation of section 337 based on infringement of the asserted claims of the patents and issued a general exclusion order and, inter alia, a cease and desist order directed against Double Diamond. 76 FR 43723-24 (July 21, 2011).

    On July 12, 2016, Double Diamond and U.S.A. Dawgs, Inc. (“USA Dawgs”) of Las Vegas, Nevada (collectively, the “requesters”) petitioned for institution of an advisory opinion proceeding as to whether their Fleece Dawgs footwear is covered by the general exclusion order or cease and desist order directed against Double Diamond. No responses were filed.

    The Commission has determined that requesters' petition complies with the requirements for institution of an advisory opinion proceeding under Commission Rule 210.79 to determine whether their Fleece Dawgs footwear infringes the '789 patent or claims 1 or 2 of the '858 patent. Accordingly, the Commission has determined to institute an advisory opinion proceeding and refer requesters' petition to the Office of Unfair Import Investigations (“OUII”). The parties will furnish OUII with information as requested, and OUII shall investigate and issue a report to the Commission within ninety (90) days of the date of publication of this notice in the Federal Register. The Commission will issue an advisory opinion within 45 days of receipt of OUII's written report. The following entities are named as parties to the proceeding: (1) Crocs; (2) Double Diamond; and (3) USA Dawgs.

    The authority for the Commission's determination is contained in sections 335 and 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1335, 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

    By Order of the Commission.

    Issued: August 11, 2016. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2016-19561 Filed 8-16-16; 8:45 am] BILLING CODE 7020-02-P
    INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Athletic Footwear, DN 3166; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).

    FOR FURTHER INFORMATION CONTACT:

    Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,1 and will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000.

    1 Electronic Document Information System (EDIS): http://edis.usitc.gov.

    General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC.2 The public record for this investigation may be viewed on the Commission's Electronic Document Information System (EDIS) at EDIS.3 Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    2 United States International Trade Commission (USITC): http://edis.usitc.gov.

    3 Electronic Document Information System (EDIS): http://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Reebok International Ltd. and Reebok International Limited on August 10, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain athletic footwear. The complaint names as respondents TRB Acquisitions LLC of New York, NY; RBX Active 01 LLC of New York, NY; RBX DIRECT LLC of New York, NY; RBX.COM LLC of New York, NY; and Elite Performance Footwear, LLC of New York, NY. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

    Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

    In particular, the Commission is interested in comments that:

    (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

    (ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

    (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

    (iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

    (v) explain how the requested remedial orders would impact United States consumers.

    Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3166”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures 4 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

    4 Handbook for Electronic Filing Procedures: http://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf.

    Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation 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 this or a related proceeding, 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,5 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.6

    5 All contract personnel will sign appropriate nondisclosure agreements.

    6 Electronic Document Information System (EDIS): http://edis.usitc.gov.

    This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

    By order of the Commission.

    Issued: August 10, 2016. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2016-19560 Filed 8-16-16; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 16-14] Lawrence E. Stewart, M.D.; Decision and Order

    On June 1, 2016, Administrative Law Judge (ALJ) Charles Wm. Dorman issued the attached Recommended Decision. Therein, the ALJ found that on multiple occasions, Respondent issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for schedule II controlled substances such as Norco 10/325mg (hydrocodone/acetaminophen) and Hycodan (hydrocodone/homatropine cough syrup),1 the schedule III controlled substance phentermine, and the schedule IV controlled substance alprazolam, in violation of 21 CFR 1306.04(a). See R.D. at 34-60.2

    1 Effective October 6, 2014, combination hydrocodone products including both Norco and Hycodan were transferred from schedule III to schedule II of the Controlled Substances Act. See Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II, 79 FR 49661. Thus, at the time Respondent issued some of the Norco and Hycodan prescriptions, the drug was a schedule III controlled substance. This, however, has no consequence for my decision.

    2 All citations to the Recommended Decision are to the slip opinion as issued by the ALJ.

    More specifically, the evidence showed that Respondent prescribed the controlled substances to his girlfriend knowing that she was seeking the drugs to abuse them. The evidence also showed that while some of the prescriptions were issued in the name of Respondent's girlfriend, in multiple instances, Respondent issued prescriptions, including multiple prescriptions for Hycodan, listing his girlfriend's two children, who were then three and five years old respectively, as the patients, and that Respondent did so knowing that his girlfriend intended to use the cough syrup because she enjoyed drinking it. The evidence further showed that on multiple occasions, Respondent issued prescriptions for Norco 3 to undercover agents who posed as acquaintances of his girlfriend, knowing that the drugs would then be provided to his girlfriend and that Respondent further instructed his girlfriend as to how her purported acquaintances should present as having headaches so that he could document a reason in the their charts for having issued the prescriptions.

    3 The evidence also showed that at one of the undercover agent's visits, Respondent also gave her a prescription for Hycodan cough syrup.

    The ALJ also found that on multiple occasions, Respondent violated Rule 1.4 of the Mississippi State Board of Medical Licensure's Rules by failing to document in his girlfriend's chart the diagnosis or justification for issuing the prescription, as well as required information including the drug's name, the dose, strength and quantity. R.D. at 37-39 (citing Miss. Code R. § 30-17-2640:1.4; also citing id. § 30-17-2640:1.16; Miss. Code §§ 73-25-29(3) and (13)). The ALJ also made a similar finding with respect to four hydrocodone cough syrup prescriptions Respondent issued in the names of his girlfriend's children. R.D. at 46-47 (Rx's issued on 6/17/14, 7/23/14, 11/19/14); id. at 49 (Rx 11/3/14).

    With respect to the phentermine prescriptions Respondent issued to his girlfriend, the ALJ found that he “completely failed to comply” with the Board's Rule 1.5 because he did not prescribe “adjunctively with caloric restriction,” “never conducted and recorded an initial comprehensive evaluation” including “a thorough patient history or physical examination,” and never recorded required histories, nor her height, weight, BMI, body measurements, and vital signs. R.D. 43. The ALJ also found that Respondent did not conduct a re-evaluation of his girlfriend every 30 days as required by Rule 1.5. Id. Finally, noting that Rule 1.5 generally requires that the patient have a BMI greater than 30 in order to justify prescribing phentermine, the ALJ observed that Respondent's girlfriend testified that she had gone from 135 to 121 pounds and that she presented at the hearing “with a slender body type.” Id. The ALJ thus explained that “[a]fter observing [her] appearance,” he found “it difficult to comprehend . . . how Respondent could have possibly believed that [she] has a high enough BMI to justify” prescribing weight-loss medication. Id. The ALJ thus found that Respondent violated 21 CFR 1306.04(a), the Board's Rule 1.5, and Mississippi Code sections 73-25-29(3) and (13) when he prescribed phentermine to his girlfriend. Id. at 44.

    Based on these findings, the ALJ concluded that Respondent had engaged in “an egregious level of intentional diversion” and that the Government had satisfied its prima facie burden of showing that “Respondent's continued registration would be inconsistent with the public interest.” R.D. at 61. Because “Respondent offered no evidence that he accepted responsibility for his misconduct or reformed his ways,” the ALJ found that he “failed to rebut the Government's prima facie case.” Id. The ALJ thus recommended that I revoke Respondent's registration and deny any application to renew or modify his registration. Id.

    Respondent filed Exceptions to the ALJ's Recommended Decision. Thereafter, the ALJ forwarded the record to me for Final Agency Action.

    Having considered the record in its entirety, including Respondent's Exceptions, I have decided to adopt the ALJ findings of fact, conclusions of law, and recommended Order. However, before I address Respondent's Exceptions, I deem it necessary to address the ALJ's ruling on the admissibility of the FDA package insert for Hycodan (GX 4).

    On motion of Respondent's counsel, the ALJ ruled inadmissible Government Exhibit 4, which the Government represented was the FDA package insert for Hycodan.4 Tr. 422, 427. The basis of Respondent's objection was that the exhibit contains “little more than generalizations and medical opinions” and that the ALJ's prehearing statement required the parties to disclose “the names and credentials and opinions of medical experts . . . who would be offering medical opinions in this case.” Id. at 420. Respondent's counsel further argued that “[t]he government did not identify any expert capable of being cross-examined on any of these opinions” and that “[t]here is no reason to believe that [the Exhibit was] authored by a physician, much less do we know whether the author had credentials to offer these opinions.” Id.

    4 There is no dispute that the Exhibit was what the Government represented it to be—a copy of the package insert. Nor is there any dispute as to how the document was obtained.

    After the Government argued that the document was the FDA package insert, which is included “with every drug purchased or sold,” id. at 422, Respondent argued that the copyright of the document was the manufacturer and that “we don't know who authored it, or what their credentials were, but it's a self-interested marketing pharmaceutical company” that is “trying to sell their [sic] medicine” and while the company has a “self-interest[] to comply with a federal regulation . . . “[i]t doesn't mean that the content is government-sanctioned.” Id. at 422-23. Respondent thus asserted that the document was “just not reliable enough.” Id. at 426.

    The ALJ sustained the objection but provided no explanation as to his reason for doing so. I conclude, however, that the Exhibit was admissible. As the FDA has explained, the package insert “is part of the FDA-approved labeling,” and “[t]he FDA approved label is the official description of a drug product, which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnant women, children, and other populations; and safety information for the patient.” See U.S. Food and Drug Administration, [email protected] Instructions: Health Information, available at www.fda.gov/Drugs/InformationOnDrugs/ucm079450.htm (accessed August 4, 2016). The FDA's approval of a drug label follows extensive clinical trials, including trials which examine the safety and effectiveness of a drug and are part of the process for approving the drug for marketing. See Food and Drug Administration, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 FR 3922 (2006) (Final Rule) (“A prescription drug product's FDA-approved labeling (also known as `professional labeling,' `package insert,' `direction circular,' or `package circular') is a compilation of information about the product, approved by FDA, based on the agency's thorough analysis of the new drug application (NDA) . . . submitted by the applicant. This labeling contains information necessary for safe and effective use.”).

    Under the Food, Drug and Cosmetic Act, a drug “shall be deemed to be misbranded . . . [u]nless its labeling bears . . . such adequate warning against use . . . by children where its use may be dangerous to health.” 21 U.S.C. 352(f). Moreover, introducing a misbranded drug into interstate commerce is a violation of 21 U.S.C. 331(a). Thus, there are ample incentives for drug manufacturers to provide reliable information in the package insert. Based on the foregoing, I find that there are sufficient indicia of reliability to support the admission of the document into evidence and make it a part of the record.5 I further find that this evidence is probative on the issue of whether the Hycodan prescriptions issued by Respondent in the name of his girlfriend's children were for a legitimate medical purpose. See, e.g., Medicine Shoppe-Jonesborough v. DEA, 300 Fed. Appx. 409, 413 (6th Cir. 2008) (holding that dispensing contraindicated controlled substance is evidence of 21 CFR 1306.04(a) violation).

    5 Hearsay evidence is admissible in administrative proceedings, provided it is relevant and material and supported by sufficient indicia of reliability. See, e.g., Mireille Lalanne, 78 FR 47750 (2013).

    As further noted above, in opposing the admission of the package insert, Respondent represented that it contained expert opinions from unidentified persons whom he could not cross-examine and thus was being offered in violation of the ALJ's Prehearing Order. However, in its pre-hearing statement, the Government provided notice that it intended to offer the Exhibit and pursuant to the ALJ's Prehearing Ruling, the Government was required to provide the document to Respondent by 2 p.m. on February 12, 2016. ALJ Ex. 9, at 2. No claim is made that the Government failed to comply with the ALJ's ruling.

    While Respondent asserts that he was unable to cross-examine the persons who wrote the package insert, he made no attempt to subpoena either an FDA official involved in reviewing the document or an employee from the manufacturer who was involved in preparing it. Moreover, Respondent could have sought to challenge the reliability of the document by producing evidence (whether through expert testimony or studies) disputing the package insert's statement regarding the risks of prescribing the drug to children less than six years of age. Respondent, however, produced no evidence which calls into question the reliability of the statements contained in the insert.

    Notably, the Hycodan package insert's safety information includes the following warning: “The use of HYCODAN is not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression.” GX 4, at 2. Notably, Respondent's girlfriend's daughter was not even five years old when he wrote the first Hycodan prescription in her name. GE 55, at 1-2. Respondent also wrote Hycodan prescriptions in the name of his girlfriend's son who was then three years old. Id. at 3-4; 11-12. In short, neither of the children who were listed as the patients on the Hycodan prescriptions was six years of age when Respondent wrote the prescriptions. Thus, I consider this as additional evidence which supports the conclusion that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he issued the Hycodan prescriptions in the names of his girlfriend's children. 21 CFR 1306.04(a). I now turn to Respondent's Exceptions.

    Exception I—The Government Failed “to Prove Violations of State or Local Laws Sufficient to Demonstrate Danger to the Public Interest.”

    Respondent argues that the ALJ failed to give proper weight to the decision of Dr. Craig, the Medical Board's Executive Director, to close the Board's investigation of his prescribing practices without recommending the initiation of a formal action against his medical license. Exceptions, at 1-2. According to Respondent, the Board reviewed “all such clinical and prescription records” for his girlfriend and her children, and it “decided that there was no evidence of any breach of any medical standard of care sufficient to bring any administrative charge against [him] related to any such prescription.” Id. at 2. He also asserts that Dr. Craig “determined that there was not even sufficient professional reason to issue [him] an informal warning as to any such prescription for pain medication.” Id.

    Respondent then argues that “[r]ather than . . . defer[] to the professional judgments made by [Dr. Craig as to] whether State laws were violated by [him], the ALJ['s] Recommendation proceeds to interpret and apply those State laws without the benefit of any medical evidence, or any medical opinion in any form, anywhere in the record of this case.” Id. And noting the ALJ's discussion that “`DEA has not required expert testimony to establish a violation of 21 CFR 1306.04(a) in cases where a prescriber engaged in drug deals, where there were notable differences between patients' medical records and diagnoses, and where a prescriber falsified patients' charts,' ” Respondent contends that the Government did not allege that he engaged in any such conduct. Id. at n.1.

    I reject the Exception. As for the contention that Dr. Craig reviewed the medical records and prescriptions and did not find the evidence sufficient to initiate a proceeding against his license, Respondent ignores the credited testimony that the Board terminated its investigation upon the request of the Mississippi Bureau of Narcotics (MBN) after the latter informed the Board that it was conducting a criminal investigation. Tr. 60 (testimony of MBN agent); GE 3, at 2 (Board Complaint form entry dated “3-20-15” stating “MBN has asked that we hold off on doing anything to this doctor because they are working a criminal case on him”).6 A Board investigator also testified that “it's customary for [the Board] to back off [of an investigation] and let a criminal agency pursue their [sic] case” and that Dr. Craig was aware of the criminal investigation. Tr. 210.

    6 The Board's investigation involved interviewing Respondent, as well as reviewing his girlfriend's patient file and a PMP report of her controlled substance prescriptions. GE 3, at 4-6. Notably, the Board's investigator testified that the Board did not interview Respondent's girlfriend. Tr. 196.

    Moreover, even then the Board's letter cautioned Respondent “that authorizing refills for Phentermine/Adipex without the benefit of a medical examination is strictly prohibited by the Board's Rules and Regulations” and specifically quoted the Board's Rule 1.5(E), which states that: “[a] patient continued on a controlled substance in schedule III, IV, V for the purpose of weight reduction or the treatment of obesity should undergo an in-person re-evaluation once every 30 days.” GE 3, at 1. Finally, as the evidence shows, subsequent to the Board's closing of its investigation, Respondent again issued multiple controlled substance prescriptions to purported acquaintances of his girlfriend knowing that the drugs would subsequently be provided to his girlfriend. Accordingly, I reject Respondent's contention that the Board's closing of its investigation reflects its “professional judgments” that Respondent acted within the bounds of accepted professional practice when he prescribed to Respondent and the undercover officers.

    Under both this and his subsequent exception, Respondent argues that the ALJ's decision is unprecedented because the Government put forward no expert testimony to support the conclusion that he violated 21 CFR 1306.04(a) in issuing the various prescriptions. However, contrary to Respondent's understanding, numerous decisions of both the federal courts in criminal cases and this Agency have held that expert testimony is not necessarily required to prove that a physician acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing a controlled substance prescription. See United States v. Pellman, 668 F.3d 918, 924 (7th Cir. 2012) (quoting United States v. Armstrong, 550 F.3d 382, 388-89 (5th Cir. 2008) (“While expert testimony may be both permissible and useful, a jury can reasonably find that a doctor prescribed controlled substances not in the usual course of professional practice or for other than a legitimate medical purpose from adequate lay witness evidence surrounding the facts and circumstances of the prescriptions.”)); Armstrong, 550 F.3d at 389 (“Jurors have had a wide variety of their own experiences in doctors' care over their lives, thus and expert testimony is not necessarily required for jurors to rationally conclude that seeing patients for as little as two or three minutes before prescribing powerful narcotics is not in the usual course of professional conduct.”).7 See also T.J. McNichol, 77 FR 57133, 57147-49 (2012), pet. for rev. denied, 537 Fed. Appx. 905 (11th Cir. 2013); Morris W. Cochran, 77 FR 17505, 17519-20 (2011) (holding, without expert testimony, that prescriptions lacked a legitimate medical purpose where physician noted in patient medical records that patients had no pain, did not document any findings to support a diagnosis, and yet diagnosed patients as having chronic pain); Robert F. Hunt, 75 FR 49995, 50003 (2010) (holding, without expert testimony, that physician lacked a legitimate medical purpose based on statements made during undercover visits and falsification of chart). See also Jack A. Danton, 76 FR 60900, 60904 (2011).

    7See also United States v. Word, 806 F.2d 658, 663 (6th Cir. 1986); United States v. Larson, 507 F.2d 385, 387 (9th Cir. 1974); United States v. Bartee, 479 F.2d 484, 488-89 (10th Cir. 1973); State v. Moody, 393 So.2d 1212, 1215 (La. 1981).

    Thus, while expert testimony is typically necessary to establish a violation of 21 CFR 1306.04(a) “ `where a physician ma[kes] some attempt to comply with various state medical practice standards and the adequacy of those efforts is at issue,' . . . the facts and circumstances surrounding the issuance of the prescription may nonetheless establish a violation even without expert testimony.” McNichol, 77 FR 57147-48 (quoting Danton, 76 FR at 60904 & n.13). Accordingly, in McNichol, the Agency found a violation proved, notwithstanding that the ALJ had rejected the testimony of the Government's Expert, because while the physician had gone through the motions of a physical exam, the physician's “comments manifest[ed] that he knew that [the patient] was an abuser of controlled substances.” Id. at 57148. See also Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (“[T]he prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.”) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)).

    Here, as the ALJ found, Respondent issued multiple prescriptions to his girlfriend while failing to document the performance of a physical exam, as well as findings and diagnoses that would support the issuance of the prescriptions. Moreover, with respect to the hydrocodone cough syrup prescriptions Respondent issued to his girlfriend which listed her children as the patients, the ALJ credited her testimony that she told Respondent that she wanted the big bottle of hydrocodone cough syrup and he “knew I would drink it too.” R.D. 7; 11 (citing Tr. 216, 251-52, 268, 273); see also Tr. 298 (girlfriend's testimony that the Norco prescriptions were “not for a headache” but were “[j]ust for fun”). Likewise, with respect to the prescriptions Respondent provided in March and April 2015 to his girlfriend's purported acquaintances, the undercover recordings clearly establish that Respondent knew that the acquaintances were not seeking the prescriptions to treat legitimate medical conditions but to provide the drugs to his girlfriend. Given the evidence that clearly shows that Respondent issued the prescriptions to support his girlfriend's abuse of controlled substances, the Government was not required to put forward expert testimony to prove its case.

    Exception II—The Government “Fail[ed] to Prove `Past Experience in the Distribution of Controlled Substances.' ”

    Respondent further argues that the ALJ erred when he refused “to allow Respondent to seek clinical evidence about [his girlfriend's] medical history through third-party document subpoenas.” Exceptions, at 2. Prior to the hearing, Respondent requested that the ALJ issue eight subpoenas to health care providers for their medical records “which reflect, relate to, or explain the clinical or medical basis for prescribing” controlled substances (primarily hydrocodone with acetaminophen) to his girlfriend. See, e.g., ALJ Ex. 13, at 6.

    In seeking the subpoenas, Respondent maintained that “[i]n order for the truth about [his girlfriend's] medical condition and needs to be revealed . . . the clinical findings and judgment of all such health care providers should be available to the Court in order to allow a comparison between Dr. Stewart's judgment and the judgments of a substantial number of other health care professionals in the same community.” ALJ Ex. 13, at 3. On the various subpoenas, Respondent explained that because one of the Government's Exhibits (the PMP report, GE 49) shows that the other health care providers had also issued hydrocodone prescriptions to his girlfriend, “[t]he presumed legitimacy of the particular clinical findings which caused [the] other health care professionals in the same community to prescribe the same medication to [her] could be strongly probative of the medical inaccuracy of the . . . core allegations against” him. See, e.g., GE 13, at 6.

    The Government opposed the issuance of the subpoenas. It argued that the information Respondent sought was irrelevant because the only allegations it raised as to the unlawful prescribing of hydrocodone with acetaminophen to his girlfriend involved the four Norco prescriptions which were identified in paragraph 4 of the Show Cause Order.8 ALJ Ex. 14, at 2-3. The Government also argued that “[i]n each of those instances,” it was “alleg[ing] that Respondent prescribed to [her] either without conducting any examination of her or without noting those prescriptions in her chart.” Id. at 3. And it further argued that none of the records would address the “actual charges against” Respondent. Id.

    8 The Show Cause Order alleged that the prescriptions were issued on May 22, June 17, September 11, and October 29, 2014. ALJ Ex. 1, at 2.

    The ALJ agreed with the Government and denied Respondent's request. ALJ Ex. 16. The ALJ explained that having reviewed the allegations of the Show Cause Order, he agreed with “the Government's assessment that the question of whether [Respondent' girlfriend] needed a particular medication is not an issue before me.” Id. at 1. And noting that “Respondent has not produced a summary of [his] expected testimony,” the ALJ then reasoned that “there is no information in the record that the Respondent based his decision to prescribe a particular medication to [his girlfriend] based upon his knowledge of what some other treating physician had prescribed for” her. Id. at 1-2. Concluding that the information sought by Respondent was irrelevant, the ALJ denied the request. Id. at 2.

    I conclude that the ALJ properly denied Respondent's request. I do not, however, read the Government's Opposition as expressing the position that his girlfriend's need for the Norco prescriptions was not at issue.

    While the Government alleged that these particular prescriptions were unlawful because: (1) Respondent did not “conduct[] an examination of” of his girlfriend or “document[] such in her file,” or (2) Respondent did not note the prescriptions in her chart and thus violated the Board's Rules 1.4, 1.11(b) and 1.16, the Government also cited 21 CFR 1306.04(a)). Because “[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose,” 21 CFR 1306.04(a), a patient's need for the drug is invariably at issue when a violation of this provision is alleged. See also Miss. Code R. § 30-17-2640:1.4 (“No physician shall prescribe, administer or dispense any controlled substance . . . without a good faith prior examination and medical indication therefore.”). Indeed, assessing whether a patient needs a controlled substance to treat a medical condition is the reason why the usual course of professional practice generally requires that a physician take a detailed history and conduct an appropriate examination of the patient to make a proper diagnosis and treatment plan.9 See id.

    9 As Rule 1.4 further states:

    Standards of proper medical practice require that, upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) Take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results. The observance of these principles as a function of the “course of legitimate professional practice” is particularly of importance in cases in which controlled substances are to play a part in the course of treatment. It is the responsibility of the physician to dispense, prescribe or administer such drugs with proper regard for the actual and potential dangers.

    Miss. Code R. § 30-17-2640:1.4.

    I nonetheless agree with the ALJ's conclusion that the information sought by the subpoenas was irrelevant. Notably, Respondent made no proffer that he had obtained and reviewed the records maintained by these other providers and had based his decisions to prescribe hydrocodone to his girlfriend on those records. Nor did Respondent proffer that he was acting as a covering physician for any of these other physicians (or any other authorized prescriber) when he prescribed the hydrocodone to his girlfriend.

    Respondent further contends that the prescriptions issued by the other providers “strongly support a conclusion that [his] own prescriptions for [h]ydrocodone for use by [his girlfriend] were within the bounds of the medical standard of care practiced in that community.” Exceptions, at 4. However, were it the case that Respondent's prescribing of hydrocodone was within the bounds of professional practice, he could have put on an expert to testify as such.10 Yet Respondent chose not do so.

    10 Respondent initially proposed to call a physician and professor from the University of Mississippi Medical Center who would testify that the prescriptions he issued “were for legitimate medical purposes” and “were in the usual course of and consistent with [his] own standard professional practices [and] were consistent with the standard of care in the medical community in which they lived.” ALJ Ex. 17, at 2-3. While the Government moved to exclude the proffered testimony, the ALJ denied the Government's motion and specifically ruled that the expert could testify to the above subjects. ALJ Ex. 28, 3-4. Respondent did not, however, call this witness.

    Of further note, even if Respondent had put on testimony that the prescriptions were “consistent with [his] own standard professional practices,” that testimony would have been unavailing because the standard of professional practice is not defined by a physician's subjective belief as to the propriety of his practices but on the application of the standards of practice in the State where he practices. United States v. Tobin, 676 F.3d 1264, 1290 (11th Cir. 2012). For similar reasons, evidence as to the standard of care in the medical community in which Respondent lived would also be unavailing.

    Respondent also contends that the evidence is insufficient to show that the hydrocodone prescriptions lacked a legitimate medical purpose because “it is clear that during the months relevant to this case [his girlfriend] was in fact suffering from a chronic migraine condition and associated headache pain, and that [he] was treating her for that condition.” Exceptions, at 3. Respondent points to the testimony of his girlfriend that she was hospitalized for migraines “[t]hree times prior to the beginning of his treatment of her in February 2014, and a fourth time during that treatment in August of 2014.” Id. He further maintains that his charts “specified that she complained of, and in fact suffered from, a chronic migraine condition.” Id.

    It is true that in two of the visit notes for his girlfriend (April 21 and Sept. 2, 2014), Respondent listed Maxalt, a non-controlled drug, and Norco (hydrocodone with acetaminophen), as the drugs he prescribed to her for this condition. GE 2, at 12. Yet prior to Respondent's issuance of the first Norco prescription to her, she had “asked him to write the big bottle” of hydrocodone cough syrup “so that [she] could have some too” and “told him I like to drink it” because she “like[d] the way it made [her] feel.” Tr. 251-52; 273. Thus, Respondent already knew that his girlfriend was a drug abuser.11

    11 Respondent points to the testimony of his girlfriend that she never told him that she was addicted to hydrocodone, dependent on the drug, or taking it “for no reason.” Exceptions, at 3. As discussed above, Respondent's girlfriend subsequently clarified that she took the Norco “just for fun.” Tr. 298.

    To the extent Respondent believes that his misconduct in writing the Norco prescriptions should be excused because his girlfriend did not tell him why she was taking the Norco, the evidence is clear that she had previously asked him to prescribe the big bottle of cough syrup so that she “could have some too” and had told him that she “like[d] to drink it” because of “the way it made [her] feel.” Thus, Respondent clearly knew that his girlfriend was a drug abuser at the time he wrote her the first Norco prescription.

    The evidence also shows that Respondent told his girlfriend that taking hydrocodone could itself “cause migraines.” Id. at 283; see also id. at 299. Respondent's girlfriend testified that he told her that taking hydrocodone “would not help” her migraines. Id. at 300. She further testified that “[t]he hydrocodone was not for a headache,” but for “[e]xtracurricular activities,” i.e., “just for fun.” Id. at 298. Moreover, Respondent issued the first of the Norco prescriptions to her without even taking a history and conducting a physical examination of her. GE 2, at 12; see Miss. Code R. § 30-17-2640:1.4. He also failed to document several of the hydrocodone prescriptions in his girlfriend's chart.12 Compare GE 2, at 12, with GE 3, at 9-10. Thus, the evidence strongly supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed Norco to his girlfriend. 21 CFR 1306.04(a).

    12 Indeed, Respondent wrote the first Norco prescription for her on February 21, 2014. The note in her patient file simply states: “2-21-14 Hc 7.5/325 (#40, 1)—may be picked up at desk.” GE 2, at 12. Thus, Respondent issued the prescription without taking a history of his girlfriend's migraines and without conducting a physical exam.

    Respondent also appears to argue that the alprazolam prescription he issued to his girlfriend was not unlawful because she suffered from anxiety and he referred her to a psychiatrist who had prescribed the drug to her. Exceptions, at 4. While Respondent acknowledges that he did not “diagnose [her] himself as to anxiety,” he argues that he issued the prescription “in reliance on that psychiatrist's independent clinical judgment” and gave her a refill so that she could “avoid[] further one-hour trips to the psychiatrist to obtain a refill.” Id.

    I am not persuaded. Notably, the psychiatrist prescribed only a seven-day supply of alprazolam extended release in the .5 mg dosage. GE 49, at 1. Respondent, however, prescribed a stronger dosage of alprazolam and greater quantity, providing her with a prescription for 40 tablets of the 1mg immediate release dosage form, with a refill for an additional 40 tablets. Id. This was not a refill of the psychiatrist's prescription at all, but a substantially different and stronger prescription. Yet the medical record contains no evidence that Respondent coordinated his prescribing with the psychiatrist. As for Respondent's explanation that he wrote the prescription so that his girlfriend would not have to make the one-hour trip to obtain a refill, this begs the question as to why the psychiatrist would not be willing to call in a refill. I thus reject Respondent's Exception to the extent it challenges the ALJ's findings as to the alprazolam prescription.

    As for the phentermine prescriptions, Respondent again invokes Dr. Craig's letter in which he stated that the Board was closing its investigation while cautioning Respondent about the need to conduct an in-person re-evaluation every 30 days. Exceptions, at 4. Respondent revisits his argument that Dr. Craig “determined that there was no sufficient medical basis for alleging any violation . . . of any medical standard in Mississippi.” Id. However, as previously explained, the Board terminated its investigation because Respondent was the subject of a criminal investigation. Moreover, the ALJ thoroughly explained the basis for his conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he issued the phentermine prescriptions to his girlfriend.13

    13 Respondent points to the evidence that on March 27, 2015, he declined to prescribe weight loss medication to one of the undercover agents. Exceptions, at 4 (citing GE 10, at 1-2). However, several weeks earlier, Respondent had been visited by a State Board Investigator who had told him that his documentation for the phentermine prescriptions that he issued to his girlfriend was inadequate and he may have already received the letter from Dr. Craig by the date of the first undercover visit. In any event, while Respondent may have taken to heart the warning he received from Dr. Craig regarding the prescribing of weight loss medications, this obviously had no impact on his prescribing of narcotics, as evidenced by his prescribing of Norco and Hycodan to the undercover agents.

    Finally, Respondent argues that “[t]he DEA, through the CI [his girlfriend], effectively caused [him] to engage in conduct, which, according to the record . . . he apparently had never engaged in on any other occasion.” Exceptions, at 5. Continuing, Respondent argues that his “conduct, in issuing prescriptions for pain medications to third parties in an effort to provide the CI with continuing relief from her migraine conditions, arose from the peculiar combination of his personal relationship and familiarity with the CI and the CI's insistence that her `friends' were seeking medication for” her use. Id. Respondent thus maintains that this “peculiar circumstance . . . provides no significant medical or other evidence sufficient to justify any conclusion that [his] conduct . . . poses, or is likely to pose in the future, any danger to the public health or safety.” Id.

    I disagree. To the extent Respondent's argument sounds in the entrapment defense, I reject it as there is ample evidence that he was predisposed to issue the unlawful prescriptions given the multiple unlawful prescriptions he wrote for his girlfriend in 2014, prior to the involvement of the MBN and DEA. See United States v. Sumlin, 271 F.3d 274 (D.C. Cir. 2001). As for the assertion that he wrote the prescriptions to the undercover agents to provide his girlfriend “with continuing relief from her migraine conditions,” this is simply counterfactual as the record abounds with evidence that Respondent knew she was seeking the drugs to abuse them. Tr. 345; GE15; 16; GE 17, at 2-4, 6-8; GE 18, at 3. I therefore reject Respondent's contention that there is no “significant medical or other evidence” to support the conclusion that he poses a danger to public health and safety.14 Exceptions, at 5. To the contrary, the evidence shows that on multiple occasions, Respondent issued prescriptions outside of the usual course of professional practices and which lacked a legitimate medical purpose to feed his girlfriend's abuse of controlled substances. This conduct amply supports the conclusion that he has committed such as acts as to render his registration “inconsistent with the public interest.” 21 U.S.C. 824(a)(4).

    14 In arguing that he does not “pose . . . any danger to public health or safety,” Respondent cites 21 U.S.C. 823(e), the provision which governs the registration of distributors of schedule III through V controlled substances and not practitioners, who are registered under section 823(f). However, to the extent Respondent argues that the Government is required to put forward such proof in seeking the revocation of his registration, the Government is not required to do so even though one of the section 823(f) factors is “such other conduct which may threaten the public health and safety.” 21 U.S.C. 823(f). While this factor encompasses conduct which is not otherwise embraced by the other section 823(f) factors, it is indisputable that issuing prescriptions to feed a person's drug abuse is conduct which threatens public health and safety.

    Exception III—The ALJ Violated Respondent's Fifth Amendment Rights When He Denied His Request To Delay the Hearing Until the End of His Criminal Trial

    Respondent's final contention is that the ALJ violated his Fifth Amendment privilege against self-incrimination when he denied his request to reschedule the hearing until after his criminal trial concluded. Exceptions, at 5-6. Notably, the Government did not call Respondent to testify and the ALJ declined to draw an adverse inference from his failure to testify on his own behalf even though doing so would have been warranted. See Keating v. Office of Thrift Supervision, 45 F.3d 322, 326 (9th Cir. 1995) (“Not only is it permissible to conduct a civil proceeding at the same time as a related criminal proceeding, even if that necessitates invocation of the Fifth Amendment privilege, but it is even permissible for the trier of fact to draw adverse inferences from the invocation of the Fifth Amendment in a civil proceeding.”) (citing Baxter v. Palmigiano, 425 U.S. 308, 318 (1976)).

    ` Here, Respondent does not contend that the need to preserve his Fifth Amendment privilege prevented him from providing testimony refuting the allegations that he unlawfully prescribed various controlled substances to his girlfriend and the undercover officers. Rather, he argues that “[b]ecause he desired understandably to preserve and not to waive his Fifth Amendment privileges with respect to his criminal trial, [he] was prohibited from `rebutting' any prima facie Government case through his own hearing testimony, which was the only practical way he had to `accept responsibility” or to affirm that he `will not engage in future misconduct.'” Id. at 6.

    I reject Respondent's contention. See Grider Drug 1 & 2, 77 FR 44069, 44104 (2012). In Grider, the respondents argued that the Agency should reject an ALJ's conclusions that the pharmacies had failed to rebut the Government's prima facie case because their owner, who was under indictment in two state criminal cases, did not testify and thus offered no evidence to show that he had accepted responsibility and implemented corrective measures. Invoking SEC v. Dresser Industries, Inc., 628 F.2d 1368, 1375-76 (D.C. Cir.1980), the Grider respondents further argued that because their owner was under indictment, the ALJ should have stayed the proceeding until the state criminal cases were concluded so as not to “undermine the party's Fifth Amendment privilege against self-incrimination.” 77 FR at 44104.

    The Agency rejected Grider's arguments. As the Agency explained, “`as a general matter, due process is not infringed merely because an accused person is subjected, without his consent, to an administrative hearing concerning matters involved in a pending criminal proceeding.'” Id. (quoting 628 F.2d at 1376 n.21). As Dresser Industries noted, “[t]he civil and regulatory laws of the United States frequently overlap with the criminal laws creating the possibility of parallel [administrative] and criminal proceedings, either successive or simultaneous” and that “[i]n the absence of substantial prejudice to the rights of the parties involved, such parallel proceedings are unobjectionable.” 628 F.2d at 1374. Thus, in Dresser Industries, the D.C. Circuit observed that “[t]he Constitution . . . does not ordinarily require a stay of civil proceedings pending the outcome of criminal proceedings.” Id. at 1375.

    To be sure, in Dresser Industries, the D.C Circuit further explained that “the strongest case for deferring civil proceedings is where a party under indictment for a serious offense is required to defend a civil or administrative action involving the same matter.” Id. However, the court further explained that the potential harm to a party's Fifth Amendment privilege is just one of the factors to be considered in determining whether to stay the noncriminal proceeding. Id. at 1376. Continuing, the court explained that “[i]f delay of the noncriminal proceedings would not seriously injure the public interest, a court may be justified in deferring it.” Id. (emphasis added). That decision is, however, committed to the discretion of the trial court. See, e.g., Keating, 45 F.3d at 325 (setting forth multiple factors).

    Here, I find no reason to conclude that the ALJ abused his discretion when he declined to continue the proceeding until the conclusion of Respondent's criminal trial. Notably, in his request for a continuance, Respondent provided no information to the ALJ as to when that trial would commence.15 That trial—and a subsequent appeal were Respondent convicted of the charges—could go on for several years. The ALJ was not required to withhold conducting the hearing while Respondent litigates in other forums. See 45 F.3d at 325 (noting that “convenience of the court in the management of its cases” is a factor). So too, the Government has a strong interest in proceeding expeditiously with this litigation, and indeed, under the Constitution, the Agency has an obligation to provide prompt post-deprivation process where the Government immediately suspends a registration. Id.; see also Barry v. Barchi, 443 U.S. 56, 64 (1979).

    15 In opposing the request, the Government noted that Respondent had also sought a continuance of the criminal case. ALJ Ex. 6, at 1 n.1.

    As for the burden on Respondent, it is true that courts have held that the prejudice to a respondent's Fifth Amendment privilege may be substantial where there are parallel administrative and criminal proceedings. Keating, 45 F.3d at 326. However, while “the extent to which the defendant's Fifth Amendment rights are implicated is a significant factor . . . to consider . . . it is only one consideration to be weighed against others.” Id. (citation omitted).

    Notably, Respondent was not otherwise foreclosed from putting on a defense. Indeed, in its pre-hearing statement, Respondent proposed to call an expert witness who would testify that the prescriptions were lawfully issued but ultimately chose not to call this witness. Notably, in his Exceptions, Respondent does not maintain that because he invoked the privilege, he was precluded from refuting the factual basis of the allegations.

    Instead, Respondent now contends that my consideration of the ALJ's recommendation “should await the disposition of the criminal case . . . following which he should be given an opportunity promptly and succinctly to tell his side of the story and express his complete remorse.” Exceptions, at 6. However, as discussed above, in his Exceptions, Respondent continues to dispute the allegations (as well as the ALJ's factual findings and legal conclusions) that he issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for each of the different drugs (i.e., the hydrocodone cough syrup, the Norco tablets, the alprazolam, and the phentermine). Thus, his argument begs the question of which allegations he now would admit to.

    The Fifth Amendment privilege is not “a sword whereby a claimant asserting the privilege [is] freed from adducing proof in support of a burden which would otherwise have been his.” United States v. Rylander, 460 U.S. 752, 758 (1983). See also MacKay v. DEA, 664 F.3d 808, 820 (10th Cir. 2011) (quoting Keating v. Office of Thrift Supervision, 45 F.3d 322, 326 (9th Cir. 1995)). Indeed, the misconduct established on this record is so egregious and occurred over such a lengthy period, that even were I to remand to allow Respondent to express his “complete remorse” and the ALJ was to find this credible, I would still find his registration to be inconsistent with the public interest. See Hatem M. Attaya, 81 FR 8221, 8244 (2016); Fred Samimi, 79 FR 18698, 18714 (2014) (denying applications noting that notwithstanding ALJ's finding that physician “credibly accept responsibility for his misconduct, this is a case where actions speak louder than words”). Thus, I find that Respondent has failed to establish that the ALJ abused his discretion when he denied Respondent's request to continue the proceeding until his criminal trial concluded.16

    16 It is, of course, commonplace that matters involving DEA registrants will lead to both a revocation proceeding and a criminal investigation and subsequent charges at either the federal or state level. However, the very purpose of a proceeding brought under 21 U.S.C. 823(f) and 824(a)(4) is to protect the public interest, and, in the Controlled Substances Act, Congress directed that these “proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter.” Thus, I conclude that the fifth Keating factor (“the interest of the public in the pending . . . litigation”) also supports the ALJ's denial of Respondent's stay request.

    As for the fourth Keating factor, “the interests of persons not parties to the [administrative] litigation,” 45 F.3d at 326, Respondent puts forward no argument as to why this factor supports the requested stay or a remand at this juncture.

    Accordingly, I reject Respondent's third exception and will adopt the ALJ's recommended sanction of revocation.

    ORDER

    Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration AS2286311 issued to Lawrence E. Stewart, M.D., be, and it hereby is, revoked. I further order that any application of Lawrence E. Stewart, M.D., to renew or modify the above registration, or for any additional registration be, and it hereby is, denied. This Order is effectively immediately.17

    17 For the same reasons that led me to immediately suspend Respondent's registration, I find that the public interest necessitates that this Order be effective immediately. See 21 CFR 1316.67.

    Dated: August 9, 2016. Chuck Rosenberg, Acting Administrator. Paul A. Dean, Esq. for the Government. J. Brad Pigott, Esq. for the Respondent. RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION

    Administrative Law Judge Charles Wm. Dorman. On December 9, 2015, the Drug Enforcement Administration (“DEA” or “Government”) served Lawrence E. Stewart, M.D. (“Respondent”), with an Order to Show Cause and Immediate Suspension of Registration (“OSC/ISO”), which immediately suspended the Respondent's DEA Certificate of Registration (“COR”), Number AS2286311. Administrative Law Judge Exhibit (“ALJ-”) 1-2. The Respondent's COR has remained suspended throughout these proceedings. In response to the OSC/ISO, the Respondent requested a hearing before an Administrative Law Judge. ALJ-3. That hearing was held in New Orleans, Louisiana on March 22 and 23, 2016. The issue currently before the Administrator is whether the Respondent's COR should be revoked, and applications for renewal or modification denied, because continued registration would be inconsistent with the public interest under 21 U.S.C. 823(f) and 824(a)(4). The following recommendations are based on my consideration of the entire administrative record, including all of the testimony, admitted exhibits, and the oral and written arguments of counsel.

    ALLEGATIONS

    1. From February 2014 to May 2015, the Respondent prescribed controlled substances, including hydrocodone and alprazolam, to a confidential informant (“CI”) 1 without conducting and/or documenting a physical examination, and without recording the controlled substance prescriptions in CI's chart, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rules 1.4, 1.11(b), and 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a). ALJ-1, at 2.

    1 The Prehearing Ruling and Protective Order directed that the confidential informant would be referred to as “CI.” ALJ-9, at 5. Accordingly, in this Recommended Decision, the confidential informant will be referred to as “CI.”

    2. On four occasions, the Respondent prescribed phentermine to CI without adequate documentation, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rule 1.5, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a). ALJ-1, at 3.

    3. From February 7, 2014 to November 19, 2014, the Respondent prescribed hydrocodone products to CI's children 2 without conducting examinations of them, and for CI's personal use, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rules 1.4, 1.10, 1.11(b), and 1.16, and Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) and 1306.05(a). ALJ-1, at 2-3. The Respondent prescribed hydrocodone-homatropine syrup to these children, who were under the age of six. ALJ-1, at 3. Hydrocodone-homatropine syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Respondent also prescribed adult dosages of hydrocodone-homatropine to these children, even though the recommended dosage for children ages six to eleven is half of the adult dosage. ALJ-1, at 2-3.

    2 The Prehearing Ruling and Protective Order directed that CI's children would be referred to as “Kid 1” and “Kid 2.” ALJ-9, at 5. Accordingly, in this Recommended Decision, CI's son will be referred to as “Kid 1,” and CI's daughter will be referred to as “Kid 2.”

    4. On five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents' prescription requests were fraudulent, in violation of 21 U.S.C. 841(a) and 842(a), and 21 CFR § 1306.04(a). ALJ-1, at 3. In total, the Respondent wrote seven prescriptions on five occasions to undercover agents, for a total of 190 dosage units of hydrocodone tablets and 72 dosage units of hydrocodone syrup. ALJ-1, at 11. On at least four of those occasions, the Respondent knew that CI would receive a portion of the prescribed controlled substances. ALJ-1, at 3-4. The Respondent also knew that CI had attempted to commit suicide using controlled substances that the Respondent had prescribed to her. ALJ-1, at 3-4.

    5. From February 2014 to October 2015, the Respondent unlawfully prescribed controlled substances in violation of 21 U.S.C. 841(a) and 842(a). ALJ-1, at 2. Specifically, the Respondent prescribed controlled substances when he knew or should have known that the prescriptions were not for legitimate medical purposes and were not made in the usual course of professional practice, in violation of 21 CFR § 1306.04(a) and Mississippi Code §§ 41-29-137(a)(1) and 41-29-141(1). ALJ-1, at 2.

    6. On September 2, 2014, the Respondent prescribed meperidine to CI. ALJ-1, at 3. The Respondent was the only practitioner to prescribe meperidine to CI. ALJ-1, at 3. CI used meperidine to attempt to commit suicide in December 2014. ALJ-1, at 3.

    STIPULATIONS OF FACT 3

    3See ALJ-9, 20; Tr. 9.

    The Government and the Respondent stipulated to the following facts:

    1. Respondent is registered with the DEA as a practitioner to handle controlled substances in Schedules II-V under DEA COR AS2286311 at 405 Marion Avenue, P.O. Box 666, McComb, Mississippi 39648-2709.

    2. DEA COR AS2286311 will expire by its terms on February 28, 2018.

    3. Respondent is presently licensed in Mississippi as a medical doctor (M.D.) with Medical License 11503.

    4. CI is the mother of Kid 1 and Kid 2.

    5. Hydrocodone-Acetaminophen 10-325 (Norco), Hydrocodone-Acetaminophen 7.5-325 (Norco), Hydrocodone-Acetaminophen 5-325 (Norco), and Hydrocodone-Homatropine Syrup (Hycodan) are all classified as Hydrocodone Combination Products.

    6. Hydrocodone Combination Products are classified by DEA as Schedule II Controlled Substances and have been so classified since October 6, 2014. Before October 6, 2014, Hydrocodone Combination Products were classified by DEA as Schedule III Controlled Substances.

    7. Alprazolam is classified by DEA as a Schedule IV Controlled Substance.

    8. Phentermine (Adipex) is classified by DEA as a Schedule IV Controlled Substance.

    9. Meperidine (Demerol) is classified by DEA as a Schedule II Controlled Substance.

    WITNESSES

    The Government presented its case through the testimony of nine 4 witnesses. First, the Government called Kendrick Lewis (“Lewis”). Tr. 24. Lewis is an employee of the Mississippi Bureau of Narcotics (“MBN”). Tr. 25. Lewis received a complaint against the Respondent on January 18, 2015. Tr. 25. Lewis spoke with CI and her husband, who had made the complaint together. Tr. 25, 29-31. Other than this conversation, Lewis had no further contact with CI. Tr. 28. Based on the nature of the complaint, Lewis contacted MBN's diversion unit, which began investigating the Respondent. Tr. 26-27, 31. During 2015, Lewis participated in the investigation by assisting with surveillance on March 27, April 8, April 29, and October 16. Tr. 27. Lewis's testimony was thorough, detailed, and internally consistent. Therefore, I merit it as credible in this Recommended Decision.

    4 Although the Government also called Antoine Battle to the stand, the Government did not elicit any testimony from Mr. Battle, and he was excused without testifying. Tr. 155-58.

    Second, the Government called Mary Flinchum (“Flinchum”). Tr. 33. Flinchum is a lieutenant for the MBN and a task force officer for the DEA's Tactical Diversion Squad. Tr. 33-34. Flinchum received an intelligence report about the Respondent from MBN. Tr. 35. Flinchum interviewed CI and her husband, separately and together, about their complaint to MBN. Tr. 36, 82. Flinchum helped decide that MBN should investigate the Respondent. Tr. 36-37. Flinchum also communicated with the Mississippi State Board of Medical Licensure (“Mississippi Board”), which was conducting an independent investigation concerning the Respondent. Tr. 58-59. Flinchum was familiar with an undercover investigation of the Respondent during March, April, and October of 2015. Tr. 77-81. Later, Flinchum was recalled to offer further testimony concerning the October 2015 undercover operation. Tr. 449-50. Through Flinchum's testimony, the Government authenticated and successfully offered into evidence Government Exhibits (“GE-”) 13 through 21, 27 through 29, 38 through 40, and 53. Tr. 38-57. I find all of these exhibits to be accurate, authentic, and meriting credibility. On cross-examination, the Respondent authenticated and successfully offered into evidence GE-2. Tr. 62-63. I find that Flinchum's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision.

    Third, the Government called Undercover Agent #1 5 (“Agent 1”). Tr. 89. Agent 1 is a female DEA task force officer and former MBN Agent. Tr. 89-90. Agent 1 participated in an undercover investigation of the Respondent. Tr. 90-91. Agent 1 attended undercover medical appointments with the Respondent on four occasions in 2015: March 27, April 8, April 29, and October 16. Tr. 91, 102, 111, 119. Agent 1 also accompanied CI to a rendezvous with the Respondent at a Walmart before the second undercover appointment on April 8, 2015. Tr. 128-29. Through Agent 1's testimony, the Government authenticated and successfully offered into evidence GE-9 through 12, 24 through 26, 30 through 33, 42 through 47, and 54. Tr. 91-128. I find all of these exhibits to be accurate, authentic, and meriting credibility. I also find that Agent 1's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision.

    5 Pursuant to the Prehearing Ruling and Protective Order, the identities of the undercover agents are not disclosed in this Recommended Decision. ALJ-9.

    Fourth, the Government called Undercover Agent #2 (“Agent 2”). Tr. 141. Agent 2 is a female MBN agent. Tr. 141. Agent 2 participated in the undercover investigation of the Respondent. Tr. 142. Agent 2 attended an undercover medical appointment with the Respondent on April 29, 2015. Tr. 143. Through Agent 2's testimony, the Government authenticated and successfully offered into evidence GE-34 through 37. Tr. 143-51. I find these exhibits to be accurate, authentic, and meriting full credibility. I also find that Agent 2's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision.

    Fifth, the Government called MBN Agent Charles Causey (“Causey”). Tr. 159. In 2015, Causey assisted with audiovisual surveillance for the DEA and MBN's undercover investigation of the Respondent on March 27, April 8, April 29, and October 16. Tr. 162-63. Causey testified that the video recordings of these undercover operations may contain incorrect internal date/time stamps, and that the dates and times on the video recordings do not necessarily correspond to the actual dates and times on which the video recordings were made. Tr. 165-66. I find that Causey's testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision.

    Sixth, the Government called Leslie Ross (“Ross”). Tr. 168. Ross is an investigations supervisor for the Mississippi Board and a task force officer for the DEA's Tactical Diversion Squad. Tr. 168-69. The Mississippi Board reviews and issues medical licenses, promulgates rules and regulations for the practice of medicine in Mississippi, investigates complaints about Mississippi licensees, and imposes disciplinary action when necessary. Tr. 170. Several days before the Mississippi Board closed its investigation concerning the Respondent, Ross received a call from Agent Flinchum, advising Ross that the DEA and the MBN were investigating the Respondent. Tr. 194-95, 210. Ross explained that the phone call influenced the Mississippi Board's decision to close its case because it was the Mississippi Board's custom “to back off and let a criminal agency pursue their case.” Tr. 210. Without interviewing CI, the Mississippi Board closed its investigation. Tr. 196. Ross also helped author part of Mississippi Administrative Rule 1.5, which regulates diet medication prescriptions in Mississippi. Tr. 172. Ross established the foundation for the Court to take official notice of Mississippi Administrative Rules 1.1, 1.2, 1.4, 1.10, and 1.16. Tr. 188-93. Additionally, while Ross did not conduct the Mississippi Board's investigation of the Respondent, she supervised Todd Pohnert, who conducted the investigation. Tr. 170, 173. Ross served administrative subpoenas for information about the Respondent to two Mississippi pharmacies, one in McComb and one in Brookhaven. Tr. 185. I find that Ross' testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Through Ross' testimony, the Government authenticated and successfully offered into evidence GE-3 and 8. Tr. 171-78. I find these exhibits to be accurate, authentic, and meriting credibility. Furthermore, through Ross' testimony, the Government established some foundation for GE-7 and 55. Tr. 185-88.

    Seventh, the Government called CI. Tr. 212. CI testified about her relationship with the Respondent and how and why she obtained controlled substance prescriptions from him. Tr. 212-31.6 Through CI's testimony, the Respondent admitted GE-49, 56, and 57. Tr. 284, 300-03, 335-38. I find these exhibits to be generally accurate, authentic, and meriting credibility. I also find that CI's testimony was generally forthright, internally consistent, and generally merited credibility 7 in this Recommended Decision.

    6 The Respondent asked CI extensively about an exhibit, pre-marked for identification as Respondent's Exhibit (“RE-”) 1. See generally Tr. 231-73. However, the Respondent never offered RE-1 into evidence. Therefore, the contents of RE-1 are not considered in this Recommended Decision.

    7 There were some inconsistencies in CI's lengthy testimony. First, when asked if she paid cash for prescriptions from the Respondent, CI answered that she believed she always used insurance. Tr. 360. However, CI's Prescription Monitoring Program report shows that, in 2014, CI paid for prescriptions from the Respondent with cash 15 times, and used her insurance only 5 times. See GE-49, at 1-3. Second, CI suggested that it was the Respondent's idea for CI to send a friend into his office to get prescriptions for her. Tr. 345-47. However, audio recordings of the Respondent's telephone calls with CI suggest that it was CI's idea for her to send a friend into the Respondent's office to get prescriptions for CI. See GE-16, file 2015-03-16_18-51-48_EDT, at 20-21; GE-16, file 2015-03-18_11-03-33_EDT, at 2. Third, CI testified that the Respondent only conducted a physical examination of her one time. Tr. 322. The Respondent's patient file for CI seems to indicate, however, that the Respondent gave CI some sort of examination on both April 21 and September 2 of 2014. GE-2, at 12. In these three instances, I do not find CI's testimony credible.

    Eighth, the Government called James Pacheco (“Pacheco”). Tr. 385. Pacheco is an agent for the MBN and a task force officer for the DEA's Tactical Diversion Squad. Tr. 386. Pacheco participated in the undercover investigation of the Respondent by coordinating the surveillance aspect of the investigation. Tr. 388. Pacheco assisted with physical surveillance of the Respondent and CI during an undercover operation at a Walmart on April 8, 2015. Tr. 388-89. Pacheco personally observed most of the operation at Walmart. Tr. 389. Pacheco also testified that he listened to the undercover operation conducted at the Respondent's clinic in October 2015. Tr. 406-07. Through Pacheco's testimony, the Government authenticated and successfully offered into evidence GE-22 and 23. Tr. 387-93. I find these exhibits to be accurate, authentic, and meriting credibility. I also find that Pacheco's testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision.

    The Government's ninth witness was Maria Gilbert (“Gilbert”). Tr. 409. Gilbert is a DEA diversion investigator, and was a case agent in the investigation of the Respondent. Tr. 409-10. Gilbert helped submit the evidence acquired by the undercover agents into a DEA evidence locker. Tr. 440. Gilbert also directed DEA personnel to obtain Prescription Monitoring Program (“PMP”) reports during the investigation. Tr. 438. Gilbert created the administrative subpoenas issued to pharmacies to obtain information about the Respondent. Tr. 412. Gilbert helped conduct an administrative search of the Respondent's office. Tr. 427-28. Through Gilbert's testimony, the Government authenticated and successfully offered into evidence GE-7, 41, 48, 50 through 52, 55, and 58 through 60. Tr. 411-18, 427-39. I find these exhibits to be accurate, uncontested, and meriting credibility. I also find that Gilbert's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision.

    The Respondent did not call any witnesses or offer any of his proposed exhibits into evidence. Tr. 458.

    The factual findings below are based on a preponderance of the evidence, including the detailed, credible, and competent testimony of the aforementioned witnesses, the exhibits entered into evidence, and the record before me.

    FACTUAL FINDINGS

    1. The Respondent has not previously been convicted of any crime related to controlled substances. GE-1, at 1. The Respondent has never had his state medical license revoked, suspended, denied, restricted, or placed on probation. GE-1, at 1.

    The Respondent's Relationship with CI

    2. The Respondent and CI became Facebook friends and began talking with each other in January 2014. Tr. 213, 237. CI asked the Respondent questions about the health of Kid 1.8 Tr. 213-14, 246-47, 261-62. The Respondent performed a tonsillectomy on Kid 1 and placed tubes in his ears on January 30, 2014. GE-57, at 13, 19-20; Tr. 219, 235, 285. Following Kid 1's tonsillectomy, CI asked the Respondent for medication for Kid 1's medical condition; the Respondent was willing to write prescriptions for Kid 1. GE-57, at 5-6; Tr. 246-47, 249. Around that time, CI and the Respondent became friends and began texting and talking on the phone. Tr. 213-14, 240.

    8See Stipulation (“Stip.”) 4; see also ALJ-9, at 5.

    3. In the spring of 2014, CI and the Respondent began to have a consensual sexual relationship. Tr. 213, 218-19, 290-92, 296, 359. During the summer of 2014, CI and the Respondent saw each other very often. Tr. 324. CI and the Respondent communicated frequently by texting and calling each other on their cell phones. Tr. 355-56.

    4. CI engaged in a sexual affair with the Respondent because she was infatuated with him and because she wanted to obtain controlled substances for her recreational use. Tr. 291-92. The controlled substances, however, were not a prerequisite for sexual relations. Tr. 289.

    5. The sexual relationship between CI and the Respondent ended in November 2014. Tr. 219.

    A. The Respondent's Medical Treatment of CI and Her Children

    6. The Respondent provided medical treatment to CI several times, beginning in 2010. GE-2, at 12-13; Tr. 215, 277. Specifically, the Respondent treated CI for a sinus infection, vertigo, and migraines. GE-2, at 12-13; Tr. 215, 277-78, 287, 321. CI had a serious migraine condition that caused her to seek treatment in emergency rooms on four occasions. Tr. 278-80, 347. CI discussed her migraines and hospitalizations with the Respondent, who gave her information about migraines. Tr. 282, 287. The Respondent prescribed Maxalt 9 to CI to treat her migraines. GE-2, at 12; Tr. 215-16, 283.

    9 Maxalt, or rizatriptan benzoate, is not a federally controlled substance. See generally 21 CFR §§ 1308.11-1308.15 (2015).

    7. The Respondent had a patient file for CI and wrote notes therein about her treatment. See GE-2, at 12-13. The Respondent conducted two physical examinations of CI, once when he was treating her for a sinus infection, and again when he was treating her for a migraine headache.10 GE-2, at 12-13; Tr. 322. The Respondent also requested a CT 11 sinus scan for CI in 2014. GE-2, at 12, 14. A CT scan showed that CI's sinuses were “clear [and] scant thickening in LNF duct.” GE-2, at 14.

    10See supra note 7.

    11 Computerized tomography.

    8. CI took Kid 1 and Kid 2 to appointments with the Respondent. Tr. 219, 261-62, 285-86, 335-36, 338; see, e.g., GE-56, at 3-4; GE-57, at 6, 9-10. The Respondent conducted legitimate medical procedures on both children and saw the children for follow-up appointments. GE-56, at 3-4; GE-57, at 5-6; Tr. 219, 261-62.

    9. CI sent the Respondent at least one message via social media requesting his medical advice about Kid 1's condition. Tr. 262-63. CI communicated with the Respondent about the physical condition of her children to get his medical advice. Tr. 263-65.

    10. Near a date stamp reading “February 4, 2014,” the Respondent recorded in Kid 1's medical file that CI had migraines, that she may call in for a prescription if needed, and that he discussed phentermine 12 with her. GE-57, at 6; see Tr. 286. The Respondent's patient file for CI also contains a telephone request form, dated July 18, 2014, and signed by the Respondent, which states that CI requested a phentermine refill. GE-2, at 15. CI's patient file, however, does not note any reasons that the Respondent prescribed phentermine to CI. See GE-2, at 12-13.

    12 CI denied asking the Respondent for phentermine in February 2014. Tr. 286-88. Phentermine is another name for Adipex. See Stip. 8; Tr. 288.

    B. CI's Drug Use

    11. Prior to her relationship with the Respondent, CI took controlled substances, including hydrocodone, which were prescribed by numerous other doctors to help treat pain resulting from four lithotripsies, kidney stones, a broken tailbone, a root canal, and TMJ 13 . GE-49, at 2; Tr. 214, 275-76, 304-09. CI told the Respondent about these prescriptions. Tr. 309.

    13 Temporomandibular joint dysfunction, or lockjaw.

    12. CI occasionally used Adderall for nonmedicinal purposes. Tr. 215. CI had not used cough syrup for nonmedicinal purposes prior to her relationship with the Respondent. Tr. 215.

    13. After Kid 1 had his tonsils removed on January 30, 2014, CI took some of Kid 1's pain medication. Tr. 273-74, 276. As a result of the tonsillectomy, the Respondent prescribed two different forms of hydrocodone for Kid 1. GE-51, at 1; GE-57, at 6, 14, 22.

    14. The Respondent first prescribed cough syrup for Kid 2 on January 24, 2014. GE-50, at 1; GE-56, at 4. The Respondent again prescribed cough syrup for Kid 2 in February 2014. Tr. 216, 258-59; GE-50, at 1; GE-56, at 4. The Respondent did not examine Kid 2 before he prescribed cough syrup for her. Tr. 217, 251; see GE-56, at 4.

    15. CI talked with the Respondent about prescribing a “big bottle” of cough syrup so that CI could drink it. Tr. 216, 251-52, 268, 273. CI thought that the Respondent knew she did not have a cough. Tr. 216, 251-52, 268. In February 2014, CI asked the Respondent to prescribe 14 a “big bottle” of hydrocodone cough syrup for Kid 2. Tr. 216-17, 250, 252-53, 259. At that time, CI told the Respondent that Kid 2 had a cough. Tr. 250-51, 253-55. On February 7, 2014, the Respondent doubled the size of Kid 2's prescription for cough syrup. GE-50, at 1; GE-55, at 1-2.

    14 CI later testified that this was a refill of a prescription written by the Respondent. Tr. 272-73.

    16. CI told the Respondent when Kid 1 or Kid 2 had a cough. Tr. 250. CI, however, did not bring her children to see the Respondent regarding a cough; she requested cough syrup from the Respondent because she liked drinking it. Tr. 220, 273; see generally GE-56, at 3-4; GE-57, at 5-6.

    17. The Respondent prescribed Norco, Xanax, and Adipex to CI on multiple occasions. Tr. 26; GE-49. The Respondent prescribed Norco 15 to CI, which she took daily instead of as needed. Tr. 297. CI took hydrocodone “[j]ust for fun.” Tr. 298. CI would tell the Respondent when she ran low on a prescription, and he would give her another prescription.16 Tr. 298-99. He advised her that hydrocodone could cause migraines. Tr. 298-99.

    15 Norco is a hydrocodone combination product. See Stip. 5.

    16 Specifically, CI testified that when she ran low on a prescription, the Respondent would refill it. Tr. 298-99. Refills are not authorized for hydrocodone combination products, such as Norco. Compare 21 U.S.C. § 829(a), with Stip. 6. The record does not contain any evidence that the Respondent attempted to give CI a refill on a hydrocodone combination product. Therefore, I interpret CI's statement as meaning that whenever she ran low on a prescription, she would tell the Respondent, and he would issue another prescription to her.

    18. On several occasions, the Respondent provided prescriptions to CI while he was at CI's house. Tr. 217-18; see Tr. 26. On those occasions, the Respondent did not communicate a diagnosis to CI or perform a physical examination of CI. Tr. 218. Sometimes, CI took her children to appointments with the Respondent as an excuse to see the Respondent, who would then occasionally give prescriptions to CI. Tr. 219-20. On one occasion, the Respondent met CI in the garden section of a Walmart, where he gave her prescriptions for cough syrup and pain medication. Tr. 218.

    19. At times, CI told the Respondent about her children's pain or physical conditions to get prescriptions for her own personal use. Tr. 267. CI would occasionally administer the prescribed medication to her children. Tr. 270-72.

    20. CI requested that the Respondent write a prescription for Adderall for her, but he declined to do so. Tr. 223. In the spring of 2014, CI asked the Respondent to write her a prescription for Adipex, a weight loss drug. Tr. 223-24, 288-89. The Respondent wrote prescriptions and refills for Adipex to CI. GE-49, at 1-2; Tr. 223-24. CI used Adipex for approximately three months. Tr. 224. The Respondent did not conduct a physical examination of CI focused on weight issues at any point before or while CI took Adipex, and the Respondent did not discuss alternative weight loss treatments with CI. Tr. 224-25; see GE-2, at 12-13.

    21. CI had anxiety, which she discussed with the Respondent. Tr. 322. The Respondent told her to visit a certain psychiatrist. Tr. 225, 295. CI visited that psychiatrist twice. Tr. 225. The psychiatrist prescribed a low dosage of time-release Xanax 17 . Tr. 225, 295, 304; see GE-49, at 1. The Respondent then prescribed 18 a stronger dosage of Xanax to CI. Tr. 226; see GE-49, at 1.

    17 Xanax is a brand name for alprazolam, which is a benzodiazepine and a Schedule IV controlled substance. Stip. 7; see 21 CFR § 1308.14(c)(2); Tr. 304.

    18 CI testified that this prescription was a refill prescription, but that it was for a different dosage. Tr. 295-96.

    22. The Respondent wrote nine prescriptions 19 to CI, contained in GE-7 and 41, which are not documented in the Respondent's patient file for CI. Compare GE-2, at 12-13 (containing the Respondent's patient file for CI), with GE-7, at 1-2 (containing a prescription written by the Respondent to CI), and GE-41 (containing prescriptions written by the Respondent and filled by CI), and GE-49 (containing CI's PMP report); see Tr. 364-77. The Respondent's patient file for CI does not include any notes from any examinations on the dates on which the Respondent wrote these nine prescriptions. GE-2, at 12-13. CI did not have a physical examination or receive counseling before the Respondent gave her any of these prescriptions. Tr. 384; see GE-2, at 12-13.20

    19 Seven of these prescriptions, written to CI in 2014, were as follows: May 19 for Adipex; May 22 for Norco; June 17 for Norco; July 24 for Adipex; September 8 for Adipex; September 11 for Norco; and October 6 for Xanax. Compare GE-2, at 12-13, with GE-41, at 1-7, 12-13, and 18-23, and GE-49. The Respondent wrote another prescription for Adipex to CI on April 9, 2014. Compare GE-2, at 12-13, with GE-7, at 1-2, and GE-49. The Respondent also wrote a prescription for Hycodan to CI, dated December 3, 2014, but CI's PMP report said that the prescription was written on December 4, 2014. Compare GE-41, at 28-29, with GE-49. Regardless of when this prescription was actually written, it was not documented in CI's patient file. See GE-2, at 12-13.

    20 CI testified about a prescription that is not in GE-41. Tr. 364, 369-70. The prescription allegedly was written in her name by the Respondent. Tr. 369-70. The prescription allegedly was dated October 29, 2014. Tr. 369-70. The Respondent's PMP report likewise lists a prescription for hydrocodone-acetaminophen (Norco) prescribed by the Respondent on October 29, 2014. GE-49, at 1. However, neither of the two copies of GE-41 submitted to me includes this prescription. Examination of both submitted copies of GE-41 reveals that no pages of GE-41 are missing. At the hearing, however, Government counsel provided CI with an excerpt of what he said was “part of Exhibit 41,” and he provided the Respondent and the ALJ with a copy of what was handed to the witness. Tr. 364. That excerpt has now been included in the administrative record as ALJ-29. Comparing ALJ-29 with GE-41, I have determined that the witness did, in fact, examine a prescription dated October 29, 2014. That prescription, however, was never offered into evidence. Furthermore, the witness was never asked if the prescription, dated October 29, 2014, refreshed her memory of having received the prescription. Accordingly, I decline to find that the Government presented sufficient evidence to establish that the Respondent wrote a prescription to CI on October 29, 2014. Following the hearing, the parties were provided with copies of ALJ-29.

    23. Two prescriptions written by the Respondent to Kid 1 are not documented in Kid 1's medical chart. Compare GE-51 (containing Kid 1's PMP report and listing prescriptions from June 17 and November 19 of 2014), and GE-55, at 3-4, 11-12 (containing prescriptions from June 17 and November 19 of 2014), with GE-57 (containing Kid 1's medical file, which does not include any examination or prescription notes for June 17 or November 19 of 2014); see also Tr. 377-81. Likewise, a prescription written by the Respondent to Kid 2 is not documented in Kid 2's medical chart. Compare GE-50 (containing Kid 2's PMP report and listing a prescription written on July 23, 2014), and GE-55, at 5-6 (containing a prescription dated July 23, 2014), with GE-56 (containing Kid 2's medical file, which does not include any examination notes or prescription notes for July 23, 2013).

    24. On one occasion in early fall of 2014, following CI's complaint of a severe migraine, the Respondent prescribed Demerol to CI. Tr. 222, 296-97, 317-18, 382. Next to the date “September 2, 2014” in CI's medical chart, the Respondent wrote that he refilled her prescription of phentermine, looked at her ears and nose, and counselled her. GE-2, at 12; Tr. 323. He also wrote that he prescribed Demerol and Xanax to CI. GE-2, at 12. CI did not ask the Respondent for Demerol. Tr. 296, 318.

    25. CI's husband discovered that CI was having an affair with the Respondent. Tr. 26, 320. Sometime after the discovery, in December 2014, CI attempted suicide using the Demerol the Respondent prescribed to her. Tr. 222, 314-17. CI went to a mental institution for a week following her suicide attempt. Tr. 227, 309. In January 2015, CI told the Respondent that she had tried to kill herself. Tr. 226-27, 309-11.

    C. The MBN Complaint

    26. After CI's husband discovered the affair and CI attempted to commit suicide, CI and her husband made a complaint against the Respondent to the MBN. Tr. 25, 29-31, 71, 228-29, 339-40. CI told MBN investigators that she got medications from the Respondent for nonmedicinal purposes because she enjoyed using them. Tr. 84.

    D. The Anonymous Letter

    27. The Mississippi Board received an unsigned letter, allegedly from CI's husband, which complained about the extramarital affair between CI and the Respondent. GE-3, at 3; Tr. 58, 66. The Mississippi Board and MBN both received a copy of the letter. Tr. 66-67, 70-71, 398-99. Several witnesses testified that CI's husband was not the author of this letter. Tr. 67-70, 326, 394, 396. The author of the letter is unknown. Tr. 67-70, 201, 326, 394-95.

    28. The letter was written in the first person, and CI's husband's name was typewritten on the bottom of the letter, along with CI's date of birth and social security number. GE-3, at 3. The letter said that the author's wife, CI, had an affair with the Respondent for over a year, and that the author did not know about it until he found a box of empty pill bottles that the Respondent had prescribed to CI, even though CI was not his patient. GE-3, at 3. The letter was stamped as received by the Mississippi Board on February 19, 2015. GE-3, at 3.

    29. By the time the MBN received a copy of the letter, it had already begun its investigation of the Respondent because of the complaint made by CI and her husband. Tr. 71, 74-76. After receiving a copy of the letter, the Mississippi Board began conducting an independent investigation of the Respondent. Tr. 58, 61, 203.

    E. The Mississippi Board Investigation

    30. A Mississippi Board investigator met with the Respondent regarding the anonymous letter. GE-3, at 4-6. At that time, the Mississippi Board was unaware that the DEA was conducting a simultaneous investigation of the Respondent. Tr. 180.

    31. In response to the investigator's inquiry, the Respondent said that he only saw CI when she or her children had appointments, and had not seen CI outside of his office. GE-3, at 5; Tr. 179, 202. The Respondent suggested that he had not engaged in sexual misconduct with CI. GE-3, at 5; Tr. 180, 207. The Respondent also suggested that he was not aware that CI had attempted to commit suicide or had been committed to a mental hospital. GE-3, at 5, 7.

    32. The investigator made copies of CI's patient charts and found several shortcomings with CI's medical records. GE-3, at 4-5; Tr. 180, 197. First, the investigator found seven prescriptions in CI's PMP report that were not documented in the Respondent's patient file for CI. GE-3, at 5. The Respondent explained that he might have documented the missing prescriptions in his patient files for CI's children instead. GE-3, at 5.

    33. Second, the investigator found that CI's patient file did not include any notes about CI's vitals, height/weight, BMI, or alternative weight control treatment plans, and did not indicate that CI received any counseling about other weight loss options. GE-3, at 5; Tr. 180.

    34. Following the investigator's visit, the Mississippi Board sent the Respondent a copy of the anonymous letter purportedly from CI's husband.21 See GE-2, at 6-8. The investigator told the Respondent that he should send a letter to the Mississippi Board as a follow-up from the investigator's visit. GE-3, at 5; Tr. 179.

    21 The handwritten notation on the bottom of the letter was likely added by a Mississippi Board investigator. Tr. 87; see GE-2, at 6.

    35. The Respondent sent a letter to the Mississippi Board. GE-3, at 7-8; Tr. 179-80. Therein, the Respondent denied knowing that CI had overdosed.22 GE-3, at 7; Tr. 180. The Respondent stated that he was “appalled, outraged, and disgusted” by the anonymous letter's allegations. GE-3, at 7; Tr. 208. The Respondent wrote that the medications CI used to overdose “were legitimately prescribed for valid medical problems.” GE-3, at 7. The Respondent wrote that he was unaware that CI had received controlled substances from other prescribers and that CI did not show “any hint of drug-seeking behavior.” GE-3, at 7. The Respondent acknowledged that he should not refill medications for a parent during a child's visit without pulling the parent's chart, and said that he would not do so in the future. GE-3, at 7. The Respondent stated that he would not refill diet drugs for patients in the future without completing the appropriate documentation. GE-3, at 7.

    22 Specifically, the Respondent wrote that he was “sorry to learn that [CI] may have deliberately taken an overdose.” GE-3, at 7.

    36. The Mississippi Board contemplated closing its investigation of the Respondent because it did not have enough evidence supporting the allegations of the Respondent's sexual misconduct. Tr. 181, 184, 194-95, 197, 209-10. Throughout the course of its investigation, however, the Mississippi Board never interviewed CI. Tr. 196.

    37. On March 20, 2015, while the Mississippi Board was contemplating closing its investigation, Flinchum contacted the Mississippi Board and requested, on the DEA's behalf, that the Mississippi Board discontinue its investigation of, and communication with, the Respondent. GE-3, at 2; Tr. 60-61, 181, 209. The Mississippi Board customarily will discontinue an investigation to allow a criminal agency to pursue a case. Tr. 210.

    38. The Mississippi Board closed its investigation of the Respondent on March 23, 2015. GE-3, at 1; Tr. 181. A letter from the Mississippi Board to the Respondent terminated the Board's investigation. GE-3 at 1; Tr. 183. The letter stated that the Mississippi Board concluded its investigation and that, after a thorough review of the information and facts from the investigation, it decided not to recommend any formal action. GE-3, at 1. This letter was a truthful and accurate reflection of the Board's reasons for terminating the investigation. Tr. 64-65, 86, 195-97.

    39. The letter also cautioned the Respondent against “authorizing refills for Phentermine/Adipex without benefit of a medical examination.” GE-3, at 1 (discussing Mississippi Administrative Rule 1.5(E)).

    40. The letter told the Respondent that the Mississippi Board had found some deficiencies with his medical records. Tr. 181, 183-84, 203. The letter did not exonerate the Respondent, but warned him about his inadequate documentation of weight loss prescriptions. Tr. 184, 203.

    F. DEA Undercover Operations

    41. The DEA began undercover operations concerning the Respondent in March 2015. Tr. 77-78.

    42. CI was told that if she cooperated with law enforcement, she would not be in any trouble. Tr. 342-43. CI signed a confidential informant agreement with the DEA. Tr. 343-44, 394.

    43. The DEA instructed CI not to have any contact 23 with the Respondent unless the DEA supervised the contact. Tr. 350. CI did not comply with this instruction and met the Respondent one time without DEA's supervision. Tr. 353, 358.

    23 The DEA did not ask CI to attend an undercover appointment with the Respondent because CI had a physical relationship with the Respondent, and because CI said that she was addicted to cough syrup. Tr. 400.

    44. With CI's consent, the DEA gave CI a telephone number that recorded all calls and text messages exchanged between CI and the Respondent. Tr. 37-38, 84-85, 230. This telephone number operated through an application that the DEA installed on CI's cellular phone. Tr. 382. This application automatically recorded all calls, conversations, and multimedia messages exchanged between CI and the Respondent. Tr. 37-38, 85-86.

    45. CI called and texted the Respondent outside of the presence of MBN and DEA agents. Tr. 85-86. The DEA did not tell CI what to say to the Respondent. Tr. 85-86.

    i. Interactions Between the Respondent and CI Before the First Undercover Appointment

    46. The DEA agents asked CI to contact the Respondent by phone or by text message and ask him for Norco and cough syrup. Tr. 346, 348-49.

    47. On March 16, 2015, at approximately 6:51 p.m., the Respondent and CI spoke on the phone. GE-15-16. CI asked the Respondent to meet her at Walmart and give her a prescription for something. GE-16, file 2015-03-16_18-51-48_EDT, at 19; see Tr. 345. The Respondent said he could not do that because the Mississippi Board was watching him and he could go to jail or lose his license. GE-16, file 2015-03-16_18-51-48_EDT, at 19-20; see Tr. 230, 345-47. He said that everything he had prescribed to CI was legitimate and written in her chart. GE-16, file 2015-03-16_18-51-48_EDT, at 20. After CI again asked the Respondent several times to give her a prescription, CI asked him instead to write a prescription for someone else.24 Id. The Respondent said he could prescribe to anyone who came into his office, and what they did with their prescriptions was “their business,” but that it had “to be a legitimate thing.” Id. at 21. CI asked him multiple times to write prescriptions for her, but in different names, and the Respondent said he could not do so without someone coming for a visit and having a chart. Id. The Respondent said he could “probably pilfer” some medication from his wife for CI. Id. at 22. CI repeatedly asked the Respondent to get her some controlled substances, and the Respondent repeatedly said he would see what he could do. Id. at 24-26.

    24Contra Tr. 346; see supra note 7.

    48. On March 17, 2015, at approximately 1:07 p.m., the Respondent and CI spoke on the phone. GE-15-16. CI asked the Respondent to slip “a couple Lorcets” into her mailbox. GE-16, file 2015-03-17_13-07-36_EDT, at 4. The Respondent joked, “I need to learn to play the guitar so you could be getting sex, drugs and rock and roll, you know.” Id. CI asked the Respondent to “sneak [her] some meds.” Id. at 7. The Respondent said, “I've got your request and I'm telling you that is highly, highly dangerous for me.” Id.

    49. On March 18, 2015, at approximately 11:03 a.m., the Respondent and CI spoke on the phone. GE-15-16. CI suggested that the Respondent could write a prescription in Kid 1's name. GE-16, file 2015-03-18_11-03-33_EDT, at 1. The Respondent responded sarcastically and attempted to change the subject. Id. at 1-2. CI said that she really needed him to find a way to write her a prescription. Id. at 2. The Respondent said he did not know how to do that. Id. CI suggested that he could write a prescription in someone else's name. Id. The Respondent said he would “have to have somebody that's legitimate” and “what they did with the medicine[,] that was up to them . . . somebody that's trustworthy.” Id. at 3. The Respondent indicated that it was like a “federal crime when you write medicine to—that are diverted to somebody else.” Id. CI said that the Respondent used to write her prescriptions “all the time.” Id. The Respondent said, “Yeah, but I wrote it for you.” Id. CI recalled that the Respondent “used to bring [his] prescription pad over and a bottle of vodka,” and that she “miss[ed] those days.” Id. The Respondent replied, “I know, me too.” Id. The Respondent joked with CI that it was good to have a boyfriend with a prescription pad. Id. at 4.

    50. On March 25, 2015, at approximately 10:36 a.m., the Respondent and CI spoke on the phone. GE-17, at 1-5.25 CI asked the Respondent if he would write a prescription to another person. GE-17, at 2. The Respondent remarked that it was dangerous and it would have to be to an established patient; he suggested that she get another doctor to write a prescription for her. GE-17, at 2. CI insisted, and the Respondent said “it has to be legitimate” and for a “legitimate patient” because the Mississippi Board was watching him. GE-17, at 2. The Respondent said he could treat a patient for CI if the patient had headaches and anxiety. GE-17, at 3. The Respondent said, “what he does with 'em is his business.” GE-17, at 3. CI asked the Respondent if he would write something to her friend who came in with a headache; the Respondent said, “Yeah, I could write him something.” GE-17, at 3. CI clarified that the prescription would really be for her, and requested that he prescribe “Lorcet or something;” the Respondent said, “Yeah, I could write him some—yeah, some stuff like that.” GE-17, at 3. The Respondent cautioned CI that taking too many Lorcet or Demerol would be harmful and painful to her. GE-17, at 4. CI said she just wanted “some pain pills from [her] boyfriend.” GE-17, at 4.

    25See GE-16, file 2015-03-25_10-36-40_EDT.

    51. On March 25, 2015, at approximately 11:43 a.m., the Respondent texted CI, “I won't be in the office tomorrow. I could see her Friday.” GE-53, file 2015-03-25_11-43-42_EDT. CI texted back, “Ok:) she is a real cool girl. I use [sic] to party with her.” GE-53, file 2015-03-25_11-47-23_EDT; see Tr. 349.

    52. On March 25, 2015, at approximately 2:36 p.m., the Respondent and CI spoke on the phone. GE-17, at 6-8.26 The Respondent asked CI for her friend's name. GE-17, at 6-8. CI told the Respondent the alias first name of Agent 1. GE-17, at 6-7. The Respondent said, “If she's coming in for what I think she's coming in, tell her not to tell me that. That needs to be your secret. I don't wanna know that. She needs to have a headache and I will treat her for a headache, and so [I] don't mind giving her prescriptions to treat a headache.” GE-17, at 7. The Respondent discussed the medications he could prescribe to Agent 1 and told CI that they “would be perfectly appropriate for you to take.” GE-17, at 7; see Tr. 349 (noting that the Respondent knew that Agent 1 was not a real patient and that medication prescribed to Agent 1 would be given to CI).

    26See GE-16, file 2015-03-25_14-36-02_EDT.

    53. On March 26, 2015, at approximately 11:18 a.m., the Respondent and CI spoke on the phone. GE-18.27 CI told the Respondent that Agent 1 had an appointment with him “tomorrow at 2:00—2:10, I think.” GE-18, at 3. The Respondent replied, “Okay. We'll see if we can't get my girlfriend fixed up.” GE-18, at 3. The Respondent said CI should remind Agent 1 to “play it straight” and tell the Respondent what he to needed to write on a chart to “keep the medical examiners at bay . . . .” GE-18, at 3. CI asked him if he would prescribe Norco to Agent 1. GE-18, at 3. The Respondent said, “Yeah, I'll write her Norco and some more Maxalt, and then you can have some Maxalt also. Just remember to hide it.” GE-18, at 3.

    27See GE-16, file 2015-03-26_11-18-28_EDT.

    54. Based on Findings of Fact 47 through 53 and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on March 27, 2015, the Respondent knew that Agent 1 was not a legitimate patient and that any medication he prescribed to her at that appointment would be given to and used by CI.

    ii. Undercover Appointment #1: March 27, 2015

    55. Agent 1's first appointment with the Respondent was on March 27, 2015. GE-10; Tr. 91. Upon arriving at the Respondent's clinic, Agent 1 signed in, completed paperwork, and waited in the Respondent's waiting room. GE-9; Tr. 92. The Respondent's nurse called Agent 1 back into an examination room and spoke briefly with her. GE-9; Tr. 92, 94.

    56. Agent 1 met with the Respondent. GE-9-10; Tr. 91; see GE-59 (containing the Respondent's patient file for Agent 1). The appointment lasted approximately seven minutes. GE-9. When the Respondent asked Agent 1 what her problem was, she told him, “Just kind of a whole head thang [sic].” GE-10, at 1; Tr. 94. The Respondent asked Agent 1 how long her head had been bothering her, and she indicated just a few days. GE-9-10. The Respondent quickly looked into Agent 1's ears, nose, and throat. GE-9-10; Tr. 94, 132. The Respondent asked her if she was dizzy, nauseous, or taking other medication. GE-9-10. He advised her that Maxalt works well for sinus headaches and gave her instructions for taking her prescriptions. GE-9-10. The Respondent did not communicate any diagnosis to Agent 1, nor did he record a diagnosis in her patient file.28 GE-9-10; GE-59, at 4.

    28 The Respondent's March 27, 2015 notes in Agent 1's patient file mention photophobia. GE-59, at 4. The transcript and recording of the office visit, however, contain no mention of photophobia or any discussion of the symptoms of photophobia. GE-9-10.

    57. Agent 1 asked the Respondent if he could help her with her weight loss. GE-9-10. The Respondent declined to prescribe anything for weight loss to Agent 1; he said that it was not his area of expertise and it was heavily regulated by the Mississippi Board. GE-10, at 2. He recommended that she could go to a licensed diet center for assistance. GE-10, at 3.

    58. The Respondent wrote two prescriptions for Agent 1: one non-refillable prescription for Norco, and one refillable prescription for Maxalt. GE-11-12; Tr. 95. The Respondent told Agent 1 that he would give her “lots of refills” on the Maxalt. GE-10, at 1.

    59. That same day, CI and the Respondent had a phone conversation about the Respondent's meeting with CI's “friend,” Agent 1. GE-13-14; GE-20, file Post Buy CI Call With STEWART 3-27-2015. The Respondent said he enjoyed meeting Agent 1 and that he was “hopeful that that helps” CI. GE-14, at 1. CI said that she could get through because the Respondent “hooked” her up. GE-14, at 1. The Respondent responded, “absolutely that needs to be about as discreet as [unintelligible].” GE-14, at 1. The Respondent told CI to “not take that other stuff but one at a time.” GE-14, at 1. He said that, during Agent 1's appointment, he “talked about headaches and pretty much left it exactly at that.” GE-14, at 1. The Respondent told CI, “[s]o um you got refills on that Maxalt. Um she does,” and noted that he could not give refills “on the other one . . ..” GE-14, at 2.

    iii. Interactions Between the Respondent and CI Between the First and Second Undercover Appointments

    60. On April 1, 2015, at approximately 8:28 p.m., the Respondent and CI spoke on the phone. GE-19.29 CI said that she spent time with Agent 1. GE-19, at 1. The Respondent asked her, “So that all went smooth with getting your medicine and all that?” GE-19, at 1; see Tr. 230-31. CI said she might need some more. GE-19, at 1. The Respondent said he was glad he could help and that it was “just because of” the Mississippi Board complaint that “it just has to be straight up and clean.” GE-19, at 1.

    29See GE-16, file 2015-04-01_20-28-54_EDT.

    61. On April 2, 2015, at approximately 2:15 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-02_14-15-50_EDT. CI told the Respondent that Agent 1 would come back and that she “took all” after CI “halved some with her.” Id. CI asked the Respondent if he could “give her a little bit more if she'd come back in.” Id. at 1. The Respondent replied, “I can do that.” Id. at 2. The Respondent asked if “she” really had migraines. Id. CI said “no” and laughed. Id. The Respondent laughed too and said he was just wondering because there were a lot of refills. Id. The Respondent said, “[l]ong as we don't get outta hand. Just be sure to keep ’em really hidden.” Id.

    62. On April 2, 2015, at approximately 3:04 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-02_15-04-43_EDT. CI asked the Respondent whether he could write her “80” if someone came in to see him. Id. at 1. The Respondent said he could not because it would be a red flag, and that “40 is a pretty substantial number.” Id. at 1-2. The Respondent joked that CI should tell her husband that he messed up CI's “drug connection” when he filed the complaint. Id. at 2.

    63. On April 6, 2015, at approximately 8:59 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-06_20-59-35_EDT. CI told the Respondent that she had talked to Agent 1, who was coming on Wednesday. Id. at 2. The Respondent said, “I'm glad to help her and take care of her.” Id. He commented that he had to follow the rules when taking care of her. Id. CI asked the Respondent to help her out when he saw Agent 1. Id. at 3. The Respondent said he would take care of Agent 1's headaches “like any other patient” and that he had to follow the rules, treating her “like anybody else.” Id.

    64. On April 7, 2015, at approximately 1:29 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-07_13-29-34_EDT. CI asked the Respondent if she could attend Agent 1's appointment. Id. at 2. The Respondent said it was “a little bit on the risky side.” Id.

    65. On April 7, 2015, at approximately 6:28 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-07_18-28-45_EDT. CI asked the Respondent if he wanted her to come with Agent 1 to her appointment the next day. Id. at 7. The Respondent said that he was nervous about it and had to treat Agent 1 the way he treated everyone else. Id. CI thanked the Respondent and said she knew he was seeing Agent 1 for her. Id. at 8. The Respondent said that he was treating her as a patient, and that it was dangerous. Id.

    66. On April 7, 2015, at approximately 7:04 p.m., CI texted the Respondent and asked if he would meet her at Walmart the next day around lunch. GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04-01_TO_2015-04-30_ALL.30

    30Contra Tr. 129.

    67. On April 8, 2015, at approximately 8:59 a.m., CI again texted the Respondent and asked him to go to Walmart on his lunch break so that she could “run into” him. GE-21, at 3. CI texted the Respondent that Agent 1 would be there and that Agent 1 knew about their relationship, but was “cool” and would “cover” for CI. GE-21, at 5-6.

    68. On April 8, 2015, at approximately 10:16 a.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-08_10-16-03_EDT. The Respondent said he would love to see CI at Walmart at noon that day. Id. at 1. CI again said Agent 1 knew that the Respondent was CI's boyfriend. Id. CI said she was fat because she was not taking Adipex anymore. Id. at 3. The Respondent said that she worried too much and that she was beautiful. Id. 31 The Respondent and CI agreed to meet in Walmart that day. Id. at 7-8.

    31See GE-27, at 1; contra Tr. 225.

    69. On April 8, 2015, at approximately 12:31 p.m., CI texted the Respondent and said, if he wanted to save Agent 1 some money, he could bring a prescription for her with him to Walmart. GE-21, at 8. At 12:37 p.m., the Respondent replied that he “MUST see her in the office. You know why.” GE-21, at 9.

    iv. Undercover Operation at Walmart: April 8, 2015

    70. On April 8, 2015, Agent 1 accompanied CI to Walmart at approximately 12:45 p.m. GE-22-23; Tr. 128-29, 133-34. The Respondent met CI in the home furnishings department. GE-22; Tr. 389. CI wore a video and audio recording device. Tr. 347-48, 389; see GE-22. The Respondent spoke with CI. Tr. 129; see GE-22. The video recording did not capture an image of the Respondent's face, and much of the recording is inaudible. GE-22.

    71. The Respondent told CI to tell Agent 1 to space out her appointments more. Tr. 129-30. The Respondent said, “[w]e will be good now, so but you can't come back like every week for a prescription cause they keep up, it's like every 4 weeks.” GE-23. CI asked the Respondent how she was “supposed to last that long.” GE-23. The Respondent told her to “go buy a bottle of Vodka . . . .” GE-23.

    72. At approximately 3:29 p.m., CI texted the Respondent that she really felt fat and asked him to write Agent 1 “something for that too.” GE-21, at 13.

    73. Based on Findings of Fact 47 through 53, Findings of Fact 56 through 72, and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on April 8, 2015, the Respondent knew that Agent 1 was not a legitimate patient and that at least some of the medication he prescribed at that appointment would be given to and used by CI.

    v. Undercover Appointment #2: April 8, 2015

    74. Agent 1 had a second appointment with the Respondent that took place on April 8, 2015. GE-24-25; Tr. 102. The Respondent's nurse asked Agent 1 why she was back so soon after her first visit and if she was taking her medication correctly. GE-24; GE-25, at 1; Tr. 103. Agent 1 said she just “ran out” of medication and was taking it twice a day. GE-25, at 1.

    The nurse told her that she did not need to take pain medication “every day all year long.” GE-25, at 1.

    75. The Respondent met with Agent 1 and asked her what she had going on. GE-25, at 1. Agent 1 said, “Same thing. Same stuff.” GE-25, at 1. The Respondent asked if the medicine had helped. GE-25, at 1. Agent 1 said it helped “a little bit.” GE-25, at 1. The Respondent began writing almost immediately after he entered the room without conducting any sort of examination of Agent 1. GE-24-25; Tr. 103-04, 132. The appointment lasted approximately seven minutes. GE-24.

    76. The Respondent and Agent 1 talked casually about boating and skiing. GE-25, at 2-3. The Respondent took out his prescription pad and wrote prescriptions for Agent 1. GE-25, at 3. The Respondent said, “[w]e need to kinda stretch this out [to] make it last a month.” GE-25, at 3.

    77. The Respondent wrote two prescriptions 32 to Agent 1: one for 40 Norco, and one for Maxalt. GE-24-26; Tr. 104. The Respondent told Agent 1 that he gave her refills for Maxalt but could not for “the other.” GE-25, at 1. The Respondent again told her to “spread it out a little bit longer.” GE-25, at 2. He said that “the other ones are not really intended for . . . daily use,” but that he would “go ahead and give [her] a refill.” GE-25, at 2.

    32 In GE-26, the Government only provided a copy of the prescription for Norco. However, the Respondent's discussion of Maxalt, preserved in GE-24 and 25, indicates that the Respondent also prescribed Maxalt to Agent 1. Additionally, Agent 1's testimony that she received two prescriptions at this appointment was credible and uncontested. Tr. 104.

    vi. Interactions Between the Respondent and CI Between the Second and Third Undercover Appointments

    78. On April 8, 2015, at approximately 5:01 p.m., CI texted the Respondent and said “[t]hank u sweetheart for hooking me up again :).” GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04-01_TO_2015-04-30_ALL.

    79. On April 8, 2015, at approximately 6:15 p.m., the Respondent and CI spoke on the phone. GE-27.33 CI asked how things went with Agent 1. GE-27, at 1. The Respondent said he thought they went okay. GE-27, at 1. The Respondent and CI discussed their encounter in Walmart. GE-27, at 3. The Respondent asked CI what Agent 1 said to CI, and she told him that Agent 1 said that they had talked about the Respondent's boat. GE-27, at 5. The Respondent said that he talked with Agent 1 about a boat because “we had to be in there more than ten seconds” so that his “nosy nurse” would not think, “[d]ang, why is this appointment over with in ten seconds?” GE-27, at 5.

    33See GE-16, file 2015-04-08_18-15-44_EDT.

    80. On April 14, 2015, at approximately 3:48 p.m., CI texted the Respondent and asked him how many friends she could “send in ur office for `headaches' lol?” GE-20, file 2015-04-14_15-48-52_EDT.

    81. On April 14, 2015, at approximately 6:47 p.m., the Respondent and CI spoke on the phone. GE-38.34 CI again asked the Respondent how many friends she could send to him with a headache. GE-38, at 2. The Respondent said they had to be really careful about it. Id. The Respondent told CI that if she had a friend who was “willing to help” her, she should not tell him about it and should just ask the friend to come by and “mention that they've got headaches.” GE-38, at 2. The Respondent said he was nervous about it because he knew he was being watched. GE-38, at 2. The Respondent said that, but for CI's husband, CI could “have all the sex, drugs, and rock and roll” that she needed. GE-38, at 2. CI told the Respondent that she was “running low” and needed “some more pills or something.” GE-38, at 3. The Respondent suggested she drink vodka. GE-38, at 3. CI asked if he would treat Agent 1 for a cough if Agent 1 came in for a cough, and if he would give Agent 1 cough medicine. GE-38, at 3. The Respondent said he could give her cough medicine for something legitimate, and warned CI that the state monitors drug-seeking behavior. GE-38, at 3-4. CI asked the Respondent to prescribe her a “big bottle,” like he used to prescribe to her. GE-38, at 4. The Respondent said he could give her about eight ounces. GE-38, at 4. The Respondent told CI that he could not prescribe Adipex to her and explained why. GE-38, at 6. The Respondent told CI that he could help her feel happier if he did not get “busted by the . . . drug police.” GE-38, at 8.

    34See GE-20, file 2015-04-14_18-47-34_EDT; GE-28, file 2015-04-14_18-47-34_EDT.

    82. On April 14, 2015, at approximately 7:02 p.m., CI texted the Respondent and asked if he had any Adipex left over from a prescription to his wife. GE-20.

    83. On April 15, 2015, at approximately 9:30 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI talked about being severely depressed. GE-28, file 2015-04-15_21-30-59_EDT, at 9. The Respondent talked about how CI's husband would not let her “have drugs.” Id. at 10.

    84. On April 22, 2015, at approximately 10:28 a.m., the Respondent and CI spoke on the phone. GE-20, 28. CI told the Respondent that Agent 1 and some of her friends were coming next week to see the Respondent. GE-28, file 2015-04-22_10-28-41_EDT, at 3. The Respondent warned CI that he had to be careful because it was “super serious.” Id. CI laughed and said that they had headaches. Id. The Respondent told CI that prescribing frequently to people from out of town was a “big” red flag. Id. The Respondent said he could not “do it on any kind of regular basis.” Id. at 4.

    85. On April 22, 2015, at approximately 12:10 p.m., the Respondent texted CI that he “CANNOT do anything other than legitimate medical stuff” because it was risky and CI's husband had everyone “on high alert.” GE-20. CI texted back and asked if he would see Agent 1 next week, and that Agent 1 and her friends would not “tell.” GE-20. CI asked him to “write in their chart it's for migraines like u always do.” GE-20. The Respondent texted back that he would see Agent 1 and treat her in a medically appropriate way. GE-20. The Respondent also texted that his usual prescription for Lorcet (40) “should last more than a month.” GE-20. The Respondent texted that his feelings for CI needed to be “totally separate from [his] medical practice.” GE-20.

    86. On April 22, 2015, at approximately 1:03 p.m., the Respondent and CI spoke on the phone. GE-20, 28. The Respondent said that they had to be really careful because the Mississippi Board was watching him. GE-28, file 2015-04-22_13-03-23_EDT, at 1-2. He compared their situation to going to “buy drugs at a crack house.” Id. at 2. The Respondent said everything needed to be “straight” and “above the board.” Id. The Respondent said that his normal prescription dosage of headache medicine should last more than 30 days, and that it would raise alarm if he saw people more than once a month or every other month for headaches. Id. CI said that it had been a month since he saw Agent 1; the Respondent said he did not remember. Id. CI asked him how he got “away with it” when he was seeing her; he replied that “they weren't watching nearly as close” and that CI had legitimate headaches and he “was writing it down every time.” Id. at 3. The Respondent said he was not giving her prescriptions “super often.” Id. The Respondent discussed headaches, Maxalt, and Lorcet with CI. Id. at 3-4. CI asked the Respondent if he would see “them” next week. Id. at 4. The Respondent said that he would see anybody that came in to his office. Id. CI asked him to “write ’em Lorcet.” Id. The Respondent said that “[i]t would even be better if I don't even know who they are” and instructed CI to not tell him their names. Id. The Respondent said that he treats everyone the same. Id. at 5. The Respondent said that he liked to be nice to Agent 1, who he identified as CI's friend. Id.

    87. On April 22, 2015, at approximately 2:32 p.m., CI texted the Respondent, “[w]hat I wouldn't do for an aipex [sic] right now ! Omg :/.” GE-20, file 2015-04-22_14-32-41_EDT.

    88. On April 27, 2015, at approximately 2:45 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI said she spoke to Agent 1, who was going to see the Respondent that Wednesday. GE-20, file 2015-04-27_14-45-16_EDT. The Respondent said he would be glad to see her. Id. CI said that Agent 1 would give CI all of Agent 1's prescriptions. Id. CI said Agent 1 and Agent 2 would split Agent 2's prescriptions. GE-28, file 2015-04-27_14-45-16_EDT, at 1. The Respondent said he did not “know anything about that and [did not] want to know anything about that.” Id. CI discussed previously taking “like 20” of the Demerol that the Respondent prescribed to her. Id. at 7.

    89. On April 28, 2015, at approximately 8:23 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI told the Respondent to not forget that Agent 1 and Agent 2 were coming tomorrow. GE-28, file 2015-04-28_20-23-38_EDT, at 1. The Respondent acknowledged that he knew they were coming and said he would see them then. Id. CI told the Respondent to “[h]ook her up good. Give her some cough medicine.” Id.

    90. On April 29, 2015, at approximately 9:38 a.m., the Respondent and CI spoke on the phone. GE-20, 28, 29. CI told the Respondent not to forget that Agent 1 was coming that day. GE-29, at 7. The Respondent replied that he would not forget and would “take care of her.” GE-29, at 7. CI told him to give her cough medicine. GE-29, at 7. The Respondent said he would see what he could do, but that CI was “really pushing [his] envelope.” GE-29, at 7.

    91. On April 29, 2015, at approximately 3:40 p.m., CI texted the Respondent that Agent 1 said that Agent 2 “ `has a cough too' if u could hook her up with some cough med . . . Please :) .” GE-39, at 5.

    92. Based on Findings of Fact 47 through 53, 56 through 72, and 75 through 91, and the transcript at pages 91, 136, 230, and 349, I find that, by the time the Respondent met with Agents 1 and 2 on April 29, 2015, the Respondent knew that Agent 1 and Agent 2 were not legitimate patients and that at least some of the medications that he prescribed to them during their appointments that day would be given to and used by CI and/or shared by the Agents.

    vii. Undercover Appointment #3: April 29, 2015, with Agent 1

    93. Agent 1 had a third appointment with the Respondent, which occurred on April 29, 2015. GE-30-31; Tr. 111.

    94. The Respondent met with Agent 1 and asked her, “Headaches for you?” GE-31, at 1. Agent 1 responded, “Yep.” GE-31, at 1. The Respondent performed a brief examination of Agent 1, checking her ears and nose. GE-30-31; Tr. 112, 132. The Respondent observed that Agent 1 still had “refills on the other.” GE-31, at 1.

    95. Agent 1 told the Respondent that she talked on the phone with a friend of hers, who told her that she was coughing a lot and needed to get something for her cough; Agent 1 also told the Respondent that she had not paid it much attention to it. GE-31, at 1; Tr. 133, 138-39. The Respondent immediately told Agent 1 that he would give her some cough syrup. GE-30; Tr. 133, 139-40. Agent 1 was not coughing during the appointment. GE-30; Tr. 138. Agent 1 did not tell the Respondent that she had a cough. GE-30-31; Tr. 113, 132. Agent 1 did not directly request cough syrup from the Respondent. GE-30-31; Tr. 113.

    96. The Respondent wrote two prescriptions to Agent 1: one for 40 Norco 10/325, and one for eight ounces of Hycodan. GE-32-33; Tr. 113.

    viii. Undercover Appointment #4: April 29, 2015, with Agent 2

    97. Agent 2 also had an appointment with the Respondent on April 29, 2015. GE-34-35; Tr. 143.

    98. The Respondent met with Agent 2. GE-34-35; Tr. 144; see also GE-58 (containing the Respondent's patient file for Agent 2). The Respondent asked her what he could do for her. Agent 2 she said she had “a little headache,” but noted that it had not been going on for a long time. GE-35, at 1; Tr. 144. The Respondent briefly looked into Agent 2's ears, nose, and mouth. GE-34-35; Tr. 144. The Respondent asked her a few questions about allergies, blood pressure, and smoking. GE-35, at 2. The Respondent then wrote prescriptions to Agent 2. GE-34. Meanwhile, the Respondent talked casually with Agent 2 about sports, Birmingham, and restaurants. GE-35, at 2-3.

    99. The Respondent wrote two prescriptions for Agent 2: one for 40 Norco 10/325, and one for Maxalt with unlimited refills. GE-35, at 3; GE-36-37; Tr. 144.

    ix. Interactions Between the Respondent and CI Between the Fourth and Fifth Undercover Appointments

    100. On April 29, 2015, at approximately 1:48 p.m., the Respondent and CI spoke on the phone. GE-29, at 9. CI asked the Respondent if he had seen Agent 1. GE-29, at 9. The Respondent said he had. GE-29, at 9. CI asked him what he gave her. GE-29, at 9. The Respondent said, “appropriate medicine,” and laughed. GE-29, at 9. He said that he gave her something for her headache and cough. GE-29, at 9. CI thanked the Respondent. GE-29, at 9.

    101. On April 30, 2015, at approximately 9:19 a.m., the Respondent and CI spoke on the phone. GE-40; see GE-20, 28. CI told the Respondent that she got her medication. GE-40, at 1. The Respondent said he was “glad all that worked out.” GE-40, at 1; see Tr. 230-31. The Respondent asked CI who Agent 2 was and if she was Agent 1's friend. GE-40, at 1. CI told the Respondent that Agent 1 gave all of hers to CI, and that Agent 1 and Agent 2 split Agent 2's prescription. GE-40, at 2. The Respondent said he was glad he could help, and that both agents were “very appropriate” because they went “through the motions.” GE-40, at 2. The Respondent said that during the appointment with Agent 2, he was thinking, “I'm not mentioning [CI] and I'm not mentioning [Agent 1].” GE-40, at 2.

    102. The DEA's investigation was suspended while the Respondent campaigned for political office. Tr. 78. The DEA contacted CI in October 2015 and asked her to talk to the Respondent again to try to get him to write another prescription. Tr. 358. CI said no. Tr. 358.

    x. Undercover Appointment #5: October 16, 2015

    103. Agent 1 had a fourth appointment with the Respondent, which took place on October 16, 2015. Tr. 78, 119. The purpose of this appointment was to refresh the investigation concerning the Respondent. Tr. 78. Upon arriving at the Respondent's clinic, the Respondent's receptionist told Agent 1 that her chart had been misplaced,35 so Agent 1 filled out new paperwork and sat in the Respondent's waiting room. GE-42-43; Tr. 119-20, 137.

    35 After the Respondent was arrested, Agent 1's original file, GE-59, was found in the Respondent's desk, along with the files for CI and CI's children. Tr. 428.

    Agent 1 waited for about an hour and twenty minutes before she was called into an exam room. GE-42; Tr. 406.

    104. Agent 1 met with the Respondent. GE-42; see GE-60 (containing Agent 1's October 16, 2015 patient file). The Respondent examined Agent 1's ears, nose, and throat. GE-60, at 4; Tr. 120, 132.36 The Respondent asked Agent 1 what her symptoms were and what he had treated her for in the past. GE-43, at 2; Tr. 135. Agent 1 thought the Respondent was acting as though he did not know who she was. Tr. 120, 135, 452; see GE-42-43.

    36 The audiovisual recording of Agent 1's appointment did not record any physical examination by the Respondent during this appointment. See GE-42. However, because the audiovisual recording was incomplete, and because Agent 1 testified that the Respondent examined her ears, nose, and throat, I find as a matter of fact that the Respondent conducted a physical examination of Agent 1 at this appointment.

    105. The Respondent discussed the most effective medication for Agent 1 to take for headaches. GE-43, at 2-3. Agent 1 asked the Respondent if he remembered Agent 2. GE-43, at 3. The Respondent stopped, thought about it, and said he did not. GE-42, 43.

    106. Agent 1's recording device partially failed and did not record the last few minutes of Agent 1's appointment with the Respondent. Tr. 79, 451.

    107. While the Respondent was writing prescriptions for Agent 1, she asked the Respondent if he had spoken with CI lately. Tr. 122, 135, 452-53. The Respondent paused and looked surprised, then continued writing the prescriptions and stated that he had not heard from CI lately. Tr. 122-23.

    108. The Respondent wrote Agent 1 prescriptions for 30 Norco 5/325, four ounces of Hycodan, Maxalt, Zyrtec, and dexamethasone. GE-44-47, 54; Tr. 120, 126-27, 452. The Respondent discussed these prescriptions with Agent 1 during the appointment. Tr. 452-53, 455-56.

    109. During this visit, Agent 1 did not say that she had a cough. GE-42-43; Tr. 126, 138-39, 454. Agent 1 only stated at the outset of the appointment that she needed the “same as before,” and did not tell the Respondent that she had any specific complaints. GE-42-43; Tr. 454. The Respondent nonetheless prescribed cough syrup to Agent 1. GE-45; Tr. 139.

    G. Search of the Respondent's Office

    110. The Respondent was arrested on December 9, 2015. Tr. 427, 432. That same day, the DEA searched the Respondent's office and examined his records and patient files. Tr. 427, 432. The Respondent's office kept patient files in a general population of files. Tr. 433.

    111. The DEA unlocked the Respondent's desk drawer and discovered several patient files that had not been kept in the general population of patient files. Tr. 428, 432. In the Respondent's desk, the DEA found one patient file for Agent 1, one file for CI, one file for Kid 1, and one file for Kid 2. Tr. 428; see GE-2, 56-57, 59.

    112. The DEA found a second patient file for Agent 1 within the general population of the Respondent's patient files. Tr. 433; see GE-60. The DEA also found a patient file for Agent 2 in the general population of the Respondent's patient files. Tr. 434; see GE-58.

    Additional facts required to resolve the issues in this case are included below in the Analysis section of this Recommended Decision.

    ANALYSIS

    To revoke a respondent's registration, the Government must prove, by a preponderance of the evidence, that the regulatory requirements for revocation are satisfied. Steadman v. SEC, 450 U.S. 91, 100-02 (1981); 21 CFR § 1301.44(e) (2015). Under 21 U.S.C. § 824(a)(4), the DEA may revoke a registrant's COR if the registrant acted in a way that renders continued registration “inconsistent with the public interest.” The DEA considers the following five factors to determine whether continued registration is in the public interest:

    (1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

    (2) The [registrant's] experience in dispensing, or conducting research with respect to controlled substances.

    (3) The [registrant's] conviction record under Federal or State laws relating to the manufacture, 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) (2012).

    These public interest factors are considered separately. See Robert A. Leslie, M.D., 68 Fed. Reg. 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005). Any one factor, or combination of factors, may be decisive. David H. Gillis, M.D., 58 Fed. Reg. 37507, 37508 (1993). Thus, there is no need to enter findings on each of the factors. Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Further, there is no requirement to consider a factor in any given level of detail. Trawick v. DEA, 861 F.2d 72, 76-77 (4th Cir. 1988). When deciding whether registration is in the public interest, the totality of the circumstances must be considered. See generally Joseph Gaudio, M.D., 74 Fed. Reg. 10083, 10094-95 (2009).

    The Government bears the initial burden of proof, and must justify revocation by a preponderance of the evidence. Steadman, 450 U.S. at 100-03. If the Government makes a prima facie case for revocation, the burden of proof shifts to the registrant to show that revocation would be inappropriate. Med. Shoppe-Jonesborough, 73 Fed. Reg. 364, 387 (2008). A registrant may prevail by successfully attacking the veracity of the Government's allegations or evidence. Alternatively, a registrant may rebut the Government's prima facie case for revocation by accepting responsibility for wrongful behavior and by taking remedial measures to “prevent the re-occurrence of similar acts.” Jeri Hassman, M.D., 75 Fed. Reg. 8194, 8236 (2010). In addition, when assessing the appropriateness and extent of sanctioning, the DEA considers the egregiousness of the offenses and the DEA's interest in specific and general deterrence. David A. Ruben, M.D., 78 Fed. Reg. 38363, 38385 (2013).

    Factor One: The Recommendation of the Appropriate State Licensing Board or Professional Disciplinary Authority

    Neither party directly advanced an argument under Factor One. However, a substantial portion of the Respondent's post-hearing brief (“ALJ-34”) argues that the DEA should give significant deference to the Mississippi Board's termination of its investigation against the Respondent. ALJ-34, at 3-6. Therefore, by inference, the Respondent advanced a theory under Factor One that his license should not be revoked because the Mississippi Board declined to take formal disciplinary action against him.

    Although the Mississippi Board did not make a formal recommendation to the DEA in this matter, the DEA interprets a state licensing board's “recommendation” broadly. See Kenneth Harold Bull, M.D., 78 Fed. Reg. 62666, 62672 (2013) (considering disciplinary actions taken by a state board under Factor One).37 A state board's disciplinary actions can provide evidence of what a state licensing board would recommend. Id. For example, when a state board puts a registrant on probation, the DEA views the probation as a recommendation from the state board. E.g., Tyson D. Quy, M.D., 78 Fed. Reg. 47412, 47417 (2013).

    37But see George R. Smith, M.D., 78 FR 44972, 44979 (2013) (finding that the absence of a state licensing board's direct recommendation weighs neither for nor against a respondent); Paul Weir Battershell, N.P., 76 FR 44359, 44365-66 (2011) (same); Gilbert Eugene Johnson, M.D., 75 FR 65663, 65666 n.3 (2010) (same).

    Here, the Mississippi Board has not revoked, suspended, or restricted the Respondent's license. GE-1, at 1; GE-3, at 1. The Mississippi Board investigated the Respondent in March 2015. See GE-3. This investigation was limited to reviewing an anonymous letter, interviewing the Respondent, and visiting the Respondent's office. See GE-3, at 1-2, 4-6. The Mississippi Board neither exonerated the Respondent nor took any formal action against him. GE-3; Tr. 184, 203. The Mississippi Board only issued a warning letter to the Respondent to conclude its investigation. GE-3, at 1. Consistent with the findings of Investigator Pohnert, the Mississippi Board warned the Respondent that doctors are only permitted to refill phentermine prescriptions if they first conduct and document medical examinations. GE-3, at 1, 5.

    The fact “that a state has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.” Carlos Gonzalez, M.D., 76 Fed. Reg. 63118, 63140 (2011) (citing Patrick W. Stodola, M.D., 74 Fed. Reg. 20727, 20730 (2009); Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 461 (2009)). Rather, the DEA, apart from the Mississippi Board, has its own independent responsibility to determine whether the Respondent's continued registration is in the public interest. See Edmund Chein, M.D., 72 Fed. Reg. 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008). Accordingly, the Mississippi Board's warning letter does not weigh either for or against the Respondent under Factor One.

    Factors Two and Four: The Respondent's Experience in Dispensing Controlled Substances and Compliance with Applicable State, Federal, or Local Laws Relating to Controlled Substances

    Allegations 1 through 5 all claim that the Respondent illegitimately prescribed controlled substances outside the course of his professional practice. See supra pp. 2-3. Regarding these allegations, the Government endeavored to show that the Respondent knowingly diverted, or attempted to divert, controlled substances. This evidence is properly analyzed under Factors Two and Four because “[p]roof that a physician knowingly diverted controlled substances is the best evidence for assessing his experience in dispensing controlled substances, although it is also relevant in assessing his compliance with applicable laws related to controlled substances.” Syed Jawed Akhtar-Zaidi, M.D., 80 Fed. Reg. 42961, 42968 n.17 (2015).

    Under the Controlled Substances Act (“CSA”), it is unlawful for a person to distribute controlled substances, except as authorized under the CSA. 21 U.S.C. 841(a)(1). To combat drug abuse and trafficking of controlled substances, “Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.” Gonzales v. Raich, 545 U.S. 1, 13 (2005). To maintain this closed regulatory system, controlled substances may only be prescribed if a DEA registrant writes a valid prescription. Gonzalez, 76 FR at 63141. As the Supreme Court explained, “the prescription requirement . . . ensures that patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.” Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)).

    A controlled substance prescription is not valid unless it 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). Federal regulations further provide that “[a]n 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 [21 U.S.C. § 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of [controlled substance laws].” Id.; see 21 U.S.C. § 842(a)(1) (establishing that, under the CSA, it is illegal for a person to distribute or dispense controlled substances without a prescription, as is required under 21 U.S.C. § 829).

    Much like the federal regulations, the Mississippi Code provides that it is illegal to dispense Schedule II 38 controlled substances except upon a valid prescription written by a practitioner. Miss. Code §§ 41-29-137(a)(1), 41-29-141(1). The Mississippi Code further provides that a registrant's license may be revoked if the registrant prescribes narcotics outside of the course of legitimate professional practice, id. § 73-25-29(3), or if the registrant violates the Mississippi Board's administrative rules, id. § 73-25-29(13).

    38 These sections of the Mississippi Code only apply to the Respondent's Schedule II controlled substance prescriptions. Notably, hydrocodone combination products, such as Norco and Hycodan, were re-classified by the federal government as Schedule II controlled substances on October 6, 2014. See Stip. 5-6. The parties made no argument, and presented no evidence, regarding the classification of hydrocodone combination products in the state of Mississippi.

    The DEA recognizes several methods to show that a registrant wrote prescriptions without a legitimate medical purpose and outside of the usual course of professional practice. See Jack A. Danton, D.O., 76 FR 60900, 60901 (2011). The Respondent, however, incorrectly suggests that the Government must provide “medical literature” or a “medical opinion” in order to establish that a registrant acted outside the usual course of professional practice and lacked a legitimate medical purpose. ALJ-34, at 5.

    Typically, the Government uses expert testimony to establish a violation of 21 CFR 1306.04(a). T.J. McNichol, M.D., 77 FR 57133, 57147-48 (2012). However, “whether expert testimony is needed is necessarily dependent on the nature of the allegations and the other evidence in the case.” Beau Boshers, M.D., 76 FR 19401, 19402 n.4 (2011). Numerous state and federal courts have found in criminal cases, which require a higher standard of proof than is required in these proceedings, that expert testimony is not required to establish a violation of 21 U.S.C. § 841 or 21 CFR § 1306.04(a). McNichol, 77 FR at 57147.39 For example, the DEA has not required expert testimony to establish a violation of 21 CFR § 1306.04(a) in cases where a prescriber engaged in drug deals,40 where there were notable differences between patients' medical records and diagnoses,41 and where a prescriber falsified patients' charts.42 Simply put, whether the Government must present expert testimony is dependent on the facts of each case. McNichol, 77 FR at 57147-48.

    39E.g., United States v. Pellman, 668 F.3d 918, 924 (7th Cir. 2012); United States v. Armstrong, 550 F.3d 382, 389 (5th Cir. 2008); United States v. Word, 806 F.2d 658, 663 (6th Cir. 1986); United States v. Larson, 507 F.2d 385, 387 (9th Cir. 1974); United States v. Bartee, 479 F.2d 484, 488-89 (10th Cir. 1973); State v. Moody, 393 So.2d 1212, 1215 (La. 1981).

    40Boshers, 76 Fed. Reg. at 19402 n.4.

    41Morris W. Cochran, M.D., 77 Fed. Reg. 17505, 17519-20 (2011).

    42Robert F. Hunt, D.O., 75 Fed. Reg. 49995, 50003 (2010).

    In the Government's post-hearing brief (“ALJ-35”), it advanced two theories regarding how the Respondent violated 21 CFR § 1306.04(a): (1) the Respondent knowingly diverted controlled substances to CI, and (2) the Respondent violated state medical practice standards. ALJ-35, at 18-24. The Government can prove that a registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose by “providing evidence showing that [the registrant] knowingly diverted drugs.” Danton, 76 Fed. Reg. at 60901. Additionally, the Government can prove that a registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose by providing evidence showing that the registrant violated a state medical practice standard “which has a substantial relationship to the CSA's purpose of preventing substance abuse and diversion.” Id. Neither of these methods of proof requires the presentation of expert testimony. Id.

    Allegation 1: Hydrocodone and Alprazolam Prescriptions to CI

    In Allegation 1, the Government claimed that the Respondent prescribed hydrocodone and alprazolam to CI from February 2014 to May 2015 43 without conducting and/or documenting a physical examination, and without recording the prescriptions in CI's patient file, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, (“Mississippi Administrative Rules”) 1.4, 1.11(b),44 and 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a). ALJ-1, at 2. Specifically, the Government alleged that the Respondent issued improper prescriptions to CI: (a) on May 22, 2014, for 40 units of a hydrocodone combination product; (b) on June 17, 2014, for 40 units of a hydrocodone combination product; (c) on September 11, 2014, for 40 units of a hydrocodone combination product; (d) on October 6, 2014, for 40 units of alprazolam with one refill for 40 units; (e) on October 29, 2014, for 40 units of a hydrocodone combination product; and (f) on December 4, 2014, for 180 units of a hydrocodone combination product. ALJ-1, at 2.

    43 The record does not contain any evidence that the Respondent prescribed controlled substances directly to CI in 2015. The 2015 prescriptions that the Government alluded to under Allegation 1 were the Respondent's 2015 prescriptions to Agent 1 and Agent 2. Those prescriptions are discussed at length under Allegation 4, infra pp. 50-58.

    44 Rule 1.11(b) requires that “[e]very written prescription delivered to a patient, or delivered to any other person on behalf of a patient, must be manually signed on the date of issuance by the physician.” Miss. Code R. § 30-17-2640:1.11(b). Although the Government alleged a violation of this provision in its OSC/ISO, the Government did not advance a theory or offer evidence to establish a violation of this specific rule. I therefore find that the Government's allegation that the Respondent violated Rule 1.11(b) is NOT SUSTAINED.

    Under the Mississippi Administrative Code, the Mississippi Board requires that a prescribing physician must:

    maintain a complete record of his or her examination, evaluation and treatment of the patient which must include documentation of the diagnosis and reason for prescribing, dispensing or administering any controlled substance; the name, dose, strength, quantity of the controlled substance and the date that the controlled substance was prescribed, dispensed or administered.

    Miss. Code R. § 30-17-2640:1.4.45 This record must “be maintained in the patient's medical records.” Id.

    45 I find that the documentation requirements of Mississippi Administrative Rule 1.4 share a substantial relationship with the CSA's purpose of preventing drug abuse and diversion.

    Further, the Mississippi Board requires that a physician cannot prescribe a controlled substance “without a good faith prior examination and medical indication therefore.” Id. This obligation is a continuing one; “upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results.” Id. (emphasis added). A physician's failure to complete these three steps is conduct outside the “course of legitimate professional practice.” Id. In fact, any violation of these rules is considered conduct outside of the course of legitimate professional practice, in violation of Section 73-25-29(3) of the Mississippi Code. Miss. Code R. § 30-17-2640:1.16.

    The evidence establishes that, on four occasions, the Respondent prescribed controlled substances to CI without writing any notes about any prescriptions or examinations in CI's patient file. On May 22, 2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE-41, at 4; GE-49, at 2. On June 17, 2014, the Respondent prescribed 40 units of Norco 7.5/325 46 to CI. GE-41, at 6; GE-49, at 2. On September 11, 2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE-41, at 20; GE-49, at 2. On December 4, 2014, the Respondent prescribed 180 units, or six ounces, of Hycodan to CI.47 GE-41, at 28; GE-49, at 1. None of these four prescriptions were recorded in CI's medical file. See GE-2, at 12-13. The Respondent did not document a diagnosis or reason for prescribing to CI on any of these dates. The Respondent did not write the names, doses, strengths, or quantities of these prescriptions to CI in CI's medical record. The Respondent did not record the dates of these prescriptions in CI's medical record. The Respondent did not record any notes in CI's medical record about any physical examinations on these dates.

    46 Originally, the Government alleged that the Respondent prescribed Norco 10/325 on June 17, 2014. See ALJ-1, at 2. However, as the Government correctly noted in its post-hearing brief, the Respondent prescribed Norco 7.5/325 on June 17, 2014. ALJ-35, at 6 n.1; see GE-41, at 6.

    47 The record reflects some confusion concerning the date of this prescription. GE-41, at 21, indicates it was written on December 3, 2014, while GE-49, at 1, indicates it was written on December 4, 2014. See supra note 19. Regardless of the one day variance, the analysis is the same.

    Because of the complete absence of this required information in CI's patient file, the prescriptions that the Respondent wrote to CI on these four dates were improper under Mississippi Administrative Rule 1.4. The Government's allegations that these four prescriptions to CI violated Mississippi Administrative Rule 1.4 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Because these prescriptions violated Mississippi Administrative Rule 1.4, these prescriptions were issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Further, there is no evidence that the Respondent even saw CI on May 22, June 17, September 11, or December 4 of 2014. Even absent expert testimony, the DEA has held that a prescriber does not act in the usual course of professional practice if the prescriber writes prescriptions to a patient without first seeing the patient. Armando B. Figueroa, M.D., 73 Fed. Reg. 40380, 40381-82 (2008). Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) on these four occasions are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    On October 6, 2014, the Respondent prescribed 40 units of alprazolam 1 mg, with one refill, to CI. GE-41, at 22; GE-49, at 1. In CI's medical file, near a date stamp reading September 2, 2014, the Respondent noted “Xanax 1mg (#40, 1),” but did not write any justification for this prescription, as is required by Mississippi Administrative Rule 1.4. See GE-2, at 12-13. The Respondent did not write any notes anywhere in CI's patient file about a diagnosis of anxiety or any of CI's alleged symptoms. See GE-2, at 12-13. Additionally, CI's testimony and her PMP report indicate that, although CI's psychiatrist prescribed a smaller dosage of alprazolam to her, the Respondent increased CI's dosage without any noted justification. GE-49, at 1; Tr. 225-26, 295, 304; see GE-2 (failing to justify an increased dosage of alprazolam); see also GE-2, at 21 (documenting that another registrant prescribed 7 units of alprazolam ER 0.5 mg to CI on September 30, 2014, and that the Respondent then prescribed 40 units of alprazolam 1 mg on October 6, 2014). Because the Respondent never documented a reason for prescribing alprazolam to CI in her patient file, the Government's allegation that the October 6, 2014 prescription violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, this prescription was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) by issuing the October 6, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    The Government also alleged that the Respondent prescribed 40 units of a hydrocodone product to CI on October 29, 2014. ALJ-1, at 2. Although this alleged prescription is noted on CI's PMP report, see GE-49, as Government counsel stated, “PMPs are not without their flaws” and are not “necessarily accurate.” Tr. 302-03. The Government offered testimony from CI related to this alleged prescription. Tr. 369-70. CI was presented with a copy of this alleged prescription, which she reviewed. Tr. 369-70. At the hearing, CI did not testify about the prescription from her personal recollection; she only looked at and read off of the copy of the prescription presented to her. Tr. 369-70. I do not find that CI's testimony proved the existence of the October 29 prescription. This copy of the prescription was not offered into evidence.48 In sum, the Government failed to offer substantial evidence that the Respondent did, in fact, prescribe hydrocodone to CI on October 29, 2014 outside of the course of his professional practice. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) by issuing an October 29, 2014 prescription are NOT SUSTAINED.

    48See supra note 20.

    Beyond the above-mentioned specific prescribing events, the Government provided ample evidence that, throughout 2014, the Respondent prescribed controlled substances to CI outside of the usual course of his professional practice and without a legitimate medical purpose. The DEA has held, even without the benefit of expert testimony, that a controlled substance prescription based on a patient's request “rather than the result of the application of the physician's medical judgment” lacks a medical purpose. Robert M. Golden, M.D., 61 Fed. Reg. 24808, 24812 (1996) (citing Robert L. Dougherty, Jr., M.D., 60 Fed. Reg. 55047 (1995); Harland J. Borcherding, D.O., 60 Fed. Reg. 28796 (1995)). Likewise, the Mississippi Administrative Rules state that a prescriber lacks good faith when he “permit[s] the patient to name the drug desired” or “dispens[es] drugs to patients having no medical need, when the physician knew or should have known that the patients were addicts.” Miss. Code R. § 30-17-2640:1.4.

    It is true that, at times, the Respondent intended to treat CI's medical conditions. GE-2, at 12-13; Tr. 215, 277-78, 287, 321. However, even if the Respondent subjectively intended to provide legitimate medical treatment to CI, “[t]he appropriate focus is not on the subjective intent of the doctor, but rather . . . whether the physician prescribe[d] medicine `in accordance with [the accepted] standard of medical practice.' ” United States v. Merrill, 513 F.3d 1293, 1306 (11th Cir. 2008) (quoting United States v. Moore, 423 U.S. 122, 139 (1975)). The Respondent's failure to perform and document physical examinations of CI, and his failure to document his prescriptions to CI, constitutes a significant failure to comply with Mississippi medical standards, regardless of the Respondent's subjective intent.

    Here, CI took Norco daily and recreationally, and the Respondent gave prescriptions to CI upon her request. Tr. 297-99. The Respondent gave prescriptions to CI at her house, at her children's appointments, and in the garden section of Walmart. Tr. 26, 217-20. The Respondent did not provide CI with a diagnosis or perform physical examinations before giving these prescriptions to CI. See Tr. 217-18; see also GE-2, at 12-13.

    Importantly, the Respondent only made three entries in CI's patient file in 2014, on February 21, April 21, and September 2, and he made no entries in CI's patient chart in 2015. See GE-2, at 12-13. Neither party presented any standard to evaluate the adequacy of the patient file entries.49 Assuming that the file entries on those dates are adequate, under Mississippi Administrative Rule 1.4, any prescriptions that the Respondent issued to CI in 2014, other than on February 21, April 21, and September 2, were issued outside of the Respondent's professional practice. CI's PMP report indicates that CI may have filled prescriptions written by the Respondent on 13 dates in 2014.50 I do not find that the PMP report, standing alone, constitutes substantial evidence that these prescriptions existed, as discussed supra. However, CI's credible, confident, and uncontested testimony that she simply requested prescriptions from the Respondent “for fun,” and that he would give them to her, considered in conjunction with the PMP report, constitutes substantial evidence that the Respondent prescribed controlled substances to CI in 2014 based on CI's request rather than in the proper exercise of sound medical judgment. On these grounds, the Government's allegations that the Respondent violated Mississippi Administrative Rules 1.4 and 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    49 CI's patient file is not entirely legible. See GE-2, at 12-13. The February 21, 2014 entry reads: “HC 7.5/325 (#40, 1)—may be picked up at desk.” GE-2, at 12. The April 21, 2014 entry reads: “Headaches ? `Sinuses' Motion sickness Occasional vertigo Ears clear OC/OP clear Nose mildly inflamed CT → clear and thickening in L NF duct Rx Maxalt (one given) HC 10/325 (#40) (refill).” GE-2, at 12. The September 2, 2014 entry reads: “Lexapro Maxalt prn has anxiety c migraines Migraine—usually responsive to Maxalt, now c brea[illegible] Ears clean; [illegible] in ® EAC @[illegible] Nose clear OC/OP clear Counseled [illegible] Rx Zofran Demerol 50 (#30) HC 10/325 (#40, 1) Phentermine (refilled) Xanax 1mg (#40, 1).” GE-2, at 12. These three notations are the only entries in the Respondent's patient file for CI during 2014.

    50 Specifically, these dates are as follows: February 21, April 9, May 19, May 22, June 17, July 19, July 24, September 2, September 8, September 11, October 6, October 29, and December 4. See GE-2, at 21-23; GE-49, at 1-3.

    Allegation 2: Phentermine Prescriptions to CI

    In Allegation 2, Government claimed that the Respondent prescribed phentermine 51 to CI without adequate documentation, in violation of Mississippi Administrative Rule 1.5, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a). ALJ-1, at 3. The Government specifically alleged that this inappropriate prescribing occurred on four occasions in 2014: April 9, for 30 dosage units; May 19, for 30 dosage units with one refill; July 24, for 30 dosage units; and September 8, for 30 dosage units with two refills. ALJ-1, at 3.

    51 Phentermine, or Adipex, is a Schedule IV controlled substance. See Stip. 8.

    The administration of weight loss medication is regulated by state medical standards. See generally Wesley G. Harline, M.D., 65 Fed. Reg. 5665 (2000) (discussing, at length, general practice and state medical standards for legitimately prescribing controlled substances for weight loss). The Mississippi Board has a special standard of care for practitioners who prescribe diet medication. See Miss. Code R. § 30-17-2640:1.5; see also GE-8; Tr. 171-72. Specifically, Rule 1.5 requires a doctor prescribing weight loss drugs to: (1) only prescribe adjunctively with caloric restriction; (2) conduct and thoroughly record an initial comprehensive evaluation; (3) record a thorough patient history and physical exam; (4) conduct an in-person re-evaluation of the patient once every 30 days, recording the patient's weight, BMI, blood pressure, pulse, and the results of all tests to monitor adverse effects of the medication; and (5) maintain records about the patient's weight loss efforts, dedication, responses, contraindications, and adverse effects during treatment. Miss. Code R. § 30-17-2640:1.5. The patient's history and physical exam must, at a minimum, document:

    1. Past medical history, past surgical history, social history, family history, weight history, dietary history, gynecological (GYN) history if female, review of systems, allergies and medications.

    2. Height, weight, Body Mass Index (BMI), blood pressure, pulse, % body fat or waist circumference/weight hip ratio, HEENT, chest, heart, abdomen, extremities.

    3. Appropriate testing related to medical weight loss . . . .

    Id.

    The Government presented evidence that the Respondent wrote four prescriptions for phentermine to CI. On April 9, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE-7, at 1-2; GE-49, at 2. On May 19, 2014, the Respondent prescribed 30 units of Adipex 37.5, with one refill to CI. GE-7, at 3-4; GE-41, at 2-3; GE-49, at 2. On July 24, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE-7, at 5-6; GE-41, at 12-13; GE-49, at 2. On September 8, 2014, the Respondent prescribed 30 units of phentermine 37.5 with two refills to CI. GE-7, at 7-8; GE-41, at 18-19; GE-49, at 2. During 2014, CI filled these prescriptions seven times. GE-49, at 1-2.

    In the administrative record, there are only four notations in the Respondent's files related to phentermine, Adipex, or weight loss prescriptions. The first mention of phentermine is in the Respondent's patient file for Kid 1 near a date stamp reading February 4, 2014. GE-57, at 6; Tr. 286. That note reads, “Mother has migraines ? in children May call in Rx if needed. Discussed phentermine c mother May consider this as well.” GE-57, at 6. The second time phentermine was mentioned was in a March 19, 2014 entry in Kid 1's patient file. That note reads, “Discussed [illegible] medications c mother Rx [illegible] Phentermine 37.5.” GE-57, at 5; Tr. 286. The third mention of phentermine, and the first in the Respondent's patient file for CI, is dated July 18, 2014. GE-2, at 15. This third mention is on a patient telephone request form, which indicated that CI called the Respondent to ask about a refill of “phentermine 37.5 (#30, 2)” for her to “pick up at front.” GE-2, at 15. The final mention of phentermine, and the only one contained in the Respondent's treatment notes of CI, is dated September 2, 2014. GE-2, at 12. This last entry simply reads, “Phentermine (refilled).” GE-2, at 12.

    Accordingly, while prescribing phentermine to CI on April 9, May 19, July 24, and September 8, the Respondent completely failed to comply with the requirements of Mississippi Administrative Rule 1.5. The Respondent never prescribed phentermine adjunctively with caloric restriction. He never conducted and recorded an initial comprehensive evaluation. He never recorded a thorough patient history or physical examination. He never conducted an in-person re-evaluation of CI once every 30 days. He never recorded CI's, BMI, blood pressure, pulse, past medical history, social history, family history, dietary history, gynecological history, height, weight, or body measurements. He did not document CI's efforts to lose weight or note her response to treatment.

    A prescriber lacks good faith if he prescribes controlled substances to a patient who the prescriber knew or should have known had no legitimate medical need for the controlled substances prescribed. Miss. Code R. § 30-17-2640:1.4. It is concerning that the Respondent wholly failed to document any justification whatsoever for CI's supposed need for weight loss medication. During 2014, CI went from 135 pounds down to 121 pounds. Tr. 224. At the hearing, CI presented with a slender body type. After observing CI's appearance, I find it difficult to comprehend, from even a layman's perspective, how the Respondent could have possibly believed that CI had a high enough BMI 52 to justify the administration of weight loss medication.

    52See Miss. Code R. § 30-17-2640:1.5(A)(4) (requiring generally a BMI of greater than 30.0 in a normal, otherwise healthy patient to justify prescribing weight loss drugs); see also Minnix v. Colvin, No. 2:12CV00038, 2014 WL 618688, at *3 n.3 (W.D. Va. Feb. 18, 2014) (defining a BMI of 30 or higher as obesity) (citing Nat'l Inst. of Health, Calculate Your Body Mass Index, http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm (last visited May 18, 2016)).

    The Respondent displayed a complete disregard for Mississippi's weight loss prescription requirements. He prescribed weight loss drugs to CI without any documented medical justification. GE-2, at 12-13. “[W]here a medical record contains no findings that support a diagnosis, . . . expert testimony is not necessary to conclude that a prescription lacked a legitimate medical purpose.” McNichol, 77 Fed. Reg. at 57151 (citations omitted). Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.5, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a), by prescribing phentermine to CI on April 9, May 19, July 24, and September 8 of 2014 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    The Respondent argued in his post-hearing brief that, after receiving the Mississippi Board's warning letter, he refused to prescribe weight loss medication to an undercover agent. ALJ-34, at 6. The Respondent argued that this refusal showed that he “came promptly into conformity” with Mississippi's weight loss medication prescribing standards. ALJ-34, at 6. However, even if the Respondent took remedial measures, those measures, standing alone, cannot rebut the Government's prima facie case for revocation unless the Respondent also accepted responsibility for his actions. See Michael S. Moore, M.D., 76 Fed. Reg. 45867, 45868 (2011); Hassman, 75 Fed. Reg. at 8236. The Respondent did not testify and did not accept responsibility. Accordingly, the Respondent failed to rebut the Government's prima facie case for revocation based upon his violation of state regulations that detail the requirements for prescribing weight loss medication.

    Allegation 3: Prescribing to CI's Children: Physical Examinations, Propriety of Prescriptions, and True Intended Recipient

    In Allegation 3, the Government claimed that, from February 7 to November 19 of 2014, the Respondent prescribed hydrocodone products to CI's children without conducting examinations, and that the prescriptions were for CI's personal use, in violation of Mississippi Administrative Rules 1.4, 1.10, 1.11(b),53 and 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) and 1306.05(a). ALJ-1, at 2-3. Mississippi Administrative Rule 1.10 requires that a prescription for a controlled substance contain “the complete name and address of the patient to whom the physician is prescribing the controlled substance.” Miss. Code R. § 30-17-2640:1.10. Likewise, 21 CFR § 1306.05(a) requires that a controlled substance prescription must “bear the full name and address of the patient.”

    53 For the reasons previously discussed, supra note 44, the Government's allegation that the Respondent violated Mississippi Administrative Rule 1.11(b) is NOT SUSTAINED.

    Additionally, the Government alleged that the Respondent prescribed hydrocodone-homatropine (“cough”) syrup, or Hycodan, to CI's children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Government alleged that the Respondent prescribed adult dosages of this cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ-1, at 2-3.

    The Government further alleged that the Respondent issued the following improper prescriptions for hydrocodone combination products to CI's children in 2014: (a) to Kid 2 on February 7, for 150 dosage units, with one refill; (b) to Kid 1 on June 17, for 180 dosage units, with one refill; (c) to Kid 2 on July 23, for 480 dosage units; (d) to Kid 2 on September 2, for 120 dosage units; (e) to Kid 2 on November 3, for 180 dosage units; and (f) to Kid 1 on November 19, for 115 dosage units. ALJ-1, at 2-3.

    A. The February 7 Prescription

    On February 7, 2014, the Respondent wrote a prescription for 240 units of Hycodan to Kid 2. GE-50, at 1; GE-55, at 1-2. The Respondent's medical file for Kid 2 appeared to contain a notation from 2014, possibly from February 7, documenting a Hycodan prescription. See GE-56, at 4. The copy of the medical file partially cut off this notation because it was at the bottom of a copied page. See GE-56, at 4. The only legible part of the notation appears to read, “Hycodan (8 oz, 2 refills) to Brookhaven Walmart.” See GE-56 at 4.

    CI testified that the Respondent did not examine Kid 2 before prescribing cough syrup to her in February. Tr. 217, 251. The Respondent's patient file for Kid 2 does not include any notes about any physical examination on that date. The Respondent did not document a diagnosis for Kid 2 on that date. Because this required information was not recorded prior to prescribing controlled substances to Kid 2, the Government's allegation that the Respondent violated Mississippi Administrative Rule 1.4 by failing to conduct a physical examination of Kid 2 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) on February 7, 2014, are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    Just 15 days before the February 7, 2014 prescription, the Respondent prescribed 120 units (or 24 days' worth) of Hycodan syrup to Kid 2. See GE-50, at 1; GE-56, at 4. Thus, Kid 2 still should have had approximately nine days of Hycodan syrup remaining from her last prescription and should not have needed additional Hycodan syrup on February 7, much less double the original dosage. See GE-50, at 1 (showing that the January 24, 2014 prescription was a 24-day supply). CI discussed the real reason that the Respondent wrote this prescription. CI testified that, in February 2014, the Respondent prescribed a big bottle of cough syrup to Kid 2 so that CI could drink it as well, even though the Respondent knew that CI did not have a cough. Tr. 216-17, 250-53, 259, 268, 273. While Kid 2 did have a cough at that time, Tr. 250-51, 253-55, I give full credit to CI's testimony that the Respondent knew that CI intended to consume some of Kid 2's Hycodan prescription. Considering the timing of the February 7 prescription and its large dosage, I find, based on a totality of the circumstances, that a preponderance of evidence supports the conclusion that the Respondent knew that CI would consume at least part of Kid 2's February 7, 2014 prescription. It is a violation of 21 CFR § 1306.05 for a registrant to prescribe controlled substances to a patient knowing that someone other than the patient named on the prescription would receive the medication. Golden, 61 FR at 24811. Therefore, the Government's allegations that the February 7, 2014 prescription violated Mississippi Administrative Rule 1.10 and 21 CFR § 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    B. The June 17, July 23, and November 19 Prescriptions

    The Respondent wrote three prescriptions to CI's children without recording the prescriptions in the children's medical records. First, on June 17, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan syrup to Kid 1. GE-51, at 1; GE-55, at 3-4. The Respondent's patient file for Kid 1 does not contain any notes dated on or about 54 June 17, 2014. See GE-57. The Respondent did not document a diagnosis for Kid 1 at this time. Then, on July 23, 2014, the Respondent wrote a prescription for 16 ounces (or 480 units) of Hycet liquid to Kid 2. GE-50, at 1; GE-55, at 5-6. The Respondent's patient file for Kid 2 does not contain any notes dated on or about July 23, 2014. See GE-56. Finally, on November 19, 2014, the Respondent wrote a prescription for eight ounces (or 115 units) of Hycodan for Kid 1. GE-51, at 1; GE-55, at 11. The Respondent's patient file for Kid 1 does not contain any notes on or about November 19, 2014. See GE-56.

    54 Although the Respondent's patient file for Kid 1 includes notes from examinations on March 19, 2014, and June 9, 2014, the notes next to these dates do not contain any notations about a Hycodan prescription. See GE-57.

    The Respondent did not write the name, dose, strength, or quantity of any of these prescriptions in the medical records of CI's children. The Respondent did not record the dates of the prescriptions or the reasons for the prescriptions. The Respondent did not record any notes about any physical examinations on these dates. There is no evidence in the record before me indicating that the Respondent ever saw CI's children on the dates that he wrote these prescriptions to them. Even absent any expert testimony, failure to see a patient before prescribing medications to the patient is outside of the legitimate practice of medicine. Figueroa, 73 FR at 40381. Therefore, the Government's allegations that the June 17, 2014, and November 19, 2014 prescriptions to Kid 1, and July 23, 2014 prescription to Kid 2, violated Mississippi Administrative Rule 1.4 are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government. Because these prescriptions violated Mississippi Administrative Rule 1.4, they were issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) by issuing the June 17, July 23, and November 19 prescriptions are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    The Government further alleged that these prescriptions were issued for CI's personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI's children on June 17, July 23, and November 19. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough; (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 265-66, 273. In addition, the administrative record supports CI's testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE-56, at 2-4; GE-57, at 5-6. I find that CI's testimony, when considered cumulatively and in conjunction with other evidence of record, establishes that, at the time the Respondent wrote the June 17, July 23, and November 19 prescriptions, he knew that CI would drink at least some of the cough syrup, though there was no medical reason for her to do so. Therefore, the Government's allegations that these three prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR § 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    C. The September 2 and November 3 Prescriptions

    On September 2, 2014, the Respondent wrote a prescription for four ounces (or 120 units) of Hycodan for Kid 2. GE-50, at 1; GE-55, at 7-8. The Respondent's patient file for Kid 2 included some notes dated September 2, 2014. GE-56, at 3. These notes stated, “URI Ears clear Nose, OC/OP mildly inflamed Lungs clear Rx [illegible] 15 Hycodan.” GE-56, at 3. Because these notes indicate that the Respondent examined Kid 2, and because the Government did not enter any evidence contesting the accuracy of these notes, I find that the Government failed to show by substantial evidence that the Respondent did not conduct a physical examination of Kid 2 on September 2, and the Government's allegation to that effect is NOT SUSTAINED. However, Kid 2's medical record did not include any diagnosis or reason for prescribing Hycodan to Kid 2, as required by Mississippi Administrative Rule 1.4. Additionally, the medical record did not clearly include the dose, strength, or quantity of Hycodan prescribed to Kid 2, as required by Mississippi Administrative Rule 1.4. Because the medical record did not contain this information, the Government's allegation that the September 2, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) by issuing the September 2, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    Similarly, on November 3, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan for Kid 2. GE-50, at 1; GE-55, at 9-10. The Respondent wrote a note near a date stamp reading November 4, 2014, in Kid 2's file. GE-56, at 2. This note said, “[illegible] 5 problems Rx Hycodan (6 oz) (requested).” GE-56, at 2. The medical record did not include documentation of a diagnosis and reason for prescribing controlled substances, other than the fact that it was “requested.” Moreover, the medical record did not include the dosage or strength of the Hycodan prescribed, as is required by Mississippi Administrative Rule 1.4. Further, the notes near the November 3, 2014 date stamp did not indicate that the Respondent conducted any examination prior to prescribing Hycodan to Kid 2, as is required by Mississippi Administrative Rule 1.4. Therefore, the Government's allegation that the November 3, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) by issuing the November 3, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    The Government also alleged that the September 2 and November 3 prescriptions were issued for CI's personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI's children on September 2 and November 3. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough: (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 266, 273. In addition, the administrative record supports CI's testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE-56, at 2-4; GE-57, at 5-6. I find that CI's testimony, when considered cumulatively and in conjunction with other evidence of record, establishes that, at the time the Respondent wrote the September 2 and November 3 prescriptions, he knew that CI would drink at least some of the cough syrup, though there was no medical reason for her to do so. Therefore, the Government's allegations that these two prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.

    D. Dangerous Prescriptions

    The Government alleged that the Respondent prescribed cough syrup to CI's children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Government also alleged that the Respondent prescribed adult dosages of cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ-1, at 2-3.

    There is no evidence on the record before me 55 that indicates that it is improper to prescribe cough syrup to children. There is no evidence on the record before me that indicates that the dosages of cough syrup that the Respondent prescribed to CI's children were improper dosages. The Government did not offer an authentic, well-founded medical opinion that the quantities and types of prescriptions to CI's children were improper. The Government had the burden of proving that the prescriptions were unlawful. See Ruben, 78 FR at 38384. The Government failed to meet this burden. Accordingly, the Government's allegations regarding the propriety of the Respondent's prescriptions to CI's children are NOT SUSTAINED.

    55 The Government offered into evidence three printouts from Web sites, allegedly obtained from the FDA's Web site, WebMD, and Drugs.com. See Gov't Proposed Exs. 4-6. Upon the Respondent's timely objection, I rejected these three exhibits because they were improper opinion testimony, lacked adequate foundation, and were not properly authenticated. See Tr. 418-26.

    Allegation 4: Fraudulent Prescriptions for CI through Undercover Agents 56

    56 In its post-hearing brief, the Government argued that this conduct should be analyzed under Factor Five. ALJ-35, at 21-24. However, in the Government's OSC/ISO and its presentation of evidence at the hearing, the Government made a strong argument that the Respondent's prescriptions to the undercover agents violated state and federal laws, and were acts of knowing diversion which reflected poorly on the Respondent's experience in dispensing controlled substances. Therefore, analysis of this conduct under Factors Two and Four is appropriate.

    In Allegation 4, the Government claimed that, on five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents' prescription requests were fraudulent, in violation of 21 U.S.C. §§ 841(a) and 842(a) and 21 CFR § 1306.04(a). ALJ-1, at 3. The Government alleged that the Respondent wrote seven hydrocodone prescriptions on five occasions to undercover agents, for 190 total dosage units of hydrocodone tablets and 72 total dosage units of hydrocodone syrup. ALJ-1, at 11. The Government alleged that, on four of those occasions, the Respondent knew that CI would receive a portion of the prescribed medications. ALJ-1, at 3-4.

    A. Undercover Appointments 1 through 4

    The evidence against the Respondent regarding the first four undercover appointments is significant, conclusive, and uncontested.

    The Respondent compared his diversion of drugs to CI with going to “buy drugs at a crack house.” GE-28, file 2015-04-22_13-03-23_EDT, at 2. In some sense, this was an apt description. Whenever CI asked the Respondent for drugs, he would attempt to convey them to her. Prior to each of the first four undercover appointments, CI clearly and repeatedly asked the Respondent for controlled substances.57 CI specifically named certain controlled substances that she wanted the Respondent to prescribe to Agent 1 and Agent 2 to divert to her.58 Although the Respondent wanted to be ignorant about the identities of CI's “friends,” 59 the Respondent knew that Agent 1 and Agent 2 were “friends” of CI 60 and that they would give CI at least some of the drugs he prescribed to them.61 The Respondent had reason to know that Agent 1 and Agent 2 did not legitimately need medication for themselves.62 The Respondent had reason to know that Agent 1, Agent 2, and CI were splitting their prescriptions.63 Therefore, based on the communications exchanged between the Respondent and CI, I find that the Respondent knew that Agent 1 and Agent 2 were “not seeking treatment for a legitimate medical condition but [were] engaged in . . . diversion.” See McNichol, 77 FR at 57148. Despite circumstances that plainly and unambiguously indicated diversion, the Respondent nonetheless prescribed drugs to Agent 1 and Agent 2 during the first four undercover appointments.

    57 GE-16, file 2015-03-16_18-51-48_EDT, at 20-21, 24-26 (expressing that CI was seeking drugs before the first undercover appointment); GE-16, file 2015-03-18_11-03-33_EDT, at 2 (same); GE-17, at 4 (same); see GE-16, file 2015-04-02_14-15-50_EDT, at 1 (expressing that CI was seeking drugs before the second undercover appointment, and indicating that she had taken all of the drugs from the first appointment too quickly); see also GE-28, file 2015-04-13_20-26-31_EDT, at 7 (expressing that CI was seeking more drugs before the third and fourth undercover appointments); GE-28, file 2015-04-28_20-23-38_EDT, at 1 (same); GE-38, at 2-3 (same).

    58 GE-16, file 2015-03-17_13-07-36_EDT, at 4 (asking for Lorcet/Norco before the first undercover appointment); GE-17, at 3 (same); GE-18, at 3 (asking for Norco before the first undercover appointment); see GE-16, file 2015-04-02_15-04-43_EDT, at 1-2 (asking for a double dosage, presumably of Norco, before the second undercover appointment); see also GE-28, file 2015-04-28_20-23-38_EDT, at 1 (asking for cough medicine before the third and fourth undercover appointments); GE-29, at 7 (same); GE-38, at 3-4 (asking for a “big bottle” of cough syrup before the third and fourth undercover appointments); GE-39, at 5 (asking for cough medicine before the third and fourth undercover appointments).

    59 GE-28, file 2015-04-22_13-03-23_EDT, at 4-5 (expressing his desire to remain ignorant before the third and fourth undercover appointments); GE-28, file 2015-04-27_14-45-16_EDT, at 1 (same); GE-38, at 2 (same). The Respondent even stated at one point, “if [Agent 1 is] coming in for what I think she's coming in, tell her not to tell me that. That needs to be your secret. I don't wanna know that. She needs to have a headache and I will treat her for a headache, and so don't mind giving her prescriptions to treat a headache.” GE-17, at 7.

    60 GE-16, file 2015-04-07_13-29-34_EDT, at 2 (discussing CI accompanying Agent 1 to her appointment); GE-16, file 2015-04-07_18-28-45_EDT, at 7-8 (same); GE-16, file 2015-04-08_10-16-03_EDT, at 1 (saying that Agent 1 knew about their relationship); GE-17, at 6-7 (identifying Agent 1 before the first undercover appointment); GE-21, at 5-6 (identifying Agent 1 before the second undercover appointment); see GE-21, at 8 (asking the Respondent to bring Agent 1's prescriptions to his rendezvous with CI at Walmart to save her money); see also GE-28, file 2015-04-22_13-03-23_EDT, at 4-5 (recognizing Agent 1 as CI's friend before the third and fourth undercover appointments); GE-28, file 2015-04-28_20-23-38_EDT, at 1 (identifying Agent 1 and Agent 2 as CI's friends before the third and fourth undercover appointments); GE-40, at 2 (recognizing that, at the time of Agent 2's appointment, the Respondent knew that Agent 2 was affiliated with CI and Agent 1).

    61 GE-16, file 2015-03-18_11-03-33_EDT, at 2-4 (suggesting that CI could send a friend in to get prescriptions before the first undercover appointment); GE-17, at 3 (same, and acknowledging, before the first undercover appointment, that any prescriptions to CI's friends would be diverted to CI); GE-17, at 7 (advising that the prescriptions he gave to Agent 1 would be fine for CI to take); GE-18, at 3 (stating, before the first undercover appointment, that the Respondent would write prescriptions for Agent 1 so CI could have the medication); see GE-14, at 1 (identifying Agent 1 as CI's friend, and discussing how the Respondent “hooked [CI] up,” before the second undercover appointment); GE-16, file 2015-04-02_14-15-50_EDT, at 1-2 (same); GE-21, at 13 (thanking the Respondent for “hooking” her up before the second undercover appointment); GE-28, file 2015-04-28_20-23-38_EDT, at 1 (asking the Respondent to “[h]ook” up CI's friend before the third and fourth undercover appointments).

    62E.g., GE-16, file 2015-04-02_14-15-50_EDT, at 2; GE-16, file 2015-04-02_15-04-43_EDT, at 1-2.

    63 GE-28, file 2015-04-27_14-45-16_EDT, at 1.

    Even beyond this, the Respondent took extra efforts to facilitate the diversion of drugs to CI. The Respondent discussed the scheduling of Agent 1 and Agent 2's appointments with CI, and CI reminded him about the timing of those appointments.64 The Respondent asked CI to tell her friends to pretend they had headaches and act like legitimate patients.65 After the third and fourth undercover appointments, the Respondent praised Agent 1 and Agent 2 for acting very appropriately by going “through the motions.” GE-40, at 2. After each of the first four appointments, CI told the Respondent that she had received the drugs prescribed to Agent 1 and Agent 2; in response, the Respondent stated that he was happy to help get drugs to CI.66

    64 GE-18, at 3 (discussing the first undercover appointment); GE-23 (discussing, before the second undercover appointment, the need to space out the appointments more); see GE-16, file 2015-04-06_20-59-35_EDT, at 2 (discussing the second undercover appointment); see also GE-28, file 2015-04-22_10-28-41_EDT, at 3-4 (discussing the third and fourth undercover appointments); GE-28, file 2015-04-22_13-03-23_EDT, at 4 (same); GE-28, file 2015-04-28_20-23-38_EDT, at 1 (same); GE-29, at 7 (same).

    65 GE-18, at 3 (instructing CI to tell Agent 1 to “play it straight” and tell him what he needed to write in his chart at the first undercover appointment).

    66 GE-14, at 1 (telling CI, after the first undercover appointment, that he was happy to meet Agent 1 and hoped it helped, and receiving thanks from CI for “hooking” her up); GE-14, at 2 (acknowledging that the prescriptions that he gave to Agent 1 went to CI); GE-19, at 1 (asking CI if everything “went smooth with getting your medication” and expressing that he was happy to help); GE-40, at 1-2 (asking CI if she got the medication and expressing that he was “glad all that worked out”).

    It is true that the Respondent conducted appointments with Agents 1 and 2, and wrote notes in their medical files. In that aspect, this case is similar to Robert F. Hunt, D.O., 75 FR 49995 (2010). Dr. Hunt had said that he wrote information on a patient's chart “just to cover [his] ass.” Id. at 50003. The DEA held that this statement made it “clear that [Dr. Hunt] knew that he lacked a legitimate medical purpose for prescribing” controlled substances. Id. Similarly, although the Respondent conducted appointments with Agents 1 and 2 and wrote notes in their medical files, the Respondent's statements to CI before and after each of the first four appointments made it clear that the Respondent was unquestionably prescribing controlled substances to Agents 1 and 2 to intentionally divert drugs to CI. His statements also make clear that the records he was keeping concerning Agents 1 and 2 were merely to keep the Mississippi Board investigators at bay. E.g., GE-18, at 3.

    Moreover, the fact that a registrant conducted a medical appointment before prescribing controlled substances does not, standing by itself, validate the prescriptions issued; rather, an appointment may be used by a prescriber as “a sham justification to support an unlawful prescription.” McNichol, 77 Fed. Reg. at 57148. An appointment can constitute a perfunctory, sham examination if the registrant “already agreed to issue” certain prescriptions to a patient. Darryl J. Mohr, M.D., 77 Fed. Reg. 34998, 35000 (2012).

    This is precisely what happened here. Before each of the first four undercover appointments, the record unambiguously shows that the Respondent knew exactly what he would prescribe to Agents 1 and 2 before they ever walked through his door, because he knew what drugs CI had requested. For example, the Respondent prescribed Hycodan to Agent 1, even though she was not coughing during her appointment, because he had told CI that he would get eight ounces of cough syrup to her. GE-33, at 1; GE-38, at 3-4, 8; Tr. 113. Following the second appointment, the Respondent himself acknowledged the sham nature of the appointment; he stated that he had made small talk with Agent 1 because “we had to be in there more than ten seconds” so that his “nosy nurse” would not think, “[d]ang, why is this appointment over with in ten seconds?” GE-27, at 1, 5. It is not surprising that, during Agent 1's second appointment, the Respondent did not bother to conduct even a sham physical examination. See GE-24-25; Tr. 103-04, 132.

    The facts of this case present an appalling and flagrant disregard of a registrant's duty to prescribe controlled substances only to legitimate patients. While the Respondent told CI that his feelings fo